US3780732A - Non-gravitational infusion set - Google Patents

Non-gravitational infusion set Download PDF

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US3780732A
US3780732A US00132516A US3780732DA US3780732A US 3780732 A US3780732 A US 3780732A US 00132516 A US00132516 A US 00132516A US 3780732D A US3780732D A US 3780732DA US 3780732 A US3780732 A US 3780732A
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plates
assembly
bag
infusion
edges
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S Leibinsoh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/12Pressure infusion

Definitions

  • ABSTRACT A pressure-applying device for use in an infusion set for feeding blood, saline solution or other fluids from a compressible bag to a catheter or needle for administration to a patient.
  • the device comprises at least a pair of highly resilient, arcuate shaped metallic plates pivoted along their adjacent edges and drawn together along their free edges by buckles or clasps.
  • the present invention relates to infusion apparatus, and more particularly to a novel sterile fluid infusion set of the non-gravitational type which is adapted to provide positive fluid flow for infusion, regardless of the relative positioning of the infusion set with regard to the patient.
  • the infusion set may be provided with a drip chamber which prevents air from entering into the flow of the exiting fluid even in cases where the orientation of the drip chamber may become accidentally altered during use.
  • Infusion apparatus finds widespread use in the medical field.
  • the fluid to be introduced into the body is typically'fed from a suitable container (e.g., of glass or plastic) supported a predetermined distance above the patients body, infusion being effected by gravity flow.
  • a suitable container e.g., of glass or plastic
  • infusion being effected by gravity flow.
  • a suitable container e.g., of glass or plastic
  • an extra person is needed to hold the infusion bottle or other container above the patient and thus provide gravitational infusion of the fluid.
  • the present invention is characterized by providing an infusion set which may be readily and simply attached to a stretcher, or any other support or surface, which need not be elevated above the patient treated and, in fact, may be suspended a predetermined distance below the patient or may simply be laid upon a hospital bed or stretcher alongside the patient, and which, at the same time, effects fluid infusion at a substantially controlled and constant rate.
  • THe present invention comprises an assembly having at least first and second arcuate shaped highly resilient members adapted to receive a compressible fluidcontaining bag between their convex surfaces.
  • the resilient members are covered by suitable heavy-duty woven fabric sheets which further serve as pivoting means aligned along a pair of adjacent edges of the arcuate shaped sheets.
  • the opposite free ends of the fabric sheets are provided with suitable fastening means adapted to retain the arcuate sheets in close proximity to one another so as to exert a large compressive force upon the compressible fluid-containing bag positioned therebetween.
  • the force exerted upon the compressible bag by the arcuate shaped resilient sheets is of significant magnitude as to enable and provide for fluid flow of a sufficient magnitude, regardless of the relative positioning between the infusion setand the body of the patient receiving the sterile fluid, thereby enabling the bag to be supported at a height which is the same as or even below that of the patient, while still providing for adequate fluid flow from the compressible bag to the patient, which flow may further be controlled by valve. and/or dripchamber means.
  • the pressure-applying device includes restraining means for limiting or preventing lateral movement of the fluid-containing bag during compression thereof.
  • restraining means for limiting or preventing lateral movement of the fluid-containing bag during compression thereof.
  • Such means which may comprise a sleeve for receiving the infusion bag, a belt for winding about the bag, or simply an adhesive surface for engaging the bag or the belt, frictionally engages the infusion bag to prevent its expulsion from, and maintain it within, the pressureapplying means during compression thereof and thus facilitate substantially continuous and uniform dispensing of the blood, saline solution or other fluid.
  • the basic components of an infusion set include the fluid container and a catheter or needle coupled thereto by suitable tubing.
  • the pressure-applying means of this invention is suitably employed in combination with these components and, typically, a stopcock or other valve means and a drip chamber for regulating the flow of the fluid infused.
  • infusion sets provided in accordance herewith may incorporate conventional catheters, drip chambers and stopcock elements, it is preferred that the drip chamber employed be of the type described in my copending application entitled Drip Chamber For Infusion Set", Ser. No. 132,789, filed Apr. 7, 1971, now US. Pat. No. 3,721,689.
  • the infusion set described hereinabove is especially adapted for use in-military applications and is ideally suited for battlefield conditions.
  • the compressive forces developed by the arcuate shaped springy members assure continuous, uniform infusion and further act to prevent cannula clogging and reverse flow.
  • the valve means controlling flow the contents of an infusion bag may be rapidly emptied. For example, 1000 ml. may be infused through an 8X 5 inch Fr. cannula within 10-12 minutes and through a 14 gallon needle in less than 5 minutes.
  • the compressive forces eliminate the need for a support normally required for conventional gravity flow systems in that the structure is capable of developing pressure equivalent to a head of cc.
  • the structure permits easy transportation of casualties in battlefield conditions as well as in ambulances, helicopters, planes or other air or ground vehicles.
  • the versatility of the infusion set permits its use under normal conditions such as exist in hospitals, clinics andthe like.
  • the infusion set is adaptable for use with all commercially available infusion bags (i.e., 400, 500 or 1000 ml.), is simple to use requiring no instruments or tools of either special or general purpose design, is quite durable and is capable of being applied in an unlimited number of applications.
  • the nature of the compressive structure is such as to provide an extremely rugged, unbreakable device having an indefinite shelf-life under any climatic conditions, and having the further added feature of providing excellent protection from an infusion bag which may be stored therein, thus minimizing the risk of rupture or other damage, when, for. example, an infusion set incorporating the same is dropped by parachute to a battlefield site or the like.
  • FIG. 1a is a top plan view of an infusion apparatus embodying the principles of the present invention
  • FIG. 1b is an end view of the embodiment of FIG.
  • FIG. 10 is a bottom plan view of the embodiment of FIG. 1a;
  • FIG. 1d is a sectional view of a portion of the infusion apparatus of FIG. 1c looking in the direction of arrows 1d1d,'
  • FIG. la is an end view of the embodiment of FIGS. 1a 1c in the closed (operating) position and containing a compressible fluid bag;
  • FIG. If is an end view of the embodiment of FIGS. 1a 1c in the closed (storage) position
  • FIGS. 2a and 2c are top and bottom plan view, respectively of another, preferred embodiment of the present invention.
  • FIG. 2b is an end view of the embodiment of FIGS. 2a and2c, showing the infusion assembly in the open position preparatory to use;
  • FIG. 2d is an end view of the embodiment of FIGS. 2a 2c showing the infusion assembly in the closed (operating) position and containing a compressible fluid container;
  • FIG. 2e is a sectional view of a portion of the embodiment of FIG. 20 looking in the direction of arrows 2e 2e;
  • FIG. 2f is an end view of another preferred embodi ment of the present invention.
  • FIG. 3 is a plot showing curves useful in explaining the advantages'of the present invention as compared with conventional gravity-flow techniques.
  • FIGS. 2a 2e One preferred embodiment of the present invention is shown in FIGS. 2a 2e.
  • the apparatus 100 shown therein is comprised of a pair of arcuate-shaped members 101 and 102 which consist of first and second arcuate-shaped metallic plates 103 and 104, shown best in cross-sectional view of FIG. 2b.
  • the plates in addition to being arcuate in shape, have a high degree of resiliency so as to retain their arcuate configuration in the absence of any external forces.
