IP Library › Granted Patent US 12,114,922
Granted Patent B2
US 12,114,922 · App. 18/177,692 · Granted Oct 15, 2024

Catheter tip with deformable portion

Inventors: Doron Harlev (Brookline, MA); Andrew Miles Wallace (Needham, MA)
Assignee: AFFERA, INC.
A61B18/1492A61B1/00087A61B5/6843A61B5/6852A61B18/1206A61B18/1233A61B18/14A61B18/148A61B18/1482A61M3/0295A61M25/001A61M25/007A61M25/0071A61M25/0082A61B2017/00039A61B2017/00053A61B2017/00154A61B2017/00477A61B2017/00526A61B2017/00867A61B2018/00011A61B2018/00029A61B2018/00065A61B2018/00077A61B2018/00083A61B2018/00089A61B2018/00101A61B2018/0016A61B2018/00166A61B2018/00214A61B2018/00238A61B2018/00267A61B2018/00351A61B2018/00357A61B2018/00577A61B2018/00642A61B2018/00714A61B2018/00726A61B2018/00744A61B2018/00767A61B2018/00791A61B2018/00797A61B2018/00815A61B2018/00821A61B2018/00839A61B2018/00875A61B2018/00904A61B2018/0091A61B2018/00982A61B2018/00988A61B2018/1417A61B2018/1465A61B2018/1467A61B2090/061A61B2090/065A61B2090/376A61B2090/3966A61B2217/007A61B2218/002A61B2218/003A61M2205/0266A61M2207/00
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Quick Facts
Patent No.
US 12,114,922
App. No.
18/177,692
Granted
Oct 15, 2024
Kind
B2
Abstract

Ablation systems and methods of the present disclosure include a catheter including one or more image sensors. The one or more image sensors can facilitate, for example, positioning an ablation electrode at a treatment site of an anatomic structure and, additionally or alternatively, can facilitate controlling delivery of therapeutic energy to a treatment site of an anatomic structure.

Claims (55)

1. A catheter, comprising:

a shaft including a proximal end portion and a distal end portion; and

a tip assembly coupled to the distal end portion of the shaft, the tip assembly including—

a deformable portion moveable between a compressed state and an expanded state in which a cross-sectional diameter of the deformable portion is larger than a cross-sectional diameter of the shaft,

wherein, at least in the expanded state, the deformable portion is (i) resiliently flexible in response to application of a threshold amount of force to an exterior of the deformable portion, (ii) configured to allow blood to flow therethrough and (iii) configured to conduct and deliver ablative electrical energy to target tissue of a patient, and

a plurality of position sensors configured to measure signals usable to determine an extent of deformation of the deformable portion, wherein at least a subset of the plurality of position sensors are disposed on the deformable portion.

2. The catheter of claim 1 wherein at least the subset of the plurality of position sensors are distributed along the deformable portion in a circumferential direction about the deformable portion.

3. The catheter of claim 1 wherein at least the subset of the plurality of position sensors are distributed along the deformable portion in an axial direction extending from a proximal portion of the deformable portion toward a distal portion of the deformable portion.

4. The catheter of claim 1 wherein at least the subset of the plurality of position sensors are uniformly distributed along the deformable portion in a circumferential direction about the deformable portion, in an axial direction along the deformable portion from a proximal portion of the deformable portion toward a distal portion of the deformable portion, or a combination thereof.

5. The catheter of claim 1 wherein at least the subset of the plurality of position sensors includes surface electrodes disposed on an exterior surface of the deformable portion, and wherein the surface electrodes are configured to measure electrical signals usable to determine the extent of the deformation of the deformable portion.

6. The catheter of claim 1 wherein at least the subset of the plurality of position sensors includes coils configured to emit a magnetic field.

7. The catheter of claim 1 wherein at least the subset of the plurality of position sensors includes coils configured to measure a magnetic field, and wherein measurements of the magnetic field captured by the coils are usable to determine the extent of the deformation of the deformable portion.

8. The catheter of claim 1 wherein the plurality of position sensors includes a magnetic position sensor fixed relative to the distal end portion of the shaft and configured to detect signals emanating from a magnetic field generator.

9. The catheter of claim 8 wherein the magnetic position sensor includes one or more coils useable for determining position with five or six degrees of freedom.

10. The catheter of claim 1 , further comprising a substantially rigid structure coupled to the distal end portion of the shaft at only a proximal end of the structure, wherein the structure protrudes from the distal end portion of the shaft into a volume defined by the deformable portion such that the structure is enclosed by the deformable portion.

11. The catheter of claim 10 wherein the plurality of position sensors includes a position sensor in or on the structure.

12. The catheter of claim 1 wherein the deformable portion has a predetermined and reproducible relationship between (a) an amount of the force applied to the exterior of the deformable portion in an axial direction and/or in a lateral direction and (b) a magnitude and direction of deformation of the deformable portion in the axial direction and/or in the lateral direction, respectively.

13. A catheter, comprising:

a shaft having a proximal end portion and a distal end portion;

an expandable assembly coupled to the distal end portion of the shaft, wherein the expandable assembly includes an ablation electrode, and wherein the expandable assembly is configured to permit blood to flow therethrough at least when the expandable assembly is in an expanded state;

a plurality of surface electrodes carried by the expandable assembly, wherein each surface electrode of the plurality is electrically isolated from the ablation electrode via an electrically insulating material positioned between the surface electrode and the ablation electrode; and

a magnetic position sensor fixed relative to the distal end portion of the shaft, wherein the magnetic position sensor includes one or more coils configured to measure a magnetic field for determining a location of the expandable assembly with five or six degrees of freedom.

