US 3358689 A
Description (OCR text may contain errors)
J. L. HIGGINS Dec. 19, 1967 INTEGRAL LANCET AND PACKAGE Filed June 2, 1964 2 Sheets-Sheet l Inventor JOHN L. HIGGING Dec. 19, 1967 J. 1.. HIGGINS 3,358,689
INTEGRAL LANCET AND PACKAGE Filed June 9, 1964 2 Sheets-Sheet 2 Inventor JoHN L. HIGGINS 3g JJMwJ wa @MM fl'lfornegs United States Patent 3,358,689 INTEGRAL LANCET AND PACKAGE John L. Higgins, Daytona Beach, Fla., assignor to Rock! Products Company, Inc, De Laud, Fla., a corporation of Delaware Filed June 9, 1954, Ser. No. 373,775 Claims. (Cl. 128-329) The present invention relates generally to an improved integral lancet and package, and more particularly to an improved package and disposable medical lancet unit of the type suitable for making a slight puncture in the skin of an individual to permit collecting a drop of blood for diagnostic purposes or the like medical use and to an improved method of producing said integral lancet unit and package.
Various means have heretofore been used for making a slight puncture or incision in the skin of a patient for effecting capillary bleeding, including such means as a pointed needle which requires sterilization immediately before use and a special stamped thin metal'lancet which is pre-sterilized and packaged in a sterile wrapper. While the latter package avoids the necessity of sterilizing each lancet immediately before use, there is considerable difficulty in packaging a small thin metal lancet, and there is the danger of the sterile wrapper being accidentally torn with consequent danger of bacterial contamination of the lancet. Also, the cost of individually packaging each sterile lancet adds appreciably to the total cost of the lancet unit. A still further disadvantage of the lancets of the latter type which are formed by stamping from thin metal is the danger of the weak stamped metal part bending during use, and the tendency of these lancets to form a painful jagged incision and destroy blood characteristics.
It is therefore an object of the present invention to provide an improved integral lancet unit and package of the foregoing type which can be produced more economically and which can be used more conveniently and safely than previously designed lancets.
It is a further object of the present invention to provide an integral lancet unit which does not require packaging in a separate wrapper in order to insure the sterility thereof for prolonged periods.
It is still a further object of the present invention to provide an improved method of producing an improved integral lancet unit and package in a more economical manner.
Other objects of the present invention will be apparent from the detailed description and the claims to follow when read in conjunction with the accompanying drawing, wherein:
FIG. I is a top plan view of the the present invention;
FIG. 2 is a side elevational view of the unit shown in FIG. 1;
FIG. 3 is a perspective view of the lancet unit in operative position with the sterile pointed end of the lancet exposed;
FIG. 4 is an end view of the unit shown in FIG. 1;
FIG. 5 is a vertical sectional view taken along the line 5-5 of FIG. 2;
FIG. 6 is a vertical sectional view taken along the line 6-6 of FIG. 2;
FIG 7 is a vertical sectional view taken along the line 7-7 of FIG. 2;
FIG. 8 is a vertical sectional view taken along the line 8-8 of FIG. 2;
FIG. 9 is a vertical sectional view taken along the line 9-9 of FIG. 2;
FIG. 10 is a side elevation view partially in vertical medical lancet unit of ICC section of a modified form of medicinal lancet of the present invention;
FIG. 11 is a side elevation view partially in vertical section of still another modified form of medicinal lancet of the present invention;
FIG. 12 is a fragmentary perspective view of lower and upper mold sections forming a mold cavity for molding the lancet unit of FIG. 1; and
FIG. 13 is a vertical sectional view of the lower and upper mold sections of FIG. 12 forming a mold cavity for molding the lancet unit of FIG. 1.
The improved medical lancet and container unit of the present invention comprises a lancet retainer section, preferably of a generally cylindrical form, moldably formed about a small diameter cylindrical lancet or pointed rod member to fixedly and protectively hold the lancet in the retainer member with a readily severable cap section integrally formed with the said retainer section so as to sealably and protectively enclose the sterile pointed end of the lancet.
