Patent Description:
Microsurgical procedures frequently require precision cutting and/or removing of various body tissues.

Currently vitrectomy devices are made of an immobile outer tube with an opening on the side and an inner tube that moves up and down working as a guillotine knife to cut the vitreous (vertical cutters). The innertube movement is typically a pneumatically driven spring-return system and maximal cutting speeds of about <NUM> cuts per minute can be obtained with this technology. Lately, dual cutting ports have been invented, effectively doubling cutting speed and maintaining a <NUM>% open duty cycle (opening of the cutter port) increasing flow capacity and decreasing particle size of the vitreous material. This however does not suffices to perform a traction free vitrectomy.

<CIT> discloses systems, apparatuses, and methods of and for an ophthalmic surgical system. An ophthalmic surgical system may include a vitrectomy probe having a housing sized and shaped for grasping by a user. The vitrectomy probe may also include a cutter extending from the housing and being sized to penetrate and treat a patient eye. The cutter may include an outer cutting tube coupled to the housing. The outer cutting tube may have an outer port formed therein that is sized and shaped to receive tissue. The cutter may include a rotatable inner cutting member disposed within the outer cutting tube. The inner cutting member may include a first cutting surface that rotates across the outer port to cut the tissue when the inner cutting member is rotated. The vitrectomy probe may include a pneumatic vane actuator positioned within the housing and configured to rotate the inner cutting member.

A disadvantage of this invention is that the device is used only for cutting or aspiration and excludes multifunctional use.

<CIT> discloses vitrectomy probes and methods related thereto are disclosed herein. The disclosure describes various example vitrectomy probes having a rotational helical cutter. An example helical cutter includes an outer cutter portion and an inner cutter portion received therewithin. The inner cutter portion is operable to rotationally reciprocate within the outer cutter portion about a longitudinal axis thereof. A helical shearing surface formed at a distal end of the inner cutter portion is operable to sever material entering the cutter via a port formed in the outer cutter portion. A disadvantage of this invention is that the device is used only for cutting or aspiration and excludes multifunctional use.

A similar disadvantage exists for the vitrectomy probe with end tissue cutter disclosed in US patent publication <CIT>.

In conclusion, there is a continuous need in a multifunctional device, which can make the time of the vitrectomy operation shorter.

The present invention provides for a vitrectomy device comprising a housing and a cutter, wherein the cutter comprising an outer tube coupled to the housing, an inner tube disposed within the outer tube, the inner tube is rotatable about a longitudinal axis thereof, a drive system positioned within the housing is coupled to the inner tube and configured to rotate the inner tube, the inner tube comprises at least one opening with at least one cutting edge at the wall of the innertube at the distal end of said innertube, the outertube comprises an opening with a cutting edge at the wall of the outer tube at the distal end of said outer tube, characterized in that the inner tube comprises a plurality of openings with a plurality of cutting edges at the wall of the inner tube at the distal end of said inner tube, the cutting edges of the inner tube and the cutting edge of the outer tube are configured to form an angle with respect to one another by rotation of the inner tube, the inner tube is closed at the distal end; and the outer tube is complete open at the distal end.

In an embodiment, the inner tube has a plurality of cutting edges spaced from one another, configured to create a variable open surface opening during rotation in the overlap between the opening of the outer tube and the plurality of openings of the inner tube.

In another embodiment, the inner tube is configured to create contact between the cutting edges of the outer tube and the cutting edges of the inner tube at any time during the rotation of the innertube.

In a next embodiment, the variable open surface of opening is between <NUM>-<NUM>% of a diameter of the outer tube.

In a further embodiment, the drive system of the cutter of the vitrectomy device comprises a motor, a drive shaft and a revolving cylinder.

In some embodiments, the inner tube is removable.

In another embodiment, the revolving cylinder of the drive system of the cutter comprises multiple chambers, wherein at least one of said chambers holds the inner tube.

In a further embodiment, the revolving cylinder of the drive system of the cutter may further comprise a vitrectomy tool selected from a flute needle, a soft tipped needle / retinal dyes / intra-ocular medication.

