CN217118467U

CN217118467U - Plugging device for perforation of ventricular septum and treatment system

Info

Publication number: CN217118467U
Application number: CN202121297168.5U
Authority: CN
Inventors: 任凯炳; 朱泽荀; 姚瑶; 程智广; 李俊菲
Original assignee: Minimally Invasive Investment Holdings Ltd
Current assignee: Minimally Invasive Investment Holdings Ltd
Priority date: 2021-06-10
Filing date: 2021-06-10
Publication date: 2022-08-05
Anticipated expiration: 2031-06-10

Abstract

The utility model relates to a perforation of room interval is with plugging device and treatment system, treatment system include plugging device and conveyer, and the perforation of room interval is with plugging device includes polymer shutoff patch and adhesive, and the conveyer includes the sacculus pipe, and the distal end of sacculus pipe is used for with shutoff patch detachable be connected, has the cavity after the shutoff patch expansion, the cavity has the open end at least, is used for at least part after the shutoff patch expansion to wear to establish in the perforation of room interval, and the adhesive is used for being connected shutoff patch and room interval to the perforation problem of treatment room interval, and can realize tight and stable shutoff.

Description

Plugging device for perforation of ventricular septum and treatment system

Technical Field

The utility model relates to the technical field of medical equipment, in particular to plugging device and treatment system for perforation of room interval.

Background

Post-myocardial infarction ventricular septal perforation (VSR) is secondary ventricular septal defect caused by ischemia and rupture of ventricular septum after acute myocardial infarction, is one of serious complications after Acute Myocardial Infarction (AMI) and accounts for about 1-2% of patients with acute myocardial infarction. The incidence of the disease is greater in men than women, and most occurs after the initial myocardial infarction. Once the perforation of the ventricular septum occurs, left-right blood shunt occurs, the blood volume of the systemic circulation is reduced, the blood volume of the pulmonary circulation is increased, and the patients have hypotension, low heart discharge syndrome, pulmonary edema, left/right heart insufficiency, oliguria, dyspnea and even multi-organ failure. The prognosis for ventricular septal perforation is very poor, with a mortality rate of 25% at 24 hours, 50% within a week, and a mortality rate of up to 80% in a month, with only 7% of patients surviving for more than a year.

Therefore, treatment of the perforation of the interventricular septum is critical. However, since it is different from congenital ventricular septal defect in terms of mechanism of formation, pathophysiology, etc., it is also very different in therapeutic methods. The current treatment methods mainly comprise medication, surgery and intervention treatment. The medical drug therapy aims to improve symptoms and cardiac function, and creates opportunities for the next operation or interventional therapy. Surgical treatment is to repair the ventricular septal perforation of a patient by means of an open chest, but since the tissues of the ventricular septal at the beginning of the perforation are extremely fragile, the surgical operation usually needs to wait at least two weeks for the tissues to initially heal to ensure the suture strength. But this is not favorable for alleviating the pain of the patient and reducing the death rate of the patient.

Currently, no specially designed occluder for ventricular septal perforation exists in interventional occlusion treatment, and clinically used occluders are congenital ventricular septal defects which easily damage fragile tissues at the ventricular septal perforation, easily cause complications such as residual shunt and the like, are unstable in fixation, and have risks such as nickel ion precipitation and allergy.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a perforation of ventricular septum is with plugging device and treatment system to be adapted to the ventricular septum perforation that arouses behind the myocardial infarction, can solve one or more among the above-mentioned technical problem that congenital ventricular septum defective plugging device exists.

In order to achieve the above object, according to the first aspect of the present invention, there is provided an occluder for perforating a room interval, comprising a polymer occlusion patch and an adhesive, wherein the polymer occlusion patch has a cavity after being expanded, the cavity has at least one opening end, the polymer occlusion patch is configured to be at least partially worn to be disposed in the room interval perforation after being expanded, and the polymer occlusion patch is adhered and fixed with the room interval by the adhesive.

Optionally, the polymeric occlusion patch has an inner side and an outer side, and a partial region of the inner side of the polymeric occlusion patch is communicated with a partial region of the outer side of the polymeric occlusion patch to allow the adhesive to flow from the inner side to the outer side of the polymeric occlusion patch.

Optionally, the polymeric occlusion patch is at least partially made of a porous material, and an inner side and an outer side of an area made of the porous material of the polymeric occlusion patch are communicated.

Optionally, the macromolecule plugging patch is made of a porous material, and the plugging device for perforation of the ventricular septum further comprises a fluid blocking body; the fluid blocking body covers the surface of the high polymer plugging patch; part of the surface of the inner side of the macromolecule plugging patch is not covered with the bluff body; the part of the surface of the outer side of the polymer plugging patch is not covered by the bluff body, and the part of the inner side of the polymer plugging patch, which is not covered by the bluff body, is communicated with the part of the outer side, which is not covered by the bluff body.

Optionally, the polymeric occlusion patch comprises a first portion and a second portion that are fixedly connected; the first portion is made of a porous material; the second portion is made of a non-porous material; wherein the first portion comprises a portion of the surface of the interior side of the polymeric occlusion patch; at least part of the area of the first part penetrates through the inner side and the outer side of the macromolecule plugging patch.

Optionally, an elastic wire is arranged inside the polymer plugging patch.

Optionally, the polymeric occlusion patch comprises: the plugging part is used for being arranged in the perforation of the ventricular septum in a penetrating way, and the fixing part is arranged on at least one side wall of the ventricular septum and is used for clamping the non-diseased cardiac muscle of the ventricular septum; wherein the elastic wire is provided inside the fixing portion.

