DESC:TECHNICAL FIELD
[0001] The present invention relates, generally, to medical devices to regulate the blood flow in a vessel, and, particularly, but not exclusively, to regulate blood flow in aorta section of a human heart.
BACKGROUND
[0002] Many times, some life-threatening issues develop in aorta section of a human heart where the aorta section includes aortic valve, aortic root, ascending aorta, aortic arch and descending aorta. These issues are usually bulging, dilation or aneurysm development in different parts of an aorta such as aortic root, aorta walls, sino-tubular junction, sinuses of valsalva and aortic annulus. In addition, the functioning of aortic valve may also weaken due to different issues including calcification of the valve, weakening of leaves etc. Due to these issues, proper blood flow is hampered because it is not regulated in normal way.
[0003] A common solution to address such issues is to implant a prosthetic heart valve, either surgically or percutaneously. However, sometimes, it is not possible to hold or anchor such prosthetic valves at their place by only applying radial force exerted by the valve on different parts of aorta. One of the reasons is not having enough calcination to provide holding surface for the implant to provide firm anchoring points. Another reason can be improper geometry of the aorta. Poor anchoring may lead to adverse events such as paravalvular leak, aortic regurgitation, implant migration and embolization.
[0004] Therefore, there is a need for a device to implant at different locations in an aorta that regulates blood flow, doesn’t dislodge from the implant location and provides support to the aorta walls. Hence, it is an objective of the invention to provide a device that regulates blood flow, addresses aortic regurgitation, paravalvular leakage and ensures robust deployment of the device at the implant location.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0005] The detailed description is described with reference to the accompanying figures.
FIG. 1 illustrates a front view of frame structure of a heart implant and FIG. 1A is front view of the same frame structure after rotating it 90° on its axis to show connectors, according to an embodiment of the present invention.
FIG. 2 illustrates a front view of frame structure of a heart implant with cover and valve attached to it, according to an embodiment of the present invention.
FIG. 2 illustrates a front view of a heart implant with cover and a branch body attached to it, according to an embodiment of the present invention.

