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
  • A61M25/09—Guide wires
  • A61M25/09041—Mechanisms for insertion of guide wires
• • 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
• • 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
  • A61M25/0097—Catheters; Hollow probes characterised by the hub
• • 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
  • A61M25/09—Guide wires
  • A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
• • 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
  • A61M25/065—Guide needles

Definitions

• embodiments disclosed herein are directed to a guidewire locking system for a Rapidly Inserted Central Catheter (RICC) placement system, and associated methods thereof.
• a catheter e.g. a RICC catheter
• a distal tip of a guidewire can reside within a needle lumen during venipuncture.
• the guidewire can be advanced into the vasculature to maintain patency of the access site.
• the needle can then be removed, preferably in such a way so as to leave the guidewire in place.
• Some RICC placement systems utilize a slotted needle including a sheath disposed thereover.
• a distal tip of the guidewire can remain in position within the vasculature and a portion of the guidewire can pass through the needle slot as the needle is withdrawn proximally.
• the sheath can cover the slot and maintain the integrity of the needle lumen, e.g. to prevent fluid leakage through the slot.
• the guidewire can tear the sheath.
• forces acting on the guidewire can dislodge the position of the distal tip within the vasculature.
• Embodiments disclosed herein are directed to a guidewire locking system configured to couple with a RICC catheter placement system and stabilize the guidewire in position as the needle is withdrawn proximally from the access site.
• a catheter placement system including, a needle supported by a needle hub and defining a needle lumen, a guidewire having a distal tip disposed within the needle lumen, a catheter disposed on a proximal portion of the guidewire, and a guidewire locking system including, a housing defining a needle lumen and a guidewire lumen communicating with the needle lumen and extending at an angle thereto, a portion of the needle extending through the needle lumen and a portion of the guidewire extending through the guidewire lumen, and a locking mechanism having a lock and a seal and transitionable between an unlocked position and a locked position, the locking mechanism in the locked position configured to inhibit axial movement of the guidewire through the guidewire lumen.
• the lock includes a collar threadably engaged with the housing and configured to urge the lock axially through the guidewire lumen as the lock is rotated about the axis of the guidewire.
• the collar includes a lever extending therefrom, perpendicular to an axis of the guidewire lumen.
• the catheter placement system further includes a peel pin extending through the seal and disposed at a junction between the guidewire lumen and an the needle lumen and configured to support the guidewire as the needle is withdrawn proximally from the needle lumen.
• the peel pin is formed integrally with the housing.
• the peel pin is formed as a separate structure and coupled with the housing using one of an interference fit, press-fit, snap-fit engagement, adhesive, bonding, or welding.
• the seal includes a seal slot extending longitudinally and communicating with one or both of the seal guidewire lumen and a seal needle lumen, the seal slot configured to allow the guidewire to pass therethrough when the locking mechanism is in the unlocked position.
• the lock includes a lock slot extending longitudinally and communicating with a lock lumen, the lock slot configured to align with the housing slot in the unlocked position and allow the guidewire to pass therethrough to disengage the guidewire locking system.
• the needle includes a guidewire aperture disposed in a side wall of the needle and configured to receive a portion of the guidewire therethrough, the needle also including a needle slot extending longitudinally between the guidewire aperture and a distal tip of the needle and communicating with a needle lumen, the needle slot configured to receive a portion of the guidewire therethrough as the needle is withdrawn proximally.
• the catheter placement system further includes a sheath encircling a portion of the needle and including a tear line extending longitudinally between a proximal end and a distal end of the sheath.
• the lock includes a compression piece rotatably coupled to a distal end of a rotation piece, the rotation piece configured to rotate about an axis of the guidewire lumen and urge the compression piece axially.
• the compression piece includes a rail extending from an outer surface thereof and configured to engage a recess disposed in an inner wall of the guidewire lumen to mitigate rotational movement of the compression piece while allowing axial movement thereof.
• the locking mechanism includes an actuator slidably engaged with the housing along an axis extending perpendicular to an axis of the guidewire lumen, the actuator transitionable between the locked and unlocked position.
