US3215141A

US3215141A - Intravenous catheter apparatus

Info

Publication number: US3215141A
Application number: US255741A
Authority: US
Inventors: Fred W Podhora
Original assignee: Individual
Current assignee: Individual
Priority date: 1963-02-04
Filing date: 1963-02-04
Publication date: 1965-11-02
Anticipated expiration: 1982-11-02
Also published as: GB1043805A

Description

Nov. 2, 1965 F. w. PODHORA 3,215,141

INTRAVENOUS CATHETER APPARATUS Filed Feb. 4, 1963 FRED D. PODHORA lNVE/VTOR.

BUG/(HORN, BLORE, KLAROU/ST 8 SPAR/(MAN ATTORNEYS United States Patent 3,215 141 INTRAVENOUS CATI IETER APPARATUS Fred W. Podhora, 7429 SW. 59th Ave., Portland, Oreg. Filed Feb. 4, 1963, Ser. No. 255,741 4 Claims. (Cl. 128214) The present invention relates to apparatus for intravenous introduction of a fluid in a patient and more particularly to apparatus for introducing a catheter into vein of a patient for use in intravenous introduction of fluid to such vein.

As it is now well known, an injection or an infusion of liquids such as blood, saline solutions, and other materials into a vein of a patient is in many cases extremely helpful and, in fact, sometimes necessary to the successful recovery of the patient. Until recently the injection or infusion was accomplished by inserting a hollow needle having a relatively large lumen into the vein or other portion of the body into which liquid was to be infused or injected and connecting a liquid conduit to the needle so as to effect the infusion of the liquid into the vein through the needle. A use of a needle in this manner is not desirable in several aspects. First the arm or portion of the body in which the needle is inserted must be immobilized during the period of transfusion or infusion to make certain that no relative movement between the needle and the patients body occurs since the sharp edges of the needle might cause trauma to the vessel walls, or the puncture of the vessel wall and unnecessarily injure the patient. Furthermore, it may be necessary to make periodic infusions over a long period of time and the presence of the needle, if left in the body, is irritating to the patient and, of course, creates a possibility of injury if left within the patients arm. Accordingly, attempts recently have been made to develop techniques wherein a catheter of plastic or similar material is inserted through a vein puncturing needle into the vessel into which the infusion is to be made and the needle removed from the opening and immobilized at some remote position leaving the catheter in place.

It is an object of the present invention to provide new and improved apparatus of the latter type.

More particularly, it is an object of the present invention to provide a new and improved apparatus for introducing a catheter into a vein in which the needle can be immobilized with greater assurance that no injury will occur to the patient.

Still another object of the invention is to provide a catheter apparatus of the class described in which the catheter is of improved configuration so as to minimize possible trauma to the vessel wall during the insertion of the catheter in a body vessel.

A further object of the invention is to provide an infusion apparatus to the type described which can be manipulated easily to insert the catheter into the vessel of a patient and which does not require the use of sterile gloves or hand scrubbing by the operator prior to the use of the device.

Still another object of the invention is to provide apparatus of the class described which is of simplified construction and which may be manufactured easily at a relatively low cost.

Still another object of the invention is to provide a catheter apparatus which will minimize any possibility of air embolism upon the attachment of an infusion apparatus to the catheter and the start of an injection of fluid into a patient.

Still other objects and advantages of the invention will become more apparent hereinafter.

For more detailed description of the invention reference is made to the following drawings wherein:

FIG. 1 is a longitudinal sectional view of apparatus made in accordance with the invention;

3,215,141 Patented Nov. 2, 1965 FIG. 2 is an enlarged cross-sectional view taken along line 2-2 of FIG. 1;

FIG. 3 is an enlarged fragmentary view of the end of a catheter made in accordance with the invention;

FIG. 4 is an enlarged sectional view of a portion of the apparatus of the invention;

FIG. 5 is another view of the apparatus shown in FIG. 4 showing it in another condition of operation;

FIG. 6 is a sectional view taken along line 66 of FIG. 4;

FIG. 7 is an enlarged sectional view taken along line 77 of FIG. 1;

FIG. 8 is a fragmentary perspective view showing the operation of the apparatus in making a venipuncture;

FIG. 9 is a perspective view showing the manner of use of the apparatus in making an infusion; and

FIG. 10 is a fragmentary perspective view, partly in section, of the apparatus of the invention showing a step in the preparation of the apparatus for making an infusion.

