CN219836043U - Minimally invasive catheter type left ventricle auxiliary device - Google Patents

Minimally invasive catheter type left ventricle auxiliary device Download PDF

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Publication number
CN219836043U
CN219836043U CN202320440605.7U CN202320440605U CN219836043U CN 219836043 U CN219836043 U CN 219836043U CN 202320440605 U CN202320440605 U CN 202320440605U CN 219836043 U CN219836043 U CN 219836043U
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sleeve
section
small holes
tail section
flexible film
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CN202320440605.7U
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胡盛寿
柳光茂
何智鹏
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Fuwai Hospital of CAMS and PUMC
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Fuwai Hospital of CAMS and PUMC
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Abstract

The utility model discloses a minimally invasive catheter type left ventricle auxiliary device. It comprises a sleeve, an elastic metal bracket, a flexible film, an inflatable-contractible saccule and a guide wire; the sleeve is sequentially divided into a front section, a middle section and a tail section in sequence, the front section of the sleeve is provided with a plurality of inflow small holes, and a one-way valve is arranged in the front section of the sleeve to control the blood to flow in one way from the front section of the sleeve to the middle section of the sleeve; the middle section of the sleeve is a bending pipe with the direction capable of being changed at will; a plurality of first outflow small holes are formed in the surface of the tail section of the sleeve; the elastic metal bracket is tightly attached to the outer surface of the sleeve tail section and limits the deformation of the sleeve tail section; the outer surfaces of the elastic metal bracket and the sleeve tail section are connected with a flexible film, the elastic modulus of the flexible film is smaller than that of the sleeve tail section, a plurality of second outflow small holes are formed on the surface of the flexible film, and the flexible film and the first outflow small holes are arranged in a staggered manner and are positioned at positions which are not overlapped with each other; an inflatable-deflatable balloon is arranged in the tail section of the sleeve; the guide wire extends through the entire cannula and out from the cannula front section.

Description

Minimally invasive catheter type left ventricle auxiliary device
Technical Field
The utility model relates to a minimally invasive catheter type left ventricle auxiliary device, and belongs to the field of medical appliances.
Background
Ventricular assist devices are a common clinical treatment for critical heart failure disease, with left ventricular assist devices being the most common. At present, the left ventricle auxiliary device mainly uses a magnetic suspension centrifugal blood pump, but the working principle of the magnetic suspension centrifugal blood pump that a metal impeller rotates at a high speed can generate high shearing stress on blood to cause complications such as hemolysis, thrombus and the like, and seriously endanger the life of patients; meanwhile, implantation of the magnetic suspension centrifugal blood pump can generate a large operation wound for a patient, which is not beneficial to postoperative rehabilitation of the patient; magnetic levitation centrifugal blood pumps, on the other hand, are more capable of providing a continuous flow of blood, reducing the pulsatility of the patient's blood and causing other related complications.
Therefore, development of a novel left ventricular assist device is needed, which can reduce complications such as hemolysis and thrombus and reduce surgical wounds of patients, thereby improving postoperative rehabilitation effects of the patients.
Disclosure of Invention
The utility model aims to provide a minimally invasive catheter type left ventricle auxiliary device which can reduce complications such as hemolysis, thrombus and the like and reduce surgical wounds of patients, so that the postoperative rehabilitation effect of the patients is improved.
