METHOD FOR PRODUCING A MEDICAL IMPLANT

Abstract

A method for the production of a medical implant, comprising a head section, which has at least one blind hole-type recess of an electrical plug-in contact socket, along which is arranged at least one electrically conductive contact element, together with a supply section, which is fixedly connected to the head section, and which comprises at least one electrical component, which is one of at least one microcontroller, and an electrical energy source, which are electrically connected to the at least one electrically conductive contact element by way of at least one electrical conductor structure.

Claims

1-9: (canceled)

10. A method for the production of a medical implant, having a head section, including at least one blind hole recess electrical plug-in contact socket, containing at least one electrically conductive contact element, and a supply section, connected to the head section which includes at least one electrical component, that is electrically connected to the at least one electrically conductive contact element by at least one electrical conductor, comprising: producing a fixing plate composed of a curable casting compound having an upper plate face and a lower plate face which the at least one electrical conductor is fixed and projects through the plate upper and lower faces; positioning the fixing plate in a casting mold with the lower face forming part of a surface of the casting mold; establishing electrical contact between at least one electrical conductor structure and the at least one electrical component, as part of a surface partially bounding the casting mold; and producing the supply section by encapsulating the at least one electrical component and the at least one electrical conductor structure which projects beyond the lower face of the plate in a curable casting compound which forms a material bond with the lower face of the fixing plate.

11. A method according to claim 10, comprising: producing the fixing plate by casting with the curable casting compound being introduced into a plate casting mold.

12. A method according to claim 11, wherein: the casting mold penetrates the at least one electrical conductor structure, while the casting process is being carried out.

13. A method according to claim 12, wherein: at least one hole is introduced into a cured fixing plate through which the electrical conductor structure passes and which is fixed in the hole by an adhesive.

14. A method according to claim 10, wherein: the at least one electrically conductive structure projects beyond the plate upper face, is electrically connected to the at least one electrically conductive contact element, and the at least one electrically conductive contact element is fixedly to the fixing plate.

15. A method according to claim 10, wherein: electrically conductive contact elements are contact ring elements which alternate in a coaxial and in an axial serial sequence with electrically insulating elastically deformable sealing rings, and are a force fit to one another with an axial clamping force; the contact ring elements and sealing ring elements are arranged in a coaxial and axially serial sequence after electrical contact has been established between the contact ring elements with at least one electrical conductor projecting beyond the plate upper face and are fixedly connected to the upper face of the fixing plate.

16. A method according to claim 14, wherein: the production of the supply section and the at least one electrically conductive contact element are electrically connected to the electrical conductor structure, are encapsulated in the curable casting compound forming the head section, with a material bond being formed with the upper face of the fixing plate.

17. A method according to claim 10, comprising: using a biocompatible epoxy resin as the casting material.

18. A method according to claim 10, wherein: supply section is an implantable medical device which functions as a pulse generator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Without any limitation of the general concept of the invention, the invention is described in an exemplary manner below by way of examples of embodiment, with reference to the drawings. Here:

[0024] FIG. 1 shows an Illustration of a medical implant designed in accordance with the invention;

[0025] FIG. 2 shows an Illustration of a fixing plate with protruding electrical conductor structures;

[0026] FIG. 3 shows a casting mold for the production of the supply section;

[0027] FIG. 4 shows the electrical connection of the electrical conductor structures to an arrangement of contact ring elements; and

[0028] FIG. 5 shows an illustration of the production of the casting compound for the head section.

DETAILED DESCRIPTION OF THE INVENTION

[0029] FIG. 1 shows a medical implant 1 manufactured in accordance with the invention, comprising a head section 2, a supply section 3, and a fixing plate 4, the upper face 4′ of which is joined to the head section 2, and the lower face 4″ of which is joined to the supply unit 3 by material bonding, which is monolithical.

