NL2036993B1

NL2036993B1 - An ophthalmic surgical phacoemulsification device, a kit of parts and methods

Info

Publication number: NL2036993B1
Application number: NL2036993A
Authority: NL
Inventors: Van 't Hof Pieter; Clements Vervaet Joost; Wörsdörfer Stefan; Timmerman Lars; Christianus Gähler Martinus
Original assignee: D O R C Dutch Ophthalmic Res Center International B V
Priority date: 2024-02-08
Filing date: 2024-02-08
Publication date: 2025-08-20
Also published as: WO2025170471A1

Abstract

Title: An ophthalmic surgical phacoemulsification device, a kit of parts and methods Abstract The invention relates to an ophthalmic surgical phacoemulsiﬁcation device. The device has an elongate housing extending along a longitudinal axis, a tip mounted to the distal end of the elongate housing and aligned With the longitudinal axis, and a sonotrode arranged for actuating the tip. The elongate housing has an interior accommodating the sonotrode such that the sonotrode is positioned so as to actuate the tip. Further, the elongate housing interior is provided With an elongate cavity, proximal to the sonotrode, for removably receiving a reusable driver unit containing a piezoelectric module for driving the sonotrode. Fig. 3

Description

P136713NL00

Title: An ophthalmic surgical phacoemulsification device, a kit of parts and methods

The invention relates to an ophthalmic surgical phacoemulsification device.

Phacoemulsification is known as a process for disintegration of the lens of an eye utilizing an ophthalmic surgical phacoemulsification device vibrating at ultrasonic frequencies. Such phacoemulsification device includes a driver unit containing a piezoelectric module for actuating, via a sonotrode, a needle having a cutting tip which is vibrated at ultrasonic frequencies to disintegrate cataractic tissue in the eye. The phacoemulsification device further includes an irrigation system and an aspiration system for irrigating and aspirating, respectively, the interior of the eye, during surgery.

Known phacoemulsification devices integrate fluidics systems into a completely reusable handpiece, requiring sterilization after each use, more specifically autoclave sterilization, in order to counteract cross- contamination between uses. With sterilization facilities possibly not being available, and sustainability concerns with autoclave sterilization, the need for sterilization poses an issue.

Also disposable phacoemulsification devices are known. Although disposable devices do not require sterilization after use, costs are relatively high, including environmental costs.

It is an object of the present invention to provide an ophthalmic surgical phacoemulsification device having a relatively low cleaning or sterilization requirement, while counteracting disposing material. Thereto, according to the invention, an ophthalmic surgical phacoemulsification device is provided, comprising an elongate housing extending along a longitudinal axis and having a distal end and a proximal end, a tip mounted to the distal end of the elongate housing and aligned with the longitudinal axis, and a sonotrode having a distal end and a proximal end, arranged for actuating the tip, wherein the elongate housing has an interior accommodating the sonotrode at a distal end thereof such that the distal end of the sonotrode is positioned so as to actuate the tip, and wherein the elongate housing interior is provided with an elongate cavity, proximal to the sonotrode, for removably receiving a reusable driver unit containing a piezoelectric module for driving the sonotrode.

The invention 1s at least partly based on the insight that a component, in particular a driver unit, that does not come into contact with patient material does not require sterilization, in principle. Similarly, the invention is also at least partly based on the insight that, on the other hand, components that do come into contact with patient material need to be sterile.

By providing a design wherein the driver unit may be removably received in a separate cavity of a phacoemulsification device, the driver unit can be kept away from sterile components, and can be removed from the device, for reuse. As such, driving electronics of the driver unit does not come into contact with patient material, thereby preserving contamination thereof. Then, not all components are disposed, after single use, thus saving environmental costs, while cleaning requirements are low. Advantageously, the sterile components and the non-sterile driver unit may be optimized for their respective functionality, arriving at a hybrid design exploiting a disposable end effector and a reusable driver unit combining into a fully usable handpiece.

The reusable part has a reduced production cost compared to the prior fully reusable design. It has an increased durability compared to the prior design. And it enables a more repairable design as no permanent sealing methods against autoclave sterilization are needed.

The complete design has a vastly reduced environmental impact considering its complete life cycle.

