Ophthalmic surgical instruments

Abstract

The apparatus comprises a. a clamp (1), b. a central body (3), and c. an actuator (5), wherein the clamp (1) has an operating end (1d) and a sleeve (2) that receives the sliding clamp (1), the central body (3) has a first proximal end (3p) which is integrated with a handle (4) and a second distal end (3d) to which the first end (1p) of the clamp (1) opposite to the operating end (1d) is fixed, and the actuator (5) has a first end (6p) which extends around the central body (3) and is connected to the central body (3), and a bushing to which the sleeve (2) is fixed. The clamp (1) is formed by a pair of levers (6) having a second end (6d) connected by a bushing (7), the levers (6) being elastically deformable between a first non-operating position and a second operating position, in which the operating end (1d) of the clamp (1) is open and protrudes from the sleeve (2), and in the second operating position, the sleeve (2) applies force to the operating end (1d) of the clamp (1) to force the operating end (1d) of the clamp (1) to close, the central body (3), the actuator (5), and the bushing (7) are integral parts.

Description

Technical Field

[0001] The present invention relates to the field of instruments used in ophthalmic surgery.

Background Art

[0002] The implementation of ophthalmic surgery, particularly vitreoretinal surgery, is intended to visualize, cut, grasp, or peel membranes formed at various sites of the eyeball in specific pathological conditions, and requires the use of a number of disposable or autoclave-sterilizable instruments.

[0003] Among these, the distal-operated retinal forceps are particularly used for grasping the membrane to be removed. In the non-operating state, the clamp is open, and the operator causes the closure of the clamp by operating the operating part (usually with simple pressure). In most current retinal forceps, the operating part of the clamp protrudes from the tubular part in such a manner that the clamp is inserted into the tubular part. The opening and closing (non-operating / operating) of the clamp are achieved by the movement of the tubular part along the clamp. Therefore, to close the clamp, the operator applies force to the operating part to move the tubular part along the clamp and act on the operating part of the clamp to close it. This movement is performed in the direction from the proximal end of the instrument towards the opposing distal end (which has the operating part of the clamp). To open the clamp, the operator releases the force applied to the operating part and moves the tubular part in the reverse direction to release the operating end of the clamp (from the distal end to the proximal end of the instrument) to open the clamp.

[0004] For example, such retinal forceps are described in WO-A-2021 / 038428 or WO-A-2018 / 156341.

Summary of the Invention

[0005] Existing retinal forceps have a large number of components, making the manufacturing process long and expensive. Furthermore, the arrangement of these different components makes cleaning difficult. Therefore, to avoid contamination associated with insufficient cleaning of the instrument, medical professionals prefer single-use (disposable) retinal forceps. Consequently, while the high manufacturing cost is currently due to the large number of components and the complexity of their assembly process, there is a need to achieve a relatively low selling price for single-use (disposable) retinal forceps. Manufacturers of surgical instruments, particularly retinal forceps, constantly face the challenge of reducing manufacturing costs without compromising the quality or ergonomics of their retinal forceps.

[0006] One objective of the present invention is to propose a retinal forceps-type instrument that is simpler to manufacture and less expensive, while maintaining its ergonomic characteristics.

[0007] For this purpose, the present invention provides a device comprising a. a clamp, b. a central body, and c. an actuator, wherein the clamp has an operating end and a sleeve that receives the clamp as it slides; the central body has a first proximal end integrated with a handle and a second distal end to which the first end opposite the operating end of the clamp is fixed; the actuator is formed by a set of levers extending around the central body and having a first end connected to the central body and a second end connected by a bushing to which the sleeve is fixed, wherein the levers are elastically deformable between a first non-operating position and a second operating position of the clamp, in which the operating end of the clamp is open and protrudes from the sleeve, and in the second operating position, the sleeve applies force to the operating end of the clamp to tighten it and force it to close.

[0008] Furthermore, according to the present invention, the central main body, the actuator, and the bushing are integral parts.

[0009] Therefore, the device according to the present invention has a very limited number of parts, making it easy and economical to manufacture and assemble, while maintaining excellent ergonomics for the practitioner.

