WO2013188459A2

WO2013188459A2 - Lancet devices without needle and related methods

Info

Publication number: WO2013188459A2
Application number: PCT/US2013/045260
Authority: WO
Inventors: Masayoshi Fukushima
Original assignee: Hns International, Inc.
Priority date: 2012-06-11
Filing date: 2013-06-11
Publication date: 2013-12-19
Also published as: WO2013188459A3

Abstract

Lancet devices without a sharp puncturing needle tip are disclosed each with a housing, a piston biased by a coil spring and operatively engaged to a trigger, and a cartridge with a nozzle having a plunger and a plunger tip disposed in a hollow chamber, and wherein a test strip for sampling blood is useable to sample the blood drawn by the lancet device.

Description

LANCET DEVICES WITHOUT NEEDLE AND RELATED METHODS

FIELD OF ART

Lancet devices are discussed herein for use to draw blood in connection with blood glucose monitoring and particularly to a lancet device that does not incoiporate a needle. Methods for drawing blood without a needle are also disclosed.

BACKGROUND

Diabetics must test their blood glucose level throughout the day to ensure that it is within medically safe levels. Blood testing is typically performed using a lancet device, which has a sharp needle for puncturing the skin to draw blood. The blood is then sampled by a test strip, which is connected to a glucose meter for analyzing the blood and displaying the results. Based on the results, the user may take steps to control his glucose level.

Aside from the obvious fear presented by the sharp needle of the lancet device, repeated testing can cause skin irritation and callous or skin thickening, which makes subsequent tests more difficult. Additional drawbacks to existing lancet devices include the potential for cross- contamination and unintended needle stick injuries, which can pass harmful viruses and germs to otherwise healthy individuals.

SUMMARY

Aspects of the present disclosure include a lancet device. In an example, the device is configured for drawing blood without a sharp puncturing needle tip. The device can comprise a housing, a piston biased by a coil spring and operatively engaged to a trigger, and a cartridge having a plunger and a plunger tip disposed in a hollow chamber, and wherein the cartridge has a nozzle with an opening of at least 3 mils and less than 30 mils.

A further aspect of the present disclosure is a lancet device for drawing blood without a sharp puncturing needle tip comprising a housing, a piston biased by a coil spring and operatively engaged to a trigger, and a cartridge having a plunger and a plunger tip disposed in a hollow chamber and wherein the cartridge has a nozzle with an opening.

A still further aspect of the present disclosure is a lancet device for drawing blood without a sharp puncturing needle tip comprising a housing, a piston biased by a coil spring and operatively engaged to a trigger, and a cartridge with a nozzle having a plunger and a plunger tip disposed in a hollow chamber, and a test strip for sampling blood following activation of the spring.

In one example, the test strip is connected to the housing. In another example, the test strip is connected to an adaptor cap.

Aspect of the present disclosure is also directed to a method for making a lancet device for drawing blood without a sharp puncturing needle tip. As provided, the method comprising the steps of providing a housing having a bore, a first end, and a second end. The method further comprises the steps of placing a piston having a head and a shaft and a spring around the shaft into the bore and capping the second end so that spring cannot slide out of the second end. The method further comprises the steps of setting a trigger to hold the spring in a compressed state and mounting a cartridge having a cavity and a plunger in dynamic sealing configuration with an interior wall surface defining the cavity. Wherein the cartridge has a nozzle having an opening of a size of at least 3 mils and less than 30 mils.

The method wherein the trigger has an opening for receiving the piston.

The method wherein the piston has a notch for forming a catch to engage the trigger. The method wherein the piston is movable along a first axis and the trigger is movable alone a second axis, which differs from the first axis.

The method wherein the cartridge is removable and disposable.

The method further comprising a cap surrounding the cartridge.

Yet another method for using a lancet device for drawing blood without a sharp puncturing needle tip include placing a housing against the skin so that a nozzle with an opening of at least 3 mils and less than 30 mils is abutting the skin; discharging high pressure fluid or gas out the nozzle by depressing a trigger to release a spring from its compressed position, said spring expanding to push a piston against a plunger, which moves through a bore of a cartridge to pressurize a head space in the bore from less than 15 psi to above 500 psi; and using a test trip to contact blood produced by the lancet device. BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present device, system, and method will become appreciated as the same becomes better understood with reference to the specification, claims and appended drawings wherein:

FIG. 1 is a perspective view of a lancet device provided in accordance with aspects of the present disclosure.

