Combined lancet and multi-function cap and lancet injector for use therewith

• US 5,324,303 A
• Filed: 01/21/1993
• Issued: 06/28/1994
• Est. Priority Date: 09/25/1992
• Status: Expired due to Term

• Current Assignee: Selfcare Inc. (Johnson & Johnson)
• Original Assignee: AMG Medical Incorporated (AMG Medical USA Inc.)
• Inventors: Strong, Bernard, Oringer, Robert
• Primary Examiner(s): Lewis, Ralph
• Application Number:
  US08/007,339
• Time in Patent Office: 523 Days
• Field of Search: 606/181, 606/182, 606/183, 604/111, 604/117, 604/192, 128/770
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

A combined lancet and multi-function cap of the disposable type, for use in obtaining blood samples for diagnostic purposes. The lancet includes a needle with a sharp end and an elongated body of plastic material embedding the needle except for its sharp end. The multi-function cap is also made of plastic material and is detachably mounted onto one end of the body to embed the sharp end and keep it sterile until the lancet is used. The multi-function cap includes a ring having a central opening sized to let pass the sharp end of the needle but not the body of the lancet. The multi-function cap also includes a set of legs or a skirt that project from the ring for connecting the same to the mouth of a lancet injector. Thus, the cap also serves as an isolation barrier between the patient'"'"'s finger and the physical lancet injector. In use, when the multi-function cap is detached from the lancet and is connected to the lancet injector, the ring of the cap extends across the mouth and positively controls the depth of penetration of the lancet in the patient'"'"'s skin. This ring also serves to lock the needle within the cap after use and thus reduces the danger of accidental finger-stick by a blood contaminated needle. Also disclosed is a lancet injector for use with the above lancet and multi-function cap.

Claims

1. A combined lancet and multi-function cap, comprising:

a lancet including a needle having a sharp end, and an elongated body of plastic material embedding said needle except for its sharp end that projects from one end of said body over a given length, said elongated body having at least one longitudinal rib; and

a cap also made of plastic material, said cap being detachably mounted on said one end of said body to cover the sharp end of said needle and keep it sterile until the lancet is used,

wherein said cap is a multi-function cap and comprises;

a ring having an inner face, an outer face and a central opening sized to let pass the sharp end of said needle but not the one end of the body of the lancet, said ring having such a thickness and a shape as to let pass the sharp end of the needle through the central opening and penetrate the skin of a patient'"'"'s finger in contact with the outer face of the ring, and

means projecting from the inner face of said ring for use to properly position the ring with respect to a lancet injector having a mouth through which said lancet may be inserted and subsequently projected out, in such a manner that the central opening of said ring is aligned with the sharp end of said needle,

whereby when the multi-function cap is detached from said lancet and is connected to said lancet injector, the ring of said tip extends across said mouth and positively controls the depth of penetration of said lancet in the patient'"'"' skin,

said lancet and multi-function cap being made of the same plastic material and together forming an integral structure in which is embedded said needle, with the body of said lancet radially projecting from the ring of said multi-function cap, said body and ring being integrally connected by a very short stem of reduced diameter that is coaxial to said needle and sized to make said tip easily detachable from said body by twisting and pulling to release said sharp end,

said means for use to properly position the ring with respect to the lancet injector including at least three legs integral to and symmetrically positioned around said ring, said legs projecting from said ring in the direction of the inner face of said ring and having resilient ends snappable into a groove provided for this purpose on said lancet injector near the mouth of said injector; and

the body of said lancet also comprising a first peripheral groove that extends parallel to the one end of said body and is sized to be snapped by the resilient ends of said at least three legs, said first peripheral groove being positioned along said body in such a manner that when the resilient ends of said at least three legs are snapped into said first groove, the ring of the multi-function cap extends past and over the sharp end of the needle projecting from the one end of the body of the lancet, thereby preventing accidental finger-sticks with said sharp end.

