CN116687553B

CN116687553B - Fluid controllable hemostatic front-end assembly, electrode and system thereof

Info

Publication number: CN116687553B
Application number: CN202310687133.XA
Authority: CN
Inventors: 敬兴义; 陈世鑫; 潘鹏程; 张凌晨; 邹雨珂
Original assignee: Chengdu Debaijia Medical Technology Co ltd
Current assignee: Chengdu Debaijia Medical Technology Co ltd
Priority date: 2023-06-12
Filing date: 2023-06-12
Publication date: 2023-10-10
Anticipated expiration: 2043-06-12
Also published as: CN116687553A

Abstract

The invention belongs to the technical field of medical equipment, and relates to a fluid controllable hemostatic front-end component, an electrode and a system thereof, wherein the front-end component comprises: the electrode body is provided with at least one group, and each group is two; each electrode body is sequentially provided with a nozzle, a fluid channel and a fluid outlet, wherein the nozzle, the fluid channel and the fluid outlet are communicated with the fluid channel, the nozzle is configured to spray fluid in a scattering mode under the action of pressure, the caliber of the fluid channel is gradually increased from the proximal end to the distal end, at least two fluid outlets are arranged, each fluid outlet is sequentially arranged from the proximal end to the distal end, and each fluid outlet is a bevel opening inclined towards the distal end. The invention solves the technical problem that the flow rate, the water outlet direction and the water outlet time of the fluid outlet can not be controlled simultaneously in the prior art, and improves the coagulation effect.

Description

Fluid controllable hemostatic front-end assembly, electrode and system thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a fluid controllable hemostatic front end assembly, an electrode and a system thereof.

Background

In the surgical operation, hemostasis treatment is often required, the hemostasis requirements of different parts are different, and some parts only need to stop bleeding and have low requirements for retaining the activity of target tissues; and other parts (such as joint ligaments, tendons and the like) are required to be capable of effectively stopping bleeding, and low in temperature during stopping bleeding, so that the activity of target tissues can be well reserved.

Electrosurgical hemostatic instruments currently in the market:

monopolar class: the high-frequency electrotome and the high-frequency electrohook are matched with the negative plate to use and do not have a water outlet function.

Bipolar: bipolar coagulation forceps, bipolar coagulation forceps and the like, which do not need to be matched with a negative plate for use and do not have a water outlet function.

Some critical areas of tissue (e.g., ligaments, tendons, perinerves, etc.) require electrosurgical coagulation electrodes to be able to coagulate effectively while not having a wide range of thermal damage to occur, within a suitable range for temperature control. The ideal temperature range for tissue coagulation is 60-100 ℃. If the coagulation temperature is lower than 60 ℃, the tissue cannot be dehydrated or contracted, and the coagulation effect cannot be achieved. If the coagulation temperature is higher than 100 ℃, the tissue is extremely easy to carbonize and eschar, and the coagulation block of the carbonize and eschar is extremely easy to fall off, so that the coagulation is extremely unstable. Conventional electrosurgical coagulation instruments are extremely prone to coagulation temperatures in excess of 100 ℃ and even 200 ℃. Therefore, the water flow is controlled to cool the tissue, so that the coagulation temperature can be controlled between 60 ℃ and 100 ℃ to obtain the optimal coagulation effect.

Although electrosurgical coagulation electrodes with water-out function (mainly cold physiological saline) are currently presented, these electrosurgical coagulation electrodes have a relatively single water-out function, which is mainly problematic:

1. when a small range coagulation is desired, the output power needs to be reduced, and the coagulation range is limited to the area between the two electrodes, and the center position between the two electrodes is aligned with the target tissue. In this case, it is desirable to cool the solidification region between the two electrodes by water flow. However, the current water outlet mode of the water outlet electrode is uncontrollable, namely, all water outlet holes are used for discharging water simultaneously, and at the moment, the areas outside the two electrodes are covered by water flow, so that 2 points of defects are generated:

(1) When the low output power is used, the energy of the electrode is lower, and when the heat generated by the tissue is relatively higher, the output power is much lower, and only the water with smaller flow is needed to cool the electrode and the tissue. However, due to the fact that the water outlet hole cannot be controlled to be opened or closed or the flow controller cannot be controlled accurately, the flow, the water outlet direction and the water outlet time cannot be controlled, the flow is large, excessive heat is taken away by water flow, and the coagulation effect (such as efficiency, coagulation depth, easiness in drying and the like of tissues at the outer side parts of the two electrodes) is poor;

(2) More water can obstruct the operation visual field in the operation process, thereby adding additional work of water absorption and being relatively complicated to process.

2. When a large range of coagulation is desired, the output power is increased and the coagulation range will include the area between and beyond the electrodes. The energy of the electrode is very high, the heat generated by the tissue is very high, the electrode and the tissue are cooled by the water with large flow, and the existing product cannot meet the requirement. In this case, it is desirable to cool the water flow at the same time in the region between the two electrodes and outside the electrodes. However, the current water outlet mode of the water outlet electrode is also uncontrollable, when the water flow is increased to a certain extent, the water flow can be sprayed to the periphery of the electrode, and the water flow can not perfectly reach the target position, so that the coagulation temperature is not in the optimal temperature range, the coagulation effect is poor, and even the electrode is obviously lost.

