PROSTHETIC HEART VALVe CREATING A VORTEX EFFECT

Abstract

A prosthetic heart valve either of the mechanical type or the bio prosthetic type, comprises a tubular or cylindrical frame element, a plurality of injectors, a suturing member surrounding the tubular or cylindrical frame element, tether lines to secure the device during diastolic filling but more predominantly during systolic contraction that creates a vortex effect with externally supplied pressurized fluid injected angularly within a transport structure is provided. Such a unit is utilized to accelerate the hemodynamics, reduce the energy required for said transport or both. The annular frame is designed to allow a passageway for blood flow and regulating flow during systolic contraction. Such a result is achieved through the introduction of pressurized fluid (blood) via a plurality of injectors situated evenly around the circumference of the subject tubular or cylindrical unit, and angled uniformly for an even pressure injection of fluid within the conveyance component thereof.

Claims

1. A prosthetic heart valve, comprising: a tubular or cylindrical frame element base having an interior surface; a circular frame element defining an opening for the passage of blood thru the tubular or cylindrical frame; openings perpendicular, and or angularly to the main tubular or cylindrical frame element; the transport device has openings on either end for the passage of blood creating a flow column, a valve element to transport blood directionally; a plurality of fluid injectors to inject angularly fluid within a transport structure; wherein, said injectors are housed on the external portion of said conveyance component; a suturing member surrounding the circular frame element and having a first radial width in a first circumferential region the circumference substantially greater than a second substantially uniform radical width in a region to define an extended portion for attachment; and tether lines to secure the cylinder base element to a portion of a patient's heart during utilization thereof within said patient's heart.

2. A prosthetic heart valve according to claim 1 where in the transport structure is a mechanical valve.

3. A prosthetic heart valve according to claim 1 wherein the transport structure includes a xenograft.

4. A prosthetic heart valve according to claim 1 wherein the transport structure includes a homograft.

5. A prosthetic heart valve according to claim 1 wherein the transport device includes a mechanical valve such as; titanium or one of various titanium alloys.

6. A prosthetic heart valve where according to claim 1 wherein the transport device is coated with a pyrolytic carbon coating.

7. A prosthetic heart valve according to claim 1 wherein the suturing member is a radial extending flange.

8. A prosthetic heart valve according to claim 1 where the suturing member includes a bio-compatible fabric.

9. The valve of claim 1 wherein said fluid injectors are mounted perpendicularly or angularly to the plane in relation to the tubular or cylindrical transport portion.

10. The valve of claim 1 wherein said tether lines attached to the base of the tubular and or cylindrical transport apparatus usually on the flange base and the other end shall be attached to the chamber wall or in some cases the patient's valve annulus depending on the orientation required to align the transport axis optimally in relation to the valve passage.

11. The valve of claim 1 wherein said conveyance component can be sized radially and the fluid injectors can be sized radially and the length of either can be sized to create the more optimal hemodynamic vortex effect desired thereby determining the proportional improvement in laminar flow.

12. A prosthetic heart valve of claim 2 wherein the metal of the tubular or cylinder transport structure includes titanium and alloys thereof.

13. A prosthetic heart valve of claim 2 wherein the fluid injectors includes titanium and alloys thereof.

14. The prosthetic heart valve of claim 3 wherein the bio-prosthetic xenograph is stretched over a plastic or polymer stent and as fluid injectors of bio-compatible materials

15. The prosthetic heart valve of claim 2 wherein the fluid injectors are metals constructed of titanium and alloys thereof.

16. A prosthetic heart valve of claim 1 that can be sutured onto an artificial valve.

17. A prosthetic heart valve of claim 2 that can be sutured onto an artificial valve.

18. A prosthetic heart valve of claim 3 that can be sutured onto an artificial valve.

19. A prosthetic heart valve of claim 4 that can be sutured onto an artificial valve.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0062] FIG. 1 is a top view showing the preferred embodiment of the mechanical heart valve prosthesis of the present invention;

[0063] FIG. 2 shows a front view of the same mechanical heart valve prosthesis of FIG. 1;

[0064] FIG. 3 shows a top perspective view of the same mechanical heart valve prosthesis of FIG. 1;

[0065] FIG. 4 shows a front cross-sectional view of the conveyance component of the same heart valve prosthesis of FIG. 1 (all showing an inventive chamber mechanical prosthetic heart valve that can be attached to a native valve, artificial heart valve, or be of a free-float tethered design in the actual heart chamber);

[0066] FIG. 5 is a top view showing the preferred embodiment of the chamber mechanical prosthetic heart valve that can be attached to a native valve, artificial heart valve, or by free-float tethered design;

[0067] FIG. 6 is a front view of the same mechanical heart valve prosthesis of FIG. 5;

[0068] FIG. 7 shows a top perspective view of the same mechanical heart valve prosthesis of FIG. 5; and

[0069] FIG. 8 shows a front cross-sectional view of the conveyance component of the same heart valve prosthesis in FIG. 5.

