Winged Catheter Introducer With Pre-Bent Wings

The present invention relates generally to the field of medical catheters. In particular it relates to a catheter for providing access to a blood vessel and the like and having features which facilitate its introduction into the vessel.

Winged infusion sets are commonly used by the medical profession for the infusion of medication and the drawing of fluids from vessels. A species of such devices (a "scalp vein set") may comprise a needle with wings attached to it. Attached to the needle, and in fluid communication with the needle bore is a translucent tube through which medication can be infused or fluids drawn. Another species (a winged catheter introducer), comprises a flexible cannula attached to a winged member and a translucent tube. Inside the cannula is a needle with a wire attached to it. The needle aids in the insertion of the catheter into a vessel and is withdrawn by pulling the wire once the cannula has been successfully introduced into the vessel.

Such devices are introduced into the vessel as follows: The wings are gripped between the practitioner's forefinger and thumb. The practitioner uses the needle to pierce the skin in the vicinity of the vessel to be accessed. When the vessel is penetrated, the pressure in the vessel will cause blood to flow up the needle bore and into the translucent tubing. The practitioner verifies the penetration of the vessel by looking for blood "flashback" in the tubing. Once the device is satisfactorily positioned in the vessel it may be left there for some time. In the case of a winged catheter introducer, the needle is withdrawn from the cannula.

A device of the second species is shown in U.S. Pat. Nos. 4,177,809 and 5,163,913, which are incorporated herein by reference. Such devices are sold under the trademarks Intima.TM. and Angioset.RTM. by Becton Dickinson & Co. of Franklin Lakes, N.J.

The gripping of the needle to facilitate insertion of the cannula is accomplished by the use of wedges on the wings which impinge on the plastic sheath surrounding the needle when the wings are brought towards each other. The needle is gripped by the inner surface of the sheath which is distorted by the wedges. This structure requires that the wings be brought towards each other in the right direction or the needle will not be gripped. Using devices of the prior art, practitioners and nurses tend to bring the wings towards each other in the wrong direction. There is therefore a need to provide an incentive to practitioners and nurses to bring the wings towards each other in the right direction to ensure that the needle is gripped properly.

The invention is a winged catheter introducer set having means for ensuring that the wings are brought toward each other in the right direction so that the needle is properly gripped during the catheter introduction process. The invention comprises a tube having a first internal lumen and a cannula for introduction into a blood vessel. The cannula has a second internal lumen. An intermediate member is disposed between the cannula and the tube such that the first and second lumens are in fluid communication. A needle having a sharp tip is disposed lengthwise in the first and second lumens and within the intermediate member.

The intermediate member has a pair of wings attached to it, substantially on opposite sides of the intermediate member. The needle is gripped by gripping means actuable by bringing the wings towards each other. Doing so causes the wings to squeeze the intermediate member which thus grips the needle.

The wings extend outwards from the intermediate member and define an angle between each other. The angle is less than 180 degrees so that the user of the device is provided with an incentive to grip the wings and bring them towards each other in the correct direction.

FIG. 1 is a perspective view of the invention;

FIG. 2 is a plan view of the invention;

FIG. 3 is side view of the needle of the invention;

FIG. 4 is a reverse plan view of the intermediate member of the invention;

FIG. 5 is a front view of the invention;

FIG. 5a is a sectional view through section 5a--5a' of FIG. 2; and,

FIG. 6 is a detailed sectional view through section 5a--5a'.

FIG. 6a is an enlarged partial detailed sectional view through section 5a--5a'.

Shown in FIG. 1 is the catheter introducer set 2 of the present invention. Catheter introducer set 2 is made up of a hollow elongate member 4 which is in turn made up of three members: first tube 6, cannula 10 and intermediate member 8. During normal use, first tube 6 is proximal to the medical practitioner or nurse and cannula 10 is distal of the practitioner or nurse. First tube 6 is made of a transparent medical grade flexible polyvinyl chloride tubing having a durometer hardness in a range of approximately 60-80 Shore A and available from Natvar Company. Preferably Natvar 660 having a hardness of 70 Shore A is used. First tube 6 is insert molded to intermediate member 8 as indicated by dotted area 9 (see FIG. 2). Intermediate member 8 is molded from polyurethane having a durometer hardness of approximately 80 Shore A. Such material is available from Dow Chemicals under the name Pellethane.RTM. 2363-80A. Intermediate member may be made of polyurethane having a durometer hardness in a range of approximately 60 to 95 Shore A. The precise durometer hardness of the polyurethane is not crucial.

