CN115364347B

CN115364347B - Double-cavity micro catheter anchored in branch vessel

Info

Publication number: CN115364347B
Application number: CN202211321828.8A
Authority: CN
Inventors: 田涛; 高立建; 袁建松; 崔锦钢; 杨伟宪
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2022-10-27
Filing date: 2022-10-27
Publication date: 2023-04-07
Anticipated expiration: 2042-10-27
Also published as: CN115364347A

Abstract

The invention discloses a double-cavity micro-catheter anchored in a branch blood vessel, which consists of a main guide wire lumen, a branch guide wire lumen and an anchoring balloon outside the branch guide wire lumen. The branched guide wire lumen is guided into the branched blood vessel through the branched guide wire; with support from the anchoring balloon, the main guidewire is punctured through the main guidewire lumen into the occlusive segment of the chronic occlusive lesion. The concrete problems are as follows: (1) The anchoring saccule capable of being filled with liquid (developer) is arranged outside the branch guide wire lumen, so that the double-cavity micro catheter main body is anchored on the branch blood vessel, and the problems that the main guide wire cannot enter the occlusion section due to insufficient puncture force and the double-cavity micro catheter is displaced are solved; (2) The guide wire outlets which are longitudinally arranged are arranged on the main guide wire lumen, so that the main guide wire penetration direction can be quickly and accurately adjusted, and the problems of long puncture direction adjustment time and inaccurate puncture position caused by the single main guide wire outlet of the traditional double-cavity micro-catheter are solved.

Description

Double-cavity micro catheter anchored in branch vessel

Technical Field

The invention belongs to the technical field of medical instruments. Relates to the field of coronary artery chronic occlusion lesion treatment devices, in particular to a double-cavity micro catheter anchored in a branch vessel.

Background

Chronic occlusive coronary lesions refer to lesions with grade 0 TIMI blood flow prior to occlusion as confirmed by coronary angiography and with occlusion times longer than three months. Due to the long occlusion time, the lesions are usually hard and are accompanied by calcification, tortuosity, angulation and the like of blood vessels, the success rate of interventional therapy is relatively low, and the incidence rate of surgical complications is relatively high. Thus, chronic occlusive lesions are also the "forts" that the coronary intervention field needs to eventually overcome.

Chronic occlusive lesions with branch vessels are the more common subtype, with no stumps at the proximal end of the segment. The fibrous cap proximal to such lesions is stiffer and the main guidewire is more difficult to access into the occluded segment of the chronic occlusion lesion and is prone to slide into the branch vessel. The first double lumen microcatheter was introduced in japan in 2006. It can strengthen the support to the main branch wire, assist the processing of this type of pathological change. The general operation is: firstly, the branch guide wire is fed into a branch blood vessel at the near end of an occlusion section with chronic occlusion lesion, then the double-cavity micro catheter is fed into the branch blood vessel through a branch lumen along the branch guide wire, and then the main guide wire is fed into the main guide wire lumen along the main guide wire lumen to open the occlusion lesion.

However, the conventional double lumen microcatheter has a great technical problem in application. First, when a very hard lesion is encountered, the main guidewire still cannot enter the occlusion section of the chronic occlusion lesion due to the limited supporting force of the microcatheter, and the microcatheter is displaced due to the reaction force effect. Second, the conventional double lumen microcatheter has only one main guidewire exit port. However, the blood vessels with different pathological changes have different shapes, and sometimes the position of the double-cavity microcatheter needs to be adjusted for many times to search the optimal puncture direction of the main guide wire. Therefore, the traditional double-cavity micro catheter has a great space for improving the success rate and the efficiency of the operation and reducing the risk of the operation.

The invention discloses a double-cavity micro-catheter capable of being anchored in a branch vessel, aiming at the limitation of the traditional double-cavity micro-catheter.

Disclosure of Invention

To overcome the problems noted in the background, the present invention provides a double lumen microcatheter anchored in a branch vessel. The catheter consists of a main guide wire lumen, a branch guide wire lumen and an anchoring balloon outside the branch guide wire lumen. The branch guide wire lumen is firstly guided to the branch blood vessel by the branch guide wire, and the main guide wire penetrates into the occlusion section of the chronic occlusion lesion through the main guide wire lumen under the supporting action of the anchoring balloon.

