CN112754621A

CN112754621A - Trigeminal semilunar junction compression system

Info

Publication number: CN112754621A
Application number: CN202110033938.3A
Authority: CN
Inventors: 张小武; 赫明; 陈蔚
Original assignee: Suzhou Innomed Medical Device Co ltd
Current assignee: Suzhou Innomed Medical Device Co ltd
Priority date: 2021-01-11
Filing date: 2021-01-11
Publication date: 2021-05-07

Abstract

The invention relates to a half-month trigeminal nerve compression system which comprises a catheter component, a puncture sheath component and an injector, wherein the catheter component comprises a sheath tube, a Ruhr three-way valve, a first Ruhr cap and a lining wire, one end of the sheath tube is fixed and communicated with a first interface of the Ruhr three-way valve, the other sleeve of the sheath tube is provided with a balloon, a plurality of through holes communicated with the balloon are formed in the wall of the sheath tube, a second interface of the Ruhr three-way valve is used for being in threaded connection with the first Ruhr cap, a third interface of the Ruhr three-way valve is used for being connected with the injector to inject developing solution into the balloon, one end of the lining wire is fixedly connected with the first Ruhr cap. According to the invention, by using the Ruhr three-way valve, a hand of a user continuously pressing the push rod of the injector to maintain the filling pressure of the balloon can be effectively released; through the threaded connection of the luer connector and the second luer cap, the serious damage to surrounding tissues caused by the looseness of the puncture sheath sleeve and the puncture sheath core in the percutaneous puncture process can be effectively prevented.

Description

Trigeminal semilunar junction compression system

Technical Field

The invention belongs to the technical field of medical instruments, relates to a surgical instrument used in a half-moon compression operation of trigeminal nerve, and particularly relates to a half-moon compression system of trigeminal nerve.

Background

Trigeminal Neuralgia (TN) is known to be one of the most severe pain suffered by humans. As early as 1773, John Fothergill described the condition in an article entitled "facial pain". TN is relatively easy to diagnose for pain, typically manifested as unilateral facial, intermittent severe stinging or shocking, needle-prick-like pain, which can also be exacerbated by skin irritation, such as facial pressure, chewing, brushing, or shaving. The prevalence rate is 183/10 ten thousand, about 1.8 per thousand, and is mostly seen in adults and old people, the onset age is 28-89 years, 70% -80% of cases occur above 40 years, and the peak age is 48-59 years; the incidence rates of TN in men and women were estimated at 2.5/10 ten thousand and 5.7/10 ten thousand, respectively, in the first few days, slightly more in women than in men, about 2-3 times that in men. Mostly, the disease is unilateral, and the left side is unnecessary on the right side. More than about 85% is caused by vascular compression. However, recent survey data of WTO show that trigeminal neuralgia tends to be younger, the prevalence rate of the population is continuously increased, and the life quality of patients is seriously influenced.

The method for clinically treating the primary trigeminal neuralgia comprises the following steps: external physical therapy (e.g., massage), drug therapy, surgical therapy (e.g., microvascular decompression (MVD), stereotactic radiofrequency thermocoagulation, trigeminal nerve root destruction by glycerol injection, balloon compression, or radiosurgery); however, some patients are not sensitive to antiepileptic drugs or cannot tolerate the corresponding side effects, and only surgical treatment can be selected. When the operation treatment is carried out, percutaneous puncture trigeminal semilunar ganglion sacculus compression is the first choice method for treating the primary trigeminal nerve by an interventional method. However, the device system used in the percutaneous puncture trigeminal ganglion balloon compression operation at present has the following defects: 1) in the process of holding pressure in the operation, the balloon catheter needs to be pressed by fingers of a user to maintain the pressure balance time, so that the hands of the user cannot be disengaged, and the user experience is poor; 2) when the trigeminal ganglion is punctured percutaneously, the puncture sheath sleeve and the puncture sheath core are not provided with locking matching devices, and the puncture sheath core can be fixed by a user to puncture the human body's bursa smoothly, so that the risk of accidentally injuring surrounding tissues is increased; 3) the surface of the balloon catheter is not smooth enough, the trafficability is not good, and the time of the whole operation is prolonged; 4) the balloon material adopts TPU, silica gel or other intravascular interventional balloons, and has the defects that when the balloons made of the materials are used, the balloon cannot reach an expected shape when pressing the Mylar sac due to the hardness, elasticity, rated burst pressure and the like of the balloon, and is difficult to shrink back to an initial outer diameter after pressure relief, so that the operation effect is not ideal or the treatment is not thorough; 5) the head ends of the puncture sheath sleeve and the puncture sheath core are not well chamfered, and the defect is that the risk of damaging surrounding tissues or blood vessels is increased during use; 6) without a guide needle of sufficient length, the puncture sheath length is difficult to reach the target lesion position during the operation, which directly leads to the failure of the operation.

