KR101479669B1 - Ventricular assist device - Google Patents

Abstract

The present invention relates to a motorcycle comprising (a) a cylindrical body 110, (b) an impeller 120, (c) a motor 130, (d) a drive line 140, and e) anchoring member (150). The device of the present invention is a device designed to reduce the invasiveness of conventional surgical operations, and the device of the present invention can be used as an anchoring member, unlike a conventional ventricular assist device, It can be easily mounted or removed, and a connection member can be used to safely connect the drive line to the outside of the ventricle, thus enabling ventricular assist function as a minimally invasive surgical procedure. In addition, the device of the present invention can improve the invasive surgical technique, which has been pointed out as the biggest disadvantage when using the conventional ventricular assist device, thereby enabling a safer operation, thereby enlarging the patient group capable of implanting the ventricular assist device The recovery period can be shortened.

Description

[0001] Ventricular assist device [0002]

The present invention relates to a ventricular assist device.

When heart muscle cells lose their elasticity due to various pathological reasons, the heart is unable to release blood out of the heart sufficiently, resulting in blood stagnation in the heart or blood stagnation in other tissues, Heart failure is the heart's failure to function normally.

Various ventricular assist devices have been used as a surgical method of heart failure therapy and are classified as implantable, paracoporeal or extracoporeal depending on the location of the ventricular assist device. The implantable ventricular assist device minimizes the exposures to the body as a large portion of the system is implanted in the body and can be completely implanted without penetrating the skin, especially when using a wireless energy signal transmission system, The risk of infection through penetrating components can be minimized, but the procedure for transplantation is complicated, and the ventricular assist device is defective or has to be re-operated to remove the device if treatment is terminated. In the case of adherent or extracorporeal type, the conduit delivering blood is externally exposed through the skin, but the ventricular assist device is mounted near the site where the conduit is exposed to minimize the length of the conduit. The ventricular assist device is mounted outside the skin, so that it can be easily removed if the device fails or the role is terminated.

A ventricular assist device (VAD) aids in weakened ventricular function by pumping blood from the heart into the aorta or pulmonary artery. In the case of a ventricular assist device, the blood pump is connected in parallel with the natural heart through a cannula through the atrium (or ventricle) and the wall of the artery, and then a part of the blood is passed through the blood pump to relieve the natural heart, Do it. It is divided into left ventricular assist device (LVAD) and right ventricular assist device (BVAD) depending on the purpose.

On the other hand, the artificial heart and LVAD can be installed through complicated surgical operations such as thoracic surgery, and therefore artificial heart and LVAD are suitable only for patients with severe heart failure.

Conventionally, graft-type VAD has been developed in the form of aortic-aorta connection. Although this technique is effective, there is a problem in that a very large artificial blood vessel or metal cannula should be connected to the heart and the aorta, which causes excessive bleeding. In addition, for patients who have undergone previous cardiac surgery, this long-time invasive surgery significantly contributes to high early mortality rates (10-20% for LVAD). The present inventors newly devised a method of inserting the VAD into the valve position in order to solve this problem. This type of VAD may cause a mechanical miniaturization problem, a problem of a method of fixing a VAD to a valve region, or a problem of processing a drive line. However, the present inventors have found that a ventricular assist device I want to develop.
The background art for the present invention is disclosed in Published Patent Application No. 10-2010-0129731 (published on December 9, 2010) and US Published Patent Application No. 2010-0249489 (published on September 30, 2010) .

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.

The present inventors have tried to develop a ventricular assist device (VAD) that can be implanted into a patient by a more noninvasive surgical technique. As a result, the present inventors have developed a ventricular assist device that can be implanted in the aortic or pulmonary valve region by miniaturizing the ventricular assist device used in cardiac replacement therapy, and the device of the present invention is different from the conventional ventricular assist device A separate anchoring member can be used to easily mount or remove the device to the implant site as needed, and a connection member can be used to securely connect the drive line to the outside of the ventricle. The present invention has been accomplished by confirming that ventricular function assisting is possible as a minimally invasive surgical technique.