2. The combined lancet and multi-function cap of claim 1, wherein:

the body of said lancet comprises a second peripheral groove extending parallel to the first groove between said first groove and the one end of said body; and

each of said at least three legs of the multi-function cap comprises a small restraining leaf projecting towards the center of the central opening of the ring of said cap, said leaves being of such a length as to engage and lock into the second groove of said body to prevent said lancet from moving out from said multi-function cap after said lancet has been projected toward the inner face of said ring and has bounded back at a safe distance where the sharp end of the needle does not project anymore from the outer face of said ring.

3. The combined lancet and multi-function cap of claim 2, wherein:

said multi-function cap comprises at least one aperture acting as a viewing window to make it possible for someone to check whether the lancet is engaged and locked by the restraining leaves, such an engagement being indicative of the fact that the lancet has been used once and is to be discarded.

4. The combined lancet and multi-function cap of claim 1, wherein:

the one end of the body of said lancet has at least one radially extending section that projects from said one end in the same direction as the sharp end of the needle; and

the inner face of the ring of said multi-function cap has different radial sections that project at different distances away from an average plane parallel to said ring,

whereby proper adjustment of the position of the multi-function cap by rotation of the same about the mouth of the lancet injector relative to the lancet allows said at least one radially extending section projecting from the one end of the body to be brought into alignment with any selected corresponding radical section of the inner face of the ring and thus to control the depth of penetration of said lancet.

5. The combined lancet and multi-function cap of claim 4, wherein:

said elongated body has several longitudinal ribs including said at least one longitudinal rib,

at least one of said ribs is sized and positioned to act also as a key for radially securing the body within said lancet injector whenever such a device is used; and

one of said legs of said multi-function cap is shaped and devised to cooperate with marks externally made on the lancet injector in order to give a visible indication of the position of the multi-function cap relative to the lancet keyed in said lancet injector, and thus of the depth of penetration that will be achieved by operating said injector.

6. The combined lancet and multi-function cap of claim 5, wherein the different radial sections that project from the inner face of the ring, consist of a plurality of steps of different heights.

7. The combined lancet and multi-function cap of claim 5, wherein the different radial sections that project from the inner face of the ring, consist of a continuous surface of helical shape.

8. The combined lancet and multi-function cap of claim 5, wherein:

the body of said lancet comprises a second peripheral groove extending parallel to the first groove between said first groove and the one end of said body; and

each of said at least three legs of the multi-function cap comprises a small restraining leaf projecting towards the center of the central opening of the ring of said cap, said leaves being a of such a length as to engage and lock into the second groove of said body to prevent said lancet from moving out from said multi-function cap after said lancet has been projected toward the inner face of said ring and has bounced back at a safe distance where the sharp end of the needle does not project anymore from the outer face of said ring.

9. The combined lancet and multi-function cap of claim 8, wherein:

said multi-function cap comprises at least one aperture acting as a viewing window to make it possible for someone to check whether the lancet is engaged and locked by the restraining leaves, such as engagement being indicative of the fact that the lancet has been used once and is to be discarded.

10. The combination of a lancet injector with a combined lancet and multi-function cap of claim 9 wherein said lancet injector comprises:

a lancet receiving sleeve having a longitudinal axis and a mouth at one end through which said lancet may be inserted and subsequently projected out;

a lancet holder slidably mounted within said sleeve, said holder being sized and shaped to receive said lancet and to cooperate with said at least one longitudinal rib of said lancet to prevent it from rotating about said longitudinal axis;

means to prevent the lancet holder from rotating within the lancet receiving sleeve said means comprising a pair of gripping wings radially projecting from said lancet holder and slidably engaged within longitudinal slots provided for this purpose within said sleeve, said gripping wings projecting radially outwardly from said sleeve through said longitudinal slots;

a central shaft integrally projecting from said lancet holder in a direction opposite to said mouth, said central shaft being coaxial with said longitudinal axis and projecting out of said lancet receiving sleeve;

