1. Technical Field
The present disclosure relates to the field of medical needle assemblies for the administration and withdrawal of fluids to and from the body. More particularly, the present disclosure relates to safety needle assemblies having rigid wing structure to facilitate stabilization of the needle assemblies relative to the patient.
2. Background of Related Art
Hypodermic needles are used for venous access in a variety of medical procedures requiring fluid sampling, percutaneous medication injection, or other delivery to or withdrawal of fluid from a patient. Various intravenous needle assemblies are known which can generally include blood collection needles, infusion needles, hemodialysis needles, needles associated with blood collection bags, etc. Problems associated with the use of intravenous needle assemblies may include needlestick injury, stabilization of the needle relative to the patient, and ease of insertion and withdrawal of the needle from the patient.
Some of the health risks associated with hazardous needle exposure include HIV, hepatitis, and other blood-borne pathogens. Medical professionals are in danger of contracting such blood-borne pathogens from infected patients by inadvertent needle sticks from a contaminated needle employed during medical, dental, laboratory, etc. procedures.
Certain known intravenous assemblies, such as, for example, winged intravenous assemblies, are employed whereby a patient receives intravenous delivery of a fluid or a fluid collection procedure is performed. A needle is connected through a winged body of the assembly to an intravenous tube. The wings are typically flexible and are used to manipulate the assembly during insertion and withdrawal of the needle from the patient. Specifically, the wings are typically folded up and pinched between the thumb and forefinger of the user during insertion of the needle into the patient. The wings are also used to stabilize the assembly against the patient, and provide a surface area for taping, attachment, etc. to the patient to prevent movement of the assembly in relation to the patient. The winged intravenous assembly must be similarly manipulated to withdraw the assembly from the patient and dispose of it without creating a risk of needlestick injury to the medical personnel.
While the known intravenous needle assemblies typically employ flexible wings to assist in insertion and stabilization of the needle assembly relative to the patient, the dual nature of the flexible wings may not optimize the ability to safely insert the needle into the patient and securely stabilize the intravenous assembly relative to the patient once it has been inserted.
Therefore, it would be desirable to have an intravenous needle assembly having a dedicated rigid wing structure for stabilizing the needle assembly relative to the patient. It would additionally be desirable to have dedicated structure on the intravenous needle assembly to facilitate grasping by the user and aid in insertion and withdrawal of the needle from the patient. Additionally, it would be desirable to have an intravenous needle assembly whereby the needle itself maintains a relatively low-profile relative to the stabilizing wing and skin surface of the patient. Furthermore, it would be desirable to have a safety needle assembly which maintains the needle in an extended position until released by the operator and which retains the needle in a locked proximal position, contained within an associated housing, to prevent reuse and/or needlestick injury.
The presently disclosed safety needle generally includes an elongate housing and a hub movably mounted within the elongate housing. A hollow needle extends distally from the hub while a fluid tube extends proximally from the hub. The disclosed safety needle includes a rigid wing extending longitudinally along the outer surface of the elongate housing and a dorsal fin. In one embodiment, the rigid wing includes a pair of side wings extending transverse to a longitudinal axis of the elongate housing in a first direction and the dorsal fin extends from the hub along an axis transverse to a longitudinal axis of the hub in a second direction. The dorsal fin facilitates insertion of the hollow needle into a patient and is movable longitudinally within a longitudinal slot formed in the elongate housing.
The safety needle further includes a release mechanism associated with the hub and the elongate housing. In one embodiment, the release mechanism includes a notch positioned distally of longitudinal slot and a flexible finger provided on the hub and movable into and out of the notch to secure and release the hub relative to the elongate housing. In one embodiment, the flexible finger is provided with a finger pad to facilitate movement of the flexible finger into and out of the notch.
In one embodiment, the safety needle includes lockout structure to secure the hub in a proximal most position with the needle contained within the elongate housing. The lockout structure includes at least one projection extending into a space defined by the slot at a location adjacent the proximal end of the slot. The hub includes a projection movable within the slot, for example the flexible finger, which can be retracted proximally beyond the projection and is retained within a proximal most position within the slot by the projection.
