WO2023114324A1 - Sealing modules for insertion assemblies of rapidly insertable central catheters and methods thereof - Google Patents

Sealing modules for insertion assemblies of rapidly insertable central catheters and methods thereof Download PDF

Info

Publication number
WO2023114324A1
WO2023114324A1 PCT/US2022/052884 US2022052884W WO2023114324A1 WO 2023114324 A1 WO2023114324 A1 WO 2023114324A1 US 2022052884 W US2022052884 W US 2022052884W WO 2023114324 A1 WO2023114324 A1 WO 2023114324A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
sealing
ricc
module
introducer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2022/052884
Other languages
English (en)
French (fr)
Inventor
Daniel B. Blanchard
Glade H. Howell
Kyle G. THORNLEY
Eric W. Lindekugel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bard Access Systems Inc
Original Assignee
Bard Access Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bard Access Systems Inc filed Critical Bard Access Systems Inc
Priority to EP22850799.2A priority Critical patent/EP4444394A1/en
Priority to JP2024535635A priority patent/JP2024543748A/ja
Publication of WO2023114324A1 publication Critical patent/WO2023114324A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61M25/06—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
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M2025/0095—Catheter tip comprising a tool being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
    • 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
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip

Definitions

  • FIG. 11 illustrates longitudinal cross section of the sealing-module insert in accordance with some embodiments.
  • FIG. 13 illustrates radial compression of the sealing-module insert in the sealing-module cavity through axial compression of the sealing-module insert in the sealingmodule cavity by a needle hub in accordance with some embodiments.
  • FIG. 14 illustrates a longitudinal cross section of another sealing-module insert with internal reliefs in an introducer-needle passageway and an access-guidewire passageway of the sealing-module insert in accordance with some embodiments.
  • a RICC insertion assembly can include a RICC, an introducer needle, an access guidewire, and a coupler coupling the RICC and the introducer needle together.
  • a proximal portion of the access guidewire is disposed in a primary lumen of the RICC.
  • a distal portion of the access guidewire is disposed in a needle shaft of the introducer needle through a needle slot thereof.
  • a coupler housing of the coupler includes a sealing-module cavity of a sealing module.
  • FIGS. 1-3 illustrate various views of a RICC insertion assembly 100 in accordance with some embodiments.
  • the access-guidewire channel 164 of the needle hub 144 is configured to allow the access guidewire 106 to pass over the needle hub 144 and direct the access guidewire 106 into the access-guidewire passageway 190 of the sealing module 180.
  • the access-guidewire channel 164 is open such that the access guidewire 106 lies in the access-guidewire channel 164 in at least the ready -to-operate state of the RICC insertion assembly 100.
  • the open access-guidewire channel 164 allows the access guidewire 106 to remain in place when the introducer needle 104 is withdrawn from the RICC insertion assembly 100 in accordance with the introducer needle-withdrawing step of the method set forth below.
  • the needle-hub connector 166 includes a needle-hub bore 168 and an optional needle-hub flange 170 about the needle-hub connector 166.
  • the introducer-needle passageway 204 of the sealing-module insert 202 can include an internal relief 210 between proximal and distal portions of the introducerneedle passageway 204 to reduce friction on the introducer needle 104 when being withdrawn from the coupler 108 and the sealing module 180 thereof in the introducer needle-withdrawing step of the method set forth below.
  • the access-guidewire passageway 190 can include an internal relief 212 in at least a proximal portion of the accessguidewire passageway 190 to reduce friction on the access guidewire 106 when being advanced into the coupler 108 and the sealing module 180 thereof in the access guidewire-advancing step of the method set forth below.
  • the RICC insertion assembly 100 includes the RICC 102, the introducer needle 104, the access guidewire 106, and the coupler 108 coupling the RICC 102 and the introducer needle 104 together in at least the ready -to-operate state of the RICC insertion assembly 100.
  • the sealing module 180 of the coupler 108 which, again, is formed between at least the sealing-module cavity 198 of the coupler housing 178 and the sealingmodule insert 202 disposed in the sealing-module cavity 198, separately seals around the proximal portion of the introducer needle 104 and the distal portion of the access guidewire 106 in at least the ready -to-operate state of the RICC insertion assembly 100.
  • the blood-aspirating step includes aspirating blood with the syringe 110 to confirm the needle tract extends into the blood-vessel lumen before withdrawing the introducer needle 104 from the coupler 108 in the introducer needle- withdraw! ng step.
  • the sheath 142 over the needle shaft 140 seals the needle slot 148 of the needle shaft 140 thereunder.
  • the sheath 142 seals the needle slot 148 outside of the sealing module 180.
  • the sealing module 180 seals over the sheath opening 162 of the sheath 142, which sheath opening 162 allows the access guidewire 106 to pass from the access-guidewire passageway 190 of the sealing-module insert 202 and into the needle shaft 140 by way of the needle slot 148.
  • the sealing module 180 also seals around the distal portion of the access guidewire 106. Such seals enable the syringe 110 to aspirate blood in the blood-aspirating step.
  • FIG. 34 illustrates the RICC-advancing step of the method in accordance with some embodiments.
  • the access guidewire-withdrawing step includes withdrawing the access guidewire 106 leaving the catheter tube 112 in place in the blood-vessel lumen.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/US2022/052884 2021-12-15 2022-12-14 Sealing modules for insertion assemblies of rapidly insertable central catheters and methods thereof Ceased WO2023114324A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP22850799.2A EP4444394A1 (en) 2021-12-15 2022-12-14 Sealing modules for insertion assemblies of rapidly insertable central catheters and methods thereof
JP2024535635A JP2024543748A (ja) 2021-12-15 2022-12-14 迅速挿入型中心静脈カテーテルの挿入アセンブリのための封止モジュール及びその方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163290049P 2021-12-15 2021-12-15
US63/290,049 2021-12-15

