A needle guidance system includes a patient imaging system, such as an ultrasound guidance system (UGS) combined with a needle tip location system (TLS). The UGS defines a needle pathway to access an epidural/ spinal space and overlays the pathway onto a live or frozen ultrasound image. The TLS magnetically determines a magnetic distal tip location of the needle including a depth with respect to a magnetic field sensor placed on the patient. A distal tip image overlayed atop the ultrasound image at a determined distal tip location. The UGS identifies the epidural/ spinal space including a depth thereof within the ultrasound image. The UGS determines that the distal tip is located within the epidural/ spinal space when the depth of the distal tip equals the depth of the epidural/ spinal space. A probe securing apparatus secures an ultrasound probe of the UGS to the patient.
Rapidly insertable central catheters ("RICCs"), RICC insertion assemblies, and methods are disclosed. RICC insertion assembly includes a RICC (100), an introducer (132), and an access guidewire (208). An introducer needle includes a needle shaft having a longitudinal gap extending from a proximal portion of the needle shaft through a needle tip. An introducer sheath includes a splittable sheath hub coupled to a splittable sheath body. The introducer sheath is disposed over the introducer needle with the sheath body sealing the needle shaft for drawing a vacuum through the introducer needle. The access guidewire (208) extends along an entirety of a primary lumen of the RICC, through a splittable valved port of the sheath hub, along a sheath body-covered needle channel of the needle shaft, and to a location in the introducer proximal of the needle tip (144) in a ready- to-operate state of the RICC insertion assembly.
Rapidly insertable central catheters ("RICCs"), introducers, and insertion devices including combinations and methods thereof are disclosed. For example, a RICC system can include an introducer and a RICC insertion assembly including a RICC assembly disposed in a RICC insertion device. The RICC assembly can include a RICC, an access guidewire, and a splittable casing over a catheter tube of the RICC and the access guidewire forming a longitudinal composite. The RICC insertion device can include a frame and a nose cover forming a split channel that splits away from a through channel of a nose of the frame. The RICC insertion device can be configured for advancing the RICC assembly by rolling the longitudinal composite across roller wheels disposed in the frame. The through channel can be configured for advancing the catheter tube therethrough while the split channel can be configured for both splitting and passing the splittable casing therethrough.
Disclosed herein are magnetically trackable stylets and methods thereof. A magnetically trackable stylet can include a stylet body including a core wire, a magnetic assembly, and an outer construction over the core wire and the magnetic assembly. The magnetic assembly can include one or more magnetic field-producing elements disposed alongside the core wire in a magnetically trackable distal portion of the stylet body. The outer construction, which can be an overmolded layer, a reflowed layer, a potting layer, or a shrink- wrapped layer, can be around the core wire and the magnetic assembly. The stylet body can be configured to be disposed in a lumen of a medical device such as a catheter for magnetically tracking a tip of the medical device in vivo without breakage of the stylet body due to bending- related fatigue. A method of such a magnetically trackable stylet can include a method of using the stylet.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61M 25/01 - Introducing, guiding, advancing, emplacing or holding catheters
Disclosed are access systems, devices, and methods for internal access to a patient's body. For example, an access device for placing an acute dialysis catheter can include a frame; a housing, a pair of guidewire clamps, and a needle disposed on the frame; a dilator coupled to the frame, and an access guidewire in a ready-to-deploy state of the access device. The pair of guidewire clamps can be disposed on the frame between an end portion of the frame and a distal end of the housing for clamping the access guidewire. A needle hub of the needle can be disposed on the frame between the pair of guidewire clamps. The dilator can distally extend from the end portion of frame. A needle shaft of the needle can distally extend beyond a distal end of the dilator allowing the needle to establish an insertion site for the acute dialysis catheter.