In yet another embodiment, the motor is selected from a pneumatically driven sterilizable air-motor with high-speed rotation of at least <NUM> rpm or an electric motor with high-speed rotation of at least <NUM> rpm.

In another embodiment, at least one cutting edge of the opening of the inner tube is vertical.

In a following embodiment, at least one cutting edge of the opening of the inner tube is oblique. The opening of the outer tube is not restricted to a particular shape. In a further embodiment, the opening of the outer tube is substantially (semi)-circular. In a particular embodiment the cutting edge of the opening of the outer tube is substantially (semi)-circular.

In yet a further embodiment, the inner tube is configured as an aspiration passageway arranged to aspirate tissue from the eye.

Although not part of the claimed invention, for illustrative purposes, a method of vitrectomy is described using a vitrectomy device as defined in the appended set of claims, said method comprising the steps of.

In an embodiment, the inner tube has a plurality of cutting edges spaced from one another, creating a variable aspiration space, i.e. creating a variable open surface opening,during rotation in the overlap between the opening of the outer tube and at least one opening of the inner tube.

The present invention will be described with respect to particular embodiments and with reference to certain drawings, but the invention is not limited thereto. The drawings, as further described, are only schematic and non-limiting. In the drawings, some of the elements may not be drawn to scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to the actual reductions to practice of the invention.

Furthermore, the terms first, second, further and the like in the description and in the claims are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner.

Thus, the scope of the expression "a product comprising A and B" should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the relevant components of the product are A and B, and that further components such as C may be present.

As used herein and unless otherwise specified, the term "distal end" is to be understood as the end located away from the center of the device along a longitudinal axis of said device. The term "distal" can be generally understood in the field to mean away from the surgeon's side of the apparatus and close to the patient's side.

As used herein and unless otherwise specified, the term "revolving" is to be understood as something that moves around a longitudinal axis thereof.

As used herein and unless otherwise specified, the term "removable" is to be understood as something that can easily be moved from its place or position.

As used herein and unless otherwise specified, the term "drive system" is to be understood as a system that drives the internal parts of a vitrectomy device, e.g. gives rotation to revolving cylinder and/or the inner tube.

It is an advantage of embodiments of the current invention that different types vitrectomy tools may be used in one vitrectomy device to perform not only cutting but also other vitrectomy procedures, what increases the speed of the vitrectomy operation.

It is yet a further advantage of embodiments of the current invention that cutting edge is constantly active due to the respective configuration and the location of the cutting edges of the inner and the outer tubes.

It is also an advantage of embodiments of the current invention that due to the fast and constant cutting, the size of the cut vitreous particles is reduced and the vitreous loses the properties of a non-Newtonian fluid, which also significantly increases the aspiration rate.

It is also an advantage of embodiments of the current invention that the vitrectomy device has a continuous open aspiration port due to the respective configuration and the location of the cutting edges of the inner and the outer tubes.

We now refer to <FIG>, showing a side view of a schematic representation of the direction of the cuts <NUM> of the vitreous material, represented schematically in the form of fibers <NUM>. This figure clearly shows that the vitreous material is not cut along the fiber <NUM>, as when using vertical cutters with horizontal cutting edges, and not across the fiber <NUM>, as when using rotary cutters with vertical cutting edges, but the cut <NUM> extends at an angle to the surface of the fiber <NUM> in several places (locations).

We now refer to <FIG>, showing a side view of a vitrectomy device <NUM>, according to an embodiment of the present invention. This figure clearly shows that the vitrectomy device <NUM> comprises an outer tube <NUM> and an inner tube <NUM> (indicated also by a dotted line) with openings at their walls. In this example, the outer tube <NUM> has an opening <NUM> at its distal end. Preferably, the outer tube <NUM> has the opening <NUM> at its wall and is closed at its end. Alternatively, the outer tube <NUM> can be open at its end. Preferably, the shape of the opening <NUM> is at least substantially semi-circular and the cutting edge <NUM> of the outer tube <NUM> is also at least substantially semi-circular. Alternatively, the opening <NUM> can be substantially circular. Alternatively, the cutting edge <NUM> can be also substantially circular. Unless provided otherwise, the term "semi-circular" should be understood as an object or arrangement of objects in the form of a half circle. For example, when a circle is cut into two halves or when the circumference of a circle is divided by <NUM>, we get semi-circular shape. As used herein, the term "(semi)-circular" is meant to include both semi-circular and circular arrangements. Substantially semi-circular and substantially circular, indicates that the shape is not restricted to semi-circles or circles but includes any overall round - semi-round shape, such as an (semi)-oval, (semi)-egg shape, (semi)-ellipsoid, and the like.

