CN111150933B

CN111150933B - Catheter electrode and in vivo implanted nerve stimulation device

Info

Publication number: CN111150933B
Application number: CN201910846478.9A
Authority: CN
Inventors: 冯智英; 陈风顺; 董亮; 王守东
Original assignee: Hangzhou Shenluo Medical Technology Co ltd
Current assignee: Hangzhou Shenluo Medical Technology Co ltd
Priority date: 2019-09-02
Filing date: 2019-09-02
Publication date: 2022-08-09
Anticipated expiration: 2039-09-02
Also published as: CN111150933A

Abstract

The application discloses a catheter electrode and a nerve stimulation device implanted in a body, wherein the catheter electrode comprises a catheter component, an electrode ring and an electrode guide wire, and the catheter component is used for conveying liquid; an electrode ring is fixed on the outer wall of the catheter component; an electrode guide wire is fixed inside the tube wall of the catheter component, and one end of the electrode guide wire is connected to the electrode ring; the in vivo implanted nerve stimulation device comprises a conductive electrode and a pulse transmitter, and a catheter electrode is connected with the stimulation generator through the electrode guide wire. Through the arrangement, the catheter electrode can provide pulse current for a human body so as to provide electrical stimulation for the human body, and meanwhile, the catheter electrode also provides a channel for injecting liquid medicine into the human body, so that the injury of necessary therapeutic instruments entering the human body to the human body is reduced, and the protection of the human body is realized.

Description

Catheter electrode and in vivo implanted nerve stimulation device

Technical Field

The application relates to the field of medical treatment, in particular to a catheter electrode and an in-vivo implanted nerve stimulation device.

Background

When the semi-implantation equipment is used for treating a human body, a catheter electrode is generally required to be connected with a stimulation generator so as to provide pulse current for the human body, so that the function of stimulating the human body is achieved; meanwhile, the treatment of injecting medicine to human body by using the medicine feeding equipment is also needed.

At present, a device for injecting medicine into a human body (particularly a neural area of the human body) and a device for providing electrical stimulation to the human body are two sets of devices which are separated, when a semi-implanted device is used for treating the human body, a medicine feeding catheter and an electrode for stimulating nerve beating in the medicine feeding device need to reach the vicinity of a nerve, and the device for injecting medicine into the nerve and the periphery of the nerve and the operation for providing electrical stimulation are carried out so as to treat the nerve and the periphery of the nerve. In this process, there are many injuries to the nerve and the periphery of the nerve.

Disclosure of Invention

The application provides a catheter electrode and an in vivo implanted nerve stimulation device, which can avoid causing repeated injuries to people.

According to a first aspect of the present application, there is provided a catheter electrode comprising:

a catheter assembly provided with an infusion space for delivering a liquid;

an electrode ring secured to an outer wall of the catheter assembly;

and the electrode guide wire is fixed inside the tube wall of the catheter assembly, and one end of the electrode guide wire is connected to the electrode ring.

Further, the catheter assembly comprises an outer catheter and an inner catheter, the inner catheter is sleeved on the outer catheter, and the inner catheter surrounds the infusion space;

the outer catheter and the inner catheter are arranged at intervals and enclose a wire passing space, a wire passing channel penetrating through the outer catheter is formed in the wall of the outer catheter and extends from the outer wall of the catheter component to the wire passing space, and the electrode guide wire is arranged in the wire passing space and the wire passing channel;

the tube wall of the outer conduit, the wire passing space and the tube wall of the inner conduit form a tube wall of the duct assembly.

Further, the conduit assembly further comprises an end pipe fixedly arranged at the end parts of the outer conduit and the inner conduit, the end pipe is fixedly arranged in the wire passing space, the outer wall of the end pipe contacts the inner wall of the outer conduit, and the inner wall of the end pipe contacts the outer wall of the inner conduit;

the end pipe is provided with a through dosing hole along the axial direction, and the dosing hole is communicated with the outside and the infusion space.

Further, the inner diameter of the administration hole is gradually increased in a direction from the infusion space to the outside.

Further, the outer wall of outer pipe inwards caves in and forms the holding tank, the electrode ring install in the holding tank, cross the line passageway and extend to the holding tank, the electrode seal wire pass through cross the line passageway and connect in the electrode ring.

Furthermore, a filling piece is arranged in the wire passing space, and the filling piece is made of a plastic body.

Further, the inner wall of the duct assembly extends radially inward to form an annular protrusion, which is provided at the front end of the duct assembly.

