Method and system for improving diastolic function of the heart

• US 20100022821A1
• Filed: 09/25/2007
• Published: 01/28/2010
• Est. Priority Date: 09/25/2006
• Status: Active Grant

• Current Assignee: CorAssist Cardiovascular Ltd.
• Original Assignee: CorAssist Cardiovascular Ltd.
• Inventors: Dubi, Shay, Kovalsky, Igor, Loshakove, Amir, Nishri, Boaz, Feld, Yair, Tubishevitz, Amit
• Granted Patent: US 8,382,653 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention provides a system for improving diastolic function of the heart comprising elastic elements and attachment elements, wherein said elastic elements and said attachment elements are configured such that they are capable of being interconnected to form a chain formed of an alternating series of said elastic elements and said attachment elements, and wherein said attachment elements are adapted to be anchored in the wall of the heart and with option for drug delivery to the wall of the heart. The invention further provides devices, methods and kits, for mounting the ventricular function assisting device of the invention.

Claims

1. A system for improving diastolic function of the heart comprising

a) Elastic elements;

and

b) Attachment elements;

wherein said elastic elements and said attachment elements are configured such that they are capable of being interconnected to form a chain formed of an alternating series of said elastic elements and said attachment elements; and

wherein said attachment elements are adapted to be anchored in the wall of the heart and with option for drug delivery to the wall of the heart.

2. The system according to claim 1, wherein the elastic elements comprise one or more torsion springs, each of which comprises two arms forming a “

V”

or “

U”

like shape.

3. The system according to claim 1, wherein the extremities of the elastic elements are bent to form curved fasteners capable of being engaged in anchoring means provided in the attachment elements.

4. The system according to claim 2, wherein the elastic elements comprise a single torsion spring and two arms forming a “

V”

-like shape, wherein each of the arms comprises a curved fastener shaped in a form of a spiral, or a “

G”

-like shape.

5. The system according to claim 4, wherein the end portion of each arm is curved into an “

S”

-like shape, wherein the bottom part of said “

S”

-like shape is further curved to provide the spiral, or a “

G”

-like shape curved fastener.

6. The system according to claim 1, wherein each elastic element is comprised of a relatively straight arm and an arm having a curved section relative to the plane of the torsion spring and the relatively straight arm of said elastic element.

7. The system according to claim 1, wherein at least one of the curved fasteners of the elastic elements comprises one or more fastening loops capable of being placed and tightened over a portion of an anchoring element.

8. The system according to claim 7, wherein the other curved fastener of the elastic elements is provided in a form of an anchoring loop

9. The system according to claim 7, further comprising a widening loop provided on, or near, the fastening loops for assisting in widening the fastening loops before placing them over a portion of the anchoring element.

10. The system according to claim 7, further comprising a saddle formed on an arm section of the elastic element near the curved fastener for assisting in widening the fastening loops.

11. The system according to claim 1, wherein the elastic elements are comprised of two “

V”

-shaped torsion springs having a mutual arm, which form a zigzagged shape element, wherein the non-mutual arms comprise curved fasteners.

12. The system according to claim 1, wherein the attachment elements are formed in a shape of a helix having an attachment section and a head section, wherein the attachment section is adapted to be threaded into a tissue and the head section comprises the anchoring means.

13. The system according to claim 12, wherein the attachment elements further comprise a neck section, provided between the attachment section and the head section, said neck section is adapted to prevent excess threading of the attachment element into the tissue.

14. The system according to claim 13, wherein the neck section is formed by abruptly reducing the distances between the helix loops above the attachment section of the attachment element.

15. The system according to claim 13, wherein the anchoring means of the attachment elements are a continuation of the neck section which helix loops are having a slightly reduced radius.

16. The system according to claim 1, wherein the anchoring means are implemented as anchoring loops provided in the attachment element.

17. The system according to claim 1, wherein the attachment elements are intramural anchors having one or more barbs attached to a nail section of the intramural anchor.

