WO2021017816A1 - Mapping guide wire, and three-dimensional mapping system using same - Google Patents

Abstract

Disclosed are a mapping guide wire (100), and a three-dimensional mapping device (200) using same. The mapping guide wire (100) comprises a guide wire core (10), a guide wire sleeve (20), an electrode wire (30), a front-end electrode (40), and a rear-end electrode (50), wherein the guide wire sleeve (20) is sheathed outside the guide wire core (10) and the electrode wire (30); the front-end electrode (40) and the rear-end electrode (50) are respectively arranged at a distal end and a proximal end of the guide wire core (10); two ends of the electrode wire (30) are respectively connected to the front-end electrode (40) and the rear-end electrode (50); and the rear-end electrode (50) is connected to the three-dimensional mapping device (200). The device is simple to operate, and can rapidly map electric signals collected by the front-end electrode (40).

Description

Mapping guide wire and three-dimensional mapping system using it

This application requires the priority of the Chinese patent application filed with the Chinese Patent Office on July 30, 2019, the application number is CN 201910697903.2, and the invention title is "Mapping Guide Wire and Three-dimensional Mapping System Using It" and on July 30, 2019 The priority of the Chinese patent application filed with the Chinese Patent Office on June 30, application number CN 201921217883.6 and invention title "Mapping Guide Wire and Three-dimensional Mapping System Using It", the entire content of which is incorporated into this application by reference.

Technical field

The invention relates to the technical field of medical devices, in particular to a mapping guide wire and a three-dimensional mapping system using the same.

Background technique

In the field of intraluminal interventional therapy, Guide Wire is an essential tool. The guide wire plays an important role in ensuring safety during the process of intervening surgical guide catheters and balloons in the lumen through the narrow section of the lumen. Guide wire, also called guide wire or guide wire, is one of the main tools for percutaneous puncture intubation. The guide wire guides and supports the catheter, helps the catheter to enter blood vessels and other cavities, and guides the catheter to reach the patient's lesion.

Interventional medical catheters with a ring-shaped tip (such as a circular pulmonary vein mapping catheter) are a common type of catheter in clinical interventional surgery. In the clinical operation of transcatheter radiofrequency (RF) ablation to treat arrhythmia caused by atrial fibrillation, the circular pulmonary vein mapping catheter is often used to check the electrical signals in the pulmonary vein or the pulmonary vein orifice. When performing this type of operation, the surgeon cannot directly visualize the patient's heart cavity structure and the position and shape of the tip of the circular lung catheter.

Currently, X-ray images and injection of contrast agents are used to determine the position of the pulmonary vein opening and the position and shape of the pulmonary catheter. Since this X-ray image is a two-dimensional image, it is not easy for doctors to judge the actual structure and position of the three-dimensional heart cavity and catheter, which requires rich experience, and excessive doses of X-rays can cause harm to the patient, which is very inconvenient to use.

In recent years, with the development of science and technology, the use of a three-dimensional positioning technology based on a magnetic field, an electric field or a mixture of electric and magnetic fields can locate the tip of the catheter, and can use computer three-dimensional cardiac electrophysiological mapping technology to reconstruct the shape of the heart cavity. This obviously facilitates the implementation of this type of surgery in clinical practice. The existing magnetic field-based positioning technology is aimed at catheters. However, the catheter-based magnetic field positioning technology uses a guide wire to feed the catheter into the distal mapping site, which is not only complicated, but also time-consuming. In addition, due to the large diameter of the catheter, which hinders the access of small-diameter blood vessels or other cavities for interventional diagnosis and interventional instruments, the catheter cannot accurately and reliably map the cardiac cavity structure of the patient.

Summary of the invention

In view of this, the embodiment of the present invention provides a mapping guide wire and a three-dimensional mapping system using the same to solve the above technical problems.

In the first aspect, an embodiment of the present invention provides a mapping guide wire. The mapping guide wire includes a guide wire core, a guide wire sleeve, an electrode lead, a front end electrode, and a back end electrode. In addition to the guide wire core and the electrode lead, the front end electrode and the rear end electrode are respectively arranged at the distal and proximal ends of the guide wire core, and both ends of the electrode lead are respectively connected to the front end electrode And the rear electrode, the rear electrode is electrically connected to a three-dimensional mapping device.

In a second aspect, an embodiment of the present invention provides a three-dimensional mapping system, including the above-mentioned mapping guide wire and a three-dimensional mapping device electrically connected to the mapping guide wire, the three-dimensional mapping device including a connector and a signal The processor, the mapping guide wire includes a guide wire core, a guide wire sleeve, an electrode lead, a front electrode and a rear electrode, the guide wire sleeve is sleeved outside the guide wire core and the electrode lead, and the front end The electrode and the rear electrode are respectively arranged at the distal and proximal ends of the guide wire core, the two ends of the electrode lead are respectively connected to the front electrode and the rear electrode, and the rear electrode is connected to In the three-dimensional mapping equipment, the proximal end of the adapter is electrically connected to the three-dimensional mapping equipment, and the signal processor is used to process the electrical signals collected by the electrodes.

The embodiment of the present invention provides a mapping guide wire and a three-dimensional mapping system using the mapping guide wire. The mapping guide wire includes a guide wire core, a guide wire sleeve, an electrode lead, a front end electrode, and a back end electrode. The guide wire sleeve is sleeved outside the guide wire core and the electrode lead, and the front end electrode and the electrode lead The rear end electrodes are respectively arranged at the distal end and the proximal end of the guide wire core, the two ends of the electrode lead are respectively connected to the front end electrode and the rear end electrode, and the rear end electrode is electrically connected to the three-dimensional The mapping equipment is not only easy to operate, but also capable of quickly mapping the electrical signals collected by the front-end electrodes. In addition, because the diameter of the guide wire is small, the guide wire can accurately and reliably map the patient's blood vessel or heart cavity structure, thereby providing a more accurate basis for the accurate positioning of the operation.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative labor.

