IP Library Granted Patent US 12,239,366
Granted Patent B2
US 12,239,366 · App. 18/477,266 · Granted Mar 4, 2025

Catheter insertion

Inventors: Doron Harlev (Brookline, MA); Andrew Miles Wallace (Needham, MA); Luke Tsai (Clifton Park, NY); Ian Matthew Collier (Newton, 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 12,239,366
App. No.
18/477,266
Granted
Mar 4, 2025
Kind
B2
Abstract

Devices, systems, and methods of the present disclosure can overcome physical constraints associated with catheter introduction to facilitate the use of a catheter with a large distal portion as part of a medical procedure benefitting from such a large distal portion, such as, for example, cardiac ablation. More specifically, devices, systems, and methods of the present disclosure can compress an expandable tip of a catheter from an expanded state to a compressed state along a tapered surface of an insertion sleeve for advancement of the expandable tip into vasculature of a patient. The tapered surface of the insertion sleeve can, for example, apply compressive forces at an angle against the advancing expandable tip. As compared to other approaches to the application of compressive force to an expandable tip, compressing the expandable tip using an angled force can reduce the likelihood of unintended deformation of the expandable tip.

Claims (26)

1. A system comprising:

a catheter including a shaft and an expandable tip disposed along a distal portion of the catheter shaft, at least one portion of the expandable tip resiliently flexible between an expanded state and a compressed state;

a sheath defining a sheath lumen and having a proximal portion and a distal portion opposite the proximal portion, wherein the at least one portion of the expandable tip, in the compressed state, is movable through the sheath lumen; and

an insertion sleeve defining an insertion sleeve lumen and including a tapered surface along a proximal portion thereof, wherein the tapered surface is adapted to compress the at least one portion of the expandable tip from the expanded state to the compressed state as the at least one portion of the expandable tip is moved through the insertion sleeve lumen, and a distal portion of the insertion sleeve is configured to be inserted into the sheath and engage the proximal portion of the sheath, wherein the distal portion of the insertion sleeve is adapted to be positioned within the sheath lumen while (a) the distal portion of the sheath is inserted into a blood vessel of a patient and (b) the insertion sleeve remains outside of the patient.

2. The system of claim 1 , wherein the tapered surface of the insertion sleeve is adapted to apply force at an angle to the at least one portion of the expandable tip to compress the at least one portion of the expandable tip to the compressed state responsive to the force applied to the expandable tip at the angle.

3. The system of claim 1 , wherein the tapered surface of the insertion sleeve is substantially frusto-conical.

4. The system of claim 3 , wherein an angle defined between the tapered surface and a center axis defined by the insertion sleeve lumen is less than about 45 degrees.

5. The system of claim 1 , wherein the insertion sleeve defines a proximal opening and a distal opening, the proximal opening having a first cross-sectional dimension sized to receive the at least one portion of the expandable tip in the expanded state and the distal opening of the insertion sleeve having cross-sectional dimension that is less than the first cross-sectional dimension.

6. The system of claim 5 , wherein the at least one portion of the expandable tip is collapsible from the expanded state to the compressed state through both distal movement of the expandable tip through the proximal opening of the insertion sleeve and through proximal movement of the expandable tip through the distal opening of the insertion sleeve.

7. The system of claim 1 , wherein the sheath includes a valve and the insertion sleeve includes an elongate tube, and the elongate tube is sized to extend beyond the valve with the insertion sleeve engaged with the sheath.

8. The system of claim 7 , wherein the elongate tube has a smaller maximum outer dimension that is less than an inner dimension of the sheath to enable insertion of a distal end of the elongate tube into the sheath beyond the valve.

9. The system of claim 7 , wherein, with the distal portion of the insertion sleeve located in the sheath lumen at a position distal to the valve of the sheath, the sheath is configured to block further distal movement of the insertion sleeve.

10. The system of claim 1 , wherein the expandable tip includes one or more electrodes.

11. The system of claim 1 , wherein the expandable tip includes an arrangement of struts that are flexible relative to one another as the expandable tip moves between the expanded state and the compressed state.

12. A system comprising:

a catheter including a shaft and an expandable tip disposed along a distal portion of the catheter shaft, at least one portion of the expandable tip resiliently flexible between an expanded state and a compressed state;

a sheath defining a sheath lumen and having a proximal portion and a distal portion opposite the proximal portion, wherein the at least one portion of the expandable tip, in the compressed state, is movable through the sheath lumen; and

an insertion sleeve defining an insertion sleeve lumen and including a tapered surface along a proximal portion thereof, wherein the tapered surface is adapted to compress the at least one portion of the expandable tip from the expanded state to the compressed state as the at least one portion of the expandable tip is moved through the insertion sleeve lumen, and a distal portion of the insertion sleeve is configured to mate with and engage the proximal portion of the sheath, wherein the distal portion of the insertion sleeve is adapted to be positioned within the sheath lumen while (a) the distal portion of the sheath is inserted into a blood vessel of a patient and (b) the insertion sleeve remains outside of the patient.

13. The system of claim 12 , wherein the expandable tip includes a coupling portion and a deformable portion, the coupling portion is fixed relative to the catheter shaft, and the deformable portion extends in a direction distal to the coupling portion and the catheter shaft.

14. The system of claim 12 , wherein the tapered surface of the insertion sleeve is adapted to apply force at an angle to the at least one portion of the expandable tip to compress the at least one portion of the expandable tip to the compressed state responsive to the force applied to the expandable tip at the angle.

15. The system of claim 12 , wherein the tapered surface of the insertion sleeve is substantially frusto-conical.

16. The system of claim 12 , wherein the insertion sleeve defines a proximal opening and a distal opening, the proximal opening having a first cross-sectional dimension sized to receive the at least one portion of the expandable tip in the expanded state and the distal opening of the insertion sleeve having cross-sectional dimension that is less than the first cross-sectional dimension.

17. The system of claim 12 , wherein the distal portion of the insertion sleeve includes an elongate tube having a smaller maximum outer dimension than an inner dimension of the sheath, and the elongate tube of is configured to be inserted into the sheath and engage the proximal portion of the sheath.

18. The system of claim 17 , wherein the sheath includes a valve beyond the valve, the insertion sleeve engageable with the sheath, the elongate tube is sized to extend beyond the valve with the insertion sleeve engaged with the sheath and, with the distal portion of the insertion sleeve located in the sheath lumen at a position distal to the valve of the sheath, the sheath is configured to block further distal movement of the insertion sleeve.

19. The system of claim 12 , wherein the expandable tip includes one or more electrodes.

20. The system of claim 12 , wherein the expandable tip includes an arrangement of struts that are flexible relative to one another as the expandable tip moves between the expanded state and the compressed state.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2023
From: HARLEV, DORON; WALLACE, ANDREW MILES; TSAI, LUKE; COLLIER, IAN MATTHEW
To: AFFERA, INC.
Reel/Frame 065069/0091 →
Continuity (13)
Continuation 17929611 · Sep 2, 2022
Continuation 15584080 · 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 62399625 · Sep 26, 2016
Provisional Application 62399632 · Sep 26, 2016
Provisional Application 62357704 · Jul 1, 2016
Provisional Application 62330395 · May 2, 2016
Related Publication 20240032997A1 · Feb 1, 2024
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