Further, a ratio of an inner diameter of the protrusion to an inner diameter of the catheter assembly is greater than or equal to 1/5 and less than or equal to 4/5.

Further, the end of the duct assembly is provided with a one-way valve which is opened when liquid flows out from the outside of the duct assembly and closed when liquid flows from the outside of the duct assembly to the inside of the duct assembly.

According to a second aspect of the present application, there is provided an in vivo implanted neurostimulation device comprising a stimulation generator and a catheter electrode connected with the stimulation generator by the electrode guidewire.

The technical scheme provided by the embodiment of the disclosure can have the following beneficial effects:

through the arrangement, the catheter electrode can provide pulse current for a human body so as to provide electrical stimulation for the human body, and meanwhile, the catheter electrode also provides a channel for injecting liquid medicine into the human body, so that the injury of necessary therapeutic instruments entering the human body to the human body is reduced, and the protection of the human body is realized.

Drawings

Fig. 1 is a schematic perspective view of an implantable neurostimulation device according to an embodiment of the present application.

Fig. 2 is a partial structural schematic view of a catheter assembly according to an embodiment of the present application.

Fig. 3 is a partial schematic structural view of a catheter assembly according to another embodiment of the present application.

Fig. 4 is a partial structural schematic view of a catheter assembly according to yet another embodiment of the present application.

Description of the reference numerals

In vivo implanted nerve stimulation device 10

Stimulus generator 100

Catheter electrode 200

Catheter assembly 300

Routing channel 301

Outer catheter 310

Wire passage 311

Inner conduit 320

Infusion space 321

Protrusion 322

End face 323

Main body portion 324

Wire passing space 330

End pipe 340

Medicine feeding hole 341

Electrode ring 400

Electrode guidewire 500

Detailed Description

Reference will now be made in detail to the exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, like numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present application. Rather, they are merely examples of apparatus and methods consistent with certain aspects of the present application, as detailed in the appended claims.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

It should be understood that the terms "first," "second," and the like as used in the description and in the claims, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Also, the use of the terms "a" or "an" and the like do not denote a limitation of quantity, but rather denote the presence of at least one. Unless otherwise indicated, "front", "rear", "lower" and/or "upper" and the like are for convenience of description and are not limited to one position or one spatial orientation. The word "comprising" or "comprises", and the like, means that the element or item listed as preceding "comprising" or "includes" covers the element or item listed as following "comprising" or "includes" and its equivalents, and does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect.

The embodiments of the present application will be described in detail below with reference to the accompanying drawings. The features of the following examples and embodiments may be combined with each other without conflict.

As shown in fig. 1, the present application relates to an intracorporeal implantable neural stimulation device 10 including a stimulation generator 100 and a catheter electrode 200. The stimulation generator 100 delivers electrical pulses provided by a battery or an external power source, and the catheter electrode 200 is connected to the stimulation generator 100 and contacts the nerve and the nerve periphery to provide the electrical pulses to the nerve and the nerve periphery to stimulate the nerve and the nerve periphery motion. The catheter electrode 200 is detachably connected with the stimulation generator 100, and when an electric pulse needs to be provided for a nerve, the catheter electrode 200 is fixedly connected with the stimulation generator 100; when it is necessary to supply a liquid medicine to the nerve and the periphery of the nerve using the catheter electrode 200, the catheter electrode 200 may be separated from the stimulation generator 100, and the catheter electrode 200 may be fixedly connected to a medicine administration apparatus (not shown), which may transfer the liquid medicine into the catheter electrode 200 so that the liquid medicine flows to the nerve and the periphery of the nerve through the catheter electrode 200 and perform liquid medicine treatment on the nerve and the periphery of the nerve.

It should be noted that the implanted neurostimulation device 10 shown in the figures includes two catheter electrodes 200. Of course, the number of catheter electrodes 200 implanted in the neurostimulation device 10 may be 1, or 3 or more. The catheter electrodes 200 are each connected to a stimulation generator 100.