DETAILED DESCRIPTION OF THE DRAWINGS AND PREFERRED EMBODIMENTS OF THE INVENTION

[0070] Without any intention of limiting the breadth and scope of the overall inventive method the following descriptions of the accompanying drawings provide a number of potentially preferred embodiments of the inventive transport improvement device, hence a prosthetic heart valve with vortex effect mechanical and/or bio-prosthetic in nature.

[0071] The accompanying Figures provided herein all pertain to different versions of prosthetic heart valves with vortex effect that may be utilized in conjunction with the broadly defined inventive prosthetic heart valve with vortex effect. This prosthesis is usually known in the art as mechanical heart valve prosthesis. For specific examples and detailed descriptions of the prior art, reference is made to U.S. Pat. Nos. 3,744,066, 3,835,475, 3,997,923, 4,364,126, and 4,106,129 (structures which are not the same as now described and claimed herein). As noted above and herein, the basic structure is a tubular or cylindrical frame element base 10 to which a plurality of injectors 12, 14, 16 have been incorporated within the conveyance component from an external source and introduced for injection within the internal portion at uniform angles and spaced around the circumference of base cylinder 10. As well, the injectors 12, 14, 16 are preferably connected simultaneously to the same fluid source (20 in FIGS. 9 and 12) in order to introduce the same fluid at the same pressure in order to generate the desired vortex effect within the conveyance component 10 of the valve. The fluid source 20 may be regulated with a gauge 36 to control the flow and pressure therefrom through separate transfer lines 38, 40, 42 to the injectors 12, 14, 16. Typical sizes of the diameter of the transport column of the conveyance component are 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, and 29 mm. In order to achieve the desired results, the structures may be produced in the following manner, dependent, certainly, upon specific sizes of base structures as it concerns the end-use desired.

[0072] Thus, for manufacturing purposes, one manner of achieving such conveyance components of the present invention would be within the following steps:

Mechanical Prosthetic Heart Valve Unit

[0073] 1. A cylindrical tube structure 10 is made titanium or titanium alloy made of sufficient diameter to connect to existing valve depending whether the prosthesis is used implantation attaching to mitral, aortal, or tricuspid heart valves. Also, the unit needs to be sufficient for either a native or artificial valve. The seamless tube structure 10 is drilled for ports (2, 4, and 6 in FIG. 1, for example) and polished. Note: The cylindrical base diameter can vary to accommodate patients of varying ages and body designs, hence valve size, chamber depth and stroke volume. Common sizes could be a range from 33 mm.-17 mm. but not limited thereto. [0074] 2. Fluid injectors 12, 14, 16 of similar material are attached to the cylinder base 10. Attachment can be accomplished in a variety of ways, but not limited to welding, flange attachment of varying types, and solid block direct bore involving taking solid block titanium and titanium allows and machining the base cylinder and the fluid injectors from one solid block of material. Flow straighteners can be inserted as desired fluid injectors of various styles; such as, but not limited to straight perpendicular, angular perpendicular, reduced leading edge, pronounced leading edge, perpendicular with directional angular inlet. [0075] 3. Calibrate and attach the fluid injectors 12, 14, 16. Note: the fluid injectors 12, 14, 16 can be of one-piece construction with the tubular cylinder 10. The ports 2, 4, 6 can be machined to improve efficiency of the unit whereas the inside diameter of the port on the interior proximal side of the cylinder 10 is as close as possible to the diameter of the fluid entrance on the distal side of the fluid injector 12, 14, 16. Precise boring can improve the efficiency of the injector up to 62%. The unit can be treated with a pyrolytic carbon coating to reduce the propensity for the patient/user to suffer from thrombosis. [0076] 4. Attach any necessary flanges 22 to the cylinder prosthesis. It is well known by those skilled in the art that a substantially conventional sewing ring is affixed by sutures (not-shown) to the living tissues (not-shown), various annular suturing members rings and suturing to the native heart tissue surrounding the existing valve. [0077] 5. Attach tethers 24, 26 lines to cylinder base 10. The attaching hardware 28, 30 can be constructed of titanium and titanium alloys due to its bio-compatible basis and reduced thrombosis affect (such titanium or one of various titanium alloys are selected with care to prevent allergic reactions, such is prevalent with, in one example, nickel-titanium a/k/a nitinol, a poor choice as a large percentage of potential patients would experience an allergic reaction). [0078] 6. The opposite eyelet 28, 30 Dacron sewing strap attachment 24, 26 can be sutured to the chamber wall or annulus for its bio-compatible features. Those skilled in the art in the light of the present disclosure that various configurations are possible within the scope of the invention, the criteria being that the attachment cooperate with the hereinafter described to distribute the surface tension to the area of attachment and to secure the valve base along its best axis of operation, such that the desired flow is directional and non-obstructive to the native and/or artificial valve it assists. The tethers 24, 26 would be anchored to the chamber wall to limit the movement of transport chamber during ejection cycle. The existing art in the field supports such anchoring system as currently utilized over the past ten years. This would define a chamber valve of a free-float design whose valve function is to alter the flow rate and thus dynamic pressure to aid native and artificial existing heart valve achieve increased throughput and thus improve cardiac output with reduced energy required from the native chamber. Dacron strap material could be utilized over a titanium alloy tie loop with a larger surface area to be sutured to the chamber wall or annulus to restrain movement during ejection cycle. Dacron would be excellent candidate for its bio-compatible properties and its aversion to thrombosis. [0079] It will be recognized by those skilled in the art in light of the present disclosures that various configurations for the tether tie loops and attachments are possible within the scope of the present invention, the criteria being that the attachment provide camming surface to cooperate with the hereinafter described.

