Methods and devices for puncturing tissue

1. An assembly for puncturing tissue, the assembly comprising:

a flexible puncturing wire for puncturing tissue, the flexible puncturing wire comprises

an RF guidewire comprising a distal electrode tip; and

a reinforced dilator including one or more polymer layers surrounding a hypotube selectively re-shapeable by a user to impart a desired curve to the reinforced dilator, the reinforced dilator supporting the flexible puncturing wire to enable force transmission to a distal end of the assembly;

wherein the flexible puncturing wire is capable of being advanced within the reinforced dilator for puncturing tissue,

wherein the flexible puncturing wire has a proximal portion having a proximal stiffness of between about 0.00107 Nm 2 and about 0.00179 Nm 2 and a distal portion, including the distal electrode tip, having a distal stiffness of between about 3.57×10 −6 Nm 2 and about 5.95×10 −6 Nm 2 such that the wire is usable independently from the reinforced dilator during another portion of the procedure to facilitate exchange and positioning of another device.

2. The assembly of claim 1 , wherein the flexible puncturing wire comprises an energy delivery device that is operable to deliver energy for puncturing tissue.

3. The assembly of claim 1 , wherein the hypotube is located between an inner polymer layer and an outer polymer layer.

4. The assembly of claim 1 , wherein the reinforced dilator provides sufficient stiffness to the flexible puncturing wire when the flexible puncturing wire is inserted therein to enable torque to be transmitted to a distal end of the assembly.

5. The assembly of claim 1 , wherein a curve portion of the reinforced dilator is shapeable to enable the curve portion to be re-shaped and to be reinserted therewith, in order to optimize the position of the assembly against a target tissue site.

6. The assembly of claim 1 , wherein the reinforced dilator comprises a dilator radiopaque marker.

7. The assembly of claim 1 , wherein the reinforced dilator comprises a radiopaque coil embedded within the one or more polymer layers at a distal tip thereof.

8. The assembly of claim 7 , wherein the substantially flexible puncturing wire comprises:

a device radiopaque marker at a distal end of thereof; and

wherein the device radiopaque marker is configured to co-operate with the dilator radiopaque marker to indicate a relative position of the substantially flexible puncturing wire.

9. The assembly of claim 1 , further comprising:

a sheath for receiving the reinforced dilator for use therewith during a portion of the procedure.

10. The assembly of claim 9 , wherein the assembly further comprises:

a locking mechanism to enable axial and rotational coupling of the dilator with the sheath for a portion of the procedure.

11. The assembly of claim 10 , wherein the dilator comprises a dilator hub and the sheath comprises a sheath hub, wherein the locking mechanism comprises one or more keys on the dilator hub for co-operatively engaging with the sheath hub.

12. The assembly of claim 8 , wherein the assembly comprises:

a first configuration, where the flexible puncturing wire is positionable within the reinforced dilator such that the device radiopaque marker is in alignment with the dilator radiopaque marker; and

a second configuration, wherein the flexible puncturing wire is advanceable within the reinforced dilator such that the device radiopaque marker is out of alignment with and distal to the dilator radiopaque marker;

wherein the second configuration indicates positioning of an energy delivery portion of the flexible puncturing wire beyond the reinforced dilator for positioning against a target tissue site for puncture of tissue.

13. The assembly of claim 1 , wherein the RF guidewire comprises a pigtail wire.

14. The assembly of claim 4 , wherein the reinforced dilator has a flexural rigidity of 0.0085 Nm 2 to 0.0145 Nm 2 .

15. An assembly for puncturing tissue, the assembly comprising:

a flexible puncturing wire for puncturing tissue; and

a reinforced dilator including one or more polymer layers surrounding a hypotube selectively re-shapeable by a user to impart a desired curve to the reinforced dilator, the reinforced dilator supporting the flexible puncturing wire to enable force transmission to a distal end of the assembly and having a flexural rigidity of 0.0085 Nm 2 to 0.0145 Nm 2 ;

wherein the flexible puncturing wire is capable of being advanced within the reinforced dilator for puncturing tissue,

wherein the flexible puncturing wire has a proximal portion having a proximal stiffness of between about 0.00107 Nm 2 and about 0.00179 Nm 2 and a distal portion having a distal stiffness of between about 3.57×10 −6 Nm 2 and about 5.95×10 −6 Nm 2 such that the wire is usable independently from the reinforced dilator during another portion of the procedure to facilitate exchange and positioning of another device, and

wherein a locking mechanism enables axial and rotational coupling of the dilator with a sheath for a portion of the procedure.

16. The assembly of claim 15 , wherein the dilator comprises a dilator hub and the sheath comprises a sheath hub, wherein the locking mechanism comprises one or more keys on the dilator hub for co-operatively engaging with the sheath hub.

17. An assembly for puncturing tissue, the assembly comprising:

a flexible puncturing wire for puncturing tissue, the flexible puncturing wire comprises an RF guidewire comprising a distal electrode tip and a device radiopaque marker at a distal end thereof; and

a reinforced dilator including one or more polymer layers surrounding a hypotube selectively re-shapeable by a user to impart a desired curve to the reinforced dilator, the reinforced dilator supporting the flexible puncturing wire to enable force transmission to a distal end of the assembly and having a flexural rigidity of 0.0085 Nm 2 to 0.0145 Nm 2 ;

wherein the flexible puncturing wire is capable of being advanced within the reinforced dilator for puncturing tissue,

wherein the flexible puncturing wire has a proximal portion having a proximal stiffness of between about 0.00107 Nm 2 and about 0.00179 Nm 2 and a distal portion, including the distal electrode tip, having a distal stiffness of between about 3.57×10 −6 Nm 2 and about 5.95×10 −6 Nm 2 such that the wire is usable independently from the reinforced dilator during another portion of the procedure to facilitate exchange and positioning of another device.

18. The assembly of claim 17 , wherein the device radiopaque marker is configured to co-operate with a dilator radiopaque marker at a distal tip of the reinforced dilator to indicate a relative position of the flexible puncturing wire.

19. The assembly of claim 18 , wherein the assembly comprises:

a first configuration, where the flexible puncturing wire is positionable within the reinforced dilator such that the device radiopaque marker is in alignment with the dilator radiopaque marker; and

a second configuration, wherein the flexible puncturing wire is advanceable within the reinforced dilator such that the device radiopaque marker is out of alignment with and distal to the dilator radiopaque marker;

wherein the second configuration indicates positioning of an energy delivery portion of the flexible puncturing wire beyond the reinforced dilator for positioning against a target tissue site for puncture of tissue.

20. The assembly of claim 15 , wherein the reinforced dilator comprises a dilator hub and the sheath comprises a sheath hub, wherein a locking mechanism comprises one or more keys on the dilator hub for co-operatively engaging with the sheath hub and enables axial and rotational coupling of the dilator with a sheath for a portion of the procedure.