CN114557762A

CN114557762A - Medical device, medical system, and control method therefor

Info

Publication number: CN114557762A
Application number: CN202210181669.XA
Authority: CN
Inventors: 刘沛丰; 赵若衡; 常兆华; 岳斌; 姚映忠
Original assignee: Shanghai Minimally Invasive Medical Technology Co ltd
Current assignee: Shanghai Minimally Invasive Medical Technology Co ltd
Priority date: 2022-02-25
Filing date: 2022-02-25
Publication date: 2022-05-31

Abstract

The invention relates to a medical device, a medical system and a control method thereof. The medical device comprises a medical device body, a conductive cavity, an energy generation component and an energy focusing component; the conductive cavity is arranged at the far end of the medical device body and used for storing a conductive medium; the energy generation component comprises at least one electrode pair, and the at least one electrode pair is arranged in the conductive cavity; the medical device body is configured to: a pulse connected to a high voltage source to cause an arc, forming a vapor bubble and a target shock wave in sequence between at least one electrode pair disposed within the conductive cavity; the energy focusing component is arranged at the near end of the medical device body and is used for focusing the target shock wave so as to increase the intensity of the target shock wave when reaching the target lesion area. The medical device can cause the target lesion area to be cracked and loose plaques, so that the medical device can quickly pass to the far end of the target lesion area.

Description

Medical device, medical system, and control method therefor

Technical Field

The invention relates to the field of medical instruments, in particular to a medical device, a medical system and a control method thereof.

Background

Chronic Total Occlusion (CTO) of coronary artery is one of the difficulties of current interventional therapy, successful opening of CTO lesion can relieve angina symptoms of a patient, improve left ventricular function, stabilize electrical activity of cardiac muscle, and further enhance tolerance of the patient to future coronary events, so that CTO blood vessels are effectively opened, and the benefit is obvious.

Therefore, how to improve the success rate of CTO lesion interventional therapy is a problem that needs to be solved at present.

Disclosure of Invention

In view of the above, it is necessary to provide a medical device, a medical system, and a control method thereof, in order to address the above-described disadvantages in the background art.

According to some embodiments, a medical device is provided that includes a medical device body, a conductive lumen, an energy generating component, and an energy focusing component; wherein,

the conductive cavity is arranged at the far end of the medical device body and used for storing a conductive medium;

the energy generating component comprises at least one electrode pair, and at least one electrode pair is arranged in the conductive cavity;

the medical device body is configured to: a pulse connected to a high voltage source to cause an arc, sequentially forming a vapor bubble and a target shock wave between at least one of the electrode pairs disposed within the conductive cavity;

the energy focusing component is arranged at the proximal end of the medical device body and used for focusing the target shock wave so as to increase the strength of the target shock wave when reaching the target lesion area.

According to the medical device provided by the embodiment, the electric arc is caused by connecting the medical device body to the pulse of the high-voltage source, so that the molecules in the conductive medium in the gap of the electrode are ionized and are broken down by the current to form the plasma; as the conductive medium is broken down, a discharge channel is generated, and meanwhile, the discharge resistance is small, so that a large discharge current is generated; the discharge current is capable of heating the conductive medium surrounding the discharge channel, causing the conductive medium to expand rapidly outward and form a vapor bubble, and a target shock wave. The target shock wave can actively cause the target focus area to generate fragmentation and loose plaque, so that the medical device can rapidly pass to the far end of the target focus area; furthermore, the medical device can reach the far end of the target focus area quickly, so that the operation time is shortened, various complications of a patient caused by long-time operation can be reduced, and the success rate of interventional therapy of the target focus area is improved. The medical device provided in the above embodiment further increases the intensity of the target shockwave in the direction of the distal target lesion region by arranging the energy focusing component to enable the target shockwave to be directionally focused to a more distant position.

In one embodiment, each of the electrode pairs comprises a positive electrode and a negative electrode; in at least one of the electrode pairs, the positive electrode is disposed opposite the negative electrode.

In one embodiment, the positive electrode and the negative electrode each include a connection region; the connection region surface of the positive electrode and the connection region surface of the negative electrode are insulated from each other.

In one embodiment, each of the electrode pairs comprises a positive electrode and a negative electrode; in at least one of the electrode pairs, the body of the positive electrode passes through the geometric center of the body of the negative electrode in the direction of extension thereof.

In one embodiment, the energy focusing component is positioned on the outer contour of the negative electrode and is provided with a concave reflecting surface; the concave reflecting surface is curved in a direction surrounding the end of the positive electrode.

In one embodiment, the concave reflective surface has a focal point;

the focus of the concave reflecting surface is positioned on the positive electrode corresponding to the concave reflecting surface; or

The focus of the concave reflecting surface is positioned on the extension line of the positive electrode corresponding to the concave reflecting surface.

In one embodiment, the focal point at the proximal end of the concave reflective surface is located between the concave reflective surface and the end of the positive electrode;

the focus of the proximal end of the concave reflecting surface is coincided with the end part of the positive electrode.

In one embodiment, the shape of the positive electrode corresponding to the concave reflective surface comprises a sphere or a hemisphere.

In one embodiment, in the electrode pair in which the body of the positive electrode passes through the geometric center of the body of the negative electrode in the extending direction thereof, there is an electrode insulating layer between the positive electrode and the negative electrode.

Based on the same inventive concept, the present application also provides according to some embodiments a medical system comprising a medical device as provided in any of the above embodiments, and a shock wave control device;

the shock wave control device is connected with at least one electrode pair of the medical device through a lead and is used for connecting the medical device body to a pulse of a high voltage source to cause an electric arc so as to form steam bubbles and target shock waves between at least one electrode pair arranged in the conductive cavity in sequence; and controlling an output parameter of the target shockwave.

The medical system provided by the above embodiment includes the medical device in the above embodiment, so that the technical effects that the medical device can achieve can be achieved, and the medical system can also achieve, and the details are not described herein; meanwhile, the medical system provided by the embodiment can adjust the output parameters of the target shock waves through the shock wave control device, so that the output parameters of the target shock waves are highly controllable, and the treatment effect and success rate of the CTO lesion interventional therapy are further improved.