Fig. 1 is a schematic structural diagram of a mapping guide wire provided by the first embodiment of the present invention.

Fig. 2 is a schematic structural view of the first embodiment of the guide wire body of the mapping guide wire in Fig. 1.

Figure 3 is a cross-sectional view of the guide wire body in Figure 2 along the direction of III-III

Figure 4 is an enlarged view of part A of the guide wire body in Figure 3

Fig. 5 is an enlarged view of part B of the guide wire body in Fig. 3.

Fig. 6 is a cross-sectional view of the guide wire body in Fig. 2 along the VI-VI direction.

Fig. 7 is a cross-sectional view of the mapping guide wire in Fig. 1 along the VII-VII direction.

Fig. 8 is an enlarged view of part C of the mapping guide wire in Fig. 7.

Fig. 9 is a left side view of the adapter of the mapping guide wire in Fig. 7.

Fig. 10 is a right side view of the adapter of the mapping guide wire in Fig. 7.

Fig. 11 is a schematic structural view of a second embodiment of the guide wire body of the mapping guide wire in Fig. 1.

Figure 12 is a cross-sectional view of the guide wire body in Figure 11 along the XII-XII direction

Fig. 13 is an enlarged view of part D of the guide wire body in Fig. 12.

Fig. 14 is an enlarged view of part E of the guide wire body in Fig. 12.

Fig. 15 is a cross-sectional view of the guide wire body in Fig. 11 along the XV-XV direction.

Fig. 16 is a schematic structural view of a third embodiment of the guide wire body of the mapping guide wire in Fig. 1.

Fig. 17 is a schematic structural diagram of a fourth embodiment of the guide wire body of the mapping guide wire in Fig. 1.

FIG. 18 is a schematic structural diagram of a three-dimensional mapping system provided by the first embodiment of the present invention.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

It should be noted that in the field of interventional medicine, the end of the instrument close to the operator is usually called the proximal end, and the end of the instrument far away from the operator is called the distal end. Specifically, the distal end refers to the end where the instrument can be freely inserted into the animal or human body. The near end refers to the end used for user or machine operation or the end used to connect other devices.

It can be understood that the terms in the specification and claims of the present invention and the above-mentioned drawings are only for describing specific embodiments, and are not intended to limit the present invention. The terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific sequence. Unless the context clearly states otherwise, the singular forms "a" and "the" are also intended to include the plural forms. The term "including" and any variations of them are intended to cover non-exclusive inclusion. In addition, the present invention can be implemented in many different forms and is not limited to the embodiment described in this embodiment. The following specific embodiments are provided for the purpose of facilitating a clearer and thorough understanding of the disclosure of the present invention. The words indicating directions such as up, down, left, and right are only for the position of the structure shown in the corresponding drawings.

The following descriptions of the specification are preferred embodiments for implementing the present invention. However, the foregoing description is for the purpose of explaining the general principles of the present invention, and is not intended to limit the scope of the present invention. The protection scope of the present invention shall be subject to those defined by the appended claims.

Please refer to FIG. 1, which is a schematic structural diagram of a mapping guide wire 100 provided by the first embodiment of the present invention. The mapping guide wire 100 is applied to the three-dimensional mapping device 200 (see FIG. 18). The mapping guide wire 100 includes a guide wire body 1 and an adapter 2 disposed at the proximal end of the guide wire body 1. The adapter 2 is sleeved outside the guide wire body 1.

Please refer to FIGS. 1 to 5 together. FIG. 2 shows a schematic diagram of the guide wire body 1 provided by the first embodiment of the present invention. FIG. 3 shows the guide wire body 1 in FIG. 2 along the III-III direction. In cross-sectional view, FIG. 4 is an enlarged view of part A of the guide wire body 1 in FIG. 3, and FIG. 5 is an enlarged view of part B of the guide wire body 1 in FIG. 3. The guide wire body 1 includes a guide wire core 10, a guide wire sleeve 20, an electrode lead 30, a front electrode 40 and a rear electrode 50. The guide wire sleeve 20 is sleeved outside the guide wire core 10 and the electrode lead 30. The front end electrode 40 and the back end electrode 50 are respectively disposed at the distal end and the proximal end of the guide wire core 10. Both ends of the electrode lead 30 are connected to the front electrode 40 and the rear electrode 50, respectively. In one embodiment, the distal end of the back electrode 50 is connected to the proximal end of the electrode lead 30, and the proximal end of the back electrode 50 is connected to the connector 201 (see FIG. 18) of the three-dimensional mapping device 200. Optionally, in other embodiments, the distal end of the adaptor 2 is connected to the back electrode 50, and the proximal end of the adaptor 2 is connected to the connector 201 of the three-dimensional mapping device 200 (see FIG. 18). In this way, since the back-end electrode 50 is electrically connected to the three-dimensional mapping device 200, the three-dimensional mapping device 200 can quickly map the electrical signals collected by the front-end electrode 40. In addition, because the diameter of the guide wire is small, the guide wire can accurately and reliably map the patient's blood vessel or heart cavity structure, thereby providing a more accurate basis for the accurate positioning of the operation.

