CN113491556A

CN113491556A - Embolism microcatheter assembly

Info

Publication number: CN113491556A
Application number: CN202110716043.XA
Authority: CN
Inventors: 黄奉康; 邓一兰; 杨安顺
Original assignee: Sichuan Aimaisi Biomedical Technology Co ltd
Current assignee: Sichuan Action Medical Technology Co ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2021-10-12
Anticipated expiration: 2041-06-25
Also published as: CN113491556B

Abstract

The invention relates to the technical field of medical instruments, in particular to an embolism microcatheter component, which comprises a catheter main body, wherein the catheter main body is connected with an interception body; the catheter main body is provided with a third flow passage which is communicated with an annular sac fixedly connected with the middle section of the catheter main body; the interception body is fixedly connected with the catheter main body through the solid filler layer; a fourth flow passage communicated with the first flow passage is arranged in the interception body, and the fourth flow passage is communicated with a plurality of outlet passages arranged on the interception body along the circumferential direction through the material cavity; a fifth flow passage communicated with the second flow passage is arranged in the interception body and is connected with the hydrogel foam layer arranged on the outer circumferential surface of the interception body through an annular cavity; a flow passage six which is communicated and connected with the flow passage five is arranged in the interception body, and a blocking material is arranged at the connection part of the flow passage five and the flow passage six; and the sixth flow channel is connected with an annular groove, and one side of the annular groove is in contact with the solid packing layer. The invention can seal the far end and the near end of the blood vessel and reduce the treatment risk.

Description

Embolism microcatheter assembly

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an embolism microcatheter component.

Background

Cerebral arteriovenous malformation (AVM) is a congenital disease with local cerebrovascular variation, intracranial vessels lose normal vascular tissue structure, and capillary beds are lacked between arteries and veins, so that arteriovenous shunt abnormality is caused, venous hypertension is caused, and the risk of rupture is caused. The existing treatment methods of AVM mainly include surgical excision, radiotherapy, intravascular embolization, etc. The intravascular embolism can seal AVM focuses, reduce AVM volume, block aneurysms and fistulas, and improve the safety of operations and radiotherapy. Wherein intravascular embolization using novel liquid embolizing agents is an important method of treating AVM.

As disclosed in publication No. CN111001046B, a microcatheter comprises a microcatheter body, a stress extension tube and a luer fitting; the micro catheter main body is connected with one end of a stress expansion pipe, and the other end of the stress expansion pipe is connected with a luer connector; the surface of the micro catheter main body is coated with a release type coating; the micro-catheter main body sequentially comprises a coating section and a supporting section from a far end to a near end; the release coating is coated on the surface of the coating section; the release coating includes a hydrophilic polymer and a surfactant. The release type coating can reduce the adhesive force of a micelle formed by the liquid embolic agent on the embedded micro catheter, so that the micro catheter can be withdrawn from the micelle formed by the embedded liquid embolic agent, and the risk of tube withdrawal is reduced.

Also disclosed in publication No. CN209075800U is a detachable microcatheter with a double-coated tip, comprising a microcatheter main body, a catheter holder connected to one end of the microcatheter main body, and a detachable microcatheter tip connected to the other end of the microcatheter main body, wherein an expandable inner coating is coated on the outer surface of the microcatheter tip, and a variable loose outer coating is hermetically and tightly coated on the inner coating. The beneficial effects of the utility model are that can improve the curative embolism rate of minimal access intervention treatment cerebral vessels malformation, reduce because of the complication and the incomplete relevant hemorrhage of embolism that liquid embolic agent backflows and lead to, simplify the treatment process, reduce economic burden.

In the prior art, when a micro catheter is used for injecting liquid embolic agent, the treatment can not be carried out only on a certain section of blood vessel, and the injected liquid embolic agent can flow into other blood vessels; meanwhile, in order to reduce the influence caused by reflux, the catheter is very inconvenient to take out after the proximal end is blocked in the prior art, and the blood vessel is easy to damage.

Disclosure of Invention

In view of the above-mentioned deficiencies, it is an object of the present invention to provide an embolic microcatheter assembly.

