US20140309618A1 - Safety Device Actuation System - Google Patents
Safety Device Actuation System Download PDFInfo
- Publication number
- US20140309618A1 US20140309618A1 US14/226,061 US201414226061A US2014309618A1 US 20140309618 A1 US20140309618 A1 US 20140309618A1 US 201414226061 A US201414226061 A US 201414226061A US 2014309618 A1 US2014309618 A1 US 2014309618A1
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- US
- United States
- Prior art keywords
- locking
- locking member
- shield
- shield member
- biasing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- 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.
- 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 FIGS. 4 and 4A .
- the locking members 208 , 208 ′ are moved from a locked position, seen in FIGS. 11 and 13 , to a release position, seen in FIGS. 12 and 14 .
- the detents 222 engage the ledge 516 to prevent axial displacement of the hub member 510 from the advanced position seen in FIG. 11 to the retracted position seen in FIG. 12 .
- the locking members 208 , 208 ′ are moved radially inward from the locked position towards the release position, i.e., in the direction indicated by arrows 2 ( FIGS.
Abstract
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.
Description
- 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.
- 1. 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.
- In 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:
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FIG. 1 is a side, perspective view of a safety needle incorporating a needle assembly and one embodiment of a safety mechanism that includes a housing, a shield member, a biasing member, and a pair of locking members in accordance with the present disclosure; -
FIG. 2 is a side, cross-sectional view of the safety needle ofFIG. 1 illustrating the safety mechanism prior to actuation and showing the shield member in a retracted position; -
FIG. 3 is a side, cross-sectional view of the safety needle ofFIG. 1 illustrating the safety mechanism subsequent to actuation and showing the shield member in an advanced position; -
FIG. 4 is a side, perspective view of one of the locking members of the safety mechanism; -
FIG. 4A is a side, perspective view of the pair of locking members seen inFIG. 1 removed from the housing; -
FIG. 5 is a cross-sectional view taken through line 5-5 inFIG. 2 illustrating the safety mechanism prior to actuation with the locking members in a locked position; -
FIG. 6 is a side, cross-sectional view of the safety needle ofFIG. 1 illustrating the safety mechanism subsequent to actuation and immediately prior to movement of the shield member into the advanced position; -
FIG. 7 is a cross-sectional view taken through line 7-7 inFIG. 6 illustrating the safety mechanism immediately subsequent to actuation with the locking members in a release position; -
FIG. 8 is a side, cross-sectional view of the safety needle ofFIG. 1 including another embodiment of the safety mechanism shown prior to actuation; -
FIG. 9 is a side, cross-sectional view of the safety needle seen inFIG. 8 showing the safety mechanism subsequent to actuation; -
FIG. 10 is a side, perspective view of another embodiment of the safety needle seen inFIG. 1 , incorporating a housing portion, a needle assembly, and a safety mechanism; -
FIG. 11 is a partial, longitudinal cross-sectional view of the safety needle ofFIG. 10 illustrating the safety mechanism prior to actuation; -
FIG. 12 is a partial, longitudinal cross-sectional view of the safety needle ofFIG. 10 illustrating the safety mechanism subsequent to actuation; -
FIG. 13 is a cross-sectional view taken through line 13-13 inFIG. 11 illustrating the safety mechanism prior to actuation with a pair of locking members in a locked position; and -
FIG. 14 is a cross-sectional view also taken through line 13-13 inFIG. 11 illustrating the safety mechanism immediately subsequent to actuation with the pair of locking members in a release position. - 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.
