Disclosure of Invention
In view of the above, the present invention aims to provide an electrode assembly, a hemostatic instrument and a system thereof, so as to solve the technical problem that the existing hemostatic instrument for a solid organ cannot realize sectional control of the area and shape of a coagulation area.
The technical scheme of the invention is as follows:
There is provided an electrode assembly comprising at least two electrode needles, each comprising:
The inner pipe is internally provided with a flow inlet channel, a plurality of points which are sequentially arranged are arranged in the axial direction of the inner pipe, and at least one point is provided with a return port;
The outer tube is sleeved outside the inner tube and is smoothly connected with the exposed distal end of the inner tube; a backflow channel communicated with the inflow channel through the backflow port is formed between the outer pipe and the inner pipe; the sum of the opening cross sections of the reflux ports is smaller than or equal to the opening cross section of the inflow channel; in the working state, the reflux port is used as a temperature difference demarcation point for the electrode needle to be subjected to sectional temperature control; the temperature difference demarcation point has at least any one of the following conditions:
1) If the reflux ports are arranged in the circumferential direction corresponding to one point position on the axial direction of the inner tube, the temperature difference demarcation point is fixed;
2) And if the reflux ports are arranged in the circumferential direction corresponding to more than two points in the axial direction of the inner pipe, the temperature difference demarcation point is variable.
Further, the case 2) of the temperature difference demarcation point corresponds to at least one of the following working states: the temperature difference demarcation point is adjustable from the proximal end to the distal end and at most to the most distal return port.
Further, under the condition 2) of the temperature difference demarcation point, the opening sectional area of each point position corresponding to the reflux port in the axial direction of the inner tube gradually decreases from the proximal end to the distal end.
Further, the proximal end of the return channel is provided with a plugging ring, and the side part of the outer tube is provided with a fluid branch pipe communicated with the proximal end of the return channel. The method aims at optimizing the production process and improving the use experience of the user side.
Further, the length and diameter of each electrode needle are the same.
Furthermore, the surface of the outer tube of each electrode needle is provided with scales, and the scales correspond to the reflux ports on each point position on the axial direction of the inner tube. Namely, the scale corresponds to the temperature difference demarcation point, so that operators can conveniently identify the temperature difference demarcation point corresponding to each flow speed and pressure gear, and the temperature difference demarcation point acts on target tissues more accurately.
Further, a closing-in is arranged at the far end of the inner tube. I.e., a structure that can block the flow of the cooling medium in the axial distal end to guide the cooling medium to the return port of the trunk portion side portion.
Furthermore, a choke component is arranged in the inflow channel and can be used as a structural design for replacing the closing-in.
By combining the scheme, the inner pipe is sleeved with the insulating piece which isolates the inner pipe from the outer pipe.
Further, at least one insulating piece is sleeved outside the inner tube to isolate each section of the outer tube into at least two sections.
Further, the outer tube is kept parallel or coaxial with the inner tube. I.e. to avoid the congestion of the fluid circulation channel as much as possible, and to use a "one-needle two/multi-pole" solution, when the inner tube and the outer tube are of different polarity, both are in contact.
Further, the outer surface of the inner tube is isolated from the outer tube by an insulating layer; the proximal end of the inner tube extends out of the outer tube, and the outer surface is exposed. The safety can be further improved, and the inner tube and the outer tube are prevented from being contacted when the polarities of the inner tube and the outer tube are different when a one-needle two/multi-pole scheme is adopted, so that the inner tube and the outer tube are not influenced by the requirement of parallelism or coaxiality.
The hemostatic instrument comprises a handle, a cable plug, a flow inlet pipe, a return pipe and the electrode assembly; the handle is provided with a control switch for respectively controlling each electrode needle.
The hemostatic system comprises a host, a fluid injector, a peristaltic pump and an aspirator, and is characterized by further comprising the hemostatic instrument, wherein the cable plug is connected with the host; one end of the inflow pipe is connected with the fluid injector, and the other end of the inflow pipe is connected with the peristaltic pump and then connected with the inflow channel; the aspirator is connected with the reflux passage through an aspiration tube.