• the locking mechanism includes a push-button mechanism having a first force applied in a first direction to transition the actuator from the unlocked position to the locked position and a second force also applied in the first direction to transition the actuator from the locked position to the unlocked position.
• a method of placing a catheter including, accessing a vasculature using a needle supported by a needle hub, advancing a guidewire through a needle lumen of the needle and into the vasculature, locking the guidewire using a guidewire locking system having a housing defining a needle lumen and a guidewire lumen communicating with the needle lumen and extending at an angle thereto, the housing releasably coupled to a distal end of the needle hub, disengaging the housing from the needle hub, withdrawing the needle proximally from the needle lumen of the housing, unlocking the guidewire stabilizing system to allow axial movement of the guidewire relative to the housing, disengaging the guidewire from the housing by sliding the guidewire through a housing slot disposed in a side wall of the housing, and advancing the catheter over the guidewire and into the vasculature.
• withdrawing the needle proximally further includes sliding a portion of the guidewire through a needle slot, from a guidewire aperture disposed in a side wall of the needle adjacent the needle hub, to a distal tip of the needle. In some embodiments, withdrawing the needle proximally further includes tearing a sheath along a tear line the sheath encircling a portion of the needle. In some embodiments, a distal tip of the guidewire is disposed within the needle lumen prior to accessing the vasculature.
• locking the guidewire further comprises, rotating a collar coupled to a lock and threadably engaged with the housing, advancing the lock axially through the guidewire lumen, and compressing a seal radially inwards to grip the guidewire extending therethrough and prevent axial movement of the guidewire relative to the housing.
• advancing the lock axially further includes compressing a portion of the seal radially inwards, the portion of the seal when the lock is advanced axially extending into a recess disposed at a distal end of the lock.
• rotating the collar includes rotating a rotation piece coupled thereto and urging a compression piece axially, the compression piece rotatably coupled to the rotation piece.
• the method further includes engaging a rail, extending from an outer surface of the compression piece, with a recess disposed in an inner wall of the guidewire lumen of the housing, to prevent the compression piece from rotating about an axis of the guidewire, while allowing the compression piece to slide axially relative to the axis of the guidewire.
• the collar includes a lever extending therefrom perpendicular to an axis of the guidewire.
• FIG. 1 A shows a perspective view of an exemplary RICC placement system, in accordance with embodiments disclosed herein.
• FIG. 1C shows a plan view of a needle of the RICC placement system of FIG. 1 A, in accordance with embodiments disclosed herein.
• FIG. 2A shows a cross-section view of a guidewire locking system, in accordance with embodiments disclosed herein.
• FIG. 2B shows a perspective view of a guidewire locking system in a locked position, in accordance with embodiments disclosed herein.
• FIG. 3A shows a perspective view of a guidewire locking system in a locked position, in accordance with embodiments disclosed herein.
• FIG. 4A shows a cross-section view of a guidewire locking system, in accordance with embodiments disclosed herein.
• FIG. 4B shows a lateral cross-section view of the guidewire locking system of FIG. 4A, in accordance with embodiments disclosed herein.
• FIG. 5 shows a cross-section view of a guidewire locking system, in accordance with embodiments disclosed herein. DESCRIPTION
• proximal portion or a “proximal end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near a clinician when the needle is used on a patient.
• proximal length of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient.
• proximal end of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient.
• the proximal portion, the proximal end portion, or the proximal length of the needle can include the proximal end of the needle, however, the proximal portion, the proximal end portion, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the needle is not a terminal portion or terminal length of the needle.
• a “distal portion” or a “distal end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near or in a patient when the needle is used on the patient.
• a “distal length” of, for example, the needle includes a length of the needle intended to be near or in the patient when the needle is used on the patient.
• a “distal end” of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient.
• the distal portion, the distal end portion, or the distal length of the needle can include the distal end of the needle, however, the distal portion, the distal end portion, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the needle is not a terminal portion or terminal length of the needle.
