Safety Device Actuation System
The present disclosure relates to a safety needle assembly that includes a syringe and a safety mechanism. The safety mechanism includes a housing defining an internal cavity, a shield member at least partially disposed within the internal cavity, and first and second locking members that are configured to selectively engage and maintain the shield member in one or more predetermined positions. The locking members are movable between a locked position, in which the locking members are in engagement with the shield member to substantially prevent axial movement thereof, and a release position, in which the locking members are disengaged from the shield member to permit axial movement thereof. The first and second locking members each include biasing members. The biasing member of the each locking member is positioned to cooperate with the other locking member to normally bias the locking members towards the locked position.
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This application is a Continuation application under 35 U.S.C. §120 and claims the benefit of and priority to co-pending U.S. patent application Ser. No. 12/489,535, filed on Jun. 23, 2009, entitled SAFETY DEVICE ACTUATION SYSTEM, which claims the benefit of and priority to expired U.S. Provisional Application Ser. No. 61/076,863, filed Jun. 30, 2008, entitled SAFETY DEVICE ACTUATION SYSTEM, the entirety of each of which is hereby incorporated by reference herein for all purposes.
BACKGROUND1. Technical Field
The present disclosure relates generally to safety devices, and methods of using and manufacturing the same. More particularly, the present disclosure relates to a safety device with a mechanism that is selectively actuable to prevent hazardous exposure and/or inadvertent contact with a sharp element.
2. Background of the Related Art
Needles, such as hypodermic needles, for example, are used in a variety of applications, both medical and non-medial in nature, including medical and veterinary procedures, clinical research, and biotechnological, chemical, and pharmaceutical applications.
Cross-contamination and infection through inadvertent needle sticks have resulted in the development of a wide variety of safety needles used in the areas of I.V. therapy, venipuncture, phlebotomy, and syringes. However, known safety needles can often be difficult to use and manufacture, and can result in uncontrolled manipulation and/or faulty operation, thus frustrating their intended purpose.
SUMMARYIn one aspect, the present disclosure relates to a safety device assembly that includes a medical device having a sharp element and a safety mechanism that is positioned at a distal end of the medical device in association with the sharp element. The safety mechanism includes a housing defining an internal cavity, a shield member at least partially disposed within the internal cavity, and first and second locking members.
The first and second locking members are configured to selectively engage the shield member to maintain the shield member in one or more predetermined positions. The first and second locking members are movable between a locked position, in which the first and second locking members are in engagement with the shield member to substantially prevent axial movement thereof, and a release position, in which the first and second locking members are disengaged from the shield member to permit axial movement of the shield member to cover the sharp element. The first and second locking members each include a biasing member, and the biasing member of each locking member is positioned to cooperate with the other of the first and second locking members to normally bias the locking members towards the locked position.
In another aspect of the present disclosure, a safety needle assembly is described that includes a syringe and a safety mechanism positioned at a distal end of the syringe. The safety mechanism includes a housing defining an internal cavity, a shield member at least partially disposed within the internal cavity, and first and second locking members. In one embodiment of the safety mechanism, the first and second locking members may be substantially identical in configuration and dimensions.
The first and second locking members are configured and dimensioned to selectively engage the shield member to maintain the shield member in one or more predetermined positions, and are movable between a locked position and a release position. In one embodiment, the first and second locking members are adapted for reciprocal movement between the locked position and the release position.
In the locked position, the first and second locking members are in engagement with the shield member to substantially prevent axial movement thereof, and in the release position, the first and second locking members are disengaged from the shield member to permit axial movement thereof. The first and second locking members each include biasing members. The biasing member of the each locking member is positioned to cooperate with the other locking member to normally bias the locking members towards the locked position. In one embodiment of the safety mechanism, the biasing members of the first and second locking members respectively include first and second resilient fingers. In this embodiment, the first and second locking members further include first and second stops, respectively. The first resilient finger is configured and dimensioned for engagement with the second stop, and the second resilient finger is configured and dimensioned for engagement with the first stop to normally bias the first and second locking members towards the locked position.
In another embodiment, the first and second locking members may each include a tactile member configured for manual engagement to facilitate movement of the first and second locking members from the locked position to the release position.
The shield member is movable between retracted and advanced positions. In one embodiment, the safety needle assembly further includes a needle extending distally from the syringe. In this embodiment, when the shield member is in the retracted position, a distal end of the needle extends distally beyond a distal end of the shield member, and when the shield member is in an advanced position, the distal end of the shield member extends distally beyond the distal end of the needle. The safety needle assembly may further include a biasing member connected to the shield member to normally bias the shield member towards either the advanced position or the retracted position. As the shield member moves between the retracted and advanced positions, the shield member passes through the first and second locking members and an opening at a distal end of the housing.
The first locking member includes a first detent and the second locking member includes a second detent. In one embodiment, the first and second detents are receivable by at least one aperture formed in the shield member. When the first and second locking members are in the locked position, the first and second detents are positioned within the at least one aperture, and when the first and second locking members are in the release position, the first and second detents are displaced from the at least one aperture. As the first and second locking members move from the locked position to the release position, the first and second locking members are displaced radially inward with respect to a longitudinal axis of the housing.