[0010] Furthermore, the apparatus according to the present invention may include a guide nose that slidably receives and guides at least a portion of the sleeve, the guide nose being fixed and connected to the central body. In a preferred embodiment, the guide nose may be connected to the central body by an arm passing between the levers. The guide nose may also have a housing that receives the sliding bushing.

[0011] Advantageously, in the present invention, the guide nose, the central body, the actuator, and the bushing are integrated components.

[0012] Furthermore, the handle and the central body portion may also be integrated parts.

[0013] The present invention also provides a method for manufacturing an apparatus according to the present invention, the method comprising: a. manufacturing an integral part including at least a central body, an actuator, a bushing, and a guide nose by additive manufacturing; b. fixing the sleeve to the bushing; c. slidably inserting the clamp into the sleeve; and d. fixing it within the central body.

[0014] Additive manufacturing makes it possible to obtain the instruments of the present invention quickly and at low cost.

[0015] Other features and advantages of the present invention will become apparent from reading the following description relating to certain non-limiting embodiments of the invention.

[0016] Refer to the attached drawings. [Brief explanation of the drawing]

[0017] [Figure 1] This is a perspective view of the device according to the present invention. The device is in a non-operating state, and the clamp is in the open position. [Figure 2] This is a longitudinal cross-sectional view of the device according to the present invention along axis X. The clamp is in the open position and is shown at a 90° angle to Figure 1. [Figure 3] This is a longitudinal cross-sectional view of the device according to the present invention, along the axis X. The clamp is in the open position. [Figure 4] This is an enlarged view along the IV line. The distal part of the central main body, bushing, clamp, sleeve, and guide nose are shown. [Figure 5] This is an enlarged view along the V-line. The distal part of the central main body, bushing, clamp, sleeve, and guide nose are shown. [Figure 6] This is a longitudinal cross-sectional view of the device according to the present invention, along the axis X. The clamp is in the closed position. [Figure 7] This is an enlarged view along line VII. The distal part of the central main body, bushing, clamp, sleeve, and guide nose are shown. The clamp is in the closed position. [Modes for carrying out the invention]

[0018] In this specification, the element described as "proximal" refers to the element closest to the practitioner's hand. On the other hand, the element described as "distal" refers to the element furthest from the practitioner's hand.

[0019] Referring to Figures 1 to 7, in a particular embodiment, the present invention relates to an instrument that is a retinal forceps, comprising a rod-shaped clamp 1 having an operational (active) distal end 1d and a proximal end 1p intended to be fixed within a central body 3.

[0020] Clamp 1 defines the longitudinal axis X of the device, passing through its distal end 1d and proximal end 1p.

[0021] The actuated distal end 1d is separated into two elastically deformable branches that terminate in gripping surfaces for gripping tissue pieces.

[0022] In the non-actuated position, the two branches of the distal end 1d of the clamp 1 are in a stationary (resting) state spaced apart from each other, particularly as shown in FIGS. 1 and 3. In the actuated position, the two branches of the distal end 1d of the clamp 1 are in an elastically deformed state in contact with each other such that the gripping surfaces can grip a tissue piece, particularly as shown in FIG. 6. One skilled in the art will know how to select the clamp 1 according to the ultimate use of the instrument that is the subject of the present invention.

[0023] The instrument according to the present invention also comprises a hollow cylindrical sleeve 2 having an inner diameter slightly larger than that of the clamp 1, and the clamp 1 is slidably engaged (fitted) within the sleeve 2. This diameter is defined such that after the clamp 1 is engaged within the sleeve, it can slide within the sleeve between the actuated and non-actuated positions. In the actuated position, the sleeve 2 enables a clamping force to be applied to the two branches of the distal end 1d of the clamp 1, thereby bringing the gripping surfaces of the branches into contact and closing (i.e., actuating) the clamp 1.

[0024] The clamp 1 and the sleeve 2 are made of a biocompatible and sterilizable material, such as, by way of non-limiting example, stainless steel or a chromium-cobalt alloy.