elastic means mounted in a housing connected to said lancet receiving sleeve opposite the mouth thereof to project forward the central shaft and lancet holder upon pressing of a release button externally mounted on said housing, said elastic means being energized while the release button is triggered in operative position every time the lancet holder is manually moved within said sleeve by said gripping winds; and

a sleeve-shaped ejector slidably mounted externally onto the lancet receiving sleeve, said ejector having longitudinally slots positioned to make it movable without being stopped by the gripping wings and means to engage the lancet with the lancet holder and being manually movable toward the mouth of the lancet receiving sleeve to push the lancet out of the lancet holder and to detach and throw out the multi-function cap connected and locked thereto without having to put the fingers on said cap to remove the used lancet from the lancet injector.

11. The combination of claim 10, wherein said elastic means comprises:

an elastomeric band held under slight tension by four points so as to form an elongated rectangle having two small sides and main axis points coaxial with said longitudinal axis and said central shaft;

a front pin and a rear pin radially projecting from said central shaft in such a manner as to respectively contact the small sides of the rectangle formed by said elastomeric band within said rectangle;

a self-tensioned detent integral to said central shaft, said detent projecting radially outwardly; and

a stop positioned onto said housing in such a manner as to extent across the detent and lock the central shaft in a rearward position where the rear pin of the central shaft presses against the elastomeric band and is biased by the same and the lancet holder extends within said lancet receiving sleeve away from said mouth, and;

said release button being positioned onto the housing so as to push said detent away from said stop whenever desired;

whereby pushing by said release button of said detent causes the central shaft, the lancet holder and the lancet mounted therein to be projected forward toward the mouth of the sleeve, and then to be pulled back by action of the elastomeric band onto the front pin, thereby causing very rapid skin perforation and speedy withdrawal of the needle.

12. The combination of a lancet injector with a combined lancet and multi-function cap of claim 5 wherein said lancet injector comprises:

a lancet receiving sleeve having a longitudinal axis and a mouth at one end through which said lancet may be inserted and subsequently projected out;

a lancet holder slidably mounted within said sleeve, said holder being sized and shaped to receive said lancet and to cooperate with said at least one longitudinal rib of said lancet to prevent it from rotating about said longitudinal axis;

means to prevent the lancet holder from rotating within the lancet receiving sleeve, said means comprising a pair of gripping wings radially projecting from said lancet holder and slidably engaged within longitudinal slots provided for this purpose within said sleeve, said gripping wings projecting radially outwardly from said sleeve through said longitudinal slots;

a central shaft integrally projecting from said lancet holder in a direction opposite to said mouth, said central shaft being coaxial with said longitudinal axis and projecting out of said lancet receiving sleeve;

elastic means mounted in a housing connected to said lancet receiving sleeve opposite the mouth thereof to project forward the central shaft and lancet holder upon pressing of a release button externally mounted on said housing, said elastic means being energized while the release button is triggered in operative position every time the lancet holder is manually moved within said sleeve by said gripping winds; and

a sleeve-shaped ejector slidably mounted externally onto the lancet receiving sleeve, said ejector having longitudinal slots positioned to make it movable without being stopped by the gripping wings and means to engage the lancet with the lancet holder and being manually movable toward the mouth of the lancet receiving sleeve to push the lancet out of the lancet holder and to detach and throw out the multi-function cap connected and locked thereto without having to put the fingers on said cap to remove the used lancet from the lancet injector.