Optionally, the polymer blocking patch is in a hat shape and includes a cap and a brim structure, the cap constitutes the blocking portion and is configured to penetrate through the through hole of the indoor space, the brim structure constitutes the fixing portion and is configured to be disposed on a side wall of the indoor space, and the elastic wire is disposed inside the brim structure.

Optionally, the polymer occlusion patch is of a structure with a closed distal end and an open proximal end, and a connecting piece is arranged at the distal end of the cavity and is used for being separably connected with a conveyor.

Optionally, the proximal open end of the polymeric occlusion patch is an outwardly extending visor structure configured to clamp the non-diseased myocardium of the ventricular septum at a sidewall of the ventricular septum.

Optionally, the distal outer surface of the polymer occlusion patch is formed with an outward-tilted flying wing, and the flying wing is used for clamping non-diseased cardiac muscle of the ventricular septum on the other side wall of the ventricular septum.

Optionally, the flying wing and/or the visor structure is internally provided with an elastic wire.

Optionally, the adhesive is a two-component material, and a first component of the adhesive is coated on a part of the surface of the polymer plugging patch.

In order to achieve the above object, according to a second aspect of the present invention, there is provided a treatment system comprising a conveyor and any one of the above occluders for perforation of ventricular septum, the conveyor comprising a balloon catheter having a distal end detachably connected to the occluder for perforation of ventricular septum; the balloon catheter comprises a balloon, wherein micropores are formed on the surface of the balloon and used for releasing the adhesive.

Optionally, the transporter further comprises a storage bin and a pressurizer, the storage bin being connected to the proximal end of the balloon catheter and the pressurizer, respectively; the storage bin is used for storing the component materials of the adhesive, and the pressurizer is used for pressurizing the storage bin to enable the component materials of the adhesive to enter the balloon catheter.

Optionally, the conveyor further comprises a valve for controlling the pressurizer to selectively communicate with one of the storage bin and the balloon catheter, and controlling the balloon catheter to selectively communicate with one of the storage bin and the pressurizer.

Optionally, the valve comprises a first three-way valve controlling the pressurizer to selectively communicate with one of the storage bin and the balloon catheter, and a second three-way valve controlling the balloon catheter to selectively communicate with one of the storage bin and the pressurizer;

the conveyer still includes connecting tube, connecting tube includes first connecting pipe, second connecting pipe and third connecting pipe, the import of first three-way valve passes through first connecting pipe with the presser is connected, an export of first three-way valve passes through the second connecting pipe with the storage storehouse is connected, another export of first three-way valve passes through the third connecting pipe with an access connection of second three-way valve, another import of second three-way valve with the storage storehouse is connected, an export of second three-way valve with the near-end of sacculus pipe is connected.

Optionally, the storage bin comprises a first storage bin and a second storage bin, the first storage bin stores the first component of the adhesive, the second storage bin stores the second component of the adhesive, the first storage bin is connected with the second storage bin, the conveyor further comprises a valve, the valve is used for controlling on-off between the first storage bin and the second storage bin and controlling the balloon catheter to be selectively connected with one of the first storage bin and the second storage bin.

Optionally, the valve includes a one-way valve and a three-way valve, the one-way valve is used for controlling on-off between the first storage bin and the second storage bin, one inlet of the three-way valve is connected with the second storage bin, the other inlet of the three-way valve is connected with the first storage bin, and one outlet of the three-way valve is connected with the proximal end of the balloon catheter.

Compared with the prior art, the utility model discloses a perforation of ventricular septum is with plugging device and treatment system has following advantage:

first, the plugging device for perforation of ventricular septum includes a polymer plugging patch and an adhesive. The interventricular septum piercing occluder is configured to: the macromolecule plugging patch is at least partially arranged in the ventricular septum perforation after being expanded, and meanwhile, the adhesive is used for fixing the macromolecule plugging patch and the ventricular septum, so that tight plugging can be realized, complications such as residual shunt and the like are reduced, the plugging performance is good, the treatment effect can be better improved, meanwhile, the risks such as nickel precipitation, allergy and the like possibly caused by long-term implantation of the nickel-titanium metal stent can be avoided, and the safety is improved. Particularly, when the polymer plugging patch is fixed by the adhesive, not only can stable fixation be realized, but also the plugging performance can be enhanced by the adhesive, and the plugging effect is better. And the utility model discloses a macromolecular material preparation shutoff patch of non-self-expanding formula makes the fragile pathological change cardiac muscle of shutoff patch in can the direct contact room interval perforation, is difficult to damage pathological change cardiac muscle.

Secondly, the polymer plugging patch is preferably made of a porous material in whole or in part, and the porous structure is convenient for the adhesive to flow from the inner side to the outer side of the polymer plugging patch, so that the structure is simple and the use is convenient.

Thirdly, the elastic wires are arranged in the polymer plugging patch, particularly in the fixing part positioned on at least one side of the compartment space, so that the shape recovery capability of the plugging patch can be enhanced, and the plugging effect is better.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

FIG. 1a is a schematic view of a preferred embodiment of the treatment system of the present invention in a delivery sheath;

FIG. 1b is a schematic view of the treatment system of a preferred embodiment of the present invention in a configuration in which the delivery sheath is pushed out to complete expansion;

FIG. 1c is a schematic view of the injection of the adhesive according to a preferred embodiment of the present invention;

fig. 1d is a schematic view of the plugging device completing plugging after the conveyor is withdrawn according to a preferred embodiment of the present invention;

fig. 2a is a schematic structural diagram of a plugging patch in a first preferred embodiment of the present invention;

fig. 2b is a perspective structural view of a plugging patch according to a first preferred embodiment of the present invention;

fig. 3 is a schematic structural diagram of a conveyor in a first preferred embodiment of the invention;

fig. 4 is a schematic structural diagram of a plugging patch according to a second preferred embodiment of the present invention;

fig. 5 is a schematic structural view of a conveyor according to a second preferred embodiment of the present invention;

fig. 6 to fig. 8 are schematic structural views of the plugging patch according to the preferred embodiment of the present invention.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It should be noted that the drawings are in a very simplified form and are not to precise scale, which is only used for the purpose of facilitating and clearly explaining the embodiments of the present invention.