Embodiments of catheter placement systems described herein include a temporary splittable sheath anchor (120), disposed on an outer surface of a needle (102). The splittable anchor moves with respect to the needle when accessing the vessel, allowing for a temporary anchor to be created as soon as venous access is confirmed via flashback. The clinician can advance the anchor over the needle once vessel access has been confirmed by flashback. The needle can then be removed without further insertion into the vessel, mitigating accidental trauma. The guidewire (170) can then be introduced through the anchor and advanced to a target location within the vasculature. The anchor can then be removed by splitting and withdrawing the anchor proximally. Embodiments further include a splittable advancement sheath (260) including a guidewire and configured to be drawn thorough a housing and split to allow the guidewire to separate from the advancement sheath and advance into the vasculature.
A needle (10) for accessing a vasculature of a patient is disclosed. The cannula (100) of the needle includes a fluid lumen (120) extending from the distal end to the proximal end and a guideway lumen (130) extending proximally away from the distal end. The guideway lumen is configured for placement of a guidewire therein, and the guideway lumen includes a guideway slot extending along a length of the guideway lumen, where the guideway slot (135) extends radially through a guideway-lumen wall and extends along the guideway lumen to the distal end. Also disclosed is a sheath (140) covering the cannula and the sheath includes a separable portion (141) through which guidewire may laterally pass. Also disclosed is a collar (960) rotatably positionable between a guidewire secure position and a guidewire release position.
A stylet for placing a catheter in a vasculature of a patient is disclosed. The stylet can include an ECG sensor assembly having an electrode, a magnetic assembly producing a magnetic field, a core wire and a coil defining a lumen. A portion of the core wire can be disposed within the lumen of the coil. An intravascular catheter is disclosed that includes the stylet disposed within a lumen of the catheter. A method of placing a catheter within a superior vena cava of a patient is provided, including inserting the stylet within a lumen of the catheter, connecting the ECG sensor assembly to an ECG system, advancing the catheter along a patient vasculature, discontinuing advancement of the catheter upon an indication via an ECG signal that a tip of the stylet is disposed within the superior vena cava, and removing the stylet from the lumen of the catheter.
Elongate blood flash flow paths can be detrimental to the operation of catheter placement systems by delaying the indication time, reducing the efficacy of the vacuum, or increasing the chance of clotting. Embodiments disclosed herein are directed to catheter placement systems with reduced blood flash fluid paths, including blood flash indicators having a proximally slidable syringe barrel and plunger that is fixedly attached to the system housing. By reversing the operation of the blood flash indicator syringe, the clinician maintains the advantages of a visual and tactile feedback while shortening the blood flow path between the needle tip and syringe barrel. Also disclosed is a needle interface structure configured to further shorten the blood flash fluid path.
Embodiments disclosed herein are directed to catheter placement systems including distally extendable support devices. When placing elongate catheters advanced insertion systems are required to maintain a "touch-free" insertion. Further longer needles are desirable to access deeper veins or penetrate deeper surface tissues. Distally extendable support devices provide columnar support to one of the elongate catheter or the needle to prevent buckling or kinking of the catheter, and maintain the needle tip within a predetermined bending arm distance. This prevents the user from contacting one of the needle or the catheter directly to provide additional support, maintaining a "touch-free" insertion.
Disclosed herein are rapidly insertable central catheters ("RICCs"), RICC assemblies, and methods thereof. A RICC includes a catheter tube (104), a suture wing (106) disposed over a medial portion of the catheter tube, a hub (108) coupled to a proximal portion of the catheter tube, and a number of extension legs (116) extending from the hub. The catheter tube includes a first section (126) in a distal portion of the catheter tube and a second section (128) proximal of the first section. The suture wing includes a projection (112) opposite a patient-facing side of the suture wing and a needle through hole (114) through the projection. The needle through hole is configured to accept a needle therethrough for insertion of the needle into a primary lumen of the catheter tube, which passes through a catheter-tube through hole through the suture wing. A method of the RICC can include using the RICC.
A section (100) is disclosed for use with a portion assembly (200). The section can include a solid core section (130) with a distal section (110, 131) having a first diameter, and a proximal section (120, 132) having a second diameter, wherein the second diameter can be greater than the first diameter. The section can include a coil (140) wound around the distal section of the solid core section. The proximal section can have a flexural stiffness that is less than a flexural stiffness of the distal section. A length of the distal section of the section may be shorter than the length of the portion. A length of the proximal section of the section may be longer than the length of the portion.