In order to achieve the above purpose, the present utility model adopts the following technical scheme:
a minimally invasive catheter-type left ventricle auxiliary device, which comprises a sleeve, an elastic metal bracket, a flexible film, an inflatable-contractible saccule and a guide wire; wherein,,
the sleeve is sequentially divided into a front section, a middle section and a tail section in sequence, the front section of the sleeve is provided with a plurality of inflow small holes, and a one-way valve is arranged in the front section of the sleeve to control the blood to flow in one way from the front section of the sleeve to the middle section of the sleeve; the middle section of the sleeve is a bending pipe with the direction capable of being changed at will so as to adapt to a complex vascular pipeline; a plurality of first outflow small holes are formed in the surface of the tail section of the sleeve;
the elastic metal bracket is tightly attached to the outer surface of the sleeve tail section and limits the deformation of the sleeve tail section; the outer surfaces of the elastic metal support and the sleeve tail section are connected with a flexible film, the elastic modulus of the flexible film is smaller than that of the sleeve tail section, a plurality of second outflow small holes are formed in the surface of the flexible film, and the second outflow small holes and the first outflow small holes are arranged in a staggered mode and are located at positions which are not overlapped with each other;
an inflatable-deflatable balloon is arranged in the tail section of the sleeve and is used for controlling the suction and discharge of blood;
the guide wire sequentially penetrates through the whole sleeve along the sleeve tail section, the sleeve middle section and the sleeve front section and extends out of the sleeve front section.
According to one embodiment of the utility model, the shape of the inflow small holes formed in the front section of the sleeve can be any shape, but the shape is preferably round or oval, the area range of a single inflow small hole is 20-30mm < 2 >, the inflow small holes are uniformly arranged along the circumferential direction of the sleeve by 360 degrees and axially arranged in multiple layers at the same time, the number of layers is 2-4, the inflow small holes of each layer are equal in number, and the inflow small holes of every two adjacent layers are staggered, so that blood can flow in from any direction.
According to one embodiment of the utility model, the inner diameter of the front section of the sleeve is 8-9mm, and the one-way valve is a duckbill valve and is used for ensuring that blood can flow in one way.
According to one embodiment of the utility model, the middle section of the sleeve is corrugated, the material is soft, the angle can be changed arbitrarily to adapt to the vascular path, the inner diameter size is equal to the front section size of the sleeve, and the outer diameter size is in the range of 12-14mm.
According to one embodiment of the utility model, the elastic metal support structure is in a woven mesh shape, and can resist radial pressure and prevent radial deformation of the sleeve tail section; the elastic metal bracket can be made of nickel-titanium or cobalt-chromium alloy with good biocompatibility and super elasticity.
According to one embodiment of the utility model, the size of the first outflow small hole formed on the surface of the sleeve tail section is 3-8mm 2 The shape of the small holes is round, the small holes are uniformly arranged along the circumferential direction of the sleeve by 360 degrees and axially arranged in multiple layers at the same time, the number of layers is 6-10, and the number of the small holes flowing out from each layer is equal.
According to one embodiment of the utility model, the flexible film has a circular ring film with a certain length along the axial direction, and the thickness of the flexible film ranges from 0.05 mm to 0.3mm; the second outflow small hole with the size equal to or smaller than that of the first outflow small hole is formed on the flexible film; the second outflow apertures are uniformly aligned 360 degrees along the circumference of the flexible film and simultaneously axially aligned in multiple layers.
According to the technical scheme of the utility model, the sleeve tail section and the flexible film form an outflow check valve, and blood can flow out of the first outflow small hole and the second outflow small hole in sequence; if there is a tendency for blood to flow out of the second tube Kong Fanliu, the flexible membrane will be held against the surface of the end section of the tube by blood having a tendency to reflux due to the fact that the flexible membrane is softer than the end section of the tube; at the same time, the first outflow apertures are staggered with the second outflow apertures and there is no overlap between the two outflow apertures, which results in a good seal at the outer surface of the sleeve tail section.
According to one embodiment of the utility model, the length of the inflatable-deflatable balloon is equal to or slightly less than the length of the sleeve tail section; the balloon is filled or sucked with fluid at a certain frequency to expand or contract, so that the outflow or inflow of blood can be realized. The fluid injected therein may be normal saline, silicone oil or helium gas.
According to one embodiment of the utility model, the number of the flexible films is 2-4, and the flexible films are respectively connected at least at the two ends of the tail section of the sleeve.
According to one embodiment of the utility model, the sleeve tail section has an outer diameter of 15-18mm.