  • the plates are described as being formed of metal, it should be understood that the plates may also be formed of a resilient plastic or other suitable material.
  • the plates 103 and 104 are covered on both surfaces thereof, as well as along their perimeters, with a heavy duty fabric such as, for example, a heavy canvas material.
  • a heavy duty fabric such as, for example, a heavy canvas material.
  • one continuous piece of fabric comprised of top portions 105a and 105b, covers the convex surfaces of metallic sheets 103 and 104, respectively.
  • the concave surfaces are also covered by the single sheet of fabric, whereby portions 106a and l06b are folded around the edges of plates 103 and 104 to cover the concave surfaces of sheets 103 and 104, respectively.
  • the fabric sheets are joined to one another along the remaining portions of the perimeter of each of the metallic plates 103 and 104, preferably by being sewn together.
  • sheet portion 105a has its extreme left-hand edge surrounding the left-hand edge 1030 of plate 103.
  • Lower sheet portion 106a is bent inwardly upon itself, as shown at 106a, with the; two sheets being sewn together, as shown at 107.
  • the fabric sheet portions 105b and 106b are joined together about the remaining perimeter of metallic sheet 104 in a similar fashion and are sewn together along their engaging margins at the location shown by the numeral 1061).
  • Sheets 105a and l05b terminate at the center line of the structure designated by phantom line 108 and are folded under, as shown at 105a and l05b'.
  • the metallic rivets 109 pierce these fabric sheet portions and metallic sheets and act to firmly secure the heavy-duty fabric to the arcuate shaped metallic sheets.
  • the rivets 109 are shown best in the top view of FIG. 2a which shows the convex surfaces and the bottom view of FIG. 20 which shows the concave surfaces of the pair of arcuate assemblies 101 and 102.
  • Assemblies 101 and 102 are of equal length and have their free ends respectively tapered, at 110 and 110a.
  • a heavy-duty woven fabric belt 111 is joined to arcuate assembly half 102 by means of rivets 102.
  • belt 111 is substantially an elongated member and, in one actual embodi ment, has a length of approximately 20 inches.
  • a buckle assembly 113 is mounted to assembly half 101 and is comprised of a short section 114 of a heavy duty woven fabric belt secured to assembly half 101 by rivets 115.
  • the free end of the short belt portion 114 is secured between a slightly curved metallic sheet 1 l6 and a narrow, elongated metallic sheet 117 by means of rivets 118.
  • the slightly arcuate shaped metallic sheet 116 is provided with a pair of ears 118 and 119 which are bent to surround a rod 120 secured at its opposite ends to a rectangular-shaped buckle member 121.
  • slightly arcuate shaped member 116 is provided with a serrated edge 122 which cooperates with the buckle member 121 to lock belt portion 111 which has passed through the region designated by dotted line 1 11 so as to retain the assembly in the infusion state, which will be more fully described hereinbelow.
  • the short belt section 114 is secured between a narrow, elongated plate 123 and assembly half 101 by the rivets 115.
  • the belt extends further to the right of plate 123 and is looped over itself to form a narrow opening for a substantially C-shaped clip 124 whose free ends 1240 and 124b extend into the opening formed in belt portion 114.
  • the looped over belt portion is sewn to the remaining belt portion, as shown by dotted lines 125.
  • Clip 124 is further provided with a second clip 126 which may be utilized to releaseably support or hang the infusion bag assembly upon a belt loop, or any other structure for that matter, to facilitate either carrying or actual usage of the assembly.
  • Belt 111 is secured between assembly half 102 and an elongated metallic plate 130 by means of the rivets 112.
  • FIG. 2e is a sectional view of a portion of assembly half 102 looking in the direction of arrows 2e2e and shows the manner in which the fabric sheets are joined together along the lower edge.
  • Metallic sheet 104 is positioned between the fabric sheets 106b'and 105b.
  • the marginal edge of fabric sheet 105b is bent under, while the marginal portion of fabric sheet 1061; is bent around the marginal edge of metallic sheet 104.
  • the engaging marginal portions are sewn together at 131.
  • the perimeters of both assembly halves 101 and 102 have their fabric sheets joined together in a similar fashion.
  • FIG. 2b shows the assembly as being further provided with a retaining means comprising a pair of sleeves 132 and 133 for retaining compressible bags of fluids which may, for example, be blood plasma, or any other sterile fluid which is to be infused into the body of a patient.
  • the sleeves are formed from a single sheet of heavyduty woven fabric material 134. One free end 134a of the single sheet is secured to assembly half 102 by means of the rivets 109. The sheet extends away therefrom to first form the left-hand side, top side and righthand side of sleeve 132.
  • the sheet then extends upwardly to form the left-hand side, top side and righthand side of sleeve 133, with the extreme free end l34b extending beneath point 135 where the right-hand side of sleeve 132 and the left-hand side of sleeve 133 share a common boundary.
  • the single sheet is then sewn together at location 136.
  • the thread employed to sew the single sheet of fabric 134 to itself is also further sewn through the center line of the single sheet comprised of sheet halves 106a and 106b along the line coincident with the central axis 108 of the assembly. If desired, one end of each sleeve may then be sewn closed to form corresponding pockets.
  • sleeve 132 is larger than sleeve 133 so as to accommodate a compressible plastic bag of larger size (and hence, volume).
  • sleeve 133 may be adapted to-accommodate a compressible plastic bag of sterile fluid having a capacity of 500 milliliters, while sleeve 132 may be adapted to receive a compressible plastic bag having a capacity of 1000 milliliters.
  • the sleeves (132 or 133) serve to retain a compressible fluid bag between the arcuate plates while during the time the plates are moved to the operating position. The manner of use of the sleeves is as follows:
  • the compressible bag is inserted into the sleeve whose opening is closest in size to the compressible fluid bag.
  • the free ends of springy plates 103 and 104 are moved from the position substantially as shown in FIG. 2b to the position shown in FIG. 2d. Closure and locking of the plates is accomplished by drawing belt 111 (see FIG. 2d) through buckle assembly 113. Although the closing of the plates 103 and 104 would otherwise tend to urge the compressible bag out from between the plates, the sleeve prevents this from occurring.
  • FIG. 2f One alternative arrangement to the sleeves 132 and 133 which may be employed is shown in FIG. 2f and is comprised of an elongated strap 140 having a first end thereof 141 sewn or otherwise secured to assembly half 101.
  • the marginal portion of the free end of strap may be provided with a strip 142 of an adhesive material which may be releaseably secured to surface portion 143 provided along the convex surface of assembly half 102 in close proximity to the center line 108 of the assembly.
  • a VELCRO fastener assembly may be employed, wherein the strip 142 may be comprised of the loop portion of a VELCRO fastener, while the strip 143 may be comprised of the hook portion of a VELCRO fastener so as to releaseably join strap 140 to surface 143.
  • VELCRO fasteners such assemblies, when joined together, are capable of remaining joined together even in the presence of great shearing stresses which may be exerted thereupon. I
  • the compressible bag of sterile fluid 145 is positioned between the two convex surfaces of assembly halves 101 and 102.
  • Strap 104 is positioned around the bag 145 in the manner shown best in FIG. 2f.
  • the strip 142 provided near the marginal end of strap 140 is then pressed against strip 143 so as to secure the compressible bag 145 and prevent the bag from moving in the direction shown by arrow 146.