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FIG. 1 illustrates asafety needle 1000 including aneedle assembly 100 and one embodiment of a safety mechanism for use therewith, referred to generally byreference character 200, in accordance with the principles of the present disclosure. Theneedle assembly 100 extends along a longitudinal axis “A” and includes asyringe 102 and aneedle 104. In alternative embodiments, theneedle 104 may be configured as a scalpel blade, stylet, lancet, etc. Thesyringe 102 and theneedle 104 may be fixedly attached or releasably coupled together using, for example, a leer-type connector, such that theneedle 104 may be removed after use. - Referring also to
FIGS. 2-3 , thesafety mechanism 200 includes ahousing 202, ashield member 204, a biasingmember 206, and twoidentical locking members housing 202 defines aninternal cavity 212 that accommodates the components of thesafety mechanism 200, i.e., theshield member 204, the biasingmember 206, and the lockingmembers distal end 216 thereof that is configured and dimensioned to allow for passage of theshield member 204. Thehousing 202 is positioned at adistal end 106 of thesyringe 102, and may be releasably connectable with thesyringe 102 or fixedly secured thereto. In the embodiment of thesafety mechanism 200 seen inFIGS. 2-3 , for example, thehousing 202 includesreceipt structure 210 corresponding in configuration and dimensions toattachment structure 108 formed at thedistal end 106 of thesyringe 102 such that thesafety mechanism 200 may be secured to and disconnected from thesyringe 102 after use. While thereceipt structure 210 and theattachment structure 108 are illustrated as luer-type connections, any structure suitable for the intended purpose of establishing a releasable connection between thesyringe 102 and thehousing 202 may be utilized, including but not limited to an interference-fit arrangement or threading. - Referring still to
FIGS. 2-3 , theshield member 204 is an elongate tubular member defining apassageway 218 therethrough that is configured and dimensioned to receive the biasingmember 206 such that theshield member 204 is coaxially positioned about the biasingmember 206. In one embodiment of thesafety mechanism 200, theshield member 204 includes a proximal pair of apertures 220 a and a distal pair of apertures 220 b that are spaced longitudinally from each other along the length of theshield member 204. The apertures 220 a, 220 b are each configured and dimensioned to receive a pair of detents 222 (FIG. 4 ) included on the lockingmembers shield member 204, the apertures 220 a, 220 b may alternatively extend completely through theshield member 204. - A
proximal end 224 of the biasingmember 206 abuts thehousing 202 such that the biasingmember 206 is at least partially positioned within thecavity 212. The biasingmember 206 extends distally through thecavity 212 within theshield member 204. A distal end of the biasingmember 206 engages aflange 213 formed within theshield member 204 to urge theshield member 204 in a distal direction about theneedle 104. - In the embodiment of the
safety mechanism 200 seen inFIGS. 2-3 , for example, the biasingmember 206 is configured as a coil spring 226. However, in alternate embodiments, the biasingmember 206 may be any member or structure that is capable of transitioning between a compressed state, seen inFIG. 2 , and an expanded state, seen inFIG. 3 . - As the biasing
member 206 transitions from the compressed state to the expanded state, the biasingmember 206 elongates axially in the direction indicated byarrow 1 inFIG. 2 , i.e., along the longitudinal axis “A” (FIG. 1 ). As the biasingmember 206 elongates, engagement between the biasingmember 206 and theflange 213 of theshield member 204 facilitates movement of theshield member 204 from a retracted position, seen inFIG. 2 , to an advanced position, seen inFIG. 3 . In the retracted position, the detents 222 (FIG. 4 ) of the lockingmembers shield member 204 in the retracted position, and thedistal end 110 of theneedle 104 extends distally beyond thedistal end 228 of theshield member 204 to allow for the penetration of tissue (FIG. 2 ). By contrast, when theshield member 204 is in the advanced position, thedetents 222 of the lockingmembers shield member 204 in the advanced position, and thedistal end 110 of theneedle 104 is concealed by thedistal end 228 of theshield member 204 to prevent potentially hazardous or inadvertent contact therewith (FIG. 3 ). - With additional reference to
