DESC:FIELD OF THE INVENTION
The present invention relates to an occluder for closing a septal defect in a human heart and particularly for closing a defect involving a septum primum and a septum secundum in the human heart.

BACKGROUND OF THE INVENTION
Cardiac defects, such as an opening in a cardiac muscle, or septal defects, atrial or venous, including Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO), often require intervention to prevent complications and improve overall cardiac function.
The PFO (106), a cardiac defect by way of example illustrated in Figure 1, is a persistent, usually flap-like opening in the wall between a right atrium (RA) and a left atrium (LA) of the heart. Because left atrial pressure is normally higher than right atrial pressure, the flap formed by septum primum (102) and septum secundum (104) usually stays closed. However, under certain conditions, specifically in case of PFO related defect, the right atrial pressure can exceed the left atrial pressure, which creates the possibility that blood and possible blood clots could pass from the right atrium to the left atrium through a PFO (106) entering the LA and then into the circulation. Further, similar situations of blood leakage from one chamber or vessel to another chamber or vessel also occur and cause a variety of heart related ailments.
Traditional surgical techniques involve open-heart procedures, which carry inherent risks and prolonged recovery periods. Now, minimally invasive interventions, such as cardiac occluder placement, have emerged as an alternative approach. However, existing occluder devices are unsuitable for complex anatomies leading to residual shunts and complications.
Therefore, there is still a need for an occluder which can prevent blood leakage or blood flow from one chamber or vessel to another chamber or vessel effectively and safely. Specifically, an occluder is needed for preventing blood or blood clots from passing through the septal defect while also being adapted to the complex anatomy of the septal defect.

SUMMARY OF THE INVENTION
Accordingly, the present invention provides an occluder for closing of a septal defect in a heart comprising a first disc for applying a compressive force on one side of a septal tissue, a second disc for applying a compressive force on another side of the septal tissue and a connector connected off-centrally or centrally to the first disc and the second disc. According to the present invention, said connector is shaped in such a way that the connector occupies an opening of the septal defect and together with compressive force applied by the first disc and second disc, the occluder closes the septal defect.
According to the present invention, the opening in the septal tissue includes a tunnel.
According to the present invention, the first disc and the second disc may be an oval or a circular shape.
According to an embodiment of the present invention, the connector may be a rectangular shaped, a circular shaped or an oval shaped cross section depending on the septal defect.
According to an embodiment of the present invention, the connector centrally connects the discs is inverted V-shaped. According to another embodiment of the present invention, the connector off-centrally connects the discs is Z-shaped.
According to the present invention, the connector has a length less than the length of the opening of the septal defect.
According to the present invention, the occluder is made up of a plurality of wires braided together.
According to the present invention, one or both of the discs may have a plurality of pads thereon to apply an additional compressive force and enable better anchorage of the occluder to the septal tissues.

BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 illustrates a cardiac septal defect, according to the background of the invention;
FIG. 2 illustrates a front view of an occluder for closing of the septal defect, according to a first embodiment of the present disclosure;
FIG. 3 illustrates the occluder deployed in the septal defect, according to a first embodiment of the present disclosure;
FIG. 4 illustrates a front view of an occluder, according to a second embodiment of the present disclosure;
FIG. 5 illustrates a front view of an occluder , according to a third embodiment of the present disclosure; and
FIG. 6 illustrates a front view of an occluder, according to a fourth embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION.
Embodiments, of the present disclosure, will now be described with reference to the accompanying drawings.
Embodiments are provided to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth relating to specific components to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
References in the present disclosure to “one embodiment” or “an embodiment” mean that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in an embodiment” or “in an implementation” in various places in the specification are not necessarily all referring to the same embodiment or implementation.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms “comprises,” “comprising,” “consists,” “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated elements, modules, units, and/or components, but do not forbid the presence or addition of one or more other elements, components, and/or groups thereof.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
Referring to FIG. 2 illustrates a front view of an occluder (200) for closing a septal defect, according to a first embodiment of the present invention. In this application, the term “defect” is applied to any anatomical configuration requiring treatment and in the present application the defect is a cardiac defect, such as an opening in a cardiac muscle, or septal defects, atrial or venous, including Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO). As shown in Figure 1, the defect can be a PFO (100) which may allow, or allows, blood to flow from the right atrium to the left atrium in a heart. It should be noted that the occluder (200) may be used for any other septal defect without limiting the scope of what is disclosed.
The occluder (200) as shown in Figure 2 includes a first disc (202) to apply a compressive force on one side of a septal tissue, a second disc (204) for applying a compressive force on another side of the septal tissue and a connector (206).
According to an embodiment of the present invention the first disc (202) and the second disc (204) may be an oval or a circular shape. It should be noted that the first disc (202) and the second disc (204) may have any other shape depending, in part, on the distribution of force desired to effect closure of a given defect without limiting the scope of what is disclosed.
The first disc (202) and second disc (204) are preferably made from a material configured to apply a compressive force to the overlapping layers of septal tissue. The movement of the two discs (202, 204) may be limited by the edges of the tunnel (which is usually between 1 mm and 20 mm wide), thereby ensuring the occluder (200) remains diagonally centered across the defect and consistently applies compressive force to the septal tissues at the locations necessary to effect closure of the defect. Accurate and consistent application of localized force can allow the use of a smaller closure device.
As illustrated in FIG. 2, the connector (206) connects the first disc (202) and the second disc (204) off-centrally or centrally. It should be noted that the connector (206) may connect the discs (202, 204) in any other manner without limiting the scope of what is disclosed. According to the present invention, the connector (206) is shaped in such a way that the connector (206) occupies an opening of the septal tissue, thereby closing the opening in the septal issue together with the first and second discs (202,204). The opening formed in the septal tissue may be a tunnel, which is occupied by the connector (206). The shape of the connector optimizes complete closure and minimizes residual leak. The connector (206) may have a rectangular shaped, a circular shaped or an oval shaped cross section. It should be noted that the connector (206) may have any other shaped cross-section without limiting the scope of what is disclosed.
FIG. 4 illustrates an occluder (300) according to a second embodiment of the present disclosure. The occluder (300) of the second embodiment has an inverted V-shaped connector (306) centrally connecting the first disc (202) and the second disc (204).
FIG. 5 illustrates an occluder (400) according to a third embodiment of the present disclosure. The occluder (400) of the third embodiment has a Z-shaped connector (406) off-centrally connecting the first disc (202) and the second disc (204).
FIG. 6 illustrates an occluder (500) according to a fourth embodiment of the present disclosure. The occluder (500) of the fourth embodiment has a connector (506) inclined between the first disc (202) and the second disc (204) and off-centrally connecting the first disc (202) and the second disc (204). The occluder (500) as shown in FIG. 6 further includes a plurality of pads (208) disposed on the second disc (204). The plurality of pads (208) applies an additional compressive force and enable better anchorage of the occluder to the septal tissue. It should be noted that one or both of the discs may have the plurality of pads thereon to apply an additional compressive force without limiting the scope of what is disclosed.
According to the present invention, the connector (206, 306, 406, 506) has a length preferably shorter than the opening in the septal tissue. According to an exemplary embodiment, the connector (206, 306, 406, 506) may have a length of 5 mm when the opening has a length less than 10 mm. As per another exemplary embodiment, the connector (206, 306, 406, 506) may have a length of 10 mm when the opening has a length greater than 10 mm. It should be noted that the connector (206, 306, 406, 506) can have any other length without limiting the scope of what is disclosed.
The occluder (200, 306, 406, 506) of the present invention is made up of a plurality of wires braided together. The material of the occluder (200, 306, 406, 506) can be a metal, non-metal, bioresorbable polymer, spring steel, shape memory material, bioresorbable shape memory polymer, or combinations thereof. The thickness of the wires can be increased or decreased to adjust the compressive force. In general, a thicker wire provides a higher compressive force. Generally, bends with smaller angles will provide more compressive force. Different parts of the occluder (200,306, 406, 506) can be treated in a different manner to provide variable force and reconfiguration.
According to the present invention, the occluder (200, 300, 400, 500) incorporates a deployment mechanism (not shown), enabling controlled expansion and accurate positioning within the septal defect. The deployment mechanism is connected to a port (210) provided on the occluder (200, 300, 400, 500). The occluder (200, 300, 400, 500) can be deployed with the help of advanced imaging techniques, such as fluoroscopy, echocardiography, or intracardiac ultrasound to visualize the defect and guide occluder (200, 300, 400, 500) placement. Image fusion technology combines multiple imaging modalities for comprehensive visualization and precise occluder (200, 300, 400, 500) positioning when required.
In another embodiment of the present invention, the occluder can be partially or completely covered with a tissue scaffold (not shown). It should be noted that the material of the tissue scaffold can be a polyester fabric, teflon-based material, ePTFE, polyurethane, metallic material, metallic foil, poly vinyl alcohol, extracellular matrix, bioengineered material, synthetic bioresorbable polymer, collagen, or combinations thereof without limiting the scope of what is disclosed. The tissue scaffold may have a drug or biological agent to improve the defect healing process and/or to prevent clotting. The tissue scaffold promotes encapsulation and endothelialization, thereby further encouraging anatomical closure of the septal defect.
According to an embodiment of the present invention, the biological agent is an anti-cancer drug, antiproliferation drug, anti-restenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, anti-inflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, or a combination thereof.
Referring FIG. 3 shows the occluder (200) deployed in the PFO (106). The connector (206) is shaped in such a way that the connector (206) occupies a tunnel of the PFO (106), and the discs (202, 204) apply a compressive force, thereby closing the PFO. The occluder of the present invention brings together tissue flaps particularly to appose together septum primum (102) and septum secundum (104) to minimize the flow of blood from the right atrium to the left atrium, by applying a compressive force between septum primum and septum secundum to bring septum primum and septum secundum together to provide a closing effect. The applied compressive force draws the more flexible septum primum toward septum secundum, thereby closing the PFO (106) without significantly distorting the septum. The connector provides mechanical closure at points of contact along the PFO such that the largest remaining opening is reduced to a size deemed small enough to block stroke-inducing embolic particles from crossing through the PFO tunnel. Because the connector does not distort the defect, the overlapping layers of septal tissues may themselves be used to close the defect as they are compressed by the connector and the discs.
The occluder of the present invention has an atraumatic shape, good embolization resistance, and an ability to conform to the anatomy. The occluder of the present invention is repositionable or/and removable during delivery and has a small profile after deployment. Further benefits include small diameter delivery sheath, ease of manufacturing, cost effectiveness, overall simplicity and above all to effectively close tunnel shaped defects without any residual flow. The occluder of the present invention also reduces the risk of incomplete closure and device migration as well as reduce the risk of stroke.
The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
Any discussion of devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
,CLAIMS:
1. An occluder (200) for closing of a septal defect in a heart (100), the occluder (200) comprising:
a first disc (202) for applying a compressive force on one side of a septal tissue;
a second disc (204) for applying a compressive force on another side of the septal tissue; and
a connector (206) connected off-centrally or centrally to the first disc (202) and the second disc (204), said connector (206) shaped in such a way that the connector (206) occupies an opening of the septal tissue, thereby closing the opening in the septal issue.

