An electrode sheath

Abstract

The utility model provides a kind of electrode sheath, the electrode sheath at least includes mutually matched catheter sheath and dilator, the catheter sheath includes sheath tube seat and sheath tube connector, sheath tube body is provided on the sheath tube seat, the head end of the sheath tube body is provided first ring electrode unit, when the first ring electrode unit includes one ring electrode, the first ring electrode unit is connected with the sheath tube connector by the metal screen of transmission channel for electric signal, when the first ring electrode unit includes multiple ring electrodes, the first ring electrode unit is connected with the sheath tube connector by ring electrode connection wire.The embodiment has the function of atrial septum puncture sheath, the head end position of the catheter sheath and / or the dilator can be displayed, so that the distal end position of the electrode sheath can be displayed under zero-ray condition after puncture, avoid electrode sheath to drop out left atrium during operation Reduce X-ray damage to operator and patient.

Description

Technical Field

[0001] This utility model relates to the technical field of catheter sheaths, and more specifically, to an electrode sheath. Background Technology

[0002] The atrial septal puncture sheath is one of the key instruments in interventional cardiac treatment. Many common interventional procedures, such as radiofrequency ablation for atrial fibrillation, mitral valve balloon dilation, and left atrial appendage occlusion, require the atrial septal puncture sheath to establish a treatment pathway. Traditional atrial septal puncture sheaths must be operated under fluoroscopy, but because X-rays are planar images, it is impossible to accurately determine the position of the distal end of the sheath, and radiation is harmful to the health of both the operator and the patient.

[0003] The electrode sheath fulfills its intended purpose as an atrial septal puncture sheath: to be used via the femoral vein approach, in conjunction with the atrial septal puncture needle, to puncture the atrial septum from the right atrium to the left atrium and establish a pathway between the two. It can also be connected to a three-dimensional electrophysiological mapping system for three-dimensional spatial positioning and display, allowing for zero-radiation positioning of the distal sheath and preventing sheath dislodgement from the left atrium during surgery. This enables low-latency, rapid tracking, increasing surgical safety and reducing radiation harm to the surgeon and patient. Existing traditional atrial septal puncture sheaths on the market cannot accurately determine the position of the sheath tip without the aid of X-rays. Utility Model Content

[0004] To address the problem that traditional interatrial septal puncture sheaths in the prior art cannot accurately determine the position of the sheath tip without the aid of X-rays, this utility model provides an electrode sheath.

[0005] In view of this, embodiments of the present invention provide an electrode sheath, the electrode sheath comprising at least a cooperating catheter sheath and a dilator, the catheter sheath comprising a sheath seat and a sheath connector, the sheath seat being provided with a sheath body, and the head end of the sheath body being provided with a first ring electrode unit. When the first ring electrode unit comprises one ring electrode, the first ring electrode unit is connected to the sheath connector through a metal wire mesh for transmitting electrical signals. When the first ring electrode unit comprises multiple ring electrodes, the first ring electrode unit is connected to the sheath connector through ring electrode connecting wires.

[0006] In some embodiments, the sheath tube body includes a first tube body intermediate layer, and a first tube body inner layer and a first tube body outer layer made of polymer are respectively disposed on the inner and outer sides of the first tube body intermediate layer. When the number of the ring electrodes in the first ring electrode unit is one, the first tube body intermediate layer is a metal mesh layer. The first ring electrode unit is connected to the head end of the first tube body intermediate layer, and the tail end of the first tube body intermediate layer is connected to the sheath connector.

[0007] In some embodiments, when there are multiple ring electrodes in the first ring electrode unit, the ring electrode connecting wire is disposed between the middle layer of the first tube body and the inner layer of the first tube body. The middle layer of the first tube body is a mesh structure woven from insulating silk threads. One end of the ring electrode connecting wire is connected to the first ring electrode unit, and the other end extends out from the tail end of the sheath tube body and is connected to the sheath connector.

[0008] In some embodiments, a first insulating sleeve is provided at the connection point between the sheath body and the sheath connector.

[0009] In some embodiments, the sheath seat is also connected to a switch via a side arm.