[0025] The apparatus of the present invention further comprises a central body 3 having substantially the form of a hollow tube. The central body 3 has a dome-shaped distal portion 3d to which the proximal end 1p of the clamp 1 is fixed. The proximal end 1p of the clamp 1 is fixed to the distal portion 3d of the central body 3 by at least one screw 10. Here, the proximal end 1p is fixed in the distal portion 3d by two screws 10 that are engaged opposite to each other in a direction perpendicular to the longitudinal axis X, thereby clamping the proximal end 1p between the two screws. That is, the proximal end 1p of the clamp 1 is held within the central body 3 between two screws 10 like a vise. Those skilled in the art will be able to adjust (change) the holding force of the clamp 1 by tightening / loosening at least one of the two screws 10. Those skilled in the art will be able to define (determine) the dimensions of the central body 3 and the fixing means of the clamp 1 based on the materials used and manufacturing constraints. As an example, the central body is made of Pa12 (polyamide 12), has a diameter of approximately 12 mm at its widest point, and a length of approximately 35 to 40 mm, preferably 38 mm.

[0026] Therefore, the central body portion 3 has a proximal end 3p that is integrated with the handle 4 and faces the distal end 3d. The handle 4 forms an extension, facilitating the operation of the instrument by the practitioner's hand. The handle 4 is also generally cylindrical in shape. Those skilled in the art will know how to determine the length and diameter of the handle according to the desired ergonomics. For example, the length of the handle is 50 to 150 mm and the diameter is 7 to 10 mm.

[0027] The apparatus of the present invention also comprises an actuator 5 formed by a pair of levers 6 extending around a central body 3. Each of these levers 6 has a first proximal end 6p connected to the central body 3 and a second distal end 6d extending beyond the distal end 3d. The second distal end 6d is connected to the distal end 3d by a bushing 7 extending coaxially with it in front of the distal end 3d. The sleeve 2 is fixed to the bushing 7 by any means such as adhesive, welding, or simply holding in place. The levers 6 are elastically deformable between a first non-operating position of the clamp 1 in which the operating end 1d of the clamp 1 is open and protrudes from the sleeve 2, and a second operating position in which the sleeve 2 covers and tightens the operating end 1d of the clamp 1, forcing the operating end of the clamp to close. Each lever 6 has a proximal segment and a distal segment, which are connected to each other by a first flexible blade that defines an opening angle of less than 180° when the actuator 5 is in the non-operating position, a second flexible blade connecting the proximal segment to the central body 3, and a third flexible blade connecting the distal segment to the bushing 7. Each (connected) segment and flexible blade is a single unit. In the operating position, as shown in particular in Figure 6, the two segments are substantially aligned to each other, and the angle formed between the two segments is substantially equal to 180°. In the operating position, the distal end of the sleeve 2 closes the operating distal end 1d of the clamp 1, but does not cover the gripping surface of the distal end 1d. A person skilled in the art will know how to determine the length of each segment and each blade and the value of the angle formed, depending on the length of the central body 3 and the travel length of the bushing 7. Furthermore, it is clear that those skilled in the art will know how to consider the properties of the materials used in determining the size of the levers, and how to determine the number of levers 6 required to form the actuator 5 based on the dimensions of each lever, the materials used, and the desired ergonomics.

[0028] As an example, the actuator 5 may consist of 10 levers 6 made of polyamide 12 (Pa12). Each lever 6 has a variable width in the distal segment ranging from 1 to 5 mm and a variable width in the proximal segment closer to the handle 4 ranging from 2 to 5 mm. At the narrowest ends of the lever segments, the proximal end 6p corresponds to the end adjacent to the proximal end 3p of the central body 3, and the distal end 6d corresponds to the end on the extension of the bushing 7. The widest part of each segment located between the two ends is intended to accommodate the operator's fingers when the instrument is in use. The proximal and distal segments of each lever 6 have lengths of approximately 30 mm and less than 10 mm, respectively, forming an angle of approximately 130° when the actuator 5 is not in operation.

