Winged Infusion Holding Device With Thermoplastic Elastomeric Body

Abstract

An intravenous infusion device includes a first wing member attached to a needle. A flexible conduit for supplying fluid to the needle is connected thereto via an intermediate sleeve of the same material as the conduit. A tiedown wing is removably attached to and movable along the conduit. Both the wing portion attached to the needle and the movable tiedown wing are composed of a synthetic thermoplastic eleastomer, preferably a block copolymer of styrene and butadiene.

Parent Case Text

This is a continuation of application Ser. No. 184,555, filed Sept. 28, 1971, now abandoned.

Description

BACKGROUND OF THE INVENTION

This invention relates to infusion devices and more particularly to intravenous infusion devices including a needle and supply tubing wherein the needle remains in place during infusion.

Infusion devices of the general type to which the present invention pertains are known to the art. A variety of such devices are commercially available. The devices presently available exhibit certain deficiencies. Among the deficiencies are convenient handles for grasping by a physician or technician during insertion procedure. Most prior art devices either have handles which are too rigid or too flexible for simple and accurate insertion. Other devices available are incapable of lying substantially tangential to the surfaces of a patient's body when in place. Preferably, a needle once inserted will lie nearly tangential to a patient's body surface so that it can be easily secured to the body without harming the vein or other tissue into which it has been inserted. A further drawback of prior art devices includes lack of security. For example, if a needle becomes disconnected from a particular insertion handle or becomes disconnected from supply tubing, it can enter a vein and cause serious damage. A still further disadvantage of presently available prior art devices is that they include no convenient means by which to tie down supply tubing. Such prior art devices are presently secured to the patient's body by means of adhesive tape applied over the tubing.

SUMMARY OF THE INVENTION

The problems encountered with prior art devices as enumerated above have been overcome by the present invention. The invention provides an intravenous infusion device comprising a hollow needle having a pointed distal end, a handle including a hub portion connected to the needle between the distal and proximal ends thereof, the handle including two winged portions normally extending sidewardly from the rib portion, the handle composed of a synthetic thermoplastic elastomer, and means attached to the proximal end of the needle for supplying fluid thereto. Another aspect of the present invention provides means for connecting the supply tubing to the needle. Such means includes a first flexible conduit means adhesively connected to the proximal end of the needle and extending a predetermined distance beyond the proximal end of the needle and second conduit means secured to the exterior of the first conduit means. Still another aspect of the invention provides a movable tiedown wing composed of a snythetic thermoplastic elastomer removably connected to the second conduit means.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a pictorial view of the intravenous infusion device of the present invention;

FIG. 2 is a top view of the needle and handle portion of the device of FIG. 1;

FIG. 3 is an enlarged cross-sectional view of FIG. 2 taken along section line 3--3;

FIG. 4 is a view of FIG. 2 taken along section line 4--4;

FIG. 5 is a pictorial view of a partial intravenous insertion of the needle;

FIG. 6 is a front view of the needle and handle wherein the handle has been flexed for insertion;

FIG. 7 is a side view of FIG. 6;

FIG. 8 is a front view of the tiedown wing of the present invention;

FIG. 9 is a front view of the tiedown wing flexed for connection to or removal from supply tubing;

FIG. 10 is an alternative embodiment of the tiedown wing;

FIG. 11 is another embodiment of the invention showing connection of infusion tubing to the handle portion.

DESCRIPTION OF THE INVENTION

The present invention will be described in relation to preferred embodiments thereof. It is to be understood that various alterations, substitutions of equivalents and other changes can be made without departing from the original concept. It is therefore intended that the invention be limited only by the definition contained in the appended claims. Throughout the specification where appropriate for clarity and conciseness like numerals will be utilized to indicate the same or similar structure.

Referring now to FIG. 1, the infusion device of the present invention includes a handle generally designated 10 having two wing portions 12 and 14 extending sidewardly from a central hub portion 16. A needle 18 having a sharpened or pointed distal end 20 extends through the hub portion 16. The proximal end 22 of the needle is connected to infusion fluid supply tubing 24. A suitable coupling 26, such as a luer coupling, is connected to the proximal end of the supply tubing 24. A removable tiedown wing 28 is connected to the tubing 24 between the handle 10 and coupling 26. The tiedown wing 28 can be removed from the tubing 24 and can also be moved in the direction of arrows 31 without removing it from the tubing 24.

