Trocar module, fluid connector and method
The design of the cannula module with a double-conical structure solves the problem of insufficient fluid flow in small sizes, achieving a larger flow rate and stable intraocular pressure, reducing wound trauma, and improving the stability of the cannula through the laser texture structure.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- NETHERLANDS EYE RES CENT (INT) LTD
- Filing Date
- 2021-10-04
- Publication Date
- 2026-08-04
AI Technical Summary
The reduction in size of existing ophthalmic surgical cannula modules leads to a decrease in fluid flow, affecting surgical performance, and requires higher irrigation pressure, making it difficult to maintain a large flow rate at a smaller size.
The tubular sleeve design with a double-conical structure includes a first conical part, a second conical part, and an intermediate tube part. When the capillary is coupled, it is aligned with the intermediate tube part through the first conical part. The intermediate tube part has a constant cross-section, and the second conical part gradually tapers to ensure that the inner diameter of the capillary is basically the same as or larger than the inner diameter of the distal part of the sleeve, forming a single-walled flow channel.
It achieves high flow rates and stable intraocular pressure in a small size, reduces wound trauma, improves flow performance, and improves the retention of the cannula in the sclera of the eye through laser-textured structures.
Smart Images
Figure CN116583248B_ABST
Abstract
Description
[0001] The present invention relates to a cannula module for ophthalmic surgery, comprising: a tubular cannula having a distal portion and a proximal portion, the distal portion for insertion through the sclera of the eye, the proximal portion for receiving a capillary of the fluid connector in a coupled state; and a valve unit disposed at the proximal portion of the cannula for sealingly surrounding the capillary in the coupled state.
[0002] Cannula modules are generally known in ophthalmic surgery for providing access to the interior of the eye via an insertion opening, or for irrigation, fluid exchange, or for use with surgical instruments to illuminate, cut, remove, or otherwise manipulate tissue. The tubular cannula passes through the sclera of the eye, and in the case of fluid exchange for irrigating the eye (such as irrigation lines or aspiration lines), a valve unit is sealingly positioned around a capillary coupled to a fluid connector of the cannula module.
[0003] On the proximal side, the sleeve is typically tapered, used to align the capillary of the fluid connector into the sleeve. During coupling of the fluid connector to the sleeve, the capillary is inserted into the sleeve via the tapered portion, beyond the tapered portion, until the capillary extends sufficiently to the distal portion of the sleeve. The capillary then also passes through a valve unit that seals around the capillary.
[0004] Recent developments in ophthalmic surgical instruments have led to a reduction in the effective diameter of the instruments passing through structures of the sclera, thereby increasing their size. However, reducing the inner diameter of the capillary also reduces the flow rate of the operating fluid, which can be detrimental to surgical performance. Higher irrigation pressures may be required due to reduced chamber stability.
[0005] Therefore, there is a need for a cannula module that can be implemented in a small size while facilitating relatively high flow rates.
[0006] The object of this invention is to provide a cannula module for ophthalmic surgery, wherein the outer diameter is relatively small while maintaining a relatively high flow rate. Therefore, according to the invention, a cannula module for ophthalmic surgery is provided, comprising: a tubular cannula having a distal portion and a proximal portion, the distal portion for insertion through the sclera of the eye, the proximal portion for receiving a capillary of a fluid connector coupled to the fluid connector; and a valve unit disposed at the proximal portion of the cannula for sealing the cannula in a non-coupled state, wherein the proximal portion of the cannula has a first tapered tube portion, a second tapered tube portion, and an intermediate tube portion located between the first and second tapered tube portions, wherein the first tapered tube portion is located proximal to the intermediate tube portion and gradually tapers toward the intermediate tube portion to align with the capillary during coupling, wherein the intermediate tube portion has a substantially constant cross-section and surrounds the distal end of the capillary in the coupled state, and wherein the second tapered tube portion gradually tapers from the intermediate tube portion toward the distal portion of the cannula.