[0029] The proximal end 6p of the lever 6 is integrally connected to the proximal part 3p of the central body 3. On the other hand, the distal end 6d of the lever 6 is integrally connected to a bushing 7 that is translatably movable relative to the central body 3 along axis X. To operate the clamp, the operator applies pressure to all or part of the lever 6 of the actuator 5, preferably to their widest parts. This causes the lever 6 to unfold (extend) and transmit translational motion to the bushing 7 until each segment of the lever 6 forms an angle substantially equal to 180° between them. This also causes the sleeve 2, which is fixed to the bushing 7, to translatably move along axis X toward its distal end 1d. This causes the distal end of the sleeve 2 to act on the two branches of the distal end 1d of the clamp 1, bringing these two branches closer together so that the clamp 1 closes, i.e., is operated. Conversely, when the operator releases the pressure applied to actuator 5, lever 6 folds due to its own elastic action, and the two segments return to form the initial angle between them. Bushing 7 and sleeve 2 perform translational movement in the opposite direction toward handle 4. As a result, the two branches of the distal end 1d of clamp 1 are released from the distal end of sleeve 2 and move away from each other due to their own elastic action. The translational movement of sleeve 2 stops when lever 6 reaches a resting state (initial state) and bushing 7 returns to the vicinity of the distal end 3d of the central body 3.

[0030] Furthermore, according to the present invention, the central body 3, the actuator 5, and the bushing 7 may be a single part (integrated part). The actuator assembly 5, consisting of the central body 3 and a pair of levers 6 connected at their distal ends, and the bushing 7 can be manufactured by additive manufacturing. For example, the central body 3, the actuator 5, and the bushing 7 can be manufactured using an EOS brand printer supplied with polyamide 12 (Pa12). This manufacturing is carried out in a series of continuous, sequential layers along the X-axis.

[0031] In a preferred embodiment of the present invention described herein, the instrument comprises a fixed guide nose 8 connected to a central body 3. The guide nose 8 extends forward of the bushing 7 and covers a portion of the bushing 7. Preferably, the guide nose 8 may be connected to the distal end of the central body 3 by a plurality of arms 12 passing between a plurality of levers 6. Here, the plurality of arms 12 are on the extension of the distal portion 3d of the central body 3. The guide nose 8 has a drilled hole collinear with axis X, which slidably receives a portion of the sleeve 2 and guides that portion of the sleeve 2, thereby reducing the risk of bending the sleeve 2. The diameter of the drilled hole is slightly larger than the diameter of the sleeve 2, and the sleeve 2 is freely slidable within the guide nose 8. The guide nose 8 here is substantially a hollow truncated cone shape with a drilled hole at its apex. The guide nose 8 further has a rear housing that freely receives a portion of the bushing 7, particularly in the operating position. Therefore, in the operating position of the device, the bushing 7 approaches the inner wall of the housing located inside the guide nose 8, and in the non-operating position of the device, the bushing 7 approaches the distal end of the central body 3. Consequently, the translational range of the bushing 7, and consequently the sleeve 2, is limited to between the distal end of the central body 3 and the inner wall of the housing of the guide nose 8. It should be noted that the guide nose is fixed. The presence of the guide nose 8 allows for improved accuracy of the device between the two extreme positions. It also facilitates sliding the sleeve 2 along the clamp 1 and can improve accuracy of the device by strengthening its retention. Furthermore, because the guide nose is fixed and integral with the central body 3, the distance between the end 1d of the clamp 1 and the top of the guide nose 8 remains constant, regardless of whether the device is operating or not. This ensures that the effective length of the clamp 1-sleeve 2 assembly inserted into the eye is fully maintained. This allows the practitioner to operate the device in the same manner, regardless of whether the device is activated or not.

[0032] Furthermore, according to the present invention, the guide nose 8, central body 3, actuator 5, and bushing 7 can be manufactured as a single, integrally molded part. The actuator assembly 5, consisting of the central body 3 and a pair of levers 6 connected at their distal ends, the bushing 7, the guide nose 8, and the arm 12 that passes between the levers 6 and lies on the extension of the distal portion of the central body 3, can be manufactured by additive manufacturing.

[0033] Preferably, the handle 4 and the central body portion 3 can also be formed as a single integrated part.

