ES2400120B1 - DEVICE FOR INSERTION OF TANTAL MARKERS IN SURGICAL INSERTS. - Google Patents

Abstract

Device for inserting tantalum markers into surgical inserts, comprising a template (1) for the surgical insert (2) and a thermal insert (3) of the tantalum marker (10) in the surgical insert (2).

Description

Device for inserting tantalum markers in surgical inserts.

Field of the Invention

The present invention relates to a device for inserting tantalum markers into surgical inserts, intended to precisely position tantalum markers, of spherical configuration, into inserts of radiolucent materials, such as polyethylene, of any type of prosthetic system, with the purpose of being able to carry out biomechanical studies of the inserts through radiological techniques.

Background of the invention

The implantation of certain types of prostheses, such as knee or hip prostheses, requires an operative follow-up to assess the degree of displacement of the prosthesis components over time. This monitoring allows, for example, to determine if a prosthesis loses its adhesion and it is necessary to replace it. The evaluation of the displacement of the prosthesis is done by radiographic techniques that allow visualizing the metallic components. However, one of the components of some prostheses is made of radiolucent material, for example polyethylene, not visible on radiographs. To visualize these polyethylene components it is known to manufacture them including one or more spherical tantalum markers, an inclusion that is carried out in the manufacturing process of the surgical insert.

However, in certain types of implants, such as knee or hip prostheses, polyethylene surgical inserts that lack radiopaque markers are often used.

Description of the invention

A subject of the present invention is a device for the insertion of tantalum markers in surgical inserts, constituted so as to allow the tantalum markers to be accurately positioned in the surgical insert or prosthesis, especially in surgical inserts or prostheses made of radiolucent materials, such as polyethylene.

The device of the invention is intended to carry out the insertion of tantalum markers into surgical inserts, or prostheses, before they are inserted into the body.

The device of the invention is comprised of a template, configured to fit the surgical insert thereon, and a thermal inserter to insert the tantalum marker into the surgical insert.

The template, of a metallic nature, will be sized to receive the surgical insert. For this, the template will have conformations between which the surgical insert is mounted. The template also has at least one guide container for the tantalum marker, which will be located in coincidence with at least one of the aforementioned conformations. This guide container can consist of a cavity made in at least one of the template conformations, a cavity that flows into the surface of the conformation on which the surgical insert rests.

The cavity that configures the guide-container can have an outer section of greater section, adjacent to the external surface of the conformation, an internal section of reduced section adjacent to the internal surface of the conformation, on which the insert rests, and a intermediate section of variable section between the external and internalized sections. The internal and external sections mentioned in the guide-container can be of cylindrical configuration, while the intermediate section will be of truncated conical configuration.

As for the thermal inserter, it is constituted by a body of thermally conductive material, of dimensions approximately equal to those of the guide-container for its fitted coupling inside said container. The aforementioned body is extended on one side in a heating head, which will be located outside the guide container, while on the other hand it is extended in a rod that is sized to pass through the inner section of the guide container and protrude therefrom, through the surface of the conformation on which the surgical insert rests. This stem is topped at its free end in a hemispherical cavity of the same radius as the tantalum markers. The rod will be of equal section to that of the internal section of the cavity that constitutes the guide container and of greater length than said internal section, in order to protrude therefrom in the manner set forth above.

With the configuration of the different sections of the guide container described above, the stem of the thermal inserter will be of circular section, equal to that of the inner section of the guide container.

The body of the thermal inserter can be composed of a central core, from which a series of radial fins that run along the core and determine a perimeter of diameter coinciding with that of the outer section of the guide chamber.

Brief description of the drawings

The attached drawings show a device for inserting tantalum markers into prostheses.

or surgical inserts, constituted according to the invention and given by way of non-limiting example. In the drawings:

Figure 1 is a front elevation of a template for the device of the invention.

Figure 2 is a side elevation of the same template.

Figure 3 is a perspective of the template with a surgical insert attached thereto.

Figure 4 is a cross section of the template with the surgical insert, taken along the line IV-IV of Figure 3.

Figure 5 is a perspective of the thermal inserter that becomes part of the device of the invention.

Figure 6 is a partial longitudinal section of the inserter, taken along the line VI-VI of the figure

5.

Figure 7 corresponds to detail A of Figure 4, on a larger scale, with a marker included in a template guide container.