In one embodiment, the at least one aperture includes a proximal pair of apertures and a distal pair of apertures. In this embodiment, the first and second detents are positionable within the distal pair of apertures to maintain the retracted position of the shield member, and are positionable within the proximal pair of apertures to maintain the advanced position of the shield member. The first detent is positioned on a first arm of the first locking member and the second detent is positioned on a second arm of the second locking member such that the first and second detents are displaced radially outward and out of engagement with the at least one aperture as the first and second locking members are displaced radially inward, thereby permitting the shield member to move from the retracted position to the advanced position.
In an alternate embodiment, the retracted position of the shield member is maintained through engagement of the distal end of the shield member with the first detent, and the advanced position of the shield member is maintained through engagement of a proximal end of the shield member with the second detent.
In another aspect of the present disclosure, a safety mechanism is disclosed that is adapted for use with a medical device. The safety mechanism includes a housing defining an internal cavity, a shield member at least partially disposed within the internal cavity, and first and second locking members.
The first and second locking members are configured and dimensioned to selectively engage the shield member to maintain the shield member in one or more predetermined positions, and are movable between a locked position and a release position. In the locked position, the first and second locking members are in engagement with the shield member to substantially prevent axial movement thereof, and in the release position, the first and second locking members are disengaged from the shield member to permit axial movement thereof. The first and second locking members each include a biasing member, the biasing member of each locking member being positioned to cooperate with the other of the first and second locking members to normally bias the locking members towards the locked position.
In another aspect of the present disclosure, a method of manufacturing a safety mechanism for use with a needle, assembly is disclosed. The method includes the steps of providing a housing, a shield member, a biasing member, a first locking member, and a second locking member, positioning the biasing member and the shield member within the housing, and positioning the first and second locking members within the housing such that the first and second locking members maintain the shield member in a retracted position. The first and second locking members define substantially identical configurations and dimensions, and are positioned within the housing such that one of the first and second locking members is in an inverted position.
Various embodiments of the present disclosure are described herein below with reference to the drawings, wherein:
In the drawings and in the description which follows, in which like references characters identify similar or identical elements, the term “proximal” should be understood as referring to the end of an apparatus, or any component thereof that is closest to a practitioner during use, while the term “distal” should be understood as referring to the end that is furthest from the practitioner during use.
Referring also to
Referring still to
A proximal end 224 of the biasing member 206 abuts the housing 202 such that the biasing member 206 is at least partially positioned within the cavity 212. The biasing member 206 extends distally through the cavity 212 within the shield member 204. A distal end of the biasing member 206 engages a flange 213 formed within the shield member 204 to urge the shield member 204 in a distal direction about the needle 104.
In the embodiment of the safety mechanism 200 seen in
As the biasing member 206 transitions from the compressed state to the expanded state, the biasing member 206 elongates axially in the direction indicated by arrow 1 in
With additional reference to
The locking member 208 includes a base 230, an arm 232, and a stop 234. In one embodiment of the locking mechanism 200, the base 230 includes an outwardly extending tactile member 236 that is adapted for manual engagement by the practitioner during use, as seen in
The arm 232 extends from the base 230 in a substantially parabolic configuration to define a crest 238. The arm 232 includes a pair of resilient biasing members, configured as fingers 244 in the illustrated embodiment, that are configured and dimensioned to engage the stop 234 formed on a corresponding locking member 208′ during use, as described in further detail below. The arm 232 may be formed from any suitable material that is at least semi-resilient in nature so as to attribute the requisite measure of resiliency to the fingers 244. Alternatively, only fingers 244 may be formed of a resilient material. Further, fingers 244 can be integrally formed with the arm 232 (
In one embodiment of the safety mechanism 200, as seen in
As best seen in
Referring now to
In the release position, the fingers 244 are in substantial abutment with both the stops 234 and the crest 238 defined by the arm 232 such that further movement of the fingers 244 is prohibited, as seen in
Referring now to
After the safety needle 1000 has served its desired purpose, the practitioner applies a force to the tactile members 236 that is directed radially inward, i.e., in the direction of arrows 2 (
As the biasing member 206 expands axially, the shield member 204 is displaced distally into the advanced position seen in
Referring now to
In contrast to the shield member 204 of the safety mechanism 200, which includes proximal and distal apertures 220a, 220b, the shield member 304 defines a substantially uniform outer surface 350.
