United States Patent 3561445

A catheter placement unit adapted to advance a catheter in a sterile state comprising a catheter having a hub, a concentric needle and hub, a sheath, and a catheter container adapted to enclose a relatively long catheter and being adapted to advance the catheter from the container through the needle and sheath without exposing the catheter. The container in its preferred form is constructed of two halves which snap together to enclose the catheter, and snap apart to expose the catheter. The halves are relatively rotatable, and one half has two concentric walls, the outer wall providing frictional force on the catheter coiled therein, and causing the catheter to advance from the container when the said half is rotated relative to the remaining half.

Katerndahl, Dean R. (Wheaton, IL)
Earl, Robert P. (La Grange, IL)
Evans, Gary D. (Waukegan, IL)
Chittenden, Richard M. (Grayslake, IL)
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International Classes:
A61M25/01; (IPC1-7): A61M5/00
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Primary Examiner:
Truluck, Dalton L.
We claim

1. In the combination including a needle having a hub with a passage extending entirely through the needle hub; a catheter within the passageway, a portion of the catheter extending from said passage at said hub, said portion of the catheter housed within a container, said container constructed of at least two separable parts, one part constructed as a drum with a cylindrical segment and one closed end, another part constructed as a cover for the end of said cylindrical segment opposed said closed end, said other part having an outlet, said catheter wound on said one part and in frictional engagement with the inner surface of said cylindrical segment whereby rotation of said one part relative to said other part causes said catheter to move through said outlet in response to the frictional engagement between said catheter and the inner surface of said cylindrical segment.

2. The container of claim 1 wherein rotation of said one part relative to said other part results in greater relative movement between said catheter and said other part than between said catheter and said one part.

3. The container of claim 2 wherein there is substantially no relative movement between said catheter and said one part upon relative movement between said one and said other parts comprises a drum which also serves as said first half and which is rotatably connected to said second half.

4. The container of claim 1 wherein said outlet is in direct communication with a needle hub.

5. The container of claim 1 wherein the catheter is provided with a wire stylet enclosed concentrically therein to render the catheter manipulatable.

6. The container of claim 1 wherein said outlet has means to free the catheter upon separation of said one part from said other part.

7. The container of claim 6 wherein said outlet is a tubular member connected tangentially to said other part.

8. The container of claim 6 wherein the means to free the catheter comprises an outlet having a diameter sufficient to pass the catheter.

9. The container of claim 6 wherein the means to free the catheter comprises an outlet having two halves adapted to be longitudinally separated to expose an axial slot of sufficient size to pass the catheter radially out said slot.

This invention broadly relates to devices used to implant catheters in a recipient. More specifically, the invention relates to implanting relative long catheters. Even more specifically, the invention relates to units adapted to store and after incision to advance a long catheter while maintaining the initial sterile condition of the catheter.

Before explaining the exact nature of this invention by reference to specific embodiments thereof, it is desirable to review the factors which prompted the invention. The improvements of the invention may best be appreciated by noting deficiencies in previously used catheter placement units.

Generally, catheters now in use for intravenous applications may be classified as "needle inside" or "needle outside." These classifications result from the provision of a needle concentrically arranged with respect to a catheter which catheter is to be placed in a vein or body cavity. This concentric arrangement has been found quite satisfactory but certain problems of a practical nature are inherent in the arrangement. When a catheter is to be implanted for such operations as transfusions of fluids to the body, it is necessary to provide access to the body-- by using an incising element-- and then to provide a conduit for fluid passage-- by using a hollow tube or catheter. Using a single element as the incising element and conduit is not recommended due to the danger of internal damage when the incising element is left in place and the lack of sterility involved. Accordingly, the concentric arrangement of incising element and conduit resulted. However, in using these devices problems were encountered since the needle used as an incising element is generally required to be long and thin resulting in flexible needles that are hard to control and breakable unless supported intermediate its ends. Additionally, a catheter arranged outside the needle was likely to be contaminated during the incision and a catheter arranged inside the needle was likely to be lost by passing completely through the needle into the vein.

