(19)
(11)EP 1 464 311 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
25.01.2006 Bulletin 2006/04

(21)Application number: 04405200.9

(22)Date of filing:  02.04.2004
(51)International Patent Classification (IPC): 
A61F 9/007(2006.01)
A61M 1/00(2006.01)

(54)

Phacoemulsification needle

Phakoemulsifikationsnadel

Aiguille de phacoemulsification


(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 PL PT RO SE SI SK TR

(30)Priority: 04.04.2003 US 406572
23.03.2004 US 806470

(43)Date of publication of application:
06.10.2004 Bulletin 2004/41

(60)Divisional application:
05023924.3

(73)Proprietors:
  • Akahoshi, Takayuki
    Tokyo 104-0051 (JP)
  • Nallakrishnan, Ravi
    Westmont, IL 60559 (US)

(72)Inventor:
  • Akahoshi, Takayuki
    Tokyo, 104-0051 (JP)

(74)Representative: Clerc, Natalia et al
Isler & Pedrazzini AG Postfach 6940
8023 Zürich
8023 Zürich (CH)


(56)References cited: : 
WO-A-96/38091
US-A- 6 126 629
US-B1- 6 491 670
US-A- 4 767 404
US-A1- 2002 099 325
  
      
    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] This invention relates to a phacoemulsification needle for an ultrasonic surgical instrument, the needle being designed for promoting cavitation in eye tissue and for the removal of fragmented lens from the eye.

    Background of the invention



    [0002] Phacoemulsification has become the preferred form of cataract, i.e. a cloudy eye lens, removal. One of the main advantages of phacoemulsification is, that only a small incision into the cornea or sclera of an eye is needed to remove the cataract. Furthermore, the removal of the cataract can be done very quickly. After the cataract is removed, an intraocular lens is inserted to replace the original lens.

    [0003] The phacoemulsification technique uses a hand held microsurgical tool known as phacoemulsifier. This phacoemulsifier comprises a handpiece and a small diameter needle with a tip to be inserted into the small incision of the eye. The needle and therefore the tip are vibrated by an ultrasonic source. It breaks the cataract into small fragments and pieces, which are sucked out through the same tip in a controlled manner. The tip is therefore designed for emulsifying, fragmenting and/or cutting tissue and also comprises a central hollow bore or lumen for the suction or aspiration of the fragments.

    [0004] During the procedure, an irrigation solution is introduced to maintain the pressure and to prevent the eye from collapsing. In order to introduce the irrigation solution, the needle is usually covered by a sleeve and the solution flows via the space between this sleeve and the needle. The solution is therefore also used to cool the tip, which is heating up during the phacoemulsification.

    [0005] Usually, the needle and often the handpiece must be changed after the removal of the cataract nucleus in order to remove the residual cortex. It takes time to change the handpiece and the continuation of the surgery is disrupted.

    [0006] US-A-5'653'724 discloses a phacoemulsification needle which is angled to provide more comfortable ergonomic angle during phacoelmulsification and lens cortex removal. This angled needle is also considered to produce less heat when emulsifying the lens. Another angled phacoemulsification needle with a concentric sleeve is disclosed in US-5'993'409.

    [0007] Different shapes of phacoemulsification needles with slits, a second infusion hole and/or with increased outside diameter at the distal end of the needle body and the needles being surrounded by sleeves are described in US-A-5'989'209, US-A-6'159'175, EP-A-1'103'238, WO 00/74615 and US 2002/0099325.

    [0008] Other techniques for cataract removal use laser energy to remove the cataract. A laser/aspiration probe is used for breaking and removing the lens. A separate infusion or irrigation probe is used for the irrigation solution.

    Summary of the invention



    [0009] It is an object of the invention to provide a phacoemulsification needle which can be used for the removal of the cataract nucleus as well as the residual cortex.

    [0010] This object is achieved with a phacoemulsification needle according to claim 1.

    [0011] With a ball-shaped or curved tip design and the opening arranged at the distal end it is possible to remove both the cataract nucleus and the residual cortex.