As shown in fig. 1 and 2, the catheter electrode 200 includes a catheter assembly 300, an electrode ring 400, and an electrode guide wire 500. Wherein the catheter assembly 300 is provided with an infusion space 321 for delivering a liquid, in this embodiment a medical liquid; the electrode ring 400 is fixed to the outer wall of the catheter assembly 300 to contact the nerve and the periphery of the nerve; the electrode guide wire 500 is fixed inside the tube wall of the catheter assembly 300, and one end of the electrode guide wire 500 is connected to the electrode ring 400, and the other end of the electrode guide wire 500 is connected to the stimulation generator 100, so that the electric pulse sent by the stimulation generator 100 is conducted to the electrode ring 400, and then the electrode ring 400 stimulates the nerve and the periphery of the nerve. At least two contacts are arranged on the electrode ring 400, corresponding contacts are arranged on the stimulation generator 100, the number of the catheter electrodes 200 is multiple, and each catheter electrode 200 is respectively connected with the corresponding contacts. When the number of the contacts of the electrode ring 400 is plural, any two contacts may form a loop on the nerve and the periphery of the nerve to realize the electrical stimulation on the nerve and the periphery of the nerve. The number of the electrode rings 400 on the catheter electrode 200 may be one, or may be plural. When the number of electrode rings 400 on the catheter electrode 200 is multiple, only one contact point may be provided on each electrode ring 400. Alternatively, when there are a plurality of catheter electrodes 200 implanted in the neurostimulation device 10, only one contact point can be arranged on each electrode ring 400, and the contact points on different electrode rings 400 can still form a loop to stimulate the nerve and the periphery of the nerve.

As shown in fig. 2, the catheter assembly 300 includes an outer catheter 310 and an inner catheter 320.

The inner catheter 320 encloses an infusion space 321 for delivering liquid, and when the catheter assembly 300 is connected to a drug administration device, the drug administration device can provide a drug solution to the catheter assembly 300, and the drug solution flows into the nerve and a designated position around the nerve along the catheter assembly 300 to treat the nerve and the periphery of the nerve.

The inner diameter of the outer guide tube 310 is larger than the outer diameter of the inner guide tube 320, and the inner guide tube 320 is sleeved on the outer guide tube 310. The outer catheter 310 and the inner catheter 320 are arranged at intervals and enclose a wire passing space 330, and the wire passing space 330 can be used for accommodating the electrode guide wire 500, so that the interference of the outside on the electrode guide wire 500 is avoided, and the stability of the treatment process is ensured. It is noted that the walls of the outer conduit 310, the wire passing space 330 and the inner conduit 320 form the walls of the duct assembly 300.

Further, the outer wall of the outer guide tube 310 is recessed inward to form a receiving groove, and the electrode ring 400 is seated in the receiving groove. In this way, the electrode ring 400 is fixed. In this embodiment, the electrode ring 400 has a ring shape surrounding the outer wall of the outer guide tube 310, and the receiving groove has a shape corresponding to the electrode ring 400. The wall of the outer conduit 310 is further provided with a through-going line passing channel 311, and the line passing channel 311 extends from the outer wall of the conduit assembly 300 to the line passing space 330. In this embodiment, the wire passage 311 extends in the radial direction of the outer catheter 310, however, in other embodiments, the wire passage 311 only needs to have a component in the radial direction of the outer catheter 310, so that it can be connected to the outer wall of the catheter assembly 300 to extend to the wire passing space 330. In this embodiment, one end of the wire passage 311 extends to the receiving groove, the electrode wire 500 is disposed in the wire passage space 330 and the wire passage 311, and the electrode ring 400 is disposed above the wire passage 311, so that the electrode wire 500 is connected to the electrode ring 400 through the wire passage space 330 and the wire passage 311. In the above arrangement, the electrode guide wire 500 is disposed inside the catheter assembly 300 to be isolated from the outside and the infusion space 321, so as to avoid the interference of the electrode guide wire 500 with external impurities, and avoid the phenomena of electric leakage and the like, thereby ensuring the stability of the treatment process and the safety of the user.

It should be noted that the number of the contacts on the electrode ring 400 is plural, correspondingly, the number of the electrode guide wires 500 is also plural, the number of the wire passing channels 311 is also plural, and one electrode guide wire 500 is arranged in each wire passing channel 311; of course, in other embodiments, a plurality of electrode wires 500 may be disposed in the same wire passage 311.

In this embodiment, a filling member is disposed in the wire passing space 330, and the filling member is made of a plastic body. In the process of assembling the catheter electrode 200, the electrode guide wire 500 is firstly arranged in the wire passing space 330 and the wire passing channel 311, the electrode guide wire 500 is connected with the electrode ring 400, and then the wire passing space 330 is filled with the filling member, which can limit the electrode guide wire 500 and support the outer catheter 310 and the inner catheter 320, so as to limit the relative positions of the outer catheter 310 and the inner catheter 320.

