Disclosure of Invention
In view of the above, the present invention is directed to an electrode assembly for preventing needle tract hemorrhage and a hemostatic apparatus thereof, so as to solve the technical problem of easily causing needle tract hemorrhage in the prior art.
The technical scheme provided by the invention is as follows:
The electrode assembly for preventing needle tract bleeding comprises an electrode needle, an insulating tube and a control member, wherein the electrode needle comprises an insulating needle head, an electrode I, an insulating member and an electrode II which are sequentially arranged from far to near, the electrode I and the electrode II are opposite in polarity, the proximal end of the electrode II is wrapped with an outer insulating layer, the insulating tube is sleeved outside the electrode needle, the distal end of the insulating tube is a cutting edge, and the side part of the insulating tube is provided with a coagulation window;
when the insulating tube is positioned at the most distal end, a single side of the first electrode and the second electrode is exposed through the curtailment window, and an insulating needle is exposed;
when the insulating tube is positioned at the nearest end, the first electrode and the second electrode are completely exposed.
Further, the cross section of the coagulation cutting window is rectangular, and the axial length of the coagulation cutting window is smaller than or equal to the sum of the axial lengths of the first electrode, the insulating piece and the second electrode.
Further, the included angle of the coagulation cutting window in the radial direction of the electrode needle is 10-270 degrees.
Further, when the insulating tube is located at the most distal end, the cutting edge of the insulating tube is smoothly connected with the insulating needle.
Further, the insulating piece and the electrode II are sequentially sleeved on the electrode I, and an inner insulating layer is wrapped outside the electrode I to isolate the electrode II.
Furthermore, the first electrode is provided with a flow outlet, and a flow inlet channel communicated with the flow outlet is arranged in the first electrode.
Further, a grid for balancing energy is arranged in the middle of the curtailment window.
Further, the first electrode, the insulating piece and the second electrode are coaxially arranged and have the same outer diameter, and the proximal end of the insulating needle head is smoothly connected with the first electrode.
The invention also provides a hemostatic instrument which comprises a handle, a cable plug, a flow inlet pipe and the electrode assembly, wherein the distal end of the handle is connected with the proximal end of the electrode assembly, and the proximal end of the handle is connected with the cable plug and the flow inlet pipe.
Furthermore, a fixed block for fixing the electrode needle is arranged in the handle, the control piece is fixed outside the insulating tube, the distal end and the proximal end of the control piece are respectively provided with a limiting step, and the control piece is clamped in the handle through the limiting steps.
Further, the proximal ends of the first and second electrodes extend into the handle and each have exposed portions for connection to the cable plug by wires.
Compared with the prior art, the invention has the main beneficial effects that:
The invention has the main improvement points that the insulating tube is additionally arranged and improved, which is different from the traditional simple insulating effect or guiding effect, and the small part with optimized structure is integrated into the electrode assembly, so that the hemostatic instrument has the functions of cutting, directional ablation and the like, not only solves the technical problem of needle tract bleeding, but also is suitable for surface coagulation and insertion coagulation, does not influence the application range of operators, and has higher acceptance of the operators after being converted into products.
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 refer to 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 fluid mainly refers to physiological saline and the like.
Proximal refers to the end facing away from the penetration direction.
Distal end refers to the end in the direction of penetration.
Curdling window refers to a window that provides release of electrocoagulation energy, and can also be used as a window for resecting tissue.
The embodiment 1, referring to fig. 1-5 and 7, provides an electrode assembly for preventing needle tract bleeding, which comprises an electrode needle 11, an insulating tube 12 and a control member 13, wherein the electrode needle 11 comprises an insulating needle head 111, an electrode I112, an insulating member 113 and an electrode II 114 which are sequentially arranged from far to near, the polarities of the electrode I112 and the electrode II 114 are opposite, the proximal end of the electrode II 114 is wrapped with an outer insulating layer 115, the insulating tube 12 is sleeved outside the electrode needle 11, the distal end of the insulating tube is provided with a cutting edge 121, the side part of the insulating tube is provided with a coagulation window 122, and the control member 13 is connected with the insulating tube 12 so as to control the insulating tube 12 to rotate and/or move upwards in the axial direction of the electrode needle 11;
When the insulating tube 12 is located at the most distal end, a single side of the first electrode 112 and the second electrode 114 (refer to the outer side corresponding to a partial angle in the circumferential direction of the first electrode 112/the second electrode 114) is exposed through the coagulation window 122 (refer to the complete or partial exposure in the axial direction of the first electrode 112 and the second electrode 114), and the insulating needle 111 is exposed;
when the insulating tube 12 is positioned at the proximal end, the first electrode 112 and the second electrode 114 are completely exposed.
