Disclosure of Invention
In view of the above, the present invention provides a multifunctional pulse power-on device and a processing method, so as to solve the problems that the pulse power-on device has a single use function, and cannot meet different use requirements and has high processing and manufacturing difficulties.
In order to solve the problems, the technical scheme of the invention is realized as follows:
a multi-functional pulse energizing apparatus comprising: a multi-cavity member having a central cavity and a plurality of peripheral cavities surrounding the central cavity, the peripheral cavities and the central cavity each extending in an axial direction and not communicating with each other, the thickness of the multi-cavity member being greater than a preset value, a portion of the multi-cavity member between a proximal end and a distal end in the axial direction being cut in an axial direction into a plurality of sub-tube portions divided in a circumferential direction, each sub-tube portion having one of the peripheral cavities therein, each sub-tube portion being provided with a through hole communicating with the peripheral cavity, the multi-cavity member being provided with a multi-layer structure at least from each sub-tube portion toward the distal end, the multi-layer structure including a cut layer for forming each sub-tube portion and an inner layer for forming the central member; the first electrode piece is sleeved on each sub-tube part and is used for introducing pulse current in a state that each sub-tube part protrudes outwards to be in a bent shape; a second electrode member disposed at a distal end of the center member for single-point discharge; a third electrode member disposed at a distal end of the multi-chamber member for single point discharge; and one end of the first drawing piece is inserted into the central cavity and extends to be connected with the third electrode piece and/or the far end of the multi-cavity piece, and the first drawing piece is used for drawing the far end of the multi-cavity piece to axially move along the central piece so as to drive each sub-pipe part to switch between two shapes of extending along a straight line and protruding outwards to form a curved shape.
In some embodiments, each of the first pole elements is connected with a first insulated electric lead arranged in the surrounding cavity, and the length of the sub-pipe part is 30mm-80mm.
In some embodiments, the center piece has a plurality of subchambers extending axially therein and in communication with the central chamber; wherein, at least one of the subchambers is provided with a second drawing piece which is used for drawing and bending the central piece; and/or at least one other of the subchambers is provided with a second insulated electrical lead for connection with the second electrode element.
In some embodiments, the multi-functional pulse energizing device further comprises a balloon for defining a position of the distal end of the multi-lumen member moving over the central member, the balloon being sleeved over the central member, and an inner lumen of the balloon being in communication with the remaining one of the subchambers for introducing inflation medium into the balloon through the subchambers.
In some embodiments, the first insulated electrical lead and the second insulated electrical lead each include a conductive core and an insulating layer, the conductive core is connected to the corresponding first electrode member or the second electrode member, the insulating layer is provided with multiple layers, and each insulating layer is sleeved on the conductive core layer by layer and extends along the length direction of the conductive core; wherein, each insulating layer all with electrically conductive core coaxial arrangement.
In some embodiments, a braid is disposed within the multi-lumen member, the braid extending from the proximal end toward a direction proximal to the sub-tube portion and not extending into the sub-tube portion region; wherein, in the radial direction, the outside of each surrounding cavity is provided with the weaving layer.
In some embodiments, the braid is circumferentially disposed around the multi-lumen member, and each of the circumferential lumens is located in an area surrounded by the braid.
In some embodiments, the cross-sectional shape of each of the surrounding cavities is at least partially the same, perpendicular to the lengthwise direction of the multi-cavity member; wherein the inner wall surface of the surrounding cavity is a smooth curved surface.
In some embodiments, the first electrode member is formed with a receiving hole for insertion of the sub-tube portion; wherein, the discharge side of the first electrode piece is provided with a voltage equalizing structure; or the discharging side of the first electrode piece is connected with a equalizing ring, and the equalizing ring is provided with a equalizing structure.
In some embodiments, the shape of the cross section of the accommodating hole is perpendicular to the length direction of the sub-tube portion, and is the same as the shape of the outer edge of the cross section of the sub-tube portion, and the first electrode member is attached to the outer wall of the sub-tube portion.
In some embodiments, the shape of the cross-sectional outer edge of the first electrode member is the same as the shape of the cross-sectional outer edge of the sub-tube portion, perpendicular to the length direction of the sub-tube portion.
The embodiment of the invention also provides a processing method for processing the multifunctional pulse energizing device, which comprises the following steps: inserting a positioning needle into a central cavity of a multi-cavity member to be processed, and respectively inserting a core rod into each peripheral cavity; placing and fixing the multi-cavity member on a processing tool, and enabling a cutting knife on the processing tool to be abutted with a part, provided with the multi-layer structure, on the multi-cavity member; driving a cutting knife on the multi-cavity member or the processing tool to move, so that the cutting knife cuts the multi-cavity member to form a plurality of sub-tube parts; taking the multi-cavity piece out of the processing tool, and respectively extracting the positioning needle and each core rod; when the cutting knife is abutted with a part to be cut on the multi-cavity piece, the cutting knife is inserted into the cutting layer and is not contacted with the inner layer.
In some embodiments, the cutting blade cuts continuously from the distal tip in a proximal direction to form a plurality of the sub-tube portions, the cutting length being 30mm-80mm.
In some embodiments, the first electrode pieces are respectively sleeved on the sub-tube parts, a first insulating electric lead is connected to each first electrode piece, and the first insulating electric leads are arranged in the surrounding cavities of the sub-tube parts where the first electrode pieces are located in a penetrating mode.