Referring now to FIGS. 2, 3 and 4, the handle portion 10 of the infusion device is preferably integrally molded about the needle 18. The handle 10 can be molded by conventional injection molding techniques. The enlarged hub portion 16 of the handle 10 structurally reinforces the channel or hole 32 through which the needle 18 extends. Any suitable surgical or stainless steel can be utilized for the needle 18. The needle 18 contains a roughened portion 34 located within the rib portion 16 which is formed by buffing or grinding that portion of the needle 18 before molding. The roughened portion 34 provides a better frictional bond between the needle 18 and the hub portion 16 of the handle 10. Most preferably, the roughened portion 34 of the needle 18 is also coated with an uncured epoxy cement before molding the handle 10 about the needle. The epoxy cement cures during molding of the handle 10 to provide a secure bond between the needle 18 and handle 10.

The handle 10 is preferably made from a suitable synthetic thermoplastic elastomer of the type disclosed in U.S. Pat. No. 3,265,765, to Holden et al. A preferred thermoplastic elastomer of the type suitable for the present invention is an ordered block copolymer of styrene and butadiene. An exemplary material is available from the Shell Chemical Company, Polymers Division, Houston, Tex., and is sold under the trademark KRATON, type designation 3202-2000. Another such material suitable for use with the present invention is an ordered block copolymer of polystyrene and polyisoprene. These thermoplastic elastomeric materials when utilized with the present invention exhibit particularly suitable and unexpected properties.

It is preferable that the bottom surface 36 (FIG. 4) of the handle 10 is flat so that it can lie substantially flat upon the exterior of a patient's body after the needle 18 has been inserted. The needle is also horizontally located as near the surface 36 as possible. Such location will aid in preventing damage to a blood vessel into which the needle has been inserted.

It will be noted that the juncture of the hub 16 and the wings 12 and 14 of the handle 10 form a relatively sharp angle. Also, the thickness of the winged portions is greater than the thickness of the hub between the needle channel and the bottom of the handle. This feature can best be seen in FIG. 1. This construction combined with the flat bottom 36 (FIG. 6) and the elastomeric composition of the handle 10 allows the wings 12 and 14 to flex near the hub 16. This feature of the invention prevents outward bowing near the midpoints of the wings 12 and 14 when they are flexed for insertion of the needle.

Fluid supply tubing, such as tubing 24, is preferably made of polyvinyl chloride. Cost and flexibility are two major factors involved in this preference. It has been difficult to form heat or adhesive bond between the block copolymer of butadiene and styrene and polyvinyl chloride tubing. Therefore, a recessed portion 30 is provided into which the proximal portion 22 of the needle 18 extends. A sleeve 38 of polyvinyl chloride tubing having an I.D. the same or slightly less than the O.D. of the needle 18 is adhesively secured to the proximal end 22 of the needle 18. Cyanoacrylate adhesives are suitable for this purpose. A preferred adhesive for this purpose is an alkyl cyano acrylate such as 1-methyl cyano acrylate, available from Eastman Kodak, Rochester, N.Y., under their tradename "Eastman 910 EM." The proximal end 40 of sleeve 38 extends a small distance past the proximal end of the needle. This provision serves as protection for the distal end of the supply tubing 24 which is adhesively bonded to the sleeve 38 by a suitable solvent such as a lower aliphatic ketone, for example, methyl ethyl ketone. The proximal end 40 of the sleeve 38 will prevent rupture of the tubing 24 if a sharp bend is caused in the supply tubing 24 near the proximal portion 22 of the needle 18. If no protection were provided by sleeve 38 it would be possible for the proximal portion 22 of the needle 18 to rupture or sever the tubing 24, and, thus, render the tubing unusable.