In one embodiment, each of the electrode pairs comprises a positive electrode and a negative electrode; in at least one of the electrode pairs, the positive electrode is disposed opposite the negative electrode;

the lead comprises a positive electrode lead and a negative electrode lead, the positive electrode is connected with the shock wave control device through the positive electrode lead, and the negative electrode is connected with the shock wave control device through the negative electrode lead.

In one embodiment, each of the electrode pairs comprises a positive electrode and a negative electrode;

in at least one of the electrode pairs, the body of the positive electrode passes through the geometric center of the body of the negative electrode in the direction of extension thereof;

the lead comprises a composite lead, the central part of the composite lead is connected with the positive electrode, and the peripheral part of the composite lead is connected with the negative electrode;

the positive electrode and the negative electrode are both connected with the shock wave control device through the composite lead.

In one embodiment, in the electrode pair in which the positive electrode passes through the negative electrode, an electrode insulating layer is provided between the positive electrode and the negative electrode, and the electrode insulating layer covers a central portion of the composite wire.

Based on the same inventive concept, the present application further provides, according to some embodiments, a control method of a medical system as provided in any of the above embodiments, including:

acquiring a starting instruction;

processing the starting instruction to obtain an adjusting instruction, wherein the adjusting instruction is used for adjusting the output parameters of the target shock wave;

and processing the adjusting instruction to obtain a control instruction, wherein the control instruction is used for controlling the medical system to generate the target shock wave corresponding to the output parameter.

The control method provided by the above embodiment is applied to the medical system in the above embodiment, so that the technical effects that the medical system can achieve can be achieved, and the control method can also be achieved, and is not described in detail here.

In one embodiment, the output parameters include vibrational modes and/or pulse modes of the output.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments or the conventional technologies of the present application, the drawings used in the descriptions of the embodiments or the conventional technologies will be briefly introduced below, it is obvious that the drawings in the following descriptions are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic view of an axial cross-sectional configuration of a medical device provided in accordance with an embodiment of the present application;

FIG. 2 is an enlarged schematic view of an axial cross-sectional configuration of a medical device provided by one embodiment of the present application;

FIG. 3 is a schematic view of a medical device according to an embodiment of the present disclosure operating in a focal region;

FIG. 4 is a schematic illustration of an outer diameter configuration of a medical device body in a medical device provided by some embodiments of the present application;

FIG. 5 is a schematic diagram of the structure of a positive electrode and a negative electrode in a medical device according to one embodiment of the present application;

FIG. 6 is a schematic side view of an arrangement of positive and negative electrodes in a medical device according to one embodiment of the present application;

FIG. 7 is a schematic diagram of the arrangement of positive and negative electrodes in a medical device according to one embodiment of the present application;

FIG. 8 is a schematic side view of an arrangement of positive and negative electrodes in a medical device according to another embodiment of the present disclosure;

FIG. 9 is a schematic diagram of the arrangement of the positive and negative electrodes in the medical device according to another embodiment of the present application;

FIG. 10 is a perspective schematic view of a medical device provided in accordance with an embodiment of the present application;

FIG. 11 is a schematic representation of the geometry of an energy focusing member focusing a target shockwave in a medical device according to one embodiment of the present application;

FIG. 12 is a schematic view of a medical device according to another embodiment of the present application;

FIG. 13 is a perspective view of a medical device according to another embodiment of the present application;

FIG. 14 is a schematic geometric relationship diagram illustrating an energy focusing element focusing a target shockwave in a medical device according to another embodiment of the present application;

FIG. 15 is a schematic diagram of a medical system provided by one embodiment of the present application;

FIG. 16 is a functional schematic diagram of a medical system provided by one embodiment of the present application;

FIG. 17 is a flow chart of a method of controlling a medical system provided by one embodiment of the present application;

fig. 18 is a flow chart of a method of using a medical system provided by an embodiment of the present application.

Description of reference numerals:

10. a medical device; 11. a medical device body; 111. an outer layer of a medical device; 112. an inner shaft of a medical device; 12. a conductive cavity; 121. a conductive medium; 13. an electrode pair; 131. a positive electrode; 132. a negative electrode; 133. a connection region; 134. a polarization region; 135. an electrode insulating layer; 14. an energy focusing component; 20. a shock wave control device; 201. a power supply module; 202. a control module; 203. a processing module; 204. an adjustment module; 205. the shock wave control device is connected with the base; 206. a screen; 207. connecting a shock wave control device; 30. a wire; 301. a positive electrode lead; 302. a negative electrode lead; 303. a composite wire; 40. a handle; 50. calcifying the tissue.

Detailed Description

To facilitate an understanding of the present application, the present application will now be described more fully with reference to the accompanying drawings. Embodiments of the present application are set forth in the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

It is to be understood that "connection" in the following embodiments is to be understood as "electrical connection", "communication connection", and the like if the connected circuits, modules, units, and the like have communication of electrical signals or data with each other.

As used herein, the singular forms "a", "an" and "the" may include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises/comprising," "includes" or "including," etc., specify the presence of stated features, integers, steps, operations, components, parts, or combinations thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, components, parts, or combinations thereof. Also, as used in this specification, the term "and/or" includes any and all combinations of the associated listed items.

The pathological and imaging researches prove that most of CTO lesions have forward or reverse collateral circulation, so that the distal end of an occluded blood vessel section keeps certain blood supply, but even if the collateral circulation is fully established, the function of the CTO lesions is only equivalent to that of 90 percent of stenotic blood vessels, the myocardial survival and the blood supply of hibernating myocardium under the resting condition can be only reluctantly maintained, and when the oxygen consumption of the myocardium is increased, the patient has myocardial ischemia symptoms such as angina pectoris, exercise tolerance and the like; successful opening of CTO lesions can relieve angina pectoris symptoms of patients, improve left ventricular function, stabilize electrical activity of cardiac muscle, and further enhance tolerance of patients to future coronary events, so that CTO vessels are effectively opened, and the benefit is obvious.

