INTRODUCER INCLUDING SHAPED DISTAL REGION

• US 20090105652A1
• Filed: 10/16/2008
• Published: 04/23/2009
• Est. Priority Date: 10/19/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Beal, James David, King, Eric Michael
• Granted Patent: US 8,608,702 B2
• Time in Patent Office: Days
• US Class Current: 604/164.30
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

An introducer for providing intravascular access to a patient is disclosed, and includes a dilator and sheath that are configured to prevent peelback, or “fishmouthing,” of the sheath during introducer advancement. In one embodiment, the introducer comprises a dilator including a distal tapered region, and a sheath including an inner bore that receives the dilator such that a portion of the tapered region of the dilator extends from the sheath distal end. A distal outer surface of the sheath includes a first curved portion defined by a first radius and extending proximally from the distal end of the sheath to a first end point, and a second curved portion defined by a second radius and extending proximally from the first end point to a second end point. Additionally, an interference fit is established between the dilator tapered region and the sheath distal end to further prevent sheath end deformation.

Claims

1. An introducer for introducing a medical device into a vasculature of a patient, comprising:

a sheath defining a proximal end, an open distal end, and a central bore extending therebetween, a distal region of the sheath including at least one curved outer surface portion proximally extending from the distal end thereof, a cross section of the at least one curved outer surface portion at least partially defined by a first radius; and

a dilator that is removably received within the central bore of the sheath such that at least a portion of a distal tapered region of the dilator extends distally of the distal end of the sheath.

2. The introducer as defined in claim 1, wherein the at least one curved outer surface portion provides an annular rounded surface to the distal end of the sheath.

3. The introducer as defined in claim 1, wherein the sheath further includes a second curved outer surface portion cross sectionally defined by second radius.

4. The introducer as defined in claim 3, wherein the at least one curved outer surface portion and the second curved outer surface portion provide a bullet-shape cross sectional profile to the distal end of the sheath.

5. The introducer as defined in claim 1, wherein a composition of the sheath includes polytetrafluorethylene.

6. The introducer as defined in claim 1, wherein the at least one curved outer surface portion extends approximately 0.05 inches proximally from the distal end of the sheath.

7. A sheath assembly for use with an introducer in introducing a medical device into a vasculature of a patient, comprising:

a sheath defining a proximal end, an open distal end, and a central bore extending therebetween, a distal region of an outer surface of the sheath including;

a first curved portion defined in cross section by a first radius and extending proximally from the sheath distal end to a first endpoint; and

a second curved portion defined in cross section by a second radius and extending proximally of the first endpoint to a second endpoint.

8. The sheath assembly as defined in claim 7, wherein the second curved portion is contiguous with the first curved portion.

9. The sheath assembly as defined in claim 7, wherein the central bore of the sheath is sized to receive a dilator therethrough, the dilator including a distal tapered region.

10. The sheath assembly as defined in claim 9, wherein the distal tapered region of the dilator includes a first tapered portion defined by a first taper angle and a second tapered portion defined by a second taper angle.

11. The sheath assembly as defined in claim 10, wherein a proximal termination of the second tapered portion is disposed proximally of the distal end of the sheath when the dilator is seated within the central bore of the sheath such that the second tapered portion extends into the central bore.

12. The sheath assembly as defined in claim 7, wherein an inner diameter of a wall defining the distal region of the sheath is substantially constant.

13. The sheath assembly as defined in claim 7, wherein an inner diameter of a wall defining the distal region of the sheath is smaller adjacent the distal end relative to a more proximal portion of the wall defining the distal region.

14. The sheath assembly as defined in claim 7, wherein the first and second curved portions are annularly defined on the outer surface of the sheath.

15. The sheath assembly as defined in claim 7, wherein the second radius of the second curved portion of the sheath is larger than the first radius of the first curved portion.

16. The sheath assembly as defined in claim 7, wherein the first radius of the first curved portion has a magnitude of from about 0.003 inch to about 0.010 inch.

17. The sheath assembly as defined in claim 7, wherein the second radius of the second curved portion has a magnitude of from about 0.15 inch to about 0.5 inch.

18. The sheath assembly as defined in claim 7, wherein the first and second curved portions are convexly shaped with respect to an exterior view of the sheath distal region.

19. An introducer for introducing a medical device into a vasculature of a patient, the introducer comprising:

a dilator including a distal tapered region; and

a sheath including an inner bore extending between a proximal and a distal end thereof for removably receiving the dilator therein such that at least a portion of the distal tapered region of the dilator distally extends from the distal end of the sheath, an outer surface of the sheath including;

a first curved portion cross sectionally defined by a first radius and extending proximally from the distal end of the sheath to a first end point; and

a second curved portion cross sectionally defined by a second radius and extending proximally from the first end point to a second end point.

20. The introducer as defined in claim 19, wherein the first and second curved portions assist in preventing deformation of the distal end of the sheath during introduction of the introducer into the patient vasculature.

21. The introducer as defined in claim 20, wherein the introducer is used to insert a catheter into the patient vasculature.

22. The introducer as defined in claim 21, wherein the distal tapered region of the dilator extends into the bore of the sheath so as to provide an interference fit between the dilator and the distal end of the sheath.

23. The introducer as defined in claim 22, wherein the distal tapered region includes a first tapered portion defined by a first taper angle and extending proximally from a distal end of the dilator and a second tapered portion defined by a second taper angle and extending proximally from a proximal end point of the first tapered portion.

24. The introducer as defined in claim 23, wherein the first taper angle has a magnitude of from about five (5) to eight (8) degrees, and wherein the second taper angle has a magnitude of from about one (1) to four (4) degrees.

25. The introducer as defined in claim 24, wherein the first and second curved portions together extend proximally at least 0.05 inch from the distal end of the sheath.

26. The introducer as defined in claim 25, wherein the sheath is splittable and wherein the proximal end of the sheath includes a splittable handle, the handle including a threaded connector for threadably engaging a locking nut disposed on a proximal portion of the dilator.

27. The introducer as defined in claim 26, wherein the dilator defines a longitudinal bore for receiving a guidewire therethrough.