Guidewire 100 including a distal section 101, a proximal section 103 and a middle section 102 disposed between the distal section and the proximal section, wherein the middle section has a flexural stiffness that is greater than a flexural stiffness of both of the distal section and the proximal section. The distal section is configured for insertion into a vasculature of a patient. A diameter of the middle section may be greater than a diameter of the distal section. The guidewires may include a tapered distal transition portion disposed between the distal section and the middle section and a solid core wire extending a length of the guidewire, the solid core wire including a first diameter extending along the distal section, a second diameter extending along the proximal section, and a third diameter extending along the middle section, wherein the third diameter is greater than the first and second diameters.
Disclosed herein is a catheter (110), which includes a distal section (121) configured to enter a skin insertion site. The distal section (121) includes a tapered junction (124) having one or more dilation structures (123,130) configured to dilate the skin insertion site. The distal section (121) includes a distal portion extending from a distal end of the tapered junction (121), the distal portion having a diameter smaller than a proximal portion of the catheter.
A mechanical dilator 100 is disclosed, which can include a first arm 104A coupled to a second arm 104B by a fulcrum 116, the first arm and the second arm cooperatively defining a lock and stop mechanism configured to limit lateral movement of the first arm with respect to the second arm. The mechanical dilator can further include a dilator body 110 having a first side extending from the first arm and a second side extending from the second arm, where the fulcrum is configured to translate lateral movement of the first arm relative to the second arm to lateral movement of the first side relative to the second side.
Disclosed herein is a catheter placement system with a stiffening system and associated methods thereof. The catheter placement system can include a needle, catheter (e.g. rapid insertion central catheter), one or more guidewires, and a stiffening system, configured to place the catheter while containing portions of the catheter placement system that contact the patient within a sterile environment. Advantageously, the catheter placement system can provide all tools necessary for accessing a vasculature, dilating the insertion site and placing the catheter within a single device, mitigating repeated insertion of multiple tools and reducing the risk of introducing pathogens or the like. Further, the overall time required to place the catheter is reduced, reducing patient down time and improving patient outcomes.
Aspiration syringes and methods thereof are disclosed. An exemplary aspiration syringe can include a barrel, a plunger disposed in the barrel, and an aspiration mechanism. The aspiration mechanism can include a thumb-support member coupled to a distal portion of the barrel and a syringe housing slidably disposed around the barrel. The syringe housing can include a proximal portion coupled to a proximal portion of the plunger and a distal portion terminating with a flange incorporated into a finger-support member. The aspiration mechanism can be configured for withdrawing the plunger from the barrel as the finger-support member is slid over the barrel toward the thumb-support member. An example method of the foregoing aspiration syringe can include a fluid-aspirating step including aspirating fluid from a fluid-containing space with a single hand over a medial portion of the syringe by squeezing together the finger-support member and the thumb-support member.
Disclosed herein is a catheter placement system including a splittable needle and dilator. The system can include a housing having one or more flexible sections and a pleated section. A user can grasp an elongate medical device using the flexible sections and transition the housing pleated section between an extended and collapsed configuration to urge the elongate medical device proximally or distally. The system can also include a needle retraction mechanism configured to split the needle long a longitudinal axis and roll up the separate portions to allow one or more elongate medical devices to pass therebetween. The system can also include a dilator splitter configured to separate a dilator along a longitudinal axis and radially displace the dilator portions to allow one or more elongate medical devices to pass therebetween. Advantageously, the system can maintain the elongate medical device in a sterile environment, mitigating the introduction of pathogens.
A valve connector for a tunable valve is disclosed, with tunable features to allow for optimization. The tunable valve can include slits, which may be preferentially placed, angled and sized to optimize the crack pressure, maintenance pressures, and clearance characteristics of the connector. The tunable valve may also include a recess in the area of an exemplary center slit, which may be sized further modify the characteristics of the connector valve. The valve may be preferentially curved along either a lateral axis or a transverse axis. The tunable valve may be a proximal valve that is capable of being secured between proximal housing and distal housing. The proximal housing opening may be preferentially shaped.
