Rotary-actuated medical puncturing device

• US 8,221,441 B2
• Filed: 05/04/2005
• Issued: 07/17/2012
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Dicesare, Paul, Battles, Christopher, Radziunas, Jeffrey
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Miles, Jonathan W
• Application Number:
  US11/568,619
• Publication Number:
  US 20090118753A1
• Time in Patent Office: 2,631 Days
• Field of Search: 606/180, 606/181, 606/182, 606/184, 606/185, 606/167, 600/583, 604/136, 604/137, 604/138, 604/139
• US Class Current: 606/182
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The medical puncturing device includes an actuator, a shield, and a skin puncturing assembly. The actuator and shield are movable relative to one another. The skin-puncturing assembly includes a carrier and a skin-puncturing element. 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 distal end of the skin-puncturing element is disposed within the shield to a puncturing position wherein the distal end of the skin-puncturing element is exposed to puncture the skin of a patient. The carrier is maintained in the retracted position by interference engagement between the carrier and shield. A drive spring is provided to move the carrier from the retracted to puncturing positions. A retraction spring is provided to return the carrier to a position wherein the shield encompasses the skin puncturing element.

Claims

1. A medical puncturing device, comprising:

an actuator having at least one rigid release element extending therefrom, the actuator including gripping surfaces on opposing sides thereof for grasping the actuator between the fingertips of a user;

a shield, the shield and the actuator movably associated with each other; and

a skin puncturing assembly disposed at least partially within the shield, the skin puncturing assembly comprising a carrier and a skin puncturing element mounted to the carrier, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier movable from a first position to a second position;

wherein the at least one rigid release element is configured such that relative movement between the actuator and shield causes the at least one rigid release element to engage the carrier and align at least one tab provided on one of the carrier and shield with at least one slot formed in the other of the carrier and shield, enabling the carrier to move from the first position to the second position;

wherein a force applied to the distal end of the shield causes the shield to move proximally relative to the actuator to cause the rigid release element to engage with the carrier about a central axis of the puncturing device enabling the carrier to move from the first position to the second position; and

wherein at least one of the rigid release element or the carrier comprises a cam surface and the other of the rigid release element and the carrier comprises a corresponding contact surface edge, the cam surface or the corresponding contact surface edge is fixed relative to the actuator during actuation and has a shape configured to rotate the carrier and wherein relative movement between the actuator and the shield causes the cam surface and the corresponding contact surface edge to contact and the shape of the cam surface or the corresponding contact surface edge causes rotation of the carrier about a central axis of the puncturing device to align the at least one tab with the at least one slot.

2. The medical puncturing device of claim 1, wherein:

when in the first position, the distal end of the skin puncturing element is disposed within the shield; and

when in the second position, the distal end of the skin puncturing element is exposed from the distal end of the shield to puncture the skin of the patient.

3. The medical puncturing device of claim 1, wherein the alignment of the at least one tab with the at least one slot is accomplished by engagement of the at least one rigid release element with the carrier, thereby rotating the carrier about a longitudinal axis of the medical puncturing device.

4. The medical puncturing device of claim 1, wherein the at least one tab is provided on the carrier and the at least one slot is formed in the shield, and wherein the at least one tab is in interference engagement with the shield to maintain the carrier in the first position, until the relative movement between the actuator and shield causes the at least one rigid release element to engage the carrier and align the at least one tab with the at least one slot.

5. The medical puncturing device of claim 1, wherein the at least one tab extends from the shield and the at least one slot is formed in the carrier, and wherein the at least one tab is in interference engagement with the carrier to maintain the carrier in the first position, until the relative movement between the actuator and shield causes the at least one rigid release element to engage the carrier and align the at least one slot with the at least one tab.

6. The medical puncturing device of claim 1, wherein the at least one rigid release element has a surface adapted to rotate the carrier about a longitudinal axis of the medical puncturing device, upon the relative movement between the actuator and shield.

7. The medical puncturing device of claim 1, further comprising a drive spring acting between the carrier and the actuator, the drive spring adapted to move the carrier from the first position to the second position upon alignment of the at least one tab with the at least one slot.

8. The medical puncturing device of claim 7, further comprising a retraction spring disposed within the shield at the shield distal end, the retraction spring adapted to return the carrier to a position wherein the shield encompasses the skin puncturing element after the carrier reaches the second position.

9. The medical puncturing device of claim 1, further comprising a removable protector cap on the distal end of the shield.

10. The medical puncturing device of claim 1, wherein the actuator extends axially along an external surface of the shield along a longitudinal axis of the medical puncturing device and a proximal end of the shield is disposed within the actuator.

11. The medical puncturing device of claim 1, wherein the cam surface has an angled surface so that contact therewith causes the carrier to rotate with respect to this angled surface.

