Trocar module, fluid connector, and method
The trocar module with a double-tapered cannula design addresses miniaturization challenges by maintaining high flow rates and stable intraocular pressure, improving surgical performance and reducing trauma.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- DUTCH OPHTHALMIC RES CENT INT
- Filing Date
- 2021-10-04
- Publication Date
- 2026-04-30
AI Technical Summary
Existing trocar modules for ophthalmic surgery face challenges in miniaturization, leading to reduced flow rates and increased fluid pressure requirements due to smaller inner diameters, which can compromise surgical performance and stability.
A trocar module with a tubular cannula featuring a double-tapered internal profile, including a first and second tapered section separated by an intermediate section, allowing secure coupling of the capillary while maintaining a larger inner diameter, thus facilitating high flow rates and stable intraocular pressure without increasing external cannula size.
The double-tapered design enhances fluid flow performance, maintaining high flow rates with low fluid pressure and stable intraocular pressure, while minimizing traumatic wounds and ensuring reliable coupling.
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Abstract
Description
Technical Field
[0001] The present invention relates to a trocar module for ophthalmic surgery, comprising a tubular cannula having a distal portion for insertion through the sclera of the eye and a proximal portion for receiving a capillary of a fluid connector in a state where the capillary is coupled to the fluid connector, and a valve unit disposed at the proximal portion of the cannula and surrounding the capillary so as to seal the capillary in a coupled state.
Background Art
[0002] Generally, trocar modules are generally known for providing access to the interior of the eye through an insertion port for surgical instruments for irrigation or fluid exchange, or for illuminating, cutting, removing or otherwise manipulating tissue in the field of ophthalmic surgery. The tubular cannula transects the sclera of the eye, and the valve unit surrounds the capillary of the fluid connector coupled to the trocar module so as to seal the capillary in the case of fluid exchange such as an irrigation line or a suction line for washing the eye.
[0003] On the proximal side, the cannula typically has a taper for aligning the capillary of the fluid connector within the cannula. In the process of coupling the fluid connector and the cannula, the capillary is inserted into the cannula beyond its tapered portion until the capillary extends sufficiently to the distal portion of the cannula through the tapered portion. Then, the capillary transects a valve unit that surrounds the capillary so as to seal it.
[0004] In recent years, the miniaturization of ophthalmic surgical instruments has advanced, and as a result, a design has been made in which the effective diameter of the portion passing through the sclera of the eye is reduced and the gauge is increased. However, if the inner diameter of the capillary is reduced, the flow rate of the working fluid decreases, which may be disadvantageous in terms of surgical performance. In addition, since the stability of the chamber decreases, a higher irrigation pressure may be required.
Summary of the Invention
Problems to be Solved by the Invention
[0005] Therefore, there is a need to provide a trocar module that can be implemented in smaller dimensions while facilitating relatively large flow rates. [Means for solving the problem]
[0006] Therefore, an object of the present invention is to provide a trocar module for ophthalmic surgery that has a relatively small outer diameter while maintaining a relatively large flow rate. According to the present invention, a trocar module for ophthalmic surgery is provided, comprising: a tubular cannula having a distal portion for insertion through the sclera of the eyeball and a proximal portion for receiving the capillary of a fluid connector in a coupled state with the fluid connector; and a valve unit positioned in the proximal portion of the cannula for sealing the capillary in a discoupled state. Here, the proximal portion of the cannula has a first tapered tubular portion, a second tapered tubular portion, and an intermediate tubular portion located between the first tapered tubular portion and the second tapered tubular portion. The first tapered tubular portion is located proximal to the intermediate tubular portion and is tapered toward the intermediate tubular portion to align with the capillary when coupled. The intermediate tubular portion has a generally constant cross-section and surrounds the distal end of the capillary when coupled. The second tapered tube section is tapered from the intermediate tube section toward the distal end of the cannula.
[0007] By applying a tubular cannula with a double-tapered internal profile interposed by an intermediate tube section, the distal end of the capillary can be moved from the first tapered section toward the second tapered section. The second tapered section tapers from the position of the capillary toward the distal end of the cannula, which has the smallest inner diameter. This allows the capillary to be securely coupled to the cannula while its inner diameter is substantially the same as or larger than the inner diameter of the distal portion of the cannula. As a result, a flow structure can be provided in which the capillary does not extend or protrude into the distal portion, which is the smallest diameter structure of the cannula. This allows for a relatively large flow rate, limited by the passage with the smallest inner diameter of the entire flow path, resulting in relatively low fluid pressure and stable intraocular pressure (IOP), while minimizing traumatic wounds by keeping the external cannula relatively small. The flow path in the distal portion of the cannula has a single wall, unlike the double wall (i.e., the capillary wall and the wall of the distal portion of the cannula) present in known trocar modules coupled to fluid connectors.
