• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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    • 专利摘要:
    Aneurysm forceps, suitable to be implanted in a tissue in which an aneurysm has formed and seal the aneurysm, which comprises a pair of claw members (2a, 2b) of non-metallic material, said members being claw provided with articulated joining means (3) that allow the pair of claw members to rotate around an axis (4) that locks them, the clamp being able to adopt at least one opening position (a) and a closing position (b); the clamp provided with spring means (6) tending to arrange the clamp in the closed position comprising at least one flexible element (7) and elastic, with a section of arched configuration (8), both in the position of opening as in the closed position, the pair of claw members accommodating the spring members. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2575727A1
    申请号:ES201431951
    申请日:2014-12-30
    公开日:2016-06-30
    发明作者:Tomas MENOVSKY；Thorsten ASAL；Markus Steffens；Salvador Llas Vargas；Pau GARCÍA ROIG；Montserrat Charles-Harris Ferrer；Marc SERRAHIMA TORNEL；Martín GURKA；Thorsten Becker
    申请人:Neos Surgery S L 100 0%；NEOS SURGERY SL；
    IPC主号:
    专利说明:

    DESCRIPTION
    Aneurysm forceps

    Technical sector of the invention 5
    The invention relates to an aneurysm clamp, suitable for being implanted in a tissue in which an aneurysm has formed and sealing the aneurysm.

    BACKGROUND OF THE INVENTION
    When an aneurysm is detected in a tissue of a body, mainly a blood vessel, it should be avoided that a rupture of said aneurysm occurs, which would entail a hemorrhage in the patient that could lead to serious sequelae and even death. It is therefore essential to be able to act when an aneurysm is detected and to make a tight seal in the tissue that prevents the aneurysm from becoming open.
     fifteen
    To this end, tweezers for aneurysms of various sizes are known which allow, through an applicator, to make a tight seal of the aneurysm. Among the best known is the clamp described in patent document US4360023 formed by a single piece provided with flexible elastic means. However, the manufacture of this clip is complicated to automate and is mainly done by hand, and the fact that it comprises metallic materials creates artifacts that make it difficult to follow the aneurysm by imaging techniques.

    It is therefore necessary to provide aneurysm forceps that do not create artifacts, so that aneurysm forceps are known as described in patent documents US Pat. No. 5,647,181 and US Pat. No. 20,130,245,653 which describe a non-metallic clamp in which both claw members are formed in a single piece, said piece being provided with a locking stop of the gripper in the closed position. However, this type of clamp is not only difficult to install, but it is also unreliable that it maintains sufficient pressure throughout the patient's life to prevent the closure from becoming leaky. 30

    Also known are aneurysm forceps such as that described in patent document EP0346084 in which the articulated claw members are made of a synthetic resin or ceramic and the spring part is made of a synthetic resin. This type of forceps markedly reduces the artifacts caused during X-ray tomography 35
    or magnetic resonance. However, the manufacture of this type of clamps is complex, since the claw and spring members must be perfectly joined, and in addition the elastic means of the clamp are exposed.

    It is therefore an object of the present invention to provide a clip for aneurysm 5 that allows its easy manufacture and allows a tight and secure closure of an aneurysm, keeping the aneurysm sufficiently closed during the entire life of the patient.

    Another objective of the present invention is to provide a kit formed by an aneurysm clamp and an applicator that allows to easily and versatile insert the clamp in places 10 difficult to access.

    It is also an object of the present invention to provide an alternative to known aneurysm forceps.
     fifteen
    Explanation of the invention
    The aneurysm clamp of the present invention is one comprising a pair of claw members of non-metallic material, for example a polymeric material, said claw members being provided with means for the articulated joining of the claw members that they allow the rotation of the pair of claw members around an axis that locks them, distinguishing in each claw member a resistance arm and a power arm, configured so that it can adopt the clamp at least: an opening position, wherein the resistance arms of the claw members are separated; and a closing position, in which the resistance arms of the claw members are applied to each other; the clamp being provided with at least one spring element tending to arrange the clamp in the closed position.

    In essence, the clamp is characterized in that the at least one spring element comprises a flexible and elastic element, with a section of arcuate configuration, snapped between the claw members both in the open position and in the closed position , and housed in the clamp, so that the spring element (s) can be introduced into the pretensioned claw members and be completely confined and protected by the claw members, without protruding, thereby allowing the spring elements are easily placed safely without necessarily having to weld or thermoform the clamp. 35

    It is also known that the flexible element is oblong, the opposite ends of the flexible element being retained in a different claw member, thus allowing to occupy a small space inside the claw members and to operate the pin properly. 5

    In a variant of interest, the flexible element is laminar, thus being able to distribute the forces exerted by said flexible element over the entire width of the clamp.

    In a variant embodiment, the thickness (e) of the flexible element, the length of the clamping surface (b) and the elastic modulus (E) of the material with which the flexible element is manufactured are related by the expression:
       = √ 3

    where (β) is a geometric factor of value 7.5. With this relationship it is achieved that the trapping surfaces exert a force of 180 grams on the aneurysm, sufficient to stop the flow of blood.

    It is also known that the width of the flexible element is between 5 and 10 times its thickness and the cord length of the bow of the flexible element in the closed position is between 20 and 60 times its thickness, thus allowing the flexible element , which will be of small dimensions, can be inserted in the clamp and allow to store enough elastic energy to stay within the elastic range both in the position of opening and closure of the clamp.
     25
    In a variant embodiment, when the material of the flexible element is Endolign aligned with the fiber, the thickness (e) of the flexible element is between 0.5 and 0.05 mm, the width (a) of the flexible element is smaller than 2 mm and the length of rope (l) of the arch of the flexible element in the closed position B is between 4 and 12 mm, advantageously allowing to fit in the clamp of reduced dimensions with a length of trapping surface 30 is 9 millimeters , while allowing the clamp to exert sufficient force on the aneurysm.

