|Publication number||US3918446 A|
|Publication date||Nov 11, 1975|
|Filing date||May 3, 1974|
|Priority date||May 3, 1974|
|Also published as||CA1055351A, CA1055351A1|
|Publication number||US 3918446 A, US 3918446A, US-A-3918446, US3918446 A, US3918446A|
|Inventors||Philip M Buttaravoli|
|Original Assignee||E Med Corp|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (7), Referenced by (155), Classifications (9)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent [191 Buttaravoli [451 Nov. 11, 1975  Inventor: Philip M. Buttaravoli, Annandale,
 Assignee: E-Med Corporation, Cincinnati,
 Filed: May 3, 1974  Appl. No.: 466,734
 US. Cl 128/133; 128/214 R; l28/DIG. 26  Int. Cl. A61M 05/00; A61M 25/02  Field of Search 128/214 R, 133, DIG. 26, 128/348-351,221,215, 132R  References Cited UNITED STATES PATENTS 2.606.555 8/1952 Solomon 128/171' 3.138.158 6/1964 Gordon et a1 l28/DIG. 26 3,630,195 12/1971 Santomieri 128/133 3,683,911 8/1972 McCormick 128/214 R 3.722.508 3/1973 Roberts l28/l33 3,826,254 7/1974 Mellor 128/133 SECUREMENT DEVICE FOR INTRAVENOUS CATHETER AND ITS TUBING Primary Examiner-Dalton L. Truluck Attorney, Agent, or Firm-Melvilee, Strasser, Foster & Hoffman [5 7 ABSTRACT A device for securing to the skin and protecting an infusion needle or catheter in the body portion of a patient and for holding a portion of the excess tubing while providing a cushion between the catheter-tubing assembly and the skin, consisting of a bottom pad and an associated upper pad, both pads being formed of flexible material. The bottom pad is provided with at least one slit extending inwardly from one edge and terminating in van enlarged perforation comprising a medicament well. A first portion of the upper pad is affixed to the bottom pad and a secondportion of the upper pad constituting a flap may overlie the slit and well in the bottom pad. Means are provided to removably affix the second portion of the upper pad to the bottom pad and to affix the bottom pad to the skin of a patient.
19 Claims, 14 Drawing Figures Boyd 128/133 Ufs. Patent Nov. 11,1975 Sheet10f3 3,918,446
US. Patent Nov. 11, 1975 Sheet 2 of 3 US. Patent Nov. 11, 1975 Sheet 3 of3 3,918,446
1 Field of the Invention The present invention relates generally to the medical field and more particularly to a device for securing .and protecting an infusion needle or catheter and for holding a portion of the excess tubing while providing access to and observation of the catheter and tubing during the intravenous infusion.
.2. Description of the Prior Art Intravenous feeding and transfusions are among the most frequently accomplished and essential treatments of seriously injured or ill patients in hospitals. Infusion apparatus employed in the intravenous feeding of blood, plasma, glucose water, salt water, and the like includes an infusion needle or catheter, a handle portion, and a length of tubing connecting the needle to a source of intravenous fluid. In conventional practice, the needle or catheter is inserted intothe vein of the patient and constrained in such position by small strips of adhesive tape connected to the handleso that .the
needle or catheter will be secured to' the skin and not fall or be pulled out. The puncture site of the needle or catheter is often protected with an antibacterial ointment and/or a gauze pad for the purpose of helping to lower the chance of infection. The gauze pad also serves as a cushion if placed under the catheter and handle portion. Whether or not the antibacterial ointment'and/orgauze pad is applied, the needle or catheter, along with the tubing, is commonly'secured to the skin or body portion of the patient with several strips of adhesive tape. A portion of theexcess tubing is then usually coiled closely adjacent to the needle or catheter and is held in place by several additional strips of adhesive tape overlying the entire structure. The purpose of this coil is to absorb any unexpected sudden tension placed upon the remainder of the tubing (as with accidentally being pulled upon) without distrubing the catheter.
