Cam-actuated medical puncturing device and method

• US 9,649,053 B2
• Filed: 11/17/2014
• Issued: 05/16/2017
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Radziunas, Jeffrey, Battles, Christopher A., DiCesare, Paul C.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US14/543,142
• Publication Number:
  US 20150073463A1
• Time in Patent Office: 911 Days
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/150564 Protectors removed by pulling or pushing
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• CPC Class Codes: A61B 5/150885 Preventing re-use
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use

Abstract

The medical puncturing device includes a housing, a shield, and a skin puncturing assembly disposed within the housing. The shield is axially movable in the housing. The skin puncturing assembly includes a movable carrier and a skin puncturing element mounted to the carrier. A distal end of the skin puncturing element is adapted for puncturing the skin of a patient. The carrier is movable from a retracted position wherein the skin puncturing element is disposed within the shield to a puncturing position wherein the distal end of the skin puncturing element is exposed. The carrier is maintained in the retracted position by engagement of flexure members or a retaining tab with the carrier. A drive spring is provided to move the carrier from the retracted position to the puncturing position. A retraction spring is provided to return the carrier and skin puncturing element into the housing.

Claims

1. A lancet device, comprising:

a housing having a proximal end and a distal end;

a shield having a proximal end and a distal end, the shield proximal end disposed within the housing, and the shield being movable relative to the housing;

a skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier movable between a first position where the distal end of the skin puncturing element is disposed within the shield, and a second position where the distal end extends out of the shield in a puncturing position;

at least one flexure member transitionable between a first state in which the at least one flexure member engages the carrier to maintain the carrier in the first position, and a second state in which the at least one flexure member does not engage the carrier and the carrier is movable from the first position to the second position;

a drive spring disposed within the housing and in contact with a portion of the carrier for biasing the carrier from the first position to the second position when the at least one flexure member is in the second state, wherein the drive spring biases the carrier toward the distal end of the shield; and

a retraction spring disposed within the shield, the retraction spring adapted to return the carrier to a position within the housing wherein the shield encompasses the skin puncturing element after the carrier reaches the puncturing position,

wherein the at least one flexure member is transitioned from the first state to the second state by a portion of the proximal end of the shield contacting a portion of the at least one flexure member thereby moving the at least one flexure member radially outward.

2. The lancet device of claim 1, wherein the shield is axially movable into the housing, and wherein the at least one flexure member is caused to change from the first state to the second state by contact with a surface as the shield is caused to move into the housing.

3. The lancet device of claim 1, wherein the at least one flexure member is generally annular.

4. The lancet device of claim 1, wherein the at least one flexure member further comprises a surface that engages a surface of the carrier to maintain the carrier in the first position.

5. The lancet device of claim 4, wherein the surface of the at least one flexure member is disengaged from the surface of the carrier when the at least one flexure member is in the second state.

6. The lancet device of claim 5, wherein the surface of the at least one flexure member is caused to move in a direction substantially parallel to a plane defined by the surface of the carrier when the at least one flexure member is caused to move between the first state and the second state.

7. The lancet device of claim 1, wherein the at least one flexure member flexes toward the housing upon contact with a camming surface to release the carrier from engagement with the at least one flexure member.

8. The lancet device of claim 7, wherein axial displacement of the shield into the housing causes the at least one flexure member to engage the camming surface and to release the at least one flexure member from the carrier.

9. A lancet device comprising:

a housing;

a shield at least partially disposed within the housing and movable with respect thereto;

a carrier having a puncture element and a first engagement surface, the carrier being movable between a first position where a distal end of the puncture element is disposed within the shield, and a second position where the distal end of the puncture element is exposed from the shield;

a flexural element having a second engagement surface, the flexural element transitionable between a first state, in which the first engagement surface is engaged with the second engagement surface, and a second state, in which the first engagement surface is not engaged with the second engagement surface; and

a drive spring disposed within the housing and in contact with a portion of the carrier for biasing the carrier towards the second position when the flexural element is in the second state,

wherein the flexural element is transitioned from the first state to the second state by a portion of the shield contacting a portion of the flexural element thereby moving the flexural element radially outward.

10. The lancet device of claim 9, wherein the flexural element is generally annular.

11. The lancet device of claim 9, wherein the second engagement surface is caused to move in a direction substantially parallel to a plane defined by the first engagement surface when the flexural element is caused to move between the first state and the second state.

12. The lancet device of claim 9, wherein the flexural element flexes toward the housing upon contact with a camming surface to release the carrier from engagement with the flexural element.

13. The lancet device of claim 12, wherein axial displacement of the shield into the housing causes the flexural element to engage the camming surface and to release the flexural element from the carrier.

14. A lancet device comprising:

a housing;

a shield disposed within the housing, the shield and housing being movable with respect to each other;

a lancet assembly disposed within the housing and comprising a movable carrier and a skin puncturing element having a sharpened tip adapted for puncturing the skin of a patient, the carrier movable between a first position where the sharpened tip is disposed within the shield, and a second position where the skin puncturing element is exposed from the shield;

at least one flexure member transitionable between a first state, in which it engages a portion of the carrier to maintain the carrier in the first position, and a second state in which it does not engage the portion of the carrier and the carrier is able to move to the second position; and

a drive spring disposed within the housing and in contact with a portion of the carrier for biasing the carrier towards the second position when the at least one flexure member is in the second state,

wherein the at least one flexure member is transitioned from the first state to the second state by a portion of the shield contacting a portion of the at least one flexure member thereby moving the at least one flexure member radially outward.

15. The lancet device of claim 14, wherein the drive spring comprises a coil spring positioned between a surface of the housing and the lancet assembly.

16. The lancet device of claim 14, wherein the at least one flexure member is generally annular.

17. The lancet device of claim 14, wherein a surface of the at least one flexure member is caused to move in a direction substantially parallel to a plane defined by a surface of the carrier when the at least one flexure member is caused to move between the first state and the second state.

18. The lancet device of claim 14, wherein the at least one flexure member may be caused to change from the first state to the second state upon movement of the shield into the housing.

19. The lancet device of claim 18, wherein movement of the shield into the housing causes the at least one flexure member to engage a camming surface which forces the at least one flexure member to expand in an outward direction and release a carrier latch from cooperation with the carrier.

20. The lancet device of claim 14, further comprising a retraction spring to bias the carrier toward the first position.

21. A medical device comprising:

a carrier comprising a puncture element;

a housing;

a shield internally movable with respect to said housing; and

a drive spring disposed within the housing and in contact with a portion of the carrier,

wherein said housing comprises a distally extending flexural element extending from a proximal end of the housing, said flexural element comprises a carrier latch,

wherein the shield comprises a proximally extending cam to engage said flexural element,

wherein the carrier comprises a surface for releasably cooperating with said carrier latch, and

wherein movement of said shield internally to said housing causes the cam of the shield to contact a portion of said flexural element to move the flexural element radially outward and release said carrier latch from cooperation with said carrier.

22. The medical device of claim 21, wherein said cam substantially resists flexure during engagement with said flexural element.