Patent Application
20110040316
This application is a non-provisional of U.S. Provisional Application No. 61234382 for Method and Apparatus for a Single Handed Squeeze Lancet, filed Aug. 17, 2009.
Some diseases, such as diabetes, require that an individual test their blood on a daily basis. As a result, lancet devices are needed that pierce a patient's skin to obtain an amount of blood sufficient for testing. Typical blood collection lancets require the patient to lance a finger by holding a lancet in one hand and pressing it onto the fingertip on the other hand. Oftentimes the anticipation of the impending pain causes the patient to involuntarily pull the fingertip back at the last second. This often results in a poor stick, insufficient blood collection, and a failed test; if only one lancet is included in a mailed blood collection kit, the kit thus becomes useless.
The present invention provides a single handed squeeze lancet apparatus that will not discharge unless the pressure from a patient's digit is sufficient to properly lance the digit. The single handed squeeze lancet has the additional benefit of guarding against accidental injuries after use by retaining the used lancet within the housing. The present invention further provides methods for use of the single handed squeeze lancet.
Thus, in a first aspect, the present invention provides a single handed squeeze lancet apparatus comprising: (a) a lancet, (b) a lancet-holder, (c) an internal housing for receiving and guiding the lancet-holder, (d) an external housing for receiving and guiding the internal housing, (e) a thumb-frame coupled to the external housing, and (f) a thumb-spring coupled to the thumb-frame and coupled to the lancet-holder.
In one embodiment, the invention provides a thumb-frame in the form of a base, such that the single handed squeeze lancet is employed between a digit and a surface.
In another embodiment, the invention further comprises a base-stand.
In a second aspect, the present invention also provides a method for lancing a digit using the single handed squeeze lancet apparatus, where the method comprises: (a) placing a digit adjacent to a proximal end of the internal housing and (b) applying force to the proximal end of the internal housing.
In one embodiment the method further comprises the steps of placing a digit from one of the same hand or the other hand adjacent to the thumb-frame and applying force to the thumb-frame.
In another embodiment, the method further comprises the steps of providing the thumb-frame in the form of a base and placing the thumb-frame against a surface.
In still another embodiment, the method further comprises the steps of providing a base-stand, removing the base-stand from a coupling to one of the thumb-frame or the external housing, coupling the base stand to one of the thumb-frame or the external housing to form a base, and placing the base against a surface.
In a first aspect, as shown in
As used herein, a “single handed squeeze lancet apparatus” can range in length from 0.5 to 7 inches, and is preferably in the range of 1.5 to 3 inches in length, which accommodates a typical span between digits on a single hand, as well as variances in the size of hands among men, women, and children. A preferred length of 2 also allows for peak grip force for both men and women.
As used herein, a “lancet” 15 is a sharp metal blade or small surgical instrument, usually a short, wide, sharp-pointed, double-edged blade, used especially for making punctures and small incisions in a person's skin. The proximal end 15a of the lancet 15 is the piercing end, while the distal end of the lancet 15 may define one or more holes that aid in coupling the lancet 15 to the lancet-holder 20.
As used herein, a “lancet-holder” 20 receives and secures the distal end of the lancet 15 to maintain the lancet's proper orientation within the single handed squeeze lancet apparatus 10. The lancet-holder 20 also acts as an interface with the internal housing 25 and thumb-spring 40 as described in more detail below. The lancet-holder 20 comprises a housing 45 that is preferably overmolded about the distal end of a medically clean lancet 15. Alternatively, the lancet-holder's housing could be pre-molded in two halves that contain male and female components that allow the two halves to be press-fit together. In this pre-molded embodiment, the one or more holes in the distal end of the lancet 15 receive corresponding male components molded on the lancet-holder housing 45 to secure the distal end of the lancet 15 within the lancet-holder 20. The lancet's distal end could also be affixed in a recess in the lancet-holder 20 via a common fastener such as rivets or small screws, for example, or via an adhesive. Alternatively, the lancet 15 may be press-fit into a slot in a one-piece lancet-holder 20. The lancet-holder 20 is preferably made of an injection molded thermoplastic, for example Polyamide (Nylon), ABS, Acetal, Polycarbonate (PC), Polyethylene (PE), Polypropylene (PP), or Polyvinyl chloride (PVC), which may further be blended or glass reinforced, though any other suitable material, such as a lightweight plastic or metal that is capable of being machined, is contemplated.