In addition to the above-noted problems common to all catheters, "long" catheters present further problems. Naturally, the longer a catheter is the more susceptible it is to contamination, especially during implanting. Additionally, long catheters were frequently found to become entangled during implanting. This not only requires destroying the sterility by manually untangling it, but also may cause the fluid flow to cease. Special situations such as intravenous pressures measurements, slow transfusions requiring several days, and patients having weak vein structure require the use of long catheters, e.g. 36 inches which are advanced through the patient's veins.

To solve the problems encountered in using needle-inside long catheters the present invention utilizes a container for a coiled length of catheter which container has means to advance the desired length of catheter from the container through the needle and into the recipient without ever exposing that portion of the catheter to be implanted and without danger of entangling the catheter.

It is a primary object of this invention to provide a catheter placement unit adapted to maintain a catheter in a sterile state during implanting operations.

Another object is to provide the described catheter container having means to readily and easily advance a catheter into a patient without manually engaging the catheter.

Still another object is to provide a catheter container which may be discarded after the catheter is implanted to facilitate the connection of extrinsic equipment.

These and other objects and advantages of this invention will become apparent from a consideration of specific embodiments illustrated in the drawings wherein like reference numerals designate like elements and wherein:

FIG. 1 is a side view showing one embodiment of the assembled catheter placement and advancement unit including a catheter container with actuator unit according to this invention;

FIG. 2 is an exploded view in perspective showing the catheter container of FIG. 1;

FIG. 3 is a side view of the sheathed needle with appurtenant needle hub and sheath according to the embodiment of FIG. 1;

FIG. 4 is a side view of the partially unsheathed needle of FIG. 3;

FIG. 5 is a side view of the catheter with appurtenant catheter hub and stylet of FIG. 1;

FIG. 6 is a side view, partly in section, of the catheter implanted in a recipient wherein the catheter hub is engaged with the needle hub and the catheter container has been discarded;

FIG. 7 is a side view, partly in section, of the catheter container of FIG. 1;

FIG. 8 is a side view, partly in section, showing a second embodiment of a catheter container with actuator according to this invention;

FIG. 9 is a side view of a third embodiment of catheter container with actuator according to this invention;

FIG. 10 is an end view of the embodiment of FIG. 9;

FIG. 11 is a side view, partly in section, of the actuator provided in the embodiment of FIG. 9.

Referring to the FIGS. generally and particularly to FIGS. 1--7, a preferred embodiment of a catheter placement unit is illustrated. In these FIGS., the following major components are designated:

2-- catheter

4-- catheter hub

6-- catheter container

8-- needle

10-- needle hub

12-- external sheath

14-- internal sheath

16-- stylet

18-- stylet hub

Now referring specifically to FIG. 1, the assembled components may be seen. In this FIG., a catheter 2 is coiled in a cylindrical container 6 having an outlet 20. The catheter 2 is threaded through outlet 20 and through a needle hub 10 and needle 8 which are interconnected with outlet 20. Thus, the catheter unit is of the needle-inside type. A protective external sheath 12 is integral with needle hub 10 as is best seen with reference to FIGS. 3 and 4, which are more fully explained hereinbelow. An internal sheath 14 initially covers needle 8. In operation, the internal sheath 14 is removed and the catheter may be advanced through hollow needle 8 by twisting the drum portion 22 of container 6.

Referring now to FIG. 2, the preferred embodiment of the catheter container is seen to comprise three parts. Reference numeral 22 designates a first half which is a hollow drum portion with a peripheral flange 24 for enclosing a coiled length of cather 2. The drum portion 22 comprises a peripheral wall 26, a rear wall 28, a hub 30, a lug 31 and the arcuate inner peripheral flange 24. The second half of the container is designated 32 and it contains a peripheral rim 34 having an inner diameter approximately the same as the outer diameter of peripheral wall 26 of drum portion 22. This size relationship allows drum portion 22 to fit within second half 32 in the assembled state. Second half 32 has a front wall 36 which contains aperture 38 adapted to frictionally engage hub 30. Outlet 20 is integrally molded as part of second half 32. The outlet 20 defines a cylindrical passage which has an axial slot 40 enabling a catheter to be forced into or out of the outlet without requiring that the entire catheter be threaded through said outlet 20. To maintain catheter sterility, axial slot 40 is normally closed by cover 42 which snaps onto outlet 20. Cover 42 has an extending rib which serves as a handle 44 and can be grasped to remove cover 42 from outlet 20 thereby exposing axial slot 40 and allowing a catheter to be separated from the catheter container 6.