The utility model has the beneficial effects that:
the left ventricular assist device of the present utility model does not rely on an impeller rotating at a high speed to transport blood, but controls the inflation and deflation of the balloon at a certain frequency to achieve inflow and outflow of blood. The shearing stress of the design principle on blood is smaller than that of a magnetic suspension centrifugal blood pump, the occurrence risk of free hemoglobin and platelet activation is reduced, the risk of complications such as hemolysis, thrombus and the like of the blood is reduced, and the blood compatibility in a human body is improved; meanwhile, the saccule has the characteristics of periodic contraction and expansion, can improve the blood flow pulsatility, and enhance the perfusion effect of each organ so as to reduce other complications; on the other hand, the left ventricular assist device is designed into a catheter type, can be implanted through the femoral artery minimally invasive aperture, reduces the operation wound area of a patient, and accordingly improves the postoperative rehabilitation effect of the patient.
Drawings
Fig. 1 is a schematic view of the left ventricular assist device of the present utility model.
Fig. 2 is a schematic view of the front section of the sleeve.
Fig. 3 is a schematic structural view of a flexible film.
Fig. 4 is a schematic structural view of the elastic metal stent.
Fig. 5 is a schematic structural view of an inflatable-deflatable balloon.
Fig. 6 is a schematic illustration of blood outflow in the tail section of the cannula.
Fig. 7 is a schematic view of the structure of the interior of the front section of the sleeve and the middle section of the sleeve.
Fig. 8 is a schematic diagram showing the spatial positional relationship of the first outflow orifice and the second outflow orifice.
Fig. 9 is a schematic view showing the implantation effect of the left ventricular assist device of the present utility model.
Detailed Description
The following describes the embodiments of the present utility model in further detail with reference to the drawings.
In the description of the present utility model, terms such as "anterior", "middle", "posterior", and the like, which indicate directions or positional relationships, are given based on the relative positional relationship of the device and the ventricle. The location of the device near the heart chamber is denoted as "anterior", and the location remote from the heart chamber is denoted as "medial", "posterior", in turn, for convenience of description only, and is not indicative or suggestive of the device or element having to have a particular orientation, be configured and operate in a particular orientation, and therefore should not be construed as limiting the utility model.
As shown in fig. 1 to 7, the ducted left ventricular assist device of the present utility model includes a sleeve 1, a flexible film 2, an elastic metal stent 3, an inflatable-contractible balloon 4, and a guide wire 5. The sleeve 1 sequentially comprises a sleeve front section 11, a sleeve middle section 12 and a sleeve tail section 13; the anterior cannula segment 11 is disposed in the left ventricle a, the middle cannula segment 12 is disposed in the aortic arch, and the posterior cannula segment 13 is disposed in the descending aorta. The front section 11 and the middle section 12 of the sleeve are soft, and can be adapted to tortuous vascular pipelines by any angle. The front sleeve section 11 is provided with a plurality of inflow small holes 111, and a one-way valve 112 is arranged in the front sleeve section 11 to control the one-way inflow of blood from the front sleeve section 11 to the middle sleeve section 12; the sleeve tail section 13 is provided with a plurality of first outflow apertures 131. The elastic metal bracket 3 is tightly attached to the outer surface of the sleeve tail section 13 and limits the deformation of the sleeve tail section 13; the outer surfaces of the elastic metal bracket 3 and the sleeve tail section 13 are connected with a flexible film 2, the elastic modulus of the flexible film is smaller than that of the sleeve tail section 13, a plurality of second outflow small holes 21 are formed in the surface of the flexible film 2, and the second outflow small holes 21 and the first outflow small holes 131 are arranged in a staggered manner and are positioned at positions which are not overlapped with each other; an inflatable-deflatable balloon 4 is arranged in the sleeve tail section 13 for controlling the suction and discharge of blood, and the area surrounded by the outer surface of the inflatable-deflatable balloon 4 and the inner surface of the sleeve tail section is the core area of the flow channel. The guide wire 5 penetrates the whole sleeve sequentially along the sleeve tail section 13, the sleeve middle section 12 and the sleeve front section 11, and extends out of the sleeve front section 11 and forms a spiral shape with a certain length. The guide wire is mainly used for realizing angiographic visualization so as to facilitate observation in operation, and simultaneously, the device can be accurately conveyed to a designated position and fixed.
