Multi-modality ablation catheter having a shape memory stylet
A multimodality or hybrid ablation system includes an ablation apparatus for creating a lesion in target tissue. The ablation apparatus has an ablation shaft including a handle, a first portion, an ablation portion, distal tip, at least one ablation energy delivery lumen, at least one ablation energy return lumen, and a stylet lumen that extends substantially along a length of the ablation shaft from the handle to at least the ablation portion. The ablation apparatus also includes a stylet that is capable of being inserted into the stylet lumen where the stylet is made of a shape-memory material. A plurality of electrodes are arranged on the ablation portion for measuring or verifying tissue contact with the tissue and applying a pulsed electric field. Optionally, the pulsed electric field may be applied after, contemporaneously, or for only a portion that the cryo-modality is applied to the target tissue.
1 . A multimodality ablation system for creating a lesion in target tissue, the system comprising:
a catheter, said catheter comprising:
a linear non-expanding and non-inflatable freezing portion;
at least one cryogen delivery lumen extending along the freezing portion;
at least one cryogen return lumen extending along the freezing portion;
an endcap extending from the freezing portion and comprising a fixed shape defining an internal cavity in which a cryogen is exchanged between the at least one cryogen delivery lumen and the at least one cryogen return lumen; and
a plurality of electrodes on an exterior surface of the freezing portion;
a cryogen controller, the cryogen controller operable to, for a first duration, circulate a cryogen through the freezing portion using the at least one cryogen delivery and return tubes such that a first volume of target tissue around the freezing portion is frozen, said first volume of target tissue comprising an interior, an ice penetration depth, and a boundary layer; and
a pulsed field ablation generator operably coupled to the plurality of electrodes to, for a second duration, create a pulsed field of electricity and defining an electric field depth to induce cell death in the target tissue at the boundary layer of the first volume of target tissue, and
wherein ablation arising from the pulsed field ablation generator is coordinated with ablation arising from the cryogen controller such that the electric field depth matches, but does not extend beyond, the ice penetration depth.
2 . The system of claim 1 , wherein the pulsed field ablation generator is operable to commence the second duration to overlap with the first duration.
3 . The system of claim 2 , wherein the pulsed field ablation generator is operable to commence the second duration after first duration has commenced.
4 . The system of claim 3 , wherein the pulsed field ablation generator is programmed operable to commence the second duration after 80% of the first duration has elapsed.
5 . The system of claim 4 , wherein the first duration ranges from 10 to 40 seconds.
6 . The system of claim 1 , wherein the first volume is characterized by a penetration depth from the freezing portion that the tissue freezes, and the penetration depth is at least 2 mm.
7 . The system of claim 1 , wherein the catheter further comprises a stylet lumen that extends substantially along a length of the ablation shaft from the handle to at least the freezing portion; and a stylet capable of being inserted into the stylet lumen, the stylet comprising a pre-set shape.
8 . The system of claim 7 , wherein the pre-set shape of the stylet is an open loop, thereby, when the stylet is fully inserted in the catheter, configures the catheter into a linear open loop shape.
9 . The system of claim 1 , further comprising a tissue contact module operable to measure tissue contact information based on information detected by the plurality of electrodes.
10 . The system of claim 1 , wherein a ratio of the penetration depth to the depth of the electric field is about 1.
11 . The system of claim 1 , wherein the electric field is characterized at the penetration depth by at least 400 V/cm.