Ophthalmic surgical phacoemulsification apparatus, kit and method

Abstract

The invention relates to an ophthalmic surgical phacoemulsification device. The device has an elongated housing extending along a longitudinal axis, a tip mounted to a distal end of the elongated housing and aligned with the longitudinal axis, and a horn arranged to actuate the tip. The elongated housing has an interior which accommodates the horn such that the horn is positioned to actuate the tip. Further, the elongated housing interior is provided with an elongated cavity proximal of the horn for removably receiving a reusable drive unit containing a piezoelectric module for driving the horn.

Description

[0001] This invention relates to an ophthalmic surgical phacoemulsification device.

[0002] The process of breaking down the lens of the eye using an ophthalmic surgical phacoemulsification device that vibrates at ultrasonic frequencies is called phacoemulsification. This phacoemulsification device includes a drive unit containing a piezoelectric module that actuates a needle with a cutting tip via an amplitude transformer. This cutting tip vibrates at ultrasonic frequencies to break down cataract tissue in the eye. The phacoemulsification device further includes an irrigation system and an aspiration system for irrigating and aspirating the interior of the eye during the procedure.

[0003] Known ultrasonic emulsification equipment integrates a fluidics system into a fully reusable handheld device, thus requiring sterilization after each use, specifically autoclaving, to eliminate cross-contamination between uses. The need for sterilization is problematic due to the potential unavailability of sterilization facilities and sustainability concerns surrounding autoclaving.

[0004] Disposable ultrasonic emulsification equipment is also known. Although disposable equipment does not require sterilization after use, the cost is relatively high, including environmental costs.

[0005] The object of this invention is to provide an ophthalmic surgical phacoemulsification device with relatively low cleaning or sterilization requirements while reducing waste materials. To this end, according to the invention, an ophthalmic surgical phacoemulsification device is provided, comprising: an elongated housing extending along a longitudinal axis and having a distal end and a proximal end; an end head mounted to the distal end of the elongated housing and aligned with the longitudinal axis; and an amplitude rod having a distal end and a proximal end, arranged for actuating the end head, wherein the elongated housing has an interior that accommodates the amplitude rod at its distal end such that the distal end of the amplitude rod is positioned to actuate the end head, and wherein the elongated housing interior has an elongated cavity disposed proximal to the amplitude rod for removably receiving a reusable drive unit including a piezoelectric module for driving the amplitude rod.

[0006] This invention is based, at least in part, on the view that, in principle, components that do not come into contact with patient materials (especially drive units) do not need to be sterilized. Similarly, this invention is also based, at least in part, on the view that, on the other hand, components that do come into contact with patient materials need to be sterile.

[0007] By providing a design in which the drive unit can be removably housed within a separate cavity of the phacoemulsification device, the drive unit can be kept away from sterile components and can be removed from the device for reuse. In this way, the drive unit's drive electronics do not come into contact with patient materials, thus keeping the drive electronics uncontaminated. Then, after a single use, not all components are discarded, saving environmental costs while reducing cleaning requirements. Advantageously, sterile components and non-sterile drive units can be optimized for their respective functions to achieve a hybrid design that combines a disposable end effector and a reusable drive unit into a fully functional handheld device.

[0008] Compared to existing fully reusable designs, the production cost of reusable parts is reduced. It offers greater durability compared to previous designs. Furthermore, because it eliminates the need for permanent sealing methods for autoclaving, it enables a more maintainable design.

[0009] Taking into account its entire life cycle, the comprehensive design greatly reduces its environmental impact.

[0010] The ophthalmic phacoemulsification device may include an infusion pathway for allowing infusion fluid to flow toward the endpiece, the infusion pathway including an infusion chamber radially formed between the distal body portion of the amplitude transformer and the elongated housing. Furthermore, an aspiration pathway for allowing aspiration fluid to flow from the endpiece may be provided, the aspiration pathway including a channel extending through the amplitude transformer. Therefore, the fluid routing design ensures that the pathway does not come into contact with reusable drive units, including vulnerable electronics. The fluid routing design also restricts access to the exterior of the elongated housing, which is used for aseptic operation of the assembled device.

[0011] In an advantageous embodiment, the amplitude transformer includes a first sealing barrier that sealably separates the infusion passage from the aspiration passage. The sealing barrier may include a first annular sealing member disposed around the amplitude transformer at a first axial position on its proximal side. By sealingly separating the infusion passage from the aspiration passage, the sterile components are effectively isolated from each other.