[0007] By applying a tubular cannula with a biconical internal profile (with an intermediate tube portion between the biconical internal profiles), the distal end of the capillary can be displaced via a first conical portion toward a second conical portion. The second conical portion tapers gradually from the location of the capillary toward the distal end of the cannula with the smallest inner diameter. The capillary can then be securely coupled to the cannula while the inner diameter of the capillary remains substantially the same as or larger than the inner diameter of the distal portion of the cannula, thereby creating a flow structure in which the capillary does not extend or protrude into the smallest diameter structure of the cannula (its distal portion). The flow velocity, typically limited by the smallest inner diameter channel throughout the flow path, can then be relatively high, allowing for relatively low fluid pressure and stable intraocular pressure (IOP), while the outer portion of the cannula can be relatively small to minimize wound trauma. The flow channel in the distal portion of the cannula has a single wall, in contrast to the double walls (i.e., the wall of the capillary and the wall of the distal portion of the cannula) present in known cannula needle modules coupled to fluid connectors.
[0008] By applying a double-cone structure, the corresponding elements engage with each other to open the flow path, resulting in a design with significantly improved flow performance for the same back pressure. High flow capacity is then achieved without the need to remove valve units. The double-cone structure (particularly the intermediate tube section between the two conical parts) leads to a design that provides reliable coupling forces.
[0009] Advantageously, the inner diameter of the intermediate tube portion is substantially the same as or greater than the outer diameter of the distal portion of the sleeve, so that the inner diameter of the capillary of the fluid connector can be equal to or greater than the inner diameter of the distal portion of the sleeve.
[0010] Preferably, the distal portion of the tubular cannula has an outer surface, which is at least partially provided with a laser-manufactured textured structure, thereby improving the retention of the cannula in the sclera of the eye.
[0011] Furthermore, the present invention relates to a fluid connector for ophthalmic surgery, comprising: a capillary and a connector body surrounding the capillary, the capillary having: a proximal portion for connection to a fluid input or output line and a distal portion for coupling to a cannula module, wherein the connector body is provided with a cavity through which the distal portion of the capillary passes for receiving at least a portion of the proximal portion of the cannula in a coupled state.
[0012] A clever coupling structure can be achieved by providing a receiving cavity in the connector body to the proximal portion of the sleeve, wherein the fluid connector is coupled to the sleeve needle module via various coupling elements, including at least: a valve unit through which the capillary passes, a sleeve intermediate tube portion that receives the distal end of the capillary, and a cavity that receives or clamps the proximal portion of the sleeve.
[0013] Preferably, the connector body is provided with a plurality of clamping elements, which are preferably evenly distributed in the circumferential direction mainly around the longitudinal axis of the connector body and extend inward into the cavity for clamping engagement of the sleeving needle module, such as its valve unit, in the coupled state.
[0014] Typically, the fluid inlet or outlet lines that are connected to the fluid connector at the proximal end of the capillary can be, for example, flushing lines, suction lines, viscous fluid injection lines, or viscous fluid extraction lines.
[0015] Furthermore, the present invention relates to a cannula system for ophthalmic surgery, comprising a cannula module coupled to a fluid connector, wherein an intermediate tube portion surrounds the distal end of a capillary.
[0016] Preferably, the capillary of the fluid connector is then engaged with the intermediate tube portion of the cannula needle module and the valve unit, thereby achieving an interference fit or friction fit between the capillary and the intermediate tube portion and the valve unit (on the one hand).
[0017] This invention also relates to a method for coupling a cannula module to a fluid connector. Additionally, this invention relates to a method for decoupling a cannula system into a cannula module and a fluid connector.
[0018] The method may include the step of determining the inner diameter of the distal portion of the tubular cannula by performing a fluid resistance measurement at the proximal side of the capillary, thereby easily identifying the specification dimensions of the cannula needle module.
[0019] Furthermore, the present invention relates to a process for preparing a cannula module for ophthalmic surgery, the process comprising: exposing the outer surface of a tubular cannula to laser radiation to generate a textured structure on at least a portion of the outer surface.
[0020] Other advantageous embodiments of the invention are described in the following claims.
[0021] It should be noted that the technical features described above or below may each be embodied individually in the cannula module, fluid connector, and / or method, i.e., isolated from the context in which they are described, separate from other features, or combined only with many other features described in the context in which they are disclosed. Each of these features may further be combined with any other disclosed feature in any combination.
[0022] The invention will be further illustrated based on the exemplary embodiments shown in the accompanying drawings. The exemplary embodiments are given by way of non-limiting description of the invention. In the drawings:
[0023] Figure 1 A schematic perspective view of the cannula needle module and fluid connector according to the present invention is shown;
[0024] Figure 2 It shows Figure 1 A schematic cross-sectional view of the cannula module and fluid connector in a decoupled state;
[0025] Figure 3 It shows Figure 1 A schematic cross-sectional view of the cannula module and fluid connector in a coupled state, as shown.
