INTRODUCER SHEATH ASSEMBLY AND METHOD

• US 20130023734A1
• Filed: 09/27/2012
• Published: 01/24/2013
• Est. Priority Date: 03/29/2010
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: OKAMURA, Ryo
• Granted Patent: US 9,089,335 B2
• Time in Patent Office: Days
• US Class Current: 600/227
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61M 2025/0206 where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2025/026 where the straps are releasably secured, e.g. by hook and loop-type fastening devices
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 sheath assembly is provided that is capable of securely fastening a sheath tube to a patient'"'"'s limb so as to keep it from being displaced after insertion into an incision. The introducer sheath assembly has an introducer sheath including a sheath tube to be inserted into the incision made on the patient'"'"'s limb and a sheath hub attached to the proximal end of the sheath tube. In one form, the introducer sheath assembly has a belt, which is connected to the sheath hub and wound around the limb, and a fastening member to fasten the belt wound around the limb.

Claims

1. An introducer sheath assembly comprising:

an introducer sheath having an elongate body for insertion into an incision in a patient'"'"'s limb;

an elongate securing device for being operatively connected to the elongate body to extend transversely thereto and being sized for extending about the patient'"'"'s limb; and

a connector mechanism of the elongate securing device that is operable to releasably secure the elongate securing device about the patient'"'"'s limb to urge a portion of the introducer sheath elongate body that remains outside the patient'"'"'s body into tight engagement with the patient'"'"'s limb.

2. The introducer sheath assembly of claim 1 wherein the elongate securing device includes an elongate belt member, and the connector mechanism includes a hook-and-loop fastener having male and female portions thereof adjacent opposite ends of the elongate belt member that allow the elongate belt member to be tightly secured about the patient'"'"'s limb to exert a downward pulling force on either side of the introducer sheath elongate body portion.

3. The introducer sheath assembly of claim 1 wherein the elongate securing device has one end directly connected to the elongate body of the introducer sheath.

4. The introducer sheath assembly of claim 3 wherein the elongate body of the introducer sheath includes a leading sheath tube portion for insertion into the incision and the portion of the elongate body that remains outside the patient'"'"'s body comprises a trailing enlarged hub portion to which the one end of the elongate securing device is directly connected.

5. The introducer sheath assembly of claim 1 wherein the elongate securing device comprises a hemostatic band having a pressing device and a receiving portion configured to releasably receive and retain the elongate body portion of the introducer sheath with the pressing device generally aligned with the hemostatic band receiving portion and operable to exert pressure on an area of the patient'"'"'s limb about the incision to stop bleeding from the incision after removal of the introducer sheath body therefrom.

6. The introducer sheath assembly of claim 5 wherein the hemostatic band receiving portion has an outlet through which the elongate body extends for insertion into the incision adjacent thereto, and the pressing device comprises at least one inflatable member that is connected to the hemostatic band to overlap the hemostatic band receiving portion outlet for exerting pressure on the area of the patient'"'"'s limb about the incision.

7. The introducer sheath assembly of claim 6 wherein the hemostatic band is of translucent or transparent material so that an operator can see therethrough to allow the receiving portion including the outlet thereof to be used as an indicator for properly securing the hemostatic band to the patient'"'"'s limb so that the outlet is adjacent the incision and the pressing device is positioned to exert pressure on the area of the patient'"'"'s limb about the incision.

8. The introducer sheath assembly of claim 5 wherein the hemostatic band includes a main elongate band portion having an outer surface for facing away from the patient'"'"'s limb and an opposite inner surface for facing toward the patient'"'"'s limb, the pressing device is secured to the inner surface of the main elongate band portion, and the hemostatic band receiving portion comprises a pocket fixed to the pressing device and having a window opening outlet through which the elongate body extends for insertion into the incision.

9. A hemostatic band device for an introducer sheath assembly having an introducer sheath including an elongate body having an enlarged, sheath hub portion and a tube portion for being inserted into an incision in a patient'"'"'s limb, the hemostatic band device comprising:

a hemostatic band for being operatively connected to the sheath elongate body to extend transversely thereto and being sized to extend about the patient'"'"'s limb;

at least one balloon of the hemostatic band that is expandable to apply pressure to an area of the patient'"'"'s limb surrounding the incision; and

introducer sheath receiving structure of the hemostatic band configured for removably receiving the sheath hub portion with the tube portion extending beyond the introducer sheath receiving structure to be inserted in the incision.

10. The hemostatic band device of claim 9 wherein the introducer sheath receiving structure comprises a pocket attached to the balloon, and the balloon is expanded before or after removal of the introducer sheath tube portion from the incision and the hub portion from the pocket to collapse the pocket attached thereto against the patient'"'"'s limb adjacent to the incision after removal of the introducer sheath tube portion therefrom while applying pressure to the area of the patient'"'"'s limb surrounding the incision.

11. The hemostatic band device of claim 10 wherein the pocket has an outlet window opening configured to tightly frictionally hold the tube portion extending out of the pocket through the outlet window opening.

12. The hemostatic band device of claim 11 in combination with the introducer sheath assembly wherein the introducer sheath tube portion has a smaller diameter, leading end portion and a larger diameter, trailing end portion adjacent the hub portion, and the pocket outlet window opening is sized in clearance with the leading end portion and in interference with the trailing end portion to allow the tube portion to be tightly frictionally held as the tube portion extends out of the pocket through the outlet window opening.

13. The hemostatic band device of claim 11 wherein the pocket includes a hook-and-loop fastener extending about the outlet window opening thereof for closing the outlet window opening tightly about the tube portion extending therethrough.

14. The hemostatic band device of claim 10 in combination with the introducer sheath assembly wherein one of the pocket and the sheath hub portion has a projection and the other of the pocket and the sheath hub portion has an aperture sized to fit the projection extending therethrough for retaining the sheath hub portion in the pocket.

15. The hemostatic band device of claim 9 wherein the introducer sheath receiving structure comprises a resilient member having a groove sized for tightly receiving the sheath tube portion extending therealong.

16. The hemostatic band device of claim 9 wherein the hemostatic band includes a main elongate band portion sized to extend about the patient'"'"'s limb, and a connecting mechanism operable to releasable secure the main elongate band portion about the patient'"'"'s limb and being disposed so that the connecting mechanism and the introducer sheath receiving structure including the balloon to which the introducer sheath receiving structure is attached are generally on opposite sides of the patient'"'"'s limb.

17. A method of securing an introducer sheath assembly to a patient'"'"'s limb, the method comprising:

aligning introducer sheath receiving structure attached to a belt of the introducer sheath assembly with an incision to be adjacent thereto;

securing the belt to extend about the patient'"'"'s limb;

placing an introducer sheath in the sheath receiving structure for extending into the adjacent incision with the secured belt resisting displacement of the introducer sheath when engaged during use thereof.

18. The method of claim 17 wherein the introducer sheath is placed in the sheath receiving structure either before or after the belt is secured to extend about the patient'"'"'s limb.

19. The method of claim 17 wherein placing the introducer sheath in the sheath receiving structure includes advancing a tube portion of the introducer sheath through an outlet opening and into the incision, and gripping the tube portion with the sheath receiving structure as the tube portion extends out therefrom through the outlet opening.

20. The method of claim 17 further comprising expanding a balloon having sheath receiving structure attached thereto to apply pressure to an area of the limb surrounding the incision to stop bleeding therefrom, and removing the introducer sheath from the incision and the sheath receiving structure either before or after the balloon is expanded.