WO1991000116A1

WO1991000116A1 - Protective sheath for use in an intravenous assembly

Info

Publication number: WO1991000116A1
Application number: PCT/US1990/003217
Authority: WO
Inventors: Elliot Kornberg; William R. Tarello
Original assignee: Pascall Medical Corporation
Priority date: 1989-06-27
Filing date: 1990-06-07
Publication date: 1991-01-10

Abstract

A protective apparatus for use with an intravenous system and especially an implanted intravenous needle assembly or a Y-junction of a piggy back intravenous system. The protective apparatus includes a protective sheath having an open end and a second end suitable for connection with a fluid introduction source. The sheath includes a slot along its lowest surface and can include a needle extending within a hollow interior defined by the sheath. The sheath features two curved runner sections or a pair of wing-shaped runners which extend from a channel section defining a portion of the slot. The curved runner sections and wing-shaped runners allow for easy insertion of a needle into a taped receptive port of an implanted intravenous needle assembly. An alternate embodiment features two slits with or without an additional channel/elongated aperture combination. The two slits allow for easy insertion of a needle into a taped receptive port while the channel/elongated aperture combination allows for use of the protective sheath with a Y-junction of an intravenous system. An additional embodiment features a needle assembly with protective guard that can be easily connected within the interior of the protective sheath.

Description

PROTECTIVE SHEATH FOR USE IN AN INTRAVENOUS

ASSEMBLY

BACKGROUND OF THE INVENTION (I) FIELD OF THE INVENTION

This invention relates to a protective shield for protection against needle contamination and accidental needle puncture. More particularly, this invention relates to a protective shield for protection against a needle which is inserted into an implanted intravenous cannula assembly or an auxiliary branch of a piggy back intravenous system.

(II) BACKGROUND DISCUSSION

Intravenous systems are commonly used in treating patients with highly contagious diseases such as AIDS and hepatitis. The intravenous systems frequently include an implanted cannula assembly which, when the intravenous system is used on a human, is inserted in the upper surface of the hand or in some other convenient location. The implanted cannula assembly usually includes a flexible conduit extending below the skin together with a reception port above the surface of the skin. The reception port provides a location at which a fluid introduction device, such as a syringe or the end of an intravenous tube, is attached. The reception port is designed for easy removal of the intravenous tube so as to free the intravenous source from the patient for the purposes of providing a heparin flush, changing the intravenous fluid, easy movement of the patient, etc.

In the situations where a cannula is inserted in the reception port to inject a fluid

(e.g. a heparin flush), the operator is subjected to the possibility of being stuck by the cannula needle as it is being manipulated for insertion into the reception port. There is also the chance of being stuck by a cannula when removing or replacing the cannula. Thus, medical personnel and, as is becoming more common today, family members in the case of home therapy and the like treating outpatients are susceptible to being stuck and being infected. Also, even if medical personnel or those people assisting outpatients are not infected, expensive tests and regulatory reports are required each time a person is stuck just to determine and record whether or not that person has been infected. The intravenous tubing systems commonly used today also frequently include a piggy-back arrangement which comprises a fluid line connected to a patient at one end and to a bag or bottle of the opposite end. A Y-site or y-junction is placed or formed in the fluid line. The Y-junction includes an auxiliary branch which is either connected to an auxiliary line and intravenous fluid source or, alternatively, provides a location for the injection of fluid with a syringe. In utilizing such intravenous tubing systems, it is often required that a person helping the patient insert a needle into the auxiliary branch or remove a needle previously inserted. The person, removing the needle from the auxiliary branch or inserting the needle, is placed in jeopardy of being stuck or contaminated by coming into contact with an infected needle. Also, medical personnel and the like are susceptible to being stuck during the various disposal stages of the needle.

