US20040039407A1 - Lancet device - Google Patents
Lancet device Download PDFInfo
- Publication number
- US20040039407A1 US20040039407A1 US10/134,995 US13499502A US2004039407A1 US 20040039407 A1 US20040039407 A1 US 20040039407A1 US 13499502 A US13499502 A US 13499502A US 2004039407 A1 US2004039407 A1 US 2004039407A1
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- US
- United States
- Prior art keywords
- lancet
- structured
- recited
- cocking seat
- cocking
- 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.)
- Abandoned
Links
- 238000005381 potential energy Methods 0.000 claims abstract description 12
- 230000014759 maintenance of location Effects 0.000 claims description 9
- 210000003811 finger Anatomy 0.000 description 6
- 238000010304 firing Methods 0.000 description 6
- 230000009286 beneficial effect Effects 0.000 description 4
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002991 molded plastic Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 210000003813 thumb Anatomy 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
- A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
- A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/15058—Joining techniques used for protective means
- A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/150885—Preventing re-use
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150885—Preventing re-use
- A61B5/150923—Preventing re-use by means for destroying components or parts, e.g. by cutting or piercing
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
- A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
Definitions
- the present invention relates to a lancet device preferably configured to provide a single use, and in all embodiments configured to substantially shield and protect a piercing tip thereof before and after use, while providing for accurate and effective piercing engagement of a patient's skin when appropriate. Furthermore, the present lancet device does not require complex and/or difficult to manipulate cocking and actuation activity in order to prepare the lancet device for piercing engagement with the skin, but rather is configured so as to be easily compressed, and in doing so provide all necessary cocking and actuation required to result in appropriate engagement of the skin by the piercing tip.
- Lancets are commonly utilized instruments which are employed both in hospitals and other medical facilities, as well as by private individuals, such as diabetics, in order to prick or pierce a patient's skin, typically on a finger of a patient, thereby leading to the generation of a blood sample which can be collected for testing. Because of the wide spread use of such lancets, there are a variety of lancet devices which are available for utilization by patients and/or practitioners in a variety of different circumstances.
- a typical lancet may merely include a housing with a sharp piercing tip that is pushed into the patient's skin.
- lancet devices which house a piercing tip and/or a lancet, have been developed which effectively encase and fire the lancet into the patient's skin, thereby eliminating the need for the person taking the sample to actually push the lancet tip into the skin.
- disposable lancet devices such devices typically include a housing which contains and directs or drives a piercing tip into the patient's skin, and which is disposed of along with the used lancet.
- a housing which contains and directs or drives a piercing tip into the patient's skin, and which is disposed of along with the used lancet.
- a further drawback associated with conventionally employed single use lancet devices is that they can often be difficult and/or complicated for elderly and/or impaired individuals to manipulate in order to achieve effective use.
- existing devices often require a user to perform a number of different actions, including one to cock and thereby prepare the device for use, and another to actually fire the device.
- those procedures even in the simplest form, can sometimes be complex and/or difficult to effectively achieve on a small compact device by certain individuals, and especially those individuals performing self testing who necessarily only have one hand to use to manipulate the device.
- a lancet device which whether single use and/or multiple use, could be very simplistic and effective to employee, not requiring a series of often complex activities to be perform in order to prepare the lancet for use and in order to actually utilize the lancet. Still, however, such a device should not comprise safety in the prevention of inadvertent use and/or reuse in exchange for the simplistic use, but rather should effectively coordinate all such beneficial characteristics. It would also be beneficial such a device could be effectively and cost effectively manufacture so as to make it available and affordable to a large variety of users, including home users.
- the present invention relates to a lancet device, and preferably a single use lancet device, utilized so as to effectively pierce a patient's skin and result in bleeding for subsequent sample collection.
- the lancet device of the present invention preferably includes a housing having an at least partially open interior.
- a lancet is movably disposed relative to the housing and includes a piercing tip which ultimately will penetrate the patient's skin.
- a biasing assembly is interposed between the lancet and the housing. The biasing assembly engages the lancet and functions to urge the lancet into its piercing orientation, when appropriate.
- the lancet device of the present invention also includes a cocking seat.
- the cocking seat is structured to engage the lancet and move the lancet against the force of the biasing assembly so as to increase a potential energy of the biasing assembly.
- the user's finger and/or another body part which is to be pierced engages the cocking seat and thereby pushes the cocking seat and the lancet until it ultimately engages a release assembly that extends into the housing.