In this embodiment, as shown in fig. 2, the outer catheter 310 and the inner catheter 320 are separate components that are fixedly attached when they are assembled to form the catheter assembly 300. Of course, in other embodiments, as shown in fig. 3, the inner catheter 320 and the outer catheter 310 may be an inseparable whole, that is, the catheter assembly 300 may be a tubular structure provided with the infusion space 321, and a through-going routing channel 301 may be formed in the catheter assembly 300 by integral molding or other means, the routing channel 301 is disposed in the wall of the catheter assembly 300, the routing channel 301 extends from one end face of the catheter assembly 300 to the outer wall of the catheter assembly 300, and the electrode guide wire 500 is disposed through the routing channel 301 and connected to the electrode ring 400 located on the outer wall of the catheter assembly 300. With the above arrangement, the occupation of the electrode guide wire 500 to the space in the catheter assembly 300 can be reduced, which is advantageous for the light and thin design of the catheter assembly 300.

Of course, as shown in fig. 2, the catheter assembly 300 further includes an end tube 340, and the end tube 340 is fixedly disposed at the ends of the outer catheter 310 and the inner catheter 320. And, the end pipe 340 is fixedly disposed in the wire passing space 330, an outer wall of the end pipe 340 contacts an inner wall of the outer guide pipe 310, and an inner wall of the end pipe 340 contacts an outer wall of the inner guide pipe 320, so that the outer guide pipe 310 and the inner guide pipe 320 are spaced apart. The end tube 340 is provided with a through administration hole 341 in the axial direction, and the administration hole 341 communicates the outside with the infusion space 321. In the process of assembling the catheter assembly 300, the outer catheter 310, the inner catheter 320 and the end tube 340 may be connected to form the wire passing space 330, the electrode guide wire 500 may be disposed in the wire passing space 330, and the filling body may be filled in the wire passing space 330 to achieve the fixed connection. With the above arrangement, the end tube 340 can support and limit the outer catheter 310 and the inner catheter 320, and the end tube 340 can conduct the liquid medicine in the infusion space 321 to transmit the liquid medicine to the nerve and the periphery of the nerve through the infusion space 321 and the administration hole 341.

Further, the inner diameter D1 of the administration hole 341 gradually increases in a direction from the infusion space 321 toward the outside. With the above arrangement, when the liquid medicine is accumulated in the nerve and the periphery of the nerve, the liquid medicine is not easy to flow back to the interior of the catheter assembly 300 through the administration hole 341, so that the nerve and the periphery of the nerve can absorb the liquid medicine more sufficiently. Meanwhile, the size of the administration hole is gradually narrowed along the direction from the outside to the infusion space 321, so that the liquid medicine can be prevented from flowing reversely, and the influence on the flow of the liquid medicine in the infusion space 321 is avoided.

In order to prevent the reverse flow of the medical fluid, a check valve (not shown) may be further provided at the end of the catheter assembly 300, which is opened when the fluid flows out from the inside of the catheter assembly 300 to the outside, i.e., when the fluid flows from the outside of the catheter assembly 300 to the outside, and closed when the fluid flows from the outside of the catheter assembly 300 to the inside of the catheter assembly 300, i.e., when the fluid flows back from the outside to the infusion space 321.

Further, the inner wall of the catheter assembly 300 extends radially inward to form an annular protrusion 322, and the protrusion 322 is disposed at the front end of the catheter assembly 300. As shown in fig. 2, in the present embodiment, the protrusion 322 is provided in the inner duct 320, the inner duct 320 includes a main body portion 324 and the protrusion 322, an outer wall of the protrusion 322 contacts an inner wall of the main body portion 324, and the protrusion 322 is provided at a front end of the main body portion 324. In this embodiment, the protrusion 322 and the main body 324 are separate components, and when the two components are assembled to form the catheter assembly 300, the protrusion 322 is inserted into the main body 324 and fixedly connected to the main body 324. Of course, in other embodiments, as shown in fig. 4, the protrusion 322 and the main body 324 may be an inseparable unit, and may be formed by integral molding.