FIG. 2 is a cross-sectional view of the lancet device of FIG. 1.

FIG. 3 is a cross-sectional view of the lancet device of FIG. 2 in the activated position. FIG. 4 is a cross-sectional view of a lancet device provided in accordance to another aspect of the present disclosure.

FIGs. 5A and 5B are end and cross-sectional views, respectively, of an adaptor cap for use with a lancet device in accordance with aspects of the present disclosure.

FIG. 6 is a schematic perspective view of a blood drawing system in accordance with aspects of the present disclosure.

FIG. 7 is a schematic perspective view of the blood drawing system in use.

FIG. 8 is a schematic perspective view of a glucose meter and test strip testing a blood droplet drawn by the lancet device and system of the present disclosure. DETAILED DESCRIPTION

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of lancet devices without any needle provided in accordance with aspects of the present disclosure and is not intended to represent the only forms in which the present devices, systems, and methods may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present devices, systems, and methods in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features. FIG. 1 is a perspective view of an exemplary lancet device provided in accordance with aspects of the present disclosure, which is generally designated 20. In one example, the lancet device 20 comprises a housing 22 having a distal end 24 and a proximal end 26. The distal end 24 may be understood to be an end that is closer to the discharge or puncturing end whereas the proximal end 26 is understood to be an end that is further away from the puncturing end. As shown, the distal end 24 comprises a removable cap 28 and an aperture 40, which exposes a cartridge 32 having a small nozzle 34 and a movable plunger 36. The cap may be secured to the housing 22 using threads or detents. A trigger 38 is positioned at the proximal end 26 for releasing the plunger 36 to generate pressure through the nozzle 34, which punctures the skin to draw a blood sample, as further discussed below. In other embodiments, the trigger 38 is positioned elsewhere, such as closer to the distal end 24 so that the user of the device 20 can grip the middle section or grip part 40 of the housing 22 and have the thumb conveniently aligned with the trigger to depress the trigger.

The housing 22, including the cap 28, may be made from a hard thermoplastic or from a metallic material capable of re-use. The cartridge 32 and the plunger 36, however, are intended to be discarded after a single use.

With reference now to FIG. 2, a cross-sectional view of the lancet device 20 of FIG. 1 is shown. In the example shown, the lancet device 20 incorporates a piston 42 and a helical spring 44, which is shown compressed and ready to release its spring energy to propel the piston. The piston 42 has a shaft 45, a piston head 46 and a shoulder 48 for capturing one end of the spring 44. In one example, the shaft 45 has a nominal shaft section 50 and a reduced shaft section 52 that forms a catch 54 for engaging a shoulder 56 on the trigger 38. In perspective view (not shown), the reduced shaft section 52 is formed by a notch 53 through the shaft 45. Engagement between the catch 54 and the shoulder 56 will retain the spring 44 in the compressed state shown. As further discussed below, even after the spring 44 is released, such as after drawing a blood sample, the spring can be reset by pushing onto the piston head 46 to compress the spring and then re-engaging the catch 54 with the shoulder 56. A cap or flange 60 may be used to retain the second end of the spring 44 within the spring well 62.

The cartridge 32 has a chamber 66, an end wall 68 with the nozzle 34 and a terminal end 70 for engaging the inner housing 72. In one example, the terminal end 70 is threaded to the inner housing 72. After use, the cap 28 may be removed then the cartridge 32 is unthreaded from the inner housing 72 and discarded. A new cartridge 32 can then be threaded to the inner housing 72 to draw another or a new blood sample. Prior to installation, the position of the plunger 36 may be adjusted relative to the nozzle 34 to change the head space 80 in the chamber 66, which changes the volumetric space and therefore pressure build up at discharge. The plunger 36 has an elastomeric plunger tip 82 at its distal end, which can be co-molded with the plunger 36 or separately formed and subsequently mounted to the plunger. The plunger tip 82 preferably has one or more raised ribs (not shown) for dynamically sealing against the wall surfaces of the chamber 66. In one example, the terminal end 70 is threaded to the inner housing 72. In another example, simple detents are used, such as a slot and a bump.