When inserting the needle 18 into a patient, the bottom surfaces of the wings 12 and 14 can be grasped between a thumb and forefinger as illustrated in FIG. 5. The needle 18 can then readily be inserted through the skin 44 of a patient and into a vein 45 thus readying the device for infusion. In front view, the handle 10 when flexed appears as in FIG. 6 and in side view appears as in FIG. 7. The unique properties of the preferred block copolymer of styrene and butadiene of the present invention allows flexure of the wings 12 and 14 near the hub portion in the manner illustrated without undue flexure at the midpoint 46 of the wings 12 and 14. The material will flex at 48 near the hub member 16 without provision of any weakening or other structure discontinuity in the handle 10. This provides a more secure, more positive acting handle than prior art devices. In addition, the unique properties of the preferred synthetic thermoplastic elastomer tends to eliminate flexure in the direction indicated by arrows 50 in FIG. 7. This enables positive and accurate placement of the needle 18 when inserting the device.

A second aspect of the invention involves a movable and removable tiedown wing 28 shown in FIGS. 8 and 9. In front view, the tiedown wing 28 includes two wing portions 54 and 56 integral with a hub portion 58. A channel 60, having an I.D. about the same or slightly less than the O.D. of the supply tubing 24 (FIG. 1), runs longitudinally through the hub portion 58. The channel 60 communicates longitudinally along its entire length with the bottom surface 62 of the wings 28 via a longitudinal slot 64.

When the lower surfaces of wings 54 and 56 are grasped between a thumb and forefinger and bent upwardly as shown in FIG. 9, the slot 64 will separate sufficiently to permit coupling of the channel 64 with the supply tubing 24, and vice versa will facilitate removal of the tiedown wing 28 from the tubing 24. In addition to opening the slot 64, flexure of the wings 54 and 56 will increase the I.D. of the channel 60. Thus the tiedown wing 28 can be moved longitudinally along tubing 24 as shown in the direction of arrows 31 (FIG. 1) without removal of the wing from the tubing. Most preferably the tiedown wing 28 is composed of the same material as is the handle 10, namely, a block copolymer of styrene and butadiene. The unique properties of that material allows some flexure in the wings 54 and 56 at location 66 and also allow the top of th hub portion 58 to flex, thus cooperating to open the slot 64.

FIG. 10 illustrates an alternate embodiment of the tiedown wing of FIGS 8 and 9. The only difference between the wing shown in FIG. 10 and that shown in FIG. 8 is that the wing 70 in FIG. 10 has an adhesive material 76 attached to the bottom surfaces of wing portions 72 and 74. Any suitable nontoxic adhesive is satisfactory for contacting the bottom surface of wing 70. Smooth removable protective tapes 78 cover the adhesive 76 during the manufacture, transportation and preliminary use. When the infusion needle has been inserted into the patient and the tiedown wing 70 properly positioned along the supply tubing 24 the tapes 78 can be removed, exposing the adhesive 76. Thus, the tiedown wing will be self-adhering when contacted with the exterior of a patient's body. Similar self-adhering adhesives can be used if desired on the needle handle 10.

Another embodiment of the handle 10 is shown in partial cross section in FIG. 11. In this embodiment an integrally molded extension 80 of the handle 10 extends from the proximal end of the hub 16 toward the proximal end of the needle 20. Polyvinyl chloride infusion tubing 82 is joined to the extension 80 with a polyurethane adhesive. To effect a good bond between tubing 82 and extension 80, the extension is first washed with a cleaning solution composed of, for example, 94.5 parts by weight water, 5 parts by weight of a weak aqueous solution of sodium hypochlorite (CLOROX) and 0.5 parts by weight of hydrochloric acid (37 percent by weight aqueous solution). Thereafter, a polyurethane adhesive is applied to the extension 80. The tubing 82 is then filtered over the extension 80. This method for connecting infusion tubing to the thermoplastic elastomeric composition of the handle 10 presents an effective alternative to that described in conjunction with FIG. 3.