Disclosure of Invention

In view of this, an object of the embodiments of the present invention is to provide a fluid controllable hemostatic front end assembly, an electrode and a system thereof, which solve the technical problem that the flow rate, the water outlet direction and the water outlet timing of the fluid outlet cannot be controlled simultaneously in the prior art, and promote the coagulation effect.

The technical scheme of the invention is as follows:

the present invention provides a fluid controllable hemostatic front end assembly, the front end assembly comprising:

a support having a distally extending fluid passage disposed therein;

the electrode body is at least provided with one group, each group is two, and the adjacent electrode bodies are arranged at the far end of the supporting piece in an insulating and isolating way;

each electrode body is sequentially provided with a nozzle, a fluid cavity channel and a fluid outlet which are communicated with the fluid channel from the proximal end to the distal end, the nozzle is configured to spray fluid in a scattering state under the action of pressure, the caliber of the fluid cavity channel is gradually increased from the proximal end to the distal end, at least two fluid outlets are arranged, each fluid outlet is sequentially arranged at intervals from the proximal end to the distal end, and each fluid outlet is an inclined opening inclined towards the distal end;

when the diffusion angle (the included angle between the fluid scattering edge and the central axis of the nozzle) of the fluid scattering is smaller than or equal to the opening angle (the included angle between the wall of the fluid channel and the central axis of the fluid channel), the fluid is ejected from the fluid outlet at the most distal end;

when the diffusion angle of the scattered fluid is larger than the opening angle of the fluid channel, each fluid outlet ejects the fluid.

Further, the fluid outlet of the most distal end of each set of the electrode bodies faces the inside or the outside.

Further, the nozzle is any one of a pipe with a shrinkage port, a cylindrical pipe, an axial-flow fan with an air deflector and a right-angle elbow with an air deflector.

Further, the caliber of each fluid outlet is larger than that of the fluid channel at the corresponding position.

Further, the diameter of the fluid outlet of each electrode body is the same or gradually increases from the proximal end to the distal end.

Further, the combination part of the fluid outlet at the most distal end of each electrode body and the fluid channel is in smooth transition.

Further, the fluid outlet on at least one inner side of each electrode body faces to the central axis or two sides of the central axis of the other electrode body in the same group.

Further, at least two of the fluid outlets face the same side, and the fluid outlets facing the same side are positioned on the same straight line or are not positioned on the same straight line.

Further, the electrode body is columnar, needle-shaped or cubic.

Further, the specifications of the electrode bodies in each group of electrode bodies are the same or different.

Further, in each group of electrode bodies, one electrode is a working electrode, and the other electrode is a loop electrode with opposite polarity.

Further, the electrode body is disposed on the support member through a positioning member.

Preferably, each set of electrode bodies is configured such that at a predetermined minimum fluid pressure, at least one of the fluid outlets ejects fluid in direct contact with another electrode body of the same set.

In a preferred embodiment, each set of electrode bodies is configured such that, at a preset minimum fluid pressure, fluid ejected from the fluid outlet on the inner side flows to the target tissue after being sputtered between the electrode bodies.

In a preferred embodiment, each set of electrode bodies is configured such that the fluid ejected from the fluid outlet on the inner side directly flows to the target tissue at a preset minimum fluid pressure.

The invention also provides a fluid controllable hemostatic electrode, which comprises a handle, wherein the proximal end of the handle is connected with a cable plug and a water inlet pipe, the hemostatic electrode further comprises a front end component, the front end component is arranged at the distal end of the handle, and the water inlet pipe is communicated with a fluid channel.

The invention also provides a fluid controllable hemostatic system, which comprises a host, a flow controller and an electrode, wherein the electrode comprises a handle and a front end assembly, the proximal end of the handle is connected with a cable plug and a water inlet pipe, the front end assembly is arranged at the distal end of the handle, and the water inlet pipe is communicated with a fluid channel;

further, the flow controller is configured to match the corresponding rotational speed according to the output power of each stage set by the host.

Compared with the prior art, the invention has the beneficial effects that:

1. when a small range of coagulation is desired, the electrodes output a low output power, and the coagulation range is limited to the area between the two electrodes. The energy of the electrode is lower, the heat generated by the tissue is much lower when the output power is relatively high, only the water (namely physiological saline) on the inner side of the electrode can be discharged, the water discharge is less, and the temperature of the electrode and the tissue can be controlled within a proper range. The method can simultaneously control the flow of the water discharged from the fluid outlet, the water outlet direction and the water outlet time, is different from the simple control of the quantity of the water discharged from the fluid outlet, and can effectively improve the coagulation effect. In addition, by reducing water outlet, the invention effectively improves the operation field in the operation process, reduces the extra work of water absorption and has better use experience.

