WO2018089385A1 - Appareil de protection d'aiguille - Google Patents

Appareil de protection d'aiguille Download PDF

Info

Publication number
WO2018089385A1
WO2018089385A1 PCT/US2017/060468 US2017060468W WO2018089385A1 WO 2018089385 A1 WO2018089385 A1 WO 2018089385A1 US 2017060468 W US2017060468 W US 2017060468W WO 2018089385 A1 WO2018089385 A1 WO 2018089385A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
needle
proximal
riser
cylindrical portion
Prior art date
Application number
PCT/US2017/060468
Other languages
English (en)
Inventor
James D. Mitchell
Andrew A. THORESON
Original Assignee
Redsmith, Inc.
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 Redsmith, Inc. filed Critical Redsmith, Inc.
Publication of WO2018089385A1 publication Critical patent/WO2018089385A1/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
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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

Definitions

  • the present invention is directed, generally, to the field of vascular access and systems for performing venipuncture, arterial puncture, placement of a vascular line, and other such related procedures. More particularly, the present invention provides an apparatus for constraining a needle, or portions of a needle, to maintain integrity of the system before use, and prevent injury to oneself immediately prior to use in the medical patient.
  • cap All sharp medical devices used in contemporary medicine require the use of a mechanism to contain or constrain the sharp end, acting as a so-called "cap". Such cap is in place to prevent the accidental injury to oneself, or premature, unintended injury to the patient, prior to the device's intended use. The cap also maintains constraint of the device together as a unit during packaging and immediately prior to use.
  • Devices that comprise a cap as a component are typically those used for venipuncture or arterial access.
  • Venipuncture refers generally to a process of obtaining percutaneous access into a patient's vein for one of many potential applications, including, but not limited to, the infusion of fluids, medication, and blood products, and the like.
  • Such device could be used to aspirate blood samples for laboratory assessment and the like.
  • devices can be used to access the arterial system in a similar manner, with typical intended use for measurement of intravascular blood pressure monitoring and arterial blood gas measurement, amongst other less common applications.
  • sharp medical devices in the scope of the present discussion include, most typically, other needles, such as sutures, trocars, and other access needles.
  • an exemplar of a needle requiring a cap is the typical intravenous or "IV" access needle.
  • the needle is linear, and comprises a needle with sharp distal end, and a proximal receiving hub.
  • a "cap”, as indicated by the term, implies a member with a cavity closed on one end as to terminate the end of an elongate member. Said cap then receives an elongate member such as a needle intended for venipuncture.
  • a cap could be a semi-fixed elongate member having both open proximal and distal ends.
  • Such cap although an open member on both ends, is constructed in such a manner for the benefit of manufacture or ease of use and is of sufficient length as to constrain the length of the entire needle, and beyond the needle tip, to prevent inadvertent injury.
  • Exemplars of such double open needle caps are typically those needles of more appreciable length as seen in trocars and biopsy devices, amongst others.
  • a needle cap comprising a generally elongate member with an elongate cavity extending axially therein to receive and constrain a needle or other sharp device.
  • the cavity of the cap is constrained on its distal end to cover and protect the sharp end of the needle contained therein.
  • the proximal portion of the cap is open to receive the needle hub and remained fixed in place until desired cap removal.
  • the cap not only constrain an access needle, but also constrains the needle and an integrated device.
  • integrated device is represented in the present invention as a central venous catheter with preassembled, preloaded needle and disclosed in U. S. Ser. No. 15/008628 for Rapid Insertion Integrated Catheter and Method of Using an Integrated Catheter, which is incorporated herein by reference.
  • the cap could also be used to cover and constrain any other combination of needle and catheter as could be envisioned.
  • needle/catheter combinations include, but are not limited to a combination of needle and central venous catheter, midline or extended dwell peripheral intravenous catheter, peripherally inserted central catheter, peripheral intravenous (IV) line, or other vascular access device.
  • the present invention comprises an elongate tubular member that covers a substantial length of a needle or needle integrated with another device.
  • the needle cap may have a closed distal end, a partially closed distal end, or an open distal end so as to cover and/or protect the needle tip. It may be desirable for the distal tip to be vented to facilitate the sterilization processes during manufacturing of the device (i.e., allow gases to escape), while also effectively providing sufficient closure to prevent accidental needle injury.
  • the proximal end of the device is open to integrate and receive the hub of the access needle. The proximal end has a locking means to integrate with the needle hub and remain locked in place until the user detaches or reattaches said cap.
  • the locking means comprises one or more tabs oriented in a generally circumferential or arcuate arrangement around the periphery of the proximal open end. These tabs then integrate with the hub of the access needle. The tabs are separated by slots, providing the tabs having the appearance of separate leaves or petals. For the purposes of this specification, this will be referred to as a "petal configuration”. Said petals, themselves, are oriented in a generally radial configuration extending proximally from the open proximal end. [012] The petals provide for the locking means while integrating with the receiving portion of the needle hub.
  • the access needle is preferably integrated with another access device.