The electrode assembly comprises at least two electrode needles, wherein each electrode needle comprises an outer tube, and an inner tube with a closed distal end is coaxially arranged in the outer tube; an inflow channel is arranged in the inner tube; a plurality of points which are sequentially arranged are arranged on the axial direction of the inner tube, and at least one point is provided with a return port; the sum of the opening cross sections of the reflux ports is smaller than or equal to the opening cross section of the inflow channel; a backflow channel communicated with the inflow channel through the backflow port is formed between the outer pipe and the inner pipe; in the working state, the reflux port is used as a temperature difference demarcation point for the electrode needle to be subjected to sectional temperature control; the temperature difference demarcation point has at least any one of the following conditions:
1) If the reflux ports (142) are arranged in the circumferential direction corresponding to only one point in the axial direction of the inner tube, the temperature difference demarcation point is fixed;
2) And if the reflux ports are arranged in the circumferential direction corresponding to more than two points in the axial direction of the inner pipe, the temperature difference demarcation point is variable.
Further, the case 2) of the temperature difference demarcation point corresponds to at least one of the following working states: the temperature difference demarcation point is adjustable from the proximal end to the distal end and at most to the most distal return port.
Further, under the condition 2) of the temperature difference demarcation point, the opening sectional area of each point position corresponding to the reflux port in the axial direction of the inner tube gradually decreases from the proximal end to the distal end.
Further, the proximal end of the return channel is provided with a plugging ring, and the side part of the outer tube is provided with a fluid branch pipe communicated with the proximal end of the return channel.
Further, the length and diameter of each electrode needle are the same.
Further, a closing-in is arranged at the far end of the inner tube.
Further, a choke component is arranged in the inflow channel.
Furthermore, the surface of the outer tube of each electrode needle is provided with scales, and the scales correspond to the reflux ports on each point position on the axial direction of the inner tube.
Compared with the prior art, the invention has the beneficial effects that:
1. The invention is different from the prior art mainly in that the structure of each electrode needle is optimized, the electrode needle is improved into an inner tube and an outer tube, the outer tube is sleeved outside the inner tube and is smoothly connected with the far end of the inner tube, and the invention is different from the traditional simple inner sleeve and outer sleeve, and the foundation structure is favorable for further improving the electrode needle and endowing more functional characteristics, such as the inner tube and the outer tube are isolated by adding an insulating piece, and the structure is changed into a single-needle multi-pole structure. That is, the simple sleeving of the inner tube and the outer tube according to the common strand can also be used as a basic electrode needle structure, and the design of the inner tube combined with the reflux mouth is only unfavorable for optimizing the richer functions of the electrode needle. Secondly, a plurality of points which are sequentially arranged are arranged on the axial direction of the inner pipe, at least one point is provided with a backflow port, and the sum of the opening sectional areas of the backflow ports is further limited to be smaller than or equal to the opening sectional area of the inflow channel, so that the backflow speed is smaller than or equal to the inflow speed, a foundation is provided for changing the temperature difference boundary point when a plurality of backflow ports are arranged (namely, when the most recent backflow port is not faster than backflow, the more distant backflow port is utilized for backflow). The electrode needle sectional temperature control is achieved by utilizing the reflux means of different fluid flow rates and different numbers of reflux ports, so that the sectional control of the area and the shape of the coagulation area is realized, and the special requirements of different target positions are met.
2. The electrode needle is mainly used in the field of liver and gall electrosurgery, the existing similar products are improved into the form of an inner tube and an outer tube, the outer surface area of the outer tube is larger than the exposed outer surface area of the inner tube, the inner tube and the outer tube are electrically isolated through an insulating piece, the inner tube and the outer tube can present different polarities through a host, namely, the inner tube and the outer tube can be used as working poles or loop poles, and the inner tube and the outer tube can be switched between the working poles and the loop poles; for a smoother penetration, the insulator is again set flush with the outer surface of the outer tube and is in smooth engagement with the tip. Thus, the problems that the puncture and hemostasis ablation of a single needle cannot be realized in the prior art are basically solved, and a local small area of the tissue can be treated, which is different from the scheme that the tissue is treated by matching two needles in the prior art. If the phenomenon of sticking a knife is easy to occur in the case of no fluid circulation channel electrode, after the phenomenon occurs, the part which is already hemostatic and ablated is easy to damage in the inserting and pulling process of the puncture, a good effect cannot be achieved, and even the damaged area of tissues can be enlarged, so that the potential medical safety hazard is greater. The reason is that the energy in the working process of the electrode is very high, the energy of the electrode itself must be taken away in time, and the optimal hemostatic ablation effect is achieved by regulating the way that the energy acts on the tissues. The invention has the fluid circulation channel, when the tip generates plasma, the insertion depth can be controlled more accurately without the risk of over-insertion basically without the violent insertion of external force when the tip is inserted into tissues. The invention solves the technical problems that the existing hemostatic instrument for the solid organ cannot be easily inserted and can not realize deep perforation and coagulation at the same time.
Detailed Description
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.