    [0012] This tip can be used for irrigation and aspiration without having to change the tip and therefore having the advantage that time can be saved. The tip can be used for irrigation and/or aspiration if desired. It can not only be used for phacoemulsification, but also for cortical removal and for polishing the capsule.

    [0013] The needle according to the invention can be used with or without an irrigation sleeve.

    [0014] In preferred embodiments, the tip has a ball-shaped, round, spherical, oval or smooth continuous curved shape.

    [0015] In a preferred embodiment, the tip has at its distal end rounded edges. This avoids unwished damage of tissue. Due to the inventive shape of the tip, especially its broad and smooth spherical surface area of the tip, no damage to the posterior capsule can occure.

    [0016] In a preferred embodiment, the tip comprises a slit extending in longitudinal direction of the needle. When a high vacuum setting is used with the phacoemulsifier, the anterior chamber, formed of a part of the lumen extending in the tip, becomes unstable when occlusion break occurs. In this case, small amount of irrigation fluid will continue to flow through the aspiration lumen. Furthermore, when occlusion surge occurs, the amount of surge can be reduced. Instead of the slit, an opening can be provided in a region adjacent to the tip.

    [0017] The tip can comprise more than one opening of the lumen, these openings being arranged in the region of the distal end. This embodiment even increases the safety from rupturing the posterior capsule.

    [0018] Further preferred embodiments of the invention are described in the dependent claims.

    Brief description of the drawings



    [0019] The present invention will be more clearly understood with reference to the following detailed description of preferred embodiments, taken in conjunction with the accompanying drawings, in which
    Figure 1
    shows a perspective view of a needle according to the invention in a first embodiment;
    Figure 2
    shows a side view of the needle according to figure 1;
    Figure 3
    shows a longitudinal view of the needle according to figure 1;
    Figure 4
    shows a magnified part of the needle tip according to figure 3;
    Figure 5
    shows a front view of the needle according to figure 1;
    Figure 6
    shows a front view of a needle according to a second embodiment;
    Figure 7
    shows a perspective view of a needle according to the invention in a third embodiment;
    Figure 8
    shows a side view of the needle according to figure 7;
    Figure 9
    shows a longitudinal view of the needle according to figure 7;
    Figure 10
    shows a magnified part of the needle tip according to figure 7;
    Figure 11
    shows a front view of the needle according to figure 7;
    Figure 12
    shows a side view perspective view of a needle according to the invention in a fourth embodiment;
    Figure 13
    shows a longitudinal view of the needle according to figure 12;
    Figure 14
    shows a magnified part of the needle tip according to figure 13;
    Figure 15
    shows a front view of the needle according to figure 12;
    Figure 16
    shows a side view of a needle according to the invention in a fifth embodiment;
    Figure 17
    shows a longitudinal of the needle according to figure 16;
    Figure 18
    shows a magnified part of the needle tip according to figure 17;
    Figure 19
    shows a longitudinal view of a needle according to a sixth embodiment;
    Figure 20
    shows a perspective view of the needle according to figure 19 and
    Figure 21
    shows a front view of the needle according to figure 19.

    Description of the preferred embodiments



    [0020] With reference to figures 1 and 2, there is shown a phacoemulsification needle in accordance with the present invention. The needle may be formed from any conventional material as is known in the art for the manufacture of phacoemulsification needles. Usually, it is made of titan.

    [0021] The needle comprises, starting with its proximal end and ending with its distal end, a threaded portion 1, a hub 2, a shaft 3 and a tip 6 having at least one opening. The threaded portion 1 and the hub 2 are used to fix the needle on a ultrasonic device of the phacoemulsification handpiece (not shown) in order to couple ultrasonic energy to the needle.

    [0022] The needle further comprises, with reference to figures 3 and 4, an aspiration lumen 4 extending through the whole longitudinal length of the needle shaft 3 and communicating with the opening of the tip for aspiration of irrigation fluid and therefore for removal of fragments and pieces of the cataract nucleus and residual cortex. Preferably, the lumen 4 comprises a first step 40 in the region of the hub 2 neighboring the shaft 3. The first diameter d1 of the part of the lumen extending within the hub 2 is therefore larger than the second diameter d2 of the lumen part extending within the shaft 2. This first step 40 has preferably a conical shape.