2. When a large range of coagulation is desired, the electrodes increase the output power, and the coagulation range may include regions between and outside the electrodes. The energy of the electrode is very high, the heat generated by the tissue is very high, the electrode and the tissue are cooled by the water with large flow, and the existing product cannot meet the requirement. According to the invention, the water flow can be cooled in the area between the two electrodes and outside the electrodes, when the water flow is increased to a certain degree, the water flow does not jet around the electrodes, and the water flow can directly reach the target position, so that the temperature of the target position can be accurately taken away, the coagulation temperature is controlled in an optimal temperature range, and the coagulation effect is improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art. The above and other objects, features and advantages of the present invention will become more apparent from the accompanying drawings. Like reference numerals refer to like parts throughout the several views of the drawings. The drawings are not intended to be drawn to scale, with emphasis instead being placed upon illustrating the principles of the invention.

Fig. 1 is a schematic diagram of the overall structure of a fluid-controllable hemostatic electrode according to the present invention;

fig. 2 is a schematic diagram illustrating waterway separation of a fluid-controllable hemostatic electrode according to the present invention;

FIG. 3 is a cross-sectional view of one embodiment of a front end assembly provided by the present invention;

FIG. 4 is a cross-sectional view of an alternate embodiment of a front end assembly provided by the present invention;

FIG. 5 is a cross-sectional view of another alternate embodiment of a front end assembly provided by the present invention;

FIG. 6 is a schematic view of one embodiment of each set of electrode bodies of the present invention (with the most distal fluid outlets being at different heights);

fig. 7 is a schematic view of the hemostatic ablation scope provided by the present invention.

Fig. 8 is a schematic view of the hemostatic ablation scope of a conventional approach.

Fig. 9 is a schematic structural diagram of an electrode body according to an embodiment of the present invention.

Fig. 10 is a schematic view of a nozzle jet at reduced pressure.

FIG. 11 is a schematic view of a nozzle jet at higher pressure.

Fig. 12 is a schematic structural diagram-in-line arrangement of two sets of electrode bodies according to an embodiment of the present invention.

Fig. 13 is a schematic structural diagram of a two-group electrode body according to an embodiment of the present invention.

Fig. 14 is a schematic view showing the influence of the orientation of the fluid outlet in the axial direction of the electrode body.

FIG. 15 is a schematic diagram of the system of the present invention in use.

Reference numerals:

1-a front end assembly; 2-a handle; 3-a cable plug; 4-a water inlet pipe; 6-a host; 7-a flow controller;

11-a support; 12-an electrode body; 31-conducting wires; 41-liquid injection piece;

111-fluid channels; 112-upper support; 113-a lower support;

121-fluid channels; 122-nozzle; 123-fluid outlet; 124-bond; 125-fluid ejection tube;

a port a of the a-fluid outlet; b-port of the fluid outlet; c-port of C-fluid outlet;

"→" -indicates the direction of fluid flow.

Description of the embodiments

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

The angle of operation can be interpreted as the angle with the target tissue at each use position.

In the following, the terms "distal" and "proximal" are defined in terms of a positional relationship with the focal tissue, where "distal" refers to an end of the component that is closer to the tissue, and "proximal" refers to an end of the component that is farther from the tissue. In the following, the "inner side" refers to the middle hemostatic ablation region of each electrode body separated by two midlines, and the "outer side" refers to the other hemostatic ablation regions of each electrode body.

[ example 1 ]

As described with reference to fig. 1 to 15, the present invention provides a front end assembly for fluid-controlled hemostasis, where the front end assembly 1 includes:

a support 11 having a distally extending fluid passage 111 disposed therein; the support 11 includes an upper support 112 and a lower support 113;

electrode bodies 12, preferably one group of two, and adjacent electrode bodies are arranged at the distal end of the support in an insulating and isolating manner; the electrode body 12 is preferably columnar, and the distal end face of the columnar electrode body may be a plane (the plane and the side face may be subjected to chamfer treatment) or may be hemispherical; in other embodiments, it may be needle-like or cube-like;

each of the electrode bodies 12 includes a body and a fluid ejection tube 125, the fluid ejection tube 125 being for connection with a fluid channel; the body is provided with a nozzle 122, a fluid channel 121 and a fluid outlet 123 which are communicated with the fluid channel 111 from the proximal end to the distal end in sequence; the nozzle 122 is configured to spray fluid under pressure in a scattering manner; the diameter of the fluid channel 121 gradually increases from the proximal end to the distal end (the fluid channel 121 is in a shape of a truncated cone, which is defined by a plane parallel to the bottom surface of the cone, and a part between the bottom surface and the cross section), two fluid outlets 123 are arranged, and each fluid outlet is sequentially arranged at intervals from the proximal end to the distal end; the fluid outlets 123 are all inclined ports inclined in the distal direction;

when the diffusion angle a of the scattered fluid is smaller than or equal to the opening angle b of the fluid channel 121, the fluid is ejected from the fluid outlet 123 at the most distal end;

when the diffusion angle a of the scattered fluid is larger than the opening angle b of the fluid channel 121, each fluid outlet 123 ejects the fluid.