Fluid: the invention mainly refers to cooling mediums such as normal saline, low-temperature water, ice water and the like.
Proximal end: refers to the end facing away from the puncture direction.
Distal end: refers to one end of the puncturing direction.
Example 1
Referring to fig. 1 to 3, the electrode assembly provided by the invention is suitable for hemostasis ablation of various organs and tissues, especially for puncture and hemostasis ablation of large vessel parenchymal organs, and comprises at least two electrode needles 1, wherein each electrode needle 1 comprises:
an inner tube 11, said inner tube 11 comprising a stem 111 and a tip 112 at the distal end of the stem 111; the main portion 111 is provided with a flow inlet channel 141, a plurality of points arranged in sequence are arranged in the axial direction of the main portion 111, and at least one point is provided with a return port 142;
An outer tube 12 sleeved outside the inner tube 11 and smoothly connected with the tip 112 exposed from the inner tube 11; a return passage 143 communicating with the inflow passage 141 through the return port 142 is formed between the outer tube 12 and the inner tube 11; the inflow passage 141, the return port 142, and the return passage 143 constitute a fluid circulation passage; the sum of the opening cross-sectional areas of the return ports 142 is less than or equal to the opening cross-sectional area of the inflow channel 141; in the working state, the return port 142 is used as a temperature difference demarcation point at which the electrode needle 1 is controlled in a segmented manner. And (3) injection: the return port 142 is defined as a rough division of the temperature difference boundary point, and the actual temperature difference boundary may deviate distally or proximally from the return port 142 by a certain deviation.
The temperature difference demarcation point has at least any one of the following conditions:
1) If the return ports 142 are provided only in the circumferential direction corresponding to one point in the axial direction of the inner tube 11, the temperature difference demarcation point is fixed;
2) Referring to fig. 4 to 5, if the return ports 142 are provided in the circumferential direction corresponding to two or more points in the axial direction of the inner tube 11, the temperature difference boundary point is variable.
The case 2) of the temperature difference demarcation point corresponds to at least one of the following operating states: the temperature differential demarcation point is adjustable in a proximal to distal direction and at most to the distal-most return port 142.
If the plugging ring 14 and the fluid branch pipe 15 are not provided in the present embodiment, a cooling medium (e.g., physiological saline) flows along the inflow channel 141 and the return channel 143, so that the desired purpose can be achieved. However, for better assembly, the proximal end of the return channel 143 is provided with a sealing ring 14 and the side of the outer tube 12 is provided with a fluid branch 15 communicating with the proximal end of the return channel 143. In this embodiment, the fluid inlet and outlet modes: referring to fig. 4 to 5, the cooling medium is fed from the proximal end of the inner tube 11, flows back from the return port 142 at the distal end of the inner tube 11 into the distal end of the outer tube 12, and finally flows out of the fluid branch tube 15 at the proximal end of the outer tube 12 due to the flow direction guided by the plugging ring 14. After the cooling medium passes through the process, the temperature of the electrode needle 1 can be taken away in time, so that the energy transmission is more proper, and the electrode and the tissue are prevented from being adhered (namely, the phenomenon of sticking a knife).
Preferably, the length and diameter of each electrode needle 1 are the same.
The outer tube surface of each electrode needle 1 is provided with scales corresponding to the return ports 142 at each point in the axial direction of the inner tube 11.
Based on the above-mentioned scheme, a closing-up (not shown in the drawings) may be added to the distal end of the inner tube 11, and the closing-up may be fully sealed, and the structure that is relatively easy to manufacture is cone-shaped or frustum-shaped, that is, a structure that can prevent the cooling medium from flowing along the axial distal end, so as to guide the cooling medium to the backflow port 142 on the side of the trunk 111.
Referring to fig. 9, an insulation member 13 may be further added in this embodiment, that is, at least one insulation member 13 is sleeved outside the inner tube 11 to separate each section of the outer tube 12 into at least two sections. This arrangement allows it to achieve a "one-needle two/more pole" effect, unlike the above-described solution which can only be used with "one needle one pole" (see figure 8). The terms "one-needle one-pole" or "one-needle two/more pole" are herein equivalent to electric polarity. Under the alternating current output by the host, the polarity of the whole needle is continuously switched between a working pole ("+") or a loop pole ("-"), the polarities of the adjacent electrode needles 1 are always opposite, and a single needle only has one pole, and belongs to one needle one pole at the moment. Under the alternating current output by the host, the polarities of the tip 112 of the inner tube 11 and the outer tube 12 in the single needle are continuously switched between working poles ("+") or loop poles ("-"), and the polarities of the same parts between the adjacent electrode needles 1 are always opposite, and the single needle has at least two poles, and belongs to one needle two/multiple poles at the moment. This "one-needle two/multi-pole" design allows it to have multiple modes of output controlled by the host, while the present embodiment further allows it to have a punch mode and a coagulation mode. For the convenience of understanding, it can be understood that the punching mode and the coagulation mode both have set host control schemes, if the operator inputs the punching mode, the host immediately controls the on-off of the relay thereof after receiving the instruction, so as to achieve the polarity distribution effect required to be presented in the punching mode, and the coagulation mode is the same as the main control aspect, and belongs to the technical content which can be known by the person skilled in the art without creative labor, so that the description is omitted.