There is also disclosed a safety needle device having an elongate housing and a hub movably mounted within the elongate housing. A needle extends distally of the hub. In this embodiment, a finger gripping surface is provided on a proximal end of the elongate housing to facilitate insertion of the needle within the patient. The elongate housing is provided with a longitudinally extending slot and, in one embodiment, a first portion and a second portion of the finger gripping surfaces are provided on opposed sides of the slot. The finger gripping surfaces are ribbed to provide secure control of the elongate housing by the fingers of the user. The finger gripping surfaces extend around a portion of the periphery of the proximal end of the elongate number.
In one embodiment, the disclosed safety needle includes an elongate housing and a hub movably mounted within the elongate housing. A needle extends distally from the hub and a rigid wing is provided on an outer surface of the elongate housing. A finger gripping surface is provided on a proximal end of the elongate housing to facilitate manipulation of the safety needle. The housing has and a longitudinally extending slot and a portion of the finger gripping surface is provided on either side of the longitudinally extending slot. In one embodiment, the finger gripping surfaces are ribbed.
In a particular embodiment, the rigid wing extends longitudinally along an outer surface of the elongate member. In another embodiment, the rigid wing extends transversely to the longitudinal axis of the elongate member. In this embodiment, the rigid wing includes a pair of generally rectangular wings extending transversely to a longitudinal axis of the elongate member.
In the disclosed embodiments, at least a portion of the hub is transparent to view the flow of fluids therethrough.
Various embodiments of the presently disclosed safety needle are disclosed herein with reference to the drawings, wherein:
Embodiments of the presently disclosed manually retracted safety needle device having a rigid wing structure will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to a position or location on a device closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to a position or location on a device further away from the user.
Rigid wing structure 22 includes at least one rigid wing which extends perpendicularly to a longitudinal axis of elongate housing 12. As shown in
As noted above, during the insertion of prior art safety needles into the arm of a patient, the operator typically grasps one or both of the flexible wings of the safety needle in order to hold the safety needle and advance the needle into the arm of the patient. The flexibility of the wing or wings may make it difficult to accurately position the needle within a vein. As further noted above, safety needle 10 is provided with rigid wing structure 22 to positively stabilize safety needle 10 on the arm of a patient. In order to advance needle 16 of safety needle 10 into the arm of the patient, safety needle 10 is provided with a dorsal fin or engagement member 30 which is configured to be gripped between the thumb and first finger of the operator in order to advance needle 16 into the arm of a patient. In this particular embodiment, dorsal fin 30 is formed on or attached to hub 14 (
In order to move hub 14 to advance needle 16 from elongate housing 12 and to retract needle 16 safely within elongate housing 12, elongate housing 12 is provided with a longitudinal slot 32 extending substantially the length of elongate housing 12. Dorsal fin 30 is movable within slot 32 to facilitate movement of hub 30 within elongate housing 12. A lockout structure is associated with slot 32 in order to secure dorsal fin 30 within a proximal most position within slot 32 and prevent reuse of safety needle 10. Specifically, a pair of projections 34a and 34b extend inwardly into slot 32. Projections 34a and 34b include angled edges 36a and 36b, respectively, which are configured to engage dorsal fin 30 as dorsal fin 30 is moved proximately within slot 32. Engagement of dorsal fin 30 with angled edges 36a and 36b spreads or forces slot 32 apart to allow dorsal fin 30 to pass proximally therethrough. Once dorsal fin 30 has moved to a proximal most position within slot 32, perpendicular edges 38a and 38b, on projections 34a and 34b respectively, prevent dorsal fin 30 from being moved distally within slot 32 thereby locking hub 18 and needle 16 safely within elongate housing 32 and preventing any further reuse of safety needle 10.