The cartridge 32 may be made from a clear plastic, such as polycarbonate (PC), cyclo- olefin-copolymer material (COC), or other similar materials, such as hard clear plastic or engineered plastic. The nozzle 34 may be molded with a raised external bump and the nozzle opening post-mold formed, such as by machining or formed by laser. However, any prior art or known forming techniques may be used, such as molding or laser cutting the opening. In another embodiment, two or more spaced apart nozzles with two or more spaced apart openings are provided at the end wall 68. If a single nozzle is used, the nozzle opening can range from 3.5 mils to about 10 mils, which can vary depending on the diameter of the chamber, the plunger tip, the spring length and spring constant. Preferably, the opening is greater than 3 mils and less than 30 mils. If multiple nozzles are used, each nozzle has an opening of 2.5 mils to 10 mils. It is believed that coil springs that can develop approximately 30 pounds or greater of force will develop enough pressure at the nozzle to pierce the skin and draw a small amount of blood. It is further believe that pressure in excess of 500 psi in the cartridge will be needed to pierce the skin. For example, 2,200 psi to 4,500 psi may be a good operating range for discharging at the nozzle. In one example, a small amount of medically approved sodium chloride may be filled in the head space 80 for discharging under the skin of the user during lancing operation.

FIG. 3 is a cross-sectional view of the lancet device 20 of FIGs. 1 and 2 following activation. As shown, the trigger 38 has been depressed by the user, which moves the opening 86 located in, on, or associated with the trigger to the right of FIG. 3. The opening is sized and shaped to allow the catch 54 to pass therethrough for setting the spring 44 in the ready position, as shown in FIG. 2, and for allowing the catch 54 to again pass therethrough to release the spring. Although not shown, the trigger 38 may include a rail or track to ensure accurate movement when depressed by the user. Movement of the trigger 38 causes the opening 86 to shift to release the catch 54 on the piston 42 from the shoulder 56 on the trigger to then release the spring 44. The spring 44 rapidly expands and pushes the head 46 of the piston 42 against the base 88 of the plunger 36, which propels the plunger tip 82 towards the end wall 68 of the cartridge 32 to generate sufficient pressure through the nozzle opening 34 to penetrate the skin and draw a small amount of blood to be used with a test strip for a glucose meter.

Following activation, as discussed above, the cap 28 may be removed then follow by the cartridge 32 and the plunger 36. While one embodiment of the present disclosure contemplates a one-time use cartridge and plunger system, a re-use version is contemplated in which the cartridge and plunger are disinfected, such as by boiling or placing in a disinfectant solution. The piston 42 can be reset by placing a reset device (not shown) in through the opening vacated by the cartridge and pushing onto the piston head 46 to compress the spring 44. As the latch 54 travels back through the opening 86 of the trigger, the shoulder 57 can be moved under the catch 54, such as by pulling on the trigger 38, to cock the piston 42.

Thus, as understood herein, when the trigger is depressed, the piston or shaft moves along a first axis while the trigger moves along a different second axis. As disclosed, the first axis and the second axis are orthogonal to one another.

FIG. 4 is an alternative embodiment provided in accordance with aspects of the present disclosure, which is generally designated 100. In the example shown, a second spring 90 is incorporated for moving the cartridge 32, piston 42 and inner housing 72 towards the end plate 92, away from the cap 28. The second spring 90 may be activated by another trigger (not shown) or by a lever, latch, or cam system that automatically activates the second spring 90 after the piston head 46 abuts the shoulder 94 of the inner housing 72. By withdrawing the cartridge 32 and the other components within the housing 22, a vacuum can be created at the cap opening 96 to facilitate in drawing a small amount of blood to the skin surface and/or into the housing 22 to contact a test strip (not shown), which is connected to a built-in glucose meter (not shown). In another example, no test trip and no glucose meter are tied or coupled to the housing. The second spring 90 merely draws a vacuum at the cap opening 96 to facilitate drawing a small amount of blood to the skin so that existing prior art test strip and glucose meter may be used to sample the blood for glucose level.