[0008] By applying a double tapered structure, each element engages with the others, opening the flow path. This provides a design that significantly improves flow performance even at the same back pressure. Furthermore, high flow rates can be obtained without removing the valve unit. The double tapered structure, particularly the intermediate pipe section between both tapered sections, provides a design that offers reliable coupling force.
[0009] Advantageously, the inner diameter of the intermediate tube is equal to or greater than the outer diameter of the distal portion of the cannula, so that the inner diameter of the capillary tube of the fluid connector is equal to or greater than the inner diameter of the distal portion of the cannula.
[0010] Preferably, the distal portion of the tubular cannula has an outer surface provided with at least a partially laser-processed textured structure. This improves the retention of the cannula in the sclera of the eyeball.
[0011] The present invention also relates to a fluid connector for ophthalmic surgery. The connector comprises a capillary tube and a connector body surrounding the capillary tube. The capillary tube has a proximal portion for connecting to a fluid input / output line and a distal portion for coupling to a trocar module. The connector body is provided with a gap traversed by the distal portion of the capillary tube for at least partially receiving the proximal portion of a cannula when coupled.
[0012] By providing a gap in the connector body to receive the proximal portion of the cannula, an ingenious coupling structure can be obtained in which the fluid connector is coupled to the trocar module via various coupling elements. This includes at least a valve unit traversed by a capillary tube, an intermediate tube portion of the cannula that receives the distal end of the capillary tube, and a gap that receives or clamps the proximal portion of the cannula.
[0013] Preferably, the connector body is provided with a plurality of clamping elements. Preferably, the plurality of clamping elements extend inward within the gap and are mainly uniformly distributed circumferentially around the longitudinal axis of the connector body in order to engage with a trocar module, such as a valve unit, in the coupled state.
[0014] Generally, the fluid input / output lines of a fluid connector connected to the proximal portion of a capillary tube may be, for example, perfusion lines, suction lines, viscous fluid injection lines, or viscous fluid extraction lines.
[0015] The present invention also relates to a trocar system for ophthalmic surgery. The system comprises a trocar module coupled to a fluid connector. Its intermediate tube portion surrounds the distal end of a capillary tube.
[0016] Preferably, the capillary of the fluid connector is engaged by the intermediate tube portion and valve unit of the trocar module. This allows for interference or frictional mating between the capillary and the intermediate tube portion and valve unit.
[0017] Furthermore, the present invention relates to a method for coupling a trocar module and a fluid connector. Moreover, the present invention relates to a method for uncoupling a trocar system and separating the trocar module and the fluid connector.
[0018] The method may include the step of determining the inner diameter of the distal portion of the tubular cannula by measuring the fluid impedance on the proximal side of the capillary. This makes it easy to determine the gauge size of the trocar module.
[0019] The present invention also relates to a process for preparing a trocar module for ophthalmic surgery. The process includes the step of exposing the outer surface of a tubular cannula to laser irradiation in order to generate a textured structure on at least a portion of its outer surface.
[0020] Further advantageous embodiments of the present invention are described in the appended claims.
[0021] It should be noted that the technical features described above or below may be implemented individually in trocar modules, fluid connectors, and / or methods. That is, these technical features may be separated from the context in which their description is given, separated from other features, or combined only with some of the other features described in the context in which they are given. Each of these features may be combined with any other feature described. [Brief explanation of the drawing]
[0022] The present invention will be further elucidated based on exemplary embodiments shown in the figures. These exemplary embodiments are provided for the non-limiting explanation of the present invention. [Figure 1] This is a schematic perspective view showing the trocar module and fluid connector according to the present invention. [Figure 2] This is a schematic cross-sectional view showing the trocar module and fluid connector shown in Figure 1 in a disconnected state. [Figure 3] A cross-section view schematically showing the trocar module and the fluid connector shown in FIG. 1 in a combined state. [Figure 4] Another perspective view schematically showing the trocar module shown in FIG. 1. [Figure 5] A diagram showing a graph of the pressure drop as a function of the flow in the trocar module according to the present invention. [Figure 6] A cross-section view schematically showing another embodiment of the fluid connector according to the present invention. [Figure 7] A cross-section view schematically showing yet another embodiment of the fluid connector according to the present invention. [Figure 8] A perspective view schematically showing a further embodiment of the fluid connector according to the present invention. [Figure 9] A cross-section view schematically showing the fluid connector and the trocar module shown in FIG. 8 in a combined state. [Figure 10] A flowchart showing the coupling method according to the present invention. [Figure 11] A flowchart showing the coupling method according to the present invention.