Referring now to
Safety needle 10 is also provided with a proximal finger gripping surface 54 which facilitates insertion of safety needle 10 into the arm of a patient and, more particularly, greatly facilitates the withdrawal of needle 16 of safety needle 10 from within the arm of the patient. Specifically, with reference to
Referring now to
As noted hereinabove, in one embodiment, flexible finger 42 is mounted on dorsal fin 30 at a pivot point 48. Pivot point 48 may be integral with flexible finger 42 and fin 30 in the form of a flexible or living hinge or, alternatively, flexible finger 42 and dorsal fin 30 may be separate structures connected at pivot point 48 by known pivotal connection means. Although dorsal fin 30 is illustrated as being formed on proximal portion 68 of hub 14, dorsal fin 30 may be positioned anywhere along the length thereof.
Referring now to
A particular advantage of the manually activated retraction mechanism of safety needle 10 is that, in the absence of a retraction spring provided within elongate housing 12, surgical needle 16 maintains a generally low-profile in relation to the arm of the patient. Specifically, the distance “d” between needle 12 and a bottom surface of rigid wing 24 is minimized. This allows insertion of needle 16 into the patient's arm at a relatively low angle of attack and allows rigid wing 24 to lay flatter against the arm of the patient thereby increasing stability of safety needle 10 as fluids are inserted or withdrawn from the arm of the patient. Additionally, the manual retraction of hub 14 and specifically needle 16 within elongate housing 12 allows the operator to control the rate of retraction of needle 16 to prevent any spilling of fluids and, more importantly, to control the position of needle 16 during the retraction of needle 16.
As also shown in
Referring for the moment to
Referring now to
Once the desired fluid transfer flow has been completed, proximal finger gripping surface 54, specifically first side 56 and second side 58, are grasped between the thumb and first finger of the user to draw safety needle 10 proximally and thereby remove needle 16 from the arm of the patient. Additionally, dorsal fin 30 may also be grasped to facilitate removal. In conjunction with, or subsequent to, the removal of needle 16 from the arm of the patient, flexible finger 44 may be biased proximally about pivot point 48 to draw projection 44 out of notch 46 in elongate housing 12. Further proximal pressure on flexible finger 44 will move dorsal fin 30 proximally within slot 32 thereby drawing hub 14 and needle 16 within elongate housing 12 to safely shield needle 16.
As dorsal fin 30 is moved to a proximal most position within slot 32, fin 30 engages angled edges 36a and 36b to spread apart slot 32 in the area of projections 34a and 34b to allow dorsal fin 30 to move into lockout zone 86 (
Referring now to
Similar to safety needle 10, safety needle 100 includes a dorsal fin 112 movable longitudinally within a slot 114 formed in elongate housing 102. Safety needle 100 also includes a release mechanism 116 provided adjacent a distal end 118 of slot 114 and lockout structure 120 provided at a proximal end 122 of slot 114. Release mechanism 116 and lockout structure 120 perform substantially identically to those described hereinabove with respect to safety needle 10.
Safety needle 100 further includes a finger pad 124 which is configured to receive the thumb of the user as safety needle 100 is grasped and needle 106 is inserted into the patient. Finger pad 124 provides an additional grasping surface on safety needle 100 to facilitate manipulation of safety needle 100.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the disclosed dorsal fins may be provided permanently affixed to the elongate housing of the safety needle and the flexible finger can be pivotally mounted directly to an associated hub. Further, the sizes and shapes of the disclosed rigid safety wings may be varied depending upon the intended application, such as, for example use in other areas of the body such as the leg, chest etc, or preferred holding method for a device. Additionally, alternative gripping structures may be provided along the length of the elongate housing to facilitate insertion and withdrawal of the needle from the body of a patient. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This patent application claims priority to U.S. Provisional Application Ser. No. 60/719,763, filed Sep. 22, 2005, which is incorporated herein in its entirety by reference.