Disclosed are two-piece rapidly insertable central catheter ("RICCs"), introducers, and methods. For example, an introducer and a distal catheter piece of a RICC can be combined in an introducer assembly configured to be actuated with a single finger of a hand while the introducer is held between a thumb and another finger or fingers of the same hand. A catheter-advancement hub of the introducer includes a manifold coupled to a proximal portion of a distal catheter-hub piece of the distal catheter piece. An introducer needle of a syringe of the introducer has a needle shaft extending through the manifold and a distal end of the distal catheter piece. An introducer housing is over a syringe tip, the manifold, and the proximal portion of the distal catheter piece. The introducer housing of the introducer configured to provide column strength to a catheter tube of the distal catheter piece during a venipuncture.
A two-piece catheter 100 includes a proximal catheter piece 102 and a distal catheter piece 110. The proximal catheter piece includes a proximal catheter-hub piece 104 and one or more extension legs 108. The distal catheter piece 110 includes a distal catheter-hub piece 112 and a catheter tube 114 including one or more catheter- tube lumens. The catheter tube is coupled to the distal catheter-hub piece by a proximal-end portion of the catheter tube. The two-piece catheter has a connected state in which the proximal catheter-hub piece is connected to the distal catheter-hub piece such that the one- or-more catheter-tube lumens are respectively fluidly connected to the one-or-more extension-leg lumens across a two-piece catheter hub.
Rapidly insertable central catheters ("RICCs") and methods are disclosed. A RICC (100) can include a first section (130) of a first polymeric material in a distal portion of a catheter tube, a second section (124) of a second polymeric material proximal of the first section, and a tapered junction therebetween (134). The first polymeric material has a first durometer. The second polymeric material has a second, lesser durometer. The junction is formed of the second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer. The first section has a proximal portion disposed in a receptacle of the junction. An abluminal surface of a distal portion of the junction smoothly transitions onto an abluminal surface of the proximal portion of the first section without an edge that catches on skin when the RICC is inserted into an insertion site of a patient.
Rapidly insertable central catheters ("RICCs") (102) including catheter assemblies (100) and methods thereof are disclosed. A RICC assembly (100) can include a RICC (102), an introducer (104), and a coupling system (106) configured to couple the RICC and the introducer together. A catheter tube (108) of the RICC includes a side aperture (116) in a distal-end portion of the catheter tube (108), which opens into an introducing lumen (124) extending to a distal end of the RICC (102). The introducer (104) includes an introducer needle (146) extending through the distal end of the RICC (102) when the RICC assembly (100) is in at least a ready-to-deploy state thereof. The introducer (104) is configured to be actuated with a single finger of a hand while holding a distal-end portion of the introducer (104) between a thumb and another finger or fingers of the hand. The coupling system (106) includes a distal coupler (186) slidably attached to the catheter tube (108) proximal of the side aperture (116).
A rapidly insertable central catheter (RICC) assembly 100 includes a RICC (102) and an introducer (106). The RICC includes a soft catheter tube (120) having an introducing aperture (104) that opens into a primary lumen of the RICC. The introducer includes an introducer catheter (132) including a hard catheter tube (134) having an introducing hole (140) that opens into a single lumen of the introducer catheter. When the RICC assembly is in a ready-to-deploy state thereof, the introducer catheter is disposed in the primary lumen of the RICC such that a distal end of the introducer catheter extends past a distal end of the RICC. In addition, an introducer needle (126) of the introducer is disposed in the introducer catheter through both the introducing aperture and the introducing hole such that a beveled tip of the introducer needle extends past the distal end of the introducer catheter.
A catheter assembly for organizing a catheter system is disclosed. The catheter assembly can include a molded hub, a catheter tube coupled to a distal end of the molded hub, a plurality of extension legs having distal ends coupled to the molded hub, and a securing mechanism. The molded hub can include a pair of hub lumens forming a hub portion of a pair of fluid pathways through the catheter assembly. The catheter tube can include a pair of catheter tube lumens. The securing mechanism can be configured to secure the plurality of extension legs together. The securing mechanism can be in the form of a slidable collar including a proximal opening and distal opening, wherein the slidable collar is positioned over the plurality of extension legs.