Mode for Carrying Out the Invention
[0023] In the figures, the same or corresponding parts are denoted by the same reference numerals. The figures are merely schematic representations of embodiments of the present invention provided by way of non-limiting examples.
[0024] FIG. 1 is a perspective view schematically showing a trocar module 10 according to the present invention and a fluid connector 50 such as an infusion connector according to the present invention. The trocar module 10 and the fluid connector 50 are arranged for ophthalmic surgery.
[0025] The trocar module 10 preferably has a tubular cannula 11 having a distal portion 12 and a proximal portion 13 formed together as a single integrated element. The distal portion 12 has a distal end 14' positioned for insertion into the eyeball through the sclera of the eyeball. The proximal portion 13 of the tubular cannula 11 has a proximal end 14'' and is positioned to receive the capillary of the fluid connector 50 when coupled with the fluid connector 50. Typically, the wall thickness of the cannula 11 may be in the range of about 0.04 mm to about 0.05 mm.
[0026] Furthermore, the trocar module 10 has a valve unit 15 positioned on the proximal portion 13 of the cannula 11. When coupled, the valve unit 15 surrounds the cannula 11 to optionally seal the capillary when received by the cannula 11. When discoupled, the valve unit 15 seals the cannula 11, i.e., closes the proximal end of the tubular cannula or the cannula head 14'' to prevent leakage of fluid flowing from inside the eyeball. In addition, in the embodiment shown in the figure, the valve unit 15 surrounds the cannula 11 adjacent to its proximal end 14'' to seal it. Here, the valve unit 15 is integrally formed and has an annular body 15'. The body 15' is open at a first axial end and closed to seal at a second axial end opposite the first axial end. The axial end, which is closed to seal, may include multiple flanges 15” as shown in particular in Figures 2 and 3. The multiple flanges 15” overlap each other, are biased against each other, and individually partially cover the proximal end 14”. Preferably, the valve unit 15 is removable to allow, for example, perfusion fluid or silicone oil to flow out of the eyeball during certain surgical conditions. However, the valve unit 15 may be permanently attached to the tubular cannula 11. In another implementation example, the valve unit 15 closes to seal the proximal end 14” without surrounding the cannula 11.
[0027] The valve unit 15 closes to seal the cannula when no device such as a fluid connector is inserted into the cannula. Furthermore, the valve unit 15 may minimize leakage when a device such as a fluid connector is inserted into the cannula.
[0028] Furthermore, the trocar module 10 is provided with a collar 16 positioned around the cannula 11, and on its outer side is a circumferential groove 17 that engages with the sclera to stabilize the position of the collar within the eyeball and functions as an engagement structure that can be clamped by forceps or another surgical instrument used to handle the trocar module 10. Alternatively, for example, a different collar 16 without a circumferential groove, or a different engagement structure may be used.
[0029] In the embodiment shown in the figure, the tubular cannula 11 has a mainly circular cylindrical shape that is rotationally symmetric with respect to its longitudinal axis Lt. The valve unit 15 and collar 16 are also rotationally symmetric and concentric with respect to the longitudinal axis Lt.
[0030] The cannula 11 may be formed from, for example, a metal or a metal alloy. Furthermore, the valve unit 15 may be formed from an elastic material such as silicone.
[0031] The fluid connector 50, also called a catheter, comprises a generally cylindrical connector body or overmolded portion 51 and, in the embodiment shown in the figure, capillaries 52 that are concentric with respect to each other and with respect to their common longitudinal axis Lc. The connector body 51 surrounds the capillaries 52 that extend through the connector body 51. The capillaries 52 have a distal portion 53' provided with a distal end 52', also called a distal tip, for coupling with the trocar module 10, and a proximal portion 53'' for connecting to fluid input / output lines such as perfusion lines, suction lines, viscous fluid injection VFI lines, or viscous fluid extraction VFE lines.
