US Patents for METHOD AND APPARATUS FOR REPAIRING A MITRAL VALVE

Reporter: Aviva Lev-Ari, PhD, RN

Personal email exchange with Ed Hlozek:

This is still an implantable surgical device , albeit in a minimally invasive fashion.  Patient population is the same surgical patient population.  Check out Mitraspan. The website is almost a non-entity, but:

http://www.faqs.org/patents/app/20130211513

In the column on the right are other patents listed…all implantables, and all MIS.  It remains to be seen if these novo implantables will be able to mimic the results achieved by the surgically implanted ring, the current gold standard for repair of the mitral valve  (assuming leaflet integrity).  Annual surgical procedures are still in the 150,000 range annually.

SOURCE

From: Edward Hlozek <mind.and.associates.inc@gmail.com> on behalf of Edward Hlozek <ehlozek@valvecure.com>

Date: Tuesday, October 6, 2015 at 1:14 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Cc: Justin MDMEPhD <jdpmdphd@gmail.com>, Gerard Loiseau <gerard.loiseau@bluewin.ch>

Subject: Re: FW: Acquisition of Valtech calling into question ?

HeartWare ($HTWR) was up about 5% in early trading on the news that activist investor Engaged Capital is opposing its acquisition of mitral valve player Valtech Cardio–and is seeking a renewed focus on LVAD with a possible sale of the company. HeartWare said in early September that it would buy Valtech for about $930 million in a cash and stock transaction, based on its share price at the time. If the deal is not terminated, Engaged Capital said it will continue to oppose it and seek board representation.

HeartWare shares quickly shed about 20% on the acquisition news when it was first disclosed, indicating that Engaged Capital isn’t alone in its disapproval of the deal, which takes the LVAD (left ventricular assist device) player into a new direction, adding Valtech’s mitral valve replacement and repair technology. Patients on LVAD often also concurrently receive a mitral or tricuspid valve procedure.

On Mon, Oct 5, 2015 at 2:41 PM, Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu> wrote:

All,

My read is as follows:

Heartware will complete the acquisition of ValTech for a Billion on top of its Market cap of a billion.

It will be in 4  month later be acquired for $3.5 Billion by Medtronic

Respectively the concentration in the Mitral Valve Repair and Replacement will be further tighten all small players will be driven out of the Scene by the 3-4 Players listed below.

A Case Study

MITRASPAN, INC.

Inventors:  Jonathan M. Rourke (Belmont, MA, US)  Mitraspan, Inc  Stanley B. Kyi (Andover, MA, US)
Assignees:  MITRASPAN, INC
IPC8 Class: AA61F224FI
USPC Class: 623 237
Class name: Heart valve annuloplasty device adjustable
Publication date: 2013-08-15
Patent application number: 20130211513

Abstract:

A method for repairing a mitral valve, the method comprising: positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location; using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location; anchoring the spanning implant at the first location; tensioning the spanning implant so as to draw the first location and the second location together; and anchoring the spanning implant at the second location.

Claims:

1. A method for repairing a mitral valve, the method comprising: positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location; using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location; anchoring the spanning implant at the first location; tensioning the spanning implant so as to draw the first location and the second location together; and anchoring the spanning implant at the second location.

2. A method according to claim 1 wherein the mitral valve is accessed by penetrating the wall of the left ventricle in the vicinity of the apex.

3. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing a first guidewire from the left ventricle to the left atrium at the first location; passing the first guidewire from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field; passing a second guidewire from the left ventricle to the left atrium at the second location; passing the second guidewire from the left atrium through the valve leaflets, through the left ventricle and out to the operative sterile field; terminating an end of the first guidewire to an end of the second guidewire at the operative sterile field so as to create the complete crossing guidewire; and passing the termination from the operative sterile field, through the left ventricle, through the valve leaflets, to the left atrium.

4. A method according to claim 3 wherein the first guidewire is passed from the left ventricle to the left atrium at the first location by advancing a first positioning sheath through the left ventricle so that the distal end of the first positioning sheath is positioned against the annulus at the first location, advancing a first curved tube out of the first positioning sheath and through the annulus at that first location, and advancing the first guidewire through the first curved tube and into the left atrium.

5. A method according to claim 4 wherein the first curved tube has a sharp distal end so that it may be pushed through the annulus.

6. A method according to claim 4 wherein the first curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the first curved tube.

7. A method according to claim 3 wherein the first guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the first guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

8. A method according to claim 3 wherein the second guidewire is passed from the left ventricle to the left atrium at the second location by advancing a second positioning sheath through the left ventricle so that the distal end of the second positioning sheath is positioned against the annulus at the second location, advancing a second curved tube out of the second positioning sheath and through the annulus at that second location, and advancing the second guidewire through the second curved tube and into the left atrium.

9. A method according to claim 8 wherein the second curved tube has a sharp distal end so that it may be pushed through the annulus.

10. A method according to claim 8 wherein the second curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the second curved tube.

11. A method according to claim 3 wherein the second guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the second guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

12. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing the crossing guidewire from the left ventricle to the left atrium at the first location; passing a funnel-shaped snare from the left ventricle to the left atrium at the second location; capturing the crossing guidewire with the funnel-shaped snare in the left atrium; retracting the funnel-shaped snare and captured crossing guidewire through the annulus at the second location and through the left ventricle.

13. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing the crossing guidewire from the left ventricle to the left atrium at the first location; passing an inflatable funnel from the left ventricle to the left atrium at the second location while the inflatable funnel is in a deflated condition; inflating the inflatable funnel; advancing the crossing guidewire into the inflatable funnel and through the annulus at the second location, and through the left ventricle.

14. A method according to claim 1 wherein the spanning implant is positioned across the mitral valve by attaching the spanning implant to the crossing guidewire and using the crossing guidewire to pull the spanning implant into position.

15. A method according to claim 1 wherein the spanning implant comprises a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

16. A method according to claim 15 wherein the spanning implant is anchored at the first location using the first anchor.

17. A method according to claim 15 wherein the first anchor is positioned on the ventricular side of the annulus.

18. A method according to claim 15 wherein the spanning implant is anchored at the second location using the second anchor.

19. A method according to claim 15 wherein the second anchor is positioned on the ventricular side of the annulus.

20. A method according to claim 1 wherein the spanning implant is dynamically tensioned while observing changes in the function of the mitral valve.

21. Apparatus for repairing a mitral valve, the apparatus comprising: a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

22. Apparatus according to claim 21 wherein the second end of the suture is configured to be secured to a guidewire.

23. Apparatus according to claim 21 wherein the first anchor comprises a T-bar anchor.

24. Apparatus according to claim 23 further comprising a control line releasably secured to the T-bar anchor.

25. Apparatus according to claim 21 wherein the second anchor comprise a T-bar anchor.

26. Apparatus according to claim 21 wherein the coaxial suture lock is configured to bind to the suture upon the application of a compressive radial force to the coaxial suture lock.

27. Apparatus for repairing a mitral valve, the apparatus comprising: a crossing guidewire extending from the left ventricle, through the annulus at a first location, into the left atrium, through the annulus at a second location, and into the left ventricle.

28. Apparatus for repairing a mitral valve, the apparatus comprising: a positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a first location, with the distal end of the positioning sheath set so that the lumen of the positioning sheath is aimed into the left atrium; and a curved tube having a distal end, a proximal end, and a lumen extending therebetween, the curved tube being configured to telescopically extend through the positioning sheath, across the annulus at the first location and present its distal end substantially parallel to the plane of the mitral valve annulus.

29. Apparatus according to claim 28 further comprising a guidewire sized to be telescopically disposed within the curved tube.

30. Apparatus according to claim 29 further comprising a snare for capturing the guidewire when the guidewire is telescopically advanced out of the distal end of the curved tube.

31. Apparatus according to claim 28 further comprising: a second positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the second positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a second location, with the distal end of the second positioning sheath set so that the lumen of the second positioning sheath is aimed into the left atrium; a second curved tube having a distal end, a proximal end, and a lumen extending therebetween, the second curved tube being configured to telescopically extend through the second positioning sheath, across the annulus at the second location and present its distal end substantially parallel to the plane of the mitral valve annulus; and a guidewire extendable through the first curved tube and receivable within the second curved tube.

32. Apparatus according to claim 31 further comprising a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture, and further wherein the second end of the suture is releasably secured to the guidewire.

SOURCE

http://www.faqs.org/patents/app/20130211513

Similar patent applications:
Date	Title
2013-09-12	Method for anchoring a mitral valve
2013-10-10	Device and method for reducing mitral valve regurgitation
2009-05-07	Method and apparatus for improving mitral valve function
2010-02-11	Method and apparatus for improving mitral valve function
2012-01-26	Method for preparing biomedical surfaces

New patent applications in this class:
Date	Title
2015-05-28	Anti-paravalvular leakage component for a transcatheter valve prosthesis
2015-05-21	Reconfiguring tissue features of a heart annulus
2015-03-19	Implant and anchor placement
2015-01-08	Implant having multiple rotational assemblies
2014-11-13	Methods and apparatus for controlling the internal circumference of an anatomic orifice or lumen

New patent applications from these inventors:
Date	Title
2015-05-14	Method and apparatus for repairing a mitral valve

Top Inventors for class “Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor”
Rank	Inventor’s name
1	Anton G. Clifford
2	Jan Weber
3	Yunbing Wang
4	Blayne A. Roeder
5	Robert Metzger

Read more: http://www.faqs.org/patents/app/20130211513#ixzz3nohClWxF
Read more: http://www.faqs.org/patents/app/20130211513#ixzz3nogUCtxl
Read more: http://www.faqs.org/patents/app/20130211513#ixzz3noaQWHo9

Adjustable Subclass of:

623 – Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

623200100 – HEART VALVE

623200360 – Annuloplasty device

Patent class list (only not empty are listed)

Deeper subclasses:

http://www.faqs.org/patents/class/000553012

SOURCE:

http://www.faqs.org/patents/app/20130211513

 http://www.faqs.org/patents/app/20130211513#ixzz3noZtbMKS

Other related articles published in this Open Access Online Scientific Journal include the following:

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/11/04/mitral-valve-repair-who-is-a-candidate-for-a-non-ablative-fully-non-invasive-procedure/