In an actual operation process, when the catheter assembly 300 needs to be inserted into the nerve and the periphery of the nerve, a support member needs to be inserted into the interior of the catheter assembly 300, i.e., the infusion space 321, and the hardness of the support member is higher than that of the catheter assembly 300, so that the catheter assembly 300 can be smoothly inserted into the nerve and the periphery of the nerve and reach a designated position, and after the catheter assembly 300 reaches the designated position, the support member is withdrawn, so that the catheter assembly 300 can be installed in the human body. However, during this process, the support member will often pass through the infusion space 321 and the administration port 341 and out of the catheter assembly 300. At this time, the supporting piece is easy to touch the human body, and the hardness of the supporting piece is high, so that the human body is easy to be seriously damaged. By providing the protrusion 322, when the support is located inside the catheter assembly 300, the support may abut against the end face 323 of the protrusion 322, so as to prevent the support from protruding out of the catheter assembly 300 through the administration hole 341, thereby ensuring the safety of the user.

Further, as shown in fig. 2, the ratio of the inner diameter D2 of the protrusion 322 to the inner diameter D3 of the catheter assembly 300, i.e., the inner diameter D2 of the protrusion 322 to the inner diameter of the inner catheter 320, is 1/5 or more and 4/5 or less. A large number of experiments show that: when the ratio of the inner diameter D2 of the protrusion 322 to the inner diameter of the inner conduit 320 is 1/5 or more and 4/5 or less, the protrusion 322 can effectively restrict the support from extending into the drug administration hole 341 and out of the catheter assembly 300, and at the same time, the protrusion 322 does not affect the liquid in the infusion space 321 from flowing out to the drug administration hole 341 and to the nerve and the periphery of the nerve.

In the above implementation, as shown in fig. 2 and 3, the ratio of the inner diameter D2 of the protrusion 322 to the inner diameter D3 of the catheter assembly 300 is 1/4 or more and 1/2 or less. With the above arrangement, the flow rate of the liquid medicine can be ensured while preventing the support from extending out of the duct assembly 300, so that the administration efficiency can be ensured to the maximum extent while ensuring the safety of the user.

Although the present application has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the application, and all changes, substitutions and alterations that fall within the spirit and scope of the application are to be understood as being covered by the following claims.

Claims

1. A catheter electrode, comprising:

a catheter assembly provided with an infusion space for delivering a liquid;

an electrode ring secured to an outer wall of the catheter assembly;

an electrode guide wire fixed inside a tube wall of the catheter assembly, and one end of the electrode guide wire is connected to the electrode ring;

the catheter assembly comprises an outer catheter and an inner catheter, the inner catheter is sleeved on the outer catheter, and the inner catheter surrounds the infusion space;

the outer guide pipe and the inner guide pipe are arranged at intervals and enclose a wire passing space;

the conduit assembly further comprises an end pipe which is fixedly arranged at the end parts of the outer conduit and the inner conduit, the end pipe is fixedly arranged in the wire passing space, the outer wall of the end pipe contacts the inner wall of the outer conduit, and the inner wall of the end pipe contacts the outer wall of the inner conduit;

the end tube is provided with a through administration hole along the axial direction, and the administration hole is communicated with the outside and the infusion space;

the end part of the outer guide pipe facing the drug delivery hole protrudes out of the end part of the inner guide pipe facing the drug delivery hole.

2. The catheter electrode as claimed in claim 1, wherein a through-line channel is formed on the wall of the outer catheter, the through-line channel extends from the outer wall of the catheter assembly to the through-line space, and the electrode guide wire is arranged in the through-line space and the through-line channel;

3. The catheter electrode according to claim 1, wherein an inner diameter of the administration hole is gradually increased in a direction from the infusion space toward the outside.

4. The catheter electrode of claim 2 wherein the outer wall of the outer catheter is recessed to form a receiving groove, the electrode ring being seated in the receiving groove, the wire passage extending to the receiving groove, the electrode guide wire being connected to the electrode ring through the wire passage.

5. The catheter electrode according to claim 2, wherein a filler is disposed in the wire passing space, and the filler is made of a plastic.

6. The catheter electrode of claim 1, wherein the inner wall of the catheter assembly extends radially inward to form an annular protrusion disposed at the forward end of the catheter assembly.

7. The catheter electrode of claim 6, wherein a ratio of an inner diameter of the protrusion to an inner diameter of the catheter assembly is 1/5 or greater and 4/5 or less.

8. The catheter electrode as claimed in claim 1, wherein an end of the catheter assembly is provided with a one-way valve which opens when liquid flows outward from the outside of the catheter assembly and closes when liquid flows from the outside of the catheter assembly to the inside of the catheter assembly.

9. An intracorporeal implantable neural stimulation device comprising a stimulation generator and the catheter electrode of any one of claims 1-8, the catheter electrode being connected to the stimulation generator via the electrode guide wire.