    It is also known that the radius between the point of support of the flexible element and the center of the axis (4) of rotation is between 0.5 and 3 millimeters, so that the force exerted by the flexible element is transferred in a manner effective to the clamp.

    In another variant embodiment, the spring element or elements comprise two flexible elements 5 each arranged in a corresponding claw member, that is to say, remaining inside the corresponding claw member, thus allowing to distribute the force of the clamp between the two claw members. claw members. Naturally, it is contemplated that the clip only has a flexible element, and may also increase its number to two, four or more. When the clamp comprises two flexible elements, the claw members 10 could be equal, thus advantageously using the same molds for both claw members and subsequently joining them by means of an articulated joint formed, for example, by a rod riveted at its ends.

    It is also known that each of the claw members is formed by a single piece, being able to be formed by a mold and without having to assemble different components to form each one of the claw members. This feature facilitates the manufacture and assembly of the clamp by reducing the number of components, in addition to facilitating the distribution of tensions in the clamp, thus avoiding the appearance of weak points. It is noted that the aneurysm forceps are small in size, so during assembly, small pieces must be handled, so it is advantageous that each claw member is formed by a single piece.

    In another variant of embodiment, considering its horizontal and frontal planes, orthogonal to each other and intersecting in the center of the axis, the flexible element (s) are placed, each one, in the same quadrant both in the opening position as in the closed position, advantageously allowing concentrating the forces that are applied on the power members

    It is also disclosed that at least one of the claw members comprises a lobe, one of the opposite ends of the flexible element being retained in a notch of the perimeter of the lobe, so that the flexible element is engaged and can actuate the clamp .

    It is also disclosed that at least one of the claw members comprises an
    an inlet, which may be ogival in shape, configured as a slot that receives and houses a corresponding flexible element, so that the flexible element is housed inside the clip without protruding. The recess may be provided with an edge for retaining one of the opposite ends of the flexible element. In this way, the flexible element being retained at each of its opposite ends by a different claw member, for example by the indentation of the perimeter of the lobe of one claw member and by the edge of the pointed inlet in the other member of the claw member. claw is achieved that the flexible element is properly confined inside the clamp and act by storing and releasing elastic potential energy for the actuation of the clamp.
     10
    It is also known that the claw members are provided with clamping surfaces complementary to each other, that is to say that in the closed position they fit together, and provided with rugosities in the form of valleys and mounds perpendicular to the longitudinal direction of the claw. the clamp, such as ripples or saw teeth, which allow to improve the grip of the clamp while facilitating its demoulding during its manufacture. fifteen

    In another variant embodiment, the recess, which may be ogee shaped, is provided with lateral retention means, such as a tooth or a side wall, to prevent the flexible element projecting laterally from said pointed recess in which it is lodged . However, these lateral retention means will not be essential, since the flexible element is always in tension, both in the open position and in the closed position of the clamp, this will already be solidly inserted and snapped inside. of the clamp. However, for greater safety, lateral retention means can be provided. These lateral retaining means will be useful especially when the flexible element is not laminar, for example if it is formed by one or more rods that could bend towards the outside of the clamp.

    In another variant of interest, the clamp comprises a rear channel between the claw members for the introduction of the flexible element. In this way it is possible to automate the assembly of the clamp by subsequently introducing the flexible element by means of said channel 30 and tightening it until it is fitted and retained between the claw members.

    According to another variant embodiment, the power arms of the claw members comprise abutment surfaces adapted to be applied to each other in the open position, limiting the opening of the clamp, and separated in the closed position. Through the 35
    Separation of these stop surfaces can predefine the maximum opening that the clamp can adopt.

    It is also known that both in the open position and in the closed position, the straight lines tangent to the ends of the arched configuration section of the flexible element 5 determine an angle greater than 90 degrees, allowing the flexible element at all times stay inside the clip without protruding. When the flexible element is housed in the recess of a claw member, the height of this recess will be designed so as to avoid retaining the arched configuration section of the flexible element, therefore, the height of the recess will always be greater than the height of the recess. arc that the flexible element determines when tightened.

    In another variant embodiment, the arched configuration section of the flexible element has the same concavity direction both in the opening position and in the closing position of the clamp, that is, the arched configuration section will remain well convex or well concave in both positions, in other words, always protrude transversely to the same side of the line joining the ends of the section of arched configuration, thus allowing at all times the flexible element is snapped between the claw members.
     twenty
    According to another characteristic of the invention, the material of the claw members and of the spring element (s) of the clamp is biocompatible, and comprises, for example, PEEK, so that it can be implanted directly into living beings to imprison an aneurysm. It is also anticipated that if some material was not directly biocompatible, it could be encapsulated in a biocompatible medium. 25

    It is also disclosed that the flexible element comprises a material with continuous carbon fiber, which is biocompatible and allows sufficient force to close the clamp on an aneurysm. Of course other flexible elements containing carbon fiber or encapsulated fiberglass could be used, since the flexible element 30 is lodged in the claw members, and therefore never protrudes from the clamp. It would also be possible to use a metallic element if necessary.

    In a variant of interest, the clamp further comprises a marking part of a radiopaque radiation material which can be used in the medical field for
    perform diagnostics by image. Preferably, the marking piece will be of a radiopaque material to the X-rays, allowing to identify the clip in a diagnostic imaging procedure, so that the clip can be identified, but without generating artifacts that may distort the image.
     5
    It is also disclosed that the marking piece may comprise a microsphere embedded in at least one of the claw members during its manufacturing step, so that the image with which the clamp will be identified will be the same regardless of the position of the clamp. the clamp, since it will always be identified with a circle.
     10
    In another variant embodiment, the marking piece comprises a metal filament embedded in at least one of the claw members, preventing artifacts from being generated by presenting a threadlike shadow.