  • the free end of belt 111 is threaded through the buckle assembly 113 in the manner shown in FIG. 2f, and is then pulled in the direction shown by arrow 147 to draw the outermost edges 101a and 102a of assembly halves 101 and 102 toward one another until the two outermost edges are either in close proximity or engage one another.
  • the resilient arcuate shaped metallic sheets 103 and 104 exert a counter-force which tends to urge the infusion assembly halves 101 and 102 apart.
  • the belt 111 in attempting to be pulled away from the buckle assembly 113, engages the serrated edge 122 of plate 116 so as to remain tightly fastened or wedged between the serrated edge 122 and buckle member 121 to prevent the assembly halves from moving apart.
  • the resilient metallic sheets thereby exert significant force upon the surfaces of the compressible bag of sterile fluid to cause the sterile fluid to be urged out of the bag through (see FIG. 2d) a piece of hollow tubing 148, valve 149, drip chamber and tubing 151, whose free end is provided with a suitable hypodermic needle 152 which may be inserted into the body to infuse the fluid into the body of the patient.
  • Valve assembly 149 may be employed to selectively cut off or enable fluid flow, while drip chamber assembly 150 may be utilized to regulate the rate of flow.
  • FIG. 2b The manner of use of the embodiment of FIG. 2b is substantially similar to that shown in FIG. 2f, except that the compressible bag of fluid is first inserted into the appropriate sleeve 132 or 133. The free end of belt 111 is then inserted through the buckle assembly in similar fashion to that described hereinabove to draw the outer ends of assembly halves 101 and 102 together so as to exert a significant compressive force upon the compressible plastic bag of sterile fluid.
  • the primary and significant feature of the infusion bag assembly resides in the fact that the assembly need not be positioned above the body of the patient so as to rely upon gravity to insure flow of the fluid from the bag or sterile container into the body.
  • the infusion bag assembly may even be mounted at or below the height of the person being carried or treated, since the relatively large compressive forces of the assembly are more than sufficient to squeeze the sterile fluid from the bag and into the body of the patient.
  • Accurate regulation of fluid flow may be controlled through the use of valve 149 and drip chamber 150, or through the use of any other suitable flow-regulating means.
  • FIG. 3 shows curves comparing the flow rate through the infusion set of FIGS. 2a-2c.
  • Curve A represents the infusion or expelling of a saline solution contained in a 1000 ml bag for an apparatus as shown in FIGS. 2a-2c which is located at the same height as the catheter. The curve indicates that the en- ,tire contents are expelled in 12 minutes.
  • Curve B represents the flow rate for an infusion set of the type shown in FIGS. 2a-2c which is located at a height of one meter above the catheter level. It can be seen that the entire contents are expelled within nine minutes.
  • Curve C represents the flow rate for a sterile fluid bag elevated at a height of one meter above the catheter level and in the absence of the infusion set hereof. It can be seen that 16 minutes are required to expel the entire contents of the fluid container. Similar results have been obtained for other solutions such as, for example, a dextrin solution from which the entire contents of a 560 ml fluid container are expelled within 11% minutes, while 17 minutes are required to expel the entire contents of a bag positioned at one meter above the catheter level in the absence of the nongravitational infusion set. The entire contents of a 560 ml container can be expelled within 9 minutes when the infusion set of FIG. 2a-2c is positioned one meter above the catheter level. Similar results have been obtained for other fluids, including blood.
  • the assembly 100 When not in use, the assembly 100 may be made quite compact by threading the belt 111 through the buckle assembly 113 in a manner similar to that described above, with the exception that no compressible bag of fluid be inserted between the assembly halves 101 and 102.
  • the assembly 100 may then be carried in any suitable mmanner such as inside of a field pack, clipped to the exterior of a field pack, or clipped to a waist belt or any other suitable place or location.
  • the assembly 100 which is formed of a very heavyduty fabric and a heavy-duty buckle assembly and fabric belt, is relatively indestructible and have an extremely long, useful operating life. In addition, the effectiveness of the assembly 100 will not be reduced or significantly altered as a result of exposure to outside elements or influences, such as rain, sleet, snow, salt water, dirt, dust, or any other influences which may normally be considered to be harmful.
  • the arcuate shaped metallic sheets in one preferred embodiment, are preferably formed from a springy, resilient steel, and it has been found that no significant reduction in effectiveness of the plates has occurred even after continued use, regardless of the conditions or situations in which the assembly is used.
  • FIGS. la-lf show another preferred embodiment 10 of the present invention, which is comprised of a plural ity of arcuate shaped metallic sheets 11 (a total of eight being employed in the assembly shown in FIGS. la and 1c, for example).
  • the assembly half 12 utilizes four of the arcuate shaped metallic sheets which are arranged in side-by-side fashion and inserted within separate sleeves l3l6, which sleeves are formed from a pair of heavy-duty woven fabric sheets 17 and 18, which are sewn together along the top, bottom and right-hand edges of assembly 12 and are further sewn along lines 19, 20 and 21 so as to form four individual sleeves which are open along their left-hand edges to permit insertion of each of the associated arcuate shaped rnetallic sheets 11.
  • the metallic sheets 11 are each retained within their associated sleeves by rivets 22.
  • the rivets 22 further serve to secure one cooperatingportion of a clasp assembly, which portions are designated by the numerals 23a-23d, respectively. Since the clasp portions 23a-23a' are substantially identical in design and function to one another, only one such assembly will be described herein for purposes of simplicity.
  • this clasp portion can be seen to be comprised of a mounting bracket 24 having a pair of mounting portions 2441-2412 (see FIG. 1b), which portions are joined to sleeve 13 by rivets 22.
  • Mounting portions 24a and 24b are integrally joined to one another by means of a yoke portion 24c, which yoke portion forms an opening for receiving the free ends 25a and 25b of a clasp membler.
  • Clasp member 25 is free to pivot about the yoke portion in either direction, as shown by the double-headed arrow 26 of FIG. lb.
  • the remaining half 12' of infusion bag assembly 10 is formed of two heavy-duty fabric sheet members 17 and 18' similar to those described hereinabove, which sheets are joined or sewn together so as to form the separate sleeves 13'16, each of which receives one of the arcuate-shaped metallic plates 11.
  • Assembly half 12 is provided with four clasp portions 27a-27d, each of which cooperate with an associated clasp portion 23a-23d, respectively, in a manner to be more fully described. Since each of the clasp portions 27a-27d are similar in design and function, only one will be described herein for purposes ofsimplicity.
  • the assembly 27a is comprised of a mounting bracket 28 having a pair of similar mounting halves 28a and 28b secured to sleeve 13' by rivets 22.
  • the mounting portions 28a and 28b are integrally joined to one another by a yoke portion 28c which has a substantially triangular shaped configuration, as can best be seen from FIG. lb, so that the head portion may be snappingly received by the associated buckle 25, in a manner to be more fully described.
  • a compressible plastic bag of sterile fluid is positioned between the convex surfaces of assembly halves l2 and 12 in the manner shown best in FIG. 1b. Halves 12 and 12 are then moved toward one another in the directions shown by arrows 29a and 2912 until the outer free ends of assembly halves l2 and 12' are brought into engagement. Each of the buckles 25 is then snapped over its associated head 280 where they re main locked in the position shown best in FIG. 1e.