18. The system according to claim 1, further comprising an elastic wire or stretchable cord mounted over the outer wall of the heart by means of attachment elements.

19. The system according to claim 1, further comprising an elastic wire or stretchable cord capable of being connected to the attachment elements at the extremities of the chain formed of the alternating series of the elastic elements and the attachment elements, wherein said elastic wire or stretchable cord and said chain of elastic elements and attachment elements encircles a perimeter of the heart.

20. The system according to claim 1, further comprising an inflatable balloon capable of being introduced into a ventricle of the heart and being inflated thereinside.

21. The system according to claim 1, further comprising one or more compressible elements adapted to be threaded into the wall of the heart.

22. A device for improving diastolic function of the heart comprising an elastic element comprising one or more torsion springs, each of which comprising two arms forming a “

V”

or “

U”

like shape, wherein the extremities of said elastic element are bent to form curved fasteners capable of being engaged in an anchoring loop or ring.

23. A method for improving diastolic function of the heart, comprising:

a) Performing a chest incision;

b) Attaching an attachment element to the wall of the heart, said attachment element—

is capable of puncturing the heart tissue and being advanced or threaded thereinto;

c) Determining the distance from a previously attached attachment element to a location for a new such attachment element to be attached to the wall of the heart;

d) Attaching said new attachment element to the wall of the heart at said location;

e) Attaching an elastic element to anchoring means provided in said previously attached attachment element and said new attachment element by means of attachment means provided in the extremities of said elastic element;

f) Repeating steps c) to e) to form a chain of an alternating series of said elastic elements and said attachment elements.

24. The method according to claim 23, wherein the attachment elements are attached by means of a gripping tool, comprising:

a) Gripping the anchoring means of an attachment element by said gripping tool;

b) Puncturing the wall of the heart with a sharp tip of said attachment element and advancing/threading said attachment element thereinto until tissue resistance is encountered; and

c) Removing said gripping tool.

25. A method according to claim 23, wherein the distance from the previously mounted attachment element is determined by means of a distance indicating instrument having one or more arms having suitable lengths.

26. A method according to claim 23, comprising mounting additional one or more such chains of alternating series of elastic elements and attachment elements on the wall of the heart, comprising:

i) Determining a distance from a previously installed chain of said elastic elements and said attachment elements; and

ii) Mounting an additional chain of alternating series of elastic elements and attachment elements on the wall of the heart within said distance, by carrying out steps b) to f) of claim 23.

27. A method according to claim 26, wherein the distance from the previously installed chain is determined by means of a distance indicating instrument having one or more arms having suitable lengths.

28. A method according to claim 26, wherein the one or more chains of alternating series of elastic elements and attachment elements are substantially parallel.

29. The method according to claim 23, further comprising attaching an elastic wire or stretchable cord to the attachment elements at the extremities of the chain formed of the alternating series of the elastic elements and the attachment elements, wherein said elastic wire or stretchable cord and said chain of elastic elements and attachment elements encircles a perimeter of the heart.

30. The method according to claim 23, further comprising introducing an inflatable balloon into a ventricle of the heart and inflating the same thereinside.

31. The method according to claim 23, further comprising threading one or more compressible elements into the wall of the heart.

32. The method according to claim 23, wherein the chest incision is a mini-left thoracotomy or small incisions performed according to the keyhole surgery approach.

33. A kit of elements and instruments for mounting a ventricular function assisting system on the wall of a heart, comprising:

one or more elastic elements capable of being attached to a wall of a heart, at least two attachment elements capable of being connected to anchoring means provided in said attachment elements, a gripping tool adapted to grip and hold said anchoring means, and one or more distance indicating instrument capable of being used to indicate distances between adjacent attachment elements and/or the distances between interconnected chains of said attachment and elastic elements.

34. The kit according to claim 33, further comprising one or more compressible elements capable of being threaded into the wall of the heart, an expandable balloons capable of being introduced into a ventricle of the heart and inflated thereinside, and/or an elastic wire or stretchable cord capable of being connected to the anchoring means of said attachment elements.