Surgical fixation clamp

Abstract

The technical solution relates to a surgical fixation clamp for use particularly in microsurgery and ophthalmic surgery, for example to prevent longitudinal displacement of fibres, tissues and other materials. Surgical fixation clamp comprises an actuating member (1) and at least one holding member (7, 2, 3) lying in the plane of the actuating member (1) and attached to the actuating member (1), wherein the actuating member (1) is elastically deformable in the plane of the actuating member for actuating the clamping of jaws (7a, 1a, 2a, 3a) of the clamp, and wherein (a) to the actuating member (1), a single holding member (7) is attached, located outside the actuating member (1), or b) to the actuating member (1), two adjacently positioned holding members (2, 3) are attached, located inside the actuating member (1). Deformation of the elastically deformable actuating member (1) in the shape of a generally planar closed curve controls, by the action of a suitable tool, the clamping of the jaws.

Description

[0001] SURGICAL FIXATION CLAMP

[0002] Field of the invention

[0003] The technical solution relates to a surgical fixation clamp for use particularly in microsurgery and ophthalmic surgery, for example to prevent longitudinal displacement of fibres, tissues and other materials.

[0004] Background

[0005] In surgery, especially microsurgery, it is often necessary to fix fibres and tissues to prevent unwanted longitudinal displacement, and to improve the visibility and the possibility of adjustment. Often the same or similar instruments are used to temporarily close blood vessels or other hollow organs.

[0006] Tweezers are used to hold the tissues and fibres, which require permanent holding and attention, or clamps with two branches connected at the pivot point and fitted with a lock (Pean forceps, Kocher forceps, etc.) which hold by themselves.

[0007] Known locking clamps allowing permanent clamping typically comprise two jaws and corresponding handles, attached at a pivot point, and a locking tooth allowing the handles to be releasably fixed together to maintain the clamping of the jaws, as described in US2796065A. Some clamps for the purpose of maintaining jaw clamping include a spring that deflects the handles against each other.

[0008] For example, US7144402B2 describes a vascular clamp for temporary occlusion of a blood vessel, typically a microvascular clamp for temporary occlusion of small blood vessels, which comprises two jaws, a sliding pivot point, and two handles between which a spring is positioned so that the closing force is evenly distributed along the length of the jaws.

[0009] US8246094B2 describes a clamping tweezers comprising two flexible arms, two handles and an adjustment block. The two flexible arms are joined together at one end to form a joined end, and begin to open from the joined end.

[0010] Another option for attaching fibres are bulldog clamps, whose jaws open with a squeeze of the surgeon's hand, and when the squeeze is released, their spring mechanism returns the jaws to the clamped position, so that the clamp continues to hold sutures, tissues or vessels.

[0011] These solutions are disadvantageous for microsurgery, e.g. for setting the necessary fibre length for flange techniques in ocular surgery, especially in that:

[0012] - the miniaturization of the jaws does not allow sufficient miniaturization of the actuating member, which may interfere;

[0013] - they are composed of several parts, the connection of which, e.g. pivoting around a pin, or the connection of flexible and inflexible parts, poses problems in their miniaturization, especially when a high clamping force is required;

[0014] - further miniaturization needed would bring handling problems;

[0015] - if the instruments could be sufficiently miniaturized, they would be at risk of being lost in handling because they are not threaded on a fibre, or they have no closed parts that would be useful for fixing or hanging them to prevent loss;

[0016] - greater height of jaws impairs the possibility of adjusting the length of the fibre in flange techniques.

[0017] In ophthalmic surgery, for example, no clamps are used to fix the fibres in the Canabrava "flange" technique, and the fibres are only held with tweezers. This makes it difficult to adjust the length of the fibres. For the above reasons, neither the surgical bulldog microclamps available on the market are suitable for holding the fibres.

