|Publication number||US3703174 A|
|Publication date||Nov 21, 1972|
|Filing date||Jul 14, 1970|
|Priority date||Jul 14, 1970|
|Also published as||CA978817A, CA978817A1, DE2135186A1|
|Publication number||US 3703174 A, US 3703174A, US-A-3703174, US3703174 A, US3703174A|
|Inventors||Smith Gordon E|
|Original Assignee||Medidyne Corp|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (14), Referenced by (94), Classifications (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent Smith  METHOD AND APPARATUS FOR CATHETER INJECTION  Inventor: Gordon E. Smith, Madison, Wis.
 Assignee: Medidyne Corporation, Chicago, Ill.
22 Filed: July 14,1970
 Appl. No.: 54,732
 US. Cl ..128/2l4.4, 128/218 R, 128/348, 221/64, 221/278, 226/97  Int. Cl. ..A61m 5/00  Field of Search ..128/214.4, 221, 348-351, 128/262, 218 R; 221/64, 278; 226/97  References Cited UNITED STATES PATENTS 3,010,453 11/1961 Doherty ..128/214.4 3,185,151 5/1965 Czorny ..128/214.4 3,262,449 7/1966 Pannier et a1 ..128/214.4 3,309,082 3/1967 Hindman ..221/278 X 3,353,823 11/1967 Sobel ..226/97 X 3,433,214 3/1969 Silverman ..128/262 X 3,433,215 3/1969 Silverman ..128/214.4 X 3,474,786 10/1969 Spademan ..l28/214.4 3,525,329 8/1970 Zeimer et a1 ..128/262 X 3,536,073 10/1970 Farb ..l28/2l4.4
[451 Nov. 21, 1972 3,561,445 2/1971 Katerndahl et al.....128/214.4 3,570,485 3/1971 Reilly ..l28/214.4
FOREIGN PATENTS OR APPLICATIONS 1,457,344 9/1966 France ..128/214.4 1,243,331 6/1967 Germany ..128/214.4
Primary Examiner-Dalton L. Truluck Att0rneyWallenstein, Spangenberg, Hattis & Strainpel 57] ABSTRACT A device for injecting an elongated member, like a catheter, into a passageway like a blood vessel, including a body from which a feeding means like a needle extends and which contains the elongated member extending into the feeding means. The space in the body including the elongated member is sealed except for its communication to the outside of the device through the feeding means. There is provided a source of fluid for said space and a means for applying pressure'to the space. The elongated member is of a smaller size. then the needle passageway so the fluid placed under pressure forms a cushion around the member which is impelled by the pressure from the outer end of the feeding means.
35 Claims, 35 Drawing Figures PATENTEDuum ma SHEET 2 UF 7 Arrvs.
PA TENTED NOV 21 I972 SHEET b UF 7 INVEN'IOR Gonaorv E. SMlrH PATENTEBnuvz: m2
SHEET 5 BF 7 luve'ron GORDON E. SMITH PATENTEDnnm I972 sum '1 or 7 INveu'roa 60200: E. SMITH METHOD AND APPARATUS FOR CATHETER INJECTION This invention relates to devices for injecting elongated members like catheters or other hollow or nonhollow members into various human and animal passageways. One of the most important applications of the invention is in injecting catheters into blood vessels for use in infusion of liquid into the vessels.
The insertion of elongated members, such as tubing or catheters of low reactivity and long length, is frequently required in the practice of medicine. The current method of catheter insertion into closed vessels (as well as other closed tubes, ducts, lumina, hollow organs, etc.) requires the manual grasping and feeding of a relatively stiff catheter (initially carried in containers of the same or greater length) into the vessel or other passageway involved. This technique has numerous disadvantages, among them being the increased risk of penetration of the vessels or other passageways, the difficulty and sometimes the impossibility of passing through very small vessels or relatively sharp bends or angles in the vessels or other passageways of the body, and the need for long housings for holding long straight lengths of the rigid catheter or other elongated member.
Where a catheter or other elongated member is passed into a blood vessel by this technique, it is manually pushed through the lumen of a needle or over the needle extending into the blood vessel. If the user should withdraw the catheter or other elongated member before the needle is withdrawn, the elongated member can be pulled against the sharp end of the needle where it is severed within the blood vessel. A piece of the catheter is then left to float through the vascular system where it poses a risk of vessel blockage. Also, the commonly used stiff catheter for infusion of fluids into a blood vessel often causes, for reasons to be explained, blood vessel irritation and infection and blood leakage at the point the catheter enters the skin.
Where the vessel or passageway involved is slit to expose the same for passing a catheter directly into the vessel, it is possible by present techniques to use longer and more pliable catheters which practically eliminates the aforesaid problems of blood vessel irritation, infection or damage, but such a placement technique requires incision of the patients skin with attendant discomfort and increased operative time by the physician. The difficulty of insertion of a very pliable catheter into a blood vessel through a needle by manually pushing it through the needle is so great that only relatively stiff catheters have been used for catheter insertion by the simpler needle guiding technique.
Where a catheter is pushed through a needle into a blood vessel, the catheter is usually provided with an enlargement on the end which prevents the catheter from being pulled completely from the needle-After catheter insertion, if it is desired to infuse fluid through the catheter with the needle separated from the catheter, the catheter must be severed at a point outside of the needle and the end of the catheter connected to an infusion bottle assembly. The technique and means for severing and connecting the catheter to an infusion bottle assembly have been tedious, cumbersome and difficult to accomplish under sterile conditions.
Accordingly, one of the objects of the present invention is to provide an improved method and apparatus for inserting elongated members like catheters into various human and animal passageways, particularly blood vessels, which method and apparatus avoids the difficulties and dangers of the methods and apparatus heretofore utilized for this purpose.
More specifically, one of the objects of the present invention is to provide a method of and apparatus for inserting elongated members like catheters or the like, whether stiff or pliable, appreciable distances into passagewayswith little or no effort in contrast to the tedious effort and/or patient discomfort resulting from the prior catheter insertion techniques and catheter insertion apparatus. A related object of theinvention is to provide a method and apparatus as just described wherein such catheters or other elongated member can be injected through needles long distances into veins or arteries with a single squeeze of a bulb or movement of a plunger or pleated body a short distance.
Another specific object of the invention is to provide a method and apparatus as just described which is effective and poses no danger of passageway damage even when the passageway is of very limited size and has obstructions and sharp angles therein.
.A further object of the invention is to provide apparatus for injecting thin elongated members like catheters into blood vessels or other passageways as described, which catheters can be made at such a small cost that it can be a single use, disposable device.
Still another object of the invention is to provide apparatus for injecting catheters or the like through a needle into a blood vessel without the danger of catheter severance within the blood vessel. A further object of the invention is to provide apparatus for injecting catheters or the like through a needle into a blood vessel with an enlargement provided on the end of the catheter to keep the end of the catheter from leaving the apparatus during catheter injection and wherein the catheter can be easily removed from the needle and securely interconnected with a fitting attachable to an infusion bottle assembly or the like under sterile conditions. A related object of the invention is providing a catheter injection apparatus as just described which enables the user to connect the catheter to an infusion bottle assembly selectively with the catheter connected to the needle or disconnected therefrom with ease and under sterile conditions.
The various aspects of the present invention satisfy one or more, and in some cases, all of the aforesaid objectives. In accordance with one of the aspects of the invention, it has been discovered that an elongated member like a catheter can be most effectively bodily impelled without affecting the basic dimensional integrity thereof through a needle or other open ended feeding means by securing the latter to a housing containing the elongated member with the front end of the elongated member extending into the feeding means so as to be readily bodily impellable therethrough. In the most advantageous, preferred forms of the invention, the space within the housing is sealed except for its communication with the outside of the assembly through the front end of the open ended feeding means. The housing contains a fluid which may be a liquid or a gas like air which, when placed under pressure causes first the front end of the elongated member and then the portions thereof behind the same to be bodily impelled forwardly through the open ended feeding means. in the injection of a catheter into a blood vessel, the fluid used is most effectively a sterile liquid like saline solution or the very liquid to be infused into the blood vessel through the catheter (such as blood plasma, etc.), and, in such case, the sterile liquid passes around the catheter in the needle and flows out of the needle where the movementof the fluid around the catheter aids in impelling the catheter into the blood vessel. The present invention is so amazingly effective that a single squeeze of a bulb or the movement of a plunger or pleated housing body over only a small fraction of an inch can propel almost the entire length of a catheter over'20 inches long through a needle into a blood vessel. Since the catheter is enclosed by the housing and needle and is not grasped in the catheter injection process, it cannot be manually pulled back against the pointed end of the needle extending into the blood vessel which could cut-off a portion of the catheter which could then float free in the blood stream.