In some embodiments, the cutting blade cuts continuously in the proximal direction from a predetermined distance from the tip of the distal end, the cutting length being 30mm to 80mm.
In some embodiments, the first electrode pieces are respectively wrapped on the sub-tube parts, a first insulating electric lead is connected to each first electrode piece, and the first insulating electric lead is arranged in the surrounding cavity of the sub-tube part where the first electrode piece is located in a penetrating mode.
In some embodiments, the second electrode member is connected to the distal end of the center member and the third electrode member is connected to the distal end of the multi-lumen member.
In some embodiments, one end of the first pull member is threaded into the central cavity of the multi-lumen member and extends to connect with the third electrode member and/or the distal end of the multi-lumen member.
The embodiment of the invention provides a multifunctional pulse energizing device and a processing method. The multi-lumen member has a central lumen and a plurality of peripheral lumens surrounding the central lumen, and a plurality of circumferentially spaced sub-tube portions each having a peripheral lumen therein are formed by axially cutting at a portion between the proximal and distal ends of the multi-lumen member. The multi-cavity piece is provided with a multi-layer structure, each sub-tube part and the central piece are directly formed through the multi-layer structure, and meanwhile, the first drawing piece is connected with the distal end, so that the distal end can move along the central piece by pulling the first drawing piece, and each sub-tube part is driven to switch between two shapes which extend along a straight line and protrude outwards to be in a bent shape. In the embodiment of the invention, the first electrode piece is arranged on each sub-tube part, so that pulse current is introduced in a state that each sub-tube part protrudes outwards to be in a curved state, and the function of annular ablation of tissues is realized. And through being provided with the second electrode in the distal end department of central part, be provided with the third electrode in the distal end department of multi-chamber spare, alright realize the purpose to the tissue single point ablation through second electrode spare and third electrode spare, the function of use is various, has satisfied the requirement to pulse power-on device function variety well. In addition, the multifunctional pulse electrifying device is directly processed on the multi-cavity part with the multi-layer structure, and excessive other complex structural designs are not needed, so that the whole structure is simpler, processing production is realized in a cutting mode, the processing method is relatively simple in process and low in requirement, and meanwhile, the pulse electrifying device can be repeatedly reproduced, and the requirement on reproducibility of the pulse electrifying device is well met.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
The individual features described in the specific embodiments can be combined in any suitable manner, without contradiction, for example by combination of different specific features, to form different embodiments and solutions. Various combinations of the specific features of the invention are not described in detail in order to avoid unnecessary repetition.
In the following description, references to the term "first/second/are merely to distinguish between different objects and do not indicate that the objects have the same or a relationship therebetween. It should be understood that references to orientations of "above", "below", "outside" and "inside" are all orientations in normal use, and "left" and "right" directions refer to left and right directions illustrated in the specific corresponding schematic drawings, and may or may not be left and right directions in normal use.
It should be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element. "plurality" means greater than or equal to two.
The multifunctional pulse energizing device is generally connected with the control device and the high-voltage pulse generator, one end of the multifunctional pulse energizing device is inserted into a blood vessel, the multifunctional pulse energizing device can move into a tissue to be treated along the blood vessel by operating the control device (such as an operating handle), after the multifunctional pulse energizing device is conveyed in place, pulse voltage with high voltage and high frequency generated by the high-voltage pulse generator is conveyed to the multifunctional pulse energizing device, so that a high-strength electric field is established at the tissue to be treated, a region with higher current density is formed, cells are acted on through the high-voltage pulse electric field, irreversible perforation is formed on the cell membranes, the cells are gradually necrotized, and finally the aim of tissue ablation is achieved.
The term "electroporation" herein refers to the application of an electric field to a cell membrane to alter the permeability of the cell membrane to the extracellular environment. The term "irreversible electroporation" herein refers to the application of an electric field to a cell membrane to permanently alter the permeability of the cell membrane to the extracellular environment. For example, cells undergoing irreversible electroporation can observe the formation of one or more pores in their cell membrane that remain after the electric field is removed. The term "proximal" as used herein refers to the end of the multifunctional pulse powered device that is near the operator or is operatively connected to the operator; "distal" refers to the end of the multifunctional pulse-on device that is inserted into a blood vessel or is proximal to the tissue to be treated.
As shown in fig. 1 to 4, a multifunctional pulse energizing device 1 according to an embodiment of the present invention includes a multi-chamber member 11 and a first electrode member 12. The multi-chamber body 11 is a generally tubular material having a circular axial cross-sectional shape, and has a central chamber 111 and a plurality of peripheral chambers 112 surrounding the central chamber 111 therein, each of the peripheral chambers 112 and the central chamber 111 extending in the axial direction and not communicating with each other. The thickness of the multi-lumen member 11 is greater than a predetermined value, and a specific thickness is desirable to meet the reliable placement of the central lumen 111 and each of the peripheral lumens 112 without resulting in an overall diameter that is too large to facilitate delivery within a vessel. The portion of the multi-lumen member 11 between the axially proximal and distal ends is axially cut into circumferentially spaced sub-tube portions 113, each sub-tube portion 113 having a surrounding cavity 112 therein, the distal end being axially movable to drive the respective sub-tube portion 113 to switch between two shapes extending in a straight line and projecting outwardly in a curved shape. Specifically, each of the sub-tube portions 113 has an elastic deformation property, and is capable of being bent by an external force, and is capable of automatically returning to an initial state or a substantially initial state by the elastic deformation force of each sub-tube portion 113 itself after the external force is removed. Typically, the multi-chamber element 11 is made of a polymeric material that meets medical use criteria, such as Pebax (thermoplastic nylon elastomer) and PA (polyamide) polymeric materials, which have high strength, and good fracture resistance and elastic properties. The multi-cavity member 11 may be formed with different hardness at different positions through gradual transition, such as gradually decreasing hardness from distal end to proximal end, so as to provide better insertion performance for distal end, facilitating guiding movement in blood vessel, while gradually decreasing hardness near proximal end, facilitating bending adjustment. The area in the middle of the multi-chamber element 11 is of moderate hardness to ensure overall strength and pushability. Of course, the hardness of the multi-cavity member 11 may be set to other forms according to the use requirement, such as making the hardness design of a local part larger or lower, and the design flexibility is good.