The number of the fluid outlets 123 is two, each fluid outlet is sequentially arranged from the proximal end to the distal end of the electrode body, and the caliber of the fluid outlets 123 can be the same or can be gradually increased from the proximal end to the distal end; in other embodiments, the fluid outlets 123 may be added according to practical situations, for example, 3, 4, 5, etc. of the electrode bodies 12 are disposed. In some special cases, for example, when it is only necessary to spray fluid (mainly, physiological saline, and the physiological saline may be frozen physiological saline) in one direction of a certain electrode body 12, only 1 fluid outlet 123 may be provided on each electrode body 12.

The fluid outlet 123 at the most distal end of each set of the electrode bodies 12 faces inward (including two cases, one is that the two electrode bodies of each set of the electrode bodies 12 are identical in specification, the fluid outlets 123 are identical in height, and the other is that the two electrode bodies of each set of the electrode bodies 12 are not identical in specification, and the fluid outlets 123 are not identical in height); typically, the most distal one of the fluid outlets 123 is spaced from the bottom of the electrode body 12 by a distance of 1mm or more, and this is not intended to exclude placement directly at the bottom. In other embodiments, the fluid outlet 123 at the most distal end of each electrode body 12 may also be oriented to the outside, mainly depending on the relationship between the set pressure and the water output from the fluid outlet, for example, when the pressure is smaller, the diffusion angle is smaller, and the fluid is ejected from the fluid outlet 123 at the most distal end; if the water is required to be discharged from each fluid outlet, the pressure is increased (the rotating speed of the flow controller is increased); if the diffusion angle a is larger than the opening angle b, the flow rate of the fluid outlet 123 gradually decreases from the distal end to the proximal end as the diffusion angle a increases.

By the above arrangement, the invention can be realized under any condition, such as different output powers of the host machine, or different rotation speeds of the flow controller 7, etc., the fluid outlets 123 on each electrode body 12 spray fluid in sequence along the distal-to-proximal direction, and the fluid outlets 123 on the inner sides of the two electrode bodies are preferentially discharged.

I.e. each set of said electrode bodies 12 is arranged such that one fluid outlet 123 of one of said electrode bodies faces inwards with one fluid outlet 123 of the other of said electrode bodies and the remaining fluid outlets face outwards.

Preferably, the caliber of each fluid outlet 123 is larger than the caliber of the fluid channel 121 at the corresponding position. The purpose of this is to bias the fluid under pressure more toward ejection from the set fluid outlet 123 to achieve the objects of the present invention.

Wherein the nozzle 122 is preferably a portion of the fluid-ejection tube 125, and in other embodiments may be a separate component that is coupled to the fluid-ejection tube 125.

Preferably, the nozzle 122 is any one of a tube with a constriction, a cylindrical tube, an axial fan with an air deflector, and a right-angle elbow with an air deflector, and preferably a tube with a constriction, referring to fig. 3.

The nozzle 122 is configured to scatter fluid at a spread angle a less than or equal to the opening angle b of the fluid channel 121 in order to ensure that the most distal inner fluid outlet 123 is discharged for the purposes of the present invention. If the diffusion angle a of the fluid scattered from the nozzle 122 is greater than the opening angle b of the fluid channels 121, the fluid channels 121 will be discharged almost simultaneously; and the size of the spacing of the individual fluid channels 121 in the axial direction may be a factor affecting the size of the individual flow rates.

The basic principle of the present invention for jet control by using the structure of the nozzle 122 and the like refers to fig. 10 and 11:

(1) when liquid or gas is ejected from the nozzle (orifice, slit), a spray-like turbulence of a diffuse shape is created.

(2) When the pressure at the nozzle is smaller, the diffusion angle a of the jet flow is smaller, and the jet flow is more concentrated;

(3) when the pressure at the nozzle is increased, the diffusion angle a of the jet flow is larger, and the jet flow is scattered;

the fluid outlet 123 at the most distal end of each electrode body 12 smoothly transitions with the junction 124 of the fluid channels 121. A smooth transition means that the junction communication fluid outlet 123 is relatively smooth with the fluid channel 121, with no or few protrusions, indentations, etc. as shown in fig. 4. This ensures that the flow rate of each fluid outlet 123 is not disturbed by other factors as much as possible.

The inclination angle of the bevel opening can also be set according to actual requirements, and the inclination angle of the bevel opening and the central axis of the electrode body can be 10 degrees to 80 degrees, preferably 10 degrees, 20 degrees, 30 degrees, 40 degrees, 45 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees and the like. The fluid outlet 123 and the fluid channel 121 are generally perpendicular to each other, which is not sufficient for the present invention. Compared with a conventional water outlet, the bevel connection is more convenient to dredge.

One of the electrode bodies 12 is a working electrode, and the other electrode is a loop electrode with opposite polarity. Preferably, the length, diameter, fluid outlet (including diameter, length, height above the electrode body 12, etc.), etc. of each set of electrode bodies 12 are the same, with the exception of the special case where any of the above specifications for each set of electrode bodies 12 is different or all of them are different. When the two electrode bodies 12 are combined, the gap d between them satisfies the following condition: preferably, the clearance d is 0.1 mm.ltoreq.d.ltoreq.12 mm, and 0.1mm, 0.15mm, 0.2mm, 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 10mm, 11mm, 12mm and the like.