Disclosure of Invention

The invention aims to solve the technical problem of providing a trigeminal semilunar node compression system and aims to overcome the defects in the prior art.

The technical scheme for solving the technical problems is as follows: a half-moon compression system of trigeminal nerve comprises a catheter component, a puncture sheath component and an injector, the catheter component comprises a sheath tube, a Ruhr three-way valve, a first Ruhr cap and a lining wire, one end of the sheath tube is fixed and communicated with a first interface of the Ruhr three-way valve, the other sleeve of the sheath tube is provided with a balloon, the wall of the sheath tube is provided with a plurality of through holes communicated with the balloon, the second interface of the luer three-way valve is used for being connected with the first luer cap in a threaded mode, the third interface of the luer three-way valve is used for being connected with the injector to inject the developing solution into the balloon, one end of the lining wire is fixedly connected with the first Ruhr cap, the other end of the lining wire extends into the sheath tube through the Ruhr three-way valve, the puncture sheath component can be punctured to the trigeminal semilunar ganglion through the skin and guides one end, provided with the saccule, of the sheath tube to be close to the trigeminal semilunar ganglion.

On the basis of the technical scheme, the invention can be further improved as follows.

Furthermore, both ends of the saccule are sleeved with metal marking rings.

The advantage of adopting above-mentioned further configuration amendment is that, the metal mark ring (metal mark point) of sacculus far and near both ends not only can play the sealed effect of enhancement, has still guaranteed X-ray detectability, the position of the sacculus of help of X-ray equipment observation during the operation of being convenient for.

Further, the outer wall of the sheath tube is coated with a hydrophilic coating.

The further structural improvement has the advantage of reducing the frictional resistance between the sheath and the surrounding tissue or the puncture sheath cannula of the puncture sheath assembly, thereby greatly reducing the operation difficulty and the operation time.

Furthermore, the outer wall of the sheath tube is provided with a first scale mark for indicating the depth of the balloon end extending into the puncture sheath component.

The improved structure has the advantages that the first scale mark is positioned at one end of the sheath tube, which is relatively close to the Ruhr three-way valve, one end of the sheath tube, which is provided with the saccule, enters the puncture sheath sleeve during operation, the first scale mark is positioned outside the puncture sheath sleeve, and an operator can estimate the depth of the saccule entering the puncture sheath sleeve through the first scale mark.

Furthermore, the lining wire is a stainless steel wire, and the length of the lining wire extending into the sheath pipe is matched with the length of the sheath pipe.

Adopt above-mentioned further institutional advancement's benefit to be, stainless steel wire toughness is good and not rusty, can be fine play penetrate the sheath intraductal purpose of strengthening its toughness of back.

Further, the puncture sheath assembly comprises a puncture sheath sleeve, a puncture sheath core, a luer connector and a second luer cap, one end of the puncture sheath sleeve is fixedly connected with one end of the luer connector, the other end of the luer connector is in threaded connection with the second luer cap, the second luer cap is fixedly connected with one end of the puncture sheath core, and the other end of the puncture sheath core extends out of one end, far away from the luer connector, of the puncture sheath sleeve.

The puncture sheath sleeve fixedly bonded with the luer connector and the puncture sheath core fixedly connected with the second luer cap are relatively fixed, so that the puncture sheath sleeve and the puncture sheath core cannot be loosened to cause serious damage to surrounding tissues in the percutaneous puncture process.

Further, a second scale mark convenient for indicating the puncture depth is arranged on the outer surface of the puncture sheath casing.

The further structural improvement has the advantage that the puncture depth can be conveniently recorded by a user.

Further, the puncture sheath sleeve is far away from the round angle of one end of the luer connector and is blunt, and the puncture sheath core is far away from one end of the luer connector and is pointed and blunt in round angle.

Adopt above-mentioned further institutional advancement's benefit to be, can avoid causing the damage to surrounding tissue or blood vessel after the fillet is blunted.

Furthermore, the puncture sheath sleeve and the puncture sheath core are both made of stainless steel materials and the surfaces of the puncture sheath sleeve and the puncture sheath core are subjected to electrolytic polishing.

The advantage of adopting above-mentioned further configuration improvement is that electropolishing makes its surface smoother, more easily punctures and has little frictional damage to surrounding tissue.