[0010] In some embodiments, the expander includes an expander base and an expander connector. An expander tube is disposed on the expander base, and a second ring electrode unit is disposed at the head end of the expander tube. The second ring electrode unit includes at least one ring electrode and is connected to the expander connector through a metal mesh for transmitting electrical signals.

[0011] In some embodiments, the expander tube includes a second tube intermediate layer, with a second tube inner layer and a second tube outer layer made of polymer respectively disposed on the inner and outer sides of the second tube intermediate layer, the second tube intermediate layer being a metal mesh layer, the second ring electrode unit being connected to the head end of the second tube intermediate layer, and the tail end of the second tube intermediate layer being connected to the expander connector.

[0012] In some embodiments, a second insulating sleeve is provided at the connection point between the expander tube and the expander connector.

[0013] In some embodiments, the ring electrode is a platinum-iridium ring exposed on the sheath body and / or the expander body.

[0014] In some embodiments, the sheath connector and the dilator connector are respectively connected to a three-dimensional electrophysiological mapping system.

[0015] This embodiment has the function of an atrial septal puncture sheath. By using ring electrode units respectively set at the tip of the catheter sheath and the dilator, and connecting them to a three-dimensional electrophysiological mapping system, the position of the tip of the catheter sheath and / or the dilator can be displayed. In this way, the distal position of the electrode sheath can be displayed under zero radiation conditions after puncture, avoiding the electrode sheath from dislodging from the left atrium during surgery and reducing the harm of X-rays to the operator and the patient.

[0016] To make the above-mentioned objects, features and advantages of the present utility model embodiments more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0017] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method. The accompanying drawings, which are provided to further understand the present invention and form part of this application, illustrate exemplary embodiments of the present invention and, together with their description, serve to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0018] Figure 1 This is a schematic diagram of the structure of the catheter sheath with a single electrode structure provided in the embodiment of this utility model;

[0019] Figure 2 This is a schematic diagram of the sheath body of the catheter sheath with a single electrode structure provided in the embodiment of this utility model;

[0020] Figure 3 This is a schematic diagram of the connection between the sheath body and the sheath connector in the catheter sheath with a single electrode structure provided in the embodiment of this utility model;

[0021] Figure 4 This is a schematic diagram of the structure of the catheter sheath with a multi-electrode structure provided in the embodiment of this utility model;

[0022] Figure 5 This is a schematic diagram of the sheath body of the catheter sheath with a multi-electrode structure provided in the embodiment of this utility model;

[0023] Figure 6 This is a schematic diagram of the connection between the sheath body and the sheath connector in the catheter sheath with a multi-electrode structure provided in the embodiment of this utility model;

[0024] Figure 7 This is a schematic diagram of the structure of the expander provided in the embodiment of this utility model;

[0025] Figure 8 This is a schematic diagram of the structure of the expander tube body of the expander provided in the embodiment of this utility model;

[0026] Figure 9This is a schematic diagram showing the connection between the expander tube and the expander connector in the expander provided in the embodiment of this utility model.

[0027] Among them, the above-mentioned appendix Figures 1-9 The following reference numerals are included:

[0028] 1-Catheter sheath; 11-Sheath seat; 12-Sheath body; 121-Inner layer of first body; 122-Middle layer of first body; 123-Outer layer of first body; 124-Ring electrode lead; 13-First ring electrode unit; 131-First ring electrode; 14-Sheath connector; 141-First lead; 15-Side arm; 16-Switch; 17-First insulating sleeve; 2-Expander; 21-Expander seat; 22-Expander body; 23-Second ring electrode unit; 231-Second ring electrode; 24-Expander connector; 241-Second lead; 25-Second insulating sleeve. Detailed Implementation

[0029] The specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings, but these are not intended to limit the scope of the present invention.

[0030] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this invention will be apparent to those skilled in the art.

[0031] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present invention and, together with the general description of the present invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0032] These and other features of the present invention will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0033] It should also be understood that although the present invention has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of the present invention, which have the features described in the claims and are therefore all within the scope of protection defined herein.

[0034] The above and other aspects, features and advantages of the present invention will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0035] Specific embodiments of the present invention will now be described with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure the present invention. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely to serve as the basis and representative basis for the claims to teach those skilled in the art to use the present invention in a variety of substantially any suitable detailed structures.