To prevent severance of the catheter it is also advantageous to provide an enlargement on the rear end of the catheter which becomes frictionally locked in place in the needle or other portion of the device at the termination of the catheter injection operation so the development of pressure conditions causing blood to flow backwards into the needle from a blood vessel will not move the catheter rearwardly in the device to bring the same against the needle, which could sever the same.
The momentum of the catheter ejected from the needle is sometimes an important factor in ejecting long catheter lengths into blood vessels, and where one has such control over the pressure applying means that less than the entire length of the catheter can be ejected each time a bulb is squeezed or a pleated housing body or plunger is moved, the pressure should be continuously applied until the desired length of catheter is ejected where the momentum effect is of importance. Otherwise, the catheter may not be again impellable from the needle once a given length has already been injected into the blood vessel. 7
Although a number of aspects of the present invention are applicable to the injection of relatively stiff catheters or other elongated members, one of the aspects of the invention is the use of a catheter in the catheter injection device just described which is so pliable it has the consistency of gum rubber or a wet noodle (ie it has substantial limpness with a rubber-like resilience). Silicone elastomer is the material most advantageously used in the present invention since, unlike gum rubber, in addition to its limp, resilient quality, it is inert to all body fluids and tissue. Gum rubber, wet noodles and silicone elastomer all have a high degree of limpness with substantial resilience or elasticity; It was found that the use of such a catheter (or other elongated member to be injected) can have a marked effect on the size and simplicity of the catheter injection device and on the effectiveness of a catheter injection operation into a blood vessel, especially when a long length of catheter is to be injected. In the first place, such a catheter or elongated member having a relative- 1y long length for insertion far into a blood vessel can be stored indefinitely in a permanently neatly coiled up condition in a short housing only a fraction of the catheter length where the coils will expand outwardly against the coil-confining walls of a part of the housing. Such a limp elongated member will unwind easily and move swiftly without any jamming in the needle or the blood vessel. In contrast to this, an elongated member with a modest but significant degree of rigidity will uncoil with difficulty, so it cannot be easily and swiftly injected, if at all, by the pressurizing of fluid around the catheter. Also, an elongated member which is not made of such a limp material will usually set into a curved shape whenleft in a sharply bent or coiled condition for only a few hours, and will jam inside the needle or housing, making injection there of unsatisfactory or even impossible.
Another important advantage of a catheter or the like used in a vascular application and having a wet noodle like consistency is that, unlike rigid and semirigid catheters or the like, a difficult to break liquid and bacteria tight seal is formed around the catheter at the point it enters the skin. (After insertion of a catheter or other elongated member into a blood vessel through a needle, the needle is pulled from the patient and discarded or positioned in a way not to damage the,
users skin.) With semi-rigid or rigid catheters, patient or catheter movement causes the skin to pull away from the catheter or the catheter to pull away from the skin, causing openings for leakage of blood and passage of bacteria and contaminants. Where the catheter has a wet noodle like consistency, patient and catheter movement is not readily transmitted to the point where the catheter passes through the skin so the skin is not readily separated from the catheter and the skin can readily form a seal around the soft pliable catheter material.
Furthermore, a straight stiff catheter will not readily pass through a blood vessel having an obstruction to easy passage of a conventional rigid or semi-rigid catheter, as where the vessel bends or is constricted, because such a catheter will catch on such obstruction and can easily penetrate the vessel if an attempt is made to force the catheter. Also, a stiff catheter will sometimes catch on the walls of even a straight blood vessel, thus precluding satisfactory advancement. When the catheter is made of a material with a wet noodle consistency, if the catheter should hit an obstruction in the blood vessel it is so flexible that it will not cause any injury to the vessel and will not usually jam within the vessel because such a catheter will readily pass around the obstruction and will tend to keep a centered position in the blood vessel.
A further aspect of the invention is the provision of a bevel at the front end of the limp catheter (which would be unthinkable in a stiff catheter since the stiff catheter would then form a needle capable of readily piercing the blood vessel involved). The bevel on the front end of such a catheter enlarges the area of the catheter entryway to prevent formation of blood clots thereat, eliminates a collapsible body at the point where the tubular catheter is most prone to collapse to obstruct the withdrawal of blood'from the vessel and makes the catheter tip so flexible that the catching of the catheter tip on an obstruction will not jam the catheter since the catheter tip can readily fold upon itself permitting the portion of the catheter behind the tip to pass by the same and then pull the folded back tip from the obstruction.
Another aspect of the application of the invention where a catheter is injected into a blood vessel is the provision of an enlargement, preferably a two-stepped enlargement, at the rear end of the catheter for preventing the rear end of the catheter from leaving the needle during the catheter injection operation. The first enlargement at the end of the catheter reaching the needle provides the aforesaid friction lock in the needle which prevents subsequent reversal of movement of the catheter. More importantly it reduces this clearance space to zero whereupon the pressure inside of the catheter causes the catheter to expand against the needle walls securely holding the catheter against further movement which the friction fit between the catheter and needle could not normally by itself achieve. The second enlargement at the very end of the catheter, among other things, acts as a further insurance against the catheter leaving the needle during catheter injection. After withdrawal of the needle from the patient, the extremely flexible catheter can be removed from the needle by simply pulling on the catheter to elongate and contract the diameter of the enlargements on the end of the catheter which then slips through the needle as it is so elongated and contracted.
The various above described features of the invention are, in accordance with more specific aspects thereof, utilized in different types of catheter injecting devices. Thus, in one form of the invention used for injection of catheters or the like into blood vessels, the device is a completely self-contained unit packaged and sterilized at the point of manufacture with saline solution or the like in the unit. Where the application of the invention is one where the catheter injection device need not incorporate a sterile liquid at the point of manufacture, the device may include a very small inexpensive, easy-to-sterilize, liquid-free, catheter containing barrel-like body which does not have any means for applying pressure to the barrel. The barrel-like body is readily supplied with the sterile liquid at the point of use by attaching it through a connector to the front end of a conventional syringe unit (with its needle removed) which is regularly stocked at hospitals and doctors offices. The syringe unit to which the catheter injection device is connected is already filled with a sterile saline solution or the like in the conventional way used to fill syringe units with liquid. The plunger of the syringe unit then becomes the instrumentality for forcing liquid through the barrel-like body and needle of the catheter injection device. Before using the device, air must first be expunged therefrom. This is accomplished by orienting the assembly so the needle of the catheter injection device points up, and then pushing the plunger of the syringe unit until liquid flows out the end of the needle. A removable liquidpassing catheter retaining means is provided on the needle to prevent the movement of the catheter from the needle while the air is removed in the manner explained.
In the specific forms of the invention described above, the catheter, after being injected into a blood vessel, can be removed from the needle and attached to an infusion bottle assembly by a connector carried by the catheter injection .device which connector slides over the catheter which is pulled into a locked sealed position in the connector. The various forms of the invention can and preferably are designed to provide the user the option of connecting the catheter to an infusion bottle assembly in a manner which does not require removal of the catheter from the needle.
in another form of the invention, the catheter injection device is designed to be connected to an infusion bottle assembly before the catheter is injected and a small quantity of the infusion liquid is drained from the infusion bottle into the initially dry catheter injection device to become the catheter infusion liquid. When the user desires to give a transfusion of blood or start an intravenous feeding operation, the needle at the front end of the device is inserted into the blood vessel involved and the catheter is injected into the vessel by squeezing a bulb-like member or the like. The needle is then withdrawn from the patient and, if desired, the catheter is pulled from the needle and separated from the entire catheter injection device and reconnected to the infusion bottle assembly, or the catheter left attached to the device. In the latter case, a needle cover is applied over the needle to protect the patient and the catheter from the needle.