SUMMARY OF THE INVENTION The present invention is directed at providing, among other things, a protective shield which protects people from becoming contaminated by a cannula or needle being inserted or removed from both an implanted cannula assembly or an auxiliary branch of a piggy back intravenous system. The present invention is well suited for adaptation with implanted cannula systems. The present invention avoids the restrictive nature of some of the prior art needle covering devices. Moreover, the present invention provides after use protection to assist in avoiding contact during the disposal of the syringe. In achieving the above advantages over the prior art, the present invention features a first embodiment of the protective apparatus designed for use with an implanted intravenous cannula assembly. The protective apparatus includes a protective sheath preferably formed of an essentially transparent plastic material of the polyolefin family such as polycarbonate or a more flexible material such as polypropelene, polyethylene, etc. The protective sheath comprises an upper portion, a lower portion, a connecting end, a hollow interior and an open end. The sheath is elongated and generally cylindrical. The dimensions of the protective sheath are such that the sheath can be inserted over the free end of the implanted intravenous cannula assembly. In a preferred embodiment, a cannula is attached at one end within a recess formed in the cylindrical extension of the connecting means. The free end of the cannula extends towards the open end of the protective sheath so as to be positioned within the hollow interior of the protective sheath. Preferably the cannula extends for about 40-75% of the entire length of the sheath.

The cannula is preferably integrally connected to the connecting means such that the protective sheath surrounds and protects one from coming into contact with the pointed end of the cannula. The open end of the main body is also dimensioned so as to enable one to insert the protective sheath over the auxiliary branch extension of the intravenous system such that the cannula can be inserted into the receptive port forming part of the auxiliary branch.

The key-hole shaped slot formed in the protective sheath is dimensioned such that the protective sheath can be slid past the main line by aligning the channel with the main line and forcing the main line through the channel and into the aperture formed at the end of the channel. The channel is preferably dimensioned such that at least a section thereof has a width which is slightly less than the diameter of the main line. The aperture is dimensioned so as to have a transverse width which is essentially the same or slightly larger than the circumference of the main line.

In a preferred embodiment, a protective sheath is formed of a flexible material such that when the main line slides through the channel, the protective sheath deforms and then snaps back into place once the main line is received within the aperture formed at the end of the channel. In this way the main line is releasably locked within the aperture and the snapping function also helps in letting the operator know that the protective sheath and cannula are in the proper position.

Alternatively, the protective sheath can be formed of a relatively stiff material and the fluid line itself can provide the greater degree of deformation so as to releasably lock the line within the elongated aperture forming part of the slot.

Another embodiment of the present invention_^includes a protective sheath having an upper section, a lower section and two slits extending_/longitudinally between the upper and lower sections. The slits are arranged so as to receive therein tent-shaped strips of tapes when the protective sheath is being inserted over the reception port of an implanted intravenous cannula assembly. The slits are designed to have smoothly curving open edges and, in a preferred embodiment, tapering inlet sections.

To provide for use with an auxiliary branch, one of the slits in the above described embodiment is widened to have a width which is greater than the oppositely positioned slit. Also, the widened slit can be formed so as to have a channel section which opens into an elongated aperture similar to the embodiments described above. Alternatively, a channel and aperture can be formed in addition to the pair of opposed slits. The channel and aperture combination provides for easy insertion over an auxiliary branch of a Y- junσtion. Also, the channel and aperture combination helps in enabling the user to look through and visually determine the proper alignment of the slits into which the tape strips are inserted when the device is used with an implanted intravenous cannula assembly. Moreover, the added channel/aperture combination can itself be used in combination with one of the slits to provide a location where the tent-shaped portion of the tape is to be inserted.

Connection means, formed at the ends of each of the above-described protective sheaths, includes a cup-shaped member with a tapered port or recess for locking engagement with a fluid insertion device. The connection means further includes a projection member having a recess which receives one end of a cannula in fixed relationship.

The preferred manner of securing the connecting means to the protective sheath includes (1) ultrasonically welding the tapering exterior of the cup shaped member to a neck extension formed at one end of the protective sheath, (2) ultrasonically welding the neck extension to the projection member attached to the cannula, and (3) forming the cup- shaped member, projection member and protective sheath as a single integrally molded article. In the latter arrangement the cannula can be insert molded with respect to a recess provided in the projection member and/or adhered to the projection member. The cup shaped member with flange is preferably formed so as to provide a luer lock arrangement with the article that is being secured to the protective sheath. Yet another embodiment of the present invention features a cannula assembly comprising a flanged hub and a cannula secured to the hub and extending out away from the hub. The interior of the protective sheath is provided with locking grooves to receive the flanged hub. Also, the projection member, forming part of the connecting means, includes a tapering extension which is tapered so as to be received by a tapering recess formed in the hub. The cannula assembly is thus releasably and yet securely retained by the combination of (1) the projection member extending into the hub recess and (2) the hub flange received by the locking grooves.