Each set of electrode bodies 12 further has one of the following conditions:

a) Each set of electrode bodies 12 is configured such that at a preset minimum fluid pressure, at least one of the fluid outlets 123 ejects fluid in direct contact with another electrode body of the same set. On the premise of fluid pressure determination, this solution mainly depends on the spacing between the two electrode bodies 12, the orientation of the fluid outlets 123 (i.e. the distribution angle of the fluid outlets 123 in the circumferential direction of the electrode bodies 12).

Specifically, it may be one of the following cases:

(1) The fluid outlets on the inner side of each electrode body 12 face the central axis (see fig. 14 (a)) or both sides of the central axis of the other electrode body 12.

(2) In each of the electrode bodies 12, one of the electrode bodies has an inner fluid outlet facing the central axis or both sides of the central axis of the other electrode body 12 in the same group, and the other electrode body also has an inner fluid outlet facing the central axis or both sides of the central axis of the electrode body 12 in the same group (refer to fig. 14, (b)), and the heights of the inner fluid outlets are different (refer to fig. 6 with respect to the horizontal line or the horizontal surface of the target tissue). I.e. the two electrode bodies 12 of each set have different specifications, wherein mainly the inner fluid outlet is at a different height.

B) The electrode bodies 12 of each set are configured such that, at a preset minimum fluid pressure (mainly controlled by the flow controller 7), the fluid ejected from the fluid outlet 123 on the inner side flows to the target tissue after being sputtered (i.e., containing the meaning of collision) between the electrode bodies. On the premise of fluid pressure determination, this solution mainly depends on the spacing between the two electrode bodies 12, the orientation of the fluid outlets 123 (i.e. the distribution angle of the fluid outlets 123 in the circumferential direction of the electrode bodies 12).

Specifically, it may be one of the following cases:

(1) In each of the electrode bodies 12, one of the electrode bodies has an inner fluid outlet directed toward the central axis of the other electrode body 12 of the same group (see fig. 14, (a)), and the other electrode body also has an inner fluid outlet directed toward the central axis of the corresponding electrode body 12 of the same group. Preferably, the height of the fluid outlet on the inner side of each electrode body 12 is the same (refer to fig. 7). There are often exceptions in the special case that the height at which the fluid outlet inside each set of electrode bodies 12 is located may be different.

(2) In each of the electrode bodies 12, one of the electrode bodies has an inner fluid outlet facing both sides of the central axis of the other electrode body 12 of the same group, and the other electrode body has an inner fluid outlet facing the central axis or the same side of the central axis of the corresponding electrode body 12 of the same group (refer to fig. 14, (b)). Preferably, the height of the fluid outlet on the inner side of each set of electrode bodies 12 is the same. There are often exceptions in the special case that the height at which the fluid outlet inside each set of electrode bodies 12 is located may be different.

C) The electrode bodies 12 of each group are configured such that the fluid ejected from the fluid outlet 123 on the inner side directly flows to the target tissue at a preset minimum fluid pressure. On the premise of fluid pressure determination, this solution mainly depends on the spacing between the two electrode bodies 12, the orientation of the fluid outlets 123 (i.e. the distribution angle of the fluid outlets 123 in the circumferential direction of the electrode bodies 12).

Specifically, it may be one of the following cases:

(1) In each set of electrode bodies 12, the two inner fluid outlets 123 are not directed to the central axis or both sides of the central axis of the other electrode body 12 of the same set (but the fluid is still injected to the inner side as a whole, but cannot directly contact with the electrode body 12), and the two inner fluid outlets 123 are biased to different sides with a larger angle to both sides of the central axis of the corresponding electrode body 12 (refer to fig. 14, (c)).

(2) The two inner fluid outlets 123 in each electrode body 12 are not directed to the central axis or both sides of the central axis of the other electrode body 12 in the same group (but the fluid is still sprayed to the inner side in general, but cannot directly contact with the electrode body 12), and the deviation angle is larger to both sides of the central axis of the corresponding electrode body 12 (refer to fig. 14, (d)).

Preferably, the electrode body 12 may be disposed on the support 11 by a positioning member (not shown in the drawings) to define the orientation of the fluid outlet 123, particularly the distal-most fluid outlet 123, for convenience of assembly and ensuring accuracy of orientation. The positioning member may have a plurality of structural modes, and may be provided on the support member 11 or the electrode body 12 alone, or may be provided on the support member 11 and the electrode body 12 as a whole. In one embodiment, for example, a groove is formed in the support 11, and a clip is further formed on the fluid ejection tube 125 of the electrode body 12, and when assembled, the clip is placed in the groove to define the orientation of the fluid outlet 123. Other schemes are not listed one by one.

