ELASTIC PROSTHETICS OF RIBS

Abstract

A prosthesis for splinting or replacing a rib, characterized in that it comprises a piece curved in the longitudinal direction and in the transverse sense, which defines a concave face and a convex face, said prosthesis having a warping on its longitudinal axis and two or more transverse grooves on its convex face to support the means for fixing the ribs. The prosthesis may eventually contain a line of radiopaque material that facilitates its radiological visibility.

Claims

1- An individual prosthesis to replace or splint a rib, said prosthesis characterized by comprising: a—a piece curved in the longitudinal direction in the form of an arc (60), said piece also presenting a curvature in the transverse direction that defines a concave face (14) and a convex face (13) and a warping along the longitudinal axis; and b—two or more transverse grooves (61) located on the convex face.

2- The prosthesis according to claim 1, characterized in that the concave face has projections (63).

3- The prosthesis according to claim 1, characterized in that the transverse grooves (61) are also spaced apart.

4- The prosthesis according to claim 2, characterized in that the transverse grooves (61) are also spaced apart.

5- The prosthesis according to claim 1, characterized in that it has at least one line of radiopaque material (7).

6- The prosthesis according to claim 2, characterized in that it has at least one line of radiopaque material (7).

7- The prosthesis according to claim 3, characterized in that it has at least one line of radiopaque material.

8- The prosthesis according to claim 4, characterized in that it has at least one line of radiopaque material (7).

9. The prosthesis according to any of the preceding claims, characterized in that the material of said prosthesis is polyether ether ketone.

10. The prosthesis according to claim 9, characterized in that it is manufactured by 3D printing.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0027] A summary description of the figures is given below.

[0028] FIG. 1 shows the components of a fractured rib.

[0029] FIG. 2 shows the use of an intramedullary nail in a fractured rib, according to the prior art.

[0030] FIG. 3 shows a metallic agrafe to be used on a fractured rib, according to the prior art.

[0031] FIG. 4 shows the application of a similar agrafe to that of FIG. 3 on a fractured rib, according to the prior art.

[0032] FIG. 5 exemplifies the use of an interwoven with threads on a group of fractured ribs, according to the prior art.

[0033] FIG. 6 exemplifies the use of a mesh-methacrylate sandwich on a group of fractured ribs, according to the prior art.

[0034] FIG. 7 shows the application of the sandwich of FIG. 6, seen from the top side.

[0035] FIG. 8 shows a complete prosthesis according to the invention.

[0036] FIG. 9 shows another complete view of the prosthesis of the invention.

[0037] FIG. 10 is a view of a section of the prosthesis of the invention from its concave face in which one end of the prosthesis can be seen.

[0038] FIG. 11 is a view of a section of the prosthesis of the invention from its concave face in which the other end of the prosthesis can be seen.

[0039] FIG. 12 is a complete view of a prosthesis of the invention from its concave face

[0040] FIG. 13 is a complete view of a prosthesis of the invention from its convex face, in which the channel for the radiopaque substance is shown.

[0041] FIG. 14 is a figure that allows to appreciate the warping of the prosthesis of the invention.

[0042] FIG. 15 is a detail of the face of one of the ends of the prosthesis of the invention.

[0043] FIG. 16 is a cross section of the prosthesis of the invention.

[0044] FIG. 17 is a view that allows the prosthesis of the invention to be seen from the convex face.

[0045] FIG. 18 is another view of the prosthesis of the invention.

[0046] FIG. 19 shows a prosthesis of the invention that is stabilizing a fractured rib.

[0047] FIG. 20 shows a prosthesis of the invention that is partially replacing a rib.

DETAILED DESCRIPTION OF THE INVENTION

[0048] The object of the invention is an individual prosthesis for replacing or splinting a rib, characterized by comprising: [0049] a—a piece curved in the longitudinal direction in the form of an arc, said piece also presenting a curvature in the transverse direction that defines a concave face and a convex face and a warping along the longitudinal axis and [0050] b—two or more transverse grooves located on the convex face.

[0051] The “concave face” is the face of the curved piece that rests on the rib, once the prosthesis is used.

[0052] The “convex face” is the face of the curved piece that faces the outer side of the body, once the prosthesis is used, that is, the face opposite to the “concave face”.