It should be noted that the guide wire body 1 is also called a guide wire or a guide wire, and is one of the main tools for percutaneous puncture and intubation. The guide wire body 1 guides and supports the catheter, helps the catheter to enter blood vessels and other cavities, and guides the catheter to reach the lesion smoothly. The guide wire body 1 can be classified according to its use. The guide wire body 1 includes, but is not limited to, a soft guide wire, a hard guide wire, a renal artery guide wire, a micro guide wire, a push guide wire, a super-smooth guide wire, a guide guide wire, and a contrast guide wire. Wherein, the micro-guide wire is used to be inserted into the micro-catheter to provide guidance and support equipment for interventional diagnosis and treatment. The head end of the micro-guide wire is relatively soft to facilitate selective access to blood vessels; the tail end of the micro-guide wire is relatively hard, so that it can play a supporting role well. The guide wire is used to enter the coronary artery or other blood vessels, so that the coronary artery surgery can be performed through the balloon and the stent set on the guide wire.

It should be noted that the present invention mainly describes the improved structure. As for other conventional structures of the guide wire body 1, any feasible solution in the prior art can be adopted, and the present invention will not repeat them. In this embodiment, the guide wire body 1 is described in detail by taking a guide wire as an example. The type of guidewire body 1 of the present invention is not limited to guidewires, and can be applied to any guidewire in the prior art, which is not limited here.

Specifically, the guide wire body 1 includes opposite guide wire head ends 101 and guide wire tail ends 102. The guide wire tip 101 of the guide wire body 1 refers to the end where the medical guide wire 100 enters the lesion site of the patient during vascular surgery, and the guide wire tail 102 of the guide wire body 1 refers to the end that is connected to the three-dimensional mapping device 200 One end. Specifically, the guide wire core 10 and the guide wire sleeve 20 are welded to the distal end of the guide wire tip 101 of the guide wire body 1. The surface of the guide wire tip 101 smoothly transitions so that the guide wire tip 101 of the guide wire body 1 smoothly enters the blood vessel or other cavities. The adapter 2 is sleeved outside the tail end 102 of the guide wire.

Optionally, in some embodiments, the guide wire body 1 is an adjustable guide wire, such as an elbow guide wire or a paranoid guide wire. In this way, the direction of the guide wire body 1 can be adjusted in the heart cavity structure, which is convenient for collecting information of various positions. The guide wire tip 101 of the guide wire body 1 is spiral or J-shaped. In other embodiments, the guide wire body 1 may also be a straight guide wire.

The guide wire core 10 extends along the length direction of the guide wire body 1. The central axis of the guide wire core 10 overlaps with the central axis of the guide wire body 1. The guide wire core 10 axially penetrates the distal and proximal ends of the guide wire body 1. The guide wire core 10 is used to support and shape the guide wire body 1. The guide wire core 10 may be made of Nitinol material, such as Nitinol wire or Nitinol wire. Optionally, the guide wire core 10 is braided by multiple strands of Nitinol wire. The head end (that is, the distal end) of the guidewire core 10 is softer to allow it to enter the patient's blood vessel, while the tail end (that is, the proximal end) of the guidewire core 10 is harder, has good maneuverability, and can be the guidewire body 1Provide strong support to ensure the stability of the operation process.

The guide wire sleeve 20 has a hollow cylindrical structure, so that the guide wire sleeve 20 is sleeved outside the guide wire core 10. In this embodiment, the guide wire sheath 20 is wrapped around the entire outer surface of the guide wire core 10 to accommodate and protect the guide wire core 10. Since the guide wire sleeve 20 is located outside the guide wire body 1, the guide wire sleeve 20 can be made of biocompatible materials to reduce the damage of the guide wire body 1 to the inner wall of the blood vessel. The biocompatible material is, for example, but not limited to expanded polytetrafluoroethylene (e-PTFE), polytetrafluoroethylene (PTFE), and fluorinated ethylene propylene copolymer (fluorinated ethylene propylene). propylene; FEP), or polyethylene terephthalate (polyethylene terephthalate; PET) and other materials with low friction coefficient. The biocompatible material can also be, but is not limited to, strong elastic materials such as silica gel, polyurethane, and polyetheramide.

The guide wire core 10 and the guide wire sleeve 20 are coaxially arranged, and the guide wire core 10 and the guide wire sleeve 20 form a receiving space 103 for receiving the electrode lead 30. Specifically, the electrode lead 30 and the guide wire core 10 are arranged side by side, that is, the axial direction of the electrode lead 30 is parallel to the axial direction of the guide wire core 10. The distal end of the electrode lead 30 is connected to the front electrode 40, and the proximal end of the electrode lead 30 is connected to the rear electrode 50. Specifically, the distal end of the electrode lead 30 is welded to the inner wall of the front electrode 40, and the proximal end of the electrode lead 30 is welded to the inner wall of the rear electrode 50.

Optionally, an insulating layer is provided on the outer surface of the electrode lead 30 except for the connection with the front electrode 40 and the rear electrode 50 to insulate the electrode lead 30 from other elements of the guide wire body 1. The insulating layer contains insulating materials such as polyurethane and polyesterimide.

The front-end electrode 40 is used to collect electrical signals of the patient’s lesion, and the back-end electrode 50 is used to transmit the electrical signals collected by the front-end electrode 40 to the three-dimensional mapping device 200 through the adapter 2, so that the three-dimensional mapping device 200 can The electrical signals collected by the front electrode 40 determine the position and shape of the guide wire tip 101 of the guide wire body 1 (ie, the guide wire visualization) and the location of the lesion, such as the position of the pulmonary vein orifice. The signals collected by the front-end electrode 40 can also be used to establish an activation time sequence diagram, a voltage diagram, an impedance diagram, and the like.

In this embodiment, the tip electrode 40 is fixedly arranged at the distal end of the guide wire body 1. Wherein, the front electrode 40 may be made of precious metal material. The precious metal materials include, but are not limited to, gold, platinum, platinum-iridium alloys or other electrical conductors.