- the release assembly is structured to disengage the lancet from the cocking seat such that the potential energy of the biasing assembly drives the piercing tip of the lancet at least temporarily into its piercing orientation.
- FIG. 1 is a side cross-sectional view of a preferred embodiment of the lancet device of the present invention in an un-used orientation
- FIG. 2 is a side cross-section view of the embodiment of FIG. 1 in a substantially cocked and immanent to release orientation
- FIG. 3 is a side cross-sectional view of a further embodiment of the lancet device of the present invention.
- FIG. 4 is an exploded view of the lancet device and cocking seat of a preferred embodiment of the present invention.
- FIG. 5 is a side cross-section view of still another embodiment of the lancet device of the present invention illustrating a re-usable configuration thereof.
- the present invention is directed towards a lancet device, generally indicated as 10 .
- the lancet device 10 is preferably a single use device such that after it is utilized for the first and only time it is configured so as to prevent subsequently use.
- a re-usable configuration may be provided.
- the lancet device of the present preferably includes a housing 20 .
- the housing 20 includes an at least partially open interior 22 and can be made of any variety materials, but preferably will be formed of a molded plastic type material for ease of manufacture and minimization of cost.
- the housing 20 preferably includes an open end 26 , which may represent a general front of the lancet device 10 , and may include any variety of axial configurations, including a square, triangle, oval, circle, etc., although a generally elongated, longitudinal configuration as illustrated in the Figures is preferred in conjunction therewith.
- the lancet device 10 further includes a lancet 40 movably disposed at least partially within the housing 20 and including a piercing tip 42 .
- the lancet 40 is a single integral unit as shown.
- what is referred to as a lancet in the claims may include a lancet body 40 ′ from which the piercing tip 42 extends, as well as a lancet receiving assembly 41 , into which the lancet body 40 ′ is disposed for movable retention.
- a new lancet body 40 ′ with piercing tip 42 is disposed within the lancet receiving assembly 41 .
- the lancet is movably disposed within the housing 20 .
- the lancet engages a biasing assembly also preferably disposed within the housing 20 .
- the biasing assembly includes a biasing element 50 such as a metal or plastic spring.
- the biasing element 50 is interposed between the lancet 40 and a rear end 55 , 55 ′ of the housing 20 .
- the rear end 55 , 55 ′ may be unitary or separate from the housing 20 .
- positioned so as to engage the lancet 40 is a cocking seat 30 .
- the cocking seat 30 is structured to engage the lancet 40 and move the lancet 40 against a force of the biasing assembly 50 so as to increase a potential energy of the biasing assembly 50 .
- the cocking seat 30 urges the lancet 40 towards the rear end of the lancet housing 20 , thereby resulting in a compression of the biasing assembly 50 and an increase in the potential energy thereof.
- a guide track assembly 24 , 32 may be provided between the cocking seat 30 and the housing 20 .
- an engagement assembly 34 , 45 is provided and preferably interposed between the cocking seat 30 and the lancet 40 so as to maintain moving engagement between the lancet 40 and the cocking seat 30 until they are disengaged, as will be described.
- the engagement assembly includes an engagement element 45 that extends from lancet 40 into effectively retained, engaging relation with a retention lip 34 on the cocking seat 30 .
- engagement assembly including one in which the engagement element extends from the cocking seat into engagement with a corresponding retention lip on the lancet, may also effectively be provided, the engagement assembly being configured so as to provide for effective substantially, although not necessarily completely, unitary movement between the lancet 40 and the cocking seat 30 until effective release thereby, as will be described.
- the present lancet device 10 further includes a release element 56 .
- the engagement element 45 of the engagement assembly preferably has a generally flexible and/or resilient characteristic relative to the lancet 40 , and/or as will be described, includes a single use pivot 46 .
- the release element 56 which also at least partially extends into an interior of the housing 20 when firing is desired, serves to engage the engagement element 45 , and ultimately causes upward movement thereof for disengagement between the engagement element 45 and a retention lip 34 .
- this disengagement is achieved after a substantial amount of potential energy has been achieved in the biasing assembly 50 .
- the guide track 32 may also serve to guide generally linear movement of the lancet 40 relative to the cocking seat 30 , as the lancet 40 moves to the open interior 31 of the cocking seat 30 and ultimately protrudes through an opening 37 in an exterior end 36 of the cocking seat 30 .