[0018] Therefore, there is a need to provide clamps that maintain a firm grip even after the release of the actuation force, provide one-handed manipulation, are manufacturable in a miniature, low weight version, preferably as disposable, with low manufacturing cost, preferably from a single piece of material, and have limited potential for loss / entrapment in patient tissue during the procedure. Description

[0019] The subject matter of the technical solution is a clamp for use in surgery, in particular in microsurgery, for example to prevent longitudinal displacement of fibres, tissues and other materials.

[0020] The essence and unifying idea of the technical solution of the clamp is an elastically deformable actuating member in the shape of a generally planar closed curve, whose deformation by the action of a suitable tool controls the clamping of the clamp jaws. The actuating member lies in a plane which is herein referred to as the "plane of the actuating member". The deformation of the actuating member controlling the clamping of the jaws of the clamp is accomplished in the plane of the actuating member, for example, by grasping the actuating member of the clamp at opposite parts of the circumference of the actuating member with tweezers or a Pean forceps and pressing the actuating member.

[0021] The elastically deformable actuating member has several functions: it serves to hold the clamp, it provides the necessary flexibility to clamp the jaws, holding member(s) is(are) attached to it, and its closed shape allows the clamp to be secured against loss, e.g. by threading it onto a fixing or auxiliary fibre.

[0022] The first and second basic embodiments of the technical solution of claim 1 a and 1 b, respectively, differ in how the jaws of the clamp are formed:

[0023] - In the first basic embodiment of claim 1 a, a single holding member, lying in the plane of the actuating member outside the actuating member, is attached to the actuating member, wherein, in the rest state of the clamp, a portion of the outer circumference of the holding member is tightly adjacent to a portion of the outer circumference of the actuating member, said adjacent portions forming the jaws of the clamp, or

[0024] - In the second basic embodiment of claim 1 b, two adjacently positioned holding members, lying in the plane of the actuating member inside the actuating member, are attached to the actuating member, wherein in the rest state of the clamp, a portion of the outer circumference of the first holding member is closely adjacent to a portion of the outer circumference of the second holding member, said adjacent portions forming the jaws of the clamp.

[0025] In both embodiments, the actuating member and the holding members lie in the same plane.

[0026] The term 'tightly adjacent' means that, for two adjacent members forming the jaws of the clamp, the distance between their adjacent parts in the rest state of the clamp is less than the thickness of the fibre or tissue for which the clamp is intended, in at least part of the length of the jaws, so that in the rest state, i.e. without an external force acting in the appropriate direction, the jaws can grip the fibre or tissue firmly due to the elasticity of the actuating member.

[0027] In a view perpendicular to the plane of the actuating member (hereinafter referred to as the "top view"), the outer circumference of the actuating member has the shape of, for example, an oval, ellipse, ring, figure of eight or polygon. The shape of the outer circumference of the actuating member is here understood to be the initial shape in the rest state of the clamp, without external force, when the clamp jaws are clamped. Deformation of the elastically deformable actuating member to open the jaws of the clamp causes a change in its shape, for example a narrowing of the actuating member in the direction of the applied force. Obviously, at least a part of the inner area of the actuating member must be empty to allow the aforementioned deformation of the actuating member.

[0028] The actuating member, when viewed from above, may continuously follow a basic geometric curve shape, such as an oval, ellipse, figure of eight, or ring throughout its outer circumference, but that geometric shape may be further deformed as needed, for example, to include straight, bent, kinked, or otherwise shaped sections.

[0029] For example, in order to facilitate gripping of the actuating member by a tool, such as tweezers, and to reduce the possibility of the tool slipping, suitable, preferably opposing, sections of the outer circumference of the actuating member may have a shape deformed from the geometric shape such that, for example, the opposing sections of the actuating member are independently shaped as a straight line when viewed from above, referred to herein as a straight section of the actuating member, or as a curved section of the actuating member, the curve pointing inwardly into the actuating member, referred to herein as a bent section of the actuating member. Embodiments are also contemplated wherein the opposing sections have a mutually different shape, e.g. one is a straight line and the other is a curved inwardly to the actuating member.

