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Publication numberUS3782383 A
Publication typeGrant
Publication dateJan 1, 1974
Filing dateMar 6, 1973
Priority dateMar 6, 1973
Publication numberUS 3782383 A, US 3782383A, US-A-3782383, US3782383 A, US3782383A
InventorsT Thompson, J Center, P Stocton
Original AssigneeVicra Sterile Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Winged infusion holding device with thermoplastic elastomeric body
US 3782383 A
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.
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Description  (OCR text may contain errors)

iliiited States Patent Thompson et a1. Jan. 1, 1974 1 WINGED INFUSION HOLDING DEVICE 3,064,648 11/1962 Bujan 128/214 R WITH THE O ELASTOMERIC 3,538,915 11/1970 Frampton..... 128/214 R BODY 3,640,275 2/1972 Burke et a]. 128/214 R 3,651,807 3/1972 Huggins 128/221 [75] Inventors: Thomas C. Thompson; John L. 3,661,693 5/1972 Pierson 24/255 X Center, both of Dallas, Tex.; Paul M. Stocton, Clarendon Hills, 111. [73] Assignee: Vicra Sterile, Inc., Dallas, Tex. jy zigi a ggs 3 2 32 Medbery [22] Filed: Mar. 6, 1973 Appl. No.: 338,424

Related US. Application Data Continuation of Ser. No. 184,555, Sept. 28, 1971, abandoned.

U.S. Cl 128/214, 24/355 A, 128/133, 128/221, 128/346 Int. Cl. A6lm 5/00, A61m 5/32 Field of Search 128/133, 214, 221, 128/214.2, 214.4, 215, 346; 24/137, 255 A, 255 R References Cited UNITED STATES PATENTS Hamilton 128/221 [57] 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.

14 Claims, 11 Drawing Figures PAIENTED AH'H 3.782.383

I I6 34 l 22 v FIG. 3-

WINGEI) INFUSION HOLDING DEVICE WITH THERMOPLASTIC ELASTOMERIC BODY This is a continuation of application Ser. No. 184,555, filed Sept. 28, 1971, now abandoned.

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 patients body when in place. Preferably, a needle once inserted will lie nearly tangential to a patients 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 patients 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 por tion, 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 taken along section line 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 conventionalinjection 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 US. Pat. No. 3,265,765, to Holden et A preferred TON, 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 is flat so that it can lie substantially flat upon the exterior of a patients 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 l2 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 l2 and 14 to flex near the hub 16. This feature of the invention prevents outward bowing near the midpoints of the wings l2 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 ID. the same or slightly less than the CD. 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 l-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.v When inserting the needle 18 into a patient, the bottom surfaces of the wings l2 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 l2 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 ID. about the same or slightly less than the CD. 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 ID. 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 00- polymer 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 patients body. Similar selfadhering 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 presents an effective alternative to that described in conjunction with FIG. 3.