13. The combination of claim 12, wherein said elastic means comprises:

an elastomeric band held under slight tension by four points so as to form an elongated rectangle having two small sides and main axis points coaxial with said longitudinal axis and said central shaft;

a front pin and a rear pin radially projecting from said central shaft in such a manner as to respectively contact the small sides of the rectangle formed by said elastomeric band within said rectangle;

a self-tensioned detent integral to said central shaft, said detent projecting radially outwardly; and

a stop positioned onto said housing in such a manner as to extent across the detent and lock the central shaft in a rearward position where the rear pin of the central shaft presses against the elastomeric band and is biased by the same and the lancet holder extends within said lancet receiving sleeve away from said mouth, and;

said release button being positioned onto the housing so as to push said detent away from said stop whenever desired;

whereby pushing by said release button of said detent causes the central shaft, the lancet holder and the lancet mounted therein to be projected forward toward the mouth of the sleeve, and then to be pulled back by action of the elastomeric band onto the front pin, thereby causing very rapid skin perforation and speedy withdrawal of the needle.

14. The combination of a lancet injector with a combined lancet and multi-function cap of claim 1 wherein said lancet injector comprises:

a lancet receiving sleeve having a longitudinal axis and a mouth at one end through which said lancet may be inserted and subsequently projected out;

a lancet holder slidably mounted within said sleeve, said holder being sized and shaped to receive said lancet and to cooperate with said at least one longitudinal rib of said lancet to prevent it from rotating about said longitudinal axis;

means to prevent the lancet holder from rotating within the lancet receiving sleeve, said means comprising a pair of gripping wings radially projecting from said lancet holder and slidably engaged within longitudinal slots provided for this purpose within said sleeve, said gripping wings projecting radially outwardly from said sleeve through said longitudinal slots;

a central shaft integrally projecting from said lancet holder in a direction opposite to said mouth, said central shaft being coaxial with said longitudinal axis and projecting out of said receiving sleeve;

elastic means mounted in a housing connected to said lancet receiving sleeve opposite the mouth thereof to project forward the central shaft and lancet holder upon pressing of a release button externally mounted on said housing, said elastic means being energized while the release button is triggered in operative position every time the lancet holder is manually moved within said sleeve by said gripping winds; and

a sleeve-shaped ejector slidably mounted externally onto the lancet receiving sleeve, said ejector having longitudinally slots positioned to make it movable without being stopped by the gripping wings and means to engage the lancet with the lancet holder and being manually movable toward the mouth of the lancet receiving sleeve to push the lancet out of the lancet holder and to detach and throw out the multi-function cap connected and locked thereto without having to put the fingers on said cap to remove the used lancet from the lancet injector.

15. The combination of claim 14, wherein said elastic means comprises:

an elastomeric band held under slight tension by four points so as to form an elongated rectangle having two small sides and main axis points coaxial with said longitudinal axis and said central shaft;

a front pin and a rear pin radially projecting from said central shaft in such a manner as to respectively contact the small sides of the rectangle formed by said elastomeric band within said rectangle;

a self-tensioned detent integral to said central shaft, said detent projecting radially outwardly; and

a stop positioned onto said housing in such a manner as to extent across the detent and lock the central shaft in a rearward position where the rear pin of the central shaft presses against the elastomeric band and is biased by the same and the lancet holder extends within said lancet receiving sleeve away from said mouth, and;

said release button being positioned onto the housing so as to push said detent away from said stop whenever desired;

whereby pushing by said release button of said detent causes the central shaft, the lancet holder and the lancet mounted therein to be projected forward toward the mouth of the sleeve, and then to be pulled back by action of the elastomeric band onto the front pin, thereby causing very rapid skin perforation and speedy withdrawal of the needle.

