INTRAVASCULAR INTRODUCER DEVICES

• US 20150305863A1
• Filed: 04/24/2015
• Published: 10/29/2015
• Est. Priority Date: 04/28/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Gray, Brian C., Le, Tung T., Le, Thanh Huy, Bowes, Robert, Oien, Andrew, Tran, Sonny, Saravia, Maria L., Trinh, Uy D., Rafi, Hamid, Froimovich Rosenberg, Alejandro J.
• Granted Patent: US 10,154,904 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient'"'"'s vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Claims

1. A device for introducing a catheter into a patient'"'"'s vasculature, the device comprising:

a housing;

a distal sheath extending distally from the housing and adapted to be inserted into a patient'"'"'s vasculature with the housing positioned outside of the patient'"'"'s vasculature;

a distal hemostatic seal mounted within the housing;

a proximal hemostatic seal mounted within the housing at a location proximal to the distal hemostatic seal;

a tube positioned within the housing and movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal; and

wherein a proximal end of the tube, or an end of another tube of the device, is movable longitudinally relative to the proximal hemostatic seal between a first position within the proximal hemostatic seal and a second position not within the proximal hemostatic seal.

2. The device of claim 1, wherein when the tube is in the distal position, a proximal end of the tube is positioned distal to the proximal hemostatic seal and the proximal hemostatic seal is closed, and when the tube is in the proximal position, the proximal end of the tube extends through the proximal hemostatic seal.

3. The device of claim 1, wherein the proximal hemostatic seal is movable longitudinally relative to a proximal end of a second tube of the device between a distal position wherein the second tube extends through the proximal hemostatic seal and a proximal position wherein the proximal hemostatic seal is closed and positioned proximal to the second tube.

4. The device of claim 1, wherein the tube is part of a shuttle that also includes an actuator that extends radially out through the housing to allow a user to move the tube between the proximal and distal positions.

5. The device of claim 3, wherein the housing comprises a main housing and a proximal end portion that are movable longitudinally relative to each other, and wherein the distal hemostatic seal is mounted within the main housing and the proximal hemostatic seal is mounted within the proximal end portion.

6. The device of claim 5, wherein when the proximal end portion is moved longitudinally toward the main housing, the proximal hemostatic seal is opened, and when the proximal end portion is moved longitudinally away from the main housing, the proximal hemostatic seal is closed.

7. The device of claim 2, wherein the tube is movable to a neutral position between the proximal and distal hemostatic seals, such that both of the proximal and distal hemostatic seals are closed.

8. The device of claim 4, wherein the actuator of the shuttle is lockable relative to the housing in the distal position and lockable relative to the housing in the proximal position.

9. The device of claim 6, wherein when the proximal end portion is moved longitudinally toward the main housing and the proximal hemostatic seal is opened, a delivery catheter can be inserted through a proximal port in the device and into the tube without the delivery catheter contacting the proximal hemostatic seal.

10. The device of claim 6, wherein when a distal end of a delivery catheter is positioned within the tube, the tube can be moved to the distal position to allow the delivery catheter to be advanced distally from the tube into the distal sheath without contacting the distal hemostatic seal.

11. The device of claim 1, wherein the device is adapted to allow a delivery catheter with an uncovered prosthetic heart valve mounted on the delivery catheter to be introduced into the patient'"'"'s vasculature through the device and to be retrieved out of the patient'"'"'s vasculature through the device without the crimped prosthetic heart valve contacting the distal and proximal hemostatic seals.

12. The device of claim 1, wherein with the tube in the distal position and the distal end of the tube extending through the distal hemostatic seal, a crimped prosthetic heart valve carried on a delivery catheter can be retracted proximally from the patient'"'"'s vasculature, through the distal sheath, and into the tube while the distal hemostatic seal is held open around the tube.

13. The device of claim 1, wherein with a crimped prosthetic heart valve positioned within the device between the distal and proximal hemostatic seals, the proximal hemostatic seal can be held open by a proximal end of the tube or by another tube of the device while the crimped prosthetic heart valve is retracted proximally through the proximal hemostatic seal and out through a proximal port of the device, without the crimped prosthetic heart valve contacting the proximal hemostatic seal.