[0032] As will be described in more detail below with reference to Figure 3, the connector body 51 is provided with a gap 54 that is traversed by the distal portion 53' of the capillary tube and at least partially receives the proximal portion 13 of the cannula 11, which includes at least a portion of the valve unit 15 when coupled. Furthermore, as will be described in more detail below with reference to Figure 3, the connector body 51 is provided with a plurality of clamping elements 55 that extend inward into the gap 54. The plurality of clamping elements 55 engage, connect, lock, and / or secure the trocar module 10, in particular its valve unit 15, when coupled. Preferably, the clamping elements 55 are mainly uniformly distributed in the circular direction C around the capillary tube 52. The clamping elements 55 have an inner surface that faces radially inward. The inner surface is either smooth or rough to improve its clamping force by increasing surface friction.
[0033] In the embodiment shown in the figure, both the connector body 51 and the gap 54 have a mainly circular cylindrical shape and are rotationally symmetric with respect to the longitudinal axis Lc. The connector body 51 is formed as a skirt at its distal end. In the embodiment shown in the figure, the skirt has a closed circumferential contour. However, the skirt may have a plurality of openings between the clamp elements 55, as shown in Figure 8, for example. The openings optionally extend toward and to the distal end of the skirt. The clamp elements 55 are formed as finger-like elements that are movable independently of each other.
[0034] In the embodiment shown in the figure, the capillary tube 52 is a separate component attached to the connector body 51. However, in principle, the capillary tube 52 and the connector body 51 can also be formed integrally as a single unit.
[0035] Figure 2 is a schematic cross-sectional view showing the trocar module 10 and fluid connector 50 shown in Figure 1 in a disconnected state. Figure 3 shows them in a connected state. The proximal portion 13 of the cannula 11 has a first tapered tubular portion 21, a second tapered tubular portion 22, and an intermediate tubular portion 23 located between the first tapered tubular portion 21 and the second tapered tubular portion 22. The first tapered tubular portion 21 is located proximal to the intermediate tubular portion 23 and is tapered toward the intermediate tubular portion 23 to align with the capillary 52 when connected. As shown in Figure 3, the intermediate tubular portion 23 has a generally constant cross-section and surrounds the distal end 53 of the capillary 52 when connected. Furthermore, the second tapered tubular portion 22 is tapered toward the distal portion 12 of the cannula from the intermediate tubular portion 23.
[0036] It should be noted that the first tapered tube section 21, the intermediate tube section 23, and the second tapered section 22 form a double-tapered fluid passage or canal 25 within the cannula 11. This allows the capillary 52 to be securely connected to the cannula 11 while its inner diameter is substantially the same as or larger than the inner diameter of the distal section 12 of the cannula. As a result, a flow structure can be provided in which the capillary 52 does not extend or protrude into the distal section 52, which is the smallest diameter structure of the cannula. This allows for a relatively large flow rate, which is limited by the passage with the smallest inner diameter of the entire flow path, resulting in relatively low fluid pressure and a stable intraocular pressure (IOP), while keeping the external area of the cannula 11 relatively small and minimizing traumatic wounds.
[0037] Each of the first tapered tube section 21, the intermediate tube section 23, and the second tapered section 22 has an inner wall that defines the local contour of the canal 25 of the cannula. Here, the entire inner wall of the intermediate tube section contacts the distal portion of the capillary when the trocar module and the fluid connector are coupled. The distal end 53' of the capillary then abuts against the second tapered tube section of the cannula. Alternatively, the capillary does not advance until it abuts against the second tapered tube section of the cannula. The proximal portion of the intermediate tube section contacts the distal portion of the capillary. In general, the intermediate tube section engages at least partially with the distal portion of the capillary of the fluid connector.
[0038] In the embodiment shown in the figure, the first tapered tube portion 21, the intermediate tube portion 23, and the second tapered tube portion 22 are arranged in this order directly adjacent to each other. The tapered end 21' of the first tapered tube portion 21 is adjacent to the proximal end of the intermediate tube portion 23, and the distal end of the intermediate tube portion 23 is adjacent to the proximal end 22' of the second tapered tube portion 22. Furthermore, the distal end 22'' of the second tapered tube portion 22 is adjacent to the proximal end of the distal portion 12 of the cannula. In the embodiment shown in the figure, the proximal portion 13 of the cannula 11 includes a double tapered tube portion 21 connected to each other via the intermediate tube portion 23. In principle, another structure may be applied between the tapered tube portions 21, 22 and the intermediate tube portion 23, for example, an annular clamp interface tube portion may be applied between the first tapered tube portion 21 and the intermediate tube portion 23.