The ophthalmic surgical phacoemulsification device may include an irrigation passage for flowing irrigation fluid towards the tip, comprising an irrigation chamber formed radially between the distal body part of the sonotrode and the elongate housing. Also, an aspiration passage may be provided for flowing aspiration fluid from the tip, the aspiration passage comprising a channel extending through the sonotrode. Then, the fluid line design ensures that the passages do not come into contact with the reusable driver unit including vulnerable electronics. The fluid passage design also inhibits the exterior of the elongate housing which is used for sterile handling of the assembled device.

In an advantageous embodiment, the sonotrode comprises a first sealing barrier sealingly separating an irrigation passage from an aspiration passage. The sealing barrier may include a first annular shaped sealing member arranged at a first axial position around the sonotrode, at a proximal side thereof. By sealingly separating the irrigation passage from the aspiration passage, sterile components are effectively separated from each other.

Advantageously, by providing the sonotrode with a second sealing barrier, for sealing, together with the first sealing barrier, the aspiration passage, both the irrigation passage and the aspiration passage are sealingly separated from the non-sterile and reusable driver unit. Then, the first and second sealing barriers closes off the aspiration passage and the irrigation passage from a remaining part of the assembled handpiece.

The sonotrode may be provided with coupling means, such a screw connection, for coupling to the removable driver unit, thereby facilitating the transmission of ultrasound from the reusable driver unit, via the sonotrode, to the tip of the disposable device.

After the cavity has received the reusable driver unit, a hybrid handpiece may be formed including both a disposable ophthalmic surgical phacoemulsification device and a reusable driver unit contained in the cavity of the device.

Generally, in the assembly of sterile medical devices comprising two components assembled through a threaded connection, specific torque applications might be required. When two threaded components are assembled in operating rooms they either have no torque requirement or they have a torque requirement and they use a torque wrench-like device, such as in the application of dental scaler tips, to reach this torque requirement. These devices pose a problem in that they require sterilization after each use for proper infection prevention control. In the application of a phacoemulsification device with a disposable component and a reusable driver unit that is designed to not require sterilization this sterilization requirement poses an issue.

Optionally, a phacoemulsification package is provided, comprising an ophthalmic surgical phacoemulsification device according to claim 1, a reusable driver unit removably receivable or received in the elongate cavity of the elongate housing interior of the device, and a package unit sealingly enclosing the ophthalmic surgical phacoemulsification device, wherein the package unit holds the ophthalmic surgical phacoemulsification device such that the ophthalmic surgical phacoemulsification device is blocked against rotation around the longitudinal axis of the elongate housing until a torque greater than a predefined value is applied to the ophthalmic surgical phacoemulsification device.

By shipping the ophthalmic surgical phacoemulsification device into a package unit, packaging features can be used for ensuring that a threaded connection has the right torque applied to it before enabling the packaging to be opened.

Advantageously, the device is blocked against rotation until a sufficient great torque is applied, adequately informing the user when the right torque has been achieved.

In a specific embodiment, the elongate housing of the ophthalmic surgical phacoemulsification device has an exterior surface provided with a local geometrical anomaly, such as a hole or indent, wherein the package unit has a section provided with a contour adjacent to and corresponding 5 with the local geometrical anomaly of the elongate housing exterior surface, such as a rib, ridge or bump, said package unit section being deformable if a torque applied to the ophthalmic surgical phacoemulsification device is greater than the predefined value. It is noted that the anomaly structure may be applied in an alternate manner, viz. the exterior surface of the device having a rib, ridge or bump, while the package unit section has a corresponding hole or indent.

Dimensioning of the rib, ridge or bump is chosen in such a way that it collapses under a specific torque applied to the device, making the whole part turn around its axis. Then, no additional tooling is required for the applying the required torque, whie still enabling a sterile assembly.

Advantageously, the package unit may be arranged such that upon deformation of the package unit section, the package unit opens or a structure disabling the package unit to be unit is disarmed, thereby guaranteeing that the package unit is opened after the right torque has been applied. Alternatively, a visual indication on the package may be enabled to show that a right torque has been applied.

In short, a faster assembly is obtained, as well as a more sustainable design wherein no additional sterilization is required for each use.

In assembling a non-sterile reusable with a cable and/or tubing and a sterile disposable part of a medical device within the sterile field, handling is an issue. A person within the sterile field cannot handle both components directly, as one is non-sterile, and a person outside the sterile field cannot handle both components directly, as one is sterile.