Number | Name | Date | Kind |
---|---|---|---|
4170993 | Alvarez | Oct 1979 | A |
4183246 | Reynolds | Jan 1980 | A |
4326519 | D'Alo et al. | Apr 1982 | A |
4445893 | Bodicky | May 1984 | A |
4676783 | Jagger et al. | Jun 1987 | A |
4690675 | Katz | Sep 1987 | A |
4711636 | Bierman | Dec 1987 | A |
4747831 | Kulli | May 1988 | A |
4781692 | Jagger et al. | Nov 1988 | A |
4813426 | Haber et al. | Mar 1989 | A |
4820282 | Hogan | Apr 1989 | A |
4850961 | Wanderer et al. | Jul 1989 | A |
4863432 | Kvalo | Sep 1989 | A |
4900307 | Kulli | Feb 1990 | A |
4900311 | Stern et al. | Feb 1990 | A |
4973316 | Dysarz | Nov 1990 | A |
4994034 | Botich et al. | Feb 1991 | A |
5084030 | Byrne et al. | Jan 1992 | A |
5085639 | Ryan | Feb 1992 | A |
5088982 | Ryan | Feb 1992 | A |
5102394 | Lasaitis et al. | Apr 1992 | A |
5108376 | Bonaldo | Apr 1992 | A |
5114410 | Caralt Batlle | May 1992 | A |
5120320 | Fayngold | Jun 1992 | A |
5125414 | Dysarz | Jun 1992 | A |
5129884 | Dysarz | Jul 1992 | A |
5147327 | Johnson | Sep 1992 | A |
5176655 | McCormick et al. | Jan 1993 | A |
5188119 | Sunderland | Feb 1993 | A |
5188599 | Botich et al. | Feb 1993 | A |
5192275 | Burns | Mar 1993 | A |
5226894 | Haber et al. | Jul 1993 | A |
5232456 | Gonzalez | Aug 1993 | A |
5267961 | Shaw | Dec 1993 | A |
5273540 | Luther et al. | Dec 1993 | A |
5312359 | Wallace | May 1994 | A |
5318538 | Martin | Jun 1994 | A |
5330438 | Gollobin et al. | Jul 1994 | A |
5338303 | King et al. | Aug 1994 | A |
5376075 | Haughton et al. | Dec 1994 | A |
5385551 | Shaw | Jan 1995 | A |
5389076 | Shaw | Feb 1995 | A |
5395347 | Blecher et al. | Mar 1995 | A |
5407431 | Botich et al. | Apr 1995 | A |
5409461 | Steinman | Apr 1995 | A |
5423758 | Shaw | Jun 1995 | A |
5498241 | Fabozzi | Mar 1996 | A |
5501675 | Erskine | Mar 1996 | A |
5538508 | Steyn | Jul 1996 | A |
5549571 | Sak | Aug 1996 | A |
5554130 | McDonald et al. | Sep 1996 | A |
5562629 | Haughton et al. | Oct 1996 | A |
5562634 | Flumene et al. | Oct 1996 | A |
5573510 | Isaacson | Nov 1996 | A |
5575777 | Cover et al. | Nov 1996 | A |
5578011 | Shaw | Nov 1996 | A |
5591138 | Vaillancourt | Jan 1997 | A |
5632733 | Shaw | May 1997 | A |
5676658 | Erskine | Oct 1997 | A |
5695475 | Best, Jr. et al. | Dec 1997 | A |
5746215 | Manjarrez | May 1998 | A |
5779679 | Shaw | Jul 1998 | A |
5810775 | Shaw | Sep 1998 | A |
5928199 | Nakagami | Jul 1999 | A |
5931815 | Liu | Aug 1999 | A |
5951525 | Thorne et al. | Sep 1999 | A |
5954708 | Lopez et al. | Sep 1999 | A |
5997512 | Shaw | Dec 1999 | A |
6015438 | Shaw | Jan 2000 | A |
6056726 | Isaacson | May 2000 | A |
6080137 | Pike | Jun 2000 | A |
6090078 | Erskine | Jul 2000 | A |
6096005 | Botich et al. | Aug 2000 | A |
