Transcorporeal delivery system and method

• US 20110172764A1
• Filed: 01/10/2011
• Published: 07/14/2011
• Est. Priority Date: 01/13/2010
• Status: Active Grant

• Current Assignee: George Loesel, Vinay Bahdwar
• Original Assignee: George Loesel
• Inventors: Badhwar, Vinay
• Granted Patent: US 9,358,109 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

Abstract

Transcorporeal delivery system and method for valve replacement surgery that is minimally invasive.

Claims

1. A transcorporeal delivery system comprising:

A. a heart valve and a frame;

B. a valve fixation device containing said heart valve;

C. a fastening means for attaching a malleable alloy support to the heart valve;

D. a valve fixation device guide rod, and

E. a mechanism for deploying said valve system and valve fixation device, wherein components B., C., and D. are contained in

F. a housing, and,

G. wherein component A is contained in a delivery cocoon;

said valve comprising at least two moveable leaflets attached to a fabric covered sewing ring said sewing ring configured in the shape of the heart valve base, said sewing ring surmounted by a malleable alloy support, said malleable metal alloy support being in wire form and having a configuration at its base essentially corresponding to the configuration of the heart valve base, wherein the malleable metal alloy support has three vertically extended posts that are equally spaced from each other around the base;

said malleable metal alloy support having three bands around the base spaced equally between the vertically extended portions;

said malleable metal alloy support being attached to the fabric of the sewing ring;

each said vertically extended portion having mounted adjacent thereto, extended posts having an inside surface and an outside surface, and a distal end;

each said extended post having a vertical slit therein through the inner and outer surfaces, said vertical slits in each inner surface and each outer surface of the extended posts being aligned within each extended post;

each said aligned vertical slit having mounted therein a drivable tab, said drivable tab having a grooved perimeter edge, each said drivable tab having a configuration that matches the apex of the vertically extended portion;

each said extended post having at least two openings near the distal end;

said valve fixation device comprising;

i. a circular plate having a threaded center opening therethrough, a perimeter edge, a top, and a bottom and six openings smaller than the centered opening and being equally spaced around the perimeter edge and near the bottom, there being

ii three solid arms, one arm centered over each small opening, said arms being hingedly attached to the bottom of the circular plate, each arm having an inside surface an outside surface, a near end and a distal end, there being at least two openings on the inside surface and near the near end, there being at least two openings in the outside surface and near the near end, the valve fixation device having threadedly attached thereto

iii a delivery arm, said delivery having a distal end and a near end;

said housing containing a lowering mechanism and a raising mechanism therein, said lowering and raising mechanisms being controllable by a trigger tabs located in a vertical slot in the wall of the solid guide rod and near the distal end, there being a

iv. a first continuous braided extremely low profile string that attaches to the circular base plate which commences its continuation through a first opening in the bottom peripheral edge of the circular flat plate, then continues along the outside surface of the first arm of the valve fixation device, continuing through an opening on the outside surface of the first arm, continuing through an opening in the inside surface of the first arm, continuing around the groove in the perimeter of the first drivable tab, continuing through the inside of the near end of the first arm to the outside surface of the first arm, continuing through the bottom of the circular plate to a second opening in the bottom of the circular plate immediately adjacent to the origin of the first string at the circular base plate;

v. a second continuous braided extremely low profile string that attaches to the circular base plate one hundred and twenty degrees from the first string attachment, which commences its continuation along the outside surface of the second arm of the valve fixation device, continues through an opening on the outside surface of the second arm, and continues through an opening in the inside surface of the second arm, continuing around the groove in the perimeter of the second drivable tab, continuing through the inside of the near end of the second arm to the outside surface of the second arm, continuing through the opening in the bottom of the circular plate immediately adjacent to the origin of the second string at the base of the circular plate;

vi. a third continuous braided extremely low profile string that attaches to the circular base plate one hundred and twenty degrees from the second string attachment, which commences its continuation along the outside surface of the third arm of the valve fixation device, and continues through an opening on the outside surface of the third arm, continuing through an opening in the inside surface of the third arm, continuing around the groove in the perimeter of the third drivable tab, continuing through the inside of the near end of the third arm to the outside surface of the third arm, continuing to, and, attaching to the circular base plate immediately adjacent to the origin of the third string.