14. A method, comprising:

deploying a tip assembly within an anatomic structure of a patient, the tip assembly at a distal end portion of a catheter shaft, wherein—

the tip assembly includes a deformable portion movable between a compressed state and a deployed state,

the deformable portion is configured, at least in the deployed state, to allow blood to flow therethrough, and

the deformable portion, at least in the deployed state, is resiliently flexible in response to application of a threshold amount of force to an exterior of the deformable portion;

receiving electrical signals from two or more sensors of a plurality of position sensors of the tip assembly, wherein at least a subset of the plurality of position sensors are disposed on the deformable portion; and

based at least in part on the received electrical signals, determining a magnitude and direction of deformation of the deformable portion.

15. The method of claim 14 wherein:

the two or more position sensors include at least two different pairs of position sensors;

a first pair of the at least two different pairs includes a first position sensor disposed on the deformable portion and a second position sensor different from the first position sensor;

a second pair of the at least two different pairs includes a third position sensor disposed on the deformable portion and a fourth position sensor different from the third position sensor, wherein the third position sensor is different from the first position sensor; and

the method further comprises driving the first pair, measuring electrical signals corresponding to the driving of the first pair, driving the second pair, and measuring electrical signals corresponding to the driving of the second pair.

16. The method of claim 15 wherein driving the first pair and the second pair includes driving the first pair and the second pair in a time-division-multiplexed manner, a frequency-division-multiplexed manner, or a code-division-multiplexed manner.

17. The method of claim 15 wherein determining the magnitude and the direction of the deformation includes comparing the measured electrical signals corresponding to the driving of the first pair to the measured electrical signals corresponding to the driving of the second pair to determine (i) a relative distance between the first position sensor and the second position sensor and (ii) a relative distance between the third position sensor and the fourth position sensor.

18. The method of claim 17 wherein the fourth position sensor is the second position sensor.

19. The method of claim 15 wherein determining the magnitude and the direction of the deformation includes fitting the measured electrical signals corresponding to the driving of the first pair to a model, comparing the measured electrical signals corresponding to the driving of the first pair to a lookup table, or a combination thereof.

20. The method of claim 15 wherein measuring the electrical signals corresponding to the driving of the first pair includes measuring the electrical signals corresponding to the driving of the first pair (a) using the first position sensor and the second position sensor, (b) using position sensors of the plurality of position sensors that are not being driven while the first pair is driven, or (c) a combination thereof.

21. The method of claim 15 wherein measuring the electrical signals corresponding to the driving of the first pair includes measuring impedance.

22. The method of claim 14 , further comprising determining a three-dimensional shape of the deformable portion based at least in part on the magnitude and the direction of the deformation of the deformable portion.

23. The method of claim 14 , further comprising determining a force applied to the exterior of the deformable portion based at least in part on the magnitude and the direction of the deformation of the deformable portion.

24. The method of claim 23 wherein determining the force includes determining the force based at least in part on a predetermined and reproducible relationship between (a) an amount of the force applied to the exterior of the deformable portion in an axial direction and/or in a lateral direction and (b) the magnitude and the direction of the deformation of the deformable portion in the axial direction and/or in the lateral direction, respectively.

25. The method of claim 24 wherein determining the force includes fitting the magnitude and the direction of the deformation to a curve, comparing the magnitude and the direction of the deformation to a lookup table, or a combination thereof.

26. The method of claim 23 , further comprising determining, based at least in part on the force applied to the exterior of the deformable portion, an energy dosing for lesion formation, a cooling dosage for lesion formation, or a combination thereof.

27. The method of claim 14 , further comprising:

measuring a magnetic field using a position sensor of the plurality of position sensors that is fixed relative to the distal end portion of the shaft; and

determining a location of the deformable portion based at least in part on the measured magnetic field.

28. The method of claim 27 wherein:

the position sensor of the plurality of position sensors includes one or more coils; and

determining the location of the deformable portion includes determining a location of the deformable portion with five or six degrees of freedom.

29. The method of claim 14 , further comprising detecting contact of the deformable portion with tissue of an anatomic structure, wherein detecting the contact includes:

driving one or more pairs of position sensors of the plurality of position sensors; and

detecting the contact based at least in part on a measured change in electrical signals received in response to driving the one or more pairs of position sensors.

30. The method of claim 29 , further comprising determining a shape of at least a portion of the anatomic structure based at least in part on the detection of the contact of the deformable portion with the tissue of the anatomic structure.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2023
From: HARLEV, DORON; WALLACE, ANDREW MILES
To: AFFERA, INC.
Reel/Frame 062941/0454 →
Continuity (14)
Continuation 17806931 · Jun 14, 2022
Continuation 17520686 · Nov 7, 2021
Continuation In Part 15584146 · May 2, 2017
Provisional Application 62468873 · Mar 8, 2017
Provisional Application 62468339 · Mar 7, 2017
Provisional Application 62434073 · Dec 14, 2016
Provisional Application 62428406 · Nov 30, 2016
Provisional Application 62424736 · Nov 21, 2016
Provisional Application 62420610 · Nov 11, 2016
Provisional Application 62399632 · Sep 26, 2016
Provisional Application 62399625 · Sep 26, 2016
Provisional Application 62357704 · Jul 1, 2016
Provisional Application 62330395 · May 2, 2016
Related Publication 20230200901A1 · Jun 29, 2023
Cited By (9)
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