(19)
(11)EP 1 587 431 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
06.05.2020 Bulletin 2020/19

(21)Application number: 04703570.4

(22)Date of filing:  20.01.2004
(51)Int. Cl.: 
A61B 17/22  (2006.01)
(86)International application number:
PCT/US2004/001274
(87)International publication number:
WO 2004/069287 (19.08.2004 Gazette  2004/34)

(54)

A DEVICE FOR PERCUTANEOUS CUTTING AND DILATING A STENOSIS OF THE AORTIC VALVE

VORRICHTUNG ZUM PERKUTANEN SCHNEIDEN UND ZUR DILATION EINER STENOSE DER AORTENKLAPPE

DISPOSITIF POUR LA COUPE PERCUTANEE ET LA DILATATION D'UNE STENOSE DE LA VALVULE AORTIQUE


(84)Designated Contracting States:
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LI LU MC NL PT RO SE SI SK TR

(30)Priority: 27.01.2003 US 353827

(43)Date of publication of application:
26.10.2005 Bulletin 2005/43

(73)Proprietor: Boston Scientific Scimed, Inc.
Maple Grove, MN 55311 (US)

(72)Inventor:
  • SCHWARTZ, Leonard
    Toronto, Ontario M2P 1J6 (CA)

(74)Representative: Peterreins Schley 
Patent- und Rechtsanwälte PartG mbB Hermann-Sack-Strasse 3
80331 München
80331 München (DE)


(56)References cited: : 
EP-A1- 0 829 238
US-A- 5 697 944
US-A1- 2003 144 677
US-A- 5 616 149
US-A- 5 697 944
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    FIELD OF THE INVENTION



    [0001] The present invention pertains generally to interventional medical devices. More particularly, the present invention pertains to catheters that can be used to incise the aortic valve between the left ventricle of the heart and the aorta for the purpose of relieving the heart condition known as aortic valve stenosis (AS).

    BACKGROUND OF THE INVENTION



    [0002] In its normal operation, the left ventricle of the heart pumps oxygen-rich blood to arteries in the vasculature of the body through the aorta. As the heart pumps, the aortic valve, which is located between the ventricle and the aorta, opens and closes to control the direction of blood flow. Specifically, during a heartbeat, the valve is open to allow blood to flow from the ventricle into the aorta. Between heartbeats, however, the aortic valve closes to form a tight seal that prevents blood from leaking back into the ventricle. For any of several reasons (e.g. aging, or birth defects), it can happen that the aortic valve is somehow damaged and may become stenosed. When this happens, the aortic valve does not open to its normal extent and the flow of blood from the heart into the aorta is constricted. This leads to a heart condition that is commonly known as aortic valve stenosis (AS).

    [0003] In a patient with AS, the aortic valve is stenosed and the heart is forced to pump blood through a narrowed opening through the aortic valve. Over time, this narrowing causes pressure to build up in the left ventricle of the heart. In order to compensate for this pressure overload, the muscles of the left ventricle enlarge (hypertrophy) so that the heart can pump with more force. It eventually happens, however, that the stenosis in the aortic valve increases to the point the heart can no longer maintain adequate blood flow through the stenosis. At this point, the patient experiences several characteristic symptoms of AS. In general, this occurs when the aortic valve, when open, has a valve opening area that is approximately one square centimeter (1 cm2).

    [0004] Heretofore, the treatment for AS has been accomplished either surgically by doing a valve replacement, or by performing a percutaneous balloon valvuloplasty. In the case of a valve replacement, an extensive surgical procedure is required wherein the aortic valve is replaced either by a mechanical or a porcine valve. On the other hand, being a percutaneous procedure, balloon valvuloplasty is somewhat less involved than a valve replacement procedure. Nevertheless, for many reasons including a high recurrence rate, and despite its initial acceptance, balloon valvuloplasty is now used infrequently and only palliatively or as a bridge to surgery.

    [0005] US 5,697,944 discloses a device for incising and dilating a stenosis in a vessel of a patient which includes a dilator housing and a plurality of blades which can be selectively extended from the housing.

    [0006] In light of the above it is the object of the present invention to provide a percutaneous device for treating aortic valve stenosis that effectively makes controlled shallow incisions in the leaflets, of the aortic valve to thereby establish a more normal flow of blood from the left ventricle of the heart into the aorta. Another object of the present invention is to provide a cutting device that can be safely advanced through the vasculature of a patient, and subsequently withdrawn therefrom, while permitting surgical incisions at selected locations in the vasculature. Still another object of the present invention is to provide a cutting device for treating aortic valve stenosis that is simple to manufacture, easy to use, and comparatively cost effective.

    SUMMARY OF THE INVENTION



    [0007] The invention is further defined in the appended claims.

    [0008] For purposes of this disclosure, the terms "proximal" and "distal" are used with reference to the direction of blood flow in the vasculature. Specifically, the "distal direction" is the direction in which blood flows outwardly from the left ventricle of the heart and into the aortic artery. Further, for consistency, "distal" and "proximal" descriptions of the device of the present invention use this same blood-flow-based reference system.

    [0009] In accordance with the present invention, a cutting device for treating aortic valve stenosis includes a catheter that has an elongated balloon mounted near its proximal end. As intended for the present invention, the balloon can be reconfigured on the catheter between an inflated configuration and a deflated configuration. Structurally, the balloon defines an axis and, in its inflated configuration, it has three identifiable sections that are located between its distal end and its proximal end. These sections are: a substantially conical-shaped distal section having a taper with an increasing radius in the proximal direction; a substantially conical-shaped proximal section having a taper with a decreasing radius in the proximal direction; and a substantially cylindrical-shaped intermediate section that is located between the distal section and the proximal section.

    [0010] At least one, but as many as three or possibly four, substantially straight, elongated blades are attached to the balloon. Importantly, these blades are oriented on the balloon so as to be coplanar with the axis of the balloon. Further, each blade is formed with a sharp edge, and each blade is attached to the balloon to project the sharp edge of the blade in a radial direction from the axis of the balloon. In more detail, the proximal portion of each blade is attached to the proximal section of the balloon, with the distal end of the blade adjacent the distal end of the balloon. The blades, however, are longer than the proximal section of the balloon. Therefore, the distal portion and the distal end of each blade is not attached to the balloon.

    [0011] In the operation of the present invention, the balloon (in its deflated configuration) is advanced into the vasculature of the patient. Specifically, for the treatment of AS, the balloon is positioned inside the left ventricle of the heart. This then places the balloon distal to the aortic valve. In any event, once the balloon is in the left ventricle it is then inflated.

    [0012] In its inflated configuration, the balloon inclines each blade relative to the axis of the balloon. Specifically, this inclination is characterized by an increasing distance between the blade and the axis of the balloon, in a distal direction along the axis. In cooperation with the balloon, each blade is inclined relative to the balloon's axis at an angle (α) that is established by the taper of the balloon's proximal section, when the balloon is inflated. Preferably, this angle (α) is in a range between approximately zero degrees, when the balloon is in its deflated configuration, and approximately forty-five degrees, when the balloon is in its inflated configuration (0°-45°). An important consequence of this is that, when the balloon is in its inflated configuration, the sharp edges of the blades are presented for cutting (incising) the aortic valve. More specifically, the distal portions and distal ends of respective blades are projected radially outward from the axis through a distance that extends beyond the radius of the cylindrical-shaped intermediate section.

    [0013] An incising action on the aortic valve is accomplished as the inflated balloon is retracted through the aortic valve in a proximal direction. After the inflated balloon has been retracted through the aortic valve, and the valve has been incised, the balloon is deflated. The deflated balloon is then withdrawn from the vasculature and the procedure is completed.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0014] The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:

    FIG. 1 is a perspective view of the incising device of the present invention;

    FIG. 2A is a side view of the balloon of the device of the present invention when the balloon is in its deflated configuration;

    FIG. 2B is a side view of the balloon of the device of the present invention when the balloon is in its inflated configuration;

    FIG. 3A is an end view of the balloon of the device of the present invention as seen along the line 3A-3A in FIG. 2A;

    FIG. 3B is an end view of the balloon of the device of the present invention as seen along the line 3B-3B in FIG. 2B;

    FIG. 4 is a cross sectional view of the catheter as seen along the line 4-4 in FIG. 1; and

    FIG. 5 is a schematic view of an inflated balloon of the present invention, positioned inside the left ventricle of a patent, ready for retraction in a proximal direction through an aortic valve for the purpose of incising the aortic valve.


    DESCRIPTION OF THE PREFERRED EMBODIMENTS



    [0015] Referring initially to FIG. 1, a system for incising tissue in accordance with the present invention is shown and generally designated 10. As shown, the system 10 includes a catheter 12 which has a distal end 14 and a proximal end 16. System 10 also has an inflatable, elongated balloon 18 that is mounted on the catheter 12 near its distal end 16. Further, it is seen that a y-site 20 is attached to the proximal end 14 of the catheter 12. Specifically, the y-site 20 allows the catheter 12 to be operationally engaged with a guidewire 22 for the purpose of advancing the catheter 12 over the guidewire 22 after the guidewire 22 has been pre-positioned in the vasculature of a patient (not shown). FIG. 1 also shows that an inflation/deflation device 24 can be connected to the y-site 20 for fluid communication with the balloon 18. Preferably, the balloon 18 is made of a resilient material such as Polyethylene Napthalate (PEN), or Polyethylene Teraphthlate.

    [0016] Still referring to FIG. 1, it will be seen that the system 10 of the present invention includes a plurality of substantially straight cutting blades 26, of which the cutting blades 26a and 26b are only exemplary. As envisioned for the present invention, the system 10 may include only one such blade 26, or it may include as many as three or four such blades 26. With this in mind, and using the blade 26a as a specific example for purposes of disclosure, it will be seen that the proximal end 28 of the blade 26a is positioned adjacent, or near, the proximal end 30 of the balloon 18. Further, it is to be appreciated that the blade 26a is oriented on the balloon 18 so that it is coplanar with the longitudinal axis 32 of the balloon 18 (see FIG. 2A). Also, it is to be appreciated by cross-referencing FIG. 1 with FIG. 2B, that the blade 26a is attached to a proximal section of the balloon 18. For purposes of the present invention, the blades 26 can be attached to the balloon 18 by any means well known in the pertinent art, such as by bonding.

    [0017] The structure for balloon 18 will be best understood by referencing both FIG. 1 and FIG. 2B. As shown, the balloon 18, when inflated, generally defines three sections. These are: a proximal section 34; an intermediate section 36; and a distal section 38. More specifically, when the balloon 18 is inflated, the proximal section 34 is generally conical-shaped and has a taper with an increasing radius in the distal direction. On the other hand, the intermediate section 36 is substantially cylindrical-shaped and has a generally constant radius. Again, there is a conical-shape for the distal section 38. This time, however, the taper for the distal section 38 has a decreasing radius in the distal direction. Preferably, the blade 26a is longer than the proximal section 34 and is attached to only the proximal section 34 of the balloon 18. Consequently, the distal end 40 of the blade 26a is not engaged with the balloon 18. As perhaps best seen in FIG. 2B, this cooperation of structure allows the sharp cutting edge 42 of the blade 26a, at the distal end 40 of the blade 26a, to extend radially outward from the axis 32 to a greater distance than the radius of the cylindrical-shaped intermediate section 36. Stated differently, with the balloon 18 in its inflated configuration, the blades 26 are inclined at an angle (α) relative to the axis 32. Preferably, the angle (α) is in a range between 0° and 45°.

    [0018] FIG. 1 also shows that the system 10 of the present invention can include radiopaque markers 44a and 44b which will assist in positioning the balloon 18 in the vasculature of the patient. Identification of the balloon 18 at a location in the vasculature can be further facilitated by using a contrast medium to inflate the balloon 18.

    [0019] As envisioned for the present invention, the balloon 18 of the present invention can be reconfigured between a deflated configuration (FIG. 2A and FIG. 3A) and an inflated configuration (FIG. 2B and FIG. 3B). As implied above, the actual inflation and deflation of the balloon 18 is accomplished by manipulating the inflation device 24 (See FIG. 1). Specifically, for this purpose, the inflation/deflation device 24 is connected at the y-site 20 in fluid communication with an inflation lumen 46 (see FIG. 4). A manipulation of the plunger 48 (see FIG. 1) can then cause the balloon 18 to selectively inflate or deflate. FIG. 4 also shows that the catheter 12 is formed with a guidewire lumen 50 for receiving the guidewire 22 therethrough.

    [0020] Referring now to FIG. 5, in the operation of the system 10 of the present invention, the guidewire 22 is pre-positioned in the vasculature of the patient. The catheter 12, with the balloon 18 in its deflated configuration (FIG. 2A and FIG. 3A) is then advanced over the guidewire 22. Note that when the balloon 18 is in its deflated configuration, material of the balloon 18 will cover the blades 26 and thereby reduce the possibility of an unintended incision of tissue.

    [0021] As intended for the operation of the present invention, the balloon 18 is advanced over the guidewire 22 until the balloon 18 has been positioned in the left ventricle 52 of the patient's heart. At this point, the inflation/deflation device 24 is manipulated to inflate the balloon 18 into its inflated configuration (FIG. 1, FIG. 2B and FIG. 3B). With the cutting blades 26 radially deployed, the system 10 is then retracted in a proximal direction through the aortic valve 54 and into the aorta 56. With this retraction, the cutting edges 42 of respective blades 26 incise the aortic valve 54 to relieve any stenosis that has developed in the aortic valve 54. After retraction, the balloon 18 is deflated, and the system 10 is withdrawn from the vasculature of the patient.


    Claims

    1. A device for incising an aortic valve stenosis, wherein the device is configured to be advanced in proximal direction through the vasculature and aortic valve into the left ventricle of the heart, wherein the device comprises:

    a substantially straight elongated blade (26) having a proximal end and a distal end (28), with a sharp cutting edge (42) located therebetween;

    a means for advancing the elongated blade (26) in a proximal direction through the vasculature and the aortic valve to position the blade (26) at a location proximal to the aortic stenosis, wherein said location is within the left ventricle of the heart;

    a balloon (18) defining a longitudinal axis (32) and having a distal end (30) and a proximal end for inclining the blade (26) relative to the axis of the balloon (18) with an increasing distance between the blade (26) and said axis in the proximal direction; and a means for retracting the blade (26) in a distal direction along a path into the vasculature of a patient to incise the aortic valve stenosis with the cutting edge (42) of the blade (26),

    wherein the advancing and retracting means are a catheter (12) having a distal end (14) and proximal end (16), wherein the balloon (18) is mounted on the catheter (12) near its proximal end (16); and

    wherein the blade (26) is attached to the distal end (30) of the balloon (18) and wherein the distal end (28) of the blade (26) is positioned adjacent the distal end (30) of the balloon (18).


     
    2. A device as recited in claim 1 wherein the balloon (18) has a distal end and a proximal end and, when inflated, the balloon (18) further comprises:

    a substantially conical-shaped distal section (34) having a taper with increasing radius in the proximal direction;

    a substantially conical-shaped proximal section (38) having a taper with decreasing radius in the proximal direction; and

    a substantially cylindrical-shaped intermediate section (36) located between the distal section and the proximal section.


     
    3. A device as recited in claim 1 or claim 2 wherein the blade (26) has a distal portion and a proximal portion, wherein the distal portion is attached to the distal section (34) of balloon (18) and the proximal portion is formed with the sharp edge (42) for cutting.
     
    4. A device as recited in any of claims 1 to 3 wherein the incline of the blade (26) relative to the axis (32) is established by the taper of the distal section (34) of the balloon (18) and is in a range between approximately zero degrees, and approximately forty-five degrees (0°- 45°).
     
    5. A device as recited in any of claims 1 to 4 further comprising a guidewire (22) for advancing said catheter (12) through the vasculature of a patient to position said balloon (18) for cutting tissue at the valve between the left ventricle of the heart and the aorta.
     
    6. A device as recited in any preceding claim further comprising a plurality of said blades (26).
     
    7. A device as recited in any of claims 1 to 6, wherein said balloon (18) is made of polyethylene napthalate (PEN).
     
    8. A device as recited in any of claims 1 to 7, wherein said balloon (18) covers said blade (26) when said balloon is in its deflated configuration.
     


    Ansprüche

    1. Vorrichtung zur Inzision einer Stenose der Aortenklappe, wobei die Vorrichtung ausgestaltet ist, um in proximaler Richtung durch das Gefäßsystem und die Aortenklappe in die linke Herzkammer vorgeschoben zu werden, wobei die Vorrichtung umfasst:

    eine im Wesentlichen gerade längliche Klinge (26) mit einem proximalen Ende und einem distalen Ende (28), zwischen denen eine scharfe Schneidkante (42) angeordnet ist;

    ein Mittel zum Vorschieben der länglichen Klinge (26) in eine proximale Richtung durch das Gefäßsystem und die Aortenklappe hindurch, um die Klinge (26) an einer Stelle proximal der Aortenstenose zu positionieren, wobei sich die Stelle innerhalb der linken Herzkammer befindet;

    einen Ballon (18), der eine Längsachse (32) definiert und ein distales Ende (30) und ein proximales Ende zum Neigen der Klinge (26) relativ zu der Achse des Ballons (18) mit zunehmendem Abstand zwischen der Klinge (26) und der Achse in der proximalen Richtung aufweist; und

    ein Mittel zum Zurückziehen der Klinge (26) in einer distalen Richtung entlang eines Pfads in das Gefäßsystem eines Patienten hinein, um die Aortenklappenstenose mit der Schneidkante (42) der Klinge (26) zu inzidieren,

    wobei die Mittel zum Vorschieben und Zurückziehen ein Katheter (12) mit einem distalen Ende (14) und einem proximalen Ende (16) sind, wobei der Ballon (18) auf dem Katheter (12) in der Nähe seines proximalen Endes (16) montiert ist; und

    wobei die Klinge (26) an dem distalen Ende (30) des Ballons (18) befestigt ist, und wobei das distale Ende (28) der Klinge (26) neben dem distalen Ende (30) des Ballons (18) positioniert ist.


     
    2. Vorrichtung nach Anspruch 1, wobei der Ballon (18) ein distales Ende und ein proximales Ende aufweist, und wobei der Ballon (18), wenn er gefüllt ist, des Weiteren umfasst:

    ein im Wesentlichen konusförmiges distales Segment (34) mit einer Abschrägung mit zunehmendem Radius in der proximalen Richtung;

    ein im Wesentlichen konusförmiges proximales Segment (38) mit einer Abschrägung mit abnehmendem Radius in der proximalen Richtung; und

    ein im Wesentlichen zylindrisch geformtes Zwischensegment (36), das sich zwischen dem distalen Segment und dem proximalen Segment befindet.


     
    3. Vorrichtung nach Anspruch 1 oder Anspruch 2, wobei die Klinge (26) einen distalen Abschnitt und einen proximalen Abschnitt aufweist, wobei der distale Abschnitt an dem distalen Segment (34) des Ballons (18) befestigt ist und der proximale Abschnitt mit der scharfen Kante (42) zum Schneiden gebildet ist.
     
    4. Vorrichtung nach einem der Ansprüche 1 bis 3, wobei die Neigung der Klinge (26) relativ zu der Achse (32) durch die Abschrägung des distalen Segments (34) des Ballons (18) erzeugt wird und in einem Bereich zwischen ungefähr null Grad und ungefähr fünfundvierzig Grad (0° - 45°) liegt.
     
    5. Vorrichtung nach einem der Ansprüche 1 bis 4, des Weiteren umfassend einen Führungsdraht (22) zum Vorschieben des Katheters (12) durch das Gefäßsystem eines Patienten hindurch, um den Ballon (18) zu positionieren, um Gewebe an der Klappe zwischen der linken Herzkammer und der Aorta zu schneiden.
     
    6. Vorrichtung nach einem der vorhergehenden Ansprüche, die des Weiteren eine Vielzahl der Klingen (26) umfasst.
     
    7. Vorrichtung nach einem der Ansprüche 1 bis 6, wobei der Ballon (18) aus Polyethylennaphthalat (PEN) gefertigt ist.
     
    8. Vorrichtung nach einem der Ansprüche 1 bis 7, wobei der Ballon (18) die Klinge (26) bedeckt, wenn der Ballon in seiner entleerten Konfiguration vorliegt.
     


    Revendications

    1. Dispositif pour inciser une sténose d'une valvule aortique, le dispositif étant configuré pour être avancé dans une direction proximale à travers le système vasculaire et la valvule aortique dans le ventricule gauche du cœur, le dispositif comprenant :

    une lame allongée sensiblement rectiligne (26) possédant une extrémité proximale et une extrémité distale (28), dotée d'un bord coupant aiguisé (42) situé entre celles-ci ;

    un moyen pour faire avancer la lame allongée (26) dans une direction proximale à travers le système vasculaire et la valvule aortique afin de positionner la lame (26) en un emplacement proximal à la sténose aortique, dans lequel ledit emplacement est à l'intérieur du ventricule gauche du cœur ;

    un ballonnet (18) définissant un axe longitudinal (32) et possédant une extrémité distale (30) et une extrémité proximale pour incliner la lame (26) par rapport à l'axe du ballonnet (18) avec une distance accrue entre la lame (26) et ledit axe dans la direction proximale ; et

    un moyen pour rétracter la lame (26) dans une direction distale le long d'un trajet dans le système vasculaire d'un patient dans le but d'inciser la sténose de la valvule aortique avec le bord coupant (42) de la lame (26),

    dans lequel les moyens d'avancée et de rétraction sont un cathéter (12) possédant une extrémité distale (14) et une extrémité proximale (16), dans lequel le ballonnet (18) est monté sur le cathéter (12) près de son extrémité proximale (16) ; et

    dans lequel la lame (26) est fixée à l'extrémité distale (30) du ballonnet (18) et dans lequel l'extrémité distale (28) de la lame (26) est positionnée adjacente à l'extrémité distale (30) du ballonnet (18).


     
    2. Dispositif selon la revendication 1, dans lequel le ballonnet (18) possède une extrémité distale et une extrémité proximale et, lorsqu'il est gonflé, le ballonnet (18) comprend en outre :

    une section distale de forme sensiblement conique (34) possédant un effilement avec un rayon croissant dans la direction proximale ;

    une section proximale de forme sensiblement conique (38) possédant un effilement avec un rayon décroissant dans la direction proximale ; et

    une section intermédiaire de forme sensiblement cylindrique (36) située entre la section distale et la section proximale.


     
    3. Dispositif selon la revendication 1 ou la revendication 2, dans lequel la lame (26) possède une partie distale et une partie proximale, dans lequel la partie distale est fixée à la section distale (34) du ballonnet (18) et la partie proximale est pourvue du bord aiguisé (42) pour découper.
     
    4. Dispositif selon l'une quelconque des revendications 1 à 3, dans lequel l'inclinaison de la lame (26) par rapport à l'axe (32) est établie par l'effilement de la section distale (34) du ballonnet (18) et se situe dans une plage entre environ zéro degré et environ quarante-cinq degrés (0° à 45°).
     
    5. Dispositif selon l'une quelconque des revendications 1 à 4, comprenant en outre un fil-guide (22) pour faire avancer ledit cathéter (12) à travers le système vasculaire d'un patient afin de positionner ledit ballonnet (18) pour découper un tissu au niveau de la valvule entre le ventricule gauche du cœur et l'aorte.
     
    6. Dispositif selon l'une quelconque des revendications précédentes, comprenant en outre une pluralité desdites lames (26).
     
    7. Dispositif selon l'une quelconque des revendications 1 à 6, dans lequel ledit ballonnet (18) est en polyéthylène-naphtalate (PEN).
     
    8. Dispositif selon l'une quelconque des revendications 1 à 7, dans lequel ledit ballonnet (18) recouvre ladite lame (26) lorsque ledit ballonnet est dans sa configuration dégonflée.
     




    Drawing









    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description