The concept of the invention is derived from the practical problems encountered in the interventional operation of chronic occlusive lesions of coronary arteries, which is an improvement of the traditional double-cavity micro-catheter and is an advance of the technology. The specific invention content comprises:

1. solution to the first technical problem

The device of the invention increases the stability of the device by arranging the anchoring saccule outside the branch guide wire lumen, thereby solving the problems that the main guide wire can not enter into occlusion lesion due to insufficient supporting force during puncture and the device is displaced. The anchoring effect of the balloon on the branch blood vessel is realized by pressurizing and filling liquid (developer) at the tail end of the double-cavity micro catheter through a pressure pump.

Need to explain: the foremost end of the main branch guide wire lumen is a main branch guide wire outlet, and the rearmost end of the main branch guide wire lumen is a main branch guide wire inlet; the foremost end of the branched guide wire lumen is a branched guide wire inlet, and the rear end of the branched guide wire lumen is provided with a branched guide wire outlet; the branch guide wire outlet is arranged at the front end of the main guide wire outlet.

Further, the setting mode of the liquid filling channel is set as follows: the liquid filling channel is a tubular liquid transmission cavity which is parallel to the main branch guide wire lumen and extends from the anchoring saccule position to the tail end of the double-cavity micro-catheter main body,

further, the liquid filling channel of the branch guide wire lumen section is a section of fine circular pipeline attached to the branch guide wire lumen, and the fine circular pipeline is communicated with the liquid transmission cavity; or the liquid filling channel of the branch guide wire lumen section is an annular liquid filling pipeline, the annular liquid filling pipeline and the branch guide wire lumen are coaxial, and the diameter of the annular liquid filling pipeline is larger than that of the branch guide wire lumen; the liquid filling channel of the branch guide wire lumen section is arranged outside the branch guide wire lumen and is communicated with the anchoring saccule; the liquid transmission cavity is communicated with the annular liquid filling pipe.

2. Solution to the second technical problem

The technical problem two is solved on the basis of solving the problem one or independently. The problem that the optimal puncture direction needs to be searched by repeatedly adjusting the position of the double-cavity micro catheter is solved by arranging a plurality of main branch guide wire outlets on a main branch lumen. The method comprises the following specific steps: 1-5 main guide wire outlets are arranged at the front end of the main guide wire lumen, wherein the preferred number of the outlets is 2-3.

Further, the multiple primary guidewire exits are aligned along the longitudinal axis of the double lumen microcatheter body.

The invention has the beneficial effects that:

firstly, the main body of the double-cavity micro catheter is anchored at an accurate position without displacement by arranging an anchoring balloon in a branch guide wire lumen, and finally the effect of enhancing the puncture force of the main guide wire is achieved.

Secondly, through the mode that sets up many main tributary seal wire exports, can make the main tributary seal wire adjust the puncture direction of main tributary seal wire faster, more accurate, save operating time, improve operation efficiency.

Drawings

FIG. 1 is a structural schematic view of a double-lumen microcatheter in a straight state without a guide wire according to the present invention;

FIG. 2 is a schematic structural view of a double lumen microcatheter of the present invention with only a branched guidewire;

FIG. 3 is a schematic structural view of a double lumen microcatheter of the present invention with only the main guidewire;

FIG. 4 is a schematic diagram of the overall structure of the double-lumen microcatheter with branch guide wire and main guide wire of the present invention;

FIG. 5 is a longitudinal sectional view of the front end of the main body of the double-lumen microcatheter of the present invention;

FIG. 6 is a partial enlarged structural view of the front end portion of the double-lumen microcatheter of the present invention, which is cut transversely from the rear end of the exit of the branch guide wire;

fig. 7 is a schematic view of the double-lumen microcatheter of the present invention in a partially enlarged configuration within a blood vessel.

In the figure, 11, the main branch guide wire lumen; 111. a main branch guide wire outlet; 112. a main branch guide wire inlet; 12. a main guidewire; 21. a branched guidewire lumen; 211. a branch guide wire inlet; 212. a branch guide wire outlet; 22. a branched guide wire; 23. an annular liquid-filled pipe; 231. a balloon front end closure structure; 232. a balloon inflation port; 233. a balloon rear end closing structure; 3. an anchoring balloon; 41. a liquid transfer chamber.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below by specific embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments, and other advantages and effects of the present invention can be easily understood by those skilled in the art from the disclosure of the present specification. The present invention can be implemented or applied by other different specific embodiments, and the features in the following embodiments and embodiments can be combined with each other without conflict, and all other embodiments obtained by a person of ordinary skill in the art without creative efforts based on the embodiments of the present invention belong to the protection scope of the present invention. The front end and the back end of the present invention are defined, wherein the end entering the blood vessel is the front end, and the opposite end is the back end.

Example 1

Reference is made to fig. 1-7; a double-cavity micro-catheter anchored in a branch blood vessel comprises a main guide wire lumen 11, a branch guide wire lumen 21, a branch guide wire 22 and a main guide wire 12; the main branch guide wire lumen 11 and the branch guide wire lumen 21 are both arranged in the double-cavity micro catheter body; the foremost end of the double-cavity micro-catheter main body only comprises a branch guide wire lumen 21 entering a branch blood vessel; an anchoring balloon 3 is arranged outside a branch guide wire lumen 21 entering a branch blood vessel; the branch guide wire lumen 21 is guided to the branch blood vessel through the branch guide wire 22; under the supporting action of the anchoring balloon 3, the main branch guide wire 12 is punctured into an occlusion section of the chronic occlusion lesion through the main branch guide wire lumen 11.

The embodiment of the structure for filling the anchoring balloon 3 with liquid is: a liquid filling pipe for filling the anchoring balloon 3; and the back end of the double-cavity micro catheter main body is provided with a filling structure for filling liquid into the anchoring saccule 3; the filling structure may be a pressure pump commonly used in clinics.

The main branch guide wire 12 and the branch guide wire 22 have the following embodiments: the foremost end of the main branch guide wire lumen 11 is a main branch guide wire outlet 111, and the rearmost end of the main branch guide wire lumen 11 is a main branch guide wire inlet 112; the foremost end of the branch guide wire lumen 21 is a branch guide wire inlet 211; a branch guide wire outlet 212 is arranged at the rear end of the branch guide wire lumen 21; a branch guide wire exit 212 is forward of the main branch guide wire exit 111.

The use method of the double-cavity micro catheter comprises the following steps: firstly, guiding the branch guide wire 22 into a branch blood vessel at the proximal end of an occlusion section with chronic occlusion lesion, then extending the tail end of the branch guide wire 22 into the branch guide wire inlet 211 at the foremost end, guiding a branch lumen into the branch blood vessel at the foremost end of the branch guide wire 22 along the branch guide wire 22, and simultaneously enabling the main branch guide wire lumen 11 to enter the main branch blood vessel; then the anchoring saccule 3 is filled with liquid or liquid through a pressure pump, and the double-cavity micro-catheter main body and the main guide wire lumen 11 are anchored at the accurate positions in a mode of anchoring the position of the branch guide wire lumen 21; the main guidewire 12 is then inserted into the main guidewire entrance 112 at the trailing end, and the main guidewire 12 is guided out of the main guidewire exit 111 along the main guidewire lumen 11 and into the occlusive segment of the chronic occlusive lesion for puncture.

The arrangement effectively leads the branch guide wire lumen 21 into the branch blood vessel, and anchors the whole double-cavity micro-catheter main body at an accurate position by using the anchoring balloon 3 without displacement; ensuring that the main branch guide wire 12 has enough supporting force to puncture the occlusion section of the chronic occlusion lesion. The placement of the branch guidewire exit port 212 forward of the main guidewire exit port 111 can avoid the branch guidewire 22 from erroneously introducing the main vessel lumen into a branch vessel.

The liquid filling channel is arranged on the double-cavity micro catheter main body in the mode that the liquid filling channel extends to the rear end of the double-cavity micro catheter main body from the position of the anchoring balloon 3; the main body portion of the double lumen microcatheter at the rear end of the branch guidewire lumen 21 contains a fluid-filled channel in parallel with the main guidewire lumen 11. More preferably, the liquid-filled channel parallel to the main branch guide wire lumen 11 is a tubular liquid transmission lumen 41 attached to the main branch guide wire lumen 11. More preferably, the fluid delivery lumen 41 is disposed with the primary guidewire lumen 11; the arrangement can ensure smooth liquid filling. The liquid filled in the anchoring saccule 3 is developer, and the liquid can display the position of the saccule, can display the position of the saccule more clearly and prevent the inaccurate inflation position.

The specific implementation mode of the liquid filling channel is as follows: the first mode is that the liquid filling channel of the branch guide wire lumen 21 section is a section of fine circular pipeline attached to the branch guide wire lumen 21, and the fine circular pipeline is communicated with the liquid transmission cavity 41; the second mode is that the liquid filling channel of the branch guide wire lumen 21 section is an annular liquid filling pipe 23, the annular liquid filling pipe 23 and the branch guide wire lumen 21 are coaxial, and the diameter of the annular liquid filling pipe 23 is larger than that of the branch guide wire lumen 21; the liquid filling channel of the branch guide wire lumen 21 section is arranged outside the branch guide wire lumen 21 and is communicated with the anchoring saccule 3; the liquid transfer chamber 41 communicates with the annular liquid fill line 23. The liquid filling of the anchoring balloon 3 can be effectively completed through the arrangement, and the guiding action of the branch guide wire 22 is not influenced.

Specifically, the annular liquid filling pipe 23 is implemented in such a way that the outer wall of the annular liquid filling pipe 23 is connected with the outer wall of the branched guide wire lumen 21 through a sealing structure, and the arrangement of the sealing structure does not affect the communication and liquid filling of the annular liquid filling pipe 23 and the liquid transmission cavity 41. The specific implementation mode of the closed structure is as follows: the closure structures include a balloon front end closure structure 231 and a balloon rear end closure structure 233; the balloon front end closing structure 231 is a closing structure arranged at the forefront of the outer wall of the annular liquid filling pipe and the outer wall of the branched guide wire lumen 21; the balloon rear closure structure 233 includes a closure structure disposed around the branch guidewire exit 212 that connects the branch guidewire lumen 21 with the circumferential fluid-filled channel, or a closure structure disposed around the branch guidewire exit 212 that connects the branch guidewire lumen 21 with the exterior of the fluid delivery lumen 41. In a more preferred embodiment, the balloon rear end closing structure 233 is a closing structure in which the outer wall of the branch guide wire outlet 212 is integrally connected with the outer wall of the annular liquid filling pipe 23, and refer to fig. 6. The arrangement realizes that the operations of filling the anchoring balloon 3 with liquid and introducing the branch guide wire lumen 21 are simultaneously completed in one double-layer lumen.

In the embodiment of providing the liquid filling port, a balloon liquid filling port 232 for filling the anchoring balloon 3 is provided on the liquid filling pipe corresponding to the position of the anchoring balloon 3. The liquid filling port has the following embodiments: a plurality of balloon liquid filling ports 232 are arranged around the outer side wall of the liquid filling pipe, and more preferably, the balloon liquid filling ports are arranged in a mode that: the multiple rows of balloon liquid filling ports 232 are arranged 360 degrees around the outer side wall of the annular liquid filling pipe 23, and the arrangement can greatly improve the efficiency of liquid filling and discharging.

The primary guidewire inlet 112 direction is embodied such that the primary guidewire inlet 112 direction coincides with the axial direction of the entire primary guidewire lumen 11.

The back end of the liquid filling channel is provided with a connecting section connected with the filling structure, and the pressure pump can be conveniently connected through the connecting section. And the connection section at the rear end of the liquid filling channel is arranged in a direction with the main guide wire inlet 112, which can prevent mutual interference during operation.

The length of the anchoring balloon 3 is implemented in such a way that the length of the anchoring balloon 3 ranges from 5 to 20mm; preferably 10-15mm; such a length may satisfy the anchoring requirements.

The diameter setting range of the anchoring balloon 3 is that the maximum diameter of the anchoring balloon 3 after expansion is 2.0-3.0mm. Such a diameter may anchor coronary branches.

The expanding shape of the anchoring balloon 3 is implemented in such a way that the expanding cross section of the anchoring balloon 3 is in a notch shape.

