Bard Access Systems, Inc.

C. R. Bard, Inc.

Becton Dickinson and Company Limited

Eric W Lindekugel

Daniel B Blanchard

Amir Orome

Daniel Pett

Ralph Lee Sonderegger

Joe Spataro

Eddie K Burnside

Jeremy B Cox

Matthew W Bown

Kevin W Stinger

Jonathan Karl Burkholz

Marty Lee Stout

Jay Allen Muse

Christian W Crook

Daniel Housley

William Randy Barron

Mark A Christensen

Huy Ngoc Tran

Jeffrey Charles O'Bryan

Matthew J Prince

Jordan P Diamond

Rex A Ribelin

Charles L Farnworth

Paul D Morgan

Jeanette E Southard

John L Loewen

Thomas S Russell

Jeffrey C O'BRYAN

A catheter system may include a catheter assembly and a catheter delivery device. The catheter assembly may include a catheter adapter, which may include a catheter adapter distal end, a catheter adapter proximal end, and a catheter adapter lumen extending through the catheter adapter distal end and the catheter adapter proximal end. The catheter assembly may include a primary catheter extending from the catheter adapter distal end. The catheter delivery device may include a housing, which may include a housing distal end coupled to the catheter assembly, a housing proximal end, and a housing lumen extending through the housing distal end and the housing proximal end. A secondary catheter may be disposed within the housing. The secondary catheter may be configured to move distally through the catheter assembly in response to a fluid pressure provided by a fluid delivery device coupled to the housing proximal end.

Catheter delivery device and related systems and methods

An intraosseous access device can include a constant-torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft configured to provide intraosseous access to a medullary cavity of a patient. A method of using an intraosseous access device can include inserting a distal end of the intraosseous needle through skin at an insertion site of a patient and applying a contacting force to a bone beneath the insertion site with the distal end of the intraosseous needle. The contacting force can initiate a winding of a metal ribbon of the constant-torque spring assembly from an output spool onto a storage spool, thereby initiating drilling rotation of the intraosseous needle. The method can further include drilling through the bone until the intraosseous needle enters a medullary cavity of the patient.

Constant-torque intraosseous access devices and methods thereof

A magnetizing system for use in selectively magnetizing a needle of a medical device is disclosed. Once magnetized, the needle can be tracked by a needle guidance system, which assists the clinician placing the needle by visualizing on a display the position and orientation of the needle after its insertion into a body of a patient. An orientation key system is included with the magnetizing system to ensure the needle is positioned correctly in the magnetizing system. This in turn ensures that the needle is properly magnetized so as to be accurately tracked by the needle guidance system. In one embodiment a first key is included with the magnetizing system and configured to cooperatively mate with a second key included with the needle of the medical device. Various types of keys are disclosed herein.

Magnetizing system for needle assemblies

Push activated intraosseous (IO) access devices include replaceable and rechargeable or non-rechargeable battery packs, or spring driven devices. Intraosseous access devices often require training to ensure correct placement of the access device. The disclosed devices include an intuitive operation with a unidirectional activation and drive force application. The trigger can be both activated and deactivated automatically to prevent premature activation and prevent 'backwalling'. The device can include various indicators to further guide a user in placing the device correctly, with little or no training. Devices can further include replaceable battery packs to ensure a full charge is available when the device is used, and to provide a multi-use device that requires less storage.

Reusable push-activated intraosseous access device

Devices and methods for an autovance intraosseous device. The autovance intraosseous device can include a trigger activated system or pressure activated system that causes a needle to advance distally for a predetermined distance. The predetermined distance ensures a needle tip extends through the bone cortex, to access the medullary cavity, without penetrating a far wall of the medullary cavity. The advancement can be driven by a spring based system or an electric motor.

Autovance feature of an intraosseous device

Apparatus and methods for a flexible obturator for use with an access assembly of an intraosseous device are disclosed. The flexible obturator can include elastic properties and relatively low columnar strength, relatively low shear strength, and/or relatively high compressive strength. When the obturator is supported in the needle, the obturator can prevent bone fragments and tissue from blocking the needle lumen. When removed from the needle, the obturator can deform under a force to prevent accidental needle stick injuries. The flexible obturator can define a radially symmetrical profile and can conform to the inner profile of the needle lumen. The flexible obturator can extend beyond a distal tip of the needle and be trimmed flush to a beveled surface of the needle. This simplifies the manufacturing process, allowing a single size obturator to be fitted to multiple sizes of needle.