[0026] Figure 4 It shows Figure 1 Another schematic perspective view of the cannula module shown;
[0027] Figure 5 A pressure drop curve as a function of flow rate is shown in the cannula module according to the present invention;
[0028] Figure 6 A schematic cross-sectional view of another embodiment of the fluid connector according to the present invention is shown;
[0029] Figure 7 A schematic cross-sectional view of yet another embodiment of the fluid connector according to the present invention is shown;
[0030] Figure 8 A schematic perspective view of another embodiment of the fluid connector according to the present invention is shown;
[0031] Figure 9 It shows Figure 8A schematic cross-sectional view of the fluid connector and cannula module in the coupled state;
[0032] Figure 10 A flowchart of a method for coupling according to the present invention is shown, and
[0033] Figure 11 A flowchart of a method for coupling according to the present invention is shown.
[0034] In the accompanying drawings, identical or corresponding parts are indicated by the same reference numerals. The drawings are merely schematic diagrams illustrating embodiments of the invention by way of non-limiting example.
[0035] Figure 1 A schematic perspective view of a cannula module 10 according to the invention and a fluid connector 50 (such as an infusion connector) according to the invention are shown, the cannula module 10 and the fluid connector 50 being arranged for ophthalmic surgery.
[0036] The cannula module 10 has a tubular cannula 11 having a distal portion 12 and a proximal portion 13, which are preferably formed together as a single element. The distal portion 12 has a distal end 14' and is arranged to be inserted into the eye through the sclera of the eye. The proximal portion 13 of the tubular cannula 11 has a proximal end 14'' and is arranged to receive a capillary of a fluid connector 50, which is coupled to the fluid connector 50. Typically, the cannula 11 may have a wall thickness ranging from approximately 0.04 mm to approximately 0.05 mm.
[0037] The cannula module 10 also includes a valve unit 15 disposed at the proximal portion 13 of the cannula 11 for optionally sealingly surrounding the capillary in a coupled state when the capillary is received in the cannula 11. In a decoupled state, the valve unit 15 seals the cannula 11, i.e., sealably closes the proximal end or cannula head 14'' of the tubular cannula to suppress leakage of fluid from inside the eye. Additionally, in the illustrated embodiment, the valve unit 15 sealably surrounds the cannula 11 adjacent to its proximal end 14''. Here, the valve unit 15 is integrally formed with an annular body 15' that opens at a first axial end and sealably closes at a second axial end opposite the first axial end. The sealably closed axial end may include a plurality of flanges 15'' that overlap, are offset from each other, and individually partially cover the proximal end 14'', particularly as shown in the figure. Figure 2 and Figure 3As shown. Preferably, the valve unit 15 is removable, for example, to allow irrigation fluid or silicone oil to flow outward from the eye during certain surgical conditions. However, the valve unit 15 may be permanently mounted to the tubular cannula 11. In another embodiment, the valve unit 15 does not surround the cannula 11, but seals off the proximal end 14''.
[0038] When no instrument, such as a fluid connector, is inserted into the sleeve, valve unit 15 seals the sleeve tightly. Additionally, when an instrument, such as a fluid connector, is inserted into the sleeve, valve unit 15 minimizes leakage.
[0039] Additionally, the cannula module 10 is provided with a collar 16 arranged around the cannula 11, and the collar has a circumferential groove 17 on its outer side. The circumferential groove is used to engage the sclera to stabilize the position of the collar in the eye and serves as an engagement structure that can be clamped by forceps or another surgical instrument handling the cannula module 10. Alternatively, another collar 16 may be used, for example, without a circumferential groove, or another engagement structure.
[0040] In the illustrated embodiment, the tubular sleeve 11 has a predominantly circular cylindrical shape and is rotationally symmetrical about its longitudinal axis Lt. Furthermore, the valve unit 15 and the collar 16 are rotationally symmetrical and concentric with the longitudinal axis Lt.
[0041] The sleeve 11 can be made of, for example, metal or a metal alloy. Additionally, the valve unit 15 can be made of an elastic material such as silicone.
