# Patent

## Title
Retention bolsters for percutaneous catheters

## Abstract

This is a continuation of application Ser. No. 07/908,713 filed on Jun. 30, 1992, abandoned, which application is a continuation-in-part of U.S Ser. No. 07/608,234, now U.S. Pat. No. 5,125,906, entitled HAND-HELD DEVICE FOR FEEDING A SPRING WIRE GUIDE, filed Nov. 2, 1990, and which is incorporated herein by reference as if set forth in full.

## Background
The present invention is directed to devices for feeding a spring wire guide into a syringe or body cavity. In particular, the present invention is directed to a device for feeding a spring wire guide into a syringe or body cavity which device can be utilized with a single hand, and which further functions to straighten the spring wire guide as it is fed.

The Seldinger technique, developed by Sven I. Seldinger in the early 1950s, is frequently used for introducing a spring wire guide into a vein or body cavity in order to facilitate catheter placement within a vein or other body cavity. Pursuant to this technique, in its most primitive form, a hollow needle punctures a vein, is inserted and rotated 180.degree.. A spring wire guide is then introduced into the vein or body cavity through the needle. The needle is removed, and the wire guide is held in place. The catheter is then threaded over the spring wire guide.

Blitt et al., in "Central Venous Catheterization Via the External Jugular Vein," Journal of the American Medical Association, Aug. 12, 1974, pp. 817-818, expanded upon the Seldinger technique by initially introducing the needle via a syringe and by then utilizing a J-shaped guide wire to facilitate catheter insertion. In practice, following the insertion of the needle and the drawing of venal blood, the syringe is detached from the needle and the spring or "J" wire guide inserted through the needle.

More recently, several devices have been developed which combine the wire guide and syringe injection functions, such as disclosed in U.S. Pat. No. 4,274,408 to Nimrod, and U.S. Pat. No. 4,813,938 to Raulerson. Such devices comprise highly specialized and complex syringes, containing central apertures for the wire guide. The main advantage of such syringes is that they minimize bleeding during the insertion of the wire guide. The present invention, in its preferred embodiment, is directed toward feeding a guide wire into such syringes.

There are several prior art devices for introducing the spring wire guide into the needle or syringe. These devices typically require the use of two hands by the administering medical professional. The required need for two hands makes the introduction of the spring wire guide cumbersome, particularly when used with syringes such as those disclosed in U.S. Pat. Nos. 4,274,408 and 4,813,938.

U.S. Pat. No. 4,713,059 to Bickelhaupt discloses such a device which must be supported by both hands of the physician or administering medical professional. As can be seen in FIGS. 5 and 6 of U.S. Pat. No. 4,713,059, the device is held by two hands and the wire probe is advanced, by the administering medical professional, by shuttling his or her fingers back and forth.

A particular problem which may arise during the introduction of the spring wire guide, sometimes referred to as "J" wire, is that the tip may bend to fold back upon itself. Once in the vein or body cavity, the vein or body cavity tends to keep the wire tip straight, but the tendency for it to assume its set position may hinder the advancement of the wire as it is moved around and turns and bends in the vessel, and in particular as it progresses through the chambers of the heart in cardiac catheterization applications.

In view of the above, it would be desirable to have a spring wire guide feed device which can be utilized with a single hand of the administering professional and which further functions to straighten the spring wire guide as it is fed into a syringe.

It is therefore an object of the present invention to provide a spring wire guide feeding device which facilitates the feeding of the spring wire guide with only one hand by the administering medical professional, and thus freeing the professional's other hand to maneuver or control the introducer needle or syringe.

It is still a further object of the present invention to provide a spring wire guide feeding device which further provides means for straightening the end or tip of the spring wire guide as it is fed through the device.

It is still a further object of the present invention to provide a spring wire guide feeding apparatus which is compact and in which the spring wire guide feed tube can be attached to the handle of the feeding device.

It is yet a further object of the present invention to provide a spring wire guide feeding apparatus which minimizes the possibility of contamination.

It is yet a further object of the present invention to provide a spring wire guide feeding apparatus having a removable wire guide straightener.