A protective guard is also provided to make it easier for insertion of the needle into locking position. The protective guard represents an elongated cigar shaped member which is releasably attached at its one open end to the hub of the cannula assembly. For example, longitudinal grooves can be formed in the hub exterior and complimentary projections enable a twisting action as well as longitudinal separation.

In operation, the protective guard with attached hub assembly is inserted into the open end of the protective sheath and, through a twisting action, the cannula assembly is fixed in place with respect to the protective sheath. The protective guard is then disconnected form the cannula assembly by drawing the guard away from the fixed cannula assembly. The protective sheaths described in the above embodiments is preferably formed of a material within the family of polyolefins such as polycarbonate or other suitable plastics which are somewhat flexible. For the purposes of this invention, polycarbonate has proven most suitable as it is well adapted to maintaining its transparency after being sterilized by ultraviolet rays.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1A shows a side view of a first embodiment of the present invention having wing sections for smooth insertion over tape holding down an implanted cannula; Fig. IB shows a partial cross-sectional view and partial bottom view taken along line B-B in Fig. 1A;

Fig. 1C shows a bottom view of the embodiment in Fig. 1A; Fig. ID shows a front view of the embodiment in Fig. 1A;

Fig. IE shows the protective sheath just prior to being in operative position with respect to an implanted cannula; Fig. IF shows a frontal view of the protective sheath positioned over tape holding an implanted cannula in position;

Fig. 1G shows the connection means and neck extension of the present invention just prior to being secured to one another;

Fig. 1H shows the positioning of the connecting means and neck extension after being ultrasonically welded to one another;

Fig. 2 shows a side view of another embodiment of the present invention having smoothly tapering curved runners for ease of insertion over tape strips;

Fig. 3 illustrates a cross-sectional view taken along line A-A in Fig. 2; Fig. 4 shows the embodiment of Fig. 2

Positioned over an implanted intravenous cannula assembly and in connection with a syringe.

Figs. 5A and 5B show the relationship between runner sections of the embodiment in Fig. 2 and the underlying tape surface as the embodiment is placed into the position shown in Fig. 4;

Fig. 6 illustrates a view looking into the open end of the embodiment in Fig. 2 as well as the arrangement of the runners with respect to the underlying tape surface.

Fig. 7 shows a perspective view of a cut¬ away portion of the embodiment in Fig. 2;

Fig. 8 shows a prior art intravenous Y- junction;

Fig. 9 shows one embodiment of the present invention in position over an intravenous Y-junction;

Fig. 10 shows a bottom view of another embodiment of the present invention; Fig. 11 shows a cross-sectional view of that which is shown in Fig. 10;

Fig. 12 shows the embodiment having wing sections in operating position on an intravenous piggy back system; and Fig. 13 shows a prior art illustration of an intravenous system attached to a patient;

Fig. 14 shows another embodiment of the present invention just prior to insertion over the reception port of an implanted intravenous cannula assembly;

Fig. 14A shows a perspective view of the embodiment of Fig. 14;

Fig. 14B shows the embodiment of Fig. 14 in position over a tent-shaped tape strip; Fig. 14C shows the embodiment of Fig. 14 with a cannula;

Fig. 14D shows the embodiment of Fig. 14 with one of the slits modified;

Fig. 15 shows, in cut away, a cannula assembly with web extension forming part of a projection member supporting the cannula;

Fig. 16A shows a partially cut away cross- sectional view of the cannula assembly depicted in Fig. 15 in position with a neck extension of a protective sheath;

Fig. 16B shows in greater detail the ultrasonic weld holding the webs of the cannula assembly to the neck extension;

Fig. 17 shows the embodiment of Fig. 14 with one of the slits widened;

Fig. 18 shows the embodiment of Fig. 17 in perspective; Fig. 19A shows another embodiment of the present invention just prior to insertion over the reception port of an implanted intravenous cannula assembly;

Fig. 19B shows the protective sheath of Fig. 19A in position over the tape strips holding the reception port in position;

Fig. 19C shows a planar view taken along line B-B in Fig. 19E of the protective sheath shown in Fig. 19A; Fig. 19D shows a side view taken along line A-A in Fig. 19E of the protective sheath shown in Fig. 19A;

Fig. 19E shows a front view taken along line C-C in Fig 19C of the protective sheath shown in Fig. 19A;

Fig. 20 shows a cross-sectional view of a protective sheath which is integrally molded with the connecting means;