12. A medical puncturing device, comprising:

an actuator;

a shield, the shield and the actuator movably associated with each other; and

a skin puncturing assembly disposed at least partially within the shield, the skin puncturing assembly comprising a carrier and a skin puncturing element mounted to the carrier, the carrier movable from a first position to a second position;

wherein the actuator extends axially over an external surface of the shield along a longitudinal axis of the medical puncturing device, a proximal end of the shield being disposed within the actuator, wherein the actuator comprises surfaces on opposing sides thereof for gripping the actuator between the finger tips of a user,

wherein, when the carrier is in the first position, the shield has a shield interference surface engageable with a carrier interference surface of the carrier; and

wherein the carrier is capable of rotation when a force is applied to the actuator, causing a portion of the carrier to engage a distally extending portion of the actuator and wherein at least a portion of the distally extending portion is fixed relative to the actuator during actuation and the rotation enables disengagement of the shield interference surface from the carrier interference surface, thereby causing the carrier to move from the first position to the second position.

13. The medical puncturing device of claim 12:

wherein the skin puncturing element includes a distal end adapted for puncturing the skin of a patient; and

wherein, when in the first position, the distal end of the skin puncturing element is disposed within the shield having a distal end, and when in the second position, the distal end of the skin puncturing element is exposed from the distal end of the shield to puncture the skin of the patient.

14. The medical puncturing device of claim 13, wherein the carrier is rotated about a longitudinal axis of the medical puncturing device.

15. The medical puncturing device of claim 14, wherein the carrier is rotated about upon relative movement between the actuator and shield.

16. A method of assembling a medical puncturing device, comprising:

providing an actuator having an open proximal end and an open distal end;

inserting a shield into the actuator proximal end, a distal end of the shield extending outward from the actuator distal end;

inserting a skin puncturing assembly into the actuator proximal end, the skin puncturing assembly comprising a movable carrier and a skin puncturing element mounted to the carrier, the skin puncturing element having a distal end adapted for puncturing the skin of a patient; and

wherein the skin puncturing assembly is inserted into the actuator proximal end such that;

the shield has a shield interference surface engageable with a carrier interference surface of the carrier, when the carrier is in a first position; and

the carrier is capable of rotation when a force is applied to the actuator causing a portion of the carrier to engage a distally extending portion of the actuator and wherein at least of portion of the distally extending portion is fixed with relative to the actuator during actuation and the rotation enables disengagement of the shield interference surface from the carrier interference surface, thereby causing the carrier to move from the first position to a second position;

wherein the actuator extends axially over an external surface of the shield along a longitudinal axis of the medical puncturing device, a proximal end of the shield being disposed within the actuator, wherein the actuator comprises surfaces on opposing sides thereof for gripping the actuator between the fingertips of a user.

17. A method of actuating a medical puncturing device comprising:

providing the medical puncturing device comprising an actuator, a shield, and a skin puncturing assembly disposed at least partially within the shield, the skin puncturing assembly comprising a movable carrier and a skin puncturing element mounted to the carrier, the skin puncturing element having a distal end adapted for puncturing the skin of a patient, the actuator extending axially over an external surface of the shield along a longitudinal axis of the medical puncturing device, a proximal end of the shield being disposed within the actuator, wherein the actuator comprises surfaces on opposing sides thereof for gripping the actuator between the fingertips of a user, the actuator and shield movably associated with each other;

wherein a force applied to a distal end of the shield causes the shield to move proximally relative to the actuator such that a distally extending portion of the actuator engages the carrier wherein at least a portion of the distally extending portion is fixed relative to the actuator during actuation to rotate the carrier from an interference engagement with the shield to a position allowing the skin puncturing assembly to move axially within the shield to a position exposing the distal end of the skin puncturing element for puncturing the skin of the patient.

18. The method of claim 17, wherein the distally extending portion of the actuator includes at least one rigid release element extending therefrom, and at least one of the rigid release element or the carrier comprises a cam surface and the other of the rigid release element or the carrier comprises a corresponding contact surface edge, the cam surface or the corresponding contact surface edge having a shape configured to rotate the carrier and wherein relative movement between the actuator and the shield causes the cam surface and the corresponding contact surface edge to contact and the shape of the cam surface or the corresponding contact surface edge causes rotation of the carrier about a central axis of the puncturing device to rotate the carrier from the interference engagement with the shield.

19. The method of claim 18, wherein the cam surface has an angled surface so that contact therewith causes the carrier to rotate with respect to this angled surface.

20. A method of actuating a medical puncturing device comprising:

providing the medical puncturing device comprising an actuator, a shield, and a skin puncturing assembly disposed at least partially within the shield, the skin puncturing assembly comprising a movable carrier and a skin puncturing element mounted to the carrier, the skin puncturing element having a distal end adapted for puncturing the skin of a patient, the actuator extending axially over an external surface of the shield along a longitudinal axis of the medical puncturing device, a proximal end of the shield being disposed within the actuator, wherein the actuator comprises surfaces on opposing sides thereof for gripping the actuator between the fingertips of a user and the actuator and shield movably associated with each other;

wherein a force applied to a distal end of the shield causes the shield to move proximally relative to the actuator such that a distally extending portion of the actuator engages the carrier wherein at least a portion of the distally extending portion is fixed relative to the actuator during actuation to rotate the carrier from an interference engagement with the shield to a position allowing the skin puncturing assembly to move axially within the shield to a position exposing the distal end of the skin puncturing element for puncturing the skin of the patient and causing relative axial movement between the actuator and shield, such that the actuator rotates a rigid release element associated with the carrier to a position allowing the carrier to move axially within the shield to a position exposing the distal end of the skin puncturing element for puncturing the skin of the patient.