Electrical stimulation lead implantation device and method

Abstract

The invention discloses an electrical stimulation lead implantation device and method, and relates to the technical field of medical equipment. The device comprises a control unit, a bendable unit and an angle adjusting unit. In the invention, a puncture technology referring to a spinal cord electrical stimulation lead implantation technology is combined with visual and bendable catheterization technologies of a fiber bronchoscope and a spine endoscope, and after a percutaneous puncture needle punctures through a vertebral plate gap to reach an epidural posterior gap, the percutaneous puncture needle enters through a puncture-assisted bendable fiber catheter; firstly, the bendable fiber catheter is placed in an epidural target position by utilizing the visual and bendable characteristics, then an electrode lead (a puncture electrode and a surgical electrode) is implanted in the position through the bendable fiber catheter, the bendable fiber catheter and a puncture needle are withdrawn, the electrode lead is fixed, and under the irradiation of an endoscope, after the epidural puncture needle enters a human body, the epidural puncture needle is inserted into the epidural target position. Video visualization is achieved in the whole process, repeated puncture is not needed, epidural space bleeding caused by repeated puncture is avoided, and the operation safety is higher.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to an electrical stimulation lead implantation device and method. Background Art

[0002] Spinal cord stimulation (SCS) is an effective method for treating chronic intractable pain and is widely used in clinical practice;

[0003] However, existing spinal cord stimulation technology still has some shortcomings:

[0004] 1. Among the two types of electrode wires required for spinal cord electrical stimulation, the implantation of puncture electrodes needs to be completed under the guidance of DSA, C-arm or CT, and both the surgeon and the patient need to be exposed to harmful radiation. Some patients also need to undergo multiple imaging-guided surgeries in a short period of time, which is not good for the patients.

[0005] 2. At the same time, surgical electrodes need to be placed in the posterior epidural space after opening the vertebral lamina during open surgery, which causes great trauma, slow recovery, and requires surgery under general anesthesia;

[0006] In view of the above problems, the inventors proposed an electrical stimulation lead implantation device and method for solving the above problems. Summary of the invention

[0007] In order to solve the problems of high radiation dose for patients, inaccurate target position and epidural hemorrhage caused by repeated punctures in spinal cord electrical stimulation technology, the purpose of the present invention is to provide a visualized electrical stimulation lead implantation device and method.

[0008] In order to solve the above technical problems, the present invention adopts the following technical solution: an electrical stimulation lead implantation device, the implantation device comprises a control unit, a bendable unit and an angle adjustment unit, the bendable unit is arranged at one end of the control unit, and the angle adjustment unit is arranged on the control unit;

[0009] The control unit comprises an end shell, a corrugated hose, a connecting pipe and a tapered connecting pipe, wherein the end shell, the corrugated hose, the connecting pipe and the tapered connecting pipe are fixedly connected;

[0010] One end of the end shell is fixedly connected to a middle hose, the middle hose passes through the end shell, the corrugated hose, the connecting pipe and the tapered connecting pipe, and the middle hose is respectively provided with a No. 1 implantation port and a No. 2 implantation port, the No. 1 implantation port and the No. 2 implantation port pass through the middle hose;

[0011] The middle hose is respectively provided with a No. 1 flushing chamber and a No. 1 light source hole;

[0012] The bending unit comprises a bendable fiber conduit, which is fixedly arranged at one end of the tapered connecting tube, and is provided with a No. 1 connecting cavity, a No. 2 connecting cavity, a No. 2 flushing cavity and a No. 2 light source hole;

[0013] The No. 1 communication cavity is connected to the No. 1 implantation port, the No. 2 communication cavity is connected to the No. 2 implantation port, the No. 2 flushing chamber is connected to the No. 1 flushing chamber, and the No. 2 light source hole is connected to the No. 1 light source hole.

[0014] Preferably, a water inlet is fixedly mounted on the end shell, and the water inlet is communicated with the No. 1 flushing chamber.