In some embodiments, as shown in fig. 1 and 2, the multi-lumen member 11 at least distally from each sub-tube portion 113 is provided with a multi-layer structure 114, the multi-layer structure 114 comprising a cut layer 114a for forming each sub-tube portion 113 and an inner layer 114b for forming the central member 115. That is, the portion of the multi-lumen member 11 for forming each sub-tube portion 113 and the region distally from the portion are each provided to include at least the dicing layer 114a and the inner layer 114b. So that each of the formed sub-tube portions 113 is located outside the formed center piece 115, and the bending deformation of each of the sub-tube portions 113 is guided by the formed center piece 115, ensuring that each of the sub-tube portions 113 can be smoothly bent and that the shape of the bending deformation can be kept uniform. In this arrangement, each sub-tube and the central member 115 can be formed by one multi-cavity member 11 without requiring excessive other structural designs, thereby greatly improving the convenience of manufacturing the multi-functional pulse energizing apparatus 1.
In some embodiments, as shown in fig. 2 and 3, a first electrode member 12 is provided on each sub-tube portion 113. Specifically, the first electrode member 12 is sleeved on each sub-tube portion 113, so as to be used for supplying pulse current in a state that each sub-tube portion 113 protrudes outwards to be in a curved shape, and the first electrode members 12 arranged on each sub-tube portion 113 are kept on the same concentric ring in the circumferential direction, so that annular ablation of tissues is realized through the combined action of the first electrode members 12 at different positions in the circumferential direction. By "substantially maintained in the same concentric ring" it is meant that the cross-sections of the first electrode members 12 taken perpendicular to the axis of the multi-chamber member 11 at the center point are on the same circle or within allowable tolerances so that the first electrode members 12 are capable of performing annular ablation of tissue at the same circumferential location.
In some implementations, as shown in fig. 1 and 2, a second pole element 13 is provided at the distal end of the center element 115, one in number. At the same time, it is used to provide a third electrode member 14 at the distal end position of the multi-chamber member 11. In this way, the second electrode member 13 and/or the third electrode member 14 can be subjected to pulse current to realize single-point ablation of the tissue, so that the use function is improved, and the use requirement of single-point ablation of the tissue is met. The "distal end of the center member 115" and the "distal end after the connection of the sub-tube portions 113" described above refer to the end farther from the operator than the operator, or the end that first enters the blood vessel when inserted into the blood vessel.
In some embodiments, as shown in fig. 2 and 3, the multifunctional pulse energizing device 1 further includes a first drawing member 15, one end of the first drawing member 15 is inserted into the central cavity 111 (refer to fig. 4) and extends to be connected to the distal end of the third electrode member 14 and/or the multi-cavity member 11, and the opposite end of the first drawing member 15 is connected to the manipulation device or is used for being held by an operator. In this way, by pulling the first pulling member 15, a force can be transmitted to the distal end of the multi-cavity member 11 or the third electrode member 14, and the distal end of the multi-cavity member 11 can be pulled to move axially along the central member 115, so as to drive each sub-tube portion 113 to switch between two shapes extending along a straight line and protruding outwards in a curved shape. Specifically, the pulling of the distal end of the multi-chamber element 11 to slide reciprocally over the central element 115 may be accomplished by connecting one end of the first pull element 15 to the distal end of the multi-chamber element 11. It may also be: since the third electrode member 14 is provided at the distal end of the multi-chamber member 11, connecting one end of the first drawing member 15 to the third electrode member 14 also enables pulling the distal end of the multi-chamber member 11 to slide reciprocally over the center member 115. Of course, it is also possible that one end of the first drawing member 15 is connected to the distal end of the multi-chamber member 11 and the third electrode member 14 at the same time, and it is also possible to achieve pulling of the distal end of the multi-chamber member 11 to slide reciprocally on the center member 115. Thus, when the first drawing member 15 pulls the sub-tube portions 113 to protrude outwards in a curved shape, pulse current is applied to the first electrode members 12, so that the purpose of treating annular ablation of tissues is achieved. While each of the sub-tube portions 113 is maintained in a straight-line extending state, the second electrode member 13 is covered at this time, and a single point ablation of the tissue can be achieved by applying a pulse current to the third electrode member 14. When the bending state of each sub-tube portion 113 is gradually reduced and the sub-tube portion is to be in a straight line extending state, the second electrode member 13 and the third electrode member 14 can be used for single-point ablation of tissues independently or simultaneously, and the use mode is flexible.