Referring now to FIGS. 3 and 4, the combined needle 8, needle hub 10, and needle external sheath 12 is shown. This structure corresponds to that disclosed in U.S. Pat. No. 3,323,523 and the entire disclosure thereof in expressly incorporated herein by reference. For purposes of understanding this invention, the unit of FIGS. 3 and 4 is described herein in its relation to the present novel catheter placement unit. A rigid cannula or needle 8 is provided with a pointed end 46 and a connecting end 48. The connecting end 48 is embedded in the needle hub 10 which is a plastic tubular member. Connecting end 48 has a connecting flange 49 to insure that needle 8 is securely held in place. Needle hub 10 is provided with an enlarged cavity 50 in one end which is initially fitted over adapter 52 on catheter container outlet 20 when the entire device is assembled (FIG. 1) and which cavity 50 also is adapted to receive the catheter hub after implanting (FIG. 6). The external sheath 12 comprises at least two parts swingably attached to needle hub 10. A narrow annular sleeve 54 is slidably mounted on the external sheath 12, so that when in position over the external sheath 12 as in FIG. 3, the two halves of the sheath are clamped together. When it is desired to use the device, the sleeve 54 is slid back from the external sheath 12 into a position on needle hub 10 (FIG. 4). The two halves of the external sheath 12, being swingably mounted on the hub 10, are extended laterally as in FIG. 1, thereby exposing the needle 8 and internal sheath 14. In the FIGS., the two halves of the external sheath 12 are hinged to the hub 10 by a narrow strip 56, which is part of the wall structure of external sheath 12 as shown in FIG. 4. After the catheter 2 is inserted into the recipient and the needle 8 is removed, the two halves of the sheath 12 are closed over the needle 8 and the annular sleeve 54 is slid over the external sheath 12 to clamp the two halves together. The catheter 2 now extends through the needle 8 and through an end slot 58 (see FIG. 4) which is formed when the two halves of the external sheath 12 are clamped together. The walls of end slot 58 gently grip the catheter without restricting it to any meaningful degree and thereby prevent the needle and needle hub assembly from slipping along the catheter 2, in the final state as seen in FIG. 6. The protective external sheath 12 maintains the catheter 2 in generally axial alignment with the tubular needle 8 so that accidental piercing of the catheter 2 by the pointed end 46 of the needle 8 cannot occur. Without such a protective sheath, the catheter oftentimes bends back against the pointed end of the needle and is punctured, necessitating its withdrawal and the reinsertion of another catheter with resultant discomfort and possible danger to the patient.

The catheter 2 is initially supplied with a stiffening member comprising an inner stylet 16 attached to a stylet hub 18. After the catheter 2 is in place and the external sheath 12 is closed as described above, the stylet 16 is removed by pulling stylet hub 18 until the entire stylet 16 is removed and discarded. Removal of the stylet hub 18 from catheter hub 4 leaves the catheter hub 4 available to be connected to administration equipment, not shown. The initial purpose of the stylet 16 is to provide rigidity in the flexible catheter 2. In order to allow the catheter 2 to be reeled from container 6 and to enable the catheter 2 to smoothly move through the veins, a certain degree of rigidity is required. Considering the reeling action, the catheter 2 with stylet 16 resists the coiled state due to the stress placed upon the wire stylet 16 so that the coiled assembly tends to fly free of the coil unless restrained. In the preferred embodiment the restraining force is provided by placing the coil in the space defined by peripheral wall 26 and inner peripheral flange 24 of container drum portion 22. The tendency of the coil to fly apart forces the coil against the peripheral wall 26 so that movement of said wall 26 by manually rotating drum portion 22 results in the coil moving also. When the coil is threaded through opening 60 in inner peripheral flange 24 and then through outlet 20 in second half 32, it is seen that revolving drum portion 22 with respect to second half 32 will force the coiled catheter 2 out of the container 6 and into the connected needle hub 10 in a smooth manner. This reeling motion is utilized after venipuncture to advance the catheter through the recipient's veins. Accordingly, it is seen that in the preferred embodiment the catheter container comprises a hollow cylinder having a drum portion and a second half wherein the actuator is said drum portion which serves to reel the catheter out of the hollow space within the container.