    [0023] A second step 41, which has preferably also a conical shape, is located within the tip 6, wherein the second diameter d2 is smaller than a third diameter d3 of the lumen part extending within the shaft 2. This diameter d3 corresponds with the diameter of the opening of the tip 6.

    [0024] With exception of the steps 40, 41, the lumen 4 preferably has throughout its whole length the same size. In particular the lumen part extending in the tip 6 has a cylindrical shape.

    [0025] The shaft 3 is preferably angled. However, it is also possible to have a rectilinear shaft. In the here described embodiment however, the shaft 3 comprises an angled portion 5 neighboring the tip 6. The aspiration lumen 4 within the tip extends in a rectilinear way.

    [0026] The tip 6 as shown in figure 5 as well and which is arranged at the distal end of the shaft 3, has a larger outer diameter D1 than the outer diameter D2 of the shaft 3. Furthermore, it has a ball-shaped surface 60 and a flat distal end 62. In this preferred embodiment, the flat distal end 62 is formed by the opening. However, the opening can also be smaller, so that the end face of the tip 6 is flat. In the here described embodiment however, the end face is formed by rounded blunt edges 61. The above mentioned second step 41 is preferably located in the tip 6 itself at a distance to the transition of the ball-shaped surface 60 to the surface of the shaft 3. In figure 4, a curved line 1 is shown at the distal end of the tip 6. This line 1 is just an auxiliary line showing that, with exception of the flat distal end, the tip has a completely spherical surface.

    [0027] A preferred embodiment of the inventive needle has an outer diameter D2 for the shaft 2 of approximately 1.06 mm, an outer diameter D1 of the tip 6 of approximately 1.6 mm, a first diameter d1 of the lumen 4 of approximately 1.32 mm, a second diameter d2 of approximately 0.72 mm, a third diameter d3 of approximately 0.8 mm, a length L of the tip 5 (extending up to the curved line 1) of approximately 1.46 mm and a distance X from the curved line 1 to the second step 41 of approximately 1.05 mm. The radius of curvature of the rounded edges 61 is approximately 0.15 mm, the angle of the first step 40 approximately 34° and the angle of the second step 41 approximately 30°. The angle γ between shaft 3 and tip 4 lays between 10 and 15°. Here it is approximately 15°. The total length of the needle up to the curved line 1 is approximately 30.15 mm.

    [0028] Figure 6 shows a second preferred embodiment of the needle according to the invention. The needle is built in the same way as the needle according to the previously described figures. The only difference is, that this tip 6 comprises a slit 7 extending in longitudinal direction of the needle, which communicates with the aspiration lumen 4.

    [0029] Figures 7 to 11 show a third embodiment of the needle according to the invention. The threaded portion 1 is slightly shorter than the one shown in figure 2. The hub 2 has not a generally circular cross section but a rectangular, preferably a quadratic one. This hub 2 and this threaded portion 1 can also be used with the tips disclosed in the other embodiments and the hup and threaded portion disclosed in figure 2 can be used with this tip.

    [0030] The aspiration lumen 4 extending through the needle shaft 3 comprises a second step 41 like the one shown in figure 1. However, this second step 41 is arranged is located outside of the tip 6. This second step 41 is in this case preferably arranged behind the angled portion 5. If the shaft 3 is rectilinear, the second step 41 is preferably arranged in a distance behind the tip 6 which has approximately the same length as the tip 6. This step 41 reduces the cross section of the lumen 4. In addition, no first step is located within the hub 2.

    [0031] This second step 41 however can also be arranged in the tip 6. Furthermore, instead of this step, the second step according to figure 2 can be used. The embodiment according to figure 2 can also have the second step 41 being arranged in the shaft 3 instead in the tip 6, wherein the second step 41 can reduce or increase the cross section of the opening at the distal end 62. Furthermore, this second step can, but must not be conical.

    [0032] Since the opening at the distal end 62 according to this third embodiment, the tip 6 has a curved shape, which is slightly different to the one of the first embodiment. The distal end 62 is less flat and the curved line 1 is shorter.