The front electrode 40 and the back electrode 50 are both embedded on the guide wire sleeve 20, and pass through the guide wire sleeve 20 to be connected to the electrode lead 30. Optionally, the outer surface of the front electrode 40 and the outer surface of the rear electrode 50 are connected to the outer surface of the guide wire sleeve 20, that is, the outer surface of the front electrode 40, the outer surface of the rear electrode 50, and the guide wire sleeve 20 The outer surfaces together form a continuous curved surface, thereby improving the smoothness of the guide wire body 1 into blood vessels and other cavities.

In this embodiment, the front end electrode 40 is connected to the electrode lead 30 by welding. In other embodiments, the front-end electrode 40 may also be connected to the electrode lead 30 by crimping, winding, crimping, crimping, thermal melting, or other connection methods.

The number of the front electrode 40 can be one or more, and the number of the back electrode 50 and the electrode lead 30 can also be one or more. The number of the rear electrode 50 and the electrode lead 30 may also be one or more. The back-end electrode 50 and the electrode wire 30 respectively correspond to the front-end electrode 40 one-to-one, and each front-end electrode 40 forms a signal path with the corresponding back-end electrode 50 and the electrode wire 30. In this way, the electrical signals collected by the respective front-end electrodes 40 do not interfere with each other, thereby improving the mapping accuracy of the three-dimensional mapping device 200 to accurately determine the position and shape of the guide wire tip 101 of the guide wire body 1 and blood vessels The location of the surgical site.

It is understandable that since the electric signal collected by the front electrode 40 is relatively weak, the number of the front electrode 40 can be multiple, so as to locate multiple positions of the front electrode 40 and enhance the electric signal collected by the front electrode 40. Signal to facilitate subsequent signal processing. A plurality of front-end electrodes 40 are arranged at intervals to avoid signal interference and reduce the accuracy of the standard. In some embodiments, the axial distance between two adjacent front-end electrodes 40 may be set at a certain distance according to the vascular surgery site. Optionally, the number of front-end electrodes 40 is 2-15.

It should be noted that the structure of the rear electrode 50 is similar to the structure of the front electrode 40, and will not be repeated here.

In some embodiments, the rear electrode 50 may have a longer axial length or other special structures, such as recesses, than the front electrode 40, so that it contacts the adapter 2 better.

In this embodiment, the number of the front end electrode 40 and the back end electrode 50 is four, and the front end electrode 40 includes a first front end electrode 41, a second front end electrode 42, a third front end electrode 43, and a fourth front end electrode 44 spaced apart from each other. . The rear electrode 50 includes a first rear electrode 51, a second rear electrode 52, a third rear electrode 53 and a fourth rear electrode 54 spaced apart from each other.

Please refer to FIG. 6. FIG. 6 shows a cross-sectional view of the guide wire body 1 in FIG. 2 along the direction VI-VI. In this embodiment, the electrode lead 30 includes a first electrode lead 31, a second electrode lead 32, a third electrode lead 33, and a fourth electrode lead 34. Both ends of the first electrode lead 31 are connected to the first front end electrode 41 and the first rear end electrode 51, respectively. Both ends of the second electrode lead 32 are connected to the second front end electrode 42 and the second rear end electrode 52, respectively. Both ends of the third electrode lead 33 are connected to the third front end electrode 43 and the third rear end electrode 53 respectively. Both ends of the fourth electrode lead 34 are connected to the fourth front electrode 44 and the fourth rear electrode 54 respectively.

Optionally, the length of the multiple electrode wires 30 can be set according to the positions of the front electrode 40 and the rear electrode 40. In this embodiment, the length of the first electrode wire 31 is equal to the length of the second electrode wire 32, the third electrode wire 33, and the fourth electrode wire 34. In other embodiments, the length of the first electrode wire 31 may also be greater or less than the length of the second electrode wire 32, the third electrode wire 33, and the fourth electrode wire 34.

As shown in FIG. 6, the tip electrode 40 may have a ring shape. The shape of the plurality of tip electrodes 40 may be the same or different. In this embodiment, the front end electrode 40 is configured as a four-electrode ring structure.

Specifically, a guide wire cavity 401 and four electrode lead cavities 402 located around the guide wire cavity 401 are provided inside the front end electrode 40 along the axial direction. The four electrode wire cavities 402 are arranged around the axis of the guide wire cavity 401. The guide wire cavity 401 and the electrode wire cavity 402 both axially penetrate the distal end and the proximal end of the front electrode 40. The four electrode lead cavities 402 are isolated and arranged circumferentially. The four electrode lead cavities 402 can be arranged adjacently or arranged at intervals of a certain distance. Specifically, the four electrode lead cavities 402 are all arranged around the guide wire cavity 401 and are arranged in isolation. The guide wire cavity 401 is approximately circular, and the electrode wire cavity 402 is approximately semicircular. Therefore, the inner cavity structure of the front electrode 40 can be configured into a petal shape, which can prevent the multiple electrode wires 30 from being twisted and the multiple electrodes The wires 30 will not interfere with each other, so that the guide wire body 1 can be made thinner, which can meet the needs of miniaturization of medical equipment. Wherein, the petal structure can be regular or irregular. In other embodiments, the electrode lead cavity 402 may also be circular or oval, which is not limited here.

In some embodiments, the petal structure may be regular, that is, the two electrode lead cavities 402 are symmetrically distributed with respect to the central axis of the front electrode 40. In some other embodiments, the petal structure may be irregular, that is, the two electrode lead cavities 402 are distributed asymmetrically with respect to the central axis of the front electrode 40.