Existing solutions in non-sterile reusables and sterile disposables exist in the shape of a reusable device with a disposable sterile sleeve used to pack the reusable in plastic, such as transducers for ultrasound imaging, endoscope applications, or dental drills. If more functions are addressed in the disposable, such as specific connection methods or fluidics, alongside this sterile barrier, existing solutions fall short, as they only focus on applying the sterile barrier.

In surgical applications interaction between a non-sterile person and sterile person are minimized for effective infection prevention control.

This interaction is mevitable with a proposed hybrid design.

Advantageously, a package unit containing a sealed ophthalmic surgical phacoemulsification device may further comprise a sterile sleeve arranged to be unfolded or unrolled, wherein the sterile sleeve is connected, at a first end, to the proximal end of the elongate housing, and, at a second end, opposite to the first end, to an inner side of the package unit, preferably near the proximal end of the elongate housing. Then, sterile handing of the non-sterile person may be facilitated, as well as a sterile handover method, and an applicable sterile barrier.

The exterior of the package unit can be handled by a non-sterile person, through which this person can assemble the non-sterile reusable component. The package unit can be opened revealing the sterile disposable with reusable assembled. This opened packaging can be presented to the sterile person, which makes the packaging into a physical barrier between the non-sterile hands and sterile hands.

In removing the assembled medical device from its packaging, a sterile barrier sleeve is unfolded or unrolled over the cable and/or tubing, which is connected on one end to the disposable part of the medical device and on the other end to the packaging. The packaging can thus be considered part of the disposable part of the medical device.

In short, not only a sterile solution is provided to assembly of a disposable and reusable component, but also an approach is obtained that prioritizes usability and assembly speed during application.

In addition, the invention relates to a method.

Further advantageous embodiments according to the invention are described in the following claims.

The invention also relates to a kit of parts.

Further, the invention relates to a method of assembling an ophthalmic surgical phacoemulsification device, and to a method of de- assembling an ophthalmic surgical phacoemulsification device.

It should be noted that the technical features described above or below may each on its own be embodied in a system or method, i.e. isolated from the context in which it is described, separate from other features, or in combination with only a number of the other features described in the context in which it is disclosed. Each of these features may further be combined with any other feature disclosed, in any combination.

The invention will now be further elucidated on the basis of a number of exemplary embodiments and an accompanying drawing. In the drawing:

Fig. 1 shows a first schematic cross-sectional view of an ophthalmic surgical phacoemulsification device according to the invention;

Fig. 2 shows a second schematic cross-sectional view of the ophthalmic surgical phacoemulsification device shown in Fig. 1;

Fig. 3 shows a perspective schematic partial view of the ophthalmic surgical phacoemulsification device shown in Fig. 1, partially cut away;

Fig. 4 shows a first perspective schematic view of a package unit with the ophthalmic surgical phacoemulsification device shown in Fig. 1;

Fig. 5 shows a second perspective schematic view of the package unit shown in Fig. 4 wherein the ophthalmic surgical phacoemulsification device has received a reusable driver unit;

Fig. 6 shows a first cross-sectional schematic view of the package unit shown in Fig. 5;

Fig. 7 shows a second cross-sectional schematic view of the package unit shown in Fig. 5;

Fig. 8 shows a third perspective schematic view of the package unit shown in Fig. 4 wherein the ophthalmic surgical phacoemulsification device is being removed from the package unit;

Fig. 9 shows a flow chart of a method of assembling according to the invention, and

Fig. 10 shows a flow chart of a method of de-assembling according to the invention.

It is noted that the figures show merely a preferred embodiment according to the invention. In the figures, the same reference numbers refer to equal or corresponding parts.

Figure 1 shows a first schematic cross-sectional view of an ophthalmic surgical phacoemulsification device 1 according to the invention.

The ophthalmic surgical phacoemulsification device 1, also referred to as phaco device 1, is used for modern-day cataract surgery that employs ultrasound energy for emulsifying the internal lens of the eye.

Figure 2 shows a second schematic cross-sectional view of the ophthalmic surgical phacoemulsification device shown in Fig. 1.

The phaco device 1 is formed as a disposable unit, and includes an elongate housing 2 extending along a longitudinal axis A, forming a handpiece. The elongate housing 2 has a distal end 3 and a proximal end 4.