Rapidly insertable central catheters ("RICCs") including catheter assemblies are disclosed. For example, a RICC assembly includes a RICC (102) and an introducer (104). The RICC includes a catheter tube (106), a catheter hub (108), and one or more extension legs (110) coupled in the foregoing order. The catheter tube includes a side aperture (114) that opens into an introducing lumen that extends from at least the side aperture to a distal end of the RICC. The introducer includes a retractable-needle device (140), a syringe (142), and a coupling hub (144) that couples the retractable-needle device and the syringe together proximal of the side aperture in a ready-to-deploy state of the RICC assembly. The retractable-needle device includes an introducer needle (146). A needle tip in a distal- end portion of a shaft of the introducer needle extends beyond the distal end of the RICC when the RICC assembly is in the ready-to- deploy state of the RICC assembly.
Preloaded catheters are manufactured with a stylet, guidewire, or similar medical device disposed within the catheter, extending through a valve of the connector at a proximal end. During storage and transport, the stylet can remain in place for a prolonged period of time, which can cause stretching, indentations, and damage to the valve faces. These indentations can cause the valve leak, resulting in failure of the device as a whole. Embodiments disclosed herein are directed to devices and methods for preventing contact between the medical device and the valve faces, mitigating damage thereto.
Rapidly insertable central catheters ("RICCs") including catheter assemblies and methods thereof are disclosed. A RICC assembly (100) can include a RICC (102), an introducer (104), and a coupling system (106) configured to couple the RICC and the introducer together. A catheter tube (108) of the RICC can include a side aperture (114) in a distal-end portion of the catheter tube, which opens into an introducing lumen (118) extending from the side aperture to a distal end of the RICC. The introducer can include an introducer needle (128) having a cannula (138). The coupling system can include a distal coupler (146) slidably attached to the catheter tube proximal of the side aperture. The cannula extends through a longitudinal through hole of the distal coupler, through the side aperture of the catheter tube, along the introducing lumen of the catheter tube, and through the distal end of the RICC when the RICC assembly is in a ready-to- deploy state thereof.
Rapidly insertable central catheters (RICCs) including catheter assemblies and methods thereof are disclosed. A catheter assembly can include an introducer catheter, an introducer needle, and a RICC. The introducer needle can be disposed in an introducer-catheter lumen of the introducer catheter forming an introducer combination. The RICC can include a catheter tube including an introducing lumen with a number of lumens and a side opening through a side of the catheter tube. The introducing lumen extends from a proximal end of the catheter tube to a distal end of the catheter tube. The side opening opens into the introducing lumen in a distal-end portion of the catheter tube. The introducer combination can be disposed through the side opening, along the distal-end portion of the catheter tube within the introducing lumen, and through the distal end of the catheter tube for introducing the RICC into a blood vessel of a patient.
Rapidly insertable central catheters ("RICCs") including catheter assemblies are disclosed. A RICC assembly can include a RICC, an introducer (104), and a coupling system configured to couple the RICC and the introducer together. A catheter tube (108) of the RICC includes a side aperture (116) in a distal-end portion of the catheter tube, which opens into an introducing lumen extending from the side aperture to a distal end of the RICC. The introducer includes a syringe (144) and an introducer needle (143) having a cannula. The coupling system includes a distal coupler (172) slidably attached to the catheter tube proximal of the side aperture. The cannula extends through a longitudinal through hole of the distal coupler, through the side aperture of the catheter tube, along the introducing lumen of the catheter tube, and through the distal end of the RICC when the RICC assembly is in at least a ready-to-deploy state thereof.
Guidewire-management devices and systems thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the gui dewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.
Guidewire-management devices and systems thereof are disclosed herein. A guidewire- management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the gui dewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire- management device. The second sleeve can be proximal of the first sleeve in the guidewire- management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire.
