CA2104269C - Lancet - Google Patents

Lancet Download PDF

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Publication number
CA2104269C
CA2104269C CA002104269A CA2104269A CA2104269C CA 2104269 C CA2104269 C CA 2104269C CA 002104269 A CA002104269 A CA 002104269A CA 2104269 A CA2104269 A CA 2104269A CA 2104269 C CA2104269 C CA 2104269C
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CA
Canada
Prior art keywords
lancet
needle
opening
hood portion
protector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002104269A
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French (fr)
Other versions
CA2104269A1 (en
Inventor
Susumu Morita
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Apls Co Ltd
Original Assignee
Apls Co Ltd
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Filing date
Publication date
Application filed by Apls Co Ltd filed Critical Apls Co Ltd
Publication of CA2104269A1 publication Critical patent/CA2104269A1/en
Application granted granted Critical
Publication of CA2104269C publication Critical patent/CA2104269C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142Devices intended for single use, i.e. disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549Protectors removed by rotational movement, e.g. torsion or screwing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/150618Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15105Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices

Abstract

A lancet comprises a body having a needle protruding from an end of the body, and a needle protector for protecting the protruding needle before use. The needle protector includes a hood portion tightly fittable on the lancet end from which the needle protrudes in such a manner that the hood can be fitted over the lancet end to substantially isolate the needle from the environment after use. The lancet body and the needle protector may be molded integrally, and separated before use to expose the end of the needle. After use, the hood of the protector is fitted over the lancet end. The lancet as a whole can be disposed of in a safer manner than in the past.

Description

~104~69 LANCET
The present invention relates to a lancet, which is a blood collecting needle device, and more particularly to a disposable lancet.
Currently, there are many types of electronic blood sugar testers available on the market, that are easy to use for diagnosis of diabetics. Therefore, the test for blood sugar value is now widely used, and is often conducted in hospitals and homes, not only by those in charge of diagnosis and treatment but also by the diabetics themselves.
Many people are now concerned more than ever with the diagnosis or prevention of geriatric diseases, and consequently the blood sugar test is now also conducted for these purposes. Pregnant women in Europe and America take examinations of their blood sugar values at proper intervals during the period of pregnancy.
Reduction in the selling price of blood sugar testers has taken place recently due to the developments in technology and competitive pricing. This situation is rapidly increasing the demand and delivery of blood sugar testers.
Performance of a blood test can usually be carried out using a marketed type of finger-pricking device in combination with a disposable lancet attached thereto. A needle protecting cap is twisted off the lancet, so that a sharp needle end is exposed, before an internal spring is compressed and looked. Then the device's front end is pressed against a finger tip from which a blood sample is to be taken, and thereafter the spring is unlocked to cause the needle end to pierce the finger tip. A small cut is made in this way so that a small amount of blood is sampled from the pricked finger.
Generally, the lancet is replaced by a new one every time a new blood sample is taken. The used and detached lancet is discarded with safety using the needle protecting cap that had been twisted off the lancet body. The cap is thrust onto the used needle end that protrudes from the lancet body (by a distance of about 2.8 - 3.3 mm, varying among marketed models) before it is thrown away.
In accordance with one aspect of the present invention there is provided a lancet comprising: a lancet body with a needle end protruding from a lancet end of the lancet body; a separable needle protector having a first opening for protecting the protruding needle end before use; and the needle protector comprising a hood portion having a second opening tightly fittable on the lancet end from which the needle end protrudes, the hood portion having a flat contact base opposite the second opening, the hood portion being substantially free-standing with the second opening upwardly oriented in such a manner that the hood portion may be fitted on the lancet end to substantially insulate the needle end from the environment after use by inserting the lancet end substantially downwardly into the second opening to surround the lancet end of the lancet body with the free-standing hood portion.
In accordance with another aspect of the present invention there is provided a method of insulating a needle end of a lancet body from the environment comprising the steps of: separating the needle end from a first opening in a needle protector; placing a flat contact base of the needle protector on a flat supporting surface such that the needle protector is free-standing with a second opening in the needle protector upwardly oriented; grasping the lancet body after appropriate use; and pressing the needle end downwardly into the second opening on the free-standing needle protector without otherwise stabilizing the needle protector, positively engaging the needle end with the second opening whereby the needle end is substantially insulated from the environment.

