Granted Patent B2

US 12,369,969 · App. 18/441,474 · Granted Jul 29, 2025

Inventor: Eduardo Moriyama (Richmond, CA)

Assignee: Boston Scientific Medical Device Limited

A61B18/1477A61B5/14552A61B5/1459A61B2017/00057A61B2017/00119A61B2017/00247A61B2018/0038A61B2018/00601A61B2090/306A61M25/09

Abstract

Claims (25)

1. A perforation device for use in transseptal perforation procedures, comprising:

a shaft having a proximal portion and an opposed distal portion, the distal portion including a distal face;

a radio frequency perforating tip coupled to the distal portion and extending distally from the distal face;

an illumination end for illuminating a region surrounding the perforating tip, the illumination end recessed proximally from the distal face or flush with the distal face; and

at least a first light collector associated with the distal portion and positioned proximate the perforating tip for collecting light from the region surrounding the perforating tip.

2. The perforation device of claim 1 , further comprising at least a first illumination optical fiber extending through the shaft from the proximal portion to the distal portion, the illumination optical fiber having a first end for receiving light from a light source, and a second end forming the illumination end.

3. The perforation device of claim 2 , wherein the first illumination optical fiber is embedded in the shaft.

4. The perforation device of claim 1 , further comprising at least a first collection optical fiber extending through the shaft from the proximal portion to the distal portion, the collection optical fiber having a light collection end that forms the light collector, and a sensor end for delivering light to a light sensor.

5. The perforation device of claim 1 , wherein the light collector is in the form of a light sensor associated with the distal portion of the shaft.

6. The perforation device of claim 1 , wherein the illumination end is shrouded within the shaft, and the perforation device further comprises a light scattering material between the illumination end and an opening in the shaft for directing light from the illumination end to an exterior of the shaft.

7. The perforation device of claim 1 , wherein the illumination end is distally facing.

8. The perforation device of claim 1 , wherein the shaft includes a longitudinal lumen and further comprising a dilator adapted to be advanced through the longitudinal lumen.

9. The perforation device of claim 1 , further comprising a plurality of illumination ends and a plurality of light collectors, wherein the plurality of illumination ends and the plurality of light collectors are arranged concentrically around the radio frequency perforating tip in an alternating pattern.

10. A medical system for providing transseptal punctures, the medical system comprising:

a perforation device including a shaft having a longitudinal axis and extending from a proximal portion to a distal portion, a perforating tip coupled to the distal portion, and a first light emitter associated with a distal face of the distal portion and positioned proximate the perforating tip for illuminating a region surrounding the perforating tip;

wherein the distal face is perpendicular to the longitudinal axis, and the first light emitter is recessed proximally from the distal face or flush with the distal face; and

an analysis system for analyzing light returned from the region surrounding the perforating tip, the analysis system including a light sensor configured to detect one or more parameters of the returned light, a processor configured to perform an analysis of the one or more parameters, and an alert system for alerting a user to a result of the analysis.

11. The medical system of claim 10 , further comprising a light source, and at least a first illumination optical fiber extending through the shaft from the proximal portion to the distal portion, the illumination optical fiber having a source end connected to the light source for receiving light from the light source, and an illumination end positioned proximate the perforating tip and forming the light emitter.

12. The medical system of claim 11 , wherein the first illumination optical fiber is embedded in the shaft.

13. The medical system of claim 10 wherein the perforation device further comprises a first collection optical fiber extending through the shaft from the proximal portion to the distal portion, the collection optical fiber having a light collection end for collecting the returned light, and a sensor end for delivering light to the sensor.

14. The medical system of claim 10 , wherein the sensor is mounted to the distal portion of the shaft.

15. The medical system of claim 10 , wherein one of the one or more parameters of analysis of the returned light is whether blood in the region surrounding the perforating tip is oxygenated blood or deoxygenated blood.

16. The medical system of claim 10 , wherein the medical system further comprises a radio frequency generator connected to a radiofrequency perforation electrode for powering the radiofrequency perforation electrode; and the generator is in communication with the analysis system and is configured to provide power to the radiofrequency perforation electrode based on the analysis.

17. The medical system of claim 16 , wherein the generator is configured to cease providing power to the radiofrequency perforation electrode if the analysis indicates that the region surrounding the perforating tip contains oxygenated blood.

18. The medical system of claim 16 , further comprising a plurality of light emitters and a plurality of light collectors, wherein the plurality of light emitters and the plurality of light collectors are arranged concentrically around the radiofrequency perforating electrode in an alternating pattern.

Assignments (2)

Continuity (2)

References Cited (323)