In some embodiments, the contact resistance between the electrode and the blood is further increased due to the scab formation on the surface of the first electrode member 12 caused by the coagulation mechanism of the blood around the first electrode member 12 generated by the temperature increase of the surface of the first electrode member 12 due to the fact that the contact resistance between the first electrode member 12 and the blood is easily generated by the nanosecond pulse with high voltage and high frequency. In the embodiment of the present invention, through holes (not shown in the drawing) communicating with the surrounding cavities 112 are formed in each of the sub-tube portions 113, and the through holes are disposed adjacent to the first electrode member 12, and by filling saline into each of the surrounding cavities 112 and then flowing out the filled saline from the corresponding through holes, the saline flowing out from the vicinity of the first electrode member 12 can not only improve the surrounding conductivity, but also play a role in continuously cooling the first electrode member 12, thereby achieving the purposes of cooling and preventing crusting of the first electrode member 12. Of course, it will be understood that through holes for the passage of saline water may be provided near the second electrode member 13 and the third electrode member 14, respectively, so as to achieve the purposes of cooling the second electrode member 13 and the third electrode member 14, preventing the second electrode member 13 and the third electrode member 14 from crusting, and improving the safety and reliability of treatment.
In the multifunctional pulse energizing device 1 provided in the embodiment of the present invention, by providing the ring of the multi-cavity member 11 and the first electrode member 12, the multi-cavity member 11 has the central cavity 111 and the plurality of peripheral cavities 112 surrounding the central cavity 111, and the plurality of circumferentially-divided sub-tube portions 113 are formed by axially cutting the portion between the proximal end and the distal end of the multi-cavity member 11, one peripheral cavity 112 is provided inside each sub-tube portion 113, and the first electrode member 12 is provided in each sub-tube portion 113, so that the annular ablation treatment of the tissue can be realized. Meanwhile, the portion of the multi-cavity member 11 at the distal end from each sub-tube portion 113 is provided as a multi-layer structure 114 for forming each sub-tube portion 113 and the center member 115; and a second electrode member 13 is provided at the distal end of the central member 115 and a third electrode member 14 is provided at the distal end of the multi-lumen member 11, whereby single point ablation treatment of tissue can be achieved with the second electrode member 13 and/or the third electrode member 14. In the embodiment of the invention, the first drawing member 15 pulls the distal end of the multi-cavity member 11 to move axially along the central member 115, so as to drive each sub-tube portion 113 to switch between two shapes extending along a straight line and protruding outwards to form a curved shape, thereby realizing the switching of the treatment modes of single-point ablation and annular ablation of tissues, and realizing various treatment modes. In addition, the multifunctional pulse energizing device 1 is directly processed on the basis of the multi-cavity member 11, the multi-cavity member 11 is simple in structure, and the structure can meet the use requirement, so that excessive other complex structural designs are not needed, and the structure of the multifunctional pulse energizing device 1 is simpler. The processing production is realized in a cutting mode, the production process is relatively simple, the requirement is low, and the device can be repeatedly reproduced, so that the requirement for reproducibly producing the multifunctional pulse energizing device 1 is well met.
In some embodiments, as shown in fig. 1 and 2, the number of the sub-tube portions 113 formed by cutting the multi-cavity member 11 may be plural, alternatively 3-12, and the specific number may be set according to actual use requirements. Thus, at the same position, each sub-tube portion 113 faces different positions in the circumferential direction, so that different parts of tissues at the positions can be ablated by discharging in the circumferential direction, the purpose of annular ablation is achieved, the treatment requirements at different positions are not required to be met by rotating at the same position, the convenience of treatment is improved, and the difficulty of patients in the treatment process is reduced. Meanwhile, each sub-tube part 113 formed by cutting is relatively independent, and the deformation performance is good, so that the fit with the first drawing piece 15 and the fit between each sub-tube part 113 are enhanced, the reduction of the overall outer diameter of the multi-cavity piece 11 is facilitated, the overall outer diameter of the multi-cavity piece 11 can be within 3.2mm, and the trafficability in a blood vessel is improved, and the use requirement of a smaller blood vessel can be met.
In some embodiments, as shown in fig. 1 and 2, the number of first electrode pieces 12 provided on each sub-tube portion 113 is 1, so that a better control of the treatment position of the first electrode pieces 12 can be achieved. Of course, it is understood that in other embodiments, the number of the first electrode members 12 provided on each sub-tube 113 may be two or more, so as to achieve the purpose of adjusting the treatment range. Specifically, the first electrode member 12 disposed on the sub-tube portion 113 may be sleeved by a distal end and moved and adjusted to a position set on the sub-tube portion 113, or may be formed by wrapping at a position set on the sub-tube portion 113, so that the flexibility of the arrangement mode is good.
In some embodiments, as shown in fig. 3 and 4, the first drawing member 15 may also be a metal wire such as stainless steel or nickel titanium, and the number of the first drawing member may be set according to the use requirement, which is not limited herein. One end of the wire is inserted through the central lumen 111 and extends in the distal direction of the multi-lumen member 11 to enable connection with the third electrode member 14 and/or the distal end of the multi-lumen member 11. The first drawer 15 is movable relative to the hub 115 to thereby pull the distal end to effect the desired switching of the respective sub-tube portions 113 in an outwardly projecting curved or cage-like condition. And the metal wire such as stainless steel or nickel titanium is also provided with a PTFE (polytetrafluoroethylene) or PI (polyimide) coating, so that the durability of the metal wire is improved, the metal wire can have higher safety, and the medical use requirement is met.