It should be understood that the structure, ratio, size and the like shown in the drawings attached to the present specification are only used for matching with the content disclosed in the specification, so as to be known and read by those skilled in the art, and are not used for limiting the limit conditions that the present invention can be implemented, so that the present invention has no technical essential meaning, and any structure modification, ratio relationship change or size adjustment should still fall within the scope that the technical content disclosed in the present invention can cover without affecting the function that the present invention can produce and the purpose that the present invention can achieve. Meanwhile, the terms such as "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for convenience of description, and are not intended to limit the scope of the present invention, and changes or adjustments of the relative relationship thereof may be made without substantial technical changes, and the present invention is also regarded as the scope of the present invention. Herein, "proximal" refers to the end of the device near the operator; "distal" as opposed to "proximal" refers to the end of the device distal to the operator; "radial" means a direction perpendicular to the axis of the device; "axial" means a direction parallel to the axis of the device.

The utility model provides a stopper (hereinafter for short stopper) is used in perforation of room interval, including polymer shutoff patch and adhesive, aim at utilizing polymer shutoff patch to perforate the room interval and carry out the shutoff, and polymer shutoff patch fixes through the adhesive. The occluder can realize tight occlusion when using a polymer occlusion patch to occlude, reduces complications such as residual shunt, has good occlusion performance, can better improve the treatment effect, can avoid the risks of nickel precipitation, allergy and the like possibly caused by the long-term implantation of a nickel-titanium metal stent, and improves the safety. And the plugging patch has the characteristic of non-self-expansion, so that the plugging patch can be directly contacted with fragile diseased cardiac muscle in the ventricular septal perforation, the fragile diseased cardiac muscle cannot be damaged, and meanwhile, when the macromolecular plugging patch is fixed by an adhesive, not only can stable fixation be realized, but also the plugging performance can be enhanced by the adhesive, and the plugging effect is better.

It should be understood that the adhesive used in the present invention includes, but is not limited to, biological glue (also called biological coagulation), and other substances that can be implanted into the human body and generate viscosity in the body are also within the scope of the present invention. In the utility model, at least part of the adhesive can be conveyed to the perforation of the ventricular septum through the balloon catheter. The adhesive has viscosity and can connect the plugging patch with the ventricular septum, namely, the adhesive can be adhered to the ventricular septum tissue and the surface of the plugging patch, so that the plugging patch is stably positioned at the ventricular septum perforation, and the device is simple in structure and good in fixing effect. The adhesive can be delivered by spraying, smearing, injecting, or the like. The specific type of adhesive is not limited herein and is selected from, for example, biological glues such as vascular sealants, surgical sutures, and the like, including, but not limited to, Coseal by Baxter, redyne by Bidi (BD), BioGlue by Cryolife, and Prevelaek by mallinkrodt Pharmaceuticals, among others.

Furthermore, the utility model also provides a treatment system, including plugging device and conveyer. The conveyor includes a balloon catheter having a distal end for detachably connecting with the occlusion patch for delivering the occlusion patch through the balloon catheter to the interventricular septum puncture and for delivering the adhesive through the balloon catheter. It should be understood that the present application does not require a detachable connection between the distal end of the balloon catheter and the occlusion patch, such as a mechanical connection including, but not limited to, a threaded connection, a snap connection, and the like, but may be other mechanical connections or chemical or electrical connections.

The technical solution proposed by the present invention will be further explained with reference to the accompanying drawings and preferred embodiments.

Fig. 1a is a schematic view of the treatment system in the delivery sheath according to the preferred embodiment of the present invention, fig. 1b is a schematic view of the treatment system in the preferred embodiment of the present invention being pushed out of the delivery sheath to complete the expansion, fig. 1c is a schematic view of the injection of the adhesive according to the preferred embodiment of the present invention, and fig. 1d is a schematic view of the plugging device after withdrawing the delivery device according to the preferred embodiment of the present invention to complete the plugging.

Referring to fig. 1a to fig. 1d, the present embodiment provides a therapeutic system, which can be delivered into the body through a delivery sheath 30, and the therapeutic system specifically includes a delivery device 10 and an occluder 20.

The occlusion device 20 comprises an occlusion patch 210 and an adhesive 220, wherein the occlusion patch 210 has a cavity (not labeled) after expansion, the cavity has at least one open end, the occlusion patch 210 can expand and at least partially penetrate into the perforation of the interventricular septum for occlusion, and the occlusion patch 210 is made of a medical polymer material with good biocompatibility, including a natural polymer material and a synthetic polymer material. Further, the plugging patch 210 is made of degradable polymer material or non-degradable polymer material. The polymer material for preparing the plugging patch 210 is not particularly limited. In some embodiments, the occlusion patch 210 is non-biodegradable, and non-degradable materials include, but are not limited to, Polyurethane (PU), poly-para-terephtalate (PETP), and the like. In some embodiments, the occlusion patch 210 may be biodegradable, and the degradable material includes, but is not limited to, polylactic acid (PLA), polydioxanone (PPDO), Polycaprolactone (PCL), Polyglycolide (PGA), polyglycolic acid/polylactic acid copolymer (PGLA), polyhydroxybutyrate/valerate copolymer (PHBV), Polyorthoesters (POE), and the like. In some embodiments, the material of the occlusion patch 210 includes a natural polymer material, such as at least one of cellulose, chitin, hyaluronic acid, collagen, gelatin, and sodium alginate. In other embodiments, the occlusion patch 210 may partially degrade.