16. The combination of a lancet injector with a combined lancet and multi-function cap comprising:

a) a lancet including a needle having a sharp end, and an elongated body of plastic material embedding said needle except for its sharp end that projects from one end of said body over a given length, said elongated body having at least one longitudinal rib; and

b) a cap also made of plastic material, said cap being detachably mounted on said one end of said body to cover the sharp end of said needle and keep it sterile until the lancet is used,

wherein said cap is a multi-function cap and comprises;

a ring having an inner face, an outer face and a central opening sized to let pass the sharp end of said needle but not the one end of the body of the lancet, said ring having such a thickness and a shape as to let pass the sharp end of the needle through the central opening and penetrate the skin of a patient'"'"'s finger in contact with the outer face of the ring, and

means projecting from the inner face of said ring for use to properly position the ring with respect to a lancet injector having a mouth through which said lancet may be inserted and subsequently projected out, in such a manner that the central opening of said ring is aligned with the sharp end of said needle,

whereby when the multi-function cap is detached from said lancet and is connected to said lancet injector, the ring of said tip extends across said mouth and positively controls the depth of penetration of said lancet in the patient'"'"' skin,

a lancet receiving sleeve having a longitudinal axis and a mouth at one end through which said lancet may be inserted and subsequently projected out;

a lancet holder slidably mounted within said sleeve, said holder being sized and shaped to receive said lancet and to cooperate with said at least one longitudinal rib of said lancet to prevent it from rotating about said longitudinal axis;

means to prevent the lancet holder from rotating within the lancet receiving sleeve, said means comprising a pair of gripping wings radially projecting from said lancet holder and slidably engaged within longitudinal slots provided for this purpose within said sleeve, said gripping wings projecting radially outwardly from said sleeve through said longitudinal slots;

a central shaft integrally projecting from said lancet holder in a direction opposite to said mouth, said central shaft being coaxial with said longitudinal axis and projecting out of said lancet receiving sleeve;

elastic means mounted in a housing connected to said lancet receiving sleeve opposite the mouth thereof to project forward the central shaft and lancet holder upon pressing of a release button externally mounted on said housing, said elastic means being energized while the release button is triggered in operative position every time the lancet holder is manually moved within said sleeve by said gripping winds; and

a sleeve-shaped ejector slidably mounted externally onto the lancet receiving sleeve, said ejector having longitudinally slots positioned to make it movable without being stopped by the gripping wings and means to engage the lancet with the lancet holder and being manually movable toward the mouth of the lancet receiving sleeve to push the lancet out of the lancet holder and to detach and throw out the multi-function cap connected and locked thereto without having to put the fingers on said cap to remove the used lancet from the lancet injector.

17. The combination of claim 16, wherein said elastic means comprises:

an elastomeric band held under slight tension by four points so as to form an elongated rectangle having two small sides and main axis points coaxial with said longitudinal axis and said central shaft;

a front pin and a rear pin radially projecting from said central shaft in such a manner as to respectively contact the small sides of the rectangle formed by said elastomeric band within said rectangle;

a self-tensioned detent integral to said central shaft, said detent projecting radially outwardly; and

a stop positioned onto said housing in such a manner as to extent across the detent and lock the central shaft in a rearward position where the rear pin of the central shaft presses against the elastomeric band and is biased by the same and the lancet holder extends within said lancet receiving sleeve away from said mouth, and;

said release button being positioned onto the housing so as to push said detent away from said stop whenever desired;

whereby pushing by said release button of said detent causes the central shaft, the lancet holder and the lancet mounted therein to be projected forward toward the mouth of the sleeve, and then to be pulled back by action of the elastomeric band onto the front pin, thereby causing very rapid skin perforation and speedy withdrawal of the needle.

18. The combination of a lancet injector with a combined lancet and multi-function cap comprising:

a) a lancet including a needle having a sharp end, and an elongated body of plastic material embedding said needle except for its sharp end that projects from one end of said body over a given length, said elongated body having at least one longitudinal rib; and

b) a cap also made of plastic material, said cap being detachably mounted on said one end of said body to cover the sharp end of said needle and keep it sterile until the lancet is used,

wherein said cap is a multi-function cap and comprises;

a ring having an inner face, an outer face and a central opening sized to let pass the sharp end of said needle but not the one end of the body of the lancet, said ring having such a thickness and a shape as to let pass the sharp end of the needle through the central opening and penetrate the skin of a patient'"'"'s finger in contact with the outer face of the ring, and