[0030] In the first basic embodiment of the technical solution, the above described deformation of the outer circumference of the actuating member is preferably located in at least one of the opposing sections of the actuating member through which the axis of the jaws does not pass. However, both embodiments also consider embodiments in which the jaws do not form a straight line.

[0031] In the second basic embodiment of the technical solution, the above described deformation of the outer circumference of the actuating member is preferably located in at least one of the opposing sections of the actuating member through which the axis of the jaws passes.

[0032] In this embodiment, the section of the actuating member through which the axis of the jaws passes is a section of suitable length for pressing the clamp with the tool, for example 0,3 to 0,1 times the longest outer dimension of the actuating member, whereby the jaw axis need not pass through the centre of the section, and the length and shape of the opposing sections may be the same or different.

[0033] A kink in the outer perimeter of the actuating member occurs naturally, for example, in an actuating member with an outer rectangular shape, where two straight parts of the actuating member are adjacent to each other at the kink.

[0034] However, it can also be used in a first basic embodiment, for example, in a actuating member with a basic shape of the figure or eight (which is understood here to mean an inside open, and the tapered part inside unconnected figure of eight shape), the upper side of which is shaped into a straight line compared to the initial geometric figure eight shape, attached to the left and right to the remaining part of the actuating member by two bends of the outer circumference of the actuating member. Thus, it is possible to obtain a straight shape of the clamp jaw formed by the part of the outer circumference of the actuating member in the first basic embodiment of the technical solution.

[0035] If, in the second basic embodiment, the actuating member is pressed, always by a force applied in the plane, in which the actuating member lies, in the direction of the longitudinal axis of the jaws, or is expanded in a direction perpendicular to the longitudinal axis of the jaws, the actuating members in the plane in which the actuating member lies are deflected away from each other, thereby opening the jaws, and conversely, the release of pressure causes the jaws to clamp together as a result of the elasticity of the actuating member.

[0036] The holding members lying in the plane in which the actuating member lies are preferably in the second basic embodiment substantially triangular in shape, but may also have other suitable shapes, for example trapezoids, and may be solid or may preferably comprise one or more holes or recesses of any shape in their surface. Preferably, the member is substantially triangular in shape, preferably a triangle provided with a recess to form a flat arrowhead or flat arrow which points inwards, preferably into the centre of the actuating member, and is attached to the actuating member by both tips of its base.

[0037] In a preferred embodiment, at least one free edge of the jaws, i.e. the point of the jaws through which the material to be held is inserted, is bevelled or rounded, when viewed from above, to facilitate insertion of the material to be held by the jaws into the slot of the jaws of the clamp.

[0038] The essence of the technical solution is that the clamp actuating member serves as a spring exerting pressure on the clamp jaws towards each other to hold the clamped material, and conversely the jaws are opened by applying a suitable external force on the actuating member. The clamping force of the jaws, or the force required to open them, can therefore be adjusted by suitable shaping and selection of the actuating member material.

[0039] Shaping of the actuating member means its overall geometric shape as viewed from above, and the course of its transverse profile along its circumference. In the simplest case, the width of the actuating member may be the same around its circumference when viewed from above. In another embodiment, the actuating member may have an increased width, for example in at least one tool gripping section of the actuating member, thereby increasing the stiffness of that section of the actuating member. Most preferably, the width of the actuating member changes continuously along its circumference.

[0040] In the simplest case, in the side view the height of the actuating member and / or members can be the same, which can be advantageous if the clamp is made from a sheet of flat material. However, the lower height of certain sections of the actuating member and / or members is also possible, for example of one or both jaw edges to increase the holding strength of the fibre, or of certain sections of the actuating member to achieve greater elastic deformation preferably in the desired sections of the actuating member.

