CN110680577A

CN110680577A - Double-balloon grading expansion blood vessel stent device

Info

Publication number: CN110680577A
Application number: CN201911013879.2A
Authority: CN
Inventors: 吴万里
Original assignee: First Affiliated Hospital of Guangxi Medical University
Current assignee: First Affiliated Hospital of Guangxi Medical University
Priority date: 2019-10-23
Filing date: 2019-10-23
Publication date: 2020-01-14

Abstract

The invention discloses a double-balloon grading vascular stent device, comprising a stent, a balloon in the stent and a guide wire cavity. The stent is connected by a main branch stent and a trunk stent through several axial sinusoidal stents bridging mesh beams back and forth. The balloon is composed of a main branch balloon and a main branch balloon that are invaginated with each other and have independent pressure chambers respectively, the main branch balloon is wrapped outside the main branch balloon, the main branch balloon runs through the entire length of the stent, and the main branch balloon runs through The trunk stent and the stent bridge the length of the mesh beam; the guide wire lumen runs through the main branch balloon and the trunk balloon. Through the double-balloon structure with independent pressure chambers, the device can expand the distal, proximal and middle segments of the implanted stent according to the different diameters of the main branch of the bifurcation lesion and the main branch vessel, so that it can be completely fitted to the main branch of the bifurcation lesion and the main branch. On the vessel wall of the main branch, while achieving good treatment of main-branch lesions, the channel into the branch is optimized. The application of the invention to treat coronary bifurcation lesions can accurately treat vascular bifurcation lesions of different calibers and angles, has good versatility, conforms to the Provisional stent strategy, has a simple and reasonable structure, and is quick and convenient to operate.

Description

Double-balloon grading expansion blood vessel stent device

Technical Field

The invention belongs to the technical field of cardiovascular stents, and particularly relates to a double-balloon fractional dilatation stent device (bifurcation lesion stent).

Background

The coronary bifurcation lesion accounts for 15-20% of the total amount of percutaneous coronary intervention treatment. In treating coronary bifurcation lesions, the optimal result is that both main and branch lesions are perfectly resolved. Naturally, one thinks that both the main and the branch completely cover the upper support, so that: crush, SKS (Simultaneous Kissing Steps), Vstents, Curotte, T tent, Y tent, TAP, and the like. However, to date, clinical findings have not demonstrated that the elegant dual-stent strategy is superior to the simple single-stent strategy. The experts of European bifurcation lesion club published in 5 months of 2019 have commonly recognized that the standard strategy recommended for most bifurcation lesions is Provisional stent, and the core concept is as follows: main stent implantation + proximal optimization technique, and if necessary, branch stents.

At present, the vascular stent used for treating bifurcation lesion comprises a common vascular stent and a vascular stent special for bifurcation lesion. The common blood vessel stent is the earliest and most commonly used blood vessel stent and is characterized by a cylindrical structure. There are three main categories of special vascular stents for bifurcation lesions: 1) the bracket with the reserved branch side hole comprises a Frontier bracket, a Petal bracket, a Twin-Rail bracket, an Antares SAS bracket, a Sidekick bracket, a Croco bracket, a Stentys bracket and the like; 2) bifurcated supraspinal stents such as AxxessPlus stents; 3) and (3) branch special supports, including a Tryton support, a Sideguard support and the like. The Provisional stent strategy used by these stents for the current mainstream has a congenital deficiency. Among them, branch-dedicated scaffolds are commonly used for the double-scaffold strategy. Both the TRYTON bracket and the Biguard bracket belong to branch special brackets.

The TRYTON scaffold is divided into three regions. 1) The branch blood vessel region has the characteristics of a common tubular stent and can be used as a support of a branch blood vessel; 2) in the transition region, the stent wires are sparsely deformable, and provide radial supporting force and branch opening support for the bifurcation nucleus; 3) the main blood vessel area is matched with the main blood vessel in size, and the diameter of the conical belt at the terminal end of the main blood vessel area is close to that of the main blood vessel. The opaque markers of the stent delivery system are located at the proximal and distal ends of the stent and at the edges of the transition zone. After the stent is unfolded, the far end of the stent is positioned in the branch, the near end of the stent is positioned in the main trunk of the blood vessel, and the transition area is spanned at the opening of the branch.