Referring to fig. 6 to 7, the invention provides a hemostatic instrument, which comprises a handle 2, a cable plug 3, a flow inlet pipe 4, a return pipe 5 and the electrode assembly; the handle 2 is provided with a control switch 6 for respectively controlling each electrode needle 1, and each electrode needle 1 is respectively connected with the cable plug 3 through a lead.
The handle 2 comprises an upper shell 21 and a lower shell 22, and the upper shell 21 is buckled on the lower shell 22. A positioning member 221 for fixing the electrode needle 1 is provided in the lower case 22. The inflow pipe 4 and the return pipe 5 are each connected to the fluid circulation channel of each electrode needle 1 through a hose 7, respectively. The cable plug 3 is connected to the electrode pin 1 via the working conductor 31 and in turn to the PCB board 61 of the control switch 6 via the control conductor 32. The control switch 6 is used for switching between a punching mode and a coagulation mode.
The invention also provides a hemostasis system, which comprises a host machine, a fluid injector, a peristaltic pump, an aspirator and the hemostasis instrument, wherein the cable plug 3 is connected with the host machine; one end of the inflow pipe 4 is connected with the fluid injector (such as a liquid injector, an infusion bag and the like), and the other end is connected with a peristaltic pump and then connected with the inflow channel 141; the aspirator is connected to the return passage 143 through an aspiration tube.
Further, the hemostatic system further comprises a foot switch for controlling each electrode needle 1. The foot switch basically has the same function as the control switch, and aims to take care of operators who are used to control by using the foot switch.
Wherein:
Referring to fig. 1 to 3, the inner tube 11 and the outer tube 12 are made of metal materials, and the same materials are recommended for conducting and discharging. The trunk portion 111 of the inner tube 11 and the outer tube 12 are tubular, i.e., may be straight or curved, and preferably straight.
The insulating member 13 and the plugging ring 14 may be made of plastic or other insulating materials. The insulating member 13 may be a circle, sleeved on the connection portion between the trunk 111 and the tip 112, and used as a positioning ring, or may further fix the outer tube 12 by means of gluing, or the sealing ring 14 may be a welding ring formed by means of welding. The width of the insulating member 13 and the plugging ring 14 (i.e. the length from the distal end to the proximal end) is 0.5-10 mm, preferably 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10mm, etc.
The tip 112 of the inner tube 11 is conical, and the tip 112 serves as a discharge site of the inner tube 11. In this embodiment, tip 112 is solid inside. The details of the construction here are that the conical bottom (i.e. the side with the larger diameter) of the tip 112 has a larger diameter than the diameter of the trunk 111, the purpose of which is to pass through the outer tube 12 and leave a return channel 143. Preferably, the length of tip 112 (along the axial direction of stem 111) is much less than the length of stem 111.
The purpose of the return port 142 is to stage the outer tube 12 for temperature control. At least in two different cases. It is necessary here to explain the temperature difference demarcation point further. The electrode needle 1 is normally operated in a vertical state and is therefore mainly explained in this state.
For easy understanding, the main portion 111 can be regarded as a return port no matter how many return ports are circumferentially arranged corresponding to one point in the axial direction.
When the temperature difference demarcation point is in case 1):
The outer tube 12 corresponds to an X portion and a Y portion separated into a distal end and a proximal end by the return port 142, and when an operator injects a cooling medium at a proper flow rate and pressure, the cooling medium is first used for filling a pit, that is, the X portion corresponds to a water storage area, and at this time, the temperature of the X portion is lower than the temperature of the Y portion due to the fact that the X portion is cooled by the cooling medium, so that the purpose of sectionally controlling temperature coagulation is achieved. However, this process is very short and not sustainable and is not suitable for the staged temperature controlled coagulation, i.e. no new cooling medium is introduced to exchange heat and carry away after the cooling medium has been heated to its limit. After the cooling medium fills the X portion, even if the flow speed and pressure are increased, the newly injected cooling medium cannot wash away or wash away less of the heated cooling medium in the X portion, and the newly injected cooling medium basically directly flows back from the return port 142 without sufficient heat exchange with the heated cooling medium in the X portion, so that the temperature difference boundary point is basically unchanged, and the temperature of the X portion is higher than the temperature of the Y portion, thereby achieving the purpose of sectional temperature control coagulation.