    In another variant of interest, the marking piece comprises a washer inserted between the two claw members, advantageously allowing the washer to be inserted during the assembly phase of the clamp, being able to decide at that instant if it is desired that the clamp be totally radiolucent or include a marking piece.

    It is also known that in a variant embodiment the marking part is the own axis of the clamp, thus avoiding having to add additional elements that act as a marking piece.

    In another variant embodiment, the marking piece is a metal incrustation in at least one of the two claw members, this metallic inlay being able to be applied by means of ultrasound.

    In another variant embodiment, the thickness of the claw members is smaller at their front end than at their rear end, allowing to better concentrate the clamping force exerted by the claw members on the aneurysm. In addition, the clip may be provided with 30
    lateral recesses on both sides to facilitate the surgeon's vision during implantation.

    Also disclosed is a kit formed by one or more clamps and an applicator for manipulating and articulating said clamp. The clamp comprises support zones in the power arms of
    the claw members adapted to cooperate with the applicator, so that the clamp rotates from the closed position to its open position when the applicator exerts pressure in said support areas. In this way it is achieved that the surgeon easily manipulates the clamp, which will usually be of very small dimensions.
     5
    In another variant of interest of the kit, the kit is characterized in that at least one of the support areas of the clamp comprises a bowl provided with two straight parallel surfaces, adapted to receive an essentially hemispherical end of the applicator provided with a set of faces straight parallel forming a polygonal prism with rounded end. In this way it is advantageously achieved to be able to operate the clamp at 10 different angles depending on the straight parallel faces of the applicator against the two straight parallel surfaces of the cups. Typically, the clamp will comprise two cups, one in each power arm of the claw members adapted to receive two essentially hemispherical ends of the applicator to protrusion modes. Naturally, it is possible to use the clamp with other applicators, as well as to use this applicator with other clamps. Although normally the bowl of the clamp will be a recess and the hemispherical end of the applicator will be a projection, they could be arranged upside down. Also the bowl could be in the applicator and the hemispherical end in the clip.

    Advantageously, the spacing between the two parallel straight surfaces of the cup of the clamp is greater than the spacing between the parallel parallel faces of the essentially hemispherical end of the applicator, thus allowing the clamp to rotate in controlled passages by exerting some lateral pressure against the clamp when it is held by the applicator.
     25
    BRIEF DESCRIPTION OF THE DRAWINGS
    To complement the description that is being made and in order to facilitate the understanding of the characteristics of the invention, a set of drawings in which, with an illustrative and non-limiting character, the following has been represented is attached to the present specification: 30

    Fig. 1 represents a perspective view of the separate claw members that will form a clamp of the present invention;
    Fig. 2 shows a perspective view of the claw members hingedly joined to form the clamp of the present invention. 35
    Fig. 3 shows a side view of the jointed claw members provided with spring elements forming a clamp according to the present invention;
    Fig. 4 represents the clamp of Fig. 3 in a lacing correlative position;
    Figs. 5a to 5c represent a closing sequence of the clamp of Fig. 3 by an applicator;
    Figs. 6a to 6c show a detail of the cup of the clamp of the present invention;
    Figs 7a and 7b show a detail of the end of an applicator for the clamp of the present invention;
    Fig. 8 shows the clip mounted on an applicator; 10
    Fig. 9 represents another variant embodiment of the clamp;
    Figs. 10 and 11 show other embodiments of the clamp; Y
    Figs. 12 to 17 present other aneurysm forceps.

    Detailed description of the drawings 15
    Fig. 1 shows a pair of claw members 2a, 2b of a non-metallic material, for example a biocompatible polymeric material such as for example PEEK which will form the clamp 1 of the present invention. Being this biocompatible material, it will allow its application inside the body, closing an aneurysm. The material will also be strong enough to not degrade inside the body. twenty

    Each of the claw members 2a, 2b can be manufactured separately by PEEK overinjection, and can then be assembled to form the clamp 1. The pair of claw members 2a, 2b shown in Fig. 1 are ready to join articulated to each other to form a clamp 1 provided with a turning shaft 4, and to house one or more spring elements 6, each claw member 2a, 2b determining that the clamp 1 pass from an opening position A, which it is illustrated, for example, in Fig.5a, in which an external force is exerted on the clamp 1, to a closing position B, which is illustrated for example in Fig.5c, when said external force is removed on the clamp 1 and can thus be closed on a tissue with an aneurysm to isolate the aneurysm from the rest of the tissue, such as a blood vessel.

