WO2001023028A1 - Ensemble catheter et aiguille d'introduction a caracteristique double avec protection d'aiguille - Google Patents

Ensemble catheter et aiguille d'introduction a caracteristique double avec protection d'aiguille Download PDF

Info

Publication number
WO2001023028A1
WO2001023028A1 PCT/US2000/025541 US0025541W WO0123028A1 WO 2001023028 A1 WO2001023028 A1 WO 2001023028A1 US 0025541 W US0025541 W US 0025541W WO 0123028 A1 WO0123028 A1 WO 0123028A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
catheter
introducer needle
introducer
needle shield
Prior art date
Application number
PCT/US2000/025541
Other languages
English (en)
Inventor
Greg L. Brimhall
Steven W. Johnson
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Priority to AU75889/00A priority Critical patent/AU7588900A/en
Publication of WO2001023028A1 publication Critical patent/WO2001023028A1/fr

Links

Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • 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
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve

Definitions

  • the subject invention relates to a catheter and introducer needle assembly that includes a needle shield that will safely shield the sharp distal tip of the introducer needle after the needle has been used to insert the catheter into a patient.
  • IV catheters are used for infusing fluid, such as normal saline solution, various medicaments and total parenteral nutrition, into a patient or withdrawing blood from a patient.
  • Peripheral IV catheters tend to be relatively short, and are on the order of about one and one- half inches in length.
  • the most common type of IV catheter is an over the needle peripheral IV catheter.
  • an over the needle catheter is mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin.
  • the catheter and introducer needle assembly is inserted at a shallow angle through the patient's skin into a peripheral blood vessel, i.e a smaller blood vessel that is not connected directly to the heart but is one of the branches of the central blood vessels that is directly connected to the heart.
  • a peripheral blood vessel i.e a smaller blood vessel that is not connected directly to the heart but is one of the branches of the central blood vessels that is directly connected to the heart.
  • the clinician confirms that there is flashback of blood in the needle and in a flashback chamber located at the proximal end of the needle, which is typically formed as part of the needle hub. Once proper placement is confirmed, the clinician applies pressure to the blood vessel by pressing down on the patient's skin over the distal tip of the introducer needle and the catheter. This finger pressure occludes further blood flow through the introducer needle.
  • the clinician withdraws the introducer needle, leaving the catheter in place, and attaches a fluid handling device to the catheter hub.
  • a fluid handling device to the catheter hub.
  • the introducer needle is withdrawn from the catheter, it is a "blood contaminated sharp" and must be properly handled.
  • This concern has arisen because of the advent of currently incurable and fatal diseases, such as Acquired Immunosuppressive Deficiency Syndrome ("AIDS"), which can be transmitted by the exchange of body fluids from an infected person to another person. Thus, contact with the body fluid of an AIDS infected person must be avoided.
  • AIDS Acquired Immunosuppressive Deficiency Syndrome
  • an introducer needle has been used to place a catheter in the vein of an AIDS infected person, the introducer needle is a vehicle for the transmission of the disease.
  • clinicians are aware of the need to properly handle "blood contaminated sharps", unfortunately in certain medical environments, such as emergency situations or as a result of inattention or neglect, needlesticks with contaminated introducer needles still occur.
  • needle shields As a result of the problem of accidental needlesticks by "blood contaminated sharps", various needle shields have been developed. Generally, such needle shields work for their intended purpose but could be improved. For example, some needle shields are bulky, difficult to use or require special features or techniques to be operative.
  • the catheter and introducer needle assembly with needle shield of this invention includes a catheter having a distal end and a proximal end connected to the distal end of a catheter hub.
  • the introducer needle has a sharp distal tip and a proximal end connected to the distal end of a needle hub.
  • a flashback chamber is defined in the needle hub.
  • the catheter is coaxially disposed over the introducer needle so the sharp distal tip of the introducer needle is distal of the distal end of the catheter.
  • the introducer needle also defines, along a distal portion thereof, an enlarged diameter portion and a notch with a distally facing shoulder distal of the enlarged diameter portion.
  • the enlarged diameter portion cooperates with a needle shield to prevent unwanted proximal movement of the introducer needle with respect to the needle shield once the introducer needle has been withdrawn into the needle shield after use