The invention provides the following technical scheme:

an embolism microcatheter component comprises a catheter main body, wherein one end of the catheter main body is connected with a luer connector I through a tube I, connected with a luer connector II through a tube II and connected with a luer connector III through a tube III; the other end of the catheter main body is connected with an interception body;

a first flow channel, a second flow channel and a third flow channel are arranged in the catheter main body, one end of the first flow channel is connected with the first tube, one end of the second flow channel is connected with the second tube, and one end of the third flow channel is connected with the third tube;

the other end of the flow passage III is communicated with an annular sac fixedly connected with the middle section of the catheter main body; when the annular bag is not filled with the medium, the annular bag is in a contracted state; when the annular bag is filled with the medium, the annular bag is unfolded, and an annular retainer ring is formed on the outer circumference of the catheter main body;

the interception body is fixedly connected with the catheter main body through the solid filler layer, when the temperature is higher than 40 ℃, the solid filler layer melts, and the interception body is disconnected with the catheter main body;

a fourth flow channel which is communicated with the other end of the first flow channel is arranged in the interception body, and the fourth flow channel is communicated with a plurality of outlet channels which are arranged on the interception body along the circumferential direction through the material cavity;

a fifth flow channel communicated with the second flow channel is arranged in the interception body and is connected with a hydrogel foam layer arranged on the outer circumferential surface of the interception body through an annular cavity; the outer side of the hydrogel foam layer is sealed, compacted and wrapped with a protective layer;

a flow passage six which is communicated with the flow passage five is arranged in the interception body, and a material blocking part is arranged at the joint of the flow passage five and the flow passage six;

and the six flow passages are connected with annular grooves, and one sides of the annular grooves are in contact with the solid packing layers.

The medium is a gas.

The outer side of the annular bag is tightly sealed and wrapped with a water-soluble degradable layer.

The annular bag is coated with a first developing layer.

The protective layer is a polymer which is soluble in DMSO and insoluble in water.

And one end of the catheter main body, which is close to the interception body, is provided with a second developing layer.

And a third developing layer is arranged on the interception body.

The interception body is characterized in that an adsorption layer is arranged on the outer side of the interception body, and a covering layer covers the adsorption layer.

The adsorption layer is a flexible layer with grooves uniformly distributed on the surface; the covering layer is a polymer which can be dissolved in DMSO and is not dissolved in water.

The blocking material is a water-soluble degradable material.

The invention has the beneficial effects that:

1. according to the invention, by arranging the interception body, the interception body and the precipitated micelle can close the far end of the blood vessel together, so that the liquid embolic agent is prevented from flowing into other blood vessels;

2. the annular bag capable of being filled with the medium is arranged, so that the near end of the blood vessel is blocked, the expansion and contraction of the annular bag can be controlled, and the blood vessel is prevented from being damaged in the process of taking out the catheter main body;

3. the invention can manually control the separation of the interception body, thereby realizing the controllability of the far-end sealing process; after distal closure, the catheter body can be used for the remainder of the treatment.

Drawings

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is a schematic view of the third flow channel and annular bladder arrangement of the present invention;

FIG. 3 is a cross-sectional view of the annular bladder of the present invention after deployment;

FIG. 4 is a cross-sectional view of a trap of the present invention;

FIG. 5 is a schematic view of the outlet channel distribution of the present invention.

Labeled as: three luer connectors 101, three tubing 102, one luer connector 103, one tubing 104, two tubing 105, two luer connectors 106, a catheter main body 107, a water-soluble degradable layer 108, two developing layers 109, one flow channel 110, three flow channels 111, two flow channels 112, an annular bag 113, one developing layer 114, a solid filler layer 115, an annular groove 116, an interception body 201, an outlet channel 202, a protective layer 203, three developing layers 204, an adsorption layer 205, four flow channels 206, a material cavity 207, a hydrogel foam layer 208, an annular cavity 209, a blocking material 210, five flow channels 211, six flow channels 212 and a covering layer 213.

