CN113796994B

CN113796994B - Aortic valve composite implant valve system and method of use

Info

Publication number: CN113796994B
Application number: CN202111211226.2A
Authority: CN
Inventors: 范卫东
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-10-18
Filing date: 2021-10-18
Publication date: 2024-11-22
Anticipated expiration: 2041-10-18
Also published as: CN113796994A

Abstract

The present invention relates to the field of medical devices, and specifically to an aortic valve composite implant valve system and a method of use, comprising a valve stent; the valve stent is divided into an upper section and a lower section, and a fixing section with a groove is arranged between the upper section and the lower section; a fixing nail is arranged at the connection between each two aortic valves, and the fixing nail cooperates with the fixing section so that the valve stent can be firmly fixed at the original aortic valve to form a new biological valve; the present invention adopts memory material or hardener as the material of the fixing nail, which is easy to set and more firm. Compared with the existing artificial aortic valve stent, the valve fixing method involved in the present invention is less likely to fall off, and solves the problem that it is difficult to fix the biological valve in patients with valvular insufficiency.

Description

Aortic valve composite implantation valve system and method of use

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to an aortic valve composite implantation valve system and method.

Background

The aortic valve is positioned between the left ventricle and the ascending aorta, plays a role of a one-way valve, and prevents blood from flowing back and returning to the left ventricle from the aorta; if the aortic valve is diseased, this may result in a loss of function, such as: the heart is not fully open (stenosed) when contracting, making left ventricular ejection difficult; or the aortic valve is not fully closed (insufficiency) during diastole, so that the blood of the ascending aorta flows back to the left ventricle; aortic valve stenosis or insufficiency can affect heart function, so that heart function is reduced, and further, whole blood supply is insufficient, various adverse reactions are caused to patients, and new failure, syncope, cardiogenic shock, sudden death and the like can be seriously caused.

For a long time, an Aortic valve replacement surgery (surgic aotic VALVE REPLACEMENT, abbreviated as SAVR) for opening chest has been a main treatment means for Aortic valve diseases, but due to the fact that Surgical wounds are large, in vitro circulation is required, surgery risks are high, and the like, nearly half patients can not receive SAVR treatment due to the reasons of advanced age, poor cardiac function, severe complications, fear of Surgical operation, and the like; the incidence of aortic valve lesions is greatly affected by age factors, and the incidence of advanced patients is higher, and many advanced patients who cannot receive SAVR treatment can only receive conservative treatment, so that the disease is further worsened and finally is removed due to the disease.

A catheter aortic valve replacement (TRANSCATHETER AORTIC VALVE REPLACEMENT, abbreviated as TAVR) is a minimally invasive valve replacement operation, mainly uses a catheter intervention technology to convey a biological valve to an aortic valve position, and fixes the biological valve to replace an aortic valve which is lost or partially lost so as to achieve the purpose of recovering the valve function; compared with SAVR, TAVR does not need to perform surgical thoracotomy with a large wound, and only needs to perform minimally invasive puncture on peripheral arteries such as femoral artery, and the biological valve is sent to the aortic valve through a catheter to replace the original aortic valve; the TAVR has small wound, avoids extracorporeal circulation, is fast to recover after operation, is suitable for old patients, and can greatly improve the treatment condition of aortic valve lesions of the old patients.

The existing biological valve is usually fixed by using a bracket, the bracket is unfolded at the aortic sinus and fixed on the aortic valve ring, and the biological valve is fixedly arranged in the bracket, so that the biological valve is fixed at the original valve position; however, the existing valve stent is generally cylindrical with an expanded upper end, has good fixing ability for patients with valve stenosis, but has serious defects for patients with valve insufficiency; insufficient fixing capability of the valve stent can lead to stent falling off, the biological valve is invalid, and the fallen biological valve and stent can also block arterial vessels under severe conditions, thereby causing serious life threat to patients.