[0012] Advantageously, by providing a second sealing barrier to the amplitude transformer to seal the aspiration passage together with the first sealing barrier, both the infusion and aspiration passages are hermetically separated from the non-sterile and reusable drive unit. The first and second sealing barriers then isolate the aspiration and infusion passages from the rest of the assembled handpiece.

[0013] The amplitude transformer may be equipped with a connecting device (such as a threaded connection) for connecting to a removable drive unit, thereby facilitating the transmission of ultrasound from a reusable drive unit to the end of a disposable device via the amplitude transformer.

[0014] After the cavity has received the reusable drive unit, a hybrid handheld device can be formed, which includes both a disposable ophthalmic phacoemulsification device and a reusable drive unit contained in the cavity of the device.

[0015] Typically, assembling sterile medical devices that consist of two components joined by a threaded connection may require applying a specific torque. When assembling two threaded components in an operating room, they either have no torque requirement or do, and this torque requirement is achieved using a torque wrench-like device (as in the application of dental scaler tips). The problem with these devices is that they require sterilization after each use for proper infection prevention and control. This sterilization requirement poses a problem in applications of phacoemulsification devices with disposable components and reusable drive units designed to not require sterilization.

[0016] Optionally, an ultrasonic emulsification package is provided, comprising the ophthalmic surgical ultrasonic emulsification device according to claim 1, a reusable drive unit, and a packaging unit, the reusable drive unit being removably received or removably received within an elongated cavity inside the elongated housing of the device, the packaging unit sealingly enclosing the ophthalmic surgical ultrasonic emulsification device, wherein the packaging unit holds the ophthalmic surgical ultrasonic emulsification device, thereby preventing the ophthalmic surgical ultrasonic emulsification device from rotating about the longitudinal axis of the elongated housing until a torque greater than a predefined value is applied to the ophthalmic surgical ultrasonic emulsification device.

[0017] By incorporating ophthalmic surgical phacoemulsification equipment into the packaging unit, packaging features can be used to ensure that the packaging can only be opened after the correct torque has been applied to the threaded connection.

[0018] Advantageously, the device is prevented from rotating until a sufficiently large torque is applied, thus adequately notifying the user when the correct torque has been reached.

[0019] In a specific embodiment, the elongated housing of the ophthalmic surgical phacoemulsification device has an outer surface with localized geometrical anomalies (such as holes or indentations). The packaging unit has a segment with a contour (such as a rib, ridge, or ridge) adjacent to and corresponding to the localized geometrical anomaly on the outer surface of the elongated housing. This packaging unit segment is deformable when a torque applied to the ophthalmic surgical phacoemulsification device exceeds a predefined value. It should be noted that the anomalous structure can be applied alternatively, i.e., the outer surface of the device has ribs, ridges, or ridges, while the packaging unit segment has corresponding holes or indentations.

[0020] The dimensions of the ribs, ridges, or bulges are chosen so that they collapse under a specific torque applied to the device, causing the entire part to rotate about its axis. Thus, the required torque can be applied without additional tools, while still achieving aseptic assembly.

[0021] Advantageously, the packaging unit can be arranged such that when the packaging unit section deforms, the structure preventing the packaging unit from becoming a unit is released, thereby ensuring that the packaging unit opens after the correct torque has been applied. Alternatively, visual indicators on the packaging can indicate that the correct torque has been applied.

[0022] In short, it achieves faster assembly and a more sustainable design, where no additional sterilization is required for each use.

[0023] Within a sterile area, handling the assembly of non-sterile reusable components with cables and / or tubing, as well as sterile disposable components of medical devices, presents a challenge. Personnel within the sterile area cannot directly manipulate these two components because one is non-sterile, and personnel outside the sterile area also cannot directly manipulate them because one is sterile.

[0024] Existing solutions for non-sterile reusable parts and sterile disposable parts consist of reusable devices coupled with disposable sterile sheaths for packaging reusable parts in plastic, such as transducers for ultrasound imaging, endoscopic applications, or dental drills. If disposable parts require additional functionality beyond this sterile barrier, such as specific connection methods or fluid control, existing solutions are insufficient because they focus solely on applying a sterile barrier.

[0025] In surgical applications, interactions between non-sterile and sterile individuals are minimized to achieve effective infection prevention and control. For the proposed hybrid design, such interactions are unavoidable.