It is therefore an object of the present invention to provide a ventricular assist device.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.

According to one aspect of the present invention, the present invention provides a ventricular assist device (100) comprising:

(a) a cylindrical body 110 having an inlet and an outlet for blood formed therein;

(b) an impeller 120 mounted within the body and rotatable about a central axis 170 of the body;

(c) a motor (130) mounted inside the main body and providing a rotational force necessary for rotating the impeller;

(d) a drive line (140) mounted on one side of the body and connectable to the outside of the body of a subject to be implanted of the ventricular assist device; And

(e) an anchoring member (150) mounted on the outside of the body for fixing the body to the implantation site of the recipient.

The present inventors have made extensive efforts to develop a ventricular assist device (VAD) that can be implanted in a patient by a more noninvasive surgical technique. As a result, it has been found that the ventricular assist device used in cardiac replacement therapy is miniaturized To develop a ventricular assist device that can be implanted in the aortic or pulmonary valve area. The device of the present invention can easily mount or remove the device to the implantation site as needed by using a separate anchoring member unlike the conventional ventricular assist device, (drive line) can be safely connected to the outside of the ventricle.

Currently, several types of implantable ventricular assist devices have been commercialized, but no device has been developed to mediate easy attachment and detachment to the human body. In addition, there have been studies on ventricular assist devices in which the VAD is inserted into the valve position. However, the problem of mechanical miniaturization of the VAD, the problem of fixing the VAD to the valve region, And the inventors of the present invention have devised a new ventricular assist device in which the above problems have been solved and improved.

As used herein, the term " ventricular assist device " refers to a device that mechanically supports the function of the ventricle in heart failure patients that can not be treated as conventional conventional heart failure medication or open heart surgery. For example, the left ventricular assist device sends the blood stream to the auxiliary device through the conduit to the heart of the left ventricle, while the auxiliary device waits for the blood flow to collect and sends the blood stream to the aorta again when it reaches a certain amount.

The ventricular assist device of the present invention is made of a medical polymer material and a metal alloy excellent in biocompatibility.

Hereinafter, the ventricular assist device of the present invention will be described in detail as follows:

Configuration (a): The main body 110

In the apparatus of the present invention, the body 110 is designed to be implantable at the aortic or pulmonary valve sites, with a diameter of about 16 mm to 26 mm and a length of 15 mm to 30 mm. With the development of technology, smaller sized ventricular assist devices are being developed and ventricular assist devices using the already commercialized axial pump principle can produce a flow of 10 L per minute with a diameter of about 25 mm .

The outer surface of the main body may be provided with a groove on which the seal ring can be mounted. FIG. 3 is a schematic view of a ventricular assist device of the present invention in which a sealing ring is mounted, and a sealing ring is mounted on the upper surface of the body.

Although the impeller and the motor exist in the body, the impeller and the motor are used for the convenience of the substrate. The apparatus of the present invention can use the motor itself as the main body. In this case, do.

Configuration (b): An impeller 120,

The apparatus of the present invention comprises an impeller rotatable about a central axis of the body. The impeller is mounted inside the body and rotates at a constant speed to form a blood flow in a certain direction. The impeller can be manufactured in various known shapes, and the number and lengths of the impeller blades can also be variously manufactured at an appropriate level. According to one example, in the present invention, the impeller has a substantially plate-like wing shape and can be manufactured as a half of the length of the main body and a half of the diameter of the main body.

The impeller rotates about a central axis 170 inside the body, thus pumping blood using the working principle of an axial pump.

In the axial pump, a velocity energy is given from a rotary car while a fluid (for example, blood) flowing in an axial direction passes through a vane as a rotary electric motor, and the fluid is delivered in the axial direction. The energy passes through the guide vane and changes into pressure energy, so that it is discharged at a pressure higher than the pressure at the outlet of the rotary choke.