Claims

What is claimed is:

1. For use in conjunction with an intravenous infusion device of the type including an elongate, hollow needle having a substantially sharp distal end and adapted for insertion under the skin and into a vein of a patient and a supply tube connected to the proximal end of the needle and adapted to receive a fluid and to direct the fluid through the needle and into the vein of the patient, apparatus for securing the intravenous infusion device to the skin of the patient which comprises:

a holding member for said device having a unitary, molded member including a hub and a pair of wings extending outwardly from the opposite edges of the bottom of the hub and having normally substantially planar bottom surfaces for engagement with the skin of the patient;

said hub having a longitudinally extending passageway formed in it which is characterized by an interior configuration normally substantially congruent with the exterior configuration of a portion of the intravenous infusion device;

said passageway intersecting the plane of the bottom surface of the wings to define a slot which is normally substantially narrower than the passageway when the wings are extended in their skin engaging position;

whereby said wings are adapted to be manually deformed upwardly and inwardly toward the hub to substantially open the slot and thereby permit said portion of the intravenous infusion device to be received in the passageway formed in the hub.

2. The apparatus according to claim 1 wherein the member is molded from a synthetic thermoplastic material.

3. The apparatus according to claim 2 wherein the member is molded from a block copolymer of styrene and butadiene.

4. The apparatus according to claim 1 wherein the member is further characterized by a layer of adhesive on the bottom surface of each wing for use in securing the member to the skin of the patient.

5. The apparatus according to claim 4 wherein the adhesive layers are protected by removable laminating sheets prior to use.

6. An intravenous infusion device comprising:

an elongate, hollow needle having a substantially sharp distal end and a blunt proximal end, and adapted for insertion under the skin and into a vein of a patient;

a holding means for securing the said device to the skin of a patient comprising a first member including a relatively thick hub surrounding and fixedly secured to the needle at a point between the distal and proximal ends thereof and a pair of relatively thin wings extending outwardly from the opposite sides of the hub and having normally coplanar bottom surfaces adapted for engagement with the skin of the patient;

a supply tube connected at one end in fluid communication with the proximal end of the needle and including means at the opposite end for connection to a source of fluid; and

a second securing member including a relatively thick hub having a passageway formed through it characterized by an inside diameter normally substantially equal to the outside diameter of the supply tube and a pair of relatively thin wings extending outwardly from the opposite sides of the hub and having normally coplanar bottom surfaces for engagement with the skin of the patient;

said passageway in the hub of the second member communicating with the bottom surfaces of the wings of the member by means of a slot normally substantially narrower than the outside diameter of the supply tube to provide a hollow means that when the slot is opened to receive the supply tube in response to bending of the wings of the second member upwardly and inwardly toward the hub and is closed to securely clamp the supply tube in the passageway of the hub in response to release of the wing when they are extended substantially flat in their skin engaging position.

7. The intravenous infusion device according to claim 6 wherein the second member comprises a unitary structure molded from a synthetic thermoplastic material.

8. The intravenous infusion device according to claim 7 wherein the second member is molded from a block copolymer of styrene and butadiene.

9. The intravenous infusion device according to claim 6 wherein the second member is further characterized by an adhesive layer formed on the bottom surface of each wing and a protective layer initially overlying each adhesive layer, whereby upon removal of the protective layers the wings of the second member may be adhesively secured to the skin of the patient.

10. Apparatus for securing a tubular member to the skin of a patient comprising:

a hub having a longitudinally extending passageway formed through it;

said passageway in the hub being characterized by an interior configuration substantially congruent to the exterior configuration of a portion of a tubular member;

a pair of wings extending outwardly from the opposite sides of the hub and comprising normally coplanar bottom surfaces for engagement with the skin of the patient; and

said passageway in the hub intersecting the plane of the bottom surfaces of the wings to define a slot which is normally substantially narrower than said portion of the tubular member;

said wings and hub having sufficient resiliency to permit upward and inward bending of the wings to open the slot and thereby facilitate positioning of said portion of the tubular member in the passageway formed in the hub and thereafter to return the wings substantially to the normal outwardly extending patient skin engaging positions thereby closing the slot and clamping said portion of the tubular member in the passageway of the hub.

11. The apparatus according to claim 10 wherein the hub and the wings comprise a unitary structure molded from a synthetic thermoplastic material.

12. The apparatus according to claim 11 wherein the synthetic thermoplastic material comprises a copolymer of styrene and butadiene.

13. The apparatus according to claim 10 further characterized by adhesive layers formed on the bottom surfaces of the wings for adhesively securing the apparatus to the skin of the patient.

14. The apparatus according to claim 13 wherein each adhesive layer is initially protected by a removable, nonadhesive layer.