  • the highly resilient arcuate shaped metallic members exert a relatively high compressive force against bag 145 to squeeze the fluid from the bag and preferably through the valve, drip chamber and injection or hypodermic needle assembly of the type shown best in FIG. 2d. It should be understood that all four clasp assemblies are locked into position in the manner shown best in FIG. 12.
  • the initial pressure applied to a com pressible fluid bag was 0.15 atmospheres (equal to about 1.5 meters of water) which yielded a flow rate of approximately 100 ml per minute at the initial stages, which flow rate decreased to about 70 ml per minute near the end of the infusion.
  • FIGS. la-lf may be provided with a releaseable clasp or other hardware for suspending the infusion bag assembly 10 from a stretcher or a field pack, for example, either during use or while being transported.
  • the assembly 10 When not in use, the assembly 10 may be made quite compact either by drawing the two concave surfaces toward one another in the manner shown in FIG. 1f or, alternatively, by bringing the two convex surfaces toward one another in the manner shown in FIG. 12, with the exception that no compressible sterile fluid bag is inserted therebetween.
  • the clasps are then joined either in the manner shown in FIG. 1f, or in the manner shown in FIG. 1e to render the assembly quite compact during either storage or transportation thereof.
  • a compressible bag may be stored between the members 12 and 12' when in the position of FIG. If.
  • the plates exert only a mild force upon the compressible fluid bag so as not to stress the bag when not in use.
  • the distinct advantage of storing compressible bags in this manner is to protect the compressible bag during storage, handling or transportation.
  • the embodiment of FIG. 2 may be utilized in a similar'fashion.
  • the assembly 10 of FIGS. la-lf may be provided with a strap of the type shown in FIG. 2e, or one or more sleeves of the type shown in FIG. 2b to facilitate retention of the compressible sterile fluid bag between the convex surfaces of the assembly halves l2 and 12 so as to retain a compressible fluid bag between the assembly halves when they are moved to the position of FIG. 1e.
  • any other suitable hinge means may be employed for pivotally connecting the curved, springy, metallic sheets in addition to the employment of the heavy-duty fabric sheets as the means for pivotally connecting the metallic sheets.
  • the present invention provides a novel non-gravitational infusion bag set for squeezing sterile fluid, and the like, from a compressible fluid bag, wherein the assembly is quite compact to facilitate storage and transportation, while having a unique design to enable infusion of sterile fluid, and the like, from a compressible bag in a nongravitational manner, thus eliminating the need for mounting or supporting the sterile fluid container a significant distance or height above the body of the patient, as is required in conventional infusion techniques which primarily rely upon gravitational flow.
  • the assembly is thus uniquely adapted for use in situations in which fluid flow by gravity is either impractical or impossible, such as, for example, the use in battlefield, riot or other disaster conditions which restrict or otherwise render impossible the infusion of a fluid into a patient through normal gravity flow techniques.
  • An assembly for exerting pressure upon a compressible fluid container comprising:
  • hinge means for hingedly mounting said inner edges of the plates to one another in substantial parallelism for pivotal movement of the plates into facing relation with the convex surfaces of the plates facing one another;
  • clasp means mounted along said outer edges of the plates for securing said edges to one another and thereby holding the plates in close proximity to one another with the convex surfaces thereof adapted to apply pressure to a compressible fluid container positioned between said plates;
  • restraining means for limiting movement of the compressible fluid container transversely of said first and second plate edges to facilitate compression of the container and dispensing of the fluid therefrom by said assembly;
  • said restraining means comprises a hollow sleeve secured to said sheath in the region of said hinge and along the concave side of said plates for receiving a compressible fluid bag to prevent movement of said bag when said plate halves are being moved to the operating position.
  • said restraining means further comprises a plurality of hollow sleeves of different diameters secured to said sheath in the region of said hinge and along the concave side of said plates for receiving compressible fluid bags of varying sizes, each of said sleeves preventing movement of the bag received therein as said plate halves are moved to the operating position.

Abstract

A pressure-applying device for use in an infusion set for feeding blood, saline solution or other fluids from a compressible bag to a catheter or needle for administration to a patient. The device comprises at least a pair of highly resilient, arcuate shaped metallic plates pivoted along their adjacent edges and drawn together along their free edges by buckles or clasps. When pivoted into facing relation the adjacent convex surfaces of the plates act to squeeze fluid from the compressible bag when positioned therebetween. Use of the device obviates the necessity to elevate the infusion bag during use, since infusion is effected by positive pressure rather than by gravity alone.

Description

Leibinsoh 1 Dec. 25, 1973 NON-GRAVITATIONAL INFUSION SET [76] Inventor: Saul Leibinsoh, ll Hagardom St.,
Rishon Lezion, Israel [22] Filed: Apr. 8, 1971 21 Appl. No.: 132,516
Related US. Application Data [63] Continuation-in-part of Ser. No. 753,405, Aug. 19,
i968, Pat. N0. 3,595,232.
[52] [1.8. CI. 128/214 F, l28/DIG.' 12, 222/336 Braley 128/402 Freedman 222/l03 Primary Examiner-Richard A. Gaudet Assistant Examiner-J. C. McGowan Attorney-Ostrolenk, Faber, Gerb & Soffen 57] ABSTRACT A pressure-applying device for use in an infusion set for feeding blood, saline solution or other fluids from a compressible bag to a catheter or needle for administration to a patient. The device comprises at least a pair of highly resilient, arcuate shaped metallic plates pivoted along their adjacent edges and drawn together along their free edges by buckles or clasps. When pivoted into facing relation the adjacent convex surfaces of the plates act to squeeze fluid from the compressible bag when positioned therebetween. Use of the device obviates the necessity to elevate the infusion bag during use, since infusion is effected by positive pressure rather than by gravity alone.
2 Claims, 13 Drawing Figures PATENTEU 3.780.732
SHEET 1 0F 4 NON-GRAVITATIONAL INFUSION SET BACKGROUND OF THE INVENTION This application is a continuation-in-part of my application, Ser. No. 753,405, filed Aug. 19, 1968, now US. Pat. No. 3,595,232 granted July 27, 1971, and is directed to an improved form of the infusion device thereof.
The present invention relates to infusion apparatus, and more particularly to a novel sterile fluid infusion set of the non-gravitational type which is adapted to provide positive fluid flow for infusion, regardless of the relative positioning of the infusion set with regard to the patient. The infusion set may be provided with a drip chamber which prevents air from entering into the flow of the exiting fluid even in cases where the orientation of the drip chamber may become accidentally altered during use.
Infusion apparatus finds widespread use in the medical field. For example, when it is desired to infuse blood or other sterile fluids into the body of a patient being treated, the fluid to be introduced into the body is typically'fed from a suitable container (e.g., of glass or plastic) supported a predetermined distance above the patients body, infusion being effected by gravity flow. in military or other field applications when, for example, the patient is carried on a stretcher an extra person is needed to hold the infusion bottle or other container above the patient and thus provide gravitational infusion of the fluid. In such situations, which may occur during warfare, riots, or other disaster conditions, it is extremely advantageous to permit infusion while eliminating the necessity for a third person to carry the fluid container.
One obvious technique for eliminating the noted problem involves the provision of a structure mounted to the stretcher to support the fluid container a predetermined height above the person being carried. In most cases, this approach is either awkward or impossible. lt thereby becomes extremely important to provide suitable alternative means for carrying out such infusion, while, at the same time, eliminating the need for a third person to accompany the stretcher bearers or eliminating the awkward support assembly which must be secured to the stretcher.