The puncture sheath is characterized by further comprising an introducer needle, wherein the introducer needle can penetrate through the puncture sheath, the length of the introducer needle is 10-15mm longer than that of the puncture sheath, an annular handle is fixed at one end of the introducer needle, and the other end of the introducer needle is sharp and blunt in a round angle mode.

The advantages of adopting the further structural improvement are that the outer diameter of the guide needle is slightly smaller than the puncture sheath core, the length is 10-15mm longer than the puncture sheath core, the guide needle can smoothly pass through the puncture sheath sleeve, and the guide needle is convenient to use when the puncture sheath core is difficult to puncture the oval hole; the doctor can select whether to use the guide needle according to different patient conditions, and some people can finish the puncture by directly using the puncture sheath, and some people need to use the small-sized guide needle to realize the puncture after finishing using the puncture sheath.

Compared with the prior art, the invention has the beneficial effects that:

1) the luer three-way valve of the catheter assembly is connected with the connectors of the sheath, and the other two connectors can be respectively connected with a first luer cap and an injector with a lining wire, the lining wire extends into the sheath to effectively enhance the toughness and strength of the sheath, so that the extrusion and bending deformation in the transportation process can be avoided to a certain extent, and in addition, the operation is more convenient when the catheter assembly is conveyed into a puncture sheath catheter due to the fact that the lining wire is not easy to bend in use; whether the injector is communicated with the sheath tube or not can be selected by rotating and adjusting the position of a handle of the Ruhr three-way valve, so that the hand of a user continuously pressing the injector push rod to maintain the balloon filling pressure is effectively released; the surface of the sheath tube is provided with the hydrophilic coating, so that the frictional resistance between the sheath tube and the surrounding tissues or the puncture sheath tube can be greatly reduced, and the operation time is greatly shortened.

2) The luer connector and the second luer cap of the puncture sheath component are in threaded connection, so that the serious damage of surrounding tissues caused by looseness of the puncture sheath sleeve and the puncture sheath core which are respectively connected with the luer connector and the second luer cap in the percutaneous puncture process can be effectively avoided.

3) Through reasonable structural design and special surface polishing process to guide needle, puncture sheath sleeve pipe and puncture sheath core, make the puncture of oval hole more effective and accurate, also greatly reduced the risk of patient's complication such as infecting simultaneously.

Drawings

FIG. 1 is a schematic diagram of a meniscal compression system for trigeminal nerve provided in accordance with the present invention;

FIG. 2 is a schematic view of a catheter assembly of the semilunar compression system of the trigeminal nerve shown in FIG. 1;

FIG. 3 is a schematic illustration of the catheter assembly of FIG. 2 after the first luer cap and the wire have been connected;

FIG. 4 is a schematic view of a puncture sheath assembly of the semilunar compression system of the trigeminal nerve shown in FIG. 1;

FIG. 5 is a schematic view of the piercing sheath assembly of FIG. 4 with the second luer cap and the piercing sheath core connected;

fig. 6 is a schematic view of the puncture sheath assembly of fig. 4 after the luer fitting and the puncture sheath tubing are connected.

In the drawings, the components represented by the respective reference numerals are listed below:

10. a catheter assembly; 20. a puncture sheath assembly; 30. an injector; 40. a guide needle;

101. a sheath tube; 102. a luer three-way valve; 103. a first luer cap; 104. lining wires; 105. a balloon; 106. a metal marker ring; 107. a first scale mark;

201. puncturing the sheath cannula; 202. puncturing the sheath core; 203. a luer fitting; 204. a second luer cap; 205. a second tick mark.

Detailed Description

The principles and features of this invention are described in connection with the drawings and the detailed description of the invention, which are set forth below as examples to illustrate the invention and not to limit the scope of the invention.

In the description of the present invention, if terms indicating orientation such as "upper", "lower", "left", "right", "top", "bottom", "inner", "outer", etc., are used, they indicate orientation or positional relationship based on that shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, should not be construed as limiting the present invention.

As shown in fig. 1 to 6, an embodiment of the present invention provides a trigeminal semilunar compression system, which includes a catheter assembly 10, a puncture sheath assembly 20 and a syringe 30, wherein the catheter assembly 10 includes a sheath 101, a luer three-way valve 102, a first luer cap 103 and a lining wire 104, one end of the sheath 101 is fixed and communicated with a first interface of the luer three-way valve 102, another end of the sheath 101 is sleeved with a balloon 105, a plurality of through holes communicated with the balloon 105 are opened on a tube wall of the sheath 101, a second interface of the luer three-way valve 102 is used for being screwed with the first luer cap 103, a third interface of the luer three-way valve 102 is used for being connected with the syringe 30 to inject a developing solution into the balloon 105, one end of the lining wire 104 is fixedly connected with the first luer cap 103, and the other end thereof extends into the sheath 101 through the luer three-way valve 102, the puncture sheath assembly 20 can be punctured percutaneously to the trigeminal semilunar junction and guide the end of the sheath 101 provided with the balloon 105 to approach the trigeminal semilunar junction.

