WO2009126935A2 - Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby - Google Patents
Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby Download PDFInfo
- Publication number
- WO2009126935A2 WO2009126935A2 PCT/US2009/040277 US2009040277W WO2009126935A2 WO 2009126935 A2 WO2009126935 A2 WO 2009126935A2 US 2009040277 W US2009040277 W US 2009040277W WO 2009126935 A2 WO2009126935 A2 WO 2009126935A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- microcatheter
- reperfusion
- stroke
- stroke device
- lumen
- Prior art date
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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
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- 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
- A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0693—Brain, cerebrum
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- This present disclosure relates to minimally invasive surgical devices, methods and systems.
- the present disclosure relates to systems designed to mitigate, extenuate or otherwise address acute stroke.
- novel devices, improved processes and systems facilitate survival from, and preserve best options for, treatment of stroke.
- a process for reperfusion during embolus removal comprising; providing a rapid exchange microcatheter system have at least two lumens, emplacing a microcatheter from the system within a blood vessel in the brain, accessing a desired treatment site, maintaining arterial access including greater support to the arterial tree, and addressing a subject embolus/blood clot.
- a process for making a neuro-monorail microcatheter includes at least one of co-extruding and skiving; co-extruding and skiving and lumen fillings; bonding tubes, and providing a predetermined microcatheter set, cutting a distal segment at 5-50 cm, aligning the same adjacent to a distal section of second microcatheter, placing guidewires in each microcatheter to maintain alignment, and applying short segments of PET along the length to secure and maintain alignment and adjacent status of the resulting device.
- a reperfusion device includes a rapid exchange system comprising a first lumen and a second lumen; a microcatheter disposed within the first lumen, comprising a stroke device, wherein the stroke device is expandable; and a guidewire disposed within the second lumen.
- the stroke device may comprise radiographic marking elements for visualization during placement, wherein the radiographic marking elements may be disposed at a distal end of the stroke device.
- the stroke device may be tethered, accessible, and retrievable through the microcatheter.
- FIG. 1 shows a schematic of an exemplary iteration of a device according to the present disclosure in a first position
- FIG. 2 shows a schematic of an exemplary iteration of a device according to the present disclosure in a second position
- FIG. 3 likewise schematically depicts an exemplary iteration of a device according to the present disclosure in a third position.
- the present inventors have discovered novel ways to treat strokes. This is done by providing microcatheter devices and therapy schemes whereby access is maintained during capture of emboli/thrombi/clot material without compromise to reperfusion of blood flow.
- the instant disclosures include microcatheters having at least second lumens for vessel stability during removal of emboli and/or in adjunct therapy modes, these devices are referred to as "Rapid Exchange” or RX systems.
- the system of the instant disclosure allows and maintains arterial access to treatment sites, and provides enhanced support to the arterial tree, while working as a rapid exchange system. This enables secure capture of emboli/thrombi/clot the proximal vessel from buckling or kinking during tensioning upon embolus removal. This is a key feature, in that the literature is demonstrative of ovalizing, whereby stripping of the embolus from capture devices happens when buckling or kinking happens.
- a stroke is often referred to as a "brain attack” and occurs when a blood vessel in the brain becomes blocked or ruptures.
- a ischemic stroke occurs when a blood vessel in the brain becomes blocked. Ischemic strokes compromise about 78% of all strokes.
- a hemorrhagic stroke which account for the remaining 22% of strokes, occurs when a blood vessel in the brain ruptures. Stroke is the third leading cause of death in the United States, behind heart disease and cancer and is the leading cause of severe, long-term disability. Each year roughly 700,000 Americans experience a new or recurrent stroke. Stroke is the number one cause of inpatient Medicare reimbursement for long-term adult care. Total stroke costs now exceeds $45 billion per year in US healthcare dollars.
- the Merci device is designed to capture an embolus or clot and remove it from the blocked vessel thereby restoring blood flow.
- the device is designed to be used in conjunction with a microcatheter. The microcatheter must cross the embolus before the Merci device can be deployed.
- the Merci device design is a cork-screwed guidewire. This device is only able to capture and remove matter that is firm or held together by itself. In most cases Merci breaks up the embolus rather than removes it and is used in combination with drug therapy to restore blood flow.
- a typical procedure using Merci will take 2-3 hours to restore blood flow if at all and mav take multiole oasses throu ⁇ h the vessel to either capture, macerate or open the vessel.
- the Merci device may capture an embolus but then lose grasp of it and deposit it incidentally in another are of the neuro vasculature creating a new stroke in a new territory.
- complications such as vessel dissection, perforation and hemorrhage arise as a results of manipulation in the vessel.
- Some issues in using Merci are that the Merci device itself is a guidewire. Therefore, once it is removed access is lost. Also, as the device is engaging an embolus and being withdrawn proximally, the vessels tent to be pulled with the device and buckle.
- a second option is an aspiration device manufactured by Penumbra, Inc.