The inner tube <NUM> comprises a plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM> at the distal end of said inner tube <NUM>. Preferably, the inner tube <NUM> is closed at the distal end. Preferably, the cutting edges <NUM> of the openings <NUM> of the rotating inner tube <NUM> are oblique with respect to the longitudinal axis LA of said inner tube.

<FIG> illustrates a separate side view of an outer tube <NUM> of a vitrectomy device <NUM> with a semi-circular cutting edge <NUM>, according to an embodiment of the present invention.

<FIG> illustrates a separate side view of an inner tube <NUM> of a vitrectomy device <NUM>, according to an embodiment of the present invention. This figure clearly shows that the inner tube comprises a plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM>.

We now refer to <FIG>, showing a side view of a vitrectomy device <NUM>, according to an embodiment of the present invention. This figure clearly shows that the vitrectomy device <NUM> comprises an outer tube <NUM> and an inner tube <NUM> (indicated also by a dotted line) with openings at their walls. In this example, the outer tube <NUM> has an opening <NUM> at its distal end. The opening <NUM> is semi-circular and the cutting edge <NUM> of the outer tube <NUM> is also semi-circular. The inner tube comprises a plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM> at the distal end of said inner tube <NUM>. The opening <NUM> between the cutting edges <NUM> can be of different widths. The theoretical advantage of this embodiment is that by aligning the largest opening <NUM> of the inner tube <NUM> with the opening <NUM> in the outer tube <NUM>, a larger flow rate can be achieved by merely applying suction without cutting. Preferably, the inner tube <NUM> is closed at the distal end. Preferably, the cutting edge <NUM> of the opening <NUM> of the rotating inner tube <NUM> is oblique with respect to the longitudinal axis (LA) of said inner tube.

