METHOD OF MANUFACTURING A SKIN PRICKING LANCET

• US 20160317072A1
• Filed: 12/09/2014
• Published: 11/03/2016
• Est. Priority Date: 12/10/2013
• Status: Active Grant

• Current Assignee: Owen Mumford
• Original Assignee: Owen Mumford
• Inventors: CALVERT, Jack
• Granted Patent: US 10,561,355 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150335 by radiation
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150648 fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/15111 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
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A method of manufacturing a skin pricking lancet includes: thermoforming a plastic component; locating the thermoformed component and, optionally, one or more further plastic components around a lancet mechanism; and joining the located component(s) to form a hermetically sealed enclosure surrounding the lancet mechanism, the component(s) being formed and joined to provide a housing that structurally supports the lancet mechanism during use, and a cap breakable from the housing to facilitate firing of the lancet mechanism.

Claims

1-24. -24. (canceled)

25. A method of manufacturing a skin pricking lancet comprising:

thermoforming a plastic component;

locating the thermoformed component and, optionally, one or more further plastic components around a lancet mechanism; and

joining the located component(s) to form a hermetically sealed enclosure surrounding the lancet mechanism, the component(s) being formed and joined to provide a housing that structurally supports the lancet mechanism during use, and a cap breakable from the housing to facilitate firing of the lancet mechanism.

26. The method of manufacturing a skin pricking lancet according to claim 25 and comprising thermoforming said one or more further components.

27. The method of manufacturing a skin pricking lancet according to claim 25 and comprising joining the located component(s) together by heat sealing abutting peripheral edges of the component(s).

28. The method of manufacturing a skin pricking lancet according to claim 25, wherein the thermoformed plastic has a thickness of between 0.4 and 1.5 mm.

29. The method of manufacturing a skin pricking lancet according to claim 25 and comprising creating a score around the enclosure at a junction between the housing and the cap in order to facilitate breaking of the cap from the housing.

30. The method of manufacturing a skin pricking lancet according to claim 25 and comprising irradiating the enclosure in order to sterilize the interior of the enclosure including the lancet mechanism.

31. The method of manufacturing a skin pricking lancet according to claim 25, wherein the or each thermoformed component forms both a part of the cap and a part of the housing.

32. The method of manufacturing a skin pricking lancet according to claim 25 and comprising forming a narrowing of the enclosure at the junction between the housing and the cap.

33. A skin pricking lancet comprising a lancet mechanism and an enclosure containing the lancet mechanism, the enclosure comprising one or more plastic components hermetically sealed together, the or at least one plastic component being formed by thermoforming, the enclosure defining a housing and cap such that permanent removal of the cap from the housing can be achieved by breaking the cap from the housing.

34. The skin pricking lancet according to claim 33 and comprising a plurality of plastic components all of which are formed by thermoforming.

35. The skin pricking lancet according to claim 34, wherein said plurality of plastic components comprise two thermoformed plastic components of substantially identical configuration, and the seal between the components lies substantially in a plane that is parallel to a firing axis of the lancet mechanism.

36. The skin pricking apparatus according to claim 33, wherein said enclosure comprises a relatively narrow neck region between the housing and the cap to facilitate breaking of the cap from the housing.

37. The skin pricking lancet according to claim 33 and comprising a score line substantially around a junction between the cap and the housing to facilitate breaking of the cap from the housing.

38. The skin pricking lancet according to claim 33, wherein the hermetic seal is a heat formed seal.

39. The skin pricking lancet according to claim 33, wherein the thermoformed plastic has a thickness of between 0.4 and 1.5 mm.

40. The skin pricking lancet according to claim 33 and comprising a narrowing of the enclosure at the junction between the housing and the cap.

41. A skin pricking lancet comprising a housing defining an opening in a proximal region thereof, and a lancet mechanism supported substantially within the housing, the lancet mechanism comprising:

a needle;

a drive spring for driving the needle proximally through said opening along a drive axis;

a trigger configured in use to be pressed against a user'"'"'s skin to move the trigger along said drive axis from an extended position to a retracted position in order to release the drive spring; and

one or more features cooperating with said trigger to lock the trigger in said retraced position following movement of the trigger to that retracted position.

42. The skin pricking apparatus according to claim 41 and comprising a frame located within said housing, said feature or features being provided by the frame.

43. The skin pricking apparatus according to claim 41, wherein said frame has a substantially “

U”

shaped cross-section, the bite of the frame being located at a distal end of the housing.

44. The skin pricking apparatus according to claim 41, the feature or features being provided on an inner surface of the housing.

45. The skin pricking lancet according to claim 41, the trigger being engaged with the drive spring such that movement of the trigger from said extended position to said retracted position cocks the drive spring prior to releasing it.

46. The skin pricking lancet according to claim 41, the trigger extending through the opening in the housing and defining a further opening through which a tip of the needle can pass upon firing.

47. The skin pricking lancet according to claim 46, further comprising a return spring, acting between the trigger and a needle carrier within which the needle is mounted, arranged to withdraw the tip of the needle through the further opening in the trigger after firing.

48. The skin pricking lancet according to claim 41, wherein the trigger comprises one or more outwardly biased legs arranged to engage with a needle carrier within which the needle is mounted, when the trigger is in said extended position and prior to the trigger reaching said retracted position, said feature(s) being configured to allow the biased leg(s) to expand radially upon the trigger reaching said retracted position, thereby locking the trigger in the retracted position whilst releasing the needle carrier and thereby releasing the drive spring.