Further, the phaco device 1 includes a tip 5 mounted to the distal end 3 of the elongate housing 2 and aligned with the longitudinal axis A. As shown in Figs. 1 and 2, the phaco device 1 has a sonotrode 6 having a distal end 6a and a proximal end 6b, arranged for actuating the tip 5. In operation, a reusable driver unit 7 containing a piezoelectric module is used for driving the sonotrode 6.

The elongate housing 2 has an interior 8 accommodating both the sonotrode 6 and the reusable driver unit 7. The interior 8 has a distal end 8a where the sonotrode 6 is placed such that the distal end 6b of the sonotrode 6 1s positioned so as to actuate the tip 5. Further, the elongate housing interior 8 is provided with an elongate cavity 9, proximal to the sonotrode 6, for removably receiving the reusable driver unit 7.

The phaco device 1 is designed for sterile, single use, as a disposable unit, while being provided, during operation, with a reusable driver unit 7 that can be removed from the phaco device 1, after surgical use, for use in another disposable phaco device 1.

In the shown embodiment, the reusable driver unit 7 has a cylindrical shape around a body axis B removably fitting in the elongate cavity 9 of the housing interior 8. The piezoelectric module of the reusable driver unit 7 is provided with a multiple number of annular shaped piezoelectric segments 7a-d arranged concentrically next to each other along the body axis of the driver unit 7. Generally, design characteristics of the reusable driver unit 7 may vary, e.g. in terms of geometry, dimensions and number of piezoelectric segments 7a-d.

Generally, the sonotrode 6 and the cavity 9 may be placed in series, and aligned with the longitudinal axis A. As shown in Fig. 1, the phaco device 1 has a wall 10 in the housing interior 8, e.g. a cylindrical wall 10, bounding the elongate cavity 9.

Further, generally, the tip 5, the sonotrode 6 and the reusable driver unit 7 are located such that ultrasound vibrations may be transferred from the reusable driver unit 7 to the sonotrode 6, and from the sonotrode 6 to the tip 5, e.g. by contacting each other.

The proximal end 6b of the sonotrode 6 may be provided with coupling means for coupling to the reusable driver unit 7. Alternatively, neither the sonotrode 6 nor the reusable driver unit 7 is provided with coupling means. Then, as an example, the reusable driver unit 7 may be firmly locked into the cavity 9 for mechanically driving the sonotrode 6.

Figure 3 shows a perspective schematic partial view of the ophthalmic surgical phacoemulsification device 1 shown in Fig. 1, partially cut away. Here, the coupling means for coupling the sonotrode 6 to the reusable driver unit 7 include a screw connection formed by an external screw thread 12 on a pin 11 extending from the driver unit 7 towards the sonotrode 6, and an internal screw thread 13 at the proximal end 6b of the sonotrode 6.

In the shown embodiment, the sonotrode 6 has a proximal body part 14, at its proximal end 6b, a distal body part 15, at its distal end 6a, and a transitional body partl6 extending between the proximal body part 14 and the distal body part 15. The proximal and distal body parts 14, 15 may have a substantially non-varying cross section, as a disc, while the transitional body part 16 may have a contour gradually running from the proximal body part radius to the distal body part radius. In practice, the proximal body part 14, the transitional body part 16 and the distal body part 15 may form an integral unit. As a passive structure, the design of the sonotrode 6 transfers the ultrasound energy from the driver unit 7 to the tip 5, modulating vibration amplitudes. As an alternative to the shown embodiment, the sonotrode 6 may be formed from separate parts and/or may include further parts.

The phaco device 1 in the shown embodiment is further provided with an irrigation passage for flowing irrigation fluid towards the tip 5. The irrigation passage is connected to an irrigation tube in the tip 5, and includes an irrigation chamber 17 formed radially between the distal body part 15 of the sonotrode 6 and the elongate housing 2. The irrigation passage further includes an irrigation channel 18 extending between the irrigation chamber 17 and a an irrigation entry port 19 connectable to an irrigation line 20. During an irrigation process, irrigation fluid flows from the irrigation line 20, via the irrigation entry port 19 and, subsequently, via the irrigation channel 18 towards the irrigation chamber 17 and subsequently to the tip 5 for irrigating the eye interior.

The phaco device 1 in the shown embodiment is further provided with an aspiration passage for flowing aspiration fluid from the tip 5. The aspiration passage is connected to an aspiration tube in the tip 5, and includes an aspiration channel 21 extending through the sonotrode 6, in the shown embodiment through both the distal sonotrode part 15 and the proximal sonotrode part 14. The aspiration channel 21 ends downstream at an aspiration exit port 22 connectable to an aspiration line 23. In the proximal sonotrode part 14, the aspiration channel 21 deviates radially away and subsequently runs mainly parallel to the elongate cavity 9.