- this may be defined by a reduce thickness region in the segment that ultimately defines the engagement element.
- the pivot 46 is configured such that when the release element 56 engages the engagement element 45 , the engagement element 45 pivots on said pivot point 45 and cannot generally return to its pre-pivoted orientation. As a result, even if re-positioning of the engagement element relative to the cocking seat was attempted, the necessary engagement could not be achieved as the reduced thickness portion snaps and or deforms to prevent such repositioning. A single use of the device is therefor further ensured.
- the cocking seat 30 and preferably the exterior end 36 of the cocking seat 30 may be configured to engage a patient, at least in a general vicinity of a portion to be pierced.
- the opening 37 at the end 36 of the cocking seat 30 is preferably aligned with a specific location to be pierced, such as on a tip of the finger.
- a corresponding support element such as another finger or a thumb of the patient, or a hand of a medical practitioner or other user, or a solid surface
- the lancet 40 moves relative to the cocking seat 30 passing, therethrough such that its piercing tip 42 protrudes from the open end 37 of the cocking seat 30 and piercingly engages the patient's skin. Therefore, in the embodiments of FIGS. 1 and 2 the cocking movement directly results in firing of the lancet 40 , requiring only a single, fluid movement to effectively utilize the present lancet device 10 .
- the effective firing can be achieved either by moving the portion of the patient, such as their finger inward against a fixed support element, by moving a support element towards a fixed portion of the body to be pierced and/or by compressing both towards one another.
- the release element 56 may not necessarily be positioned at all times in an appropriate location to effectively release the lancet 40 from its engagement with the cocking seat 30 .
- a stopper 25 is position such that movement of the cocking seat 30 and therefore the lancet 40 towards the rear end 55 ′ will not result in a sufficient travel distance such that the engagement element 45 is released by the release element 56 .
- actuation of the rear end 55 ′ inwardly is required so as to effectively move the release element 56 into a position where it may engage the engagement element 45 and provide for appropriate release of the lancet 40 from the cocking seat 30 .
- a spring or a stopper may be provided so as to also restrict movement of the actuation element 55 ′, as it is ultimately preferred that actuation thereof be utilized only so as to effectively position the release element 56 in a position and orientation such that the previous or subsequent movement of the cocking seat 30 and/or the housing 20 in the manner previously described for cocking and firing results in the releasing engagement between the release element 56 and the engagement element 45 .
- actuation assemblies 55 ′ may be effectively provided so as to position the release element 56 in its appropriate position.
- a side, spring loaded button and/or resilient button may be provided such that the release element 56 is retained at least partially out of the housing and/or out of engaging relation with the engagement element 45 until it is actuated and moved at least partially into the interior of the housing 20 .
- cover element 43 which is structured to protect and shield the piercing tip 42 of the lancet 40 prior to use.
- the cover element 43 preferably extends out from the open interior 31 of the cocking seat 30 , out through the opening 37 so as to be effectively grasped by a user for removal thereof when preparing the lancet device 10 for use.
- exterior cover that covers the cocking seat and/or surrounds the piercing tip may also be provided.
- the cocking seat 30 is configured such that even when the cover element 43 is removed, the piercing end 42 is protected and/or shielded within the interior 31 thereof unless and until use.
- a single biasing assembly 50 may be sufficient so as to both drive the lancet 40 into its piercing orientation and so as to generally retracted back into its protective shielding within the cocking seat 30
- a secondary biasing assembly 52 may also be positioned and interposed between the lancet 40 and the cocking seat 30 , the secondary biasing assembly 52 being structured and disposed so as to not hinder movement of the piercing tip 42 into its piercing orientation, but so as to effectively retract the lancet 40 back into its protective containment within the cocking seat 30 .
- that retraction should not be sufficient so as to return the lancet 40 into its engagement relation with the cocking seat 30 for unitary movement therebetween.
Abstract
A lancet device including a housing with an at least partially open interior, a cocking seat moveably coupled with the housing and structured to define an open interior therewith, a lancet with a piercing tip moveably disposed within the open interior, and a biasing assembly engaging the lancet. The cocking seat is structured to engage the lancet and move the lancet against a force of the biasing assembly so as to increase a potential energy of the biasing assembly. A release element is provided to at least partially disengage the lancet from the cocking seat such that the potential energy of the biasing assembly moves the lancet relative to the cocking seat and drives the piercing tip of the lancet at least temporarily into a piercing orientation.