DESCRIPTION OF THE INVENTION
[0006] Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or the like parts. Wherever possible, corresponding, or similar reference numbers will be used throughout the drawings to refer to the same or corresponding parts.
[0007] Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated.
[0008] The invention is described below in detail with reference to accompanying drawings to make the purposes, technical solutions and advantages of invention understood more clearly with help of the specific embodiment of the invention.
[0009] The invention explained in the present disclosure provides a medical device, specifically a heart implant, that can be implanted percutaneously in a human body. The heart implant is mainly used to address anatomical issues of aortic valve and aorta. The main objectives of the heart implant, as per the present invention, are to provide better blood flow regulation in aorta, accurate positioning and firm anchoring.
[0010] According to the present invention, the heart implant comprises a frame that is primarily a cylindrical structure with varying diameters along the longitudinal axis. The peripheral surface of the frame is a grid-type structure made of a plurality of ringlets that are connected through a plurality of connectors. The ringlets are made of a plurality of struts. The struts, ringlets and the connectors can be of different sizes and configurations. Hence, the grid structure of the frame can be of different designs based on combination of struts and connectors of different designs and sizes. Defined configuration of struts and connectors together form cells of different designs and shapes. Further, based on connection scheme between any adjacent two ringlets, cell configuration is closed-type, open-type or a combination of both, that is call hybrid type. Closed-type cell configuration forms when each peak of one ringlet is connected to at least one peak of the adjacent ringlet. In this type of configuration, usually rectangular, diamond-shaped, hexagonal, octagonal or any closed multisided geometry forms. In open-type cell configuration, two adjacent ringlets are connected by only two connectors connecting peak or valley of one ringlet to peak or valley of another ringlet. In hybrid-cell type configuration, two adjacent ringlets are connected by more than two connectors while at least one peak or valley is free to expand or contract and not restricted due to any connector. The frame may comprise cells of all three types.
[0011] More specifically, according to the present invention, the frame has a proximal end, a distal end and a valve that is situated inside the frame and between the proximal end and the distal end. Between the proximal end and the distal end, the frame is divided in multiple sections depending on the cell configuration and their functionality. In one such embodiment, the frame comprises a first section, a second section and a third section. The diameter of the proximal end of the frame is smaller than the diameter of the distal end. These three sections in the frame are made of ringlets formed by struts connected where the struts can be straight or curved and may be joined together to form different configurations. The length of the struts may remain same or vary in different ringlets along the longitudinal axis. Further, the ringlets are connected through connectors. In this embodiment, three types of connectors employed: at least a short connector, at least a long connector and at least a curved connector. These connectors can be connected in either peak-to-peak manner or in peak-to-valley manner. Based on placement of connectors, the adjacent ringlets form closed cells, open cells or hybrid cells. Closed cells provide rigidness in a particular section while open cells provide flexibility. Curved connectors also provide and enhance flexibility. The hybrid cells provide a combination of flexibility and structural rigidity. According to an embodiment of the present invention, the frame is designed to have a rigid section, the second section, that will also comprise the valve. The second section is made rigid by forming closed cell by connecting peaks of the adjacent ringlets using short connectors or fusing the peaks together. In addition, the second section, comprises a plurality of commissure points as well to attach a valve. The first section comprises open cells and made of mainly struts and connected to the second section through the curved connectors. The first section also comprises a plurality of anchors protruding outwardly from its outer peripheral surface. These anchors provide anchorage to the implant and the curved connectors impart flexibility to the structure. The third section may comprise the hybrid cells, the open cells, or a combination thereof. In illustrated embodiment, the third section comprises a combination of hybrid cells and open cells. The flared distal end helps in conformance with the anatomy of the aorta and also helps in anchorage. The second section is also connected with the third section through the curved connectors that provide good flexibility to the structure. The presence of these curved connectors helps the heart implant in adjusting with the anatomy of the ascending aorta.
[0012] In addition, a plurality of anchor are attached on the peripheral surface of the first section of the frame and directed outwards. The frame is wrapped from outside using a cover. The cover is sutured to the frame at different locations. The cover sutured to the frame, optionally, has a branch joint to accommodate additional embodiments and that exposes the frame, according to the present invention.