This procedure poses several problems; namely, (1) the accumulation of several items (i.e., ointment, gauze pad and tape) into one convenient location; (2) the separate application of these items at the time of insertion of the 'infusion needle or catheter; (3) the necessity of tearing multiple strips of tape often of varying lengths and widths; (4) the individual application of each strip of tape over the infusion needle or catheter tape carefully and individually when and if the needle or catheter needs to be inspected without .dislodging the needle or catheter; and (7) the inability to maintain the sterility of the above mentioned items.
While many prior art securement devices and the like have endeavored to alleviate certain of the aforementioned problems, for one reason or another theyhave generally proven to be unsatisfactory. Suchprior art devices known to applicant, are: U.S. Pat. Nos.
3,046,989 Hill; 2,159,947 Gansel; 2,402,306 Turkel; 2,669,231 Fisher; 2,814,294 Figge; 2,898,917 Wallace; 3,046,984 Eby; 3,059,645 Hasbrouck, et al.; 3,138,158 Gordon, et al.; 3,146,778Krawiec; 3,286,713 Kurtz, et al.; 3,367,332 Groves; 3,422,817 Mishkin; 3,430,300 Doan; 3,461,869 l-largest; 3,542,321 Kahabka;
3,613,663 Johnson; 3,630,195 Santomieri; 3,670,727
Reiterman; 3,677,250 Thomas; 3,683,91 l McCormick; 3,724,456 Waxman; 3,726,280 Lacount; and 3,782,378 Page.
SUMMARY OF THE INVENTION According to the present invention, the aforemen tioned problems are solved by providing an improved device for securing and protecting an infusion needle or catheter of a variety of dimensions and configurations in the body portion of a patient to the skin and for holding a'portion of the excess tubing in a U-shaped loop while providing a cushion between the cathetertubing assembly and the skin.
Briefly, in its broadest form, the improved securement device includes a bottom pad formed of flexible material having upper and lower surfaces and at least one slit extending from one edge inwardly of the bottom pad and preferably terminating in an enlarged perforation comprising a medicament well. Means are provided to affix the lower surface of the bottom pad to the skin or body portion of the patient. An upper pad, also formed of flexible material, is also provided. A first portion of the lower surface of the upper pad is affixed to the upper surface of the bottom pad. The upper pad is also provided with a second portion constituting a flap which may overlie the slit and enlarged perforation comprising the medicament well. Finally, means are provided to removably affix the second portion of the upper pad to the upper surface of the bottom pad.
In a preferred embodiment, 'the bottom pad is provided with two substantially parallel slits extending from the same edge, with each slit terminating in the aforementioned enlarged perforation, and the first portion of the lower surface of the upper pad is affixed to the upper surface of the bottom pad alongthe central portion thereof between the slits, creating two flap portions. In practice, one of the flaps serves to cover the perforation being used and the other of the flaps is used to hold an additional portion of the tube. The two slits give the operator an option of sliding either one or the other slit around the intravenous catheter, thereby a1- lowing the operator to position the bottom pad on the most propitious area of the body portion of the patient (i.e., on the dorsal rather than the ventral surface of the forearm to avoid resting the pad on the bed sheets while the patient rests in a prone position).
In still another embodiment of the invention, the bottom pad includes two slits extending from opposite edges thereof inwardly, with each slit terminating in the aforementioned enlarged perforation. The upper and lower pads are integral at mating edges thereof.
The improved securement device of the present invention overcomes all of the aforementioned and specifically enumerated problems in connection with the prior art procedure for attaching an intravenous needle or catheter to the skin of any body portion of a patient.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partially exploded view of one embodiment of the securement device of the present invention.
FIG. 2 is an end view of the securement device of FIG. 1.
FIGS. 3 through 8 are perspective views showing how the securement device of FIGS. 1 and 2 is placed on a body portion of a patient.
FIG. 9 is a plan view of a second embodiment of the securement device of the present invention.
FIG. 10 is an end view of the securement device of FIG. 9.
FIG. 11 is an end view of the securement device of FIG. 9 in the closed position.
FIG. 12 is a perspective view showing how the securement device of FIGS. 9 through 11 is placed on a body portion of a patient.