Although it is preferable and most advantageous to use manually applied pressure to cause the liquid to inject a cathetef intothe blood stream, in the example of the invention just described, it is within the purview of some of the aspects of the invention to use the gravity forced flow of liquid to force the catheter from the needle into a blood vessel in the direction of blood flow therein.
Where manual force is used to create a flow of liquid which impels the catheter into a blood vessel, where the catheter remains attached to the catheter injection device it is important that the portion thereof squeezed or otherwise moved to decrease the volume of the liquid-filled system involved be a unidirectionally movable member to avoid the creation of a negative pressure which could draw air into the device when the needle is withdrawn from the patient and before infusion of liquid through the catheter begins. Accordingly, where a squeeze bulb is provided, the bulb is designed so it snaps into a permanently collapsed condition when squeezed until infusion of fluid through the device is again initiated which then creates a pressure which expands the bulb into its original shape.
It should be understood that some of the aspects of the invention are useful in applications where it is not desirable or necessary to use a liquid as the impelling medium. Thus, for some applications, the catheter impelling fluid may be air. Such applications would be the injection of a catheter or other elongated member into the urethra, rectum, ear, throat, lungs, etc.
The above described and other objects, advantages, and features of the invention will become more clear and apparent upon making reference to the specification to follow, the claims and the drawings wherein:
FIG. 1 is a view of one form of the invention comprising a self-contained, sterile liquid containing catheter injection device resembling a syringe unit with an enclosure applied to the needle containing end thereof;
FIG. 2 is an enlarged longitudinal sectional view through the catheter injection device shown in FIG. 1 and enclosure thereof;
FIG. 3 is an enlarged fragmentary sectional view of the needle end of the catheter injection device shown in FIG. 2 after removal of the enclosure and needle cover, the device shown being used to inject a catheter into a blood vessel;
FIG. 4 is a greatly enlarged transverse sectional view through the needle shown in FIG. 3;
FIG. 5 is a greatly enlarged fragmentary longitudinally sectional view of the base or inner end of the needle of the catheter injection device shown in FIG. 3, as the enlarged rear end of the catheter reaches the rear end of the needle;
FIG. 5A is a perspective view of the rear end of the catheter showing the enlargement on the end thereof;
FIG. 6 illustrates the withdraw] of the needle from the blood vessel shown in FIG. 3 as a first step in removing the catheter from the catheter injection device involved;
FIG. 7 is a view corresponding to FIG. 6 showing the infusion liquid-receiving connector unit initially surrounding the needle shifted into a position immediately beyond the tip of the needle where it is positioned around the catheter;
FIG. 8 is an enlarged fragmentary sectional view of the rear end of the needle showing the elongation and contraction of the enlarged end of the catheter caused by a pulling force applied to the catheter, permitting the same to pass through the needle;
FIG. 9 is a view of the front end of the needle as the end of the catheter is being pulled therefrom;
FIG. 10 is a view of the infusion liquid-receiving connector unit when the enlarged end of the catheter of FIG. 9 has been pulled into its final snugly fitting position within the infusion liquid-receiving connector unit;
FIG. 11 is a view corresponding to FIG. 10 when the end connector of an infusion bottle assembly has been secured within the connector unit of FIG. 10;
FIG. 12 is a perspective view of an infusion bottle assembly showing the end connector thereof adjacent the infusion liquid-receiving connector unit of the catheter injection device shown in FIG. 11; I
FIG. 13 illustrates a second form of the invention comprising a self-contained, sterile liquid containing catheter injection device and with an enclosure applied around the needle containing end thereof;
FIG. 14 is an enlarged longitudinally sectional view through the catheter injection device and enclosure of FIG. 13;
FIG. 15 is a greatly enlarged side elevational view of the needle and its mounting hub used in the catheter injection device of FIGS. 13 and 14, before the needle assembly has been assembled with other parts of the device;
FIG. 16 is a substantially enlarged fragmentary longitudinal sectional view of the rear end of the needle assembly of FIG. 16, taken along section 16-16 thereof;
FIG. 17 shows a third and preferred form of the invention comprising a self-contained sterile liquid containing catheter injection device and with an enclosure applied thereto encompassing most of the length thereof;
FIG. 18 is an enlarged longitudinal sectional view through the catheter injection device and the enclosure thereof of FIG. 17;
FIG. 19 is a longitudinal sectional view of the catheter injection device of FIG. 18 after the enclosure and needle cover have been removed therefrom;
FIG. 20 is a greatly enlarged fragmentary longitudinal sectional view of the inner end portion of the needle assembly of the catheter injection device of FIG. 17 through 19, showing the manner in which the needle assembly is mounted within the device;
FIG. 21 is a greatly enlarged fragmentary longitudinal sectional view through the pleated portion of the catheter containing body of the catheter injection device of FIGS. 17 through 20, showing the manner in which air bubbles are trapped therein;
FIG. 22 is a fragmentary longitudinal sectional view of the rear end portion of a catheter injection device constituting a variation of the form of catheter injec tion device shown in FIGS. 18 through 21;
FIG. 23 is a plan view of a non-self-contained liquidfree form of the present invention packaged in a flexible, transparent sealed bag, which device must be connected to a conventional liquid containing syringe unit or the like to form an overall assembly capable of injecting a catheter into a blood vessel or the like;
FIG. 24 is an enlarged longitudinal sectional view of the catheter injection device of FIG. 23;
FIG. 25 is an enlarged fragmentary sectional view of the catheter injection device of FIG. 24 assembled with a conventional syringe unit;
FIG. 26 is a greatly enlarged longitudinal sectional view of the front end portion of the assembly of FIG. 24, showing the manner in which air is ejected from the assembly;
FIG. 27 is another form of the invention comprising a non-seIf-contained, liquid-free catheter injection device which forms a complete catheter injection device when connected to a conventional infusion bottle assembly;
FIG. 28 shows the connection of the catheter injection device of FIG. 27 to an infusion bottle assembly;
FIG. 29 is an enlarged longitudinal sectional view of the catheter injection device shown in FIG. 28;
FIG. 30 is a fragmentary longitudinal sectional view of the front end portion of the catheter injection device of FIG. 29 after a needle cover has been removed therefrom;
FIG. 31 is a fragmentary longitudinal sectional view of the squeeze-bulb portion of the catheter injection device of FIGS. 27 through 30 after the same has been operated to inject a catheter into a blood vessel and before re-establishment of infusion;
FIG. 32 is a fragmentary longitudinal sectional view of the front end portion of the catheter injection device of FIG. 30 after a catheter has been injected into a blood vessel and the needle withdrawn within a needle retraction sleeve, where infusion of liquid through the catheter is to be effected through the catheter injection device;
FIG. 33 is a view showing the separation of the catheter and infusion liquid-receiving connector from the rest of the catheter injection device when it is desired to feed an infusion liquid through the catheter separately from the catheter injection device; and
FIG. 34 is a longitudinal sectional view of the catheter and infusion liquid-receiving connector of FIG. 33 attached to the complementary connector of the infusion bottle assembly of FIG. 28.
