US20090270838A1 - Catheter Flushing Mandrel - Google Patents

Catheter Flushing Mandrel Download PDF

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Publication number
US20090270838A1
US20090270838A1 US12/109,265 US10926508A US2009270838A1 US 20090270838 A1 US20090270838 A1 US 20090270838A1 US 10926508 A US10926508 A US 10926508A US 2009270838 A1 US2009270838 A1 US 2009270838A1
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US
United States
Prior art keywords
diameter
mandrel
barrel section
lumen
flushing
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.)
Abandoned
Application number
US12/109,265
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English (en)
Inventor
William Berthiaume
Don Tran
Chris Collins
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.)
Medtronic Vascular Inc
Original Assignee
Medtronic Vascular 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 Medtronic Vascular Inc filed Critical Medtronic Vascular Inc
Priority to US12/109,265 priority Critical patent/US20090270838A1/en
Assigned to MEDTRONIC VASCULAR, INC. reassignment MEDTRONIC VASCULAR, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BERTHIAUME, WILLIAM, COLLINS, CHRIS, TRAN, DON
Priority to ES09735403.9T priority patent/ES2543986T3/es
Priority to JP2011506312A priority patent/JP5694917B2/ja
Priority to PCT/US2009/035967 priority patent/WO2009131750A1/en
Priority to EP20090735403 priority patent/EP2303396B1/en
Publication of US20090270838A1 publication Critical patent/US20090270838A1/en
Priority to US12/862,505 priority patent/US8002763B2/en
Abandoned legal-status Critical Current

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M2025/0079—Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
    • 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
    • A61M2025/0183—Rapid exchange or monorail 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
    • 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
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Definitions