The Biguard bracket designed and produced in China also belongs to a branch bracket, and is almost the same as the design of a TRYTON bracket. The bracket is divided into three parts: a proximal section, a middle section, and a distal section. The length of the proximal segment is 1mm, and the displacement is prevented; the middle section is 3mm long and is surrounded by 3 bracket trabeculae, and the interval between every two bracket trabeculae is 120 degrees; the far section is designed as a common bracket, and a gold mark is arranged at the junction of the far section and the middle section and used for positioning the branch opening. This stent design is primarily intended to facilitate placement of the guidewire, balloon and stent in the main branch after the Biguard is implanted in the branch. Care should be taken to only pressure expand the distal portion of the Biguard into the bifurcation, otherwise the proximal and middle portions of the Biguard would protrude into the main branch vessel. The diameter of the proximal portion of the stent varies depending on the diameter of the dilatation balloon, ranging from 2.5-4.0 mm.

During operation of both the TRYTON stent and the Biguard stent, a branch stent is preferentially implanted, then the main stent is treated by adjusting a guide wire and a saccule, and then the stent is implanted into the main stent and the trunk-main stent in a Culotte or Crush operation mode. This process may affect the quick and smooth implantation of the main stem-main stent. Is not in accordance with the current mainstream Provisional strategy. In addition, the balloon is a two-stage step balloon, when the balloon is pressurized and inflated, the far end and the near end are simultaneously pressurized and inflated, the stents at the far end and the near end are expanded in equal proportion, however, the caliber of a trunk of each bifurcation is different from that of a branch vessel, and the treatment of all bifurcation lesions with a fixed ratio of the trunk caliber to the caliber of the branch vessel is obviously not suitable. When the diameter of the branched main vessel is larger or the pressure in the balloon is unbalanced due to calcification and distortion of the vessel, the near-middle section of the branch vessel stent may protrude into the main vessel, which may cause the failure of implantation of the main vessel and the main branch stent and cardiovascular events during and after the operation.

Disclosure of Invention

The invention aims to solve the technical problem of providing a double-balloon fractional dilatation stent device which accords with provisionalstant strategy, has simple and reasonable structure and quick and convenient operation, can accurately treat the bifurcation lesions of blood vessels with different calibers and different angles and has better universality.

In order to solve the technical problems, the invention adopts the following technical scheme:

the double-balloon grading expansion blood vessel stent device comprises a stent, a balloon and a guide wire cavity in the stent, wherein the stent is formed by connecting a main stent and a main stent front and back through a plurality of axial sinusoidal stent bridging mesh beams; the balloon consists of a main balloon and a main balloon which are mutually nested and respectively provided with independent pressure cavities, the main balloon is wrapped outside the main balloon, the main balloon penetrates through the length of the whole stent, and the main balloon penetrates through the length of the main stent and the length of a stent bridging web beam; the guide wire cavity penetrates through the main branch balloon and the main branch balloon.

The main stent and the main stent are both common tubular stents, and the diameter of the main stent is different from that of the main stent by 0.25mm or 0.5 mm.

The support bridging net roof beam is 3-6, and the support bridging net roof beam is 3mm length, is axial sinusoidal form, has ductility and can be plastic.

The main and main balloons are coaxial.

The main branch sacculus is provided with a main branch sacculus pressure cavity which extends out of the tail part of the main branch sacculus and is connected with the main needle seat; the main balloon is provided with a main balloon pressure cavity which extends out of the tail part of the main balloon and is connected with the side needle seat.

One end of the guide wire cavity extends out of the front end of the main branch balloon, the other end of the guide wire cavity extends out of the tail portion of the main branch balloon, and the guide wire cavity can guide a guide wire through a coronary artery with the diameter of 0.014 inches.

The support is provided with four lightproof marks which are respectively positioned at the head and tail ends of the main support and the main support.

The use method of the double-balloon staged expansion intravascular stent device comprises the steps of conveying the stent device to a target position by using a guide wire, pressurizing and expanding the main balloon to enable the main balloon to be full and enable the main stent to adhere to the wall; then, pressurizing and expanding the main balloon to enable the main balloon to be full and enable the main stent to adhere to the wall; and finally, decompressing the main branch balloon and the main trunk balloon, and taking out the main branch balloon and the main trunk balloon through the guide wire.