Fig. 21A shows a cross-sectional view of an alternate embodiment of the present invention which is suited for receipt of a releasable locking cannula assembly;

Fig. 21B shows a releasable locking cannula assembly covered by a protective guard; Fig. 21C shows a casing for holding a protective sheath, guard and cannula prior to use;

Fig. 21D shows in cross-section the cannula assembly and protective guard in locked position; and Fig. 21E shows the cannula assembly in locked position with the protective guard removed.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Fig. 13 depicts a prior art piggy back intravenous system 10 being used in the treatment of patient 12. Piggy back intravenous system 10 features st d 14 supporting main fluid source 16 as well as auxiliary fluid source 18. A main line 20 extends from main fluid source 16 down towards Y- junction 22. Auxiliary line 24 extends down from its point of connection with auxiliary fluid source 18. At the end of auxiliary line 24 is positioned a needle or cannula 26 (Fig. 8) having at its end needle hub 28. As shown in Fig. 8, needle hub 28 is secured to adaptor 30 forming part of auxiliary line 24. Y-junction 22 is comprised of auxiliary branch 32 and main branch 34 which come together at a point above mixed fluid line 36. Mixed fluid line 36 has cannula 38 imbedded in the upper surface of the patient's hand and taped in position. Fig. 8 further shows auxiliary branch 32 having cup 39 through which needle 26 is inserted with cup 29 providing a sealing function. A person removing or inserting needle 26 or

38 is faced with the possibility of becoming contaminated by being stuck or scratched by the needle.

Fig. 1A shows, in side view, a first embodiment of the present invention featuring protective apparatus 200 which comprises protective sheath 202 and connecting means 204 secured to connecting end 206 of sheath 202.

Generally straight line edge sections 226 and 228 are shown in Fig. lC. Channel 224 opens at one end into aperture 230 which has a transverse width slightly iarger than the transverse width of channel 224 such that an intravenous fluid line which is slid along channel 224 becomes releasably locked in place within aperture 230. This arrangement is described in greater detail below .

At the opposite end of channel 224 is a pair of wing sections 232 which are preferably formed by injection molding or by folding portions of sheath 202 at the end region of slot 220 outwardly in a manner which provides a pair of smooth, planar runner surfaces 234. Planar runner surfaces 234 preferably have a width which is about 1.5 to 4 times the average thickness of sheath 202 and more preferably 2 times the average thickness.

Fig. IE show protective apparatus 200 immediately prior to being placed into operative position with respect to an implanted cannula 256 held in position with tape strips 258. As illustrated, cannula 252 is received within a receptive port forming part of implanted cannula assembly 256. Syringe 260 is connected at its forward end to connecting means 204 and the combination is slid into position over tape 258.

Fig. IF shows how runners 234 easily slide over the tent portion 262 of tape strip 258 that holds in place implanted cannula assembly 256. The smooth, planar surface 234 is adapted to slide over tape strip 258 without disrupting strip 258 from its adhesive position on skin surface 264.

Fig. 12, and in greater detail Fig. 9, show protective sheath 200 in its subordinate use as a protective shield for use with an intravenous tubing system. As shown, fluid introduction device 270, which typically is a syringe or the end of an auxiliary line, is attached at the connecting end of protective apparatus 200. As shown in Fig. 9, elongated aperture 230 (Fig. lC) receives fluid line 272 and the channel section 224, which opens into aperture 230, has a smaller width than the diameter of line 272 such that deformation of the sheath and/or fluid line occurs during passage of fluid line 272 in channel 224.

Fig. 2 shows a second embodiment of the present invention featuring protective apparatus 50 having protective sheath 52 and connecting means 54 secured to the connecting end 56 of sheath 52.

Fig. 3 shows slot 57 formed in a lower portion of protective sheath 52. Slot 57 extends from open end 62 of protective sheath 52 inwardly towards connecting end 56. Slot 57 is defined by edge 63 which defines curved sections 58, 60, planar sides 59, 61 defining channel 66, and edge section 65 defining elongated aperture 68. Elongated aperture 68 preferably extends for about 25 to 35% of the entire length of the sheath.