As shown in fig. 2, the front section 11 of the sleeve is provided with inflow small holes 111, and the shape of the inflow small holes 111 can be any shape, and is preferably circular or elliptical. The area of the single inflow orifice 111 ranges from 20 to 30mm 2 The inflow small holes are uniformly arranged along the circumferential direction of the sleeve by 360 degrees and axially arranged in multiple layers, the number of layers is 2-4, the number of inflow small holes of each layer is equal, the inflow small holes of every two adjacent layers are staggered, and the inflow of blood from any direction is ensured. The cannula front section 11 is provided with a tapered tip 113, the tapered tip 113 being foraminous, allowing the percutaneous inserted 0.035 inch guidewire 5 to pass out.
As shown in FIG. 3, the flexible film 2 is a ring shape with a certain axial length, the axial length is between 60 and 100mm, the thickness of the flexible film 2 is between 0.05 and 0.3mm, and the flexible film 2 can be made of high polymer materials with good compatibility, such as Polyurethane (Polyurethane), silicon rubber, high-density polyethylene film (DHPE) and the like. The surface of the flexible film 2 is provided with a second outflow small hole 21, and the size of a single small hole is 3-8mm 2 The aperture shape is circular. The second outflow apertures 21 are uniformly arranged in the circumference of the flexible film 2 and are arranged in layers in the axial direction, the number of layers being 6-10. The flexible film end edge 22 is fixed with the sleeve tail section 13 and the elastic metal bracket 3, and the fixing mode can adopt an adhesive mode, and the flexible film end edge 22 does not allow blood leakage, so that the complete sealing is realized.
As shown in fig. 4, the elastic metal stent 3 is made of a wire 31 of a mesh-like memory alloy material, which may be made of a material having superelasticity and good biocompatibility, such as nickel titanium or cobalt chromium alloy. The elastic metal support 3 is radially symmetrical or rotationally symmetrical, the diameter of the middle part is larger than that of the two side parts, and the shape of the outer envelope ends 32 of the two sides is designed to be circular. The wire diameter of the wire 31 is between 0.3 and 0.5mm and the length of the resilient metal support 3 should be equal to the length of the sleeve tail section 13. The resilient metal support 3 is able to resist radial pressure and prevent radial deformation of the casing tail section.
As shown in fig. 5, inflatable-deflatable balloon 4 is comprised of balloon inlet tube 41 and balloon 42, placed in sleeve tail lumen 133 through sleeve tail inlet 132. Saline, silicone oil or helium is periodically injected into the balloon 42 or sucked out of the balloon 42 through the balloon inlet pipe 41 according to a certain frequency, and the injection mode can adopt a miniature piston pump or a gear pump (not shown in the figure) and the injection pressure is 0.1-0.2MPa. The length of the inflatable-deflatable balloon 4 is equal to or slightly smaller than the sleeve tail section, the outer diameter of which is 15-18mm.
As shown in fig. 6, the surface of the sleeve tail section 13 is provided with first outflow small holes 131, the first outflow small holes 131 are uniformly distributed circumferentially, and the size and the number of distribution layers of the single outflow small holes can be equal to those of the second outflow small holes 21. The first outflow aperture 131 on the surface of the sleeve end section 13 is to be completely covered by the flexible membrane 2, and there is no overlap between the first outflow aperture 131 and the second outflow aperture 21. The elastic modulus of the flexible film 2 is smaller than that of the sleeve tail section 13, and the first outflow small holes 131 and the second outflow small holes 21 are staggered in space, so that the design aims to reduce the blood flow resistance and prevent the blood from flowing backwards, and the function of the one-way valve is realized, and the specific principle is that: when there is a tendency for blood flow back in the blood vessel, the flexible membrane 2 is pressed by the blood and closely contacts the surface of the end section 13 of the cannula because the flexible membrane 2 is made of a material softer than the end section 13 of the cannula, and the first outflow small holes 131 and the second outflow small holes 21 are staggered, as shown in fig. 8, so that the first outflow small holes 131 are completely covered by the flexible membrane 2, and thus no gap exists to allow blood flow back into the cannula 1.