CTO lesions account for about 30% of all coronary lesions, compared with common complex lesions, the success rate of CTO lesion surgery is low, the incidence rate of complications is high, along with the improvement of interventional devices, the accumulation of experience and the new knowledge of CTO lesion theory, the success rate of CTO is improved in recent years, the success rate of CTO of a plurality of large international intervention centers is more than 90%, but the overall success rate is still required to be further improved; therefore, how to improve the success rate of CTO lesion interventional therapy is a problem which needs to be solved at present.

Analyzing the factors for CTO failure, the guidewire failed (by about 63% to 92%) to pass through the high-lying first, including failing to penetrate the occluding proximal/distal fibrous cap, into the false lumen or puncture; secondly, the inability of the balloon to pass (about 10%), and finally the inability to dilate the lesion (5%); therefore, the successful opening of the CTO lesion is inseparable from the successful selection and application of the guide wire. In addition, the general operation time of the CTO intravascular interventional open treatment is long, the dosage of the contrast agent is large, the X-ray exposure is large, the risks of complications such as nephropathy of the contrast agent, radioactive skin damage, cerebral hemorrhage and the like of a patient can be increased, and the health of a patient who is engaged in the CTO intravascular interventional open treatment for a long time is also adversely affected; therefore, there is a need for shortening the operation time, reducing the amount of contrast agent and X-ray exposure by technical improvement; common technologies for opening CTO lesions include a forward guide wire opening technology and a reverse guide wire opening technology; generally, the anterior guidewire technique is preferred for opening CTO lesions because it is generally relatively safe, while the retrograde guidewire technique is only applied as a secondary option after the failure of the anterior guidewire technique because the operation time is long, the radiation exposure is large, the application of contrast agents is numerous, and complications are likely to occur; however, the current guide wire realizes the characteristics of thin diameter, hard head end and the like through materials and structures to pass through CTO lesions with serious calcification and hard fiber cap, has higher operation requirements on operators, and does not have a guide steel wire to meet the interventional therapy of various chronic totally-occluded lesions. At present, a guide wire with the ability of rapidly penetrating CTO pathological changes is needed, so that the success rate of the operation is greatly improved, the operation time is reduced, a better treatment effect is provided for a patient, and meanwhile, the guide wire is beneficial to the health of an operator.

In view of the above, the present application provides, according to some embodiments, a medical device; fig. 1 to 3 are schematic views showing an axial sectional structure of a medical device 10 in fig. 1, an enlarged view showing the axial sectional structure of the medical device 10 in fig. 2, and a schematic view showing an operation principle of the medical device 10 at a focal region in fig. 3; in particular, in some embodiments, the medical device 10 may be used to provide a "track" for a balloon, stent, ultrasonic medical device, or rotational atherectomy tip, or other instrument that subsequently enters a vessel in the region of a target lesion, through a coronary stenosis or occlusion to the distal end of the vessel.

The medical device 10 may include a medical device body 11, a conductive cavity 12, an energy generating component, and an energy focusing component 14. Wherein, the conductive cavity 12 can be disposed at the distal end of the medical device body 11 for storing the conductive medium 121; the energy generating means comprise at least one pair of electrodes 13, the at least one pair of electrodes 13 being arranged in the electrically conductive cavity 12; the medical device body 11 may be configured to: a pulse connected to a high voltage source to cause an arc, sequentially forming a vapor bubble and a target shock wave between at least one electrode pair 13 disposed within the conducting chamber 12, the target shock wave operable to destroy a target lesion area such that the target lesion area allows passage of an instrument; the energy focusing component 14 is disposed at the proximal end of the medical device body 11 for reflecting the target shockwave to increase the intensity of the target shockwave when it reaches the target lesion.

Note that, in the present application, the distal end of the medical device body 11 refers to an end of the medical device body 11 near the target lesion area; correspondingly, the proximal end of the medical device body 11 refers to the end of the medical device body 11 away from the target lesion area.

It should be noted that the voltage value of the high-voltage source pulse connected to the medical device body 11 is not particularly limited in the present application, and the voltage value of the high-voltage source pulse may be adaptively set according to the actual operating condition.

Unlike the conventional guiding guide wire, which requires the operator to select the guide wire for different target lesion areas and skilled operation skill to determine whether the interventional operation can be successful, the medical device 10 of the above embodiment causes an electric arc by connecting the medical device body 11 to the pulse of the high voltage source, so that molecules in the conductive medium 121 are ionized in the gap of at least one electrode pair 13 and are broken down by the current to form plasma; as the conductive medium 121 is broken down, a discharge channel is generated, and meanwhile, the discharge resistance is small, so that a large discharge current is generated; the discharge current can heat the conductive medium 121 around the discharge channel, causing the conductive medium 121 to expand rapidly outward and form a vapor bubble, and a target shock wave. The target shock wave can actively cause the target lesion area to be cracked and loosened so that the medical device 10 can rapidly pass to the far end of the target lesion area; furthermore, the medical device 10 can reach the far end of the target focus area quickly, so that the operation time is shortened, various complications of a patient caused by long-time operation can be reduced, the success rate of interventional therapy of the target focus area is improved, the X-ray exposure time of an operator can be reduced, and the influence on the health of the operator is reduced.

The medical device 10 provided in the above embodiment further increases the intensity of the target shockwave in the direction of the distal target lesion region by disposing the energy focusing member 14 so that the target shockwave can be reflected directionally to a more distant position.

The form of the target focus area is not particularly limited, and can be any area with calcified tissues; illustratively, the target lesion area may include, but is not limited to, calcified lesions and chronic occlusions of coronary, peripheral and intracranial vessels.

Meanwhile, the medical device 10 provided by the above embodiment seals the conductive medium 121 and the electrode pair 13 inside, so that the problems of complications and the like caused by the discharge of the electrode pair 13 in blood are prevented, and the safety of the product is improved. Further, enclosing the conductive medium 121 and the electrode pair 13 inside also reduces the required outer diameter of the medical device 10, reducing the volume of the medical device 10.