FIGS. 4 and 4A , the lockingmembers members identical locking members members member 208 will be described. - The locking
member 208 includes abase 230, anarm 232, and astop 234. In one embodiment of thelocking mechanism 200, thebase 230 includes an outwardly extendingtactile member 236 that is adapted for manual engagement by the practitioner during use, as seen inFIGS. 1-3 , for example. Thebase 230 defines a height “HB” (FIG. 2 ) that substantially approximates an internal height “HC” of thecavity 212 defined in thehousing 202 such that axial displacement of the lockingmembers housing 202, i.e., along the longitudinal axis “A”, is substantially prevented. - The
arm 232 extends from the base 230 in a substantially parabolic configuration to define acrest 238. Thearm 232 includes a pair of resilient biasing members, configured asfingers 244 in the illustrated embodiment, that are configured and dimensioned to engage thestop 234 formed on acorresponding locking member 208′ during use, as described in further detail below. Thearm 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 thefingers 244. Alternatively, onlyfingers 244 may be formed of a resilient material. Further,fingers 244 can be integrally formed with the arm 232 (FIG. 4 ) or attached to thearm 232 using any suitable method of attachment, e.g., adhesives, pins, screws, etc. Thearm 232 further includes theaforementioned detent 222, which is configured and dimensioned for receipt by the apertures 220 a, 220 b (FIGS. 2-3 ) formed in theshield member 204. - In one embodiment of the
safety mechanism 200, as seen inFIGS. 2-7 , thearm 232 extends eccentrically from the base 230 such that thearm 232 is positioned closer to one end of the base 230 than the other. However, an alternate embodiment of thesafety mechanism 200 in which thearm 232 extends from the base 230 such that thearm 232 is positioned equidistant from each end is also within the scope of the present disclosure. With reference toFIG. 3 in particular, in the illustrated embodiment of thesafety mechanism 200, thearm 232 is positioned a first distance “D1” from afirst end 240 of thebase 230 and a second, greater distance “D2” from asecond end 242 of thebase 230. The difference between the distances “D1” and “D2” is approximately equivalent to the width “W” defined by thearm 232 to facilitate relative positioning of the lockingmembers arm 232 with respect to thebase 230 allows one of the locking members, i.e., lockingmember 208′ in the illustrated example, to be inverted such that thearm 232 of the lockingmember 208 is positionable on top of thearm 232 of the lockingmember 208′. Accordingly, thefirst end 240 of thebase 230 of the lockingmember 208 is positioned proximally of thesecond end 242, whereas thefirst end 240 of thebase 230 of the lockingmember 208′ is positioned distally of thesecond end 242. - As best seen in
FIG. 4 , thestop 234 extends from the base 230 towards thecrest 238 of thearm 232. Thestop 234 includes anarcuate surface 246 that defines a well 248 extending into thebase 230. Thearcuate surface 246 ofstop 234 is configured and dimensioned to engage theresilient fingers 244 formed on thearm 232. - Referring now to
FIGS. 2-7 , the lockingmembers cavity 212 defined by thehousing 202, and are movable upon actuation of thesafety mechanism 200 between a locked position, seen inFIGS. 2-3 and 5, and a release position, seen inFIGS. 6-7 . In the locked position, thedetents 222 extend into the apertures of theshield member 204, i.e., apertures 220 a, 220 b, to thereby prevent axial displacement of theshield member 204 along the longitudinal axis “A”, e.g., from the retracted position seen inFIG. 2 to the advanced position seen inFIG. 3 . As the lockingmembers FIGS. 2 , 5, 7), thedetents 222 are moved radially outward, i.e., in the direction indicated byarrows 3. Additionally, as the lockingmembers fingers 244 of the lockingmember 208 are forced into engagement with thestop 234 of the lockingmember 208′, and thefingers 244 of the lockingmember 208′ are forced into engagement with thestop 234 of the lockingmember 208. As the lockingmembers fingers 244 traverse thearcuate surface 246 of thestops 234 and are deflected towards the crests 238 (FIG. 4 ) defined by thearms 232, thereby creating a biasing force in thefingers 244 that urges the lockingmembers - In the release position, the
