WO2012099418A2

WO2012099418A2 - Ventricular partitioning device

Info

Publication number: WO2012099418A2
Application number: PCT/KR2012/000500
Authority: WO
Inventors: 심은보
Original assignee: 강원대학교산학협력단
Priority date: 2011-01-20
Filing date: 2012-01-19
Publication date: 2012-07-26
Also published as: KR101270233B1; WO2012099418A3; KR20120084458A

Abstract

The present invention relates to the treatment of a congestive heart failure patient, and more particularly, to a device for partitioning the ventricles of a patient. According to the present invention, provided is a ventricular partitioning device comprising a bag which can be inflated from a folded state, enabling a cannula to pass therethrough, to an inflated state, enabling the ventricles of a patient to be partitioned to an operating portion and a non-operating portion; an inflating wire coupled to the inner surface of the bag so a sto transform the bag from the folded state to the inflated state; and support means fixed at the center of the bag, extending to a ventricular wall, and installed at the ventricular wall. The ventricular partitioning device according to the present invention may partition ventricles into an operating portion and a non-operating portion to reduce the volume of the ventricles and stresses being applied to the ventricles. Thus, the ventricular partitioning device according to the present invention may increase the ejection fraction of the heart of a congestive heart failure patient.

Description

Ventricular compartment device

The present invention relates to the treatment of patients with congestive heart failure, and more particularly to a device for partitioning the ventricles of a heart failure patient.

Heart failure is a group of diseases caused by the heart's structural or functional abnormalities that result in a decrease in the heart's ability to receive blood (relaxation) or squeezing pumps (contraction), resulting in poor blood supply to body tissues. .

Heart failure is characterized by gradual dilation of the heart, especially the left ventricle. As the heart expands, the heart becomes more difficult to pump blood efficiently through the heart beat.

In the early stages of heart failure, medication can slow the progression of the disease, but the disease cannot be cured. Surgical treatment is a limited use in severe heart failure that usually does not respond well to medical treatments such as medication. Coronary artery bypass surgery in heart failure associated with coronary artery disease, surgery to cut the enlarged heart and reduce volume In some cases, a patient with severe dysfunctional heart failure who waits for a period of time, such as viral acute myocarditis, may have resuscitation when a mitral valve leaks severely due to heart failure. It is also possible to buy time by attaching expensive Ventricular Assistance Device (VAD) that bypasses the deficient heart.

The only permanent treatment for heart failure is heart transplantation. Even with the best medical treatment, the annual mortality rate of severe heart failure patients is 30-50% or more. Considering that the transplant surgery is the best treatment for the treatment of end-stage heart failure patients. However, there are limitations to the widespread implementation of such problems as the number of providers is much smaller than necessary.

The present invention is to solve the above-described problems, the ventricular compartment is divided into a movable part and a non-moving part ventricular compartment device that can increase the ejection fraction of the heart by reducing the volume of the ventricles and stress on the ventricles It aims to provide.

According to the present invention, the cannula includes a pocket that can be expanded in an expanded state to partition the ventricles into movable and non-movable portions in a folded state that can be moved through; An expansion wire coupled to an inner surface of the bag and deforming the bag in a folded state in a folded state; It is fixed to the center of the bag, extends to the ventricular wall, there is provided a ventricular compartment device comprising; a support means for seating on the ventricular wall.

The outer peripheral surface of the bag in contact with the ventricular wall is preferably provided with a sharp tip element to be inserted and fixed in the ventricular wall.

Preferably, the bag is a biocompatible polymer selected from polytetrafluoroethylene (ePTFE), expanded polytetrafluoroethylene (NPT), nylon (Nylon), polyethylene terephthalate (PET), and polyester.

The expansion wire is made of a shape memory alloy or a shape memory polymer, or made of an elastic material and preferably provides elasticity in the direction in which the bag is unfolded.

Preferably, the expansion wire further includes a marker capable of identifying the position by ultrasound, X-ray, or the like, so that the position of the ventricular compartment device may be easily located in the process of arranging the ventricular compartment device.

It is preferable that the said support means are three cylindrical forms which open at a fixed angle.

The ventricular compartment device according to the present invention can partition the ventricles into movable parts and non-movable parts to reduce the volume of the ventricles and the stress applied to the ventricles. Therefore, the cardiac ejection rate of heart failure patients can be increased.

1 is a perspective view of a ventricular compartment device according to an embodiment of the present invention.

Figure 2 is a perspective view showing a state in which the ventricular compartment device shown in Figure 1 is folded.

Figure 3 is a schematic diagram showing a state in which the ventricular compartment device shown in Figure 1 is seated in the ventricles.

Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. However, embodiments of the present invention may be modified in many different forms, and the scope of the present invention should not be construed as being limited to the embodiments described below. The embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art. Therefore, the shape and the like of the elements in the drawings are exaggerated in order to emphasize more clear description, the elements denoted by the same reference numerals in the drawings means the same elements.

1 is a perspective view of a ventricular compartment device according to an embodiment of the present invention, FIG. 2 is a perspective view showing a folded ventricular compartment device shown in FIG. 1, and FIG. 3 is a ventricular compartment device shown in FIG. 1. Schematic diagram showing the state of rest in the ventricles. The ventricular compartment device is delivered to the ventricle through the catheter in a folded state as shown in FIG. 2 and then expanded as shown in FIGS. 1 and 3 to divide the ventricle into a movable part and a non-moving part. After the ventricular compartment is installed, the non-moving part is initially filled by a thrombus and then by cell growth. Bioresorbable fillers such as polylactic acid, polyglycolic acid, polycaprolactone, etc. may be used to fill the non-movable parts.