When the temperature difference demarcation point is in case 2):
The outer tube 12 is also divided into a distal X portion and a proximal Y portion by the return port 142, but when the operator injects the cooling medium at a proper flow rate and pressure, the cooling medium is first used for filling the sump, i.e., the X portion is equivalent to a water storage area, and at this time, the temperature of the X portion is lower than the temperature of the Y portion due to the cooling medium in the X portion, so that the purpose of sectional temperature-controlled coagulation is achieved, as shown in fig. 16. But this process is very short and not sustainable and is not suitable for use in the staged control Wen Ningxie. After the cooling medium fills the X portion, the flow speed and pressure are increased, the newly injected cooling medium washes away the cooling medium heated by the X portion from the reflux port 142 at the farther end, and the newly injected cooling medium and the cooling medium heated by the X portion generate sufficient heat exchange, so that the temperature difference boundary point moves to the far end to form that the temperature of the X portion is higher than the temperature of the Y portion, and the low temperature area of the Y portion can be prolonged and expanded to the far end along with the increase of the flow speed and pressure of the cooling medium, thereby achieving the purpose of adjusting the temperature-controlled coagulation area, as shown in fig. 17. Wherein, the return ports 142 of each point are required to be matched with different flow rates and pressures through experiments.
For this purpose, the cross-sectional area of the opening of the return port 142 corresponding to each point in the axial direction of the inner tube 11 may be the same (there are a plurality of return ports 142 at the same point), but it is preferable that the cross-sectional area gradually decreases from the proximal end to the distal end. So as to avoid that the reflux of the reflux port at the far end is excessive, and the temperature difference demarcation point is not obvious, thereby influencing the sectional temperature control coagulation effect.
In order to achieve the similar effect, the following scheme can be adopted as well:
Referring to fig. 18, a choke assembly 16 is disposed within the intake passage 141. The choke assembly 16 is preferably not present at the same time as the above-described closing-in, and may be an alternative to closing-in. The choke assembly 16 includes a resilient expansion member 161 (e.g., a spring) having one end fixed to a distal end of the inflow channel 141, and a stopper 162 connected to the other end, the stopper 162 being capable of blocking the passage of the cooling medium through the return port 142.
The choke assembly 16 also has at least any one of the following conditions:
1) In the initial state, the stop 162 blocks all the return openings 142 from flowing back, no matter how many return openings 142 are (the same point is regarded as one return opening 142); as the flow rate and pressure increase, the cooling medium washes and extrudes the stop block 162 in the distal direction, and gradually opens all the reflux ports 142 for reflux; the return ports 142 at each point need to be tested to match different flow rates, pressures.
2) In the initial state, the stop 162 only guides the cooling medium to flow back from the most proximal return port 142, other return ports 142 are blocked, and as the flow speed and pressure increase, the cooling medium flushes and extrudes the stop 162 in the distal direction, and all the return ports 142 are gradually opened for backflow; the return ports 142 at each point need to be tested to match different flow rates, pressures.
When using the choke assembly 16, as explained in state 1) thereof, the temperature difference demarcation point likewise has at least one of the following:
1) If the return ports 142 are provided only in the circumferential direction corresponding to one point in the axial direction of the inner tube 11, the temperature difference demarcation point is fixed;
2) If the return ports 142 are provided in the circumferential direction corresponding to two or more points in the axial direction of the inner tube 11, the temperature difference boundary point may be variable.
When the temperature difference demarcation point is in case 1):
The outer tube 12 corresponds to an X portion and a Y portion which are separated into a distal end and a proximal end by the return port 142, when an operator injects a cooling medium at a proper flow rate and pressure, the cooling medium presses the stop block 162 and opens the return port 142, and water storage is started at this time, that is, the X portion corresponds to a water storage area, and at this time, the temperature of the X portion is lower than that of the Y portion due to the fact that the X portion is cooled by the cooling medium, so that the purpose of sectionally controlling temperature coagulation is achieved. But this process is very short and not sustainable and is not suitable for use in the staged control Wen Ningxie. After the cooling medium fills the X portion, even if the flow speed and pressure are increased, the newly injected cooling medium cannot wash away or wash away less of the heated cooling medium in the X portion, and the newly injected cooling medium basically directly flows back from the return port 142 without sufficient heat exchange with the heated cooling medium in the X portion, so that the temperature difference boundary point is basically unchanged, and the temperature of the X portion is higher than the temperature of the Y portion, thereby achieving the purpose of sectional temperature control coagulation.