It is to be understood that the number of the electrode pairs 13 included in the energy generating unit is not particularly limited.

The length of the medical device body 11 is not particularly limited, and the length of the medical device body 11 can be adaptively selected according to actual use requirements; in one embodiment, the length of the medical device body 11 may be 1.3m to 3.5m, for example, the length of the medical device body 11 may be 1.3m, 1.7m, 2.5m, 3m, or 3.5m, etc.; illustratively, when the medical device 10 is used in the coronary field, the length of the medical device body 11 may be 1.7 m; when the medical device 10 is used for a peripheral blood vessel of the lower limb, the length of the medical device body 11 may be 3 m.

The size of the axial outer diameter of the medical device body 11 is not particularly limited, and the outer diameter of the medical device body 11 can be adaptively selected according to actual use requirements; in one embodiment, the outer diameter of the medical device body 11 may be 0.8mm to 2mm, for example, the outer diameter of the medical device body 11 may be 0.8mm, 1.2mm, 1.5mm, 2mm, or the like; in one embodiment, the medical device body 11 has an outer diameter of 1.5mm, which allows sufficient intravascular pushing performance while achieving a small through outer diameter.

Meanwhile, the axial outer diameter of the medical device body 11 may be constant, as shown in (a) of fig. 4; different reducing effects can be formed according to actual needs, and for example, the axial outer diameter of the medical device body 11 can be uniformly reduced, as shown in (b) of fig. 4; it is also possible to uniformly reduce the diameter of the proximal end while the distal end of the medical device body 11 has the same outer diameter, as shown in fig. 4 (c).

The structure of the medical device body 11 is not particularly limited in the present application; in one embodiment, with continued reference to fig. 1, the medical device body 11 may include a medical device outer layer 111 and a medical device inner shaft 112.

In this case, the medical device outer layer 111 may play a role of filling the internal space, protecting the internal structure, supporting the medical device body 11, and the like.

The material of the outer layer 111 of the medical device is not specifically limited in the present application, and those skilled in the art can select and/or combine the material of the outer layer 111 of the medical device adaptively according to the selection and/or the overall outer diameter of the inner shaft 112 of the medical device, and the compliance and the pushing performance can be improved while the generation of the target shock wave is realized through the combination of different materials.

Illustratively, the medical device outer layer 111 may be constructed using any one or a blend of materials including, but not limited to, polyamide, polyurethane, polysulfone, poly-p-phenylene terephtalate (PET), and/or block polyether amide resin (PEBAX).

Illustratively, the material of the outer layer 111 of the medical device may have a positive stress elastic modulus in the range of 100MPa to 3000MPa, which not only achieves a better positive stress rigidity, but also reduces the rigidity of the shear stress; for example, the medical device outer layer 111 material can have a positive stress modulus of elasticity of 100MPa, 500MPa, 1100MPa, 2000MPa, 3000MPa, or the like. In one embodiment, it is suggested to use a material with a positive stress elastic modulus of 1100MPa for the medical device outer layer 111. Illustratively, the Shore hardness (Shore hardness) of the medical device outer layer 111 material may be in the range of 55D to 120D, e.g., the Shore hardness of the medical device outer layer 111 material may be 55D, 75D, 95D, or 120D, etc.

When viewed from the axial direction, the material composition of the outer layer 111 of the medical device can be adjusted, or materials with different hardness can be selected; for example, in one embodiment, a harder material may be used at the proximal end of the medical device outer layer 111 and a softer material may be used at the distal end of the medical device outer layer 111 to ensure adequate pushability of the medical device 10.

It will be appreciated that the volume of the conductive cavity 12 will be determined by the outer diameter of the medical device body 11.

In one embodiment, the volume of the conductive cavity 12 may be such that: the single wall thickness of the medical device body 11 wrapped around the conductive cavity 12 is larger than 0.1mm, so that the pushing performance of the medical device 10 can be ensured, and the problems of liquid leakage or breakage and the like of the conductive cavity 12 in the using process can be avoided, for example, the single wall thickness of the medical device body 11 wrapped around the conductive cavity 12 can be 0.1mm, 0.15mm, 0.2mm, 0.25mm or 0.3mm and the like. Too large a single wall thickness may prevent the electrode pairs 13 inside the conducting cavity 12 from functioning properly.

Meanwhile, the shape of the conductive cavity 12 is not particularly limited in this application. In one embodiment, the conductive cavity 12 is cylindrical in shape, which maximizes the volume of the interior cavity of the conductive cavity 12.

The selection of the conductive medium 121 is not particularly limited in the present application; the selection of the conductive medium 121 includes a polar solution and a non-polar solution.

In polar solution, for example, the conductive medium 121 can be purified water, physiological saline or hydrogel (e.g., polyvinylpyrrolidone, agar or polyvinyl alcohol), etc.; in the non-polar solution, the conductive medium 121 may be, for example, but not limited to, silicone.

In one embodiment, the conductive medium 121 comprises deionized water, which increases the dielectric constant to increase the targeted shock wave formed when the conductive medium 121 is broken down; in another possible embodiment, the conductive medium 121 comprises a 7.5% sodium chloride aqueous solution.

Referring to fig. 10 in conjunction with fig. 1-2, in one embodiment, an energy focusing element 14 is disposed on a side of the electrode pair 13 near the proximal end of the medical device body 11 for focusing the target shockwave to increase the intensity of the target shockwave reaching the target lesion area.

The medical device 10 provided in the above embodiment increases the intensity of the target shockwave in the direction of the distal lesion by arranging the energy focusing member 14 so that the target shockwave can be directionally focused to a more distant position.

It will be appreciated that in order to enable the targeted shockwave to be directionally focused to a more remote location, the energy focusing means 14 should be located at least to one side of the pair of electrodes 13 within the conducting cavity 12; when the energy generating component includes more electrode pairs 13, the relative position relationship between the energy focusing component 14 and the electrode pairs 13 outside the conductive cavity 12 is not particularly limited.

