Handheld medical diagnostic devices with lancing speed control

• US 9,717,452 B2
• Filed: 12/30/2010
• Issued: 08/01/2017
• Est. Priority Date: 12/30/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Chen, Max, Roe, Steven N., Fruhauf, Chris
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/981,816
• Publication Number:
  US 20120172760A1
• Time in Patent Office: 2,406 Days
• Field of Search: 600583, 600584, 600573576, 606181-183
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A method of controlling lancing speed of a lancing structure of a portable handheld medical diagnostic device includes providing an elongated lancet structure having a skin piercing end and a blood transport portion adjacent the skin piercing end. The skin piercing end when displaced makes an incision at a skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion transports the amount of bodily fluid away from the skin site for use by a measurement system in making a physiological measurement. A spring-driven motor assembly is operatively connected to the lancet structure. The spring-driven motor assembly displaces the lancet structure toward the skin site to make the incision for producing the amount of bodily fluid and retracts the lancet structure to carry the amount of bodily fluid away from the skin cite. A speed control mechanism is engaged with the spring-driven motor assembly as the spring-driven motor assembly retracts the lancet structure thereby decelerating the lancet structure as the lancet structure is retracted away from the skin site.

Claims

1. A portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient, comprising:

a protective enclosure;

a measurement system including a controller for facilitating a physiologic measurement;

a display device connected to the measurement system that configured to display information related to the physiologic measurement; and

a lancet control system for controlling lancing speed of a lancet structure, the lancet control system comprising;

an elongated lancet structure having a skin piercing end and a blood transport portion adjacent the skin piercing end, the skin piercing end when displaced configured to make an incision at the skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion configured to transport the amount of bodily fluid away from the skin site for use by the measurement system in making the physiological measurement;

a spring-driven motor assembly operatively connected to the lancet structure, wherein the spring-driven motor assembly configured to displace the lancet structure toward the skin site to make the incision for producing the amount of bodily fluid and configured to retract the lancet structure to carry the amount of bodily fluid away from the skin site; and

a speed control mechanism configured to engage the spring-driven motor assembly slowing movement of the spring-driven motor assembly as the spring-driven motor assembly retracts the lancet structure,

wherein the speed control mechanism comprises a gearbox comprising an engagement gear configured to engage a spring wheel assembly of the spring-driven motor assembly having an eccentric member providing an increase in dimension that engages the engagement gear at a location remote from the lancet structure upon onset of a return stroke of the lancet structure to decelerate the spring-driven motor assembly and the lancet structure as the lancet structure is retracted away from the skin site and into the protective enclosure, the eccentric member releasing the engagement gear after the return stroke.

2. The medical diagnostic device of claim 1, wherein the gearbox comprises a flywheel connected to the engagement gear that is configured decelerates the spring wheel assembly when engaged with the engagement gear.

3. The medical diagnostic device of claim 1, wherein the lancet structure is configured to accelerate during an extending phase and decelerates during a retracting phase.

4. The medical diagnostic device of claim 3, wherein a ratio of time during the extending phase to time during the retracting phase is at least 1:

25.

5. The medical diagnostic device of claim 1 further comprising a lancet housing assembly comprising multiple lancet compartments.

6. The medical diagnostic device of claim 1, wherein the eccentric member is a single peripheral member that extends continuously about a periphery of the spring wheel assembly to provide a continuous increase in dimension about the periphery of the spring wheel assembly during the return stroke to decelerate the spring-driven motor assembly.

7. A lancet control system for controlling lancing speed of a lancet structure for use with a portable handheld diagnostic device, the lancet control system comprising:

an elongated lancet structure having a skin piercing end and a blood transport portion adjacent the skin piercing end, the skin piercing end when displaced configured to make an incision at a skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion configured to transport the amount of bodily fluid away from the skin site for use by a measurement system in making a physiological measurement;

a spring-driven motor assembly operatively connected to the lancet structure, wherein the spring-driven motor assembly is configured to displace the lancet structure toward the skin site to make the incision for producing the amount of bodily fluid and configured to retract the lancet structure to carry the amount of bodily fluid away from the skin site; and

a speed control mechanism that engages the spring-driven motor assembly slowing movement of the spring-driven motor assembly as the spring-driven motor assembly retracts the lancet structure;

wherein the speed control mechanism comprises a gearbox comprising an engagement gear configured to engage a spring wheel assembly of the spring-driven motor assembly having an eccentric member providing an increase in dimension that engages the engagement gear at a location remote from the lancet structure upon onset of a return stroke of the lancet structure to decelerate the spring-driven motor assembly and the lancet structure as the lancet structure is retracted away from the skin site and into the protective enclosure.

8. The lancet control system of claim 7, wherein the gearbox comprises a flywheel connected to the engagement gear is configured to decelerate the spring wheel assembly when engaged with the engagement gear.

9. The lancet control system of claim 7, wherein the lancet structure is configured to accelerate during an extending phase and decelerates during a retracting phase.

10. The lancet control system of claim 9, wherein a ratio of time during the extending phase to time during the retracting phase is at least 1:

25.

11. The lancet control system of claim 7 further comprising a lancet housing assembly comprising multiple lancet compartments.

12. A method of controlling lancing speed of a lancing structure of a portable handheld medical diagnostic device, the method comprising:

providing an elongated lancet structure having a skin piercing end and a blood transport portion adjacent the skin piercing end, the skin piercing end when displaced makes an incision at a skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion transports the amount of bodily fluid away from the skin site for use by a measurement system in making a physiological measurement;

connecting a spring-driven motor assembly operatively to the lancet structure, wherein the spring-driven motor assembly displaces the lancet structure toward the skin site to make the incision for producing the amount of bodily fluid and retracts the lancet structure to carry the amount of bodily fluid away from the skin site, and wherein the spring-driven motor assembly comprises a spring wheel assembly having an eccentric member providing an increase in diameter that engages a periphery of an engagement gear of a speed control mechanism at a location remote from the lancet structure; and

engaging the speed control mechanism with the spring-driven motor assembly at the location remote from the lancet structure thereby slowing movement of the spring-driven motor assembly as the spring-driven motor assembly retracts the lancet structure thereby decelerating the lancet structure as the lancet structure is retracted away from the skin site, wherein the speed control mechanism comprises a gearbox comprising the engagement gear that engages the spring-driven motor assembly at the location remote from the lancet structure as the lancet structure is carried away from the skin site;

wherein the step of engaging occurs upon onset of a return stroke of the lancet structure and the speed control mechanism remains in engaged with the spring-driven motor assembly as the lancet structure carries the amount of bodily fluid away from the skin site during the return stroke.

13. The method of claim 12, wherein the gearbox comprises a flywheel connected to the engagement gear that decelerates the spring wheel assembly when engaged with the engagement gear.

14. The method of claim 12, wherein the lancet structure is configured to accelerate during an extending phase and decelerates during a retracting phase.

15. The method of claim 14, wherein a ratio of time during the extending phase to time during the retracting phase is at least 1:

25.