The conveyor 10 specifically includes a balloon catheter 110, and the balloon catheter 110 includes a catheter body 111 and a balloon 112 connected to a distal end of the catheter body 111. The balloon 112 is adapted to be disposed within the occlusion patch 210. The balloon 112 may expand the occlusion patch 210 on the one hand and be used to deliver an adhesive 220 on the other hand. Wherein the distal end of the balloon catheter 110 is detachably connected to the occlusion patch 210, and in this embodiment, the distal end of the balloon catheter 110 is threadedly connected to the occlusion patch 210. In practice, as shown in fig. 1a, the release and deployment of the occlusion patch 210 may be accomplished by pushing the occlusion patch 210 within the delivery sheath 30 using the balloon catheter 110.

In more detail, in the initial state, as shown in fig. 1a, the occlusion patch 210 is in a folded state and is received within the delivery sheath 30. Further proximal to distal advancement of the balloon catheter 110 pushes the occlusion patch 210 off the distal end of the delivery sheath 30 for release, such that the occlusion patch 210 is positioned at the puncture of the ventricular septum 40 and, after release of the occlusion patch 210, the occlusion patch 210 is also expanded by the expansion of the balloon 112, as shown in fig. 1 b. Further, as shown in fig. 1c, adhesive 220 is delivered through balloon catheter 110, and adhesive 220 flows into the interventricular septum perforation via balloon 112 and the micropores in balloon 112. After waiting for a period of time, the adhesive 220 sets and develops a tack that creates a secure connection of the occlusion patch 210 to the myocardial tissue at the ventricular septum 40. Finally, after confirming that the occlusion is correct, the balloon catheter 110 is removed, and the occlusion is completed, so that the occlusion state shown in fig. 1d is obtained. In this embodiment, adhesive 220 may be filled into balloon 112 to achieve inflation of balloon 112, although other materials, such as saline, may be filled into balloon 112 to inflate balloon 112. In addition, the occlusion patch 210 may or may not be attached to the ventricular septum puncture after expansion, and if attached, the force of attachment is slight, avoiding damage to the delicate tissue at the ventricular septum puncture (the delicate tissue may also be referred to as diseased myocardium). It should be understood that the adhesive 220 in fig. 1c is in its pre-cured state and the adhesive 220 in fig. 1d is in its cured state, and as can be seen from fig. 1d, the adhesive 220 is filled between the inter-chamber perforation holes and the plugging patch 210 after being cured, which not only can fix the plugging patch 210, but also can further plug the inter-chamber perforation holes.

Further, the occlusion patch 210 preferably includes an occlusion portion configured to be inserted into the perforation of the ventricular septum and a fixing portion disposed on at least one sidewall of the ventricular septum for holding the non-diseased myocardium of the ventricular septum (the non-diseased myocardium is the normal myocardium). In one embodiment, the blocking patch 210 is in the shape of a hat and includes a cap constituting the blocking portion and configured to be inserted into the through hole of the compartment, and a visor structure constituting the fixing portion and configured to be clamped by a sidewall provided at the compartment. In this embodiment, the ventricular septum has a side wall adjacent the right ventricle and a side wall adjacent the left ventricle, with the visor structure serving to sandwich the ventricular septum on the side of the ventricular septum adjacent the right ventricle.

The specific shape of the occlusion patch 210 is not limited by the present application and includes, but is not limited to, the illustrated cap shape with a proximal opening and a distal end closed.

In the following preferred embodiment, the plugging patch 210 is illustrated as a cap shape, and the plugging device and the conveyor of the present invention will be further described, but it should be understood by those skilled in the art that the plugging patch 210 may have other shapes.

< example one >

Referring to fig. 2a and 2b, the occlusion patch 210 is preferably shaped like a cap, the distal end of which is closed and the proximal end is open. Specifically, the plugging patch 210 includes a cap 211 and a brim structure 212, wherein the cap 211 is used for being inserted into the through hole of the ventricular septum, the brim structure 212 is used for being clamped on a side wall of the ventricular septum close to the right ventricle, the brim structure 212 can further plug the through hole of the ventricular septum, and the plugging patch 210 can be further positioned, so that the plugging performance is better. Further, the patch 210 has opposite inner and outer sides, and the patch 210 is configured such that a partial area of the inner side is perforated with a partial area of the outer side to allow the adhesive 220 to flow to the outer side via the inner side of the patch 210.

