CN210170240U

CN210170240U - Heart isolation device

Info

Publication number: CN210170240U
Application number: CN201822027940.6U
Authority: CN
Inventors: Zhihui Sun; 孙智慧; Qifeng Mei; 梅奇峰; Zhifeng Chang; 常志峰
Original assignee: SHANGHAI XINRUI MEDICAL TECHNOLOGY Co Ltd
Current assignee: SHANGHAI XINRUI MEDICAL TECHNOLOGY Co Ltd
Priority date: 2018-12-04
Filing date: 2018-12-04
Publication date: 2020-03-24
Anticipated expiration: 2028-12-04

Abstract

The utility model discloses a heart isolating device. The heart isolation device comprises: an expandable device body and a polymeric membrane attached to the device body; the device main part is the umbelliform, and encloses by many cradling pieces and close and form, the head end of cradling piece is used for laminating ventricular inner wall, the outside extension in position of cradling piece between head end and tail end is formed with at least one fixed part, the fixed part is configured to can pierce behind the ventricular inner wall, for the power of the laminating ventricular inner wall that the head end of cradling piece provided. The utility model discloses a technological effect lies in, improves the compactness of heart isolating device and the laminating of ventricular inner wall, promotes heart isolating device and subtracts the choked flow effect of appearance.

Description

Heart isolation device

Technical Field

The utility model relates to the field of medical equipment, more specifically relates to a heart isolating device.

Background

The treatment of heart disease has been a long-standing development in recent years, but the lack of heart failure, one of the ultimate outcomes of all heart diseases, is always threatening human health. There are numerous causes of heart failure, one of the most common causes being acute myocardial infarction. Acute myocardial infarction leads to the enlargement of the heart and the occurrence of heart failure due to myocardial injury and subsequent scarring, and particularly, patients with anterior myocardial infarction complicated with ventricular aneurysms are more likely to suffer from heart failure, so that the life quality of the patients is influenced, and huge economic burden is caused to families and society.

Currently, most treatments for heart failure involve interventional procedures, in which a heart isolation device is implanted in the left ventricle of a patient. Compared with the traditional surgical operation, the treatment mode has the advantages of small trauma, less complications, short operation time and the like, and is gradually favored by doctors and patients. Conventional heart isolation devices suffer from a number of drawbacks.

On the one hand, the fitting condition of the existing heart isolation device and the ventricular wall is poor, so that blood can leak to the interior of a ventricular lesion part through the contact edge part of the device and the ventricular wall, the volume reduction and flow blocking effects of the device are poor, and the lesion part is easy to expand continuously outwards. On the other hand, the existing heart isolation device has poor stability after being implanted into the left ventricle, and is easy to cause the displacement phenomenon of the device along with the contraction movement of the heart.

Therefore, there is a need for a new type of heart isolation device to overcome the above-mentioned drawbacks.

SUMMERY OF THE UTILITY MODEL

It is an object of the present invention to provide a new solution for a heart isolation device.

According to a first aspect of the present invention, there is provided a heart isolation device, the device comprising: an expandable device body and a polymeric membrane attached to the device body;

the device main part is the umbelliform, and encloses by many cradling pieces and close and form, the head end of cradling piece is used for laminating ventricular inner wall, the outside extension in position of cradling piece between head end and tail end is formed with at least one fixed part, the fixed part is configured to can pierce behind the ventricular inner wall, for the power of the laminating ventricular inner wall that the head end of cradling piece provided.

Optionally, the support rod has a plurality of branches, the branches are sequentially distributed from the head end to the tail end of the support rod, and the branches form the fixing portion.

Optionally, the lengths of the fixing parts from the head end to the tail end of the support rod in the radial direction of the umbrella-shaped device body are sequentially decreased.

Optionally, the length of the head end of the strut in the radial direction of the umbrella device body is greater than the length of the fixing portion in the radial direction of the umbrella device body.

Optionally, the head end of the support rod is configured to be attached to the inner wall of the ventricle under the action of the elastic restoring force of the head end of the support rod; the fixation portion is configured such that the head end of the stent rod provides additional force against the inner wall of the ventricle.