Fig. 7 shows a perspective view of the open end 62 of protective sheath 52. Fig. 7 also illustrates curved sections 58, 60 defining a portion of slot 57. Curved sections 58, 60 are shown to be in mirror image arrangement equally spaced about center line 90. Curved sections 58, 60 feature a smooth, planar edge surface which provide protective sheath 52 with sleigh-like runners extending from the open end back towards the connecting end of the protective sheath. The planar edge surface defining curved sections 58, 60 are arranged transverse to view line V representing a line of sight extending directly into the open end of protective sheath 52. Fig. 4 illustrates protective sheath 52 being placed into operating position with respect to implanted intravenous cannula assembly 92 featuring flexible cannula 94 implanted under the patient's skin as well as tape sections 96. Intravenous cannula assembly 92 further comprises extension conduit 98 having receiving port member 100 attached to it. Protective sheath 52 is also shown in Fig. 4 to be connected with a syringe 102. Fig. 6 further illustrates the manner in which the runners as well as the remainder of the slot provide for a smooth transition over the tent-shaped section 102 of the portion of tape 96 extending about conduit 98. Fig. 6 further illustrates planar contact areas 104, 106 which exist between runners 58, 60 and tape 96. The embodiment shown in Fig. 2 can be inserted over the auxiliary branch of an intravenous Y-junction in a manner similar to that which is shown in Fig. 9 for the first embodiment. In a position such as that shown in Fig. 9, protective sheath 52 protects a person from being stuck by a cannula upon insertion or removal of the cannula into the auxiliary branch. Protective sheath 52 would be connected with a fluid insertion device which could include a syringe or the distal end of an intravenous tube connected to an auxiliary fluid source of the piggy back intravenous system in securing the cannula into the auxiliary branch of a Y-junction, the slot 57 is aligned such that channel sides 59, 61 are laterally spaced about the main line of the intravenous tube system. The width of the channel is preferably made less that the diameter of the main line such that, when the protective sheath 52 is pushed over the auxiliary branch, the main line slides along channel 66 while deforming sides 59, 61 until the main line is received within elongated aperture 68 and sides 59, 61 snap back into their non-deformed position. The sliding arrangement between the main line and channel 66 also helps to ensure proper insertion of cannula 84 into auxiliary 108.

Figs. 10 and 11 illustrate a third embodiment of the invention particularly suited for protecting a person inserting or removing a cannula into/from an auxiliary branch of an intravenous system's Y-junction. Protective sheath 114 is provided with a keyhole-shaped slot 116 having channel 118 defined by side edges 120. Aperture 122 is formed in protective sheath 114 so as to open into the end of channel 118 which is closest to connecting end 124. Protective sheath 114 includes edge section 124 defining open end 126. The cannula and connecting means arrangement described for the first embodiment is preferably the same for the third embodiment and thus, further description is not required. Moreover, the channel 118 and aperture 122 are dimensioned in a manner similar to that described for the first and second embodiments wherein channel 118 has a width less than the main line of an intravenous system and aperture 122 has a transverse width which is the same or siightly larger than the main lines. With this arrangement, the main line is releasably locked within aperture 122 following insertion of the main line through channel 118.

Forming the sheath of a flexible material provides for deformation of the channel during the sliding through of the main line and the sheath is adapted to snap back into place following placement of the main line in aperture 122.

Fig. 14 shows an additional embodiment of the present invention in position for insertion over reception port 302 of implanted cannula assembly 304. The embodiment of Fig. 14 features protective sheath 306. Protective sheath 306, as shown in Fig. 14 and 14A, features a pair of slits, 308, 310 extending for over a third or more of the length of main body 312 of protective sheath and more preferably for about 45 to 55% of the length of main body 312 or about 40 to 50% of the entire length of protective sheath 306.

Neck extension 314 and main body 312 combine together in forming protective sheath 306. Protective sheath 306 further includes curved inlet portions 316, 316' and 318, 318' which combine together to facilitate insertion of tape strips 320. Fig. 14B illustrates tent-shaped tape portion 322 in position within slits 308, 310.

Fig. 14C illustrates cannula 324 and its position with respect to protective sheath 306. Fig. 14D illustrates a modification of the embodiment of Fig. 14A wherein one of the opposed slits includes an elongated aperture 326 in combination with a channel section 328 which together facilitates use of protective sheath 306 at a y-site of an intravenous system.