The specific form of the energy focused by the energy focusing element 14 is not limited in the present application, as long as it can focus the target shockwave to increase the intensity of the target shockwave when it reaches the target focal region; in some possible embodiments, the energy focusing element 14 may include a shockwave reflecting structure for achieving directional focusing of the target shockwave in a reflected manner, increasing the intensity of the target shockwave in the direction of the distal lesion.

With continued reference to FIG. 10, in one embodiment, the shock wave reflecting structure may include at least one concave reflecting surface that may be curved in a direction to surround the ends of the electrode pair 13. Therefore, not only can the directional reflection of the target shock wave be realized, but also the strength of the target shock wave in the direction of the far-end focus can be further increased.

It is understood that the above-mentioned structure is only an example, and the focusing form and shape of the energy focusing component 14 are not limited to the above-mentioned example in practical cases.

In the present application, the end of the electrode pair 13 refers to an end of the electrode pair 13 close to the target lesion region.

Referring to fig. 11, in one embodiment, the energy focusing element 14 has an axisymmetric structure; the midpoint of the line connecting the positive electrode 131 and the negative electrode 132 falls on the axis of symmetry of the energy focusing member 14.

In one embodiment, the energy focusing element 14 has a focal point.

With continued reference to fig. 11, aa 'in fig. 11 represents the axis of symmetry of the energy focusing element 14, the dashed arc in fig. 11 represents the imaginary portion of the energy focusing element 14 that does not actually exist, point F1 in fig. 11 represents the focal point at the proximal end of the energy focusing element 14, and point F1' in fig. 11 represents the focal point at the distal end of the energy focusing element 14.

Note that, in the present application, the proximal end of the energy focusing member 14 refers to an end near the proximal end of the medical device body 11; correspondingly, the distal end of the energy focusing member 14 refers to the end near the distal end of the medical device body 11.

As shown in fig. 11, the midpoint of the line connecting the positive electrode 131 and the negative electrode 132 may coincide with the focal point F1 at the proximal end of the energy focusing member 14. In this manner, a portion of the target shockwave emitted from point F toward the proximal end of the medical device body 11 may be reflected by the energy focusing member 14 and propagated distally in a parallel manner in accordance with the rigid propagation of the wave.

The focal length of the energy focusing element 14 is not particularly limited in this application; in one embodiment, the focal length of the energy focusing element 14 may be 1mm to 3mm, for example, the focal length of the energy focusing element 14 may be 1mm, 1.5mm, 2mm, 2.5mm, or 3 mm.

The electrode pair 13 referred to in the present application is explained in more detail below:

with continued reference to fig. 1, in one embodiment, each electrode pair 13 may include a positive electrode 131 and a negative electrode 132; in at least one electrode pair 13, the positive electrode 131 is disposed opposite to the negative electrode 132.

It should be understood that in the electrode pair 13 where the positive electrode 131 is disposed opposite the negative electrode 132, the spatial relationship of the positive electrode 131 and the negative electrode 132 may be reversed, other than the orientation shown in fig. 1, without affecting the disposition of any function or structure of the medical device 10.

The materials of the positive electrode 131 and the negative electrode 132 are not particularly limited, and metal materials with good corrosion resistance and good conductivity can be selected; illustratively, the materials of the positive electrode 131 and the negative electrode 132 may include, but are not limited to, pure metals or alloys of tungsten, platinum, and/or gold.

In one embodiment, the positive electrode 131 and the negative electrode 132 are made of platinum-iridium alloy, so that the positive electrode and the negative electrode can achieve better corrosion resistance.

The arrangement of the positive electrode 131 and the negative electrode 132 is not particularly limited in this application, and the positive electrode 131 and the negative electrode 132 may be designed symmetrically or asymmetrically.

As shown in fig. 5, in one embodiment, the positive electrode 131 and the negative electrode 132 may each include a connection region 133, and the surface of the connection region 133 of the positive electrode 131 and the surface of the connection region 133 of the negative electrode 132 are insulated from each other.

In the medical device 10 provided in the above embodiment, the surface of the connection region 133 of the positive electrode 131 and the surface of the connection region 133 of the negative electrode 132 are insulated from each other, so that it is possible to prevent an uncontrolled electrical breakdown from occurring in advance between the positive electrode 131 and the negative electrode 132 which are in close contact.

It should be noted that the manner of insulating the surface of the connection region 133 of the positive electrode 131 and the surface of the connection region 133 of the negative electrode 132 from each other is not particularly limited in the present application. For example, in one embodiment, the surface of the connection region 133 of the positive electrode 131 and the surface of the connection region 133 of the negative electrode 132 are both covered with an electrode insulation layer, which can be used to electrically insulate the surface of the connection region 133 of the positive electrode 131 from the surface of the connection region 133 of the negative electrode 132.

With continued reference to fig. 5, in one embodiment, the positive electrode 131 and the negative electrode 132 may further include a polarized region 134, and there is no division between the polarized region 134 and the connecting region 133.

In one embodiment, the polarized region 134 of the positive electrode 131 is disposed opposite the polarized region 134 of the negative electrode 132.

When the polarized region 134 of the positive electrode 131 and the polarized region 134 of the negative electrode 132 are disposed opposite to each other, due to the relatively large acoustic impedance of the positive electrode 131 and the negative electrode 132, the medical device 10 provided in the above embodiment can play a role in restricting the target shock waves spreading to both sides, reduce the influence on non-focal tissues, enable the target shock waves to propagate along the axial direction, and achieve good directional guidance for the transmission of the target shock waves.

For example, as shown in fig. 6 and 7, the positive electrode 131 and the negative electrode 132 may be two concentric arcs that are mirror symmetric; fig. 6 is a schematic side view of the arrangement of the positive electrode 131 and the negative electrode 132, and fig. 7 is a schematic perspective view of the arrangement of the positive electrode 131 and the negative electrode 132.

For example, as shown in fig. 8 and 9, the positive electrode 131 and the negative electrode 132 may also be two parallel plates; fig. 8 is a schematic side view of the arrangement of the positive electrode 131 and the negative electrode 132, and fig. 9 is a schematic perspective view of the arrangement of the positive electrode 131 and the negative electrode 132. This arrangement of the electrode pair 13 enables the positive electrode 131 and the negative electrode 132 to have a larger pole-opposing area, so that the energy of the target shock wave formed when the conductive medium 121 in the gap between the positive electrode 131 and the negative electrode 132 is broken down is larger.