In the preferred embodiment illustration of the present invention shown in FIGS. 1-9 of the drawing, the unitary lancet retaining member and container Ill has a main body section 11 molded directly about a lancet 20 which is comprised of a generally cylindrical rod section 21 provided with a sharply pointed end section 2 2. The main body section 11 is generally cylindrical in form with generally cylindrical end sections 12, 13'. The end section 12, 13, are connected by a small diameter axial cy lindrical section 14 and a plurality of longitudinal ribs 15 extending radially from the axial cylindrical section 14. There are preferably four ribs 15 which are spaced angulary at The ribs 15 facilitate holding the retainer section between the operators fingers when the lancet 20 is used. Two of the diametrically oppositely disposed ribs 15 have formed intermediate the ends thereof one or more narrow transversely extending slots 16. The lancet 20 is disposed within the body section 11 with the pointed end section 22 extending a short distance beyond an abutment end wall surface 17 of the body section 11. The lancet 20 is fixedly held in the body section I I by having the body of the container molded directly about the rod member 21 which can be notched, roughened or otherwise deformed, if necessary, to provide a secure engagement therewith.
The pointed end section 22 of the lancet 20 can be formed in any manner desired but preferably is provided with one or more sharp cutting edges 23 which will effect bleeding from the capillaries immediately below the surface of the skin for Withdrawal of a drop of blood from a patients finger or eat. One method of providing the desired cutting edges 23 on the end of the rod member 21 is by precision grinding thereon one or more outwardly beveled surfaces which extend axially inwardly about Aa-inch from the end thereof in the same manner as a point is provided in a hypodermic needle cannula. A precision ground point of the foregoing type on the end of the lancet rod member 21 gives superior blood collecting qualities with less pain and discomfort to the patient. The pointed end section 22 preferably extends outwardly beyond the abutment surface 17 a distance about of an inch so that the incision or puncture formed by the lancet will extend into the capillary structure of the patient just below the surface of the skin. The distance the pointed end'section 22 projects beyond the abutment surface 17 can be made more or less than the preferred /8 -inch, if desired, by altering the length of the rod member 21 or the position of the rod member 21.
The portion of the lancet 20 and the pointed end section 22 which extend beyond the end of the body section 11 are completely sealably enclosed by a unitary cap section 30 formed integrally with the body section 11 and sealably joined therewith so that the end section 22 and the rod section 21 cannot become contaminated with bacteria or the like before the cap section 30 is removed. The cap section 30 is integrally and sealably joined to the body section 11 by a frangible section 35 which is preferably of a reduced diameter so that the frangible section 35 can be readily fractured and the cap section 30 removed from the end section 11 by applying a twisting or pulling force, as by rotating the cap section 30 relative to the container main body section 11 about the longitudinal axis thereof. In the form shown in the drawing the cap section 30 has circular periphery of a. diameter larger than the outer diameter of the main body section 11. Also, the cap section 30 in the form illustrated in the drawing has a thickness substantially less than its diameter, and thus its oppositely disposed lateral surfaces are generally parallel and present a relatively flat or disc-like form which can be readily held between the ends of the thumb and forefinger when it is desired to rotate the cap member 30 relative to the container body section. It will be apparent from the foregoing description that the lancet retainer and container serves both as an integral support to hold the lancet 20 during use and as a container to protectively and sealably en close the pointed end section 22 until the lancet is used.
The unitary container 10 is preferably formed of a relatively non-vitreous plastic material which can be readi- 1y severed when a rotating force is applied to either the body section 11 or the cap section 30 for exposing the pointed end 22 of the lancet 20 and which preferably does not form sharp cutting edges along the fracture line at the frangible section 35 adjacent the abutment surface 17. Thus, plasticized organic polymeric compositions,
such a polyvinyl chloride, polyethylene, polypropylene and the like plastic materials, are well suited for molding the container 10.