In a preferred embodiment, the occluding patch 210 is made entirely (i.e., entirely) of a porous material, including but not limited to polyurethane, expanded polytetrafluoroethylene, such that the material of the occluding patch 210 itself has densely packed pores to facilitate penetration of the adhesive 220 from the inside to the outside of the occluding patch 210 to create a connection with the interventricular septum tissue. Of course, in other embodiments, the plugging patch 210 may be woven, or the plugging patch 210 may be made porous and permeable to the adhesive 220. At the same time, a portion of the surface of the patch 20 is covered with a dense, liquid-impermeable baffle 230, such as a thin film of polytetrafluoroethylene. The bluff body 230 can prevent the adhesive 220 from entering the ventricle, and can further enhance the occlusion performance of the occlusion patch 220. It should be appreciated that a portion of the surface of the exterior side of the occluding patch 220 (i.e., the side facing the ventricular septum 40) is not covered by the bluff body 230 to facilitate attachment of the adhesive 220 to the ventricular septum tissue, while a portion of the surface of the interior side of the occluding patch 220 (i.e., the side facing away from the ventricular septum 40) is not covered by the bluff body 230, and the portion of the interior side of the occluding patch 210 that is not covered by the bluff body 230 is continuous with the portion of the exterior side that is not covered by the bluff body 230 to facilitate penetration of the adhesive 220 from the interior side of the occluding patch 210 to the exterior side after injection. In addition, the adhesive 220 is only located at the site where the occlusion patch 210 needs to be bonded to the ventricular septum, preventing other sites from generating adhesive to damage the heart tissue.

In this embodiment, the adhesive 220 may be selected from the Coseal biogum of Baxter, which is a polyethylene glycol sealant activated under alkaline conditions, and comprises a powder (including pentaerythritol polyethylene glycol ether tetrasuccinimide glutaric acid and pentaerythritol polyethylene glycol ether tetrathiol) and two solutions (the first solution is hydrochloric acid diluent, and the second solution is a mixture of sodium dihydrogen phosphate and sodium carbonate). It will be appreciated that the powder and the first solution form a first component 221 and the second solution forms a second component 222, which are delivered sequentially to the perforations of the compartment, the first component 221 being capable of generating a viscosity upon encountering the second component 222.

In a non-limiting mode of operation, the powder is dissolved in a hydrochloric acid diluent to form the first component 221 prior to implantation, and the first component 221 may be applied to the outer side of the occluding patch 210 at specific locations, such as the locations indicated by symbol a in fig. 2a, where the occluding patch 210 needs to be bonded to the interventricular tissue. Of course, in other embodiments, the first component 221 may be delivered to the location indicated by a by means of the balloon catheter 110. Here, by coating the sealing patch 210 on the outer side in advance, the position of bonding can be better controlled, and unnecessary damage is avoided. Therefore, the second component 222 can be delivered through the balloon catheter 110, and the fluid-blocking body 230 can prevent glue from spreading into the ventricle during the injection of the second component 222, then, the portion of the inner side of the occlusion patch 210 not covered by the fluid-blocking body 230 (i.e. the position indicated by the symbol b) is used to achieve the injection of the second component 222, and is mixed with the first component 221 through the air holes inside the occlusion patch 210, so that the portion coated with the first component 221 is changed from weak acidity to weak alkalinity, thereby activating the biological glue to generate viscosity.

Further, the distal end of the cavity of the occlusion patch 210 is provided with a connector 240, the connector 240 is detachably connected with the distal end of the balloon catheter 110, and optionally, the connector 240 is a threaded connector.

Referring to fig. 3, fig. 3 is a schematic diagram of a conveyor according to a preferred embodiment of the present invention, wherein a partial enlarged view of portion c is shown to illustrate the micropores 114 on the balloon 112.

As shown in fig. 3, the delivery device 10 provided in the present embodiment includes a balloon catheter 110, a distal end of the balloon catheter 110 is screwed with the occlusion patch 210, specifically, a screw head 113 is provided at a distal-most end of the balloon catheter 110, and the screw head 113 is screwed with a connector 240. In addition, the surface of the balloon 112 is formed with a number of micropores 114. The second component 222 may be ejected from the micropores 114 on the balloon 112 and into the occlusion patch 210 to mix with the first component 221.

The conveyor 10 may also include a storage bin 120 and a pressurizer 130. The adhesive 220 includes a first component 221 and a second component 222, the second component 222 being previously placed in a storage cartridge 120, the storage cartridge 120 being connected at one end to the pressurizer 130 and at the other end to the proximal end of the balloon catheter 110. The pressurizer 130 may be provided with a pressure gauge 131 for displaying the pushing pressure to facilitate the pushing of the second component 222. In practice, the storage cartridge 120 is pressurized by manually pushing or rotating the pressurizer 130, thereby pushing the piston 121 in the storage cartridge 120 to move and inject the second component 222 into the balloon catheter 110. When the second component 222 reaches the expanded balloon 112, it further flows out of the micropores 114 and further penetrates to the outside of the occlusion patch 220. After waiting a period of time, the adhesive 220 solidifies, completing the securement of the patch 210.

Of course, in other embodiments, the proximal end of the balloon catheter 110 may be directly connected to the pressurizer 130, and the second component 222 may be stored in the pressurizer 130, in which case the cartridge 120 may be eliminated and the pressurizer 130 may be used to push the second component 222 directly into the balloon catheter 110. The storage bin 120 has the advantages of saving the amount of the second component 222, reducing digestion and saving cost, because the second component 222 in the storage bin 120 can be completely injected into the body by the movement of the piston 121 without remaining in the storage bin 120. In addition, in this embodiment, the balloon 112 may be inflated by saline before the second component 222 is injected.

Optionally, the delivery device 10 further comprises a valve 140, the valve 140 being adapted to control the pressurizer 130 to selectively communicate with one of the storage bin 120 and the balloon catheter 110, and to selectively communicate the balloon catheter 110 with one of the storage bin 120 and the pressurizer 130. The valve 140 preferably includes a first three-way valve 141 and a second three-way valve 142, the first three-way valve 141 controlling the pressurizer 130 to selectively communicate with one of the storage bin 120 and the balloon catheter 110, and the second three-way valve 142 controlling the balloon catheter 110 to selectively communicate with one of the storage bin 120 and the pressurizer 130. Of course, the pressurizer 130, the storage bin 120 and the balloon catheter 110 are connected to each other through the connecting catheter 150.

