CA2648870A1 - Rotational atherectomy device with fluid inflatable support elements supported by fluid bearings - Google Patents

Rotational atherectomy device with fluid inflatable support elements supported by fluid bearings Download PDF

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Publication number
CA2648870A1
CA2648870A1 CA002648870A CA2648870A CA2648870A1 CA 2648870 A1 CA2648870 A1 CA 2648870A1 CA 002648870 A CA002648870 A CA 002648870A CA 2648870 A CA2648870 A CA 2648870A CA 2648870 A1 CA2648870 A1 CA 2648870A1
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CA
Canada
Prior art keywords
fluid
drive shaft
support element
proximal
wall
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.)
Granted
Application number
CA002648870A
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French (fr)
Other versions
CA2648870C (en
Inventor
Leonid Shturman
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Individual
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2648870A1 publication Critical patent/CA2648870A1/en
Application granted granted Critical
Publication of CA2648870C publication Critical patent/CA2648870C/en
Expired - Fee Related legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22052—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22054—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with two balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22068—Centering
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A61B2017/320008—Scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320766—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven eccentric

Abstract

A rotational atherectomy device comprises a rotatable, flexible, hollow drive shaft (2) having an open distal end. The drive shaft comprising a fluid impermeable wall (3), an abrasive element (1002) mounted to the drive shaft proximal to and spaced away from its distal end, the fluid impermeable wall being formed from a torque transmitting coil (4) and at least one fluid impermeable membrane which define a lumen for the antegrade flow of pressurized fluid through the drive shaft and into a distal fluid inflatable support element (10) to inflate said fluid inflatable support element. The distal fluid inflatable support element is located at the distal end of the drive shaft and has an outer wall comprising an outflow opening located such that said outflow opening (20) faces an inner surface of a treated vessel during rotation of the drive shaft so that a layer of fluid forms a fluid bearing.

Claims (20)

1. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising a rotatable, flexible, hollow drive shaft having an open distal end, the drive shaft comprising a fluid impermeable wall, an abrasive element mounted to the drive shaft proximal to and spaced away from its distal end, the fluid impermeable wall being formed from a torque transmitting coil and at least one fluid impermeable membrane which define a lumen for the antegrade flow of pressurized fluid through the drive shaft and into a distal fluid inflatable support element to inflate said fluid inflatable support element, the distal fluid inflatable support element being located at the distal end of the drive shaft and having an outer wall comprising an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft so that a flow of fluid out of said opening forms a layer of fluid between the outer wall of the fluid inflatable distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel.
2. A rotational atherectomy device according to claim 1, wherein the drive shaft has a longitudinal axis and the distal fluid inflatable support element has a centre of mass spaced radially away from the longitudinal axis of the drive shaft when the distal inflatable support element is fluid inflated.
3. A rotational atherectomy device according to claim 2, wherein a fluid inflatable space within the distal fluid inflatable support element extends only partially around a circumference of the drive shaft so that, when the distal inflatable support element is inflated with fluid its centre of mass is offset from a longitudinal axis of the drive shaft in one direction so that it acts as a counterweight to the abrasive element, which has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.
4. A rotational atherectomy device according to claim 1, wherein the drive shaft has a longitudinal axis and the distal fluid inflatable support element has a centre of mass coaxial with the longitudinal axis of the drive shaft whenever the distal inflatable support element is fluid inflated.
5. A rotational atherectomy device according to claim 4, wherein there is a plurality of openings in the outer wall of the fluid inflatable distal support element, said openings being located around the circumference of the outer wall of the fluid inflatable distal support element such that at any time during rotation of the drive shaft a flow of fluid through the opening forms a layer of fluid between the outer wall of the fluid inflatable distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotatable fluid inflated distal support element and the wall of the treated vessel.
6. A rotational atherectomy device according to any preceding claim, wherein the drive shaft is provided with a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element, the proximal support element having at least one inflow opening for communicating the fluid impermeable lumen of the drive shaft with a fluid inflatable space within the proximal support element, the proximal support element being inflatable by the pressurized fluid flowing in an antegrade direction through the fluid impermeable lumen of the drive shaft which is re-directed into the proximal fluid inflatable support element through its inflow opening, wherein the proximal fluid inflatable support element has an outer wall formed by one of the fluid impermeable membranes, said outer wall of the proximal fluid inflatable support element having outflow openings located such that, following inflation of the proximal fluid inflatable support element, at least one of said outflow openings faces an inner surface of a treated vessel during rotation of the drive shaft so that a flow of fluid through said openings forms a layer of fluid between the outer wall of the fluid inflated proximal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel.
7. A rotational atherectomy device according to claim 6, wherein the drive shaft has a longitudinal axis and the proximal fluid inflatable support element has a centre of mass spaced radially away from the longitudinal axis of the drive shaft when the proximal inflatable support element is fluid inflated.
8. A rotational atherectomy device according to claim 7, wherein a fluid inflatable space within the proximal fluid inflatable support element extends only partially around a circumference of the drive shaft so that, when the proximal inflatable support element is inflated with fluid its centre of mass is offset from a longitudinal axis of the drive shaft in one direction so that it acts as a counterweight to the abrasive element, which has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.
9. A rotational atherectomy device according to claim 6, wherein the drive shaft has a longitudinal axis and the proximal fluid inflatable support element has a centre of mass coaxial with the longitudinal axis of the drive shaft whenever the proximal inflatable support element is fluid inflated.
10. A rotational atherectomy device according to claim 9, wherein there is a plurality of openings in the outer wall of the fluid inflatable proximal support element, said openings being located around the circumference of the outer wall of the fluid inflatable proximal support element such that at any time during rotation of the drive shaft a flow of fluid through the openings forms a layer of fluid between the outer wall of the fluid inflatable proximal support element and a wall of the treated vessel during rotation of the drive shaft, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel.
11. A rotational atherectomy device according to any preceding claim, wherein the abrasive element has its centre of mass spaced radially away from a longitudinal axis of the drive shaft.
12. A rotational atherectomy device according to any of claims 4, 5, 9 and 10, wherein the abrasive element has its centre of mass coaxial with a longitudinal axis of the drive shaft.
13. A rotational atherectomy device according to claim 11, wherein the fluid inflatable space within both the distal and proximal fluid inflatable support elements extends circumferentially only partially around circumferential segments of the drive shaft which are spaced away in one direction with respect to the longitudinal axis of the drive shaft so that, when both the distal and proximal fluid inflatable support elements are inflated by fluid, their centers of mass become offset from a longitudinal axis of the drive shaft in said one direction and the distal and proximal fluid inflatable support elements act as counterweights to the abrasive element which is located on the drive shaft between the support elements and has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.
14. A rotational atherectomy device according to claim 1, wherein a valve is formed near the distal end of the drive shaft integrally with a wall of the distal fluid inflatable support element.
15. A rotational atherectomy device according to claim 14, wherein the valve is a flexible leaf valve.
16. A rotational atherectomy device according to claim 15, wherein the flexible leaf valve is formed integrally with the wall of the distal fluid inflatable support element.
17. A rotational atherectomy device according to any of claims 14 to 16, wherein the valve is moved to its closed position by pressure of fluid, which is pumped in an antegrade direction through the drive shaft after advancing the drive shaft over a guidewire across a stenotic lesion to be treated and withdrawing the guidewire from the drive shaft.
18. A rotational atherectomy device according to any preceding claim, wherein the fluid impermeable membrane lines the torque transmitting coil.
19. A rotational atherectomy device according to any of claims 1 to 17, wherein the fluid impermeable membrane extends around the torque transmitting coil.
20. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising a turbine housing and a rotatable, flexible, hollow drive shaft having a distal end, a proximal end and, an abrasive element mounted to the drive shaft, the drive shaft comprising a torque transmitting coil and at least one fluid impermeable membrane forming a fluid impermeable lumen for the antegrade flow of fluid through the drive shaft from the proximal end of the drive shaft towards its distal end, wherein a proximal end portion of the drive shaft is attached to a distal end portion of a hollow turbine shaft rotatably mounted in the turbine housing and, a cylindrical stationary fluid supply tube is received within the hollow turbine shaft to provide a flow of pressurised fluid from a fluid source into the fluid impermeable lumen of the drive shaft, the cylindrical wall of the stationary fluid supply tube comprising a plurality of openings which face an inner surface of the hollow, rotatable turbine shaft, the openings being configured such that a portion of the pressurised fluid flowing in an antegrade direction through the stationary fluid supply tube is re-directed through said openings to form a layer of fluid between the outer surface of the stationary fluid supply tube and the inner surface of the hollow rotatable turbine shaft, said layer of fluid acting as a fluid bearing between the stationary fluid supply tube and the rotatable turbine shaft.