It should be understood that the unitary container 10 need not form a substantially continuous engagement with the lancet 20 throughout its entire length in order to effect the desired permanent connection. Thus, in the modified form of the invention shown in FIG. 10, the container 10a is similar in exterior form to the container 10 and, like container 10, container 10a preferably has an overall length of about one inch. However, only a portion of the generally cylindrical body section 11a is formed of solid plastic in direction engagement with the cylindrical rod member or lancet 20a, with the remainder of the body section 11a being tubular in form. A small diameter axial sleeve section 25 extending rearwardly from the forward end section 12a of the body section He can be provided for frictionally engaging the lancet 20a rather than having a major portion of the body section 1141 in the form of a solid cylindrical section as in FIG. 1.
The still further modified form of the invention shown in FIG. 11 is generally similar to the other embodiments illustrating the present invention, and the lancet container unit 10b has an elongated geerally cylidrical body section 11b molded about a portion of the rod-like lancet 2% with two oppositely disposed ribs 15b extending radially from the body section 11b, and a cap section 3% integrally connected with the body section 11b by a small diameter frangible section 35b. Only about a third of the length of the forward portion of the body section 11b, however, is in direction engagement with the lancet 2%.
In manufacturing a medical lancet of the present invention each of the lancets 20, a or 2011 is preferably comprised of a short section of a cylindrical stainless steel wire, and after being provided with a sharp point, can be cleaned in any desired manner before the lancet container is molded thereabout, such as by injection molding. Sterilization of the pointed end of the lancet 20, however, is not necessary prior to injection molding, since the elevated temperature of the molten plastic completely sterilizes the point and adjacent surfaces of the lancet, as will be described hereinafter. The completed article of the present invention, after molding with the sterilized penetrating point completely sealably enclosed, does not re quire any further sterile packaging to keep the pointed end section in a completely sterile condition indefinitely.
The preferred form of the medical lancet support and container unit illustrated in FIGS. l-9 of the drawing is preferably made by a novel injection molding process whereby the pointed end section 22 of the lancet 20 is automatically sterilized and positioned relative to the body section 11 of the container 10 by the molten plastic entering the mold cavity. As shown in FIG. 12 of the drawing, the lower mold section 70 has formed therein a plurality of spaced mold cavities 71 each forming the lower half of the lancet support and container unit 10 with the mold cavity gate portion 72 connecting with the outer end of the cap section 73 of the mold cavity. The body section 74 of the mold cavity intermediate the ends thereof has two spaced insert plates 75, 76 disposed in transverse slots 77, 78, respectively, cut in the mold section 70 which extend transversely across each of the mold cavities 71. Each of the insert plates 75, 76 has a plurality of transverse grooves 79 cut across the upper edge thereof so as to loosely support between the spaced plates 75, '7 6, axially in each mold cavity 71 a lancet 20. The lancet 20 has a length somewhat longer than the body section 11 of the container 10, and the lancet 20 is supported by the spaced insert plates 75, 76 with the end section 22 pointing toward the gate 72.
The upper mold section 8i) forming the upper half of the lancet container 10, also shown in FIG. 12, is generally similar in form to the lower mold section 70. Thus, the mold section 80 has a plurality of mold cavities 81 with the gate portion 82 connecting with the outer end of the cap section 83. The upper mold section 80 differs from the lower mold section 70 in having mounted transversely therein only one mold insert plate which extends transversely across each of the mold cavities 81 intermediate the ends of the body section 84 thereof. The mold insert plate 85 has transverse grooves 86 formed therein at a point corresponding with the axis of each of the mold cavities 81 so as to provide an axial guide for each of the lancets 20 supported by the insert plates 75, 76 in the lower mold section 70 when the mold sections 70, 80am closed in operative position without, however, the plates 0 75, 76, and 85 tightly engaging the lancet 29.