    Both claw members 2a, 2b are provided with respective recesses 12 for housing the spring elements 6, so that the spring elements 6 are fully integrated into the interior of the claw members 2a, 2b of the clamp 1 without protruding 35
    of the claw members 2a, 2b of the clamp 1. It is observed in the variant shown that both claw members 2a, 2b are provided with a recess 12, which may be ogive, in which the spring elements 6 are inserted. , one of the ends of the spring elements 9a being disposed against one edge of said recess 12 and the other end 9b in a notch 11 made in a lobe 10 of the other claw member 2a, 2b. It is emphasized that both the recesses 12, and the lobe 10 with notch 11 of both claw members 2a, 2b are symmetrical, so that both claw members 2a, 2b could be manufactured by the same mold by means of for example injection, adding a shaft as an additional piece if necessary.
     10
    The variant of pair of claw members 2a, 2b shown in Fig. 1 are jointed together as shown in Fig. 2. It is noted that the claw members 2a, 2b are provided with articulated joint means 3. that allow the rotation of the pair of claw members 2a, 2b around an axis 4 that locks them. This articulated joint 3 is formed, in the variant shown, by a rod 21 of one of the claw members 2b passing through a hole 22 of the other claw member 2a acting as axis 4, as illustrated in FIG. variant shown in Figs. 1 and 2, the rod 21 provided with retention means 23, in the manner of terminal expansion of the rod 21, to prevent the rod 21 from coming out of the hole 22 after its insertion under pressure. It is also envisaged in other embodiments that both claw members 2a, 2b are provided with holes 22, and the rod 21 is a separate element that can be inserted and held hingedly joined to the pair of claw members 2a, 2b to form the axis 4 of the articulated joint 3, for example by means of a rivet. It is also envisaged that other joining means, such as a thread passing through both holes and being held by a corresponding counter-thread while holding the pair of claw members 25a, 2b in an articulated manner, can be used. It is also contemplated that instead of riveting the shank, it may be provided with end holding parts, such as starlock keys or washers.

    It is noted that the pair of claw members 2a, 2b comprise trapping surfaces that serve to close the tissue tightly and isolate the aneurysm of the vessel, in the closed closed position B of the clamp 1, in the manner to be illustrated later, for example in Fig. 5c. These clamping surfaces will preferably be rough, so that a perfectly tight closure of the clamp 1 is achieved on the tissue, thus isolating the part of the tissue with the aneurysm from the rest of the tissue and preventing the clip from slipping. For example, the trapping surfaces may be
    complementary to each other and provided with rugosities in the form of valleys and mountains perpendicular to the longitudinal direction of the clamp such as undulations or saw teeth. It can be observed in FIG. 2 that in each pair of claw members 2a, 2b there are levers formed by a power arm 5a and a resistance arm 5b, the fulcrum axis 4 of both levers acting. In this way, after the insertion of the spring elements 6, as illustrated in FIG. 3, it is achieved that the articulated joint means 3 allow the rotation of the pair of claw members 2a, 2b around the axis 4 which locks them, the clamp 1 being able to adopt at least one opening position A, in which the resistance arms 5b of the claw members 2a, 2b are separated and a closing position B, in which the resistance arms 5b of the claw members 2a, 2b are applied to each other and an aneurysm is adequate to exert sufficient pressure. The power arm 5a is defined as that in which an external force will be applied and the resistance arm 5b as that which receives the force transmitted by the applicator.

    In Fig. 3 it is seen that the spring elements 6 of the clamp 1 comprise at least 15 a flexible and elastic element 7, with a section of arched configuration 8, both in the open position A and in the closed position B which remains lodged in the pair of claw members 2a, 2b without protruding from the contour of the clamp 1. It is envisioned that a radiolucent material, such as PEEK, can be injected into the spring elements 6 to secure them in the clamp 1. twenty

    It is also noted that the flexible element 7 is oblong and laminar, and its opposite ends 9a, 9b are retained in a different claw member 2a, 2b. In other embodiments, it is provided that the flexible element can also have other oblong shapes, such as a rod shape. It is noted that the flexible element 7 is only in contact with the claw members 2a, 2b at its ends. The variant shown in Fig. 3 is provided with two flexible elements 7 in arched laminar shape remaining, the front end 9a of each flexible element 7 housed in an edge 13 of the recess 12 of a claw member 2a, 2b and the rear end 9b housed in the notch 11 of the lobe 10 of the other claw member 2a, 2b, so that the clamp 1 will present the same side view 30 from one side as from the other.

    The insertion of the flexible element 7 into the interior of the pin after joining the two claw elements 2a, 2b can be carried out by sufficiently folding the flexible element 7 until it can be introduced into the recess 12, being retained between the edge 13 of the recess 12 35
    and the notch 11 of the lobe upon release of the flexible element 7 after its introduction, forcing the closing position B of the clamp 1 shown in Fig. 3. Alternatively, the flexible element 7 can be introduced by a rear channel 15 of separation between the pair of claw elements 2a, 2b, in this way the flexible element 7 must be introduced until one of its opposite ends 9a is applied against the edge 13, and continue 5 forcing the flexible element, so that it is bent until its other opposite end is applied against the recess 12. The use of this rear channel 15 will be advantageous if the recess 12 is provided with lateral retention means 14 that prevent the flexible element 7 from protruding laterally of the recess 12 in which it is housed. even his exit. Naturally, these lateral retention means 14 could also allow the lateral entrance 10 of the flexible element 7 in the recess 12, but not its exit, for example these being a tongue that could be bent sufficiently to allow the entrance of said flexible element 7 but not its exit from the recess 12. However, if it is envisaged that the lateral retention means 14 is a band that completely traverses the recess 12, for example transversely, the clamp 1 of the rear channel 15 must be provided for 15 the introduction of the flexible element 7. Naturally, when the clamp 1 comprises two flexible elements 7, arranged one on each side of the clamp 1, two rear channels 15 will be needed, one for each flexible element.

    In Fig. 3 the horizontal cutting planes H and vertical F of the clamp 1, 20 orthogonal to each other and intersecting in the center of the axis 4 are also illustrated, observing that the flexible elements 7 are located, each in a same quadrant in the closed position B, As will be seen later, the flexible elements 7 are kept located, each one, in the same quadrant as in the closed position B when going to the open position A.
    It is envisaged that both the material of the claw members 2a, 2b and of the spring elements 6 be biocompatible, that is, allow their implantation inside the body of a patient. Of course, it is also contemplated that if any of the parts is not biocompatible, it is housed or encapsulated in a biocompatible material, so that it does not represent a risk.
     30
    The flexible element 7 forming the spring elements 6 will preferably be formed by a sheet of a material with continuous carbon fiber, which will allow sufficient force to keep the clamp 1 closed, in addition to being resistant and biocompatible. In other embodiments, it is contemplated that a material with continuous carbon fiber with other shapes, such as rods, be used in the spring elements 6. Advantageously, the element 35
    flexible 7 that will form the spring elements 6, being housed in the recess 12 without protruding, may not necessarily be biocompatible, thus, it is contemplated that the flexible element 7 may be of materials not considered biocompatible, such as fiberglass , that had the appropriate mechanical characteristics. These materials not considered biocompatible could also be encapsulated in a biocompatible material, for example a biocompatible resin. Of course, it is envisaged that the spring elements 6 may also be made of other materials, such as polymers or polymers reinforced with fibers, if these have the appropriate mechanical characteristics.

    A pair of rear arrows Fa, representing the external force 10 that will be made on the power arms 5a of the claw elements 2a, 2b to move from the closing position B shown in FIG. 3, are shown in FIG. 3. 3 to the opening position A. This external force will preferably be applied in respective support zones 18 formed by cups 19 as will be explained later. In this way, by means of the levers formed by the claw members 2a, 2b and the axis 4, which will act as a fulcrum of the levers, it is possible to exert a force on the resistance arms 5b of the claw members 2a, 2b, represented by the pair of front arrows Fb, to separate them and adopt an opening position A. It is envisaged that the gripper 1 is provided with stop surfaces 16, initially separated in the closing position B of the clip 1, of the illustrated in Fig. 3, and which will be applied to each other in the opening position A, 20 thus limiting the opening of the clamp 1, as will be seen later.

    FIG. 4 shows the clamp 1 previously shown in FIG. 3 now in a correlative position of fit, where it can be seen that the clamp 1 is formed by two flexible elements 7 provided with a section of arched configuration 8 that will be introduced in respective recesses 12 provided in each of the claw members 2a, 2b leaving the flexible elements 7 arranged on each of the sides of the clamp 1 and placed symmetrically inside the clamp 1. It is thus observed that clip 1 will be symmetrical.
     30
    Preferably, the sheets forming the flexible elements 7 will be prestressed and will have at least one section of arched configuration 8. It is provided that the entire flexible element 7 conforms to a single section of arched configuration 8, although there could also be different arched sections or the flexible element provided with straight reinforcing ends. It is expected that both in the opening position A and in the closing position B 35
    of the clamp 1, the crossing of the tangent lines to the ends of the arched configuration section 8 of the flexible element 7 determines an angle α greater than 90 degrees, so that the flexible element can be perfectly lodged in the recess 12 of each member of claw 2a, 2b without creating loops. It is further noted that the arcuate configuration section 8 of the flexible element 7 has the same concavity direction both in the opening position 5 A and in the closing position B of the clamp 1, thus allowing the flexible element to be at all times snapped between the claw members 2a, 2b.

    As previously introduced, the clamp 1 is provided with support areas 18 formed by cups 19 to receive an external force and move from the position of closure B to the open position A, suitable for being placed in a tissue . After the placement of the clamp 1 in the aneurysm, when withdrawing the external force, it will again adopt the closing position B, isolating the aneurysm. These cups 19 determine support zones 18 in the power arms 5a of the claw members 2a, 2b adapted to cooperate with an applicator 100, so that the clamp rotates from the closing position B to its opening position A at exerting the pressure applicator in said support zones, in the manner illustrated in Fig. 5a.
    After joining the clamp 1 and the applicator 100 so that the clamp assumes the opening position A, in which the abutment surfaces 16 of the power arms 5a of the claw members 2a, 2b are applied to each other to limit the opening of the clip 1, the surgeon 20 may place the clip 1 on the tissue. Advantageously, the clamp 1 is provided with side recesses 17 on both sides to facilitate the surgeon's vision, besides that the thickness of the claw members 2a, 2b is smaller at its front end than at its rear end, so that get a better precision to make a tight seal on the tissue, to conveniently isolate an aneurysm. 25

    After appropriately placing the clip 1 on the tissue to be imprisoned, the surgeon will activate the applicator 100, progressively withdrawing the external force exerted on the support areas and exerting force the spring elements 6, after passing through the intermediate position shown in FIG. Fig. 5b, the clip 1 will adopt the closing position B shown in Fig. 5c. At this point, the surgeon will be able to completely free the applicator 100 from the clip 1 and remove it, leaving the clip 1 conveniently placed making a closure while in the aneurysm.

    The flexible element 7 forming the spring elements 6 must be dimensioned and
    placed in the clamp 1 to allow the clamp 1 to keep the aneurysm correctly closed when it adopts the closed position B. To achieve this sealing of the aneurysm it is necessary that the clamp 1 perform a closing force on the aneurysm of approximately 180 grams when it adopts the closing position B shown in Fig. 5c. 5

    In order to achieve this effect, ideally the thickness (e) of the flexible element 7, the length of the clamping surface (1) of the clamp 1 and the elastic modulus (E) of the material of the flexible element 7 should comply with the following equation:
     10 = √ 3

    Where (β) is a geometric factor of value 7.5. Naturally, it is expected that there is a range around the ideal values that will sufficiently satisfy the requirements of this closing force. For better identification, these dimensions have been indicated in the clamp 1 and its flexible element 7 previously described in Fig. 4. 15

    The elastic modulus (E) will depend on each material, this elastic modulus (E) being an example of 110GPa for Titanium, 210GPa for stainless steel, 150GPa for Endolign aligned with the fiber; 9.4 GPa for Endolign perpendicular to the direction of the fiber and 18GPa for PEEK 30cf. The material that allows obtaining a thickness (e) of the flexible element 7 suitable for the length of the clamping surface (b) of the clamp 1 will therefore be chosen.

