Methods and apparatus for treatment of cardiac valve insufficiency

• US 8,974,445 B2
• Filed: 01/07/2010
• Issued: 03/10/2015
• Est. Priority Date: 01/09/2009
• Status: Active Grant

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Warnking, Reinhard, Jung, Eugene J., Zou, Yong, Seguin, Jacques, Iyer, Mano
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US12/684,067
• Publication Number:
  US 20100179424A1
• Time in Patent Office: 1,888 Days
• Field of Search: 606 27- 46, 601 2- 3, 607/96, 604/22
• US Class Current: 606/27
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Mitral valve insufficiency is treated by introducing an expansible device such as a balloon bearing an ultrasonic transducer into the heart so that the transducer is positioned adjacent the mitral annulus but spaced from the mitral annulus, and actuating the transducer to heat the mitral annulus, denature collagen in the annulus and thereby shrink the annulus.

Claims

1. An apparatus for ablating cardiac tissue while reducing disruption of natural blood flow through a cardiac valve of a mammalian subject, the apparatus comprising:

an elongated catheter having proximal and distal regions; and

an emitter unit including an ultrasonic transducer and an expandable balloon positioned along a distal portion of the elongated catheter, the expandable balloon comprising a proximal portion, a distal portion and a transition region therebetween, the transition region extending from a distal end of the proximal portion to a proximal end of the distal portion, wherein a diameter of the expandable balloon, when expanded, at the distal end of the proximal portion is larger than a diameter of the balloon at the proximal end of the distal portion, wherein the expandable balloon, when expanded, comprises an abrupt change in diameter along the transition region, the distal end of the proximal portion of the expandable balloon, when expanded, being angled relative to a proximal end of the transition region by an angle greater than zero degrees, wherein the distal portion of the expandable balloon, when expanded, tapers in the distal direction from the proximal end of the distal portion to a distal end of the distal portion, wherein the ultrasonic transducer extends axially at least partially over the transition region of the expandable balloon, wherein the expandable balloon surrounds the ultrasonic transducer, wherein the ultrasonic transducer is configured and arranged such that, in use, when ultrasonic energy is emitted, the emitted ultrasonic energy causes shrinkage of the annulus of the valve, wherein, in use, the expandable balloon is constructed and arranged to hold the transducer spaced apart from the annulus of the valve and to retain the leaflets of the valve out of a path of the ultrasonic energy when the expandable balloon is deployed in situ and expanded, and the ultrasonic transducer is generally aligned with the annulus of the valve;

wherein the apparatus is configured so that, when the emitter unit is positioned within the valve, (i) the leaflets of the valve contact an exterior of the expandable balloon and form a seal against the expandable balloon, and (ii) an outer diameter of the expandable balloon is less than a cross-sectional dimension of the annulus of the valve so that the expandable balloon does not completely occlude the annulus thereby permitting blood to uninterruptedly flow through the valve, between the leaflets and the exterior of the expandable balloon, wherein the distal portion of the expandable balloon comprises a smooth outer surface so as to reduce the likelihood of damage to the leaflets of the valve.

2. The apparatus of claim 1 wherein the catheter is configured, when in use, to position the emitter unit adjacent to a posterior aspect of the annulus.

3. The apparatus of claim 1, wherein the distal portion of the expandable balloon includes a smaller cross-sectional area than the proximal portion of the expandable balloon when the expandable balloon is in an expanded condition during use.

4. The apparatus of claim 1, wherein the distal portion of the expandable balloon comprises a curved outer profile from the transition region to the distal end of the distal portion.

5. The apparatus of claim 1, wherein there is a decrease in diameter at the transition region between the proximal and distal portions to facilitate aligning the ultrasonic transducer with the annulus of the valve.