[0026] Advantageously, a packaging unit comprising a sealed ophthalmic surgical phacoemulsification device may further include a sterile sheath arranged to be unfolded or rolled up, wherein the sterile sheath is connected at a first end to the proximal end of an elongated housing and at a second end opposite to the first end to the inner side of the packaging unit, preferably connected to the inner side of the packaging unit near the proximal end of the elongated housing. This facilitates aseptic operation by non-sterile personnel, as well as aseptic transfer methods and suitable sterile barriers.

[0027] A non-sterile person can manipulate the exterior of the packaging unit and assemble non-sterile reusable components through this exterior. The packaging unit can be opened to expose sterile, disposable components assembled with the reusable components. This opened packaging can be presented to a sterile person, making the packaging a physical barrier between non-sterile and sterile hands.

[0028] When removing the assembled medical device from its packaging, a sterile barrier sheath is unwound or rolled up on the cable and / or tubing, one end of which is connected to a disposable component of the medical device and the other end to the packaging. Therefore, the packaging can be considered part of the disposable component of the medical device.

[0029] In short, it not only provides a sterile solution for assembling disposable and reusable parts, but also provides a way to prioritize availability and assembly speed during application.

[0030] Furthermore, the present invention relates to a method.

[0031] Further advantageous embodiments of the invention are described in the following claims.

[0032] The present invention also relates to a kit.

[0033] Furthermore, the present invention relates to a method for assembling an ophthalmic surgical phacoemulsification device and a method for disassembling and assembling an ophthalmic surgical phacoemulsification device.

[0034] It should be noted that the technical features described above or below may each be embodied individually in the system or method, that is, isolated from the context in which these technical features are described, separate from other features, or combined only with multiple other features described in the context in which these technical features are disclosed. Each of these features may further be combined with any other disclosed feature in any combination.

[0035] The invention will now be further illustrated with reference to several exemplary embodiments and the accompanying drawings. In the drawings: Figure 1 A first schematic cross-sectional view of the ophthalmic surgical phacoemulsification apparatus according to the present invention is shown; Figure 2 It shows Figure 1 A second schematic cross-sectional view of the ophthalmic phacoemulsification device shown. Figure 3 Partially cut out Figure 1 A partial three-dimensional schematic diagram of an ophthalmic phacoemulsification device is shown. Figure 4 A first perspective view of a packaging unit is shown, the packaging unit having Figure 1 The ophthalmic phacoemulsification equipment shown is for ophthalmic surgery. Figure 5 It shows Figure 4 The second perspective view of the packaging unit shown, wherein the ophthalmic surgical phacoemulsification device has incorporated a reusable drive unit; Figure 6 It shows Figure 5 A schematic diagram of the first cross-section of the packaging unit shown; Figure 7 It shows Figure 5 The diagram shows a second cross-section of the packaging unit. Figure 8 It shows Figure 4 The third perspective view of the packaging unit shown depicts the removal of an ophthalmic phacoemulsification device from the packaging unit. Figure 9 A flowchart of the assembly method according to the present invention is shown, and Figure 10 A flowchart of the disassembly and assembly method according to the present invention is shown.

[0036] It should be noted that the accompanying drawings only illustrate preferred embodiments according to the present invention. In the drawings, the same reference numerals refer to the same or corresponding parts.

[0037] Figure 1 A first schematic cross-sectional view of an ophthalmic surgical phacoemulsification device 1 according to the present invention is shown. The ophthalmic surgical phacoemulsification device 1 (also known as a phaco device 1) is used in modern cataract surgery that uses ultrasonic energy to emulsify the internal lens of the eye.

[0038] Figure 2 It shows Figure 1 A second schematic cross-sectional view of the ophthalmic phacoemulsification device shown.

[0039] The phacoemulsification device 1 is formed as a disposable unit and includes an elongated housing 2 extending along a longitudinal axis A, thereby forming a handheld component. The elongated housing 2 has a distal end 3 and a proximal end 4. Further, the phacoemulsification device 1 includes an end cap 5, which is attached to the distal end 3 of the elongated housing 2 and aligned with the longitudinal axis A. Figure 1 and Figure 2 As shown, the phacoemulsification device 1 has an amplitude rod 6 arranged for actuating the end 5, the amplitude rod having a distal end 6a and a proximal end 6b. In operation, the amplitude rod 6 is driven using a reusable drive unit 7 containing a piezoelectric module.