[0053] By “splinting” it should be understood that the prosthesis allows two parts of a fractured rib to be held firmly so that the fractured ends are facing and located next to each other to allow the bone to weld. Splinting prevents fractured ends from moving and thus allows proper bone welding.

[0054] Preferably, the prosthesis will be constructed in a material that has a stiffness (and therefore also an elasticity) comparable to the natural stiffness (and elasticity) of the ribs, so as to facilitate the necessary bending for a correct support on the outer surface of the rib. “Correct support” means a firm and uniform support against the bone. Thus, the prosthesis behaves similarly to a natural rib during inspiration and expiration movements.

[0055] The outer surface of the human rib has curvature on its longitudinal axis and that curvature changes as it goes from the spine to the sternum area. Therefore, the expert will understand that the curved piece must have a warping on its own longitudinal axis, so as to emulate the outer surface of a human rib. This configuration will facilitate the correct support on the outer surface of the rib.

[0056] Warping along the longitudinal axis implies that, if the prosthesis rests on a plane over its length, the angle formed between the plane and the line that joins the two transverse ends to the curved piece on the face of one of the ends Longitudinal will be approximately 90°, so as to emulate the shape of the rib in the area of the spine, while the angle formed between the plane and the line that joins the two transverse ends to the curved piece will gradually decrease along the piece and on the face of the other of the longitudinal ends the angle formed between the plane and the line that joins the two transverse ends will be an acute angle, so as to emulate the shape of the rib in the sternum area. Obviously, the acute angle and therefore warping will depend on the rib for which the prosthesis is applied.

[0057] The said angle of approximately 90 will preferably be between 85° and 95°. Preferably, it will be an angle of 90°.

[0058] The aforementioned acute angle depends on the rib for which the prosthesis is intended to be applied.

[0059] The warping along the axis is then performed so that the prosthesis takes an approximate shape to that of the fractured rib, so that the prosthesis that best fits the shape of a particular rib can be chosen and can be supported correctly over the fractured rib. In other words, warping along the axis approximately emulates the shape of a certain rib or a group of ribs.

[0060] The transverse grooves fulfill two functions: they allow the prosthesis fixing elements to be accommodated to the rib and allow the prosthesis to be cut manually, without tools, to adjust it to the desired length.

[0061] The presence of grooves allows the prosthesis to be attached to the rib by means of fixing elements and in this way, there is no need to pierce the rib. This procedure reduces operating time, which is of fundamental importance in an operation because surgery times are reduced, operating room costs are reduced, and less anesthesia is required (because the operating time is reduced). Any known biocompatible fixation means can be used to fix the prosthesis to the rib, and no special fixation means are necessary. For example, suture thread or conventional sterile seals can be used.

[0062] In some cases, it may be necessary to cut the prosthesis to adjust its length to the desired length. To cut the prosthesis, it will be enough for the surgeon to press with his thumbs on both sides of the chosen groove. The groove will behave like a weak zone that will allow the piece to be cut. This is also relevant in a surgical intervention, because the operating time of the operating room is reduced, sterile tools are not required, and no dust is generated.

[0063] Preferably, the transverse grooves will be uniformly spaced along the curved piece.

[0064] The prosthesis does not require the existence of through holes, which helps to facilitate its fabrication.

[0065] Ribs are not all the same: each rib has its own length and curvature. The expert will then understand that the prosthesis should fit the fractured rib, so there will not be a single size of prosthesis. It will usually be convenient to have four or five prostheses for the ribs on the right side and four or five prostheses for the ribs on the left side, especially for emergency situations.

[0066] Since the prosthesis has a certain degree of flexibility and elasticity, it is possible to bend it slightly to adapt it to the shape of the rib. For that reason, it is enough with four or five rib prostheses of each side so that it is possible to use any of the prostheses with a particular rib. The expert will not have difficulty choosing the right prosthesis for each case.

[0067] Obviously, if necessary, it is possible to manufacture a customized prosthesis for a particular rib, since the manufacturing process is relatively quick. In that case, the warping along the axis will follow exactly the natural warping of the rib, so as to replicate its shape.

[0068] Preferably, the prostheses will have an average size of 290 mm long, 10 mm wide and 3 mm thick, with a variation of +/−30% in any of these dimensions, according to which ribs the prosthesis is directed.