Referring now to the drawings and more particularly to FIG. 1, the apparatus of the invention includes an elongate hollow needle 20 of uniform inner and outer diameter throughout its length, the needle having a proximal end 22 provided with a sharpened edge for making a venipuncture. The distal end of the needle 20 is slipfitted into a counterbore 24 formed in the proximal end of a tubular needle holder 26 which is preferably formed of a semirigid plastic material such as molded polyethylene or vinyl. The counterbore 24 defines a shoulder 28 against which the distal end of the needle 20 engages. The distal end of the needle holder 26 is provided with an enlarged opening 30 of predetermined diameter, the purpose for which will be described subsequently. The portion of the needle holder adjacent the proximal end is of relatively small diameter while the portion of the needle holder adjacent the distal end thereof is of larger diameter, both portions preferably tapering slightly towards the proximal end, the overall length of the needle holder being about twice the diameter of the larger portion. 'As best seen in FIG. 10, the outer edge of the distal end of the needle holder is provided with a generous radius. Slip-fitted over the larger end of the needle holder 26 is a sleeve 36 also of a semirigid plastic material such as molded polyethylene or vinyl. The sleeve 36 is provided with a shallow counterbore in its proximal end defining a shoulder 38 against which the end of the needle holder 30 engages. A slight flat 39 (FIG. 2) is provided on the wall of the counterbore to assure a snug fit of the needle holder 26 within the counterbore. The proximal end of the sleeve 36 is provided with an outwardly protruding flange 40 and the opposite end of the sleeve is preferably beveled on its inner surface as indicated at 41.

Bonded to the outer surface of the sleeve 36 by heat fusing or suitable adhesive is an elongate sac 42 of poly ethylene or vinyl or other suitable transparent plastic material which is relatively permeable to ethylene oxide or other like sterilizing medium. An adhesive tape 43 may be wrapped about the sac 42 to protect the bond and which tape may be color coded to indicate the needle size or other information. The opposite end of the sac 42 is provided with a closure seal 44.

Disposed Within the sac 42 and the needle 20 is a catheter 46 which may be formed of polyethylene or vinyl plastic or other suitable material. In the initial condition of the assembled apparatus of the invention the catheter 46 is positioned with one end thereof within the lumen of the needle 20, the body of the catheter being loosely disposed within the sac 42. This end of the catheter is preferably tapered, as shown in FIG. 3 at 47, and free of any sharp edges. Tapering is accomplished by inserting the end of the catheter into a heated conical die and rotating the die relative to the catheter whereupon the heat softened plastic will conform to the die convergence and any rough edges will flow and round off because of the surface tension effect. Fixedly secured to the opposite end of the catheter is a tubular adapter member 50 of a semi-rigid plastic material such as molded polyethylene or vinyl.

Referring to FIGS. 4 and 5, the adapter member 50 includes a proximal portion 52 formed with an opening 54 of sufiicient diameter snugly to receive the catheter 46. The intermediate portion 56 of the adapter member is of slightly larger diameter and is formed with an opening 58 of larger diameter than the opening 54, the end of the opening 53 adjacent the opening 54 being provided with a conically tapered portion 60. The end of the catheter 46 extends into the opening 58 and is flared against the conical portion 60 so that the tube 46 cannot be pulled forwardly from the adapter member 50.