• FIGS. 1 A-1C show details of an exemplary Rapidly Insertable Central Catheter (RICC) placement system (“placement system”) 10 generally including a needle 20, a guidewire 30, a syringe system 40, and a RICC catheter 50.
• the RICC catheter 50 can generally include a catheter 52 supported at a proximal end by a catheter hub (“hub”) 60.
• the hub 60 can include one or more extension legs 62 extending proximally therefrom. Each extension leg 62 of the one or more extension legs can be in fluid communication with a lumen of the catheter 52.
• a syringe system 40 can draw a fluid flow proximally through a needle lumen 22 to observe a color and/or pulsatile flow and confirm correct vascular access.
• the guidewire 30 can then be advanced through the needle lumen 22 and into the vasculature to maintain patency of the insertion site.
• the needle 20 and syringe system 40 assembly can then be withdrawn proximally.
• a distal tip of the guidewire 30 can reside within the needle lumen 22 during venipuncture, which can expedite accessing the vasculature once venous access is confirmed and maintain patency of the insertion site.
• the needle 20 can include a slot 26 configured to facilitate removal of the needle 20 and syringe system 40 from the guidewire 30 while leaving the guidewire 30 in place, as described in more detail herein.
• FIGS. 1B-1C show further details of the slotted needle 20 of the RICC system 10.
• the needle 20 can define a lumen 22 and can be supported at a proximal end by a needle hub 28.
• the needle hub 28 can be coupled to the syringe system 40 and can provide fluid communication between the syringe system 40 and the needle lumen 22.
• the needle 20 can include a guidewire aperture 24 disposed in a side wall of the needle 20, adjacent the needle hub 28 and communicating with the needle lumen 22.
• the guidewire aperture 24 can be configured to receive a portion of the guidewire 30 extending therethrough and into to the needle lumen 22.
• the sheath 70 can include a tear line 72, extending longitudinally between the sheath guidewire aperture 74 and a distal end of the sheath 70.
• the tear line 72 can include a groove, score line, perforation, laser cut line, or similar line of weakness configured to allow the sheath 70 to separate therealong as the guidewire 30 is urged through the needle slot 26.
• the placement system 10 can further include a blade configured to cut the sheath 70 along the tear line 72 to facilitate disengaging the guidewire 30 from the needle 20.
• the needle 20 can be withdrawn proximally.
• a portion of the guidewire 30 can pass through the slot 26 from the guidewire aperture 24 to a distal end of the needle 20.
• the guidewire 30 can tear the sheath 70 along the tear line 72 allowing the guidewire 30 to separate from the needle 20 and sheath 70 assembly.
• various apparatus and methods of removing the needle 20 while leaving the guidewire 30 in place within the vasculature are contemplated to fall within the scope of the present invention. Further details and embodiments of such systems can be found in U.S. Patent Application No. 17/746,113 filed May 17, 2022, and U.S. Patent Application No. 17/883,490 filed August 8, 2022, each of which is incorporated by reference in its entirety into this application.
• the guidewire locking system 100 can generally include a housing 110 defining a needle channel 112 and a guidewire channel 114.
• the guidewire channel 114 can communicate with the needle channel 112 and extend at an angle therefrom.
• the needle channel 112 can be configured to receive a portion of the needle 20 therethrough.
• the guidewire aperture 24 of the needle 20 can align with the guidewire lumen 114.
• the guidewire 30 can extend through the guidewire lumen 114, through the guidewire aperture 24 of the needle 20 and into the needle lumen 22.
• the seal 120 can define a seal needle lumen 122 configured to receive a portion of the needle 20 therethrough, and a seal guidewire lumen 124 configured to receive the guidewire 30 therethrough.
• a diameter of the seal needle lumen 122 can be equal to, or less than, an outer diameter of the needle 20.
• the seal 120 can slidably engage the needle 20 in an interference fit while preventing a fluid flow between the outer surface of the needle 20 and an inner surface of the seal needle lumen 122.
