TAVR Guidewire

Patent metadata

Field	Value
Publication number	US-2020397577-A1
Application number	US-202016904661-A
Country	US
Kind code	A1
Filing date	Jun 18, 2020
Priority date	Jun 21, 2019
Publication date	Dec 24, 2020
Grant date	—

Abstract

A guidewire may be configured for insertion into a heart of a patient during a procedure such as a transcatheter aortic valve replacement procedure. The guidewire may include a proximal end and a distal end portion. The distal end portion may include (i) a leading section, (ii) a loop structure at a terminal distal end of the guidewire, and (iii) a transition section extending between the leading section and the loop structure. In the absence of applied forces, the leading section is not tangential to the loop structure. With such a configuration, the guidewire may avoid contact with the ventricular septum of the heart when the loop structure is seated within the left ventricle, which may mitigate potential interference with conduction pathways in the ventricular septum, which may in turn mitigate the need for a pacemaker.

First claim

1 . A guidewire for insertion into a heart, the guidewire comprising:
a proximal end; and a distal end portion, the distal end portion including (i) a leading section; (ii) a loop structure at a terminal distal end of the guidewire; and (iii) a transition section extending between the leading section and the loop structure, wherein, in the absence of applied forces, the leading section is not tangential to the loop structure.

2 . The guidewire of claim 1 , wherein, in the absence of applied forces, (i) the leading section extends along a guidewire axis; (ii) the loop structure defines a first point at which a first line tangential of the first point is substantially parallel to the guidewire axis; and (iii) the loop structure defines a second point diametrically opposed from the first point, a second line tangential of the second point being substantially parallel to the guidewire axis.

3 . The guidewire of claim 2 , wherein, in the absence of applied forces, the guidewire axis is positioned between the first line and the second line.

4 . The guidewire of claim 3 , wherein, in the absence of applied forces, the first point and the second point are substantially equidistant from the guidewire axis.

5 . The guidewire of claim 1 , wherein the loop structure extends from the transition section to a distal tip of the guidewire, the loop structure having a helical or corkscrew configuration so that portions of the loop structure lie within a plane that does not pass through the leading section.

6 . The guidewire of claim 5 , wherein the loop structure coils about a coil axis, the coil axis being substantially perpendicular to a guidewire axis along which the leading section extends.

7 . The guidewire of claim 1 , wherein the loop structure is a single wire and forms a spherical shape in the absence of applied forces.

8 . The guidewire of claim 1 , wherein the loop structure includes a plurality of wires each having a distal end fixedly coupled to the distal end of the guidewire, and each having a proximal end that is slideable relative to the guidewire, so that upon the proximal ends sliding relative to the guidewire, the plurality of wires being forced to bow outwardly upon sliding of the proximal ends relative to the guidewire.

9 . (canceled)

10 . A method of positioning a guidewire within a heart, the method comprising:
advancing a distal end portion of the guidewire into a left or right ventricle of the heart until a loop structure at a terminal distal end of the guidewire is seated within the left or right ventricle, the distal end portion of the guidewire including a leading section and a transition section extending between the leading section and the loop structure, wherein when the loop structure is seated within the left or right ventricle, an entire length of the leading section positioned between a native valve annulus of the heart and the transition section of the guidewire is out of contact with a ventricular septum separating the left ventricle from the right ventricle of the heart.

11 . The method of claim 10 , wherein advancing the distal end portion of the guidewire includes advancing the distal end portion of the guidewire into the left ventricle, by advancing the distal end portion of the guidewire into a femoral artery, around an aortic arch, and through the aortic valve annulus.

12 . The method of claim 11 , further comprising advancing a delivery device over the guidewire while the loop structure is seated within the left ventricle, until a distal end portion of the delivery device is adjacent the aortic valve annulus.

13 . The method of claim 12 , further comprising retracting a sheath of the delivery device to allow a collapsible prosthetic heart valve positioned within the sheath to expand into contact with the aortic valve annulus.

14 . A guidewire for insertion into a heart, the guidewire comprising:
a proximal end; and a distal end portion having a distal fixation member configured to temporarily fix the distal end portion of the guidewire relative to the heart; a first magnetic section being positioned on the guidewire at a first location along the guidewire; and a second magnetic section being positioned on the guidewire at a second location along the guidewire a spaced distance from the first magnetic section, wherein the second magnetic section is configured to pull or push the first magnetic section toward or away from the second magnetic section.

15 . The guidewire of claim 14 , wherein the distal fixation member is either (i) a braided mesh configured for placement in a left atrial appendage of the heart; or (ii) a stent configured for placement in a pulmonary vein of the heart.

16 . The guidewire of claim 14 , wherein the first magnetic section and the second magnetic section are electromagnets.

17 . A guidewire for insertion into a heart, the guidewire comprising:
a proximal end; and a distal end portion having a distal tip, the distal tip being formed of a polymer or elastomer, the distal tip having a central portion adapted to contact a ventricular apex of the hear, the distal tip having a collapsed delivery condition and an expanded functional condition.

18 . The guidewire of claim 17 , wherein the distal tip includes a central portion and a plurality of extensions extending proximally from the central portion, the plurality of central portions being spaced apart from one another in a circumferential direction.

19 . The guidewire of claim 17 , wherein the distal tip is configured to passively transition between the collapsed delivery condition and the expanded functional condition.

20 . The guidewire of claim 17 , wherein the distal tip is configured to actively transition between the collapsed delivery condition and the expanded functional condition.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Alkhatib Yousef F
• Morrissey Michael Shane
• Reimer Jay
• Vietmeier Kristopher Henry
• Ness Peter J

Classifications

• A61M2025/09183

  having tools at the distal tip · CPC title

• A61M2025/09175

  having specific characteristics at the distal tip · CPC title

• A61M25/09 Primary

  Guide wires · CPC title

• A61M2025/09075

  having a core without a coil possibly combined with a sheath · CPC title

• A61M2025/09141

  made of shape memory alloys which take a particular shape at a certain temperature · CPC title