EMBODIMENT OF THE INVENTION SHOWN IN FIGS. 1-12 The embodiment of the invention shown in FIGS. l-12 is a catheter injection device 2 which is a self-contained, sterile liquid-containing device resembling a needle syringe unit. It includes a catheter-containing body assembly 6 comprising a cylindrical barrel 6a, which may be made of a suitable synthetic plastic material such as polyethylene and the like, from the front end of which extends a catheter feeding needle 6b. The needle has attached thereto a conventional hub 7 preferably made of a synthetic plastic material which hub interflts in a conventional way with the reduced nose portion 8 at the front end of the barrel 6a. The rear end of the barrel 6a terminates in a pair of laterally extending finger-receiving wings 10-10 and is open slidably to receive the body portion of a plunger stem 6c which may be made of the same synthetic plastic material as the barrel 6a. The plunger stem 60 has at the front end thereof a head portion 12 which makes a sealing and sliding engagement with the inner surface of the cylindrical chamber 14 of the barrel 6a. A catheter 12 is coiled within the cylindrical barrel chamber 14 which retains the same in a neatly coiled condition so the coils will easily uncoil under the force of the forwardly moving catheter ahead of the same front end portion of the catheter extends substantially into the lumen 16 of the needle 6b. The catheter 12 is shown provided with equally spaced index marks 13 thereon to provide an indication of the distance between the front end of the catheter and any given position thereon in a manner to be described. The tip 12' of the catheter is beveled for reasons previously explained and marked with a wide marker 13 so that upon withdrawal of the catheter from a blood vessel the user can identify the end of the catheter to be certain that no catheter breakage has taken place. The barrel chamber 14 is filled with a suitable sterile liquid 18 such as a saline solution which also fills the needle lumen 16 and a space in front of a needle cover 20 whose closed front end snugly surrounds the needle 6b and forms a tight liquid seal therewith at a point just rearward of the beveled front end of the needle. The rear open end of the needle cover 20 flares outwardly and snugly engages around the beveled front end por tion of an infusion liquid-receiving connector 22 snugly but slidably disposed around the base portion of the needle just in front of the needle hub 7. The needle cover maintains a seal even during the sterilizing process preferably used, which is an autoclaving process. The needle cover 20, connector 22 and the needle hub 7 are enclosed by an outer dust cover-forming enclosure 24 which is closed at its front end and open at its rear end where it telescopes snugly around the front of the main body portion of the barrel 6a. The outer enclosure 24 and the needle cover 20 may be made of a suitable synthetic plastic material, such as polyethylene and the like.
Although, in accordance with the broadest aspects of the invention, the catheter 12 could be made of an uncoiled rigid or semi-rigid fiaterial, it is most advantageous that the catheter be made of a material which is so limp that it was not heretofore thought possible to inject the same into a blood vessel, manually or otherwise. The catheter 12, which is most desirable made of a silicone elastomer or other similar inert limp, resilient material, is so limp and pliable that it has the consistency of gum rubber or a wet noodle. Silicone elastomer materials are in solid form incompressible but when hollow like a catheter can be compressedinwardly. It is also of significance that the catheter 12 be made of a material which can remain in a fairly tightly coiled condition as illustrated indefinitely without any significant curvature setting therein, so that the catheter will at all times uncoil in a straight condition when it is fed through the needle. If the catheter had any substantial curvature set therein, the catheter could readily catch on the walls of the needle or housing making it impossible to feed the catheter from the needle.
The catheter 12 must be of a size during a catheter ejection operation to. pass freely but preferably with a small clearance through the needle lumen 16. In one exemplary form of the invention, the diameter of the needle lumen was 0.052 inch, the outer diameter of the catheter was 0.047 inches and the inner diameter of the passageway within the catheter was 0.025 inches. (It should be understood that the various dimensions are given by way of example only since the dimensions obviously vary widely with the desired catheter size and other factors.) A small clearance space is preferred between the needle lumen and the catheter so that a small movement of the plunger stem 6c will result preferably in a high velocity flow of liquid around the catheter to provide a moving fluid cushion around the catheter which will impel the same from the needle and uncoil the catheter. The limpness of the catheter allows the catheter to uncoil with ease and to readily enable the catheter to be centered in the blood stream and to readily allow the same to pass around obstructions and sharp bends in the blood vessel. Also the momentum of the extremely limp catheter material adds much to the amazing easy injection of the catheter substantial distances into the blood vessels involved. Thus, it was found that the velocity of ejection of the catheter is substantially greater for a long catheter. It was found, for example, that a movement of the plunger stem 6c to effect delivery of 1 cc. of fluid was sufficient to uncoil and eject a limp catheter having lengths of from 12 or more inches into a vessel. This generally means that the syringe plunger 6c need be advanced only a small fraction of an inch to impel a catheter of 12 to 26 inches and more.
It would be especially undesirable to have liquid flowing through the catheter under such pressure conditions that the catheter would expand outwardly against the lumen-defining walls of the needle 6b, which would prevent the free movement of the catheter through the needle. To this end, it would appear desirable to make the cross-sectional area of the passageway within the catheter substantially less than that of the clearance space between the catheter and the lumenforming wall of the needle 6. However, with the exemplary dimensions given above, the cross-sectional area of the catheter passageway is actually larger than that of the clearance space fo r the catheter. This curious result is due probably to the fact that because of the length of the catheter behind the needle there is a much greater frictional opposition to the flow of liquid at the interface between the liquid and the inner walls of the catheter than there is at the interface between the liquid and the inner walls of the needle passageway which results in a lower pressure inside the catheter where it enters the needle. Although there is liquid within the catheter before the same is impelled, the application of the pressure results only in the forward flow of catheter impelling liquid around the catheter, the liquid within the catheter having no appreciable forward component of flowrelative to the forward moving catheter. Consequently, no liquid flows from inside the catheter during catheter ejectionv To inject the catheter into a vessel, it is obviously necessary first to remove the outer enclosure 24 and the needle cover 20. A tourniquet is placed on the limb involved, and after insertion of the end of the needle 6b through the skin 25 into the vein 27 as shown in FIG. 3, a small depression imparted to the plunger stern 6c will place pressure on the saline solution 18 to force the liquid around the catheter in the needle 6b which will surprisingly eject the entire length of the catheter 12 from the barrel 6a except for the rear end thereof. As best shown in FIG. A, the rear end of the catheter 12 preferably has a two-step enlargement, the first step of the enlargement being identified by reference numeral 12a and the second step thereof being identified by reference numeral 12b. The inner end of the first enlargement 12a joins the catheter body in front of the same through a forwardly tapered or beveled portion 12a (FIGS. 5, 5A and 8). The wall thickness of the first and second enlargements are progressively greater than that of the rest of the catheter to provide an increase rigidity with diameter. As shown in FIG. 5, the outer diameter of the first enlargement 12a is somewhat greater then the inner diameter of the needle 6b so that when the taper 1211 at the enlargement 12a reaches the needle 6b the clearance space between the catheter and the needle lumen is reduced to zero and the catheter stops. Also, as shown in FIG. 5, the tapered front end portion 12a of the first enlargement 12a enters the needle lumen; At that time, the pressure of liquid in the passageway of the catheter, will expand the expandable catheter outwardly to force the same snugly against the needle wall which maintains the stoppage of movement of the catheter through the needle.
As previously indicated, the fact that the size of the enlargement 12a is greater than the inner diameter of the needle also frictionally keeps the catheter in the needle and prevents any passable backward movement of the catheter which could bring the catheter against the sharp end of the needle to sever the catheter. Such backward movement without a friction fit could occur if the user withdrew the plunger stem (is.
Referring now to FIG. 6, after the catheter has been injected to its maximum degree into the blood vessel involved, the tourniquet applied to the patients arm may be removed. Blood may back flow into thecatheter to fill at least in part the same with blood. The needle 6b is then withdrawn from the patient and, in a manner to be described, the catheter 12 is removed from the needle to permit the catheter tmached to a source of infusion liquid by means of the infusion liquid-receiving connector 22. After the needle 6b has been removed from the patient, if the doctor desires less than the full length of the catheter to extend into the blood vessel involved, he withdraws the catheter the proper distance by counting the number of index marks 13 of the catheter 12 which are removed from the patient during the withdrawal of the catheter.
The infusion liquid-receiving connector 22 has a front cylindrical portion 22a and a rear outwardly flaring portion 22b. The front portion 22a of the connector 22 has a passageway 30 therein interrupted preferably by one or more grooves 32 to minimize the area of the defined walls of the passageway 30 which frictionally engages the needle 6b, so that the connector can be easily pulled from the needle by pulling the same down along the needle 61) to a point where it slides off the needle and surrounds the catheter 12 as shown in FIG. 7. The connector passageway 30 merges with a relatively short opening 34 of greater diameter which opening is of a size to accommodate the outermost enlargement 12b of the catheter. The first enlargement 12a of the catheter is of a size which snugly fits within the connector passageway 30. The opening 34 within the front portion 22a of the connector 22 joins a still larger cylindrical space 36 which is of a sine frictionally to receive the nose portion 38 of a connector 40 (see FIG. 11) at the end of an infusion bottle assembly 39 to be described.
