Granted Patent B2

US 12,685,557 · App. 18/805,071 · Granted Jul 21, 2026

Inventors: John To (Sunnyvale, CA); Paul Escudero (Sunnyvale, CA)

Assignee: NIPRO VASCULAR INNOVATIONS AMERICAS, INC.

A61B17/320725A61B17/320758A61B2017/00292A61B2017/320733

Abstract

Claims (75)

1 . A highly flexible, telescoping atherectomy device, comprising:

a distal end, a proximal end, a long axis, and a guidewire lumen passing through the device in the direction of the long axis;

a flexible sheath having an outer diameter and a sheath lumen;

a cutter having a proximal end, a distal end, and a body with a plurality of helical flutes, a point at the distal end having a plurality of cutting lips, a cutter lumen, and a cleared diameter;

a drive assembly having

an unsheathed and flexible driveshaft including an axis, a proximal end, a distal end, an outer surface, and a driveshaft lumen, the distal end of the unsheathed and flexible drive shaft having a fixed connection with the cutter, wherein the unsheathed and flexible drive shaft is rotatably translational within the lumen of the flexible sheath to drive the cutter;

and,

a reversibly-expandable, lateral pushing member at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a collapsed state, and an expanded state, the proximal end having a connector assembly with the flexible sheath, and the distal end having an operable connection with the cutter;

wherein,

the cleared diameter of the cutter is greater than the outer diameter of the flexible drive shaft;

the guidewire lumen includes the cutter lumen and the driveshaft lumen; and

the unsheathed and flexible drive shaft is longer than the flexible sheath to enable a reversible telescoping of the unsheathed and flexible drive shaft from the distal end of the flexible sheath to increase the flexibility of the atherectomy device when directing the cutter to a target site for the cutter;

the connector assembly with the flexible sheath and the operable connection with the cutter are each configured to receive an axial force (i) applied along the axis of the flexible drive shaft from the cutter to the flexible sheath and (ii) transferred through the lateral pushing member during the collapse and the expansion of the lateral pushing member with the reversible telescoping of the flexible drive shaft from the flexible sheath; and,

the connector assembly with the cutter is configured as a rotatably translatable connection to facilitate a rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherectomy device.

2 . The atherectomy device of claim 1 , wherein the cleared diameter of the cutter is greater than the outer diameter of the flexible sheath.

3 . The atherectomy device of claim 1 , further comprising a screw pump attached to the outer surface of the drive shaft, the distal end of the screw pump being adjacent to the helical flutes at the proximal end of the cutter.

4 . The atherectomy device of claim 3 , wherein the screw pump extends beyond the flexible sheath during use of the atherectomy device within the vascular lumen;

is a right hand screw when the cutter is rotated in the right-hand direction; or,

is a left hand screw when the cutter is rotated in the left-hand direction.

5 . A method of performing an atherectomy in a subject using the atherectomy device of claim 3 , the method comprising

creating a point of entry in a vascular lumen of the subject;

inserting the atherectomy device into the vascular lumen;

telescoping the flexible drive shaft, the telescoping including unsheathing the flexible drive shaft and increasing the flexibility of the flexible drive shaft when directing the cutter to a target site for the cutter;

cutting a plaque from the vascular lumen with the cutter of the atherectomy device;

discharging the cut plaque from the vascular lumen with the screw pump; and,

removing the atherectomy device from the vascular lumen of the subject.

6 . A system comprising the atherectomy device of claim 1 and a guidewire.

7 . A method of performing an atherectomy in a subject using the atherectomy device of claim 1 , the method comprising

creating a point of entry in a vascular lumen of the subject;

inserting the atherectomy device into the vascular lumen;

telescoping the flexible drive shaft;

cutting a plaque from the vascular lumen with the cutter of the atherectomy device;

discharging the cut plaque from the vascular lumen with the screw pump; and,

removing the atherectomy device from the vascular lumen of the subject.

8 . A highly flexible, telescoping atherectomy device, comprising:

a flexible sheath having a proximal end, a distal end, and a sheath lumen;

a cutter having a proximal end, a distal end, and a body with a plurality of helical flutes, a point at the distal end having a plurality of cutting lips, a cutter lumen, and a cleared diameter;

a drive assembly for the cutter having

a flexible driveshaft including an axis, a proximal end, a distal end, an outer surface, and a driveshaft lumen, the distal end of the flexible drive shaft having a fixed connection with the cutter, wherein

the flexible drive shaft is rotatably translational within the lumen of the flexible sheath to drive the cutter; and,

the flexible drive shaft is longer than the flexible sheath to enable a reversible telescoping of the flexible drive shaft from the distal end of the flexible sheath to unsheath the flexible drive shaft and increase the flexibility of the flexible drive shaft when directing the cutter to a target site for the cutter;

and,

a reversibly-expandable, lateral pushing member at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a collapsed state, and an expanded state, the proximal end having a connector assembly with the flexible sheath, and the distal end having an operable connection with the cutter.