Configuration (c): Motor 130:

The apparatus of the present invention includes a motor that provides a rotational force necessary for rotational movement of the impeller. The motor is mounted inside the body, and various motors known in the art can be used. The impeller and motor serve to pump the blood of the left ventricle into the ascending aorta.

Configuration (d): A drive line (140)

The device of the present invention includes a power transmission line mounted on one side of the main body and connectable to the outside of the body of a subject to be implanted of the ventricular assist device. The power transmission line is connected to an external power source and supplies external power to the ventricular assist device, and the operation of the pump can be controlled or monitored. The outer coating of the power transmission line may be coated with a biocompatible polymeric material (biocompatible polymeric polymer). The power transmission line also has appropriate stiffness and hardness for non-traumatic contact with the pericardium or skin.

The power transmission line extends from the body 110 to the outside of the patient's body or to a power source implanted within the patient's body. According to one example, the power source is a transcutaneous energy transfer ("TET") mechanism and is typically mounted near the patient's skin, far away from the heart.

Configuration (e): Anchoring member (150)

The device of the present invention is mounted on the outside of the main body and includes fixing means for fixing the main body to the implantation site of the recipient.

The device of the present invention may be mounted at the aortic or pulmonary valve sites, in which case separate fastening means are required to secure the device. For example, the securing means may comprise (i) a radial self-expandable stent mounted on the exterior of the body and at the implantation site of the ventricular assist device, or (ii) mounted on top of the body, And a sewing ring fixable to the implantation site of the device. If a self-expandable stent is used instead of a suture ring, implantation of the ventricular assist device is possible without a suture line.

The stent may be made of a known biocompatible shape memory alloy material and may be made of, for example, (i) a nickel-based material, a copper-based material, an iron-based material, and (ii) Cu-Al-Ni, Ag-Ni, and Au-Cd, which is a combination of metals such as Al, Au, and Ag. According to one example, nitinol, which is a nickel-titanium (Ni-Ti) alloy, may be used as the shape memory alloy material. By attaching a self expandable stent to the body, sutureless ventricular assist devices can be inserted quickly and easily into the transplantation site (eg, aortic or left ventricular, aortic or pulmonary valve sites).

The seal ring is made of a known biocompatible metal material and the seal ring can be mounted on the top of the body to secure the body to the implant site as a suture. In the case of fixing the sewing line, the sewing ring may be positioned close to the upper part of the outlet of the main body so that the main body can be easily fixed.

The perimeter of the suture ring may be attached to the patient's left ventricle by suturing the patient's aortic or pulmonary valve site. For example, the seal ring may be a metallic structure having a peripheral flange with a plurality of holes formed therein for sealing or stapling the ring to the aortic or pulmonary valve site.

One of the features of the present invention is a placement technique for securing a ventricular assist device (i.e., body) to a particular implantation site using a securing means. The fixing means is a configuration for overcoming the disadvantage of the existing commercialized VAD (the point that the ventricular assist device is attached to the heart as an invasive surgical technique), and it is possible to perform non-invasive surgery as compared with the case of using the device of the present invention The number of patients who can undergo VAD surgery is getting wider and the recovery rate is expected to improve dramatically.

In addition, a connection member 160 for connecting the power transmission line of the ventricular assist device of the present invention to the outside of the ventricle may be additionally included. For example, the connecting means includes a fabric skirt, an artificial tube, and a synthetic blood vessel.

The fabric skirt is made of a fabric material, and the fabric skirt is mounted on the arterial wall of the artery as shown in FIG. 4, and the power transmission line is passed through the fixed fabric skirt and directed to the outside. Artificial blood vessels and artificial blood vessels can be used as the means for extracting the power transmission line to the outside of the ventricle as a minimum bleeding. An artificial blood vessel is fixed to the arterial wall as a suture as shown in FIG. 4, To direct the power transmission line to the outside.