SUMMARY OF THE INVENTION The present invention is characterized by providing an infusion set which may be readily and simply attached to a stretcher, or any other support or surface, which need not be elevated above the patient treated and, in fact, may be suspended a predetermined distance below the patient or may simply be laid upon a hospital bed or stretcher alongside the patient, and which, at the same time, effects fluid infusion at a substantially controlled and constant rate.
THe present invention comprises an assembly having at least first and second arcuate shaped highly resilient members adapted to receive a compressible fluidcontaining bag between their convex surfaces. The resilient members are covered by suitable heavy-duty woven fabric sheets which further serve as pivoting means aligned along a pair of adjacent edges of the arcuate shaped sheets. The opposite free ends of the fabric sheets are provided with suitable fastening means adapted to retain the arcuate sheets in close proximity to one another so as to exert a large compressive force upon the compressible fluid-containing bag positioned therebetween. The force exerted upon the compressible bag by the arcuate shaped resilient sheets is of significant magnitude as to enable and provide for fluid flow of a sufficient magnitude, regardless of the relative positioning between the infusion setand the body of the patient receiving the sterile fluid, thereby enabling the bag to be supported at a height which is the same as or even below that of the patient, while still providing for adequate fluid flow from the compressible bag to the patient, which flow may further be controlled by valve. and/or dripchamber means.
In accordance with a further feature of the invention, the pressure-applying device includes restraining means for limiting or preventing lateral movement of the fluid-containing bag during compression thereof. Such means, which may comprise a sleeve for receiving the infusion bag, a belt for winding about the bag, or simply an adhesive surface for engaging the bag or the belt, frictionally engages the infusion bag to prevent its expulsion from, and maintain it within, the pressureapplying means during compression thereof and thus facilitate substantially continuous and uniform dispensing of the blood, saline solution or other fluid.
The basic components of an infusion set include the fluid container and a catheter or needle coupled thereto by suitable tubing. The pressure-applying means of this invention is suitably employed in combination with these components and, typically, a stopcock or other valve means and a drip chamber for regulating the flow of the fluid infused. Whereas infusion sets provided in accordance herewith may incorporate conventional catheters, drip chambers and stopcock elements, it is preferred that the drip chamber employed be of the type described in my copending application entitled Drip Chamber For Infusion Set", Ser. No. 132,789, filed Apr. 7, 1971, now US. Pat. No. 3,721,689.
The infusion set described hereinabove is especially adapted for use in-military applications and is ideally suited for battlefield conditions. The compressive forces developed by the arcuate shaped springy members assure continuous, uniform infusion and further act to prevent cannula clogging and reverse flow. Upon appropriate operation of the valve means controlling flow, the contents of an infusion bag may be rapidly emptied. For example, 1000 ml. may be infused through an 8X 5 inch Fr. cannula within 10-12 minutes and through a 14 gallon needle in less than 5 minutes.
The compressive forces eliminate the need for a support normally required for conventional gravity flow systems in that the structure is capable of developing pressure equivalent to a head of cc. In use, the structure permits easy transportation of casualties in battlefield conditions as well as in ambulances, helicopters, planes or other air or ground vehicles. Obviously, the versatility of the infusion set permits its use under normal conditions such as exist in hospitals, clinics andthe like. The infusion set is adaptable for use with all commercially available infusion bags (i.e., 400, 500 or 1000 ml.), is simple to use requiring no instruments or tools of either special or general purpose design, is quite durable and is capable of being applied in an unlimited number of applications. The nature of the compressive structure is such as to provide an extremely rugged, unbreakable device having an indefinite shelf-life under any climatic conditions, and having the further added feature of providing excellent protection from an infusion bag which may be stored therein, thus minimizing the risk of rupture or other damage, when, for. example, an infusion set incorporating the same is dropped by parachute to a battlefield site or the like.
THE DRAWINGS The preceding and other objects and advantages of the invention will become apparent from the following description taken in connection with the accompanying drawings in which:
FIG. 1a.is a top plan view of an infusion apparatus embodying the principles of the present invention;
FIG. 1b is an end view of the embodiment of FIG.
FIG. 10 is a bottom plan view of the embodiment of FIG. 1a;
FIG. 1d is a sectional view of a portion of the infusion apparatus of FIG. 1c looking in the direction of arrows 1d1d,'
FIG. la is an end view of the embodiment of FIGS. 1a 1c in the closed (operating) position and containing a compressible fluid bag;
FIG. If is an end view of the embodiment of FIGS. 1a 1c in the closed (storage) position;
FIGS. 2a and 2c are top and bottom plan view, respectively of another, preferred embodiment of the present invention;
- FIG. 2b is an end view of the embodiment of FIGS. 2a and2c, showing the infusion assembly in the open position preparatory to use;
FIG. 2d is an end view of the embodiment of FIGS. 2a 2c showing the infusion assembly in the closed (operating) position and containing a compressible fluid container;
FIG. 2e is a sectional view of a portion of the embodiment of FIG. 20 looking in the direction of arrows 2e 2e;
FIG. 2f is an end view of another preferred embodi ment of the present invention;
FIG. 3 is a plot showing curves useful in explaining the advantages'of the present invention as compared with conventional gravity-flow techniques.
THE PREFERRED EMBODIMENTS One preferred embodiment of the present invention is shown in FIGS. 2a 2e. Turning initially to a consideration of FIGS. 24 2c, the apparatus 100 shown therein is comprised of a pair of arcuate-shaped members 101 and 102 which consist of first and second arcuate-shaped metallic plates 103 and 104, shown best in cross-sectional view of FIG. 2b. The plates, in addition to being arcuate in shape, have a high degree of resiliency so as to retain their arcuate configuration in the absence of any external forces. Whereas the plates are described as being formed of metal, it should be understood that the plates may also be formed of a resilient plastic or other suitable material.
The plates 103 and 104 are covered on both surfaces thereof, as well as along their perimeters, with a heavy duty fabric such as, for example, a heavy canvas material. As shown best in FIG. 2b, one continuous piece of fabric, comprised of top portions 105a and 105b, covers the convex surfaces of metallic sheets 103 and 104, respectively. The concave surfaces are also covered by the single sheet of fabric, whereby portions 106a and l06b are folded around the edges of plates 103 and 104 to cover the concave surfaces of sheets 103 and 104, respectively. The fabric sheets are joined to one another along the remaining portions of the perimeter of each of the metallic plates 103 and 104, preferably by being sewn together.
Noting FIG. 2b, sheet portion 105a has its extreme left-hand edge surrounding the left-hand edge 1030 of plate 103. Lower sheet portion 106a is bent inwardly upon itself, as shown at 106a, with the; two sheets being sewn together, as shown at 107. The fabric sheet portions 105b and 106b are joined together about the remaining perimeter of metallic sheet 104 in a similar fashion and are sewn together along their engaging margins at the location shown by the numeral 1061). Sheets 105a and l05b terminate at the center line of the structure designated by phantom line 108 and are folded under, as shown at 105a and l05b'. The metallic rivets 109 pierce these fabric sheet portions and metallic sheets and act to firmly secure the heavy-duty fabric to the arcuate shaped metallic sheets. The rivets 109 are shown best in the top view of FIG. 2a which shows the convex surfaces and the bottom view of FIG. 20 which shows the concave surfaces of the pair of arcuate assemblies 101 and 102.