[0042] The fluid connector 50 (also referred to as a conduit) has a generally cylindrical connector body or overmolded portion 51 and a capillary 52, which, in the illustrated embodiment, are concentric with each other and with respect to their common longitudinal axis Lc. The connector body 51 surrounds the capillary 52 extending through the connector body 51. The capillary 52 has a distal portion 53' and a proximal portion 53'', the distal portion being provided with a distal end 52' (also referred to as a distal tip) for coupling with the cannula needle module 10, and the proximal portion for connection to a fluid inlet or outlet line, such as a flushing line, a suction line, a viscous fluid injection (VFI) line, or a viscous fluid extraction (VFE) line.
[0043] The connector body 51 is provided with a cavity 54 through which the distal capillary portion 53' passes, for receiving at least one portion of the proximal portion 13 of the sleeve 11 in the coupled state, including at least one portion of the valve unit 15, as referenced. Figure 3A more detailed explanation follows. Additionally, the connector body 51 is provided with a plurality of clamping elements 55 that extend inwardly into the cavity 54 for clamping, engaging, connecting, locking, and / or securing the sleeve needle module 10, particularly its valve unit 15, in a coupled state, as referenced. Figure 3 To explain in more detail. Preferably, the clamping elements 55 are evenly distributed around the capillary 52 in the circumferential direction C. The clamping elements 55 have an inner surface facing radially inward, which may be smooth or rough to increase their clamping force by increasing surface friction.
[0044] In the illustrated embodiment, both the connector body 51 and the cavity 54 have a predominantly circular cylindrical shape that is rotationally symmetrical with respect to their longitudinal axis Lc, with the connector body 51 forming a skirt at its distal end. In the illustrated embodiment, the skirt has a closed circumferential profile. However, the skirt may have openings (e.g., Figure 8 As shown), for example, in the opening between the clamping elements 55, the opening optionally extends toward and all the way to the far end of the skirt, and then the clamping elements 55 are formed as fingers that can move independently of each other.
[0045] In the illustrated embodiment, the capillary 52 is a separate component mounted within the connector body 51. However, in principle, the capillary 52 and the connector body 51 can be integrally formed as a single unit.
[0046] Figure 2 It shows Figure 1 The schematic cross-sectional view of the cannula module 10 and fluid connector 50 in the decoupled state is shown. Figure 3 They are shown in their coupled state. The proximal portion 13 of the sleeve 11 has a first tapered tube portion 21, a second tapered tube portion 22, and an intermediate tube portion 23 located between the first tapered tube portion 21 and the second tapered tube portion 22. The first tapered tube portion 21 is located proximal to the intermediate tube portion 23 and tapers towards the intermediate tube portion 23 to align with the capillary 52 during coupling. The intermediate tube portion 23 has a substantially constant cross-section and surrounds the distal end 53' of the capillary 52 in the coupled state, as shown... Figure 3 As shown. In addition, the second tapered tube portion 22 gradually tapers from the middle tube portion 23 toward the distal end portion 12 of the sleeve.
[0047] It should be noted that the first tapered tube portion 21, the intermediate tube portion 23, and the second tapered portion 22 form a double-tapered fluid channel or conduit 25 located within the sheath 11 for securely coupling the capillary 52 to the sheath 11. The inner diameter of the capillary 52 can still be substantially the same as or larger than the inner diameter of the distal portion 12 of the sheath, thereby creating a flow structure in which the capillary 52 does not extend or protrude into the minimum diameter structure of the sheath (i.e., its distal portion 52). The flow velocity, typically limited by the minimum diameter channel throughout the flow path, can then be relatively high, allowing for relatively low fluid pressure and stable intraocular pressure (IOP), while the outer portion of the sheath 11 can be relatively small to minimize wound trauma.
[0048] The first tapered tube portion 21, the intermediate tube portion 23, and the second tapered portion 22 each have an inner wall defining a partial profile of the sleeve conduit 25. Here, in the coupled state of the sleeve needle module and the fluid connector, the entire inner wall of the intermediate tube portion contacts the distal portion of the capillary. Then, the distal end 53' of the capillary abuts against the second tapered tube portion of the sleeve. Alternatively, the capillary is not advanced until it reaches the second tapered tube portion adjacent to the sleeve. Then, the proximal portion of the intermediate tube portion contacts the distal portion of the capillary. Typically, the intermediate tube portion engages at least a portion of the distal portion of the capillary of the fluid connector.
[0049] In the illustrated embodiment, the first tapered tube portion 21, the intermediate tube portion 23, and the second tapered tube portion 22 are positioned directly adjacent to each other in the indicated order. The tapered end 21' of the first tapered tube portion 21 then abuts the proximal end of the intermediate tube portion 23, while the distal end of the intermediate tube portion 23 abuts the proximal end 22' of the second tapered tube portion 22. Additionally, the distal end 22'' of the second tapered tube portion 22 abuts the proximal end of the distal end portion 12 of the sleeve. In the illustrated embodiment, the proximal end portion 13 of the sleeve 11 includes a double tapered tube portion 21 interconnected via the intermediate tube portion 23. In principle, another structure can be applied between the tapered portions 21, 22 and the intermediate tube portion 23, for example, an annular clamping interface tube portion between the first tapered tube portion 21 and the intermediate tube portion 23.
[0050] Additionally, in the illustrated embodiment, the proximal portion 13 of the sleeve 11 has an extending tube portion 24 between the proximal end 14'' of the sleeve 11 and the first tapered tube portion 21, the extending tube portion 24 having a substantially constant cross-section.
[0051] During the coupling of the cannula module 10 to the fluid connector 50, the capillary 52 of the fluid connector 50 is received in the proximal portion 13 of the tubular sleeve 11 of the cannula module 10, thereby receiving at least a portion of the proximal portion 13 of the sleeve 11 (including its valve unit 15) in the cavity 54 of the connector body 51 of the fluid connector 50. Additionally, the capillary 52 of the fluid connector 50 is advanced into the sleeve 11 until the intermediate tube portion 23 surrounds the distal tube portion 52' of the capillary 52.
[0052] In a coupled state, such as Figure 3 As shown, the cannula module 10 and the fluid connector 50 form a cannula system. Here, the intermediate tube portion 23 surrounds the distal end or distal tip 52' of the capillary 52. Furthermore, the capillary 52 of the fluid connector 50 is joined by both the intermediate tube portion 23 and the valve unit 15 of the cannula module 10. Additionally, the skirt of the connector body (especially the clamping element 55 thereon) clamps the proximal portion 13 of the cannula 11 (including its valve unit 15). Preferably, the radially facing inner surface of the clamping element 55 defines a circle with a diameter smaller than the outer diameter of the valve unit 15, such that, in the coupled state, the clamping element 55 is pressed into the preferred elastic material of the valve unit 15.
[0053] Preferably, the inner diameter of the capillary 52 surrounding the capillary fluid channel or conduit 26 is substantially the same as or larger than the inner diameter of the distal portion 12 of the sleeve, so that the fluid resistance of the capillary 52 does not have a significant impact on the overall fluid resistance, thereby making the fluid flow performance of the fluid channel or conduit 25 in the sleeve 11 optimally utilized.
[0054] Similarly, the inner diameter of the intermediate tube portion 23 is substantially the same as or larger than the outer diameter of the distal end portion 12 of the sleeve, thereby reducing the fluid resistance of the capillary 52.
[0055] During the process of decoupling or not coupling back to the cannula module 10 and fluid connector 50 as independent components, the capillary 52 of the fluid connector 50 is retracted from the cannula 11 of the cannula module 10 until the capillary 52 is released by the intermediate tube portion 23 and the valve unit 15, and the proximal portion 13 of the cannula 11 (including its valve unit 15) is released by the skirt of the connector body 51.
[0056] Figure 4 It shows Figure 1Another schematic perspective view of the cannula module 10 shown. Here, the valve unit 15 has been removed. As shown, the distal portion 12 of the tubular cannula 11 has an outer surface 12', which is at least partially provided with a laser-manufactured texture structure 12'' or pattern. By providing the laser texture structure 12'', an outer surface 12' with increased surface roughness or surface pattern is obtained, improving the retention of the cannula 11 in the sclera of the eye. On the other hand, by applying the laser process, damage that occurs on cannulas that are typically thin-walled (such as excessive deformation at surface edges or the risk to the roundness of tool insertion) is counteracted, as opposed to rolling and / or machining processes, especially if the cannula 11 has relatively small dimensions. Preferably, the surface has graded roughness to avoid counteracting wound damage or uneven insertion forces during surgery. Additionally, the laser-manufactured texture structure or pattern can have a regular structure, such as repeating roughness profiles. According to one aspect, a process is provided for fabricating a cannula module for ophthalmic surgery, the cannula module 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 the fluid connector coupled to the fluid connector, the process comprising: exposing an outer surface of the tubular cannula to laser radiation to generate a textured structure on at least a portion of the outer surface. Advantageously, the laser process is applied to optimize or fine-tune the textured structure.