  • the notch with its distally facing shoulder cooperates with the needle shield to prevent unwanted distal movement of the introducer needle once the introducer needle has been withdrawn proximally into the needle shield after use
  • the notch is distal of the enlarged diameter portion
  • the needle shield includes a main body portion defining a longitudinally extending passage through which the introducer needle extends
  • the needle shield also includes a means for engaging the distally facing shoulder of the notch of the introducer needle to prevent unwanted distal movement of the introducer needle once the introducer needle has been proximally withdrawn into the needle shield
  • the needle shield also includes a means for engaging the enlarged diameter portion of the introducer needle to prevent unwanted proximal movement of the introducer needle once the introducer needle has been proximally withdrawn into the needle shield
  • the means for engaging the distally facing shoulder of the enlarged diameter portion of the introducer needle and the means for engaging the enlarged diameter portion of the introducer needle is a tube located in the main body portion of the needle shield
  • the tube is coaxially located in the longitudinal passage of the main body portion and preferably includes at least two movable lanced protrusions or tabs that extend inwardly into the tube Because the tabs are movable, the enlarged diameter portion of the introducer needle can move proximally past the tabs Once the introducer needle has been withdrawn proximally into the needle shield past the enlarged diameter portion, one of the tabs drops into the notch such that the tab is distal of the distally facing shoulder of the notch In this way, any subsequent distal movement of the introducer needle will be prevented by the distally facing shoulder of the notch engaging the tab At least two tabs are used to allow the clinician to rotate the needle with respect the needle shield and the catheter and still ensure that one of the tabs will engage the notch
  • the tube also has a
  • the needle shield is sized so it can fit inside the catheter hub with a friction fit. This ensures that the needle shield remains engaged with the catheter until the introducer needle has been completely removed from the catheter and is safely shielded in the needle shield.
  • FIG. 1 is a perspective view of the catheter and introducer needle assembly with needle shield of this invention
  • FIG. 2 is an exploded perspective view of the catheter and introducer needle assembly with needle shield of this invention
  • FIG. 3 is an enlarged cross-sectional view of the needle shield located in the catheter hub with the sharp distal tip of the introducer needle located distal of the needle shield;
  • FIG. 4 is an enlarged cross-sectional view of the needle shield removed from the catheter hub with the enlarged diameter portion of the introducer needle engaged with the small diameter proximal portion of the tube preventing unwanted proximal movement of the introducer needle out of the needle shield;
  • FIG. 5 is an enlarged cross-sectional view of the needle shield similar to FIG. 4 but showing engagement of one of the tabs of the tube with the distally facing shoulder of the notch preventing unwanted distal movement of the introducer needle out of the needle shield;
  • FIG. 6 is a perspective view of the tube that is used to lock the introducer needle in the needle shield.
  • proximal refers to a location on the catheter and introducer needle assembly with needle shield of this invention closest to the clinician using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation.
  • distal refers to a location on the catheter and introducer needle assembly of this invention farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation.
  • the catheter and introducer needle assembly of this invention is identified generally by the numeral 10. It includes a catheter assembly 20 and an introducer needle assembly 30 that includes a needle shield 40.
  • Catheter assembly 20 includes a catheter 21 that has a proximal end, a distal end and a catheter hub 24 affixed to the proximal end of catheter 21.
  • Suitable materials for catheter 21 include, but are not limited to, thermoplastic resins such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), polyurethane and the like.
  • catheter 21 is formed from a thermoplastic hydrophilic polyurethane that softens with exposure to physiological conditions present in the patient's body.
  • Suitable materials for catheter hub 24 include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene and the like.
  • Catheter hub 24 may include a radially outwardly extending tab, not shown, which is useful for advancing catheter 21 into the patient's blood vessel.
  • Introducer needle assembly 30 includes introducer needle 31 having a sharp distal tip defined by bevel 32 and a proximal end connected to needle hub 34.
  • Introducer needle 31 is preferably formed from stainless steel.
  • Needle hub 34 can include an integrated flashback chamber 35. Needle hub 34 is preferably formed from the same types of materials that are used to form catheter hub 24.