[0039] Furthermore, in the embodiment shown in the figure, the proximal portion 13 of the cannula 11 has an extension tube portion 24 between the proximal end 14" of the cannula 11 and the first tapered tube portion 21. The extension tube portion 24 has a generally constant cross-section.
[0040] During the coupling process between the trocar module 10 and the fluid connector 50, the capillary 52 of the fluid connector 50 is received by the proximal portion 13 of the tubular cannula 11 of the trocar module 10. This allows the proximal portion 13 of the cannula 11, including its valve unit 15, to be received at least partially in the gap 54 of the connector body 51 of the fluid connector 50. Furthermore, the capillary 52 of the fluid connector 50 advances within the cannula 11 until the intermediate tube portion 23 surrounds the distal tube portion 52' of the capillary 52.
[0041] In the coupled state shown in Figure 3, the trocar module 10 and the fluid connector 50 form a trocar system. Here, the intermediate tube portion 23 surrounds the distal end or distal tip 52' of the capillary tube 52. Furthermore, the capillary tube 52 of the fluid connector 50 engages with both the intermediate tube portion 23 of the trocar module 10 and the valve unit 15. In addition, the skirt of the connector body, particularly its clamping element 55, clamps the proximal portion 13 of the cannula 11, which includes the valve unit 15. Preferably, the radially oriented inner surface of the clamping element 55 defines a circle with a diameter smaller than the outer diameter of the valve unit 15. This ensures that, in the coupled state, the clamping element 55 is pressed against the preferably elastic material of the valve unit 15.
[0042] Preferably, the inner diameter of the capillary fluid passage or the capillary 52 surrounding the canal 26 is substantially the same as or larger than the inner diameter of the distal portion 12 of the cannula. This allows the fluid flow performance of the fluid passage or canal 25 within the cannula 11 to be optimally utilized without the fluid impedance of the capillary 52 significantly contributing to the overall fluid impedance.
[0043] Similarly, the inner diameter of the intermediate tube section 23 is substantially the same as or larger than the outer diameter of the distal section 12 of the cannula. This reduces the fluid impedance of the capillary tube 52.
[0044] During the disconnection process that returns the trocar system to its separate components, the trocar module 10 and the fluid connector 50, the capillary 52 of the fluid connector 50 is released by the intermediate tube portion 23 and the valve unit 15, and the capillary 52 is retracted from the cannula 11 of the trocar module 10 until the capillary 52 of the fluid connector 50 is released by the intermediate tube portion 23 and the valve unit 15, and the proximal portion 13 of the cannula 11, including the valve unit 15, is released by the skirt of the connector body 51.
[0045] Figure 4 is another perspective view schematically showing the trocar module 10 shown in Figure 1. Here, the valve unit 15 has been removed. As shown in the figure, the distal portion 12 of the tubular cannula 11 has an outer surface 12' on which a laser-processed textured structure 12” or pattern is provided at least partially. By providing the laser-processed textured structure 12” an outer surface 12' with increased surface roughness or surface pattern can be obtained, which can improve the retention of the cannula 11 in the sclera of the eyeball. On the other hand, applying laser processing can counteract damage such as excessive deformation at the surface edges or impact on roundness for tool insertion, which can occur in cannulas with generally thin wall thicknesses, especially when the cannula 11 has a relatively small gauge size, as opposed to rolling and / or machining. Preferably, the surface has a gradient roughness to avoid damage to the wound or counteracting uneven insertion forces during surgery. Furthermore, the laser-processed textured structure or pattern may have a regular structure such as a repeating roughness profile. According to one embodiment, a process is provided for preparing a trocar module for ophthalmic surgery. The trocar module comprises a tubular cannula having a distal portion for insertion through the sclera of the eyeball and a proximal portion for receiving the capillaries of a fluid connector coupled with the fluid connector. The process includes the step of exposing the outer surface of the tubular cannula to laser irradiation in order to generate a textured structure on at least a portion of the outer surface. Advantageously, the laser treatment is applied for optimization or fine-tuning of the textured structure.
[0046] However, it should be noted that, in principle, the outer surface 12' of the distal portion 12 of the tubular cannula 11 may have another texture pattern, for example, provided by rolling and / or machining, or it may not have any texture pattern at all.