[0040] The elongated housing 2 has an interior 8 that houses both the amplitude rod 6 and the reusable drive unit 7. The interior 8 has a distal end 8a at which the amplitude rod 6 is positioned, such that the distal end 6b of the amplitude rod 6 is positioned as the actuation end 5. Furthermore, the elongated housing interior 8 has an elongated cavity 9 provided proximal to the amplitude rod 6 for removably receiving the reusable drive unit 7.

[0041] The phacoemulsification device 1 is designed as a disposable unit for sterile single use, while a reusable drive unit 7 is provided during operation. This reusable drive unit can be removed from the phacoemulsification device 1 after the operation for use in another disposable phacoemulsification device 1.

[0042] In the illustrated embodiment, the reusable drive unit 7 has a cylindrical shape around the body axis B, thus being removably fitted into the elongated cavity 9 inside the housing 8. The piezoelectric module of the reusable drive unit 7 is provided with a plurality of annular piezoelectric segments 7a-d arranged concentrically adjacent to each other along the body axis of the drive unit 7. Typically, the design characteristics of the reusable drive unit 7 can vary, for example, in terms of geometry, size, and the number of piezoelectric segments 7a-d.

[0043] Typically, the amplitude transformer 6 and the cavity 9 can be placed in series and aligned with the longitudinal axis A. For example... Figure 1 As shown, the hyperemulsification device 1 has a wall 10, for example a cylindrical wall 10, inside the housing 8, which defines an elongated cavity 9.

[0044] Furthermore, typically, the end cap 5, the amplitude transformer 6, and the reusable drive unit 7 are positioned such that ultrasonic vibrations can be transmitted from the reusable drive unit 7 to the amplitude transformer 6, and from the amplitude transformer 6 to the end cap 5, for example, by contacting each other.

[0045] The proximal end 6b of the amplitude rod 6 may be provided with a connecting device for connection to the reusable drive unit 7. Alternatively, neither the amplitude rod 6 nor the reusable drive unit 7 is provided with a connecting device. Then, as an example, the reusable drive unit 7 can be securely locked into the cavity 9 to mechanically drive the amplitude rod 6.

[0046] Figure 3 Partially cut out Figure 1The diagram shows a partial perspective view of the ophthalmic phacoemulsification device 1. Here, the connection device for connecting the amplitude rod 6 to the reusable drive unit 7 includes a threaded connection formed by an external thread 12 on a pin 11 extending from the drive unit 7 toward the amplitude rod 6 and an internal thread 13 at the proximal end 6b of the amplitude rod 6.

[0047] In the illustrated embodiment, the amplitude transformer 6 has a proximal body portion 14 at its proximal end 6b, a distal body portion 15 at its distal end 6a, and a transition body portion 16 extending between the proximal body portion 14 and the distal body portion 15. The proximal body portion 14 and the distal body portion 15 may have substantially constant cross-sections, being disc-shaped, while the transition body portion 16 may have a profile that gradually extends from the radius of the proximal body portion to the radius of the distal body portion. In practice, the proximal body portion 14, the transition body portion 16, and the distal body portion 15 may form a single unit. As a passive structure, the amplitude transformer 6 is designed to transfer ultrasonic energy from the drive unit 7 to the end 5, thereby modulating the vibration amplitude. As an alternative to the illustrated embodiment, the amplitude transformer 6 may be formed from separate portions and / or may include additional portions.

[0048] In the illustrated embodiment, the phacoemulsification device 1 is further provided with an infusion passage for allowing infusion fluid to flow toward the end cap 5. The infusion passage connects to an infusion tube in the end cap 5 and includes an infusion chamber 17 formed radially between the distal body portion 15 of the amplitude rod 6 and the elongated housing 2. The infusion passage further includes an infusion channel 18 extending between the infusion chamber 17 and an infusion inlet port 19 connectable to the infusion line 20. During the infusion process, infusion fluid flows from the infusion line 20 through the infusion inlet port 19 and subsequently through the infusion channel 18 toward the infusion chamber 17, and then flows to the end cap 5 for infusing the interior of the eye.

[0049] In the illustrated embodiment, the phacoemulsification device 1 is further provided with a suction passage for allowing aspirated fluid to flow from the end 5. The suction passage connects to a suction tube in the end 5 and includes a suction channel 21 extending through the amplitude rod 6 (in the illustrated embodiment, through both the distal portion 15 and the proximal portion 14 of the amplitude rod). The suction channel 21 terminates downstream at a suction outlet port 22, which can be connected to a suction line 23. In the proximal portion 14 of the amplitude rod, the suction channel 21 is radially offset from the elongated cavity 9 and then extends generally parallel to the elongated cavity. During the aspiration process, aspirated fluid flows from inside the eye through the end 5 toward the suction channel 21, and then through the suction outlet port 22 to the suction line 23.

