ES2885531A1 - EQUIPMENT AND PROCEDURE FOR POSITIONING AND BLOCKING THE INTRAMEDULAR NAIL (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Intramedullary nail positioning and locking equipment comprising a cannula (5) insertable in an intramedullary nail (1) housed in the medullary canal of a bone (11). The cannula (5) is traversed by a beam of laser light (6) that changes direction when it hits a reflection element (7). The cannula (5) also comprises convergent lenses (8), facing the reflection element (7) such that the laser light beam (6) incident on the reflection element (7) is projected through the converging lenses (8) towards the outside of the cannula (5) and, with the converging lenses (8) facing a distal through hole (4) of the intramedullary nail (1), said projection is made to the outside of the bone (11). An intramedullary nail (1) positioning and locking procedure with said equipment is also described. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

EQUIPMENT AND PROCEDURE FOR POSITIONING AND LOCKING THE NAIL

INTRAMELLULAR

OBJECT OF THE INVENTION

The object of the present invention falls within the technical field of medical instruments and the like. More specifically, an equipment and a procedure for positioning and blocking intramedullary nails are described.

The equipment and procedure proposed make it possible to determine the exact position in which the locking screws used to join the intramedullary nail to the fractured bone should be inserted. Both the equipment and the procedure are based on the use of laser technology.

TECHNICAL PROBLEM TO SOLVE AND BACKGROUND OF THE INVENTION

Intramedullary locking systems, such as intramedullary nails, are used to help fix bone fractures, especially in long bones. They are configured to be introduced into the medullary canal of the fractured bone and give stability to said bone. Intramedullary nails are attached to the bone using, for example, locking screws. It is generally known that blocking the intramedullary systems in a patient's bone prevents rotation of the bone fragments relative to each other.

Intramedullary nails are attached to external supports, supplied by the manufacturers/sellers themselves, which allow the fixation of the nail to the bone in the area of the head (proximal end) of the nail.

A known problem with the use of intramedullary nails is that, when inserted into the medullary canal of the patient's bone, they undergo a torsional force that alters the position of the distal end of the intramedullary nail. Thus, the real position, both longitudinal and angular, of said distal end of the intramedullary nail is displaced with respect to the theoretical position. This causes insecurity in the placement of the fixation elements of the distal end.

To solve this problem, solutions have been developed in the state of the art that propose the use of X-rays during the positioning of the fixing elements. Until now, this solution has allowed surgeons to know the exact position of the holes in the distal end of the intramedullary nail in order to perform precise placement of the fixation elements.

Currently, fluoroscopic-type techniques are used for these procedures, in which X-ray images are worked on in real time.

However, this solution is not without drawbacks. On the one hand, a learning curve is necessary for the surgeon to be able to use the technique properly. On the other hand, the surgical time necessary to carry it out is long and, sometimes, excessive.

Additionally, the use of X-rays can predispose both the patient and the surgeon to disease. This danger occurs especially in the case of surgeons who are exposed to X-rays in each of the procedures of this type that they perform. Throughout the professional life of a surgeon, many interventions are performed, so the risks of diseases caused by radiation increase.

Other solutions of the state of the art that do not include the use of X-ray radiation are the use of external or internal directing guides, based on the use of magnetic fields.

Document ES2151964 is known from the state of the art, for example, which describes a drilling template for the mechanical alignment of a drill guide with at least one hole for a transverse bone screw to the intramedullary nail. The intramedullary nail has a straight distal part, a proximal end adapted for template attachment, and holes for receiving bone screws. It comprises an external template that is attached to the nail at its distal end and that determines, from the outside of the patient's body, the positions in which the holes for the bone screws remain and therefore the positions in which to drill.

Thus, it is necessary to develop new equipment and a new procedure to accurately determine the position of the distal holes of the intramedullary nails when they are already in their final position with respect to the patient's bone.