[0069] Preferred materials for the construction of the prosthesis are biocompatible polymeric materials. Especially preferred is polyether ether ketone (PEEK). The polyether ether ketone makes it possible to manufacture a prosthesis that has a degree of stiffness comparable to the natural flexibility of the ribs.

[0070] Preferably, at least one line of radiopaque material will be included within the body of the prosthesis and throughout its length. This will facilitate your radiological visibility.

[0071] Preferably, that line of radiopaque material will be formed by a substance that contains radiopaque material, said substance being incorporated in a channel that travels the curved piece from one end to the other. In those cases in which it is desired to include a radiopaque material, the curved piece will have at each of its longitudinal ends, a hole that connects with the channel that the piece will travel along its entire length. Through one of these holes the radiopaque material will be injected along the entire channel. Preferably, the radiopaque material is included in a resin that flows through the channel and then polymerizes and solidifies. The expert will understand that the curved piece can be constructed with more than one longitudinal channel, so as to have more than one line of radiopaque material.

[0072] Examples of radiopaque materials that can be used are barium sulfate and iodinated contrast media, such as iotalamate, ioxaglate or iopamidol.

[0073] Preferably, the surface of the concave face will not be flat but will have relief to facilitate support. Especially preferred is the presence of projections or projections, which not only facilitate support, but allow the tissue to grow around said reliefs and thereby help to keep the prosthesis fixed. The projections may be distributed over the entire surface of the concave face or only part thereof, although it is preferred that the projections be distributed over the entire surface, more preferably that said distribution is uniform.

[0074] By “projections or protrusions” it refers to elements that protrude from the surface of the convex face.

[0075] Preferably, the projections will have a pyramidal shape. However, the expert will understand that he can give it any other suitable form, such as, for example, conical, cylindrical or striated.

[0076] Below are drawings that allow a better understanding of the invention. The drawings should be considered as particular embodiments of the invention, not being in any way limiting thereof.

[0077] FIG. 1 shows a fractured rib 1, with fractured ends 11, 12. The rib 1 is then divided into two segments 1a, 1b due to the fracture. Convex face 13 of the rib and concave face 14 of the rib is shown

[0078] FIG. 2 shows the use of an intramedullary nail to repair the fracture, according to the state of the art. In this technique, the nail, which consists of a thick wire 2, is introduced through the convex face 13 of one of the segments 1b of the fractured rib 1 a few centimeters from the fracture focus 10 and into the medullary canal of the bone. The fractured ends are faced and the wire 2 is advanced through the medullary canal of the bone until it exits the convex face 13 of the other segment 1a of the fractured rib 2

[0079] FIG. 3 shows a metallic agrafe 3 according to the state of the art. The agrafe comprises a narrow sheet 30 that supports a series of open clamps 31. In this case four clamps are shown, but the number could be greater or lesser.

[0080] FIG. 4 shows the application of the agrafe 3 in a fractured rib 1. The fractured ends are faced, the agrafe 3 is placed and then the clamps 31 are closed and tightened on the healthy bone with a special clamp, thereby fixing the focus of fracture 10.

[0081] FIG. 5 exemplifies the use of an interwoven with threads on a group of ribs 100, 101, 102, 103, 104, according to the state of the art. The interwoven consists of a thread 4 that joins the different ribs and has threads 40 alternately placed above and below said thread 4 between ribs.

[0082] FIG. 6 exemplifies the use of a mesh-methacrylate sandwich 5 on a group of ribs 500, 501, 502, 503, 504, according to the state of the art.

[0083] FIG. 7 shows the application of the sandwich of FIG. 6, seen from the top side. A rib 502 and sandwich 5 are seen.

[0084] FIG. 8 shows a prosthesis 6 according to the invention. The prosthesis comprises a piece 60 longitudinally curved and several grooves 61 in its convex face.

[0085] FIG. 9 shows another view of the prosthesis 6. This view shows more clearly the curvature and warping on the longitudinal axis of the piece 60, which emulates the shape of the rib.

[0086] FIG. 10 is a view of a section of the prosthesis from its concave face and in the area of the end that will be located closer to the sternum. The warping of the piece 60 on its longitudinal axis is appreciated. The face 62 has the two transverse ends to the curved part 620, 621.

[0087] In this case, the piece has projections 63 to improve bone fixation. The number of projections may vary depending on the part or possibly the part may not contain projections.