Aiming at the problems of the existing branch special stent for treating coronary bifurcation lesion, the inventor designs and manufactures a double-balloon fractional dilatation stent device which comprises a stent, a balloon and a wire guide cavity in the stent, wherein the stent is formed by connecting a main stent and a main stent front and back through a plurality of axial sinusoidal stent bridging mesh beams; the balloon consists of a main balloon and a main balloon which are mutually nested and respectively provided with independent pressure cavities, the main balloon is wrapped outside the main balloon, the main balloon penetrates through the length of the whole stent, and the main balloon penetrates through the length of the main stent and the length of a stent bridging web beam; the guide wire cavity penetrates through the main branch balloon and the main branch balloon. The device can expand the far section and the near section and the middle section of the implanted stent respectively according to different calibers of a main branch pathological change trunk and a main branch vessel through a double-balloon structure with independent pressure cavities, so that the device is completely attached to the vessel walls of the main branch pathological change trunk and the main branch vessel, and the branch entering channels are optimized while the trunk-main branch pathological change is well treated. Accordingly, the inventor also establishes a corresponding use method. The device and the using method of the invention are used for treating coronary artery bifurcation lesion, can accurately treat the vessel bifurcation lesion with different calibers and different angles, have better universality, accord with the Provisional stent strategy, and have simple and reasonable structure and quick and convenient operation.

Drawings

Fig. 1 is a structural schematic view of the double-balloon staged expanding stent device of the invention in an unexpanded state.

Fig. 2 is a structural diagram illustrating a first-stage expanded state (main stent balloon expansion) of the double-balloon staged expansion blood vessel stent device in fig. 1.

Fig. 3 is a structural diagram of the double-balloon staged expanding intravascular stent device in fig. 1 in a second-stage expansion state (main stent balloon expansion).

Fig. 4 is a schematic diagram of the operation process and the use state of the invention.

In the figure: 1 guide wire, 2 guide wire cavities, 3 main branch sacculus, 4 main branch support, 5 support bridging net beam, 6 main branch support, 7 main branch sacculus, 8 main branch sacculus pressure chambers, 9 main branch sacculus pressure chambers, 10 pre-expansion sacculus, 11 main needle seats, 12 side needle seats, 13 1 st mark point, 14 nd mark point, 2 rd mark point, 15 rd mark point, 16 th mark point, 4 th mark point, 17 main branch region, 18 transition region, 19 main branch region, 20 main branch blood vessels, 21 blood vessel plaque, 22 branch blood vessels, 23 blood vessel bifurcation spine and 24 main branch blood vessels.

Detailed Description

Basic structure

As shown in fig. 1 to 3, the double-balloon staged stent device of the present invention comprises a stent and a balloon inside the stent and a guide wire chamber 2. Wherein,

the bracket is formed by connecting a main bracket and a main bracket 6 front and back through a plurality of axial sine curve-shaped bracket bridging net beams 5. The main stent and the main stent are both common tubular stents, and the diameter of the main stent is different from that of the main stent by 0.25mm or 0.5 mm. Therefore, the stent is formed by connecting two tubular stents with slightly different diameters at the front and the rear through a stent bridging net beam.

The overall design of the stent can be three sections, namely a near section, a middle section and a far section: the stent distal segment is a main branch vessel area (main branch area 17) and can be used as the support of the main branch vessel; the proximal section of the stent is a main blood vessel region (main region 19) which can be used as a support of the main blood vessel; the middle section of the stent is a transition region (transition region 18) which is a plurality of axial sinusoidal stent bridging net beams, connects the main stent (stent far section) and the main stent (stent near section), has certain ductility and plasticity, and is suitable for bifurcation lesion blood vessels with different main, main and branch calibers and different angulations; the bracket bridging web is typically 3mm in length and can be stretched to 6mm in length. When optimized at the proximal end, the stent can be reshaped to provide radial support to the bifurcated nucleus of the vessel and support of the bifurcation ostium. The mesh of the stent at the position is larger, and a large-caliber 360-degree omnibearing access channel is provided for entering a branch when necessary (namely, when the branch opening is positioned, the stent only needs to be moved forwards and backwards, so that the proximal end mark of the distal section of the stent is aligned with the bifurcation ridge of the blood vessel, the operation is simplified.