Detailed Description

Example one

As shown in the figure, the embolism microcatheter assembly comprises a catheter main body 107, wherein one end of the catheter main body 107 is connected with a first luer connector 103 through a first tube 104, is connected with a second luer connector 106 through a second tube 105, and is connected with a third luer connector 101 through a third tube 102. The liquid embolic agent can be injected through luer one 103, the auxiliary solvent can be injected through luer two 106, and the medium can be injected through luer three 101. The catheter main body 107 is provided with a first flow passage 110, a second flow passage 112 and a third flow passage 111, wherein the first flow passage 110 and the second flow passage 112 penetrate through the catheter main body 107, and the third flow passage 111 only passes through the middle section of the catheter main body 107. One end of the first flow channel 110 is connected with the first tube 104, one end of the second flow channel 112 is connected with the second tube 105, and one end of the third flow channel 111 is connected with the third tube 102.

The other end of the third flow passage 111 is connected to an annular bag 113 fixedly connected to the middle section of the catheter main body 107. Specifically, an annular mounting groove is formed on the outer circumferential surface of the catheter main body 107, and the third flow passage 111 is connected to the annular mounting groove in a penetrating manner. One side of the inner circumferential surface of the annular bag 113 is firmly adhered to the annular mounting groove, an air inlet is formed in the annular bag 113, the air inlet is communicated with the third flow passage 111, the connecting position of the air inlet and the third flow passage 111 is strictly sealed, and the medium injected into the third flow passage 111 is prevented from overflowing from the connecting position. When the annular bladder 113 is not filled with the medium, the annular bladder 113 is in a contracted state; when the annular bladder 113 is filled with media, the annular bladder 113 deploys forming an annular collar around the outer circumference of the catheter body 107, thereby occluding the blood vessel at the proximal end.

The medium may be selected to be a gas, and the annular bladder 113 may be expanded by inflating the annular bladder 113 with the gas; gas may also be evacuated to deflate the annular bladder 113. Meanwhile, a developing layer one 114 may be coated on the annular pouch 113, thereby facilitating observation of the position and the expanded and contracted states of the annular pouch 113. The degree of deployment of the annular bladder 113 can be controlled by controlling the air pressure to avoid the annular bladder 113 from damaging the blood vessel.

The other end of the catheter main body 107 is connected with a trapping body 201, and the trapping body 201 is fixedly connected with the catheter main body 107 through a solid filler layer 115. Specifically, the trap body 201 is provided with a flange, the catheter main body 107 is provided with a groove, and after the flange is placed in the groove, the flange is covered with the solid filler layer 115 so that the solid filler layer 115 can fix the flange, thereby fixedly connecting the trap body 201 and the catheter main body 107 together. When the temperature is higher than 40 ℃, the solid filler layer 115 melts, and the interception body 201 and the catheter main body 107 can be disconnected.

A fourth flow channel 206 communicated with the other end of the first flow channel 110 is arranged in the interception body 201, and the fourth flow channel 206 is communicated with a plurality of outlet channels 202 arranged on the interception body 201 along the circumferential direction through a material cavity 207. When the retention body 201 is connected to the catheter body 107, the liquid embolic agent injected in the first flow channel 110 can enter the fourth flow channel 206 and then flow out of the outlet channel 202.

A fifth flow channel 211 communicated with the second flow channel 112 is arranged in the interception body 201, and the fifth flow channel 211 is connected with a hydrogel foam layer 208 arranged on the outer circumferential surface of the interception body 201 through an annular cavity 209. The outer side of the hydrogel foam layer 208 is hermetically and tightly wrapped with a protective layer 203, and the protective layer 203 is a polymer which is soluble in DMSO and insoluble in water. A small amount of liquid embolic agent is injected through the outlet channel 202, DSDA can be selected as the protective layer 203, so that the protective layer 203 is dissolved, the hydrogel foam layer 208 is exposed, an auxiliary solvent such as physiological saline is injected through the luer connector II 106, the physiological saline sequentially passes through the flow channel II 112 and the flow channel V211 to enter the annular channel cavity 209, the hydrogel foam layer 208 absorbs the physiological saline and blood to expand, the far end of the blood vessel is blocked, and the liquid embolic agent injected subsequently is prevented from entering other blood vessels through the far end. By covering the hydrogel foam layer 208 with the protective layer 230, the hydrogel protective layer 208 is prevented from swelling in contact with blood during the insertion of the catheter main body 107 and the retention body 201, and the insertion difficulty is increased.