In some embodiments, as shown in fig. 1 and 4, each first pole element 12 is connected to a first insulated electrical lead (not shown) disposed within the surrounding cavity 112, through which electrical current is delivered to the first pole element 12. The effective diameter of the first insulating electric lead is not smaller than 0.12mm, the overall diameter of the first insulating electric lead is not larger than 0.25mm, the insulating breakdown strength of the lead reaches more than 5kV, electromagnetic interference is prevented from being generated during corona discharge through a multilayer insulating structure, and the short circuit caused by conduction during filling of saline can be prevented. Meanwhile, the length of the sub-pipe portion 113 is 30mm-80mm, so that the length of the sub-pipe portion 113 is in a proper range, and the sub-pipe portion 113 can have a diameter size meeting the use requirement in a bent state, so that the problem that the overall structural strength is reduced due to the fact that the length is too small to provide an effective working area or too long is avoided.
In some embodiments, as shown in fig. 4 and 6, the center piece 115 has a plurality of subchambers 1151 extending axially therein and in communication with the central chamber 111; wherein a second drawer for pulling to bend the centerpiece 115 is disposed in at least one subchamber 1151; and/or at least one other subchamber 1151 is provided with a second insulated electrical lead (not shown) for connection to the second pole element 13 (see fig. 1). Alternatively, the subchambers 1151 are typically provided in a number of 3 or more and are provided in a circumferentially evenly spaced apart manner. Since the center 115 generally enters the blood vessel first during the actual treatment, and since the blood vessel has various shapes and more bending places, the smoothness of the pushing needs to be improved by enabling the center 115 to follow the bending during the pushing. Therefore, by adopting the configuration that the plurality of subchambers 1151 are provided inside the central member 115, and then a movable second drawing member is provided in any one of the subchambers 1151, one end of the second drawing member is connected to the distal end of the central member 115, and the other end extends toward the operator, so that the second drawing member can be connected to the operation device or drawn by the operator to obtain drawing force, thereby realizing adjustment of the distal end shape of the central member 115 and improving the smoothness of the pushing. At the same time, a second insulated electrical lead for connection to the second pole element 13 is provided in at least one of the remaining subchambers 1151, so that a pulsed current can be supplied to the second pole element 13. The remaining subchamber 1151 may be used as a saline fill channel for input to effect cooling of the second electrode assembly 13 and to prevent scabbing, although it may be used as an extension of the reserved function.
In some embodiments, the proximal end of the multi-lumen member 11 is also configured to adjust the bending near each sub-tube portion 113, thereby allowing for shape adjustment as needed during pushing, improving ease of handling of the multi-lumen member 11.
In some embodiments, the third electrode member 14 is disposed at the distal end of the multi-cavity member 11, so that, in order to achieve the pulse current input by the third electrode member 14, a third insulated electrical lead (not shown in the figure) may be connected to the third electrode member 14, and connected to the high-voltage pulse generator by passing through the peripheral cavity 112 in any of the sub-tube portions 113, without increasing the radial dimension of the multi-cavity member 11, and the design is smart.
In some embodiments, the multi-functional pulse energizing device further comprises a balloon (not shown) for defining the position of the distal end of the multi-lumen member 11 for movement on the central member 115, the balloon being positioned over the central member 115 with the inner lumen of the balloon communicating with the remaining one of the subchambers 1151 for introducing inflation medium into the balloon through subchamber 1151. Specifically, the balloon is made of a film capable of being inflated or contracted elastically, the balloon is sleeved on the central piece 115 and is positioned between the distal end of the multi-cavity piece 11 and the central piece 115, so that when the balloon is inflated, a gap between the distal end of the multi-cavity piece 11 and the central piece 115 can be filled, and further, the positioning of the distal end of the multi-cavity piece 11 on the central piece 115 is realized, the bending state of each sub-tube 113 can be positioned, the requirement for adjusting the bending shape of each sub-tube 113 under different treatment modes is met, the arrangement is ingenious, and the treatment means of the multifunctional pulse energizing device are greatly improved. The filling medium may be a gas or a liquid, etc.
In some embodiments, as shown in fig. 5, each of the first insulated electrical lead and the second insulated electrical lead includes a conductive core 61 and an insulating layer 62, where the conductive core 61 is connected to the corresponding first electrode member 12 or second electrode member 13, the insulating layer 62 is provided in multiple layers, and each insulating layer 62 is sleeved on the conductive core 61 layer by layer and extends along the length direction of the conductive core 61; wherein each insulating layer 62 is coaxially disposed with the conductive core 61. Specifically, the conductive core 61 may be formed of a copper core with a diameter not smaller than 0.12 mm, and the copper extremely fine wires forming the copper core may be insulated with a PTFE (polytetrafluoroethylene) or PI (polyimide) coating to improve the insulation ability of the conductive core 61. In the embodiment of the present invention, each insulating layer 62 is optionally provided with four layers, so that the overall size of the insulated electrical lead can pass through the corresponding peripheral cavity 112 (refer to fig. 3) on the premise of meeting the overall insulation performance requirement. It will be appreciated that the structure of the third insulated electrical lead remains the same as that of the first insulated electrical lead and that of the second insulated electrical lead, and also includes a conductive core 61 and insulating layers 62, the conductive core 61 is connected to the third electrode member 14, the insulating layers 62 are provided in multiple layers, and each insulating layer 62 is sleeved on the conductive core 61 layer by layer, so that the third insulated electrical lead does not need to be separately selected, and the convenience of production is improved.
