Steerable sheath access device

• US 20120108938A1
• Filed: 01/13/2012
• Published: 05/03/2012
• Est. Priority Date: 10/10/2006
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Kauphusman, James V., Fuentes, Allan M., Tegg, Troy T., Just, Dale E.
• Granted Patent: US 9,247,990 B2
• Time in Patent Office: Days
• US Class Current: 600/373
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00244 adapted to separate target tissue from other tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 2562/222 : Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: Y10T 29/4913 : Assembling to base an electrical component, e.g., capacitor, etc.

Abstract

The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.

Claims

1. A steerable introducer, comprising:

an elongated member comprising a distal portion, a proximal portion, and a lumen extending between the proximal and distal portions, wherein the lumen is sized and configured to pass a medical device therethrough;

an electrode coupled to the distal portion of the elongated member; and

a handle assembly coupled to the proximal portion of the elongated member, the handle assembly comprising;

a body; and

a deflection member movably coupled to the body and operably coupled to the elongated member such that movement of the deflection member relative to the body causes the elongated member to deflect.

2. The steerable introducer of claim 1, further comprising a plurality of electrodes coupled to the distal portion of the elongated member.

3. The steerable introducer of claim 1, further comprising a valve assembly coupled to a proximal end of the handle assembly, wherein the valve assembly comprises an aperture coupled to an inner cavity of the handle assembly, and wherein the inner cavity is coupled to the lumen of the elongated member such that the aperture, inner cavity, and lumen define a passageway sized and configured to pass a medical device therethrough.

4. The steerable introducer of claim 1, further comprising an electrical connector coupled to the handle assembly, wherein the electrical connector is electrically coupled to the electrode.

5. The steerable introducer of claim 4, wherein the electrical connector is configured to be connected to a visualization or mapping system.

6. The steerable introducer of claim 1, wherein the elongated member further comprises a distal tip portion adjacent the distal portion, wherein the distal tip portion is tapered or chamfered.

7. The steerable introducer of claim 1, wherein the distal portion of the elongated member is more flexible than the proximal portion of the elongated member.

8. The steerable introducer of claim 1, wherein the elongated member comprises a thermoplastic material, wherein the thermoplastic material is braided.

9. The steerable introducer of claim 1, wherein the lumen is surrounded by a lining configured to reduce friction when a medical device is inserted into the lumen.

10. The steerable introducer of claim 1, wherein when the elongated member is in a fully extended configuration, the deflection member may be moved in only one direction.

11. The steerable introducer of claim 1, wherein when the elongated member is in a fully extended configuration, the deflection member may be moved in two directions.

12. The steerable introducer of claim 1, wherein the deflection member is rotatable with respect to the body of the handle assembly.

13. The steerable introducer of claim 1, further comprising a pull wire extending from the handle assembly through at least a portion of the elongated body and operably coupled to the deflection member such that movement of the deflection member relative to the body of the handle assembly exerts a force on the pull wire.

14. The steerable introducer of claim 13, wherein the pull wire is encased inside a guide tubing.

15. The steerable introducer of claim 13, wherein the pull wire is positioned between an inner and an outer layer of the elongated member.

16. The steerable introducer of claim 1, further comprising two pull wires extending from the handle assembly through at least a portion of the elongated body and operably coupled to the deflection member such that movement of the deflection member relative to the body of the handle assembly exerts a force on at least one pull wire.

17. The steerable introducer of claim 1, further comprising four pull wires extending from the handle assembly through at least a portion of the elongated body, wherein at least one pull wire is operably coupled to the deflection member such that movement of the deflection member relative to the body of the handle assembly exerts a force on the at least one pull wire.

18. A deflectable medical device, comprising:

a shaft having a proximal end, a distal end, and a major lumen disposed therein extending between the proximal and distal ends and configured to receive a second medical device therein, the shaft further comprising;

an inner liner having an inner surface and an outer surface, the inner surface forming the major lumen; and

an outer layer comprising a polymeric material adjacent the outer surface of the inner liner;

means for deflecting the shaft in at least one direction relative to a longitudinal axis of the shaft coupled to a proximal portion of the shaft; and

an electrode mounted on the shaft.

19. The medical device of claim 18, wherein the outer layer further comprises a braided wire assembly.

20. The medical device of claim 18, wherein the means for deflecting the shaft comprises four deflectable elements disposed within the outer layer of the shaft and offset from each other by 90 degrees.

21. The medical device of claim 18, wherein the outer layer of the shaft comprises a plurality of portions having different durometers.

22. A system for performing at least one of a therapeutic and diagnostic medical procedure, comprising:

a first medical device having an elongate shaft and at least one electrode mounted on the shaft, the shaft comprising a proximal end, a distal end, and a major lumen therein extending between the proximal and distal ends and sized so as to receive a second medical device therein;

a processor configured to receive signals from the at least one electrode and, in response to the received signals, perform at least one of;

determining a position of the at least one electrode; and

monitoring electrophysiological data.