The utility model provides a controllable hemostatic electrode of fluid, includes handle 2, the handle proximal end is connected with cable plug 3 and inlet tube 4, still includes front end subassembly 1, front end subassembly set up in the distal end of handle 2, inlet tube 4 and fluid channel 111 intercommunication. The inlet pipe 4 comprises a pipe and an injector 41. The fluid passage 111 may be a part of the water inlet pipe 4, or may be provided separately by a flow divider such as a tee. The cable plug 3 is connected to the electrode body 12 via a wire 31.

A fluid-controlled hemostatic system, referring to fig. 15, comprising a host 6, a flow controller 7, and an electrode, wherein the electrode comprises a handle 2 and a front-end assembly 1, the proximal end of the handle is connected with a cable plug 3 and a water inlet pipe 4, the front-end assembly is arranged at the distal end of the handle 2, and the water inlet pipe 4 is communicated with a fluid channel 111; the flow controller 7 is configured to control the flow according to the rotational speeds corresponding to the output powers of the stages set by the host 6, that is, the rotational speeds corresponding to the output powers of the stages set in advance.

Basic principle of electrode operation:

(1) coagulation principle of electrode: the heat effect of the high-frequency current, namely when the high-frequency current passes through the tissue, the tissue can generate heat, and the heat can dehydrate and shrink the tissue, so that the coagulation effect is realized.

(2) Each group of electrode bodies is provided with 2 metal electrode heads, the polarities of the electrode heads are opposite, and the 2 metal electrode heads contact with tissues to coagulate the tissues.

(3) The metal electrode head is internally provided with a channel and a water outlet, and fluid (normal saline) is delivered to target tissues.

The electrodes may be provided with manual keys, which may be 1, 2 or 3, such as 1. The number of key settings is related to the functions of the key, the implementation of the functions needs to be matched with the setting of the host 6, and the possible functions of each key may be:

(1) When 1 key is set: the switch is powered on and powered off;

(2) When 2 keys are arranged: one effect is coagulation and the other effect is ablation;

(3) When 3 keys are arranged: one effect is the effect of the switch being turned on and off, the other effect is coagulation, and the last effect is ablation.

In other embodiments, the electrodes may not be provided with manual keys, but are controlled by means of foot switches to achieve the corresponding functions.

The rotation speed of the flow controller 7 configured to match the output power of each stage according to the setting of the host 6 is not a main invention point of the present invention, and a person skilled in the art can implement the flow controller according to the prior art and common knowledge, so that a detailed description thereof is omitted.

Since the flow controller 7 can control the pressure in the pipe, the pressure can control the diffusion angle, and the diffusion angle can control the water outlet sequence; then the water outlets of different front and back positions, different circumferential angle positions and different horizontal angles can be arranged on the electrode, so that water outlets of different time machines, different directions and different angles can be controlled to realize accurate water control.

The invention can solve the technical problems that the flow of the discharged water, the spraying direction and the spraying time are not controlled. In particular:

1. when a small range of coagulation is desired, the electrodes output a low output power, and the coagulation range is limited to the area between the two electrodes. The energy of the electrode is lower, the heat generated by the tissue is much lower when the output power is relatively high, only the water (namely physiological saline) is discharged from the inner side (other embodiments can also be the outer side) of the electrode, the water discharge is less, and the temperature reduction of the electrode and the tissue can be controlled within a proper range. The method can simultaneously control the flow of the water discharged from the fluid outlet, the water outlet direction and the water outlet time, is different from the simple control of the quantity of the water discharged from the fluid outlet, and can effectively improve the coagulation effect. In addition, by reducing water outlet, the invention effectively improves the operation field in the operation process, reduces the extra work of water absorption and has better use experience.

2. When a large range of coagulation is desired, the electrodes increase the output power, and the coagulation range may include regions between and outside the electrodes. The energy of the electrode is very high, the heat generated by the tissue is very high, the electrode and the tissue are cooled by the water with large flow, and the existing product cannot meet the requirement. According to the invention, the water flow can be cooled in the area between the two electrodes and outside the electrodes, when the water flow is increased to a certain extent, the water flow does not jet around the electrodes, and the water flow can directly reach the target position, so that the temperature of the target position can be accurately taken away, the coagulation temperature is controlled in an optimal temperature range, and the coagulation effect is improved.

The coagulation ranges illustrated with reference to fig. 7 and 8:

(1) when only a small range of coagulation is needed, the output power is lower, and the coagulation range is only in the area shown by the 'x'; the range of physiological saline is expected to be limited mainly to the region indicated by "×".

In this case, the rotation speed of the flow controller 7 can be reduced, and the pressure in the tube (nozzle) can be reduced, so that the physiological saline mainly flows out from the port a.

(2) When only large-range coagulation is needed, the current power is higher, and the coagulation range is in the region shown by the symbols together with the symbols; the range of physiological saline to be expected at this time needs to be increased.

At this time, the rotation speed of the flow controller 7 can be increased to increase the pressure in the tube (nozzle) and allow the physiological saline to flow out from the port a and the port B simultaneously.