- 2a -To enable the prior art to be described with the aid of diagrams, the figures of the drawings will first be listed.
Fig. 1 diagrammatically shows a prior art lancet before use;
Fig. 2 shows this lancet after use and in its discarded state;
Fig. 3 is plan view of a .Lancet according to an embodiment of the invention before use:
Fig. 4 is a side elevation of the lancet of Fig. 3;
Fig. 5 is also a side elevation illustrating the end of the lancet shown in Fig. 3, before being fitted into a hood portion;
Fig. 6 is another side elevation showing the lancet end fitted in the hood portion;
Fig. 7 is a side elevation showing a further embodiment before use;
Fig. 8 is a bottom perspective view of the lancet of Fig. 7;
Fig. 9 is a side elevation illustrating the end of the lancet of Fig. 7 before being fitted into a hood portion;
Fig. 10 is another side elevation showing this lancet end fitted in the hood portion;
Fig. 11 is a side elevation showing a still further embodiment before use;
Fig. 12 is a side elevation illustrating the end of the lancet of Fig. 11, after being fitted in a hood portion; and Fig. 13 is a perspective view corresponding to Fig. 12.
The prior art lancet 1 shown in Fig. 1 comprises a body 5 and a needle protecting cap 7. To use this device, the cap 7 is twisted off the body 5 to Expose its needle end 3.

- .2b -After use, a side portion of the cap 7 is forced over the needle end 3 so that this end 3 remains within the cap when discarded, as shown in Fig. 2.