  • the technical field of this disclosure is medical devices, particularly, a catheter flushing mandrel.
  • Catheters are used in a number of medical procedures to deliver medical devices to a target site within a body and other purposes.
  • Catheters typically, define an inner lumen with an inner wall of the catheter, and this inner lumen can be divided into dedicated lumens for a number of purposes, such as holding contrast fluids, delivering devices, or the like.
  • catheters Prior to insertion into the body, catheters must be flushed with a fluid, often saline.
  • flushing can be difficult and time consuming, as two separate connections must be made to flush the inner lumen and outer lumen. This requires not only extra time in the surgical suite, but also mandates additional handling. Additionally, at times medical professionals create a physical seal for the flushing operation using their fingers, which is undesirable.
  • One aspect according to the present invention provides a mandrel that includes a mandrel body with a proximal major diameter barrel section, a diameter reducing portion, such as a tapered or step down (shoulder) portion and a distal minor diameter barrel section.
  • the tapered portion connects the proximal major diameter barrel section and distal minor diameter barrel section.
  • the proximal major diameter barrel section has a major diameter
  • the distal minor diameter barrel section has a minor diameter, the minor diameter less than the major diameter.
  • the minor diameter is less than a diameter of an inner lumen of a coaxial catheter, and the major diameter exceeds an inner diameter of a guidewire exit port on the outer lumen of the coaxial catheter, and the tapered portion is sized to form a fluid seal with the guidewire exit port on the outer lumen of the coaxial catheter.
  • the coaxial catheter includes an inner lumen member defining an inner lumen and an outer lumen member defining an outer lumen.
  • the system includes a mandrel that includes a mandrel body with a proximal major diameter barrel section, a tapered portion and a distal minor diameter barrel section.
  • the tapered portion connects the proximal major diameter barrel section and distal minor diameter barrel section.
  • the proximal major diameter barrel section has a major diameter
  • the distal minor diameter barrel section has a minor diameter, the minor diameter less than the major diameter.
  • the minor diameter is less than a diameter of an inner lumen of a coaxial catheter, and the major diameter exceeds an inner diameter of a guidewire exit port on the outer lumen of the coaxial catheter, and the tapered portion is sized to form a fluid seal with the guidewire exit port on the outer lumen of the coaxial catheter.
  • the method includes providing a coaxial catheter, the coaxial catheter including an inner lumen and an outer lumen, and inserting a flushing mandrel into the inner lumen.
  • the method further includes forming a fluid seal between the flushing mandrel and the wall defining the inner diameter of the outer lumen guidewire exit port based on the insertion, flushing the outer lumen based on the formed seal, and breaking the fluid seal after the flushing by removal of the flushing mandrel entirely from the coaxial catheter.
  • the method includes flushing the inner lumen based on the broken seal and removal of the flushing mandrel based on the flushing of the outer lumen.
  • FIG. 1A is a side view of a mandrel
  • FIG. 1B is an end view of a mandrel
  • FIG. 2 is a cross sectional view of a catheter system
  • FIG. 3 is a flowchart of the steps of a method of flushing a catheter.
  • FIGS. 4 , 5 , and 6 illustrate the use of the mandrel and fluid flow in a catheter system.
  • distal and proximal are used herein with reference to the treating clinician during the use of the catheter system: “distal” indicates delivery system portion distant from, or a direction away from the clinician and “proximal” indicates an apparatus portion near to, or a direction towards the clinician.
  • FIGS. 1A and 1B illustrate one embodiment of a mandrel 100 .
  • Mandrel 100 includes a mandrel body 110 including a proximal major diameter barrel section 120 , a tapered portion 130 (a diameter reducing section, e.g., a step down portion or a shoulder), and a distal minor diameter barrel section 140 .
  • Tapered portion 130 connects the proximal major diameter barrel section 120 to the distal minor diameter barrel section 140 .
  • the proximal major diameter barrel section 120 has a major diameter C and the distal minor diameter barrel section 140 has a minor diameter A. Minor diameter A is less than the major diameter C. Minor diameter A is less than a diameter of an inner lumen 225 ( FIG.
  • a coaxial cavity such as self expanding device(stent) or drug shielding space or covering
  • the major diameter A exceeds an inner diameter of a guidewire exit port located on the outer lumen 235 ( FIG. 2 ) of the coaxial catheter 210 ( FIG. 2 ).
  • C is 0.019 inches.
  • A is 0.015 inches.
  • the mandrel overall length is approximately 15′′.
  • the proximal major diameter barrel section 120 is approximately 5.5 inches long.
  • the distal minor diameter barrel section 140 is approximately 8.5 inches long.
  • tapered section 130 is approximately 1′′ long.
  • the proximal major diameter barrel section 120 includes a ball 122 of approximately 0.035′′ diameter.
  • Tapered portion 130 is sized to form a fluid seal with a guidewire exit port of an outer lumen 235 ( FIG. 2 ) of the sheath of the coaxial catheter 210 ( FIG. 2 ).
  • the coaxial catheter is a self expanding device delivery rapid exchange catheter. While illustrated in FIG. 1 as substantially linear, any number of shapes, including arcuate shapes, can be used for the mandrel.
  • FIG. 2 illustrates a catheter coaxial element delivery system 200 .
  • Catheter system 200 includes a coaxial catheter 210 including an inner lumen 225 and an outer lumen 235 . Additionally, catheter system 200 includes a mandrel 100 , as described in FIG. 1 .
  • the device to be delivered contained within the outer sheath and outside the inner shaft enclosing the guidewire lumen is not shown, but a stent stop element part of the delivery system for a self expanding stent is shown (without the stent). Persons skilled in the art are familiar with the configuration.
  • FIG. 3 illustrates a flowchart of a method 300 for flushing a catheter.
  • Method 300 begins at step 310 by providing a coaxial catheter, the coaxial catheter including an inner lumen and an outer lumen, with an internal guidewire exit of the inner lumen communicating to an external guidewire exit port on the outer lumen.
  • a flushing mandrel such as mandrel 100 is inserted into the inner lumen via (and through) the outer lumen guide wire exit port, forming a fluid seal with the outer lumen guidewire exit port.
  • the flushing mandrel is inserted into the inner lumen by advancing the mandrel into the inner lumen until a taper (or other diameter reducing portion or step down or shoulder) on the mandrel contacts the wall defining the inner diameter of the outer lumen guidewire exit port.
  • the catheter is a self expanding rapid exchange catheter, and the mandrel is inserted into the proximal guidewire exit ports of the sheath and inner member.
  • a fluid seal is formed between the flushing mandrel and the wall defining the inner diameter of the outer lumen guidewire exit port based on the insertion.
  • the outer lumen is flushed by introducing a flushing fluid, such as saline, around the mandrel, and into the outer lumen at step 340 .
  • a flushing fluid such as saline
  • a syringe is connected to a volume of flushing fluid, and the flushing fluid is introduced into the outer lumen via the syringe.
  • a luer connector or stylet may be used to introduce the flushing fluid. As the fluid enters the outer lumen, any air within the lumen is expelled.
  • the fluid seal is broken at step 350 .
  • the fluid seal is broken by removal of the flushing mandrel from the coaxial catheter.
  • the mandrel may then be disposed of in any appropriate manner.
  • the inner lumen is flushed at step 360 .
  • the inner lumen is flushed by introducing additional volumes of the flushing fluid.
  • FIG. 4 illustrates a mandrel in the process of being inserted into a coaxial sheath equipped device delivery RX catheter.
  • a fluid seal has been formed between the mandrel and the sheath such that the smaller portion of the mandrel substantially occupies the guidewire lumen extending proximally from the guidewire exit port. Flushing fluid flow from the proximal portion of the catheter is initiated (indicated with arrows on a continuous line indicating the direction and path of fluid flow).
  • the mandrel blocks fluid flow into the guidewire lumen and causes flushing fluid flow into the outer lumen, flushing the outer lumen (and for example a self expanding stent or drug coating disposed in this outer lumen space.
  • the flushing mandrel is placed into the coaxial catheter prior to shipping, providing additional support for the end of the catheter during shipping, and prior to use in a clinical procedure.
  • the mandrel may be manufactured from any appropriate material, but stainless steel is currently preferred. Other biocompatible materials or other easily sterilized materials may also be used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US12/109,265 2008-04-24 2008-04-24 Catheter Flushing Mandrel Abandoned US20090270838A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US12/109,265 US20090270838A1 (en) 2008-04-24 2008-04-24 Catheter Flushing Mandrel
ES09735403.9T ES2543986T3 (es) 2008-04-24 2009-03-04 Mandril para enjuagar catéteres
JP2011506312A JP5694917B2 (ja) 2008-04-24 2009-03-04 カテーテル洗浄マンドレル
PCT/US2009/035967 WO2009131750A1 (en) 2008-04-24 2009-03-04 Catheter flushing mandrel
EP20090735403 EP2303396B1 (en) 2008-04-24 2009-03-04 Catheter flushing mandrel
US12/862,505 US8002763B2 (en) 2008-04-24 2010-08-24 Catheter flushing mandrel