Referring to fig. 7 and 8, when low output power is selected, it can be clearly seen that the fluid in the conventional scheme is uncontrollable, the hemostatic ablation range is significantly larger, and the hemostatic ablation ranges on the two inner sides cannot be accurately controlled. If the output power is increased, the invention does not generate the water surge outside the two electrodes (namely, the spray is far and does not directly act on the target part), but the water surge outside the two electrodes is easy to generate in the conventional scheme.

Referring to fig. 4, a reverse example is provided, which is mainly different from the present invention in that the fluid outlet 123 is a bevel, but the caliber of the fluid channel 121 is the same (e.g. cylindrical) from the proximal end to the distal end, and the junction 124 of the fluid channel 121 is not a smooth transition, i.e. has protrusions, recesses, etc. as shown in fig. 4, which results in that the solution cannot control the outflow sequence of the respective fluid outlets 123.

The main difference between this solution and the present invention, which is an opposite example provided with reference to fig. 5, is that the fluid outlets 123 are not beveled, the aperture of the fluid channel 121 is the same from the proximal end to the distal end (e.g. cylindrical), which also results in that the solution cannot control the outflow sequence of the individual fluid outlets 123.

[ example 2 ]

The main difference between this embodiment and the other embodiments is that, referring to fig. 9, each set of the electrode bodies 12 has two electrode bodies, and each electrode body is provided with at least three fluid outlets 123 (e.g. A, B, C). The plurality of fluid outlets 123 may be the same size or gradually increase from the proximal end to the distal end, and may be the same or different in angular position in the circumferential arrangement of the electrode body. Each set of the electrode bodies 12 is configured such that two or more fluid outlets 123 of one of the electrode bodies (one of which is located at the most distal end) face inward and one fluid outlet 123 of the most distal end of the other electrode body faces outward (not shown in the drawings).

The caliber of the fluid channel 121 gradually increases from the proximal end to the distal end, and the fluid outlets are sequentially arranged from the proximal end to the distal end; the fluid outlets 123 are all inclined ports inclined in the distal direction;

the fluid outlets 123 facing the same side may or may not be co-linear. I.e. in the circumferential direction of the electrode body 12, the fluid outlets 123 are distributed towards different angles, see fig. 9.

[ example 3 ]

The main difference between this embodiment and the other embodiments is that each set of the electrode bodies 12 is configured such that two or more fluid outlets 123 of one of the electrode bodies (one of which is located at the most distal end) face inward and two or more fluid outlets 123 of the other electrode body (one of which is located at the most distal end) face outward (the remaining fluid outlets are not shown in the drawings).

The fluid outlets 123 facing the same side may or may not be co-linear. I.e. in the circumferential direction of the electrode body 12, the fluid outlets 123 are directed towards different angular distributions, see fig. 9.

[ example 4 ]

Referring to fig. 12 and 13, the main difference between this embodiment and other embodiments is that the number of the electrode bodies is two, each group is two, and the adjacent electrode bodies are arranged at the distal end of the supporting member in an insulating and isolating manner. In other embodiments, the case of having three or more sets of electrode bodies 12 is not precluded. The remaining arrangements may be employed singly in the embodiments described above, or may be combined with the arrangements disclosed in any of the embodiments described above or with the arrangements disclosed in the embodiments described above.

At least two fluid outlets 123 communicating with the fluid channels are arranged on each electrode body 12, and each fluid outlet is arranged in sequence from the proximal end to the distal end of the electrode body;

in each set of the electrode bodies 12, one fluid outlet 123 at the most distal end of each electrode body faces inward;

[ example 5 ]

The main difference between this embodiment and other embodiments is that the fluid is not physiological saline but gas, and the principle is based on the recent emerging research field, that is, the atmospheric pressure low temperature plasma technology, which is used in the medical field to promote scar healing mainly by using atmospheric pressure low temperature plasma therapy. Atmospheric pressure cryogenic plasma is a very specific gaseous material that contains reactive oxygen species, reactive nitrogen species, electromagnetic fields, heat, ultraviolet light and other charged particles, radicals, and the like. Studies have shown that atmospheric pressure cryogenic plasmas have demonstrated the ability to excite, boost, control, and catalyze a variety of complex behaviors and reactions in biological systems. The atmospheric pressure low temperature plasma contains active ingredients such as nitric oxide, hydrogen peroxide and the like, and the active oxygen-containing ingredients in the atmospheric pressure low temperature plasma have been proved to have broad-spectrum bactericidal effect and can start a natural coagulation mechanism to quickly stop bleeding of wounds; hydrogen peroxide can affect the wound closure process by activating a redox reaction; nitric oxide is an important mediator that affects the skin's response to infection, and is a substance that affects many biological functions including regulating coagulation, immune response, neural communication, relaxing smooth muscle, regulating hormone secretion, and can act as a bactericide, anticancer agent, etc. The atmospheric pressure cryogenic plasma is generated in an atmospheric pressure environment and does not require a vacuum system, and the working gas may be air, a rare gas, or a mixture of gases. The atmospheric pressure low temperature plasma can directly act on various materials, skin surfaces and the like; the composition of various components of the atmospheric pressure low-temperature plasma can be adjusted by adjusting different discharge parameters such as voltage, discharge distance or discharge gas, and the like, and the accessibility and the adjustability enable the atmospheric pressure low-temperature plasma to be more suitable for being applied to the field of biological medical treatment.