Figs. 15, 16A and 16B illustrate the ultrasonic welding of cannula assembly 330 within neck extension 314. As shown, cannula assembly 330 includes cannula 324, projection member 332, webs 334 and hub 336. Hub 336 includes flange extension 337 as shown in Fig. 16A. Flange extension 337 provides the male component of a luer lock assembly. Raised section 338 of neck extension 314 comes together with webs 334 so as to provide contacting surfaces for forming ultrasonic weld 240.

Figs. 17 and 18 show protective sheath 306 with a modified slit 308' and "normal" slit 310. Modified slit 308' is made wider than slit 310 so as to facilitate use of protective sheath 306 at a Y- site of an intravenous system. Preferably, width x is about .2 to .3 of an inch and width Y is about 1/8 of an inch.

Fig. 19A reveals another modification of sheath 306 wherein, in addition to slits 308 and 310, there is provided elongated aperture 342 and channel 344. Aperture 342 and channel 344 help the user align the two slits on to the tape strip by enhancing visibility. Fig. 19A further illustrates protective sheath 306 just prior to being inserted over implanted cannula assembly 304. Fig. 19B illustrates tape sections 320 having been inserted into slits 308 and 310.

Fig. 19C illustrates, in planar view, protective sheath 306 having channel 344 and elongated aperture 342. Fig. 19C also shows channel 344 having curved inlet sections 346 and 348 which are useful upon insertion of the tape strips within channel 344 and one of the two slits 308 and 310 as opposed to only between slits 308 and 310. Channel 344 and elongated aperture 342 combine to represent about 45 to 55% of the length of the main body of protective sheath 306 and more preferably about 50% with the ratio of aperture length to channel length being from about 1:1 to 1.5:1. The slits extend inwardly for about the same length as that described for the channel and aperture combination.

Fig. 19D shows a side view of the embodiment shown in Fig. 19C wherein slits 308 and 310 are modified to include tapered sections 350 extending from curved inlet sections 352, 354. The angle of incline of tapered sections 350 is represented by Z which is preferably about 6 to 10%. Fig. 19E shows a front view of the open end of protective sheath 306. The positioning of the slits 308 and 310 is preferably within the range of 90°C to 120°C from verticle center line 360 as represented by Fig. 20 shows an alternate embodiment of the present invention with protective sheath 362 being integrally molded with connecting means 364. Connecting means 364 includes cup-shaped member 366 with female recess 368 for receiving the male counterpart of a fluid insertion device (not shown). Flange 370 also forms part of connecting means 364 and provides a locking function with respect to the male counterpart of a fluid insertion device. Connecting means 364 further includes stepped projection member 372 extending into the hollow interior of sheath 362. Cannula 374 can be insert molded, adhered or a combination of both into a recess provided in stepped projection member 372. Fig 21A shows an alternate embodiment of the present invention featuring protective sheath 380 having recess groove 382 formed on the interior surface os sheath 380. Connecting means 384 includes a cup-shaped member with tapered recess 386 and flange 388 so as to provide the male component of luer lock arrangement. Extending inwardly into the hollow interior of sheath 380 is tapered projection member 390.

Fig. 21B shows cannula assembly 392 having cannula 394, hub 396 and flange 398.

Protective guard 400 is inserted over cannula 394 and is releasably connected at its open end to hub 396.

Fig. 21C shows packaging 402 for holding a protective sheath 380, cannula assembly 392, and guard 400. Package 402 can include a molded stiff plastic body with a clear plastic seal thereover.

Fig. 21D reveals the locking arrangement between sheath 380, cannula assembly 392 and protective guard 400. As shown, flange 398 is releasably locked in position within groove 382 by twisting action of guard 400 and the attached cannula assembly 392. Tapered projection member 390 is arranged so as to frictionally come in contact with the surface defining the tapered recess formed in hub 396.

The combination of flange 398 in groove 382 and projection member 390 within hub 396 ensures a secure, sealed fit between cannula assembly 392 and sheath 380. When the protective sheath and attached cannula assembly are to be utilized, protective guard 400 can be removed by drawing it out away from the open end of sheath 380. Fig. 21E depicts having cannula assembly 392 in operating position and protective guard 400 remove. hile the device and method of the present invention have been described with regard to certain embodiments and exemplifications thereof, further variations thereof will be apparent to those skilled in the art and are intended to be encompassed by the claims appended hereto. For example, the inclusion of planar strips attached at their midsection and in a perpendicular relationship to the sleigh-like runners to enhance the sliding surface is a contemplated modification of the present invention (see Fig. 6, 300) .