A flow passage six 212 communicated with the flow passage five 211 is arranged in the interception body 201, and a blocking material 210 is arranged at the joint of the flow passage five 211 and the flow passage six 212. The plug 210 is a water soluble degradable material such as starch or chitosan. The flow passage six 212 is connected with an annular groove 116, and one side of the annular groove 116 is contacted with the solid packing layer 115. The time for the plug 210 to dissolve can be controlled by controlling the volume of the plug 210. The 40 ℃ physiological saline can be injected into the luer connector II 106, so that the 40 ℃ physiological saline sequentially passes through the flow channel II 112 and the flow channel five 211, the blocking material 210 is dissolved within a set time, then the 40 ℃ physiological saline enters the annular groove 116 through the flow channel six 212, the solid filler layer 115 is dissolved, and the interception body 201 is separated from the catheter main body 107. During the dissolution of the plug 210, the liquid embolic agent is injected through the first luer 103 at the same time, and the liquid embolic agent flows out through the outlet channel 202, so that the precipitation is carried out at the far end of the blood vessel to form a micelle. During the time when the blocking material 210 is dissolved, the far end of the blood vessel can completely form a micelle, and then the interception body 201 is separated from the catheter main body 107, and the interception body 201 and the formed micelle are together left at the far end of the blood vessel; the liquid embolic agent then flows out through flow channel one 110 for subsequent treatment, and the deployed annular balloon 113 prevents the liquid embolic agent from flowing through the proximal vessel to other locations.

For the convenience of observation, a second developing layer 109 is provided at one end of the catheter main body 107 close to the interception body 201, and a third developing layer 204 is provided on the interception body 201.

Example two

The difference between the embodiment and the embodiment is that the water-soluble degradable layer 108 is tightly and tightly wrapped outside the annular bag 113. The water soluble degradable layer 108 is preferably starch or chitosan, and the water soluble degradable layer 108 protects the annular pouch 113 from being damaged and ruptured when the product is not in use. In using this product, the water-soluble degradable layer 108 begins to dissolve after the catheter body 107 is inserted into the blood vessel, thereby facilitating subsequent deployment of the annular pouch 113.

EXAMPLE III

The difference between this embodiment and the first two embodiments is that an adsorption layer 205 is disposed outside the interception body 201, and the adsorption layer 205 is covered with a cover layer 213. The adsorption layer 205 is a flexible layer with grooves uniformly distributed on the surface, and the cover layer 213 is a polymer which can be dissolved in DMSO and is not dissolved in water, such as DSDA. After the liquid embolic agent comes out of the outlet channel 202, the cover layer 213 is dissolved to expose the adsorption layer 205, and the adsorption layer 205 with the grooves enables the micelle to be firmly adhered to the interception body 201, so that the interception body 201 and the micelle can block the far end of the blood vessel together.

Example four

The specific application method of the invention is as follows:

s1, inserting the interception body 201 and the catheter main body 107 into the blood vessel;

s2, injecting a small amount of liquid embolic agent through the luer connector I103, wherein the liquid embolic agent flows out from the outlet channel 202, and the protective layer 203 is dissolved;

s3, injecting 40 ℃ physiological saline through a second luer 106 to enable the hydrogel foam layer 208 to expand and block the far end of the blood vessel;

s4, continuously injecting 40 ℃ physiological saline through the luer connector II 106, and dissolving the blocking material 210 within a set time;

meanwhile, a set dose of liquid embolic agent is injected through the luer connector I103, the liquid embolic agent flows out from the outlet channel 202, and the liquid embolic agent is precipitated into a micelle in the blood vessel within the dissolution time of the plugging material 210, and the micelle is firmly adhered to the adsorption layer 205;

