Endoventicular device for the treatment and correction of cardiomyopathies

• US 8,622,884 B2
• Filed: 04/27/2010
• Issued: 01/07/2014
• Est. Priority Date: 04/13/2000
• Status: Expired due to Fees

• Current Assignee: Cube Corporation (Babcock International Group PLC)
• Original Assignee: Cube Corporation (Babcock International Group PLC)
• Inventors: Ferrazzi, Paolo
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US12/662,641
• Publication Number:
  US 20110066235A1
• Time in Patent Office: 1,351 Days
• Field of Search: 606/191, 606/273, 623/1.26, 623/2.34, 623/2.36, 623/2.37, 623/2.11, 267/167, 267/168, 600 16- 18, 600/37
• US Class Current: 600/16
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

An endocardial heart function intervention device that optimizes the cardiac geometry in patients with heart failure. The device comprises one or more elastic elements sutured in place within a heart that will establish radial elasticity in a direction towards the inside of the ventricle and plastic deformation in a direction that is transversal to the ventricle and is configured to be adjusted axially and radially to and along a section of the endocardial wall while in a neutral rest condition and can thereafter expand to receive energy from the endocardial wall during the diastolic phase, to cede energy received to the endocardial wall during a systolic phase.

Claims

1. A mitral valve repair device for mitral annuloplasty comprising one annular coil spring being formed as an elastic structure having flexibility along an axis of a ventricular cavity and having radial elasticity and at least one attachment member for effectively suturing the elastic structure within a heart in a rest condition in which the coil spring does not statically constrict the mitral valve, but establishes a connection to the mitral valve native annulus;

wherein the annular coil spring comprises a plurality of spaced apart coils and is so configured and sized as a function of the volumetric and geometric characteristics of the mitral valve native annulus to expand from its rest position undergoing an elastic deformation and receive energy from the mitral valve native annulus during a diastolic phase of heart pumping activity under endoventricular pressure; and

to collapse from the rest condition and cede the energy received to the mitral valve native annulus during a systolic phase of heart pumping activity, the spring thereby operating alternatively during the cardiac cycle as an extension spring and as a compression spring, and wherein the device, exhibits non-linear elastic properties.

2. The device according to claim 1, wherein the relationship between elastic deformations of the device and the endoventricular pressure is not linear.

3. The device according to claim 2, wherein said elastic deformation decreases as endoventricular pressure increases.

4. The device according to claim 3, wherein said elastic deformation continuously limits diastolic dilatation.

5. The device according to claim 1, wherein the annular coil spring is an open ring.

6. The device according to claim 1, wherein the annular coil spring is a closed ring.

7. An endocardial heart function intervention device comprising an elastic structure including an annular coil spring and at least one attachment member for suturing the elastic structure within a heart thereby effectively establishing a connection to an interior endocardium wall, said annular coil spring comprising a plurality of spaced apart coils and having flexibility along an axis of a ventricular cavity and, upon being connected to heart tissue internally of the ventricular cavity via the attachment member and configuring spring elasticity to effectively establish a radial elasticity during a diastolic phase the annular coil spring and the attachment member being so configured and sized as a function of the volumetric and geometric characteristics of the ventricle to expand from a rest condition, in which said elastic structure does not statically constrict the endocardium wall, undergoing an elastic deformation and receive energy from the endocardium wall, during a diastolic phase of heart pumping activity under endoventricular pressure;

and to collapse from the rest condition, and cede the energy received to the mitral valve native annulus during a systolic phase of heart pumping activity, and the device exhibits non-linear elastic properties.

8. The endocardial heart function intervention device as in claim 7, wherein the annular coil spring is an open ring.

9. The endocardial heart function intervention device as in claim 7, wherein the annular coil spring is a closed ring.

10. The endocardial heart function intervention device as in claim 7, wherein the attachment member includes biocompatible material attached to the annular coil spring for being sutured to the heart.

11. The endocardial heart function intervention device as in claim 7, wherein the annular coil spring comprises formed connection portions and spring portions;

the formed connection portions being dimensionally different from the spring portions within the body shape.

12. An endocardial heart function intervention device comprising, at least one ring shaped device having a substantially elliptical, circular or asymmetrical body shape and being formed as an elastic structure having transversal dimensional variations in the form of coil spring portions each comprising a plurality of spaced apart coils, and formed connection portions created from the material comprising the coil spring, the formed connection portions being positioned along the device thus configuring the device to be directly sutured in place within a heart and onto an endocardium wall, said elastic structure having flexibility along an axis of a ventricular cavity and configuring spring elasticity the elastic structure being so configured and sized as a function of the volumetric and geometric characteristics of the ventricle to expand from a rest condition, in which said elastic structure does not statically constrict the endocardium tissue undergoing an elastic deformation during a diastolic phase of heart pumping activity under endoventricular pressure;

and to collapse from the rest condition and cede the energy received to the endocardial wall during a systolic phase of heart pumping activity, and the device exhibits non-linear elastic properties.

13. The endocardial heart function intervention device as in claim 12 wherein the device is configured to position about the mitral annulus.

14. The endocardial heart function intervention device as in claim 12 further including biocompatible material attached to the shaped device for being sutured to the heart.

15. The endocardial heart function intervention device as in claim 14 wherein the biocompatible material comprises a covering including at least one lip portion extending outwardly from the shaped device.

16. The endocardial heart function intervention device as in claim 15 wherein the covering is a woven structure.

17. The endocardial heart function intervention device as in claim 12 wherein the formed connection portions exhibit a different shape from the remainder of the body shape.

18. An endocardial heart function intervention device comprising, at least one device comprising an elastic spring and an attachment member to be sutured in place within a heart and onto an endocardium wall, said elastic spring comprising a plurality of spaced apart coils, having flexibility along an axis of a ventricular cavity, and configuring spring elasticity in a radial direction;

the elastic spring being so configured and sized as a function of the volumetric and geometric characteristics of the ventricle to expand from a rest condition, in which the elastic spring does not constrict the endocardial wall, undergoing an elastic deformation during a diastolic phase of heart pumping activity under endoventricular pressure; and

to collapse from the rest condition, and cede the energy received to the endocardial wall during a systolic phase of heart pumping activity, the spring thereby operating alternatively during the cardiac cycle as an extension spring and as a compression spring, and the device exhibits non-linear elastic properties.