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 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.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2989053 *Jan 17, 1956Jun 20, 1961Baxter Don IncHypodermic needle
US3064648 *Apr 16, 1958Nov 20, 1962Abbott LabIntravenous needle assembly
US3538915 *Sep 12, 1968Nov 10, 1970Deseret PharmaInfustion device and method
US3640275 *May 5, 1970Feb 8, 1972Burron Medical Prod IncIntravenous needle assembly
US3651807 *Feb 19, 1970Mar 28, 1972Huggins James ADetachable, hollow guide needle
US3661693 *Aug 18, 1969May 9, 1972Environmental Structures IncReinforced seam for sheet material
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3901226 *Mar 29, 1974Aug 26, 1975Anthony ScardenzanProtective guard for a hypodermic needle
US3973565 *Jul 5, 1974Aug 10, 1976Everett Medical Products LimitedWinged cannula with skin securing means
US4129128 *Feb 23, 1977Dec 12, 1978Mcfarlane Richard HSecuring device for catheter placement assembly
US4165748 *Nov 7, 1977Aug 28, 1979Johnson Melissa CCatheter tube holder
US4192305 *Aug 21, 1978Mar 11, 1980Abbott LaboratoriesCatheter placement assembly having axial and rotational alignment means
US4192306 *Aug 21, 1978Mar 11, 1980Abbott LaboratoriesCatheter placement assembly having axial and rotational alignment means
US4261363 *Nov 9, 1979Apr 14, 1981C. R. Bard, Inc.Retention clips for body fluid drains
US4324236 *Dec 3, 1979Apr 13, 1982Whitman Medical Corp.Fitting for use in performing a vascular puncture
US4353369 *Jan 17, 1980Oct 12, 1982Abbott LaboratoriesVenipuncture device
US4362156 *Apr 18, 1979Dec 7, 1982Riverain CorporationIntravenous infusion assembly
US4539003 *Jan 24, 1983Sep 3, 1985Tucker Annabelle DAngio-catheter/infusion tubing lock
US4838867 *Aug 18, 1987Jun 13, 1989Glenda G. KaltUniversal clamp
US4838878 *Mar 23, 1987Jun 13, 1989Glenda G. KaltUniversal clamp
US4838880 *Aug 20, 1987Jun 13, 1989Nifco, Inc.Plastic inserter
US4919654 *Aug 3, 1988Apr 24, 1990Kalt Medical CorporationIV clamp with membrane
US4966590 *Dec 13, 1988Oct 30, 1990Kalt Medical CorporationIV Clamp with membrane dressing
US5037397 *Jun 13, 1989Aug 6, 1991Medical Distributors, Inc.Universal clamp
US5088982 *Oct 13, 1988Feb 18, 1992Ryan Medical, Inc.Safety winged needle medical devices
US5147322 *Nov 26, 1991Sep 15, 1992Highpoint Medical CorporationMedical appliance securing device
US5154699 *Jul 11, 1990Oct 13, 1992Ryan Medical, Inc.Safety winged needle device for use with fistulas
US5304146 *Oct 23, 1992Apr 19, 1994Johnson Melissa CMedical appliance securing device
US5308339 *Oct 5, 1992May 3, 1994Medical Distributors, Inc.Universal clamp
US5354281 *Mar 25, 1994Oct 11, 1994Chen Shih ShuanSafety disposable infusion set
US5795335 *Feb 26, 1997Aug 18, 1998Zinreich; Eva S.Intravenous tube restraint and cover device
US6197006 *Oct 10, 1994Mar 6, 2001Ernst Sigurd Gustaf Folke WiklundSyringe handle
US6358230 *Sep 29, 1998Mar 19, 2002Scimed Life Systems, Inc.Percutaneous catheter with slip hub
US6709428 *May 25, 2001Mar 23, 2004Baxter International, Inc.Needle design and manufacturing method for medical applications
US7070579 *Apr 30, 1998Jul 4, 2006Medtronic, Inc.Device used to connect an external ventricular drainage catheter
US7988673Jul 14, 2005Aug 2, 2011Venetec International, Inc.Protective dressing and methods of use thereof
US8162890 *May 6, 2007Apr 24, 2012Flexicath Ltd.Catheter insertion apparatus and method of use thereof
US8197447 *Apr 19, 2005Jun 12, 2012Venetec International, Inc.Flexible IV site protector
US8269059Aug 2, 2011Sep 18, 2012Venetec International, Inc.Protective dressing and methods of use thereof
US8357124Mar 17, 2006Jan 22, 2013Venetec International, Inc.Catheter securement device
US8465458Aug 25, 2011Jun 18, 2013Venetec International, Inc.Insertion site protection device
US8496862Jan 15, 2009Jul 30, 2013West Pharmaceutical Services, Inc.Collet mechanism and method of molding cannula to a syringe barrel
US8613728Nov 6, 2006Dec 24, 2013Flexicath Ltd.Removable adapter for a splittable introducer and method of use thereof
US8636701Apr 22, 2010Jan 28, 2014Venetec International, Inc.Medical article securement system
US8657791Aug 22, 2006Feb 25, 2014Venetec International, Inc.Catheter securement device
US20090054845 *Apr 11, 2007Feb 26, 2009Arne PuhasmagiCatheter tubing, catheter, and catheter assembly
DE19543313A1 *Nov 21, 1995Jun 5, 1997Saueressig UlrichSafety cannula for use in dialysis
DE19543313C2 *Nov 21, 1995Jul 22, 1999Saueressig UlrichSicherheitskanüle
EP0166742A1 *Nov 8, 1984Jan 8, 1986KAMEN, Dean L.Catheter stabilization pad
EP0253990A2 *May 23, 1987Jan 27, 1988Saueressig, Ulrich, Dr. med.Intravenous cannula
WO1981001518A1 *Nov 3, 1980Jun 11, 1981Whitman Med CorpFitting for use in performing a vascular puncture
WO2007052278A2 *Nov 6, 2006May 10, 2007Flexicath LtdA removable adapter for a splittable introducer and method of use thereof
Classifications
U.S. Classification604/177, 128/DIG.240, 24/545
International ClassificationA61M25/06
Cooperative ClassificationA61M25/0637, Y10S128/24
European ClassificationA61M25/06D3