fingers 244 are in substantial abutment with both thestops 234 and thecrest 238 defined by thearm 232 such that further movement of thefingers 244 is prohibited, as seen inFIG. 6 . Additionally, thedetents 222 are removed from the apertures 220 b in theshield member 204, as seen inFIG. 7 , thereby allowing for axial displacement of theshield member 204 from the retracted position to the advanced position. - Referring now to
FIGS. 1-7 , the use and function of theneedle assembly 100 will be described. Prior to use of theneedle assembly 100, the biasingmember 206 is in the compressed state (FIG. 2 ), and consequently, theshield member 204 is in the retracted position. Additionally, the lockingmembers detents 222 are in engagement with the distal apertures 220 b formed in theshield member 204. The engagement of thedetents 222 with the distal apertures 220 b prevents distal advancement of theshield member 204, thus maintaining the shield member in the retracted position and facilitating the penetration of tissue with theneedle 104. - After the
safety needle 1000 has served its desired purpose, the practitioner applies a force to thetactile members 236 that is directed radially inward, i.e., in the direction of arrows 2 (FIGS. 2 , 5, 7), thereby advancing the lockingmembers FIG. 6 . As the lockingmembers detents 222 move radially outward, i.e., in the direction of arrows 3 (FIGS. 2 , 5, 7), such that thedetents 222 are displaced from the distal apertures 220 b, thereby allowing the biasingmember 206 to expand axially in the direction of arrow 1 (FIG. 2 ). Additionally, as the lockingmembers fingers 244 engage thestops 234 and are deflected towards the crest 238 (FIG. 4 ) of thearm 232, thus creating a biasing force that urges the lockingmembers - As the biasing
member 206 expands axially, theshield member 204 is displaced distally into the advanced position seen inFIG. 3 to conceal theneedle 104. Subsequently, the practitioner can release thetactile members 236, thereby allowing the biasing force in thefingers 244 to urge the lockingmembers FIGS. 2 , 5, 7). As the lockingmembers detents 222 move radially inward in the direction ofarrows 2 and into engagement with the proximal apertures 220 a formed in theshield member 204. The engagement of thedetents 222 with the proximal apertures 220 a prevents proximal displacement of theshield member 204, thus maintaining the advanced position of theshield member 204 and preventing inadvertent contact with theneedle 104. - Referring now to
FIGS. 8-9 , an alternate embodiment of the safety mechanism, referred to generally assafety mechanism 300, will be discussed in connection with theneedle assembly 100 seen inFIG. 1 . Thesafety mechanism 300 is substantially similar to thesafety mechanism 200 discussed above with respect toFIGS. 1-7 , but for the configuration of theshield member 304, and accordingly, will only be discussed with respect thereto. - In contrast to the
shield member 204 of thesafety mechanism 200, which includes proximal and distal apertures 220 a, 220 b, theshield member 304 defines a substantially uniformouter surface 350. - Prior to use, the biasing
member 306 is in the compressed state seen inFIG. 8 , and consequently, theshield member 304 is in the retracted position. In the retracted position, thedistal end 328 of theshield member 304 is positioned proximally of thedetent 322 included on the lockingmember 308 such that thedistal end 328 of theshield member 304 rests thereupon. The engagement of thedetent 322 with thedistal end 328 of theshield member 304 prevents distal displacement theshield member 304, thus maintaining the retracted position of theshield member 304 and facilitating the penetration of tissue with theneedle 104. - Following use, the practitioner actuates the
safety mechanism 300 by engaging thetactile members 336 and advancing the lockingmembers arrows 2 and into the release position. As the lockingmembers detents 322 move radially outward in the direction ofarrows 3 and out of engagement with thedistal end 328 of theshield member 304 such that theshield member 304 is allowed to advance distally between thedetents 322, through the lockingmembers opening 314 at thedistal end 316 of the housing 302, and into the advanced position seen inFIG. 9 . Thereafter, the practitioner can release thetactile members 336, thus allowing the lockingmembers detents 322 prevent proximal displacement of theshield member 304, thus maintaining the advanced position of theshield member 304 and preventing inadvertent contact with theneedle 104. - With reference now to