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US12/109,265 US20090270838A1 (en) 2008-04-24 2008-04-24 Catheter Flushing Mandrel

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/862,505 Division US8002763B2 (en) 2008-04-24 2010-08-24 Catheter flushing mandrel

Publications (1)

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US20090270838A1 true US20090270838A1 (en) 2009-10-29

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US12/109,265 Abandoned US20090270838A1 (en) 2008-04-24 2008-04-24 Catheter Flushing Mandrel
US12/862,505 Active US8002763B2 (en) 2008-04-24 2010-08-24 Catheter flushing mandrel

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Application Number Title Priority Date Filing Date
US12/862,505 Active US8002763B2 (en) 2008-04-24 2010-08-24 Catheter flushing mandrel

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US (2) US20090270838A1 (enExample)
EP (1) EP2303396B1 (enExample)
JP (1) JP5694917B2 (enExample)
ES (1) ES2543986T3 (enExample)
WO (1) WO2009131750A1 (enExample)

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US20120136340A1 (en) * 2009-09-15 2012-05-31 Terumo Kabushiki Kaisha Catheter
US20140257244A1 (en) * 2013-03-11 2014-09-11 Covidien Lp Flushing stylet
EP2810684A4 (en) * 2012-02-03 2015-11-04 Terumo Corp EMBASE AND CATHETER WITH EMBASE
US20150374889A1 (en) * 2014-06-27 2015-12-31 Harrison M. Lazarus Surgical kits for body cavity drainage and related methods
US20150374891A1 (en) * 2014-06-27 2015-12-31 Harrison M. Lazarus Placement tools for body cavity drainage devices and related methods
US9604033B2 (en) 2014-06-27 2017-03-28 Harrison M. Lazarus Body cavity drainage devices with locking devices and related methods
US9821097B2 (en) 2014-06-27 2017-11-21 Merit Medical Systems, Inc. Body cavity drainage devices including drainage tubes having inline portions and related methods
US20180147010A1 (en) * 2014-01-24 2018-05-31 Denervx LLC Cooled microwave denervation catheter configuration and method
US10232150B2 (en) 2010-03-11 2019-03-19 Merit Medical Systems, Inc. Body cavity drainage devices and related methods
US10286183B2 (en) 2015-11-25 2019-05-14 Merit Medical Systems, Inc. Steerable sheath catheter and methods of use
US20220088362A1 (en) * 2019-01-21 2022-03-24 W. L. Gore & Associates, Inc. Systems and methods for endoluminal device treatment
US11559662B2 (en) 2018-04-13 2023-01-24 Merit Medical Systems, Inc. Steerable drainage devices
USD1078041S1 (en) * 2022-09-02 2025-06-03 NDI Medical Technolgies Inc. Grooved mandrel for producing an embolic coil
US12472343B2 (en) 2008-06-04 2025-11-18 W. L. Gore & Associates, Inc. Valve assembly for medical procedures