The connection duct 150 includes a first connection pipe 151, a second connection pipe 152, and a third connection pipe 153. An inlet of the first three-way valve 141 is connected to the pressurizer 130 through a first connection pipe 151, one outlet of the first three-way valve 141 is connected to the storage bin 120 through a second connection pipe 152, and the other outlet of the first three-way valve 141 is connected to one inlet of the second three-way valve 142 through a third connection pipe 153. The other inlet of the second three-way valve 142 is connected to the storage cartridge 120, and one outlet of the second three-way valve 142 is connected to the proximal end of the balloon catheter 110.

In actual operation, the pressurizer 130 is filled with physiological saline, the first three-way valve 141 and the second three-way valve 142 are firstly rotated to sequentially communicate the first connecting pipe 151, the third connecting pipe 153 and the balloon catheter 110, and the pressurizer 130 is pushed or rotated to pressurize, so that the physiological saline can be injected into the balloon 112 to expand the balloon; after the balloon 112 is expanded, the first three-way valve 141 and the second three-way valve 142 are rotated to sequentially communicate the second connection 152, the storage bin 120 and the balloon catheter 110, and the pressurizer 130 is pushed or rotated to pressurize the storage bin 120, so as to push the piston 121 in the storage bin 120 to move, and inject the second component 222 into the balloon catheter 110. When the second component 222 reaches the balloon 112, it flows out of the micropores 114 of the balloon 112 and mixes with the first component 221 through the pores, thereby activating the viscosity of the bio-glue, which bonds the occlusion patch 210 and the interventricular tissue, thereby connecting and fixing the occlusion patch 210 and the interventricular tissue.

As shown in fig. 2a and 2b, the plugging patch 210 is made of the same porous material as a whole, and the processing method is not limited to extrusion molding, injection molding, and the like.

< example two >

Referring to fig. 4, in another embodiment, the occluding patch 210 is partially made of a porous material, and more particularly at least two materials, one of which is a porous material and the other of which is a non-porous material (i.e., a dense material). Porous materials are described previously and include, but are not limited to, polyurethane and expanded polytetrafluoroethylene. By non-porous material is understood a material that is substantially impermeable to liquids, which material is inherently relatively dense and capable of being sealed. Non-porous materials include, but are not limited to, PET (poly-p-phenyl-formate). The first portion 2101 made of porous material and the second portion 2102 made of non-porous material may be fixedly attached to each other by bonding, sewing, or heat fusing. Wherein at least a partial area of said first portion 2101 extends through the inside and outside of the occlusion patch 210.

Wherein the first portion 2101 constitutes a partial surface of the inside of the occlusion patch 210; the first portion 2101 also constitutes part of the surface of the outer side of the occlusion patch 210. In more detail, the first portion 2101 is located at a specific position outside the occlusion patch 210 (i.e. the position indicated by symbol a), i.e. where the occlusion patch 210 needs to be bonded to the interventricular tissue, while the first portion 2101 is also located at some position inside the occlusion patch 210 (e.g. the position indicated by symbol b), so that after injection of the bio-glue, the inner first portion 2101 may penetrate to the outer first portion 2101, eventually creating a connection with the interventricular tissue. The material of the second portion 2102 is relatively compact, which on the one hand prevents the biological glue from flowing around and on the other hand enhances the sealing properties of the sealing patch 210.

In addition, the first component of the adhesive 220 may be pre-applied to the outer first portion 2101 or injected sequentially into the balloon catheter 110. In this embodiment, the first component and the second component of the adhesive 220 are injected into the balloon catheter 110 sequentially.

In this embodiment, the adhesive 220 is selected from Tridyne manufactured by Bidi medical company ^TM The vascular sealant is shown schematically and further illustrates the preferred mode of delivery of the two components separately and sequentially.

Tridyne ^TM The vascular sealant is also a biological glue and comprises a first component 221 and a second component 222, wherein the first component 221 is Human Serum Albumin (HSA) and the second component 222 is a polyethylene glycol (PEG) cross-linking agent. When the two components are mixed, a transparent hydrogel is produced with viscosity. After the plugging patch 210 is implanted and the balloon 112 is expanded, the human serum albumin solution and the polyethylene glycol solution are injected into the plugging patch 210 in sequence, the two solutions penetrate into the porous structure in sequence and generate viscosity after a period of time, so that the plugging patch 210 is connected with the interventricular tissue.

Referring to fig. 5, fig. 5 shows a schematic view of a conveyor according to another preferred embodiment of the present invention, wherein a partial enlarged view of portion c is also shown to illustrate the micropores 114 on the balloon 112.

In another embodiment, as shown in fig. 5, the storage bin 120 may comprise a first storage bin 1201 and a second storage bin 1202, the second component 222 being previously placed in the second storage bin 1202, and the first component 221 being previously placed in the first storage bin 1201. Both reservoirs are connected to the pressurizer 130 and are in controlled connection via a valve 140, and are also selectively connected to the balloon catheter 110 via the valve 140. Of course, in other embodiments, the two storage cartridges may not be connected, and each may be independently connected to the balloon catheter and the pressurizer.

The valve 140 may include a one-way valve 143 and a second three-way valve 142. The connection duct 150 includes a first connection pipe 151 and a second connection pipe 152. The pressurizer 130 is connected to the first storage tank 1201 through the first connection pipe 151, and the first storage tank 1201 and the second storage tank 1202 are connected and disconnected by the check valve 143. One inlet of the second three-way valve 142 is connected to the second storage cartridge 1202 through the second connection tube 152, the other inlet of the second three-way valve 142 is connected to the first storage cartridge 1201, and one outlet of the second three-way valve 142 is connected to the proximal end of the balloon catheter 110.