Optionally, a plurality of the fixing parts are distributed on the support rod at equal intervals.

Optionally, the polymeric membrane is attached on an inner surface of the stent rod; or, the polymer film is provided with at least two layers which are respectively attached to the inner surface and the outer surface of the support rod, and the fixing part penetrates through the polymer film on the outer surface.

Optionally, an included angle between the head end of the support rod and the fixing portion is in a range of 15 ° to 60 °.

Optionally, another polymer film is attached to the inner surface and the outer surface of the fixing part, respectively.

Optionally, the method further comprises: the base is located at the bottom end of the device main body and connected with the tail end of the support rod.

The utility model discloses a technological effect lies in, outwards extends through the position between the head end and the tail end of the cradling piece that device main part and heart inner wall combine to be formed with at least one fixed part, can improve the compactness of heart isolating device and the laminating of ventricle inner wall, promotes heart isolating device volume reduction choked effect.

Other features of the present invention and advantages thereof will become apparent from the following detailed description of exemplary embodiments of the invention, which proceeds with reference to the accompanying drawings.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.

FIG. 1 is a schematic diagram of a heart isolation device according to an embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is another schematic view of a heart isolation device according to an embodiment of the present invention;

FIG. 4 is a schematic view of the heart isolation device of the present invention in use;

fig. 5 is a schematic view of another application of the heart isolation device of the present invention.

Detailed Description

Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that: unless specifically stated otherwise, the relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present invention.

The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.

Techniques and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail, but are intended to be considered a part of the specification where appropriate.

In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

Fig. 1 and fig. 3 show two kinds of schematic structural diagrams of the heart isolation device provided by the present invention respectively, from which two different improved structures of the heart isolation device can be seen, fig. 2 is a partial enlarged view of fig. 1, and fig. 4 and fig. 5 show two kinds of schematic application diagrams of the heart isolation device provided by the present invention respectively, which show the specific position, setting mode, etc. of the heart isolation device. The structure, principle, etc. of the heart isolation device of the present invention will now be described in detail with reference to fig. 1 to 5.

The utility model provides a heart isolating device, this isolating device includes: an expandable device body 1 and a polymeric membrane. The device body 1 is of an umbrella structure and the polymer membrane is attached to the expandable device body. When the isolating device is implanted into a ventricle, a diseased part of the ventricle is isolated into two parts, and the polymer film is used for blocking blood flowing to the diseased part. The device main body is umbrella-shaped and is formed by enclosing a plurality of support rods, and the plurality of support rods arranged in the circumferential direction gradually diffuse and extend outwards to form the umbrella-shaped device main body.

Further, the head end 11 of the support rod is used for fitting the inner wall of the ventricle, and the support rod 10 is formed with at least one fixing part 12 extending outwards at a position between the head end and the tail end. In this embodiment, the fixing portion 12 may be integrally formed on the support rod 10 through a cutting process, or may be formed through a process familiar to those skilled in the art, which is not limited in this embodiment. The head end 11 of the support rod and the at least one fixing portion 12 are both directed towards the inner wall of the ventricle for engaging with or penetrating into the inner wall of the ventricle to fix the heart isolation device within the ventricle. In particular, the "tip end" in this embodiment refers to the end of the umbrella-shaped device body where the stent rod is spread and flared outward. The opposite "tail end" is the other end of the support rod in the main body of the device, which is far away from the head end.

As shown in fig. 1 and 3, the head end 11 of the stent rod is higher than the fixing part 12, the head fixing part 12 is distributed at a position between the head end and the tail end of the stent rod, and the fixing part 12 is configured to pierce the inner wall of the ventricle and then provide a force for the head end 11 of the stent rod to adhere to the inner wall of the ventricle. Like this, the head end of cradling piece can with the laminating of ventricle inner wall, avoids blood to flow to pathological change position through the clearance between device main part and the ventricle inner wall, leads to the ventricle to subtract the volume and flow the choked flow effect variation.