The thickness of the positive electrode 131 and the negative electrode 132 is not particularly limited, and the thickness of the positive electrode 131 and the negative electrode 132 can be 0.05 mm-0.5 mm to ensure the charge capacity of the capacitor; for example, the positive electrode 131 and the negative electrode 132 may each have a thickness of 0.05m, 0.1mm, 0.2mm, 0.35mm, or 0.5mm, among others.

In the present application, the formation manner of the connection region 133 and the polarization region 134 is not particularly limited, as long as there is no division between the connection region 133 and the polarization region 134. Illustratively, the connecting region 133 and the polarization region 134 may be formed by, but not limited to, integral injection molding or conventional metal machining such as turn milling.

In addition, the length of the conductive cavity 12 is not specifically limited in the present application; in one embodiment, the length of the conductive cavity 12 may be 0.5mm to 2.5mm, for example, the length of the conductive cavity 12 may be 0.5mm, 0.75mm, 1.2mm, 2mm, or 2.5 mm. Too long a conductive cavity 12 can interfere with the installation of the energy focusing element 14, and too short a conductive cavity 12 can interfere with the installation of the positive and

negative electrodes

131, 132.

It is understood that in other possible embodiments, the positive electrode 131 and the negative electrode 132 may also be designed asymmetrically.

Referring to fig. 12, in one embodiment, in at least one electrode pair 13, the body of the positive electrode 131 passes through the geometric center of the body of the negative electrode 132 along the extending direction.

Specifically, as shown in fig. 12, each of the positive electrode 131 and the negative electrode 132 may include a connection region 133, the connection region 133 of the positive electrode 131 and the negative electrode 132 are insulated from each other, and the connection region 133 of the positive electrode 131 passes through the center of the negative electrode 132.

It should be noted that the manner of insulating the surface of the connection region 133 of the positive electrode 131 and the negative electrode 132 from each other is not particularly limited in the present application. For example, as shown in fig. 12, in one embodiment, the surface of the connection region 133 of the positive electrode 131 may be covered with an electrode insulation layer 135, and the electrode insulation layer 135 may be used to achieve electrical insulation between the surface of the connection region 133 of the positive electrode 131 and the negative electrode 132.

Referring to fig. 13, in one embodiment, the energy focusing element 14 is located on the outer contour of the negative electrode 132 and has a concave reflective surface; the concave reflecting surface is curved in a direction to surround the end of the positive electrode 131.

In the medical device 10 provided in the above embodiment, the energy focusing component 14 is located on the outer contour of the negative electrode, so that the negative electrode function and the shock wave focusing function can be combined, and the purpose of simplifying the structural design of the medical device 10 is achieved.

The shape of the concave reflecting surface is not particularly limited in the present application; in one embodiment, the concave reflective surface can comprise a concave shape having a focal point; for example, the concave reflecting surface may be a partial spherical surface, a partial ellipsoidal surface, a paraboloidal surface, or the like.

Referring to fig. 14 in conjunction with fig. 13, bb 'in fig. 14 represents the axis of symmetry of the concave reflecting surface of the negative electrode 132, the dashed arc in fig. 14 represents the imaginary portion of the concave reflecting surface that does not actually exist, point F2 in fig. 14 represents the focal point at the proximal end of the concave reflecting surface, and point F2' in fig. 11 represents the focal point at the distal end of the concave reflecting surface.

Note that, in the present application, the proximal end of the concave reflecting surface refers to the end near the proximal end of the medical device body 11; correspondingly, the distal end of the concave reflecting surface refers to the end near the distal end of the medical device body 11.

In one embodiment, the focal point of the concave reflective surface falls on the positive electrode 131 corresponding thereto; or an extension line of the positive electrode 131 corresponding thereto.

In one embodiment, the focal point F2 at the proximal end of the concave reflective surface coincides with the central region of the electrode pair 13, as shown in fig. 14.

In the above embodiment, the central region of the electrode pair 13 refers to the midpoint of the line connecting the end of the positive electrode 131 and the negative electrode 132 on the axis bb', i.e., the geometric midpoint position of the electrode pair 13. Specifically, in the above embodiment, the focus F2 at the proximal end of the concave reflective surface is located at the geometric midpoint of the electrode pair 13, where the central region (i.e., the focal spot) of the electrode pair 13 is at the same distance s from the negative electrode 132 on the axis bb 'and the focus F2 at the proximal end of the concave reflective surface is at the same distance F from the negative electrode 132 on the axis bb', i.e., s ═ F; this enables a large reflection angle to be maintained.

It should be noted that the end of the positive electrode 131 refers to an end of the positive electrode 131 close to the target lesion area.

It is understood that in the above-described embodiment, the relative positions of the end portions of the positive electrodes 131 and the negative electrodes 132 are relatively far.

The shape of the positive electrode 131 is not particularly limited in the present application; illustratively, the shape of the end of the positive electrode 131 may include, but is not limited to, a sphere or a hemisphere.

Specifically, in the above-described embodiment, the end of the positive electrode 131, that is, the portion for the hydro-electric reaction, may include, but is not limited to, a sphere or a hemisphere; every point on the other part of the positive electrode 131 has the same closest distance to the negative electrode 132.

With continued reference to fig. 12, in one embodiment, in the electrode pair 13 in which the body of the positive electrode 131 passes through the geometric center of the body of the negative electrode 132 along the extending direction thereof, an electrode insulating layer 135 is disposed between the positive electrode 131 and the negative electrode 132.

In the medical device provided by the above embodiment, the electrode insulating layer 135 may be used to achieve electrical insulation between the positive electrode 131 and the negative electrode 132.

Based on the same inventive concept, the present application also provides a medical system according to some embodiments.

Referring to fig. 15, the medical system may include a medical device 10 as provided in any of the previous embodiments, and a shock wave control device 20.