[0050] The amplitude rod 6 may have a first sealing barrier that seals the infusion passage from the suction passage, specifically separating the infusion channel 18 from the suction channel 21. In the illustrated embodiment, the first sealing barrier includes a first annular sealing member or O-ring 24 arranged around the proximal body portion 14 of the amplitude rod at a first axial position on the proximal side of the amplitude rod.

[0051] The amplitude rod 6 may also have a second sealing barrier that, together with the first sealing barrier, seals the suction passage. Specifically, the first and second sealing barriers at least isolate the suction passage 21 from other structures within, for example, the interior 8 of the elongated housing 2. In the illustrated embodiment, the second sealing barrier includes a second annular sealing member or O-ring 25 arranged at a second axial position around the proximal body portion 14 of the amplitude rod on its proximal side, closer to the proximal end 6b of the amplitude rod 6 than the first annular sealing member 24.

[0052] The elongated cavity 9 may be provided with a third sealing barrier, which seals the elongated cavity 9 as a sealed compartment within the interior 8 of the elongated housing 2 when receiving the reusable drive unit 7. In the illustrated embodiment, the third sealing barrier includes a third annular sealing member or O-ring 26 disposed adjacent to the amplitude transformer 6 at the cavity wall 10. Therefore, any contamination of the reusable drive unit 7 is kept at a relatively low level.

[0053] It should be noted that the first sealing barrier, the second sealing barrier, and / or the third sealing barrier can be implemented in another manner. As an example, the third sealing barrier may include a third annular sealing member arranged on the circumferential exterior of the reusable drive unit 7.

[0054] As discussed above, during operation of the disposable phacoemulsification device 1, the elongated cavity 9 contains a reusable drive unit 7. After a single use, the reusable drive unit 7 can be removed from the phacoemulsification device 1, particularly by removing the drive unit 7 from the elongated cavity 9, for use in another disposable phacoemulsification device 1.

[0055] After the cavity has received the reusable drive unit, a hybrid handheld device can be formed, which includes both a disposable ophthalmic phacoemulsification device 1 and a reusable drive unit 7 contained in the cavity 9 of the device 1.

[0056] In practice, a kit can be provided comprising multiple disposable ophthalmic phacoemulsification devices 1 as described above, none of which include a drive unit 7. Further, the kit may include a reusable drive unit 7 for driving the amplitude lever 6 of a particular phacoemulsification device 1 after it has been removably received within the plurality of phacoemulsification devices 1. Thus, the reusable drive unit 7 can be used multiple times, while each of the disposable phacoemulsification devices 1 is used only once.

[0057] Figure 4 A first perspective view of packaging unit 30 is shown, which has as follows: Figure 1 The ophthalmic phacoemulsification device 1 shown does not have a reusable drive unit 7 that is removably housed in an elongated cavity 9 inside the housing 8. Figure 5 It shows Figure 4 The second perspective view of the packaging unit 30 shown shows that the ophthalmic surgical phacoemulsification device 1 has removably received the reusable drive unit 7.

[0058] The packaging unit 30 includes a top portion 31 and a bottom portion 32, which are sealed together to define an internal space for accommodating the ophthalmic surgical phacoemulsification device 1. It should be noted that the packaging unit 30 may typically include more than two packaging portions, for example, four or six. The packaging unit 30 seals the ophthalmic surgical phacoemulsification device 1 to maintain sterile conditions. The packaging unit 30 holds the ophthalmic surgical phacoemulsification device 1 in place, thereby preventing rotation of the device about the longitudinal axis A of the elongated housing 2 in the direction of rotation R. However, when a torque greater than a predefined value is applied to the ophthalmic surgical phacoemulsification device 1, rotation of the device 1 relative to the packaging unit 30 is released, as explained in more detail below.

[0059] exist Figure 4 In this configuration, the reusable drive unit 7 is offset from the ophthalmic surgical phacoemulsification device 1 and is not yet housed within the elongated cavity 9 of the housing 8 of the phacoemulsification device 1. The inlet 33, providing access to the elongated cavity 9, remains sealed by the packaging unit 30. As shown, the reusable drive unit 7 has a pin 11 on its distal side and a rotary knob 7' on its proximal side, which is connected to a power supply line 7'' for powering the piezoelectric segments 7a-d of the reusable drive unit 7.