Disclosure of Invention

The invention aims to provide an aortic valve composite implantation valve system and a using method thereof, which are used for solving the problem that a valve support is not firmly fixed when a patient with aortic valve insufficiency uses TAVR for treatment.

Based on the above purpose, the invention adopts the following technical scheme:

the aortic valve composite implantation valve system comprises a valve bracket, wherein the valve bracket is sequentially divided into an upper section bracket, a fixed section and a lower section bracket from top to bottom, the diameter of the upper section bracket is larger than that of the lower section bracket, and the diameter of the lower section bracket is larger than that of the fixed section; the valve bracket is internally and fixedly provided with a biological valve.

Preferably, the valve stent is arranged at an aortic valve, and the aortic valve is provided with fixing nails; the fixing nails are matched with the fixing sections of the valve bracket.

Preferably, the staples are made of a memory material.

Preferably, the staple is made of a hardener.

Preferably, the fixing nails are respectively arranged at the root parts of the junctions of every two aortic valves; in addition, the fixing nails can be arranged at the root of each leaflet, and the position of the fixing nails can be adjusted according to actual conditions.

Preferably, the method is characterized by comprising the following steps:

S1, inserting a guide wire: extending the guide wire into a target position to enable the end of the guide wire to exceed the target position;

S2, inserting a catheter: pushing the catheter to a target position along the guide wire, so that the outlet of the head end of the catheter stays above the target position;

s3, setting nail points: fixedly arranging the fixing nails on the valve at the target position along the guide tube inserted in the step S2;

S4, feeding the stent: pushing the catheter downward to enable the outlet of the head end of the catheter to exceed the target position; pushing the valve stent in the folded state to a target position along the interior of the catheter, so that the fixed section of the valve stent is aligned with the position of the fixed nails;

s5, mounting brackets: the position of the valve stent is kept unchanged, the valve stent is released by the recovery catheter, and the valve stent can self-expand after being separated from the catheter, so that the diameter of the valve stent is increased; the valve stent is completely unfolded and then is attached to the vessel wall, and the fixed section on the valve stent is matched with the fixed nails, so that the valve stent is arranged at the target position; in addition to self-expanding, the valve stent may also be released by means of balloon dilation.

Preferably, the total of 3 staples in step S3 are made of a memory material; the fixing nails are in a flexible stretching state when being positioned in the guide pipe, the part which leaves firstly penetrates through the valve under the control of the blocking rope to form nail points, and the part which remains in the blood vessel is contracted into a spherical nail head; three fixing nails are respectively arranged at the root part of the juncture of every two aortic valves.

Preferably, the total of 3 staples in S3, all made of hardener; the hardening agent is filled on the valve at the target position through the hardening agent catheter, and the joint of every two adjacent aortic valves is filled with the hardening agent; the hardener is removed from the hardener conduit and hardens to form a staple.

Preferably, in the step S4, the upper section support of the valve support is arranged above the fixing nails, the fixing sections are matched with the fixing nails, and the lower section support is arranged below the fixing nails.

The invention has the beneficial effects that:

The biological valve is fixed by adopting the valve bracket, so that the fixing mode of the valve bracket is improved; the middle part of the bracket is provided with a fixing section with a groove, and a fixing nail mode is arranged on the valve annulus in advance, and the fixing nail is matched with the fixing section to fix the valve bracket, so that the biological valve is fixed; compared with the prior art that the valve stent is fixed by means of matching of the valve stent and the vessel wall and the native valve, the fixing effect of the valve stent designed by the invention is more firm, the risk of falling off of the biological valve is greatly reduced, and the life safety of a patient is ensured.