When the temperature difference demarcation point is in case 2):
The outer tube 12 is also divided into a distal portion X and a proximal portion Y by the return port 142, but when the operator injects the cooling medium at a proper flow rate and pressure, the cooling medium presses the stopper 162 and opens the return port 142 at the nearest end, and water storage is started at this time, i.e., the portion X is equivalent to a water storage area, and at this time, the temperature of the portion X is lower than the temperature of the portion Y due to the cooling medium in the portion X, so that the purpose of the sectional temperature-controlled coagulation is achieved, as shown in fig. 16. But this process is very short and not sustainable and is not suitable for use in the staged control Wen Ningxie. When the cooling medium fills the X portion, the flow speed and pressure are unchanged, the newly injected cooling medium cannot wash away or wash away much of the heated cooling medium in the X portion, and the newly injected cooling medium basically directly flows back from the return port 142, and does not generate sufficient heat exchange with the heated cooling medium in the X portion, so that the temperature difference boundary point is basically unchanged, and the temperature of the X portion is higher than the temperature of the Y portion, thereby achieving the purpose of sectional temperature control coagulation, and referring to fig. 17. If the flow speed and pressure continue to be increased at this time, the stop block 162 will continue to move towards the distal direction, so as to open the corresponding return port 142, the newly injected cooling medium washes away the cooling medium heated at the X portion from the return port 142 at the farther end for return, and the newly injected cooling medium and the cooling medium heated at the X portion generate sufficient heat exchange, so that the temperature difference boundary point moves towards the distal end, the temperature of the X portion is higher than the temperature of the Y portion, and the low temperature region of the Y portion can be prolonged and enlarged towards the distal end along with the increase of the flow speed and pressure of the cooling medium, thereby achieving the purpose of adjusting the temperature-controlled coagulation area. Wherein, the return ports 142 of each point are required to be matched with different flow rates and pressures through experiments.
The above conditions are all generated on the premise of proper flow rate and pressure, if the set flow rate and pressure are large, the effect of the sectional temperature control coagulation does not exist, and therefore, the conditions are not in the discussion range.
If the cooling medium is not used for cooling, the heat effect of the electrode needle 1 is strong, quick eschar is easy to cause, and the electrode needle 1 is easy to cause sticking of a knife and cause secondary bleeding in the process of inserting and extracting, so that the cooling medium is required to be introduced for cooling. The electrode needle 1 after being introduced with the cooling medium for cooling can form a coagulation area on the target tissue relatively regularly, and the cross section of the coagulation area is rectangular, so that the coagulation area is beneficial to the subsequent tissue excision and other operations of operators.
The difference brought by the sectional temperature control of the lead-in electrode needle 1 is as follows: the section with a higher temperature has a stronger thermal effect on the target tissue than the section with a lower temperature of the electrode needle 1, and the region of action is larger. However, in the sectional temperature control, the sectional shape of the coagulation region of a section with a high temperature may not be easily controlled due to the influence of the flow rate and pressure of the cooling medium, that is, the sectional shape of the missing region needs to be controlled by finding a proper flow rate and pressure through a lot of experiments, so it is generally recommended to perform the operation for a long period of time by using the electrode needle 1 in a sectional temperature control. Referring to fig. 17, in a large area ablation coagulation electrosurgical procedure, for example, a portion of a target tissue is provided with a blood vessel, and a low temperature segment is positioned at the portion of the target tissue provided with the blood vessel to perform a segmented control Wen Ningxie, thereby improving the efficiency.
In the process of the sectional temperature-control coagulation, if a scheme of adding an insulating member 13 is adopted, referring to fig. 9, 10, 11 and 13, that is, at least one insulating member 13 is sleeved outside the inner tube 11 to isolate each section of the outer tube 12 into at least two sections, and each section of the outer tube 12 and the inner tube 11 can be respectively connected into the cable plug 3 through wires. In this embodiment, a section of the outer tube 12 close to the tip 112 of the inner tube 11 is actually connected to the tip 112 of the inner tube 11 without isolation of the insulation 13, so that the section of the so-called outer tube 12 already corresponds to a part of the inner tube 11. The device belongs to 'one-needle two/multi-pole', and has two working modes of punching and coagulation.
