WO2015165135A1

WO2015165135A1 - Branch controllable type integrated vascular stent and implantation apparatus thereof

Info

Publication number: WO2015165135A1
Application number: PCT/CN2014/078306
Authority: WO
Inventors: 蒙炜; 李涛; 卢强; 肖正华
Original assignee: 四川大学华西医院
Priority date: 2014-04-30
Filing date: 2014-05-23
Publication date: 2015-11-05
Also published as: CN103948454A; CN103948454B

Abstract

A branch controllable type integrated vascular stent and an implantation apparatus thereof. The branch controllable type integrated vascular stent comprises a main stent (1), a branch stent (2), and the implantation apparatus. The branch stent (2) is seamlessly connected to the outer side wall of the main stent (1) and is in communication with the inner part of the main stent (1). Both the main stent (1) and the branch stent (2) have two states: a compressed state and an unfolded state. The sizes of the main stent (1) and the branch stent (2) in the compressed state are smaller than those of the main stent (1) and the branch stent (2) in the unfolded state. Under the constriction of the implantation apparatus, the main stent (1) and the branch stent (2) are in the compressed state; when separated from the implantation apparatus, the main stent (1) and the branch stent (2) are in the unfolded state. According to the vascular stent and the implantation apparatus thereof, the main stent (1) for supporting a main blood vessel and the branch stent (2) for supporting a branch blood vessel are integrally formed and are implanted into the blood vessels at a time by means of the implantation apparatus, so that the operation time for vascular stent implantation is shortened, the pain of a patient is relieved, and the time and the dosage that a doctor and the patient are exposed to rays are reduced.

Description

Branch controllable integral vascular stent and implant device thereof

The present invention relates to a medical device, and more particularly to a blood vessel stent and an implant device therefor.

Background technique

In the vascular stent implantation operation, there is a case where the main blood vessel and its branch blood vessels need to be implanted, and the existing method is to first implant the main stent supporting the main blood vessel into the main blood vessel by using the implant device, and then support the branch. The sub-bracket of the blood vessel is fed into the branch vessel through the implanted main stent, and an outlet suitable for the sub-stent to pass through is reserved on the wall of the main stent, and the above-mentioned outlet needs to be aligned with the branch vessel when the main stent is implanted. There are many links and long time, and there is a risk of endoleaking at the joint of the two brackets. Although there are reports of stents with branches, these stents rely on invasive methods to directly implant the vessels under direct vision. There is a lack of one-way implantation of the main vessels and branches through minimally invasive intervention. The branch of the blood vessel is a controllable integral vascular stent and a corresponding implant device.

Summary of the invention

The present invention aims to provide a branch-controllable integral blood vessel stent and an implant device thereof, which will be used for supporting a main stent and a sub-bracket for supporting a branch vessel, and adopting a minimally invasive intervention method and implantation. The device is implanted into the blood vessel at one time, thereby shortening the operation time of implanting the blood vessel stent, reducing the pain of the patient, and shortening the time for the clinician and the patient to be exposed to the radiation during surgery.

In order to achieve the above object, the present invention is achieved by the following technical solutions:

The branch controllable integral blood vessel stent and the implant device thereof include a main stent, a sub-bracket and an implant device, wherein the sub-bracket is connected to an outer sidewall of the main stent and communicates with the interior of the main stent; The main bracket and the sub-bracket are both in a compressed state and an unfolded state. When the main bracket and the sub-bracket are in a compressed state, the size is smaller than that in the unfolded state, and the main bracket and the sub-bracket are in a compressed state under the restraint of the implant device. It is in an unfolded state when it is released from the implant device. The main stent and the sub-bracket are fed into the blood vessel through the implant device, and after reaching the predetermined position, the bifurcated stent and the main stent are restrained when the implant device is taken out, and the branch stent and the main stent support the branch vessel and the main body in the unfolded state. Blood vessels.

Preferably, the implant device comprises an inner sheath tube, an outer sheath tube and a guide wire, the outer diameter of the inner sheath tube is smaller than the inner diameter of the outer sheath tube, and the inner sheath tube wall is provided with a through hole, and the outer sheath tube The front end pipe wall is notched, and the pipe wall on the side of the notch is provided with a pressure plate passage, and the pressure plate passage communicates with the notch and penetrates the outer sheath pipe wall along the axial direction, and the pressure plate is provided with a pressure plate, and the pressure plate penetrates the pressure plate The front end of the pressure plate is divided into two pressure arms, and the pressure arm partially covers the notch, and the gap width between the two pressure arms can satisfy the passage of the guide wire.

Further, the inner sheath tube is supported inside the main bracket, and the outer sheath tube wraps the main bracket and the sub-bracket in a compressed state, and the side wall of the sub-bracket is stuck in the notch, and the top of the sub-bracket is in contact with the lower surface of the pressing arm. .