2~~~~~~9 _ 3 The material forming the protecting cap is usually a linear-molecule low-density polyethylene which is so soft that it can be easily and readily penetrated by the needle end.
Twelve typical modals of lancets on the market have their needle ends protruding from their bodies by a distance of from about 2.8 to 3.2 mm. The maximum thickness T~ of the protecting caps falls within a range from about 3.8 - 4.0 mm.
Thus, the pointed end of any needle piercing the cap from one side will not jut out from its other side.
The needle or canula will not usually tend to drop off the cap once it has been pierced, since the compressive elasticity of the cap grips the needle.
The force required to pull the needle off the cap depends on the length of needle end projecting from the lancet body.
The longer the needle end, the stronger is the force needed to withdraw it.
The present inventor has carried out measurements to ascertain the relationship between the exposed length of the needle end (which length is substantially equal to the pierced depth of the cap) and the force needed to withdraw the needle end from the pierced cap. The twelve typical models referred to above were subjected to this measurement (in which five samples were tested for each model). As a result, it was confirmed that the force needed to withdraw the needle end was 400 - 500 grams for the shortest needle ends protruding 2.8 -2.9 mm, and, in contrast with this data, 800 - 880 grams for the longest needle ends protruding 3.2 - 3.3 mm.
As was foreseen, a needle end that had not perfectly pierced the cap could be withdrawn with a much weaker force.
This data indicates that, in accordance with the current practice, any needle end used to take a blood sample and pierce the protecting cap can be discarded safely only when the protruding length of the needle end is sufficient, and/or the protruding length is fully caught by and fixedly held in the cap, and/or most carefully handled after piercing the cap.
If such a condition is satisfied, the used needle would never 2~o~~s9 again be exposed to the outside and never come into contact with any other person.
In other words, any needle end used to take a blood sample and then pierce the protecting cap cannot be discarded safely if the protruding length of the needle end is insufficient, or the protruding length is not fully caught by and fixedly held in the cap, or is not carefully handled after piercing the cap. In such an event, the used needle could possibly be exposed to the outside and might contact other persons.
The hematogenous infection of the virus of AIDS (Acquired Immune Deficiency Syndrome) or the virus of B-hepatitis is becoming a serious problem. In the event that a lancet is used to take a blood sample from a carrier of such a disease, and thereafter the lancet's needle comes into contact with any other person, such other person may catch the carrier°s disease.
An object of the present invention is therefore to meet the social demand for a lancet that can be discarded more safely than the prior art lancets. This object can be achieved in the present invention by providing a lancet that comprises a lancet body with a needle end protruding from a lancet end: and a needle protector for protecting the protruder needle end before use; the needle protector comprising a hood portion that can be tightly fitted on the lancet end from which the needle end protrudes in such a manner that, after use, the needle end is substantially isolated from the outside.
The words "the needle end ... substantially isolated" are intended herein to include a situation in which the used needle end is substantially shielded or sealed, or completely closed. However, in the light of the object of the invention, it is sufficient for these words to indicate that the used needle end in the discarded lancet cannot come into contact with a finger tip or other body portion of a person who handles the lancet with usual care. In short, the needle end is herein deemed isolated if it cannot touch a finger tip _ 5 _ under careful handling, even though not totally shielded or sealed.
The words "needle end" herein denote a needle portion that is to pierce a human body portion from which a blood sample is to be taken, and the needle portion protrudes from a lancet portion made of a resin and fiacedly supports the needle end. The lancet body is thus composed of the resin portion and the needle end.
The words "needle protector" herein denote a member that insulates and protects the needle end protruding from the lancet body before use. The needle protector is disposed adjacent the lancet body and is capable of being twisted off the lancet body. The needle end is positioned inside the needle protector before use.
The needle protector of a lancet according to the present invention comprises a hood portion that can tightly engage the lancet end from which the used needle end will protrude. The hood portion has two regions, one of them receiving the lancet end, while the other receives the needle end protruding therefrom. Thus, the hood portion not only receives the lancet end but also isolates the protruding needle end from the outside.
The engagement of the hood portion with the lancet end may be realized with any structure and in any manner provided that they can be brought into rigid connection to one another with certainty. The "rigid connection" means that, once fitted in the hood portion, the lancet end cannot be, disengaged therefrom in the usual manner of operation in use.
Preferably, the rigid connection is stronger and more reliable than the conventional connection of the needle end with the prior art protecting "cap,°° when handled after use and discarded. ' The preferred structure for ensuring this rigid connection is either an "interference fit" or a "snap fit.°' Therefore, the outer periphery of the lancet end, as well as the inner periphery of hood portion, need to be of such a size and shape as to enable the tight fitting of them together. If both the peripheries of the lancet end and the hood portion are cylindrical, their diameters may differ from one another to t:he degree necessary for an interference fit. In another case, wherein one of the peripheries has an annular lug and the other has an annular groove, the lug and groove can be complementary to provide a snap-fit one on the other. The lug and groove need not be continuous around the periphery, but may be arranged at intervals.
In an embodiment of the present invention, a lancet comprises a lancet body and a needle protector formed with a hood portion, the lancet body having a needle end protruding therefrom. The hood portion has an opening to receive the needle end and a closed bottom opposite this opening. The closed bottom is of sufficient thickness to receive at least partially the needle end which pierces the bottom, and, more desirably, this thickness is substantially the same or greater than the length of the needle end.