[0013] According to an embodiment of the present invention, the frame has a branch body attached to the frame near its proximal end. The branch body comprises a branch frame that is also primarily a cylindrical structure. The peripheral surface of the branch frame is also a grid-type structure made of a plurality of ringlets that are connected through a plurality of connectors. The ringlets are made of a plurality of struts. The struts, ringlets and the connectors can be of same or different sizes and configurations. The branch frame is wrapped from outside using a branch cover. The branch cover is sutured to the branch frame at different locations. In addition, the branch cover, optionally, is longer than the branch frame and exceeds the distal end, towards the distal end of the frame, of the branch body. The excess length of the branch cover forms a free end. The free end is flexible to form any shape and accommodates any contour. The free end can be sutured to the branch joint present on the cover that is sutured to the frame. Thus the branch body is connected to the heart implant as per the present invention.
[0014] According to an embodiment of the present invention, diameter of the proximal end is smaller than the diameter of the distal end.
[0015] According to an embodiment of the present invention, part of the frame above the valve and below the valve are made flexible then the remaining frame to accommodate the frame according to the curvature in the aorta.
[0016] According to an embodiment of the present invention, the shape of the ringlet is selected from a linear shape, curved, helical, S-shaped, Z-shaped, N-shaped, V-shaped, M-shaped, W-shaped, irregular shape or combinations thereof.
[0017] According to an embodiment of the present invention, the shape of the connector is selected from a linear shape, curved, helical, S-shaped, Z-shaped, N-shaped, V-shaped, M-shaped, W-shaped, irregular shape or combinations thereof. Connector’s size, shape and number of connectors placed between the ringlets decide the mechanical properties of the frame such as radial strength, flexibility etc.
[0018] According to an embodiment of the present invention, a valve is sutured inside the valve of the frame. The valve at least has two leaflets. Further, the heart implant can be deployed in such a manner so that the valve need not to be necessarily at the natural valve position rather it can be situated longitudinally anywhere along the ascending aorta. In addition, the commissure points of the valve need not be aligned with the natural commissure points.
[0019] According to an embodiment of the present invention, the frame may have additional means for sealing including, but not limited to, an inner cover, an outer skirt, a ring or a combination thereof.
[0020] According to an embodiment of the present invention, the frame or branch frame or both may have a plurality of anchoring means on their peripheral surface or on the ends. These anchoring means further aid the anchoring effect produced due to radial force exerted in axial direction by the frame and/or branch frame on their expansion.
[0021] According to an embodiment of the present invention, the frame has a plurality of commissure points to attach the valve with the frame.
[0022] According to an embodiment of the present invention, the frame or the branch frame or both may have radiopaque markers at suitable points on their peripheral surface.
[0023] According to an embodiment of the present invention, the branch frame is directly connected to the frame at the branch joint and the branch cover does not have a free end.
[0024] According to an embodiment of the present invention, the branch joint is situated closer to the proximal end and above the valve.
[0025] According to an embodiment of the present invention, the heart implant is deployed at the desired location by unveiling the implant from the distal end and expanding it gradually as unveiling progresses. In addition, the implant is positioned in such a manner so that the branch body expands in one of the arteries originating from the aortic arch.
[0026] According to an embodiment of the present invention, the heart implant is recapturable and repositionable until 50% length of the main body from the distal end.
[0027] According to an embodiment of the present invention, the heart implant is deployed at the desired location, after accurate positioning, by expanding the implant using a balloon mechanism.
[0028] According to an embodiment of the present invention, the heart implant can be anchored at different locations including, but not limited to, ascending aorta, aortic arch, sino-tubular junction, brachiocephalic arteries or a combination thereof.
[0029] According to the present invention, the heart implant can be deployed in such a manner so that need of a pacemaker implantation is eliminated. Also, the heart implant can be positioned and deployed in such a manner so that the coronary arteries are not blocked. Overall, placing the prosthetic heart valve in the ascending aorta region will regulate the blood flow in better manner and reduces aortic regurgitation. Cover along with increased diameter of the distal end will help in preventing paravalvular leakage. Radial strength of the implant and anchors will ensure robust deployment of the device at the implant location. The implant distal end will not overlap the entrance of coronary arteries or sinus node.
[0030] According to an embodiment of the present invention, the material of the frame or branch frame or of both is selected from, but not limited to, metal, non-metal, alloy, polymer, biodegradable, bioresorbable material or combinations thereof. More specifically, the material of the frame or branch frame or of both is selected from, but not limited to, Stainless steel, Cobalt alloys, pure Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, CuZnAl, CuAlNi, or combinations thereof. In addition, based on the material selected for frame or branch frame or both, the delivery mechanism can be a balloon catheter or a catheter for self-expanding devices.
[0031] According to an embodiment of the invention, the material of the cover or branch cover is selected from a polymeric material, a non-polymeric material, a tissue, silk, cotton, cellulose, lignin, or combinations thereof.