FIG. 13 is a series of enlarged views showing exemplary end enlarged perforations which may be used with the securement devices of the present invention.
FIG. 14 is an enlarged view showing a large notch on the side of a bottom pad, with associated slits extending therefrom, which may be used with the securement devices of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, wherein like parts are designated with like numerals throughout, and more particularly to FIGS. 1 and 2, one embodiment of the improved securement device of the present invention is designated at 10. As can be seen, the securement device 10 includes a bottom pad 12 and an upper pad 14, both formed of flexible material, and preferably of suitable polyurethane foam material.
The bottom pad 12 is provided with at least one slit 16 extending from one edge 18 inwardly of the bottom pad 12 and terminating in a enlarged perforation 20 comprising a medicament well for ointment or encapsulated ointment 22, which may be included in the pad 12 or may be placed in the perforation 20 separately during application of the pad 12 to the skin, as will be more fully explained hereinafter. The slit 16 preferably widens, such as in V-notch fashion 24, at the edge 18 to form a lead-in portion.
The lower surface 12b and 14b of the bottom and upper pads 12 and 14, respectively, are each provided with an adhesive material 26, which is exaggerated in the drawings for purposes of clarity of illustration. The adhesive material 26 will preferably contain a bacteriostatic or bacteriocidal chemical to arrest the growth of or destroy any organisms present in deep pores or sweat glands or hair follicles of the skin surface of the body portion of the patient and securement device. Furthermore, the ointment 22 is antibiotic; for example ointments such as are presently sold under the trademarks Polysporin or Betadine, and the bottom and upper pads 12 and 14, if made of foam, may be sterilized and also contain a bacteriostatic or bacteriocidal chemical. Thus, bacteria are precluded from reaching the incision through or under the securement device 10 or along the infusion needle or catheter, and those which may be present are destroyed. The incision is thereby insulated from a major source of infection by a physical barrier if not a chemical one.
A removable backing sheet 28 of paper, plastic or the like is preferably maintained in contact with the adhesive material or coating 26, on the lower surface 12b, l4b of the bottom and upper pads 12 and 14, respectively. The removable backing sheet 28 also preferably has at least one exposed and easily accessible portion 30 to enable it to be readily removed. For example, this may be accomplished by rounding the corners 12c and 140 of the bottom and upper pads 12 and 14, respectively, while maintaining the corners 28a of the removable backing sheet 28 in a square configuration.
The securement device 10 of FIGS. 1 and 2 may be packaged and shipped as two separate pads; namely, the bottom and upper pads 12 and 14 as previously described. However, it has been found preferable to sever the removable backing sheet 28 of the upper pad 14 lengthwise in two parallel lengths defining a strip substantially at the mid-point thereof and to remove this strip of backing sheet 28 so as to expose a first portion 34 on the lower surface 14b of the upper pad 14. The first portion 34 of the lower surface 14b of the upper pad 14 is then affixed to the central portion 36 of the upper surface 12a of the bottom pad 12 so as to form two flaps 38 and 40, each of which may overhang an edge 19 and 21 of the bottom pad 12.
If desirable, perforations 42 may be inserted through the flaps 38 and 40 for purposes of inspection of the infusion needle, tubing and the like, and for injection of further medication at a subsequent time into the tubing or intravenous feeding line.
A fabric or other coating 32 may be placed on the upper surface 12a of the bottom pad 12 to allow for a reversible adhesion between the bottom of the flaps 38 and 40 and the upper surface of the bottom pad 12.
A label 44 may be afiixed to the upper surface of the upper pad 14 between the flaps 38 and 40 to enable medical personnel to indicate thereon the type of intravenous needle or catheter, the size of the catheter and the date and time the infusion needle or catheter was inserted.
Turning now to FIGS. 3 through 8, the application of the securement device 10 of FIGS. 1 and 2 will now be explained. As can be seen, a vein puncture is made in the arm or other suitable body portion 46 by penetrating the flesh and vein (not shown) with a hollow intravenous needle or catheter 48 as shown in FIG. 3. The infusion tube 50, which is connected to the needle or catheter 48 by the coupling 52, is adapted to be coupled to a source of infusion liquid (not shown). These aforementioned items all vary somewhat in size, shape, and configuration from one manufacturer to another.