17. A rotational atherectomy device according to claim 16, wherein the openings in the cylindrical wall of the stationary fluid supply tube extend in a radially outward direction relative to the axis of rotation of the hollow, rotatable turbine shaft.

18. A rotational atherectomy device according to claim 17, wherein the cylindrical stationary fluid supply tube is received within the hollow rotatable turbine shaft such that pressurised fluid flowing in an antegrade direction out of the distal end of the stationary fluid supply tube traverses a portion of the hollow rotatable turbine shaft prior to flowing into the fluid impermeable lumen of the drive shaft.

19. A turbine housing for a rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the turbine housing comprising a stationary cylindrical fluid supply tube received within a hollow rotatable turbine shaft, the cylindrical wall of the stationary fluid supply tube having openings therein spaced from its distal end which face an inner surface of the hollow, rotatable turbine shaft, the openings being configured such that a portion of the pressurised fluid flowing in an antegrade direction through the stationary fluid supply tube is re-directed through said openings to form a layer of fluid between an outer surface of the stationary fluid supply tube and the inner surface of the hollow rotatable turbine shaft, said layer of fluid acting as a fluid bearing between the stationary fluid supply tube and the rotatable turbine shaft.

20. A rotational atherectomy device according to claim 1, wherein the drive shaft is provided with a solid proximal support element located proximal to and spaced away from the abrasive element, the membrane that forms a fluid impermeable lumen for the antegrade flow of fluid through the drive shaft into the distal fluid inflatable support element also forming a lumen for the antegrade flow of fluid through the drive shaft into an outflow channel extending through said solid proximal support element, the solid proximal support element having a rounded outer surface, said outflow channel having an outflow opening in the rounded outer surface of the solid proximal support element such that, during rotation of the drive shaft, said outflow opening on the outer surface of the solid proximal support element is facing an inner surface of a treated vessel so that a flow of fluid out of said outflow opening forms a layer of fluid between the solid proximal support element and a wall of the treated vessel during rotation of the drive shaft, said layer of fluid forming a fluid bearing between the rotating solid proximal support element and the wall of the treated vessel.
CA002648870A 2006-07-13 2007-06-28 Rotational atherectomy device with fluid inflatable support elements supported by fluid bearings Expired - Fee Related CA2648870C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0613980.2 2006-07-13
GBGB0613980.2A GB0613980D0 (en) 2006-07-13 2006-07-13 Rotational Atherectomy Device with Fluid Inflatable Elements supported by Fluid Bearings
PCT/EP2007/056500 WO2008006705A2 (en) 2006-07-13 2007-06-28 Rotational atherectomy device with fluid inflatable support elements supported by fluid bearings

Publications (2)

Publication Number Publication Date
CA2648870A1 true CA2648870A1 (en) 2008-01-17
CA2648870C CA2648870C (en) 2009-11-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002648870A Expired - Fee Related CA2648870C (en) 2006-07-13 2007-06-28 Rotational atherectomy device with fluid inflatable support elements supported by fluid bearings

Country Status (6)

Country Link
US (4) US8137369B2 (en)
EP (1) EP2040627B1 (en)
AU (1) AU2007271820A1 (en)
CA (1) CA2648870C (en)
GB (2) GB0613980D0 (en)
WO (1) WO2008006705A2 (en)

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US8500764B2 (en) 2013-08-06
GB0712600D0 (en) 2007-08-08
WO2008006705A2 (en) 2008-01-17
US9333006B2 (en) 2016-05-10
GB2440222A (en) 2008-01-23
CA2648870C (en) 2009-11-24
AU2007271820A1 (en) 2008-01-17
WO2008006705A3 (en) 2008-04-10
GB0613980D0 (en) 2006-08-23
US20090326568A1 (en) 2009-12-31
US20130296905A1 (en) 2013-11-07
US20160213397A1 (en) 2016-07-28
US20120165847A1 (en) 2012-06-28
EP2040627B1 (en) 2016-06-01
EP2040627A2 (en) 2009-04-01
US8137369B2 (en) 2012-03-20

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