The enlargements 12a and 12b at the end of the catheter 12 are made of such a size and thickness as illustrated so that by pulling on the catheter 12 the enlargements will distend in length and contract in diameter so the catheter can be readily pulled through the needle 6b, as shown in FIGS. 8 and 9. When the catheter is removed from the needle 6b, the catheter is pulled to the front of the connector 18 where the innermost enlargement 12a snugly fits within the aforementioned connector passageway 30 and the outermost enlargement 12b fits within the aforementioned connector opening 34, as shown in FIG. 10 where, because of the relative thickness and size thereof, it acts as a stop abutment preventing the catheter from being pulled through the connector passageway 30. The outwardly flaring rear portion 22b of the connector 22 defines a skirt which prevents the end of the catheter from dropping upon an unsterile surface when the end of the catheter leaves the needle 61;. It is, of course, important to keep sterile those outer surfaces of the catheter which engage that part of the connector 22 which can be contacted by the infusion liquid to be directed through the catheter 12.
The separation of the catheter from the needle is desirable for a number of reasons including the fact that after catheter injection the needle can be disposed of so that there is no problem of keeping the needle from scratching the patients skin or puncturing the catheter. However, the catheter need not be separated from the needle. The needle hub 7 is of a standard shape so after catheter injection where the enlarged end of the catheter is sealed within the rear end of the needle, the needle can be removed from the barrel 6a and connected to the connector 40 of the infusion bottle assembly. In such case, the infusion liquidreceiving connector 22 is pulled down to a point where it covers the sharp beveled end of the needle 6b as shown in dashed lines in FIG. 6.
The conventional infusion bottle assembly 39 illustrated in FIG. 12 includes a relatively long flexible tube 43 extending from an inverted bottle 44 containing the infusion fluid. The bottle 44 includes a strap 47 extending around the bent portion 48 of a horizontally extending arm 50 of a support stand 51. The arm 50 extends from a vertical rod section 52 vertically adjustable within a tubular base 54. The flow of fluid from the bottle 44 is controlled by a pinch clamp 46 applied around a portion of the tube 43. Before the connector 22 to which the catheter 12 is attached is connected to the infusion bottle assembly connector 40, the clamp 46 is released so that the entire length of the tube 43 and the connector 40 is filled with the infusion fluid involved, so that there is no air which passes along with the infusion fluid. As previously indicated, the catheter 12 extending from the patient is filled with blood and/or a portion of the injecting fluid so that it too is free of air.
It should be noted that in the embodiment of the invention just described the saline solution 18 within the barrel 6a makes contact with the needle hub 7. If the needle hub 7 were made of a metal like aluminum, the saline solution will corrode the same if the hub is subjected thereto for prolonged periods of time. The use of a needle with a synthetic plastic hub as described, although desirable, is presently unsatisfactory because, the manner in which commercially available needles with plastic hubs are made, the connection between the plastic hub and metal needle cannot withstand the conditions of the sterilizing process required to sterilize the saline solution-filled catheter injection device 2.
EMBODIMENT OF THE INVENTION OF FIGS. 13-16 The catheter injection device shown in FIGS. 13-16 and identified by reference numeral 56 comprises a catheter containing body assembly 58 including a tapered barrel 58a preferably made of polyethylene or other suitable synthetic plastic material, a stainless steel needle 58b secured to the front end of the barrel 58a, and a depressible end cap 58:: at the rear end of the barrel 58a preferably made of a suitable synthetic plastic material like polyethylene. The barrel 58a defines a forwardly tapering chamber 60 which opens onto the front and rear of the barrel 58a. The outer surface of the barrel 58a terminates at the rear thereof in a cylindrical rear end portion 62 which sealingly receives the end cap 580. The catheter containing body assembly 58 is filled with saline solution 18 and the catheter is coiled within the end cap 58c and extends through the barrel 58a into the needle 58b. The end cap 58c is sufficiently snugly mounted around the barrel 58a that it forms a liquid seal and remains in the position illustrated until the user depresses the same inwardly to reduce the volume of the space within the catheter containing body assembly 58, to effect ejection of the catheter 12 in the same manner as explained in connection with the catheter injection device of portion 63. The needle 58bisanchored in place at the front end of the nose portion 63 of the barrel 58a by means including a needle holder member 64 having a skirt 64 (FIG. 14) which extends securely around and is anchored to the nose portion 63 of the barrel 58a. The needle holder member 64 has a cylindrical bore 66 therein which receives a deformable but not too compressible sleeve surrounding the rear end of the needle. As best shown in FIG. 16, the rear end of the needle 58b terminates in a flared end position 58b on the inner side of which the sleeve 70 is mounted. The flared end 58b of the needle abuts against a correspondingly shaped end surface of the nose portion 63 of the barrel 58a. The forward end of the bore 66 of the needle holder member 64 is defined by a wall or shoulder which presses longitudinally rearwardly on the sleeve 70 to cause the same to deform outwardly so the sleeve becomes tightly sandwiched between the needle 58b and the defining wall of the bore 66 of the needle holder member 64. The manner in which the needle 58b is anchored as just described is an inexpensive and effective means for mounting hubless needle bodies, overcoming the problem of corrosion present when using needle bodies secured to metal hubs and the problem of withstanding sterilization conditions when needle bodies using conventional plastic hubs are utilized. It should be understood, however, that the form of the invention'shown in this application using the unique needle anchoring technique just described could be modified to use needle bodies with plastic hubs as shown in the embodiment of FIG. 2 if the manufacturing techniquesused thereon are improved to permit them to be used in the sterilization process required for the saline solution-filled embodiments of the invention.
An infusion liquid-receiving connector 68 substantially identical to the previously described connector 22 closely surrounds the inner end of the needle 58b, with the outwardly flaring rear end portion 68!) thereof engaging the front outer surface of the needle holder member 64. A liquid sealing needle cover 69 like the needle cover 20 previously described sealingly engages the needle behind the bevel at the front end thereof and engages the forward end of the connector 68. A cylindrical closure member 71 forms a dust cover around the needle 58b, the connector 68 and the holder member 64. The closure member 71 which is open at its rear end, frictionally engages and is anchored around the needle holder member 64.
THE EMBODIMENTS OF FIGS. 17-22 Refer now more particularly to FIGS. 17-19 which shows the most preferred form of a self-contained, catheter injection device identified by reference numeral 72. This form of the invention has a housing 74 which encloses the catheter injection device 72 (FIGS. 18-19) substantially its entire length, unlike the enclosure 24 of the embodiment of FIG. 1 and the enclosure 70 of the embodiment of FIG. 13 which encloses only the front end portion of the device including the needle, needle cover and infusion liquid-receiving connector. The catheter injection device 72 has a catheter containing body assembly 76 comprising a barrel 76a made of a suitable synthetic plastic material and opened at the front thereof. The barrel 76a is shown cylindrical in shape for most of its length and is interrupted by longitudinally spaced, accordion-like pleats 78 forming deep peripheral pockets 80 on the interior of the barrel. The pleats 78, which are shown as having generally triangularly shaped cross sections, enables the barrel to be expanded or contracted preferably at least about percent of its initial length. The rear end of the barrel 76a has a rearwardly flaring portion 82 terminating in an enlarged cylindrical end portion 84 which is closed off at the end thereof by a concave wall 86. The housing 74 has a closed front end 74a and an open rear end 741; which is snugly applied over the enlarged end portion 84 of the barrel 76a. The catheter 12 is coiled up within the enlarged end portion 84 of the barrel 76a, the catheter extending the length of the barrel and passing into the needle 76b.
The front end of the barrel 76a is provided with an internal annular locking rib 88 and external annular locking ribs 92 (FIG. 20). Where, as illustrated, the pleats 78 imparts such flexibility to the barrel 76a that the barrel cannot support itself in a straight condition, the pleated portion of the barrel is given support by a sleeve 92 extending in close proximity to the barrel 76a within the barrel chamber 90. The sleeve 92, which like the other parts may be a synthetic plastic molded part, has a thick front end portion 94 with a shoulder 93 therein behind which extends the aforementioned internal locking rib 88.