6179812 | Botich et al. | Jan 2001 | B1 |
6210371 | Shaw | Apr 2001 | B1 |
6221055 | Shaw et al. | Apr 2001 | B1 |
RE37439 | Firth et al. | Nov 2001 | E |
6494863 | Shaw et al. | Dec 2002 | B1 |
6517522 | Bell et al. | Feb 2003 | B1 |
6524276 | Halseth et al. | Feb 2003 | B1 |
6547762 | Botich et al. | Apr 2003 | B1 |
6572584 | Shaw et al. | Jun 2003 | B1 |
6582402 | Erskine | Jun 2003 | B1 |
6620136 | Pressly, Sr. et al. | Sep 2003 | B1 |
6641555 | Botich et al. | Nov 2003 | B1 |
6659984 | Maclean et al. | Dec 2003 | B2 |
6673047 | Crawford et al. | Jan 2004 | B2 |
6743186 | Crawford et al. | Jun 2004 | B2 |
6773419 | Crawford et al. | Aug 2004 | B2 |
6786875 | Barker et al. | Sep 2004 | B2 |
6835190 | Nguyen | Dec 2004 | B2 |
6860872 | Teichert | Mar 2005 | B2 |
6905478 | Ingram et al. | Jun 2005 | B2 |
6945960 | Barker et al. | Sep 2005 | B2 |
6969376 | Takagi et al. | Nov 2005 | B2 |
6972002 | Thorne | Dec 2005 | B2 |
6976976 | Doyle | Dec 2005 | B2 |
7037292 | Carlyon et al. | May 2006 | B2 |
20020099340 | Crawford et al. | Jul 2002 | A1 |
20020103465 | Crowford et al. | Aug 2002 | A1 |
20030040717 | Saulenas et al. | Feb 2003 | A1 |
20030078540 | Saulenas et al. | Apr 2003 | A1 |
20030083624 | Smith et al. | May 2003 | A1 |
20030093035 | Mohammed | May 2003 | A1 |
20030176842 | Wilkinson et al. | Sep 2003 | A1 |
20030199830 | Nguyen | Oct 2003 | A1 |
20030220619 | Polidoro et al. | Nov 2003 | A1 |
20040143195 | Bressler et al. | Jul 2004 | A1 |
20040193110 | Giambattista et al. | Sep 2004 | A1 |
20040267200 | Carlyon et al. | Dec 2004 | A1 |
Number | Date | Country |
---|---|---|
0 566 769 | Oct 1993 | EP |
1 221 300 | Jul 2002 | EP |
1 221 305 | Oct 2005 | EP |
04-180772 | Jun 1992 | JP |
2002-011098 | Jan 2002 | JP |
2002-210018 | Jul 2002 | JP |
2002-210018 | Jul 2002 | JP |
WO 0047256 | Aug 2000 | WO |
Entry |
---|
International Search Report (Form PCT/ISA/210 (first & second sheet) (Apr. 2005) for International Appln. No. PCT/US06/37278, filed Sep. 22, 2006. |
Office Action issued Jun. 11, 2012 from related Japanese Patent Application Serial No. 2008-532433, 1 pg. |
Office Action issued Aug. 16, 2012 from European Application No. 06804065.8, 5 pages. |
European Search Report dated Jul. 20, 2012 from European Application No. 06804065.8, 3 pages. |
English translation of Notice of Reasons for Rejection from corresponding Japanese Application No. 2011-286268 issued Feb. 18, 2013, 2 pages. |
English Translation of Decision on Dismissal of Amendment issued Mar. 29, 2013 in related Japanese Patent Application No. 2008-532433, 2 pgs. |
Number | Date | Country | |
---|---|---|---|
20070088262 A1 | Apr 2007 | US |
Number | Date | Country | |
---|---|---|---|
60719763 | Sep 2005 | US |