• a diameter of the seal guidewire lumen 124 can be equal to, or less than, an outer diameter of the guidewire 30. As such, the seal 120 can slidably engage the guidewire 30 in an interference fit.
• one or more of the seal 120, guidewire 30, and/or needle 20 can include a biocompatible, lubricious coating disposed on a surface thereof to provide a fluid tight seal therebetween.
• exemplary lubricious coatings can include hydrogels, silicone oil, silicone grease, or similar suitable lubricants.
• the sealing member 120 can form a robust seal between one or both of the needle 20 and the guidewire 30 and the housing 110 to support a vacuum pressure during blood flash visualization.
• the guidewire locking system 100 can further include a locking mechanism 130 configured to lock the guidewire 30 relative to the housing 110, preventing any movement therebetween.
• the locking mechanism 130 can include a “Tuohy-Borst” style locking mechanism 130 defining a lock lumen 132 configured to align with the seal guidewire lumen 124 and receive a portion of the guidewire 30 therethrough.
• a proximal end of the lock lumen 132 can define a funnel shape, configured to facilitate directing a distal tip of the guidewire 30 into the lock lumen 132.
• a distal end of the locking mechanism 130 can define a tapered recess 134 configured to receive a portion of the seal 120 therein.
• the tapered recess 134 can compress a portion of the seal 120 radially inwards, onto the guidewire 30 gripping the guidewire 30 and preventing the guidewire 30 from sliding relative to the housing 110.
• the locking mechanism 130 can be threadably engaged with the housing 110.
• an inner surface of a collar 138 of the locking mechanism 130 can threadably engage an outer surface of the housing 110.
• Rotating the collar 138 can rotate the locking mechanism about the axis of the guidewire 30 and urge the tapered recess 134 onto the seal 120 to grip the guidewire 30.
• the guidewire locking system 100 can further include a peel pin 128 extending laterally through the seal 120 and disposed adjacent a junction between the seal needle lumen 122 and the seal guidewire lumen 124.
• a cross-sectional shape of the peel pin 128 can define a circular, oval, ellipsoidal, wedge, or triangular shape.
• the peel pin 128 can be formed integrally with the housing 110.
• the peel pin 128 can be formed as a separate structure from the housing and coupled thereto with an interference fit, press-fit, snap-fit engagement, adhesive, bonding, welding, combinations thereof, or the like.
• the peel pin 128 can provide a structural support to the guidewire 30 at the point where the guidewire 30 disengages the needle 20.
• the peel pin 128 can prevent the needle slot 26 from “dragging” the guidewire 30 proximally, as the needle 20 and guidewire 30 as withdrawn and disengaged. This can prevent the guidewire 30 from kinking or snagging on the needle slot 26 preventing disengagement and failure of the guidewire locking system 100.
• the housing 110 can include a housing slot 116 extending longitudinally between a proximal end of the guide channel 114 and a distal end of the needle channel 112, and communicating with one or both of the guide channel 114 and the needle channel 112.
• the locking mechanism 130 can include a lock slot 136 extending longitudinally between the distal end and the proximal end of the locking mechanism 130 and communicating with the lock lumen 132.
• the seal 120 can include a seal slot 126, as described herein.
• the collar 138 can include a lever 140 extending therefrom, perpendicular to an axis of the lock lumen 132.
• the lever 140 can provide mechanical advantage to facilitate rotating the collar 138 about the axis of the lock lumen 132, providing a secure engagement with the guidewire 30, as described herein.
• a position of the lever 140 relative to the housing 110 can provide a quick and intuitive indicator to the user as to whether the guidewire locking system 100 is in the locked or unlocked position.
• one or more of the collar 138, lever 140, housing 110, combinations thereof, or the like can include a symbol, different colored portions, alphanumeric symbol, or the like to indicated to a user when the collar 138 is in one of the locked or unlocked positions.
• a first side of the lever 140 can include an open padlock symbol, green color, or the like to indicate the collar 138 is in the unlocked position
• a second side of the lever 140 can include a closed padlock symbol, red color, or the like to indicate the collar 138 is in the locked position.
