Steerable sheath access device

Patent metadata

Field	Value
Publication number	US-9247990-B2
Application number	US-201213350471-A
Country	US
Kind code	B2
Filing date	Jan 13, 2012
Priority date	Oct 10, 2006
Publication date	Feb 2, 2016
Grant date	Feb 2, 2016

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.

First claim

What is claimed is:

1. A steerable introducer, comprising:
an elongated member having a longitudinal axis and defining a cross-sectional area transverse to the longitudinal axis, the elongated member comprising an open-ended distal tip portion, a distal portion defining a first curve, a proximal portion defining a second curve, and a lumen extending along the longitudinal axis between the proximal portion and the open-ended distal tip portion, wherein the lumen comprises a majority of the cross-sectional area and defines a passageway through which a medical device may pass and exit the elongated member;
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;
a first pull wire extending from the handle assembly through at least a substantial portion of the proximal portion of the elongated body and operably coupled to the deflection member such that a first movement of the deflection member relative to the body of the handle assembly exerts a first force on the first pull wire; and
a second pull wire extending from the handle assembly through at least the substantial portion of the proximal portion of the elongated body and operably coupled to the deflection member such that a second movement of the deflection member relative to the body of the handle assembly exerts a second force on the second pull wire,
wherein the first pull wire and the second pull wire are configured to separately actuate the distal portion at a primary deflection point and the proximal portion at a secondary deflection point.

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 the passageway through which the medical device may pass and exit the elongated member.

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 open-ended 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 , wherein the first pull wire is encased inside a guide tubing.

14. The steerable introducer of claim 1 , wherein the first pull wire is positioned between an inner and an outer layer of the elongated member.

15. The steerable introducer of claim 1 , wherein the first and second pull wires comprise four pull wires, including a primary pair of pull wires and a secondary pair of pull wires, wherein the primary pair of pull wires extends from the handle assembly through the proximal and distal portions of the elongated body to a distal end of the distal portion, wherein the secondary pair of pull wires extends from the handle assembly through the proximal portion of the elongated body to a point where the distal portion intersects the proximal portion, wherein each pull wire of the primary pair of pull wires 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 at least one pull wire of the primary pair of pull wires, and wherein each pull wire of the secondary pair of pull wires 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 at least one pull wire of the secondary pair of pull wires.

16. A deflectable medical device, comprising:
a shaft having a longitudinal axis and defining a cross-sectional area transverse to the longitudinal axis, the shaft having a proximal end, a distal end, an open-ended distal tip portion, and a major lumen disposed therein and extending between the proximal end and the open-ended distal tip portion, the shaft being 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, wherein the major lumen comprises a majority of the cross-sectional area; 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,
wherein the means for deflecting the shaft comprises a primary deflection point in a distal section of the shaft and a secondary deflection point in a proximal section of the shaft.

17. The medical device of claim 16 , wherein the outer layer further comprises a braided wire assembly.

18. The medical device of claim 16 , 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.

19. The medical device of claim 16 , wherein the outer layer of the shaft comprises a plurality of portions having different durometers.

20. The steerable introducer of claim 13 , wherein the elongated member further comprises an outer body, and wherein the guide tubing is at least partially embedded into an inner surface of the outer body.

21. The steerable introducer of claim 15 , wherein the handle is configured such that (i) movement of the deflection member that exerts a force on at least one pull wire of the primary pair of pull wires changes the first curve, and (ii) movement of the deflection member that exerts a force on at least one pull wire of the secondary pair of pull wires changes the second curve.

Assignees

• Kauphusman James V
• Fuentes Allan M
• Tegg Troy T
• Just Dale E
• St Jude Medical Atrial Fibrill

Inventors

• Kauphusman James V
• Fuentes Allan M
• Tegg Troy T
• Just Dale E

Classifications

• A61B2018/00351

  Heart · CPC title

• A61B5/0422

  Human Necessities · mapped topic

• A61B2018/1497

  Electrodes covering only part of the probe circumference · CPC title

• A61B2018/00023

  closed, i.e. without wound contact by the fluid · CPC title

• A61B2018/00577

  Ablation · CPC title