In particular, since mapping of intracardiac potential signals is required during PFA (pulsed electric field ablation) procedures, immediate efficacy assessment of electrophysiological examination and ablation therapy is achieved. Mapping is performed by amplifying and collecting weak electrocardiosignals, and ablation is performed by releasing high-voltage pulse energy through electrodes. In order to prevent the high voltage pulse from damaging the detection circuit of the electrocardiosignal. In the embodiment of the invention, each first electrode piece 12 is independently led, and the insulation among all the first electrode pieces 12 can reach more than 5kV, so that the mapping function and the ablation function are integrated together, and the multiplexing of the ablation function and the mapping function is realized through the rapid switching inside the host.
In some embodiments, as shown in fig. 1 and 4, a braid 116 is disposed within the multi-lumen member 11, the braid 116 extending proximally toward the sub-tube portion 113 and not extending into the region of the sub-tube portion 113; wherein, in the radial direction, the outer side of each peripheral cavity 112 is provided with a braiding layer 116. By providing a braid 116 for enhancing the torque transmission capability of the multi-lumen member 11, the whole can be reliably moved in the blood vessel. The braid 116 may be a stainless steel braid, strong, and also has suitable elastic bending deformation properties. The manner in which the braid 116 is provided in the multi-chamber element 11 may be such that it is not provided continuously in the circumferential direction, but is provided outside the position where each peripheral chamber 112 is located, and each braid 116 is not connected, so that not only the strength of the peripheral chamber 112 can be enhanced, but also the overall structural strength can be enhanced. In addition, since the distal end of the multi-lumen member 11 needs to be cut to form each sub-tube portion 113, the braid does not extend into the region of the sub-tube portion 113, thereby not affecting the cutting of the multi-lumen member 11.
In some embodiments, as shown in fig. 1 and 4, it may also be employed to arrange the braid 116 circumferentially around the multi-lumen member 11, with each circumferential lumen 112 being located in the area surrounded by the braid 116. In this way, the same braid 116 surrounds the outer side of each sub-tube portion 113 in the circumferential direction of the multi-chamber body member 11, and can simultaneously provide protection for each sub-tube portion 113 from accidental puncture.
In some embodiments, in order to enable the hardness of the multi-cavity member 11 to be adjusted as required, not only the material forming the multi-cavity member 11 but also the thickness or the density of the woven layer may be adjusted, so that the multi-cavity member 11 is variously arranged.
In some embodiments, the cross-sectional shape of each surrounding cavity 112 is at least partially identical perpendicular to the lengthwise direction of the multi-cavity member 11, i.e. the cross-sectional shape of each surrounding cavity 112 obtained in the same reference direction is at least partially identical. Since the insulated electric leads need to be threaded out of the surrounding cavity 112, the insulated electric leads do not need to be selectively threaded out due to different shapes of the surrounding cavity 112, and the convenience of installation is improved. And, set up the inner wall surface of the cavity 112 around as smooth curved surface, frictional resistance is little, is favorable to improving insulating electric lead wire and passes smooth and easy nature. While also facilitating the flow of brine. Specifically, the inner wall surface of the peripheral cavity 112 may be formed as a smooth curved surface by a machining process or by providing a PTFE (polytetrafluoroethylene) inner liner. Also, it is possible to improve the smoothness of the surface by providing the inner wall surface of the central cavity 111 with a PTFE (polytetrafluoroethylene) inner liner.
In some embodiments, as shown in fig. 7 to 9, the first electrode member 12 is formed with a receiving hole 121 for insertion of the sub-pipe portion 113 (refer to fig. 1), thereby enabling the first electrode member 12 to be mounted to the sub-pipe portion 113. And, the voltage equalizing structure 122 is arranged on the discharge side of the first electrode member 12; or the discharging side of the first electrode member 12 is connected with a equalizing ring 123, and the equalizing ring 123 is provided with an equalizing structure 122. Specifically, since the voltage required to be born by the multifunctional pulse energizing apparatus 1 is higher, the high-voltage pulse energy is released through the catheter electrode when performing the pulse electric field ablation operation, and the electric field distribution is designed to be more uniform in order to prevent the tip discharge or the spark discharge when performing the high-voltage pulse discharge. In the embodiment of the invention, the voltage equalizing structure 122 is arranged on the discharge side of the first electrode member 12 or the voltage equalizing ring 123 with the voltage equalizing structure 122 is arranged, the voltage equalizing structure 122 is a smooth arc curved surface, and under the action of the voltage equalizing structure 122, the discharge side of the first electrode member 12 can be free from a tip, so that the electric field distribution is more uniform, serious power line distortion points are not formed at the two ends of the first electrode member 12, the first electrode member 12 is ensured to generate no spark discharge caused by the tip under the high-voltage nanosecond pulse with the voltage of 10kV, and the use safety and the service life are improved.
In some embodiments, a equalizing ring 123 having a equalizing structure 122 or having a equalizing structure 122 may be provided on the discharge side of the second electrode member 13 and the third electrode member 14 as well, so as to prevent spark discharge caused by tips of the second electrode member 13 and the third electrode member 14 during operation, thereby improving safety and service life.