DESCRIPTION OF THE INVENTION

The invention refers to an equipment and a procedure for positioning and blocking intramedullary nails. They are based on the use of laser technology to improve these intramedullary nail positioning and locking operations in the treatment of bone fractures.

Thanks to the present invention, the use of X-rays is no longer necessary. In this way, the risk of radiation is avoided both for the patient and for the professionals who work in the operating room, such as surgeons, anesthesiologists, nurses, lightning etc.

The kit is configured to be used with at least one hollow intramedullary nail and comprises a cannula into which a beam of laser light is projected. In a possible embodiment, the equipment comprises an optical fiber, which is housed inside the cannula and through which the laser light beam travels. The cannula is in turn housed inside the intramedullary nail in a position in which converging lenses through which the laser light beam is projected outside the cannula face a distal through hole in the nail. intramedullary Said distal through hole is the hole through which a locking screw is inserted to join the intramedullary nail to the bone.

Inside the cannula there is also a reflection element, which is responsible for changing the direction of the light beam and directing it towards the converging lenses. Preferably the reflection element and the converging lenses are arranged at the same height of the cannula.

The projection of the light beam from inside the bone is visible from the outside of the bone and determines the point at which the surgeon or corresponding healthcare personnel must place the locking screw of the intramedullary nail in the bone. This kit allows pinpointing the exact position of the distal through hole of the intramedullary nail regardless of its position. theoretical. In other words, it allows solving the positioning problems derived, for example, from the insertion of the nail in the medullary canal.

The equipment of the present invention does not depend on additional external devices to be able to function since the projection is carried out from inside the bone. To lock the intramedullary nail, it is simply necessary to drill a hole at the point marked by said projection.

One of the advantages of the present invention is that the projection of the laser light beam is carried out through two converging lenses, which are in opposite angular positions. Said lenses can be at the same height as the cannula, in the event that it is going to be used for the positioning and blocking of intramedullary nails with through holes perpendicular to a longitudinal direction of the nail. Distal through holes are always perpendicular to the long axis of the nail. There may be one or more other through holes at another level, sometimes with an angular difference. The cannula of the present invention contemplates it, since at the proximal and external level the surgeon controls it with the end of said cannula. A single cannula is used to perform all desired distal locks.

The proposed procedure is based on the use of previously described equipment and laser technology. By projecting the laser light beam from inside the bone, the surgeon drills the bone in the exact position where the locking screw must be placed to be locked in the distal through hole of the intramedullary nail.

During the positioning and blocking procedure of an intramedullary nail, which must be hollow in order to be used with the proposed equipment, the following steps are carried out: - inserting the intramedullary nail into the medullary canal of a bone;

- insert, inside the intramedullary nail, the cannula connected to the laser light source, until a position in which the converging lenses are facing the distal through hole of the intramedullary nail such that the laser light beam projected outwards from the cannula projects through the distal through hole to the patient's skin;

- perforate the cortical bone of the patient at a point marked by the projection of the beam of laser light projected from inside the bone;

- position the locking screw in correspondence with the perforation made.

The proposed procedure is universal, fast, safe, reliable and easily reproducible. It also allows to reduce the surgical time which is a great benefit for the patient who is subjected to less anesthesia and surgery time. This makes it possible to reduce morbidity.

Both the equipment and the procedure are applicable with the majority of currently existing hollow body (cannulated) intramedullary nails. In other words, the equipment is endowed with great versatility.

BRIEF DESCRIPTION OF THE FIGURES

To complete the description and in order to help a better understanding of the characteristics of the invention, a set of drawings is attached to this description, as an integral part of it, where for illustrative and non-limiting purposes, it has been represented the next:

Figure 1 represents a sectional elevation view of an intramedullary nail positioning and locking set housed in the intramedullary canal of a patient's femur.

Figure 2 represents a plan section of the equipment of Figure 1 in the intramedullary canal of the patient's femur.

Figure 3 represents a perspective view of the intramedullary nail positioning equipment.