2-4, In order to implement the above scheme, the following measures may be specifically adopted:
The first electrode 112 is configured to include a connection tube 1121 and an exposed tube 1122, and the lengths of the exposed tube 1122 and the second electrode 114 may be 1cm, 1.5cm, 2cm, 2.5cm, etc. the insulating member 113 may be slightly shorter, such as 0.5cm, 1cm, etc., as required to isolate the electrical effect, and the shorter the insulating member 113 may result in a stronger energy near both ends of the insulating member 113 as required. The outer diameter of the exposed tube 1122, the insulator 113 and the electrode two 114 are coaxially arranged and have the same outer diameter, the outer diameter is about 1-2mm, the outer diameter of the connecting tube 1121 is smaller than the outer diameter of the exposed tube 1122, about 0.5-1.8mm, it is generally ensured that the outer diameter of the connecting tube 1121 is smaller than the outer diameter of the exposed tube 1122 by more than 0.2mm, of course, in some special cases, the above-mentioned dimensions may be changed, for example, after changing the target tissue, the surgical site enters the channel to be narrow, or when the requirement for ablation accuracy is raised, the dimensional requirement may be smaller, in contrast, if the surgery is not limited by the access channel or the ablation accuracy, the dimensional requirement may be larger. In some cases, it may not be necessary to deliver normal saline to the target site, such as in the case of surface ablation of avascular tissue, where both the connecting tube 1121 and the exposed tube 1122 may be solid connecting rods or hollow metal tubes. Generally, since the diameters of the connection tube 1121 and the exposed tube 1122 are different, if a metal tube with a hollow interior is used, the connection portion between the two should be sealed when the connection tube 1121 is connected to the exposed tube 1122, such as welding, etc., if the connection tube 1121 and the exposed tube 1122 are both solid, the insulator 113 is preferably a ring-shaped sleeve, the connection tube 1121 and the exposed tube 1122 are coaxially arranged, the connection tube 1121 is wrapped with an inner insulating layer 118 to isolate the two electrodes 114, and the inner insulating layer 118 and the outer insulating layer 115 are preferably heat shrink tubes. The insulating member 113 and the electrode two 114 are sleeved on the connecting pipe 1121 coated with the inner insulating layer 118, so that the exposed pipe 1122, the insulating member 113 and the electrode two 114 are prevented from being on the same axis due to shaking, the outer sides of the exposed pipe 1122, the insulating member 113 and the electrode two 114 are ensured to be flush as much as possible, and the joint between the exposed pipe 1122, the insulating member 113 and the electrode two 114 is ensured to have no gap, so that the electrode needle 11 is prevented from being excessively blocked in the process of inserting into tissues.
Further, the proximal end of the insulated needle 111 is smoothly engaged with the electrode one 112. That is, the connection between the insulating needle 111 and the first electrode 112 is smooth, and no stagnation is generated during the insertion into the tissue. Specifically, the insulating needle 111 may be provided as a needle 1111 and a coupling portion 1112, the needle 1111 being used for piercing, and the coupling portion 1112 being used for connecting the electrode one 112. Since a solid exposed tube 1122 may be used in this embodiment, a connecting rod (not shown in the drawings) may be provided at the center of the distal end face of the exposed tube 1122, and the joint 1112 may be provided as a groove for interference riveting after insertion of the connecting rod.