The choice of the polyurethane material described above provides certain benefits. Among other advantages discussed herein, it provides good bond strength between the intermediate member 8 and first tube 6 and cannula 10, thus making insert molding of the device feasible. It also provides cost savings over materials of the prior art.

Intermediate member 8 includes a substantially cylindrical section 12. Attached to the substantially cylindrical section 12 is a pair of wings 14, 14', the function of which will be described presently. First tube 6 and cannula 10 respectively have bores 6b and 10b which are in fluid communication (via bore 8b of intermediate member 8) and generally coaxial with each other. The term "bore" is taken to encompass a lumen.

Attached to intermediate member 8 by insert molding is cannula 10. Cannula 10 is an intravenous catheter tube preferably made of a polyurethane material and tip configuration as described in U.S. Pat. No. 4,588,398 which is incorporated herein by reference. The catheter tube is intended for insertion into a patient's blood vessel. Alternatively second member many be made of Teflon.RTM.. Proximal end 11 of second member 10 (indicated by dotted line in FIG. 2) is partially covered by cylindrical section 12.

Needle 16 is slidably mounted in bores 6b, 8b and 10b. Needle 16 itself has lumen 17 defined by cylindrical wall 44 (see FIG. 5a). When needle 16 lies in bores 6b, 8b and 10b, an annular space 30 is formed between bores 6b, 8b and 10b and cylindrical wall 44 of needle 16. Needle 16 has a sharpened end 34 for piercing the skin and a blood vessel of a patient to assist in the introduction of at least part of second member 10 into the vessel. At the end of needle 16 opposite to sharp end 34 finger grip 19 is provided to assist in the manipulation of needle 16.

As shown in FIG. 3, needle 16 is conceptually divided into regions 36, 38 and 40 which respectively spatially correspond to first, intermediate and second members 6, 8 and 10 of hollow elongate member 4 when needle 16 is placed longitudinally in bores 6b and 10b. This is shown by the juxtaposition of FIGS. 2 and 3.

In region 36 wall 44 is provided with a first notch-like opening 18 which permits fluid to flow from lumen 17 into annular space 30 when needle 16 is placed lengthwise in hollow elongate member 4. Located in region 40 is a second notch-like opening 19 in wall 44 which also permits fluid to flow from lumen 17 into annular space 30 when needle 16 is in hollow elongate member 4.

Wings 14, 14' and intermediate member 8 will now be described in greater detail. Intermediate member 8 is made up of substantially cylindrical member 12 with a portion of enlarged diameter 50 for accommodating first member 6 which is insert molded into substantially cylindrical member 12.

Wings 14, 14' are integrally molded with intermediate member 8 and are oriented at an angle .alpha. to each other. Wings 14, 14' are respectively substantially on opposite sides of intermediate member 8. Angle .alpha. is approximately 170 degrees. The purpose of choosing .alpha. to be less than 180 degrees is to provide an incentive for the user to grip wings 14, 14' and bring them together in the direction indicated by arrows A and A'. As will be seen, it is important to the proper operation of the device that wings 14, 14' be bent in the right direction. The "pre-bend" of angle .alpha. assists in ensuring that the nurse or practitioner bends the wings in the direction of arrows A, A'.

Wings 14, 14' have surfaces 14a, 14a' which are provided with generally wedge-shaped ramps 52, 52' which have surfaces 52a, 52a' adjacent substantially cylindrical member 12. Ramps 52, 52' slope upwards from the outer ends 14a, 14a' of wings 14, 14' to the inner ends 14b, 14b' of wings 14, 14' which are adjacent substantially cylindrical member 12. When wings 14, 14' are brought towards each other in the direction of arrows A, A', as shown in FIG. 6 surfaces 52a, 52a' touch outer walls 54a, 54a' of substantially cylindrical member 12. Further bending of wings 14, 14' in the direction of arrows A, A' causes ramps 52, 52' to squeeze substantially cylindrical member 12. The squeezing of member 12 causes inner surface 42 of intermediate member 8 to touch and thus grip needle 16.