Assemblies 101 and 102 are of equal length and have their free ends respectively tapered, at 110 and 110a. A heavy-duty woven fabric belt 111 is joined to arcuate assembly half 102 by means of rivets 102. Although not shown for purposes of simplicity, belt 111 is substantially an elongated member and, in one actual embodi ment, has a length of approximately 20 inches.
A buckle assembly 113 is mounted to assembly half 101 and is comprised of a short section 114 of a heavy duty woven fabric belt secured to assembly half 101 by rivets 115. The free end of the short belt portion 114 is secured between a slightly curved metallic sheet 1 l6 and a narrow, elongated metallic sheet 117 by means of rivets 118. The slightly arcuate shaped metallic sheet 116 is provided with a pair of ears 118 and 119 which are bent to surround a rod 120 secured at its opposite ends to a rectangular-shaped buckle member 121. The left-hand end of slightly arcuate shaped member 116 is provided with a serrated edge 122 which cooperates with the buckle member 121 to lock belt portion 111 which has passed through the region designated by dotted line 1 11 so as to retain the assembly in the infusion state, which will be more fully described hereinbelow.
As can best be seen from FIG. 2c, the short belt section 114 is secured between a narrow, elongated plate 123 and assembly half 101 by the rivets 115. The belt extends further to the right of plate 123 and is looped over itself to form a narrow opening for a substantially C-shaped clip 124 whose free ends 1240 and 124b extend into the opening formed in belt portion 114.
. The looped over belt portion is sewn to the remaining belt portion, as shown by dotted lines 125. Clip 124 is further provided with a second clip 126 which may be utilized to releaseably support or hang the infusion bag assembly upon a belt loop, or any other structure for that matter, to facilitate either carrying or actual usage of the assembly.
The belt 111 is provided with a similar overlapped portion which is retained against the main body of the belt by sewing the two portions together, as designated by dotted lines 127. The bent-over portion of the belt provides a narrow opening for receiving the free ends 128a and 128b of a second clip 128 which, in turn, is
provided with an additional clip 129 for releaseably mounting the assembly to any suitable structure or to a belt loop field pack, or any other apparatus. Belt 111 is secured between assembly half 102 and an elongated metallic plate 130 by means of the rivets 112.
FIG. 2e is a sectional view of a portion of assembly half 102 looking in the direction of arrows 2e2e and shows the manner in which the fabric sheets are joined together along the lower edge. Metallic sheet 104 is positioned between the fabric sheets 106b'and 105b. The marginal edge of fabric sheet 105b is bent under, while the marginal portion of fabric sheet 1061; is bent around the marginal edge of metallic sheet 104. The engaging marginal portions are sewn together at 131. The perimeters of both assembly halves 101 and 102 have their fabric sheets joined together in a similar fashion.
FIG. 2b shows the assembly as being further provided with a retaining means comprising a pair of sleeves 132 and 133 for retaining compressible bags of fluids which may, for example, be blood plasma, or any other sterile fluid which is to be infused into the body of a patient. The sleeves are formed from a single sheet of heavyduty woven fabric material 134. One free end 134a of the single sheet is secured to assembly half 102 by means of the rivets 109. The sheet extends away therefrom to first form the left-hand side, top side and righthand side of sleeve 132. The sheet then extends upwardly to form the left-hand side, top side and righthand side of sleeve 133, with the extreme free end l34b extending beneath point 135 where the right-hand side of sleeve 132 and the left-hand side of sleeve 133 share a common boundary. The single sheet is then sewn together at location 136. The thread employed to sew the single sheet of fabric 134 to itself is also further sewn through the center line of the single sheet comprised of sheet halves 106a and 106b along the line coincident with the central axis 108 of the assembly. If desired, one end of each sleeve may then be sewn closed to form corresponding pockets.
It should be noted that sleeve 132 is larger than sleeve 133 so as to accommodate a compressible plastic bag of larger size (and hence, volume). For example, sleeve 133 may be adapted to-accommodate a compressible plastic bag of sterile fluid having a capacity of 500 milliliters, while sleeve 132 may be adapted to receive a compressible plastic bag having a capacity of 1000 milliliters. The sleeves (132 or 133) serve to retain a compressible fluid bag between the arcuate plates while during the time the plates are moved to the operating position. The manner of use of the sleeves is as follows:
The compressible bag is inserted into the sleeve whose opening is closest in size to the compressible fluid bag. Once the fluid bag is inserted, the free ends of springy plates 103 and 104 are moved from the position substantially as shown in FIG. 2b to the position shown in FIG. 2d. Closure and locking of the plates is accomplished by drawing belt 111 (see FIG. 2d) through buckle assembly 113. Although the closing of the plates 103 and 104 would otherwise tend to urge the compressible bag out from between the plates, the sleeve prevents this from occurring.
One alternative arrangement to the sleeves 132 and 133 which may be employed is shown in FIG. 2f and is comprised of an elongated strap 140 having a first end thereof 141 sewn or otherwise secured to assembly half 101. The marginal portion of the free end of strap may be provided with a strip 142 of an adhesive material which may be releaseably secured to surface portion 143 provided along the convex surface of assembly half 102 in close proximity to the center line 108 of the assembly. As another alternative, a VELCRO fastener assembly may be employed, wherein the strip 142 may be comprised of the loop portion of a VELCRO fastener, while the strip 143 may be comprised of the hook portion of a VELCRO fastener so as to releaseably join strap 140 to surface 143. As is well known with regard to VELCRO fasteners such assemblies, when joined together, are capable of remaining joined together even in the presence of great shearing stresses which may be exerted thereupon. I
In use, the compressible bag of sterile fluid 145 is positioned between the two convex surfaces of assembly halves 101 and 102. Strap 104 is positioned around the bag 145 in the manner shown best in FIG. 2f. The strip 142 provided near the marginal end of strap 140 is then pressed against strip 143 so as to secure the compressible bag 145 and prevent the bag from moving in the direction shown by arrow 146. The free end of belt 111 is threaded through the buckle assembly 113 in the manner shown in FIG. 2f, and is then pulled in the direction shown by arrow 147 to draw the outermost edges 101a and 102a of assembly halves 101 and 102 toward one another until the two outermost edges are either in close proximity or engage one another. The resilient arcuate shaped metallic sheets 103 and 104 exert a counter-force which tends to urge the infusion assembly halves 101 and 102 apart. However, the belt 111, in attempting to be pulled away from the buckle assembly 113, engages the serrated edge 122 of plate 116 so as to remain tightly fastened or wedged between the serrated edge 122 and buckle member 121 to prevent the assembly halves from moving apart.
The resilient metallic sheets thereby exert significant force upon the surfaces of the compressible bag of sterile fluid to cause the sterile fluid to be urged out of the bag through (see FIG. 2d) a piece of hollow tubing 148, valve 149, drip chamber and tubing 151, whose free end is provided with a suitable hypodermic needle 152 which may be inserted into the body to infuse the fluid into the body of the patient. Valve assembly 149 may be employed to selectively cut off or enable fluid flow, while drip chamber assembly 150 may be utilized to regulate the rate of flow.