[0034] Therefore, the apparatus according to the present invention may consist of only the following three distinguishable elements: - Clamp 1, -Sleeve 2, - A single, integrated component comprising a central body 3, actuator 5, bushing 7, and optional guide nose 8 and handle 4.

[0035] Consequently, manufacturing costs are significantly reduced. This is because the single component is manufactured by additive manufacturing, the sleeve 2 is fixed within the bushing 7, and finally the clamp 1 is slid into the sleeve 2 and fixed within the central body 3. This feature is even more effective if the single component also encloses the guide nose 8 and / or the handle 4.

[0036] This invention also relates to such manufacturing methods.

[0037] Sleeve 2 is secured manually or automatically. Sleeve 2 is inserted into the drilled hole of the guide nose 8, and then into the drilled hole of the bushing 7, where it is secured. Finally, after sleeve 2 is secured within the bushing 7, clamp 1 is slidably inserted into sleeve 2, with its proximal end 1p reaching the fixing means 10 connected to the central body 3. Once clamp 1 is correctly positioned within the central body 3, the fixing means (in this case, a screw 10) is tightened to secure clamp 1 and prevent its translational movement along axis X.

[0038] Therefore, the instrument according to the present invention has a small number of parts. This simplifies assembly and reduces manufacturing costs. The adoption of additive manufacturing makes it possible to manufacture shapes that would be difficult or impossible with other techniques. For example, it makes it possible to manufacture the instrument according to the present invention to have a fixed guide nose 8 integrated with the central body 3. This also reduces manufacturing time, especially assembly time. The adoption of additive manufacturing makes it possible to easily manufacture the instrument at extremely low cost while maintaining its ergonomics and precision.

[0039] Naturally, the present invention is not limited to the embodiments described herein, but encompasses all modifications that fall within the scope of the invention as defined by the claims.

[0040] In particular, the clamp is held in place by two screws within the central body, although the proximal end of the clamp may be held in place by one screw. Alternatively, the proximal end of the clamp may be glued or welded into the central body.

Claims

1. It is a device, a. Clamp (1) and, b. Central main body (3) and c. Actuator (5) and, Equipped with, The clamp (1) has an operating end (1d) and a sleeve (2) that receives the sliding clamp (1), The central main body (3) has a first proximal end (3p) which is integrated with the handle (4), and a second distal end (3d) to which the first end (1p) opposite to the operating end (1d) of the clamp (1) is fixed. The actuator (5) is formed by a set of levers (6) having a first end (6p) that extends around the central body portion (3) and is connected to the central body portion (3), and a second end (6d) that is connected by a bushing (7) to which the sleeve (2) is fixed. The lever (6) is elastically deformable between a first non-operating position and a second operating position of the clamp (1), In the first non-operating position, the operating end (1d) of the clamp (1) opens and protrudes from the sleeve (2). In the second operating position, the sleeve (2) applies force to the operating end (1d) of the clamp (1) to force the operating end (1d) of the clamp (1) to close. The central body portion (3), the actuator (5), and the bushing (7) are integral parts. The device is equipped with a guide nose (8), and at least a portion of the sleeve (2) is guided through the guide nose (8). The guide nose (8) is fixed and connected to the central main body (3). An apparatus characterized by the following features.

2. The guide nose (8) is connected to the central main body (3) by an arm that passes between the levers (6). The apparatus according to feature 1.

3. The guide nose (8) has a housing that freely accommodates the bushing (7). The apparatus according to claim 1 or 2.

4. The guide nose (8), the central body portion (3), the actuator (5), and the bushing (7) are integral parts. The apparatus according to any one of the features described in 1 to 3.

5. The handle (4) and the central body portion (3) form a single integrated part. The apparatus according to any one of features 1 to 4.

6. A method for manufacturing the apparatus described in any one of claims 1 to 5, a. A process of manufacturing an integral component including at least a central body (3), an actuator (5), a bushing (7), and a guide nose (8) by additive manufacturing, b. The step of fixing the sleeve (2) to the bushing (7), c. The step of slidably inserting the clamp into the sleeve (2), d. The step of fixing it within the central main body (3), A method characterized by comprising:

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