We now refer to <FIG>, showing a side view of a vitrectomy device <NUM>, according to an embodiment of the present invention. This figure clearly shows that the vitrectomy device <NUM> comprises a housing <NUM>, that is sized and shaped for grasping by a hand of a user, and a cutter <NUM>, configured for insertion into the eye of a patient. The cutter <NUM> extends from a distal portion <NUM> of the housing <NUM> along a longitudinal axis (LA). The cutter <NUM> comprises an outer tube <NUM> coupled to and extending from the housing <NUM>. The outer tube <NUM> has an opening <NUM> on the wall at the distal end. In this example, the outer tube <NUM> is complete open at the distal end. Preferably, the outer tube <NUM> is closed at the distal end. The cutter <NUM> comprises further an inner tube <NUM> disposed within the outer tube <NUM>, the inner tube <NUM> is rotatable about a longitudinal axis thereof, which in this implementation, is coaxial with the longitudinal axis LA. The inner tube <NUM> and outer tube <NUM> fit together tightly. The inner tube <NUM> comprises at least one opening <NUM> with at least one cutting edge <NUM> at the wall of the inner tube <NUM> at the distal end of said inner tube <NUM>. In this example, the inner tube <NUM> comprises a plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM> at the distal end of said inner tube <NUM>. Preferably, the plurality cutting edges <NUM> of the inner tube <NUM> are spaced from one another. Preferably, the inner tube <NUM> is configured to create a variable open surface of the opening <NUM> during rotation in the overlap between the opening <NUM> of the outer tube <NUM> and the plurality of openings <NUM> of the inner tube <NUM>. Preferably, at least one cutting edge <NUM> of the opening <NUM> of the rotating inner tube <NUM> may be vertical, i.e. along or oblique with respect to the longitudinal axis of the inner tube Alternatively all of the cutting edges <NUM> of the plurality of openings <NUM> of the rotating inner tube <NUM> may be parallel with one another, along or oblique with respect to the longitudinal axis of the inner tube. Alternatively, at least one cutting edge <NUM> of the opening <NUM> of the rotating inner tube <NUM> may be slightly curved, i.e. smoothly rounded with respect to the longitudinal axis of the inner tube. Alternatively, all of the cutting edges <NUM> of the plurality of openings <NUM> of the rotating inner tube <NUM> may be slightly curved, i.e. smoothly rounded with respect to the longitudinal axis of the inner tube, in particular in a parallel orientation to one another. Said vertical and/or slightly curved orientations of the cutting edges <NUM> of the openings107 of the rotating inner tube <NUM> improve the cutting movement. In this example, the plurality of the cutting edges <NUM> of the opening <NUM> of the inner tube <NUM> is oblique with respect to the longitudinal axis of the inner tube. The outer tube <NUM> comprises an opening <NUM> with a cutting edge <NUM> at the wall of the outer tube <NUM> at the distal end of said outer tube <NUM>. In this example, the opening <NUM> of the outer tube <NUM> is semi-circular; in particular the cutting edge <NUM> of the outer tube <NUM> is semi-circular. Alternatively, the opening <NUM> can be substantially circular. Alternatively, the cutting edge <NUM> can be also substantially circular. The inner tube <NUM> of the cutter <NUM> is in an extreme position characterized by the fact that the distal end of the inner tube <NUM> does not extend beyond the distal end of the outer tube <NUM>, and therefore the cutting edges <NUM> of the inner tube <NUM> and the cutting edge <NUM> of the outer tube <NUM> form an angle α (shown in <FIG>) with respect to one another by rotation of the inner tube <NUM>. Preferably, the inner tube <NUM> is configured to create contact, i.e. form the angle α, between the cutting edges <NUM> of the outer tube <NUM> and at least one of the cutting edges <NUM> of the inner tube <NUM> at any time during the rotation of the inner tube <NUM>. Expressed differently, the plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM> are preferably configured to create contact between the cutting edges <NUM> of the outer tube <NUM> and at least one of the cutting edges <NUM> of the inner tube <NUM> at any turning position of the inner tube with respect to the outer tube. Such configuration provides cutting conditions at any turning position, enabling a continuous cutting at any time during the rotation of the inner tube <NUM>. It will be apparent to the skilled person, that the distance between the openings <NUM> in the inner tube <NUM> and/or the orientation of the cutting edges <NUM> can allow such a continuous cutting at any time of the rotation of the inner tube <NUM>. Preferably, the openings <NUM> are arranged in such a way that at least two cutting edges <NUM> of the inner tube <NUM> form an angle α with respect to the cutting edge <NUM> of the outer tube <NUM>. Therefore, the continuous cutting is achieved by two cuttings with every rotation of the inner tube <NUM>. Preferably, the angle α is variable and is between <NUM>° at the beginning of the cutting, when the cutting edge <NUM> of the inner tube <NUM> first contacts the cutting edge <NUM> of the outer tube <NUM>, and <NUM>° at the end of the cutting, when the cutting edge <NUM> of the inner tube <NUM> touches the last point of the cutting edge <NUM> of the outer tube <NUM>, since the cutting follows the shape of the opening <NUM>.

In a particular embodiment the cutting edges <NUM> of the plurality of openings <NUM> of the rotating inner tube <NUM> are parallelly spaced from one another in an oblique or slightly curved orientation, and the cutting edge <NUM> of the outer tube <NUM> is substantially (semi)-circular, wherein the openings <NUM> are arranged in such a way that at least two cutting edges <NUM> of the inner tube <NUM> form an angle α with respect to the cutting edge <NUM> of the outer tube <NUM>. It has been observed that such a configuration provides the best result in cutting and fast aspiration of fibrous vitreous material as it is being pulled towards the aspiration passageway of the inner tube <NUM>.

