CN112890902B - Heart isolating device - Google Patents

Abstract

The present disclosure discloses a heart isolation device. The heart isolation device comprises a device main body and a balloon structure, wherein the device main body is in an unfolded state, and is in an umbrella shape in the unfolded state; the balloon structure is located on a deployment side of the device body; the balloon structure comprises at least a first balloon and a second balloon, the first balloon and the second balloon being connected; the balloon structure has an inflated state in which the transverse dimension of the second balloon is greater than the transverse dimension of the first balloon, and the first and second balloons each form a butt-grip against the deployed side of the device body to place the device body in the deployed state.

Description

Heart isolating device

Technical Field

The present disclosure relates to the field of medical devices, and more particularly, to a heart isolation device.

Background

In recent years, there has been a great deal of progress in the treatment of heart disease, but heart failure, one of the ultimate outcomes of all heart diseases, is always threatening the health of humans. There are many causes of heart failure, one of the most common causes of which is acute myocardial infarction. Acute myocardial infarction is caused by myocardial injury and subsequent scarring, so that the heart is enlarged and heart failure occurs, and particularly, the heart failure is more likely to occur to patients with anterior myocardial infarction combined with ventricular aneurysms, which not only seriously affects the quality of life of the patients, but also causes huge economic burden to families and society.

Currently, most treatments for heart failure involve interventional procedures, which involve the implantation of a heart isolation device into 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. However, the existing heart isolation devices still have a plurality of defects. For example, when a balloon in the existing heart isolation device is matched with a stent, the stent cannot be completely expanded, so that the tip of the stent cannot be completely inserted into the inner wall of the heart, and even part of supporting rods of the stent may fall off, thereby causing poor isolation effect.

In view of the above, a new technical solution is needed to solve the above technical problems.

Disclosure of Invention

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

According to a first aspect of the present disclosure, there is provided a cardiac isolation device comprising:

a device body having an expanded state in which the device body is umbrella-shaped;

a balloon structure located on a deployment side of the device body; the balloon structure comprises at least a first balloon and a second balloon, the first balloon and the second balloon being connected; the balloon structure has an inflated state in which the transverse dimension of the second balloon is greater than the transverse dimension of the first balloon, and the first and second balloons each form a butt-grip against the deployed side of the device body to place the device body in the deployed state.

Optionally, the first balloon has a first attaching portion attached to the device main body, and the second balloon has a second attaching portion attached to the device main body; the cross section width of the first attaching portion is smaller than that of the second attaching portion.

Optionally, the wall thickness of the first balloon is less than the wall thickness of the second balloon.

Optionally, the balloon structure is made of an elastic material.

Optionally, the balloon structure is made of a thermoplastic elastomer.

Optionally, the balloon structure is made by a blow molding process.

Optionally, in the inflated state, the interior of the balloon structure is filled with saline.

Optionally, the device main body comprises a support and a membrane body covered and arranged on the support; the support comprises a plurality of support rods which are arranged in a radial mode from the same vertex.

Optionally, a reinforcing member is arranged between two adjacent support rods.

Optionally, the reinforcement is a degradable material.

According to the heart isolating device that an embodiment of this disclosure provided, it is through setting up the sacculus structure to include first sacculus and second sacculus at least to the transverse dimension of second sacculus is greater than the transverse dimension of first sacculus, thereby make first sacculus and second sacculus respectively to the side formation top of expanding of device main part and hold the effect, this sacculus structure can laminate with the device main part more like this, sacculus structure and device main part cooperate inseparabler, the sacculus structure can strut the device main part better, thereby reach more effective isolation.

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

Drawings

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

FIG. 1 is a schematic view of a balloon in a heart isolation device according to one embodiment of the present disclosure;

FIG. 2 is a first schematic structural view of a cardiac isolation device according to one embodiment of the present disclosure;

fig. 3 is a schematic structural diagram two of a cardiac isolation device according to one embodiment of the present disclosure.

Detailed Description

Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that: 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 disclosure unless specifically stated otherwise.

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

Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be 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.