The insulating tube 12 is a non-metal tube, and can be used as an insulating layer to prevent accidental injury, and meanwhile, a material with certain strength, such as a PEEK material, is selected, so that the cutting edge 121 and the coagulation cutting window 122 are arranged. When the insulating tube 12 is positioned at the most distal end, the cutting edge 121 of the insulating tube 12 is smoothly engaged with the insulating needle 111. That is, the connection between the cutting edge 121 and the adjacent position of the insulating needle 111 is smooth, and the blocking feeling is not generated in the process of inserting the cutting edge into tissues. It may be that the tip of the insulating needle 111 is conical (also may be a tip with an angle, refer to fig. 2), the included angle between the outer side of the cutting edge 121 and the axial direction is half of the included angle between the outer side of the tip of the insulating needle 111 (i.e. the distal end of the needle 1111), or the most distal end of the cutting edge 121 is just located at the most proximal end of the tip of the insulating needle 111, and both cases are provided.
The cross section of the coagulation cut window 122 is rectangular, and the axial length thereof is less than or equal to the sum of the axial lengths of the first electrode 112, the insulating member 113 and the second electrode 114. The rectangular cross-section of the curettage window 122 is only one preferred shape, and the shape of directional ablation is more square, which is more beneficial to the ablation after ablation, and does not exclude the possibility of adopting other cross-sectional shapes such as ellipse, circle and the like. The angle of the coagulation cut window 122 in the radial direction of the electrode needle 11 is 10 ° -270 °, preferably 10 °, 15 °,20 °,30 °, 45 °, 60 °, 90 °, etc., in order to ensure a sufficiently large energy release window. The curdling window 122 is a window with a 'cutting edge-shaped chamfer', and the window is preferably provided with the 'cutting edge-shaped chamfer', and the 'cutting edge-shaped chamfer' can be also arranged on two sides of the window in the axial direction or the radial direction, and the curdling window 122 can be used as a window for directional ablation, can strip tissues from an electrode, and does not damage the tissues. In order to assist in observing the orientation and the approximate position of the curtailment window 122, a window positioning mark 132 may be added to the control member 13, where the window positioning mark 132 may be set in various manners, for example, the window positioning mark 132 and the curtailment window 122 are set on the same straight line, a single striking color mark may be used, and the surface of the control member 13 may be protruded to be set into a bead shape, so that the position of the curtailment window 122 is determined with visual assistance, and the orientation of the curtailment window 122 is positioned with tactile assistance.
Referring to fig. 1 and 4, the hemostatic instrument is specifically applied to a hemostatic instrument, and comprises a handle 2, a cable plug 3 and an inflow tube 4, and further comprises the electrode assembly 1, wherein the distal end of the handle 2 is connected with the proximal end of the electrode assembly 1, and the proximal end of the handle 2 is connected with the cable plug 3 and the inflow tube 4.
The handle 2 is internally provided with a fixed block 21 for fixing the electrode needle 11, the control member 13 is fixed outside the insulating tube 12, the distal end and the proximal end of the control member 13 are respectively provided with a limiting step 131, and the control member 13 is clamped in the handle 2 through the limiting steps 131.
The proximal ends of the first and second electrodes 112, 114 extend into the interior of the handle 2 and each have exposed portions for connection to the cable plug 3 via the lead 31. The handle 2, the cable plug 3, the inflow tube 4, etc. are arranged in the prior art, and are not described here again.
The hemostatic instrument is connected into a corresponding host machine and can be used by being matched with a foot switch, the foot switch mainly controls the energy output mode and the energy on-off of the hemostatic instrument, and even a hand control switch replacing the foot switch can be arranged on a handle so as to reduce objects in a surgical scene, and the part is the prior art and is not repeated.