[0036] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the utility model described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0037] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in other embodiments,” all of which may refer to one or more of the same or different embodiments according to the present invention.

[0038] An embodiment of this utility model provides an electrode sheath, which can be used as an atrial septal puncture sheath. The atrial septal puncture sheath is used to insert an atrial septal puncture needle into the right atrium, and after puncture, it enters the left atrium to form a channel into the left side of the heart. The atrial septal puncture needle is a type of electrophysiological surgical instrument, which generally consists of a needle hub, a needle tube, and a needle tip. The atrial septal puncture needle is used in conjunction with the atrial septal puncture sheath to create a primary perforation in the atrial septum, so that the atrial septal puncture sheath and / or catheter can pass through the atrial septum from the right atrium to the left atrium.

[0039] In this embodiment, as Figures 1-9 As shown, the electrode sheath includes a catheter sheath 1, a dilator 2, and a guidewire. The dilator 2 works in conjunction with the catheter sheath 1, and the guidewire is a flexible guidewire. Specifically, as... Figure 1As shown, the catheter sheath 1 includes a sheath seat 11, a sheath body 12 is disposed on the sheath seat 11, and a first ring electrode unit 13 is disposed at the head end of the sheath body 12. The first ring electrode unit 13 includes at least one first ring electrode 131, which is a platinum-iridium ring disposed on the sheath body 12 and is used to mark and measure electrical signals after being energized.

[0040] The sheath seat 11 is also connected to a sheath connector 14 via a cable. The sheath connector 14 can be connected to an external three-dimensional electrophysiological mapping system. This system allows for real-time dynamic display of the catheter sheath tip, particularly the position of the first ring electrode unit 13. Furthermore, the sheath seat 11 is connected to a switch 16 via a side arm 15. This switch can be a three-way switch.

[0041] Specifically, in this embodiment, the first ring electrode unit 13 is connected to the three-dimensional electrophysiological mapping system through the sheath connector 14, thereby enabling the visualization of the head position of the catheter sheath 1 through the first ring electrode unit 13.

[0042] Furthermore, depending on the number of the first ring electrodes 131 in the first ring electrode unit 13 located at the tip of the sheath body 12, the catheter sheath can be divided into two structures: a single-electrode structure and a multi-electrode structure. When there is only one first ring electrode 131 in the first ring electrode unit 13, the catheter sheath is a single-electrode structure; when there are multiple first ring electrodes 131 in the first ring electrode unit 13, the catheter sheath is a multi-electrode structure. The single-electrode structure is simple and easy to manufacture, while the multi-electrode structure offers greater stability and precision. Users can choose between the single-electrode and multi-electrode structures according to different surgical types or needs.

[0043] Specifically, when the catheter sheath has a single-electrode structure, that is, when the first ring electrode unit 13 includes a first ring electrode 131, the sheath body 12 has a three-layer structure, including a first inner layer 121, a first middle layer 122, and a first outer layer 123. The first inner layer 121 is made of a polymer with a low coefficient of friction, such as PTFE, which reduces the resistance when other instruments are inserted. The first outer layer 123 can also be made of a polymer with a low coefficient of friction. The first middle layer 122 is a metal mesh layer, wherein the first middle layer 122 is a reinforcing structure formed by the braiding of conductive metal mesh, which not only improves the strength of the first middle layer 122, but also allows the first middle layer 122 to serve as a transmission channel for electrical signals.

[0044] The three-layer structure of the sheath body 12 is formed using a rheological process. The first annular electrode 131 is connected to the distal end of the intermediate layer 122 of the first tube body, and the proximal end of the intermediate layer 122 is connected to the sheath connector 14 via a first wire 141. This three-layer structure of the sheath body 12 ensures the catheter sheath meets the requirements for support and flexural strength, and allows for the use of a metal mesh layer as a conductive medium instead of wires, thereby connecting the first annular electrode unit 13 and the sheath connector 14. The metal mesh portion located at the proximal end of the sheath body 12 is connected to the first wire 141 of the sheath connector 14 by brazing, and the connection point is protected and fixed by a first insulating sleeve 17.