Referring to fig. 1-2, a heart isolation device is provided according to one embodiment of the present disclosure. The heart isolation device comprises adevice body 11 and aballoon structure 12, wherein thedevice body 11 has an unfolded state, and in the unfolded state, thedevice body 11 is umbrella-shaped; theballoon structure 12 is located on the deployment side of thedevice body 11; theballoon structure 12 comprises at least afirst balloon 121 and asecond balloon 122, thefirst balloon 121 and thesecond balloon 122 being connected; theballoon structure 12 has an inflated state in which the transverse dimension of thesecond balloon 122 is larger than the transverse dimension of thefirst balloon 121, and thefirst balloon 121 and thesecond balloon 122 respectively support the deployment side of thedevice body 11, so that thedevice body 11 is in the deployed state.

In the heart isolation device provided by the embodiment of the application, thedevice body 11 can be expanded to the unfolding state in an involute manner, and thedevice body 11 presents an umbrella-shaped structure in the unfolding state. When the heart isolation device is implanted into a ventricle, a lesion in the ventricle is isolated into two parts, and thedevice body 11 is used for blocking blood flowing to the lesion. Wherein theballoon structure 12 is used to expand thedevice body 11 to the deployed state; in particular, theballoon structure 12 has an inflated state in which theballoon structure 12 is supported on the deployment side of thedevice body 11, i.e. the inner side of thedevice body 11 facing the opening. In the heart isolation device provided in the embodiment of the present application, theballoon structure 12 is composed of at least two balloons, for example, referring to fig. 1, theballoon structure 12 includes afirst balloon 121 and asecond balloon 122 connected to each other, thefirst balloon 121 and thesecond balloon 122 have different sizes, and specifically, when theballoon structure 12 is in the filling state, the transverse size of thesecond balloon 122 is larger than that of thefirst balloon 121. Since the devicemain body 11 is an involute expansion umbrella structure, the transverse dimension of the devicemain body 11 is gradually increased along the involute expansion direction thereof, and therefore theballoon structure 12 of the embodiment of the present application can exert a plurality of support actions on the deployment side of the devicemain body 11 in the involute expansion direction of the devicemain body 11. For example, referring to fig. 1, along the direction of the involute expansion of thedevice body 11, thefirst balloon 121 and thesecond balloon 122 respectively form a supporting function on the unfolding side of thedevice body 11, so that theballoon structure 12 can be more attached to thedevice body 11, theballoon structure 12 and thedevice body 11 can be more tightly fitted, and theballoon structure 12 can better support thedevice body 11, thereby achieving a more effective isolation function.

Referring to fig. 2, in one embodiment, further, thefirst balloon 121 has a first fitting portion fitted to thedevice body 11, and thesecond balloon 122 has a second fitting portion fitted to thedevice body 11; the cross section width of the first attaching portion is smaller than that of the second attaching portion.

In this specific example, thefirst balloon 121 is bonded to theapparatus body 11 at the position of the first bonded portion, and thesecond balloon 122 is bonded to theapparatus body 11 at the position of the second bonded portion. To ensure that both thefirst balloon 121 and thesecond balloon 122 are tightly fitted to thedevice body 11, the second fitting portion has a cross-sectional width larger than that of the first fitting portion. In one particular example, the volume ofsecond balloon 122 in the inflated state may be made greater than the volume offirst balloon 121 in the inflated state, such that theentire balloon structure 12 exhibits a gourd-like configuration.

In one embodiment, further, the wall thickness of thefirst balloon 121 is smaller than the wall thickness of thesecond balloon 122.

The wall thickness of the balloon influences the expansion speed of the balloon when the balloon is switched from the contraction state to the filling state, specifically, the expansion speed of thefirst balloon 121 with the thin wall thickness is faster than that of thesecond balloon 122 with the thick wall thickness, which is beneficial to enabling thefirst balloon 121 to be firstly expanded to the filling state, so that thefirst balloon 121 firstly jacks the devicemain body 11 to be in an umbrella shape, and then when thesecond balloon 122 is also completely expanded to the filling state, thesecond balloon 122 can further jack the devicemain body 11, so that the tip of the devicemain body 11 is more firmly inserted into the inner wall of the heart, thereby achieving a more effective isolation effect.

In one embodiment, theballoon structure 12 is made of an elastic material.

Theballoon structure 12 made of an elastic material can be smoothly and easily inflated to a full state.