[0060] exist Figure 5In the process, the reusable drive unit 7 has been inserted into the elongated cavity 9 of the phacoemulsification device 1 through inlet 33. The reusable drive unit 7 is then removably received within the elongated cavity 9. In a subsequent step, the proximal end 6b of the amplitude rod 6 is coupled to the drive unit 7. In the illustrated embodiment, the coupling step includes screwing the drive unit 7 onto the amplitude rod 6, specifically by rotating the rotary knob 7', for example, in a clockwise rotation direction T. Rotation of the knob 7' continues until the external thread 12 on the pin 11 can no longer extend along the internal thread 13 of the amplitude rod 6. The coupling process is then complete.

[0061] As the knob 7' is further rotated, torque is transmitted from the elongated housing 2 to the packaging unit 30. When the torque exceeds a predefined value, the elongated housing 2 begins to rotate relative to the packaging unit 30 about its longitudinal axis A, thus notifying the user that the connection process is complete.

[0062] When assembling the phacoemulsification device 1, rotate the reusable drive unit 7 until the applied torque is greater than a predefined value, and then complete the connection process.

[0063] The function of preventing the rotation of the elongated housing 2 or the phacoemulsification device 1 and releasing the rotation when the torque has reached a value greater than a predefined value can be achieved in various ways.

[0064] It should be noted that, typically, packaging unit 30 may include more than two packaging portions, for example, four or six packaging portions. Alternatively, packaging unit 30 may be formed as a single unit.

[0065] Figure 6 The packaging unit 30 is shown along... Figure 5 The diagram shows a first cross-sectional view of line C. In the illustrated embodiment, the elongated housing 2 of the ophthalmic surgical phacoemulsification device 1 has an outer surface 2' with local geometric anomalies, such as local depressions 2'', as shown. In another embodiment, the local geometric anomaly can be formed as a notch. Further, the packaging unit 30 (the top portion 31 in the illustrated embodiment) has a section with a contour 33 adjacent to and corresponding to the local geometric anomaly 2'' on the outer surface 2' of the elongated housing. In the absence of a torque greater than a predefined value, the packaging contour 33 exerts a resisting force on the local depression 2'' on the outer surface 2' of the housing, thereby preventing the elongated housing 2 or the phacoemulsification device 1 from rotating relative to the packaging unit 30. However, the packaging unit section 33 is deformable, such that it deforms when a torque greater than a predefined value is applied to the phacoemulsification device. The elongated housing 2 or the phacoemulsification device 1 will then begin to rotate about its longitudinal axis A relative to the packaging unit 30.

[0066] It should be noted that the deformable profile 33 of the packaging unit 30 can be formed in the top portion 31 of the packaging, or in the bottom portion 32 of the packaging, or in both portions 31 and 32. In the latter case, multiple releasable locking structures can be implemented.

[0067] Other implementations for achieving the blocking and releasing functions are available, such as using a frictional or adhesive connection between the elongated housing 2 of the phacoemulsification device 1 and the packaging unit 30.

[0068] The predefined torque value can be selected within a range, for example, between about 1 Nm and about 50 Nm, preferably between about 5 Nm and about 20 Nm. However, other predefined torque values ​​may also be applied, for example, values ​​greater than about 50 Nm, such as about 100 Nm.

[0069] Packaging unit 30 and the enclosed ultrasonic emulsification device 1 (with or without a removably received drive unit) form an ultrasonic emulsification package 1. The package can be arranged such that it opens when the deformable profile 33 of the packaging unit segment deforms, as shown in reference... Figure 8 As described. The top portion 31 of the packaging can then be at least partially disconnected from the bottom portion 32 of the packaging, allowing the user to pick up the sterile, disposable phacoemulsification unit 1 and remove the device 1 from the packaging unit 30. Alternatively, the user can open the packaging unit 30 in a separate step.

[0070] The packaging can be further arranged such that deformation of the deformable profile 33 of the packaging unit segment causes an acoustic signal, thereby audibly alerting the user that the connection process has been completed.