In the manner shown in Figs. 3 - 6 illustrating a first embodiment, the lancet 10 comprises a lancet body 12 and a needle protector 14. A needle end 16 protruding from the body 12 is received in and protected by the protector 14, as shown in Fig. 3 and 4. The protector 14 is connected to the body 12, but is capable of being twisted off the body at a region 18. Accordingly, it is easy for an operator to separate the former from the latter to expose the needle end 16.
The lancet 10 in its unused state shown in Figs. 3 and 4 will be mounted on an appropriate finger-pricking device.
Then the protector 14 will be twisted off the body 12 to expose the needle end 16 and to render the device ready to use.
After use, the lancet end 20 from which the exposed needle end 16 protrudes will be moved towards and fitted into a hood portion 22 of the protector 14, as shown by the arrow in Fig. 5. The hood portion 22 has an opening 28 to receive the end 20 and a closed bottom 30 opposite the opening 28.
The hood portion 22 is devoid of any pre-bored aperture for the needle end 16, so that the needle end or at least a sharp extremity thereof has to pierce a thick wall 32 of the closed bottom 30. Therefor, the thickness of the wall 32 (i.e., a distance Tz between an inner surface 34 and an outer surface of the bottom 30 (with the inner surface coming into contact with the inserted lancet end) has to be greater than the length L~
of the exposed needle end. In preferred examples, the thickness TZ is usually from 3.8 mm to 5.0 mm. As shown in Fig. 6, the hood portion has a shoulder 36 which prevents a base portion of the needle from contacting the wall 32, whereby a gap 40 is formed between the end 20 and the wall 32.
It is possible to dispense with the shoulder 36, thereby allowing the needle end to be fully received in the wall 32.
The lancet end 20 in this embodiment has lugs 24 formed integrally with and disposed along the outer periphery of the end. The hood portion 22 has an annular groove 26 formed integrally with and along its inner periphery. The lugs 24 can be "snap-fitted" in the groove 26 as shown in Fig. 6.
Alternatively, the lugs 24 can be formed on the inner periphery of the hood portion, with the annular groove being formed around the outer periphery of the lancet end. In any case, the lugs and the groove must be complementary in shape and size. For example, they may be rectangular or semicircular in cross section. If the groove in the hood portion is rectangular, its width and depth may be 0.8 mm and 0.2 mm, respectively. Correspondingly, the lugs on the lancet end may be four small protrusions that are about 0.8 mm wide and about 0.2 mm wide.
In a further embodiment of the invention, the hood portion of the needle protector is formed with a bore that penetrates the bottom of the opening receiving the lancet end.
The bore has an open end opposite the opening, and the bore and its open end have such a length and diameter and are of such a shape as to isolate the needle end.
A preferable structure of the further embodiment is shown in Figs. 7 - 10. Similarly to the already described embodiment, the lancet 10 comprises a body 12 and a protector 14. The needle end 16 protrudes from the body 12 and is 2I0~~69 -$_ posii~ioned in and protected by the protector 14. The protector 14 is connected to the body 12, but is capable of being twisted off the body at a region 18. Accordingly, it is easy for the operator to separate the former from the latter to expose the needle end 16.
The lancet 10 in its unused state shown in Fig. 7 will be mounted on an appropriate finger-pricking device. Then the needle protector 14 will be twisted off the body 12 to expose the needle end 16 and render the device ready to use.
After use of the device, the lancet end 20 from which the exposed needle end 16 protrudes will be moved towards and fitted into the hood portion 22 of the protector 14, as shown by the arrow in Fig. 9. In this embodiment, the hood portion 22 has an opening 28 to receive the end 20 and a bottom with an open end 30 opposite the opening 28, a bore 38 extending between the open end 30 arid the opening 28. The length and shape of the bore 38 are designed so that the operator's finger either cannot enter the bore or cannot contact the needle end even if it does enter the bore. The shape of the bore at the open end 30 may be circular, rectangular, polygonal or the like, and the dimension in an equivalent diameter "D" of the bore at the open end may be preferably from about 1.0 mm - 4.0 mm, and more preferably about 2.0 mm.
Because it may occur that a finger tip portion could be forced into the bore through the open end 30, even though the finger itself could not enter it, the bore preferably has an appropriate length Lz of about 3.5 - 5.0 mm, and more preferably 3.8 - 4.0 mm, as shown in Fig. 9. As shown in Fig. 8, the hood portion is not formed with any shoulder 36 producing the gap 40 around the root or base portion of the needle end, as in the preceding embodiment. Thus, the needle end is fully received in the bore 38.
The lancet end 20 in this embodiment also has lugs 24 formed on its outer periphery. The hood portion 22 has an annular groove 26 formed integrally with and along its inner periphery. The lugs 24 can be "snap-fitted" into the groove 26 as shown in Fig. 10. Alternatively, the lugs 24 and groove 210~~69 _ g _ 26 can be dispensed with, and, instead, the lancet end and the hood portion may be of such a shape and size as to achieve an "interference fit."
rn a still further embodiment of the invention, the hood portion of the needle protector is formed with an elongate recess that extends outwardly from the bottom of the opening receiving the lancet end. However, the elongate recess terminates short of the bottom's outer surface opposite the cpening. The needle end is received in and isolated from the outside by the elongate recess.
As will be seen clearly from Fig. 11, the lancet in this embodiment does not differ from that in the embodiment shown in Figs. 7 - 10, except for the elongate recess 42 opposite the opening 28 and the interference fit of the lancet end into the hood portion.
The depth and shape of the elongate recess 42 are not restricted to those shown in the drawings but may be modified in any manner, provided that at least the sharp extremity of the needle end can be received. Usually, the elongate recess is circular in cross section, having a diameter substantially equal to that of the needle end, although it may be of a rectangular, polygonal or other cross section. Likewise, the depth of the elongate recess is modifiable on the condition that the needle end be entirely received or at least its , distal portion is received (as shown in Fig. 12) in this "
recess.
The lancet end 20 in this embodiment is fitted close in hood portion 22, by a so-called "interference fit" or "stationary fit" arrangement. Therefore, neither lugs nor groove are needed on these members for them to engage one another tightly.
The above embodiments represent some highly desirable modes, but the present invention is not limited to those embodiments. The invention includes any other embodiments in which the lancet end is hardly disengageable from the hood portion of the needle protector and the needle end is substantially isolated from the outside.