As used herein, an “internal housing” 25 preferably defines two opposing sidewalls 50a,b of substantially equal dimension in length, width and wall thickness. The length is in the range of 0.5 up to 7 inches and is preferably in the range of 0.5 to 1.5 inches. The width is in the range of 0.08 to 1 inch and is preferably in the range of 0.15 up to 0.5 inches. The wall thickness is in the range of 0.01 up to 0.3 inches and is preferably in the range of 0.02 to 0.12 inches. The internal housing 25 also defines a front wall 55 and a back wall 60 of substantially equal dimension in length, width and thickness. The length is in the range of 0.5 up to 7 inches and is preferably in the range of 0.5 to 1.5 inches. The width is in the range of 0.25 up to 3 inches and is preferably in the range of 0.4 to 2 inches. The wall thickness is in the range of 0.01 up to 0.3 inches and is preferably in the range of 0.02 to 0.12 inches. The opposing sidewalls 50a,b can be of different dimensions than the front and back walls 55, 60. These four walls further define an opening at both the distal end 25b and proximal end 25a of the internal housing 25. In assembly, the lancet-holder 20 is received in the internal housing 25 via its distal opening and in use the lancet 15 will discharge through the internal housing's proximal opening. The internal housing 25 interfaces with both the external housing 30 and the lancet-holder 20, as described in more detail below. The internal housing 25 is preferably made of ABS, though any other suitable material, such as another lightweight plastic or metal, is contemplated.
As used herein, an “external housing” 30 preferably defines two opposing sidewalls 65a,b of substantially equal dimension in height, length, width and thickness. The length is in the range of 0.5 to 7 inches and is preferably in the range of 0.75 to 2 inches. The width is in the range of 0.08 to 1 inch and is preferably in the range of 0.15 to 0.5 inches. The wall thickness is in the range of 0.01 to 0.3 inches and is preferably in the range of 0.02 to 0.12 inches. The external housing 30 also defines a front wall 70 and a back wall 75 of substantially equal dimension in height, length, width and thickness. The length is in the range of 0.5 to 7 inches and is preferably in the range of 0.75 to 2 inches. The width is in the range of 0.25 to 3 inches and is preferably in the range of 0.5 to 2 inches. The wall thickness is in the range of 0.01 to 0.3 inches and is preferably in the range of 0.02 to 0.12 inches. The opposing sidewalls 65a,b can be of different dimensions than the front and back walls 70, 75. These four walls further define an opening at both the distal end 30b and proximal end 30a of the external housing 30. The external housing 30 is dimensioned to circumscribe the internal housing 25 to substantially prevent the internal housing 25 from rotating and to guide the internal housing 25 during assembly and operation of the single handed squeeze lancet apparatus 10. In assembly, the internal housing 25, the lancet-holder 20, and the thumb-spring 40 are received in the external housing 30 via its distal opening, as described in more detail below. Post-assembly, a predetermined length of the internal housing 25 protrudes from the proximal opening of the external housing 30. The external housing 30 is preferably made of ABS, though any other suitable material, such as another lightweight plastic or metal, is contemplated.
As used herein, a “thumb-frame” 35 is coupled to the external housing 30 at or near the housing's distal end. The thumb-frame 35 preferably defines a ledge 80 that either covers or nests within the distal end 30b of the external housing 30, sealing the internal housing 25, lancet-holder 20, lancet 15, and thumb-spring 40 within the external housing 30. For reasons discussed in detail below, the thumb-frame 35 preferably defines a square or rectangular outer profile for receiving a digit on a hand. In addition, regardless of the shape of the thumb-frame's outer profile, the portion of the thumb-frame's inner profile that receives a digit may take the form of a flat surface or an arcuate notch. Alternatively, the thumb-frame 35 may only partially border the digit (not shown), preventing the digit from slipping off the distal end of the lancet apparatus 10. This partial thumb-frame (not shown) could take the form of an Omega, a U-shape, or an arcuate notch, for example. The thumb-frame's inner profile accommodates a diameter ranging from 0.5 to 2 inches, preferably the diameter is 1 inch. Diameters larger than 1 inch, however, allow more than one digit to be employed in the thumb-frame 35. The thumb-frame 35 is preferably made of an injection molded thermoplastic, for example Polyamide (Nylon), ABS, Acetal, Polycarbonate (PC), Polyethylene (PE), Polypropylene (PP), or Polyvinyl chloride (PVC), which may further be blended or glass reinforced, though any other suitable material, such as a lightweight plastic or metal that is capable of being machined, is contemplated.