[0045] Furthermore, when the catheter sheath has a multi-electrode structure, the sheath body 12 includes a first inner layer 121, a first intermediate layer 122, and a first outer layer 123. The first ring electrode 131 of the first ring electrode unit 13 is connected to the first wire 141 of the sheath connector 14 via a ring electrode connecting wire 124. The ring electrode connecting wire 124 can be disposed between the first inner layer 121 and the first intermediate layer 122. Alternatively, the ring electrode connecting wire 124 can be combined with the first wire 141 into a single wire.

[0046] Compared to the single-electrode structure, in the multi-electrode structure of the catheter sheath, the first intermediate layer 122 of the sheath body 12 is a mesh structure woven from insulating and non-conductive threads, such as PEEK (polyether ether ketone) threads. This ensures that the catheter sheath meets the requirements for support and flexural strength, and does not interfere with the signal transmission of the annular electrode connecting wire 124.

[0047] Furthermore, for the multi-electrode structure, one end of the ring electrode connecting wire 124 is connected to the first ring electrode unit 13 located at the head end of the sheath body 12, and the other end extends from the tail end of the sheath body 12 and is connected to, for example, the first wire 141 of the sheath connector 14. Here, the connection position can also be protected and fixed by the first insulating sleeve 17.

[0048] Furthermore, the dilator 2 that cooperates with the catheter sheath 1 includes a dilator seat 21, on which a dilator tube body 22 is disposed. A second ring electrode unit 23 is disposed at the head end of the dilator tube body 22. Here, the second ring electrode unit 23 includes at least one second ring electrode 231. The second ring electrode 231 is a platinum-iridium ring disposed on the dilator tube body 22 and is used to measure signals after being energized.

[0049] The expander base 21 is connected to the expander connector 24, which can be connected to an external three-dimensional electrophysiological mapping system. Through the expander connector 24, the external three-dimensional electrophysiological mapping system can dynamically display the head end of the expander in real time, especially the position of the second ring electrode unit 23. The second ring electrode unit 23 is connected to the three-dimensional physiological mapping system via the expander connector 24, and the head end of the expander 2 is visualized through the first ring electrode unit 23.

[0050] The expander tube 22 has a three-layer structure, including a second inner tube layer 221, a second middle tube layer 222, and a second outer tube layer 223. The second inner tube layer 221 is made of a polymer with a low coefficient of friction, such as HDPE (high-density polyethylene) or PTFE (polytetrafluoroethylene). The second outer tube layer 223 is also made of a polymer with a low coefficient of friction, such as HDPE. The second middle tube layer 222 is a metal mesh layer. The second middle tube layer 222 is a reinforcing structure formed by the weaving of conductive metal mesh, which not only improves the strength of the second middle tube layer 222 but also allows it to serve as a transmission channel for electrical signals.

[0051] The three-layer structure of the expander tube body 22 is formed by rheological process. The second ring electrode 231 of the second ring electrode unit 23 is connected to the far end of the second tube body intermediate layer 222, and the proximal end of the first tube body intermediate layer 222 is connected to the expander connector 24 through the second wire 241.

[0052] The expander tube body 22, with its three-layer structure, ensures the expander's support and bending resistance requirements. It also utilizes a metal mesh layer as a conductive medium to replace wires, thereby connecting the second ring electrode unit 23 and the expander connector 24. The metal mesh portion near the proximal end of the expander tube body 22 is brazed to the second wire 241 of the expander connector 24, and the connection is protected and fixed at the point by a second insulating sleeve 25.

[0053] In this embodiment, the improved electrode-equipped atrial septal puncture sheath, i.e., the electrode sheath, has a ring electrode unit at the tip of both the catheter sheath and the dilator. At the same time, the catheter sheath has different signal transmission structures for single-electrode and multi-electrode structures, and can also cooperate with a three-dimensional electrophysiological mapping system to indicate the position of the tip. In this way, after the atrial septal puncture sheath is punctured, the position of the distal end of the sheath can be displayed under zero radiation conditions, avoiding the sheath from dislodging from the left atrium during surgery.

