Needleless transseptal access device and methods

1. A needleless transseptal device assembly, comprising:

a tubular body with an outer diameter sized to navigate human vasculature;

a dilator comprising a proximal end and a distal end, the dilator substantially housed and axially movable within the tubular body; and

a guidewire having an outer diameter that is substantially housed and axially movable within the dilator, the guidewire comprising a flexible proximal section and a flexible distal section that comprises an end surface region having rotatable, needleless septal tissue cutting elements and a blunt, substantially planar distal end surface normal to the primary axis of the guidewire,

wherein the distal section is configured to initiate, and complete, cutting of septal tissue to form a septal access hole with a diameter substantially equivalent to the outer diameter of the guidewire,

wherein the rotatable, septal tissue cutting elements comprise at least one of drill bit-like, screw-like and helical cutting surfaces for cutting sepal tissue by a rotation action, and

further wherein the distal section of the guidewire forms a j-shape only when the entirety of the distal section is advanced outside of the dilator past the septal access hole into a heart atrium.

2. The device assembly according to claim 1 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of substantially the same material.

3. The device assembly according to claim 1 , wherein the flexible proximal section and the flexible distal section of the guidewire each possess substantially equivalent flexibility.

4. The device assembly according to claim 1 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of material selected from the group consisting of titanium alloys, nickel-titanium alloys and stainless steel alloys.

5. The device assembly according to claim 1 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of material with a modulus of elasticity in the range of approximately 70 to 110 Gigapascals.

6. The device assembly according to claim 1 , further comprising:

a torquing member coupled to the flexible proximal section of the guidewire, wherein the torquing member is adapted to assist in a rotational movement of the rotatable, septal tissue cutting elements to cut septal tissue.

7. The device assembly according to claim 1 , wherein the dilator further comprises a tapered end adapted to widen the septal access hole.

8. A needleless transseptal device assembly, comprising:

a tubular body with an outer diameter sized to navigate human vasculature;

a dilator comprising a proximal end and a distal end, the dilator substantially housed and axially movable within the tubular body; and

a guidewire having an outer diameter that is substantially housed and axially movable within the dilator, the guidewire comprising a flexible proximal section and a flexible distal section that comprises an end surface region having rotatable, needleless septal tissue cutting elements and a blunt, substantially planar distal end surface normal to the primary axis of the guidewire,

wherein the distal section is configured to initiate, and complete, cutting of septal tissue to form a septal access hole with a diameter substantially equivalent to the outer diameter of the guidewire,

wherein the rotatable, septal tissue cutting elements comprise at least one of drill bit-like, screw-like and helical cutting surfaces for cutting septal tissue by a rotational action,

further wherein the distal section of the guidewire forms a j-shape only when the entirety of the distal section is advanced outside of the dilator past the septal access hole into a heart atrium, and

further wherein at least one of the tubular body and the dilator further comprises a wire that allows a medical practitioner to steer the at least one of the tubular body and the dilator within the vasculature.

9. The device assembly according to claim 8 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of substantially the same material.

10. The device assembly according to claim 8 , wherein the flexible proximal section and the flexible distal section of the guidewire each possess substantially equivalent flexibility.

11. The device assembly according to claim 8 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of material selected from the group consisting of nickel-titanium alloys and stainless steel alloys.

12. The device assembly according to claim 8 , wherein the flexible proximal section and the flexible distal section of the guidewire each comprise a core of material with a modulus of elasticity in the range of approximately 70 to 110 Gigapascals.

13. The device assembly according to claim 8 , further comprising:

a torquing member coupled to the flexible proximal section of the guidewire, wherein the torquing member is adapted to assist in a rotational movement of the rotatable, septal tissue cutting elements to cut septal tissue.

14. The device assembly according to claim 8 , wherein the dilator further comprises a tapered end adapted to widen the septal access hole.