Further, the number of the main brackets is one, the number of the sub-brackets is 1 to 8, the number of the inner sheath tubes is one, the number of the outer sheath tubes is one, and the number of the guide wires is the number of the sub-brackets + One.

Further, the inner sheath tube is provided with a partition plate in the axial direction. According to the number of the branch bracket and the guide wire, the partition plate divides the inner sheath tube into a plurality of channels, and the number of channels is consistent with the number of guide wires, wherein one channel runs through The main bracket, the remaining channels are connected to the sub-brackets.

Preferably, the connection between the sub-bracket and the main bracket is a hard connection or a soft connection. When the sub-bracket is hard-wired to the main bracket, the sub-bracket and the main bracket can be integrally manufactured. The soft connection is through the coating layer on the surface of the main bracket, and the sub-bracket is connected to the main bracket, which can reduce the positioning accuracy requirement of the sub-bracket, and is convenient for operation and control during operation. Preferably, the angle between the sub-stent and the main stent and the angle between the branch vessel and the main blood vessel are matched.

Preferably, the main bracket and the sub-bracket are made of various types of memory alloys such as nickel-titanium memory alloy, medical stainless steel, cobalt-chromium alloy, metal such as platinum, gold, rhodium, degradable biomaterial or multi-layer composite. Materials, etc.

Further, depending on the materials used, the main stent and the sub-bracket may be a bare stent, a surface-coated stent, a degradable biomaterial stent or a drug-coated stent.

Preferably, the sub-bracket length is 0. 5-8cm (unfolded state), 0-2cm (compressed state), diameter is 0. l-4cm (unfolded state), 0. l-3cm (compressed state); main stent length 5- 90cm (expanded state), 5-90cm (compressed state), diameter 0. l_5cm (expanded state), 0. l_3cm (compressed state).

Preferably, the distance between the sub-brackets is 0. 5-30 cm (compressed state).

The branch controllable integral blood vessel stent and the implant device thereof are suitable for intravascular interventional treatment, and the main stent for supporting the main blood vessel and the sub-bracket for supporting the branch blood vessel are integrally constructed, and the minimally invasive intervention mode is adopted. Implantation of the blood vessel with the implant device not only avoids the risk of endoleaking in the existing split stent, but also facilitates the vascular stent implantation procedure, shortens the operation time, and alleviates the patient's pain.

DRAWINGS

Figure 1 is a schematic view showing the unfolded state of the main bracket of the present invention;

2 is a schematic view showing a compressed state of a main bracket of the present invention;

Figure 3 is an axial sectional view of the present invention;

Figure 4 is a radial sectional view of the present invention;

Figure 5 is a rear view of the present invention;

Figure 6 is a plan view of the present invention; In the figure: 1-main bracket, 2-bracket, 3-sheath tube, 4-sheath tube, 5-notch, 6-platen, 7-baffle channel, 8-baffle, 9-branched guide wire, 10-dominant wire, 11-through hole, 61-pressure arm.

detailed description

In order to make the objects, technical solutions, and advantages of the present invention more comprehensible, the present invention will be further described in detail with reference to the accompanying drawings.

As shown in FIG. 1 and FIG. 2, the branch-controllable integral blood vessel stent disclosed in the present invention comprises a main bracket 1 and a sub-bracket 2, and the main bracket 1 and the sub-bracket 2 are both tubular, and the sub-bracket 2 is seamlessly connected to the main bracket. The outer side wall of 1 is connected with the inside of the main bracket; the main bracket 1 and the sub-bracket 2 have two forms of compression state and release state, and the size of the main bracket 1 and the sub-bracket 2 in the compressed state are smaller than those in the release state. . Main stent 1. The sub-bracket 2 is in a compressed state under the restraint of the implant device, and is in a released state after being detached from the implant device.

As shown in Figures 3, 4, 5, and 6, the present invention further includes an implant device including an inner sheath tube 3, an outer sheath tube 4, and a guide wire, the guide wire including the main guide wire 10 and the branch guide wire. 9, the outer diameter of the inner sheath tube 3 is smaller than the inner diameter of the outer sheath tube 4, the inner sheath tube 3 has a through hole 11 in the tube wall, the front end tube wall of the outer sheath tube is provided with a notch 5, and the tube wall on the side of the notch 5 is provided with a pressure plate passage 7. The pressure plate passage 7 communicates with the notch 5 and penetrates the wall of the outer sheath tube 4 in the axial direction. The pressure plate 6 is disposed in the pressure plate passage 7, and the pressure plate 6 passes through the pressure plate passage 7, and the front end of the pressure plate 6 branches to form two pressure arms 61. The pressing arm 61 partially covers the notch 5. The inner sheath tube 3 is provided with a partition plate 8 in the axial direction, and the partition plate 8 divides the inner sheath tube 3 into two passages, one of which is in communication with the through hole 11.