The number of the fixing portions 12 may be one or more. For example, the head end 11 and the fixing portion 12 of one stent rod are formed on the stent rod 10 through one bifurcation, and the head end 11 and the fixing portion 12 of one stent rod are formed on the stent rod 10 through two bifurcations. The number of the fixing parts with proper number can be selected by those skilled in the art according to actual needs. The anchoring portion is configured to pierce an inner wall of the ventricle. For example, an anchoring structure is provided at the fixation portion and at an end facing the inner wall, the anchoring structure being capable of penetrating the inner wall to fix the isolation device inside the ventricle. The fixing parts are respectively penetrated into the inner wall of the ventricle, when the heart contracts and moves, the fixing parts are stably connected with the inner wall of the heart, so that the problems of displacement, torsion and the like of the heart isolating device can be avoided, and the possibility of failure of the device is reduced.

In this embodiment, the support rod 10 is formed with at least one fixing portion 12 at a position between the head end and the tail end. As shown in fig. 2, the fixing parts 12 are sequentially distributed at positions of the support rod 10 near the head end. Alternatively, the stent rod may be cut to form a plurality of fixing portions at a certain position, i.e., the plurality of fixing portions may extend from the same position to penetrate into the inner wall of the heart. Both of these alternative embodiments are within the scope of the present invention.

The heart isolation device provided by the embodiment is applied to interventional therapy of the heart, at least one fixing part is formed by outwards extending the position between the head end and the tail end of the support rod combined by the device main body and the inner wall of the heart, and the head end of the support rod is tightly attached to the inner wall of a ventricle through the fixing part, so that the tightness of the attachment of the heart isolation device and the inner wall of the ventricle is improved. Compare in traditional heart isolating device, a plurality of fixed parts pierce heart inner wall in proper order, form firm being connected with ventricular inner wall, avoid the device problem that the aversion appears. The fixing parts penetrate into the inner wall tissue to provide force for the head end of the support rod to be attached to the inner wall of the ventricle, so that the attaching effect of the head end of the support rod and the inner wall of the ventricle can be enhanced, the blood is prevented from flowing to a lesion part through a gap between the device main body and the inner wall of the ventricle, and the effect of reducing volume and blocking flow of the ventricle is reduced.

Optionally, the support bar 10 has a plurality of branches thereon. As shown in fig. 3, three branches are sequentially distributed from the head end to the tail end of the support rod 10, and the branches constitute the fixing portion 12. In this embodiment, the stent rod 10 is bifurcated from the head end to the tail end to form a plurality of fixing portions 12, each fixing portion 12 facing the inner wall of the ventricle. Compared with the situation that only one fixing part 12 is arranged, the heart isolation device can increase the stability of the fixed connection of the fixing part 12 and the heart inner wall tissue, the fixing parts 12 penetrate the inner wall tissue to provide an acting force towards the heart inner wall for the head end of the support rod, the head end of the support rod can be tightly attached to the heart inner wall by the component force of the acting force in the horizontal direction, blood flowing to a pathological change part is effectively blocked, and the volume reduction and flow blocking effects of the heart isolation device are remarkably improved.

In addition, a developing device is provided in the fixing portion 12. After the heart isolation device is implanted into the ventricle of a patient, the position of the isolation device, whether the support rod is stably connected with the inner wall of the ventricle or not and the like can be accurately judged through perspective or shooting images, and therefore the personal safety of the patient is guaranteed.

In a possible embodiment, the length of the fixing parts 12 from the head end to the tail end of the support rod 10 in the radial direction of the umbrella-shaped device body 1 decreases sequentially. As shown in fig. 3, a heart isolating device with three fixing portions 12 is shown. In this embodiment, three fixing portions 12 are distributed from the head end of the support rod 10 to the bottom in sequence, and the lengths of the three fixing portions 12 in the horizontal direction are X₂、X₃、X₄. Wherein, X₂＞X₃＞X₄. In this way, it is ensured that each of the fixing portions 12 can pierce the inner wall of the ventricle and form a firm connection with the tissue of the inner wall of the ventricle.

As shown in fig. 4, the ventricle is in an irregular conical shape, the inner wall of the ventricle gradually shrinks inwards towards the apex of the heart, and the fixing part 12 close to the apex of the heart can be penetrated into the inner wall tissue only by branching a short length from the stent rod 10. In this embodiment, the plurality of fixing portions are adapted to the shape of the ventricle, and the fixing portions, the lengths of which are sequentially decreased in the radial direction of the umbrella-shaped device main body, effectively increase the binding force between the support rod and the inner wall of the ventricle, and contribute to the close attachment of the head end of the support rod and the inner wall of the ventricle.