4. A method of providing a heart valve through minimal invasive surgery using a transcorporeal delivery system, the method comprising:

a. providing a transcorporeal delivery system as claimed in claim 1 minus the housing wherein the heart valve has been placed in iced saline prior to use;

b. manipulating the transcorporeal delivery system to compress the fixation device, malleable metal alloy support and the heart valve to diminish them in size;

c. providing a housing and placing the transcorporeal delivery system into the housing;

d. delivering the device to a target within the thoracic cavity;

e. removing the housing;

f. cutting all the sutures on the malleable metal alloy support bands;

g. suturing the heart valve to existing heart tissue;

h. cutting the strings and removing;

i. removing the transcorporeal delivery system minus the heart valve.

2. In combination, a valve fixation device for surmounting a heart valve and a valve fixation device guide rod.

3. A valve fixation device for surmounting a heart valve.

5. A transcorporeal delivery system comprising:

A. a heart valve and a frame;

B. a valve fixation device containing said heart valve;

C. a fastening means for attaching a malleable alloy support to the heart valve;

D. a valve fixation device guide rod, and

E. a mechanism for deploying said valve system and valve fixation device, wherein components B., C., and D. are contained in

F. a housing, and,

G. wherein component A is contained in a delivery cocoon;

H.

said valve comprising at least two moveable leaflets attached to a fabric covered sewing ring said sewing ring configured in the shape of the heart valve base, said sewing ring supporting a malleable alloy support, said malleable metal alloy support being in wire form and having a configuration at its base essentially corresponding to the configuration of the heart valve base, wherein the malleable metal alloy support has three vertically extended posts that are equally spaced from each other around the base;

said malleable metal alloy support having three bands around the base spaced equally between the vertically extended portions;

said malleable metal alloy support being attached to the fabric of the sewing ring by sutures around the bands;

each said vertically extended portion having mounted adjacent thereto, extended posts having an inside surface and an outside surface, and a distal end;

each said extended post having a vertical slit therein through the inner and outer surfaces, said vertical slits in each inner surface and each outer surface of the extended posts being aligned within each extended post;

each said aligned vertical slit having mounted therein a drivable tab, said drivable tab having a grooved perimeter edge, each said drivable tab having a configuration that matches the apex of the vertically extended portion;

each said extended post having at least two openings near the distal end;

said valve fixation device comprising;

(i) a circular plate having a threaded center opening therethrough, a perimeter edge, a top, and a bottom and six openings smaller than the centered opening and being equally spaced around the perimeter edge and near the bottom, there being

(ii) three solid arms, one arm centered over each small opening, said arms being hingedly attached to the bottom of the circular plate, each arm having an inside surface an outside surface, a near end and a distal end, there being at least two openings on the inside surface and near the near end, there being at least two openings in the outside surface and near the near end, the valve fixation device having threadedly attached thereto

(iii) a delivery arm, said delivery arm having a distal end and a near end;

said housing containing a lowering mechanism and a raising mechanism therein, said lowering and raising mechanisms being controllable by trigger tabs located in a vertical slot in the wall of the delivery arm and near the distal end, there being a

iv. a first continuous braided extremely low profile string that attaches to the circular base plate which commences its continuation through a first opening in the bottom peripheral edge of the circular flat plate, then continues along the outside surface of the first arm of the valve fixation device, continuing through an opening on the outside surface of the first arm, continuing through an opening in the inside surface of the first arm, continuing around the groove in the perimeter of the first drivable tab, continuing through the inside of the near end of the first arm to the outside surface of the first arm, continuing through the bottom of the circular plate to a second opening in the bottom of the circular plate immediately adjacent to the origin of the first string at the circular base plate;

v. a second continuous braided extremely low profile string that attaches to the circular base plate one hundred and twenty degrees from the first string attachment, which commences its continuation along the outside surface of the second arm of the valve fixation device, continues through an opening on the outside surface of the second arm, and continues through an opening in the inside surface of the second arm, continuing around the groove in the perimeter of the second drivable tab, continuing through the inside of the near end of the second arm to the outside surface of the second arm, continuing through the opening in the bottom of the circular plate immediately adjacent to the origin of the second string at the base of the circular plate;

vi. a third continuous braided extremely low profile string that attaches to the circular base plate one hundred and twenty degrees from the second string attachment, which commences its continuation along the outside surface of the third arm of the valve fixation device, and continues through an opening on the outside surface of the third arm, continuing through an opening in the inside surface of the third arm, continuing around the groove in the perimeter of the third drivable tab, continuing through the inside of the near end of the third arm to the outside surface of the third arm, continuing to, and, attaching to the circular base plate immediately adjacent to the origin of the third string.