After the infusion needle or catheter 48 is satisfactorily inserted in a vein, the appropriate portion of the bottom pad 12 with the most desirable slit 16 is chosen so as to offer the most advantageous position of the pad 12 on the patients body portion. At this point, it should be emphasized that any slit 16 of the pad 12 may be utilized. The removable backing sheet 28 from the selected side of the bottom pad 12 is then removed. The flap portion of the associated upper pad 14, such as the flap 40, is then folded back and the slit 16 is carefully slid around the infusion needle or catheter 48 until the skin puncture site is surrounded to the well 20 at the end of the slit 16. The half of the base or bottom pad 12 having the slit 16 being used is then pressed securely against the skin of the body portion 56 of the patient,
such that this half of the base pad 12 is affixed to the the upper surface 12a of the bottom pad 12, as shown in FIG. 5. Accordingly, the infusion needle or catheter 48 is sandwiched between the lower surface 14b and the upper surface 12a of the upper and bottom pads 14 and 12, respectively. The removable backing sheet 28 is then removed from the bottom or base pad 12 on the adjoining unused side, and pressed against the skin or body portion 56. The infusion tube 50 is then looped around, and positioned between the upper surface 12a of the adjoining unused side of the base or bottom pad 12 and the lower surface 14b of the unused wing or flap 38, ignoring the remaining slit l6 and associated perforation 20, as best seen in FIGS. 6 and 7. The backing sheet 28 is then removed from the lower surface 14b of the wing or flap 38, and the wing or flap 38 is pressed down over the infusion tubing 50, sandwiching the tubing 50 between the lower surface 14b of the flap 38 of the upper pad and the upper surface 12a of the base or bottom pad 12.
As can be seen, the full infusion line 50 and the head of the infusion needle or catheter 48 may be checked or inspected by lifting the wings or flaps 38 and 40 of the upper pad 14. The wings or flaps 38 and 40 may then be repositioned over the infusion tubing 50 and infusion needle or catheter 48 for continued securement. Any shock to the infusion line 50, such as, for example, by patient pull andthe like, will be absorbed by the securement device in an area which is isolated from the head of the infusion needle or catheter 48. In this way pulling upon the infusion line 50 will not cause the infusion needle or catheter 48 to be' disturbed. It will, of course, be seen that the securement device 10 of the present invention will readily accept infusion needles or catheters 48 of varying sizes and configurations.
It will, of course, be seen that the entire head of the infusion needle or catheter 48 is covered so that it can not be disturbed, or moved, either by patient jarring or disruption by a foreign object or force. Furthermore, the incision area is continuously protected by the securement device 10 from any exposure to bacteria and the like.
It will be seen that the securement device 10, as described in connection with FIGS. 1 and 2, and as shown in connection with FIGS. 3 through 8, when applied to the body portion 56 of a patient, overcomes the aforementioned short comings of prior art devices. The securement device 10 eliminates the accumulation of several items, such as, ointment (if ointment is included in the well 22), gauze pad and multiple tape strips and it eliminates the separate application of these items at the time of insertion of the infusion needle or catheter 48. The necessity of tearing multiple strips of tape, often of varying lengths and widths, is also eliminated, as is the individual application of each strip of tape over the infusion needle or catheter 48 and the tubing 50 to secure these to the skin or body portion 56 and provide a loop 58 in the tubing 50 to allow for a sudden pull on the tubing 50. In so doing, the resultant pressing of the hub of the infusion needle or catheter 48 against the skin or body portion 58, which can cause discomfort and actual skin damage, is also eliminated. The difficulty and time consuming task of having to remove each piece of tape carefully and individually when and if the infusion needle or catheter 48 needs to be inspected without dislodging the needle or catheter 48 is also eliminated. Finally, this device may be packaged in a sterile condition which also protects the patient from the hazards of potentially contaminated rolls of tape.