During an aspiration process, aspiration fluid flows from the interior of the eye, via the tip 5 towards the aspiration channel 21, and subsequently via the aspiration exit port 22 to the aspiration line 23.

The sonotrode 6 may have a first sealing barrier sealingly separating the irrigation passage from the aspiration passage, in particular at least separating the irrigation channel 18 from the aspiration channel 21.

In the shown embodiment, the first sealing barrier includes a first annular shaped sealing member or O-ring 24 arranged at a first axial position around the sonotrode proximal body part 14, at a proximal side of the sonotrode.

The sonotrode 6 may also have a second sealing barrier sealing, together with the first sealing barrier, the aspiration passage, in particular the first sealing barrier and the second sealing barrier at least sealing the aspiration channel 21, e.g. from other structures in the interior 8 of the elongate housing 2. In the shown embodiment, the second sealing barrier includes a second annular shaped sealing member or O-ring 25 arranged at a second axial position around the sonotrode proximal body part 14, at a proximal side of the sonotrode, closer to the proximal end 6b of the sonotrode 6 than the first annular shaped sealing member 24.

The elongate cavity 9 may be provided with a third sealing barrier for sealing the elongate cavity 9, upon receiving the reusable driver unit 7, as a sealed compartment within the interior 8 of the elongate housing 2. In the shown embodiment, the third sealing barrier includes a third annular shaped sealing member or O-ring 26 arranged at the cavity wall 10, adjacent to the sonotrode 6. Then, any contamination of the reusable driver unit 7 is kept at a relatively low level.

It is noted that the first, second and/or third sealing barriers may be implemented in another way. As an example, the third sealing barrier may include a third annular shaped sealing member arranged on a circumventing exterior of the reusable driver unit 7.

As discussed above, the elongate cavity 9 contains the reusable driver unit 7, during operation of the disposable phaco device 1. After the single use, the reusable driver unit 7 may be removed from the phaco device 1, in particular by removing the driver unit 7 from the elongate cavity 9, for use in another disposable phaco device 1.

After the cavity has received the reusable driver unit, a hybrid handpiece may be formed including both the disposable ophthalmic surgical phacoemulsification device 1 and the reusable driver unit 7 contained in the cavity 9 of the device 1.

In practice, a kit of parts may be provided, including a multiple number of disposable ophthalmic surgical phacoemulsification devices 1 as described above, none of the phaco devices 1 containing a driver unit 7.

Further, the kit of parts may include a reusable driver unit 7 for driving the sonotrode 6 of a particular phaco device 1 of the multiple number of phaco devices 1, after being removably received in the particular phaco device 1.

Then, the reusable driver unit 7 can be used multiple times, while each of the disposable phaco devices 1 is used a single time only.

Figure 4 shows a first perspective schematic view of a package unit 30 with the ophthalmic surgical phacoemulsification device 1 as shown in

Fig. 1, without a reusable driver unit 7 to be removably received in the elongate cavity 9 of the housing interior 8, and Figure 5 shows a second perspective schematic view of the package unit 30 shown in Fig. 4 wherein the ophthalmic surgical phacoemulsification device 1 has removably received the reusable driver unit 7.

The package unit 30 includes a top package part 31 and a bottom package part 32 that are sealingly closed to each other, defining an interior space accommodating the ophthalmic surgical phacoemulsification device 1.

It 1s noted that, generally, the package unit 30 may include more than two package parts, e.g. four or six package parts. The package unit 30 sealingly encloses the ophthalmic surgical phacoemulsification device 1 for maintaining sterile conditions. The package unit 30 holds the ophthalmic surgical phacoemulsification device 1 such that the ophthalmic surgical phacoemulsification device 1 is blocked against a rotation in a rotation direction R around the longitudinal axis A of the elongate housing 2.

However, if a torque greater than a predefined value is applied to the ophthalmic surgical phacoemulsification device 1 rotation of the phaco device 1 relative to the package unit 30 1s released, as explained in more detail below.