The distal end of the adapter member 50 is provided with an inwardly tapered opening 64 that defines a shoulder 66 with the wall defining the opening 58. Adapted to fit within the opening 64 is a plug 68 having a body 70 tapered complementarily to the opennig 64. The plug is formed with a circumferential rib 72 which is adapted to engage with a circumferential groove 74 in the wall of the opening 64 before the plug is fully seated in the opening 64, the maximum diameter of the rib being slightly less than the maximum diameter of the recess. The inner wall of the opening 64 is preferably provided with a protuberance 75 to urge the rib on the opposite side of the plug into the groove 74. The protuberance is of narrow width so as to cause a space 76 to be provided between the walls of the plug and the opening as shown in FIGS. 4 and 6, so that a passage for air between the wall of the adapter and the plug body is provided when the plug is in this position. The plug 70 is, however, adapted to be further inserted into the opening 64 as shown in FIG. 5, the elasticity of the Walls of the adapter member permitted inward movement of the plug. In the inward position of the plug the rib 72 is in snug engagement with the wall of the recess 64 so as to provide a circumferential seal between the plug and the adapter member 50 to prevent the escape of any fluid matter from the interior of the adapter member.

Preferably a tubular guard 80 is provided over the needle 20, the guard having a hub 82 which is slip-fitted upon the end portion 24 of the needle holder 26.

The proximal end of the guard 80 is reduced in diameter and the opening 83 through such end is of a diameter slightly less than the diameter of the needle 20 to prevent the needle from protruding outwardly of the sleeve in the event any accidental movement should cause disengagement of the needle 20 from the needle holder 24. Also, the guard 80 is provided with a plurality of inwardly projecting radial elements 84 (FIG. 7) which are spaced from one another so as to provide a space for a gas passage therebetween, but which meet at the center of the guard so as to provide a stop and prevent any accidental extension of the catheter 46 outwardly of the guard.

Enclosing all of the elements described heretofore is an outer envelope or sac 90 which also is preferably formed of a transparent, gas permeable, pliant, plastic material such as polyethylene or vinyl. The end of the sac 90 adjacent the needle guard 80 is provided with a complete transverse seal. The opposite end is likewise provided with a transverse seal, but which is interrupted by a multi-strand, loose, cotton wick 92, the purpose of which will be described. The thickness of both the sac 42 and sac 90 is exaggerated for ease of illustration, the actual thickness of both being only about 0.005" to 0.010.

In assembling the apparatus shown in FIG. 1 the catheter 46 is inserted through the opening 54 and partially into the opening 58 of the adapter member 50 and the end of the catheter tube expanded by pressing a heated expanding tool against the end of the tube, to cause the same to spread outwardly against the conical wall as shown in FIG. 4. Thereafter the plug 68 is positioned in the adapter with the rib 72 within the recess 74. The catheter and adapter member 50 are then inserted into the sac 42 which has previously been secured in position upon the sleeve 36. The needle 20 and needle holder 26 are then assembled and the needle holder inserted into the sleeve 36 at the same time manipulating the proximal end of the catheter 46 so that it is guided into the lumen of the needle 20. The needle guard is then positioned over the needle and this assembly positioned Within the envelope which is then sealed. This entire apparatus can then be placed within an autoclave for sterilization.

In the sterilizing procedure the autoclave is evacuated to about 28 mm. of mercury and the temperature raised to about F. with the relative humidity maintained at about 40 percent. This stimulates anerobic bacteria and makes them vulnerable to ethylene oxide. After a predetermined period of time ethylene oxide (mixed with 80 percent carbon dioxide) is introduced into the autoclave and the pressure raised to about 33 p.s.i. The ethylene oxide will, of course, penetrate the sac 90 through the wall thereof, but the wick 92 also facilitates passage of the gas into the sac. Likewise, some ethylene oxide will pass through the Wall of the sac 42, but the passage through the end of the needle guard will permit gas to flow rapidly into the interior of the needle and catheter which are of course substantially evacuated during the previous step. After a predetermined period of time the pressure in the autoclave is reduced to atmospheric pressure. It is during the initial evacuation and final pressure reduction that the wick 92 plays a most important function in providing a passage for the relatively rapid escape of gas from the sac 90. Unless the gas is bled from the sac at a relatively rapid rate so as to minimize the pressure differential as the autoclave pressure drops, the sac 90 is likely to rupture. The diffusion rate through the envelope wall is so slow as to require an inordinatey long .and uneconomic period to bleed gas in this manner at a safe rate. The wick 92, on the other hand, permits the autoclave pressure to be dropped rapidly.