Claims

WHAT IS CLAIMED IS:

1. A protective apparatus for use in an intravenous system having an auxiliary branch, comprising: a protective sheath having a first end, a hollow interior, and an open end, said hollow interior being dimensioned so as to receive therein the auxiliary branch of the intravenous system, and said protective sheath having a slot formed therein which includes a channel and an aperture opening into said channel, and said channel being dimensioned to include at least one channel section having a width less that the diameter of a line forming part of the intravenous system, and said aperture having a width equal to or greater than the diameter of the line such that the line is releasably retained in said aperture when the channel section is forced past the line of the intravenous system and the line is received within the aperture formed in said protective sheath.

2. A protective apparatus as recited in claim 1, wherein said protective sheath is formed of a material of sufficient flexibility such that the portion of said protective sheath defining the channel is deformed while the line is inserted along said channel, and snaps back into position when the line is inserted entirely through the channel and into said aperture.

3. A protective apparatus as recited in claim 1, further comprising connection means, positioned at said first end of said sheath, for securing said protective apparatus to a fluid insertion device, said connections means including a cup-shaped member having a tapered recess and a flange extending about one end of said cup-shaped member, said connection means further including an extension member extending off of the other end of said cup-shaped member and said protective sheath including a neck extension dimensioned so as to receive said extension member.

4. A protective apparatus as recited in Claim 3, further comprising a needle assembly having a needle with a free end positioned within the hollow interior of said sheath and a second end fixedly secured to said connection means.

5. A protective apparatus as recited in Claim 4 wherein said connection means is integrally molded with said protective sheath.

6. A protective apparatus as recited in Claim 3 further comprising a needle assembly secured to said connection means and extending within said hollow interior, and the interior of said protective sheath includes a locking groove and said needle assembly includes a hub with a flanged end lockingly receivable within said locking groove, said connection means having an inwardly converging extension member and said hub having a converging recess which are dimensioned and arranged such that, when said hub flange is lockingly received within said locking groove, said inwardly converging extension member is contained within the converging recess of said hub.

7. A protective apparatus as recited in Claim 6 further comprising a protective guard having εecure ent means for releasably securing said protective guard in position over said needle.

8. A protective apparatus as recited in

Claim 3 wherein said protective apparatus includes an ultra-sonic weld between said cup-shaped member and said neck extension.

9. A protective apparatus as recited in Claim 1 wherein said aperture is elongated.

10. A protective apparatus for use in an intravenous system, comprising: a protective sheath having a central axis, an upper portion, a lower portion, a first end, a hollow interior and an open end, said sheath having a slot formed therein and an edge defining the slot, said edge including a pair of curved sections originating at the upper portion and extending on opposite sides of the central axis downwardly to said lower portion and towards said first end of said sheath, and said edge further defining a channel region that extends in essentially planar fashion from the lowermost portion of said pair of curved sections further towards the first end of said sheath.

11. A protective apparatus as recited in Claim 10 further comprising connecting means at said first end of said protective sheath and a needle assembly secured to connection means and extending within said hollow interior, and the interior surface of said protective sheath includes a locking groove and said needle assembly includes a needle and a hub having a flanged end lockingly receivable within said locking groove, said connection means having an inwardly converging extension member and said hub having a converging recess which are dimensioned and arranged such that, when said hub flange is lockingly received within said locking groove, the converging extension member is contained within the converging recess of said hub.

12. A protective apparatus as recited in Claim 11 further comprising a protective guard having securement means for releasably securing said protective guard in position over said needle.

13. A protective apparatus for protection against being stuck by a needle, comprising: a protective sheath having an upper portion, a lower portion, a first end, a hollow interior and an open end, said sheath also including a slot formed in the lower portion of said sheath, said slot including a channel section with a first and second end, and said protective sheath including a pair of wing-shaped runners each originating at the first end of said channel and extending to the open end of said sheath, and said runners each including a planar surface.

14. A protective apparatus as recited in Claim 13, further comprising a needle extending into the hollow interior of said protective sheath, said needle having free end which extends to a position between the first and second ends of said channel.

15. A protective apparatus as recited in Claim 13 wherein said slot extends for more than a third of the length of said protective sheath.