The manner of use of the embodiment of FIG. 2b is substantially similar to that shown in FIG. 2f, except that the compressible bag of fluid is first inserted into the appropriate sleeve 132 or 133. The free end of belt 111 is then inserted through the buckle assembly in similar fashion to that described hereinabove to draw the outer ends of assembly halves 101 and 102 together so as to exert a significant compressive force upon the compressible plastic bag of sterile fluid.
The primary and significant feature of the infusion bag assembly resides in the fact that the assembly need not be positioned above the body of the patient so as to rely upon gravity to insure flow of the fluid from the bag or sterile container into the body. For example, in battlefield situations, it may be quite impractical, if not impossible, to mount a container of sterile fluid upon a stretcher, whereby the container of sterile fluid is positioned well above the height of the person being carried. With the present invention, the infusion bag assembly may even be mounted at or below the height of the person being carried or treated, since the relatively large compressive forces of the assembly are more than sufficient to squeeze the sterile fluid from the bag and into the body of the patient. Accurate regulation of fluid flow may be controlled through the use of valve 149 and drip chamber 150, or through the use of any other suitable flow-regulating means.
FIG. 3 shows curves comparing the flow rate through the infusion set of FIGS. 2a-2c. As shown in FIG. 3, Curve A represents the infusion or expelling of a saline solution contained in a 1000 ml bag for an apparatus as shown in FIGS. 2a-2c which is located at the same height as the catheter. The curve indicates that the en- ,tire contents are expelled in 12 minutes. Curve B represents the flow rate for an infusion set of the type shown in FIGS. 2a-2c which is located at a height of one meter above the catheter level. It can be seen that the entire contents are expelled within nine minutes.
Curve C represents the flow rate for a sterile fluid bag elevated at a height of one meter above the catheter level and in the absence of the infusion set hereof. It can be seen that 16 minutes are required to expel the entire contents of the fluid container. Similar results have been obtained for other solutions such as, for example, a dextrin solution from which the entire contents of a 560 ml fluid container are expelled within 11% minutes, while 17 minutes are required to expel the entire contents of a bag positioned at one meter above the catheter level in the absence of the nongravitational infusion set. The entire contents of a 560 ml container can be expelled within 9 minutes when the infusion set of FIG. 2a-2c is positioned one meter above the catheter level. Similar results have been obtained for other fluids, including blood.
When not in use, the assembly 100 may be made quite compact by threading the belt 111 through the buckle assembly 113 in a manner similar to that described above, with the exception that no compressible bag of fluid be inserted between the assembly halves 101 and 102. The assembly 100 may then be carried in any suitable mmanner such as inside of a field pack, clipped to the exterior of a field pack, or clipped to a waist belt or any other suitable place or location.
The assembly 100, which is formed of a very heavyduty fabric and a heavy-duty buckle assembly and fabric belt, is relatively indestructible and have an extremely long, useful operating life. In addition, the effectiveness of the assembly 100 will not be reduced or significantly altered as a result of exposure to outside elements or influences, such as rain, sleet, snow, salt water, dirt, dust, or any other influences which may normally be considered to be harmful. The arcuate shaped metallic sheets, in one preferred embodiment, are preferably formed from a springy, resilient steel, and it has been found that no significant reduction in effectiveness of the plates has occurred even after continued use, regardless of the conditions or situations in which the assembly is used.
FIGS. la-lf show another preferred embodiment 10 of the present invention, which is comprised of a plural ity of arcuate shaped metallic sheets 11 (a total of eight being employed in the assembly shown in FIGS. la and 1c, for example). The assembly half 12 utilizes four of the arcuate shaped metallic sheets which are arranged in side-by-side fashion and inserted within separate sleeves l3l6, which sleeves are formed from a pair of heavy-duty woven fabric sheets 17 and 18, which are sewn together along the top, bottom and right-hand edges of assembly 12 and are further sewn along lines 19, 20 and 21 so as to form four individual sleeves which are open along their left-hand edges to permit insertion of each of the associated arcuate shaped rnetallic sheets 11.
The metallic sheets 11 are each retained within their associated sleeves by rivets 22. The rivets 22 further serve to secure one cooperatingportion of a clasp assembly, which portions are designated by the numerals 23a-23d, respectively. Since the clasp portions 23a-23a' are substantially identical in design and function to one another, only one such assembly will be described herein for purposes of simplicity.
Considering assembly 23a, this clasp portion can be seen to be comprised of a mounting bracket 24 having a pair of mounting portions 2441-2412 (see FIG. 1b), which portions are joined to sleeve 13 by rivets 22. Mounting portions 24a and 24b are integrally joined to one another by means of a yoke portion 24c, which yoke portion forms an opening for receiving the free ends 25a and 25b of a clasp membler. Clasp member 25 is free to pivot about the yoke portion in either direction, as shown by the double-headed arrow 26 of FIG. lb.
The remaining half 12' of infusion bag assembly 10 is formed of two heavy-duty fabric sheet members 17 and 18' similar to those described hereinabove, which sheets are joined or sewn together so as to form the separate sleeves 13'16, each of which receives one of the arcuate-shaped metallic plates 11.
Assembly half 12 is provided with four clasp portions 27a-27d, each of which cooperate with an associated clasp portion 23a-23d, respectively, in a manner to be more fully described. Since each of the clasp portions 27a-27d are similar in design and function, only one will be described herein for purposes ofsimplicity.
The assembly 27a is comprised of a mounting bracket 28 having a pair of similar mounting halves 28a and 28b secured to sleeve 13' by rivets 22. The mounting portions 28a and 28b are integrally joined to one another by a yoke portion 28c which has a substantially triangular shaped configuration, as can best be seen from FIG. lb, so that the head portion may be snappingly received by the associated buckle 25, in a manner to be more fully described.
The manner in which the infusion bag assembly 10 is put into use is as follows:
A compressible plastic bag of sterile fluid is positioned between the convex surfaces of assembly halves l2 and 12 in the manner shown best in FIG. 1b. Halves 12 and 12 are then moved toward one another in the directions shown by arrows 29a and 2912 until the outer free ends of assembly halves l2 and 12' are brought into engagement. Each of the buckles 25 is then snapped over its associated head 280 where they re main locked in the position shown best in FIG. 1e. The highly resilient arcuate shaped metallic members exert a relatively high compressive force against bag 145 to squeeze the fluid from the bag and preferably through the valve, drip chamber and injection or hypodermic needle assembly of the type shown best in FIG. 2d. It should be understood that all four clasp assemblies are locked into position in the manner shown best in FIG. 12.
For a device of the type similar to that shown in FIGS. la-lc comprising three pairs of curved, springy, metallic sheets (formed by cutting a cylinder of metallic material in half and by cutting each of the halves into three parts), the initial pressure applied to a com pressible fluid bag was 0.15 atmospheres (equal to about 1.5 meters of water) which yielded a flow rate of approximately 100 ml per minute at the initial stages, which flow rate decreased to about 70 ml per minute near the end of the infusion.
The use of separate arcuate shaped metallic sheets in each half 12 and 12 of the assembly as opposed to the use of only a single arcuate-shaped metallic sheet as in the case of assembly 100 of FIG. 2, for example, facilitates locking of the clasp assemblies, since the arcuate shaped metallic sheets of significantly smaller size individually exert smaller counteracting forces, thereby making it easier to latch each of the individual clasps.
Although not shown for purposes of simplicity, the assembly of FIGS. la-lfmay be provided with a releaseable clasp or other hardware for suspending the infusion bag assembly 10 from a stretcher or a field pack, for example, either during use or while being transported.
