FR2796268A1 - DEVICE FOR HOLDING A FRAMEWORK FOR RECEIVING A HOLDING AND FILLING PRODUCT WITHOUT THE RISK OF SPREADING THE SAME INSIDE THE HUMAN BODY - Google Patents

Abstract

This is a device 1 for maintaining a framework composed of a cutable, deformable container 2, returning to its initial shape, and having an injection hole 21, this first means is combined with a prop 3 which allows thanks to two pins 31 and 34 to center the container when it is placed between two vertebrae. This device 1 is perfectly suited in the case of bone ablations from metastases, it allows after its placement, the injection of a maintenance and filling product, without risk of dangerous spreading in the human body, very good mechanical strength is obtained. The position of the device before injection of the product is shown in the figure below.

Description

Device for supporting a framework enabling a product to be received

  maintenance and filling without risk of spreading it inside

of the human body.

  Field of the Invention: The invention is a holding device which also makes it possible to contain a product of the cement type. The assembly thus formed can replace, for example, one or more vertebrae which can no longer provide the holding function.

  especially the spine.

  PRIOR ART: In the context of surgical operations carried out for example to treat vertebral metastases, the surgeon proceeds to the partial or complete removal of the bone which may be a vertebra. No mechanical resistance or maintenance is then ensured. In the prior art, these deficiencies were remedied by placing a simple rod between the vertebrae, then a cement was injected to fill the empty spaces left by the surgical ablations. This rod was introduced between two healthy bones (or vertebrae) to ensure a first shoring, then we proceeded to fill with a product to solidify the cement type appropriate for this type of operation. The absence of a container for the product led to an expansion with drawbacks: Form of the injected product, once solidified, uncontrolled and not guaranteeing the expected rigidity Damage to the surrounding organs by the cement which, when it solidifies, gives off heat, on vital organs À such as for example the spinal cord which can lead to

prohibit certain operations.

  Another technique used also consisted of replacing

  cer the rod and the cement by a rigid grid structure called: Harms cage in which bone graft is introduced to fill as best as possible and obtain a bone support, but whose installation is not easy and requires , distract the adjacent vertebral bodies. This technique is mainly applied in the case of patients who have healthy bones with trauma, but it does not apply in most cases of metastases where bone grafts are ineffective. The present device object of one invention is on the other hand capable of solving the problems posed both in the case of healthy bones

only bones with metastases.

  It will therefore consist essentially of a central retaining rod called prop having appropriate means which will be described to fulfill the following functions maintain good mechanical strength of the framework maintain at the periphery a container which will receive the product for maintaining and filling which will thus be contained and cannot therefore spread in the human body during the injection

DESCRIPTION

  Figures 1, lbis and Ib of board 1/3 give three

  overview of a first means of the invention called was.

  Figure 2 of Plate 1/3 shows a type of container

  used, either: a hollow and flexible cylinder provided with an injection hole.

  FIG. 3 of plate 1/3 shows the two preceding means which combined form the holding device, the latter being taken in a clamp for positioning by the surgeon. FIG. 4 of plate 2/3 shows a method of placement of the device comprising all of its means between two half-view vertebrae in section with a representation of the spinal cord

  Figure 5 of Plate 2/3 shows on the same con-

  bone figuration the device in place ready for injection Figure 6 of plate 3/3 shows the device, once the

filler injected.

  The holding device I which is the subject of the invention comprises two main means: A container 2, preferably cylindrical, intended to enclose a filling and holding product which will be injected into this cylinder through a hole 21 placed at the center of its lateral surface . This container must be able to be made of a material such that it is easily cut to adapt to the dimensions of the cavity and sufficiently flexible to deform during its introduction and to adapt to the shape of the cavity while avoiding the product. to inject to spread into the human body. It can be manufactured in a deformable material having as essential function to regain its initial shape, it can be manufactured in a polymer, composite or metallic material provided that it is flexible enough to admit elastic deformations. The container, once manufactured, can be cut, with a pair of scissors by the

  surgeon who adapts it, as he wishes, to the height of the cavity.

  A strut 3 rod preferably made of titanium or: any other resistant and stainless material, has at its ends two points 35 and 36 which will fix the strut by penetration into healthy bones. This strut has in the upper half of its length a perpendicular pin 31 fitted on a ring 32 sliding on the strut; said pin completely passing through the prop 3, its end being able to move in an oblong slot 33 made in the axis of the prop 3 which allows the assembly 31 and 32 a sort of variable bracket 37, formed by means 31 and 32 to move in translation down during installation and then up when the prop has found its position. In its lower part, the strut 3 also has a second fixed pin 34, which prevents the container 2 from decentring with respect to the strut, which would be very detrimental, at the time of injection, in positioning and

  filling of the product as well as its rigidity and mechanical strength.