FIGS. 10-14 , an alternate embodiment of the safety needle, referred to generally byreference character 2000, will be discussed. Thesafety needle 2000 is suitable for use in a variety of surgical procedures requiring the infusion, injection, or withdrawal of fluids from the body of a patient. Thesafety needle 2000 includes ahousing portion 400, aneedle assembly 500, and thesafety mechanism 200 discussed above with respect toFIGS. 1-7 . - Referring now to
FIGS. 11-12 in particular, thehousing portion 400 includes one ormore wings 402 to stabilize thesafety needle 2000 with respect to a patient, e.g., with respect to a patient's arm, by providing an attachment point for tape, or any other such securing means.Wings 402 provide structure for grasping the safety needle 20000 as known in the art. Thehousing portion 400 defines aninternal cavity 404 that is configured and dimensioned to accommodate movement of theneedle assembly 500 between retracted and advanced positions, as will be described below, as well as the components of thesafety mechanism 200. Thehousing portion 400 includes a distal opening 406 (FIG. 12 ) that allows theneedle assembly 500 to extend therethrough. Aninternal ridge 408 is recessed within thedistal opening 406 and is configured to engage adistal end 502 of a biasingmember 504. Although illustrated in an abutting relationship, thedistal end 502 of the biasingmember 504 may be fixedly secured to thehousing portion 400 at theinternal ridge 408. - The
needle assembly 500 includes an elongate,hollow needle 506,tubing 508, ahub member 510, and theaforementioned biasing member 504. Theneedle 506 is of the type typically used during intravenous procedures to insert and withdraw fluids from the body, and includes adistal tip 512 that is adapted to penetrate tissue. Theneedle 506 is in fluid communication with thetubing 508 to facilitate the passage of fluid into and out of the body through theneedle 506. - The
hub member 510 is positioned within theinternal cavity 404 defined by thehousing portion 400. Adistal end 514 of thehub member 510 is fixedly secured to theneedle 506. Thehub member 510 and theneedle 506 may be secured together in any suitable manner, e.g., crimping, adhesives, press-fitting, etc. Thehub member 510 includes aledge 516 formed at aproximal end 518 that is configured and dimensioned to engage thedetents 222 of the lockingmembers FIGS. 4 and 4A . While theledge 516 is illustrated as extending only partially through thehub member 510, theledge 516 may alternatively extend completely through thehub member 510 to define an aperture or other such opening. Thehub member 510 further includes a ridge, or step 520 positioned distally of theledge 516 that is configured and dimensioned to engage aproximal end 522 of the biasingmember 504. Although illustrated in an abutting relationship, theproximal end 522 of the biasingmember 504 may be fixedly secured to thehub member 510 at theridge 520. In the embodiment of thesafety needle 2000 seen inFIGS. 11-12 , for example, the biasingmember 504 is configured as acoil spring 524 that is positioned coaxially about thehub member 510. However, in alternative embodiments of thesafety needle 2000, it is envisioned that the biasingmember 504 may be any member or structure that is capable of transitioning between a compressed state, seen inFIG. 11 , and an expanded state, seen inFIG. 12 . - As the biasing
member 504 transitions from the compressed state to the expanded state, the biasingmember 504 elongates axially in the proximal direction indicated by arrow 1 (FIG. 11 ). Distal movement of the biasingmember 504 is substantially restricted through the engagement of thedistal end 502 of the biasingmember 504 with theinternal ridge 408 of thehousing portion 400. As the biasingmember 504 elongates proximally, thehub member 510 will be forced proximally in the direction ofarrow 1 due to the engagement between theproximal end 522 of the biasingmember 504 and theridge 520 formed on thehub member 510, to thereby reposition theneedle assembly 500 from an advanced position, seen inFIG. 11 , to a retracted position, seen inFIG. 12 . When theneedle assembly 500 is in the advanced position, theneedle 506 extends distally beyond thehousing portion 400 to facilitate the penetration of tissue with theneedle 506, and when theneedle assembly 500 is in the retracted position, theneedle 506 is positioned within thehousing portion 400 to prevent inadvertent contact with theneedle 506. The advanced position of theneedle assembly 500 is maintained until actuation of thesafety mechanism 200 by the practitioner through the engagement of theledge 516 formed at theproximal end 518 of thehub member 510 with thedetents 222 of the lockingmembers - As previously discussed with respect to