[0015] Preferably, a display interface is fixedly mounted on the end shell, a light source interface is fixedly mounted on the display interface, and the display interface and the light source interface are in communication with the No. 1 light source hole.

[0016] Preferably, the angle adjustment unit comprises a fixed ring and a movable ring, the fixed ring is fixedly mounted on the outer wall of the end shell, and the movable ring is fixedly mounted on the outer wall of the connecting pipe;

[0017] An L-shaped plate is fixedly mounted on the outer wall of the fixed ring, a threaded rod is threadedly rotatably mounted on one end of the L-shaped plate, a connecting rod is fixedly mounted on the outer wall of the movable ring, and one end of the threaded rod is rotatably connected to one end of the connecting rod.

[0018] The present invention also provides a method for implanting an electrical stimulation lead device, comprising the following steps:

[0019] S1. Use a special epidural puncture needle to penetrate into the posterior space of the epidural space through the interlaminar space of the puncture segment;

[0020] S2. The light source interface, display interface and water inlet on the end shell are connected to the external light source, display and flushing water pipe;

[0021] S3, insert one of the puncture electrodes, insert the surgical electrode from the No. 2 implantation port, insert the puncture electrode and the surgical electrode into the front end through the No. 1 implantation port and the No. 2 implantation port, and place them flush with the front end of the bendable fiber catheter, and place the external locker under the No. 1 implantation port and the No. 2 implantation port, so that the external locker clamps the puncture electrode and the surgical electrode to prevent them from sliding forward or backward by themselves;

[0022] S4. Insert the bendable fiber catheter into the posterior space of the epidural space through the epidural puncture needle. Bend the front end of the bendable fiber catheter to a certain angle through the angle adjustment unit under visualization. Then control and lock the angle through the angle adjustment unit. Then insert the bendable fiber catheter upward into the epidural space of the spinal canal. During the insertion process, the angle of the bendable fiber catheter is continuously adjusted by the angle adjustment unit according to the visual situation. The bendable fiber catheter is implanted into the target position, which includes the center of the spinal cord, the dorsal horn and the lateral space. Whether it is correct is determined under the C-arm and CT imaging.

[0023] S5. Release the fixation of the puncture electrode and the surgical electrode by the external locker, fix the puncture electrode and the surgical electrode with one hand, and withdraw the entire implant device with the other hand;

[0024] S6. Fix the control unit on the skin, and then manually withdraw the dedicated epidural puncture needle;

[0025] S7. Place the puncture electrode and surgical electrode in the posterior epidural space and fix them to the skin.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1. In the present invention, by referring to the puncture technology of spinal cord electrical stimulation wire implantation technology, combined with the visualization and bendable catheterization technology of fiber bronchoscope and spinal endoscope, after the percutaneous puncture needle punctures through the interlaminar space to reach the epidural posterior space, the puncture-assisted bendable fiber catheter is entered, and the bendable fiber catheter is first placed in the epidural target position by using the visualization and bendability characteristics, and then the electrode wire (puncture electrode, surgical electrode) is implanted at the position through the bendable fiber catheter, the bendable fiber catheter and the puncture needle are withdrawn, and the electrode wire is fixed. Under the illumination of the endoscope, after the epidural puncture needle enters the human body, there is video visualization of the whole process, and repeated puncture is not required, which avoids repeated punctures and causes epidural bleeding, and the operation is safer;

[0028] 2. In the present invention, surgical electrodes are implanted under puncture technology, eliminating the need for open surgery and general anesthesia, thereby making the minimally invasive surgery less traumatic and safer;

[0029] 3. Compared with the prior art, in the present invention, the entire surgical process requires radiation exposure. Now, radiation exposure only needs to be performed at the beginning of the operation, and the subsequent operation is assisted by an endoscope, which reduces radiation exposure. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 It is a schematic diagram of the overall structure of the electrical stimulation lead implantation device of the present invention.

[0032] Figure 2 This is another overall structural schematic diagram of the electrical stimulation lead implantation device of the present invention.