Description
- 1. Field of the Invention
- The present invention relates to a lancet device preferably configured to provide a single use, and in all embodiments configured to substantially shield and protect a piercing tip thereof before and after use, while providing for accurate and effective piercing engagement of a patient's skin when appropriate. Furthermore, the present lancet device does not require complex and/or difficult to manipulate cocking and actuation activity in order to prepare the lancet device for piercing engagement with the skin, but rather is configured so as to be easily compressed, and in doing so provide all necessary cocking and actuation required to result in appropriate engagement of the skin by the piercing tip.
- 2. Description of the Related Art
- Lancets are commonly utilized instruments which are employed both in hospitals and other medical facilities, as well as by private individuals, such as diabetics, in order to prick or pierce a patient's skin, typically on a finger of a patient, thereby leading to the generation of a blood sample which can be collected for testing. Because of the wide spread use of such lancets, there are a variety of lancet devices which are available for utilization by patients and/or practitioners in a variety of different circumstances.
- For example, a typical lancet may merely include a housing with a sharp piercing tip that is pushed into the patient's skin. More commonly, however, lancet devices, which house a piercing tip and/or a lancet, have been developed which effectively encase and fire the lancet into the patient's skin, thereby eliminating the need for the person taking the sample to actually push the lancet tip into the skin.
- Within the various types of specialized lancet devices, one variety are typically configured for multiple and/or repeated uses, while another category is particularly configured for single use, after which the entire device is disposed of Looking in particular to the single use, disposable lancet devices, such devices typically include a housing which contains and directs or drives a piercing tip into the patient's skin, and which is disposed of along with the used lancet. Naturally, so as to make such disposable devices cost effective for frequent use, such devices tend to be rather simplistic in nature providing only a sufficient mechanism for firing, and not overly complicating the design so as to minimize that cost.
- While existing single use devices are generally effective for achieving the piercing of the skin required for effective operation, such single use, disposable devices typically do not incorporate a large number of safety features to ensure the safe use and disposal of the device. For example, one primary area of safety which must be addressed with all lancet devices pertains to the purposeful and/or inadvertent reuse of a contaminated lancet. Unfortunately, most currently available single use lancet devices are configured such that after a use thereof has been achieved, it is possible for a patient to re-cock the device, thereby allowing for a subsequent, inappropriate use.
- As a result, it would be highly beneficial to provide a single use lancet device which is substantially compact and disposable, can be manufactured in a substantially cost effective manner, and which nevertheless is substantially safe to utilize, affirmatively preventing re-use, once contaminated.
- A further drawback associated with conventionally employed single use lancet devices is that they can often be difficult and/or complicated for elderly and/or impaired individuals to manipulate in order to achieve effective use. In particular, such existing devices often require a user to perform a number of different actions, including one to cock and thereby prepare the device for use, and another to actually fire the device. As can be appreciated, those procedures, even in the simplest form, can sometimes be complex and/or difficult to effectively achieve on a small compact device by certain individuals, and especially those individuals performing self testing who necessarily only have one hand to use to manipulate the device. Indeed, to avoid these complexities, some manufactures have turned to the use of pre-cocked and ready to use devices, however, this can often result in misfires and/or pre-fires of the lancet such that a certain of percentage of the lancet devices are not usable.
- As a result, it would also be beneficial to provide a lancet device, which whether single use and/or multiple use, could be very simplistic and effective to employee, not requiring a series of often complex activities to be perform in order to prepare the lancet for use and in order to actually utilize the lancet. Still, however, such a device should not comprise safety in the prevention of inadvertent use and/or reuse in exchange for the simplistic use, but rather should effectively coordinate all such beneficial characteristics. It would also be beneficial such a device could be effectively and cost effectively manufacture so as to make it available and affordable to a large variety of users, including home users.
- The present invention relates to a lancet device, and preferably a single use lancet device, utilized so as to effectively pierce a patient's skin and result in bleeding for subsequent sample collection. The lancet device of the present invention preferably includes a housing having an at least partially open interior. Furthermore, a lancet is movably disposed relative to the housing and includes a piercing tip which ultimately will penetrate the patient's skin. Similarly, a biasing assembly is interposed between the lancet and the housing. The biasing assembly engages the lancet and functions to urge the lancet into its piercing orientation, when appropriate.