More specifically, in one embodiment, the material of theballoon structure 12 is a thermoplastic elastomer material.

The thermoplastic elastomer material has various excellent performances of high elasticity, aging resistance, oil resistance and the like, and has the characteristics of convenient processing and wide processing and forming modes. Theballoon structure 12 made of the thermoplastic elastomer material is environment-friendly and nontoxic. Optionally, the thermoplastic elastomer material may be one of thermoplastic polyurethane elastomer rubber (TPU), PEBAX resin, nylon, and polyethylene.

In one embodiment, further, theballoon structure 12 is made by a blow molding process.

The blow molding process has the advantages of simple processing process, easy operation and lower processing cost.

In one embodiment, further, in the inflated state, the interior of theballoon structure 12 is filled with saline.

The normal saline is filled, so that theballoon structure 12 can be smoothly and easily expanded to the filling state, and the normal saline is non-toxic and harmless to the human body and does not produce side effects. Further, the inflation volume of theballoon structure 12 can be controlled by controlling the injection amount of the saline injected into theballoon structure 12.

Referring to fig. 3, in one embodiment, thedevice body 11 further includes a support and amembrane 112 covering the support; the bracket includes a plurality of support bars 111 radiating from the same apex.

In this specific example, thedevice body 11 is specifically composed of a stent and amembrane 112 covering the stent, wherein the stent is surrounded by a plurality ofsupport rods 111 radially arranged from the same vertex, and in use, themembrane 112 blocks blood flowing to a lesion, and the stent supports themembrane 112.

Referring to fig. 3, in one embodiment, a reinforcingmember 113 is further disposed between twoadjacent support rods 111.

In this specific example, the provision of the reinforcingmember 113 can improve the supporting strength of the entire apparatusmain body 11, thereby further ensuring the insulating effect of the apparatusmain body 11.

In one embodiment, the reinforcingmember 113 is made of degradable material.

In this specific example, thereinforcement member 113 made of a degradable material may not only serve to increase strength in an early stage of implantation of thedevice body 11 into the human body, but also reduce the implant in the human body along with degradation of thereinforcement member 113 in a later stage of implantation, thereby improving safety.

In the above embodiments, the differences between the embodiments are described in emphasis, and different optimization features between the embodiments can be combined to form a better embodiment as long as the differences are not contradictory, and further description is omitted here in consideration of brevity of the text.

Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the foregoing examples are for purposes of illustration only and are not intended to limit the scope of the present disclosure. 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 present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims (8)

1. A cardiac isolation device, comprising:

a device body (11), the device body (11) having an expanded state in which the device body (11) is umbrella-shaped;

a balloon structure (12), the balloon structure (12) being located on a deployment side of the device body (11); the balloon structure (12) comprises at least a first balloon (121) and a second balloon (122), the first balloon (121) and the second balloon (122) being connected; the balloon structure (12) has an inflated state in which the transverse dimension of the second balloon (122) is greater than the transverse dimension of the first balloon (121), and the first balloon (121) and the second balloon (122) respectively form a butt against the deployment side of the device body (11) to bring the device body (11) into the deployed state;

the first balloon (121) has a first bonded portion bonded to the device body (11), and the second balloon (122) has a second bonded portion bonded to the device body (11); the cross section width of the first attaching part is smaller than that of the second attaching part; the wall thickness of the first balloon (121) is smaller than the wall thickness of the second balloon (122).

2. A cardiac isolation device according to claim 1, wherein the balloon structure (12) is of an elastic material.

3. A cardiac isolation device according to claim 2, wherein the balloon structure (12) is of a thermoplastic elastomer material.

4. The heart isolation device of claim 1, wherein the balloon structure (12) is made by a blow molding process.

5. Cardiac isolation device according to claim 1, wherein in the inflated state the interior of the balloon structure (12) is filled with saline.

6. A cardiac isolation device according to claim 1, wherein the device body (11) comprises a stent and a membrane body (112) disposed over the stent; the support comprises a plurality of support rods (111) which are arranged in a radial mode from the same vertex.

7. A cardiac isolation device according to claim 6, wherein a reinforcement (113) is arranged between two adjacent support rods (111).

8. The heart isolating device as recited in claim 7, wherein the reinforcing element (113) is a degradable material.

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