The invention adopts the memory material to manufacture the fixing nail, and has simple arrangement and good fixing effect; specifically, the memory material nail becomes soft and easy to deform at low temperature, and the contact body temperature is heated to remorse the original shape of the memory material nail; the invention adopts the filiform memory material nail, is soft filiform at low temperature, and can be sent to the affected part along the catheter; the memory material wire is quickly restored to the original shape after being separated from the catheter and heated by the body temperature of the patient, so that a spherical fixing nail is formed; the nail tip part which extends out firstly can be accurately punctured and attached to a proper position on the valve annulus by controlling the blocking rope, so that the fixing effect is realized; the memory material nails which are restored to be contracted into the spherical fixing nails can be matched with the fixing sections on the valve stent to fix the valve stent at the position of the primary valve, so that the primary valve can be replaced by the biological valve to perform the work to maintain the vital activity of a patient.

The invention can also adopt hardener to replace the fixing nails made of memory materials, so as to cope with the condition that partial valves do not have the fixing nails made of memory materials; when the hardening agent fixing nail is used, the hardening agent guide pipe extends into the affected part along the guide pipe, and hardening filling is smeared on the valve ring of a patient through the spray head; the hardener adheres to the patient's annulus and rapidly hardens, forming a spherical staple; the hardening agent fixing nails can also be matched with the fixing sections on the valve bracket to fix the valve bracket at the position of the primary valve, so that the primary valve is replaced by the biological valve to continue working; the use of the hardener staple can reduce damage to the native valve, and is suitable for patients for whom the native valve is not suitable for using the memory material staple.

The invention sets the position of the fixing nail at the joint between every two valves, and sets the fixing nail on the valve ring at the joint; because the aortic valve is divided into three pieces and trisected, every two fixing nails are arranged at 120 degrees, the three fixing nails are evenly arranged on the plane of the valve annulus, the stress is equal, and the total service life of the biological valve is prolonged to the maximum; meanwhile, the stress direction of each nail point of the uniformly distributed fixing nails is equal, so that the valve support is prevented from receiving redundant shear stress, and the risk of falling off the valve support is reduced.

Drawings

FIG. 1 is a schematic illustration of the valve stent structure of the present invention;

FIG. 2 is a schematic view of embodiment 1 of the present invention with staples;

FIG. 3 is a schematic view of embodiment 1 of the present invention after the staple is installed;

FIG. 4 is a schematic view of the valve stent according to embodiment 1 of the present invention;

FIG. 5 is a schematic view of the staple of the present invention in a deployed position;

FIG. 6 is a schematic view of embodiment 2 of the present invention with staples;

FIG. 7 is a schematic view of embodiment 2 of the present invention after the staples are installed;

fig. 8 is a schematic view of embodiment 2 of the present invention after the valve stent is disposed.

In the figure: a valve holder 1; an upper stage bracket 11; a fixed section 12; a lower section bracket 13; a vessel wall 2; a guide wire 3; a conduit 4; a memory material nail 5; a memory material fixing nail 51; a fixed point 52; a rail 53; an aortic valve 6; a left coronary artery 7; a right coronary artery 8; a hardener conduit 9; hardener staples 91.

Detailed Description

Example 1

In the following, the present invention will be explained in detail with reference to the specific drawings, as shown in fig. 1, the valve stent 1 used in this embodiment is designed to be substantially the same as the currently common stent, and is divided into upper and lower ends, and the diameter of the lower stent 13 is smaller than that of the upper stent 11, but the difference from the existing stent is that the valve stent 1 designed in this embodiment is provided with a connecting fixing section 12 between the upper stent 11 and the lower stent 13.

As shown in fig. 1, the diameter of the fixing section 12 is smaller than the diameter of the lower section stent 13, and is the thinnest of the three parts of the valve stent 1, specifically, the radius of the fixing section 12 is 1 to 2mm smaller than the radius of the lower section stent 13; since the diameter of the fixing section 12 is smaller than the diameter of the upper and lower parts, the valve holder 1 forms a ring-shaped fixing groove at the fixing section 12.