[0033] Figure 3 It is a schematic diagram of the cross-section structure of the end shell, the corrugated hose, the tapered connecting pipe and the connecting pipe of the present invention.

[0034] Figure 4 For the present invention Figure 3 A magnified schematic diagram of part A in FIG.

[0035] Figure 5 It is a partial structural schematic diagram of the control unit of the present invention.

[0036] Figure 6 It is a schematic structural diagram of the bending unit of the present invention.

[0037] Figure 7 FIG. 4 is another schematic diagram of the structure of the bending unit of the present invention.

[0038] In the figure: 1. control unit; 3. bending unit; 4. angle adjustment unit; 11. end shell; 12. corrugated hose; 13. tapered connecting pipe; 131. connecting pipe; 14. middle hose; 15. implantation port No. 1; 16. implantation port No. 2; 17. flushing chamber No. 1; 18. light source hole No. 1; 19. water inlet; 2. display interface; 21. light source interface; 31. bendable fiber duct; 32. connecting chamber No. 1; 33. connecting chamber No. 2; 34. flushing chamber No. 2; 35. light source hole No. 2; 41. fixing ring; 42. movable ring; 43. L-shaped plate; 44. threaded rod; 45. connecting rod; 46. knob. DETAILED DESCRIPTION

[0039] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only 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 ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0040] Example: Figure 1-7 As shown, the present invention provides an electrical stimulation lead implantation device, the implantation device comprises a control unit 1, a bendable unit 3 and an angle adjustment unit 4, the bendable unit 3 is arranged at one end of the control unit 1, and the angle adjustment unit 4 is arranged on the control unit 1;

[0041] The control unit 1 includes an end shell 11, a corrugated hose 12, a connecting pipe 131 and a tapered connecting pipe 13. The end shell 11 is a spirally adjustable bendable structure. The end shell 11, the corrugated hose 12, the connecting pipe 131 and the tapered connecting pipe 13 are fixedly connected. One end of the end shell 11 is fixedly connected to a middle hose 14, which passes through the end shell 11, the corrugated hose 12, the connecting pipe 131 and the tapered connecting pipe 13. The middle hose 14 is respectively provided with a first implantation port 15 and a second implantation port 16. No. 1 implantation port 16, No. 1 implantation port 15 and No. 2 implantation port 16 penetrate the middle hose 14, the middle hose 14 is respectively provided with a No. 1 flushing chamber 17 and a No. 1 light source hole 18, a water inlet 19 is fixedly mounted on the end shell 11, the water inlet 19 is connected with the No. 1 flushing chamber 17, a display interface 2 is fixedly mounted on the end shell 11, a light source interface 21 is fixedly mounted on the display interface 2, and the display interface 2 and the light source interface 21 are connected with the No. 1 light source hole 18;

[0042] The bending unit 3 includes a bendable fiber catheter 31, the end of which is spherical. The bendable fiber catheter 31 is fixedly arranged at one end of the conical connecting tube 13. The bendable fiber catheter 31 is provided with a No. 1 connecting cavity 32, a No. 2 connecting cavity 33, a No. 2 flushing chamber 34 and a No. 2 light source hole 35. The No. 1 connecting cavity 32 is connected to the No. 1 implantation port 15, the No. 2 connecting cavity 33 is connected to the No. 2 implantation port 16, the No. 2 flushing chamber 34 is connected to the No. 1 flushing chamber 17, and the No. 2 light source hole 35 is connected to the No. 1 light source hole 18.

[0043] The outer diameter of the middle hose 14 is 2.6 mm, the inner diameter of the implantation channel of the No. 1 implantation port 15 is 1.5 mm, the total length of the middle hose 14 and the bendable fiber catheter 31 is 200-500 mm, and the cross-section of the No. 1 implantation port 15 and the No. 1 connecting cavity 32 is cylindrical.