[0088] Also shown on face 62 is the inlet opening 64 to the longitudinal channel intended to contain the opaque radio material. On the other end (not visible in this figure) is the other hole in the channel. In this case, the piece has a single channel, but the expert will understand that there could be more than one channel to place radiopaque material. The expert will also understand that the piece may not contain a channel for radiopaque material: this arrangement makes it more difficult to locate the prosthesis from outside the body but does not prevent the normal functioning of the prosthesis.

[0089] FIG. 11 is a view of a section of the prosthesis from its concave face and in the area of the opposite end to that of FIG. 10, that is, the end that will be located closer to the spine. In this case it can be seen that the warping of the piece 60 on the longitudinal axis is different from that seen in FIG. 10. The face 65 of the other longitudinal end of the prosthesis and the other entrance hole 66 to the channel for the radiopaque material. The face 65 has the two transverse ends to the curved piece 650, 651.

[0090] FIG. 12 is a complete view of a prosthesis from its concave face. The two ends 62, 65 and the holes 64, 66 of the entrance to the inner channel are appreciated to locate the radiopaque material. The projections 63 cover partially the concave face.

[0091] FIG. 13 is a complete view of the prosthesis from its convex face. Channel 7 carrying the radiopaque material is shown. The channel 7 is represented with a dotted line to represent that it is internal to the piece 60 and therefore is not visible from the outside (unless the prosthesis does manufacture in some transparent material).

[0092] FIG. 14 makes it possible to better appreciate the warping of the piece 60. If the piece 6 is supported on a plane along its entire length, different angles can be seen at the ends. The C lines represent the plane on which the prosthesis rests.

[0093] At one end, the angle formed between the plane and the line that joins the two ends 650, 651, belonging to the face 65 and which are transverse to the piece 60, is an angle A of 90°. The angle between the plane and the line that joins the two transverse ends varies continuously as you move along the piece 60, until at the other end the angle formed between the plane and the line that joins the two ends 620, 621, belonging to the face 62 and which are transverse to the piece 60, is an acute angle B.

[0094] This form is convenient because in that way the prosthesis 6 emulates the shape of the rib. The curvature and warping of the piece 60 allows a better support against the convex surface of the rib.

[0095] FIG. 15 is a detail of the face 65, in which the orifice 66 of entrance to the channel 7 can be seen. The angle between the line passing through the transverse ends 650, 651 and the support plane is 90°.

[0096] FIG. 16 is a section of the piece 60 after advancing a few centimeters in a longitudinal direction from the face 65. The channel 7 is appreciated and that the angle between the line passing through the transverse ends and the support plane is a smaller angle of 90°.

[0097] FIG. 17 is a view that allows a prosthesis according to the invention to be clearly seen from the convex face.

[0098] FIG. 18 is another view of the prosthesis of the invention, which allows to see the arch shape of the prosthesis.

[0099] FIG. 19 shows a prosthesis of the invention fulfilling the function of splinting a fractured rib. The prosthesis is fixed in this case to the rib by means of suture thread (not shown) that passes through the grooves.

[0100] FIG. 20 shows the prosthesis of the invention fulfilling the function of partially replacing a fractured rib. For this, the prosthesis is attached to the ends that remain in the rib and the structure's own rigidity, which is similar to that of the natural rib, allows the structure to behave naturally as if it were part of the rib during the inspiration and expiration movements.

[0101] The prosthesis can be manufactured by any known method. For example, it could be manufactured by extrusion with subsequent shaping of the grooves. It could also be manufactured by injection, if it does not carry the channel for the opaque radio material.

[0102] A preferred form of manufacturing would be by additive manufacturing (3D printing). Especially preferred is manufacturing by means of molten filament (FFI) or by laser sintering.

[0103] Once the prosthesis is manufactured, it is sterilized by any known sterilization method and packaged in sterile form.

[0104] As preferred sterilization methods, autoclave sterilization, peroxide sterilization and ethylene oxide sterilization are cited. Especially preferred is ethylene oxide sterilization.

[0105] To apply the prosthesis, the prosthesis that best suits the fractured rib is chosen and that will be the one that will rest properly against the bone. Then the prosthesis is adjusted with a suitable means, for example surgical thread, which passes through the grooves and is tied to the bone.