In some embodiments, as shown in fig. 1 and 7, at least the receiving hole 121 has the same shape as the outer edge of the sub-tube 113 in cross section perpendicular to the length direction of the sub-tube 113, and the first electrode 12 is attached to the outer wall of the sub-tube 113. In this way, the first electrode member 12 can be tightly attached to the outer surface of the sub-tube portion 113 after being mounted on the sub-tube portion 113, and not only can discharge be reliably achieved, but also no local protruding portion is provided, thereby facilitating the reduction of the overall radial dimension of the multi-cavity member 11. In this manner, the shape of the outer edge of the cross section of the first pole element 12 may be the same as or different from the shape of the accommodating hole 121, and may be set as needed.
In some embodiments, the shape of the cross-sectional outer edge of the first electrode member 12 is the same as the shape of the cross-sectional outer edge of the sub-tube portion 113, perpendicular to the length direction of the sub-tube portion 113. By this arrangement, the cross-sectional shape of the multi-chamber member 11 as a whole perpendicular to the axial direction can be kept uniform, and the multi-chamber member is circular, has good overall aesthetic property, and is convenient for being delivered in a blood vessel.
In some embodiments, a positioning sensor (not shown) for positioning is provided on at least any one of the sub-tube portions 113, the positioning sensor being located near the proximal end of the multi-lumen member 11. The positioning sensor can position the position of the sub-tube 113, so that accurate treatment can be realized. Optionally, the positioning sensor is a magnetic positioning sensor, so that the positioning effect is good and the use is safe.
According to the multifunctional pulse electrifying device 1 provided by the embodiment of the invention, the multi-cavity piece 11 is arranged, and the multi-cavity piece 11 is directly processed on the basis of the multi-cavity piece 11, so that excessive other complex structural designs are not needed, the structure of the multifunctional pulse electrifying device 1 is simpler, the processing and the production are realized in a cutting mode, the production process is relatively simple, the requirement is lower, and the requirement on the reproducibility of the multifunctional pulse electrifying device 1 is well met. In the embodiment of the present invention, the annular ablation treatment of the tissue can be achieved by providing the first electrode member 12 in each sub-tube portion 113. Forming each sub-tube portion 113 and the center member 115 by arranging the portion of the multi-chamber member 11 at a distal end from each sub-tube portion 113 into a multi-layer structure 114; and a second electrode member 13 is provided at the distal end of the central member 115 and a third electrode member 14 is provided at the distal end of the multi-lumen member 11, whereby single point ablation treatment of tissue can be achieved with the second electrode member 13 and/or the third electrode member 14. Through the multilayer insulation design of the insulated electric leads, the insulation capability among the first electrode pieces 12 is improved, so that the insulation level of each first electrode piece 12 can meet the nanosecond pulse discharge requirement of higher voltage and higher repetition frequency, and corona discharge and interference electric signal generation are prevented. The electric field distribution is more uniform through the design of the voltage equalizing structure 122 of the end face of each electrode piece, the spark discharge is effectively prevented, and the heat generation in the discharge process is greatly reduced. By the conforming design of the first electrode member 12 and the sub-tube portion 113, the overall outer diameter of the multi-chamber member 11 is effectively reduced, and the overall transportability and passability are improved. And, also adopt and connect each first electrode piece 12 by the first insulated electric lead wire that is independent and mutual insulation, realized the multiplexing of timesharing of first electrode piece 12, make in PFA operation in-process, based on the same first electrode piece 12 can carry out ablation and mapping simultaneously.
The embodiment of the invention also provides a processing method for processing the multifunctional pulse energizing device 1, and as shown in fig. 8, the processing method is used for processing the multi-cavity member 11 by means of the processing tool 2. The machining tool 2 comprises a workbench 21, a tool rest 22 mounted on the workbench 21, a cutting tool 23 mounted on the tool rest 22, a positioning block 24 for positioning the multi-cavity member 11, a positioning seat 25 for abutting against the multi-cavity member 11, and a push rod 26 for pushing the positioning seat 25. The processing method comprises the following steps:
As shown in fig. 8 and 9, a positioning needle 27 is inserted into a central cavity 111 of the multi-cavity member 11 to be processed, and a core rod 28 is inserted into each peripheral cavity 112, and the rigidity of the whole multi-cavity member 11 is increased by the positioning needle 27 and the core rod 28 to prevent deformation. And then the multi-cavity member 11 is placed on the workbench 21 of the processing tool 2, one end of the multi-cavity member is abutted against the positioning seat 25, and the middle position of the multi-cavity member 11 is pressed by the positioning block 24 for positioning, so that the multi-cavity member 11 is prevented from warping during moving cutting. After the position of the multi-chamber element 11 is positioned, the cutter 23 on the processing tool 2 is brought into contact with a portion of the multi-chamber element 11 having the multilayer structure 114. After that, the positioning seat 25 is moved by the push rod 26 to move the multi-chamber member 11 relative to the cutter blade 23, and the cutter blade 23 cuts the multi-chamber member 11 to form the plurality of sub-tube portions 113. Of course, the plurality of sub-tube portions 113 may be formed by preventing the movement of the multi-chamber member 11 by the push rod 26 abutting the positioning seat 25, and then cutting by moving the cutter blade 23 relative to the multi-chamber member 11. After the cutting is completed, the pressing block is released, the processed multi-cavity member 11 is removed from the processing tool 2, and the positioning needle 27 and each core rod 28 are respectively extracted.