Wherein, the inner diameter of the guidewire cavity 401 is greater than or equal to the diameter of the guidewire core 10 so that the guidewire core 10 can pass through the guidewire cavity 401. Further, the central axis of the guidewire cavity 401 is collinear with the central axis of the guidewire core 10, so as to ensure that the guidewire core 10 smoothly passes through the guidewire cavity 401. The electrode lead cavity 402 and the receiving space 103 penetrate axially. Thus, the electrode wire cavity 402 and the receiving space 103 form an electrode wire channel for the electrode wire 30 to pass through. Optionally, the electrode wire cavities 402 correspond to the electrode wires 30 one-to-one, that is, each electrode wire cavity 402 allows one electrode wire 30 to pass through, thereby preventing multiple electrode wires from being twisted. The distal and proximal ends of the electrode lead 30 are welded to an inner peripheral wall of the electrode lead cavity 402 away from the guide wire cavity 401 to increase the contact area between the electrode lead 30 and the electrode lead cavity 402, so that the front electrode 40 and the rear electrode 50 The contact between is better.

It should be noted that the number of electrode wire cavities (that is, the number of electrode rings) can be determined according to the number of electrode wires, that is, the electrode wire cavity corresponds to the electrode wire one to one, so each electrode wire cavity can be used as a single electrode wire path , So as to prevent multiple electrode wires from twisting, which is not limited here. In some other embodiments, the number of electrode lead cavities may be more than the number of electrode leads, so that the remaining leads can pass through, which is not limited here.

Please refer to FIGS. 7 to 10 together. FIG. 7 shows a cross-sectional view of the mapping guide wire 100 in FIG. 1 along the VII-VII direction, and FIG. 8 shows part C of the mapping guide wire 100 in FIG. 7 In an enlarged view, FIG. 9 is a left view of the adapter 2 of the mapping guide wire 100 in FIG. 7, and FIG. 10 is a right view of the adapter 2 of the mapping guide wire 100 in FIG. 7. As shown in FIG. 7, the adapter 2 is detachably fixed to the proximal end of the guide wire sheath 20. In this way, when the electrical signal sensed by the front electrode 40 of the guide wire body 1 needs to be transmitted to the three-dimensional mapping device 200, the adapter 2 is connected to the proximal end of the guide wire body 1, and the front end is conducted through the electrode lead 30 The electrode 40 collects the electrical signal collected by the front electrode 40. After collecting the electrical signals, the adapter 2 can be removed from the guide wire body 1. At this time, the guide wire body 1 can be used as a guide structure for the catheter to guide and support the catheter to help The catheter smoothly enters blood vessels and other cavities.

In this embodiment, the distal end of the adapter 2 defines a receiving cavity 21 for receiving the guide wire tail end 102 of the guide wire body 1 along the axial direction. Wherein, the inner wall of the receiving cavity 21 is provided with a metal elastic piece 211. The metal spring 211 is correspondingly connected to the rear electrode 50. The cross section of the receiving cavity 21 is substantially circular.

Optionally, the diameter of the receiving cavity 21 is slightly larger than the outer diameter of the tail end 102 of the guide wire, and the distance between two adjacent metal elastic pieces 211 is equal to the distance between two adjacent rear electrodes 50, so that the rear electrode 50 The metal elastic sheet 211 can be abutted or pressed to realize telecommunications conduction between the two.

The proximal end of the adapter 2 is provided with a connection port 22 in the axial direction for the connector 201 (refer to FIG. 18) to be inserted. A first connecting head 221 is provided in the connecting port 22. The connector 201 is provided with a second connector 2011 that is matched with the first connector 221. The proximal end of the first connector 221 is connected to the second connector 2011, and the distal end of the first connector 221 is correspondingly connected to the metal spring 211. Specifically, in this embodiment, the first connector 221 is configured as a pin, and the second connector 2011 is configured as a socket that matches the pin. Specifically, in other embodiments, the first connector 221 is configured as a socket, and the second connector 2011 is configured as a pin that matches the socket.

The number of metal elastic pieces 211 is equal to the number of back-end electrodes 50, and each metal elastic piece 211 is electrically connected to the corresponding back-end electrode 50. The number of first connecting heads 221 is equal to the number of metal elastic pieces 211. The adapter 2 further includes a wire 23, and each first connector 221 is electrically connected to a corresponding metal spring 211 through a corresponding wire 23. In this embodiment, the number of metal elastic sheets 211 and the number of first connecting heads 221 are both four.

Wherein, the extending direction of the first connecting head 221 is parallel to the axial direction of the guide wire body 1, thereby improving the stability of the two ends of the adapter 2 respectively connected to the guide wire body 1 and the connector 201, and avoiding the guide wire body The proximal end of 1 is deformed, which affects the efficiency and safety of the operation.

Optionally, in some embodiments, as shown in FIGS. 9 and 10, the plurality of first connecting heads 221 are symmetrically distributed from the central axis of the adapter 2. The central axis of the receiving cavity 21 is collinear with the central axis of the adapter 2.

In some other embodiments, the adapter 2 of the guide wire body 1 may be omitted, that is, the guide wire body 1 may be directly connected to the connector 201 of the three-dimensional mapping device 200 through the electrode wire 30.

Please refer to FIGS. 11 to 14 together. FIG. 11 shows a schematic diagram of the guide wire body 1A provided by the second embodiment of the present invention. FIG. 12 shows the guide wire body 1A in FIG. 11 along the XII-XII direction. In cross-sectional views, FIG. 13 is an enlarged view of part D of the guide wire body 1A in FIG. 12, and FIG. 14 is an enlarged view of part E of the guide wire body 1A in FIG. In the second embodiment, the structure of the guide wire body 1A is similar to the structure of the guide wire body 1 of the first embodiment, except that the number of electrode leads 30A, front electrodes 40A, and rear electrodes 50A of the guide wire body 1A Both are two.

