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EP-4171711-B1 - RAPIDLY INSERTABLE CENTRAL CATHETERS INCLUDING ASSEMBLIES

EP4171711B1EP 4171711 B1EP4171711 B1EP 4171711B1EP-4171711-B1

Inventors

  • HOWELL, GLADE, H.

Dates

Publication Date
20260513
Application Date
20210628

Claims (15)

  1. A rapidly insertable central catheter ("RICC") assembly (100), comprising: a RICC (102) including: a soft catheter tube (120) having an introducing aperture (104) through a side of the soft catheter tube in a distal-end portion thereof, the introducing aperture opening into an introducing portion of a primary lumen (108) of the RICC that extends from the introducing aperture to a distal end of the RICC; a catheter hub (122) coupled to a proximal-end portion of the soft catheter tube; and one or more extension legs (124), each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal-end portion thereof; and an introducer (106) including: an introducer catheter (132) including a hard catheter tube (134) having an introducing hole (140) through a side of the hard catheter tube in a distal-end portion thereof, the introducing hole opening into an introducing portion of a single lumen of the introducer catheter that extends from the introducing hole to a distal end of the introducer catheter; and an introducer needle (126), the introducer catheter disposed in the primary lumen of the RICC such that the distal end of the introducer catheter extends past the distal end of the RICC and the introducer needle disposed in the introducer catheter through both the introducing aperture and the introducing hole such that a beveled tip (146) in a distal-end portion of the introducer needle extends past the distal end of the introducer catheter when the RICC assembly is in a ready-to-deploy state thereof.
  2. The RICC assembly of claim 1, further comprising an access guidewire (148) disposed in the introducer needle such that a distal end of the access guidewire is proximal of the beveled tip but distal of the distal end of the RICC when the RICC assembly is in the ready-to-deploy state.
  3. The RICC assembly of claim 2, wherein the access guidewire includes a stop about a proximal-end portion of the access guidewire forming a stop end (150) thereof, the stop end of the access guidewire configured to provide a distal limit for advancing the access guidewire into the RICC.
  4. The RICC assembly of any of claims 1-3, further comprising a maneuver guidewire (152) disposed in the introducer catheter such that a distal end of the maneuver guidewire is proximal of the introducing hole but distal of the catheter hub when the RICC assembly is in the ready-to-deploy state.
  5. The RICC assembly of claim 4, wherein the maneuver guidewire includes a stop about a proximal-end portion of the maneuver guidewire forming a stop end (156) thereof, the stop end of the maneuver guidewire configured to provide a distal limit for advancing the maneuver guidewire into the RICC.
  6. The RICC assembly of any of claims 1-5, wherein the soft catheter tube (120) is formed of a first material having a first durometer and the hard catheter tube (134) is formed of a second material having a second durometer greater than the first durometer, thereby providing the RICC assembly a column strength for advancing the RICC into a blood-vessel lumen over a guidewire.
  7. The RICC assembly of any of claims 1-6, wherein the RICC includes a set of three lumens including the primary lumen (108), a secondary lumen (110), and a tertiary lumen (112) formed of fluidly connected portions of three catheter-tube lumens, three hub lumens, and three extension-leg lumens.
  8. The RICC assembly of claim 7, wherein the primary lumen (108) has a primary-lumen aperture (114) in the distal end of the RICC, the secondary lumen (110) has a secondary-lumen aperture (116) in the side of the soft catheter tube proximal of the primary-lumen aperture, and the tertiary lumen (112) has a tertiary-lumen aperture (118) in the side of the soft catheter tube proximal of the secondary-lumen aperture but distal of the introducing aperture.
  9. A rapidly insertable central catheter ("RICC") assembly (200), comprising: a RICC (202) including: a soft catheter tube (220) having a primary-lumen aperture (114) in a distal end of the soft catheter tube and a secondary-lumen aperture (116) in a side of the soft catheter tube in a distal-end portion thereof; a catheter hub (122) coupled to a proximal-end portion of the soft catheter tube; and one or more extension legs (124), each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal-end portion thereof; and an introducer (106) including: an introducer catheter (132) including a hard catheter tube (134) having an introducing hole (140) through a side of the hard catheter tube in a distal-end portion thereof; and an introducer needle (126), the introducer catheter disposed in a primary lumen (108) of the RICC such that a distal end of the introducer catheter extends past a distal end of the RICC and the introducer needle disposed in the introducer catheter through a combination of the secondary-lumen aperture, a septum (128) dividing a secondary lumen from the primary lumen, and the introducing hole such that a beveled tip (146) in a distal-end portion of the introducer needle extends past the distal end of the introducer catheter when the RICC assembly is in a ready-to-deploy state thereof.
  10. The RICC assembly of claim 9, further comprising an access guidewire (148) disposed in the introducer needle such that a distal end of the access guidewire is proximal of the beveled tip but distal of the distal end of the RICC when the RICC assembly is in the ready-to-deploy state.
  11. The RICC assembly of claim 10, wherein the access guidewire includes a stop about a proximal-end portion of the access guidewire forming a stop end (150) thereof, the stop end of the access guidewire configured to provide a distal limit for advancing the access guidewire into the RICC.
  12. The RICC assembly of any of claims 9-11, further comprising a maneuver guidewire (152) disposed in the introducer catheter such that a distal end of the maneuver guidewire is proximal of the introducing hole but distal of the catheter hub when the RICC assembly is in the ready-to-deploy state.
  13. The RICC assembly of claim 12, wherein the maneuver guidewire includes a stop about a proximal-end portion of the maneuver guidewire forming a stop end (156) thereof, the stop end of the maneuver guidewire configured to provide a distal limit for advancing the maneuver guidewire into the RICC.
  14. The RICC assembly of any of claims 9-13, wherein the soft catheter tube (220) is formed of a first material having a first durometer and the hard catheter (134) tube is formed of a second material having a second durometer greater than the first durometer, thereby providing the RICC assembly a column strength for advancing the RICC into a blood-vessel lumen over a guidewire.
  15. The RICC assembly of any of claims 9-14, wherein the RICC includes a set of three lumens including the primary lumen (108), the secondary lumen (110), and a tertiary lumen (112) formed of fluidly connected portions of three catheter-tube lumens, three hub lumens, and three extension-leg lumens, optionally wherein the primary lumen (108) has the primary-lumen aperture (114) in the distal end of the RICC, the secondary lumen (110) has the secondary-lumen aperture (116) in the side of the soft catheter tube proximal of the primary-lumen aperture, and the tertiary lumen (112) has a tertiary-lumen aperture (118) in the side of the soft catheter tube proximal of the secondary-lumen aperture.