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WO2010129075A1 (en) 2009-04-28 2010-11-11 Avinger, Inc. Guidewire support catheter
EP4145111A1 (en) 2009-05-28 2023-03-08 Avinger, Inc. Optical coherence tomography for biological imaging
WO2011003006A2 (en) 2009-07-01 2011-01-06 Avinger, Inc. Atherectomy catheter with laterally-displaceable tip
US11382653B2 (en) 2010-07-01 2022-07-12 Avinger, Inc. Atherectomy catheter
US9949754B2 (en) 2011-03-28 2018-04-24 Avinger, Inc. Occlusion-crossing devices
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US9345406B2 (en) 2011-11-11 2016-05-24 Avinger, Inc. Occlusion-crossing devices, atherectomy devices, and imaging
US11406412B2 (en) 2012-05-14 2022-08-09 Avinger, Inc. Atherectomy catheters with imaging
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WO2013172974A1 (en) 2012-05-14 2013-11-21 Avinger, Inc. Atherectomy catheter drive assemblies
US11284916B2 (en) 2012-09-06 2022-03-29 Avinger, Inc. Atherectomy catheters and occlusion crossing devices
WO2014143064A1 (en) 2013-03-15 2014-09-18 Avinger, Inc. Chronic total occlusion crossing devices with imaging
US10932670B2 (en) 2013-03-15 2021-03-02 Avinger, Inc. Optical pressure sensor assembly
WO2014142954A1 (en) 2013-03-15 2014-09-18 Avinger, Inc. Tissue collection device for catheter
US10130386B2 (en) 2013-07-08 2018-11-20 Avinger, Inc. Identification of elastic lamina to guide interventional therapy
EP3166512B1 (en) 2014-07-08 2020-08-19 Avinger, Inc. High speed chronic total occlusion crossing devices
EP3322338B1 (en) 2015-07-13 2025-02-12 Avinger, Inc. Micro-molded anamorphic reflector lens for image guided therapeutic/diagnostic catheters
JP6927986B2 (ja) 2016-01-25 2021-09-01 アビンガー・インコーポレイテッドＡｖｉｎｇｅｒ， Ｉｎｃ． 遅延補正を備えたｏｃｔイメージングカテーテル
JP6959255B2 (ja) 2016-04-01 2021-11-02 アビンガー・インコーポレイテッドＡｖｉｎｇｅｒ， Ｉｎｃ． 粥腫切除用カテーテルデバイス
WO2017210466A1 (en) 2016-06-03 2017-12-07 Avinger, Inc. Catheter device with detachable distal end
CN109414273B (zh) 2016-06-30 2023-02-17 阿维格公司 具有可塑形的远侧头端的斑块切除导管
US11253644B2 (en) 2017-02-20 2022-02-22 Avent, Inc. Bladder for an infusion assembly
US11351301B2 (en) 2017-02-20 2022-06-07 Avent, Inc. Mandrel for an infusion assembly
US12167867B2 (en) 2018-04-19 2024-12-17 Avinger, Inc. Occlusion-crossing devices
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Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12472343B2 (en) 2008-06-04 2025-11-18 W. L. Gore & Associates, Inc. Valve assembly for medical procedures
US20120136340A1 (en) * 2009-09-15 2012-05-31 Terumo Kabushiki Kaisha Catheter
US9550042B2 (en) * 2009-09-15 2017-01-24 Terumo Kabushiki Kaisha Catheter
US10232150B2 (en) 2010-03-11 2019-03-19 Merit Medical Systems, Inc. Body cavity drainage devices and related methods
EP2810684A4 (en) * 2012-02-03 2015-11-04 Terumo Corp EMBASE AND CATHETER WITH EMBASE
US20140257244A1 (en) * 2013-03-11 2014-09-11 Covidien Lp Flushing stylet
US11738170B2 (en) 2013-03-11 2023-08-29 Mozarc Medical Us Llc Flushing stylet
US10279143B2 (en) * 2013-03-11 2019-05-07 Covidien Lp Flushing stylet
US10179029B2 (en) * 2014-01-24 2019-01-15 Denervx LLC Cooled microwave denervation catheter configuration and method
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EP2303396A1 (en) 2011-04-06
JP5694917B2 (ja) 2015-04-01
EP2303396B1 (en) 2015-05-06
ES2543986T3 (es) 2015-08-26
US20100324537A1 (en) 2010-12-23
JP2011518606A (ja) 2011-06-30
US8002763B2 (en) 2011-08-23
WO2009131750A1 (en) 2009-10-29

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