FIGS. 2-7 , upon actuation of thesafety mechanism 500, the lockingmembers FIGS. 11 and 13 , to a release position, seen inFIGS. 12 and 14 . In the locked position, thedetents 222 engage theledge 516 to prevent axial displacement of thehub member 510 from the advanced position seen inFIG. 11 to the retracted position seen inFIG. 12 . However, as the lockingmembers FIGS. 11 and 13 ), thedetents 222 are moved radially outward, i.e., in the direction indicated byarrows 3, and out of engagement with the ledge 516 (FIG. 14 ), thereby allowing for proximal, axial displacement of thehub member 510, and thus, movement of theneedle assembly 500 from the advanced position into the retracted position. It is envisioned that thehub member 510 can include a distal ledge, step, or recess which is positioned to receivedetents 222 when thehub member 510 is in the retracted position to retain the hub member in the retracted position. - 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 (21)
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.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/226,061 US20140309618A1 (en) | 2008-06-30 | 2014-03-26 | Safety Device Actuation System |
Applications Claiming Priority (3)
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US7686308P | 2008-06-30 | 2008-06-30 | |
US12/489,535 US8708969B2 (en) | 2008-06-30 | 2009-06-23 | Safety device actuation system |
US14/226,061 US20140309618A1 (en) | 2008-06-30 | 2014-03-26 | Safety Device Actuation System |
Related Parent Applications (1)
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US12/489,535 Continuation US8708969B2 (en) | 2008-06-30 | 2009-06-23 | Safety device actuation system |
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US20140309618A1 true US20140309618A1 (en) | 2014-10-16 |
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US12/489,535 Active 2033-02-11 US8708969B2 (en) | 2008-06-30 | 2009-06-23 | Safety device actuation system |
US14/226,061 Abandoned US20140309618A1 (en) | 2008-06-30 | 2014-03-26 | Safety Device Actuation System |
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US12/489,535 Active 2033-02-11 US8708969B2 (en) | 2008-06-30 | 2009-06-23 | Safety device actuation system |
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EP (1) | EP2145641B1 (en) |
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US20140222009A1 (en) * | 2011-09-09 | 2014-08-07 | O.P.A. Medical. S.R.L. | Assembly for kyphoplasty procedures |
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US20140066894A1 (en) | 2010-09-10 | 2014-03-06 | C. R. Bard, Inc. | Self-Sealing Pad for a Needle-Based Infusion Set |
CA2806393A1 (en) * | 2010-09-10 | 2012-03-15 | C.R. Bard, Inc. | Systems for isolation of a needle-based infusion set |
US10525234B2 (en) | 2010-09-10 | 2020-01-07 | C. R. Bard, Inc. | Antimicrobial/haemostatic interface pad for placement between percutaneously placed medical device and patient skin |
AU2012335825B2 (en) | 2011-11-07 | 2017-02-16 | Safety Syringes, Inc. | Contact trigger release needle guard |
US9445790B2 (en) * | 2011-12-23 | 2016-09-20 | Medical Components, Inc. | Insertion device for providing fine needle aspiration and core biopsy |
WO2013140982A1 (en) * | 2012-03-21 | 2013-09-26 | テルモ株式会社 | Medical needle |
US9498580B2 (en) * | 2012-04-03 | 2016-11-22 | Alexander Werbickas | Hypodermic syringe apparatus having a needle guard assembly with shielding for protection from the needle after use |
WO2013173617A1 (en) | 2012-05-16 | 2013-11-21 | The Seaberg Company, Inc. | Safety needle |
US10765816B2 (en) | 2018-08-07 | 2020-09-08 | Gina DiGiacomo | Safety syringe and methods of making and using same |
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Also Published As
Publication number | Publication date |
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US20090326476A1 (en) | 2009-12-31 |
EP2145641A1 (en) | 2010-01-20 |
US8708969B2 (en) | 2014-04-29 |
EP2145641B1 (en) | 2013-11-27 |
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Legal Events
Date | Code | Title | Description |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |