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
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
  • A61M29/02—Dilators made of swellable material
• • 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
• • 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
  • A61B2017/22097—Valve removal in veins

Definitions

• the invention relates to a microcommissurotome with levers, that is to say a cardiac catheterization device intended to eliminate stenosis of the cardiac valves by separation of the valvular commissures by means of a lever retractor, with manual control.
• the document FR-A-2,071,338 describes an apparatus of this type comprising an elastic base traversed by an axial operating rod. At the proximal end of the elastic base is a manual control handle. At the distal end, the elastic base is integral with a sleeve in which a slide fixed to the end of the axial rod can slide. A spacer made up of two parallel branches is arranged around the sleeve-slide assembly. Each of the two branches is retained at its proximal end by a helical spring fixed to a ring secured to the elastic base. The purpose of this spring is to prevent the branch from catching on the heart tissue.
• each branch is articulated on the end of a lever, the other end of which is articulated on the socket integral with the elastic base.
• This lever is articulated at its midpoint on a second lever, one end of which is articulated on the slide fixed to the end of the axial rod, and the other end of which slides freely in the branch on the side of its proximal part.
• This device is put in place by engagement in the heart by following the surgeon's finger, then it is put into action by manual control which ensures relative movement of the axial rod and the elastic base, that is to say slide and socket.
• the points of articulation of the two levers of each branch located respectively on the slide and the socket come closer. This results in a separation of their point of mutual articulation and a separation of the branch with respect to the axial rod and the elastic base.
• the spreading movement is symmetrical and the two branches move away from each other while remaining parallel. This movement is sufficient to remove the stenosis of the heart valves.
• This device is designed to be inserted into the heart through the wall of an atrium, following the surgeon's finger, which is why it is limited to cases of invasive procedures.
• An object of the present invention is to provide a microcommissurotome which does not require invasive intervention.
• Another object of the invention is to provide an arrangement of levers which prevents jolts when opening the spacer.
• Yet another object of the invention is to provide an accessory for opening the spacer.
• the present invention relates to a microcommissurotome with levers, comprising a spacer with two active sides moving symmetrically and substantially parallel to the axis of the spacer, the opening of the spacer being ensured by manual control by movement of the distal end of the retractor with respect to its proximal sleeve, characterized in that the retractor is mounted at the distal end of a catheter, and in that, in the closed position, the retractor has a substantially equal radial size to that of the catheter.
• the retractor is constituted by two deformable parallelograms symmetrical with respect to the axis of the retractor, the first side of which is constituted by the proximal sleeve of the retractor and the second side by the active side;
• the third side of the parallelogram is articulated on the sleeve and carries a leaf spring which, in the closed position of the retractor, biases said third side towards the outside;
• the fourth side of the parallelogram has in the vicinity of its middle a point of articulation for a link articulated at its other end on the distal end of the retractor;
• the two points of articulation of the link are located on either side of the axis of the spacer;
• the distal end of the retractor is carried by a sliding tube in the proximal socket of the retractor;
• the tube is linked to a traction wire and slides in a flexible internal to the catheter, the traction and compression being transmitted from the proximal end to the distal end of the catheter through the combination of the pull wire and the internal hose to the catheter;
• the tube opens at the distal end of the retractor to form a passage to a wire-shaped guide for guiding the retractor to the place of the commissurotomy;
• the wire-shaped guide carries a flexible, atraumatic end, and, in line with the connection between the guide and its flexible end, an attached olive capable of cooperating with the distal end of the retractor to ensure opening complete with the spacer;
• the catheter ensures the longitudinal position of the retractor instead of the commissurotomy
• the active sides of the retractor are covered with a non-slip coating
• the retractor is made of one or more materials capable of ensuring its location by X-ray or ultrasound imaging techniques;
• the retractor and the catheter are covered with a biocompatible coating.
• the microcommissurotome with levers comprises at its distal end a retractor of small diameter, mounted on a catheter to be introduced by a blood vessel, for example an artery, and at its proximal end a manual control.
• the catheter 1 is constituted by an external metal hose 2, in the form of a helical spring, and by a flexible plastic outer set 3, covering the hose 2.
• the spacer 4 consisting essentially of a proximal sleeve 5, a distal end 6, two deformable parallelograms 7 (of which only one is shown), and two crossed rods 8 and 9.
• the proximal sleeve 5 is rigidly fixed to the distal end of the catheter 1, for example by means of a crimped ring 10. It has a certain length and is crossed axially by a tube 11 ending at the distal end 6 of the spacer 4 and opening out at the front of the distal end 6.
• the tube 11 is attached to metallic wires 12 of constant length, which can be rectilinear or in crossed helices, and which are traction wires connected to the manual control of the proximal end, not shown, of the microcommissurotome.
• a flexible hose 13 is provided around the wires 12, internal to the catheter
• a parallelogram 7 is defined by its four vertices 15, 16, 17, 18, which constitute points of reciprocal articulation for the sides of the parallelogram.
• the first side 19, between the points of articulation 15 and 16, is formed practically by the length of the sleeve 5.
• the second side 20, parallel to the first side 19 is the active side of the microcommissurotome. It is he who performs the commissurotomy by moving parallel to the axis of the retractor.
• the third side 21 is between the articulation points 15 and 17.
• the fourth side 22, parallel to the third side 21, constitutes the lever for opening the spacer 4. In the vicinity of its middle, the fourth side 22 carries a articulation point 23 for the link 8 whose other end is articulated on the distal end 6 at the articulation point 24.
• the rod 8 When the spacer 4 is in the closed position, the rod 8 is in the position shown at the top of the figure.
• the side 22 is then applied longitudinally against the tube 11 and the side 20 is in the position shown at the top of the figure.
• the sides 20 and 21 are then in the extension of one another. They have on the outside a semi-cylindrical lining, respectively 25 and 26.
• the spacer 4 being symmetrical, it is entirely contained inside the external cylindrical surface of the lining 25, 26 and of the symmetrical lining of the other parallelogram 7.
• the circular section of this cylindrical surface corresponds to that of the sleeve 5 and that of the ogival head of the distal end 6.
• the radial size of the spacer 4 in the closed position is thus substantially that catheter 1 and its insertion to the heart can be ensured by catheterization through a blood vessel and in particular through an artery.
• the links 8 and 9 are crossed.
• the link 8, for example, has its articulation point 24 on the distal end 6 on one side of the tube 11 and its other articulation point 23 on the fourth side 22, on the other side of the tube 11.
• the tube 11 which is subjected to traction by the wire 12 is between the two articulation points 23 and 24 which facilitates the opening of the spacer 4.
• the third side 21 of the parallelogram 7 carries a leaf spring 27.
• the spring bears on the sleeve 5 and urges the third side 21 towards the 'outside.
• a guide is placed from a blood vessel, for example an artery, at least to the valve having a stenosis.
• This guide is in the form of a metal wire for example.
• this rigid guide ends with a flexible, atraumatic end, of a few centimeters, 10 cm for example, intended to facilitate the positioning of the guide.
• a flexible, atraumatic end of a few centimeters, 10 cm for example, intended to facilitate the positioning of the guide.
• an added olive is provided, capable of playing a role at the time of the commissurotomy.
• the wire 12 When the microcommissurotome is at rest, the wire 12 is urged towards the distal end 6 and the hose 13 towards the proximal end of the catheter so that the retractor 4 is kept in the closed position (upper part of the figure).
• the proximal end of the guide is introduced into the tube 11 through the distal end 6 of the retractor 4.
• the assembly of the retractor 4 and of the catheter 1 is then introduced into the blood vessel being guided by the guide until 'to the stenosed valve.
• the retractor 4 is made of one or more materials allowing its location by imaging techniques, for example X-ray or ultrasound.
• imaging techniques for example X-ray or ultrasound.
• the external hose 2 of the catheter 1, covered by the plastic sheath 3, works in compression to maintain the spacer 4 in the longitudinal position on the guide.
• the opening of the retractor 4 is then triggered by manual control, by pushing on the internal hose 13 and pulling on the wire 12, the pushing on the flexible 13 intervening to avoid the only flexible 2 of the catheter having to balance pulling the wire 12.
• the tensile force is transmitted from the wire 12 to the tube] 1 and to the distal end 6 of the retractor.
• This axial force is applied between the two articulation points 23 and 24 of the link 8, (and between the two corresponding articulation points of the link 9, the two links 8 and 9 being crossed), which avoids a suddenly upon opening.
• the leaf spring 27 begins to move the third side 21 of the parallelogram 7 away from the sleeve 5 (a symmetrical opening movement applies to the other parallelogram of the spacer 4).
• the fourth side 22 opens parallel to the third side 21 and the second side 20 departs from the axis of the retractor while remaining parallel to it.
• the link 8 pivots and tends to assume an inclined position on the axis of the retractor, which facilitates the movement of withdrawal of the tube 11 and of the distal end 6.
• the fourth side 22 acts as a lever to ensure the opening of the spacer 4 up to the fully open position shown at the bottom of the figure, the link 8 then having its point of articulation 24 in the position shown, and the distal end 6 being erased in the space defined by the two halves of the spacer 4.
• this opening of the retractor 4 it is the second sides 20 of the deformable parallelograms 7 which ensure the commissurotomy.
• the outer surface of their lining 25 is advantageously covered with an anti-slip coating.
• the microcommissurotome can be provided with a device allowing the measurement of the blood pressure in line with the retractor.
• This device can for example be a channel placed in the sheath of the catheter and filled with liquid, the channel opening into the central part of the retractor and being connected, in the proximal part of the catheter, with a pressure sensor.
• this channel can be used for the injection of a contrast agent or a treatment liquid.
• the friction parts are provided with an anti-wear coating to avoid the appearance of play affecting the precision of the surgical operation.

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• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Surgical Instruments (AREA)
• Prostheses (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• External Artificial Organs (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=9487896

Family Applications (1)

Country Status (10)

Families Citing this family (11)

Family Cites Families (9)

• 1996
  • 1996-01-05 FR FR9600064A patent/FR2743301B1/fr not_active Expired - Lifetime
• 1997
  • 1997-01-06 JP JP9524907A patent/JP2000502927A/ja active Pending
  • 1997-01-06 TR TR1998/01278T patent/TR199801278T2/tr unknown
  • 1997-01-06 CN CNB971915482A patent/CN100369642C/zh not_active Expired - Fee Related
  • 1997-01-06 AU AU13826/97A patent/AU716741B2/en not_active Ceased
  • 1997-01-06 EP EP97900230A patent/EP0873152A1/fr not_active Withdrawn
  • 1997-01-06 EA EA199800506A patent/EA000649B1/ru not_active IP Right Cessation
  • 1997-01-06 BR BR9706959-0A patent/BR9706959A/pt not_active IP Right Cessation
  • 1997-01-06 WO PCT/FR1997/000013 patent/WO1997025092A1/fr not_active Application Discontinuation
  • 1997-01-06 US US09/077,464 patent/US6183494B1/en not_active Expired - Lifetime

Non-Patent Citations (1)

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