FIG. 1d, which is a sectional view of a portion of the assembly shown in FIG. lc taken along the lines 1d 1d, shows the manner in which the fabric sheets are sewn together. Fabric sheet 18 has its marginal edge folded around the marginal edge of the arcuate metallic sheet 11. Fabric sheet 17 has it marginal portion folded under so that the two engaging portions may be sewn as shown at the location designated by numeral 31. The fabric sheets are further sewn together as shown by numeral 21 to form the two separate sleeves l6 and 15, each of which is adapted to receive one of the arcuate shaped metallic resilient sheets 11, 11. The remaining peripheral portions of the assembly halves l2 and 12' are sewn together in a similar fashion.
When not in use, the assembly 10 may be made quite compact either by drawing the two concave surfaces toward one another in the manner shown in FIG. 1f or, alternatively, by bringing the two convex surfaces toward one another in the manner shown in FIG. 12, with the exception that no compressible sterile fluid bag is inserted therebetween. The clasps are then joined either in the manner shown in FIG. 1f, or in the manner shown in FIG. 1e to render the assembly quite compact during either storage or transportation thereof. If desired, a compressible bag may be stored between the members 12 and 12' when in the position of FIG. If. The plates exert only a mild force upon the compressible fluid bag so as not to stress the bag when not in use. The distinct advantage of storing compressible bags in this manner is to protect the compressible bag during storage, handling or transportation. The embodiment of FIG. 2 may be utilized in a similar'fashion.
As another obvious alternative, the assembly 10 of FIGS. la-lf may be provided with a strap of the type shown in FIG. 2e, or one or more sleeves of the type shown in FIG. 2b to facilitate retention of the compressible sterile fluid bag between the convex surfaces of the assembly halves l2 and 12 so as to retain a compressible fluid bag between the assembly halves when they are moved to the position of FIG. 1e.
As another possible alternative to the preferred embodiments of the present invention, any other suitable hinge means may be employed for pivotally connecting the curved, springy, metallic sheets in addition to the employment of the heavy-duty fabric sheets as the means for pivotally connecting the metallic sheets.
- It can be seen from the foregoing description that the present invention provides a novel non-gravitational infusion bag set for squeezing sterile fluid, and the like, from a compressible fluid bag, wherein the assembly is quite compact to facilitate storage and transportation, while having a unique design to enable infusion of sterile fluid, and the like, from a compressible bag in a nongravitational manner, thus eliminating the need for mounting or supporting the sterile fluid container a significant distance or height above the body of the patient, as is required in conventional infusion techniques which primarily rely upon gravitational flow. The assembly is thus uniquely adapted for use in situations in which fluid flow by gravity is either impractical or impossible, such as, for example, the use in battlefield, riot or other disaster conditions which restrict or otherwise render impossible the infusion of a fluid into a patient through normal gravity flow techniques.
Although this invention has been described withrespect to particular embodiments, it should be understood that many variations and modifications will now be obvious to those skilled in the art, and, therefore, the scope of this invention is limited not by the specific disclosure herein, but only by the appended claims.
What is claimed is:
1. An assembly for exerting pressure upon a compressible fluid container, comprising:
a. a pair of curved resilient plates having respective inner and outer planar edges extending transversely of the curvature thereof;
b. hinge means for hingedly mounting said inner edges of the plates to one another in substantial parallelism for pivotal movement of the plates into facing relation with the convex surfaces of the plates facing one another;
c. clasp means mounted along said outer edges of the plates for securing said edges to one another and thereby holding the plates in close proximity to one another with the convex surfaces thereof adapted to apply pressure to a compressible fluid container positioned between said plates;
d. restraining means for limiting movement of the compressible fluid container transversely of said first and second plate edges to facilitate compression of the container and dispensing of the fluid therefrom by said assembly;
e. said restraining means comprises a hollow sleeve secured to said sheath in the region of said hinge and along the concave side of said plates for receiving a compressible fluid bag to prevent movement of said bag when said plate halves are being moved to the operating position.
2. The assembly of claim 1, wherein said restraining means further comprises a plurality of hollow sleeves of different diameters secured to said sheath in the region of said hinge and along the concave side of said plates for receiving compressible fluid bags of varying sizes, each of said sleeves preventing movement of the bag received therein as said plate halves are moved to the operating position.

Claims (2)

1. An assembly for exerting pressure upon a compressible fluid container, comprising: a. a pair of curved resilient plates having respective inner and outer planar edges extending transversely of the curvature thereof; b. hinge means for hingedly mounting said inner edges of the plates to one another in substantial parallelism for pivotal movement of the plates into facing relation with the convex surfaces of the plates facing one another; c. clasp means mounted along said outer edges of the plates for securing said edges to one another and thereby holding the plates in close proximity to one another with the convex surfaces thereof adapted to apply pressure to a compressible fluid container positioned between said plates; d. restraining means for limiting movement of the compressible fluid container transversely of said first and second plate edges to facilitate compression of the container and dispensing of the fluid theRefrom by said assembly; e. said restraining means comprises a hollow sleeve secured to said sheath in the region of said hinge and along the concave side of said plates for receiving a compressible fluid bag to prevent movement of said bag when said plate halves are being moved to the operating position.
2. The assembly of claim 1, wherein said restraining means further comprises a plurality of hollow sleeves of different diameters secured to said sheath in the region of said hinge and along the concave side of said plates for receiving compressible fluid bags of varying sizes, each of said sleeves preventing movement of the bag received therein as said plate halves are moved to the operating position.
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Cited By (14)

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US4090514A (en) * 1976-10-22 1978-05-23 Howard Helmut Hinck Pressure infusion device
US4187847A (en) * 1977-07-11 1980-02-12 Loeser Edward A Airless intravenous fluid system
US4161179A (en) * 1977-08-08 1979-07-17 Metatech Corporation Vacuum bag for wound drainage
US4337769A (en) * 1980-08-01 1982-07-06 Baxter Travenol Laboratories, Inc. Pressure infusion module
US5019047A (en) * 1989-06-16 1991-05-28 Science Incorporated Fluid delivery apparatus
US5346476A (en) * 1992-04-29 1994-09-13 Edward E. Elson Fluid delivery system
WO2002041937A1 (en) * 2000-11-22 2002-05-30 Roland Wex Mechanically actuated liquid pump
US20040024380A1 (en) * 2002-08-05 2004-02-05 Darnell Lawrence W. Container for delivery of fluid to ophthalmic surgical handpiece
US6921385B2 (en) 2002-08-05 2005-07-26 Alcon, Inc. Apparatus for delivery of fluid to opthalmic surgical handpiece
US7160268B2 (en) 2002-08-05 2007-01-09 Alcon, Inc. Container for delivery of fluid to ophthalmic surgical handpiece
WO2008080442A1 (en) * 2007-01-03 2008-07-10 Horn Gmbh Tempering device
WO2013019275A1 (en) * 2011-08-02 2013-02-07 Tibble Adam Fluid delivery devices and methods of use for collapsible fluid containers
WO2013163364A1 (en) * 2012-04-27 2013-10-31 Covidien Lp Fluid delivery device having a connector and a collapsible reservoir
US20160199573A1 (en) * 2013-08-13 2016-07-14 Mahusaca Sprl Autonomous liquids pump for transporting a fluid to a living being

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