    [0033] Figures 12 to 15 show a fourth embodiment of the invention. In this embodiment, an opening 8 in the shape of a circular hole is located behind the tip 6. If the shaft 3 is angled, this opening 8 is preferably located in the angled portion 5. This opening 8 communicates with the aspiration lumen 4. Like the slit 7, this opening 8 helps when the anterior chamber, formed of a part of the lumen extending in the tip, becomes unstable when occlusion break occurs. In this case, small amount of irrigation fluid will continue to flow through the aspiration lumen. Furthermore, when occlusion surge occurs, the amount of surge can be reduced by this slit 7 or this opening 8. This fourth embodiment can also comprise instead of the opening 8 the slit 7 shown in figure 6.
    Figures 16 to 18 show a fifth embodiment of the invention. Here, there exists no second step 41, neither in the shaft 3 nor in the tip 6. This embodiment can be used with the opening 8 or the slit 7 or without any of them. Furthermore, any of the above mentioned embodiments can comprise the opening 8 as well as the slit 7.

    [0034] A sixth embodiment, which is not part of the present invention, is shown in the figures 19 to 21. The first and second steps 40 and 41 can be arranged or being nonexistent as described in any of the previous embodiments. Furthermore, this embodiment can comprises an opening 8 and/or a slit 7 or none of them. The tip 6 of this embodiment still has a curved shaped. This embodiment however comprises instead of the flat distal end 62 being defined by a distal opening of the lumen 4 at least two openings 63 of the lumen 4 being arranged in the region of the distal end 62. Here, we have such four openings 63. However, there can also be three, five or more openings. Preferably, the are arranged in a symmetrical manner around the longitudinal axis A defined by the shaft 3. These openings 63 have like the single opening of the other embodiments blunt or rounded edges 61. In order to communicate with these openings 63, the lumen 4 is divided into sublumens 4', each sublumen 4' ending in one of the mentioned openings 63. This division is preferably made only in the tip 6. If a slit 7 or an opening 8 are provided, they can be arranged in the region of the undivided lumen 4" or the different sublumens 4' can comprise a subslit each ending in a common slit 7 or each sublumen 4'' can comprise an one opening 8.

    [0035] In the above description, the shape of the tip was normally described a ball-shaped. However, the tip 6 can have a generally curved shape, preferably a ball-shaped, round, spherical, oval or smooth continuous curved shape.

    [0036] The needle according to the invention can be used for the ultrasonic part of the phacoemulsification procedure, i.e. for the removal of the cataract nucleus, as well as for the irrigation/aspiration part of the procedure, i.e. for the removal of the residual tissue.

    List of reference numbers



    [0037] 
    1
    threaded portion
    2
    hub
    3
    shaft
    4
    lumen
    4'
    sublumen
    4''
    undivided lumen
    40
    first step
    41
    second step
    5
    angled portion
    6
    tip
    60
    ball-shaped surface
    61
    rounded edges
    62
    flat distal end
    63
    opening of the lumen
    7
    slit
    8
    opening
    d1
    first diameter
    d2
    second diameter
    d3
    third diameter
    D2
    outside diameter of the shaft
    D1
    outside diameter of the tip
    L
    length of the tip
    I
    curved line
    X
    distance
    γ
    angle
    A
    longitudinal axis



    Claims

    1. A phacoemulsification needle comprising
    a shaft (3),
    a tip (6), disposed at a distal end of said shaft (3), said tip (6) having a larger outer diameter than said shaft, and an aspiration lumen (4) extending through said shaft (3) and said tip (6), the tip (6) having an opening communicating with said aspiration lumen (4),
    characterized in that said tip (6) has a flat distal end (62) comprising said opening and that said tip (6) has a smooth, continuous curved shape with exception of said flat distal end (62), and that said opening has rounded edges (61).
     
    2. The needle according to claim 1, wherein said tip (6) has a ball-shaped surface with exception of said flat distal end (62).
     
    3. The needle according to claim 1 or 2, wherein said opening is disposed centrally in said tip (6).
     
    4. The needle according to claim 1, wherein said tip (6) has at its distal end rounded edges.
     
    5. The needle according to claim 1, wherein the part of said aspiration lumen (4) extending within the tip (6) is rectilinear.
     