The sacculus comprises coaxial main tributary sacculus 3 and trunk sacculus 7 that intussusception just has independent pressure chamber respectively each other, and the trunk sacculus parcel is in the main tributary sacculus outside, and the main tributary sacculus runs through whole support length, and the trunk sacculus runs through main tributary support and support bridging web beam length. The main branch sacculus has main branch sacculus pressure chamber 8, and main branch sacculus pressure chamber stretches out from main branch sacculus afterbody and connects main needle file 11, is the pressure conduction channel who fills main branch sacculus; the main balloon is provided with a main balloon pressure cavity 9 which extends out from the tail part of the main balloon and is connected with a side needle seat 12 and is a pressure conduction channel for filling the main balloon.

The sacculus is designed into a double-independent sacculus intussusception structure: the main branch sacculus and distal segment support match, run through in whole support, and during its full expansion, nearly, middle and distal three-section support evenly atress, the cylindrical inflation, the diameter of support increases along with main branch sacculus increase of pressure in a certain extent, is called first order expansion, and the expansion result is that the support distal segment hugs closely the main tributary vascular wall. The main balloon is matched with the proximal section stent and exists in the proximal section stent and the middle section stent, the far end of the main balloon is pasted on the middle section of the main stent balloon, the straight section of the main balloon is positioned in the proximal section stent, the top of the conical section of the far end of the main balloon reaches the near end of the distal section stent (the far end of the middle section transition area), the bottom of the conical section of the near end of the main balloon reaches the near end of the proximal section stent (the near end of the middle section transition area), the bottom of the conical section of the near end of the main. On the basis of the first-stage expansion, when a main balloon is pressurized and filled, the near-section and middle-section stents (main region and transition region stents) are further expanded under stress, the main stent is cylindrically expanded, the diameter of the near-section of the stent in a certain range is increased along with the increase of the pressure of the main balloon, namely the second-stage expansion, and the expansion result is that the near-section of the stent is tightly attached to the wall of the main vessel; simultaneously, the transition region stent is expanded in a conical shape, and the transition region stent is expanded, deformed and remolded and is tightly attached to the bifurcation core; meanwhile, the branch opening is opened, so that a guide wire, a balloon and a bracket can enter the branch when necessary.

The guide wire cavity penetrates through the main branch balloon and the main branch balloon. One end of the guide wire cavity extends out of the front end of the main support sacculus, the other end of the guide wire cavity extends out of the tail of the main support sacculus, the guide wire can be guided by a coronary artery with the diameter of 0.014 inches, the guide wire enters from the port at the far end of the catheter and penetrates through the whole stent, and the guide wire can be guided out of a side hole of the conveying rod 25cm away from the port to a target blood vessel.

Four lightproof marks are arranged on the bracket and are respectively positioned at the head and tail ends of the main bracket and the main bracket, namely two sides of the near section, the far section and the transition area, and the total number of the lightproof marks is four. The 1

st

13 and 2 nd 14 markers indicate the length of the distal stent, the 3

rd

15 and 4 th 16 markers indicate the length of the proximal stent, and the 2 nd and 3 rd markers indicate the length of the transition region stent. After the stent is unfolded, the far section is positioned in the main branch vessel, the near section is positioned in the main branch vessel, and the transition area is spanned at the branch opening.

According to actual needs, the stent diameter and specification in the double-balloon staged expanding stent device of the present invention can be designed with reference to tables 1-2 and fig. 3.

TABLE 1 support diameter Specification (mm, mm)

Main branch area	2.5	2.75	3.0	3.5	4.0
						Trunk area	2.75/3.0	3.0/3.25	3.25/3.5	3.25/4.0	4.25/4.5

TABLE 2 support Length Specification (mm, mm)

Main branch area	8.0
		Trunk area	8.0
Transition zone	3.0

Method of use (as shown in FIG. 4)

1. Guide wires are placed in the main branch vessel 24 and the branch vessel 22, respectively. (see FIG. 4a)

2. The main branch vessel is pre-dilated using the pre-dilation balloon 10 without intervention by the branch vessel. (see FIG. 4b)

3. And implanting a stent in the main blood vessel. The stent is selected according to the reference diameter 1:1 of the main branch vessel, the second marker point is aligned with the vessel bifurcation ridge 23 when the stent is implanted, and then the main branch balloon is pressurized and inflated to make the main branch stent adhere to the wall. (see FIG. 4c)

4. Then, the main balloon is pressurized and filled, the proximal end of the stent is optimized (POT technology), the main region stent is made to be attached to the wall of the main vessel 20, and the transition region stent bridges the net beam to extend, deform and reshape, so as to support the bifurcation nucleus, the main branch and the branch opening. Therefore, the main trunk-main branch vessel is kept unobstructed, and a guide wire, a balloon and a stent are enabled to pass through meshes in a transition area to enter a branch vessel to intervene branches when necessary. (see FIG. 4d)

5. And withdrawing the saccule and the guide wire to finish the operation. (see FIG. 4e)

The stent implantation and the proximal optimization (POT technology) are completed at one step, the operation is simple, quick and accurate, and the adverse consequences that the stent adheres badly or expands excessively, the stent is damaged or bridges, mesh beams are overlapped and shifts and the like caused by mismatching and inaccurate positioning of the optimized saccule are avoided.

6. Balloon and stent anastomosis technology.

After the step 3, if branch occlusion occurs, further performing saccule support kiss-dilatation (BSK technology). (see fig. 4f) thereafter, step 4-5 is performed, completing the surgery. (see FIG. 4f)

7. Double stent technology.

And 4, relieving the pressure of the main balloon, keeping the main balloon full, enabling the main-branch channel to be smooth, and blocking the main branch, so that the guide wire can conveniently pass through the meshes of the stent in the transition area to enter the branch blood vessel. (see FIG. 4g)

8. Another guide wire passes through the mesh of the stent at the transition region to enter the branch vessel (the reWire technology). (see FIG. 4h)

9. And (3) expanding the meshes of the stent in the transition area at the branch opening by the saccule, and performing saccule stent anastomosis (BSK technology). (see FIG. 4i)

10. The branches are implanted into the stent and are expanded with the main branch balloon (TAP technique). (see FIG. 4j)

11. The branch balloon was withdrawn and proximal optimization was performed again (rePOT technique). (see FIG. 4k)

12. And withdrawing the main branch balloon catheter and the guide wire, and ending the operation. (see FIG. 4 l).

Claims

1. The utility model provides a two sacculus grades of expansion blood vessel support device, includes sacculus and guide wire chamber in support and the support, its characterized in that: the bracket is formed by connecting a main bracket and a main bracket front and back through a plurality of axial sine curve-shaped bracket bridging net beams; the balloon consists of a main balloon and a main balloon which are mutually nested and respectively provided with independent pressure cavities, the main balloon is wrapped outside the main balloon, the main balloon penetrates through the length of the whole stent, and the main balloon penetrates through the length of the main stent and the length of a stent bridging web beam; the guide wire cavity penetrates through the main branch balloon and the main branch balloon.

2. The double-balloon staged expansion vessel stent device according to claim 1, wherein: the main support and the main support are both common tubular supports, and the diameter difference of the main support and the main support is 0.25mm or 0.5 mm.

3. The double-balloon staged expansion vessel stent device according to claim 1, wherein: the support bridging web beam is 3-6, and the support bridging web beam is 3mm length, is axial sinusoidal form, has ductility and can plastic nature.

4. The double-balloon staged expansion vessel stent device according to claim 1, wherein: the main and main balloon are coaxial.

5. The double-balloon staged expansion vessel stent device according to claim 1, wherein: the main branch balloon is provided with a main branch balloon pressure cavity which extends out of the tail part of the main branch balloon and is connected with the main needle seat; the main balloon is provided with a main balloon pressure cavity which extends out of the tail part of the main balloon and is connected with the side needle seat.

6. The double-balloon staged expansion vessel stent device according to claim 1, wherein: one end of the guide wire cavity extends out of the front end of the main support balloon, the other end of the guide wire cavity extends out of the tail of the main support balloon, and the guide wire can be guided by a coronary artery with the diameter of 0.014 inches.

7. The double-balloon staged expansion vessel stent device according to claim 1, wherein: the support is provided with four lightproof marks which are respectively positioned at the head and tail ends of the main support and the main support.

8. The use method of the double-balloon staged dilation intravascular stent device of claim 1, wherein: the stent device is sent to a target position by using a guide wire, and the main balloon is pressurized and expanded to be full so that the main stent adheres to the wall; then, pressurizing and expanding the main balloon to enable the main balloon to be full and enable the main stent to adhere to the wall; and finally, decompressing the main branch balloon and the main trunk balloon, and taking out the main branch balloon and the main trunk balloon through the guide wire.