Specifically, the shock wave control device 20 is connected to at least one electrode pair 13 of the medical device 10 via a lead 30, and can be used to connect the medical device body 11 to a pulse of a high voltage source to cause an electric arc, so as to sequentially form a steam bubble and a target shock wave between at least one electrode pair 13 disposed in the conductive cavity 12; and controlling an output parameter of the target shockwave.

The medical system provided in the above embodiment includes the medical device 10 in the foregoing embodiment, and therefore, the technical effects that can be achieved by the medical device 10 can be achieved by the medical system, and detailed description thereof is omitted. Meanwhile, the medical system provided in the above embodiment can be used for energy conversion, lesion positioning and energy conduction, and can also adjust the output parameters of the target shock waves through the shock wave control device 20, so that the output parameters of the target shock waves are highly controllable, and the treatment effect and success rate of CTO lesion interventional therapy are further improved.

The form of the output parameter is not specifically limited in the present application; in one embodiment, the output parameters may include, but are not limited to, vibration mode and pulse mode of the output, and the like.

In one embodiment, the wire may be wrapped inside the medical device outer layer 111 material.

With continued reference to fig. 1, in one embodiment, each electrode pair 13 may include a positive electrode 131 and a negative electrode 132; in at least one electrode pair 13, the positive electrode 131 is disposed opposite to the negative electrode 132; in this embodiment, the lead 30 may include a positive electrode lead 301 and a negative electrode lead 302, in which case, the positive electrode 131 may be connected to the shock wave control device 20 via the positive electrode lead 301, and the negative electrode 132 may be connected to the shock wave control device 20 via the negative electrode lead 302.

The material of the lead 30 is not particularly limited in the present application. In one embodiment, the wires 30 may include, but are not limited to, copper wires or silver wires, among others.

The size of the conductive wires 30 is not particularly limited in this application. In one embodiment, the wire 30 has a size of 0.03mm to 0.3mm, for example, the wire 30 may have a size of 0.03mm, 0.08mm, 0.2mm, 0.25mm, or 0.3mm, etc.

Preferably, in one embodiment, the wire 30 is a copper wire with a dimension of 0.08 mm.

With continued reference to fig. 12 and 13, in one embodiment, in at least one electrode pair 13, the body of the positive electrode 131 passes through the geometric center of the body of the negative electrode 132 along the extending direction; in the present embodiment, the wire 30 may include a composite wire 303, a central portion of the composite wire 303 being connected to the positive electrode 131, and an outer peripheral portion of the composite wire 303 being connected to the negative electrode 132; in the present embodiment, the positive electrode 131 and the negative electrode 132 are connected to the shock wave control device 20 through the composite wire 303.

In some possible embodiments, the central portion of composite wire 303 and the outer peripheral portion of composite wire 303 are insulated from each other. The manner in which the mutual insulation between the central portion of the composite wire 303 and the outer peripheral portion of the composite wire 303 is achieved is not particularly limited in the present application. In one embodiment, the surface of the inside of composite wire 303 may be covered with an electrode insulation layer that may be used to achieve mutual insulation between the central portion of composite wire 303 and the outer peripheral portion of composite wire 303.

With continued reference to fig. 12, in one embodiment, an electrode insulating layer 135 may be disposed between the positive electrode 131 and the negative electrode 132, and the electrode insulating layer 135 covers a central portion of the composite conductive line 303.

In the present embodiment, the positive electrode 131 may include the connection region 133, and the connection region 133 of the positive electrode 131 may be connected to the electrode insulating layer covered on the inner side surface of the composite wire 303 and pass through the center of the negative electrode 132.

It is to be understood that the medical device inner shaft 112 is not considered to be used based on the fact that the position of the medical device inner shaft 112 is filled by the composite wire 303.

In one embodiment, a harder polymeric material may be used throughout or at the proximal end of the medical device body 11 to ensure the pushability of the medical device 10.

Referring to fig. 16 in conjunction with fig. 15, in one embodiment, the shock wave control device 20 may specifically include a control module 202, a processing module 203, and a regulating module 204.

Specifically, the control module 202 may be configured to obtain a start instruction and send the start instruction to the processing module 203; the processing module 203 may process the start instruction to obtain an adjustment instruction, and send the adjustment instruction to the adjusting module 204, where the adjustment instruction may be used to adjust an output parameter of the target shockwave; the adjustment module 204 may process the adjustment instructions to obtain control instructions for controlling the medical system to generate the target shockwave corresponding to the output parameter.

The form of the control module 202 is not particularly limited in this application. Illustratively, the control module 202 may include, but is not limited to, a manipulation button.

In one embodiment, the shock wave control device 20 may further include a power supply module 201.

Specifically, the power supply module 201 may be connected to some or all of the modules of the shock wave control device 20 except the power supply module 201 itself, and configured to provide stable voltage and current to other modules.

The form of the power supply module 201 is not particularly limited in the present application. Illustratively, the power supply module 201 may include, but is not limited to, a wire-type power supply or a rechargeable power supply such as a lithium battery.

In one embodiment, the adjusting module 204 may output a voltage of 0V to 3000V, and perform a pulse frequency signal of 1Hz to 100Hz through the logic signal output by the processing module 203 to intermittently generate the target shock wave.

With continued reference to FIG. 15, in one embodiment, shock wave control device 20 may further include a screen 206.

In particular, the screen 206 may be used to display product specifications, time of use, and/or other information.

With continued reference to fig. 15, in one embodiment, the medical system may further include a handle 40.

In particular, the handle 40 may be used to connect the medical device 10 to the lead 30, while facilitating actuation of the medical system; in this embodiment, the proximal end of the medical device 10 may be connected to circuitry inside the handle 40.

The manner in which the circuitry inside the handle 40 is connected to the medical device 10 is not particularly limited by the present application; illustratively, the lead 30 may be connected to the circuitry within the handle 40 by, but not limited to, a thermal fusion weld such as a solder.

With continued reference to fig. 15, in one embodiment, the medical system may further include a shock wave control device connector 205 and a shock wave control device connector 207.