In Fig. 4, the reusable driver unit 7 is offset from the ophthalmic surgical phacoemulsification device 1, and is not yet received in the elongate cavity 9 of the housing interior 8 of the phaco device 1. An entrance 33 providing access to said elongate cavity 9 is still sealed by the package unit 30. As shown, the reusable driver unit 7 is provided, at a distal side, with the pin 11, and, at a proximal side, with a turning knob 7’ connected to a feeding line 7” for feeding the piezoelectric segments 7a-d of reusable driver unit 7.

In Fig. 5, the reusable driver unit 7 has been inserted, through the entrance 33, into the elongate cavity 9 of the phaco device 1. Then, the reusable driver unit 7 is removably received in the elongate cavity 9. In a subsequent step, the proximal end 6b of the sonotrode 6 is coupled to the driver unit 7. In the shown embodiment, the coupling step includes screwing the driver unit 7 onto the sonotrode 6, in particular by turning the turning knob 7’, e.g. in a clockwise turning direction T. The process of turning the knob 7’ continues until the external screwing thread 12 on the pin 11 can not run further along the internal screwing thread 13 of the sonotrode 6.

Then, the coupling process has completed.

When further continuing with the process of turning the knob 7’, a torque is transferred from the elongate housing 2 to the package unit 30. If the torque exceeds the predefined value, the elongate housing 2 starts rotating around its longitudinal axis A relative to the package unit 30, alerting the user that the coupling process has completed.

In assembling the phaco device 1, the reusable driver unit 7 is turned until an applied torque is greater than the predefined value, than finalizing the coupling process.

The functionality of blocking the elongate housing 2 or phaco device 1 against rotating and releasing rotation if a torque greater than a predefined value has reached can be implemented in various ways.

It 1s noted that, generally, the package unit 30 may include more than two package parts, e.g. four or six package parts. Alternatively, the package unit 30 may be formed as a single unit.

Figure 6 shows a first cross-sectional schematic view of the package unit 30, along line C shown in Fig. 5. In the shown embodiment, the elongate housing 2 of the ophthalmic surgical phacoemulsification device 1 has an exterior surface 2’ provided with a local geometrical anomaly such as a local depression 2”, as shown. In another embodiment, the local geometrical anomaly may be formed as a notch. Further, the package unit 30, in the shown embodiment the top package part 31, has a section with a contour 33 adjacent to and corresponding with the local geometrical anomaly 2” of the elongate housing exterior surface 2’. In the absence of a torque greater than the predetermined value, the package contour 33 exerts a blocking force against the local depression 2” of the housing exterior surface 2’, thereby blocking the elongate housing 2 or phaco device 1 against rotation relative to the package unit 30. However, said package unit section 33 is deformable such that deformation occurs if a torque greater than a predefined value is applied to the phaco device. Then, the elongate housing 2 or phaco device 1 will start rotating around its longitudinal axis A relative to the package unit 30.

It is noted that the deformable contour 33 of the package unit 30 may be formed in the top package part 31 or in the bottom package part 32, or in both parts 31, 32. In the latter case, multiple releasable locking structures may be realized.

Other implementations for realizing the blocking and releasing functionality can be obtained, e.g. using a friction coupling or a glue connection between the elongate housing 2 of the phaco device 1 and the package unit 30.

The predefined torque value may be selected in a range varying between e.g. circa 1 Nm and circa 50 Nm, e.g. preferably between circa 5

Nm and 20 Nm. However, other predefined torque values may also be applicable, e.g. a value greater than circa 50 Nm such as circa 100 Nm.

The package unit 30 and the enclosed phaco device 1 with or without the removably received driver unit form a phacoemulsification package 1. Said package may be arranged such that upon deformation of the deformable contour 33 of the package unit section, the package opens as described referring to Fig. 8. Then, the top package part 31 may at least partly disconnect from the bottom package part 32 for enabling the user to take the sterile disposable phaco unit 1, and remove the device 1 from the package unit 30. Alternatively, the user may open the package unit 30 in a separate step.

Said package may be further arranged such that deforming the deformable contour 33 of the package unit section casus an acoustic signal, audibly alerting the user that the coupling process has completed.

Figure 7 shows a second cross-sectional schematic view of the package unit 30, along lines F shown in Fig. 5. The package unit 30 sealingly encloses the ophthalmic surgical phacoemulsification device 1 including the elongate housing 2 and the tip 5. Here, the phacoemulsification package further comprises a sterile sleeve 38 arranged to be unfolded or unrolled. The sterile sleeve is connected, at a first end 37, to the proximal end 4 of the elongate housing 2, and, at a second end 36, opposite to the first end 37, to an inner side of the package unit 30, preferably near the proximal end 4 of the elongate housing 2.