After the catheter 2 has been advanced to the desired extent the container 6 may be removed from engagement with the catheter 2 and needle hub 10 by pulling the needle hub out of engagement with adapter 52. The pulling action causes the entire needle hub assembly to slide along catheter 2. Next the cover 42 is removed by pulling on handle 44 thereby exposing axial slot 40 of container outlet 20. Now the container is separated by slight manual pressure applied with the thumb on the projecting portion 62 of hub 30 which extends through aperture 38. When the two halves are thus separated the catheter hub 4 may be removed from drum portion 22 and the catheter 2 may be disengaged from second half 32 by pulling it out of axial slot 40 in outlet 20. When the stylet 16 is removed extrinsic equipment may be connected to the catheter hub 4 and the needle hub 10 may be slid back to engage catheter hub 4 in cavity 50. This sequence of steps results in a catheter which has been advanced to the desired extent without even being exposed to unsterile conditions or to manual handling.

The materials of construction may be any of those conventionally used in catheter assemblies. The entire assembly with the possible exceptions of stylet 16 and needle 8 may be formed of molded plastic. By way of specific example polyethylene, polypropylene or acrylic resins may be used. In choosing a suitable plastic the catheter 2 and the catheter container 6 should preferably be of translucent plastic allowing observation of fluid flow and of the length of catheter remaining in the container.

Numbers may be printed on the enable designating increments of length e.g. inches or centimeters to enable a user to readily determine by looking at the container and the remaining coils how much catheter has been advanced into a recipient. The needle 8 and stylet 16 may be formed of any suitable materials such as stainless steel, nylon, high density polyethylene or the like.

While particular emphasis has been placed on the preferred "reel" embodiment, other suitable embodiments are at once evident from the basic teaching. For example, FIG. 8 illustrates another container for a coiled catheter wherein a bottlelike container 70 is employed. In this embodiment the structure used to advance the catheter 2 from the container 70 while maintaining a sterile condition comprises a length of flexible plastic tubing 72. The operation of this embodiment is similar with respect to the initial preparation in that the same needle 8, needle hub 10 and external sheath 12 are used. After sliding sleeve 54 onto needle hub 10, the halves of external sheath 12 may separate by the hinge action of narrow strips 56 to expose needle 8 and internal sheath 14. Internal sheath 14 may be removed by sliding it off needle 8. The container 70 comprises a conical container formed of translucent plastic and having each end open. A first end 74 serves as an outlet and receives flexible tubing 72 by frictionally engaging same to provide a removable but hermetically sealed junction. A second end 76 comprises a depending skirt which receives in overlapping relationship a rigid plastic closure 78. Rigid plastic closure 78 serves to house a coiled length of catheter 2 and attached catheter hub 4. Again, the catheter contains a wire stylet 16 and stylet hub 18 which stylet makes the catheter 2 rigid and therefore manipulatable. To restrain the stressed catheter coils, flanges 80 are provided on rigid closure 78. The catheter hub 4 may be allowed to lie on the face of closure 78 or it may be restrained by suitable upstanding lugs (not shown) attached to closure 78 at its face which supports said hub. Catheter 2 is threaded through a space provided in restraining flanges 80 which space is analogous to opening 60 of FIG. 2 and then up through outlet 74 into plastic tubing 72 and thence through needle hub 10 and needle 8.