A two-step rapid insertion central catheter ("RICC") system (100) that can include an introducer placement system (100), a docking station (200) and a catheter placement system (300). The introducer placement system can place an introducer (150) within a vasculature, which is supported by a docking station that detaches from a distal end of the introducer placement system. A catheter placement system can be configured to couple with the docking station, and a catheter can be advanced through the introducer into the vasculature. The introducer can then be split and retracted before the catheter placement system disengages the docking station. The docking station can be configured to split and disengage from the catheter. The RICC system can include a guidewire hub to prevent guidewire embolisms, collapsible sterile barriers to prevent contamination, and locking features to prevent premature advancement of guidewires, dilators and the like.
Diagnostic systems and methods including temperature-sensing vascular devices. A diagnostic system can include a catheter assembly for establishing vascular or other access within a body of a patient. The catheter assembly can be equipped with one or more sensors such as temperature sensors that enable monitoring of one or more physiological aspects of the patient, such as temperature, when a portion of the catheter assembly is disposed within the patient. The catheter assembly can be configured to transmit or otherwise forward data relating to the physiological aspects to another location, such as a console, a smartphone or another mobile device, a nurse station, a patient electronic medical record, etc. A method of the diagnostic system can include an instantiating step of instantiating in memory of the console a diagnostic process having one or more functions for at least processing temperature data from the catheter assembly.
Disclosed herein are wound-healing systems and methods thereof. A wound-healing system can include a wound dressing, a catheter-stabilization device, and an electrical- stimulation means for applying electrical stimulation to heal or protect at least a wound associated with a percutaneous insertion site of a patient. The wound dressing can be configured as an electrode for placement around the wound. The catheter-stabilization device can include an anchor pad and a retainer coupled to the anchor pad. The anchor pad can be configured to adhere to skin of the patient proximate the insertion site. The retainer can be configured to stabilize a catheter assembly while a catheter tube of the catheter assembly is disposed in the insertion site. The electrical-stimulation means can include an electrical power source and an external circuit between the catheter-stabilization device and the wound dressing for applying the electrical stimulation.
Rapidly insertable central catheters ("RICC") and methods thereof are disclosed. For example, a RICC can include a catheter tube, a suture wing disposed over a medial portion of the catheter tube, a hub coupled to a proximal-end portion of the catheter tube, and a number of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube and a second section proximal of the first section. The second section of the catheter tube can include an outer layer extruded over an inner layer such that an outer diameter of the catheter tube is larger in the second section than the first section of the catheter tube. The catheter tube can have a column strength sufficient to prevent buckling when the catheter tube is inserted into an insertion site and advanced through vasculature of a patient.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
Guidewire-management devices and methods thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire- management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire. Methods of the guidewire-management devices can include a method of using a guidewire-management device such as the foregoing guidewire-management device.
A61B 50/00 - Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
A61B 50/30 - Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
Rapidly insertable central catheters ("RICC") and methods thereof are disclosed. In an example, a RICC includes a catheter tube, a suture wing disposed over a medial portion of the catheter tube, a hub coupled to a proximal-end portion of the catheter tube, and a number of extension legs extending from the hub. The catheter tube can include a first section in a distal portion of the catheter tube formed of a first polymeric material having a first durometer. The catheter tube can also include a second section proximal of the first section of the catheter tube formed of a second polymeric material having a second durometer less than the first durometer. The catheter tube can have a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient without use of the Scldingcr technique.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
Rapidly inserted central catheters ("RICC") and methods thereof are disclosed. For example, a RICC can include a first section in a distal -end portion of a catheter tube, a second section in the distal -end portion of the catheter tube proximal of the first section of the catheter tube, and a junction joining the first and second sections of the catheter tube. The first section of the catheter tube can be formed of a first polymeric material having a first durometer. The second section of the catheter tube can be formed of a second polymeric material having a second durometer less than the first durometer. The first section of the catheter tube can have a proximal-end portion disposed in a receptacle of the junction and solvent bonded thereto. For example, a method can include a method of making or using a RICC.