Referring to fig. 1-5, the working mechanism and effect recommended by the invention are as follows:
1. open ablation mode
This mode is embodied by "the first electrode 112 and the second electrode 114 are completely exposed, and the insulating tube 12 is located at the nearest end". To achieve this, the operator simply dials the control member 13 to the nearest end. The target tissue may be ablated by either "surface ablation" or "insertion ablation". Taking "insertion ablation" as an example, the operator finds the target tissue first, dials the control element 13 to the nearest end, inserts the target tissue (when encountering some conditions that the insertion is inconvenient by mechanical force, the operator can start the host to provide energy to assist in puncturing), and selects a proper energy output mode to work. The invention is different from the prior art in that after the ablation is finished, the control piece 13 can be controlled to push the self-contained insulating tube 12 to the most distal end so as to directly cut off the adhesion between the ablated tissue and the electrode needle 11 by utilizing the cutting edge 121, thereby not only facilitating the extraction of the electrode needle 11, but also avoiding the tearing of the tissue in the process of extracting the electrode needle 11 and effectively preventing the occurrence of needle tract bleeding. Referring to fig. 5, since the electrodes 112 and 114 are opposite in electrical polarity during operation, energy is transferred only between the electrodes 112 and 114, and the target tissue forms a substantially fusiform ablation zone after ablation is completed.
2. Directional ablation patterns
This mode is embodied by "a single side of the first electrode 112 and the second electrode 114 is exposed through the coagulation window 122, the insulating needle 111 is exposed, and the insulating tube 12 is located at the most distal end". To achieve this, the operator simply dials the control member 13 to the furthest end. The target tissue may be ablated by either "surface ablation" or "insertion ablation". Taking "insertion ablation" as an example, the operator first finds the target tissue, dials the control member 13 to the most distal end for insertion into the target tissue, in this process, the control member 13 needs to be held by hand, the insulating tube 12 is prevented from returning to the most proximal end during the insertion process (in other embodiments, a corresponding mechanism can be further added for improvement), and a suitable energy output mode is selected for operation. Compared with the prior art, the surgical method provided by the invention does not need to use complex developing functions, such as directly adding components with developing functions on the hemostatic instrument, and accurately positioning by using CT and other instruments, so that the production cost of the hemostatic instrument can be effectively reduced, the number of instruments used by a surgeon can be effectively reduced, the manpower resources are greatly reduced, and the surgical efficiency is improved. Because electrosurgical procedures for solid organs such as the liver can be performed directly with the naked eye (open surgery) or with an under-scope image (under-scope surgery), or by touching or pressing with hands or instruments, the position of the target tissue can be obtained. After the position of the target tissue is obtained, the directional ablation mode provided by the invention can be adopted under the condition that surrounding important organs or blood vessels need to be avoided. After ablation, the control piece 13 can be pushed and pulled or rotated to directly cut off adhesion between the ablated tissue and the electrode needle 11 by utilizing the coagulation and cutting window 122, so that the electrode needle 11 can be conveniently pulled out, the tissue can be prevented from being torn in the process of pulling out the electrode needle 11, the condition of needle tract bleeding can be effectively prevented, in addition, a pen-holding mode is adopted by an operator, the rotating action can be completed on one hand only by matching a thumb with an index finger, if pushing and pulling needs larger force, the other hand is matched, other manpower is saved, and the operation efficiency is greatly improved. In addition, the invention can change the orientation of the coagulation cutting window 122 by rotating the control member 13, so that the operator can change the coagulation cutting direction at any time according to the actual situation, and the invention can be completed on one hand by only matching the thumb with the index finger, thereby saving other manpower and greatly improving the operation efficiency. Referring to fig. 5, since the electrodes 112 and 114 are opposite in electrical polarity during operation, energy is transferred only between the electrodes 112 and 114, and the target tissue forms an ablation zone having a substantially fan-shaped cross-section after ablation is completed.
Due to the structural features of the present invention, in both modes, the insulated needle 111 may destroy tissue or blood vessels and even cause bleeding, especially in the directional ablation mode, which requires careful use of the "insert coagulation" approach. Therefore, it is more preferable to gradually go deep and close to the target tissue by means of "insert coagulation", then to cut the ablated site to expose the target tissue as much as possible, and then to perform directional ablation by means of "surface coagulation". In order to reduce the risk of accidental injuries by the needle 111, the needle 1111 of the needle 111 may be made as short as possible.
