Steerable sheath access device
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.
1. A steerable sheath access device, comprising:
an elongated member having a proximal end, a distal end, and a lumen extending through the elongated member from the proximal end to the distal end;
a handle assembly coupled to the proximal end of the elongated member, wherein the handle assembly is configured to control a deflection of the elongated member;
a plurality of pull wires, wherein a distal end of each of the plurality of pull wires is coupled to the elongated member and a proximal end of each of the plurality of pull wires is coupled to the handle assembly; and
at least one anchor ring coupled to the elongated member and, at least one of the plurality of pull wires, the at least one anchor ring including a plurality of recessed grooves configured to receive and secure the plurality of pull wires;
wherein the plurality of recessed grooves include a plurality of first recessed grooves extending into to an exterior surface of the anchor ring, and a plurality of second recessed grooves extending into an interior surface of the anchor ring.
2. The device of claim 1 , wherein the distal section of the elongated member has a hardness less than a hardness of the proximal section of the elongated member.
3. The device of claim 1 , wherein the elongated member and the handle assembly are configured such that actuation of the handle assembly causes deflection of the elongated member via at least one of the plurality of pull wires such that a distal section of the elongated member defines a primary curve including a first inner radius of curvature and a proximal section of the elongated member defines a secondary curve including a second inner radius of curvature, and wherein the first inner radius of curvature is smaller than the second inner radius of curvature.
4. The device of claim 2 , further comprising a tip portion disposed on the distal end of the elongated member, wherein the tip portion is less rigid than the proximal section and distal section of the elongated member.
5. The device of claim 2 , wherein the length of the distal section ranges from about 1.5 inches to about 3.5 inches.
6. The device of claim 2 , wherein the length of the distal section is 2.5.+−.0.1 inches.
7. The device of claim 1 , wherein the plurality of recessed grooves do not extend entirely through the anchor ring.
8. The device of claim 1 , wherein the length of the proximal section is 14.5.+−.0.5 inches.
9. The device of claim 3 , wherein the at least one anchor ring includes a distal anchor ring and a proximal anchor ring offset along a length of the elongated member, and the plurality of pull wires include primary pull wires and secondary pull wires; and
wherein the primary pull wires extend distally from the handle assembly through a first length of the elongated member to the distal anchor ring and is coupled thereto, and the secondary pull wires extend distally from the handle assembly through a second different length of the elongated member to the proximal anchor ring and is coupled thereto.
10. The device of claim 1 , wherein a guide encompasses at least one of the plurality of pull wires along a length of the elongated member, and the guide is positioned within at least one of the recessed grooves with the at least one of the plurality of pull wires encompassed therein.
11. The device of claim 9 , wherein the primary pull wires are configured to be actuated by the handle assembly to effect the primary curve, and the secondary pull wires are configured to be actuated by the handle assembly to effect the secondary curve.
12. The device of claim 11 , wherein the primary pull wires are secured to the plurality of first recessed grooves of the distal anchor ring and the secondary pull wires are secured to the plurality of second recessed grooves of the proximal anchor ring.
13. A steerable sheath access device assembly, comprising;
an elongated member having a proximal end, a distal end, and a lumen extending through the elongated member from the proximal end to the distal end;
a handle assembly including an outer body portion having a proximal end and a distal end, the distal end of the assembly is coupled to the proximal end of the elongated member, the handle assembly further including a deflection handle portion for controlling the deflection and movement of the elongated member and an inner cavity extending along the length of the handle assembly;
a plurality of pull wires, wherein a distal end of each of the plurality of pull wires is coupled to the elongated member and a proximal end of each of the plurality of pull wires is coupled to the handle assembly;
at least one anchor ring coupled to the elongated member, wherein the at least one anchor ring is coupled to at least one of the plurality of pull wires;
a valve assembly having an opening coupled to the inner cavity of the handle assembly and the lumen of the elongated member therein providing a passageway;
wherein the elongated member is configured such that deflection of the elongated member comprises a distal section defining a primary curve including a first inner radius of curvature and a proximal section defining a secondary curve including a second inner radius of curvature, and wherein the first inner radius of curvature is smaller than the second inner radius of curvature.
14. The device of claim 13 , wherein the distal section includes a hardness less than the proximal section.
15. The device of claim 14 further comprising a tip portion disposed on the distal end of the elongated member providing an outlet for the lumen extending through the elongated member.
16. An ablation assembly for use in performing ablation procedures, comprising;
a steerable sheath access device assembly including an elongated member, a handle assembly, and a valve assembly;
the elongated member comprises a proximal end, a distal end, and a lumen extending through the elongated member from the proximal end to the distal end, wherein the handle assembly is configured to deflect the elongated member, and wherein the deflection of the elongated member is configured to define a primary curve in a proximal section and a secondary curve in a distal section, and wherein an inner radius of the primary curve is greater than an inner radius of the secondary curve;
a plurality of pull wires, wherein a distal end of each of the plurality of pull wires is coupled to the elongated member and a proximal end of each of the plurality of pull wires is coupled to the handle assembly; and
at least one anchor ring coupled to the elongated member, wherein the at least one anchor ring is coupled to at least one of the plurality of pull wires,
wherein the handle assembly comprises an outer body portion having a proximal end, a distal end, and an inner cavity, the distal end of the assembly is coupled to the proximal end of the elongated member, and
wherein the valve assembly comprises an opening that is longitudinally coupled to the inner cavity of the handle assembly and the lumen of the elongated member therein providing a passageway extending through the steerable sheath access device assembly.
17. The ablation assembly of claim 16 , wherein the handle assembly further comprises a deflection handle portion for controlling the deflection and movement of the elongated member.
18. The ablation assembly of claim 16 further comprising a tip portion disposed on the distal end of the elongated member providing an outlet for the lumen extending through the elongated member.
19. The ablation assembly of claim 16 , wherein the elongated member is comprised of a thermoplastic.
20. The ablation assembly of claim 16 , further comprising an electrode coupled to the distal section of the elongated member.