9 . The atherectomy device of claim 8 , further comprising a screw pump attached to the outer surface of the drive shaft, the distal end of the screw pump being adjacent to the helical flutes at the proximal end of the cutter.

10 . The atherectomy device of claim 9 , wherein the screw pump extends beyond the flexible sheath during use of the atherectomy device within the vascular lumen;

is a right hand screw when the cutter is rotated in the right-hand direction; or,

is a left hand screw when the cutter is rotated in the left-hand direction.

11 . The atherectomy device of claim 10 , wherein

the connector assembly with the flexible sheath and the operable connection with the cutter are each configured to receive an axial force (i) applied along the axis of the flexible drive shaft from the cutter to the flexible sheath and (ii) transferred through the lateral pushing member during the collapse and the expansion of the lateral pushing member with the reversible telescoping of the flexible drive shaft from the flexible sheath; and,

the connector assembly with the cutter is configured as a rotatably translatable connection to facilitate a rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherectomy device.

12 . A system comprising the atherectomy device of claim 10 and a guidewire.

13 . A method of performing an atherectomy in a subject using the atherectomy device of claim 10 , the method comprising

creating a point of entry in a vascular lumen of the subject;

inserting the atherectomy device into the vascular lumen;

telescoping the flexible drive shaft, the telescoping including unsheathing the flexible drive shaft and increasing the flexibility of the flexible drive shaft when directing the cutter to a target site for the cutter;

cutting a plaque from the vascular lumen with the cutter of the atherectomy device;

discharging the cut plaque from the vascular lumen with the screw pump; and,

removing the atherectomy device from the vascular lumen of the subject.

14 . The atherectomy device of claim 9 , wherein

the connector assembly with the flexible sheath and the operable connection with the cutter are each configured to receive an axial force (i) applied along the axis of the flexible drive shaft from the cutter to the flexible sheath and (ii) transferred through the lateral pushing member during the collapse and the expansion of the lateral pushing member with the reversible telescoping of the flexible drive shaft from the flexible sheath; and,

the connector assembly with the cutter is configured as a rotatably translatable connection to facilitate a rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherectomy device.

15 . A system comprising the atherectomy device of claim 9 and a guidewire.

16 . A method of performing an atherectomy in a subject using the atherectomy device of claim 9 , the method comprising

creating a point of entry in a vascular lumen of the subject;

inserting the atherectomy device into the vascular lumen;

telescoping the flexible drive shaft, the telescoping including unsheathing the flexible drive shaft and increasing the flexibility of the flexible drive shaft when directing the cutter to a target site for the cutter;

cutting a plaque from the vascular lumen with the cutter of the atherectomy device;

discharging the cut plaque from the vascular lumen with the screw pump; and,

removing the atherectomy device from the vascular lumen of the subject.

17 . The atherectomy device of claim 8 , wherein the cleared diameter of the cutter is greater than the outer diameter of the flexible sheath.

18 . The atherectomy device of claim 8 , wherein the connector assembly with the flexible sheath and the operable connection with the cutter are each configured to receive an axial force (i) applied along the axis of the flexible drive shaft from the cutter to the flexible sheath and (ii) transferred through the lateral pushing member during the collapse and the expansion of the lateral pushing member with the reversible telescoping of the flexible drive shaft from the flexible sheath.

19 . The atherectomy device of claim 8 , wherein

the connector assembly with the flexible sheath and the operable connection with the cutter are each configured to receive an axial force (i) applied along the axis of the flexible drive shaft from the cutter to the flexible sheath and (ii) transferred through the lateral pushing member during the collapse and the expansion of the lateral pushing member with the reversible telescoping of the flexible drive shaft from the flexible sheath; and,

the connector assembly with the cutter is configured as a rotatably translatable connection to facilitate a rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherectomy device.

20 . A system comprising the atherectomy device of claim 8 and a guidewire.

Assignments (2)

Continuity (5)

References Cited (400)