The amount of blood flow output depends on the one hand on the volume of the cannula lumen 133, so that the amount of blood flow output can be adjusted by varying the inner diameter and length of the cannula tail section 13; second, the amount of blood flow discharged is also dependent on the number of flexible films 2, and the number of corresponding first and second outflow holes 131, 21. The number of flexible membranes 2 is 2-4 and it is necessary to provide flexible membranes 2 at both ends of the sleeve tail section 13, as shown in fig. 6, which is designed to ensure a better perfusion of the aortic arch and descending aortic and venous branches etc. when blood passes through the first and second outflow apertures 131, 21. The inner wall 134 of the sleeve tail section 13 should be smooth to facilitate blood flow.
As shown in FIG. 7, the inner diameter of the front section 11 of the sleeve is 8-9mm, and a one-way valve 112 is arranged in the front section, the shape of the one-way valve is the same as that of the duckbill valve, and the one-way valve 112 is positioned at any position between the inflow small hole 111 and the middle section 12 of the sleeve. The bending tube of the middle section 12 of the sleeve is corrugated, is soft in material, can be randomly changed in angle to adapt to a vascular path, has an inner diameter dimension D2 equal to the dimension of the front section 11 of the sleeve, and has an outer diameter dimension D1 ranging from 12 mm to 14mm.
As shown in fig. 9, the device of the utility model is implanted percutaneously via a femoral artery minimally invasive, and is passed through the descending aorta, the aortic arch and the ascending aorta, and finally the front section 11 of the sleeve extends into the left ventricle a, so that negative pressure is generated in the sleeve by contracting the saccule; blood in the left ventricle A enters the sleeve through the inflow small hole, and then the outer surface of the sleeve generates pressure on the blood by expanding the saccule, so that the blood is discharged out of the device to realize organ perfusion. The working principle of the utility model is as follows: fluid is injected into the balloon 42 at a specific cycle such that the outer surface of the balloon 42 becomes larger in diameter and is sized to approximate the inner diameter of the sleeve tail section 13. At this time, the outer surface of the balloon 42 generates a certain pressure to the blood, which flows out along the first outflow orifice 131, and the flexible membrane 2 is pushed out toward the outer surface away from the tail section 13 of the cannula due to the blood pressure, and the blood flows into the blood vessel along the second outflow orifice 21. The inflow aperture 111, the first outflow aperture 131, and the second outflow aperture 21 may be manufactured using a stamping or laser process, or the like.
The utility model has the advantages that:
the left ventricle auxiliary device does not depend on the rotor rotating at high speed to convey blood, but realizes the blood suction and discharge device by means of the contraction or expansion of the saccule, reduces the shearing stress of the blood, improves the anti-hemolysis and thrombus performance of the blood, has simple structure in the catheter, and can reduce the phenomena of stagnation, backflow and the like of the blood; on the other hand, the saccule expands and contracts according to a certain frequency, so that the blood flow pulsatility can be enhanced, and the blood perfusion effect of each organ can be improved; because the left ventricle auxiliary device adopts a conduit type structure, the utility model can be implanted in a minimally invasive way, and the occurrence rate of surgical wounds and related complications of patients is reduced.
Finally, it should be understood that the foregoing description is illustrative of the preferred embodiments of the present utility model and is not intended to limit the utility model to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the utility model.