Publications (1)

Publication Number Publication Date
WO2023114324A1 true WO2023114324A1 (en) 2023-06-22

Family

ID=85150733

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/052884 Ceased WO2023114324A1 (en) 2021-12-15 2022-12-14 Sealing modules for insertion assemblies of rapidly insertable central catheters and methods thereof

Country Status (5)

Country Link
US (1) US20230181878A1 (https=)
EP (1) EP4444394A1 (https=)
JP (1) JP2024543748A (https=)
CN (2) CN218980164U (https=)
WO (1) WO2023114324A1 (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12427285B2 (en) 2021-05-20 2025-09-30 Bard Access Systems, Inc. Rapidly insertable central catheters, introducers, insertion devices including combinations and methods thereof
US12527941B2 (en) 2021-08-09 2026-01-20 Bard Access Systems, Inc. Introducer components, assemblies, and methods thereof
US12594403B2 (en) 2021-08-24 2026-04-07 Bard Access Systems, Inc. Introducer components, assemblies, and methods thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5380290A (en) * 1992-04-16 1995-01-10 Pfizer Hospital Products Group, Inc. Body access device
EP0641571A1 (de) * 1993-09-08 1995-03-08 B. Braun Melsungen Ag Venenpunktionskanüle für die Katheterverlegung
WO2005096778A2 (en) * 2004-04-05 2005-10-20 University Of Medicine And Dentistry Of New Jersey Vascular access needle
WO2011143621A1 (en) * 2010-05-14 2011-11-17 C.R. Bard, Inc. Catheter placement device and method
US8882713B1 (en) * 2013-10-17 2014-11-11 Arizona Medical Systems, LLC Over-the-needle guidewire vascular access system
WO2016123278A1 (en) * 2015-01-29 2016-08-04 Redsmith, Inc. Rapid insertion integrated catheter and method of using an integrated catheter
US20210085927A1 (en) * 2019-09-24 2021-03-25 Bard Access Systems, Inc. Integrated Acute Central Venous Catheter and Peripherally Inserted Venous Catheter

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7766870B2 (en) * 2005-04-21 2010-08-03 The United States Of America As Represented By The Secretary Of The Army Foley catheter adaptor
US8029481B2 (en) * 2006-10-17 2011-10-04 Matthew Dickson Reavill Apparatus and method of inserting an infusing catheter and determining catheter depth without a guidewire or direct contact with the catheter
US20090187147A1 (en) * 2008-01-22 2009-07-23 Pressure Products Medical Supplies, Inc. Apparatus and method for achieving micropuncture
US8585651B2 (en) * 2008-05-22 2013-11-19 Terumo Kabushiki Kaisha Catheter retaining tool
US11376408B2 (en) * 2016-10-12 2022-07-05 Cygnus Medical Llc Pressure-sensing bleed-back control valve with improved sealing
US20200197682A1 (en) * 2016-10-17 2020-06-25 Prytime Medical Devices, Inc. Access device with guidewire and related methods
JP7174500B2 (ja) * 2018-11-09 2022-11-17 ノースウォード・ベンチャーズ・エルエルシー 静脈内カテーテルを患者に導入するカテーテルシステムおよび方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5380290A (en) * 1992-04-16 1995-01-10 Pfizer Hospital Products Group, Inc. Body access device
EP0641571A1 (de) * 1993-09-08 1995-03-08 B. Braun Melsungen Ag Venenpunktionskanüle für die Katheterverlegung
WO2005096778A2 (en) * 2004-04-05 2005-10-20 University Of Medicine And Dentistry Of New Jersey Vascular access needle
WO2011143621A1 (en) * 2010-05-14 2011-11-17 C.R. Bard, Inc. Catheter placement device and method
US8882713B1 (en) * 2013-10-17 2014-11-11 Arizona Medical Systems, LLC Over-the-needle guidewire vascular access system
WO2016123278A1 (en) * 2015-01-29 2016-08-04 Redsmith, Inc. Rapid insertion integrated catheter and method of using an integrated catheter
US20210085927A1 (en) * 2019-09-24 2021-03-25 Bard Access Systems, Inc. Integrated Acute Central Venous Catheter and Peripherally Inserted Venous Catheter

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12427285B2 (en) 2021-05-20 2025-09-30 Bard Access Systems, Inc. Rapidly insertable central catheters, introducers, insertion devices including combinations and methods thereof
US12527941B2 (en) 2021-08-09 2026-01-20 Bard Access Systems, Inc. Introducer components, assemblies, and methods thereof
US12594403B2 (en) 2021-08-24 2026-04-07 Bard Access Systems, Inc. Introducer components, assemblies, and methods thereof

Also Published As

Publication number Publication date
US20230181878A1 (en) 2023-06-15
EP4444394A1 (en) 2024-10-16
CN218980164U (zh) 2023-05-09
JP2024543748A (ja) 2024-11-25
CN116262156A (zh) 2023-06-16

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