[0047] Figure 5 shows Figure 30 illustrating a graph of pressure drop as a function of flow in a trocar module 10 according to the present invention. Specifically, the pressure drop P (mmHg) is shown as a function of the flow rate Fl (ml / min). The first pressure drop graph corresponds to a trocar unit having a first bore diameter or gauge size D1. Typically, the effective bore diameter of trocar units belonging to the same gauge class may deviate due to manufacturing tolerances, and the corresponding pressure drop may also deviate. The first pressure drop graph 71 reflects the average pressure drop behavior of the first bore diameter or gauge size D1, also called the first set of trocar units. The second pressure drop graph 72 corresponds to another trocar module 10 of the first set of trocar units, however this shows the maximum pressure drop behavior. Similarly, the third pressure drop graph 73 corresponds to yet another trocar module of the first set of trocar units, however this shows the minimum pressure drop behavior. The first set of trocar units having a first inner diameter or gauge size exhibits a pressure drop curve that statistically deviates in a bandwidth between the second and third pressure drop graphs 72 and 73, defined statistically, for example, by the proportion of its overall population distribution, e.g., 95%.
[0048] Similarly, a second set of trocar units having a second inner diameter or gauge size D2 that is larger than the first inner diameter or gauge size D1 will, on average, exhibit a pressure drop corresponding to the fourth pressure drop graph 74 shown in Figure 30, and may deviate statistically between the fifth pressure drop graph 75 corresponding to the maximum pressure drop and the sixth pressure drop graph 76 corresponding to the minimum pressure effect.
[0049] Furthermore, a third set of trocar units having a second inner diameter or gauge size D3 that is larger than the second inner diameter or gauge size D2 will, on average, exhibit a pressure drop corresponding to the seventh pressure drop graph 77 shown in Figure 30, and may deviate statistically between the eighth pressure drop graph 78, which corresponds to the maximum pressure drop, and the ninth pressure drop graph 79, which corresponds to the minimum pressure drop.
[0050] As shown in Figure 30 of Figure 5, the pressure drop graphs of the first, second, and third sets of the trocar unit are shown at the threshold flow rate level Fl threshold They do not overlap beyond a certain point. Therefore, in surgical situations, each set of trocar units is used in conjunction with a corresponding set of other ophthalmic surgical devices to counteract suboptimal treatment of the eyeball during surgery, so it may be necessary to easily identify the first, second, and third sets of trocar units. By specifying the gauge size of the trocar units, preferably preoperatively or at the start of surgery, a surgical system setting scan can be configured to optimize intraocular pressure (IOP) and IOP stability during surgery. For example, the first set of trocar units is used in combination with a phacovitrectomy device having a relatively small bore diameter or a relatively large gauge size, and preferably not in combination with a phacovitrectomy device having a relatively large bore diameter or a relatively small gauge size. This avoids requiring a lot of time for the infusion or aspiration process. As a further example, the third set of trocar units is used in combination with an ophthalmic surgical device having a relatively large bore diameter or a relatively small gauge size, and preferably not in combination with a phacovitrectomy device having a relatively small bore diameter or a relatively large gauge size. This prevents the infusion or aspiration process from occurring with excessively large fluid flows that could potentially damage the eyeball.
[0051] To identify the trocar module, the inner diameter of the distal portion 12 of the tubular cannula 11, or its gauge size, can be determined by measuring the fluid impedance on the proximal side of the capillary 52 of the fluid connector, preferably after coupling with the fluid connector 50. By evaluating the measured fluid impedance or the pressure drop P per flow rate FL, the corresponding effective inner diameter or gauge size can be found, thereby identifying the trocar module.
[0052] It should be noted that the step of identifying the trocar module can be performed not only for the trocar module described in claim 1, but more generally for ophthalmic surgical trocar modules comprising a tubular cannula having a distal portion for insertion through the sclera of the eyeball and a proximal portion for receiving the capillaries of a fluid connector in conjunction with the fluid connector.
[0053] Figure 6 is a schematic cross-sectional view showing another embodiment of the fluid connector 50 according to the present invention. Similar to the fluid connector described with reference to Figure 1, the fluid connector includes a connector body 51 and a capillary tube 52 surrounded by the connector body 51. The connector body 51 is provided with a gap 54 for at least partially receiving the proximal portion 13 of the cannula 11 when coupled. The connector body 51 also has a plurality of clamping elements 55. The plurality of clamping elements 55 extend inward within the gap 54 to engage in a clamping manner with the trocar module 10 when coupled.