2. The occluder (200) as claimed in claim 1 wherein the opening in the septal tissue is a tunnel.

3. The occluder (200) as claimed in one of the preceding claims 1 to 2, wherein one or both of the discs (202, 204) have a plurality of pads (208) thereon to apply an additional compressive force and enable better anchorage of the occluder to the septal tissue.

4. The occluder (200) as claimed in one of the preceding claims 1 to 3, wherein the first disc (202) and the second disc (204) have an oval or a circular shape.

5. The occluder (200) as claimed in one of the preceding claims 1 to 4, wherein the connector (206) has a rectangular shaped, a circular shaped or an oval shaped cross section depending on the opening in the septal tissue.

6. The occluder (200) as claimed in one of the preceding claims 1 to 5, wherein the connector (206) connecting the discs (202, 204) centrally is inverted V-shaped.
7. The occluder (200) as claimed in one of the preceding claims 1 to 6, wherein the connector (206) connecting the discs (202, 204) off-centrally is Z-shaped.

8. The occluder (200) as claimed in one of the preceding claims 1 to 7, wherein the connector (206) has a length less than the length of opening in the septal tissue.

9. The occluder (200) as claimed in one of the preceding claims 1 to 8, wherein the connector (206) has a length of 5 mm when the opening has a length less than 10 mm, and the connector (206) has a length of 10 mm when the opening has a length greater than 10 mm.

10. The occluder (200) as claimed in one of the preceding claims 1 to 9, wherein the occluder (200) is made up of a plurality of wires braided together.

11. The occluder (200) as claimed in the claim 10, wherein a change in the cross section of the plurality of wires can enhance or reduce the amount of compressive force applied.

12. The occluder (200) as claimed in one of the preceding claims 1 to 11, wherein the material of the occluder (200) can be a metal, non-metal, bioresorbable polymer, spring steel, shape memory material, bioresorbable shape memory polymer, or combinations thereof.

13. The occluder (200) as claimed in one of the preceding claims 1 to 12, wherein the material of a tissue scaffold of the occluder (200) can be a polyester fabric, teflon-based material, ePTFE, polyurethane, metallic material, metallic foil, poly vinyl alcohol, extracellular matrix, bioengineered material, synthetic bioresorbable polymer, collagen, or combinations thereof.

14. The occluder (200) as claimed in claim 13, wherein the tissue scaffold has a drug or biological agent.

15. The occluder (200) as claimed in the claim 14, wherein the biological agent is an anti-cancer drug, antiproliferation drug, anti-restenosis drugs, neurolytic agents, Quaternary ammonium salts, Sodium channel blockers, anesthetics, amino acids, amines, Calcium channel blockers, diuretics, vasovasorum constrictors, neurotransmitter chemicals, venom, sclerosant agents, anti-nerve growth agents, aminosteroids, neurotoxins, antithrombotics, antioxidants, anticoagulants, antiplatelet agents, thrombolytics, anti-inflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, or a combination thereof.