simultaneously, injecting gas through the luer connector III 101 to enable the annular sac 113 to be unfolded and block the proximal end of the blood vessel; controlling the air pressure to avoid damaging the blood vessel by the annular bladder 113 while allowing the catheter body 107 to be pulled;

s5, after the blockage 210 is dissolved, the normal saline at 40 ℃ enters the annular groove 116, the solid filler layer 115 is dissolved, and the catheter main body 107 is pulled to separate the catheter main body 107 from the interception body 201;

s6, injecting the liquid embolic agent with the set dosage through the luer connector I103;

s7, the air in the annular bag 113 is evacuated, and the catheter body 107 is evacuated.

Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An embolism microcatheter assembly is characterized by comprising a catheter main body (107), wherein one end of the catheter main body (107) is connected with a first luer connector (103) through a first tube (104), is connected with a second luer connector (106) through a second tube (105), and is connected with a third luer connector (101) through a third tube (102); the other end of the catheter main body (107) is connected with an interception body (201);

a first flow channel (110), a second flow channel (112) and a third flow channel (111) are arranged in the catheter main body (107), one end of the first flow channel (110) is connected with the first tube (104), one end of the second flow channel (112) is connected with the second tube (105), and one end of the third flow channel (111) is connected with the third tube (102);

the other end of the flow channel III (111) is communicated with an annular sac (113) fixedly connected with the middle section of the catheter main body (107); when the annular sac (113) is not filled with the medium, the annular sac (113) is in a contraction state; when the annular bag (113) is filled with the medium, the annular bag (113) is unfolded to form an annular retainer ring on the outer circumference of the catheter main body (107);

the interception body (201) is fixedly connected with the catheter main body (107) through the solid filler layer (115), when the temperature is higher than 40 ℃, the solid filler layer (115) is melted, and the interception body (201) is disconnected with the catheter main body (107);

a fourth flow channel (206) which is communicated with the other end of the first flow channel (110) is arranged in the interception body (201), and the fourth flow channel (206) is communicated with a plurality of outlet channels (202) which are arranged on the interception body (201) along the circumferential direction through a material cavity (207);

a fifth flow channel (211) communicated with the second flow channel (112) is arranged in the interception body (201), and the fifth flow channel (211) is connected with a hydrogel foam layer (208) arranged on the outer circumferential surface of the interception body (201) through an annular cavity (209); the outer side of the hydrogel foam layer (208) is sealed and tightly wrapped with a protective layer (203);

a flow passage six (212) communicated with the flow passage five (211) is arranged in the interception body (201), and a blocking material (210) is arranged at the joint of the flow passage five (211) and the flow passage six (212);

the six flow channels (212) are connected with an annular groove (116), and one side of the annular groove (116) is in contact with the solid filler layer (115).

2. The embolic microcatheter assembly of claim 1, wherein: the medium is a gas.

3. The embolic microcatheter assembly of claim 1, wherein: the outer side of the annular bag (113) is sealed and tightly wrapped with a water-soluble degradable layer (108).

4. The embolic microcatheter assembly of claim 3, wherein: the annular bag (113) is coated with a first developing layer (114).

5. The embolic microcatheter assembly of claim 1, wherein: the protective layer (203) is a DMSO-soluble, water-insoluble polymer.

6. The embolic microcatheter assembly of claim 1, wherein: and a second developing layer (109) is arranged at one end of the catheter main body (107) close to the interception body (201).

7. The embolic microcatheter assembly of claim 1, wherein: and a third developing layer (204) is arranged on the interception body (201).

8. The embolic microcatheter assembly of claim 1, wherein: an adsorption layer (205) is arranged on the outer side of the interception body (201), and the adsorption layer (205) is coated with a covering layer (213).

9. The embolic microcatheter assembly of claim 8, wherein: the adsorption layer (205) is a flexible layer with grooves uniformly distributed on the surface; the covering layer (213) is a polymer which can be dissolved in DMSO and can not be dissolved in water.

10. The embolic microcatheter assembly of claim 1, wherein: the blocking material (210) is a water-soluble degradable material.