A) Perforation mode: referring to fig. 10 to 11, the same parts of the electrode pins 1 have the same corresponding electric polarities, and the tip (112) is used as a working electrode to excite plasma (electrolyte solution of human tissue can be used as physiological saline environment to excite plasma);
b) Coagulation mode: referring to fig. 13, the same portions of adjacent electrode needles 1 have opposite electric polarities.
To ensure optimum perforating, the sum of the outer surface area of the tip 112 and the section of the outer tube 12 near the tip 112 of the inner tube 11 is smaller than the outer surface area of the other sections to facilitate plasma excitation.
Referring to fig. 12 to 13, the current has a characteristic, and a path having a small impedance is always selected. Because the inside of the tissue has the conditions of blood vessels, uneven density, sticking knives and the like, the impedance of the tissue is also different, so that current always flows in a certain area; so that in the case of large-area coagulation, there is always a coagulation difference: i.e., a portion of the blood is sufficiently coagulated and another portion still does not achieve the blood coagulation effect, which may be due to sticking of a knife or other factors. The invention is improved to a sectional electrode, and the host can identify the impedance (R=U/I) of different areas so as to judge the coagulation effect of the different areas. The host computer then controls the on-off of the electrodes (including the tip 112) at different sections to realize regional accurate coagulation, or regional coagulation by regulating and controlling the fluid flow rate.
Since the same insulator 13 and outer tube 12 are used, the insulator 13 remains flush with the outer surface of the outer tube 12. In this case, the insulator 13 serves not only to separate the inner tube 11 from the outer tube 12 but also to separate the outer tube 12 from the outer tube 12. The number of insulation members 13 here for separating the outer tube 12 from the outer tube 12 may be 1, 2,3, 4, 5 etc., depending on the overall length of the outer tube under the correspondence, the length of each minor segment.
Because the polarities of the sections of the inner tube 11 and the outer tube 12 may be different, for medical safety, firstly, the inner tube 11 and the outer tube 12 may be ensured to be parallel or coaxial as much as possible, secondly, an insulating layer 8 may be further added on the outer surface of the main portion 111, referring to fig. 20 to 21, corresponding holes of the insulating layer 8 are provided at corresponding positions of the reflux ports 142 as a part of the reflux ports 142, and furthermore, the insulating member 13 may be also sleeved outside the insulating layer 8 to increase safety. The insulating layer 8 may be an insulating material such as a heat shrink tube; the proximal end of the trunk 111 extends beyond the outer tube 12 and the outer surface is exposed to facilitate connection of the cables. In the field of hepatobiliary electrosurgery, the diameter of the electrode needle 1 is about 0.5-2 mm, and under the size of the electrode needle 1 commonly used, the gap between the outer tube 12 and the main portion 111 is about 0.2mm, even if the outer tube 12 and the main portion 111 are initially arranged in parallel, if not arranged as the insulating layer 8, contact easily occurs during use, and adverse events are caused.
The electrode needle 1 is mainly used in the field of liver and gall electrosurgery, the existing similar products are improved into an inner tube and an outer tube, the inner tube 11 and the outer tube 12 are electrically isolated through an insulating piece 13, the inner tube 11 and the outer tube 12 can present different polarities through a host, namely, the inner tube 11 and the outer tube 12 can be used as working poles or loop poles; for a smoother penetration, the insulator 13 is again positioned flush with the outer surface of the outer tube 12 and in smooth engagement with the tip 112. Thus, the problems that the puncture and hemostasis ablation of a single needle cannot be realized in the prior art are basically solved, and a local small area of the tissue can be treated, which is different from the scheme that the tissue is treated by matching two needles in the prior art. However, if the electrode is stopped, the electrode only meets the minimum requirements, and safer puncture and hemostasis ablation cannot be realized, namely, the electrode is easy to generate a phenomenon of sticking a knife, after the phenomenon, the part which is subjected to hemostasis ablation is easy to damage in the inserting and pulling process of the puncture, a good effect is not achieved, and even the damaged area of tissues can be enlarged, so that the potential medical hazard is greater. The reason is that the energy in the working process of the electrode is very high, the energy of the electrode itself must be taken away in time, and the optimal hemostatic ablation effect is achieved by regulating the way that the energy acts on the tissues. Therefore, the present invention improves the circulation structure of the cooling medium based on the above scheme, that is, the inflow channel, the return port and the return channel form a fluid circulation channel, and the mode of applying energy to the tissue can be regulated and controlled by the rf plasma host or manually matching the flow rate of the cooling medium under different output powers, and the use of the return port 142 in embodiment 1. When the tip 112 generates plasma, it has the ability to punch holes, substantially without the need for violent insertion by external forces, allowing for more precise control of the depth of insertion without risk of over-insertion. The invention solves the technical problem that the existing hemostatic instrument for the solid organ can not realize safe puncture and hemostatic ablation of a single needle.