With external sheath 12 open, venipuncture is made and the catheter 2 is fed into the recipient by reciprocating flexible tubing 72. The tubing 72 may be flexed downwardly and pressed inwardly so the fingers indirectly grasp catheter 2 within said tubing, then the tubing is flexed upwardly while still grasping catheter 2 and the catheter is thus pulled out of the container and fed through needle 8 into the recipient. Repeated reciprocal movements are used until the desired length of catheter has been implanted. The length implanted can be readily determined since the conical bottle container 70 is translucent and the catheter may be marked in serial numbers designating increments of length (e.g. inches or centimeters). When the desired length has been implanted, the catheter may be freed of the container by pressing inwardly on the flexible conical container 70. This pressure expands depending skirt portion 76 of second end so that rigid closure 78 falls free. Now catheter hub 4 may be grasped and separated along with any remaining coils of catheter 2 from rigid closure 78.

Catheter 2 and catheter hub 4 may be separated from conical container 70 and flexible tubing 72 by pulling tubing 72 away from first end 74 thereby allowing the catheter and catheter hub 4 to pass through outlet 74. Easy passage is achieved since first end 74 is larger in diameter than catheter hub 4. The flexible tubing 72 need not be separated but can remain a part of the final assembly if desired. By forcing catheter hub 4 into the tubing 72, catheter adapter 82 of catheter hub 4 will engage the cavity 50 of needle hub 10 within tubing 72 and a rigid enclosed junction exists. Now external sheath 12 may be closed and secured by sleeve 54 and wire stylet 16 may be removed to clear catheter hub 4 for connection to administration equipment, now shown.

Alternatively, tubing 72 may be removed by pulling needle hub 10 out of said tubing and then forcing catheter hub 4 through said tubing 72. Now the needle hub 10 and catheter hub 4 may be connected as before described with reference to FIG. 6. This results in a final assembly identical to the final assembly achieved with the first embodiment as shown in FIG. 6.

A third embodiment is illustrated in FIGS. 9--11. The assembled structure is shown in FIG. 9 and comprises a container 90 for a coiled catheter 2 which container comprises two interfitted halves 92 and 94. First half 92 contains an outlet 96 having an actuator 98. The outlet 96 serves also to support a needle 8 having a protective sheath 100 slidably engaged thereon and the conventional inner sheath 14. The opposite end of first half 92 contains an inlet 102 having plug 104 therein. The plug 104 serves to prevent contaminating foreign matter from reaching the catheter prior to use and when removed aids in freeing the catheter from the container 90 as is described hereinbelow. The catheter 2 and catheter hub 4 are enclosed between first half 92 and second half 94 and contain a stylet with stylet hub (not shown) to render the catheter manipulatable. To operate this embodiment, protective sheath 100 is removed exposing needle 8 and internal sheath 14 is removed. Then, venipuncture is made. Next, the catheter 2 is advanced into the recipient by reciprocating actuator 98 within slot 99. If desired, slot 99 may be fitted with a slotted flexible plastic sleeve, not shown, which will engage actuator 98 and seal the space but still will allow reciprocation of actuator 98. As seen in FIG. 11, actuator 98 comprises a depending lug 106 which engages a length of catheter (not shown) within the outlet 96 to carry it forward as actuator 98 is moved forward. At the extreme limit of the forward stroke of actuator 98 it may be disengaged from the catheter 2 by pressing it into the position of FIG. 11. Then actuator 98 is moved backward and allowed to engage the catheter for another forward stroke. This action forces catheter out of container 90 through needle 8 into the recipient without manual engagement of the catheter. The container 90 is translucent and the catheter is marked in increments of length so the length advanced is readily discernable. To remove the container 90 flange 108 carried by first half 92 may be engaged and pulled up and away from second half 94, thus opening the two halves of container 90 and exposing needle hub 10 for attachment to catheter hub 4 by sliding catheter adapter 82 of catheter hub 4 into cavity 50 of needle hub 10 as was done with the prior embodiments. Now the container 90 may be discarded and the stylet within catheter 2 may be removed to allow connection of the catheter to suitable administration equipment.

While the embodiments herein described are structurally different in certain specific details they all provide novel containers with actuators to encase and implant a long catheter. The materials of construction of the parts may be the same in each embodiment; however, the specific materials are in no way limiting and are given only by way of specific examples. From the inventive concepts herein above-disclosed many modifications will become apparent to those skilled in the art and mere substitutions of equivalent parts and obvious modifications of the disclosed embodiments are encompassed within the inventive concept. Having described this invention in clear and concise and full terms;