14. The device of claim 1, wherein the distal hemostatic seal or the proximal hemostatic seal comprises a narrow guidewire passageway adapted to hemostatically seal around a guidewire extending through the seal and comprises a flap or flaps adjacent to the guidewire passageway adapted to hemostatically seal when nothing is extending through the seal.

15. The device of claim 14, wherein both the distal hemostatic seal and the proximal hemostatic seal comprise a narrow guidewire passageway adapted to hemostatically seal around a guidewire extending through the seals and comprise a flap or flaps covering the guidewire passageway and adapted to hemostatically seal when nothing is extending through the seals.

16. The device of claim 1, wherein the housing comprises a proximal housing and a distal housing that are movable longitudinally relative to each other, and wherein the distal hemostatic seal is mounted within the distal housing and the tube is stationary relative to the proximal housing, such that when the proximal housing moves toward the distal housing, the distal end of the tube moves through the distal hemostatic seal, and when the proximal housing moves away from the distal housing, the distal end of the tube moves out of the distal hemostatic seal.

17. The device of claim 16, wherein the proximal housing and the distal housing are arranged to allow one to move over the other in a telescopic manner as the proximal housing is moved distally relative to the distal housing.

18. The device of claim 16, wherein the proximal housing and the distal housing are coupled together with a hinged arms that flex radially outwardly as the proximal housing is moved distally relative to the distal housing.

19. A method of introducing a delivery catheter into a patient'"'"'s vasculature, the method comprising:

positioning a proximal tube portion of an introducer through a proximal hemostatic seal of the introducer such that the proximal hemostatic seal is open;

inserting a distal end portion of a delivery catheter distally through the proximal tube portion and through the open proximal hemostatic seal such that a medical device mounted on the distal end portion of the delivery catheter is positioned between the proximal hemostatic seal and a distal hemostatic seal of the introducer;

positioning a distal tube portion of the introducer through the distal hemostatic seal such that the distal hemostatic seal is open; and

advancing the delivery catheter distally such that the medical device mounted on the delivery catheter moves distally through the distal tube portion and through the open distal hemostatic seal and into the patient'"'"'s vasculature.

20. The method of claim 19, wherein the medical device comprises a radially crimped prosthetic heart valve for implantation in the patient'"'"'s heart.

21. The method of claim 19, wherein the distal hemostatic seal is closed while the proximal hemostatic seal is open.

22. The method of claim 19, wherein the proximal hemostatic seal is closed around a portion of the delivery catheter while the distal hemostatic seal is open.

23. The method of claim 19, wherein the proximal tube portion and the distal tube portion are parts of the same tube.

24. The method of claim 19, wherein the proximal tube portion and the distal tube portion are parts of two different tubes that can move independently of each other.

25. The method of claim 19, wherein positioning the proximal tube portion of an introducer through a proximal hemostatic seal comprises moving a proximal end portion of the introducer distally relative to a main housing portion of the introducer.

26. The method of claim 19, wherein positioning the proximal tube portion of an introducer through a proximal hemostatic seal comprises moving a shuttle of the introducer proximally relative to the proximal hemostatic seal.

27. The method of claim 19, wherein positioning the distal tube portion of the introducer through the distal hemostatic seal comprises moving a shuttle of the introducer distally relative to the distal hemostatic seal such that a distal end of a shuttle sheath moves distally through the distal hemostatic seal.

28. The method of claim 19, further comprising:

positioning the distal tube portion through a distal hemostatic seal such that the distal hemostatic seal is open;

retracting the delivery catheter proximally from the patient'"'"'s vasculature such that the medical device mounted on the distal end portion of the delivery catheter is positioned within the distal tube portion;

moving the distal tube portion proximally out of the distal hemostatic seal such that the distal hemostatic seal closes;

positioning the proximal tube portion through the proximal hemostatic seal such that the proximal hemostatic seal is open; and

retracting the delivery catheter proximally such that the medical device mounted on the delivery catheter moves proximally through the proximal tube portion and through the open proximal hemostatic seal and out of the introducer.