It is yet a further object of the present invention to provide a spring wire guide feeding apparatus having means for assisting finger access, activation and movement of the spring wire guide, while minimizing friction between the user's finger and the device.

Accordingly, the present invention is thus directed to the combination of a straightening tube and hand-held feed device which supports and feeds a spring wire guide. The device of the present invention is held and supported in a single hand of the administering medical professional. The device of the present invention permits the spring wire guide to be held and advanced between the thumb and forefinger of the administering medical professional, through a straightening bore, and then through the syringe plunger, and into the vein or body cavity.

In accordance with the present invention, a hand-held spring wire guide feeding apparatus is disclosed. The invention comprises a longitudinal base having an attached rear end having an opening for feeding a spring wire guide; a flexible tube for holding a spring wire guide and having a proximal end attached to said attached rear end, said longitudinal base having a forward end affixed to a removable tube having a coaxially extending bore for receiving and straightening said spring wire guide as it is fed from said rear end, a central open section separating said rear and forward ends for providing finger access to said spring wire guide so as to advance said spring wire guide between said rear end means and said forward end; and a handle affixed to the underside of said longitudinal base proximate to said central open section for holding and supporting said wire guide feeding apparatus, said handle having an arcuate surface configured to cup the fingers of the user and further having a clamp for securing the distal end of said flexible tube to said handle.

In more preferred embodiments, the present invention comprises a longitudinal base having an attached first rear end member having a first axial bore for receiving a spring wire guide; a flexible tube for housing said spring wire guide, said flexible tube having a proximal end port interconnected with said axial bore, said longitudinal base having a second end member having attached thereto a removable straightening tube having a second axial bore for receiving and straightening said spring wire guide as it is fed from said attached rear end member, each of said first and second bores being in substantial axial alignment; a central open section separating said first and second members for providing unrestricted access to said spring wire guide so as to allow for the advancement of said spring wire guide between said first and second end members said central open section including an arced boss for facilitating finger access and movement of said spring wire guide; and an arced handle affixed to the underside of said base proximate to said central open section said handle being configured to cup the fingers of the hand of the user for holding and supporting said elongated base member, said handle having a u-shaped clamp for securing said flexible tube to said handle.

The disclosed device is designed to be held and operated with one hand by the administering medical professional, leaving the other hand free to position the introducer needle or syringe.

FIG. 1 is a perspective view of the spring wire guide feeding mechanism of the present invention.

FIG. 2 is an overhead plan view of the longitudinal base and barrel for the spring wire guide feeding apparatus of the present invention.

FIG. 3 is a section view of the handle of the spring wire guide feeding mechanism along line 3--3 of FIG. 2.

FIG. 4 is a read perspective view of the spring wire guide feeding mechanism of the present invention.

FIG. 5 is an isolated view of the U-shaped clamping mechanism of the spring wire guide of the present invention along line 5--5 of FIG. 3.

FIG. 6 is a perspective view of an alternative spring wire guide feed mechanism in accordance with the present invention.

FIG. 6A is an isolated side perspective view of a removable straightening tube in accordance with the present invention.

FIG. 6B is an isolated elevated side perspective view of a semi-cylindrical boss attached to the top of longitudinal base member to assist in spring wire guide feeding.

The present invention is described with reference to the enclosed Figures wherein the same numbers are utilized where applicable. Referring to FIGS. 1-5, the spring wire guide feeding mechanism 10 of the present invention is shown. The device will preferably be constructed from a molded plastic. As can be seen, the device comprises a longitudinal base member 12. The longitudinal base member 12 includes an attached elevated rear end member 13 which fastens to and attaches a flexible tube 14. Flexible tube 14 houses a coiled spring wire guide 16 (represented by the broken lines of FIG. 1). The coil spring wire guide 16 is introduced into the flexible tube 14 by removing stopper 18.

The central section 20 of the longitudinally extending member is open and attaches to an elevated barrel member 22. The barrel member 22 includes an axial bore 24, shown most particularly in FIGS. 3 and 4, which permits the spring wire guide 16 to be fed through and straightened. The elevation of the barrel 22 and rear end member 13 suspend the spring wire guide within the central open section 20, and thus facilitate its access to the thumb and forefinger of the medical professional administering the catheterization. Preferably, the barrel member has a tapered distal end portion 25. The tapered distal end portion 25 facilitates connection to the introducer needle or syringe, and the feeding of the wire guide 16.