  • this preferred device we will refer to this preferred device as a central venous catheter (CVC).
  • CVC central venous catheter
  • the example given in this specification also includes a nonlinear needle that is integrated with the central line.
  • a linear needle it is in the scope of the present invention to utilize a linear needle.
  • the needle in the example takes an elongated S-shaped curvilinear course, beginning at the hub, bending slightly in one direction, and then the opposite, to reassume an all-together forward-oriented needle.
  • the needle cap is not completely linear in the example.
  • one skilled in the art could envision a cap of slightly varying shape from truly linear, and other designs having varying relationships between the cap opening and the other substantial portion of the needle barrel.
  • Figure 1 is a side perspective view showing the needle cap of the needle cover according to the present invention.
  • Figure 2 is a top plan view of the needle cap of Figure 1 ;
  • Figure 3 is a bottom plan view of the needle cap of Figure 1 ;
  • Figure 4 is a perspective view of the needle cap of Figure 1 ;
  • Figure 5 is a proximal end view of the needle cover
  • Figure 6 is a side perspective view of the needle cover in a locked position with the needle and integrated central line;
  • Figure 7 is a perspective view of a catheter with the needle cap thereon;
  • Figure 8 is a side elevational view of the needle cap connected to a needle hub
  • Figure 9 is a side elevational view, partially broken away, of the needle cover.
  • Figure 10 is a perspective view, partially broken away, of the needle cover.
  • proximal is used to refer to the end of the member or device closest to the practitioner using the member or device.
  • distal is used to refer to the end of the member or device in the direction of use of the device, such as the end for obtaining vascular access.
  • longitudinal axis refers to an axis extending between proximal and distal ends.
  • radial refers to a direction transverse to the longitudinal direction, at any angle.
  • the needle cap assembly 10 includes a needle cap body 21 having a medial cylindrical portion 1 land a tapered conical distal portion 12 defining a cap tip 14.
  • the medial cylindrical portion 11 has a predetermined diameter to accommodate the needle 19 and defines a proximal opening 24.
  • the medial cylindrical portion 11 is hollow and, together with the hollow tapered conical distal portion 12, defines a first cavity 22 configured for receipt of the access needle. As shown in Figure 1, the first cavity 22 has a longitudinal axis A.
  • the needle cap assembly 10 also includes cap riser 13 on its proximal end.
  • the cap riser 13 defines a cap opening 15 and has a width which is greater than the diameter of the medical cylindrical portion 11 as shown.
  • the needle cap 10 defines a second cavity 18 having a second longitudinal axis B configured for receipt of the integrated medical device 20, such as a medical device 20 including a needle hub 30.
  • the longitudinal axis A is offset from the longitudinal axis B to accommodate an integrated medical device wherein the needle hub 30 is received within the second cavity 18 of the cap riser 13 and the needle 19 is received within the first cavity 22 defined by the medial cylindrical portion 11 and conical portion 12.
  • the second cavity 18 is defined by the proximal cap riser opening 15 and cap riser distal wall 23.
  • the cap riser distal wall 23 is positioned distally to the medial portion opening 24. Together, the medial portion opening 24 and the cap riser proximal opening 15 form a substantially continuous opening. However, the first and second cavities 22, 18 are not substantially in open communication along lengths thereof.
  • a cap tip 14 terminates the distal end of the needle cap 10 at the distal end of the tapered conical portion 12 in order to completely cover the sharp tip of the needle 19.
  • distal cap tip 14 includes an open tubular portion of the cap that is sufficiently long to cover the needle and prevent inadvertent injury.
  • the cap riser opening 15 comprises a system of one or more petal tabs 16 that removably integrate with the needle hub 30 of needle 19.
  • our exemplary system comprises three petal tabs 16. The tabs are separated by tab slots 37.
  • the tabs 16 and slots 37 integrate with the needle hub 30 so as to slidably fit the needle hub 30. More specifically, a clipping action occurs with the slidable action so the needle cap 10 remains engaged with the needle 19 until removal. Such removal requires sufficient force to allow the petals 16 to unclip and/or expand radially outwardly from the needle hub 30. The remaining movement of the cap 10 removal is forward/distal sliding of the cap 10 to substantially expose the full length of the needle 19 and integrated device for its use. Should the device not be used, the cap can be replaced in a similar method of first slidably advancing the cap back over the sharp device and engaging the petal tabs to clip onto the hub once again.
  • cap device 10 for the intended use with a needle 19 that is integrated with another device.
  • the cap 10 requires a cap riser 13 to allow for the larger-sized and nonlinear preassembled needle-device.
  • the needle cap member 10 could altematively be straight to cover only a single linear needle, or comprise a different size or shape of the riser 13 to accommodate alternate devices.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un ensemble de capuchon d'aiguille pour protéger une aiguille d'accès utilisée avec un dispositif médical intégré. L'ensemble de capuchon d'aiguille comprend un corps de capuchon d'aiguille comportant une partie cylindrique médiane et une partie distale conique effilée. La partie cylindrique médiane et la partie distale conique effilée définissent une cavité configurée pour la réception de l'aiguille d'accès. Un élément d'élévation de capuchon est raccordé à la partie cylindrique médiane et comprend une cavité configurée pour recevoir le dispositif médical intégré.
PCT/US2017/060468 2016-11-08 2017-11-07 Appareil de protection d'aiguille WO2018089385A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662419444P 2016-11-08 2016-11-08
US62/419,444 2016-11-08