FIG. 9 discloses a further embodiment 60 of the securement device of the present invention. As can be seen, the securement device 60 comprises a base or bottom pad 62 and an upper pad 64, the pads being integrally hinged at 66 along the mating edges 68 and 70, respectively.
The pads 62 and 64 are formed of flexible material, preferably of polyurethane foam, and the upper pad 64 may be of suchidimension as to overhang at least one edge of the bottom pad 62, as at 72.
The lower surface 62b of the base pad is provided with an adhesive material 63 adapted to affix the lower surface 62b of the base pad to the skin or body portion of a patient. The upper surface 64a of the upper pad 64 is provided with an adhesive 65 such that the upper pad 64 may be folded over and affixed to the upper surface 62a of the base pad 62. The upper surface 62a of base pad 62 may be covered with a cloth or plastic surface such as is shown at 67, to assist in the removability of the upper surface 64a of the upper pad 64 from the upper surface 62a of the base pad 62 once it is adhered to the base pad 62. As hereinbefore explained, the adhesive material 63 and 65 is preferably antibacterial in that it possesses bacteriostatic or bacteriocidal properties which enable it to arrest the growth of or destroy any organisms present in deep pores or sweat glands or hair follicles of the skin surface and securement device 60. Thus, bacteria are precluded from reaching the incision through or under the securement device 60 or along the infusion needle or catheter by physical if not chemical means. It will, of course, be obvious that the thickness of the adhesive material 63 and 65 is exaggerated in the drawings for clarity of illustration.
The base or bottom pad 62 is provided with slits 76 extending from opposite edges 78 and 80 inwardly of the bottom pad 62, with each slit 76 terminating in an enlarged perforation 82 comprising a medicament well. The well 82 may hold suitable ointment or encapsuled ointment 84. The slits 76 preferably widen, such as in V-notch fashion 81, at the opposite edges 78 and 80 to form lead-in portions.
As indicated in connection with the embodiment of FIGS. 1 and 2, suitable removable backing sheet 86 of plastic, paper or the like may be maintained in contact with the adhesive material or coatings 63 and 65 to prevent the coatings from becoming attached to material other than desired prior to the actual placement of the device 60 around the infusion needle or catheter.
In operation, the backing sheet 86 is removed from the lower surface 62b of the bottom or base pad 62 and the most desirable slit 76 is slid around the infusion needle or catheter 48 to the enlarged perforation 82 at the end of the slit 76. The base or bottom pad 62 is then pressed securely against the skin or body portion 56 of the patient, thereby being affixed to the skin or body portion 56 by means of the adhesive 63.
The backing sheet 86 is then removed from the upper surface 640 of the upper pad 64. The infusion tubing 50 is looped around, and positioned on the upper surface 62a of the bottom pad 62, after which time the upper pad 64 is folded over about the hinge 66 and pressed down over the infusion tubing 50 and infusion needle or catheter 48 and the upper surface 62a of the bottom pad 62.
It will, of course, be readily seen that the securement device 60, as described in connection with FIG. 9, eliminates the aforementioned disadvantages in connection with the prior art as readily as the securement device 10, as described in connection with FIGS. 1 through 8.
Turning now to FIG. 13, it will be seen that A, B and C thereof disclose various enlarged perforations, 88, 90 and 92, each with an associated slit 94, 96 and 98, in the bottom pads 100, 102 and 104, respectively, which may be satisfactory with the securing devices and 60 of the present invention. D, E, F and G of FIG. 13 show other modifications whereby only a perforation, as at 106 and 108 in the base pads 110 and 112 of D and E, respectively, or only a slit, as at 114 and 116 in the base pads 118 and 120 of F and G, respectively, may be satisfactory with the securing devices 10 and 60 of the present invention.
While several of the specific embodiments of the se curement device of the present invention have been shown and described, it will be apparent that various modifications may be made therein without departing from the scope of the invention. Such modifications include the forming of a securement device with the base and upper pads as separate parts, or as integral, the provision of an adhesive material or coating on less than the entire lower surfaces of the pads and the elimination of removable sheets if found desirable, or the use of an additional layer of a fabric or suitable material in the upper surface of the bottom pads to insure the removable nature of the upper pad after it is affixed to the bottom pad, or an upper pad covering less than the full dimension of the lower pad. Additionally as shown in FIG. 14, the V-notch lead-in portions 122, each with an associated slit 124 and enlarged perforation 126, may extend inwardly from a large notch 128 on the side 130 of a bottom pad 132.