[0071] Figure 7 The packaging unit 30 is shown along... Figure 5 The diagram shows a second cross-section of line F. The packaging unit 30 seals the ophthalmic surgical phacoemulsification device 1, which includes an elongated housing 2 and an end 5. Here, the phacoemulsification package further includes a sterile sheath 38 arranged to unfold or roll up. The sterile sheath is connected to the proximal end 4 of the elongated housing 2 at a first end 37 and to the inside of the packaging unit 30 at a second end 36 opposite to the first end 37, preferably near the proximal end 4 of the elongated housing 2.

[0072] exist Figure 7 In the illustrated embodiment, the top portion 31 of the packaging includes a raised portion 34, while the bottom portion 32 includes a deepened portion 35 for accommodating a sterile sheath 38 to be unfolded or rolled up. The sheath 38 may include sections stacked generally parallel to the outer surface of the elongated housing, such as... Figure 7As shown, or it can be arranged in another structural manner, for example, including sections stacked generally transversely to the outer surface of the elongated shell.

[0073] Figure 8 It shows Figure 4 The third perspective view of the packaging unit shows the ophthalmic surgical phacoemulsification device 1 being removed from the packaging unit 30. Here, the packaging unit 30 is already open, with the top portion 31 of the packaging rotating about the axis of rotation S, thus providing access to the phacoemulsification device 1. As the phacoemulsification device 1 is removed from the packaging unit 30 in a first direction D1 opposite to the axis of rotation S, the sterile sheath 38 unfolds or rolls up to cover the power supply line 7'', providing a sterile surface near the phacoemulsification device 1. The opened packaging unit 30 can be removed in a second direction D2 opposite to the first direction D1, further unfolding or rolling up the sterile sheath 38, for example, towards the feed port. Alternatively, the packaging unit 30 can be completely removed from the power supply line 7'' and the rolled-up sheath 38.

[0074] Figure 9 A flowchart of an assembly method according to the present invention is shown. This method is used to assemble an ophthalmic phacoemulsification device 1 as described above. Method 100 includes step 110 of removably receiving a reusable drive unit within an elongated cavity inside an elongated housing of the device.

[0075] Figure 10 A flowchart of a disassembly and assembly method according to the present invention is shown. This method is used for disassembling and assembling an ophthalmic phacoemulsification device 1 as described above. Method 200 includes step 210 of removing a reusable drive unit from an elongated cavity inside the elongated housing of the device.

[0076] It should be noted that a packaging unit that hermetically encloses an ophthalmic surgical phacoemulsification device (wherein the packaging unit holds the ophthalmic surgical phacoemulsification device, thereby preventing the ophthalmic surgical phacoemulsification device from rotating about the longitudinal axis of the elongated housing until a torque greater than a predefined value is applied to the ophthalmic surgical phacoemulsification device) is applicable not only to the ophthalmic surgical phacoemulsification device according to claim 1, but more generally to surgical devices comprising an elongated housing extending along a longitudinal axis and having a distal end and a proximal end, the device being hermetically enclosed in a packaging unit, wherein the device is arranged to removably receive a disposable drive unit, or is arranged to permanently receive a reusable drive unit or a disposable drive unit, or another module.

[0077] Similarly, it should be noted that a sterile sheath arranged to unfold or roll up (wherein the sterile sheath is connected at a first end to the proximal end of an elongated housing and at a second end opposite to the first end to the inside of a packaging unit) can be used not only in combination with the ophthalmic phacoemulsification device according to claim 1, but more generally, it can be used in combination with an ophthalmic phacoemulsification device comprising an elongated housing extending along a longitudinal axis and having a distal end and a proximal end, the device being hermetically enclosed within a packaging unit.

[0078] This invention is not limited to the embodiments described herein. It should be understood that many variations may exist.

[0079] These and other embodiments will be apparent to those skilled in the art and are considered to fall within the scope of the invention as defined in the following claims. For the purposes of clarity and concise description, features are described herein as part of the same or separate embodiments. However, it should be understood that the scope of the invention may include embodiments having all or some of the features described.

Claims

1. An ophthalmic surgical phacoemulsification device, comprising: - An elongated shell that extends along a longitudinal axis and has a distal end and a proximal end; - An end piece, which is mounted to the distal end of the elongated housing and aligned with the longitudinal axis, and - An amplitude transformer, having a distal end and a proximal end, is arranged to actuate the end. The elongated housing has an interior that houses the amplitude rod at its distal end, such that the distal end of the amplitude rod is positioned to actuate the end cap. The elongated housing contains an elongated cavity near the amplitude rod for removably receiving a reusable drive unit containing a piezoelectric module for driving the amplitude rod.