    It is necessary that the dimensions of the flexible element 7 allow it to remain within its elastic range at maximum opening, that is, when the clamp 1 adopts its opening position A, so that the clamp 1 tends to adopt the position of Closing B. It has been observed that this happens when the width of the spring element is between 5 and 10 times the thickness of the spring element (e), and when the cord length of the bow of the flexible element 7 in the closing position B of the clamp 1 is between 20 and 60 times the thickness of said spring element (e). 30

    Taking into account the above restrictions, considering a length of the trapping surface (b) of 9 mm and using as Endolign material aligned with the fiber it has been
    determined that a good compromise is obtained when the thickness (e) of the flexible element 7 is between 0.05 and 0.5 millimeters, obtaining that its width (a) is less than 2 millimeters, for example between 0.25 and 2 millimeters and its length of string (l) of the arch is between 4 and 12 millimeters. These dimensions allow the flexible element 7 to be placed in a clamp 1 of small dimensions, giving it a sufficient closing force to keep an aneurysm closed and at the same time remaining within its elastic range at maximum opening. To reinforce this effect, it is preferable that the radius between the point of support of the flexible element 7, which is the notch 11 of the lobe 10, and the center of the rotation axis 4 of the clamp 1 be between 0.5 and 3 millimeters .
     10
    Figs. 6a, 6b and 6c show details of the clamp 1 in which it is observed that the cup 19 is advantageously provided with two straight parallel surfaces 20a, 20b, adapted to receive a substantially hemispherical end 101 of the applicator 100, the applicator 100 being provided with a set of straight parallel faces 102 forming a polygonal prism as illustrated in Figs. 7a and 7b, so that the clamp 1 can be arranged in 15 different orientations depending on the two parallel straight surfaces 20a, 20b of the clamp 1 arranged against the essentially hemispherical end 101 of the applicator 100. In the variant illustrated, in which the set of straight parallel faces 102 of the applicator 100 forms an octagon, the clip can be arranged, in addition to aligned with the applicator, rotated 45 degrees or 90 degrees right or left. Naturally it is foreseen to be able to use 20 polygons of more faces to allow more granularity in the angles that the clamp 1 can adopt in relation to the applicator 100.

    It is envisaged that the different variants of the clamp 1 may be provided with one or more marking parts of a material opaque to X-rays or other radiations used to obtain images, so that the presence of the clamp can be clearly identified in FIG. an image taken. This marking piece can be for example a microsphere or a metal filament embedded in at least one of the claw members 2a, 2b. It is also envisaged that the marking piece can be a washer inserted between the two claw members 2a, 2b or that the same axis 4 is metallic, thus acting as a marked piece.
    The marking piece can also be a metal inlay in at least one of the two claw members 2a, 2b applied by ultrasound.

    It is further emphasized that in Fig. 6b which represents a side view in section of the clip 1 35.
    it is possible to observe the recesses 12 and notches 11 of each claw member 2a, 2b that house each of the two flexible elements 7 of the clamp 1. In this section view the symmetry of the clamp 1 can be seen, which in the Other Figures could be hidden.

    It is envisaged that the spacing between the two straight parallel surfaces 20a, 20b of the cup 5 19 of the clamp 1 will be greater than the spacing between the parallel parallel faces 102 of the essentially hemispherical end 101 of the applicator 100, so that after coupling the clamp 1 in the applicator 100 forming the kit 200 showing in Fig. 8, the surgeon can modify the rotation of the clip 1 relative to the applicator 100 by exerting some pressure on the clip 1, so that if for example the applicator 100 is the above shown in the 10 Figs. 7a, 7b, and the clamp 1 is initially aligned with the applicator, a stable position with a 45 degree inclination can be achieved, and if a certain pressure is exerted, the inclination of 90 degrees is achieved. Naturally, the spacing between the two straight parallel surfaces 20a, 20b of the cup 19 of the clamp 1 must be calculated so that this optional rotation effect can be achieved without affecting the stability of the position of the clamp 15 1. It is also it is possible to design the clamp kit 1 and applicator 100 devoid of this rotating effect, the support areas 18 of the clamp 1 being compatible with the known applicators, for example, as shown in FIG. 9.

    Fig. 9 shows an alternative embodiment of the clamp 1, in which unlike the variant previously shown in Fig. 3, the claw members 2a, 2b intersect, thus allowing the opening direction of the resistance arm 5b of each claw member 2a, 2b coincides with the direction of the force applied in its corresponding power arm 5a. In this way, a variant of gripper 1 provided with connecting teeth on its rear suitable for use with known applicators is achieved. In the variant shown in FIG. 9 there is further illustrated band-like lateral retention means 15 which passes through the recess 12 and prevent the flexible element 7 from protruding.

    Fig. 10 presents an alternative embodiment of the clamp 1 in which flexible element 7 reaches the rear end of the members in which the notch 11 is located. Fig. 11 shows another variant of the clamp similar to that shown in FIG. of Fig. 10 in which the flexible element is overinjected into one of the claw members.

    Figs. 12 to 17 show other clips 1 for aneurysms. 35

    Fig. 12 presents a clamp 1 whose claw members 2a, 2b are formed by a single piece, the clamp 1 being provided with external spring elements 6 formed by a flexible element 7 in the form of a C facing the front part of the body. the clamp that surrounds its back. In another clamp, the two claws could be joined by means of a pivot, 5 the spring elements 6 remaining passing through the two claws in the central part.