    6. The needle according to claim 1, wherein the needle is angled.
     
    7. The needle according to claim 1, wherein said opening has a larger diameter than the part of the aspiration lumen (4) extending within said shaft (3).
     
    8. The needle according to claim 1, wherein said opening has a smaller diameter than the part of the aspiration lumen (4) extending within said shaft (3).
     
    9. The needle according to claim 1, wherein said aspiration lumen (4) comprises a step (41) within the tip (6).
     
    10. The needle according to claim 1, wherein said aspiration lumen (4) comprises a step (40) within the shaft (3).
     
    11. The needle according to claim 1, wherein said opening has a diameter of 0.3 mm to 0.8 mm.
     
    12. The needle according to claim 4, wherein said edges have a radius of curvature of 0.1 mm to 0.15 mm.
     
    13. The needle according to claim 1, wherein said tip (6) comprises a slit (7) extending in longitudinal direction of the needle and communicating with said aspiration lumen (4).
     
    14. The needle according to claim 1, wherein said shaft (3) comprises an opening extending through its surface, the opening communicating with said aspiration lumen (4).
     
    15. The needle according to claim 2, wherein said opening has a diameter of approximately 0.8 mm.
     
    16. The needle according to claim 2, wherein said tip (6) has at its distal end (62) rounded edges and wherein said edges have a radius of curvature of approximately 0.15 mm.
     


    Ansprüche

    1. Phakoemulsifikationsnadel, aufweisend
    einen Schaft (3),
    eine an einem distalen Ende des Schafts (3) angeordnete Spitze (6), welche einen grösseren Aussendurchmesser als der Schaft aufweist, und
    ein Aspirationslumen (4), welches sich durch den Schaft (3) und die Spitze (6) hindurch erstreckt, wobei die Spitze (6) eine Öffnung aufweist, die mit dem Aspirationslumen (4) kommuniziert,
    dadurch gekennzeichnet, dass die Spitze (6) ein flaches distales Ende (62) aufweist, welches die Öffnung enthält, und dass die Spitze (6) eine glatte, kontinuierliche gebogene Form mit Ausnahme von des flachen distalen Endes (62) aufweist, und dass die Öffnung abgerundete Kanten (61) aufweist.
     
    2. Nadel nach Anspruch 1, wobei die Nadel (6) eine kugelförmige Oberfläche mit Ausnahme des flachen distalen Endes (62) aufweist.
     
    3. Nadel nach Anspruch 1 oder 2, wobei die Öffnung in der Spitze (6) zentral angeordnet ist.
     
    4. Nadel nach Anspruch 1, wobei die Spitze (6) an ihrem distalen Ende abgerundete Kanten aufweist.
     
    5. Nadel nach Anspruch 1, wobei der Teil des Aspirationslumens (4), welcher sich innerhalb der Spitze (6) erstreckt, geradlinig ist.
     
    6. Nadel nach Anspruch 1, wobei die Nadel abgewinkelt ist.
     
    7. Nadel nach Anspruch 1, wobei die Öffnung einen grösseren Durchmesser als derjenige Teil des Aspirationslumens (4) aufweist, der sich innerhalb des Schafts (3) erstreckt.
     
    8. Nadel nach Anspruch 1, wobei die Öffnung einen kleineren Durchmesser als derjenige Teil des Aspirationslumens (4) aufweist, der sich innerhalb des Schafts (3) erstreckt.
     
    9. Nadel nach Anspruch 1, wobei das Aspirationslumen (4) eine Stufe (41) innerhalb der Spitze (6) aufweist.
     
    10. Nadel nach Anspruch 1, wobei das Aspirationslumen (4) eine Stufe (40) innerhalb des Schafts (3) aufweist.
     
    11. Nadel nach Anspruch 1, wobei die Öffnung einen Durchmesser zwischen 0,3 mm und 0,8 mm aufweist.
     
    12. Nadel nach Anspruch 4, wobei die Kanten einen Krümmungsradius zwischen 0,1 mm und 0,15 mm aufweisen.
     
    13. Nadel nach Anspruch 1, wobei die Spitze (6) einen Schlitz (7) aufweist, der sich in einer Längsrichtung der Nadel erstreckt und mit dem Aspirationslumen (4) kommuniziert.
     