In operation, in the first stage, the one-way valve 143 is closed, the second three-way valve 142 is opened until the first storage chamber 1201 communicates with the balloon catheter 110, and then the first storage chamber 1201 is pressurized by the pressurizer 130 to push the piston 121 in the first storage chamber 1201 to move, so that the first component 221(HSA solution) is injected into the balloon catheter 110 to expand the balloon 112, and at the same time, the first component 221 flows into the first part 2101; in the second stage, the one-way valve 143 is opened to connect the first storage chamber 1201 with the second storage chamber 1202, at which time the piston 121 in the first storage chamber 1201 has moved to the bottom, and then the second three-way valve 142 is opened to connect the second connection tube 152 with the balloon catheter 110, and the first storage chamber 1201 is pressurized continuously, which pushes the piston 121 in the second storage chamber 1202 to move, so that the second component 222(PEG solution) is injected into the balloon catheter 110 and flows into the first portion 2101, and is mixed with the first component 221 of the first stage, thereby generating viscosity.

Further, referring to fig. 6, in order to enhance the shape recovery capability of the occlusion patch 210, it is preferable to embed an elastic wire, especially a shape memory alloy wire, including but not limited to nitinol, inside the occlusion patch 210, and the elastic wire is more preferably embedded in a structure of at least one side wall of the occlusion patch 210 located in the interventricular septum, such as an opening position of the cap-shaped occlusion patch 210 (i.e., in the brim structure 212), so as to further enhance the occlusion performance. Here, if the elastic wire is a nickel titanium wire, since the number of embedded nickel titanium wires is small and the elastic wire is covered by the second portion 2102, the risk of nickel ion precipitation and allergy is greatly reduced, and safety can still be ensured. Of course, in the first embodiment, when the plugging patch 210 is made of a porous material, it is preferable to arrange an elastic wire inside to enhance the shape recovery capability, and the coating of the blocking body 230 can prevent the nickel ions from being extracted or the allergy risk.

Further, referring to fig. 7, to enhance visibility during implantation, a visualization structure 260 may preferably be provided at the distal and/or proximal end of the occlusion patch 210, the visualization structure 260 being made of a visualization material. The present application does not limit the developing material. The structure of the developing structure 260 includes, but is not limited to, a developing point, and may also be a sheet, a line, etc. Optionally, the developing structure 260 is disposed at the edge of the visor structure 212 and at the center of the cap 211. Of course, in the solution provided in the first embodiment, when the plugging patch 210 is made of a porous material as a whole, the developing structure 260 is preferably disposed at the proximal end and/or the distal end.

Further, referring to fig. 8, the distal outer surface of the occlusion patch 210 is preferably provided with an outwardly tilted flying wing 270, the flying wing 270 is used for clamping the non-diseased cardiac muscle of the ventricular septum at the other side wall of the ventricular septum, and the elastic wire 250 is preferably arranged in the flying wing 270 to enhance the capability of restoring to the predetermined shape after implantation, and the added flying wing 270 can enhance the occlusion performance and is not easy to fall off. It will be appreciated that the wings 270 are clamped to a side wall of the interventricular septum adjacent to the left ventricle, and that the wings 270 may further occlude the interventricular septum perforation and may further position the occluding component 210 for better occlusion performance. It should also be understood that embodiments of providing the flying wing 270 are not limited to plugging patches 210 made of porous and non-porous materials, and are equally applicable to plugging patches 210 made entirely of porous materials. It should also be appreciated that embodiments of the elastic wire 250 and the visualization structure 260 are also applicable to the occlusion patch 210 that is woven or otherwise fabricated.

Further, in any of the above embodiments, the adhesive 220 includes, but is not limited to, a two-component material, and in other embodiments, the adhesive 220 may also be a one-component material, such as a substance that coagulates and generates viscosity when exposed to water or blood.

To sum up, according to the utility model provides a technical scheme uses the utility model discloses a behind treatment system and plugging device, in the treatment of perforating in the interatrial interval, the treatment is intervened to accessible plugging device, in the intervention treatment process, the utility model discloses a plugging device can utilize the shutoff patch that macromolecular material made to perforate to the interatrial interval and carry out the shutoff, and the polymer shutoff patch is fixed through the adhesive. The occluder can realize tight occlusion when using a polymer occlusion patch to occlude, reduces complications such as residual shunt, has good occlusion performance, can better improve the treatment effect, can avoid the risks of nickel precipitation, allergy and the like possibly caused by the long-term implantation of a nickel-titanium metal stent, and improves the safety. Particularly, when the polymer plugging patch is fixed by the adhesive, not only can stable fixation be realized, but also the plugging performance can be enhanced by the adhesive, and the plugging effect is better. And the utility model discloses a macromolecular material preparation shutoff patch of non-self-expanding formula makes the fragile pathological change cardiac muscle of shutoff patch in can the direct contact room interval perforation, is difficult to damage pathological change cardiac muscle.

It should be understood that the foregoing is only a preferred embodiment of the present invention and is not intended to limit the invention in any way and essentially, it should be noted that modifications and additions may be made by those skilled in the art without departing from the method of the invention, and such modifications and additions are also considered to be within the scope of the invention. Those skilled in the art can make various changes, modifications and evolutions equivalent to those made by the above-disclosed technical content without departing from the spirit and scope of the present invention, and all such changes, modifications and evolutions are equivalent embodiments of the present invention; meanwhile, any changes, modifications and evolutions of equivalent changes to the above embodiments according to the actual technology of the present invention are also within the scope of the technical solution of the present invention.

