Multiple segment encapsulated medical lancing device

• US 5,514,152 A
• Filed: 08/16/1994
• Issued: 05/07/1996
• Est. Priority Date: 08/16/1994
• Status: Expired due to Fees

• Current Assignee: Roger E. Smith
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Smith, Roger E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/291,234
• Time in Patent Office: 630 Days
• Field of Search: 606/181, 606/182, 606/183, 128/751
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile

Abstract

A novel two part lancing device comprising a multiple compartment housing for lancets and a carrier. The compartments are joined in a common multiple lancet housing for improved handling and distribution. The housing consists of two end compartments and at least two serially linked, frangibly separable, disposable lancet compartments which comprise presterilized, self-actuating lancets. When fired, each lancet, driven by a precocked torsion spring, executes one reciprocal cycle wherein the lancet tip is driven outward a precise distance to lance a patients finger or the like and is then fully retracted into the housing compartment. The spent lancet can be frangibly separated from the housing to provide access to the next-to-be-used lancet which remains aseptically pure until the moment of separation of the spent lancet. Because the used lancet tip is fully retracted into the housing, the separated lancet compartment can be safely discarded without special handling. The carrier is a handler for the lancet housing and provides a convenient tool of constant length and "feel" for positioning and firing the lancets.

Claims

1. A disposable lancet actuating apparatus which can be triggered to discharge a lancet tip from a housing and retract the lancet tip into the housing for safe disposal comprising:

a lancet body comprising the lancet tip;

means for storing energy which can be released from a state of high potential energy to provide a unidirectional angular form of kinetic energy through a period of time while energy is being released, said energy storing means comprising means for communicating with a triggerable release;

means for coupling between the energy storing means and the body such that kinetic displacement of the energy storing means forcefully drives the lancet tip linearly outward from the housing and then forcefully retracts the lancet tip back into the housing through the period of energy release;

the housing comprising;

means for enveloping and encapsulating the lancet body;

a manually operated triggerable release for releasing the energy storing means from the high potential energy state thereby permitting the lancet tip to be triggerably actuated;

guide means which restrain travel of the lancet tip to linear motion;

means for precisely limiting depth of lancet tip penetration.

2. A disposable lancet actuating apparatus according to claim 1 further comprising means for frangible attachment to at least one other lancet actuating apparatus.

3. A disposable lancet actuating apparatus according to claim 1 wherein said energy storing means comprise torsion spring means which comprise a first end which is immobilized within the housing.

4. A disposable lancet actuating apparatus according to claim 1 wherein said triggerable release comprises a frangible connection to the rest of the housing.

5. A disposable lancet actuating apparatus according to claim 1 wherein the housing comprises means for restricting the linear motion to one reciprocal cycle, thereby restricting said lancet actuating apparatus to being used just once and lancet tip entry into a patient but once.

6. A disposable lancet actuating apparatus according to claim 1 wherein the housing comprises actuating means which are irreversibly altered upon actuation to restrict a lancet tip to being used just once.

7. A self-actuating and automatically retracting lancing device for uses comprising pricking a fingertip and other percutaneous puncture sites of a medical patient, said device comprising:

a lancet housing comprising torsion spring restraining means, torsion spring releasing means, and lancet guide means;

precocked torsion spring means;

lancet means comprising sharpened lancet tip and;

in combination, said housing, spring means and lancet means comprising means for translating rotary motion of said torsion spring means to a desired linear motion for said lancet means through a period while the torsion spring means undergo spring unwinding.

8. A self-actuating and automatically retracting lancing device according to claim 7 wherein said spring means and lancet means are an integral part of the same means formed from one length of stainless steel spring wire having bending points used in translation of spring rotary motion to desired lancet linear motion.

9. A self-actuating and automatically retracting lancing device according to claim 8 wherein bending points on said wire are annealed to form reliable hinges.

10. A combination comprising a plurality of lancing devices, a housing for joining said plurality of lancing devices into a single lancet strip and a carrier for the housing, said combination comprising:

the housing which comprises;

means for serially interconnecting a plurality of said lancing devices;

means for sealing and maintaining said lancing devices in a sterile condition until opened for use;

at least one means for separating portions of the housing by which said lancing devices can be opened for use and separated from the rest of the housing for disposal after use;

opposing ends of said housing which aid in maintaining a sealed sterile environment for the lancing devices and at least one of said ends which must be separated from the rest of the housing before a first lancing device can be used;

each of said lancing devices comprising a lancing part, precocked torsion spring means, means for translating rotary motion of said spring means to desired linear motion of said lancet part, means for discharging said torsion spring means which, when released, dynamically and forcefully fire the lancet outward from the housing by positive spring force and likewise retract the lancet part into the housing for safe disposal while the precocked torsion spring means is releasing energy which has been previously stored in a precocking phase;

the carrier comprising;

means for transporting and containing the housing;

means for precisely positioning said housing and firmly holding the housing during lancing;

means for actuating the torsion spring discharging means to trigger and thereby fire the lancing part.

11. A combination according to claim 10 wherein said carrier comprises a proximal tunnel end into which said housing is fed and a distal tunnel end where lancet devices are used and frangibly separated.

12. A combination according to claim 10 wherein said positioning means comprise a detent which restricts travel of said housing through said carrier to only one direction.