In this embodiment, the electrode body 12 is only used as a cavity for accommodating gas, and does not need to discharge, and the material of the electrode body 12 may be conductive metal material or nonconductive insulating material, and a set of discharge electrodes are separately disposed in the fluid channel 121 of the electrode body 12, where the set of discharge electrodes includes a working electrode and a loop electrode, the fluid channel 111 is filled with high-pressure gas and enters the fluid channel 121, the working electrode and the loop electrode discharge breakdown the gas to generate gas plasma, and the gas plasma is discharged through the fluid outlet 123 under the pressure. At this time, the position of the fluid outlet 123 may be set to the distal end face of the electrode body 12 or the circumferential direction of the electrode body 12 according to actual demands.

The specific line connection, installation mode and the like of the embodiments of the present invention are not important, and can be implemented by referring to the above content in combination with common sense, or by referring to the prior art schemes CN201910670161.4, CN201910669993.4, CN202010819571.3 and the like, and thus are not described in detail.

The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, combination, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A fluid-controlled hemostatic front end assembly, characterized in that the front end assembly (1) comprises:

-a support (11) having a distally extending fluid channel (111) disposed therein;

the electrode bodies (12) are at least provided with one group, each group is two, and adjacent electrode bodies are arranged at the far end of the supporting piece in an insulating and isolating way;

each electrode body (12) is sequentially provided with a nozzle (122), a fluid channel (121) and fluid outlets (123) which are communicated with the fluid channel (111) from the proximal end to the distal end, the nozzle (122) is configured to spray fluid in a scattering state under the action of pressure, the caliber of the fluid channel (121) is gradually increased from the proximal end to the distal end, at least two fluid outlets (123) are arranged, each fluid outlet is sequentially arranged at intervals from the proximal end to the distal end, and each fluid outlet (123) is an inclined opening inclined towards the distal end;

when the diffusion angle a of the scattered fluid is smaller than or equal to the opening angle b of the fluid cavity (121), the fluid is sprayed out from the fluid outlet (123) at the farthest end;

when the diffusion angle a of the scattered fluid is larger than the opening angle b of the fluid channel (121), each fluid outlet (123) ejects the fluid.

2. A fluid controlled hemostatic front assembly according to claim 1 wherein the fluid outlet (123) of the distal most end of each set of electrode bodies (12) is directed inboard or outboard.

3. A fluid controlled hemostatic front assembly according to claim 1 wherein the nozzle (122) is any one of a tube with a constriction, a cylindrical tube, an axial fan with an air deflector, a right angle elbow with an air deflector.

4. A fluid controlled hemostatic front assembly according to claim 1 wherein each of said fluid outlets (123) has a caliber greater than a caliber of the fluid channel (121) at the corresponding location.

5. A fluid controlled hemostatic front assembly according to claim 1 wherein the fluid outlet of each electrode body (12) is of the same caliber or gradually increases in caliber from proximal to distal direction.

6. A fluid controlled hemostatic front assembly according to claim 1 wherein at least one of said electrode bodies (12) of each set has an inner fluid outlet directed toward the central axis of the other electrode body (12) of the same set.

7. A fluid controlled hemostatic front assembly according to claim 1 wherein the fluid outlets (123) are at least two co-directed and wherein the co-directed fluid outlets (123) are co-linear or non-co-linear.

8. A fluid controlled hemostatic front assembly according to claim 1 wherein the electrode body (12) is cylindrical, needle-like or cube-like.

9. A fluid controlled hemostatic front assembly according to claim 8 wherein the specifications of the individual electrode bodies in each set of electrode bodies (12) are the same or different.

10. A fluid controlled hemostatic front assembly according to claim 1 wherein the electrode body (12) is disposed on the support (11) by a positioning member.

11. A front end assembly for fluid controlled hemostasis according to any one of claims 1-10, characterized in that one of the electrode bodies (12) in each set is a working electrode and the other is a return electrode of opposite polarity.

12. The utility model provides a controllable hemostatic electrode of fluid, includes handle (2), the handle proximal end is connected with cable plug (3) and inlet tube (4), its characterized in that still includes front end subassembly (1) of any one of claims 1~11, front end subassembly set up in the distal end of handle (2), inlet tube (4) and fluid channel (111) intercommunication.

13. A fluid controllable hemostatic system comprising a host (6), a flow controller (7), and a electrode according to claim 12, wherein the electrode comprises a handle (2) and a front end assembly (1), the proximal end of the handle is connected with a cable plug (3) and a water inlet pipe (4), the front end assembly is arranged at the distal end of the handle (2), and the water inlet pipe (4) is communicated with a fluid channel (111).

14. A fluid controlled hemostatic system according to claim 13, wherein the flow controller (7) is configured to match the corresponding rotational speed in dependence of the output power of the stages set by the host (6).