In the embodiment shown in Fig. 7, the top package part 31 includes an elevated portion 34, while the bottom package part 32 includes a deepened portion 35 for accommodating the sterile sleeve 38 to be unfolded or unrolled. The sleeve 38 may include sections that are stacked mainly parallel to the exterior surface of the elongate housing, as shown in Fig. 7, or may be arranged in another structure, e.g. including sections that are stacked mainly transverse to the exterior surface of the elongate housing.

Figure 8 shows a third perspective schematic view of the package unit shown in Fig. 4 wherein the ophthalmic surgical phacoemulsification device 1 1s being removed from the package unit 30. Here, the package unit has opened, wherein the top package part 31 swivels around a swiveling axis S providing access to the phaco device 1. Upon taking the phaco device 1 from the package unit 30 in a first direction D1 away from the swiveling axis S, the sterile sleeve 38 unfolds or unrolls covering the feeding line 7” so as to provide sterile surfaces near the phaco device 1. The opened package 30 unit 30 may be taken in a second direction D2, opposite to the first direction

D1, further unfolding or unrolling the sterile sleeve 38, e.g. towards a feeding port. Optionally, the package unit 30 may be completely removed from the feeding line 7” and the unrolled sleeve 38.

Figure 9 shows a flow chart of a method of assembling according to the invention. The method is used for assembling an ophthalmic phacoemulsification device 1 as described above. The method 100 comprises a step 110 of removably receiving a reusable driver unit in the elongate cavity of the elongate housing interior of the device.

Figure 10 shows a flow chart of a method of de-assembling according to the invention. The method is used for de-assembling an ophthalmic phacoemulsification device 1 as described above. The method 200 comprises a step 210 of removing a reusable driver unit from the elongate cavity of the elongate housing interior of the device.

It is noted that a package unit sealingly enclosing an ophthalmic surgical phacoemulsification device, wherein the package unit holds the ophthalmic surgical phacoemulsification device such that the ophthalmic surgical phacoemulsification device is blocked against rotation around the longitudinal axis of the elongate housing until a torque greater than a predefined value is applied to the ophthalmic surgical phacoemulsification device can not only be applied to an ophthalmic surgical phacoemulsification device according to claim 1, but also, more generally, to a surgical device comprising an elongate housing extending along a longitudinal axis and having a distal end and a proximal end, the device being sealingly enclosed in a package unit, wherein the device is arranged for removably receiving a disposable driver unit or for permanently receiving a reusable or disposable driver unit, or another module.

Similarly, it is noted that a sterile sleeve arranged to be unfolded or unrolled, wherein the sterile sleeve is connected, at a first end, to the proximal end of the elongate housing, and, at a second end, opposite to the first end, to an inner side of the package unit, can not only be used in combination with an ophthalmic surgical phacoemulsification device according to claim 1, but also, more generally, in combination with an ophthalmic surgical phacoemulsification device comprising an elongate housing extending along a longitudinal axis and having a distal end and a proximal end, the device being sealingly enclosed in a package unit.

The invention is not restricted to the embodiments described herein. It will be understood that many variant s are possible.

These and other embodiments will be apparent for the person skilled in the art and are considered to fall within the scope of the invention as defined in the following claims. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments. However, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described.

Claims

Conclusions

An ophthalmic surgical device for phacoemulsification, comprising: - an elongate housing extending along a longitudinal axis, the housing having a distal end and a proximal end; - a tip attached to the distal end of the elongate housing and in alignment with the longitudinal axis, and - a sonotrode having a distal end and a proximal end adapted to actuate the tip, the elongate housing having an interior space within which the sonotrode is disposed at a distal end thereof so that the distal end of the sonotrode is positioned to actuate the tip, and the interior space of the elongate housing including an elongate cavity proximal to the sonotrode for removably receiving a reusable drive unit having a piezoelectric module for driving the sonotrode.

The ophthalmic surgical device for phacoemulsification of claim 1, wherein the sonotrode and the elongated cavity are aligned with the longitudinal axis.

An ophthalmic surgical device for phacoemulsification according to claim 1 or 2, wherein the proximal end of the sonotrode is provided with coupling means for coupling to the drive unit.