Figure 8 is a section similar to Figure 7, with the thermal inserter included in a template guide container.

Detailed description of one embodiment

The constitution, features and mode of operation of the device of the invention will be better understood with the following description, made with reference to the embodiment shown in the accompanying drawings.

The device of the invention is composed of a template 1, figures 1 to 4, for the surgical insert 2, and a thermal inserter, figure 5, of the tantalum marker in the surgical insert 2.

As can be seen in Figures 1 to 4, the template, which can be of a metallic nature, has a central surface 3 limited by lateral conformations 4, between which the surgical insert 2 is attached and fixed.

The conformations 4 have voids 5, each constituting a guide container for the tantalum marker. This guide or emptying container is located in the conformations 4 so that it ends internally on the surface of the conformation on which the surgical insert 2 rests, as can be best seen in Figures 7 and 8.

The cavities or guide containers 5 comprise a cylindrical outer section of greater section adjacent to the external surface of the conformation 4, an internal section 7 also cylindrical and of reduced section, and an intermediate section 8 frustoconical, which delimits a transition zone between the sections 6 and 7. Section 7 flows through the internal surface 9 of the conformations 4.

In the example represented in the drawings, one of the conformations has two cavities 5, which delimit as many guide containers for the tantalum markers, while the other conformation 4 has a single cavity or guide container 5.

The conformations 4 will be arranged so that, together with the central surface 3, they define a housing that ensures the positioning of the surgical insert 2.

The template 1 is a sterilizable component that serves to position the guide container or the guide containers, if it has more than one, with respect to the surgical insert 2. For each type and size of insert, a specific type of template 1 must be designed.

The insertion template 1 must be designed so that the mouth of the internal section 7, figure 7, contacts the surgical insert 2, said insert being tangent to the internal surface 9 of the template 1 so that the tantalum markers 10, Figure 7, may remain within section 7 by gravity, during the process of thermal insertion, as will be discussed below.

The function of the guide containers 5 is to contain the tantalum markers 10 and direct them towards their definitive location in the surgical insert 2. During the insertion process, the mouth of the section 6 of the largest section of the corresponding guide container 5 must be oriented upwards , so that the tantalum marker 10 is guided to the section 7 of smaller diameter by gravity.

The thermal inserter, figure 5, consists of a piece of a thermally conductive material, for example of a metallic nature, and comprises a body 11 whose diameter is of equal diameter to that of section 6 of greater section of the guide containers 5, to fit tightly in said section, as shown in figure 8. This body is extended on one side in a heating head 12, which is located outside the guide container 5, while on the opposite side it is prolonged on a rod 13 of approximately equal diameter that of the inner section 7 of the guide containers 5, but of greater length, so that when the body 11 is coupled in a guide container 5, the rod 13 protrudes from the inner surface 9 of the corresponding conformation 4.

In the example shown in the drawings, the body 11 includes a core 14 from which a series of radial fins 15 protrude along the entire length of the core 14. These fins 15 delimit a contour of diameter coinciding with that of the section 6 of greater section of the guide containers 5. The fins 15 will serve to minimize thermal losses during the process of insertion of tantalum markers.

The free end of the rod 13 has at its end a hemispherical cavity of the same diameter as the tantalum markers 10 to be used. The external head 12 of the thermal inserter 3 will be configured so as to adapt to the heating device used in the process.

The surgical insert or prosthesis 2 will be made of a radiolucent material, not visible on radiographs, such as polyethylene.

The device of the invention, with the constitution described, is manually operated and allows precise positioning of spherical tantalum markers 10 in surgical inserts or prostheses 2, in order to allow biomechanical studies of the inserts by radiological techniques.

For the insertion of a marker 10 in a surgical insert or prosthesis 2, the adaptation of the insertion template 1 to the surgical insert 2 is started, which purpose is intended for the guide container or containers 5 to be placed in the desired position and orientation. of insertion with respect to the surgical insert 2, so that the mouth of the section 7 of the corresponding guide container is in contact with the surgical insert 2, as shown in Figure 7. The template 1 will hold the surgical insert 2 fixed, during the entire insertion process.

