Catheter guide wire introducing device and method

Details Catheter guide wire introducing device and method Catheter guide wire introducing device and method

1997-07-17

2001-08-21

Seidel, Richard K. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S217000, C604S167010, C604S167030

Reexamination Certificate

active

06277100

ABSTRACT:

BACKGROUND OF THE INVENTION
Catheters for the introduction or removal of fluids may be located in various venous locations and cavities throughout the body for introducing or removing fluids. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter in which one lumen introduces fluids and one lumen removes fluids. Catheterization may also be performed by using separate, single lumen catheters inserted through two different incisions into an area to be catheterized. Such multiple catheter assemblies are known as Tesio catheters.
Generally, to insert any catheter in a blood vessel, the vessel is identified by aspiration using an introducer device, such as a syringe having a long hollow needle in accordance with the Seldinger technique. Generally, a needle is attached to a syringe and inserted under the patient's skin, with the plunger being withdrawn as the needle is inserted. When blood enters the syringe attached to the needle, indicating that the vessel has been found, the syringe body is removed and a thin guide wire is introduced through the needle lumen and into the interior of the vessel. The needle is then removed leaving a portion of the guide wire within the vessel and the remainder projecting outwardly to a point beyond the surface of the patient's skin. Other guide wire introducing devices and syringes are also available as discussed below. At this point, the catheter is inserted by the physician over the guide wire using one of several known techniques.
In the case of single-lumen catheters typically used in multiple catheter assemblies (e.g., a Tesio catheter), a physician may use an introducer sheath. If a Tesio catheter is used for hemodialysis, for example, each catheter may be inserted in two separate veins. Alternatively, each catheter may be inserted in two different locations of the same vein, such as the internal jugular vein or in a single insertion site as described in U.S. Pat. No. 5,624,413. The introducer sheath is simply a large, stiff, thin-walled tube which serves as a temporary conduit for the permanent catheter which is being placed. The introducer sheath is positioned by placing a dilator device inside of the introducer and passing both the dilator and the introducer together into the vessel over the guide wire. The guide wire, which is partially within the vessel after insertion as described above, and the dilator are then removed, leaving the thin-walled introducer sheath in place. The catheter is placed through the introducer sheath.
In each case, the first step is aspirating the vessel or area to be catheterized prior to introducing the guide wire. This is often troublesome, especially when aspirating blood vessels, due to the flashback of blood. Arterial blood may spurt from the needle insertion point with considerable force and may contact a physician or other attendant assisting the physician, causing the risk of contamination with blood borne pathogens, such as HIV virus or hepatitis. While some known devices attempt to address this problem by providing a blood reservoir to collect such flashback blood, they do not provide any positive means for controllably drawing blood into the reservoir. In other known devices, blood can be controllably drawn into a reservoir by a plunger with a syringe-type device. However, such devices require two hands to operate.
A second problem which is of greater concern to the patient is exposing certain venous blood vessels or other body cavities to atmospheric pressure. Veins are often under negative pressure as blood is being drawn back to the thoracic cavity due to the process of inspiration during the breathing cycle, and a hole in a venous blood vessel could lead to air being drawn into the blood vessel, creating an air embolism.
In other types of catheterization procedures, such as a pleural effusion where fluid which collects around the lungs is drained, it is important to have a closed system guide wire introduction device which prevents atmospheric air from entering the thoracic cavity. Breathing movement creates negative pressure in the thoracic cavity which, in combination with the air in the lungs, keeps the lungs expanded. The introduction of air into the thoracic cavity could cause the lungs to partially collapse. It is therefore important during the insertion of a guide wire for catheterization that the risk of introducing air into the thoracic cavity or a vessel be minimized.
There is a need in the art for a closed system catheter guide wire introducing device which can be used with one hand and which minimizes the risk of contamination by blood borne pathogens as well as reducing the risk of the introduction of air into a body cavity or an air embolism.
BRIEF SUMMARY OF THE INVENTION
Briefly stated, the present invention provides a catheter guide wire introducing device for aspiration of a body part and insertion of a guide wire into the body part. The catheter guide wire introducing device comprises a flexible bulb having a first end, a closed second end and an interior cavity. A fitting is located on the first end of the bulb. The fitting includes an internal chamber and first and second axially aligned passageways in fluid communication with the chamber. A third passageway is provided in fluid communication between the chamber and the interior of the cavity of the flexible bulb. An introducer needle having first and second ends and a lumen is provided. The first end of the needle is connected to the fitting such that the first passageway is in fluid communication with the lumen. A conduit having first and second ends and a passageway extending therethrough is also provided. The conduit is axially aligned with the introducer needle. The first end of the conduit is connected to the fitting such that the conduit passageway is in fluid communication with the second passageway. The conduit and the introducer needle are axially aligned. A guide wire penetrable seal assembly is connected to the second end of the conduit in fluid communication with the conduit passageway for preventing the passage of fluid from within the conduit and air from outside the conduit, and for introduction of the guide wire into the conduit.
In another aspect, the present invention provides a catheter guide wire introducing device for aspiration of a body part and insertion of a guide wire into the body part. The catheter guide wire introducing device includes a flexible bulb having a first end, a second end and an interior cavity. A fitting is located on the first end of the flexible bulb. The fitting includes a chamber. An introducer needle having first and second ends and a lumen is provided, with the first end of the needle being connected to the fitting such that the lumen is in fluid communication with the chamber. A conduit is provided having first and second ends and a passageway extending therethrough. The conduit is axially aligned with the introducer needle, and the first end of the conduit is connected to the fitting such that the conduit passageway is in fluid communication with the chamber. A guide wire penetrable seal assembly is connected to the second end of the conduit in fluid communication with the conduit passageway for preventing the passage of fluid from within the conduit and air from outside the conduit therethrough, and for introduction of a guide wire into the conduit.
In another aspect, the present invention provides a method for using an introducer device for aspirating and inserting a guide wire into a body part. The device includes (i) a flexible bulb having a first end, a closed second end and an interior cavity, (ii) a fitting located on the first end of the bulb, the fitting including an internal chamber and first and second axially aligned passageways in fluid communication with the chamber, and a third passageway in fluid communication between the chamber and the internal cavity of the flexible bulb; (iii) an introducer needle having first and second ends and a lumen, the

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