[0044] The angle adjustment unit 4 includes a fixed ring 41 and a movable ring 42. The fixed ring 41 is fixedly installed on the outer wall of the end shell 11, and the movable ring 42 is fixedly installed on the outer wall of the connecting pipe 131. An L-shaped plate 43 is fixedly installed on the outer wall of the fixed ring 41, and a threaded rod 44 is threadedly installed on one end of the L-shaped plate 43. A connecting rod 45 is fixedly installed on the outer wall of the movable ring 42. One end of the threaded rod 44 is rotatably connected to one end of the connecting rod 45, and a knob 46 is fixedly installed on the other end of the threaded rod 44. By rotating the knob 46, the knob 46 can make the threaded rod 44 rotate and rise and fall. In the process of threaded rotation and lifting, the threaded rod 44 makes the connecting pipe 131, the tapered connecting pipe 13 and the bendable fiber duct 31 descend or rise through the connecting rod 45 and the movable ring 42, thereby realizing the angle adjustment of the bendable fiber duct 31 and the fixation after the angle adjustment.

[0045] The present invention also provides a method for implanting an electrical stimulation lead device, comprising the following steps:

[0046] S1. Use a dedicated epidural puncture needle to penetrate into the posterior space of the epidural space through the interlaminar space of the puncture segment. The dedicated epidural puncture needle adopts a Touhy needle. The outer diameter of the Touhy needle is 3.0 mm, the inner diameter is 2.8 mm, and the length is 100 mm.

[0047] S2, the light source interface 21, the display interface 2 and the water inlet 19 on the end shell 11 are connected to the external light source, the display and the flushing water pipe;

[0048] S3, insert one of the puncture electrodes, insert the surgical electrode from the No. 2 implantation port 16, insert the puncture electrode and the surgical electrode into the front end through the No. 1 implantation port 15 and the No. 2 implantation port 16, and flush with the front end of the bendable fiber catheter 31, and place the external locker under the No. 1 implantation port 15 and the No. 2 implantation port 16, so that the external locker clamps the puncture electrode and the surgical electrode to prevent the puncture electrode and the surgical electrode from sliding forward or backward by themselves;

[0049] S4, insert the bendable fiber catheter 31 into the posterior space of the epidural space through the epidural puncture needle, bend the front end of the bendable fiber catheter 31 to a certain angle through the angle adjustment unit 4 under visualization, control and lock the angle through the angle adjustment unit 4, and then insert the bendable fiber catheter 31 upward into the epidural space of the spinal canal. During the insertion process, the angle of the bendable fiber catheter 31 is continuously adjusted by the angle adjustment unit 4 according to the visual situation, and the bendable fiber catheter 31 is implanted into the target position, which includes the center of the spinal cord, the dorsal horn and the lateral space, and whether it is correct is determined under the C-arm and CT imaging;

[0050] S5. Release the fixation of the puncture electrode and the surgical electrode by the external locker, fix the puncture electrode and the surgical electrode with one hand, and withdraw the entire implant device with the other hand;

[0051] S6, fix the control unit 1 on the skin, and then manually withdraw the dedicated epidural puncture needle;

[0052] S7. Place the puncture electrode and surgical electrode in the posterior epidural space and fix them to the skin.

[0053] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. An electrical stimulation lead implantation device, characterized in that: The implant device comprises a control unit (1), a bendable unit (3) and an angle adjustment unit (4), wherein the bendable unit (3) is arranged at one end of the control unit (1), and the angle adjustment unit (4) is arranged on the control unit (1); The control unit (1) comprises an end shell (11), a corrugated hose (12), a connecting pipe (131) and a tapered connecting pipe (13); the end shell (11), the corrugated hose (12), the connecting pipe (131) and the tapered connecting pipe (13) are fixedly connected; One end of the end shell (11) is fixedly connected to a middle hose (14), the middle hose (14) passes through the end shell (11), the corrugated hose (12), the connecting pipe (131) and the conical connecting pipe (13), the middle hose (14) is respectively provided with a first implantation port (15) and a second implantation port (16), the first implantation port (15) and the second implantation port (16) pass through the middle hose (14); The middle hose (14) is provided with a first flushing chamber (17) and a first light source hole (18); The bending unit (3) comprises a bendable fiber conduit (31), the bendable fiber conduit (31) is fixedly arranged at one end of the tapered connecting tube (13), and the bendable fiber conduit (31) is provided with a first connecting cavity (32), a second connecting cavity (33), a second flushing cavity (34) and a second light source hole (35); The No. 1 communication cavity (32) is connected to the No. 1 implantation port (15), the No. 2 communication cavity (33) is connected to the No. 2 implantation port (16), the No. 2 flushing chamber (34) is connected to the No. 1 flushing chamber (17), and the No. 2 light source hole (35) is connected to the No. 1 light source hole (18).