It should be noted that, in the operation, a user may select a passage or close the passage by rotating a handle of the luer three-way valve, and when the passage is formed, the sheath is communicated with a third port connected to the syringe or a second port connected to the first luer cap (at this time, the first luer cap and the lining wire are detached and removed), and then the developing solution filled in the balloon is discharged to the syringe or overflows from the second port; when the balloon is closed, the sheath tube is not communicated with the second and third interfaces of the Ruhr three-way valve and is in a closed state, the balloon is filled with developing solution and is continuously in a constant pressure state, and due to the effect of the Ruhr three-way valve, the problem that the signal injector needs to be continuously pressed to maintain pressure balance time in the operation is solved, and the two hands of a user are released.

In the above embodiment, in order to allow the lining wire fixedly connected to the first luer cap to enter and exit the sheath tube more conveniently, the first and second ports of the luer three-way valve are preferably arranged on the same straight line, i.e. coaxially, so that the lining wire can be straight into and out of the sheath tube without bending. It will be appreciated that the first and second interfaces are preferably co-linear, and may be offset by any suitable angle as required. In addition, when the first and second ports are coaxial, the third port to which the syringe is connected is preferably perpendicular to the axis of the first and second ports.

In one embodiment of the present invention, as shown in fig. 2, the balloon 105 is sleeved with metal marker rings 106 at both ends. That is, the sheath tube penetrates through the saccule, and a metal marking ring is respectively sleeved at the penetrating inlet and outlet, so that the tight adhesion and the sealing property (adhesion by glue) of the penetrating position of the saccule and the wall of the sheath tube are ensured, and the metal marking ring can be clearly observed under X-rays and is used for indicating the position of the saccule. In this embodiment, the balloon is preferably manufactured and customized by using a natural latex material, has an inflation pressure more than 2 times that of a normal PBC surgical balloon, and has good fatigue resistance and softness, so that the expected effect of the surgery can be met.

On the basis of the above embodiment, the outer wall of the sheath 101 is coated with a hydrophilic coating. The hydrophilic coating can greatly reduce the frictional resistance between the sheath and the surrounding tissue or the puncture sheath, thereby greatly reducing the operation time. The surface of the balloon is also coated with a hydrophilic coating.

In one embodiment of the present invention, the outer wall of the sheath 101 is provided with a first graduation mark 107 for indicating the depth of the end of the sheath provided with the balloon 105 extending into the puncture sheath assembly 20.

In one embodiment of the present invention, as shown in fig. 2 and 3, the lining wire 104 is a stainless steel wire and extends into the sheath 101 by a length matching the length of the sheath 101. In other words, the lining wires exist in the whole length of the sheath, and the whole sheath is supported and toughened by the lining wires.

In one embodiment of the present invention, as shown in fig. 4 to 6, the puncturing sheath assembly 20 includes a puncturing sheath cannula 201, a puncturing sheath core 202, a luer 203 and a second luer cap 204, wherein one end of the puncturing sheath cannula 201 is fixedly connected with one end of the luer 203, the other end of the luer 203 is in threaded connection with the second luer cap 204, the second luer cap 204 is fixedly connected with one end of the puncturing sheath core 202, and the other end of the puncturing sheath core 202 protrudes from one end of the puncturing sheath cannula 201 far away from the luer 203. In this embodiment, the luer connector is adhesively secured to the puncture sheath cannula and the second luer cap is adhesively secured to the puncture sheath core.

In one embodiment of the present invention, the outer surface of the puncture sheath 201 is provided with a second graduation mark 205 for indicating the puncture depth.

In the above embodiment, the end of the puncture sheath cannula 201 away from the luer 203 is rounded, and the end of the puncture sheath core 202 away from the luer 203 is pointed and rounded. The puncture sheath sleeve 201 and the puncture sheath core 202 are both made of stainless steel materials and the surfaces thereof are subjected to electrolytic polishing.