Publications (1)

Publication Number Publication Date
WO2018089385A1 true WO2018089385A1 (fr) 2018-05-17

Family

ID=62109279

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/060468 WO2018089385A1 (fr) 2016-11-08 2017-11-07 Appareil de protection d'aiguille

Country Status (1)

Country Link
WO (1) WO2018089385A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11517719B2 (en) 2019-09-24 2022-12-06 Bard Access Systems, Inc. Integrated acute central venous catheter and peripherally inserted venous catheter
US11819638B2 (en) 2020-05-21 2023-11-21 Bard Access Systems, Inc. Rapidly insertable central catheters including catheter assemblies and methods thereof
US11826526B2 (en) 2020-01-23 2023-11-28 Bard Access Systems, Inc. Splitable catheter docking station system and method
US11890429B2 (en) 2019-09-10 2024-02-06 Bard Access Systems, Inc. Rapidly inserted central catheter and methods thereof
US11918767B2 (en) 2020-04-23 2024-03-05 Bard Access Systems, Inc. Rapidly insertable central catheters including catheter assemblies and methods thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5163916A (en) * 1990-01-05 1992-11-17 Sherwood Medical Company Safety syringe with offset needle
US7108678B2 (en) * 2003-12-31 2006-09-19 Biotop Holding Co., Ltd. Captive cover for a hypodermic needle of an intravenous (IV) tube assembly
US20140012206A1 (en) * 2008-06-10 2014-01-09 Retractable Technologies, Inc. Medical Device with Sliding Frontal Attachment and Retractable Needle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5163916A (en) * 1990-01-05 1992-11-17 Sherwood Medical Company Safety syringe with offset needle
US7108678B2 (en) * 2003-12-31 2006-09-19 Biotop Holding Co., Ltd. Captive cover for a hypodermic needle of an intravenous (IV) tube assembly
US20140012206A1 (en) * 2008-06-10 2014-01-09 Retractable Technologies, Inc. Medical Device with Sliding Frontal Attachment and Retractable Needle

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11890429B2 (en) 2019-09-10 2024-02-06 Bard Access Systems, Inc. Rapidly inserted central catheter and methods thereof
US11517719B2 (en) 2019-09-24 2022-12-06 Bard Access Systems, Inc. Integrated acute central venous catheter and peripherally inserted venous catheter
US11826526B2 (en) 2020-01-23 2023-11-28 Bard Access Systems, Inc. Splitable catheter docking station system and method
US11918767B2 (en) 2020-04-23 2024-03-05 Bard Access Systems, Inc. Rapidly insertable central catheters including catheter assemblies and methods thereof
US11819638B2 (en) 2020-05-21 2023-11-21 Bard Access Systems, Inc. Rapidly insertable central catheters including catheter assemblies and methods thereof

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