Locking vascular introducer assembly with adjustable hemostatic seal

• US 7,192,433 B2
• Filed: 03/14/2003
• Issued: 03/20/2007
• Est. Priority Date: 03/15/2002
• Status: Active Grant

• Current Assignee: Oscor Inc
• Original Assignee: Oscor Inc
• Inventors: Osypka, Thomas P., DeBella, Ernest G., Sass, Timothy L., Ries, Thomas C.
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US10/389,229
• Publication Number:
  US 20030216771A1
• Time in Patent Office: 1,467 Days
• Field of Search: 604/506, 604/158, 604104-109, 604/161, 604/256, 604/264, 60416401-16407, 604/164.1, 604/164.13, 60416501-16504, 60416701-16704, 604/167.06, 60417001-17003, 604246-248, 604/523, 604/537, 604533-535, 604/905, 606/167, 606/185, 606/108
• US Class Current: 606/108
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A vascular introducer assembly is disclosed that includes a dilator, a sheath having an axial lumen for accommodating the dilator, a locking collar for securing the dilator and the sheath to one another and an adjustable hemostatic seal for preventing fluid egress from the axial lumen and restricting insertion of instruments through the axial lumen.

Claims

1. A vascular introducer assembly comprising:

a) an elongated dilator having a tapered distal end portion;

b) an elongated hollow sheath having opposed proximal and distal end portions and an axial lumen extending therethrough to accommodate the dilator; and

c) a selectively adjustable annular seal operatively associated with the proximal end portion of the sheath and configured for radial movement between an open position in which passage of an instrument through the axial lumen of the sheath is unrestricted and a closed position in which insertion of an instrument through the axial lumen of the sheath is restricted; and

d) score lines longitudinally disposed on a wall of the sheath to facilitate splitting of the sheath.

2. A vascular introducer assembly as recited in claim 1, further comprising a hub operatively associated with the proximal end portion of the sheath, the hub having a body portion including an axial passage to accommodate the dilator therein and for being in fluid communication with the axial lumen, a distal end portion and a proximal end portion.

3. A vascular introducer assembly as recited in claim 1, further compnsing:

a dilator handle configured for directing movement of the dilator relative to the sheath and having a body portion with a proximal portion including a receiving port in communication with the dilator and a distal portion including a tapered stem; and

a locking collar having an axial bore therethrough, a proximal portion including a first seating engagement configured for rotatably mounting the tapered stem of the dilator handle therein and a distal portion including a second selectively lockable engagement configured for alternately securing and unsecuring the locking collar with the proximal end portion of the sheath to restrict axial movement of the dilator relative to the sheath.

4. A vascular introducer assembly as recited in claim 3, wherein the second selectively lockable engagement on the distal portion of the locking collar includes cooperative interlocking structures defined on the proximal end portion of the sheath and on an inner wall of the locking collar, the cooperative interlocking structures being engaged and disengaged by rotational movement of the locking collar relative to the proximal end portion of the sheath.

5. A vascular introducer assembly as recited in claim 4, wherein movement of the selectively adjustable annular seal between the open position and closed position is actuated by the engagement and disengagment of the locking collar with the proximal end portion of the sheath.

6. A vascular introducer assembly having an adjustable hemostatic seal comprising:

a) an elongated hollow sheath defining an axial lumen, the sheath having opposed proximal and distal end portions;

b) a hub operatively associated with the proximal end portion of the sheath, the hub including a hub body portion with an axial bore in fluid communication with the axial lumen of the sheath and a tapered proximal portion having a helical thread defined along an outer periphery thereof, a recessed channel defined circumferentially along an inner periphery thereof, and handle members protruding radially outward from the hub body portion, wherein the handle members are radially opposed from one another relative to the axis of the hub body portion;

c) an elastic annular seal disposed within the recessed channel of the hub; and

d) a cap having an axial bore extending therethrough with a helical thread for cooperating with the helical thread of the tapered proximal portion of the hub so that rotational movement of the cap relative to the hub causes the annular seal to move radially relative to the axial bore of the hub.

7. A vascular introducer assembly as recited in claim 6, wherein the radial movement of the annular seal is actuated by axial rotation of the cap about a 90 degree arc.

8. A vascular introducer assembly as recited in claim 6, wherein the annular seal is fabricated of an elastomeric material.