A catheter assembly includes a peripheral intravenous ("PIV") portion that provides expedited vascular access. The catheter assembly includes an elongate catheter body defining a first lumen and includes a CVC portion, a transition portion, and a PIV portion. The PIV portion defines a relatively smaller diameter, a tapered tip, and a lumen configured to receive a needle. The needle extends through a needle access aperture, disposed through a side wall of the catheter body, through the PIV lumen, to a point beyond a distal end of the catheter body. A clinician accesses a vasculature using the needle and the PIV portion. The needle is then removed and a guidewire advanced through the lumen of the catheter body and the PIV portion into the vasculature. The CVC portion is then advanced over the guidewire into the vasculature, self-dilating the insertion site as the transition portion enters the vasculature.
Disclosed herein is an ultrasound system for accessing a vasculature of a patient. The ultrasound system is configured to depict an enhanced ultrasound image of a subcutaneous portion of the patient including an icon surrounding a target vessel depicted on the display. The icon indicates to a clinician the target vessel is within range of a percentage vessel occupancy or vessel purchase length depending on a size of cannula or angle of insertion. The icon can also indicate blood flow strength, vessel type, or vessel deformation. The enhanced image can further include cannula trajectory guidelines and visual alerts for the clinician if the cannula tip can potentially backwall the vessel. Additional icons can indicate obstructions disposed on the cannula trajectory.
Rapidly inserted central catheters ("RICC"), and methods thereof. A RICC can include a catheter tube including a first section in a distal-end portion of the catheter tube, a second section in the distal -end portion of the catheter tube proximal of the first section, and a junction between the first and second sections of the catheter tube. The first section of the catheter tube can be formed of a first material having a first durometer. The second section of the catheter tube can be formed of a second material having a second durometer less than the first durometer. The first and second sections of the catheter tube can have a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A guidance system for guiding insertion of a needle into a body of a patient utilizes ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of the internal body portion target, such as a blood vessel. The imaging device can be configured to provide at least one indication of status via sensory feedback based on a determined position of the needle, for example via a plurality of light-emitting diodes located on the device. One or more sensors can be included with the probe that can sense a magnetic field associated with the needle. The system may include a processor that can receive magnetic field data sensed by the at-least-one sensor to determine the position of the needle. The system can also include a display that depicts the determined position of the needle.
Shape-sensing systems and methods for medical devices. The shape-sensing system can include a medical device, an optical interrogator, a console, and a display screen. The medical device can include an integrated optical-fiber stylet having fiber Bragg grating ("FBG") sensors along at least a distal-end portion thereof. The optical interrogator can be configured to send input optical signals into the optical -fiber stylet and receive FBG sensor-reflected optical signals therefrom. The console can be configured to convert the reflected optical signals into plottable data for displaying plots thereof on the display screen. The plots can include a plot of curvature vs. time for each FBG sensor of a selection of the FBG sensors in the distal-end portion of the optical-fiber stylet for identifying a distinctive change in strain of the optical- fiber stylet as a tip of the medical device is advanced into a superior vena cava of a patient.
A61B 5/06 - Devices, other than using radiation, for detecting or locating foreign bodies
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
G01B 11/24 - Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures
G01L 1/24 - Measuring force or stress, in general by measuring variations of optical properties of material when it is stressed, e.g. by photoelastic stress analysis
46.
OPTICAL-FIBER CONNECTOR MODULES INCLUDING SHAPE-SENSING SYSTEMS AND METHODS THEREOF
Optical-fiber connector modules are disclosed. In one example, an optical -fiber connector module can include a receptacle disposed in a housing, a cable extending from the housing, and an optical fiber within at least the cable. The receptacle can be configured to accept insertion of a first plug for establishing a first optical connection between the optical-fiber connector module and an optical-fiber stylet of a medical device. The cable can include a second plug for establishing a second optical connection between the optical-fiber connector module and an optical interrogator. The optical fiber extends from the receptacle through the cable to the second plug. The optical fiber can be configured to convey input optical signals from the optical interrogator to the optical-fiber stylet and reflected optical signals from the optical-fiber stylet to the optical interrogator. Shape-sensing systems including the optical-fiber connector modules and methods of the foregoing are also disclosed.
