Granted Patent B2

US 12,582,466 · App. 17/686,001 · Granted Mar 24, 2026

Inventors: Randell L. Werneth (San Diego, CA); David Zarbatany (Laguna Niguel, CA); Ricardo David Roman (Chula Vista, CA)

Assignee: Argá Medtech SA

A61B18/1492A61B5/283A61B18/1206A61B2018/00351A61B2018/00577A61B2018/00613A61B2018/00767A61B2018/0091A61B2018/1226A61B2018/1253A61B2018/126A61B2018/1417A61B2018/1435

Abstract

Claims (51)

1 . An ablation assembly to treat target regions of a tissue in organs comprising:

an ablation catheter comprising an elongate shaft having a longitudinal main direction (X-X), said elongate shaft comprising at least a shaft distal portion, said shaft distal portion comprising a shaft distal portion distal end;

said ablation catheter comprising an inner lumen arranged within the elongate shaft;

said ablation catheter comprising a shaft ablation assembly fixedly disposed at said shaft distal portion, the shaft ablation assembly being configured to deliver both thermal energy for ablating said tissue and non-thermal energy for treating said tissue;

at least a shape setting mandrel disposed within the ablation catheter, the shape setting mandrel being insertable within the inner lumen and removable from the inner lumen, wherein the shape setting mandrel is free to move in respect of the inner lumen avoiding any constraint with said shaft distal portion during the shape setting mandrel insertion,

wherein the shape setting mandrel comprises at least a pre-shaped configuration and the shape setting mandrel is reversibly deformable between at least a straight loaded configuration and said pre-shaped configuration,

wherein, when the shape setting mandrel is fully inserted in the shaft distal portion, the shape setting mandrel is configured to shape set said shaft distal portion with said pre-shaped configuration,

wherein said shape setting mandrel comprises a mandrel distal portion, wherein said mandrel distal portion comprises a mandrel seat, wherein a retention element is fixed to said shape setting mandrel and partially housed in said mandrel seat,

wherein said inner lumen proximal to said shaft distal portion distal end presents a neck portion, and

wherein said retention element interferes with said neck portion to lock said shape setting mandrel in a mandrel fully inserted position.

2 . The ablation assembly of claim 1 , wherein said shape setting mandrel comprises a mandrel proximal portion, wherein said mandrel proximal portion is disposed outside said inner lumen so that said shape setting mandrel is drivable by a user,

wherein said elongate shaft comprises a shaft proximal end, wherein said ablation catheter comprises a steering device attached to said shaft proximal end, wherein said ablation catheter comprises a handle, wherein said steering device is connected to said handle and is drivable in rotation with respect to said handle so that a rotation of said steering device with respect to said handle causes a rotation of said elongate shaft.

3 . The ablation assembly of claim 2 , wherein said steering device comprises a through hole in communication with said inner lumen, wherein during insertion or removal of the shape setting mandrel within or from said ablation catheter said shape setting mandrel passes through said through hole, and wherein when the shape setting mandrel is fully inserted in the shaft distal portion, said mandrel proximal portion is outside said steering device,

and/or wherein, when the shape setting mandrel is fully inserted in the shaft distal portion, said shape setting mandrel deforms said shaft distal portion at least in a shaft distal portion plane (P),

wherein said steering device comprises at least two protrusions, wherein said at least two protrusions and said shaft distal portion plane (P) are coplanar to help a user to handle the catheter assembly.

4 . The ablation assembly of claim 1 , wherein said ablation catheter comprises at least one steering wire configured to deflect the shaft distal portion in one or more deflection directions, wherein said at least one steering wire is fixedly connected to said shaft distal portion, wherein said at least one steering wire comprises a wire proximal extension that is arranged outside with respect to a shaft proximal portion, wherein said wire proximal extension comprises a wire gripping portion configured to pull at least one the steering wire for steering the shaft distal portion with shape setting mandrel fully inserted into the shaft distal portion.

5 . The ablation assembly of claim 4 , wherein said shaft distal portion comprises a shaft distal portion proximal end, wherein said ablation catheter comprises at least two steering wires.

6 . The ablation assembly of claim 5 , wherein a first steering wire of said at least two steering wires is fixedly connected proximal to the shaft distal portion distal end;

and/or wherein a second steering wire of said at least two steering wires is fixedly connected proximal to the shaft distal portion proximal end;

and/or wherein a third steering wire of said at least two steering wires is fixedly connected proximal to the shaft distal portion distal end;

and/or wherein a fourth steering wire of said at least two steering wires is fixedly connected proximal to the shaft distal portion distal end.

7 . The ablation assembly of claim 1 , wherein when the shape setting mandrel is fully inserted in the shaft distal portion defines said mandrel fully inserted position,

wherein said ablation assembly comprises a locking mechanism configured to lock said shape setting mandrel to said shaft distal portion when said shape setting mandrel is in said mandrel fully inserted position.