Before the implantation operation, the outer sheath tube 4 wraps the main stent 1 in a compressed state, and the opposite side walls of the sub-bracket 2 in the compressed state are stuck in the notch 5, and the pressing arm 61 presses against the top of the sub-bracket 2, and the sub-bracket The nozzle of 2 is located directly above the through hole 11, that is, the main bracket 1 is bound by the outer sheath tube 4, and the sub-bracket 2 is bound by the notch 5 and the pressure plate 6, and both are in a compressed state. In actual operation, the main guidewire 10 is first implanted in the main blood vessel, and the implant device and the stent are guided to the main blood vessel as a whole, and the branch guide wire 9 is used to guide the sub-bracket 2 to the required position, and the branch guide wire 9 and the main guide wire 10 are respectively Through the respective passages on both sides of the partition plate 8, the mutual interference between the branch guide wire 9 and the main guide wire 10 is avoided. When the sub-bracket 2 reaches the branch vessel mouth position, the inner sheath tube 3 is fixed, and the branch guide wire 9 is sequentially passed through the through hole. 11. After the gap between the bracket 2 and the two pressing arms 61, the branch vessel is sent to the branch vessel, and then the pressure plate 6 is withdrawn, so that the stent 2 is deployed in the axial direction, and the stent 2 is divided into the branch vessel. After the stent 2 is adjusted into position, the sheath tube is sequentially withdrawn. 4. The branch guide wire 9, the inner sheath tube 3 and the main guide wire 10 are such that the sub-bracket 2 and the main stent 1 are completely separated from the binding of the implant device, returning to the expanded state, and supporting the blood vessel.

There are a variety of other embodiments of the present invention, and various changes and modifications can be made in accordance with the present invention without departing from the spirit and scope of the invention. And modifications are intended to fall within the scope of the appended claims.

Claims

claims

1. A branch-controllable integral vascular stent and its implantation device, which is characterized in that it includes a main stent, a sub-stent and an implantation device. The sub-stent is connected to the outer wall of the main stent and communicates with the interior of the main stent. ; The main stent and sub-stent have two forms: compressed state and expanded state. The size of the main stent and sub-stent in the compressed state is smaller than the size in the expanded state. The main stent and sub-stent are in a compressed state under the constraints of the implantation device. , in the deployed state when detached from the implanted device.

2. The branch-controllable integral vascular stent and its implantation device according to claim 1, characterized in that: the implantation device includes an inner sheath, an outer sheath and a guide wire, and the outer sheath of the inner sheath is The diameter is smaller than the inner diameter of the outer sheath tube, the wall of the inner sheath tube is provided with a through hole, the wall of the front end of the outer sheath tube is provided with a notch, and the wall on the side of the notch is provided with a pressure plate channel, and the pressure plate channel is connected with the notch. And it penetrates the wall of the outer sheath along the axial direction. A pressure plate is provided in the pressure plate channel. The pressure plate penetrates the pressure plate channel. The front end of the pressure plate bifurcates to form two pressure arms. The pressure arms partially cover the gap.

3. The branch-controllable integral vascular stent and its implantation device according to claim 2, characterized in that: the inner sheath is supported inside the main stent, and the outer sheath wraps the main stent in a compressed state and Sub-bracket, the side wall of the sub-bracket is stuck in the gap, and the top of the sub-bracket is in contact with the lower surface of the pressure arm.

4. The branch controllable integral vascular stent and its implantation device according to claim 1, characterized in that: the number of the main stent is 1, the number of sub-stents is 1 to 8, and the number of the inner sheath tube is 1 The number is 1, the number of outer sheaths is 1, and the number of guide wires is the number of sub-stents + 1.

5. The branch-controllable integral vascular stent and its implantation device according to claim 4, characterized in that: the inner sheath is provided with partitions along the axial direction, and the partitions are arranged according to the number of branch stents and guide wires. The plate divides the inner sheath into several channels. The number of channels is consistent with the number of guide wires. One of the channels runs through the main stent, and the remaining channels are connected to the sub-stent.

6. The branch-controllable integral vascular stent and its implantation device according to claim 1, wherein The characteristics are: The connection between the sub-bracket and the main bracket is a hard connection or a soft connection.

7. The branch-controllable integral vascular stent and its implantation device according to claim 1, characterized in that: the angle between the branch stent and the main stent is equal to the angle between the branch blood vessels and the main blood vessel. adaptation.

8. The branch controllable integral vascular stent and its implantation device according to claim 1, characterized in that: the main stent and sub-stent are made of memory alloy, medical stainless steel, alloy, platinum, gold, tantalum, Degradable biomaterials or multilayer composites.

9. The branch-controllable integral vascular stent and its implantation device according to claim 1, characterized in that: the main stent and sub-stent are bare stents, surface-coated stents, degradable biomaterial stents or drug-coated stents. layer bracket.