Preferably the inner tube <NUM> is removable. The vitrectomy device <NUM> comprises further a drive system <NUM> positioned within the housing <NUM>, the drive system <NUM> coupled to the inner tube <NUM> and configured to rotate the inner tube <NUM>. Preferably, the drive system <NUM> of the cutter <NUM> comprises a motor <NUM>, a drive shaft <NUM> and a revolving cylinder <NUM>. Preferably, the revolving cylinder <NUM> of the drive system <NUM> of the cutter <NUM> comprises multiple chambers <NUM>, located symmetrically about its longitudinal axis. In this example the revolving cylinder <NUM> comprises four chambers <NUM>, wherein one of said chambers <NUM> holds the inner tube <NUM>. The revolving cylinder <NUM> may further comprise a vitrectomy tool selected for example from a flute needle, a soft tipped needle / retinal dyes / intra-ocular medication etc. The inner tube <NUM> may be replaced with this vitrectomy tool in the outer tube <NUM> to perform other surgical procedures. The motor <NUM> of the drive system <NUM> is for example selected from a pneumatically driven sterilizable air-motor with high-speed rotation of at least <NUM> rpm or an electric motor with high-speed rotation of at least <NUM> rpm. The plurality of cutting edges <NUM> of the inner tube <NUM> spaced from one another creates a variable aspiration space during rotation in the overlap between the opening <NUM> of the outer tube <NUM> and the openings <NUM> of the innertube <NUM>. This configuration of the respective location of the cutting edges of the inner and the outer tubes allows the vitrectomy device <NUM> to have a continuous open aspiration port. The variable open surface of the opening <NUM> is between <NUM>-<NUM>% of a diameter of the outer tube <NUM>. At the inside, the inner tube <NUM> is an aspiration passageway arranged to aspirate tissue from the eye.

We now refer to <FIG>, showing a detailed side view of a distal end of a cutter <NUM>, according to an embodiment of the present invention. This figure clearly shows that the inner tube <NUM> comprises a plurality of openings <NUM> with a plurality of cutting edges <NUM> at the wall of the inner tube <NUM> at the distal end of said inner tube <NUM> and that the plurality of the cutting edges <NUM> of the opening <NUM> of the rotating inner tube <NUM> is oblique with respect to the longitudinal axis of the inner tube. The cutting edges <NUM> of the inner tube <NUM> and the cutting edge <NUM> of the outer tube <NUM> form an angle α with respect to one another by rotation of the inner tube <NUM>.

The method of a vitrectomy using a vitrectomy device <NUM> is carried out as follows.

The vitrectomy device <NUM> inserts into a vitreous cavity of the eye. A drive system of the cutter <NUM> of the vitrectomy device <NUM> turns on to rotate the inner tube <NUM> of the cutter <NUM> of the vitrectomy device. The vitreous material is cut by the cutter <NUM> and then is removed from said vitreous cavity by aspiration. The cutting is achieved by an angle α formed between the cutting edges <NUM> of the inner tube <NUM> and the cutting edge <NUM> of the outer tube <NUM>.

Claim 1:
A vitrectomy device (<NUM>) comprising
- a housing (<NUM>)
- a cutter (<NUM>),
wherein the cutter (<NUM>) comprises:
- An outer tube (<NUM>) coupled to the housing (<NUM>), the outer tube (<NUM>) having an opening (<NUM>) on the wall at the distal end;
- An inner tube (<NUM>) disposed within the outer tube (<NUM>), the inner tube (<NUM>) being rotatable about a longitudinal axis thereof
- a drive system (<NUM>) positioned within the housing (<NUM>), and configured to rotate the inner tube (<NUM>);
- the outer tube (<NUM>) comprising an opening (<NUM>) with a cutting edge (<NUM>) at the wall of the outer tube (<NUM>) at the distal end of said outer tube (<NUM>); wherein
- the inner tube (<NUM>) comprises a plurality of openings (<NUM>) with a plurality of cutting edges (<NUM>) at the wall of the inner tube (<NUM>) at the distal end of said inner tube (<NUM>);
- the cutting edges (<NUM>) of the inner tube (<NUM>) and the cutting edge (<NUM>) of the outer tube (<NUM>) are configured to form an angle (α) with respect to one another by rotation of the inner tube (<NUM>);
characterized in that
- the inner tube (<NUM>) is closed at the distal end; and
- the outer tube (<NUM>) ) is complete open at the distal end.