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Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination

 

The present invention is directed to the parenteral procurement of bodily-fluid samples. The present invention is also directed to systems and methods for parenterally procuring bodily-fluid samples with reduced contamination from dermally-residing microbes. In some embodiments, a bodily-fluid withdrawing system is used to withdraw bodily fluid from a patient for incubation in culture media in one or more sample vessels. Prior to withdrawing bodily fluid into the one or more sample vessels for incubation, an initial volume of withdrawn bodily fluid is placed in one or more pre-sample reservoirs and is not used for the incubation in culture media.

Patent Number

US 8197420 - 6/12/2012

US 8231546 - 7/31/2012

US 8337418 - 12/25/2012

US 8647286 - 2/11/2014

US 8876734 - 11/4/2014

US 9855002 - 1/2/2018

US 9872645 - 1/23/2018

US 9861306 - 1/9/2018

US 9855001 - 1/2/2018

US 10028687 - 7/24/18

US 10028688 - 7/24/18

US 10052053 - 8/21/18

US 10045724 - 8/14/18

US 10028689 - 7/24/18

 

Fluid diversion mechanism for bodily-fluid sampling

 

An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Patent Number

US 8535241 - 9/17/2013

US 8864684 - 10/21/2014

US 9060725 - 6/23/2015

US 9060724 - 6/23/2015

US 9022950 - 5/5/2015

US 9022951 - 5/5/2015

US 9204864 - 12/8/2015

US 10039483 - 8/7/2018

AU 2013267448 - 9/7/2017

CN ZL20130040468.7 - 12/8/2017

EP 2854643 - 11/30/2016

EP 3173021 - 5/31/2017

JP 6242386 - 11/17/2017

GB 2521787 - 5/9/2018

 

Sterile Bodily-Fluid Collection Device and Methods

An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.

Patent Number

US 2014/0155782 - 6/5/2014

CN ZL201380072185.0 - 12/8/2017

EP 2928375 - 1/31/2018

JP 6335186 - 5/11/2018

Apparatus and Methods for Disinfection of a Specimen Container

An apparatus includes a fluid reservoir, a sterilization member, and a transfer adapter. The sterilization member operably couples to the fluid reservoir. The sterilization member is configured to be transitioned between a first configuration, in which the sterilization member obstructs an inlet surface of the fluid reservoir and maintains the inlet surface in a substantially sterile environment, and a second configuration, in which the inlet surface is unobstructed. The transfer adapter is configured to be placed in fluid communication with a portion of a patient. The transfer adapter is configured to move relative to the sterilization member from a first position to a second position such that a surface of the transfer adapter contacts the sterilization member to transition the sterilization member to the second configuration. The fluid reservoir is placed in fluid communication with the transfer adapter when the transfer adapter is in the second position.

Patent Number

US 9950084 - 4/24/2018

US 10123783 - 11/13/2018

Devices and Methods for Verifying a Sample Volume

A system for verifying a sample volume includes a sample reservoir and a volumetric verification device. The sample reservoir defines an inner volume and is configured to receive a volume of bodily fluid. The inner volume of the sample reservoir contains an additive. The volumetric verification device includes a first indicator and a second indicator. The volumetric verification device is configured to selectively engage the sample reservoir to (1) place the first indicator in a first position along a length of the sample reservoir such that the first indicator is substantially aligned with a surface and/or meniscus of the additive and (2) place the second indicator in a second position along the length of the sample reservoir such that the second indicator is substantially aligned with a predetermined fill volume when bodily fluid is transferred to the inner volume.

Patent Number

US 2016/0324454 - 11/10/2016

Methods and Apparatus for Selectively Occluding the Lumen of a Needle

A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

Patent Number

US 9788774 - 10/17/2017

US 9788775 - 10/17/2017

CN ZL201480013879.1 - 5/29/2018

EP 2967462 - 10/17/2018

JP 2016-511083 - 4/14/2016

Bodily-Fluid Sampling Device

Patent Number

US D731643 - 6/9/2015

US D794779 - 8/15/2017

CA 150682 - 6/9/2014

CA 156721 - 6/9/2014

CA 156722 - 6/9/2014

CA 156724 - 6/9/2014

Patent Number

CA 156723 - 6/9/2014

EM 001368104-0001 - 7/10/2013

EM 001368104-0002 - 7/10/2013

EM 001368104-0003 - 7/10/2013

EM 001368104-0004 - 7/10/2013

EM 001368104-0005 - 7/10/2013

 

Syringe-based fluid diversion mechanism for bodily fluid sampling

 

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

Patent Number

US 9155495 - 10/13/2015

US 9999383 - 6/19/2018

EP 2925228 - 9/26/2018

JP 6329965 - 4/27/2018

Systems and methods for delivering a fluid to a patient with reduced contamination

 

An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

Patent Number

US 9149576 - 10/6/2015

US 9931466 - 4/3/2018

EP 2906269 - 1/3/2018