[0057] However, it should be noted that, in principle, the outer surface 12' of the distal portion 12 of the tubular sleeve 11 may have a different textured pattern (e.g., provided by rolling and / or machining processes), or may not have a textured pattern at all.
[0058] Figure 5A pressure drop curve diagram 30, as a function of flow rate, is shown in the cannula module 10 according to the present invention. Specifically, the pressure drop P, in mmHg, is described as a function of the flow rate Fl, in ml / min. A first pressure drop curve 71 corresponds to a cannula unit having a first inner diameter or specification size D1. Typically, the effective inner diameter of cannula units falling within the same specification category may deviate due to manufacturing tolerances. Consequently, the corresponding pressure drop may also deviate. The first pressure drop curve 71 reflects the average pressure drop behavior of a group of cannula units having the first inner diameter or specification size D1 (also referred to as the first group of cannula units). A second pressure drop curve 72 corresponds to another cannula module 10 of the first group of cannula units, but with the maximum pressure drop behavior. Similarly, a third pressure drop curve 73 corresponds to yet another cannula module of the first group of cannula units, but with the minimum pressure drop behavior. Then, the pressure drop curve of the first set of cannula units with the first inner diameter or specification size is statistically deviated from the bandwidth between the second pressure drop curve 72 and the third pressure drop curve 73 in a statistical sense, for example, defined by the percentage of its total population distribution (e.g., 95%).
[0059] Similarly, the average pressure drop of the second set of cannula needle units with a second inner diameter or specification size D2 (greater than the first inner diameter or specification size D1) corresponds to the fourth pressure drop curve 74 shown in the pressure drop curve diagram 30, and statistically may deviate between the fifth pressure drop curve 75 corresponding to the maximum pressure drop and the sixth pressure drop curve 76 corresponding to the minimum pressure drop.
[0060] Furthermore, the average pressure drop of the third group of cannula needle units with a second inner diameter or specification size D3 (greater than the second inner diameter or specification size D2) corresponds to the seventh pressure drop curve 77 shown in the pressure drop curve diagram 30, and statistically it can deviate between the eighth pressure drop curve 78 corresponding to the maximum pressure drop and the ninth pressure drop curve 79 corresponding to the minimum pressure drop.
[0061] like Figure 5 The pressure drop curves are shown in Figure 30. The pressure drop curves of the first, second, and third groups of cannula needle units at the threshold flow level Fl thresholdThe above are not overlapping. Therefore, in surgical procedures, it may be necessary to easily identify the first, second, and third groups of cannula units, as the corresponding groups of cannula units will be used in conjunction with other ophthalmic surgical devices of the corresponding group to counteract suboptimal treatment of the eye during surgery. By identifying the size and specifications of the cannula units, the surgical system setup scan is preferably set to optimize intraocular pressure (IOP) and IOP stability during surgery, either before or at the start of the procedure. As an example, the first group of cannula units will be used in combination with a vitrectomy device having a relatively small inner diameter or a relatively large size (preferably not in combination with a vitrectomy device having a relatively large inner diameter or a relatively small size) to avoid excessive time spent on infusion or aspiration procedures. As another example, the third group of cannula units will be used in combination with an ophthalmic surgical device having a relatively large inner diameter or a relatively small size (preferably not in combination with a vitrectomy device having a relatively small inner diameter or a relatively large size) to avoid infusion or aspiration procedures with excessive fluid flow, which could potentially cause damage to the eye.
[0062] To identify the cannula module, the inner diameter or its specification dimension of the distal portion 12 of the tubular cannula 11 can be determined by performing a fluid resistance measurement near the capillary 52 of the fluid connector, preferably after coupling with the fluid connector 50. By evaluating the measured fluid resistance or pressure drop P for each flow rate FL, the corresponding effective inner diameter or specification dimension can be found, thereby identifying the cannula module.
[0063] It should be noted that the step of identifying the cannula module can generally be performed on a cannula module used in ophthalmic surgery, the cannula module 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 the fluid connector coupled to the fluid connector.
[0064] Figure 6 A schematic cross-sectional view of another embodiment of the fluid connector 50 according to the present invention is shown. (Similar to reference...) Figure 1 The fluid connector described includes a connector body 51 and a capillary tube 52 surrounded by the connector body 51. The connector body 51 is provided with a cavity 54 for receiving at least a portion of the proximal portion 13 of a sleeve 11 in a coupled state. The connector body 51 also has a plurality of clamping elements 55 extending inwardly into the cavity 54 for clampingly engaging the sleeve needle module 10 in a coupled state.