    Fig. 13 presents another clamp 1 provided with a spring element 6 formed by a flexible element C-shaped protruding from the claw members 2a. 2b. The spring element 6 can be welded on one side of the clip or inserted into the clip, where the claws 2a, 2b would have a housing where the spring elements would be introduced. The opening of this clamp would be done when an applicator exerted an opening force on the back.

    Fig. 14 shows another clamp 1 in which the spring elements 6 which are flexible elements 7 are housed in the claw members 2a, 2b, the spring elements 6 adopting a straight position in the closed position shown in FIG. Fig. 14. In this clamp 1 the two spring elements 6 are fixed in a claw member 2a at one of their ends, while the other end is free and applied against the other claw member 2b. In this way, the free end of the spring element 6 rubs with a cam geometry that allows the force to be exerted on the claw member 2b in which it is applied when the clamp 1 is opened.
    Fig. 15 presents another clamp 1 in which the spring elements 6 formed by a flexible element 7 are fixed in one of the claw members 2b and are applied against the other claw member 2a, the spring means adopting a position straight at 25 the closing position shown in Fig. 14.

    Fig. 16 presents another clamp 1 in which the spring elements 6 are formed by the same claw members 2a, 2b, that is to say, they have been molded together with the claw members 2a, 2b, so they are the same material. In this clamp the claw 2a has 30 pivots that interact with the tabs of the claw 2b causing force to be exerted on the claws of the clip.

    Fig. 17 presents another clamp 1 in which the spring element 6 are flexible elements 7 which are adhered to the external part of the claw members 2a, 2b. In this case, 35
    flexible elements 7 are anchored in the front part of the clamp and is free in its rear part, allowing it to bow outwards during the opening of clamp 1, thus generating a closing force.

     5
    权利要求:
    Claims (32)
    [1]

    [ 1]
     1.- Clamp (1) for aneurysm comprising a pair of claw members (2a, 2b) of non-metallic material, and means for the articulated joint (3) of the claw members that allow rotation of the pair of claw members about an axis (4) that locks them, 5 distinguishing in each claw member a power arm (5a) and a resistance arm (5b), configured so that it can adopt the clamp at least:
    - an opening position (A), in which the resistance arms of the claw members are separated; and 10
    - a closing position (B), in which the resistance arms of the claw members are applied to each other;
    the clamp being provided with at least one spring element (6) tending to arrange the clamp in the closed position, the clamp being characterized in that the at least one spring element comprises a flexible (7) and elastic element, with a section of arched configuration (8), snapped between the claw members both in the open position and in the closed position, and housed in the clamp.

    [2]
    2. Clamp (1) according to the preceding claim, characterized in that the flexible element (7) 20 is oblong, the opposite ends (9a, 9b) of the flexible element being retained in a different claw member (2a, 2b).

    [3]
    3. Clamp (1) according to any one of the preceding claims, characterized in that the flexible element (7) is laminar. 25

    [4]
    4. Clamp (1) according to the preceding claim, characterized in that the thickness (e) of the flexible element (7), the length of the clamping surface (b) and the elastic modulus (E) of the material with which it is attached. manufactures the flexible element are related by the expression: 30
       = √ 3
    where (β) is a geometric factor of value 7.5.

    [5]
    5. Clamp (1) according to any one of the preceding claims, characterized in that the width (a) of the flexible element (7) is between 5 and 10 times its thickness (e) and the length of rope (l) of the arch of the flexible element in the closed position (B) is between 20 and 60 times its thickness. 5

    [6]
    6. Clamp (1) according to any one of the preceding claims, characterized in that the thickness (e) of the flexible element (7) is between 0.5 and 0.05 millimeters, the width (a) of the flexible element ( 7) is less than 2 mm and the cord length (l) of the arch of the flexible element in the closed position (B) is between 4 and 12 millimeters. 10

    [7]
    7. Clamp (1) according to any one of the preceding claims, characterized in that the radius (r) between the point of support of the flexible element (7) and the center of the axis (4) of rotation is between 0.5 and 3 mm.
     fifteen
    [8]
    8. Clamp (1) according to any one of the preceding claims, characterized in that the spring means (6) comprise two flexible elements (7) each housed in a corresponding claw member (2a, 2b).

    [9]
    9. Clamp (1) according to any one of the preceding claims, characterized in that each of the claw members (2a, 2b) is formed by a single piece.

    [10]
    10. Clamp (1) according to any one of the preceding claims, characterized in that considering its horizontal (H) and frontal (F) planes, orthogonal to each other and intersecting in the center of the axis (4), the or the flexible elements (7) are each located in the same quadrant both in the open position (A) and in the closed position (B).

    [11]
    Clamp (1) according to any one of the preceding claims, characterized in that one of the claw members (2a, 2b) comprises a lobe (10), one of the opposite ends (9a, 9b) of the element being flexible (7) retained in a notch (11) of the perimeter of the lobe.

    [12]
    12. Clamp (1) according to any one of the preceding claims, characterized in that at least one of the claw members (2a, 2b) comprises a recess (12) configured to
    slot mode receiving and housing a corresponding flexible element (7).

    [13]
    13. Clamp (1) according to the preceding claim, characterized in that the recess (12) is provided with an edge (13) for the retention of one of the opposite ends (9a, 9b) of the flexible element (7). 5

    [14]
    14. Clamp (1) according to any one of the preceding claims, characterized in that the claw members (2a, 2b) are provided with clamping surfaces complementary to each other and provided with rugosities in the form of valleys and mountains perpendicular to the longitudinal direction of the clamp. 10

    [15]
    15. Clamp (1) according to the preceding claim, characterized in that the recess (12) is provided with lateral retention means (14) to prevent the flexible element (7) projecting laterally from said recess in which it is housed.
     fifteen
    [16]
    16. Clamp (1) according to any one of the preceding claims, characterized in that it comprises a rear channel (15) between the claw members (2a, 2b) for the introduction of the flexible element (7).