Specifically, in this embodiment, the electrode lead 30A includes a first electrode lead 31A and a second electrode lead 32A. The tip electrode 40A includes a first tip electrode 41A and a second tip electrode 42A spaced apart from each other. The rear electrode 50A includes a first rear electrode 51A and a second rear electrode 52A spaced apart from each other. Both ends of the first electrode lead 31A are connected to the first front end electrode 41A and the first rear end electrode 51A, respectively. Both ends of the second electrode lead 32A are connected to the second front end electrode 42A and the second rear end electrode 52A, respectively.

Please refer to FIG. 15. FIG. 15 is a cross-sectional view of the guide wire body 1A in FIG. 11 along the XV-XV direction. In this embodiment, the structure of the front electrode 40A is similar to the structure of the front electrode 40 of the first embodiment, except that the front electrode 40A is configured as a double electrode ring structure. Specifically, a guide wire cavity 401A and two electrode wire cavities 402A located around the guide wire cavity 401A are provided inside the front end electrode 40A along the axial direction. The structure of the rear electrode 50A is the same as that of the front electrode 40A, and will not be repeated here.

It should be noted that in this embodiment, only two metal springs corresponding to the first rear electrode 51A and the second rear electrode 52A are provided in the receiving cavity of the adapter, and two metal springs are provided in the connecting port of the adapter. The first connector will not be repeated here.

Please refer to FIG. 16, which is a schematic diagram of a partial structure of a guide wire body 1B provided by the third embodiment of the present invention. In this embodiment, the structure of the guidewire body 1B is similar to the structure of the guidewire body 1A of the second embodiment. The difference is that the guidewire body 1B further includes a sheath 70 that houses the guidewire core 10 and the electrode lead 30.

In this embodiment, the sheath 70 is sheathed outside the guide wire core 10 and the electrode lead 30A. The sheath tube 70 is disposed between the adjacent front electrode 40A and the tail electrode 50A, and the front electrode 40A and the tail electrode 50A are exposed outside the sheath tube 70. In some embodiments, when the number of the electrode lead 30A is one, the length of the sheath tube 70 is the same as the length of the electrode lead 30A. When the number of electrode wires 30A is multiple, the length of the sheath tube 70 is shorter than the length of the electrode wire 30A, that is, the length of the sheath tube 70 is equal to or less than the minimum distance between the front electrode 40A and the tail electrode 50A.

Optionally, the sheath 70 may be made of a polymer material. The polymer materials include, but are not limited to nylon or polyester block amide (PEBAX) and the like. Further, the sheath tube 70 can be made of a metal material, which includes, but is not limited to, stainless steel, nickel-titanium alloy, etc., so as to enhance the mechanical strength of the guide wire body 1A and can shield external interference signals.

Please refer to FIG. 17, which is a schematic diagram of a partial structure of a guide wire body 1C according to a fourth embodiment of the present invention. In this embodiment, the structure of the guide wire body 1C is similar to the structure of the guide wire body 1A of the second embodiment. The difference is that the guide wire body 1C further includes a sensor 80 disposed at the distal end of the guide wire body 1C, and Used to detect the three-dimensional coordinates and direction of the magnetic field.

In some embodiments, the sensor 80 is disposed inside the front electrode 40. In this way, the electrical signal collected by the front-end electrode 40 and the induction signal sensed by the sensor 80 are used to simultaneously map the patient's blood vessel or heart cavity structure, thereby providing a more accurate basis for the accurate positioning of the operation. In other embodiments, the sensor 80 may also be spaced apart from the front electrode 40. For example, the sensor 80 is disposed between two adjacent front electrodes 40, so that signal shielding is performed between the sensor 80 and the front electrode 40, thereby reducing or avoiding The influence between the sensor 80 and the tip electrode 40.

Specifically, in this embodiment, the sensor 80 is disposed at the guide wire tip 101 of the guide wire body 1C. The guide wire body 1C also includes a signal cable 33 and a receiving electrode 53. The signal cable 33 and the electrode lead 30A are arranged side by side, and the receiving electrode 53 is arranged at the proximal end of the guide wire body 1C. Both ends of the signal cable 33 are connected to the sensor 80 and the receiving electrode 53 respectively.

Optionally, the adapter is further provided with a metal spring and a connector that are electrically connected to the receiving electrode 53, wherein the arrangement of the adapter can refer to the arrangement of the adapter 2 of the first embodiment. Repeat it again.

The sensor 80 is a magnetic sensor, so the guide wire body 1C in this embodiment can be applied to a three-dimensional electroanatomical mapping system (CARTO) or other three-dimensional mapping systems. The number of sensors 80 may include one or more. The plurality of sensors 80 are arranged at intervals of a certain distance, so as to locate the positions of the sensor 80 and enhance the magnetic signal collected by the sensor 80, thereby facilitating subsequent signal processing.

In some embodiments, the guide wire body 1C can omit electrodes, that is, the magnetic signal detected by the sensor 80 is directly transmitted to the 3D mapping system to detect the 3D coordinates and direction in the magnetic field where the sensor 80 is located. It is understandable that the guide wire bodies 1A, 1B, and 1C in the second embodiment to the fourth embodiment are all applicable to the mapping guide wire 100 in the first embodiment, and will not be repeated here.