2. The electrical stimulation lead implantation device according to claim 1, characterized in that: A water inlet (19) is fixedly mounted on the end shell (11), and the water inlet (19) is connected to the first flushing chamber (17).

3. The electrical stimulation lead implantation device according to claim 1, characterized in that: A display interface (2) is fixedly mounted on the end shell (11), a light source interface (21) is fixedly mounted on the display interface (2), and the display interface (2) and the light source interface (21) are in communication with the first light source hole (18).

4. The electrical stimulation lead implantation device according to claim 1, characterized in that: The angle adjustment unit (4) comprises a fixed ring (41) and a movable ring (42), wherein the fixed ring (41) is fixedly mounted on the outer wall of the end shell (11), and the movable ring (42) is fixedly mounted on the outer wall of the connecting pipe (131); An L-shaped plate (43) is fixedly mounted on the outer wall of the fixed ring (41), a threaded rod (44) is rotatably mounted on one end of the L-shaped plate (43), a connecting rod (45) is fixedly mounted on the outer wall of the movable ring (42), and one end of the threaded rod (44) is rotatably connected to one end of the connecting rod (45).

5. The electrical stimulation lead implantation device according to claim 6, characterized in that: A knob (46) is fixedly mounted on the other end of the threaded rod (44).

6. A method for applying the electrical stimulation lead implantation device according to any one of claims 1 to 7, characterized in that: The following steps are involved: S1. Use a special epidural puncture needle to penetrate into the posterior space of the epidural space through the interlaminar space of the puncture segment; S2, the light source interface (21), the display interface (2) and the water inlet (19) on the end shell (11) are connected to an external light source, a display and a flushing water pipe; S3, insert one of the puncture electrode devices, insert the puncture electrode and the surgical electrode into the front end through the No. 1 implantation port (15) and the No. 2 implantation port (16), and make them flush with the front end of the bendable fiber catheter (31), and place the external locker under the No. 1 implantation port (15) and the No. 2 implantation port (16), so that the external locker clamps the puncture electrode and the surgical electrode to prevent the puncture electrode and the surgical electrode from sliding forward or backward by themselves; S4, inserting the bendable fiber catheter (31) into the posterior space of the epidural space through the epidural puncture needle, bending the front end of the bendable fiber catheter (31) to a certain angle through the angle adjustment unit (4) under visual observation, controlling and locking the angle through the angle adjustment unit (4), and then inserting the bendable fiber catheter (31) upward into the epidural space of the spinal canal. During the insertion process, the angle of the bendable fiber catheter (31) is continuously adjusted by the angle adjustment unit (4) according to the visual situation, and the bendable fiber catheter (31) is implanted into the target position, which includes the center of the spinal cord, the dorsal horn and the lateral space, and whether it is correct is determined under the C-arm and CT imaging; S5. Release the fixation of the puncture electrode and the surgical electrode by the external locker, fix the puncture electrode and the surgical electrode with one hand, and withdraw the entire implant device with the other hand; S6. Fix the control unit (1) on the skin, and then manually withdraw the dedicated epidural puncture needle; S7. Place the puncture electrode and surgical electrode in the posterior epidural space and fix them to the skin.

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