As used herein, a “thumb-spring” 40 has a distal end coupled to the thumb-frame 35 and a proximal end coupled to the lancet-holder 20. The thumb-spring 40 is preferably integrally formed with the thumb-frame 35 using conventional molding techniques, and the thumb-spring's proximal end is integrally formed into a substantially U-shaped coupling member 85. This coupling member is received in a corresponding recess or channel 90 in the lancet-holder's housing. Alternatively, the thumb-spring's proximal end may comprise a post that is received in a corresponding hole in the lancet holder's housing 45. Further, the thumb-spring 40 may be snap-fit to the lancet holder's housing 45 or the thumb-spring 40 and lancet holder housing 45 could be molded as one piece. Still alternatively, the thumb frame 35, thumb spring 40 and the entire lancet holder assembly 20 may be molded as one piece. The thumb-spring 40 is preferably made of an injection molded thermoplastic, for example Polyamide (Nylon), ABS, Acetal, Polycarbonate (PC), Polyethylene (PE), Polypropylene (PP), or Polyvinyl chloride (PVC), which may further be blended or glass reinforced, though any other suitable material, such as a lightweight plastic or metal that is capable of being machined, is contemplated. In this form, the thumb-spring may comprise a sinusoidal spring 40, as shown in FIGS. 2 and 8A-D, or may comprise 2 to 4 symmetric, stacked loops 40′, as shown in
In one embodiment, the lancet-holder 20 comprises a housing 45, at least two guide pins 46, and at least two detents 47. The lancet-holder 20 is dimensioned to be received within the internal housing 25. Similar to the internal housing 25, the lancet-holder housing 45 defines opposing sidewalls of substantially equal dimension in length, width, height, and thickness, as well as a front wall and a back wall of substantially equal dimension in length, width, height, and thickness. Also note, the lancet-holder housing's sidewalls can be of different dimension than the front and back walls of the lancet-holder housing 45. The front and back walls of the lancet-holder housing 45 preferably define a rectangular profile, though different profiles are contemplated, for example, an oval, a triangle, or a hexagon.
The guide pins 46 are preferably located on both the front and back walls of the lancet-holder housing 45. There are preferably four guide pins on the front wall arranged symmetrically as if each guide pin were located at the corner of a square or rectangle. The preferred arrangement results in a proximal pair of guide pins 46a and a distal pair of guide pins 46b. As shown in
In another preferred embodiment, the lancet-holder 20 may further comprise a pull-tab 95, as shown in
In one preferred embodiment, shown in
In another preferred embodiment, shown in
In one preferred embodiment, the internal housing 25 includes tongues or cantilever arms 105 on opposing sidewalls, wherein each internal-housing tongue 105 includes an interference nub 106 on a free end. As used herein, an interference nub 106 is a knob or protuberance, preferably integrally molded with the internal-housing tongue 105. In another preferred embodiment, the interference nubs 106 interface with the external housing 30 such that the internal-housing tongues 105 are biased inward. As shown in
In a further preferred embodiment, the external housing 30 defines a release-window 110 on each opposing sidewall 65a,b. During assembly, as the internal housing 25 enters the distal opening of the external housing 30 and advances toward the proximal end 30a, the interference nubs 106 on the internal-housing tongues 105 will enter the release-windows 110. A tool can be used to block the release-windows 110 (as well as the openings 125 on opposing sidewalls 65a,b, discussed below) during assembly of the apparatus 10 until the internal housing 25 has been advanced to a point where the interference nubs 106 are proximally located relative to the release-windows 110. The function of the release-windows 110 is described below.
In another preferred embodiment, the interference nubs 106 interface with the lancet-holder detents 47 when the internal-housing tongues 105 are biased inward. The interference nubs 106 thereby prevent the lancet-holder 20 from moving proximally until the single handed squeeze lancet apparatus 10 is in use. As pressure is applied to the proximal end 25a of the internal housing 25, the internal housing 25 begins to advance distally within the external housing 30. The interference nubs 106 on the internal housing 25 translate that distal movement to the detents 47 and, in turn, to the lancet-holder 20, which subsequently pre-loads the thumb-spring 40. The thumb-spring 40 continues to pre-load until the interference nubs 106 of the internal housing 25 enter the release-windows 110 of the external housing 30, which unbiases the internal-housing tongues 105 and eliminates the interface between the detents 47 and the interference nubs 106. As the interference nubs 106 travel the length of the release-windows 110, the thumb-spring 40 rapidly moves the lancet-holder 20 proximally and the lancet 15 pierces the skin of the digit applying pressure to the proximal end 25a of the internal housing 25. After the lancet-holder 20 and lancet 15 are released by the interference nubs 106, the interference nubs 106 bottom-out on the distal side of the release-windows 110, halting the distal movement of the internal housing 25. The interference nubs 106 are now trapped in the release-windows 110 preventing significant movement of the internal housing 25 relative to the external housing 30. Similarly, the thumb-spring 40 is now in a static position, which prevents the lancet 15 from extending beyond the proximal end 25a of the internal housing 25.