The device 10 further includes an arced handle member 26 attached to the underside of longitudinal base member 12. The arced handle member 26 cups the middle, ring, and small fingers of the medical professional administering the catheterization. The arced handle member 26 includes a forward beveled U-shaped clamp 28, which as most particularly shown in FIGS. 1, 3, 4 and 5, facilitates the attachment of flexible tube 16 to the arced handle member 16.

FIG. 2 is a plan view of the handle 26 and barrel member 22 of the present invention. As can be seen, the spring wire guide is fed from tube 14 through the elevated rear member 13, through the central open section which extends over the longitudinal member 12 and through the axial bore 24 of barrel 22.

The operation of the present invention is now described with reference to the enclosed Figures. Referring to FIG. 1, a spring wire guide 16 may be initially fed through the flexible tube 14 via an opening created by the removal of stopper 18. The flexible tube 14 is then connected to the spring wire guide feed device at the attached elevated rear end member 13. The wire 16 is then fed forward over the open section 20 and into the axial bore 24 of barrel 22 where the wire 16 is straightened. The flexible holding tube 14 is then bent around and secured to the forward beveled U-shaped clamp 28 located at the base of the arced handle member 26. The elevation of the barrel 22 and rear end member 13 effectively suspend the wire 16 with the open section thus facilitating thumb and forefinger access by the administering medical professional. Typically, the assembly with flexible tube 14 and wire guide in place, as just described, is provided by the manufacturer to the end user in a sterile package along with other components useful for the catheterization of a blood vessel.

The device is held and supported at the arced handle member 26 by the middle, ring, and small fingers of the gloved medical professional introducing the spring wire guide. The medical professional will typically be wearing a sterile glove. The gloved thumb and forefinger of the medical professional are then used to advance or retract the suspended spring wire guide 16 at open section 20. Although the spring wire guide may then be introduced directly through a hollow needle or an introducer catheter, it is most preferably then fed through an opening in the proximal end of the plunger of a syringe such as that disclosed in U.S. Pat. Nos. 4,272,408 and 4,813,938. Use of the device allows for the advancement of the wire guide with one hand, leaving the other hand free for use in positioning the syringe. Because only a small portion of wire guide 16 is exposed to the outside air and the two fingers of the gloved administering professional, use of the device minimizes risk of contamination of the wire guide during the insertion procedure.

FIGS. 6, 6A and 6B illustrate an alternative embodiment of the spring wire guide feed apparatus of the present invention. In this embodiment, a removable straightening tube 30 attaches to the front of the spring wire guide feed apparatus 10. In one alternative, the removable straightening tube 30 forms a cone 30a having an axial bore 30b which mates with a truncated front end barrel 32 of the spring wire guide feed device of the alternative embodiment. The coaxially extending bore 30b straightens a guidewire 16 as it is fed into and out of the tube 30. It is to be appreciated that straightening tube 30 may take a variety of shapes other than that of a cone.

The completely removable straightening tube 30 is designed so that it can be utilized completely independently of the spring wire guide feed apparatus of the present invention to straighten a spring wire guide. In this respect, the tube represents the more conventional spring wire guide straightening apparatus used by many medical professionals.

Referring to FIG. 6B, the alternative embodiment further includes means 34 for facilitating the finger advancement and retraction of the spring wire guide. In a preferred embodiment, means 34 preferably comprises an arced surface such as a semi-cylindrical boss 34 which is affixed to the top of the longitudinal base member 12 within the central open section 20. The boss 34 facilitates access and feeding of the spring wire guide and minimizes friction between the user's thumb or finger, and the spring wire guide 16 as it is advanced or withdrawn. It is to be appreciated that arced surfaces having a variety of shapes can be used as means 34 in the present invention. The alternative embodiment is, in all other ways, identical to the first embodiment.

While the present invention has been described with reference to the above discussed enclosed preferred embodiments, it is to be appreciated that other embodiments fulfill the scope of the present invention and that the present invention should be construed with reference to the claims attached hereto.