- The lancet device of the present invention also includes a cocking seat. The cocking seat is structured to engage the lancet and move the lancet against the force of the biasing assembly so as to increase a potential energy of the biasing assembly. In the preferred embodiment, the user's finger and/or another body part which is to be pierced, engages the cocking seat and thereby pushes the cocking seat and the lancet until it ultimately engages a release assembly that extends into the housing. The release assembly is structured to disengage the lancet from the cocking seat such that the potential energy of the biasing assembly drives the piercing tip of the lancet at least temporarily into its piercing orientation. It is the movement of the lancet by the cocking seat which ultimately moves the lancet into its releasing engagement with the release element. As a result, in the preferred, illustrated embodiment, as the cocking seat moves the lancet, simultaneously cocking it and moving it into its engaging relation with the release element for effective actuation and firing thereof to pierce the skin of the patient.
- These and other features and advantages of the present invention will become more clear when the drawings as well as the detailed description are taken into consideration.
- For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:
- FIG. 1 is a side cross-sectional view of a preferred embodiment of the lancet device of the present invention in an un-used orientation;
- FIG. 2 is a side cross-section view of the embodiment of FIG. 1 in a substantially cocked and immanent to release orientation;
- FIG. 3 is a side cross-sectional view of a further embodiment of the lancet device of the present invention;
- FIG. 4 is an exploded view of the lancet device and cocking seat of a preferred embodiment of the present invention; and
- FIG. 5 is a side cross-section view of still another embodiment of the lancet device of the present invention illustrating a re-usable configuration thereof.
- Like reference numerals refer to like parts throughout the several views of the drawings.
- Shown throughout the Figures, the present invention is directed towards a lancet device, generally indicated as10. In the preferred embodiment of the present invention, as illustrated in FIGS. 1 through 3 the
lancet device 10 is preferably a single use device such that after it is utilized for the first and only time it is configured so as to prevent subsequently use. Ultimately, however, as illustrated in FIG. 5, a re-usable configuration may be provided. - Looking specifically to the Figures, the lancet device of the present preferably includes a
housing 20. Thehousing 20 includes an at least partiallyopen interior 22 and can be made of any variety materials, but preferably will be formed of a molded plastic type material for ease of manufacture and minimization of cost. Also in the preferred embodiment, thehousing 20 preferably includes anopen end 26, which may represent a general front of thelancet device 10, and may include any variety of axial configurations, including a square, triangle, oval, circle, etc., although a generally elongated, longitudinal configuration as illustrated in the Figures is preferred in conjunction therewith. - The
lancet device 10 further includes alancet 40 movably disposed at least partially within thehousing 20 and including apiercing tip 42. In the single use embodiment of FIGS. 1 through 3 thelancet 40 is a single integral unit as shown. Alternatively, as illustrated in the embodiment of FIG. 5, what is referred to as a lancet in the claims may include alancet body 40′ from which thepiercing tip 42 extends, as well as alancet receiving assembly 41, into which thelancet body 40′ is disposed for movable retention. In such an embodiment, each time thelancet device 10 is to be re-used, anew lancet body 40′ withpiercing tip 42 is disposed within thelancet receiving assembly 41. In either embodiment, however, the lancet is movably disposed within thehousing 20. - Preferably the lancet engages a biasing assembly also preferably disposed within the
housing 20. In the illustrated preferred embodiments, the biasing assembly includes abiasing element 50 such as a metal or plastic spring. Preferably, thebiasing element 50 is interposed between thelancet 40 and arear end housing 20. Therear end housing 20. Moreover, positioned so as to engage thelancet 40 is a cockingseat 30. In particular, the cockingseat 30 is structured to engage thelancet 40 and move thelancet 40 against a force of thebiasing assembly 50 so as to increase a potential energy of thebiasing assembly 50. In the illustrated embodiments, and as best seen in FIG. 2, the cockingseat 30 urges thelancet 40 towards the rear end of thelancet housing 20, thereby resulting in a compression of thebiasing assembly 50 and an increase in the potential energy thereof. Further, so as to maintain effectively appropriate alignment of the lancet and the cockingseat 30 as they are moving relative to thehousing 20, in the preferred embodiment, aguide track assembly seat 30 and thehousing 20. In the preferred, illustrated embodiments, anengagement assembly seat 30 and thelancet 40 so as to maintain moving engagement between thelancet 40 and the cockingseat 30 until they are disengaged, as will be described. In the illustrated embodiments, the engagement assembly includes anengagement element 45 that extends fromlancet 40 into effectively retained, engaging relation with aretention lip 34 on the cockingseat 30. As a result, as the cockingseat 30 moves inward towards therear end 55 of thehousing 20, the effective engagement between theengagement element 45 and theretention lip 34 results in movement of thelancet 40 in unison with the cockingseat 30. In this regard, it is understood that a variety of different engagement assemblies, including one in which the engagement element extends from the cocking seat into engagement with a corresponding retention lip on the lancet, may also effectively be provided, the engagement assembly being configured so as to provide for effective substantially, although not necessarily completely, unitary movement between thelancet 40 and the cockingseat 30 until effective release thereby, as will be described. - In particular, the