Integrated tubing is disclosed including a tubing wall, one or more lumens, and a longitudinal bead of the integrated tubing including one or more optical fibers disposed therein. Each lumen of the one or more lumens is defined at least in part by the tubing wall. The longitudinal bead of the integrated tubing is between opposing sides of the tubing wall. A medical device is also disclosed including a catheter tube and an integrated stylet. The catheter tube includes a catheter-tube wall and one or more lumens of the catheter tube. Each lumen of the one or more lumens is defined at least in part by the catheter-tube wall. The integrated stylet includes one or more optical fibers. The catheter tube also includes a longitudinal bead between opposing sides of the catheter tube having the one or more optical fibers disposed therein. Method for manufacturing the foregoing are also disclosed.
A61B 1/00 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor
A61B 1/07 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
A microintroducer system including an introducer sheath coupled to a handle, the handle and introducer sheath defining a channel therethrough, and an adapter. The adapter includes a receiver tube having a predetermined angled portion, the receiving tube providing a pathway from a proximal opening to the channel of the microintroducer. The adapter can be integral with the microintroducer or separately attached. A separately attached adapter can include a spin nut or other attachment mechanism to couple the adapter to the microintroducer. The predetermined angled portion can include a plurality of curved portions to form, for example, a helical pathway. The microintroducer system can include a shape sensing stylet system. The predetermined angled portion of the adapter can provide a fiduciary point for calibrating the shape sensing stylet. As the stylet passes through the predetermined angled portion, an external device coupled to the stylet calibrates the deflection.
Embodiments disclosed herein are generally directed to blood flash detection systems and methods thereof. Embodiments include an indicator device including a needle and needle hub, defining a lumen and in fluid communication with a medical line. The needle hub includes a marker, such as an RFID tag, with electrodes extending to the lumen. When a fluid flow, for example blood, enters the lumen, an electrical connection between the electrodes is bridged, completing the circuit and activating the marker. The marker can then be responsive to an interrogation signal, and can provide a response signal. The response signal can be detected and interpreted by a detection device that indicates to a user that the vasculature has been accessed without the user directly observing the insertion site or the device.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
50.
PUNCTURING DEVICES, PUNCTURING SYSTEMS INCLUDING THE PUNCTURING DEVICES, AND METHODS THEREOF
Disclosed herein are puncturing devices and puncturing systems including the puncturing devices. Such puncturing devices and systems include those that sense a difference between venous blood and arterial blood as a function of blood oxygen, impedance, or pressure. As a result, the puncturing devices and systems are able to differentiate between a venipuncture and an arterial puncture. Methods of the puncturing devices and systems for differentiating between a venipuncture and an arterial puncture for are also disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 25/06 - Body-piercing guide needles or the like
51.
CATHETER SECUREMENT DEVICE INCLUDING EXTENDED ANCHOR PAD AND RELEASE LINER CLASPING FEATURES
Embodiments disclosed herein are directed to a securement device including a retainer defining a channel and at least one mounting wing extending therefrom. The mounting wing extends distally of an insertion site a skin surface adjacent to the insertion site to prevent "rocking" or "pistoning." The mounting wing further includes channels of reduced thickness configured to impart malleable properties on the mounting wing. This can allow the mounting wing to be shaped to fit different portions of the patient. The retainer further includes various locking and anti-rotational features to guide the catheter into position within the retainer and further prevent "rocking" or "pistoning." The securement device also includes a protective pad to inhibit abrasions from a medical line, spin nuts, and the like, and includes a clasping feature to retain a portion of the release liner to prevent obstructing ingress/egress of the catheter.
Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet.
A wound dressing device for use with a transcutaneous medical device such as a cannula or a catheter comprises a polyurethane matrix which may be covered with a film backing. Chlorhexidine di-gluconate and a polyanhydroglucuronic salt are contained in the polymer matrix. The wound dressing device prevents microbial colonization of the dressing and stops bleeding from the insertion site. The device provides combined haemostatic and antimicrobial effects at the insertion site but without adversely affecting wound healing.
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