• the locking mechanism 130 can include a rotation piece 142 and a compression piece 144.
• the rotation piece 142 and the compression piece 144 can co-operate to define the lock lumen 132.
• a proximal end of the compression piece 144 can be rotatably coupled to a distal end of the rotation piece 142.
• the rotation piece 142 can rotate freely relative to the position of the compression piece 144, about the axis of the lock lumen 132.
• the proximal end of the rotation piece 142 can be fixedly coupled to the collar 138. As such, rotating the collar 138 can rotate the rotation piece 142 about the axis of the lock lumen 132.
• the compression piece 144 can remain rotationally stationary relative to the rotation piece 142 as the rotation piece 142 and the collar 138 are rotated.
• the actuator 232 can engage the housing in a push-button mechanism wherein a first axial force applied to the actuator 232 can transition the actuator 232 from the unlocked position to the locked position. A second axial force applied to the actuator 232 can transition the actuator 232 from the locked position to the unlocked position.
• the first axial force and the second axial force can be applied along the same axis and/or in the same direction.
• the first axial force and the second axial force can be applied along different axes or along different directions, e.g. opposite directions.
• the actuator 232 can be threadably engaged with the housing 110 and can include a rotation piece and a compression piece, as described herein.
• the guidewire locking system 100 can include one or more valves 150 configured to allow one or both of the needle 20 and the guidewire 30 to slide axially while controlling a fluid flow through one or both of the needle channel 112 and the guidewire lumen 114 of the housing 110.
• the one or more valves 150 can mitigate a fluid leakage from the guidewire aperture 24 as a fluid passes through the needle lumen 22, or mitigate a fluid leakage into the guidewire aperture 24 when a vacuum is applied to the needle lumen 22, as described herein.
• the one or more valves 150 can engage one or both of the needle 20 and the guidewire 30 in an interference fit to prevent one or both of the needle 20 and the guidewire 30 from sliding freely.
• a user can position one or both of the needle 20 and guidewire 30 in a first position relative to the housing 110 and the one or more valves 150 can engage the needle 20 and/or guidewire 30 and can remain in the first position until repositioned to a second position.
• a RICC system 10 including a guidewire locking system 100, as described herein.
• a distal tip of the guidewire 30 extends into the lumen of the needle 20.
• the RICC system 10 is urged distally to access a vasculature of a patient with the needle 20 and confirm vascular access, as described herein.
• the guidewire 30 can be advanced through the needle lumen 22 until a distal tip of the guidewire 30 extends distally of the distal tip of the needle 22 and into the vasculature.
• the user can transition the locking mechanism 130, 230 to the unlocked position prior to advancing the guidewire 30 distally through the needle lumen 22 and into the vasculature of the needle 22.
• the user can then transition the locking mechanism 130, 230 from the unlocked position to the locked position.
• this includes rotating a collar 138 or a lever 140.
• this includes rotating a rotation piece 142 and advancing a compression piece 142 onto a seal 120.
• this includes compressing the seal 120 radially inwards to impinge on the guidewire 30 and prevent axial movement of the guidewire 30 relative to the housing 110.
• a user can actuate an actuator 232 along an axis extending at an angle relative to the axis of the guidewire 30 to impinge on the guidewire 30 and prevent axial movement thereof.

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Citations (36)

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• 2022
  • 2022-10-21 JP JP2024523684A patent/JP2024536584A/ja active Pending
  • 2022-10-21 WO PCT/US2022/047444 patent/WO2023069726A1/en not_active Ceased
  • 2022-10-21 CN CN202222792210.1U patent/CN219167433U/zh active Active
  • 2022-10-21 US US17/971,182 patent/US20230129318A1/en active Pending
  • 2022-10-21 EP EP22812891.4A patent/EP4415795A1/en active Pending
  • 2022-10-21 CN CN202211295418.0A patent/CN115999017A/zh active Pending

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