present lancet device 10 further includes arelease element 56. In the illustrated embodiments, theengagement element 45 of the engagement assembly preferably has a generally flexible and/or resilient characteristic relative to thelancet 40, and/or as will be described, includes asingle use pivot 46. As a result, when the cockingseat 30 and therefore thelancet 40 are urged sufficiently into an interior 22 ofhousing 20, therelease element 56 which also at least partially extends into an interior of thehousing 20 when firing is desired, serves to engage theengagement element 45, and ultimately causes upward movement thereof for disengagement between theengagement element 45 and aretention lip 34. Moreover, this disengagement is achieved after a substantial amount of potential energy has been achieved in the biasingassembly 50. As a result, disengagement between thelancet 40 and the cockingseat 30 results in thelancet 40 moving relative to the cockingseat 30 under a force achieved by the potential energy stored in the biasingassembly 50. Theguide track 32 may also serve to guide generally linear movement of thelancet 40 relative to the cockingseat 30, as thelancet 40 moves to theopen interior 31 of the cockingseat 30 and ultimately protrudes through anopening 37 in anexterior end 36 of the cockingseat 30. - Looking further to the
single use pivot 46, this may be defined by a reduce thickness region in the segment that ultimately defines the engagement element. Thepivot 46 is configured such that when therelease element 56 engages theengagement element 45, theengagement element 45 pivots on saidpivot point 45 and cannot generally return to its pre-pivoted orientation. As a result, even if re-positioning of the engagement element relative to the cocking seat was attempted, the necessary engagement could not be achieved as the reduced thickness portion snaps and or deforms to prevent such repositioning. A single use of the device is therefor further ensured. - As previously indicated, the cocking
seat 30, and preferably theexterior end 36 of the cockingseat 30 may be configured to engage a patient, at least in a general vicinity of a portion to be pierced. Furthermore, in the preferred, illustrated embodiment, theopening 37 at theend 36 of the cockingseat 30 is preferably aligned with a specific location to be pierced, such as on a tip of the finger. That portion of the body, such as the finger, is thereby utilized as an abutment on one of thelancet device 10, while a corresponding support element, such as another finger or a thumb of the patient, or a hand of a medical practitioner or other user, or a solid surface, engages thehousing 20 of thelancet device 10. In this regard, as either or both the body section and the support element are moved towards one another such that a spacing therebetween is reduced, the cockingseat 30 moves further into thehousing 20 until ultimately theengagement element 45 engages and is released by the releasedelement 56. Once this release is achieved, thelancet 40 moves relative to the cockingseat 30 passing, therethrough such that its piercingtip 42 protrudes from theopen end 37 of the cockingseat 30 and piercingly engages the patient's skin. Therefore, in the embodiments of FIGS. 1 and 2 the cocking movement directly results in firing of thelancet 40, requiring only a single, fluid movement to effectively utilize thepresent lancet device 10. Looking in further detailed to the previous description, it is understood that the effective firing can be achieved either by moving the portion of the patient, such as their finger inward against a fixed support element, by moving a support element towards a fixed portion of the body to be pierced and/or by compressing both towards one another. - Turning to the embodiment of FIG. 3, it is also understood, that for further safety reasons, if desired, the