Embodiment 2, referring to fig. 2, 3 and 7, the main difference between this embodiment and the above embodiment is that:
The connecting tube 1121 is hollow in the interior to serve as a fluid passage (i.e., inflow or return), and is mainly used as an inflow passage 117 for physiological saline. The exposed tube 1122 of the first electrode 112 is provided with a plurality of outflow openings 116, and the outflow openings 116 are generally uniformly distributed or regularly arranged on the exposed tube 1122. The connecting tube 1121 extends into the interior of the exposed tube 1122 and may further have an outlet 116 at a portion within the exposed tube 1122, both coaxially disposed, with the connecting tube 1121 having a gap at the distal-most end of the exposed tube 1122.
To optimize the structure, the insulating needle 111 may be provided as a needle 1111 and a coupling portion 1112, the needle 1111 being used for piercing, the coupling portion 1112 being used for connecting the electrode one 112. Since the hollow connecting tube 1121 and the exposed tube 1122 are used in the present embodiment, the joint 1112 may be configured as a tube in which the connecting tube 1121 is inserted and then interference-riveted, and the length of the joint 1112 is the same as that of the gap, so as to ensure that there is no gap as much as possible after the insulating needle 111 and the electrode one 112 are assembled.
Embodiment 3, referring to fig. 6, the main difference between this embodiment and the above embodiment is that:
The present embodiment improves the structure of the curdling window 122, that is, the present embodiment is provided with a grating 1221 in the middle of the curdling window 122, and the grating 1221 has a shielding strip and a gap. The overall length of the grid 1221 may be set to 0.5cm, 1.5cm, 2cm, 2.5cm, etc. as desired, i.e., the grid 1221 bisects the curtailment window 122, and the grid 1221 shields at least a portion of the first electrode 112 or the second electrode 114 adjacent to the insulator 113, and even shields a portion of the first electrode 112 and the second electrode 114 adjacent to the insulator 113 at the same time, without the insulator 113 being so-called blocked.
In the above embodiments, the problem is that, whether an open ablation mode or a directional ablation mode is adopted, the area of the first electrode 112 and the second electrode 114 near the insulating member 113 is relatively far away from both ends of the insulating member 113, the energy of the target tissue is stronger in the working state, and in the same gear and at the same time, the ablation degree of the target tissue is higher, for example, the energy output gear is higher and the ablation time is shorter, the target tissue corresponding to both ends of the first electrode 112 and the second electrode 114 may have a significantly poor ablation effect, while the target tissue corresponding to the area near the insulating member 113 may have a thin and fragile ablation effect, even if the target tissue adhered to the first electrode 112 and the second electrode 114 is cut off by the curett window 122 first, the secondary bleeding is also easy after the extraction, in order to improve the situation, the working time needs to be prolonged appropriately, and especially, the ablation effect of the target tissue corresponding to the area near the insulating member 113 needs to be controlled is required, so that in order to provide the operator, although the working time of each gear can be provided, the operator may have a better clinical experience than the operator, and the quality of the operator may not be controlled by using the clinical apparatus.
While the addition of the grating 1221 in this embodiment effectively reduces the energy effect, that is, the energy is transferred by the gaps of the grating 1221, and the area of the energy effect is reduced to weaken the tissue, so as to balance the energy of the whole coagulation windows 122. It should be noted that, the energy applied to the tissue will spread to some extent, so that, after the grille 1221 is added, the whole grille 1221 is smaller, and thus the target tissue covered by the grille 1221 will not be affected and will not be ablated.
Further, the edges of the grating 1221 may still be provided with "knife-edge-like chamfers" having a cutting action, in order to better maintain the action of the curdling window 122. However, the possible clogging defect of the grating 1221 needs to be considered, and thus the gap of the grating 1221 needs to be set to be sufficiently large, for example, the small width of the gap is set to be 1.5mm, 2mm, 2.5mm and above, so that sufficient energy can be transmitted, and the clogging is prevented from being inconvenient to clean. The width of the barrier rib of the grating 1221 itself may be set with reference to the size of the gap, or may be slightly wider or narrower than the gap.
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.