When the apparatus is to be used the envelope 90 is opened as by cutting off one end and stripped off the enclosed apparatus. The needle guard 80 is next removed from the needle 20 and a venipuncture in a patients arm made by forcing the needle 20 through the arm of the patient and into a vein 91 in the customary manner and is indicated in FIG. 8. Of course, the usual customary precautions are taken to sterilize the area of the patients arm prior to thrusting the needle therethrough. The sleeve 36 is then grasped with one hand and the catheter 46 grasped with the other hand through the sac 42 and pushed through the needle 20 into the vein 91 of the patient. The catheter can be pushed any desired distance into the vein. The tapered and rounded end 47 of the catheter minimizes the possibility of trauma of the wall of the vein as is likely to occur with the sharp and jagged edges remaining after the catheter is severed by a knife or other instrument from a longer length of tubing. When the catheter 46 is properly positioned, a sterile pledget is placed over the puncture in the patients arm and with digital pressure applied to the arm above the position of the catheter within the vein to hold it in place, the needle 20 is withdrawn from the vein by grasping the sleeve 36 and applying withdrawal pressure. The catheter is then secured in place on the arm with adhesive tape 94 immediately adjacent the point of insertion, see FIG. 9. Thereafter the needle holder 24 is grasped in one hand and the sleeve 30 in the other, and the sleeve rotated lengthwise, as indicated by the arrow in FIG. 10, so as to remove the sleeve from the needle holder 26. As will 75 be apparent, the fact that the diameter of the needle holder is no greater than the depth of penetration of the needle holder into the sleeve 36 facilitates the removal of the sleeve as does the provision of the gently rounded edge on the distal end of the needle holder. Of course, it is necessary the respective elements be of semirigid material to permit deflection to effect removal in this manner. Removal of the sleeve 36 from the needle holder 26 in this manner also prevents any accidental withdrawal of the needle from the holder as might occur if movement purely in the axial direction were attempted. Furthermore, it the needle should be moved longitudinally of the catheter at this point, there is a possibility that the sharp edge of the needle would cut or scarify the surface of the catheter. After removal of the sleeve 36 from the needle holder the sleeve and sac 42 can be discarded. The bevel 41 on the distal end of the sleeve 36 minimizes any possibility of the sleeve catching upon the adapter member 50 as the sleeve is drawn over the adapter member.

Thereafter the needle is firmly grasped and the needle holder 26 moved axially relative to the needle so as to remove the needle holder from the needle. The needle can then be immobilized on the patients arm by securing the needle in place with a strip 95 of adhesive tape, as indicated at 98 in FIG. 9. Preferably a piece of tape 99 is positioned on the patients arm beneath the point of the needle so as to prevent any possibility of injury to the patient from the needle. If desired, a piece of tape can be wrapped about the needle point and the catheter to prevent any movement of the catheter relative to the needle and thus further assure against cutting of the catheter. A strip of tape 100 is also positioned over the catheter immediately above the needle so that the catheter and needle are held in immobile position upon the patients arm. The needle holder 24 can be then slipped up the catheter and engaged on the proximal end 52 of the adapter member 50.

In the insertion of the needle 20 and the catheter 46 into the patients vein the pressure of the blood within the vein will force the blood into the needle and up the catheter 46. The loose engagement of the plug 68 is important in this regard since it permits the escape of air from the catheter so that blood may completely fill the catheter and the cavity within the adapter mem- 'ber 50. When all of the air has been forced out of the catheter 46 and adapter member 50 the plug 68 can be moved inwardly to the position shown in FIG. 5 to seal the adapter and prevent further escape of blood. It may be necessary to do this before steps to secure the needle in place on the arm are completed.