The catheter containing housing assembly 76'further includes the needle 76b carrying on the inner outwardly flaring end thereof a needle mounting sleeve 95 like the sleeve 70 in FIGS. and 16. The thick front end portion 94 of the pleat support sleeve 92 presents a forwardly facing inwardly tapering conical surface 98 which forms an abutment for the outwardly flared rear end of the needle 76b. The flared ends of needles of various sizes can be accommodated by the forwardly facing conical sleeve surface 98. The needle 76b is anchored in place by a needle holder member 100 having a cavity 102 therein which opens rearwardly of the member. The cavity 102 hasrecesses 104 corresponding to the external locking ribs 93 of the barrel 76a, permitting the needle holder member 100 to be snapped into place around the front end of the barrel 76a. The needle holder member 100 has an internal hub 105 with a longitudinal bore 107 therein through which extends the needle 76b. When the needle holder member 100 is snapped into place on the front end of the barrel 7 6a, the rearwardly facing end of the internal hub 105 of the needle holder member 100 deforms the needle mounting sleeve 95 so it conforms to the irregular shape of the conical surface 98 at the front end of the sleeve 92, thereby securely to anchor the needle 76b in place, as best shown in FIG. 20.
The needle 76b carries a needle cover 110 which snugly is applied around the needle to cover and seal the same in the same manner as the other needle covers previously described, and an infusion liquid-receiving connector 112 positioned at the rear end of the needle cover 110. The connector 112 is identical to the infusion liquid-receiving connectors previously described in connection with the other embodiments of the invention.
The various interconnecting spaces within the catheter injection device 72 are filled with a sterilized saline solution 113 as in the case of the other embodiments of the invention. The catheter injection device 72 is used in a manner similar to the other catheter injection devices previously described except that the saline solution is ejected around the catheter by placing the thumb against the concave rear wall 86 of the barrel 76a and the other fingers in front of the pleats 78 and pulling the thumb toward the fingers so the volume of the chamber within the barrel is reduced, so the catheter impelling liquid is forced through the needle 76b and around the catheter 12 to eject the same in the manner described previously. If there should be any air bubbles within the barrel chamber, the deep pockets 80 formed by the pleats 78 in the embodiment of the invention shown in FIGS. 18 and 19 will catch any air bubbles moving toward the needle and entrap the same as shown in FIG. 21 if the catheter injection device is operated in a position where the needle end points in a v EMBODIMENT OF THE INVENTION OF FIGS. 23-25 As previously indicated, it is desirable to manufac ture and package a catheter injection device in a dry state (i.e. without the presence of any sterile catheter impelling liquid) when a source of such a liquid is available at the point of use of the catheter injection device. To this end, the embodiment of the invention shown in FIGS. 23-25 was developed. 1
The catheter injection device 112 shown in FIGS. 23-25 is preferably packaged in a transparent synthetic plastic bag 114 in which it can be sterilized in accordance with well-known gas sterilizing techniques. The catheter injection device 112 includes a catheter containing body assembly 115 including a short barrel 115a having a relatively large cylindrical portion 117 closed by a cap 119 having a hollow neck 121 projecting rearwardly therefrom with an open-ended passageway 123 communicating with a catheter containing chamber 125 in the barrel 115a. The neck 12] is adapted to interfit with the nose portion 127 of a conventional syringe unit barrel 129 shown in FIG. 25 or with the connector 40 of an infusion bottle assembly where infusion of liquid is to be made through the catheter injection device 112. In the exemplary barrel 115a, the barrel has a forwardly tapering wall portion 131 extending from the front end of the cylindrical barrel portion 117, wall portion 131 terminating in a cylindrical neck 133 having an apertured end wall 135. Extending forwardly from the apertured end wall 135 is a hollow cylindrical sleeve 137 in which is mounted a needle 1 15b carrying at the rear end thereof a deformable sleeve 139. The sleeve 139 on the needle 115b serves the same purpose as the sleeve 95 on the needle 76b described in connection with the embodiment of the invention as shown in FIG. 18. The needle 1 15b has a flared end 140 which engages the end wall 135 of the neck 133 of the barrel 1154 around an aperture 142 therein. The needle sleeve 139 is expanded tightly into engagement with the defining walls of the needlereceiving chamber 144 within the sleeve 137 by an internal hub 146 of a needle holder member 148 which is snapped into a position around the sleeve 137. An interfitting projection 137a and recess 148a are provided on the sleeve 137 and the needle holder member 148. An infusion liquid-receiving connector 150 surrounds the needle lb immediately behind the needle .holder member 148. The connector 150 is of the same construction and serves the same function as the previously described infusion liquid-receiving connectors. The barrel 115a contains a coiled up catheter 12 which has a portion extending into the needle 1 15b.
The front end of the needle l15b is initially covered by an open-ended needle cover generally indicated by reference numeral 152. As best shown in FIG. 26, the needle cover 152 has a main cylindrical portion 152a defining a corresponding cylindrically shaped passageway 154 therein, the defining walls of which snugly engage the needle 115b. The needle cover member 152 has a rearwardly outwardly flaring portion 152b which engages around the front end portion of the infusion liquid-receiving connector 150 (FIG. 24).
The needle cover 152 has a nose portion 1520 which has a generally spherically shaped cavity 156 therein in which is located the spherically shaped protuberance 158 of a catheter holding member 160. The catheter holding member 160 is a tubular member having an open-ended passageway 162 therein extending the full length of the catheter holding member 160. The catheter holding member 160 has a portion 160a projecting forwardly of the protuberance 158 and the nose portion 1526 of the needle cover member 152, and a portion 160!) extending rearwardly from the protuberance 158 within the cylindrical chamber 154 of the needle holding member 152. The rear portion 16% of the catheter holding member 160 passes within the needle 1 15b and forms an abutment which prevents the expulsion of the catheter 12 from the needle when liquid is forced in and through the barrel 115a when the same is connected to the syringe unit 129. The beveled tip 12 of the catheter forms a clearance space 161 between the tip of the catheter 12 and the confronting open end of the rear portion 160!) of the catheter holding member 160 through which air and liquid can pass into the open-ended passageway 162 in the catheter holding member. The catheter holding member 160 and the needle cover member 152 are removed as a unit from the needle after air has been expunged from the barrel 115a and catheter injection is to be initiated.
The manner in which the initially dry catheter injection device 1 12 is used can be best explained as follows. At the point of use, the package 114 is opened so that the catheter injection device 112 can be removed therefrom. The syringe unit 129, which is initially provided with a needle (not shown) attached to the nose portion 127 thereof, is filled with a saline solution (or other suitable sterile injection fluid) by puncturing the soft cap of a saline solution containing a bottle or the like (not shown) with the syringe needle and drawing the saline solution into the chamber 129 of the syringe unit by withdrawing the plunger stem 12% from the chamber. Air is then expunged from the syringe unit in the usual way by pointing the needle upwards so all of the air rises to the top of the chamber and then depressing the plunger stem to drive air and some saline solution from the needle. The needle is then withdrawn from the noseportion 127 of the syringe unit and the neck 121 of the catheter injection device 112 is inserted in place within the nose portion 127 of the syringe unit 129 to replace the needle removed therefrom. The plunger stem 12% of the syringe unit 129 is then again depressed to force saline solution through the barrel a and the needle 11511 of the catheter injection device 112 while the needle is pointed upwards to drive the air from the catheter injection device. The catheter holding member then acts to prevent ejection of the catheter 12 from the needle 115b as previously indicated. The assembly of the catheter holding member 160 and the needle cover member 152 may then be removed so that further depression of the plunger stem 12% of the syringe unit 129 will impel the catheter 12 through the needle into the blood vessel involved. After the catheter 12 is fully injected into the blood vessel and withdrawn the desired distance, the catheter 12 may be removed from the needle 11512 and securely anchored within the infusion liquid-receiving connector 150 which is then attached to the connector 40 (FIG. 13) at the end of an infusion bottle assembly in the same manner previously described in connection with the other embodiments of the invention. Alternatively, as previously indicated, the rear end of the, catheter 12 can be left in its sealed position within the rear end of the needle 115b and the neck 121 of the barrel 115a attached to the infusion bottle assembly connector 40.