Prior to use, the biasing member 306 is in the compressed state seen in
Following use, the practitioner actuates the safety mechanism 300 by engaging the tactile members 336 and advancing the locking members 308, 308′ radially inward in the direction of arrows 2 and into the release position. As the locking members 308, 308′ move radially inward, the detents 322 move radially outward in the direction of arrows 3 and out of engagement with the distal end 328 of the shield member 304 such that the shield member 304 is allowed to advance distally between the detents 322, through the locking members 308, 308′ and the opening 314 at the distal end 316 of the housing 302, and into the advanced position seen in
With reference now to
Referring now to
The needle assembly 500 includes an elongate, hollow needle 506, tubing 508, a hub member 510, and the aforementioned biasing member 504. The needle 506 is of the type typically used during intravenous procedures to insert and withdraw fluids from the body, and includes a distal tip 512 that is adapted to penetrate tissue. The needle 506 is in fluid communication with the tubing 508 to facilitate the passage of fluid into and out of the body through the needle 506.
The hub member 510 is positioned within the internal cavity 404 defined by the housing portion 400. A distal end 514 of the hub member 510 is fixedly secured to the needle 506. The hub member 510 and the needle 506 may be secured together in any suitable manner, e.g., crimping, adhesives, press-fitting, etc. The hub member 510 includes a ledge 516 formed at a proximal end 518 that is configured and dimensioned to engage the detents 222 of the locking members 208, 208′, which can also be seen in
As the biasing member 504 transitions from the compressed state to the expanded state, the biasing member 504 elongates axially in the proximal direction indicated by arrow 1 (
As previously discussed with respect to
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are intended to be construed as non-limiting, exemplary embodiments, and that the features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Additionally, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
Claims
1-25. (canceled)
26. A method of using a safety medical device comprising:
- inserting a sharp element of the safety medical device into a patient; and
- actuating a safety mechanism provided on the safety medical device to cover a tip of the sharp element with a shield member by advancing a first locking member towards a second locking member, wherein advancing the first locking member towards the second locking member increases a biasing force created in a biasing member included on the first locking member via engagement of the biasing member included on the first locking member with the second locking member.
27. The method of claim 26, wherein actuating the safety mechanism includes moving the first and second locking members towards each other.
28. The method of claim 27, wherein moving the first and second locking members towards each other increases the biasing force created in a biasing member included on the second locking member via engagement of the biasing member included on the second locking member with the first locking member.
29. The method of claim 26, wherein actuating the safety mechanism includes moving the first locking member radially inwards toward the sharp element.
30. The method of claim 29, wherein moving the first locking member radially inwards includes displacing the first locking member within a housing receiving at least a portion of the shield member.
31. The method of claim 29, wherein moving the first locking member radially inwards includes disengaging the first locking member from the shield member.
32. The method of claim 31, wherein disengaging the first locking member from the shield member includes removing a detent included on the first locking member from a corresponding first aperture defined in the shield member.
33. The method of claim 32, wherein actuating the safety mechanism includes expanding a biasing member in engagement with the shield member.
34. The method of claim 32 further including locking the shield member such that the tip of the sharp element remains covered.
35. The method of claim 34, wherein locking the shield member includes moving the first locking member radially outwards away from the sharp element.
36. The method of claim 35, wherein moving the first locking member radially outwards includes re-engaging the first locking member with the shield member.
37. The method of claim 36, wherein re-engaging the first locking member with the shield member includes positioning the detent included on the first locking member within a corresponding second aperture defined in the shield member, the second aperture being located proximally of the first aperture.
38. A method of using a safety medical device comprising:
- inserting a sharp element of the safety medical device into a patient; and
- actuating a safety mechanism provided on the safety medical device to cover a tip of the sharp element with a shield member by advancing a first locking member towards an identical second locking member, wherein advancing the first locking member towards the second locking member increases a biasing force in a biasing member included on the first locking member via engagement with the second locking member.
39. The method of claim 38, wherein actuating the safety mechanism includes moving the first and second locking members towards each other.
40. The method of claim 39, wherein moving the first and second locking members towards each other increases a biasing force in a biasing member included on the second locking member via engagement of the biasing member included on the second locking with the first locking member.
41. The method of claim 38, wherein actuating the safety mechanism includes disengaging the first locking member from the shield member.
42. The method of claim 41, wherein disengaging the first locking member from the shield member includes removing a detent included on the first locking member from a corresponding aperture defined in the shield member.
43. A method of manufacturing a safety device comprising:
- positioning a shield member within a housing such that the shield member covers a portion of a sharp element of the safety device;
- positioning a shield biasing member within the housing in engagement with the shield member;
- positioning first and second locking members within the housing to maintain the shield member in a retracted position, whereby a biasing force is generated within the shield biasing member; and
- orienting the first and second locking members within the housing such that a biasing member included on the first locking member engages the second locking member, whereby the first locking member is normally biased away from the second locking member.
44. The method of claim 43, wherein orienting the first and second locking members includes engaging a biasing member included on the second locking member with the first locking member, whereby the second locking member is normally biased away from the first locking member.
45. The method of claim 43, wherein orienting the first and second locking members within the housing includes inverting one of the first and second locking members.
Type: Application
Filed: Mar 26, 2014
Publication Date: Oct 16, 2014
Applicant: Covidien LP (Mansfield, MA)
Inventor: James Carlyon (Farmington, MO)
Application Number: 14/226,061
International Classification: A61M 5/32 (20060101);