Cam-actuated medical puncturing device and method

• US 8,998,941 B2
• Filed: 05/05/2005
• Issued: 04/07/2015
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Dicesare, Paul, Radziunas, Jeffrey, Battles, Christopher A.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US11/568,634
• Publication Number:
  US 20080188882A1
• Time in Patent Office: 3,624 Days
• Field of Search: 600/573, 600/583, 606181-182, 606184-185, 606/189
• US Class Current: 606/182
• 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 (12), a shield (13), 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 medical puncturing device, comprising:

a housing having a proximal end and a distal end, the housing comprising at least one flexure member extending internally therein;

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

a skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element integral with the carrier, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier 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 is exposed from the shield to puncture the skin of the patient, the carrier maintained in the retracted position by engagement of the at least one flexure member with the carrier and moved from the retracted position to the puncturing position upon release of the at least one flexure member from the carrier;

a drive spring disposed within the housing and in direct contact with the carrier, the drive spring adapted to move the carrier from the retracted position to the puncturing position upon release of the at least one flexure member from the carrier, 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.

2. The medical puncturing device of claim 1, wherein the at least one flexure member comprises an inward-directed projection engaging an edge on the carrier to maintain the carrier in the retracted position.

3. The medical puncturing device of claim 2, wherein the projection defines a camming surface and the shield proximal end defines an opposing camming surface, and wherein axial displacement of the shield into the housing causes the opposing camming surfaces to engage and release the projection from the carrier edge.

4. The medical puncturing device of claim 1, wherein the at least one flexure member comprises a distal end engaging the carrier to maintain the carrier in the retracted position, wherein the distal end defines a camoming surface engaging an opposing camming surface on the shield proximal end, and wherein axial displacement of the shield into the housing causes the opposing camming surfaces to engage and release the distal end of the at least one flexure member of engagement with the carrier.

5. The medical puncturing device of claim 1, further comprising an end cap enclosing the housing proximal end, the drive spring acting between the carrier and an inner side of the end cap.

6. The medical puncturing device of claim 5, wherein the end cap comprises a raised detent cooperating with a circumferential recess formed in an internal surface of the housing to connect the end cap to the housing proximal end.

7. The medical puncturing device of claim 1, wherein the shield proximal end comprises at least one engagement tab adapted to engage an internal edge formed in the housing for limiting distal axial movement of the shield in the housing.

8. The medical puncturing device of claim 1, wherein the carrier comprises at least one guide tab engaging at least one slot defined in the shield for guiding movement of the carrier in the shield upon release of the at least one flexure member.

9. The medical puncturing device of claim 8, wherein the at least one guide tab is formed substantially at the carrier distal end and the at least one slot extends longitudinally substantially the length of the shield.

10. A medical puncturing device, comprising:

a housing having a proximal end and a distal end, the housing comprising a pair of opposing flexure members extending internally therein;

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

a skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element integral with the carrier, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier 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 is exposed from the shield to puncture the skin of the patient, the carrier maintained in the retracted position by engagement of the opposing flexure members with the carrier and moved from the retracted position to the puncturing position upon release of the opposing flexure members from the carrier;

a drive spring disposed within the housing and in direct contact with the carrier, the drive spring adapted to move the carrier from the retracted position to the puncturing position upon release of the opposing flexure members from the carrier, 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 opposing flexure members have distal ends engaging the carrier to maintain the carrier in the retracted position, and wherein the distal ends of the opposing flexure members define tapered camming surfaces engaging an opposing, oppositely tapered camming surface on the shield proximal end, the engagement of the opposing camming surfaces adapted to spread the opposing flexure members radially outward upon axial displacement of the shield into the housing, such that the opposing flexure members are released of engagement with the carrier permitting the drive spring to move the carrier from the retracted position to the puncturing position.

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

providing a medical device having;

a housing comprising at least one flexure member extending internally therein;

a shield having a proximal end disposed in the housing and axially movable relative to the housing;

a skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element mounted to the carrier, a distal end of the skin puncturing element adapted to puncture the skin of a patient;

a drive spring disposed within the housing and in direct contact with the carrier, wherein the drive spring is adapted to move the carrier in the shield; and

a retraction spring disposed within the shield;

wherein the at least one flexure member engages the carrier, and wherein the at least one flexure member defines a camming surface and the shield proximal end defines an opposing camming surface;

axially displacing the shield into the housing causing the opposing camming surfaces to engage and release the at least one flexure member of engagement with the carrier;

driving the carrier via the drive spring from a retracted position wherein the distal end of the skin puncturing element is disposed within the shield to a puncturing position toward a distal end of the shield, wherein the distal end of the skin puncturing element is exposed from the shield to puncture the skin of the patient under the biasing force of the drive spring; and

moving the carrier to a position within the housing wherein the shield encompasses the skin puncturing element under the biasing force of the retraction spring.