Granted Patent B2

US 12,551,665 · App. 17/735,895 · Granted Feb 17, 2026

Inventor: Thomas P. Osypka (Palm Harbor, FL)

Assignee: Greatbatch Ltd.

A61M25/0668A61M25/0136A61M25/0147

Abstract

Claims (57)

1 . A deflectable vascular introducer, comprising:

a) an elongated sheath comprising opposed proximal and distal end portions extending along a longitudinal axis, wherein at least two axial lumens extend through the sheath;

b) a movable pull-wire positioned within one of the at least two axial lumens in the sheath, wherein the pull-wire extends from a pull wire proximal portion to a pull wire distal portion anchored to the distal end portion of the elongated sheath;

c) a hub positioned at the proximal end portion of the sheath; and

d) a proximal handle assembly connected to the hub, the proximal handle assembly comprising a breakaway spreadable handle opposite a spreadable rotating twist deflection handle, wherein the spreadable rotating twist deflection handle comprises:

i) a pair of spaced apart first and second hub arms extending proximally from the hub, the first and second hub arms each comprising first and second curved exterior surfaces meeting respective first and second planar interior surface, wherein the first and second planar interior surfaces have respective first and second interior curved surfaces facing each other to form a longitudinal guide slot;

ii) a pull wire actuator disposed in the longitudinal, guide slot and comprising a cylindrically shaped central actuator portion supporting opposed outwardly extending first and second actuator arms provided with external threads, wherein the central actuator portion has a longitudinally extending central actuator opening comprising a proximal central actuator opening of a first diameter extending part-way along the actuator in open communication with a distal central anchor opening of a second diameter greater than the first diameter, and wherein a lateral opening extends through the cylindrically shaped central actuator portion in open communication with the distal central actuator opening;

iii) a cylindrically shaped pull wire anchor comprising a longitudinal anchor opening that is sized to receive a proximal portion of the pull wire and a threaded lateral anchor opening that threadingly receives a set screw;

iv) a rotatable deflection knob comprising circumferential internal threads, wherein with the pull wire actuator disposed in the longitudinal guide slot between the pair of spaced-apart first and second hub arms, and with the anchor received in the distal central opening of the pull wire actuator with the proximal portion of the pull wire extending through the proximal central opening in the pull wire actuator and into the longitudinal anchor opening with the set screw threaded into the lateral anchor opening to connect the pull wire to the anchor, the anchor in turn residing in the distal central opening in the pull wire actuator, the circumferential internal threads of the rotatable deflection knob are threadingly engaged with the external threads of the opposed first and second actuator arms so that:

A) rotation of the rotatable deflection knob in one of a clockwise or counterclockwise direction causes the pull wire actuator to translate in a proximal direction along the longitudinal guide slot between the spaced-apart first and second hub arms and away from the hub to move the pull wire proximally within the one of the at least two axial lumens in the sheath to thereby cause the distal end portion of the sheath to deflect out of axial alignment with the proximal end portion of the sheath, and

B) rotation of the rotatable deflection knob in the other of the clockwise or counterclockwise direction causes the pull wire actuator to translate in a distal direction along the longitudinal guide slot between the spaced-apart first and second hub arms and towards the hub to thereby cause the distal end portion of the sheath to return to its normal, undeflected position.

2 . The deflectable vascular introducer of claim 1 , wherein the elongated sheath includes a tubular sheath wall, and wherein the movable pull-wire positioned within the one of the at least two axial lumens is embedded within the sheath wall.

3 . The deflectable vascular introducer of claim 1 , wherein the movable pull-wire is anchored within the one of the at least two axial lumens in the sheath with epoxy at the distal end portion of the elongated sheath.

4 . The deflectable vascular introducer of claim 1 , wherein the elongated sheath includes a tubular sheath wall, and wherein a second of the at least two axial lumens in the sheath is defined within an inner diameter of the tubular sheath wall.

5 . The deflectable vascular introducer of claim 1 , wherein the proximal end portion of the elongated sheath is stiffer and less flexible than the distal end portion of the elongated sheath.

6 . The deflectable vascular introducer of claim 5 , wherein the distal end portion of the elongated sheath includes at least two softer sections with different stiffness, and wherein a first of the two softer sections is configured and adapted to be deflected to a primary curve of predetermined Deflection Curve Diameter (DCD), and wherein a second of the two softer sections is pre-shaped to a secondary curve.

7 . The deflectable vascular introducer of claim 6 , wherein the primary curve is longer in arc-length than the secondary curve.