Finally, the plug 68 may be removed from the adapter and a fitting 102 of an infusion set inserted into the adapter opening 64 so that the transfusion or injection of other fluid into the patient may commence. Filling of the catheter 46 and adapter 50 with blood is important of course to prevent any possibility of air embolism.

It will be apparent that the sac 42 protects the catheter 46 and adapter member 50 from contamination during insertion of the needle and manipulation of the catheter to insert it into a vein. The guard 80 protects the needle 20, of course, until the guard is removed. Thus, with reasonable precautions the needle 20 may be inserted and catheter made ready for infusion without the necessity of the operator scrubbing or using sterile gloves since there is no need for the operator to touch any part that must remain sterile.

The fact that the needle 20 is of uniform outer diameter throughout its length is important in that it permits the needle to lie flatly along the patients arm, thus to minimize any possibility of penetration of the needle into the arm, as may result from movement by the patient. Furthermore, the needle may be maintained in axially parallel relation with the catheter so that accidental cutting of the catheter is not likely to occur.

The catheter 46 may be left in place in the patients vein between transfusions or infusions of fluid. When introductionof fluid in a particular sequence is completed, the infusion set can be disconnected from the adapter 50 and the plug 68, or another similar sterile plug, may be reinserted in place and pushed into sealing position as shown in FIG. 5 so as to prevent any loss of blood or contamination of the interior of the catheter between infusions.

Having illustrated and described a preferred embodiment of the invention it should be apparent to those skilled in the art that the invention permits of modification in arrangement and detail. I claim as my invention all such modifications as come within the true spirit and scope of the appended claims.

What is claimed is:

1. Apparatus for use in intravenous introduction of a fluid comprising,

an elongate hollow needle of uniform inner and outer diameter throughout its length,

one end of said needle being formed to provide a sharpened edge for making a venipuncture,

a tubular needle holder removably mounted upon the opposite end of said needle,

a sleeve fitted over said needle holder,

a pliable sac secured at one end to the outer surface of said sleeve and extending rearwardly therefrom, the opposite end of said sac being sealed,

and a flexible catheter positioned within said sac with one end within said needle and extendable outwardly of said one needle end by manipulation through said sac, the uniform outer diameter of the said needle permitting the same to be positioned flatly against a patients body after withdrawal of the needle from the venipuncture and removal of said needle holder from said needle.

2. Apparatus for use in intravenous introduction of a fluid comprising,

a tubular needle holder removably mounted upon the opposite end of said needle,

said needle holder having a counterbore in one end thereof snugly receiving said needle and defining a shoulder against which said needle is seated,

a sleeve having a counter bore in one end slidably receiving said needle holder,

a pliable sac fixedly secured at one end to the outer surface of said sleeve and extending rearwardly therefrom, the opposite end of said sac being sealed,

and a flexible catheter positioned within said sac with one end within said needle and extendable outwardly of said one needle end by manipulation through said sac, the uniform outer diameter of the said needle permitting the same'to be positioned flatly against a patients body after withdrawal of the needle from the venipuncture and removal of said needle holder from said needle.

3. Apparatus for use in intravenous introduction of a fluid comprising,

a tubular needle holder having a proximal and a distal end removably mounted upon the opposite end of said needle said needle holder having a counterbore in said proximal end snugly receiving said needle and defining a shoulder against which said needle is seated,

said needle holder including a first portion adjacent said proximal end of relatively small external diameter and a second portion adjacent the distal end of relatively larger diameter,

a sleeve having a proximal and a distal end and a counter bore in said proximal end'slidably receiving said distal end of said needle holder,

said sleeve counter bore defining a shoulder spaced from said sleeve proximal end by a distance less than the diameter of said needle holder distal end, whereby said needle holder may be removed from said sleeve by rotating the same relative to one another about an axis transverse to the longitudinal axes of said holder and said sleeve.

a pliable sac fixedly secured at one end to the outer surface of said sleeve and extending rearwardly of the distal end thereof, the opposite end of said sac being sealed,

and a flexible catheter positioned within said sac with one end within said needle and extendable outwardly of said one needle end by manipulation through said sac.