  Figure 3 shows the grip of the device 1 with pliers; the variable pin 31, and the fixed pin 34 ensure correct centering of the container 2, during and after installation

of device 1.

  During the installation of the device 1, object of the invention (fig4), the surgeon grasps the device 1 with pliers by passing it through the hole 21 of the container 2; it presents the assembly at an angle along an oblique axis; it penetrates the two points of the prop 3 in the bones by a straightening movement which follows an arc of rotation so that the 2 points of the prop 3 can enter one after the other into the two bones. This operation is possible thanks to the momentary deformation of the container 2 during the positioning, as well as to the possible escape of the pin 31 thus avoiding abutting on the vertebral plate during the positioning of the stay. The surgeon will thus have inserted the device 1 into the cavity to be filled. This device is then ready for injection of the

  product chosen for maintenance and filling (fig 5).

  The injection is then carried out through the hole 21 of the container 2 at

  using for example a syringe or any other suitable means.

  Thanks to the high viscosity of the injected product, said product is housed in the interstices between the bones and the device, without

  disrupt surrounding organs; the whole: injected product

  bined with the device 1, forms a solid and homogeneous block (fig 6) This device 1 can also be used to fill cavities between two bones which are not necessarily vertebrae either come

  fill one or more cavities formed after ablation in particular

  ment of one or more metastases located inside a bone which the surgeon will have removed, and which is absolutely

necessary to stiffen.

  Of course, all the materials are compatible with long-term implantations in the human body, there are no major rejection problems on this side, because they are already used in other surgical applications A variant of the prop 3 is proposed (fig 1 ter), prop 3 in

  this case has two fixed perpendicular pins 31 bis and 34.

  This type of prop is used when the distance between the two bones is sufficient to allow implantation similar to that already described; in this case it is a question of inserting the device 1 between two bones far enough apart so as not to require the presence of the variable pin 31; the penetration of the tips 35 and 36 is effected by biasing the device 1, relatively easy to perform

  when the intervertebral distance is sufficient.

  Another application of this invention consists in the possibility of passing the device 1 through a trocar thus making it possible to carry out interventions under endoscopy. The container

  can by the flexibility of the material which composes it be folded up on itself-

  even to get into the trocar. This intervention is performed on the thoracic vertebrae and thus avoids a heavy operation (large opening). The positioning of the prop 3 and of the container 2 which make up the device 1 is also done by endoscopy, as

  it is now described: the main variant with respect to the application

  previous cation, coming from the fact that the container is made of a material whose flexibility allows the folding of the latter for its introduction by a trocar, the container 2 resuming its

  initial shape as soon as it is placed in the cavity.

  The product can be injected by passing it through pipes reaching the hole 21 of the container 2 at the end of which is the injection syringe

Claims (4)

  1-Holding device (1) intended to be placed between two bones which receives a holding and filling product, characterized in that it comprises the combination of two means 5 -a first means which is a container (2) of said deformable, cut, foldable product, returning to its original shape, and   comprising a central hole (21) for injecting the product.   a second means which is a strut (3) consisting of a rod made of rigid material, these two means allowing an easy positioning and adapted to each cavity, resulting from ablation of the bone while ensuring a solid anchoring and avoiding dangerous spreading   maintenance and filling product in the human body.   2-holding device (1) according to claim 1 characterized in that the container (2) consists of a flexible material of the polymer, composite or metallic type which admits the   elastic or plastic deformations during its insertion and which can return to its initial shape without exerting constraints on the support points, thus allowing easy installation of the device.   3- Holding device (1) according to any one of   previous claims characterized in that its stay (3)   has at least two pins perpendicular to its axis, at least one of which is fixed, which allows the said center to be correctly centered   container (2) when it is placed between the two bones.   4-Holding device (1) according to any one of   previous claims characterized in that its was (3)   comprises fixing points (35) and (36) allowing the forestay (3) to penetrate into the two bones thus ensuring a solid anchoring of the device (1) Holding device (1) according to one of the preceding   claims characterized in that its stay (3) has a pin   fixed (34) and a movable pin (31) which can move perpetually   diculary to the axis of the forestay through an oblong slot (33). 6Support device (1) according to one of the preceding   claims characterized in that its container (2) is manufactured in   a material whose characteristics must be such that it can be cut, for example, with a simple pair of scissors, at the desired height so that it can be tailored to the cavity to be filled, and that it is possible to fold it up so you can easily insert it in the accommodation provided.