The anchoring balloon 3 is arranged at the position of the branch guide wire lumen 21 in the following way: the anchoring balloon 3 is arranged at the most front end of the branch guide wire lumen 21 or the position of the end point with the most front end is less than 2cm in length. This arrangement can achieve anchoring effectively. More preferred is: the branch guide wire outlet 212 is at the rear end of the anchoring balloon 3 and has no overlapping area with the anchoring balloon 3. The distance range from the most front end of the anchoring saccule 3 to the branch guide wire inlet 211 is 3-10mm; the distance between the rearmost end of the anchoring balloon 3 and the branch guide wire outlet 212 is 3-10mm; the distance setting can avoid the interference or damage to the saccule caused by the operation process.

The length of the branch guide wire lumen 21 is set to be 10-40mm; this length ensures that a sufficient length of the branch guidewire lumen 21 enters the branch vessel for stable anchoring.

The branch guidewire exit 212 is shaped such that the branch guidewire exit 212 is a slanted oval exit, which facilitates the directional adjustment of the branch guidewire 22.

The filling structure is implemented as follows: the pressure pump is for accomplishing filling and the filling structure of release, when anchoring time overlength or operation can not once be accomplished, can temporarily release liquid or liquid in the anchoring sacculus 3 through the pressure pump, guarantee the branch blood flow, prevent to block up the damage of anchoring to branch blood vessel for a long time.

Example 2

Refer to fig. 5; because the blood vessels with different pathological changes have different shapes, when the branch guide wire lumen 21 enters different branch blood vessels or the entering depths are different, the main guide wire 12 is punctured through the single main guide wire outlet 111, the puncturing deflection problem is easy to occur because the puncturing direction is inaccurate, and thus, a doctor needs to repeatedly adjust the position of the main guide wire lumen 11, which consumes long time and causes inaccurate puncturing direction. In order to ensure that the main guide wire 12 passes out of the main guide wire outlet 111 at the fastest speed and in the most accurate direction, and is punctured with the largest puncturing force, the following embodiments are added on the basis of example 1 or the basis of the double-cavity micro catheter in the prior art:

the method specifically comprises the following steps: 1-5 main guide wire outlets 111 are arranged at the front end of the main guide wire lumen 11, wherein the preferred number is 2-3. The arrangement of the multiple main guide wire outlets 111 can adjust the position of the main guide wire 12 as fast as possible, and the main guide wire outlet 111 with the most appropriate direction is selected, so that the main guide wire 12 can puncture an occlusion section with chronic occlusion lesion in the most appropriate direction, and the time for repeatedly adjusting the position of the main body of the bidirectional microcatheter during entering is saved.

The multiple primary guidewire exit ports 111 are arranged such that the multiple primary guidewire exit ports 111 are aligned along the longitudinal axis of the double lumen microcatheter body, which arrangement is effectively adjustable between different primary guidewire exit ports 111.

The spacing between the adjacent main guide wire outlets 111 is implemented in such a way that the spacing distance between two adjacent main guide wire outlets 111 is 1-10mm, and this arrangement can realize gradual direction adjustment, and prevent the adjacent main guide wire outlets 111 from having too large direction deviation due to too large spacing and being unable to be selected.

The main branch guide wire outlet 111 is in the shape of an inclined oval outlet, so that the main branch guide wire 12 can be guided out more conveniently, and the puncture difficulty is reduced.

The main branch guidewire exit port 111 and the branch guidewire exit port 212 are positioned such that all of the main branch guidewire exit port 111 is disposed at the rear end of the branch guidewire exit port 212, which arrangement minimizes the possibility that the main branch guidewire lumen 11 will be erroneously introduced into a branch vessel.

The above description of the embodiments is only for the understanding of the present invention. It should be noted that modifications could be made to the invention without departing from the principle of the invention, which would also fall within the scope of the claims of the invention.