In this embodiment, the shock wave control device connection wire 207 may be connected to the shock wave control device 20 via the shock wave control device connection socket 205, and the handle 40 may be connected to the shock wave control device 20 via the shock wave control device connection wire 207.

Based on the same inventive concept, the present application also provides, according to some embodiments, a control method of a medical system as provided in any of the preceding embodiments.

Referring to fig. 17, the control method may specifically include the following steps:

s10: and acquiring a starting instruction.

S20: processing the starting instruction to obtain an adjusting instruction; the adjustment instructions may be used to adjust an output parameter of the target shockwave.

S30: processing the adjusting instruction to obtain a control instruction; the control instructions may be used to control the medical system to produce a target shockwave corresponding to the output parameter.

The control method provided in the above embodiment can be applied to the medical system in the above embodiment, so that the technical effects that the medical system can achieve can be achieved, and the control method can also be achieved, and is not described in detail here.

Based on the same inventive concept, the present application also provides, according to some embodiments, a method of using the medical system as provided in any of the preceding embodiments.

Specifically, as shown in fig. 18, the using method may specifically include the following steps:

s11: placing the medical device body 11 into an area where calcified tissue 50 is present;

s21: starting a shock wave control device 20, applying a preset voltage to the electrode pair 13, so that the medical device 10 generates a target shock wave; in particular, the target shock wave may be used to fragment and/or soften calcified tissue 50.

The use method provided in the above embodiment can be applied to the medical system in the above embodiment, so that the technical effects that the medical system can achieve and the control method can also be achieved, and the detailed description is omitted here.

In one embodiment, step S11 may be preceded by the step of puncturing the femoral artery or radial artery of the patient to open the access for the interventional procedure.

In one embodiment, step S11 may specifically include the following steps: under the non-invasive blood vessel imaging technology (CT imaging), the medical device body 11 of the medical system is placed near the lesion area of the patient along the sheath or guiding medical device 10.

In one embodiment, step S21 may specifically include the following steps: the discharge of the conditioning module 204 inside the shock wave control device 20 is initiated by the handle 40 or the control module 202, and the high voltage potential reaches the electrode pair 13 through the lead 30.

In step S21, by applying a preset voltage to the electrode pair 13, the molecules in the conductive medium 121 in the gap between the electrode pair 13 are ionized and broken down by the current to form a plasma; as the conductive medium 121 is broken down, a discharge channel is generated, and meanwhile, the discharge resistance is small, so that a large discharge current is generated; the discharge current can heat the conductive medium 121 around the discharge channel, so that the conductive medium 121 expands outward rapidly, and the outer edge of the rapidly expanded air cavity generates target shock waves in the conductive medium 121; the targeted shock wave can actively cause fragmentation, loosening of plaque, in the targeted lesion area, allowing rapid passage of the medical device 10 to the distal end of the targeted lesion area.

In one embodiment, step S21 may further include the following steps: by further strengthening the energy focusing member 14, the target shock wave can act on the calcified tissue at the far end of the working area of the medical device 10, so that the calcified tissue is cracked and softened, and the effects of modifying the focus and opening the access are achieved.

In one embodiment, step S21 may be followed by steps of withdrawing the medical device body 11 along the access route, evaluating the effect of the therapy using other related therapeutic and diagnostic instruments, or continuing the subsequent therapy.

In the description herein, references to "some embodiments," "other embodiments," "desired embodiments," or the like, mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, a schematic description of the above terminology may not necessarily refer to the same embodiment or example.

All possible combinations of the technical features of the above embodiments may not be described for the sake of brevity, but should be considered as within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A medical device is characterized by comprising a medical device body, a conductive cavity, an energy generation component and an energy focusing component; wherein,

the medical device body is configured to: a pulse connected to a high voltage source to cause an arc, sequentially forming a vapor bubble and a target shock wave between at least one of the pair of electrodes disposed within the conductive chamber;

2. The medical device of claim 1, wherein each of the electrode pairs comprises a positive electrode and a negative electrode; in at least one of the electrode pairs, the positive electrode is disposed opposite the negative electrode.

3. The medical device of claim 2, wherein the positive electrode and the negative electrode each include a connection region; the connection region surface of the positive electrode and the connection region surface of the negative electrode are insulated from each other.

4. The medical device of claim 1, wherein each of the electrode pairs comprises a positive electrode and a negative electrode; in at least one of the electrode pairs, the body of the positive electrode passes through the geometric center of the body of the negative electrode in the direction of extension thereof.

5. The medical device of claim 4, wherein the energy focusing component is located on an outer profile of the negative electrode and has a concave reflective surface; the concave reflecting surface is curved in a direction surrounding the end of the positive electrode.

6. The medical device of claim 5, wherein the concave reflecting surface has a focal point;

7. The medical device of claim 6, wherein a focal point of the proximal end of the concave reflective surface coincides with a central region of the electrode pair.

8. The medical device of claim 5, wherein the positive electrode end shape corresponding to the concave reflective surface comprises a sphere or a hemisphere.

9. The medical device according to claim 4, wherein in the electrode pair in which the body of the positive electrode passes through the geometric center of the body of the negative electrode in the direction of extension thereof, there is an electrode insulating layer between the positive electrode and the negative electrode.

10. A medical system comprising a medical device as claimed in any one of claims 1 to 9, and a shock wave control device;

11. The medical system of claim 10, wherein each of the electrode pairs comprises a positive electrode and a negative electrode;

in at least one of the electrode pairs, the positive electrode is disposed opposite the negative electrode;

12. The medical system of claim 10, wherein each of the electrode pairs comprises a positive electrode and a negative electrode;

13. The medical system of claim 12, wherein in the electrode pair with the positive electrode passing through the negative electrode, there is an electrode insulation layer between the positive electrode and the negative electrode, the electrode insulation layer covering a central portion of the composite wire.

14. A method of controlling a medical system according to any of claims 10 to 13, comprising:

acquiring a starting instruction;

15. A control method according to claim 14, wherein the output parameters comprise vibrational modes and/or pulse modes of output.