Next, the temperature of the thermal inserter 3 of Figure 5 will be raised, until reaching approximately 500 ° C, this heating can be carried out by means of a commercial system, for example a pyrograph, which will act as a system to grab and handle the inserter thermal, which can be manufactured to adapt, for example by threading, to the heating system. The inserter 3 is then introduced into the corresponding guide container 5, so that the cylindrical rod 13 of the insertor creates a channel 16 in the surgical insert 2, due to the temperature of the inserter 3, said channel 16 being of equal or slightly smaller diameter 16 than the diameter of the sphere 10, to ensure its retention. Finally, the inserter 3 of the guide container 5 is removed, and a marker 10 is placed inside said guide container which, by gravity, will reach the section of smaller section 7 of the container. Then the thermal inserter 3 is introduced again and by manually pressing on it, its total coupling is achieved in the guide container 5, pushing the rod 13 through its hemispherical end cavity 14 to the marker 1 to the insertion position shown in the Figure 8, where said marker is indicated by reference 10 '. Then, by manually removing the inserter 3, the marker 10 ’is secured and sealed inside the surgical insert 2.

All the components of the device of the invention can be sterilized and can be made of surgical stainless steel.

The device of the invention has been designed to employ commercial spherical tantalum markers. Depending on the diameter of the markers to be used, the hole 14 of the stem 13 of the thermal inserter 3 must be machined with the same diameter.

Claims (6)

1. Device for inserting tantalum markers into surgical inserts, characterized in that it comprises a template (1) for the surgical insert (2) and a thermal inserter (3) of the tantalum marker (10) in the surgical insert; whose template (1) has conformations (4) between which the surgical insert (2) is mounted and has at least one guide-container (5) for the tantalum marker (10), located in coincidence with at least one of the conformations (4) mentioned and leading to the surface of said conformation on which the surgical insert (2) rests; and whose thermal inserter (3) is constituted by a body (11) of thermally conductive material, of dimensions approximately equal to those of the guide-container, which extends on one side in a heating head (12) and the opposite in a rod (13) capable of protruding through the surface (9) of the conformation on which the surgical insert (2) rests and is topped at its free end in a recess (14) hemispherical of the same radius as the tantalum markers (10). 2. Device according to claim 1, characterized in that the guide-container 5 consists of a cavity made in at least one of the conformations (4) of the template (1), and comprises a section of greater section, adjacent to the surface external of said conformation, an internal section (7) of reduced section and adjacent to the internal surface of the conformation (4) on which the insert rests, and an intermediate transition section (8) of variable section between the sections of greater and smaller section cited. 3. Device according to claims 1 and 2, characterized in that the rod (13) of the thermal inserter (3) is of equal section to that of the inner section (7) of the cavity (5) constituting the guide-container and of longer than said cylindrical section. 4. Device according to claims 2 and 3, characterized in that the internal (7) and external (6) sections of the guide-container are cylindrical and the intermediate section (8) frustoconical; and because the stem (13) of the thermal inserter (3) is of circular section, equal to that of the inner section (7) of the guide container. 5. Device according to claim 1, characterized in that the body (11) of the thermal inserter comprises a central core (14), from which a series of radial fins (15) protrude along the length of the core and determine a diameter perimeter coinciding with that of the outer section (6) of the guide chambers (5). SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201130995 SPAIN Date of submission of the application: 06.15.2011 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61F2 / 30 (2006.01) RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

TO

FR 2908630 A1 (CREASPINE) 23.05.2008, one

page 1, line 26; page 3, lines 26-33; page 4, line 27 - page 5, line 5; page 6,

lines 20-33; figure 3.

TO

US 4349498 A1 (CARBOMEDICS INC.) 14.09.1982, one

column 1, line 53 - column 2, line 10; column 3, lines 14-51; claim 1; figures.

TO

WO 2010096927 A1 (HALIFAX BIOMEDICAL INC.) 02.09.2010, one

paragraphs [6-12], [20-23]; figures 1-2.

TO

ES 2274556 T3 (SCHNEIDER INC.) 05/16/2007, one

claims 22-24.

TO

US 2005234336 A1 (BECKMAN et al.) 20.10.2005, one

paragraphs [63], [81]; Figures 4A-6C.