8 . The deflectable vascular introducer of claim 1 , wherein the elongated sheath defines a predetermined usable length (UL) extending from the proximal end portion to the distal tip of the distal end portion of the sheath.

9 . The deflectable vascular introducer of claim 8 , wherein the UL ranges from 30 cm to 70 cm.

10 . The deflectable vascular introducer of claim 1 , wherein the elongated sheath includes at least two axially extending sheath lines of weakness that are diametrically opposed to one another across the elongated sheath.

11 . The deflectable vascular introducer of claim 10 , wherein the diametrically opposed at least two axially extending sheath lines of weakness comprise longitudinal score lines extending spaced from but parallel to the longitudinal axis of the elongated sheath.

12 . The deflectable vascular introducer of claim 11 , wherein the longitudinally extending score lines comprising each line of weakness are defined by a longitudinally extending narrow depth “V” opposite from one another across an inner diameter of the elongated sheath, and wherein each line of weakness further includes an axially extending detent formed in an outer diameter surface of the elongated sheath, and wherein each axially extending detent is opposite from a respective one of the longitudinally extending score lines across a sheath wall.

13 . The deflectable vascular introducer of claim 1 , further comprising a hemostatic valve abutting a proximal end of the hub and positioned between the breakaway spreadable handle opposite the spreadable rotating twist deflection handle.

14 . The deflectable vascular introducer of claim 1 , wherein the hub comprises diametrically opposed hub lines of weakness disposed between the breakaway spreadable handle opposite the spreadable rotating twist deflection handle.

15 . The deflectable vascular introducer of claim 1 , wherein the breakaway spreadable handle includes a side port conduit extending therefrom, the side port conduit having a two-way or three-way stop cock.

16 . The deflectable vascular introducer of claim 15 , wherein the side port conduit is in fluid communication with one of the at least two axial lumens in the sheath.

17 . The deflectable vascular introducer of claim 1 , wherein the pair of spaced-apart first and second hub arms extending distally from the hub have laterally aligned openings, and wherein a locking pin resides in the laterally aligned openings.

18 . The deflectable vascular introducer of claim 1 , wherein the pull wire distal portion is anchored to the distal end portion of the elongated sheath via a pull wire anchor ring.

19 . The deflectable vascular introducer of claim 12 , wherein a wall thickness of the elongated sheath where an apex of the narrow depth “V” meets the detent is approximately 0.003 inches.

20 . The deflectable vascular introducer of claim 1 , further comprising a memory wire positioned within a second of the at least two axial lumens in the sheath, wherein the memory wire is configured and adapted to assist with straightening the distal end portion of the elongated sheath after deflection out of axial alignment with the proximal end portion of the sheath.

21 . A method for deflecting a deflectable vascular introducer, comprising the steps of:

a) providing a deflectable vascular introducer, comprising:

i) an elongated sheath having opposed proximal and distal end portions extending along a longitudinal axis, wherein at least one axial lumen extends through the sheath;

ii) a movable pull-wire positioned in the at least one axial lumen in the sheath, wherein the -pull-wire extends from a pull wire proximal portion to a pull wire distal portion anchored to the distal end portion of the elongated sheath;

iii) a hub positioned at the proximal end portion of the sheath; and

iv) a proximal handle assembly connected to the hub, the proximal handle assembly comprising a breakaway spreadable handle opposite a spreadable rotating twist deflection handle, wherein the spreadable rotating twist deflection handle comprises:

A) a pair of spaced-apart first and second hub arms extending proximally from the hub, the first and second hub arms each comprising first and second curved exterior surfaces meeting respective first and second planar interior surface, wherein the first and second planar interior surfaces have respective first and second interior curved surfaces facing each other to form a longitudinal guide slot;

B) a pull wire actuator disposed in the longitudinal guide slot and comprising a cylindrically shaped central actuator portion supporting opposed outwardly extending first and second actuator arms provided with external threads, wherein the central actuator portion has a longitudinally extending central actuator opening comprising a proximal central actuator opening of a first diameter extending part-way along the pull wire actuator in open communication with a distal central anchor opening of a second diameter greater than the first diameter, and wherein a lateral opening extends through the cylindrically shaped central actuator portion in open communication with the distal central actuator opening;

C) a cylindrically shaped pull wire anchor comprising a longitudinal anchor opening that is sized to receive a proximal portion of the pull wire and a threaded lateral anchor opening that threadingly receives a set screw;