When the body is fixed to the implantation site using a stent, a certain space may be formed between the stent and the body. In this case, blood flow into the space can be freely carried and consequently serious aortic regurgitation may result. Therefore, in order to eliminate the space between the body and the stent, an artificial valve membrane or polymer artificial fiber can be inserted between the body and the stent, thereby preventing the occurrence of aortic valve failure. The artificial valve includes, for example, a heart valve of a mammal or a prosthetic valve prepared by processing a pericardium, and a bovine pericardium or a porcine aortic valve can be used. The polymeric man-made fibers include dacrone, Teflon, polyethylene, polyurethane, and polytetraethylene.

The ventricular assist device of the present invention may further include a power supply for supplying power to the motor in addition to the above-described configuration.

The features and advantages of the present invention are summarized as follows:

(a) The present invention relates to ventricular assist devices for reducing the invasiveness of conventional surgical procedures.

(b) Unlike conventional ventricular assist devices, the device of the present invention can easily mount or remove the device to the implantation site as needed by using an anchoring member, The drive line can be safely connected to the outside of the ventricle, enabling minimally invasive surgery to assist ventricular function.

(c) In addition, the device of the present invention can improve the invasive surgical technique, which has been pointed out as the greatest disadvantage when using the conventional ventricular assist device, thereby enabling safer operation, thereby allowing a patient group And can shorten the recovery period after surgery.

Fig. 1 is a schematic view of the ventricular assist device of the present invention viewed from the lower side. Fig.
FIG. 2 is a schematic view of a self-expandable stent replacing a suture ring. It can be transaortic or transventricularly inserted without a suture, and can be installed very easily and quickly.
FIG. 3 is a schematic view showing a sewing ring installed at the upper end of an outlet of a main body to fix the ventricular assist device of the present invention to the aortic valve position. An axial pump is shown as including both a body, an impeller and a motor.
Figure 4 shows a schematic diagram illustrating the processing of a drive line when the device of the present invention is present in the recipient's body. In this case, since the device is located in the body, the power transmission line must be pulled out through the aorta. For example, a fabric skirt may be made around the power transmission line and sutured to the perforated aorta, or the artificial vessel may be fixed to the aortic wall, the power transmission line may be removed through the conduit, and the artificial blood vessel may be surgically tied You can use the bundling method.

Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

Example

Example 1: Fabrication of a ventricular assist device

A ventricular assist device 100 of the present invention includes (a) a cylindrical body 110; (b) an impeller 120; A motor 130; (d) a drive line 140; And (e) an anchoring member 150 mounted on the exterior of the body for securing the body to the implantation site.

The cylindrical body 110 has a diameter of 20 mm or less, and a groove can be formed on the outer surface of the body so that the seal ring can be mounted.

An impeller 120 is mounted inside the body and is rotatable about a central axis of the body. The impeller is mounted inside the body and rotates at a constant speed to form a blood flow in a certain direction. The impeller can be manufactured in various known shapes, and the number and lengths of the impeller blades can also be variously manufactured at an appropriate level. In Fig. 1, the impeller has a substantially plate-like vane shape and is formed with a diameter of about 1/2 of the body length and 1/2 of the body diameter. The impeller rotates about a central axis within the body, thus pumping blood using the working principle of an axial pump.

A motor 130 is mounted inside the main body and provides a rotational force necessary for rotating the impeller. The impeller and motor serve to pump the blood of the left ventricle into the ascending aorta.

A drive line 140 is mounted on one side of the body and is connectable to the exterior of the subject's body of the ventricular assist device to deliver power from the exterior to the ventricular assist device. The outer coating of the power transmission line may be coated with a biocompatible polymeric material (biocompatible polymeric polymer). The power transmission line also has appropriate stiffness and hardness for non-traumatic contact with the pericardium or skin. The power transmission line extends from the body 110 to the outside of the patient's body or to a power source implanted within the patient's body.