2~0~269 Among the three embodiments given above, those shown in Fig. 7 or Fig. 11 can be produced more easily, and are more advantageous than that shown in Fig. 3.
It is an important feature in the present invention that the hood portion 22 has a stopper surface (e. g., the portion 34 in the drawings) that contacts and supports the lancet end inserted through the opening 28 located opposite said surface.
Each of the illustrated embodiments comprises a stopper surface, and in Fig. 3 the thick wall 32 will function as such a stopper surface if the shoulder is dispensed with.
Any appropriate materials such as those that have been used to make the prior art lancets can be employed herein to form a lancet in accordance with the present invention. A
stainless steel needle having a diameter of 0.65 mm can be employed to be supported and protected by the needle protector, which in turn can be formed of a proper plastic, such as a linear-molecular low-density polyethylene, polypropylene or low-density polyethylene.
In a case wherein the plastic needle protector is formed integrally with the needle, the lancet body can also be produced integrally with the needle protector. Alternatively, the lancet body and the protector can be prepared separately and then combined by appropriate means. For the purpose of shielding or protecting the unused needle end, the former case is preferable.
In use, the operator who will have taken a blood sample can put the needle protector on a table with the opening of the hood portion facing upwards. The lancet body will be positioned with its end facing downwards, and then pressed against the protector, thus causing its opening to receive the lancet end.
Since both the lancet body and the protector are made of a relatively soft plastic, such as linear-molecular low-density polyethylene, the lancet end will expand and advance into the hood portion of the protector without any significant difficulty, until the four lugs on the lancet end gently click into the groove in the hood portion. At the same time, this 210~26~