An ophthalmic surgical device for phacoemulsification according to any preceding claim, wherein the device is formed as a disposable unit.

An ophthalmic surgical device for phacoemulsification according to any preceding claim, comprising an irrigation passage for flowing an irrigation fluid towards the tip, comprising an irrigation chamber formed radially between a distal body portion of the sonotrode and the elongated housing.

The ophthalmic surgical device for phacoemulsification of any preceding claim, further comprising an aspiration passage for allowing aspiration fluid to flow from the tip, comprising a channel extending through the sonotrode.

The ophthalmic surgical device for phacoemulsification of any preceding claim, wherein the sonotrode comprises a first sealing barrier that sealingly separates the irrigation passage from the aspiration passage.

The ophthalmic surgical device for phacoemulsification of any preceding claim, wherein the first sealing barrier comprises a first annular sealing element disposed at a first axial position about the sonotrode, at a proximal side thereof.

The ophthalmic surgical device for phacoemulsification of any preceding claim, wherein the sonotrode comprises a second sealing barrier that, together with the first sealing barrier, seals the aspiration passage.

An ophthalmic surgical device for phacoemulsification according to any preceding claim, wherein the second sealing barrier comprises a second annular sealing element disposed at a second axial position about the sonotrode, at a proximal side thereof, closer to a proximal end of the sonotrode than the first annular sealing element.

An ophthalmic surgical device for phacoemulsification according to any preceding claim, wherein the elongate cavity is provided with a third sealing barrier, preferably including a third annular sealing element for sealing the elongate cavity as a sealed compartment within the elongate housing upon receipt of the reusable drive unit.

The ophthalmic surgical device for phacoemulsification of any preceding claim, wherein the elongated cavity contains the reusable steering unit.

A kit of parts comprising a plurality of disposable ophthalmic surgical phacoemulsification devices according to any one of the preceding claims 1-12, and a reusable drive unit comprising a piezoelectric module for driving a sonotrode of an ophthalmic surgical phacoemulsification device of said devices after the reusable drive unit is removably received in one of said devices.

A phacoemulsification package comprising an ophthalmic surgical phacoemulsification device according to any one of claims 1 to 12, a reusable drive unit removably receivable or received within the elongated cavity of the interior space of the elongated housing of the device, and a package unit sealingly enclosing the ophthalmic surgical phacoemulsification device, the package unit retaining the ophthalmic surgical phacoemulsification device such that rotation of the ophthalmic surgical phacoemulsification device about the longitudinal axis of the elongated housing is blocked until a moment greater than a predetermined value is applied to the ophthalmic surgical phacoemulsification device.

The phacoemulsification package of claim 14, wherein the elongated housing of the ophthalmic surgical phacoemulsification device has an outer surface provided with a local geometric deviation, the package unit having a section contoured adjacent to and corresponding to the local geometric deviation of the outer surface of the elongated housing, said package unit being deformable when a moment greater than a predetermined value is applied to the ophthalmic surgical phacoemulsification device.

16. A phacoemulsification package as claimed in claim 14 or 15, arranged such that upon deformation of the package unit section the package unit opens.

17. A phacoemulsification package as claimed in claim 14, 15 or 16, arranged such that the deformation of the material causes an acoustic signal.

18. The phacoemulsification package of claims 14-17, further comprising a sterile sleeve adapted to be unfolded or unrolled, the sterile sleeve being connected at a first end to the proximal end of the elongated housing, and at a second end, opposite the first end, to an interior of the package unit, preferably near the proximal end of the elongated housing.

A method of assembling an ophthalmic surgical phacoemulsification device according to any one of claims 1 to 12, comprising a step of removably receiving a reusable drive unit within the elongated cavity of the interior space of the elongated housing of the device.

20. The method of claim 19, further comprising a step of coupling the proximal end of the sonotrode to the drive unit.

21. The method of claim 19 or 20, wherein the coupling step comprises screwing the drive unit onto the sonotrode.

22. The method of claim 21 further comprising the steps of: - providing a phacoemulsification package according to claim 14, - rotating the reusable drive unit until an applied torque is greater than the preset value.

23. A method of disassembling an ophthalmic surgical phacoemulsification device according to any one of claims 1 to 12, including a reusable drive unit within the elongate cavity, the method comprising a step of removing the reusable drive unit from the elongate cavity of the interior of the elongate housing of the device.