[0065] The capillary 52 has a distal portion 53' and a proximal portion 53'', the distal portion passing through the cavity 54 and having a distal end or distal tip 52' for coupling with the cannula needle module 10. Here, the proximal portion 53'' is arranged for connection to a viscous fluid extraction (VFE) line. The connector body 51 also has a proximal cavity 56 for receiving the distal end of the VFE line connected to the capillary 52.
[0066] Figure 7 A schematic cross-sectional view of yet another embodiment of the fluid connector 50 according to the present invention is shown. The fluid connector 50 is designed similarly to... Figure 6 The fluid connector 50 is shown, however, the proximal portion 53'' is now arranged for connection to a viscous fluid injection VFI line. Additionally, the distal end 52' of the capillary 52 is significantly larger than... Figure 6 The length in the illustrated embodiment allows the distal end 52' to pass through the proximal portion 13 of the tubular sleeve 11 and through most of the distal portion 12 of the tubular sleeve 11, thereby allowing for greater internal overpressure without decoupling and removing the fluid connector 50 and the coupled cannula needle module 10 from each other.
[0067] Figure 8 A schematic perspective view of another embodiment of the fluid connector 50 according to the present invention is shown. (Similar to reference numerals) Figure 6 and Figure 7 The fluid connector 50 described includes a connector body 51 and a capillary tube 52 surrounded by the connector body 51. The connector body 51 is provided with a cavity 54 for receiving at least a portion of the proximal portion 13 of the sleeve 11 in a coupled state. The connector body 51 also has a plurality of clamping elements 55 extending inwardly into the cavity 54 for clampingly engaging the sleeve needle module 10 in a coupled state.
[0068] The connector body 51 is formed as a skirt at its distal end. In the illustrated embodiment, the skirt has an opening 60 to receive a circumferential portion of the valve unit 15 of the cannula module 10 in the coupled state. Here, the valve unit 15 is allowed to extend slightly into the opening 60. Additionally, a clamping element 55 forms an undercut engaging below the valve unit 15, thereby releasably locking the cannula module 10 to the fluid connector 50 in the coupled state.
[0069] Figure 9 It shows Figure 8 The diagram shows a schematic cross-sectional view of the fluid connector 50 and the cannula module 10 in a coupled state. Figure 9 As can be clearly seen, the finger-shaped member 55 engages around and below the valve unit 15 of the cannula needle module 10. Figure 10A flowchart of a method according to the present invention is shown. The method is used to couple a cannula module to a fluid connector to form a cannula system. Method 100 includes: receiving a capillary of the fluid connector 110 in a proximal portion of a tubular sleeve of the cannula module, thereby receiving at least a portion of the proximal portion of the sleeve in a cavity of a connector body of the fluid connector; and advancing the capillary of the fluid connector 120 into the sleeve until an intermediate tube portion surrounds the distal end of the capillary. Preferably, the method further includes: advancing the capillary of the fluid connector into the sleeve until the distal end of the capillary abuts against a second tapered tube portion of the sleeve.
[0070] Method 100 may further include the step of determining the inner diameter of the distal portion 12 of the tubular sleeve 11 by performing a fluid resistance measurement at the proximal side of the capillary 52 of the fluid connector, for example, to identify the specification dimensions of the cannula needle module 10 as described above.
[0071] Figure 11 A flowchart of a method 200 according to the present invention is shown. The method is used to decouple a cannula system into a cannula module 10 and a separate fluid connector 50. Method 200 includes the step of retracting the capillary 52 of the fluid connector 50 from the cannula 11 of the cannula module 10 210.
[0072] This invention is not limited to the embodiments described herein. It should be understood that many variations are possible.
[0073] It should be noted that the aforementioned cannula module can be used not only to couple to the corresponding fluid connector, but also to be passed through by other ophthalmic surgical devices (such as laser devices, vitrectomy devices, or forceps).