[0080] Other variables that would change the dynamic pressure of the prosthetic valve and hence the heart chamber is as follows: [0081] 1. The dimensional size, length, wall thickness and material the tubular and or cylindrical base is constructed of. [0082] 2. The number of orifices and the locations they are placed on the transport column. [0083] 3. Various attachment of suture rings and or suture-less attachments rings of varying designs. [0084] 4. Three dimensional modeling 3-D, and four dimensional modeling 4-D, in which three dimensional objects are tested for flow patterns in a dynamic pressure chamber for flow characteristics, as well as finite element analysis and modeling for further improving hemodynamics of inventive device. [0085] 5. The diameter of the fluid injectors, wall thickness, approach angle, leading and following edge angle, and even the material the injector is constructive of and/or treated with, such as; medical grade urethane and plastics, nylatron, nylon and various alloys. [0086] 6. Another variable that can be added is a radiographic ring such as; chromium, /or embedded micro-gps chip. [0087] 7. The shape of the cylinder can be altered to effect dynamic pressure. For example, the shape of the cylinder can be hexagonal rather than cylindrical or any irregular shape to affect the energy level from the vortex effect; this will in turn change the dynamic pressure of the valve and hence the chamber. [0088] 8. Another important note is that the vortex effect does not have to be perfectly symmetric to work.

[0089] In terms, then, of the actual operation of the invention, for all structures, basically. With a few notable exceptions, the tubular and or cylindrical transport structure is to contain the material being conveyed or transported. The ports with or without orifices are to convey blood angularly against the interior sidewall of the cylinder to create differential pressure that creates a vortex effect inside the cylinder. Calibrate and attach fluid injectors to cylinder. The size, angle, and number of fluid injectors depend on the dynamic pressure flow required by the application. For example, a 19 mm. diameter cylinder might require fewer ports than a 27 mm. cylinder and or the diameter of the fluid injectors might be three (3) mm. versus a five (5) mm. respectively. The angle of the fluid injector in relation to the cylinder wall will affect velocity.

[0090] The low-pressure area would serve as a vacuum and as the pressure would attempt to equalize more blood would exit the chamber on the positive pressure end of the tube to aid the chamber output and more blood would enter the vacuum low pressure side of the transport column. As the fluid injectors flow starts motion more blood would enter the open orifice as the pressure outside the orifice attempted to equalize based on the laws of fluid dynamics, and the cycle would continue. This would reduce the amount of energy to open the chamber valve while attributing to gains in chamber output. The valve would appear to pump itself, when, in actuality, the pressure differential of a fluid entering a restricted orifice striking angularly a cylinder wall converts the kinetic energy into a vortex effect force that reduces the frictional drag of a transport column temporarily reducing the specific weight of the material in the transport column. This leads to an increased flow rate exiting the column.

[0091] The unit is also directional and configured to increase acceleration when installed in the conveyance direction and to decrease acceleration when installed in reverse. The chamber will create negative pressure on the opposite end of the transport column as the push end of the column creates positive pressure.

[0092] Having described the invention in detail it is obvious that one skilled in the art will be able to make variations and modifications thereto without departing from the scope of the present invention. Accordingly, the scope of the present invention should be determined only by the claims appended hereto.