The gripping of needle 16 is enhanced by the provision of slot 13 in member 12. Slot 13 is molded into member 8. The effect of slot 13 is to provide an area of member 12 with a reduced wall thickness which facilitates the squeezing of member 12. This enhanced squeezing causes needle 16 to be gripped more effectively than it would be in the absence of slot 13. The gripping of needle 16 is shown more clearly in FIGS. 6 and 6a. In FIG. 6 it can be seen that slot distorts when wings 14, 14' are brought towards each other in the direction of arrows A, A'. This phenomenon is more clearly seen in FIG. 6a which also shows the gripping of needle 16 by inner surface 42.

To enhance the gripping of needle 16 further, ramps 52, 52' are provided with ribs 53, 53' which lie between surfaces 52a and outer wall 12a of member 12. Ribs 53, 53' are integrally molded with member 12. They extend from surfaces 52a, 52a' towards slot 13, terminating at walls 13a, 13a' of slot 13. Ribs 53, 53' assist in the squeezing of member 12 by transmitting force from surfaces 52a, 52a' to walls 13a, 13a' of slot 13. It will be recognized that intermediate member will not effectively grip needle 16 if wings 14, 14' are not bent in the direction of arrows A, A'.

In addition to the improved gripping provided by the geometry described above, gripping of the needle is further enhanced by the choice of the material of intermediate member 8. The polyurethane described above has properties of "stickiness" which improve the grip between needle 16 and inner surface 42 of intermediate member 10. Using that material obviates the need to roughen needle wall 44 to enhance gripping.

Needle 16 assists in the introduction of the catheter tube of second member 10 into a blood vessel. Sharp end 34 pierces the skin and the vessel to make a puncture hole through which catheter tube 10 can enter the vessel. Since catheter tube 10 is made of a soft material, it needs the assistance of needle 16 if it is to be introduced into the vessel. The gripping of needle 16 by wings 14, 14a' enables catheter tube 10 to be held relative to needle 16 and hence enables it to be introduced into the vessel when needle 16 penetrates the vessel. In order to avoid damaging the vessel, needle 16 is withdrawn from the vessel and the soft catheter tube 10 remains. Needle 16 is withdrawn by simply releasing wings 14, 14' so that surfaces 52a, 52a' no longer grip substantially cylindrical member 12 and hence needle 16. Once wings are released, needle 16 is withdrawn by pulling finger grip 19. Wings 14, 14' can be used to secure the device to the skin of the patient by taping or suturing wings to the skin. Suture holes 15, 15' are provided on wings 14, 14' to facilitate suturing.

It will be noted that when needle 16 is gripped the annular space 30 which is between substantially cylindrical member 12 and needle 16 is constricted (see FIG. 6a). Thus, fluid flow in annular space 30 is inhibited. In order to determine whether needle 16 has penetrated a blood vessel as opposed to muscle or other tissue, it is necessary to observe whether blood has entered lumen 17 of needle 16 when needle 16 is inserted into the patient. The blood pressure in the vessel will cause blood to be forced up lumen 17 of needle 16 if needle 16 penetrates a blood vessel. If no blood or a very small amount has entered lumen 17, it is unlikely that a vessel has been pierced. If blood enters lumen 17, the vessel has probably been penetrated. Thus it is necessary to provide means for observing blood entering needle 16. When needle 16 penetrates the vessel, blood will flow through first opening 19 and into annular space 30. Since annular space 30 is constricted during insertion of needle 16 into the vessel due to the bending of wings 14, 14', blood cannot be observed flowing though annular space 30 from second member 10 into first member 6. To solve this problem, second opening 18 is provided in first region 36. Second opening 18 provides a fluid path from lumen 17 of needle 16 to annular space 30 in the vicinity of member 6. Thus, on penetration of the vessel by needle 16, blood is able to flow up lumen 17 and through openings 18 and 19. Blood can be observed in tube 6 because it is translucent.

The foregoing description is of the preferred embodiment of the invention. It is intended to exemplify the invention and not to limit it. The scope of the invention is to be determined by the appended claims and their equivalents.