[0054] This embodiment has the function of an atrial septal puncture sheath. By using ring electrode units respectively set at the tip of the catheter sheath and the dilator, and connecting them to a three-dimensional electrophysiological mapping system, the position of the tip of the catheter sheath and / or the dilator can be displayed. In this way, the distal position of the electrode sheath can be displayed under zero radiation conditions after puncture, avoiding the electrode sheath from dislodging from the left atrium during surgery and reducing the harm of X-rays to the operator and the patient.

[0055] In the above embodiments of this utility model, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0056] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways, rotated 90 degrees, or in other orientations, and the spatial relative descriptions used herein will be interpreted accordingly.

[0057] In addition to the above, it should be noted that the terms "one embodiment," "another embodiment," and "embodiment" used in this specification refer to specific features, structures, or characteristics described in connection with that embodiment, which are included in at least one embodiment described in the general description of this application. The appearance of the same expression in multiple places in the specification does not necessarily refer to the same embodiment. Furthermore, when a specific feature, structure, or characteristic is described in connection with any embodiment, the intention is to suggest that implementing such a feature, structure, or characteristic in conjunction with other embodiments also falls within the scope of this utility model.

[0058] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0059] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. An electrode sheath, characterized in that, The electrode sheath includes at least a cooperating catheter sheath and a dilator. The catheter sheath includes a sheath seat and a sheath connector. A sheath body is disposed on the sheath seat. A first ring electrode unit is disposed at the head end of the sheath body. When the first ring electrode unit includes one ring electrode, the ring electrode is connected to the sheath connector through a metal wire mesh for transmitting electrical signals. When the first ring electrode unit includes multiple ring electrodes, the multiple ring electrodes are connected to the sheath connector through ring electrode connecting wires.

2. The electrode sheath according to claim 1, characterized in that, The sheath tube body includes a first tube body intermediate layer. The inner and outer sides of the first tube body intermediate layer are respectively provided with a first tube body inner layer and a first tube body outer layer made of polymer. When the number of the ring electrodes in the first ring electrode unit is one, the first tube body intermediate layer is a metal mesh layer. The first ring electrode unit is connected to the head end of the first tube body intermediate layer, and the tail end of the first tube body intermediate layer is connected to the sheath connector.

3. The electrode sheath according to claim 2, characterized in that, When there are multiple ring electrodes in the first ring electrode unit, the ring electrode connecting wire is disposed between the middle layer of the first tube body and the inner layer of the first tube body. The middle layer of the first tube body is a mesh structure woven from insulating silk threads. One end of the ring electrode connecting wire is connected to the first ring electrode unit, and the other end passes through the tail end of the sheath tube body and is connected to the sheath connector.

4. The electrode sheath according to claim 3, characterized in that, A first insulating sleeve is provided at the connection position between the sheath tube body and the sheath connector.

5. The electrode sheath according to claim 4, characterized in that, The sheath seat is also connected to a switch via a side arm.

6. The electrode sheath according to claim 3, characterized in that, The expander includes an expander base and an expander connector. An expander tube is disposed on the expander base. A second ring electrode unit is disposed at the head end of the expander tube. The second ring electrode unit includes at least one ring electrode. The second ring electrode unit is connected to the expander connector through a metal mesh for transmitting electrical signals.

7. The electrode sheath according to claim 6, characterized in that, The expander tube includes a second tube intermediate layer, with a second tube inner layer and a second tube outer layer made of polymer respectively disposed on the inner and outer sides of the second tube intermediate layer. The second tube intermediate layer is a metal mesh layer. The second ring electrode unit is connected to the head end of the second tube intermediate layer, and the tail end of the second tube intermediate layer is connected to the expander connector.

8. The electrode sheath according to claim 7, characterized in that, A second insulating sleeve is provided at the connection position between the expander tube and the expander connector.

9. The electrode sheath according to claim 6, characterized in that, The ring electrode is a platinum-iridium ring exposed on the sheath tube body and / or the expander tube body.

10. The electrode sheath according to claim 6, characterized in that, The sheath connector and the dilator connector are respectively connected to the three-dimensional electrophysiological mapping system.

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