release element 56 may not necessarily be positioned at all times in an appropriate location to effectively release thelancet 40 from its engagement with the cockingseat 30. For example, in the embodiment of FIG. 3 astopper 25 is position such that movement of the cockingseat 30 and therefore thelancet 40 towards therear end 55′ will not result in a sufficient travel distance such that theengagement element 45 is released by therelease element 56. Rather, in this illustrated embodiment actuation of therear end 55′ inwardly is required so as to effectively move therelease element 56 into a position where it may engage theengagement element 45 and provide for appropriate release of thelancet 40 from the cockingseat 30. Also in this embodiment a spring or a stopper may be provided so as to also restrict movement of theactuation element 55′, as it is ultimately preferred that actuation thereof be utilized only so as to effectively position therelease element 56 in a position and orientation such that the previous or subsequent movement of the cockingseat 30 and/or thehousing 20 in the manner previously described for cocking and firing results in the releasing engagement between therelease element 56 and theengagement element 45. Also on such an embodiment is recognized that a variety ofdifferent actuation assemblies 55′ may be effectively provided so as to position therelease element 56 in its appropriate position. For example, a side, spring loaded button and/or resilient button may be provided such that therelease element 56 is retained at least partially out of the housing and/or out of engaging relation with theengagement element 45 until it is actuated and moved at least partially into the interior of thehousing 20. - Looking again to FIG. 1, further features that may be provided with the present invention may be the inclusion of a
cover element 43 which is structured to protect and shield the piercingtip 42 of thelancet 40 prior to use. Thecover element 43 preferably extends out from theopen interior 31 of the cockingseat 30, out through theopening 37 so as to be effectively grasped by a user for removal thereof when preparing thelancet device 10 for use. Alternately, and exterior cover that covers the cocking seat and/or surrounds the piercing tip may also be provided. It is also noted, that the cockingseat 30 is configured such that even when thecover element 43 is removed, the piercingend 42 is protected and/or shielded within theinterior 31 thereof unless and until use. Indeed, it is only when the driving force of the biasingassembly 50 urges the lancet's movement relative to the cockingseat 30 that the piercingtip 42 temporarily passes through theopening 37. Still, as a final safety measure, although asingle biasing assembly 50 may be sufficient so as to both drive thelancet 40 into its piercing orientation and so as to generally retracted back into its protective shielding within the cockingseat 30, in some embodiments asecondary biasing assembly 52 may also be positioned and interposed between thelancet 40 and the cockingseat 30, thesecondary biasing assembly 52 being structured and disposed so as to not hinder movement of the piercingtip 42 into its piercing orientation, but so as to effectively retract thelancet 40 back into its protective containment within the cockingseat 30. Moreover, that retraction should not be sufficient so as to return thelancet 40 into its engagement relation with the cockingseat 30 for unitary movement therebetween. - Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
- Now that the invention has been described,
Claims (23)
1. A lancet device comprising:
a) a housing, said housing including an at least partially open interior;
b) a lancet moveably disposed at least partially within said housing and including a piercing tip;
c) a biasing assembly engaging said lancet;
d) a cocking seat, said cocking seat structured to engage said lancet and move said lancet against a force of said biasing assembly so as to increase a potential energy of said biasing assembly;
e) a release element structured to at least partially disengage said lancet from said cocking seat such that said potential energy of said biasing assembly drives said piercing tip of said lancet at least temporarily into a piercing orientation; and
f) said cocking seat structured to move said lancet into releasing engagement with said release element.
2. A lancet device as recited in claim 1 wherein said lancet includes an engagement assembly interposed between said cocking seat and said lancet and structured to maintain said moving engagement between said lancet and said cocking seat until disengaged by said release element.
3. A lancet device as recited in claim 2 wherein said engagement assembly includes an engagement element extending from said lancet into engaging relation with a retention lip on said cocking seat.
4. A lancet device as recited in claim 3 wherein said release element is structured to engage said engagement element upon substantial movement of said lancet against said force of said biasing assembly so as to release said engagement element from said engaged relation with said retention lip.
5. A lancet device as recited in claim 4 wherein said release element extends at least partially into an interior of said housing and is structured to inwardly bias said engagement element.
6. A lancet device as recited in claim 4 further comprising a single use pivot operatively associated with said engagement element, said release element structured pivot said engagement element about said single use pivot so as to release said engagement element from said engaged relation with said retention lip, and so as to result in deformity of said single use pivot sufficient to prevent repositioning of said engagement element in engaging relation with said retention lip.
7. A lancet device as recited in claim 1 wherein said cocking seat is structured to engage a body section in a vicinity of a portion to be pierced by said piercing tip, and said housing is structured to engage a support element, such that a decrease in a relative spacing between the body section and the support element results in movement of said cocking seat, and accordingly said lancet, against said force of said biasing assembly.