FIG. 5 A shows an end view of an adaptor cap 102 provided in accordance with aspects of the present disclosure. The adaptor cap 102 may be used between the lancet device 20 and the skin to provide a cushioning surface between the end wall 68 of the lancet device and the skin, as further discussed below. The adaptor cap 102, following activation of the device 20, is also configured to create a vacuum to facilitate drawing a small amount of blood to the outer skin surface for testing.

As shown, the adaptor cap 102 comprises a body 104 in the form of a skirt 105 and an end surface 106 defining an opening 108. The size of the opening 108 may be adjusted or shaped by incorporating an annular projection or flange 110 that can reduce the opening to a modified opening 108a. In some example, the modified opening and the end opening are the same. In an alternative embodiment, the end opening 108 is modified, such as reduced, by tapering or shaping the skirt section 105. The skirt section 105 has an interior surface 112 and an exterior surface 1 14.

An end wall 1 16 is provided at the opposite end of the opening 108, which comprises an interior surface 1 18 and an exterior surface 120. A cavity or recess 122 is formed on the interior surface 1 18 of the end wall 1 16. The cavity has a tapered sidewall 124 that extends outwardly in the direction of the end opening 108. An end wall opening 126 is provided through the recess 122. In another embodiment, the end wall opening 126 is provided without a recess and without a tapered sidewall 124. In use, the tapered sidewall 105 and the skirt 105 allow the adaptor cap 102 to collapse, such as to buckle, when pushed by the lancet device 20, to position the tip of the lancet device near the skin to pneumatically prick the skin. In other examples, one or more dimples and/or grooves may be incorporated to the exterior surface 114 of the skirt section to facilitate buckling of the skirt section.

FIG. 5B is a cross-sectional side view of the adaptor cap 102 taken at line A-A of FIG. 5A. The cap may be constructed from an elastomer material, such as polytetrafluoroethylene (PTFE) or silicone, a rubber material, or from a thermoplastic elastomer (TPE).

FIG. 6 shows a schematic drawing of a system 130 provided in accordance with aspects of the present disclosure. As shown, a lancet device 132 is pushed against an adaptor cap 102, which is placed against the skin 134, such as the abdomen, the forearm, or the inner thigh. In one example, the lancet device 132 comprises a replaceable cartridge 134 comprising a nozzle 136 and a plunger (not shown) for propelling air through the nozzle to pneumatically pierce the skin and draw blood. The lancet device 132 further comprises a power end or injector end 138 comprising a compression spring (not shown) for propelling a piston (not shown) to propel the plunger into the ampule. The spring (not shown) may be held in a compressed state for triggering by a trigger 140, which has a lever or a tab that extends through the housing 142 for holding the spring in the compressed state. The trigger 140 is pivotably mounted to the housing 142 by a pin 144 in between two mounting flanges 146a, 146b.

An end plate 148 is provided at the proximal end 150 of the housing 142. The end plate

148 is removable from the housing 142 following release of the spring to expose the interior of the housing 142. This in turn allows the spring (not shown) to be re-used or recycled. This also allows the remaining parts of the lancet device 132 to be recycled separately from the spring. Further discussions regarding exemplary injectors with removable end plates are disclosed in U.S. Provisional application No. 61/701 ,824, filed September 17, 2012, and in U.S. Provisional application No. 61/814,576, filed April 22, 2013, the contents of each of which are expressly incorporated herein by reference as if set forth in full.

With reference now to FIG. 7 in addition to FIGs. 2 and 6, the lancet device 132, which can also be the device 20 of FIGs. 1-3 or device 100 of FIG. 4, is shown pushed against the exterior surface 120 of the end wall 1 16 to buckle or deform the skirt section 105 and the end wall 116. The end surface 106 of the skirt 105 is placed against the skin 136 of a location on the body to be pneumatically pricked. The cartridge 134 is positioned such that the nozzle on the cartridge aligns with the end wall opening 126 of the adaptor cap 102. The lancet device 132 is pushed until contact is made with the skin, this typically implies that the interior wall surface 1 18 of the end wall 116 contacts the skin and/or the nozzle of the cartridge 134 contacts the skin. Upon compressing the adaptor cap 102, air from inside the cap is forced out at the interface with the skin due to the interior being decreased in volume by the compression.