13. A combination according to claim 10 wherein said carrier comprises a pocket clip means for pocket transport.

14. A combination according to claim 10 wherein said lancing part comprises a frangibly releasable segment and said actuating means comprise a cantilever comprising a raised part positioned to effectively impact against said frangible segment having a length of travel such that the raised part frangibly separates the frangibly releasable segment from the part thereby discharging the torsion spring and activating the lancet part.

15. A combination according to claim 14 wherein said raised part keywise matches the form of the frangible lancet actuation means to provide a measure of safety wherein the likelihood of other means discharging the lancet actuation means is reduced.

16. A method for utilizing a lancet instrument for multiple self-actuating and automatically retracting lancing devices whereby the lancing devices may be individually and sequentially used comprising the following steps:

providing said lancet instrument comprising a housing for a plurality of said lancing devices and means for frangibly separating the lancing devices which are maintained by the housing in sterile condition before being opened for use, said housing comprising notches to be used with a lancing device positioning means;

providing a carrier, to enclose and hold said housing, comprising;

a housing positioning means to position and hold said housing within the carrier such that, prior to use, each lancing device can be firmly held against a puncture site; and

triggering means to fire the lancet;

inserting the lancet housing through the carrier until the detent means catches and positions the housing with a frangibly separable segment fully exposed;

breaking away the frangible separation means to open one aseptic lancing device for use;

placing the lancing device against the puncture site and activating the triggering means whereupon the puncture site is lanced by release of energy previously stored in a spring, the lancing occurring while the energy is being released, the energy release causing spring motion in a single direction which forces egress/ingress action of said lancing device, said lancet tip being safely restored into the lancing device by constraining spring motion in the same direction.

17. A method according to claim 16 comprising the further step of breaking away a last used lancet device and safely disposing of the last used lancet which is directly and safely disposable because the spent lancet means is wholly returned into the housing at the end of a lancing cycle.

18. Structure for obtaining a droplet blood sample from a medical patient comprising:

lancet means comprising a finger piercing element, an associated potential-energy-storing, biasing element and means associating the piercing element and the biasing element by which a single direction of motion of the biasing element resulting during release of the potential energy is converted to bidirectional substantially linear displacement of the piercing element;

enveloping means substantially encapsulating the finger piercing element therein before and after use, the enveloping means comprising egress/ingress means for the finger piercing element;

actuator means associated with the enveloping means whereby use of the actuator means releases the stored potential energy and initiates the single direction of motion which is translated into said bidirectional displacement whereby the finger piercing element is first caused to forcibly move outward through the egress/ingress means to cause the finger piercing element to pierce a desired body site and to thereafter retract into the enveloping means through the egress/ingress means.

19. Structure according to claim 18 wherein the actuator means comprise a frangible segment of the enveloping means.

20. Structure according to claim 18 wherein the actuator means comprise frangible means by which the one form of motion by the biasing element is manually triggered.

21. Structure according to claim 18 wherein the biasing element comprises a torsion spring.

22. Structure according to claim 21 wherein the torsion spring and the piercing element are integrally connected as one continuous piece.

23. Structure according to claim 21 wherein the torsion spring, the finger piercing element and the motion converting means are formed as one piece.

24. Structure according to claim 18 wherein the motion converting means comprise annealed hinge means.

25. Structure according to claim 18 wherein the biasing means comprises a coiled spring and the motion converting means comprises hinge means comprising two spaced pivot sites whereby same direction rotational unwinding of the coiled spring twice bi-pivots the hinge means to extend and then retract the piercing element.

26. Structure according to claim 18 wherein the biasing element and the piercing element are formed as one piece.

27. Structure according to claim 18 wherein the egress/ingress means comprises a port initially closed as a part of a hermetic seal.

28. Structure according to claim 27 wherein the part is manually frangibly removable by a user to expose the port at a desired time.

29. Structure according to claim 18 wherein the biasing means and the finger piercing element comprise separate parts interconnected in cam/cam follower arrangement.

30. Structure according to claim 18 wherein the motion converting means comprise a guide track which obstructs non-linear travel of the piercing element.

31. Structure according to claim 18 wherein the biasing element comprises a coiled spring having a cam end and the piercing element comprises a cam follower slot along which the cam end travels upon actuation of the actuator means.

32. Structure according to claim 18 wherein the biasing means comprise a torsion spring an end of which is anchored against said single direction of motion to the enveloping means at the actuator means whereby actuation of the actuator means releases said end from its anchored condition.

33. Structure according to claim 18 further comprising means for limiting penetration of the piercing means into the body site to a precise predetermined depth.

34. A method of obtaining a droplet of blood sample from a medical patient comprising the steps of:

providing a percutaneous piercing element enclosed within enveloping means comprising an egress/ingress port;

placing the egress/ingress port of the enveloping means at a puncture site of a medical patient;

manually actuating exposed actuator means causing an associated biasing element to be nonlinearly, but unidirectionally displaced;

converting the unidirectional displacement into a first substantially linear displacement of the finger piercing element outward through the egress/ingress port and into the puncture site and thereafter a second opposite substantially linear displacement of the percutaneous piercing element to retract the element entirely within the enveloping means through the egress/ingress port.

35. A method according to claim 34 further comprising the step of manually exposing the egress/ingress port by removal of a portion of a hermetic seal prior to the placing step.

36. A method according to claim 35 wherein the manually exposing step comprises manually breaking a frangible connection disposed distal to a user of the egress/ingress port.