1 and 2, the ventricular compartment device according to an embodiment of the present invention is a pocket 10 for dividing the ventricle into a movable part and a non-moving part, an expansion wire 20 to expand the pocket 10, a pocket 10 It has a support means (30) extending from).

The bag 10 may be a biocompatible polymer, for example, polytetrafluoroethylene (ePTFE), expanded polytetrafluoroethylene (Nylon), polyethylene terephthalate (PET), polyester, or the like. The pocket 10 is stored in a folded state until it is delivered to the ventricles through the catheter, and is expanded to partition the ventricles when delivered to the ventricles. A sharp tip element 11 engages around the central portion of the pocket 10 so that it can be inserted into and fixed to the ventricular wall. The central lower end of the pocket 10 is fixed to the support means 30.

The inflation wire 20 is for inflating the pocket 10. Expansion wire 20 is coupled to the inside of the pocket (10). When the inflation wire 20 expands, the inflation wire 20 is circular. The portion of the bag 10 to which the expansion wire 20 is coupled is the portion of the bag 10 having the widest cross-sectional area, and the part of the bag 10 is in contact with the ventricular wall when the ventricular compartment is seated in the ventricle. The tip element 11 described above is also coupled to this portion. The expansion wire 20 is preferably a shape memory alloy or shape memory polymer. The stored shape is a shape required for unfolding the bag 10 so as to easily partition the ventricles, and is circular in this embodiment. Shape memory alloys or shape memory polymers are restored to the ideal state stored at temperatures above the human heart temperature. The expansion wire 20 may be made of a resilient metal so that the ventricular compartment may expand when it is detached from the catheter.

The expansion wire 20 may be provided with a marker for identifying the position by ultrasound, X-ray, or the like to help locate the position in the process of placing the ventricular compartment in the ventricles. As the marker, stainless steel, platinum, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth or the like can be used.

The support means 30 extend from the pocket 10. The support means 30 seats on the ventricular wall and serves to secure the ventricular compartment device to the ventricular wall with the leading elements 11 around the pocket 10. The support means 30 is made of a flexible material so that it can be folded and inserted into the catheter that delivers the ventricular compartment device to the ventricles. The support means 30 may be in various forms, but in the present embodiment, three support means 30 having a cylindrical shape are opened at a predetermined angle.

Hereinafter, the operation of the ventricular compartment device having the above-described configuration will be described.

The pocket 10, the expansion wire 20, and the support means 30 of the ventricular compartment device are folded and inserted into the catheter as shown in FIG. The catheter into which the ventricular compartment device is inserted is introduced into the patient's body using a conventional method. When the catheter reaches the ventricle, the ventricular compartment is detached from the catheter. The expansion wire 20 of the ventricular compartment device separated from the catheter is deformed into a memorized shape to unfold the pocket 10 of the ventricular compartment device. Three cylinders, which are the support means 30, also spread out and rest on the ventricles. The unfolded pocket 10 partitions the ventricles into movable and non-moving portions. The ventricular compartment device is seated in the ventricle by the tip element 11 and the support means 30 around the pouch 10. When the ventricular compartment is seated, the non-moving part of the ventricle is initially filled by a thrombus and then by cell growth. The result is a decrease in ventricular volume and stress on the ventricles, and an increase in cardiac ejection rates in heart failure patients.

The embodiments described above are merely illustrative of the preferred embodiments of the present invention, the scope of the present invention is not limited to the described embodiments, those skilled in the art within the spirit and claims of the present invention It will be understood that various changes, modifications, or substitutions may be made thereto, and such embodiments are to be understood as being within the scope of the present invention.

Claims

The cannula includes a pocket that can be expanded in an expanded state to partition the ventricles into movable and non-movable portions in a folded state that can be moved through;

An expansion wire coupled to an inner surface of the bag and deforming the bag in a folded state in a folded state;

And a support means fixed to the center of the bag and extending to the ventricular wall and seated on the ventricular wall.
The method of claim 1,

Ventricular compartment device, characterized in that the outer peripheral surface of the pocket in contact with the ventricular wall is provided with a sharp tip element to be inserted and fixed to the ventricular wall.
The method of claim 1,

The bag is a ventricular compartment device, characterized in that the biocompatible polymer material selected from polytetrafluoroethylene (ePTFE; expanded Polytetrafluoroethylene), nylon (Nylon), PET (polyethylene terephthalate), polyester.
The method of claim 1,

The expansion wire is a ventricular compartment device, characterized in that consisting of shape memory alloy or shape memory polymer.
The method of claim 1,

The expansion wire is made of a material having elasticity, ventricular compartment device, characterized in that to provide elasticity in the direction in which the bag is unfolded.
The method of claim 1,

The expansion wire further comprises a marker that can identify the position by ultrasound, X-ray, etc., so as to easily locate the position in the process of placing the ventricular compartment in the ventricles.
The method of claim 1,

The support means is a ventricular compartment device, characterized in that three cylindrical forms that are opened at a predetermined angle.