Claims (10)

1. A minimally invasive catheter-type left ventricular assist device, characterized in that: it comprises a sleeve, an elastic metal bracket, a flexible film, an inflatable-contractible saccule and a guide wire; wherein,,
the sleeve is sequentially divided into a front section, a middle section and a tail section in sequence, the front section of the sleeve is provided with a plurality of inflow small holes, and a one-way valve is arranged in the front section of the sleeve to control the blood to flow in one way from the front section of the sleeve to the middle section of the sleeve; the middle section of the sleeve is a bending pipe with the direction capable of being changed at will; a plurality of first outflow small holes are formed in the surface of the tail section of the sleeve;
the elastic metal bracket is tightly attached to the outer surface of the sleeve tail section and limits the deformation of the sleeve tail section; the outer surfaces of the elastic metal support and the sleeve tail section are connected with a flexible film, the elastic modulus of the flexible film is smaller than that of the sleeve tail section, a plurality of second outflow small holes are formed in the surface of the flexible film, and the second outflow small holes and the first outflow small holes are arranged in a staggered mode and are located at positions which are not overlapped with each other;
an inflatable-deflatable balloon is arranged in the tail section of the sleeve and is used for controlling the suction and discharge of blood;
the guide wire sequentially penetrates through the whole sleeve along the sleeve tail section, the sleeve middle section and the sleeve front section and extends out of the sleeve front section.
2. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the shape of the inflow small hole formed at the front section of the sleeve is round or oval, and the area of the single inflow small hole is 20-30mm 2 The inflow small holes are uniformly arranged along the circumferential direction of the sleeve by 360 degrees and axially arranged for multiple layers at the same time, and the layers areThe number of inflow small holes of each layer is 2-4, and the inflow small holes of every two adjacent layers are staggered.
3. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the inner diameter of the front section of the sleeve is 8-9mm, and the one-way valve is a duckbill valve.
4. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the middle section of the sleeve is corrugated, the material is soft, the angle can be changed at will to adapt to the vascular path, the inner diameter size is equal to the front section size of the sleeve, and the outer diameter size is in the range of 12-14mm.
5. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the elastic metal bracket structure is in a woven net shape, and is made of nickel-titanium alloy or cobalt-chromium alloy with good biocompatibility and super elasticity.
6. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the size of the first outflow small hole formed on the surface of the sleeve tail section is 3-8mm 2 The shape of the small holes is round, the small holes are uniformly arranged along the circumferential direction of the sleeve by 360 degrees and axially arranged in multiple layers at the same time, the number of layers is 6-10, and the number of the small holes flowing out from each layer is equal.
7. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the flexible film is provided with a circular ring film with a certain length along the axial direction, and the thickness of the flexible film ranges from 0.05 mm to 0.3mm; the second outflow small hole with the size equal to or smaller than that of the first outflow small hole is formed on the flexible film; the second outflow apertures are uniformly aligned 360 degrees along the circumference of the flexible film and simultaneously axially aligned in multiple layers.
8. The minimally invasive ducted left ventricular assist device of claim 1 wherein: the length of the inflatable-deflatable balloon is equal to or slightly less than the length of the sleeve tail section; the fluid injected into the container is normal saline, silicone oil or helium.
9. The minimally invasive ducted left ventricular assist device of claim 7 wherein: the number of the flexible films is 2-4, and the flexible films are respectively connected at least at the two ends of the tail section of the sleeve.
10. The minimally invasive ducted left ventricular assist device of claim 4 wherein: the outer diameter of the tail section of the sleeve is 15-18mm.
CN202320440605.7U 2023-03-09 2023-03-09 Minimally invasive catheter type left ventricle auxiliary device Active CN219836043U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117797381A (en) * 2024-02-23 2024-04-02 杭州迪远医疗科技有限公司 Interventional catheter and left ventricle auxiliary system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117797381A (en) * 2024-02-23 2024-04-02 杭州迪远医疗科技有限公司 Interventional catheter and left ventricle auxiliary system

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