When molten plastic material, such a polyethylene or polypropylene, is injected into the mold cavity 87 formed by the mold sections 70, 80, as shown in FIG. 13, through the gate 88 formed by the gate portions 72, 82, respectively, the hot plastic coming into contact with the beveled pointed end section 22 of the lancet 20 quickly sterilizes the end section 22 and adjacent portions of the lancet 28. The pressure of the molten plastic material on the pointed end section 22 also tends to force the lancet 29, which is loosely and slidably supported between the insert plates 75, 76, and 35, into engagement with the rear wall of the mold cavity. Thus, if any of the lancets 2d are not initially accurately positioned within the mold cavity and have their pointed end section 22 extending too far outwardly into the cap section of the mold cavity, these lancets 20 will be automatically accurately positioned by the force of the incoming molten plastic moving the lancet 20 rearwardly until the end thereof engages the rear wall of the mold cavity.
It will be evident from the foregoing description that the preferred method of molding the lancet support and container unit of the present invention avoids the necessity of using individual mold core inserts for each mold cavity and thus markedly simplifies the molding apparatus required and permits a substantial increase in the rate of production compared with the molding apparatus using individual mold core pins for each mold cavity.
The modified forms of the lancet unit invention shown in FIGS. 10 and 11 are readily madeby molding apparatus using a conventional mold core pin for each mold cavity, if desired.
Others may practice the invention in any of the numerous ways which are suggested to one skilled in the art by this disclosure, and all such practice of invention are considered to be a part hereof which fall within the scope of the appended claims.
1. A medical lancet unit which comprises: a molded lancet retaining member having a main body section adapted to be held between the fingers of an operator and a lancet member having a solid sterile pointed end section fixedly mounted in said retaining member with said sterile pointed end section extending beyond the end of said main body section and having a solid cap section molded integrally with said main body section and sealably embedding and enclosing said sterile pointed end section in the material thereof to prevent bacterial contamination, and said cap section being sealably connected with said main body section by a frangible section which is readily severable to effect separation of said cap section from said body section for exposing said sterile pointed end section immediately before using said lancet.
2. A medical lancet unit for effecting capillary bleeding comprising: a molded lancet retaining member having a plastic main body section adapted to be held between the fingers of an operator and a lancet member having a solid rod section with a sterile pointed end section fixedly disposed in said retaining member with said lancet being disposed in said body section with only said sterile pointed end section extending beyond the forward end of said retaining member and having a removable solid plastic cap section molded integrally with said main body section and sealably embedding and enclosing said sterile pointed end section in the material thereof to prevent bacterial contamination, and said cap section being sealably connected with said main body section by a frangible section Which is readily severable to facilitate separation of said cap section from said body section for exposing said sterile pointed end section immediately before use of said lancet.
3. A medical lancet as in claim 2, wherein said cap section has generally parallel axially extending oppositely disposed lateral wall surfaces spaced less than the diameter of said body section which form a relatively fiat cap section adapted to being readily held for application of a severing force to effect separation of said cap section from said body section.
4. A medical lancet unit as in claim 2, wherein said main body section has a generally elongated cylindrical form with a substantially transverse end wall surface adjacent said pointed end section to provide an abutment surface at the base of said pointed end section; whereby said end wall surface serves to limit the extent of penetration of said sterile pointed end section and effect only capillary bleeding.
5. A medical lancet unit for effecting capillary bleeding which comprises: a molded plastic lancet retaining member having a generally cylindrical main body section adapted to be held between the fingers of an operator and a solid lancet member having a generally cylindrical rod section with a sterile pointed end section fixedly disposed in said retaining member with only said sterile pointed end section extending beyond the forward end of said main body section and having a removable solid plastic cap section molded integrally with said main body section and connected therewith by a frangible section, and said cap section sealably embedding and enclosing said sterile pointed end section in the material thereof Whereby a sterile pointed end section is provided on a lancet without requiring sterilizing of the said lancet.
References Cited UNITED STATES PATENTS 1/1963 Stevens 20643 X 7/1965 Rubin 128253