16. A protective apparatus as recited in Claim 13 further comprising a needle assembly secured to said connection means and extending within said hollow interior, and the interior of said protective sheath includes a locking groove and said needle assembly includes a needle and a hub having a flanged end lockingly receivable within said locking groove, said connection means having a converging extension member and said hub having a converging recess such that when said hub flange is lockingly received within said locking groove, said converging extension member is in contained within the converging recess of said hub.

17. A protective apparatus as recited in

Claim 16 further comprising a protective guard having securement means for releasably securing said protective guard in position over said needle.

18. A protective apparatus for use in an intravenous system, comprising: a protective sheath having an upper portion, a lower portion, a first end, a hollow interior, and an open end, said upper and lower portions being separated by a pair of slits formed in said protective sheath, said slits originating at said open end and extending towards said first end for at least a third of the length between said open end and said first end.

19. A protective apparatus as recited in Claim 18, wherein said slits extend for about 40 to 55% of the length between said open end and said first end.

20. A protective apparatus as recited in

Claim 18, further comprising an elongated slot extending from said open end toward said first end over at least a third of the length between said open end and said first end.

21. A protective apparatus as recited in

Claim 20 wherein said elongated slot includes a straight channel section originating at said open end and extending towards said first end, and said slot further including an aperture having a width larger than said channel, said aperture opening into said channel and extending toward said first end.

22. A protective apparatus as recited in Claim 20, wherein said slot extends for about 40 to 55% of the length between said open end and said first end.

23. A protective apparatus as recited in Claim 18, wherein said slits each include a pair of curved front end sections which taper inwardly toward one another to form a tapering inlet.

24. A protective apparatus as recited in

Claim 23 wherein one of said pair of slits includes an elongated aperture which extends away from said tapering inlet and has a width which is greater than the width of the narrowest portion of said tapering inlet.

25. A protective apparatus as recited in Claim 18 wherein said protective sheath is generally cylindrical in shape and said slits have a center point which is from 90° to 120° from a vertical center line.

26. A protective apparatus as recite din Claim 18, further comprising connecting means positioned at said first end of said sheath and a needle having a free end positioned within said hollow interior and a second end secured to said connecting means.

27. A protective apparatus as recited in Claim 26, wherein said connection means is integrally molded with said protective sheath.

28. A protective apparatus as recited in Claim 26 further comprising a needle assembly secured to said connection means and extending within said hollow interior, and the interior of said protective sheath includes a locking groove and said needle assembly includes a needle and a hub having a flanged end lockingly receivable within said locking groove, said connection means having an inwardly converging extension member and said hub having a converging recess which are dimensioned and arranged such that, when said hub flange is lockingly received within said locking groove, said inwardly converging extension member is contained within the converging recess of said hub.

29. A protective apparatus as recited in Claim 28 further comprising a protective guard having securement means for releasably securing said protective guard in position over said needle, and said protective guard extending out past the open end of said protective sheath when said hub flange is lockingly received within said locking groove.

30. A protective apparatus as recited in Claim 18 wherein one of said slits is wider than the other of said slits.

31. A protective apparatus for use in an intravenous system, comprising: a protective sheath having a first end, an open end, and a hollow interior; connecting means secured to said first end, said connecting means including a positioning member extending into said hollow interior; and a needle assembly which includes a needle having a free end positioned within said hollow interior, said needle assembly including a needle hub with a recess, said recess being adapted to receive said positioning member, and said protective sheath having locking means on an interior surface which receives, in locking fashion, said hub.

32. A protective apparatus as recited in Claim 31 further comprising a protective guard having securement means for releasably securing sid protective guard in position over said needle.

33. A protective apparatus as recited in Claim 31 wherein said positioning member is a converging extension member and said hub includes a converging recess which fits over said converging extension member, said hub further including a flange member and said locking means of said protective sheath including at least one groove adapted to receive said flange member.

34. A protective apparatus as recited in

Claim 31 wherein said protective sheath has a pair of elongated slits formed therein which each extend from the open end toward the first end.

35. A protective apparatus as recited in Claim 31 wherein said protective sheath includes a channel extending from the open end toward said first end and an elongated aperture extending from one end of said channel toward said first end.

36. A protective apparatus for use with an implanted cannula assembly, comprising: a protective sheath having an upper portion, a lower portion, a first end, a hollow interior, and an open end, said upper and lower portions being separated by a pair of slits formed in said protective sheath, said slits originating at said open end and extending towards said first end and said slits being dimensioned so as to receive therein means holding down the implanted cannula.