9. A vascular introducer assembly as recited in claim 6, wherein the annular seal is fabricated of silicone.

10. A vascular introducer assembly as recited in claim 6, further comprising a trocar seal disposed about the axial bore of the cap for preventing fluid flow from the lumen and permitting insertion of devices through the axial bore of the cap.

11. A vascular introducer assembly comprising:

a) an elongated dilator having a tapered distal end portion and an axial passage extending therethrough;

b) an elongated hollow sheath having opposed proximal and distal end;

portions and an axial lumen extending therethrough to accommodate the dilator;

c) a hub operatively associated with the proximal end portion of the sheath, the hub including a hub body portion with an axial passage for accommodating the dilator and being in fluid communication with the axial lumen of the sheath, and having a tapered proximal portion;

d) a dilator handle associated with a proximal end of the dilator including a proximal receiving port in communication with the axial passage of the dilator and a distal mounting stem; and

e) a locking collar having an axial bore with a proximal portion configured to receive the distal mounting stem of the dilator handle to facilitate rotation of the dilator handle and a distal portion configured to engage the tapered proximal portion of the hub.

12. A vascular introducer assembly as recited in claim 11, wherein the distal portion of the locking collar and the tapered proximal portion of the hub include cooperative interlocking structures defined respectively thereon.

13. A vascular introducer assembly as recited in claim 12, wherein the cooperative interlocking structures are configured to be engaged by rotational movement of the locking collar relative to the hub about a 90 degree arc through an axial plane.

14. A vascular introducer assembly as recited in claim 12, wherein the cooperative interlocking structures include a pair of pins radially projecting from the tapered proximal portion of the hub and a corresponding pair of receiving slots for the pins defined in an interior wall of the locking collar.

15. A vascular introducer assembly as recited in claim 11, further comprising a selectively adjustable annular seal operatively associated with the proximal end portion of the hub and configured for movement of the axial passage between an open position in which the passage of instruments through the axial lumen is unrestricted and a closed position in which insertion of an instrument through the axial lumen is restricted.

16. A vascular introducer assembly as recited in claim 15, wherein engagement of the distal portion of the locking collar with the tapered proximal portion of the hub moves the axial passage to the closed position.

17. A vascular introducer assembly as recited in claim 15, wherein the adjustable seal and the cooperative interlocking structures are alternatively engaged and disengaged by rotational movement of the locking collar about a 90 degree arc in the axial plane.

18. A vascular introducer assembly as recited in claim 15, wherein the selectively adjustable annular seal includes:

a) a threaded portion defined on the tapered proximal portion of the hub;

b) a circumferential recessed channel defined in an interior wall of the tapered proximal portion of the hub;

c) an annular compressible sealing ring disposed in the circumferential recessed channel of the hub; and

d) a sealing cap having an axial bore and a threaded portion defined therein for being threadably engaged with the threaded portion defined on the tapered proximal portion of the hub, wherein the annular compressible sealing ring in the circumferential recessed channel of the tapered proximal portion of the hub is selectively moved from a compressed position in which fluid egress through the axial passage is restricted and a decompressed position in which fluid egress through the axial passage is unrestricted by alternate threadable engagement of the sealing cap.

19. A vascular introducer assembly as recited in claim 18, wherein the sealing cap is seated within the axial bore of the locking collar such that alternate rotational movement of the locking collar effectuates the threaded engagement and disengagement of the sealing cap with the tapered proximal portion of the hub.

20. A vascular introducer assembly comprising:

a) an elongated dilator having a tapered distal end portion;

b) an elongated splitable sheath having opposed proximal and distal end portions and having an axial lumen extending therethrough to accommodate the dilator;

c) a handle portion operatively associated the proximal end portion of the sheath and including a splitable central hub forming a passageway into the central lumen of the sheath, the handle portion including diametrically opposed handle members extending radially outward from the central hub;

d) a two-part annular seal disposed within the splitable central hub of the handle portion for interacting with the dilator; and

e) means for radially compressing the annular seal around the dilator.

21. A vascular introducer assembly as recited in claim 20, wherein the means for radially compressing the annular seal around the dilator includes a threaded collar mounted for axial rotation on the central hub of the handle portion to facilitate radial compression of the central hub.

22. A vascular introducer assembly as recited in claim 20, wherein the diametrically opposed handle members are adapted and configured to be pulled radially outward to facilitate splitting of the central hub.