The next embodiment of the invention to be described is a catheter injection device secured to an infusion bottle assembly before injection of the catheter, and wherein the liquid from the infusion bottle assembly is used as the catheter impelling fluid and infusion of the liquid into the blood vessel may begin immediately after injection of the catheter into the patient without any additional operations except for the adjustment of the pinch clamp of the infusion bottle assembly to control the rate of flow of the infusion liquid.
THE EMBODIMENT OF THE INVENTION OF FIGS. 27-34 A catheter injection device 164 is shown in FIGS. 27-34 initially packaged in a sterilized state in a suitable transparent container or bag 165 made of a transparent synthetic plastic sheet material in which the device may be gas sterilized in a conventional way. The catheter injection device 164 includes a catheter containing body assembly 166 comprising a main tubular body portion 166a which may be made of a suitable synthetic plastic tubing. The rear end of the tubing terminates in a bulb-like portion 166b, also made of a synthetic plastic material, which is the fluid pressure applying means of the catheter injection device 164. The catheter containing body assembly further includes a hollow needle hub 168 which is somewhat larger than the tubing 166a and over which hub the tubing is securely anchored. A needle 166c is anchored within the hub 168. The needle lumen 170 forms a continuation of an open-ended passageway 174 within the tubing 166a. The catheter 12 extends through the passageway 174 and part of the length of the needle 1660. Where the length of catheter desired is longer than the distance between the bulb-like portion 16612 of the catheter containing body assembly 166 and a point near the forward end of the needle 1660, the catheter 12 is coiled up within the bulb-like portion 166b.
The bulb-like portion 166b is most advantageously a member having a dome-shaped depressible wall 175 joining a generally cylindrical side wall 177 through a thickened annular portion 179. The tubing 166a extends within an extension 180 of the cylindrical wall 177 where the tubing communicates with a chamber 182 within the bulb-like portion 16Gb. A short tubular section 184 communicates with the chamber 182 and forms a nose portion for snugly receiving the connector 40 at the end of the infusion bottle assembly 39.
The depressible dome-shaped wall 175 when depressed snaps into an inverted shape as shown in FIG. 31, so that once the bulb is compressed, the depressed wall 175 remains collapsed to avoid the possibility of creating a negative pressure in the catheter injection device which could draw air into the device after the catheter 12 has been injected into the patient by depression of the wall 175 and the needle 166a is withdrawn from the blood vessel involved.
The end of the needle 1660 carries a needle cover 185 to which is attached a tubular catheter holding member 187 which has the same construction and function as the aforesaid described catheter holding member 160 referred to in connection with the description of the embodiment of the invention shown in FIGS. 23-26. The base portion of the needle 1660 is initially tightly enveloped by the nose portion 190 of an infusion liquid-receiving connector 189 which has a hollow cylindrical rear portion 191 which fits within the front end of a needle retraction sleeve 194. The rear end of the needle retraction sleeve 194 has a tapered portion 194a which defines an opening 196 into a cylindrical space 199 within the sleeve 194. The tubing 166a fits with a slide friction fit into the opening 196. The needle hub 168 with the tubing 166a thereover makes a slide friction fit within the sleeve 194. When the catheter injection device is packaged, however, the needle hub 168 is positioned from the infusion liquid-receiving connector 189, as best shown in FIGS. 27 and 29.
As best shown in FIG. 34, the internal construction of the connector 189 resembles that of the front portion of the infusion liquid-receiving connector utilized in the other embodiments of the invention. Thus, the cylindrical rear portion 191 of the connector 189 has a cylindrical opening 200 for snugly receiving the end of the connector 40 of the infusion bottle assembly 39. Connector 189 is also provided with a recess 202 for receiving the outermost enlarged portion 12b of the rear end of the catheter 12. The nose portion 190 of the connector 189 has a passageway 206 therein which is somewhat smaller in size then the first enlargement 12a at the end of the catheter l2 and of the needle 1666.
To connect the catheter injection device to an infusion bottle assembly, the package 165 is opened and the end portion thereof including the bulb-like portion l66b is removed from the package and the projecting nose portion 184 thereof is connected to the connector 40 at the end of the infusion bottle assembly 39 as best shown in FIG. 28. To prepare the catheter injection device for use, while the rest of the catheter injection device is left in the package 165, the package with the device therein is picked up and held so that the tip of the catheter holding member 187 carried thereby are removed by pulling the same from the end of the needle. The needle 1660 is then inserted into the blood ves sel involved after a tourniquet has been applied in the usual manner for catheter injection and the depressible wall of the bulb-like portion 16612 is depressed to inject the catheter 12 into the blood vessel involved.
There are two ways in which the catheter injection device now can be utilized for feeding of infusion liquids. In the more commonly used application of the invention, such as intravenous feeding and blood trans fusions it is desired to have infusion feeding through the entire assembly of the catheter injection device described. This use requires a full ejection of the catheter so a liquid tight seal is formed between the enlarged end of the catheter and the connector 189. After withdrawal of the needle from the patient, the user grasps the needle retraction sleeve 194 in one hand and pulls on the tubing 166a to bring the needle hub portion 168 closer to the rear of the sleeve 194 where the tip of the needle is retracted within the connector 189. The assembly of the connector 189 and the sleeve 194 may then be taped to the patients arm or other portion of the body where catheter injection has occurred, and infusion feeding proceeds by once again releasing the pinch clamp to the extent necessary to provide the proper feeding rate. The resumption of flow of infusion fluid through the bulb-like portion 166b will generally cause the depressed wall 175 thereof to return to its initial convex shape if it has not already been pushed into this shape in the manner described. The second application of the catheter injection device illustrated is one wherein all the components making up this device except the catheter 12 and the infusion liquid-receiving connector 189 are to be disposed of after injection of the catheter 12. In such case, the connection to the infusion bottle assembly is made through the connector 189. In such case, the needle 1660 is withdrawn from the blood vessel involved and the needle tip is retracted within the connector 189 in the same manner previously described. The connector 189 and the sleeve 194 are then grasped and squeezed so that the assembly of the catheter, connector and sleeve are held together as a unit. Then, the tubular body portion 166a is pulled so the needle 166s attached thereto is pulled over the enlarged end of the catheter as shown in FIG. 33 and is removed from the sleeve 194. The sleeve 194 then acts like the catheter holding skirt of the infusion liquid-receiving connectors of the previously described embodiments of the invention by preventing the catheter from dropping upon contaminating surfaces. The catheter is then pulled fully into the connector 189 where it is drawn into its extreme position therein, as shown in FIG. 34, and the sleeve 194 is pulled from the connector 189 and thrown away. The rear cylindrical portion 191 of the connector 189 is then connected to the connector 40 of the infusion bottle assembly also shown in FIG. 34.
The catheter injection device 164 could be modified so the bulb-like portion l66b is eliminated and the device integrated with the infusion bottle assembly tube 43 so the tubular body portion 166a forms a continuation of the tube 43. The bulb-like portion 166b can be merely a collapsible portion of the tube 43 or a collapsible drip chamber 43 for the infusion bottle (see FIG. 28) with a shut-off valve provided above the same (not shown).
It is apparent that the various embodiments of the present invention provide an exceedingly effective, easy to use, and relatively inexpensive means for injecting catheters into blood vessels. As previously indicated, the same principles of the invention utilized in the injection of catheters by liquid into blood vessels can be applied in injecting catheters or other slim elongated members into other passageways of the body with liquid or air.
It should be understood that numerous modifications may be made in the most preferred forms of the invention described without deviating from the broader aspects of the invention.