Variations in the features of the invention are set forth in the following claims.
1. A device securable to the skin of a patient for holding in place and protecting an infusion needle or catheter in the puncture site of a body portion of a patient and for holding a portion of the excess tubing while providing a cushion between the catheter tubing assembly and the skin, which comprises top and bottom pads, said bottom pad being formed of flexible material having upper and lower surfaces and having at least one slit extending from one edge inwardly of said bottom pad to a termination point within the confines of said bottom pad; means to affix the lower surface of said bottom pad to the body portion of the patient; said upper pad overlying said bottom pad and being formed of flexible material having upper and lower surfaces; a portion of the lower surface of said upper pad being affixed to a portion of the upper surface of said bottom pad, said portions forming a line of juncture dividing said bottom pad into first and second parts and said upper pad into first and second flaps overlying said first and second bottom pad parts, respectively, said one slit being located in one of said bottom pad parts; and means to releasably affix substantially the lower surface of said first and second flaps of said upper pad to the upper surface of said first and second bottom pad parts, respectively, whereby in use said slit cradles the infusion needle or catheter and substantially surrounds the puncture site, protecting it from bacterial infiltration, one of said flaps overlying said slit and with said slit in said line of juncture securing the infusion needle or catheter and the tubing behind it over an extended length to secure against lateral and longitudinal movement, and the other of said flaps serving to cover and hold an additional loop portion of the tubing against one of said bottom pad parts to provide a safety loop of the tubing, thereby insulating any shock to the tubing transmitted by the infusion needle or catheter.
2. The securing device according to claim 1, wherein said slit terminates in an enlarged perforation comprising a medicament well.
3. The securement device according to claim 1, wherein said means to affix the lower surface of said bottom pad to the body portion of said patient comprises an adhesive coating on the lower surface of said bottom pad.
4. The securement device according to claim 3, wherein said adhesive coating is protected by a removable sheet prior to adhering the lower surface of said bottom pad to the body portion of the patient.
5. The securement device according to claim 4, wherein said releasable sheet has an exposed, easily accessible portion to enable it to be readily removed.
6. The securement device according to claim 1, wherein said means to affix the lower surface of said bottom pad to the body portion of said patient, and said means to releasably affix the lower surface of said first and second flaps of said upper pad to the upper surface of said first and second bottom pad parts, respectively comprises an adhesive coating on the lower surface of said bottom pad and the lower surface of said first and second flaps.
7. The securing device according to claim 6, wherein said adhesive coating on the lower surface of said bottom pad and on the lower surface of said first and second flaps is provided with a removable sheet.
8. The securement device according to claim 1, wherein said upper pad is permanently affixed to said lower pad along said line of juncture.
9. The securement device according to claim 1, wherein said upper pad is integral and one piece with said lower pad along said line of juncture.
10. The securement device according to claim 1, wherein said first and second flaps overhang at least one edge of said bottom pad.
11. The securement device according to claim 1, wherein a second slit is provided in the other one of said first and second bottom pad parts extending inwardly of said bottom pad to a termination point within the confines of said bottom pad.
12. The securement device according to claim 2, wherein said bottom pad includes two slits extending from opposite edges inwardly of said bottom pad.
13. The securement device according to claim 2,
wherein ointment is provided in said medicament well.
wherein said line of juncture extends substantially parallel to said one slit.
18. The securement device according to claim 1, wherein said line of juncture is located along the central portion of said bottom pad.
19. The securement device according to claim 1, wherein said bottom pad parts are of equal width and said flaps are of equal width.
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|U.S. Classification||604/180, 128/DIG.260|
|International Classification||A61M25/02, A61M5/158|
|Cooperative Classification||A61M2025/0273, A61M25/02, Y10S128/26, A61M2025/0246|