8. A lancet device as recited in claim 1 wherein said biasing assembly includes a spring.
9. A lancet device as recited in claim 1 further comprising a secondary biasing element between said cocking seat and said lancet and structured to return said lancet to a retracted orientation after said piercing tip has moved into said piercing orientation.
10. A lancet device as recited in claim 1 further comprising a removable cover element structured to cover said piercing tip prior to use.
11. A lancet device as recited in claim 10 wherein said cover element is structured to protrude from said cocking seat so as to be grasped for removal thereof.
12. A lancet device as recited in claim 11 wherein said cocking seat is structured to shield said piercing tip of said lancet after said cover assembly is removed and before said lancet is driven into said piercing orientation.
13. A lancet device as recited in claim 1 further comprising a guide track structured to guide generally linear movement of said lancet into said piercing orientation.
14. A lancet device as recited in claim 1 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat, said rlease element further structured to to disengage said lancet from said cocking seat only after substantial movement of said lancet against said force of said biasing assembly results in positioning of said lancet in a releasable orientation.
15. A lancet device comprising:
a) a housing, said housing including an at least partially open interior;
b) a cocking seat moveably coupled with said housing and structured to define an open interior therewith;
c) a lancet moveably disposed at least partially within said open interior and including a piercing tip;
d) a biasing assembly engaging said lancet;
e) said cocking seat structured to engage said lancet and move said lancet against a force of said biasing assembly so as to increase a potential energy of said biasing assembly; and
f) a release element structured to at least partially disengage said lancet from said cocking seat such that said potential energy of said biasing assembly moves said lancet relative to said cocking seat and drives said piercing tip of said lancet at least temporarily into a piercing orientation.
16. A lancet device as recited in claim 15 wherein said cocking seat structured to move said lancet into releasing engagement with said release element.
17. A lancet device as recited in claim 15 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat.
18. A lancet device as recited in claim 15 wherein said cocking seat is structured to move said lancet against said force of said biasing assembly and into a releasable orientation.
19. A lancet device as recited in claim 18 wherein said release element is structured to be exteriorily actuated so as to disengage said lancet from said cocking seat only when said lancet is disposed in said releasable orientation.
20. A lancet device as recited in claim 19 further comprising a stopper element structured to prevent further movement of said lancet against said force of said biasing assembly upon movement of said lancet into said releasable orientation.
21. A lancet device as recited in claim 20 wherein said stopper element is structured to abut said cocking seat.
22. A lancet device as recited in claim 15 wherein said lancet comprises a lancet receiving assembly and a lancet body removably coupled thereto, said lancet body containing said piercing tip.
23. A lancet device as recited in claim 15 further comprising a single use pivot operatively associated with said cocking seat, said single use structured to be deformed upon said release element disengaging said lancet from said cocking seat so as to prevent repositioning of said lancet in engaged, pre-fired relation with said cocking seat.
Priority Applications (7)
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US10/134,995 US20040039407A1 (en) | 2002-04-29 | 2002-04-29 | Lancet device |
PCT/US2003/011087 WO2003092512A1 (en) | 2002-04-29 | 2003-04-11 | Lancet device |
CA2484942A CA2484942C (en) | 2002-04-29 | 2003-04-11 | Lancet device with a single use pivot |
AU2003237803A AU2003237803A1 (en) | 2002-04-29 | 2003-04-11 | Lancet device |
EP03736459A EP1501428A4 (en) | 2002-04-29 | 2003-04-11 | Lancet device |
US10/716,385 US8118825B2 (en) | 2002-04-29 | 2003-11-18 | Lancet device |
US13/401,226 US8715309B2 (en) | 2002-04-29 | 2012-02-21 | Lancet device |
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US10/134,995 US20040039407A1 (en) | 2002-04-29 | 2002-04-29 | Lancet device |
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Also Published As
Publication number | Publication date |
---|---|
US20040147948A1 (en) | 2004-07-29 |
WO2003092512A1 (en) | 2003-11-13 |
CA2484942A1 (en) | 2003-11-13 |
EP1501428A1 (en) | 2005-02-02 |
AU2003237803A1 (en) | 2003-11-17 |
CA2484942C (en) | 2012-03-20 |
EP1501428A4 (en) | 2008-03-12 |
US8118825B2 (en) | 2012-02-21 |
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