Alternatively, in another embodiment shown in
In one preferred embodiment, a proximal end 25a of the internal housing 25 defines an indentation 115 for receiving a user's digit. The indentation 115 preferably takes the form of an arcuate notch, though other reliefs, such as a squared off, or stepped, relief with multiple flat surfaces, are also contemplated.
In another preferred embodiment, the internal housing 25 and external housing 30 each taper from the distal end 25b, 30b to the proximal end 25a, 30a, as shown in
In one preferred embodiment, the thumb-frame 35 is coupled to two spaced-apart tongues 120, wherein each thumb-frame tongue has a detent 121 at the free end, and wherein the external housing 30 defines openings 125 on opposing sidewalls 65a,b. The openings 125 on the opposing sidewalls 65a,b of the external housing 30 are located near the housing's distal end 30b to receive the detents 121 from the thumb-frame tongues 120 during assembly.
In another embodiment, the thumb-frame 35 is in the form of a base (not shown), such that the single handed squeeze lancet 10 is employed between a digit and a surface. As used herein, the distal end of the thumb-frame 35 provides a planar surface that stabilizes the single handed squeeze lancet 10 when the apparatus is employed between a digit and a surface. This planar surface may take any number of shapes, for example, a square, a rectangle, a circle, or a cross, as long as the surface provides enough stability to prevent the apparatus 10 from tipping over or sliding away from the user's digit.
In one embodiment, the single handed squeeze lancet apparatus 10 may further comprise a base-stand 130, shown in
In one preferred embodiment, the base-stand 130 is coupled to the thumb-frame 35 such that the base-stand 130 and thumb-frame 35 together form a base, whereby the single handed squeeze lancet apparatus 10 is employed between a digit and a surface. Here, the base-stand 130 and thumb-frame 35 are substantially perpendicular to each other, as shown in
As shown in
In a second aspect, present invention provides a method for lancing a digit using the single handed squeeze lancet apparatus of the first aspect of the invention, where the method comprises: (a) placing a digit adjacent to a proximal end of the internal housing 25 and (b) applying force the proximal end of the internal housing 25.
In one embodiment, the method further comprises: (a) placing a digit from one of the same hand or the other hand adjacent to the thumb-frame 35 and (b) applying force to the thumb-frame 35. As discussed above, applying pressure to the internal housing 25 and thumb-frame 35 activates the lancet apparatus 10. After activation, the user simply discards the disposable lancet apparatus 10 which retains the lancet 15 within internal housing 25 to prevent subsequent accidental piercing. The methods of the invention can be used to draw blood from any subject in need of having blood drawn, including but not limited to diabetic subjects.
In one preferred embodiment, the method further comprises the step of removing a covering from the lancet-holder 20 to expose the lancet 15. As used herein, a “covering” may take the form of heat-sealed packaging or a pull-tab 95 that is either integral or separate from the lancet-holder 20.
In another preferred embodiment, the step of applying force causes: (a) the internal housing 25 to advance distally within the external housing 30, (b) the thumb-spring 40 to preload until interference nubs 106 on the free ends of inwardly biased tongues 105 on opposing walls 50a,b of the internal housing 25 enter release-windows 110 defined by the external housing 30, (c) the lancet 15 to advance proximally until it lances the digit adjacent to the proximal end 25a of the internal housing 25, and (d) the internal housing 25 to continue to advance until the interference nubs 106 travel the length of the release-windows 110.
In one preferred embodiment, the method further comprises the step of retaining the lancet 15 inside the internal housing 25 after the digit is lanced.
In one embodiment, the present invention further provides a method for lancing a digit using the single handed squeeze lancet apparatus 10, where the method comprises: (a) providing the thumb-frame 35 in the form of a base, (b) placing the thumb-frame 35 against a surface, (c) placing a digit adjacent to a proximal end of the internal housing 25, and (d) applying force to the proximal end of the internal housing 25.
In one embodiment, the present invention provides a method for lancing a digit using the single handed squeeze lancet apparatus 10, where the method comprises: (a) providing a base-stand 130, (b) removing the base-stand 130 from a coupling to one of the thumb-frame 35 or the external housing 30, (c) coupling the base-stand 130 to one of the thumb-frame 35 or the external housing 30 to form a base, (d) placing the base against a surface, (e) placing a digit adjacent to the proximal end of the internal housing 25, and (f) applying force to the proximal end of the internal housing 25.
All embodiments of the single handed squeeze lancet of the invention can be used in the methods of the second and third aspects of the invention.
Note that any of the foregoing embodiments of any aspect may be combined together to practice the claimed invention.
| Number | Date | Country | |
|---|---|---|---|
| 61234382 | Aug 2009 | US |