[0041] A suitable material for the actuating member is an elastically deformable, heat- resistant material, preferably steam-sterilizable, such as metal, such as stainless steel, preferably nitinol, which takes advantage of its superelasticity. For example, the longest dimension of the actuating member of the clamp suitable for holding the filament in eye surgery may be 2-4 mm. For other applications, for example in vascular surgery, clamps with correspondingly enlarged dimensions are also considered.

[0042] Depending on the intended use and the size and clamping force required, the use of plastic is also possible in some cases. However, solutions where different parts of the clamp are made of different materials are also considered, e.g. the edges of the members may be made of flexible plastic to achieve a gentler grip, etc.

[0043] Depending on the technical solution, the clamps can be produced, for example, by laser or other cutting from a sheet of suitable metallic or non-metallic material. In the case of plastic, it may be possible, for example, to press or extrude a tubular profile and cut it into sections of suitable length according to the required clamping force of the jaws.

[0044] Brief description of the drawings

[0045] Figure 1 shows a clamp according to the first basic solution with the holding member lying outside the actuating member, as viewed from above. Figure 1 a shows the clamp in a rest state with the jaws clamped. Figure 1 b shows an embodiment of the clamp wherein a portion of the outer circumference of the actuating member is formed in the shape of a straight section in one of the opposing sections and in the shape of a bent section in the other. Figure 1 c shows a clamp with the jaws partially open in the direction indicated by the empty arrows, due to the force exerted on the actuating member of the clamp by a tool (the parts of the tool in contact with the clamp are shown in grey in the figures) in the direction indicated by the grey arrows, with an embedded filament whose cross-section is shown by the empty circle.

[0046] Figure 2 shows a clamp according to the first basic solution with the holding member lying outside the actuating member, as viewed from above, in a preferred solution with straight jaws. Figure 2a shows the clamp in a rest state with the jaws clamped. Figure 2b shows a clamp with the jaws partially open due to the force applied to the clamp actuating member by the tool in the direction indicated, with a fibre inserted between the jaws.

[0047] Figure 3 shows a clamp according to the second basic solution with two side- by-side holding members, viewed from above. Figure 3a shows the clamp in a rest state with the jaws clamped. Figs. 3b and 3c show the clamp with the jaws partially open due to the force exerted on the clamp actuating member by the tool in the direction indicated, with a fibre inserted between the jaws.

[0048] Figure 4 is a perspective view of the clamp at rest.

[0049] Figure 5 is a side view of the clamp at rest.

[0050] Examples

[0051] Example 1

[0052] In the embodiment in Figure 1 a top view of the fixation clamp according to the first basic embodiment is shown, wherein to the actuating member 1 in the form of an oval, a holding member 7 is attached lying in the plane of the actuating member 1 outside the actuating member 1, wherein, in the illustrated rest state of the clamp, a portion of the outer circumference of the holding member 7 facing the actuating member 1 forms a jaw 7a of the clamp, said jaw being tightly adjacent to a portion of the outer circumference of the actuating member 1 facing the holding member 7 and forming a jaw 1 a of the clamp. The free edge of the jaw 7a, i.e. its upper edge, is rounded when viewed from above to facilitate fitting to the fibre. The clamp actuating member 1 serves as a spring to apply pressure to the jaws 7a, 1 a of the clamp towards each other to hold the clamped material, and also serves to control the opening of the jaws when required as follows: by applying pressure of a suitable tool ( Pean forceps, tweezers) to the upper and lower sides of the clamp actuating member 1 from the outside, as shown in Figure 1 c, in this embodiment by pressing the actuating member 1 at the locations of the opposing bent sections 5 (Figure 1 a) or the straight section 4 and the bent section 5 (Figure 1 b), the jaws 7a, 1 a of the clamp are separated and a slot is formed between the jaws 7a, 1 a which can be fitted onto the fibre. By releasing the pressure, the jaws 7a, 1 a are clamped and the filament is fixed. The clamp is made from a flat sheet of nitinol material by laser cutting, thus having the same height in all its parts. The holding member 7 is made with an empty interior, the actuating member (1 ) also has an empty interior to allow control. The empty parts (holes or recesses in the clamp material) are preferably used to secure the clamp with an auxiliary fibre against loss.