[0054] The capillary tube 52 has a distal portion 53' that crosses the gap 54 and is provided with a distal end or distal tip 52' for coupling with the trocar module 10, and a proximal portion 53'', where the proximal portion 53'' is positioned for connection with the viscous fluid extraction VFE line. Furthermore, the connector body 51 is provided with a proximal gap 56 for accommodating the distal end of the VFE line connected to the capillary tube 52.
[0055] Figure 7 is a schematic cross-sectional view showing a further embodiment of the fluid connector 50 according to the present invention. This fluid connector 50 has a similar design to the fluid connector 50 shown in Figure 6, except that the proximal portion 53'' is positioned for connection to a viscous fluid injection VFI line. Furthermore, the distal tip 52' of the capillary tube 52 is significantly longer than that in the embodiment shown in Figure 6. This allows the distal tip 52' to pass through the proximal portion 13 of the tubular cannula 11 and traverse most of the distal portion 12 of the tubular cannula 11. This allows for greater internal overpressure without disconnecting the fluid connector 50 and the trocar module 10 coupled thereto and separating them from each other.
[0056] Figure 8 is a schematic perspective view showing a further embodiment of the fluid connector 50 according to the present invention. Similar to the fluid connector described with reference to Figures 6 and 7, this fluid connector 50 includes a connector body 51 and a capillary tube 52 surrounded by the connector body 51. The connector body 51 is provided with a gap 54 for at least partially receiving the proximal portion 13 of the cannula 11 when coupled. The connector body 51 also has a plurality of clamping elements 55. The plurality of clamping elements 55 extend inward within the gap 54 to engage in a clamping manner with the trocar module 10 when coupled.
[0057] The connector body 51 is formed as a skirt at its distal end. In the embodiment shown in the figure, the skirt has an opening 60 for receiving the circumferential portion of the valve unit 15 of the trocar module 10 when coupled. Here, the valve unit 15 can extend slightly into the opening 60. Furthermore, the clamping element 55 forms an undercut portion that engages below the valve unit 15. This allows the trocar module 10 to be releasably locked to the fluid connector 50 when coupled.
[0058] Figure 9 is a schematic cross-sectional view showing the fluid connector 50 and trocar module 10 shown in Figure 8 in a coupled state. As clearly shown in Figure 9, the finger-like elements 55 engage around and below the valve unit 15 of the trocar module 10. Figure 10 shows a flowchart of a method according to the present invention. This method is used to couple a trocar module and a fluid connector to form a trocar system. Method 100 includes the steps of receiving the capillary of the fluid connector with the proximal portion of the tubular cannula of the trocar module, thereby at least partially receiving the proximal portion of the cannula within the gap of the connector body of the fluid connector, and advancing the capillary into the cannula until the intermediate tubular portion surrounds the distal end of the capillary of the fluid connector. Preferably, the method includes the step of advancing the capillary into the cannula until the distal end of the capillary of the fluid connector abuts against a second tapered tubular portion of the cannula.
[0059] Furthermore, as described above, the method 100 may also include the step of determining the inner diameter of the distal portion 12 of the tubular cannula 11 by performing a fluid impedance measurement on the proximal side of the capillary tube 52 of the fluid connector in order to determine the gauge size of the trocar module 10, for example.
[0060] Figure 11 shows a flowchart of Method 200 according to the present invention. The Method is used to uncouple a trocar system and separate the trocar module 10 from the fluid connector 50. Method 200 includes step 210 of retracting the capillary 52 of the fluid connector 50 from the cannula 11 of the trocar module 10.
[0061] The present invention is not limited to the embodiments described herein. It should be noted that many modifications are possible.
[0062] Furthermore, it should be noted that the trocar module described above can be used not only to connect to the corresponding fluid connector, but also to be traversed by other ophthalmic surgical instruments such as laser devices, vitrectomy devices, or forceps.
[0063] These embodiments and other embodiments will be obvious to those skilled in the art and will be considered to fall within the scope of the invention as defined in the appended claims. For the sake of clear and concise description, the above features are described herein as part of the same or distinct embodiments. However, it should be noted that the scope of the invention may include embodiments having all or some combinations of the described features.