As shown in fig. 4, the fixation section 12 is provided to mate with a memory material fixation peg 51 provided on the wall 2 of the aorta Dou Xieguan; the memory material fixing nails 51 are made of memory materials and are fixedly arranged on the aortic valve at the aortic sinus, the fixing sections 12 of the valve stent 1 are matched with the memory material fixing nails 51, and the memory material fixing nails 51 are inserted into the fixing sections 12 to fix the valve stent 1.

As shown in fig. 2, the memory material anchor 51 is to be delivered to the aortic sinus through the catheter 4, the catheter 4 is to be set by guiding the guide wire 3, and the guide wire 3 is to be fed into the aorta by puncturing at the femoral artery and to extend below the aortic sinus; after the setting of the guide wire 3 and the guide tube 4 is completed, the memory material nail 5 is sent into the patient through the guide tube 4, so that the memory material nail 5 extends out of the guide tube 4; simultaneously, the blocking rope 53 is also fed into the catheter 4, and the memory material nails 5 are guided to point to the correct positions through the blocking rope 53.

As shown in fig. 5, the aortic valve 6 consists of three valves, each occupying one third of the aortic vessel; the fixed points 52 are arranged at the juncture of every two valves, and the three fixed points 52 are arranged at an included angle of 120 degrees with each other; as shown in fig. 2, the memory material nail 5 is made of a memory material, specifically a memory material which is softened at low temperature and recovers shape when meeting body temperature; before extending into the catheter 4, the memory material nails 5 are softened by low-temperature treatment, enter the human body through the catheter 4, and are in a straightened state in the catheter 4; after leaving the catheter 4 and entering the blood vessel, the temperature starts to rise under the influence of the body temperature; the memory material nail 5 resumes its shape while heating up, starts to curl, the flexible memory material nail 5 forms a ball-shaped memory material fixing nail 51 by curling so that one end of the fixing nail will puncture the valve to fix the memory material fixing nail 51 on the native valve of the patient, as shown in fig. 3; in the process, the blocking rope 53 is used for limiting and guiding the pointed part of the memory material nail 5 in the crimping process, so that the memory material nail 5 can be correctly inserted into the valve at the fixed point 52, and the setting of the fixing nail is completed; after the three staple settings are completed, the stopper 53 is again retrieved through the path of the catheter 4.

After the memory material fixing nails 51 are arranged, the valve is sent into the aortic sinus together with the valve stent 1 through the catheter 4; the inside of the valve bracket 1 is provided with a biological valve, the valve bracket 1 is in a folded state in the catheter 4, and the diameter of the valve bracket is matched with the catheter 4; the valve stent 1 is arranged in the catheter 4 in the backward direction of the front and the rear of the upper section stent 11 according to the lower section stent 13, and when the valve stent 1 reaches the aortic sinus, the catheter 4 starts to be recovered, the lower section stent 13 extends out of the catheter 4; the lower support 13 is positioned below the valve, i.e. below the height of the memory material staples 51.

After the valve stent 1 is sent to the appointed position, the position of the valve stent 1 is kept unchanged, and the catheter 4 is recovered, so that the valve stent 1 is gradually exposed out of the catheter 4 from the lower section stent 13; the valve stent 1 exposed from the catheter 4 is self-expanded so that the valve stent 1 increases in diameter until it comes into close contact with the vessel wall 2; the position of the fixing section 12 of the valve bracket 1 is matched with the position of the memory material fixing nail 51, so that the memory material fixing nail 51 can be embedded into the groove of the fixing section to fix the valve bracket 1; as shown in fig. 4, after the valve stent 1 is completely detached from the catheter 4, the valve stent 1 is completely unfolded and the biological valve in the valve stent 1 is firmly fixed at the aortic valve of the patient under the cooperation of the valve stent 1 and the memory material fixing nails 51 to replace the native valve work of the patient.

Example 2

The technical solutions used in this embodiment are not substantially different from those of the above embodiments, and the main differences are that: this embodiment is an alternative to when the patient's native valve is not provided with a memory material staple 51, and a hardener is used instead of the memory material as the material of the staple.