    [17]
    17. Clamp (1) according to any one of the preceding claims, characterized in that the power arms (5a) of the claw members (2a, 2b) comprise abutment surfaces (16) adapted to be applied to each other in the opening position (A) and separated in the closing position (B).

    [18]
    18. Clamp (1) according to any one of the preceding claims, characterized in that both in the opening position (A) and in the closing position (B), the crossing of the tangent lines to the ends of the section of arched configuration (8) of the flexible element (7) determine an angle greater than 90 degrees.

    [19]
    19. Clamp (1) according to any one of the preceding claims, characterized in that 30 of the arcuate configuration section (8) of the flexible element (7) has the same concavity direction both in the open position (A) and in the closing position (B) of the clamp.

    [20]
    20. Clamp (1) according to any one of the preceding claims, characterized in that
    The material of the claw members (2a, 2b) and of the spring means (6) is biocompatible.

    [21]
    21. Clamp (1) according to any one of the preceding claims, characterized in that the flexible element (7) comprises a material with continuous carbon fiber. 5

    [22]
    22. Clamp (1) according to any one of the preceding claims, characterized in that it also comprises a marking part of a material opaque to X-rays.

    [23]
    23. Clamp (1) according to the preceding claim, characterized in that the marking piece 10 comprises a microsphere embedded in at least one of the claw members (2a, 2b)

    [24]
    24. Clamp (1) according to claim 22, characterized in that the marking piece comprises a metal filament embedded in at least one of the claw members (2a, 2b). fifteen

    [25]
    25. Clamp (1) according to claim 22, characterized in that the marking piece comprises a washer inserted between the two claw members (2a, 2b).

    [26]
    26.- Clamp (1) according to claim 22, characterized in that the marking piece is the axis (4).

    [27]
    27. Clamp (1) according to claim 22, characterized in that the marking piece is a metal inlay in at least one of the two claw members (2a, 2b).
     25
    [28]
    28. Clamp (1) according to any one of the preceding claims, characterized in that it comprises lateral recesses (17) on both sides to facilitate viewing.

    [29]
    29. Kit (200) formed by a clamp (1) according to any of the preceding claims and an applicator (100) to articulate said clamp, characterized in that the clamp 30 comprises support areas (18) in the power arms ( 5a) of the claw members (2a, 2b) adapted to cooperate with the applicator (100), so that the clamp rotates from the closed position (B) to its open position (A) when the applicator presses on said support zones.
     35
    [30]
    30. Kit (200) according to the preceding claim, characterized in that at least one of the support areas (18) of the clamp (1) comprises a bowl (19) provided with two straight parallel surfaces (20a, 20b), adapted to receive a substantially hemispherical end (101) of the applicator (100) provided with a set of straight parallel faces (102).
     5
    [31]
    31.- Kit (200) according to the preceding claim, characterized in that the separation between the two straight parallel surfaces (20a, 20b) of the cup (19) of the clamp (1) is greater than the separation between the straight parallel faces (102) of the essentially hemispherical end (101) of the applicator (100).
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    同族专利:
    公开号 | 公开日
    JP2018500134A|2018-01-11|
    EP3241508B1|2020-02-26|
    US10743885B2|2020-08-18|
    WO2016107952A1|2016-07-07|
    CN107106183B|2019-11-29|
    CN107106183A|2017-08-29|
    EP3241508A1|2017-11-08|
    ES2575727B1|2017-04-12|
    US20180008275A1|2018-01-11|
    JP6722674B2|2020-07-15|
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    US4324248A|1980-05-30|1982-04-13|Metatech Corporation|Microsurgical clip|
    US4932955A|1984-06-29|1990-06-12|Baxter International Inc.|Clip|
    WO2004080275A2|2003-03-06|2004-09-23|Applied Medical Resources Corporation|Spring clip and method for assembling same|
    WO2007124579A1|2006-04-29|2007-11-08|Klassen James B|Surgical clip, applicator, and applicator methods|
    US20110224700A1|2010-03-09|2011-09-15|Teleflex Medical Incorporated|Narrow Profile Surgical Ligation Clip|
    US20130245653A1|2012-03-19|2013-09-19|Craig Michael Litherland|Zero artifact vascular clip method and apparatus|
    US4147167A|1976-08-05|1979-04-03|Horst R. Hickmann|Ophthalmic prosthesis implant instrument|
    US4813107A|1987-09-04|1989-03-21|Warren Tool Corporation|Spring clamp|
    US7144402B2|2003-06-16|2006-12-05|Synovis Life Technologies, Inc.|Vascular clamp|EP3461435B1|2017-09-28|2019-09-04|Lazic Besitz GmbH & Co. KG|Surgical clip made from carbon fibre reinforced plastic material|
    法律状态:
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    优先权:
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    ES201431951A|ES2575727B1|2014-12-30|2014-12-30|Aneurysm clamp|ES201431951A| ES2575727B1|2014-12-30|2014-12-30|Aneurysm clamp|
    JP2017534935A| JP6722674B2|2014-12-30|2015-12-28|Clip for aneurysm|
    US15/540,635| US10743885B2|2014-12-30|2015-12-28|Clip for aneurism|
    EP15831144.9A| EP3241508B1|2014-12-30|2015-12-28|Clip for aneurysm|
    CN201580071809.6A| CN107106183B|2014-12-30|2015-12-28|For aneurysmal fixture|
    PCT/ES2015/070957| WO2016107952A1|2014-12-30|2015-12-28|Clip for aneurysm|
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