Claims
1. A trocar module for ophthalmic surgery, A tubular cannula having a distal portion for insertion through the sclera of the eyeball, and a proximal portion for receiving the capillary of a fluid connector in a state connected to the fluid connector, - A valve unit positioned at the proximal portion of the cannula for sealing the cannula when it is disconnected, Equipped with, The proximal portion of the cannula has a first tapered tubular portion, a second tapered tubular portion, and an intermediate tubular portion located between the first tapered tubular portion and the second tapered tubular portion. The first tapered tube portion is located proximal to the intermediate tube portion and is tapered toward the intermediate tube portion in order to align with the capillary tube when joined. The aforementioned intermediate tube portion has a generally constant cross-section and, when joined, surrounds the distal end of the capillary tube. The second tapered tube portion is tapered from the intermediate tube portion toward the distal portion of the cannula. The distal end of the capillary tube abuts against the second tapered tubular portion of the cannula. Trocar module.
2. The trocar module according to claim 1, wherein the first tapered tube portion, the intermediate tube portion, and the second tapered tube portion form a double-tapered canal within the cannula.
3. The trocar module according to claim 1 or 2, wherein each of the first tapered tube portion, the intermediate tube portion, and the second tapered portion has an inner wall that defines the local contour of the canal of the cannula.
4. The trocar module according to any one of claims 1 to 3, wherein the intermediate pipe portion has a proximal end and a distal end.
5. The trocar module according to any one of claims 1 to 4, wherein the tapered end of the first tapered pipe portion is adjacent to the proximal end of the intermediate pipe portion.
6. The trocar module according to any one of claims 1 to 5, wherein the distal end of the intermediate tube portion is adjacent to the proximal end of the second tapered tube portion.
7. The tubular cannula mainly has a circular cylindrical shape, according to any one of claims 1 to 6.
8. The trocar module according to any one of claims 1 to 7, wherein the inner diameter of the capillary is substantially the same as or larger than the inner diameter of the distal portion of the cannula.
9. The trocar module according to any one of claims 1 to 8, wherein the inner diameter of the intermediate tube portion is substantially the same as or larger than the outer diameter of the distal portion of the cannula.
10. The trocar module according to any one of claims 1 to 9, further comprising a collar positioned around the cannula, wherein a circumferential groove is provided on the outside of the collar.
11. The trocar module according to any one of claims 1 to 10, wherein the valve unit surrounds the cannula adjacent to the proximal end of the tubular cannula in a sealing manner.
12. The trocar module according to any one of claims 1 to 11, wherein the distal portion of the tubular cannula has an outer surface provided with at least a partially laser-processed textured structure.
13. A fluid connector for ophthalmic surgery, comprising a capillary tube and a connector body surrounding the capillary tube, wherein the capillary tube has a proximal portion for connecting to a fluid input / output line and a distal portion for coupling to a trocar module according to claim 1, and the connector body is provided with a gap traversed by the distal portion of the capillary tube for at least partially receiving the proximal portion of a cannula when coupled.
14. The fluid connector according to claim 13, wherein the connector body mainly has a circular cylindrical shape.
15. The fluid connector according to claim 13 or 14, wherein the void mainly has a circular cylindrical shape.
16. The fluid connector according to any one of claims 13 to 15, wherein the connector body is provided with a plurality of clamping elements, and the plurality of clamping elements extend inward within the gap to engage with the trocar module in a coupled state to clamp it.
17. The fluid connector according to claim 16, wherein the plurality of clamping elements are mainly uniformly distributed in the circular direction around the capillary tube.
18. The fluid connector according to any one of claims 13 to 17, wherein the fluid input / output line connected to the proximal portion of the capillary is a perfusion line, a suction line, a viscous fluid injection line, or a viscous fluid extraction line.
19. A trocar system for ophthalmic surgery, comprising a trocar module according to claim 1 coupled to a fluid connector according to claim 13, wherein the intermediate tube portion surrounds the distal end of the capillary when coupled.
20. The trocar system according to claim 19, wherein the capillary of the fluid connector is engaged by the intermediate pipe portion and valve unit of the trocar module.
21. The trocar system according to any one of claims 19 to 20, wherein the intermediate tube portion engages at least partially with the distal portion of the capillary tube.
22. The trocar system according to any one of claims 19 to 21, wherein the intermediate tube portion has an inner wall that defines the local contour of the canal of the cannula, and the entire inner wall of the intermediate tube portion is in contact with the distal portion of the capillary.
Citation Information
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