The embodiment of the present invention provides a mapping guide wire and a three-dimensional mapping system using the mapping guide wire. The mapping guide wire includes a guide wire core, a guide wire sleeve, an electrode lead, a front end electrode, and a back end electrode. The guide wire sleeve is sleeved outside the guide wire core and the electrode lead, and the front end electrode and the electrode lead The rear end electrodes are respectively arranged at the distal end and the proximal end of the guide wire core, the two ends of the electrode lead are respectively connected to the front end electrode and the rear end electrode, and the rear end electrode is electrically connected to the three-dimensional mapping The equipment is not only easy to operate, but also capable of quickly mapping the electrical signals collected by the front-end electrodes. In addition, because the diameter of the guide wire is small, the guide wire can accurately and reliably map the patient's blood vessel or heart cavity structure, thereby providing a more accurate basis for the accurate positioning of the operation.

It should be noted that the present invention mainly describes the structure related to the improvement in detail. As for other conventional structures of the mapping guide wire, any feasible solution in the prior art can be adopted, which will not be repeated here.

Please refer to FIG. 18, which is a schematic diagram of program modules of the three-dimensional mapping system 1000 provided by the first embodiment of the present invention. The three-dimensional mapping system 1000 includes a mapping guide wire 100 and a three-dimensional mapping device 200 connected to the mapping guide wire 100.

It should be noted that the components of the mapping guide wire 100 and the connection relationship between the various parts have been described in detail in the first embodiment. In addition, the guide wire bodies 1A, 1B, and 1C of the second embodiment to the fourth embodiment can also be applied to the three-dimensional mapping system 1000. I won't repeat them here.

In this embodiment, the three-dimensional detection device 200 includes a connector 201, a connection cable 202, a signal processor 203, and a display 204. The connector 201, the signal processor 203, and the display 204 may be coupled through a connection cable 202. Those skilled in the art should understand that FIG. 18 is only an example of the three-dimensional mapping system 1000 and does not constitute a limitation on the three-dimensional mapping system 1000. The three-dimensional mapping system 1000 may include more or more than those shown in FIG. A few components, or a combination of some components, or different components, for example, the three-dimensional mapping system 1000 may also include a signal extraction device, a signal amplification device, an input and output device, and so on.

The adapter 2 of the mapping guide wire 100 is connected to the connector 201 of the three-dimensional inspection device 200. In this way, the electrical signal collected by the front-end electrode 40 and/or the induction signal detected by the sensor 80 can be transmitted to the signal processor 203 of the three-dimensional detection device 200.

Specifically, in this embodiment, the adapter 2 has a first connector 221, and the connector 201 has a second connector 2011 that matches the first connector 221. In other embodiments, the first connector 221 and the second connector 2011 may be wireless signal interfaces, such as, but not limited to, parallel interfaces, wifi, Bluetooth, or Ethernet, or near field communication technologies (NFC) such as RFID Wait.

The signal processor 203 is configured to receive the electrical signal detected by the front electrode 40 and/or the magnetic signal detected by the sensor 80 through the connecting cable 202, and perform arithmetic processing on the electrical signal and the magnetic signal to conduct The position and shape of the guide wire tip 101 of the wire body 1 are simulated.

The signal processor 203 may be a central processing unit (Central Processing Unit, CPU), other general-purpose processors, digital signal processors (Digital Signal Processor, DSP), application specific integrated circuits (Application Specific Integrated Circuit, ASIC), on-site Field-Programmable Gate Array (FPGA) or other programmable logic devices, discrete gates or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or the processor may also be any conventional processor or the like. The signal processor 203 is the control center of the three-dimensional mapping equipment 200, and connects various parts of the entire three-dimensional mapping equipment 200 through various interfaces and lines.

The display 204 is used to simulate and display the position and shape of the guide wire tip 101 of the guide wire body 1 calculated by the signal processor 203. The display 204 includes, but is not limited to, a tablet computer, a display, a liquid crystal panel, an OLED panel, a TV, and any other products and components with display functions.

In some embodiments, the three-dimensional detection device 200 further includes a memory 205 for storing the initial characteristic parameters of the guide wire tip 101 of the guide wire body 1, for example, the number of tip electrodes 40 provided on the guide wire tip 101, The distribution position of the electrode 40, the total length of the guide wire tip 101, and so on. When the guide wire body 1 is connected to the three-dimensional inspection device 200, the memory 205 can obtain the initial characteristic parameters of the guide wire tip 101 and transmit it to the signal processor 203 for calculation.

Taking a common atrial fibrillation operation as an example, the guide wire body 1 is a circular pulmonary vein mapping guide wire (hereinafter referred to as a circular lung guide wire), and the clinical application of the three-dimensional mapping device 200 provided by the embodiment of the present invention is described in detail. Application process.

Before proceeding, first place the magnetic field generator to the proper position of the operating table, so that the patient's heart cavity is located in the best detection area of the magnetic field positioning system.

Then the operator, such as a cardiologist, inserts the circular lung guide wire into the patient’s lesion through the patient’s vascular system so that the tip 101 of the guide wire enters the right atrium of the patient’s heart, punctures the atrial septum into the left atrium, and then The guide wire tip 101 is released into the left atrial cavity, and the front electrode 40 and the sensor 80 provided on the guide wire tip 101 are located in the positioning magnetic field area.

The adapter 2 of the guide wire body 1 is connected to the connector 201 of the three-dimensional mapping device 200. The signal processor 203 can preliminarily process the electrical signals detected by the front electrode 40 and the magnetic signals detected by the sensor 80 and convert them into digital signals, and read the initial characteristic parameters of the guide wire tip 101 stored in the memory 205. The signal processor 203 reconstructs the shape of the guide wire tip 101 according to the obtained converted digital signal and initial characteristic parameters, and displays the position and shape of the guide wire tip 101 on the display 204.