Claims

1. A double-cavity micro-catheter anchored in a branch blood vessel comprises a main guide wire lumen, a branch guide wire and a main guide wire; it is characterized in that the main guide wire lumen and the branch guide wire lumen are both arranged in the double-cavity micro-catheter main body; the foremost end of the double-cavity micro catheter main body only comprises a branch guide wire lumen entering a branch blood vessel; an anchoring saccule is arranged outside a branch guide wire lumen entering a branch blood vessel; the branch guide wire lumen is guided to the branch blood vessel through the branch guide wire; under the supporting action of the anchoring saccule, the main guide wire is punctured into an occlusion section with chronic occlusion lesion through the main guide wire lumen; 2-5 main guide wire outlets are arranged at the front end of the main guide wire lumen; 2-5 main guide wire outlets are arranged along the longitudinal axis of the double-cavity micro-catheter main body; the liquid filling channel parallel to the main branch guide wire lumen is a tubular liquid transmission cavity attached to the main branch guide wire lumen; the liquid delivery lumen is disposed with the main guidewire lumen; a balloon liquid filling port for filling liquid into the anchoring balloon is arranged on the liquid filling pipeline corresponding to the position of the anchoring balloon; a plurality of balloon liquid filling ports are arranged around the outer side wall of the liquid filling pipeline; the liquid filling channel of the branch guide wire lumen section is an annular liquid filling pipeline, the annular liquid filling pipeline and the branch guide wire lumen are coaxial, and the diameter of the annular liquid filling pipeline is larger than that of the branch guide wire lumen; the liquid filling channel of the branch guide wire lumen section is arranged outside the branch guide wire lumen and is communicated with the anchoring saccule; the liquid transmission cavity is communicated with the annular liquid filling pipeline; the outer wall of the annular liquid filling pipeline is connected with the outer wall of the branched guide wire lumen through a sealing structure, and the communication and liquid filling of the annular liquid filling pipeline and the liquid transmission cavity are not influenced by the arrangement of the sealing structure; the arrangement of the multiple main branch guide wire outlets can adjust the position of the main branch guide wire as fast as possible, and the main branch guide wire outlet in the most appropriate direction is selected, so that the main branch guide wire can puncture the occlusion section with chronic occlusion lesion in the most appropriate direction, and the time for repeatedly adjusting the position of the main body of the bidirectional microcatheter during entering is saved; when the device is used, the branch guide wire is guided into a branch blood vessel at the proximal end of an occlusion section with chronic occlusion lesion, the tail end of the branch guide wire is extended into an inlet of the branch guide wire at the foremost end, a branch lumen is introduced into the branch blood vessel at the foremost end of the branch guide wire along the branch guide wire, and a main branch guide wire lumen also enters the main branch blood vessel; then the anchoring saccule is filled with liquid through a pressure pump, and the double-cavity micro catheter main body and the main guide wire lumen are anchored at accurate positions in a mode of anchoring the branch guide wire lumen.

2. The double-lumen microcatheter of claim 1, wherein the branch guide wire exit port is forward of the main guide wire exit port.

3. The double-lumen microcatheter of claim 1, wherein a fluid-filled conduit configured to anchor the balloon fluid-filled; and the rear end of the double-cavity micro catheter main body is provided with a filling structure for filling liquid into the anchoring saccule; the liquid filling channel extends from the anchoring balloon position to the rear end of the double-cavity micro catheter main body; the main body part of the double-cavity micro-catheter at the rear end of the branch guide wire lumen also comprises a liquid filling channel which is parallel to the main guide wire lumen.

4. The dual lumen microcatheter of claim 1, wherein the closure structure comprises a balloon front end closure structure and a balloon rear end closure structure; the balloon front end closing structure is a closing structure which is arranged at the forefront of the outer wall of the annular liquid filling pipe and the outer wall of the branched guide wire pipe cavity; the balloon rear end closing structure comprises a closing structure which is arranged around the branch guide wire outlet and is used for connecting the branch guide wire lumen with the annular liquid filling channel, or a closing structure which is arranged around the branch guide wire outlet and is used for connecting the branch guide wire lumen with the outside of the liquid transmission cavity.

5. The double-lumen microcatheter of claim 1, wherein a plurality of rows of balloon ports are provided 360 ° around the outside wall of the annular liquid filled tube.

6. The dual lumen microcatheter of claim 1, wherein the anchoring balloon has a length in the range of 5-20mm; the maximum diameter of the anchoring saccule after expansion is 2.0-3.0mm; the cross section of the anchoring saccule is in a notch shape.