  • Introducer needle assembly 30 also includes needle shield 40 which includes main body portion 41 and which in turn defines a longitudinally extending passage 42 having a proximal opening 43 and a distal opening 44. This allows introducer needle 31 to extend longitudinally through main body portion 41.
  • the diameter of main body portion 41 is approximately the same size as the diameter of the inside of catheter hub 24.
  • needle shield 40 is friction fitted inside catheter hub 24 so needle shield 40 can remain snugly fitted inside catheter hub 24. This way, needle shield 40 remains engaged with catheter hub 24 while introducer needle 31 is moved proximally until the sharp distal tip of introducer needle 31 is trapped inside needle shield 40.
  • Introducer needle 31 includes a notch 37 defining a distally facing shoulder 37a and an enlarged diameter portion 38.
  • Notch 37 is located distal of enlarged diameter portion 38.
  • enlarged diameter portion 38 is formed on introducer needle 31 by centerless grinding a larger diameter introducer needle.
  • the means for engaging distally facing shoulder 37a of notch 37 and the means for engaging enlarged diameter portion 38 of introducer needle 31 is a tube 50 located in needle shield 40.
  • tube 50 is formed from stainless steel, although other relatively rigid material that can be formed with a flexible portion can be used.
  • Tube 50 is press fit into needle shield 40 so that tube 50 is coaxially located in longitudinally extending passage 42.
  • Tube 50 includes at least one movable lanced tab 51 that extends inwardly into tube 50 and flanges 52 that flare outwardly from tube 50.
  • two such tabs 51 are formed on opposite sides of tube 50. This ensures that at least one of such tabs 51 engages notch 37 even if the clinician rotates introducer needle 31 with respect to needle shield 40.
  • tabs 51 are movable, enlarged diameter portion 38 can move past the proximal ends of tabs 51 as introducer needle 31 is withdrawn proximally into needle shield 40. Once introducer needle 31 has been withdrawn proximally into needle shield 40 such that tabs 51 are distal of distally facing shoulder 37a of notch 37, one of tabs 51 will extend into notch 37. Thus, any subsequent distal movement of introducer needle 31 will be prevented by the engagement of the proximal end of one of tabs 51 with distally facing shoulder 37a of notch 37.
  • Tube 50 also includes a proximal portion 55, which has a diameter that is smaller than the diameter of enlarged diameter portion 38.
  • the diameter of proximal portion 55 is large enough to allow the proximal portion of introducer needle 31 to pass therethrough.
  • main body portion 41 of needle shield 40 could be formed with a proximal opening having a diameter smaller than the diameter of enlarged diameter portion 38 to prevent enlarged diameter portion 38 from passing through proximal opening 43.
  • tube 50 is used as the needle shield without main body portion 41.
  • tube 50 is located in catheter hub 24 with flanges 52 engaging the inside of catheter hub 24 so tube 50 remains inside catheter hub 24 until the sharp distal tip of introducer needle 31 is safely trapped inside tube 50.
  • the clinician substantially longitudinally aligns introducer needle 31 and catheter 21 with the target blood vessel. Bevel 32 should be facing substantially away from the skin surface during venipuncture.
  • the clinician inserts introducer needle 31 and catheter 21 at a shallow angle, preferably less than about 35 degrees, into the skin so that the sharp distal tip of introducer needle 31 enters the target blood vessel.
  • the clinician will observe blood flashback in the flashback chamber of needle hub 34 if the venipuncture is successful.
  • the clinician After confirming placement of introducer needle 31 and catheter 21 in the target blood vessel, the clinician advances catheter 21 distally axially along introducer needle 31 into position in the blood vessel. After proper placement of catheter 31 is achieved, the clinician places a finger from her other hand on the patient's skin over the blood vessel approximately over distal end of catheter 31. By placing her finger on the patient's skin and applying sufficient pressure on the skin, the clinican thereby substantially occludes blood flow through catheter 31. The clinican then withdraws introducer needle 31 from catheter 21 by moving needle hub 34 proximally. This movement causes introducer needle 31 to move proximally into needle shield 40.
  • needle shield 40 remains engaged with catheter hub 24 until the sharp distal tip of introducer needle 31 is moved proximally into needle shield 40.
  • proximally directed force applied to needle hub 34 causes enlarged diamter portion 38 to engage proximal portion 55 and transmits enough force to needle shield 40 so that it becomes disengaged from catheter hub 24.
  • the sharp distal tip 32 is locked in needle shield 40.
  • the clinician may then attach any desired fluid handling device to catheter hub 24 and commence the planned treatment. Introducer needle 31 and needle shield 40 may then be disposed of according to the facility's disposal protocol.
  • a catheter and introducer needle assembly with needle shield is provided that is compact, simple and easy to use and that requires no special features or technique to be operative.