Claims

1. The plugging device for the perforation of the compartment is characterized by comprising a polymer plugging patch and an adhesive, wherein the polymer plugging patch is provided with a cavity after being expanded, the cavity is at least provided with an opening end, the polymer plugging patch is configured to be at least partially arranged in the perforation of the compartment after being expanded, and the polymer plugging patch is fixedly bonded with the compartment through the adhesive.

2. The occluder of claim 1, wherein said polymeric occluding patch has opposing inner and outer sides, and wherein a portion of the inner side of said polymeric occluding patch is connected to a portion of the outer side of said polymeric occluding patch to allow said adhesive to flow from the inner side to the outer side of said polymeric occluding patch.

3. The occlusion device for perforation of ventricular septum of claim 2, wherein the polymeric occlusion patch is at least partially made of porous material, and the inner side and the outer side of the area made of porous material of the polymeric occlusion patch are connected.

4. The compartmental perforating block of claim 3 wherein said polymeric blocking patch is made entirely of a porous material and further comprising a bluff body; the fluid blocking body covers the surface of the high polymer plugging patch; part of the surface of the inner side of the macromolecule plugging patch is not covered with the bluff body; the part of the surface of the outer side of the polymer plugging patch is not covered by the bluff body, and the part of the inner side of the polymer plugging patch, which is not covered by the bluff body, is communicated with the part of the outer side, which is not covered by the bluff body.

5. The occluding device for perforation of a ventricular septum of claim 3, wherein the polymeric occluding patch comprises a first portion and a second portion fixedly attached; the first portion is made of a porous material; the second portion is made of a non-porous material; wherein at least a partial region of the first portion penetrates through the inside and outside of the polymeric occlusion patch.

6. The occluder of any of claims 1-5, wherein an elastic thread is provided inside the polymeric occlusion patch.

7. The occluding device for perforation of an interventricular septum of claim 6, wherein the polymeric occluding patch comprises: the plugging part is used for being arranged in the perforation of the ventricular septum in a penetrating way, and the fixing part is arranged on at least one side wall of the ventricular septum and is used for clamping the non-diseased cardiac muscle of the ventricular septum; wherein the elastic wire is provided inside the fixing portion.

8. The stopper according to claim 7, wherein the polymer stopper patch is in a cap shape and includes a cap constituting the stopper portion and adapted to be inserted into the inter-chamber perforation, and a visor structure constituting the fixing portion and adapted to be disposed on a sidewall of the inter-chamber, and the elastic wire is disposed inside the visor structure.

9. The occlusion device for ventricular perforation according to claim 1, wherein the polymeric occlusion patch has a structure with a closed distal end and an open proximal end, and the distal end of the cavity is provided with a connector for detachable connection with a conveyor.

10. The occluder of claim 9, wherein the proximal open end of the polymeric occluding patch is an outwardly extending visor structure configured to clamp the non-diseased myocardium of the ventricular septum at a sidewall of the ventricular septum.

11. The occluder of claim 10, wherein the polymeric occluding patch has an outwardly projecting wing formed on the outer surface of the distal end thereof, said wing serving to clamp the non-diseased myocardium of the ventricular septum at the other side wall of the ventricular septum.

12. A closure for perforation of a compartment according to claim 11, wherein an elastic wire is provided inside the flying wing and/or the visor structure.

13. The occlusion device for ventricular perforation according to claim 1, wherein the adhesive is a two-component material, and a first component of the adhesive is coated on a portion of the surface of the polymeric occlusion patch.

14. A treatment system comprising a conveyor and the interventricular perforation occluder of any one of claims 1 to 13, the conveyor comprising a balloon catheter having a distal end detachably connected to the interventricular perforation occluder; the balloon catheter comprises a balloon, wherein micropores are formed on the surface of the balloon and used for releasing the adhesive.

15. The treatment system of claim 14, wherein the delivery device further comprises a storage cartridge and a pressurizer, the storage cartridge being connected to the proximal end of the balloon catheter and the pressurizer, respectively; the storage bin is used for storing the component materials of the adhesive, and the pressurizer is used for pressurizing the storage bin to enable the component materials of the adhesive to enter the balloon catheter.

16. The treatment system of claim 14, wherein the transporter further comprises a valve for controlling the pressurizer to selectively communicate with one of the storage cartridge and the balloon catheter, and controlling the balloon catheter to selectively communicate with one of the storage cartridge and the pressurizer.

17. The treatment system of claim 16, wherein the valve comprises a first three-way valve controlling the pressurizer to selectively communicate with one of the reservoir and the balloon catheter, and a second three-way valve controlling the balloon catheter to selectively communicate with one of the reservoir and the pressurizer;

18. The system of claim 15, wherein the cartridge comprises a first cartridge and a second cartridge, the first cartridge storing the first component of the adhesive, the second cartridge storing the second component of the adhesive, the first cartridge coupled to the second cartridge, the delivery device further comprising a valve for controlling the opening and closing between the first cartridge and the second cartridge and for controlling the balloon catheter to be selectively coupled to one of the first cartridge and the second cartridge.

19. The treatment system of claim 18, wherein the valve comprises a one-way valve for controlling the opening and closing of the first storage chamber and the second storage chamber, and a three-way valve having an inlet connected to the second storage chamber, an inlet connected to the first storage chamber, and an outlet connected to the proximal end of the balloon catheter.