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 04.04.2013

Examiner J. Square Prados Page 1/5

REPORT OF THE STATE OF THE TECHNIQUE Minimum documentation sought (classification system followed by classification symbols) A61F Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ, ECLA.  WRITTEN OPINION Date of Completion of Written Opinion: 04.04.2013 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-5 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-5 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base. This opinion has been made on the basis of the patent application as published. WRITTEN OPINION  1. Documents considered. The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

FR 2908630 A1 (CREASPINE) 05/23/2008

D02

US 4349498 A1 (CARBOMEDICS INC.) 14.09.1982

D03

WO 2010096927 A1 (HALIFAX BIOMEDICAL INC.) 02.09.2010

D04

ES 2274556 T3 (SCHNEIDER INC.) 05/16/2007

D05

US 2005 23336 A1 (BECKMAN et al.) 20.10.2005

 2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The application refers to a device for inserting tantalum markers into surgical inserts, intended to accurately position spherical tantalum markers on inserts of radiolucent materials, such as polyethylene, in any type of prosthetic system, in order to perform Biomechanical studies of the inserts by radiological techniques. Few examples of devices specifically designed for the purpose of the device of the application have been found in the state of the art, that is, for use in the insertion of radiopaque tantalum markers into surgical inserts. Although the incorporation of such markers in an insert or prosthesis is well known, the procedure or devices used for their incorporation are not usually required. Examples of prior art are documents D01 to D05 cited in the Report (IET). In the opinion of this Administration, these documents only show the general state of the art and are not considered of particular relevance. None of the documents cited in the EIT show or suggest the particular relationship of components that follows from the object of the main claim of the application. Document D01 shows a manufacturing process by coextrusion of a prosthesis, especially intervertebral, although it is applicable to any prosthesis (page 6, lines 30-31), formed by a transparent radio material and incorporating an insert of a radiopaque material, such as barium sulfate, although in the background the use of tantalum is cited as known in the art. This document also outlines a device for carrying out the manufacturing process (see figure 3 and associated description), which is only an example of the state of the art in relation to the object of the main claim of the application. Document D02 shows a method and a device for the insertion of one or several radiopaque markers, specifically citing the tantalum (column 3, line 41) in surgical prostheses. Although its validity is indicated for any type of prosthesis (column 3, lines 14-16, column 7, lines 43-45), its main use is envisaged in mobile pyrolytic carbon prostheses in the human body, such as valve prostheses cardiac The device shown in the application for insertion of the marker in the prosthesis is very different from that described in the main claim and only reflects an example of the state of the art. Document D03 illustrates an implant with a spherical radiopaque tantalum marker, but it does not clarify the procedure or the device used to place the marker on the implant, simply its pressure fixation is suggested (paragraph 21). It is therefore only a sample of the state of the art. Document D04 refers to bioabsorbable markers with radiopaque components (among many others, the tantalum is cited) for use in an implantable stent, such as a stent, and anticipates a procedure to modify an implantable stent in order to temporarily increase a visualization. thereof during its implantation, and after it, in a body lumen, comprising providing a stent intended for delivery to a treatment site within a body lumen; providing a radiopaque marker with a proximal end, a distal end and a thickness comprising a bioabsorbable material and a radiopaque material, and intended to degrade live; and before an implant of the stent, fix the radiopaque marker with respect to the stent in a way that facilitates the live location of the stent by fluoroscopic imaging of the marker. It is therefore a non-relevant example of the state of the art that includes a procedure for fixing a radiopaque marker (tantalum) in a stent, but no device specially designed for this procedure is anticipated.  WRITTEN OPINION Finally, document D05 is cited as an example illustrating the use of radiopaque markers (such as tantalum, see claim 4 or paragraph 81, for example) directly in regions of the human body, and includes a device for implanting these permanent markers in the site of an injury or tumor for, for example, its follow-up. It is also known to include radiopaque markers in the patient's own bone for in-vivo measurements by radiographs of the kinematics or biomechanics of bones, joints or associated implants. In D05 the marker is inserted into the body (paragraph 63) by a minimally invasive procedure using devices such as a catheter, an introducer or a similar insertion device such as an injector. Thus, D05 does not show a device for insertion of tantalum markers into surgical inserts such as that of the main claim and is cited only to illustrate the use of marker insertion devices in an area of the human body. Thus, none of the aforementioned documents anticipates all the features that limit the object of protection of the main claim. Thus, the documents cited only show the general state of the art, and are not considered of particular relevance. It would not be obvious for a person skilled in the art to apply the features included in the cited documents and arrive at the invention as disclosed in the first claim. Therefore, the object of this main claim meets the requirements of novelty and inventive activity. Dependent claims 2 to 5 delimit additional optional features and as the first general also meet the requirements regarding novelty and inventive activity.