Flexible intraosseous obturator

Embodiments disclosed herein are directed to apparatus and methods for a stepped needle for an intraosseous device that uses the outer surface of the bone cortex as a reference point. Since the thickness of the bone cortex does not vary significantly between patients, the accuracy of needle placement can be improved. The device includes a needle with a stepped increase in outer diameter disposed along the needle shaft. The abrupt change in outer diameter provides a substantial increase in insertion force. In embodiments, the stepped increase prevents any further insertion into the bone cortex. Embodiments include a tapered needle lumen for medullary access confirmation and an overtube that is rotatably and slidably engaged to protect surrounding tissues and prevent needle stick injuries. Further, a needle hub can be rotatable or slidable, and can transition an overtube to an extended position to prevent accidental needle stick injuries.

Step needle for intraosseous access device

Disclosed herein are medical device systems, and methods thereof, for automatically detecting access to a medullary cavity. Embodiments include intraosseous access systems with sensing obturators, configured to detect a change in modality, e.g. pressure, oxygen saturation, electrical impedance, etc. at a distal tip thereof. Signals can be transmitted to a control logic that can modify the activation of a driver in response. Signals can be transmitted by way of wired or wireless communication. In an embodiment, signals can be transmitted through conductive polymer material that forms the obturator and allows the obturator to be flexible enough to mitigate accidental needle stick injuries.

Intraosseous device including a sensing obturator

An ultrasound probe assembly includes an ultrasound probe, an ultrasound cap, a solid hydrogel component, and a cover. The ultrasound probe can include a probe head and an orientation indicator. The probe head includes an acoustic surface. The ultrasound cap can include an opening defined by an opening perimeter, and a base configured to support a removable needle guide. The base can be aligned with the orientation indicator. The solid hydrogel component can include a probe-contacting side contacting the acoustic surface, a skin-contacting side extending through the opening, and an outer perimeter larger than the opening perimeter. The cover can be configured to cover the hydrogel component and at least a portion of the ultrasound cap.

Support and cover structures for an ultrasound probe head

Disclosed herein are push activated intraosseous (IO) access devices, and methods thereof. Embodiments include replaceable and rechargeable or non-rechargeable battery packs, or spring driven devices. Intraosseous access devices often require training to ensure correct placement of the access device. Users must coordinate the opposing actions of pulling proximally on a trigger, while applying sufficient distal drive force to penetrate the bone. Devices disclosed herein include an intuitive operation with a unidirectional activation and drive force application. Further the trigger is both activated and deactivated automatically to prevent premature activation and prevent 'backwalling'. The device includes various indicators to further guide a user in placing the device correctly, with little or no training. Devices further include replaceable battery packs to ensure a full charge is available when the device is used, and to provide a multi-use device that requires less storage.

An intraosseous access device can include a device body, a trocar needle, and an intraosseous catheter removably disposed on the trocar needle. The device body can be configured to enable a user of the access device to manually insert a distal tip of the trocar needle through a skin surface of a body of a patient to an external surface of a bone of the patient. The intraosseous access device can include a first advancement member configured to provide a first distal advancement force sufficient to distally advance a distal tip of the trocar needle and the catheter through a skin surface to an external surface of a bone of a patient, and a second advancement member configured to provide a second distal advancement force sufficient to distally advance the distal tip of the trocar needle and the catheter through the external surface of the bone.

Intraosseous access device

Constant-torque intraosseous access devices and methods thereof are disclosed. An intraosseous access device can include a constant-torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft configured to provide intraosseous access to a medullary cavity of a patient. A method of such an intraosseous access device can include inserting a distal end of the intraosseous needle through skin at an insertion site of a patient; applying force to bone at the insertion site with the distal end of the intraosseous needle, which starts winding a metal ribbon of the constant-torque spring assembly from an output spool onto a storage spool, thereby starting rotation of the intraosseous needle; and drilling through the bone until the intraosseous needle enters a medullary cavity of the patient, thereby achieving intraosseous access with the intraosseous access device.

Disclosed herein are intraosseous access devices having various operating mechanisms, as well as methods of the intraosseous access devices. For example, an intraosseous access device includes, in some embodiments, a constant-torque spring assembly, a drive shaft, an intraosseous needle, and an interlock mechanism. The constant-torque spring assembly is disposed in a housing, and the drive shaft extends from the housing. The drive shaft is coupled to the constant-torque spring assembly. The intraosseous needle is coupled to the drive shaft. The intraosseous needle is configured for drilling through bone and providing intraosseous access to a medullary cavity of a patient. The interlock mechanism is configured to prevent rotation of the intraosseous needle and the drilling therewith until the interlock mechanism is disengaged.

Growing community of inventors

Salt Lake City, UT, United States of America

Eric W Lindekugel