[0053] Example 2

[0054] In the embodiment shown in Figure 2, a top view of a preferred fixation clamp according to the first basic embodiment is shown, wherein said clamp differs from the embodiment shown in Example 1 by having an actuating member 1 in the shape of a vertically curved, internally open figure of eight, the left side of which is deformed into a straight line compared to the initial geometric figure of eight, and is attached to the remaining part of the actuating member 1 at the top and bottom by two bends of the outer circumference of the actuating member. This results in a straight shape of the jaw 1 a of the clamp, which in the rest state of the clamp shown in Figure 2a is tightly adjacent to the jaw 7a on the holding member 7. Figure 2b shows the state of the clamp with the jaw 1 a separated from the jaw 7a in the direction of the empty arrow, due to the force exerted on the clamp actuating member 1 by a tool in the direction indicated by the grey arrows. The lower part of the clamp connecting the actuating member 1 to the holding member 7 is reinforced to increase the rigidity of the actuating member 1 and said connection.

[0055] Example 3

[0056] In the embodiment shown in Figure 3, the top view of a fixation clamp with an oval-shaped actuating member 1 is shown according to the second basic embodiment, where two side-by-side members 2, 3 in the shape of flat arrows run out from the actuating member I to its centre, said arrows with their rounded tips pointing to the centre of the actuating member 1, and being attached to the actuating member 1 by the outer tips 6, 6' of their base, while in the rest state of the clamp (Figure 3a) said members 2, 3 by their adjacent lateral sides fit closely together and form the jaws 2a, 3a of the clamp. The actuating member 1 of the clamp serves as a spring to exert pressure on the jaws 2a, 3a of the clamp towards each other to hold the clamped material, and also serves to control the opening of the jaws if necessary as follows: by pressing a suitable tool (Pean forceps, tweezers) on the upper and lower sides of the actuating member 1 from the outside, in this embodiment by pressing the actuating member 1 at the locations of the bent opposite sections 5 (Figure 3b), or by applying pressure to the right and left sides of the actuating member 1 from the inside (Figure 3c), the jaws 2a, 3a of the clamp are separated and an open slot is formed between the jaws 2a, 3a from above which can be fitted onto the fibre threaded through the actuating member 1_. Fitting the clamp onto the fibre is facilitated by the rounded upper edge of the jaws 2a, 3a, which is closer to the centre of the actuating member 1.

[0057] In the indicated embodiment, when viewed from above, the width of the actuating member 1 in the upper bent section 5 is increased to increase the stiffness of this section and thereby achieve a wider opening of the jaws 2a, 3a. The clamp is made from a flat sheet of nitinol material by laser cutting, thus having the same height in all its parts.

[0058] Example 4 In a specific double or four flange technique surgery with anchoring of the fibre flanges into the sclera, the polypropylene fibre is threaded through a tunnel in the sclera. A clamp is threaded onto the outer (externalized) part of the fibre according to the technical solution, the closed shape of the clamp threaded through the fibre preventing the loss of the clamp when it slips.

[0059] By applying pressure with tweezers or other similar tool from the outside on the opposite longer sides of the actuating member 1_, as shown in Figure 3b, or from the inside of the actuating member 1_, as shown in Figure 3c, the jaws 2a, 3a of the clamp are separated. Alternatively, the clamp jaws can be released by applying pressure, e.g. with tweezers, from the inside of the clamp to the opposite shorter sides of the actuating member 1_.