Preferably, the length of the fixing portion 12 accounts for 25% -75% of the length of the head end 11 of the support rod. Since the head end 11 of the stent rod needs to be attached to the inner wall of the ventricle, and the fixing portion 12 is located below the head end 11 of the stent rod, it needs to pierce the inner wall of the ventricle. Therefore, the length of the fixing part 12 is in the range of 25% -75% of the length of the head end 11 of the support rod, and the fixing part, the head end of the support rod and the inner wall of the ventricle can be well combined. As will be appreciated by those skilled in the art, the length of the fixation section as a percentage of the length of the head end of the stent rod varies for different fixation sections. For example, three fixing parts are distributed downwards from the head end of the support rod, and the ratio of the length of each fixing part is 75%, 50% and 25% in sequence.

Correspondingly, the length of the head end 11 of the support rod accounts for 15% -40% of the length of the device main body 1. As shown in fig. 3, since the fixing portion 12 is formed by branching from the head end of the stent rod 10, the head end 11 of the stent rod is subjected to a pre-tightening force applied by the fixing portion 12 towards the inner wall of the ventricle, so that the head end 11 of the stent rod is tightly attached to the inner wall of the ventricle. The length of the head end 11 of the support rod is closely related to the position and the area of the joint. For different heart isolation devices, the length of the head end of the support rod accounts for 15% -40% of the length of the device main body, so that a good fitting effect can be realized, the head end of the support rod cannot interfere with other tissues in a heart chamber, and the stability of the heart isolation device is ensured.

Alternatively, the fixing parts 12 are distributed on the support rod 10 at equal intervals. Thus, the plurality of fixing portions 12 are more compliant with the inner wall of the ventricle, and a stable bond can be formed. Each fixing part can bear acting force with the same size, and when the heart contracts, the possibility that the isolating device is displaced and broken can be reduced by each fixing part, so that the isolating device has better fatigue strength and is beneficial to improving the stability of the isolating device.

Further, the length of the head end 11 of the holder rod in the radial direction of the umbrella device body 1 is larger than the length of the fixing portion 12 in the radial direction of the umbrella device body 1. As shown in FIG. 3, the length of the head end 11 of the stent pole in the radial direction of the umbrella-shaped device body 1 is X₁The lengths of the three fixing portions 12 in the horizontal direction are X₂、X₃、X₄. Since, on the apparatus main body 1, the head end 11 of the holder bar is higher than the plurality of fixing portions 12, and the head end 11 of the holder bar is to be attached to the inner wall of the ventricle. Therefore, the length of the head end of the support rod in the radial direction of the umbrella-shaped device main body is larger than that of the fixing part in the radial direction of the umbrella-shaped device main body, so that the attaching effect of the head end of the support rod and the inner wall of the ventricle is improved.

In another possible embodiment, the head end 11 of the stent rod is configured to be attached to the inner wall of the ventricle by its own elastic restoring force. The fixation portion 12 is configured such that the head end 11 of the stent rod provides additional force against the inner wall of the ventricle. As shown in FIGS. 4 and 5, the heart isolation device of the present invention is shown in two alternative ways to be implanted in the ventricle, one way to implant the isolation device transapically in the ventricle and the other way to implant the isolation device transapically in the ventricle. In the actual implantation process, after the isolating device is expanded by the aid of the saccule, the support rod is expanded from the center to the periphery, and the head end of the support rod can be attached to the inner wall of the ventricle for the first time by the aid of elastic restoring force of the support rod by utilizing the characteristics of self materials. Because there is certain contained angle between the head end of fixed part and cradling piece, after the fixed part stabbed the ventricular inner wall, the fixed part can receive an effort towards the ventricular inner wall, and this effort can make the head end of cradling piece provide extra effort along the component of horizontal direction, makes the head end of cradling piece tightly laminate on the ventricular inner wall, has strengthened the further laminating effect of cradling piece and ventricular inner wall. Through the combined action of the two progressive modes, the isolation device can be tightly and firmly attached to the ventricle, and the volume reduction and flow blocking effects of the heart isolation device are improved.