After the trigger 140 is squeezed and lifted or moved away from the adaptor cap 102, the skirt section 105 and the end wall 1 16 recover to their less stressed or un-biased state, as shown in FIGs. 5B and 6. As the cap 102 recovers to its less stressed state, a vacuum is generated inside the cap due to the expanding cap. This in turn assists in drawing out blood from the hole in the skin caused by the high pressure coming out of the nozzle of the lancet device and is similar to a "sucking" action directed on the hole formed in the skin.

FIG. 8 is a schematic drawing showing a glucose meter 140 and a test strip 142 in contact with a droplet of blood 144 extracted by the drawing system 130 of FIG. 5. The test strip 142 and the glucose meter 140 may be any number of strips and meters currently commercially available. In one example, a test strip is incorporated into the adaptor cap 102 and has an end extending away from the cap for connection to a glucose meter.

The spent adaptor cap 102 may be discarded following use and the spent cartridge 134 removed from the lancet device and discarded. A new cartridge 134 may be connected to the injector end 138 after the spring inside the housing 142 has been reset.

Although limited embodiments of the lancet assemblies, systems, and methods and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the various components described may be formed from additional parts and subsequently assembled together or from different materials than described. Also, while specific aspects of features of a particular embodiment may be discussed for one embodiment but not another, the features may be applied to the other embodiments provided the overall function does not conflict. Accordingly, it is to be understood that the lancet assemblies and their components constructed according to principles of the disclosed devices, systems, and methods may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.

Claims

CLAIMS What is claimed is:

1. A lancet device for drawing blood without a sharp puncturing needle tip comprising a housing, a piston biased by a coil spring and operatively engaged to a trigger, and a cartridge having a plunger and a plunger tip disposed in a hollow chamber, and wherein the cartridge has a nozzle with an opening of at least 3 mils and less than 30 mils.

2. The lancet device of claim 1 wherein the cartridge has a second nozzle with an opening.

3. The lancet device of claim 1, further comprising a test strip for sampling blood following activation of the spring.

4. The lancet device of claim 1 , further comprising an adaptor cap comprising an end wall having an opening and a skirt section depending from the end wall.

5. The lancet device of claim 4, wherein the cartridge is in contact with the end wall.

6. The lancet device of claim 5, wherein the skirt section is folded due to being compressed.

7. The lancet device of claim 1 , wherein the trigger has an opening and the piston projects, at least in part, through the opening.

8. The lancet device of claim 1, wherein the piston comprises a notch for forming a catch to engage the trigger.

9. The lancet device of claim 1 , wherein the cartridge is removable and disposable and the coil spring can be reset.

10. A method for making a lancet device for drawing blood without a sharp puncturing needle tip comprising:

providing a housing having a bore, a first end, and a second end;

placing a piston having a head and a shaft and a spring around the shaft into the bore; capping the second end so that spring cannot slide out of the second end of the housing; setting a trigger to hold the spring in a compressed state;

mounting a cartridge having a cavity and a plunger in dynamic sealing configuration with an interior wall surface defining the cavity; and wherein the cartridge has a nozzle with an opening of at least 3 mils and less than 30 mils.

1 1. The method of claim 10, wherein the trigger has an opening for receiving the piston.

12. The method of claim 10, wherein the piston has a notch for forming a catch to engage the trigger.

13. The method of claim 10, wherein the piston is movable along a first axis and the trigger is movable alone a second axis, which differs from the first axis.

14. The method of claim 10, wherein the cartridge is removable and disposable.

15. The method of claim 10, further comprising a cap surrounding the cartridge.

16. A method for using a lancet device for drawing blood without a sharp puncturing needle tip comprising:

placing a housing against the skin so that a nozzle with an opening of at least 3 mils and less than 30 mils is abutting the skin;

discharging high pressure fluid or gas out the nozzle by depressing a trigger to release a spring from its compressed position, said spring expanding to push a piston against a plunger, which moves through a bore of a cartridge to pressurize a head space in the bore from less than 15 psi to above 500 psi; and

using a test trip to contact blood produced by the lancet device.