end contacts the stopper surface and the lancet body is stopped and secured held stationary in this location.
In an example of the described embodiment(s), the outer radial ends of four lugs on the lancet end are on a single circumference whose diameter is greater than the inner diameter of the hood portion of the needle protector by about 0.4 mm (corresponding to a difference of 0.2 mm in radius).
Once the lugs fit in the groove, they can hardly be displaced.
In another example of the described embodiment(s), an "interference fit" is substituted for the "snap fit"
mechanism. This substitution, however, does not impair the rigid connection of the hood portion to the lancet end.
The needle end, which pierces the thick wall or is accommodated in the bore or the elongate recess is thus surely isolated from the exterior.
In the preferable examples described above, the end surface of the lancet end will contact the bottom surface of the hood portion when the lancet body is pressed into the protector. This contact of the surfaces stops the lancet body, so that, even if an excessively strong force were ,;
applied, it cannot advance beyond the predetermined position where the "snap fit" or ''interference fit" occurs. Thus, the lancet end will always take the correct position regardless of the strength of the applied force.
In a case wherein the "snap fit" mechanism is employed, the force urging the lancet body will suddenly be lost when the lugs snap in the groove. This gives a signal to the operator of the perfect engagement of the mating members, thus avoiding any imperfect coupling.
In a case wherein the outer surface 30 of the bottom of the needle protector lies in parallel with the opening 28 thereof, as shown in the drawings, the protector can rest stably on a table with the surface 30 in contact with the table and with the opening thereby facing upwards.
Consequently, the operator can press down the lancet body towards the protector on the table, without any danger of erroneously injuring his or her finger with the used needle end.
After the lancet end has been received in and fixedly engaged with the hood portion, the protector not only isolates the needle end from the exterior but also covers the lancet end. Although a small amount of blood is likely to be left sticking to the needle end after the sampling, this lancet is much safer than the prior art ones.
Exam,~l a A lancet was designed with the structure shown in Fig. 11 illustrating one embodiment of the invention, and a mold was manufactured to have the following dimensions. The portion giving the lancet body had a diameter of 6.5 mm, and a length of 22.9 mm; each of the portions giving the lugs had a height of 0.2 mm, a width of 0.8 mm and a length of 1 mmt the portion giving the hood portion of the protector had an inner diameter of 6.5 mm and a depth of 2.95 mm; the portion giving the elongate recess receiving the needle end had an inner diameter of 2 mm and a depth of 3.5 mm: and the protruding length of the needle end was 3.15 mm.
The mold was set in an injection molding machine of a pressing capacity of 20 tons, made by the NISSEI RESIN
INDUSTRIES CO., LTD. Needles made of SUS304 stainless steel and having an outer diameter of 0.65 mm and a length of 25.4 mm were inserted in respective cavities of the mold. An amount of '°REXLON" (a trademark of a linear low-density polyethylene made by NIHON PETROCHEMICALS CO., LTD.) was injected into the cavities to form one hundred sets of the lancets. Each lancet comprised a lancet body integral with a needle protector. The molding process was smooth as in the case of the prior art lancets.
Fifty lancets were selected at random from the one hundred lancets thus molded. Their needle protectors were twisted off the respective lancet bodies and placed on a table so that their openings faced upwards. The lancet ends from which the needle ends protruded were positioned downwards to face the respective hood portions of said protectors, and then forced into the hood portions. Due to curved guiding edges having a radius of 0.4 - 0.5 mm and formed around an end surface of each lancet body and around an entrance of each hood portion, the lancet bodies could be inserted very smoothly into the respective hood portions. The lugs on each lancet body were clicked into the groove in each hood portion, thereby affording a neat and sure engagement of the former with the latter.
It was observed that, with each lancet body being pressed into the hood portion of each protector, the needle end automatically entered the elongate recess having an inner diameter of 2 mm and a depth of 3.5 mm.
The fifty lancet bodies that had been connected in this manner to the protectors were then successively mounted on a tensile tester "92508" made by AIKO ENGINEERING CO., LTD. , Each needle protector was clamped and fixed in place, while '"
the lancet body was pulled away from the protector, whereby to measure the force (which corresponded to the strength of the "snap fit") needed to separate the latter from the former.
The maximum, minimum and average forces fox separation were 1.39 Kg, 0.98 Kg and 1.12 Kg, respectively. As referred to hereinbefore, the maximum and minimum separation forces were respectively 880 grams and 400 grams for the twelve types of the marketed prior art lancets. Thus, the fact that the snap fitting of the protector on the lancet body was effective to achieve a rigid connection between them was clearly confirmed.
Each lancet end with the needle end protruding therefrom was put into its hood portion a distance of about 26 mm so as to be entirely shielded therein. This structure proved safer than the prior art lancets that each comprise a needle end that merely pierces the protecting cap and each comprise a lancet end that remains exposed.
Lancets of the present invention can be produced with a mold that is not of a sophisticated or complicated structure.
The molded lancets can be easily discharged from the mold, and the insertion of the needles in the cavities of the mold can 2~.0~269 be done in the same manner as in the prior art. Therefore, it is feasible to produce and supply lancets of the invention at a relatively low price, in a stable manner and on a large scale, similar to the prior art lancets.
The present invention can be applied to any type of lancet whose needle ends are of a varied length protruding from their lancet ends.
All the finger-pricking devices that are currently on the market for use with prior art lancets are also applicable to lancets of the present invention.