Specifically, when the cutter abuts against a portion to be cut on the multi-cavity member 11, the cutter is inserted into the cut layer 114a without contacting the inner layer 114b, so as to prevent the inner layer 114b from being ruptured. When the multi-chamber member 11 is cut, the number of the cutting blades 23 is equal to the number of the sub-tube portions 113 to be cut, and the angle between the cutting blades 23 and the axis line direction of the multi-chamber member 11 is adjusted to tilt the cutting blades 23 by a predetermined angle with respect to the axis line direction of the multi-chamber member 11, so that the cutting resistance is reduced and the abrasion of the cutting blades 23 can be reduced. Meanwhile, the angle of the blade pressing block can be adjusted, so that after the cutter blade 23 is arranged in the cutter frame 22, the cutter blade 23 is tightly attached to the wall of the cutter frame 22 by the lateral force of the spring pressure all the time, and the position accuracy of the cutter blade 23 is ensured.
Specifically, when cutting the multi-cavity member 11, the cutting blade 23 may be continuously cut from the distal end to the proximal direction to form a plurality of sub-tube portions 113, and the cut length may be 30mm to 80mm. Thus, the distal end of each sub-tube portion 113 is formed as a free end. Then, the first electrode pieces 12 are sleeved from the ends of the sub-tube walls, so that the first electrode pieces 12 are respectively sleeved on each sub-tube portion 113, each first electrode piece 12 is connected with a first insulating electric lead, the first insulating electric leads are arranged in the surrounding cavities 112 of the sub-tube portions 113 where the first electrode pieces 12 are arranged in a penetrating mode, and then extend towards the proximal end until the first electrode pieces can be connected with a high-voltage pulse generator.
Specifically, when cutting the multi-cavity member 11, it is also possible to continuously cut the cutter 23 in the proximal direction from a predetermined distance from the distal tip spacing to form a plurality of sub-tube portions 113 with a cutting length of 30mm to 80mm. Specifically, in this cutting mode, the cutter 23 does not directly start cutting from the distal end, but is spaced from the distal end by a predetermined distance, which may be between 5mm and 15mm, so that the distal ends of the sub-tube portions 113 formed are not dispersed after cutting is completed, and of course, may be other predetermined distances. After the cutting is completed to form each sub-tube portion 113, the first electrode members 12 are respectively wrapped around each sub-tube portion 113, and each first electrode member 12 is connected with a first insulated electric lead wire, and the first insulated electric lead wires are inserted into the surrounding cavities 112 of the sub-tube portion 113 where the first electrode members 12 are located, and then extend proximally until being connectable to a high-voltage pulse generator.
Specifically, after the first electrode member 12 is disposed, a second electrode member 13 is connected to the distal end of the central member 115, and a second insulated electrical lead wire connected to the second electrode member 13 is passed out of one of the subchambers 1151 inside the central member 115 to be connected to the high voltage pulse generator. A third electrode member 14 is connected to the distal end of the multi-chamber member 11, and a third insulated electrical lead wire connected to the third electrode member 14 is connected to the high-voltage pulse generator by being passed through the peripheral chamber 112 in the arbitrary sub-tube portion 113. Specifically, if the cutting is performed to make each sub-tube portion 113 have a free end, the free end of each sub-tube portion 113 is connected to the central member 115 to form a whole, and can reciprocate relative to the central member 115, and then the third electrode member 14 is disposed.
In one embodiment, after the first electrode member 12 is disposed, one end of the first drawing member 15 is inserted into the central cavity 111 of the multi-chamber member 11 and extends to be integrally connected to the third electrode member 14 and/or the distal end of the multi-chamber member 11. By pulling the first pulling member 15, it is thereby achieved that the distal end of the multi-chamber element 11 can be moved axially along the central element 115, so as to bring about a switching of the respective sub-tube portions 113 between two shapes extending in a straight line and protruding outwards in a curved shape. Specifically, when the distal end of the multi-cavity member 11 is cut, after the first electrode member 12 is disposed on each sub-tube portion 113, one end of the first drawing member 15 may be inserted into the central cavity 111 of the multi-cavity member 11, and then the free end of each sub-tube portion 113 is connected to the distal end of the first drawing member 15. Or the free ends of the sub-tube portions 113 are integrally connected around the center member 115, and after the third electrode member 14 is provided at the connection, the first drawing member 15 is connected to the third electrode member 14. Or the third drawer may be connected to both the distal end of the multi-chamber element 11 and the third electrode element 14, thereby completing the manufacture. When the cutting blade 23 is continuously cut in the proximal direction from the preset distance from the distal end, one end of the first drawing member 15 may be inserted into the central cavity 111 of the multi-cavity member 11 and bonded or welded to the distal end of the multi-cavity member 11, and then cut to form each sub-tube 113. Namely, the processing method is various and the flexibility is good.
According to the processing method provided by the embodiment of the invention, the positioning needle 27 is inserted into the central cavity 111, the core rods 28 are respectively inserted into the peripheral cavities 112, the multi-cavity member 11 to be cut is placed on the processing tool 2 to be cut, each sub-tube portion 113 is formed, and then the distal end of the first drawing member 15 is connected with the distal end of the multi-cavity member 11 by arranging the first electrode member 12 on each sub-tube portion 113 and connecting the first drawing member 15. Thus, the production process of the multifunction pulse energizing device 1 is completed. The processing method realizes processing production by cutting, has relatively simple process, low requirement and good repeatability, and well meets the requirement of reproducible production of the multifunctional pulse energizing device 1.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.