Abstract

La présente invention concerne un ensemble cathéter et aiguille d'introduction doté d'une protection d'aiguille, dans lequel l'aiguille comprend une partie à diamètre élargi et une encoche définissant un épaulement distalement opposé. La protection d'aiguille comporte un élément conçu pour entrer en contact avec l'épaulement distalement opposé de l'encoche de façon à prévenir tout mouvement distal non souhaité de l'aiguille une fois qu'elle a été rentrée dans sa protection. Cette dernière comporte également un élément servant à prévenir tout mouvement proximal non souhaité de l'aiguille une fois qu'elle a été rentrée dans sa protection.
PCT/US2000/025541 1999-09-24 2000-09-18 Ensemble catheter et aiguille d'introduction a caracteristique double avec protection d'aiguille WO2001023028A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU75889/00A AU7588900A (en) 1999-09-24 2000-09-18 Catheter and dual feature introducer needle assembly with needle shield

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/406,206 1999-09-24
US40620699A 1999-09-28 1999-09-28

Publications (1)

Publication Number Publication Date
WO2001023028A1 true WO2001023028A1 (fr) 2001-04-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/025541 WO2001023028A1 (fr) 1999-09-24 2000-09-18 Ensemble catheter et aiguille d'introduction a caracteristique double avec protection d'aiguille

Country Status (2)

Country Link
AU (1) AU7588900A (fr)
WO (1) WO2001023028A1 (fr)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004007013A1 (fr) * 2002-06-20 2004-01-22 Becton Dickinson And Company Procede et appareil de protection de l'embout d'une aiguille d'introduction de catheter
EP1731192A2 (fr) * 2005-05-27 2006-12-13 Becton, Dickinson and Company Catheter et ensemble d'aiguille d'introduction avec protection d'aiguille
EP2077133A1 (fr) * 2008-01-03 2009-07-08 Eastern Medikit Ltd. Cathéter intraveineux de sécurité avec serrure de pointe d'aiguille.
WO2010141290A1 (fr) * 2009-06-02 2010-12-09 Becton, Dickinson And Company Canule ayant un élément canule et un élément cran chevauchants
EP2366422A1 (fr) * 2005-03-30 2011-09-21 Access Scientific, Inc. Outil pour accès vasculaire
JP2013527005A (ja) * 2010-06-02 2013-06-27 スミス・メディカル・エイエスディ・インコーポレーテッド 安全カテーテルのための先端保護具
EP2617447A3 (fr) * 2001-04-30 2013-08-28 Injectimed, Inc. Protection de pointe d'aiguille pour aiguilles à injection percutanée
US9555221B2 (en) 2014-04-10 2017-01-31 Smiths Medical Asd, Inc. Constant force hold tip protector for a safety catheter
US9764117B2 (en) 2007-04-18 2017-09-19 Access Scientific, Llc Access device
US10010343B2 (en) 2013-03-15 2018-07-03 Access Scientific, Llc Vascular access device
US10136916B2 (en) 2010-02-08 2018-11-27 Access Scientific, Llc Access device
US10569059B2 (en) 2018-03-01 2020-02-25 Asspv, Llc Guidewire retention device
US11027099B2 (en) 2015-04-30 2021-06-08 Smiths Medical Asd, Inc. Vascular access device
USRE49056E1 (en) 2007-01-24 2022-05-03 Smiths Medical Asd, Inc. Access device

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991004761A1 (fr) * 1989-10-04 1991-04-18 Ryan Medical, Inc. Dispositifs medicaux a aiguilles ailees proteges
EP0554841A1 (fr) * 1992-02-07 1993-08-11 Becton, Dickinson and Company Dispositif d'introduction d'un cathéter avec protection d'aiguille
US5833670A (en) * 1994-04-20 1998-11-10 Noble House Group Protective device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991004761A1 (fr) * 1989-10-04 1991-04-18 Ryan Medical, Inc. Dispositifs medicaux a aiguilles ailees proteges
EP0554841A1 (fr) * 1992-02-07 1993-08-11 Becton, Dickinson and Company Dispositif d'introduction d'un cathéter avec protection d'aiguille
US5833670A (en) * 1994-04-20 1998-11-10 Noble House Group Protective device