[0032] According to an embodiment of the invention, the frame and the branch frame are coated, completely or partially, with a coating. The coating composition may be selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, pharmaceutical, chemical, non-polymeric or combinations thereof. In addition, the coating may contain at least an active agent, an additive to enhance either physical, chemical or biological performance, a biodegradable polymer, a hydrophilic compound, or combinations thereof.
[0033] According to an embodiment of the present invention, the polymer used in the coating are selected from, but not limited to biodegradable polymers, non-biodegradable polymers, polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, and copolymers and combinations thereof.
[0034] According to an embodiment of the present invention, the term “active agent” refers to any biologically active compound or a pharmaceutical compound or a drug compound that can be used in a composition that is suitable for administration in mammals including humans. According to one embodiment of the present disclosure, the active agent is 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. Examples of the drug include, but are not limited to, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin and combination thereof. In another embodiment, there can be more than one active agent in the coating to deliver at the target lesion.
[0035] According to another embodiment of the present invention, the coating formulation can be coated on the heart implant through spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method and 3-D printing.
[0036] Given below an embodiment of the present invention is described using accompanying drawings. Fig. 1 illustrates front view of a heart implant (100) that comprises a frame (108) that has a proximal end (104), a distal end (102), a plurality of anchors ((116) attached to the proximal end (104), at least a short connector (111), a long connector (112) and at least a curved connector (113) arranged among the ringlets along with a plurality of commissure points (114) situated, in a cross-sectional plane, between the proximal end (104) and the distal end (102) to attach a valve (106), not shown in this Figure. The frame (108) is divided in three sections depending on the cell configuration and their functionality. The frame (108) has a first section (103), a second section (105) and a third section (107). Further, the valve (106) is attached to the second section (105). The diameter of the proximal end (104) of the heart implant (100) is smaller than the diameter of the distal end (102). The frame (108) is made of ringlets formed by straight struts (109) connected in V-shape. The length of the struts (109) varies in different ringlets along the longitudinal axis. The ringlets are connected through three type of connectors: the short connectors (111), the long connector (112) and the curved connector (113). The short connector (111) and the curved connector (113) are used in peak-to-peak manner. The long connectors (112) are used in peak-to-valley manner. Based on placement of connectors, the adjacent ringlets form closed cells, open cells or hybrid cells. The frame (108) comprises closed cells, open cells and hybrid cells in different parts along the longitudinal axis. Closed cells provide rigidness in a particular section while curved connectors provide flexibility. The second section (105) comprises closed cells made of struts (109) and the short connectors (111). The second section is most rigid section in the implant. The first section (103) comprises open cell and made of mainly struts (109) and connected to the second section (105) through the curved connectors (113). The first section (103) also comprises a plurality of anchors (116) protruding outwardly from its outer peripheral surface. These anchors provide anchorage to the implant and the curved connectors (113) impart flexibility to the structure. The third section (107) comprises a combination of hybrid cells and open cells. A combination of struts (109), the long connectors (112) and the short connectors (111) provide a good balance of flexibility and structural rigidity. The flared distal end (102) helps in conformance with the anatomy of the aorta and also helps in anchorage. The second section (105) is also connected with the third section through the curved connectors (113) that provide good flexibility to the structure. The presence of these curved connectors (113) helps the heart implant (100) in adjusting with the anatomy of the ascending aorta. Fig. 1A shows placement of connectors (112) and the commissure points (114) from a different viewing angle.
[0037] Fig. 2 illustrates front view of a heart implant (100) that shows the frame (108) wrapped from outside using a cover (110). In addition, a valve (106) is attached to the frame (108) at three commissure points (114). The cover provides sealing effect and also provides a closed contour for the blood flow.
[0038] Fig. 3 illustrates front view of an embodiment of a heart implant (100), according to the present invention, wherein a branch body (200) is attached to the frame (108). The branch body (200) comprises a branch frame (206) that is wrapped from outside using a branch cover (204). The excess length of the branch cover (204) forms a free end (208). The free end (208) is sutured to the branch joint (210) present on the cover (110) that is sutured to the frame (108). Further, the branch joint (210) is located between the first section (103) and the second section (105). In this embodiment, the proximal end of the branch body (200) is not situated in same plane as is the proximal end (104) of the frame (108).
[0039] In the above description, for purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the present disclosure may be practiced without these details. One skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into a number of systems. Further, structures and devices shown in the figures are illustrative of exemplary embodiment of the present disclosure and are meant to avoid obscuring the present disclosure.