After the setting of the guide wire 3 and the catheter 4 is completed according to the method of the above embodiment, as shown in fig. 6, the hardener catheter 9 is extended into the aortic sinus of the patient along the catheter 4; the hardener conduit 9 can send the hardener out of the spray head and fill the hardener at a suitable fixing point 52 as in fig. 5; the hardener will adsorb to the valve and harden quickly after contact with body temperature, forming a firm hardener staple 91, as shown in fig. 7.

After the hardener fixation nails 91 are arranged, the valve is sent into the aortic sinus together with the valve stent 1 through the catheter 4; the inside of the valve bracket 1 is provided with a biological valve, the valve bracket 1 is in a folded state in the catheter 4, and the diameter of the valve bracket is matched with the catheter 4; the valve stent 1 is arranged in the catheter 4 in the backward direction of the front and the rear of the upper section stent 11 according to the lower section stent 13, and when the valve stent 1 reaches the aortic sinus, the catheter 4 starts to be recovered, the lower section stent 13 extends out of the catheter 4; the lower section stent 13 is positioned below the valve, i.e. below the height of the hardener staples 91.

After the valve stent 1 is sent to the appointed position, the position of the valve stent 1 is kept unchanged, and the catheter 4 is recovered, so that the valve stent 1 is gradually exposed out of the catheter 4 from the lower section stent 13; the valve stent 1 exposed from the catheter 4 is self-expanded so that the valve stent 1 increases in diameter until it comes into close contact with the vessel wall 2; the position of the fixing section 12 of the valve bracket 1 is matched with the position of the hardening agent fixing nail 91, so that the hardening agent fixing nail 91 can be embedded into the fixing section 12 to fix the valve bracket 1; as shown in fig. 4, after the valve stent 1 is completely detached from the catheter 4, the valve stent 1 is fully relaxed and deployed, and the biological valve within the valve stent 1 is firmly secured at the aortic valve of the patient under the cooperation of the valve stent 1 and the hardener staples 91.

The foregoing detailed description of the present invention is provided for illustration only and not for the purpose of limiting the invention as defined by the appended claims, and any changes or substitutions that may be readily contemplated by those skilled in the art within the scope of the present invention are intended to be embraced by the claims.

Claims

1. An aortic valve composite implantable valve system, comprising a valve stent, characterized in that: the valve stent is divided into an upper stent, a fixed section and a lower stent from top to bottom, the diameter of the upper stent is larger than the diameter of the lower stent, and the diameter of the lower stent is larger than the diameter of the fixed section; a biological valve is fixedly arranged in the valve stent; the valve stent is arranged at the aortic valve, and a fixing nail is arranged on the aortic valve; the fixing nail cooperates with the fixed section of the valve stent; the fixing nail is punctured and fixed on the aortic valve, and the fixing nail is respectively arranged at the root of the junction of each two aortic valves; the fixing nail is made of memory material or hardener.

2. The aortic valve composite implant valve system according to claim 1 is characterized in that: there are three fixing pins in total; the fixing pins are in a flexible stretched state when in the catheter, and the first part that leaves penetrates the valve under the control of the cable to form a pin tip, and the part that remains in the blood vessel curls up into a spherical pin head; the three fixing pins are respectively arranged at the root of the junction of each two aortic valves.

3. The aortic valve composite implant valve system according to claim 1 is characterized in that: there are three fixing pins in total; the hardener is filled on the valve at the target position through a hardener catheter, and the connection between every two adjacent aortic valves is filled with the hardener; the hardener hardens to form a fixing pin after leaving the hardener catheter.

4. The aortic valve composite implant valve system according to claim 2 is characterized in that the upper section of the valve stent is arranged above the fixing pin, the fixing section is arranged in cooperation with the fixing pin, and the lower section of the valve stent is arranged below the fixing pin.