Description

PRIORITY This application claims the benefit of priority to U. S. Provisional Application No. 63/045,599, filed June 29, 2020. BACKGROUND A central venous catheter ("CVC") is formed of a material having a relatively low durometer, which contributes to the CVC having a lack of column strength. Due to the lack of column strength, CVCs are commonly introduced into patients and advanced through their vasculatures by way of the Seldinger technique. The Seldinger technique utilizes a number of steps and medical devices (e.g., a needle, a scalpel, a guidewire, an introducer sheath, a dilator, a CVC, etc.). While the Seldinger technique is effective, the steps are time consuming, handling the number of medical devices is awkward, and both of the foregoing can lead to patient trauma. In addition, there is a relatively high potential for touch contamination due to the number of medical devices that need to be interchanged during the number of steps of the Seldinger technique. As such, there is a need to reduce the number of steps and medical devices involved in introducing a catheter such as a CVC into a patient and advancing the catheter through a vasculature thereof. US 2019/025594 A1 discloses an integrated catheter assembly for rapid vascular insertion including a catheter configured for receipt of a needle and a guidewire; a catheter assembly comprising an integrated assembly comprising a catheter, needle and guidewire; and a method of rapidly inserting a catheter to obtain vascular access. The catheter includes a central lumen for receiving the needle and guidewire. The lumen includes a distal port and a transverse side of the port adjacent an intermediate portion thereof which provide open vascular communication from two ports between the central lumen and the vasculature. The needle and guidewire, when integrated with the catheter, extend through the transverse side port wherein a proximal end of the needle extends contiguous to and exterior of a proximal portion of the catheter. US 5,380,290 discloses a device for providing access to a living body. WO 2019/066728 A1 discloses an obturator, sheath and method for using the same. Disclosed herein are rapidly insertable central catheters ("RICCs") including catheter assemblies and methods thereof that address the foregoing. SUMMARY The invention is defined in independent claims 1 and 9. Further aspects are defined in respective dependent claims 2-8 and 10-15. Methods of use mentioned herein do not form part of the claimed invention and are left for illustrative purposes. Disclosed herein is a RICC assembly including, in some embodiments, a RICC and an introducer. The RICC includes a soft catheter tube, a catheter hub, and one or more extension legs. The soft catheter tube has an introducing aperture through a side of the soft catheter tube in a distal-end portion of the soft catheter tube. The introducing aperture opens into an introducing portion of a primary lumen of the RICC, which portion extends from the introducing aperture to a distal end of the RICC. The catheter hub is coupled to a proximal-end portion of the soft catheter tube. Each extension leg of the one-or-more extension legs is coupled to the catheter hub by a distal-end portion of the extension leg. The introducer includes an introducer catheter and an introducer needle. The introducer catheter includes a hard catheter tube having an introducing hole through a side of the hard catheter tube in a distal-end portion of the hard catheter tube. The introducing hole opens into an introducing portion of a single lumen of the introducer catheter, which portion extends from the introducing hole to a distal end of the introducer catheter. The introducer catheter is disposed in the primary lumen of the RICC such that the distal end of the introducer catheter extends past the distal end of the RICC when the RICC assembly is in a ready-to-deploy state of the RICC assembly. In addition, the introducer needle is disposed in the introducer catheter through both the introducing aperture and the introducing hole such that a beveled tip in a distal-end portion of the introducer needle extends past the distal end of the introducer catheter. In some embodiments, the RICC assembly further includes an access guidewire. The access guidewire is disposed in the introducer needle such that a distal end of the access guidewire is proximal of the beveled tip but distal of the distal end of the RICC when the RICC assembly is in the ready-to-deploy state. In some embodiments, the access guidewire includes a stop about a proximal-end portion of the access guidewire forming a stop end of the access guidewire. The stop end of the access guidewire is configured to provide a distal limit for advancing the access guidewire into the RICC. In some embodiments, the RICC assembly further includes a maneuver guidewire. The maneuver guidewire is disposed in the introducer catheter such that a distal end of the maneuver guidewire is proxi