Reference to Numerals

Numeric Reference Element Name
100 Heart Implant
102 Distal end
104 Proximal end
106 Valve
108 Frame
103 First Section
105 Second Section
107 Third Section
109 Strut
110 Cover
111 Short Connector
112 Long Connector
113 Curved Connector
114 Commissure Point
116 Anchor
200 Branch body
204 Branch frame
206 Branch cover
208 Free end
210 Branch joint
,CLAIMS:
1. A heart implant (100) for deployment in ascending aorta, the heart implant (100) comprising:
a frame (108) having a proximal end (104) and a distal end (102) opposite to the proximal end (104), the frame (108) is structured using a plurality of struts (109), and a combination of at least one long connector (112), at least one short connector (111) and at least one curved connector (113), and comprises:
a first section (103) proximate to the proximal end (104);
a second section (105) disposed between the proximal end (104) and the distal end (102) and includes a valve (106) attached to the second section (105), the second section (105) has closed cell configuration; and
a third section (107) proximate to the distal end (102).

2. The heart implant (100) as claimed in claim 1, wherein the third section (107) has a hybrid cell configuration, an open cell configuration, or combination thereof.

3. The heart implant (100) as claimed in claim 1, wherein the struts (109) in the frame (108) are of different lengths and connected in V-shaped configuration.

4. The heart implant (100) as claimed in claim 1, wherein the struts (109) in any particular row in the frame (108) are of same length and connected in V-shaped configuration.

5. The heart implant (100) as claimed in claim 1, wherein the curved connector (113) can be present between any two rows and imparts flexibility to the frame (108).

6. The heart implant (100) as claimed in claim 1, wherein the short connector (111) can be present between any two rows and imparts rigidity to the frame (108).

7. The heart implant (100) as claimed in claim 1, wherein the long connector (111) can be present between any two rows connecting peak in a row to a valley in the adjacent row.

8. The heart implant (100) as claimed in claim 1, wherein at least one commissure point (114) is present in the second section (105).

9. The heart implant (100) as claimed in claim 1, wherein at least one anchor (116) is present in the first section (103).

10. The heart implant (100) as claimed in claim 1, wherein the proximal end (102) and the distal end (104) are flared.

11. The heart implant (100) as claimed in claim 1, wherein the frame (108) has a cover (110) that covers at least one portion of the peripheral surface of the frame (108).

12. The heart implant (100) as claimed in claim 1, wherein the frame (108) has at least one branch body (200) joined to the heart implant (100) at a branch joint (210).

13. The heart implant (100) as claimed in claim 12, wherein the branch body (200) has a free end (208) and a branch frame (204) made of struts and connectors.

14. The heart implant (100) as claimed in claim 12, wherein the branch body (200) has a branch cover (206) covering at least one portion of peripheral surface area of the branch frame (204).

15. The heart implant (100) as claimed in claim 1, wherein the material of the frame (108) is selected from metal, non-metal, alloy, shape memory alloy, shape memory polymer, polymer, biodegradable material, bioresorbable material or combinations thereof.

16. The heart implant (100) as claimed in claim 1, wherein the material of the frame (108) is selected from Stainless steel, Cobalt alloys, Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol, CuZnAl, CuAlNi, or combinations thereof.

17. The heart implant (100) as claimed in claim 11, wherein the cover (110) material is selected from a polymeric material, a non-polymeric material, silk, cotton, cellulose, lignin, or combinations thereof.

18. The heart implant (100) as claimed in claim 1, wherein the frame (108) coated, completely or partially, with a coating.

19. The heart implant (100) as claimed in claim 18, wherein the coating is selected from polymeric, metallic, metallic alloy based, non-metallic, clay-based, biological, biodegradable, pharmaceutical, chemical, non-polymeric coatings or combinations thereof.

20. The heart implant (100) as claimed in claim 18, wherein the coating comprises at least one active agent.

21. The heart implant (100) as claimed in claim 18, wherein the coating comprises at least one additive to enhance either physical, chemical, therapeutical or biological performance of the coating.

22. The heart implant (100) as claimed in claim 19, wherein the polymer used in the coating is selected from biodegradable polymers, nonbiodegradable polymers, polymers of L-lactide, Glycolide, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers or combinations thereof..

23. The heart implant (100) as claimed in claim 20, wherein the active agent is selected from anti-cancer drug, antiproliferation drug, antirestenosis 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, antiinflammatories, antimitotic, antimicrobial, smooth muscle cell inhibitors, antibiotics, fibrinolytic, immunosuppressive, antiangiogenic, antirestenotic, antineoplastic, antimigrative, anti-antigenic agents, everolimus, sirolimus, pimecrolimus, tacrolimus, zotarolimus, biolimus, paclitaxel, rapamycin or combinations thereof.

24. The heart implant (100) as claimed in claim 18, wherein the heart implant (100) is coated by a method selected from spray coating, dip coating, chemical vapor deposition, physical vapor deposition, Plasma enhanced chemical vapor deposition, evaporating deposition, sputtering deposition, ion plating, atmospheric pressure plasma deposition, sol-gel method, 3-D printing or combinations thereof.

25. The heart implant (100) as claimed in claim 1, wherein the heart implant (100) is sized according to anatomy of the aorta.