    14. Nadel nach Anspruch 1, wobei der Schaft (3) eine sich durch seine Oberfläche erstreckende Öffnung aufweist, und wobei die Öffnung mit dem Aspirationslumen (4) kommuniziert.
     
    15. Nadel nach Anspruch 2, wobei die Öffnung einen Durchmesser von ungefähr 0,8 mm aufweist.
     
    16. Nadel nach Anspruch 2, wobei die Spitze (6) an ihrem distalen Ende (62) abgerundete Kanten aufweist und wobei diese Kanten einen Krümmungsradius von ungefähr 0,15 mm aufweisen.
     


    Revendications

    1. Aiguille de phacoémulsification, comprenant:

    une tige (3),

    une pointe (6) disposée à une extrémité distale de ladite tige (3), ladite pointe (6) présentant un diamètre extérieur plus grand que ladite tige, et

    une lumière d'aspiration (4) s'étendant à travers ladite tige (3) et ladite pointe (6), la pointe (6) comportant une ouverture communiquant avec ladite lumière d'aspiration (4),


    caractérisée en ce que ladite pointe (6) présente une extrémité distale plate (62) comprenant ladite ouverture, et en ce que ladite pointe (6) présente une forme courbe continue régulière à l'exception de ladite extrémité distale plate (62), et en ce que ladite ouverture comporte des bords arrondis (61).
     
    2. Aiguille selon la revendication 1, dans laquelle ladite pointe (6) présente une surface en forme de bille à l'exception de ladite extrémité distale plate (62).
     
    3. Aiguille selon la revendication 1 ou 2, dans laquelle ladite ouverture est disposée d'une façon centrale dans ladite pointe (6).
     
    4. Aiguille selon la revendication 1, dans laquelle ladite pointe (6) présente des bords arrondis à son extrémité distale.
     
    5. Aiguille selon la revendication 1, dans laquelle la partie de ladite lumière d'aspiration (4) s'étendant à l'intérieur de la pointe (6) est rectiligne.
     
    6. Aiguille selon la revendication 1, dans laquelle l'aiguille est coudée.
     
    7. Aiguille selon la revendication 1, dans laquelle ladite ouverture présente un diamètre plus grand que la partie de la lumière d'aspiration (4) s'étendant à l'intérieur de ladite tige (3).
     
    8. Aiguille selon la revendication 1, dans laquelle ladite ouverture présente un diamètre plus petit que la partie de la lumière d'aspiration (4) s'étendant à l'intérieur de ladite tige (3).
     
    9. Aiguille selon la revendication 1, dans laquelle ladite lumière d'aspiration (4) comporte un gradin (41) à l'intérieur de ladite pointe (6).
     
    10. Aiguille selon la revendication 1, dans laquelle ladite lumière d'aspiration (4) comporte un gradin (40) à l'intérieur de la tige (3).
     
    11. Aiguille selon la revendication 1, dans laquelle ladite ouverture présente un diamètre compris entre 0,3 mm et 0,8 mm.
     
    12. Aiguille selon la revendication 4, dans laquelle lesdits bords présentent un rayon de courbure compris entre 0,1 mm et 0,15 mm.
     
    13. Aiguille selon la revendication 1, dans laquelle ladite pointe (6) comporte une fente (7) s'étendant dans la direction longitudinale de l'aiguille et communiquant avec ladite lumière d'aspiration (4).
     
    14. Aiguille selon la revendication 1, dans laquelle ladite tige (3) comporte une ouverture s'étendant à travers sa surface, l'ouverture communiquant avec ladite lumière d'aspiration (4).
     
    15. Aiguille selon la revendication 2, dans laquelle ladite ouverture présente un diamètre approximativement égal à 0,8 mm.
     
    16. Aiguille selon la revendication 2, dans laquelle ladite pointe (6) présente des bords arrondis à son extrémité distale (62), et dans laquelle lesdits bords présentent un rayon de courbure approximativement égal à 0,15 mm.
     




    Drawing