Compared with the prior art, the scheme ensures that the cooling medium is influenced by the main part 111 and the inflow in the process of refluxing, and the residence time of the cooling medium in the electrode needle 1 is relatively longer, so that the position, the number and the size of the reflux ports 142 are more beneficial to controlling the flow velocity of the cooling medium in the electrode needle 1 and the speed regulation of each gear bit stream of the external peristaltic pump is more obvious. Therefore, the electrode needle 1 also solves the technical problem that the prior art cannot accurately regulate the temperature of the electrode needle 1 of the hemostatic instrument for the solid organ puncture. Of course, the present invention may still perform a wide range of leveling or surface coagulation.
Of course, the most important aspect of the present invention is based on the design of the reflux port 142 as a temperature difference dividing point for the electrode needle 1 to be controlled in a segmented manner, and the temperature difference dividing point can be moved in the axial direction of the electrode needle 1 when the number of reflux ports 142 is more than two. The design can realize sectional control of the size of the coagulation area, and the lengths of the high-temperature area and the low-temperature area are adjustable, so that the special requirements of different target sites, such as certain sites with blood vessels, can be met. And the blood coagulation efficiency is not reduced due to the influence of blood vessels, but can be improved by reasonably utilizing the high Wen Duanlai.
Example 2
The main difference between this embodiment and the above-described embodiment is that:
Referring to fig. 19 to 21, in this embodiment, an insulating member 13 is added between the tip 112 and the outer tube 12 and sleeved on the trunk 111, so as to isolate the outer tube 12 from the inner tube 11. In this way, a single electrode needle 1 can achieve a wide range of "surface coagulation" and "insertion coagulation" of the target tissue. Other structures, materials, principles, effects and further modified combinations are substantially identical to those mentioned in the above embodiments, such as temperature difference demarcation points, segmented outer tube 12, perforation mode, coagulation mode principles, effects and the like, reference being made to the above embodiments. This design shortens the length of the tip 112 as a working electrode in the punching mode and thus shortens the section of the outer tube 12 near the proximal end. In the case of a limited length of the electrode needle 1, a multiple segmentation is facilitated, which means a more precise positioning of the ablation effect.
Example 3
The main difference between this embodiment and the above-described embodiment is that:
Referring to fig. 22, the electrode assembly according to the present embodiment is provided in which the electrode needle 1 is constructed in a common inner and outer sheathing structure, and is not constructed in such a manner that the inner tube 11 having the tip 112 is smoothly coupled to the outer tube 12 after being passed out of the outer tube 12 in the above-described embodiment. The main structure of the electrode needle comprises at least two electrode needles 1, wherein each electrode needle 1 comprises an outer tube 12, and an inner tube 11 with a closed distal end is coaxially arranged in the outer tube 12; a plurality of points which are sequentially arranged are arranged on the axial direction of the inner pipe 11, and at least one point is provided with a return port 142; the inner pipe 11 is used as an inflow channel 141, the outer pipe 12 is used as a return channel 143, and the inflow channel 141, the return port 142 and the return channel 143 form a fluid circulation channel; the sum of the opening cross-sectional areas of the return ports 142 is less than or equal to the opening cross-sectional area of the inflow channel 141; in the working state, the return port 142 is used as a temperature difference demarcation point at which the electrode needle 1 is controlled in a segmented manner. Other structures, materials, principles, effects and further modified combinations are substantially identical to those mentioned in the above embodiments, such as temperature difference demarcation points, segmented outer tube 12, perforation mode, coagulation mode principles, effects and the like, reference being made to the above embodiments.
Example 4
The main difference between this embodiment and the above-described embodiment is that:
Referring to fig. 14 to 15, this embodiment also discloses a hemostatic instrument, which mainly changes the external structure of the handle 2, and the internal installation mode is adaptively adjusted. The handle 2 can be divided into left and right parts, and each part is provided with at least one electrode needle 1, and the electrode needle 1 can adopt the structure of one needle and one pole in the embodiment 1, and can also adopt the structure of one needle and two/multiple poles. In a normal use state, the left part and the right part are connected through a connecting piece, so that each electrode needle 1 forms a straight-line arrangement; in some cases, the left and right parts may also be connected by a connecting member, so that the respective electrode pins 1 are arranged in a mouth-like arrangement (i.e., rectangular arrangement). Reference may be made specifically to the prior patent CN211243675U, etc., and no further description is given here.
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, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.