## Claims

1. A hand-held spring wire guide feeding apparatus comprising: feeding a spring wire guide; attached to said attached rear end, defining a bore therethrough for receiving and straightening said spring wire guide as it is fed from said rear end, finger access to said spring wire guide so as to advance said spring wire guide between said rear end and said forward end; and said central open section for holding and supporting said wire guide feeding apparatus, said handle configured to cup at least one finger of the user and further having means for securing the distal end of said flexible tube to said handle.

2. The hand-held spring wire guide feeding apparatus of claim 1 wherein said means for securing is a clamp.

3. The hand-held spring wire guide feeding apparatus of claim 1 wherein said handle includes an arcuate surface extending downwardly and forwardly which forms a curved surface so as to cup at least one finger of the user, thereby providing support for the apparatus during advancement of the wire guide.

4. The hand-held spring wire guide feeding apparatus of claim 3 wherein said clamp extends generally rearwardly of said curved surface for securing the distal end portion of said flexible tube thereto.

5. The hand-held spring wire guide feeding apparatus of claim 1 wherein said central open section separating said rear and forward ends for providing finger access to said spring wire guide includes means for facilitating finger access and movement of said spring wire guide.

6. A The hand-held spring wire guide feeding apparatus of claim 5 wherein said means for facilitating finger access and movement of said spring wire guide comprises an arced surface.

7. A hand-held spring wire guide feeding apparatus comprising: first end member having a wire guide passageway extending therethrough; flexible tubular housing having a proximal end portion attached to said first end member for interconnecting the elongated flexible tubular housing with said passageway, said elongated flexible tubular housing further having a distal end portion having a sealing stopper for protecting a spring wire guide within the housing from airborne contaminants, said removable tube defining a bore therethrough for receiving and straightening said spring wire fed from said elongated flexible tubular spring wire guide housing through the passageway in said first end member; providing unrestricted access to said spring wire guide so as to allow for advancement of said guide to advance said guide between said first and second end members, said central section including means for facilitating finger movement of said spring wire guide, and for minimizing friction; and central open section, said handle for cupping at least one finger of the user thereby providing support for the apparatus during advancement of the wire guide, said handle having means extending generally rearwardly of said curved surface for securing the proximal end portion of said flexible tube thereto.

8. A hand-held spring wire guide feeding apparatus comprising: therethrough for receiving a spring wire guide; tube is interconnected with said first end member, removable straightening tube, said straightening tube defining a bore therethrough for receiving and straightening said spring wire guide as it is fed from said first end member; providing unrestricted access to said spring wire guide so as to allow for the advancement of said spring wire guide between said first and second end members, said central open section including a boss for facilitating finger access and movement of said spring wire guide, and for minimizing friction; and open section, said handle being configured to cup at least one finger of the hand of the user for holding and supporting said elongated base member, said handle having clamp means for securing said flexible tube to said handle.

9. A hand-held spring wire guide feeding apparatus comprising: spring wire guide; attached to said rear end; therethrough for receiving and straightening said spring wire guide as it is fed from said rear end; finger access to said spring wire guide so as to advance said spring wire guide between said rear end and said forward end; and supporting said wire guide feeding apparatus, said handle configured to cup at least one finger of the user.

10. The hand-held spring wire guide feeding apparatus of claim 9, wherein said handle includes means for securing a distal end of said flexible tube to said handle.

11. A hand-held spring wire guide feeding apparatus comprising: having a wire guide passageway extending therethrough; flexible tubular housing having a proximal end portion attached to said first end member for interconnecting the elongated flexible tubular housing with the wire guide passageway, said elongated flexible tubular housing further having a distal end portion having means for protecting a spring wire guide within the housing from airborne contaminants; a passageway therethrough for receiving and straightening said spring wire from said elongated flexible tubular spring wire guide housing through the passageway in said first end member; providing access to said spring wire guide to allow for advancement of said guide so as to advance said guide lengthwise between said first and second end members; and extending downwardly and forwardly forming a curved surface which cups at least one finger of the user thereby providing support for the apparatus during advancement of the wire guide, said handle having means extending generally rearwardly of said curved surface for securing the proximal end portion of said flexible tube thereto.