Cited By (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2617447A3 (fr) * 2001-04-30 2013-08-28 Injectimed, Inc. Protection de pointe d'aiguille pour aiguilles à injection percutanée
EP2014328A1 (fr) * 2002-06-20 2009-01-14 Becton, Dickinson and Company Procédé et appareil pour protéger la pointe d'une aiguille d'introduction de cathéter
WO2004007013A1 (fr) * 2002-06-20 2004-01-22 Becton Dickinson And Company Procede et appareil de protection de l'embout d'une aiguille d'introduction de catheter
JP2005529719A (ja) * 2002-06-20 2005-10-06 ベクトン・ディキンソン・アンド・カンパニー カテーテル導入針の先端を遮へいするための方法および装置
EP2366422A1 (fr) * 2005-03-30 2011-09-21 Access Scientific, Inc. Outil pour accès vasculaire
US8657790B2 (en) 2005-03-30 2014-02-25 Access Scientific, Inc. Access device with blunting device
EP1731192A3 (fr) * 2005-05-27 2007-10-17 Becton, Dickinson and Company Catheter et ensemble d'aiguille d'introduction avec protection d'aiguille
US7635352B2 (en) 2005-05-27 2009-12-22 Becton, Dickinson And Company Catheter and introducer needle assembly with needle shield
EP1731192A2 (fr) * 2005-05-27 2006-12-13 Becton, Dickinson and Company Catheter et ensemble d'aiguille d'introduction avec protection d'aiguille
USRE49056E1 (en) 2007-01-24 2022-05-03 Smiths Medical Asd, Inc. Access device
US11291804B2 (en) 2007-04-18 2022-04-05 Smiths Medical Asd, Inc. Access device
US9764117B2 (en) 2007-04-18 2017-09-19 Access Scientific, Llc Access device
US10441752B2 (en) 2007-04-18 2019-10-15 Access Scientific, Llc Access device
EP2077133A1 (fr) * 2008-01-03 2009-07-08 Eastern Medikit Ltd. Cathéter intraveineux de sécurité avec serrure de pointe d'aiguille.
CN102458552A (zh) * 2009-06-02 2012-05-16 贝克顿·迪金森公司 具有重叠的插管特征部和切口特征部的插管
JP2012528681A (ja) * 2009-06-02 2012-11-15 ベクトン・ディキンソン・アンド・カンパニー 重なり合うカニューレフィーチャーおよびノッチフィーチャーを有するカニューレ
WO2010141290A1 (fr) * 2009-06-02 2010-12-09 Becton, Dickinson And Company Canule ayant un élément canule et un élément cran chevauchants
US10849651B2 (en) 2010-02-08 2020-12-01 Smiths Medical Asd, Inc. Access device
US11766277B2 (en) 2010-02-08 2023-09-26 Smiths Medical Asd, Inc. Access device
US10136916B2 (en) 2010-02-08 2018-11-27 Access Scientific, Llc Access device
JP2013527005A (ja) * 2010-06-02 2013-06-27 スミス・メディカル・エイエスディ・インコーポレーテッド 安全カテーテルのための先端保護具
US9555220B2 (en) 2010-06-02 2017-01-31 Smiths Medical Asd, Inc. Tip protector for a safety catheter
CN105169524A (zh) * 2010-06-02 2015-12-23 史密斯医疗Asd公司 用于安全导管的尖头保护器
US11369749B2 (en) 2010-06-02 2022-06-28 Smiths Medical Asd, Inc. Tip protector for a safety catheter
US10314984B2 (en) 2010-06-02 2019-06-11 Smiths Medical Asd, Inc. Tip protector for a safety catheter
US10682157B2 (en) 2013-03-15 2020-06-16 Asspv, Llc Vascular access device
US10010343B2 (en) 2013-03-15 2018-07-03 Access Scientific, Llc Vascular access device
US9555221B2 (en) 2014-04-10 2017-01-31 Smiths Medical Asd, Inc. Constant force hold tip protector for a safety catheter
US11027099B2 (en) 2015-04-30 2021-06-08 Smiths Medical Asd, Inc. Vascular access device
US11712543B2 (en) 2015-04-30 2023-08-01 Smiths Medical Asd, Inc. Vascular access device
US10569059B2 (en) 2018-03-01 2020-02-25 Asspv, Llc Guidewire retention device
US11738179B2 (en) 2018-03-01 2023-08-29 Smiths Medical Asd, Inc. Guidewire retention device

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