1. A medical injection device for injecting an elongated member into a passageway of the body of an animal or human, the device including a housing having a feeding nose portion with means for emplacing the feeding nose portion in said passageway and from which feeding nose portion said elongated member is to be ejected into said passageway after the feeding nose portion has been inserted therein, said feeding nose portion having an open-ended lumen communicating with a fluid-holding space within said housing, a limp elongated member to be injected into said passageway located in said space and having its front end extending into or in close proximity to said feeding nose portion lumen where at least when pressure is applied to said space there is a clearance between said elongated member and the defining walls of said feeding nose portion lumen and so the entire front end of the elongated member and the portion behind the same except for the rear end portion thereof can be impelled through said feeding nose portion lumen and be guided thereby into said body passageway said elongated member having a gum rubber-like limp consistency, means for preventing the ejection of the rear end portion of said elongated member from said feeding nose portion lumen, and means for selectively applying pressure to fluid in said space to provide a cushion of fluid flowing around said elongated member and out of said feeding nose portion which fluid cushion impels the elongated member through the outer end of the feeding nose portion lumen where it is ejected from the device.
2. The injection device of claim 1 wherein said feeding nose portion is a eannulated needle whose front end can pierce skin and tissue, and said injection device includes means for preventing the reverse movement of said catheter after termination of said application of fluid pressure.
3. The injection device of claim 1 wherein said elongated member has a permanently unset conformation so it has a substantially straight conformation when guided into such a conformation, said elongated member having a portion coiled a number of times in said housing so it has a length much greater than the length of said barrel-like member and held in a coiled condition where the catheter readily uncoils.
4. The injection device of claim 1 wherein said feeding nose portion is a eannulated needle adapted to be extended into a blood vessel into which the member is to be injected.
5. The injection device of claim 1 wherein said elongated member is beveled at the front tip thereof.
6. The injection device of claim 4 wherein said fluid is a sterile liquid, said housing is initially completely separate from said liquid, the assembly of said housing and feeding nose portion and elongated member being packaged dry in a sterile condition and sealed within an enclosure, and said housing includes liquid-passing connecting means for externally connecting the same to a source of said liquid when said enclosure is opened to permit such connection.
7. The injection device of claim 6 wherein said is a barrel-like member, and said fluid forcing means is a syringe-like unit containing said sterile liquid.
8. The injection device of claim 1 wherein the elongated member is resilient and has a permanently unset conformation so it has a substantially straight conformation when guided into such a conformation, said elongated member having a portion coiled a number of times within the housing so it has an overall length much greater than the length of the housing, and said coiled portion of said elongated member resiliently engaging a portion of said housing which holds the coils in position readily to unwind one coil at a time.
9. A medical injection device for injecting an elongated member into a passageway of an animal or human, the device in-cluding a housing having a feeding nose portion from which nose portion said elongated member is to be'ejected into said passage-way, and includes means for emplacing the feeding nose portion in said passageway, said feeding nose portion having an open-ended lumen communicating with a space for holding liquid within said housing, a elongated member to be injected into said passageway and located in said housing space and having its front end extending into or in close proximity to said feeding nose portion lumen where at least when pressure is applied to said space there is a clearance between said elongated member and the defining walls of said feeding nose portion lumen and so the entire front end of the elongated member and the portion behind the same except for the rear end portion thereof can be impelled through said feeding nose portion lumen, said elongated member having a gum rubber-like consistency, means for preventing the ejection of the rear end portion of said elongated member from said feeding nose portion lumen, and means for selectively applying pressure to liquid in said space for pressurizing said liquid around said elongated member to provide a cushion of liquid flowing around said elongated member and out of said feeding nose portion which impels the elongated member through the outer end of the feeding nose portion lumen where it is ejected from the device, and the clearance space between the elongated member and the walls of the nose portion lumen being so small during application of said pressure that a relatively small volume of liquid relative to the volume of liquid required to fill said space is required to impel the entire length of the elongated member into said passageway.
10. The injection device of claim 9 wherein said elongated member is a catheter where both ends thereof are initially open so flow of said liquid through said catheter is theoretically possible, but the relative size of the catheter interior and exterior dimensions and that of said clearance between the catheter and the feeding nose portion lumen are such that the relative friction and pressure condition inside and around the catheter result in little or no liquid passing through the catheter during the ejection thereof from said feeding nose portion of the device.
11. The injection device of claim 1 wherein the elongated member is a catheter open at both ends and which can expand outwardly when there is a positive pressure inside the catheter, and the clearance space between the catheter and the wall of the surrounding nose portion passageway during catheter injection is such that the pressure conditions around the catheter will be greater than the pressure conditions within the catheter so that the catheter will not expand outwardly against the walls of the feeding nose portion lumen to jam therein during catheter injection.
12. The injection device of claim 11 wherein the elongated member is a catheter open at both ends and is made of a relatively flexible material which can expand outwardly when there is a positive pressure inside the catheter, and the rear end of the catheter has an enlargement which, when the end of the catheter reaches the feeding nose portion lumen, leaves little or no clearance space between the catheter and thewalls of the feeding nose portion lumen, so that suddenly pressure in the catheter expands the catheter outwardly positively to lock the same against the walls of the feeding nose portion lumen to prevent the end of the catheter from leaving the same.
13. The injection device of claim 1 wherein said fluid is a sterile liquid and said housing has relatively deep annular pockets at the periphery thereof which catch and hold gas bubbles.
14. The injection device of claim 13 wherein said pockets are formed by semi-rigid but flexible longitudinally spaced pleats formed in the walls of said housing to form accordian pleated-like fluid forcing means, the housing being longitudinally collapsible by collapsing said pleats, to provide the pressure therein for ejecting the elongated member from the device into said passageway.
15. The injection device of claim 1 wherein said pressure applying means comprise pleats formed in said housing enabling the housing to expand or contract at least about 10% of its normal extent and said housing is initially completely filled with a sterile liquid constituting said fluid.
16. A device for feeding a catheter through a hollow feeding nose portion into a blood vessel or other passageway, the device comprising: a body from which the feeding nose portion extends, the body and feeding nose portion defining a space, a catheter in said space to be fed through the feeding nose portion into the passageway involved, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which prevents the passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such that, by manually pulling on the portion of the catheter projecting from the feeding nose portion, the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose portion.
17. The device of claim 16 wherein the device is provided with a liquid-passing connector adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said liquid-passing connector and catheter, on the one hand, and at least said feeding nose portion of said body on the other hand being manually separable after the catheter has been injected into said passageway, and said connector having a passageway initially in spaced surrounding relationship with said catheter and with a passageway portion within which the rear end portion of the catheter sealingly tits at least after the catheter has been injected into said passageway and at least said feeding nose portion of said body has been separated from said catheter and connector.
18. The device of claim 17 wherein said enlarged portion at the end of the catheter includes an inner section of intermediate enlargement which sealingly fits within said connector passageway, functionally to hold the same in place thereon, and an outer section of maximum enlargement which acts as a stop preventing the pulling of the catheter through said connector unit passageway.
19. The device of claim 17 wherein there is provided means forming 'an enclosure for said catheter which supports the rear end portion of the catheter when the catheter is separated from said feeding nose portion and is pulled toward the front of the connector sealingly to seat the enlarged rear end portion of the catheter in said passageway portion.
20. The injection device of claim 6 in combination with a sterile liquid containing means having connecting means interfitted with said connecting means of said device, said sterile liquid containing means being a syringe unit with a plunger which can force sterile liquid through said connecting means into said housing to eject said elongated member therefrom.
21. A device for injecting an elongated member into a passageway of an animal or human, the device comprising an initially liquid-free housing having a feeding nose portion projecting therefrom and from which feeding nose portion said elongated member is to be ejected into said passage-way, said feeding nose portion having an open-ended lumen communicating with a space within said housing, an elongated member to be injected into said passageway and located in said space and having its front end portion extending or extendable into said feeding nose portion where the entire front end of the elongated member and the portion behind the same except for the rear end portion thereof can be impelled through said feeding nose portion when liquid pressure is built up in said space, said housing including a liquid-passing connector for externally connecting the same to a complimentary connector of an initially separate sterile liquid containing unit and a removable member retaining means attached to the feeding nose portion for holding the elongated member against movement from the feeding nose portion, so air can first be removed from the device by forcing liquid around the member from said liquid containing unit without feeding the member from the device, said member retaining means including an outer sleeve portion removably secured around said feeding nose por-
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