2. The ophthalmic surgical phacoemulsification device according to claim 1, wherein, The amplitude rod and the elongated cavity are aligned with the longitudinal axis.

3. The ophthalmic surgical phacoemulsification device according to claim 1 or 2, wherein, The near end of the amplitude rod is provided with a connecting device for connecting to the drive unit.

4. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims is formed as a disposable unit.

5. The ophthalmic surgical phacoemulsification apparatus according to any one of the preceding claims, comprising an infusion passage for allowing infusion fluid to flow toward the end, the infusion passage including an infusion chamber radially formed between the distal body portion of the amplitude transformer and the elongated housing.

6. The ophthalmic surgical phacoemulsification apparatus according to any one of the preceding claims further includes an aspiration passage for allowing aspiration fluid to flow from the end, the aspiration passage including a channel extending through the amplitude transformer.

7. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The amplitude rod includes a first sealing barrier that seals the infusion passage from the suction passage.

8. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The first sealing barrier includes a first annular sealing member arranged around the amplitude rod at a first axial position on the proximal side of the amplitude rod.

9. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The amplitude rod includes a second sealing barrier that, together with the first sealing barrier, seals the suction passage.

10. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The second sealing barrier includes a second annular sealing member arranged around the amplitude rod at a second axial position on the proximal side of the amplitude rod, closer to the proximal end of the amplitude rod than the first annular sealing member.

11. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The elongated cavity is provided with a third sealing barrier, which preferably includes a third annular sealing member for sealing the elongated cavity as a sealed compartment inside the elongated housing when receiving the reusable drive unit.

12. The ophthalmic surgical phacoemulsification device according to any one of the preceding claims, wherein, The elongated cavity contains the reusable drive unit.

13. A kit comprising a plurality of disposable ophthalmic phacoemulsification devices according to any one of claims 1 to 12, and a reusable drive unit including a piezoelectric module for driving an amplitude transformer of one of the devices after being removably received in one of the ophthalmic phacoemulsification devices.

14. An ophthalmic surgical phacoemulsification package comprising an ophthalmic surgical phacoemulsification device according to any one of claims 1 to 12, a reusable drive unit, and a packaging unit, wherein the reusable drive unit can be removably received or removably received in an elongated cavity within the elongated housing of the device, and the packaging unit hermetically encloses the ophthalmic surgical phacoemulsification device, wherein... The packaging unit holds the ophthalmic phacoemulsification device in place, thereby preventing the ophthalmic phacoemulsification device from rotating about the longitudinal axis of the elongated housing until a torque greater than a predefined value is applied to the ophthalmic phacoemulsification device.

15. The ultrasonic emulsification packaging according to claim 14, wherein, The elongated housing of the ophthalmic surgical phacoemulsification device has an outer surface with local geometrical anomalies. The packaging unit has a section with a contour adjacent to and corresponding to the local geometrical anomalies on the outer surface of the elongated housing. The packaging unit section is deformable when the torque applied to the ophthalmic surgical phacoemulsification device is greater than a predefined value.

16. The ultrasonic emulsification package according to claim 14 or 15, arranged such that the package unit opens when the package unit section deforms.

17. The ultrasonic emulsification package according to claim 14, 15 or 16, arranged such that deformation of the material generates an acoustic signal.

18. The ultrasonic emulsification packaging according to any one of claims 14 to 17, further comprising a sterile sheath arranged to be unfolded or rolled up, wherein, The sterile sheath is connected to the proximal end of the elongated housing at a first end and to the inside of the packaging unit at a second end opposite to the first end, preferably to the inside of the packaging unit near the proximal end of the elongated housing.

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

20. The method of claim 19, further comprising the step of connecting the proximal end of the amplitude rod to the drive unit.

21. The method according to claim 19 or 20, wherein, The connection step includes screwing the drive unit onto the luffing rod.

22. The method of claim 21, further comprising the following steps: - Provide an ultrasonic emulsification packaging according to claim 14, - Rotate the reusable drive unit until the applied torque is greater than the predefined value.

23. A method for disassembling and assembling an ophthalmic surgical phacoemulsification device according to any one of claims 1 to 12, the ophthalmic surgical phacoemulsification device having a reusable actuator disposed in an elongated cavity, the method comprising the step of removing the reusable actuator unit from the elongated cavity inside the elongated housing of the device.

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