An anchoring member 150 is mounted to the exterior of the body and is a means for securing the body to the implant. The securing means may comprise (i) a radial self-expandable stent (see FIG. 2) mounted on the exterior of the body and at the implantation site of the ventricular assist device, or (ii) , And a sewing ring that is fixable to the implantation site of the ventricular assist device. If a self-expandable stent is used instead of a suture ring, implantation of the ventricular assist device is possible without a suture line.

 The material of the stent is nitinol, a nickel-titanium (Ni-Ti) alloy, used as a shape memory alloy material, and a self- expandable stent is combined with the main body so that the main body is sutureless, Or pulmonary valve sites.

The ventricular assist device of the present invention may use a sewing ring to secure the ventricular assist device to the aortic or pulmonary valve position. The seal ring is installed at the top of the outlet of the body.

Meanwhile, since the ventricular assist device of the present invention is completely inside the human body, the drive line must be connected to the outside of the human body through the aorta. For example, a fabric skirt is formed around a drive line, and a hole is formed in the aorta to seal it to the aorta. (2) An artificial blood vessel is fixed to the aorta wall, A power transmission line is pulled out to the outside, and a saphenous vein is bundled with a surgical tie.

The ventricular assist device of the present invention is mounted on a ventricle outer surface of a subject to be implanted and includes a connection member 160 for connecting the power transmission line to the outside of the ventricle. Fig. 4 shows a case in which a fabric skirt or artificial blood vessel is used as the connecting means.

When the main body 110 is fixed to the implantation site using a stent, a certain space may be formed between the stent and the main body. In this case, the bloodstream can freely move into the space, resulting in serious aortic regurgitation . Therefore, in order to eliminate the space between the body and the stent, an artificial valve membrane or polymer artificial fiber can be inserted between the body and the stent, thereby preventing the occurrence of aortic valve failure. A space between the main body and the stent is filled with a dacrone, which is artificial valve membrane or artificial fiber using bovine pericardium to block unnecessary blood flow.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the same is by way of illustration and example only and is not to be construed as limiting the scope of the present invention. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

100: Ventricular assist device of the present invention
110:
120: impeller
130: motor (motor)
140: drive line
150: anchoring member
160: connection member
170: center axis
A: Ascending aorta
B: Aortic sinuses
C: Aortic valve annulus
D: Left ventricle

Claims (9)

A ventricular assist device (100) comprising:
(a) a cylindrical body 110 having an inlet and an outlet for blood formed therein;
(b) an impeller 120 mounted inside the main body and rotatable about a central axis of the main body;
(c) a motor (130) mounted inside the main body and providing a rotational force necessary for rotating the impeller;
(d) a drive line (140) mounted on one side of the body and connectable to the outside of the body of a subject to be implanted of the ventricular assist device;
(e) an anchoring member (150) for securing the body to the implantation site of the recipient, the radial self-expanding stent (150) mounted on the exterior of the body and secured to the implantation site of the ventricular assist device self-expandable stent); And
(f) an artificial valve membrane or polymer artificial fiber filling a space between the body and the stent.
The ventricular assist device of claim 1, wherein the ventricular assist device is actuated by an axial pump principle.
delete delete The ventricular assist device according to claim 1, wherein the prosthetic valve is a tissue valve.
The ventricular assist device of claim 1, wherein the polymeric fiber is dacrone, Teflon, polyethylene or polytetraethylene.
2. The method of claim 1, wherein the ventricular assist device is mounted on a ventricle outer surface of a subject and additionally includes a connection member (160) for connecting the power transmission line to the exterior of the ventricle Wherein the ventricular assist device is a ventricular assist device.
The ventricular assist device of claim 1, wherein the connecting means is a fabric skirt, artificial tube or artificial blood vessel.
The ventricular assist device of claim 1, wherein the implantation site is the aortic or pulmonary valve site.

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