[0060] The fiber is slid longitudinally through the clamp held with the jaws apart near the tunnel in the sclera until proper centration of the intraocular lens is achieved by pulling the fiber. By releasing the pressure of the tweezers on the actuating member 1 of the clamp, the jaws of the clamp are then brought closer together so that the fiber is fixed between the jaws 2a, 3a of the clamp, preventing it from moving into the eye through the tunnel in the sclera.

[0061] The fibre is then shortened at a suitable distance (according to the required flange size), e.g. 1 mm from the jaws 2a, 3a of the clamp, and the flanges are formed by melting.

[0062] Industrial applicability

[0063] According to the technical solution, the clamp is suitable for use in surgery, especially in microsurgery, for example to prevent longitudinal displacement of fibres, tissues and other materials. For example, the clamp is useful for fixing and adjusting the length of the surgical suture fibres in the flange technique for scleral fixation of a lens capsule or an artificial intraocular lens. List of reference signs

[0064] 1 actuating member

[0065] 1 a jaw

[0066] 2 holding member

[0067] 2a jaw

[0068] 3 holding member

[0069] 3a jaw

[0070] 4 straight section

[0071] 5 bent section

[0072] 6, 6' top of the base

[0073] 7 holding member

[0074] 7a jaw

Claims

Claims1 . Surgical fixation clamp characterized in that it comprises an actuating member (1 ) in the shape of a generally planar closed curve, and at least one holding member (7, 2, 3) lying in the plane of the actuating member (1 ) and attached to the actuating member (1 ), wherein the actuating member (1 ) is elastically deformable in the plane of the actuating member for actuating the clamping of jaws (7a, 1 a, 2a, 3a) of the clamp, and wherein(a) to the actuating member (1 ), a single holding member (7) is attached, located outside the actuating member (1 ), where in the rest state of the clamp a portion of the outer circumference of the holding member (7) is tightly adjacent to a portion of the outer circumference of the actuating member (1 ), said adjacent parts forming the jaws (7a, 1 a) of the clamp, or b) to the actuating member (1 ), two adjacently positioned holding members (2, 3) are attached, located inside the actuating member (1 ), where in the rest state of the clamp a portion of the outer circumference of the first holding member (2) is tightly adjacent to a portion of the outer circumference of the second holding member (3), said adjacent parts forming the jaws (2a, 3a) of the clamp.

2. Surgical fixation clamp according to claim 1 , characterized in that the outer circumference of the actuating member (1 ) is in the shape of an oval, ellipse, ring, figure of eight or polygon.

3. Surgical fixation clamp according to claim 1 or 2, characterized in that a portion of the outer circumference of the actuating member (1 ) is formed in at least one of the opposing sections in the shape of a straight section (4) or a bent section (5), wherein the bend is directed inwardly of the actuating member (1 ).

4. Surgical fixation clamp according to any one of claims 1 b, 2 and 3, characterized in that a portion of the outer circumference of the actuating member (1 ) is formed in at least one of the opposing sections of the actuating member (1 ) through which the axis of the jaws (2a, 3a) of the clamp passes, in the shape of a straight section (4) or a bent section (5), wherein the bend is directed inwardly of the actuating member (1 ).

5. Surgical fixation clamp according to any one of the preceding claims, characterized in that the outer circumference of the actuating member (1 ) comprises at least one kink.

6. Surgical fixation clamp according to any one of claims 1 b, 2 to 5, characterized in that said at least one holding member (2, 3) is shaped, viewed from above, as an arrow with its tip pointing inwards towards the actuating member (1 ), said arrow being attached to the actuating member (1 ) by both the tips (6, 6') of its base.

7. Surgical fixation clamp according to any one of the preceding claims, characterized in that, when viewed from above, the free edge of at least one of the jaws (7a, 2a, 3a) is bevelled or rounded.

8. Surgical fixation clamp according to any one of the preceding claims, characterized in that, when viewed from above, the width of the actuating member (1 ) is increased in at least one part thereof to increase the stiffness of this part of the actuating member (1 ).

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