A list of the different elements represented in the figures that make up the invention is provided below:

1. Intramedullary nail

2. Distal end

3. Proximal end

4. Distal Through Hole

5. Cannula

6. Laser light beam

7. Reflection Element

8. Converging lens

9. Fiber optic cable

10. Laser light generator

11. Bone

12. Proximal Through Hole

DETAILED DESCRIPTION

The present invention is not to be limited to the embodiment described herein. Other configurations can be made by those skilled in the art in view of the present description. Accordingly, the scope of the invention is defined by the following claims.

The key to the invention is that it allows laser technology to be applied by means of fiber optics to locate the holes at the tip of intramedullary nails to avoid the use of X-rays.

Figure 1 shows the intramedullary nail positioning and locking equipment in its position in the medullary canal in a patient's bone. As can be seen in the figure, the equipment is used with intramedullary nails (1) of the type that are attached to the bone by locking screws that go through the patient's bone and the intramedullary nail (1). The locking is performed through a distal end (2) of said intramedullary nail (1), the locking screw passing through at least one distal through hole (4), and through a proximal end (3) of the intramedullary nail (1). ).

The equipment comprises a distal and rotational positioning cannula (5) whose interior is hollow, allowing the passage of a laser light beam (6) in the longitudinal direction of said cannula (5). At the distal end of the cannula (5) it comprises a reflection element (7) oriented so that the laser light beam (6) falls on said reflection element (7), changing its direction, and comprises converging lenses (8).

The converging lenses (8) are arranged on the perimeter of the cannula (5), at the same height as the reflection element (7), in angular positions opposite each other. In this way, the laser light beam (6), upon reaching the reflection element (7) and changing direction, it is projected through the converging lenses (8) towards the outside of the cannula (5), as seen in the zoom of Figure 1.

Figure 2 shows a section of the patient's bone (11) with the intramedullary nail (1) arranged in the medullary canal of said bone (11) and with the cannula (5) housed inside the intramedullary nail (1). ). The reflection element (7) and the converging lenses (8) can also be seen. As can be seen in the figure, the converging lenses (8) are arranged facing the distal through hole (4) of the intramedullary nail (1). In this way, the projection of the laser light beam towards the outside of the intramedullary nail (1) and the patient's bone (11) is carried out. Thus, when the cannula (5) is housed in the intramedullary nail in a position where the converging lenses (8) face the distal hole (4), the laser light beam (6) projected from the cannula (5), projects through the distal hole (4) and the patient's skin such that said projection determines a point at which to drill a positioning hole for placing the locking screws of the intramedullary nail.

As can be seen in Figure 3, the equipment also comprises a laser light generator (9), connected to the cannula (5), configured to emit the laser light beam (6).

In an embodiment, such as the one shown in said figure 3, the equipment also comprises a fiber optic cable (10) through which the laser light beam is passed and said cable (10) is housed inside the cannula (5).

Preferably, the reflection element (7) has a configuration in the form of a conical or truncated conical prism. In an exemplary embodiment, the prism comprises at least one face inclined at 45° such that when the laser light beam (6) hits it, it is projected in a direction perpendicular to the longitudinal direction of the cannula (5).

Thus, thanks to the equipment of the invention, the exact position, both angular and longitudinal, of the through distal hole (4) where the perforation must be made to lock the intramedullary nail (1) is determined precisely and without using X-rays. ).

Another object of the present invention is an intramedullary nail positioning and locking procedure with the previously described equipment. This procedure comprises the following stages:

- introducing a hollow intramedullary nail (1) into the medullary canal of a bone;

- insert, inside the intramedullary nail (1), the cannula (5) connected to the laser light source (9), until a position in which the converging lenses (8) face the distal through hole (4) of the intramedullary nail (1) such that the laser light beam (6) projected towards the outside of the cannula (5) is projected through the distal through hole (4) to the patient's skin;

- perforating the cortical bone of the patient at a point marked by the projection of the laser light beam (6) projected from inside the bone;

- position the locking screw in correspondence with the perforation made.