- the embolus is removed by aspirating or sucking from the proximal side.
- a microwire is passed through the catheter into the embolus to aide in aspirating.
- an OTW system including a microcatheter having a delivery system tube is combined with a rapid exchange system as discussed above.
- the OTW system may be configured to fit within a lumen of the RX system.
- a microcatheter may be configured to fit within another lumen of the RX system. Examples of such a guidewire include Transend® or Synchro® brands. Examples of such a microcatheter include Cordis® MASSTRANSIT® or RenegadeTM HI-FLO brands.
- the rapid exchange delivery catheter functions with, for example, CORDIS® brands of microcatheters available from them, and may be assembled as detailed below, or as known to those skilled in the art.
- microcatheter 101 having at least two lumens. Stroke device 103 is shown in a state of transition from a first (collapsed) position to a second (expanded) position emerging from a lumen of RX microcatheter 101.
- guidewire 99 may be at least partially disposed within one of the two lumens of RX microcatheter 101.
- stroke device 103 includes radiographic marking elements 105 for visualization during placement.
- radiographic marking elements 105 for visualization during placement.
- stroke device 103 is shown in a fully expanded position, whereby it functions consistently and safely such that arterial support is maintained in virtue of guidewire 99 keeping the arterial tree from mechanical stress, while embolus removal, clot capture and other procedures are done. Thus, reperfusion is established and therapy administered without risks to patients present with other devices.
- stroke device 103 may be tethered such that, while emplaced at a treatment site within a blood vessel, it remains accessible via a microcatheter and readily retrievable therein while maintaining reperfusion of the blood vessel.
- stroke device 103 may be emplaced on a long-term of permanent basis, or as needed based on the amount and type of recanalization prescribed.
- stroke device 103 is self-expandable, such that is may expand substantially radially when removed from within the catheter.
- additional therapies may be provided while stroke device 103 is fully expanded, for example, through another lumen of RX microcatheter 101.
- a process for making a neuro-monorail microcatheter may include cutting a first microcatheter at a distal end. A segment may be cut at about 5 cm to 50 cm from a distal end of the microcatheter. The segment of the first catheter may be aligned adjacent to a distal section of a second microcatheter. Guidewires may be placed in each of first and second microcatheters to maintain their respective alignments and keeo their lumens ooen. A resin, such as Polvethvlene tereohthalate (PET ⁇ mav be applied in short segments along the lengths of the first and second microcatheters to secure and maintain alignment and adjacent status of the finished device.
- PET ⁇ mav Polvethvlene tereohthalate
- a first and second catheter as described above, may be co-extruded and skived, in lieu of the cutting discussed above, and joined as discussed above.
- each physical element disclosed should be understood to encompass a disclosure of the action which that physical element facilitates.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09730066.9A EP2271390A4 (en) | 2008-04-11 | 2009-04-10 | Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby |
JP2011504226A JP2011517607A (en) | 2008-04-11 | 2009-04-10 | Monorail nerve microcatheter for delivery of medical devices to treat stroke, monorail nerve microcatheter process, and monorail nerve microcatheter product |
CN200980110391XA CN101977650A (en) | 2008-04-11 | 2009-04-10 | Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby |
AU2009234268A AU2009234268A1 (en) | 2008-04-11 | 2009-04-10 | Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4439208P | 2008-04-11 | 2008-04-11 | |
US61/044,392 | 2008-04-11 | ||
US5761308P | 2008-05-30 | 2008-05-30 | |
US61/057,613 | 2008-05-30 | ||
US16672509P | 2009-04-04 | 2009-04-04 | |
US61/166,725 | 2009-04-04 |
Publications (2)
Publication Number | Publication Date |
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WO2009126935A2 true WO2009126935A2 (en) | 2009-10-15 |
WO2009126935A3 WO2009126935A3 (en) | 2010-01-07 |
Family
ID=41162669
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2009/040277 WO2009126935A2 (en) | 2008-04-11 | 2009-04-10 | Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby |
Country Status (6)
Country | Link |
---|---|
US (1) | US8545514B2 (en) |
EP (1) | EP2271390A4 (en) |
JP (1) | JP2011517607A (en) |
CN (1) | CN101977650A (en) |
AU (1) | AU2009234268A1 (en) |
WO (1) | WO2009126935A2 (en) |
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- 2009-04-10 EP EP09730066.9A patent/EP2271390A4/en not_active Withdrawn
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Also Published As
Publication number | Publication date |
---|---|
EP2271390A4 (en) | 2016-07-20 |
CN101977650A (en) | 2011-02-16 |
US8545514B2 (en) | 2013-10-01 |
EP2271390A2 (en) | 2011-01-12 |
WO2009126935A3 (en) | 2010-01-07 |
JP2011517607A (en) | 2011-06-16 |
AU2009234268A1 (en) | 2009-10-15 |
US20100100106A1 (en) | 2010-04-22 |
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