[0074] 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 by the following claims. For clarity and brevity, features described herein are 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. A cannula module (10) for ophthalmic surgery, comprising: A tubular cannula (11) having a distal portion (12) and a proximal portion (13), the distal portion for insertion through the sclera of the eye, and the proximal portion for receiving a capillary (52) of a fluid connector (50) in a coupled state. A valve unit (15) is arranged at the proximal portion (13) of the sleeve (11) for sealing the sleeve (11) in a non-coupled state. The proximal portion (13) of the sleeve (11) has a first tapered tube portion (21), a second tapered tube portion (22), and an intermediate tube portion (23) located between the first tapered tube portion (21) and the second tapered tube portion (22). The first tapered tube portion (21) is located proximal to the intermediate tube portion (23) and gradually tapers toward the intermediate tube portion (23) for alignment with the capillary (52) during coupling. The intermediate tube portion (23) has a constant cross-section and surrounds and engages at least a portion of the distal end (53') of the capillary (52) in the coupled state, wherein the second tapered tube portion (22) tapers gradually from the intermediate tube portion (23) toward the distal end portion (12) of the sleeve, wherein in the coupled state, the distal end (53') of the capillary abuts against the second tapered tube portion (22), and wherein the first tapered tube portion (21), the intermediate tube portion (23), and the second tapered tube portion (22) form a double tapered tube (25) located in the sleeve (11). The valve unit sealably surrounds the tubular sleeve adjacent to its proximal end. In the coupled state, the capillary of the fluid connector is joined by the valve unit and the intermediate tube portion of the cannula needle module.
2. The cannula module according to claim 1, wherein, The inner diameter of the capillary is the same as or greater than the inner diameter of the distal portion of the sleeve.
3. The cannula module according to claim 1, wherein, The inner diameter of the intermediate tube portion is the same as or greater than the outer diameter of the distal portion of the sleeve.
4. The cannula module according to any one of claims 1-3 further includes a collar, the collar being arranged around the cannula, and the collar having a circumferential groove on its outer side.
5. A fluid connector (50) for ophthalmic surgery, comprising: The capillary tube (52) and a connector body (51) surrounding the capillary tube, the capillary tube (52) having: a proximal portion (53'') for connection to a fluid input or output line, and a distal portion (53') for coupling to a cannula module (10) according to claim 1, wherein the connector body (51) is provided with a cavity (54) for receiving at least a portion of the proximal portion (13) of the cannula (11) in the coupled state, the distal portion (53') of the capillary tube passing through the cavity, wherein the valve unit (15) of the cannula module (10) is made of an elastic material, and wherein the connector body (51) is provided with a plurality of clamping elements (55) extending inwardly into the cavity (54) for clampingly engaging the valve unit (15) in the coupled state.
6. The fluid connector according to claim 5, wherein, The clamping elements are evenly distributed around the capillary in a circumferential direction.
7. The fluid connector according to claim 5 or 6, wherein, The fluid inlet or outlet line to be connected to the proximal portion of the capillary is a flushing line, a suction line, a viscous fluid injection line, or a viscous fluid extraction line.
8. A cannula system for ophthalmic surgery, comprising the cannula module according to claim 1 and the fluid connector according to claim 5, wherein, In the coupled state, the distal end (53') of the capillary against which the intermediate tube portion (23) abuts is the distal end (53') of the capillary of the fluid connector.
9. The cannula system according to claim 8, wherein, The intermediate tube portion has an inner wall that defines a partial profile of the conduit within the sleeve, and wherein the complete inner wall of the intermediate tube portion contacts the distal portion of the capillary.
10. A method for coupling a cannula module (10) according to claim 1 with a fluid connector (50) according to claim 5 to form a cannula system according to claim 8, the method comprising the steps of: The capillary (52) of the fluid connector (50) is received in the proximal portion (13) of the tubular sleeve (11) of the cannula needle module (10), thereby receiving at least a portion of the proximal portion (13) of the sleeve (11) in the cavity (54) of the connector body (51) of the fluid connector (50), and The capillary (52) of the fluid connector (50) is advanced into the sleeve (11) until the intermediate tube portion (23) surrounds and engages at least a portion of the distal tip (52') of the capillary (52). It also includes the following steps: The capillary of the fluid connector is advanced into the sleeve until the distal end of the capillary abuts against the second tapered portion of the sleeve.
11. The method of claim 10, further comprising: The step of determining the inner diameter of the distal portion of the tubular sleeve by performing a fluid impedance measurement at the proximal side of the capillary.
12. A method for decoupling a cannula system according to claim 8 from its coupled state to a cannula module according to claim 1 and a fluid connector according to claim 5, the method comprising: The step of retracting the capillary of the fluid connector from the sleeve of the cannula needle module.