Introducer assembly extension and method of use

• US 10,232,149 B2
• Filed: 11/14/2016
• Issued: 03/19/2019
• Est. Priority Date: 03/17/2010
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Lentz, David Christian
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US15/350,771
• Publication Number:
  US 20170056627A1
• Time in Patent Office: 855 Days
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/486 involving generating temporal series of image data
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0905 extendable, e.g. mechanisms for extension
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An introducer set includes an introducer and dilator along with an extension in a sealed sterile peal open package. The extension is available for use during procedures where the puncture access site to the patient is close enough to the site to be treated in the patient that the physician'"'"'s hands and/or head may be positioned in the fluroscopic area while the physician is attempting to maneuver a wire guide to a desired location. When the extension is attached to the introducer, the physician may perform a procedure, such as an antigrade stick in the lower leg of a patient, while maintaining their hands and head outside of the fluroscopic area while direct radiation is being supplied and the wire guide is being maneuvered to a desired treatment location. After the wire guide has been properly positioned and the radiation has been terminated, the extension may be disconnected from the introducer and the remaining portions of the procedure (guide catheter insertion, balloon catheter insertion and dilation, etc.) may proceed in a known manner. The extension need only be in the range of ten to thirty centimeters to allow the physician to work a safe distance from the fluroscopic area undergoing direct radiation.

Claims

1. An introducer set comprising:

an introducer;

a wire guide;

a dilator mated to the introducer;

an extension that includes a flexible tube extending between a first end and a second end, and a first fitting with a male luer attached to the first end, and a second fitting with a female luer attached to the second end, and a length between the male luer and the female luer being in a range of ten to thirty centimeters;

the introducer, the dilator, the wire guide and the extension being sterile and sealed in a peal-open package; and

wherein the introducer set has an assembled configuration in which the extension is axially connected with the female luer to the introducer and the wire guide extends through both the introducer and the extension.

2. The introducer set of claim 1 wherein the dilator has a length that is shorter than a combined length of the introducer and extension, when the extension is connected to the introducer.

3. The introducer set of claim 2 including an introducer needle in the peal-open package.

4. The introducer set of claim 1 wherein a proximal fitting of the introducer includes adhesive tabs for securing the proximal fitting to skin of a patient.

5. The introducer set of claim 1 wherein the introducer includes a distal segment loaded with an echogenic material and a radiopaque material.

6. The introducer set of claim 1 wherein the flexible tube of the extension includes a kink resistant reinforcement.

7. An introducer set comprising:

an introducer with a distal segment sized to be received through a puncture site and into a passageway within a patient, and a proximal segment with a fitting having a male luer, and the introducer having a longitudinal axis extending between a proximal end and a distal end;

a wire guide;

a dilator mated to the introducer;

an extension that includes a flexible tube with a longitudinal axis extending between a first fitting with a female luer and a second fitting with a male luer, and a length between the male luer and the female luer being in a range of ten to thirty centimeters;

the introducer, the dilator, the wire guide and the extension being sterile and sealed in a package; and

wherein the introducer set has an assembled configuration in which the female luer of the extension is connected to the male luer of the introducer with the longitudinal axis of the introducer, a centerline of the female luer, a centerline of the male luer and the longitudinal axis of the flexible tube are co-linear, and the wire guide extends through the introducer and the extension.

8. The introducer set of claim 7 wherein the dilator has a length that is shorter than a combined length of the introducer and extension, when the extension is connected to the introducer.

9. The introducer set of claim 8 including an introducer needle in the package.

10. The introducer set of claim 7 wherein a proximal fitting of the introducer includes adhesive tabs for securing the proximal fitting to skin of a patient.

11. The introducer set of claim 7 wherein the introducer includes a distal segment loaded with an echogenic material and a radiopaque material.

12. The introducer set of claim 7 wherein the flexible tube of the extension includes a kink resistant reinforcement.