Claims (18)

1. A lancet comprising:
a lancet body with a needle end protruding from a lancet end of the lancet body;
a separable needle protector having a first opening for protecting the protruding needle end before use; and the needle protector comprising a hood portion having a second opening tightly fittable on the lancet end from which the needle end protrudes, the hood portion having a flat contact base opposite the second opening, the hood portion being free-standing with the second opening upwardly oriented in such a manner that the hood portion may be fitted on the lancet end to insulate the needle end from the environment after use by inserting the lancet end downwardly into the second opening to surround the lancet end of the lancet body with the free-standing hood portion.
2. The lancet as defined in claim 1, wherein the lancet end is interference-fitted into the hood portion of the needle protector.
3. The lancet as defined in claim 1, wherein the lancet end is snap-fitted into the hood portion of the needle protector.
4. The lancet as defined in claim 1, wherein the hood portion has at its one end an opening for receiving the lancet end, and at its other end a closed bottom comprising a thick wall to be pierced by at least a portion of the protruding needle end.
5. The lancet as defined in claim 1, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom through which a bore is formed with a further opening, each of the bore and the further opening being of such a length, diameter and shape as to isolate the needle end from the exterior.
6. The lancet as defined in claim 1, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom having an elongate recess extending towards but short of the other end in such a manner as to isolate the needle end from the exterior.
7. The lancet as defined in claim 2, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a closed bottom comprising a thick wall to be pierced by at least a portion of the protruding needle end.
8. The lancet as defined in claim 2, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom through which a bore is formed with a further opening, each of the bore and the further opening being of such a length, diameter and shape as to isolate the needle end from the exterior.
9. The lancet as defined in claim 2, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom having an elongate recess extending towards but short of the other end in such a manner as to isolate the needle end from the exterior.
10. The lancet as defined in claim 3, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a closed bottom comprising a thick wall to be pierced by at lease a portion of the protruding needle end.
11. The lancet as defined in claim 3, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom through which a bore is formed with a further opening, each of the bore and the further opening being of such a length, diameter and shape as to isolate the needle end from the exterior.
12. The lancet as defined in claim 3, wherein the hood portion has at one end an opening for receiving the lancet end, and at its other end a bottom having an elongate recess extending towards but short of the other end in such a manner as to isolate the needle end from the exterior.
13. The lancet as defined in claim 1, wherein the lancet body and the needle protector are integrally formed as a single structure, the needle protector being separable from the lancet body.
14. The lancet as defined in claim 4, wherein the lancet body and the needle protector are integrally formed as a single structure, the needle protector being separable from the lancet body.
15. The lancet as defined in claim 5, wherein the lancet body and the needle protector are integrally formed as a single structure, the needle protector being separable from the lancet body.
16. The lancet as defined in claim 6, wherein the lancet body and the needle protector are integrally formed as a single structure, the needle protector being separable from the lancet body.
17. The lancet as defined in claim 13, wherein the lancet body and the needle protector comprise molded polymeric material.
18. A method of insulating a needle end of a lancet body from the environment comprising the steps of;
separating the needle end from a first opening in a needle protector;
placing a flat contact base of the needle protector on a flat supporting surface such that the needle protector is free-standing with a second opening in the needle protector upwardly oriented;
grasping the lancet body after appropriate use; and pressing the needle end downwardly into the second opening on the free-standing needle protector without otherwise stabilizing the needle protector, positively engaging the needle end with the second opening whereby the needle end is insulated from the environment.
CA002104269A 1992-08-28 1993-08-17 Lancet Expired - Lifetime CA2104269C (en)

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DE69326930D1 (en) 1999-12-09
JP2561697Y2 (en) 1998-02-04
US5385571A (en) 1995-01-31
DE69326930T2 (en) 2004-07-01
EP0589186B1 (en) 1999-11-03
EP0589186A1 (en) 1994-03-30
DK0589186T3 (en) 2000-01-03
AU4441493A (en) 1994-03-03
CA2104269A1 (en) 1994-03-01
KR940005080U (en) 1994-03-16
KR0137072Y1 (en) 1999-03-20
ES2137212T3 (en) 1999-12-16
JPH0623505U (en) 1994-03-29

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