8 . The ablation assembly of claim 7 , wherein said locking mechanism comprises said retention element that reversibly locks said shape setting mandrel in said mandrel fully inserted position, and wherein said retention element is configured to release said shape setting mandrel from said mandrel fully inserted position when a pull force is applied to said shape setting mandrel;

and/or wherein said retention element is made of metal, metal alloy, rubber or polymer; and/or wherein said shape setting mandrel comprises a ball-tip configured to engage said retention element when said shape setting mandrel is in said fully inserted position.

9 . The ablation assembly of claim 7 , wherein said retention element is an O-ring, wherein said mandrel seat is toroidal.

10 . The ablation assembly of claim 1 , comprising a distal ablation assembly disposable at least at said shaft distal portion distal end,

said distal ablation assembly being configured to deliver both thermal energy for ablating said tissue and non-thermal energy for treating said tissue,

wherein said distal ablation assembly comprises at least an electrode tip disposable at least at said shaft distal portion distal end,

wherein said shaft electrodes are arranged along the shaft distal portion spaced apart from each other

and/or wherein said shaft ablation assembly ( 20 ) is configured also to map a tissue.

11 . The ablation assembly of claim 10 , wherein at least one of said shaft electrodes comprises at least two conductive portions (N) electrically isolated from each other, wherein each conductive portion (N) covers radially less than 180° around the shaft distal portion and/or wherein at least one of said shaft electrodes comprises at least four conductive portions (N) electrically isolated from each other, wherein each conductive portion (N) covers radially less than 90° around the shaft distal portion.

12 . The ablation assembly of claim 10 , wherein when the shape setting mandrel is fully inserted in the shaft distal portion define said mandrel fully inserted position,

wherein the shaft distal portion distal end is open and the shape setting mandrel is slidable outside said shaft distal portion distal end from said mandrel fully inserted position to a mandrel maximum exposed position,

wherein the shape setting mandrel comprises a mandrel distal portion, wherein said distal ablation assembly is fixedly disposed at said mandrel distal portion, wherein said distal ablation assembly comprises a plurality of mandrel electrodes, wherein said mandrel electrodes ( 132 ) are axially spaced along said mandrel distal portion.

13 . The ablation assembly of claim 12 , wherein when said shape setting mandrel is in said mandrel fully inserted position, the shaft electrodes are electrically connected with at least a part of the plurality of mandrel electrodes;

and/or wherein when said shape setting mandrel is in said mandrel maximum exposed position the shaft electrodes are electrically disconnected from any electrical source.

14 . An ablation assembly to treat target regions of a tissue in organs comprising:

an ablation catheter comprising an elongate shaft having a longitudinal main direction (X-X), said elongate shaft comprising at least shaft distal portion, said shaft distal portion comprising a shaft distal portion distal end;

said ablation catheter comprising an inner lumen arranged within the elongate shaft;

said ablation catheter comprising a shaft ablation assembly fixedly disposed at said shaft distal portion, the shaft ablation assembly being configured to deliver both thermal energy for ablating said tissue and non-thermal energy for treating said tissue;

said assembly comprising a distal ablation assembly disposable at least at said shaft distal portion distal end, the distal ablation assembly being configured to deliver both thermal energy for ablating said tissue and non-thermal energy for treating said tissue;

at least a shape setting mandrel disposed within the ablation catheter, the shape setting mandrel being insertable within the inner lumen and removable from the inner lumen, wherein the shape setting mandrel is free to move in respect of the inner lumen avoiding any constraint with said shaft distal portion during the shape setting mandrel insertion,

wherein the shape setting mandrel comprises at least a mandrel distal portion, wherein said distal ablation assembly is fixedly disposed at said mandrel distal portion,

wherein the shape setting mandrel comprises at least a pre-shaped configuration and the shape setting mandrel is reversible deformable between at least a straight loaded configuration and said pre-shaped configuration,

wherein the shape setting mandrel is slidable outside the shaft distal portion distal end from a mandrel fully inserted position to a mandrel maximum exposed position,

wherein in said mandrel fully inserted position, the mandrel is in said loaded straight configuration,

wherein in said mandrel maximum exposed position, the mandrel is in said pre-shaped configuration,

wherein said mandrel distal portion comprises a mandrel seat, wherein a retention element is fixed to said shape setting mandrel and partially housed in said mandrel seat,

wherein said inner lumen proximal to said shaft distal portion distal end presents a neck portion,

wherein said retention element interferes with said neck portion to lock said shape setting mandrel in said mandrel fully inserted position.

Assignments (2)

Continuity (4)

References Cited (34)