4. Apparatus for use in intravenous introduction of a fluid comprising,

a tubular needle holder of semi-rigid material and having a proximal and a distal end removably mounted upon the opposite end of said needle,

said needle holder having a counter bore in said proximal end thereof snugly receiving said needle and defining a shoulder against which said needle is seated, the distal end of said needle holder having an opening of predetermined larger diameter,

said needle holder including a first portion adjacent said proximal end of relatively small external diameter and a second portion adjacent the distal end of relatively larger diameter, the overall length of said needle holder being substantially twice said larger diameter,

a sleeve of semi-rigid material having a proximal and a distal end and having a counter bore in said proximal end slidably receiving said distal end of said needle holder in a slip fit,

a pliable sac bonded at one end to the outer surface of said sleeve and extending rearwardly of the distal end thereof, the opposite end of said sac being sealed,

a catheter of flexible plastic positioned within said sac with one end within said needle and extendable outwardly of said one needle end by manipulation through said sac,

a said catheter one end being conically tapered to facilitate entry of the same into a vein,

a tubular adapter member of a semi-rigid material fixedly secured at one end thereof to the opposite end of said catheter,

said one end of said adapter member being of an outer diameter snugly to fit within the opening in said needle holder distal end,

the opening in the opposite end of said adapter member being inwardly tapered and having an annular recess in the wall thereof adjacent said opposite end,

a plug of complementary taper inserted in said adapter opening from said opposite end,

said plug having an annular rib adapted to fit within said annular recess,

the maximum diameter of said rib being slightly less than the maximum diameter of said recess and said rib being positioned in said plug so that said rib engages in said recess before said plug is fully seated in said opening whereby air may escape from said catheter through the clearance space between said plug and said adapter member,

and an elongate tubular guard enclosing said needle and detachably secured to said needle holder.

References Cited by the Examiner UNITED STATES PATENTS 2,421,313 5/47 Brandon 215-47 2,731,012 1/56 Henderson 128-215 2,799,272 7/57 Peach 128-221 2,915,063 12/59 Cutter 1282l4 2,947,415 8/60 Garth.

3,017,884 1/62 Doherty et a1 128-214 3,030,953 4/62 Koehn 128221 X 3,055,361 9/62 Ballard 128214 3,084,793 4/63 Pitman 206-632 3,094,122 6/63 Gauthier et a1. 128--221 3,123,211 3/64 Sorenson 20663.2

RICHARD A. GAUDET, Primary Examiner.

JORDAN FRANKLIN, Examiner.

Claims

1. APPARATUS FOR USE IN INTRAVENOUS INTRODUCTION OF A FLUID COMPRISING, AN ELONGATE HOLLOW NEEDLE OF UNIFORM INNER AND OUTER DIAMETER THROUGHOUT ITS LENGTH, ONE END OF SAID NEEDLE BEING FORMED TO PROVIDE A SHARPENED EDGE FOR MAKING A VENIPUNCTURE, A TUBULAR NEEDLE HOLDER REMOVABLY MOUNTED UPON THE OPPOSITE END OF SAID NEEDLE, A SLEEVE FITTED OVER SAID NEEDLE HOLDER, A PLIABLE SAC SECURED AT ONE END TO THE OUTER SURFACE OF SAID SLEEVE AND EXTENDING REARWARDLY THEREFROM, THE OPPOSITE END OF SAID SAC BEING SEALED, AND A FLEXIBLE CATHETER POSITIONED WITHIN SAID SAC WITH ONE END WITHIN SAID NEEDLE AND EXTENDABLE OUT-