means projecting from the inner face of said ring for use to properly position the ring with respect to a lancet injector having a mouth through which said lancet may be inserted and subsequently projected out, in such a manner that the central opening of said ring is aligned with the sharp end of said needle,

whereby when the multi-function cap is detached from said lancet and is connected to said lancet injector, the ring of said tip extends across said mouth and positively controls the depth of penetration of said lancet in the patient'"'"'s skin, and

said lancet and multi-function cap being made of the same plastic material and together forming an integral structure in which is embedded said needle, with the body of said lancet radially projecting from the ring of said multi-function cap, said body and ring being integrally connected by a very short stem of reduced diameter that is coaxial to said needle and sized to make said tip easily detachable from said body by twisting and pulling to release said sharp end,

said means for use to properly position the ring with respect to the lancet injector consisting of a peripheral skirt integral to and projecting from said ring in the direction of the inner face of said ring, said skirt being sized and shaped to fit onto the mouth of the lancet injector and thus allow connection of said ring to said lancet injector across said mouth,

said plastic material of which said lancet and cap are made, having color corresponding to the thickness of the ring of the cap, thereby making it possible to know the depth of penetration allowed by said ring as a function of said color and thus to determine whether said combined lancet and multi-function cap is suitable for a given patient,

a lancet receiving sleeve having a longitudinal axis and a mouth at one end through which said lancet may be inserted and subsequently projected out;

a lancet holder slidably mounted within said sleeve, said holder being sized and shaped to receive said lancet and to cooperate with said at least one longitudinal rib of said lancet to prevent it from rotating about said longitudinal axis;

means to prevent the lancet holder from rotating within the lancet receiving sleeve, said means comprising a pair of gripping wings radially projecting from said lancet holder and slidably engaged within longitudinal slots provided for this purpose within said sleeve, said gripping wings projecting radially outwardly from said sleeve through said longitudinal slots;

a central shaft integrally projecting from said lancet holder in a direction opposite to said mouth, said central shaft being coaxial with said longitudinal axis and projecting out of said lancet receiving sleeve;

elastic means mounted in a housing connected to said lancet receiving sleeve opposite the mouth thereof to project forward the central shaft and lancet holder upon pressing of a release button externally mounted on said housing, said elastic means being energized while the release button is triggered in operative position every time the lancet holder is manually moved within said sleeve by said gripping winds; and

a sleeve-shaped ejector slidably mounted externally onto the lancet receiving sleeve, said ejector having longitudinally slots positioned to make it movable without being stopped by the gripping wings and means to engage the lancet with the lancet holder and being manually movable toward the mouth of the lancet receiving sleeve to push the lancet out of the lancet holder and to detach and throw out the multi-function cap connected and locked thereto without having to put fingers on said cap to remove the used lancet from the lancet injector.

19. The combination of claim 18, wherein said elastic means comprises:

an elastomeric band held under slight tension by four points so as to form an elongated rectangle having two small sides and main axis points coaxial with said longitudinal axis and said central shaft;

a front pin and a rear pin radially projecting from said central shaft in such a manner as to respectively contact the small sides of the rectangle formed by said elastomeric band within said rectangle;

a self-tensioned detent integral to said central shaft, said detent projecting radially outwardly; and

a stop positioned onto said housing in such a manner as to extent across the detent and lock the central shaft in a rearward position where the rear pin of the central shaft presses against the elastomeric band and is biased by the same and the lancet holder extends within said lancet receiving sleeve away from said mouth, and;

said release button being positioned onto the housing so as to push said detent away from said stop whenever desired;

whereby pushing by said release button of said detent causes the central shaft the lancet holder and the lancet mounted therein to be projected forward toward the mouth of the sleeve, and then to be pulled back by action of the elastomeric band onto the front pin, thereby causing very rapid skin perforation and speedy withdrawal of the needle.