When the operator manipulates the proximal end of the guide wire body 1, the circular lung guide wire is moved at different positions in the left atrial cavity. The front-end electrode 40 and the sensor 80 acquire positioning data that can be updated in real time, and the guide wire on the display 204 The image is also updated at any time. The surgical operator can adjust the position of the loop lung guide wire to reach the target area according to the feedback of the guide wire image on the display 204.

When the circular lung guide wire enters the pulmonary vein, move the guide wire along the blood vessel of the pulmonary vein and record the movement track of the tip end 101 of the guide wire to obtain the position and shape of the pulmonary vein. When the circular lung guide wire is located in the heart cavity, a known algorithm can be used to reconstruct a three-dimensional model of the inner wall of the left atrium according to the position and shape of the tip end 101 of the guide wire.

When the three-dimensional model of the inner wall of the left atrium is established, the surgical operator can use the radiofrequency ablation guidewire with positioning function under the guidance of the established three-dimensional model of the heart cavity, and operate the guidewire according to the position of the ablation electrode on the ablation guidewire. The ablation electrode reaches the target location, and then ablation treatment is performed on the tissue at the target location.

The embodiments of the present invention are described in detail above, and specific examples are used in this article to illustrate the principles and implementation of the present invention. The descriptions of the above embodiments are only used to help understand the methods and core ideas of the present invention; Those of ordinary skill in the art, based on the idea of the present invention, will have changes in the specific implementation and the scope of application. In summary, the content of this specification should not be construed as limiting the present invention.

Claims (17)

A mapping guide wire, characterized in that the mapping guide wire comprises a guide wire core, a guide wire sleeve, an electrode lead, a front end electrode and a rear end electrode, and the guide wire sleeve is sleeved on the guide wire core and In addition to the electrode lead, the front end electrode and the rear end electrode are respectively arranged at the distal end and the proximal end of the guide wire core, and both ends of the electrode lead are connected to the front end electrode and the rear end electrode, respectively , The rear electrode is electrically connected to the three-dimensional mapping equipment. The mapping guide wire according to claim 1, wherein the number of the front end electrode is one or more, the number of the back end electrode and the electrode lead is one or more, and each electrode lead The opposite two ends are respectively connected to the corresponding front-end electrode and the back-end electrode, and each of the front-end electrodes forms a signal path with the corresponding electrode wire and the back-end electrode. The mapping guide wire of claim 1, wherein the front electrode and the rear electrode are embedded on the guide wire sleeve, and the outer surface of the front electrode and the rear electrode The outer surface of the guide wire is connected with the outer surface of the guide wire sleeve. The mapping guide wire according to claim 1, wherein the guide wire core and the guide wire sleeve are arranged coaxially, and a shelter is formed between the guide wire core and the guide wire sleeve The housing space of the electrode lead. The mapping guidewire according to claim 4, wherein the front electrode and/or the rear electrode is provided with a guidewire cavity for the guidewire core to pass through and a guidewire cavity along the axial direction. At least one electrode lead cavity through which the electrode lead passes. The mapping guide wire of claim 5, wherein the guide wire cavity and the at least one electrode wire cavity are arranged side by side, and the at least one electrode wire cavity is disposed on the inner peripheral wall of the guide wire cavity . 8. The mapping guide wire of claim 5, wherein the electrode lead cavity corresponds to the electrode lead one to one. The mapping guidewire according to claim 5, wherein the central axis of the guidewire cavity is collinear with the central axis of the guidewire core, and the electrode lead cavity is axially through the receiving space. The mapping guide wire according to claim 1, wherein the mapping guide wire further comprises a sheath, and the sheath is sleeved outside the guide wire core and the electrode lead. The mapping guide wire according to claim 1, wherein the mapping guide wire further comprises a sensor, the sensor is arranged at the distal end of the mapping guide wire, and is used to detect the magnetic field Three-dimensional coordinates and directions. The mapping guide wire of claim 1, wherein the mapping guide wire further comprises an adapter, and the adapter is connected to the connector of the rear electrode and the three-dimensional mapping device between. The mapping guide wire according to claim 11, wherein the adaptor is detachably fixed to the proximal end of the guide wire sleeve. The mapping guidewire according to claim 12, wherein the distal end of the adaptor defines a receiving cavity for accommodating the tail end of the mapping guidewire along the axial direction. The mapping guide wire according to claim 13, wherein the inner wall of the receiving cavity is provided with a metal shrapnel, and the metal shrapnel is correspondingly connected to the rear electrode. The mapping guide wire according to claim 14, wherein the proximal end of the adaptor is provided with a connecting port along the axial direction for the connector of the three-dimensional mapping device to insert, and the connecting port is provided with a first A connector, the connector is provided with a second connector, the proximal end of the first connector is correspondingly connected to the second connector, and the distal end of the first connector is correspondingly connected to the metal shrapnel . The mapping guide wire according to claim 1, wherein the outer surface of the electrode lead is provided with an insulating layer except for the connection with the front electrode and the rear electrode. A three-dimensional mapping system, characterized by comprising the mapping guide wire according to any one of claims 1 to 16 and a three-dimensional mapping device electrically connected to the mapping guide wire, the three-dimensional mapping device comprising Connector and signal processor, the mapping guide wire includes a guide wire core, a guide wire sleeve, an electrode lead, a front end electrode and a back end electrode, the guide wire sleeve is sleeved outside the guide wire core and the electrode lead The front end electrode and the back end electrode are respectively arranged at the distal end and the proximal end of the guide wire core, the two ends of the electrode lead are respectively connected to the front end electrode and the back end electrode, and the back The terminal electrode is electrically connected to the three-dimensional mapping equipment, and the signal processor is used to process the electrical signal collected by the electrode.

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