In another embodiment, after inserting the cannula (5) into the intramedullary nail (1) arranged in the medullary canal, the following steps are performed:

- drill the cortical bone in correspondence with a proximal through hole (11) of the intramedullary nail with a fenestrated drill,

- Passing a fiber optic cable (10) through the interior of the fenestrated drill to the interior of the cannula (5).

This example of carrying out the procedure is suitable in cases in which it is desired to first position and hold the proximal end (3) of the intramedullary nail (1). In this case, a stage prior to the placement of the optical fiber (10) is performed, drilling the cortical bone with a fenestrated drill. The fenestrated drills have a hollow interior, so that, when drilling the cortical bone, the interior of the fenestrated drill comes into communication with the interior of the bone (medullary canal) to allow the introduction of the cannula (5), through said fenestrated drill, to the inside of the intramedullary nail (1) already arranged in the medullary canal.

Claims (6)

1. Intramedullary nail positioning and locking equipment in the medullary canal of a patient's bone to be used with an intramedullary nail (1) of the type that is attached to the bone by means of locking screws that pass through the patient's bone and the intramedullary nail (1) through a distal end (2), the locking screw passing through at least one through distal hole (4), and through a proximal end (3), and the equipment is characterized in that it comprises: - a distal and rotational positioning cannula (5) whose interior is hollow, allowing the passage of a laser light beam (6) in the longitudinal direction of said cannula (5), and the cannula (5) comprises at its distal end: - a reflection element (7) oriented such that the laser light beam (6) falls on said reflection element (7), changing its direction; - converging lenses (8) arranged on the perimeter of the cannula (5), at the same height as the reflection element (7), in angular positions opposite each other so that the laser light beam (6), at reaching the reflection element (7) and changing direction, it is projected through the converging lenses (8) towards the outside of the cannula (5); - a laser light generator (9), connected to the cannula (5), configured to emit the laser light beam (6), such that, when the cannula (5) is housed in the intramedullary nail in a position where the converging lenses (8) face the distal hole (4), the laser light beam (6) projected from the cannula (5), projects through the distal hole (4) and the patient's skin such that said projection determines a point at which to drill a positioning hole for placing the locking screws of the intramedullary nail. 2. Intramedullary nail positioning and locking equipment according to claim 1, which comprises a fiber optic cable (10) through which the laser light beam is passed and said optical fiber (10) is housed inside the cannula (5). 3. Intramedullary nail positioning and locking equipment according to any one of the preceding claims, in which the reflection element (7) has a configuration in the form of a conical prism or truncated conical prism. 4. Intramedullary nail positioning and locking equipment according to any one of the preceding claims, wherein the reflection element (7) comprises at least one 45° inclined face such that when the laser light beam (6) hits it, it is projected in a direction perpendicular to the longitudinal direction of the cannula (5). 5. Procedure for positioning and blocking the intramedullary nail with the equipment described in any one of claims 1 to 4, characterized in that it comprises the following steps: - introducing a hollow intramedullary nail (1) into the medullary canal of a bone; - insert, inside the intramedullary nail (1), the cannula (5) connected to the laser light source (9), until a position in which the converging lenses (8) face the distal through hole (4) of the intramedullary nail (1) such that the laser light beam (6) projected towards the outside of the cannula (5) is projected through the distal through hole (4) to the patient's skin; - perforating the cortical bone of the patient at a point marked by the projection of the laser light beam (6) projected from inside the bone; - position the locking screw in correspondence with the perforation made. 6. Procedure for positioning and blocking the intramedullary nail according to claim 5, wherein before inserting the cannula (5) in the intramedullary nail (1) arranged in the medullary canal, the following steps are performed: - drill the cortical bone in correspondence with a proximal through hole (12) of the intramedullary nail with a fenestrated drill, - pass the cannula (5) through the fenestrated drill in position to the desired level of distal locking where the distal through hole (4) is located.