Specifically, the included angle between the head end 11 of the support rod and the fixing part 12 ranges from 15 degrees to 60 degrees. As shown in FIG. 2, when the fixing portion 12 pierces the inner wall of the ventricle, the fixing portion 12 is subjected to a force toward the inner wall of the heart, and the horizontal component of the force can make the head end 11 of the stent rod tightly fit on the inner wall of the ventricle. The range of the included angle between the head end 11 of the support rod and the fixing part 12 is related to the component force applied to the head end of the support rod. Preferably, the included angle between the head end 11 of the support rod and the fixing part 12 is 25-45 degrees, so that the head end of the support rod can be better attached to the inner wall of the heart chamber to isolate blood flowing to a lesion part and improve the volume reduction and flow blocking effects of the heart isolation device.

Optionally, the polymeric membrane is attached on an inner surface of the stent rod. The polymer membrane is used for isolating blood, so that the blood cannot flow to the outer side of the isolating device, and the effect of plugging is achieved. The polymer film is at least provided with two layers which are respectively attached to the inner surface and the outer surface of the support rod, and the fixing part penetrates through the polymer film on the outer surface. The polymer membrane on the bracket rod is completely and tightly attached to the inner wall of the ventricle, so that the blood flow can not flow to the lesion part through the gap between the polymer membrane and the ventricle.

Preferably, another polymer film is attached to the inner surface and the outer surface of the fixing part, respectively. The polymer film attached to the fixing part can be used as another flow blocking barrier to prevent blood passing through the head end of the support rod from entering a diseased part, so that the volume reduction and flow blocking effects of the heart isolation device are ensured. As shown in fig. 4 and 5, the polymer film 3 attached to the inner surface of the support rod and the other polymer film 4 attached to the outer surface may be made of the same or different materials, for example, EPTFE, PET film, polyurethane, etc.

Further, the present embodiment provides a heart isolation apparatus, further comprising: and the base 2 is positioned at the bottom end of the device main body 1, and the base 2 is connected with the tail end of the support rod 10. The base 2 may be woven from NITI filaments or injection molded from a polymeric material for securing the isolation device within the ventricle.

Although some specific embodiments of the present invention have been described in detail by way of illustration, it should be understood by those skilled in the art that the above illustration is only for purposes of illustration and is not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A cardiac isolation device, comprising: an expandable device body and a polymeric membrane attached to the device body;

2. The heart isolating device of claim 1, wherein the support rod has a plurality of branches, the branches are distributed from the head end to the tail end of the support rod, and the branches constitute the fixing portion.

3. The heart isolating device as recited in claim 2, wherein the fixing portions from the head end to the tail end of the support rod have a length in a radial direction of the umbrella-shaped device body that decreases sequentially.

4. The heart isolating device of claim 1, wherein the head end of the strut has a length in a radial direction of the umbrella device body that is greater than a length of the fixation portion in the radial direction of the umbrella device body.

5. The heart isolation device of claim 1, wherein the head end of the stent rod is configured to engage the inner wall of the ventricle under its own elastic restoring force; the fixation portion is configured such that the head end of the stent rod provides additional force against the inner wall of the ventricle.

6. The heart isolating device of claim 1, wherein the plurality of fixation portions are equidistantly distributed on the support rod.

7. The heart isolation device of claim 1, wherein the polymeric membrane is attached to an inner surface of the stent rod; or, the polymer film is provided with at least two layers which are respectively attached to the inner surface and the outer surface of the support rod, and the fixing part penetrates through the polymer film on the outer surface.

8. The heart isolating device of claim 1, wherein an angle between the head end of the stent rod and the fixing portion is in a range of 15 ° -60 °.

9. The heart isolation device of claim 1, wherein another polymer film is attached to the inner surface and the outer surface of the fixing portion, respectively.

10. The cardiac isolation device of claim 1, further comprising: the base is located at the bottom end of the device main body and connected with the tail end of the support rod.