D) a rotatable deflection knob comprising circumferential internal threads, wherein with the pull wire actuator disposed in the longitudinal guide slot between the pair of spaced-apart first and second hub arms, and with the anchor received in the distal central opening of the pull wire actuator with the proximal portion of the pull wire extending through the proximal central opening in the pull wire actuator and into the longitudinal anchor opening with the set screw threaded into the lateral anchor opening to connect the pull wire to the anchor, the anchor in turn residing in the distal central opening in the pull wire actuator, the circumferential internal threads of the rotatable deflection knob are threadingly engaged with the external threads of the opposed first and second actuator arms so that:

b) rotating the rotatable deflection knob in one of a clockwise or counterclockwise direction causes the pull wire actuator to translate in a proximal direction along the longitudinal guide slot between the spaced-apart first and second hub arms and away from the hub to move the pull wire proximally within the at least one axial lumen in the sheath to thereby cause the distal end portion of the sheath to deflect out of axial alignment with the proximal end portion of the sheath, and

c) rotating of the rotatable deflection knob in the other of the clockwise or counterclockwise direction causes the pull wire actuator to translate in a distal direction along the longitudinal guide slot between the spaced-apart first and second hub arms and towards the hub to thereby cause the distal end portion of the sheath to return to its normal, undeflected position.

22 . The method of claim 21 , further including:

a) providing the sheath having at least two diametrically opposed axially extending sheath lines of weakness extending spaced from but parallel to the longitudinal axis of the elongated sheath;

b) providing the hub comprising diametrically opposed hub lines of weakness disposed between the breakaway spreadable handle opposite the spreadable rotating twist deflection handle; and

c) splitting the deflectable vascular introducer along the hub lines of weakness and the sheath lines of weakness.

23 . A deflectable vascular introducer, comprising:

a) an elongated sheath comprising opposed proximal and distal end portions extending along a longitudinal axis, wherein at least one axial lumen extends through the sheath;

b) a movable pull-wire positioned within the axial lumen in the sheath, wherein the pull-wire extends from a pull wire proximal portion to a pull wire distal portion anchored to the distal end portion of the elongated sheath;

c) a hub positioned at the proximal end portion of the sheath; and

d) a proximal handle assembly connected to the hub, the proximal handle assembly comprising a breakaway spreadable handle opposite a spreadable rotating twist deflection handle, wherein the spreadable rotating twist deflection handle comprises:

i) a pair of spaced-apart first and second hub arms extending proximally from the hub, the first and second hub arms each comprising first and second curved exterior surfaces meeting respective first and second planar interior surface, wherein the first and second planar interior surfaces have respective first and second interior curved surfaces facing each other to form a longitudinal guide slot;

ii) a pull wire actuator disposed in the longitudinal guide slot and comprising a cylindrically shaped central actuator portion supporting opposed outwardly extending first and second actuator arms provided with external threads, wherein the central actuator portion has a longitudinally extending central actuator opening comprising a proximal central actuator opening of a first diameter extending part-way along the actuator in open communication with a distal central anchor opening of a second diameter greater than the first diameter, and wherein a lateral opening extends through the cylindrically shaped central actuator portion in open communication with the distal central actuator opening;

iii) a cylindrically shaped pull wire anchor comprising a longitudinal anchor opening that is sized to receive a proximal portion of the pull wire and a threaded lateral anchor opening that threadingly receives a set screw;

iv) a rotatable deflection knob comprising circumferential internal threads, wherein with the pull wire actuator disposed in the longitudinal guide slot between the pair of spaced-apart first and second arms, and with the anchor received in the distal central opening of the pull wire actuator with the proximal portion of the pull wire extending through the proximal central opening in the pull wire actuator and into the longitudinal anchor opening with the set screw threaded into the lateral anchor opening to connect the pull wire to the anchor, the anchor in turn residing in the distal central opening in the pull wire actuator, the circumferential internal threads of the rotatable deflection knob are threadingly engaged with the external threads of the opposed first and second actuator arms so that;

A) rotation of the rotatable deflection knob in one of a clockwise or counterclockwise direction causes the pull wire actuator to translate in a proximal direction along the longitudinal guide slot between the spaced-part first and second hub arms and away from the hub to move the pull wire proximally within the at least one axial lumen in the sheath to thereby cause the distal end portion of the sheath to deflect out of axial alignment with the proximal end portion of the sheath, and

B) rotation of the rotatable deflection knob in the other of the clockwise or counterclockwise direction causes the pull wire actuator to translate in a distal direction along the longitudinal guide slot between the spaced-apart first and second hub arms and towards the hub to thereby cause the distal end portion of the sheath to return to its normal, undeflected position.

Assignments (1)

Continuity (2)

References Cited (17)