In the above embodiment, the puncture sheath further comprises an introducer needle 40, the introducer needle 40 can be passed through the puncture sheath 201, the introducer needle 40 is 10-15mm longer than the puncture sheath 201, one end of the introducer needle 40 is fixed with an annular handle, and the other end of the introducer needle 40 is a sharp end and is rounded (the head end of the introducer needle is in accordance with the treatment manner of the head end of the puncture sheath core). When the puncture sheath length is difficult to reach the target lesion position during the operation, the operation is directly disabled, and the deeper puncture can be continued by using a longer guide needle.

It should be noted that, after the puncture is completed by using the puncture sheath assembly, the second luer cap 204 is rotated to be separated from the luer 203, and then pulled outward, the second luer cap 204 drives the puncture sheath core 202 to be separated from the puncture sheath 201 together, then the end of the sheath with the balloon is inserted inward into the puncture sheath 201, the balloon penetrates out from the other end of the puncture sheath 201 until it is close to the trigeminal semilunar junction, then the first luer cap 103 is rotated to be separated from the luer three-way valve 102 and drive the lining wire 104 to leave the sheath 101, the handle of the luer three-way valve 102 is rotated to make the luer three-way valve have the third interface and only have the third interface to be communicated with the sheath, the syringe fills the balloon with the developing solution through the sheath via the third interface to make the balloon inflated and expanded, when the pressure is proper, the handle of the luer is rotated to make one end of the sheath communicated with the luer three-way valve closed to ensure that the pressure of the balloon is, after the operation is finished, the handle is rotated to close the sheath tube and is communicated with the second or third interface, then the developing solution overflows or returns to the injector, the balloon is decompressed, and then the sheath tube and the puncture sheath sleeve are pulled out.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. A half-month trigeminal compression system is characterized by comprising a catheter assembly (10), a puncture sheath assembly (20), an injector (30) and a guide needle (40), wherein the catheter assembly (10) comprises a sheath tube (101), a luer three-way valve (102), a first luer cap (103) and a lining wire (104), one end of the sheath tube (101) is fixed and communicated with a first interface of the luer three-way valve (102), a balloon (105) is arranged on the other sleeve of the sheath tube (101), a plurality of through holes communicated with the balloon (105) are formed in the tube wall of the sheath tube (101), a second interface of the luer three-way valve (102) is used for being in threaded connection with the first luer cap (103), a third interface of the luer three-way valve (102) is used for being connected with the injector (30) to inject a developing solution into the balloon (105), one end of the lining wire (104) is fixedly connected with the first luer cap (103), the other end of the puncture sheath component (20) can be punctured to the half-moon joint of the trigeminal nerve through the skin and guides the end, provided with the balloon (105), of the sheath tube (101) to be close to the half-moon joint of the trigeminal nerve.

2. A trigeminal semilunar compression system as claimed in claim 1 wherein the balloon (105) is sheathed at both ends with metal marker rings (106).

3. The system of claim 1, wherein the sheath (101) is coated on its outer wall with a hydrophilic coating.

4. The system of claim 1, wherein the sheath (101) has a first graduation mark (107) on its outer wall for indicating the depth of the end with the balloon (105) extending into the puncture sheath assembly (20).

5. The system of claim 1, wherein the spacer wire (104) is a stainless steel wire and extends into the sheath (101) to a length matching the length of the sheath (101).

6. A semilunar compression system according to any of claims 1 to 5, characterized in that said puncture sheath assembly (20) comprises a puncture sheath cannula (201), a puncture sheath core (202), a luer connector (203) and a second luer cap (204), one end of said puncture sheath cannula (201) is fixedly connected with one end of said luer connector (203), the other end of said luer connector (203) is in threaded connection with said second luer cap (204), said second luer cap (204) is fixedly connected with one end of said puncture sheath core (202) and the other end of said puncture sheath core (202) protrudes from one end of said puncture sheath cannula (201) away from said luer connector (203).

7. The system as claimed in claim 6, wherein the puncture sheath sleeve (201) is provided with a second graduation mark (205) on its outer surface for indicating the puncture depth.

8. A meniscal pressure system according to claim 6, wherein the end of the puncture sheath cannula (201) remote from the luer fitting (203) is rounded and the end of the puncture sheath core (202) remote from the luer fitting (203) is pointed and rounded.

9. The system of claim 6, wherein the sheath sleeve (201) and the sheath core (202) are made of stainless steel and have surfaces electropolished.

10. The trigeminal semilunar junction compression system according to claim 6, further comprising an introducer needle (40), wherein the introducer needle (40) can be penetrated through the puncture sheath cannula (201), the introducer needle (40) is longer than the puncture sheath cannula (201) by 10-15mm, one end of the introducer needle (40) is fixed with an annular handle, and the other end is sharp and blunt rounded.