[0030] The head section 2 has a blind hole-type recess 5 providing an electrical plug-in contact socket, along which are arranged electrical contact elements 6 in the form of contact ring elements in a serial sequence, in each case axially spaced apart by interposed electrically insulating sealing rings 7. The serial sequence of contact ring elements 6 and sealing rings 7 is subjected to an axial clamping force F, by means of which the contact ring elements 6 and the sealing rings 7 are clamped together in a manner impermeable to fluids. For the electrical signal and energy supply, the electrical contact ring elements 6 are connected by way of wire-type electrical conductor structures 8 to a microcontroller 9 introduced within the supply section 3, and to an electrical energy source 10 electrically connected to the microcontroller 9. The electrical energy source 10 can be designed as a battery, accumulator, biofuel cell, or in the form of an inductive coupling loop for a contactless inductive transfer of energy. Needless to say, alternative or further electrical components can be included in the supply section 1.

[0031] All components of the medical implant 1 are in each case encapsulated in a biocompatible casting compound monobloc, which preferably is a plastic or resin compound, and most preferably is an epoxy resin compound.

[0032] For the production of the medical implant 1 illustrated in FIG. 1, the fixing plate 4 is manufactured from a biocompatible casting compound in the course of a casting process as shown in FIG. 2, wherein the wire-form electrical conductor structures 8 project through the fixing plate 4 orthogonally with respect to the top 4′ and bottom 4″ of the plate. Optionally, a mechanical connecting means 11 is introduced within the fixing plate 4, preferably in the form of a threaded nut with a screw that can be introduced therein, for the stationary fixing of the head section-side serial sequence of sealing rings 7 and contact ring elements 6. In this respect see also the contact ring/sealing ring element arrangement 14 in FIG. 14, which can be equipped with an appropriate mechanical holder (not shown), for an additional fixing to the fixing plate 4 by a screw connection 11.

[0033] The fixing plate 4, which is designed as a separate semi-finished product, with the wire-form electrical conductor structures 8 attached therein, serves furthermore as part of the surface of a casting mold 12 for the production and design of the supply section 3. First of all, it is necessary to electrically connect the electrical conductor structures 8, which protrude beyond the plate lower face 4″, to the microcontroller 9 shown, as well as to the electrical energy source 10. The electrical connections can be made before or after the insertion of the fixing plate 4 into the casting mold for forming a boundary for the latter.

[0034] FIG. 3 shows the fixing plate 4 inserted into the casting mold 12, of which the lower face of the plate 4″ is capable of bounding the interior of the casting mold 12 in a manner impermeable to fluids. In what follows, the casting mold 12 is completely filled with a biocompatible curable casting compound. The biocompatible curable casting compound used for filling the casting mold 12 is identical to that of which the fixing plate 4 is made, so that a materially bonded, monolithic connection is formed between the lower face 4″ of the fixing plate 4 and the casting compound.

[0035] Following the casting process, electrical contacts are established between the electrical conductor structures 8 projecting beyond the upper side 4′ of the fixing plate 4 and the contact ring elements 6, as shown in FIG. 4.

[0036] The axial stacking arrangement 14 illustrated in FIG. 4, has electrical contact ring elements 6 and interposed sealing rings 7, which is a semi-finished product, with a rod-shaped assembly tool 13, along which the electrically conductive contact ring elements 6, and the interposed electrically insulating sealing rings 7, made of an elastomeric material, are arranged in an axially alternating sequence. On both sides of the axial stacking arrangement 14, composed of the alternating sequence of contact ring elements 6 and sealing rings 7, fastening means 15 and 16 are in each case attached along the rod-shaped assembly tool 13. In the case of the fastening means 16 shown in FIG. 4, this takes the form of a mechanical stop which is integrally connected to the assembly tool 13, which is otherwise rod-shaped in design. The stop is designed in the form of a plate or disc, to which the axial stacking arrangement 14 is directly adjacent on one side. The fastening means 15, which is arranged opposingly to the stop along the axial stacking arrangement 14, is designed to be axially movable along the rod-shaped assembly tool 13, and also has a locking mechanism, which is capable of fixing the fastening means 15 in an axially secure manner relative to the rod-shaped assembly tool. The fastening means 15 preferably takes the form of a nut or a plate with an internal thread, which engages with an external thread (not shown), provided at one end along the rod-shaped assembly tool 13.

[0037] In order to apply the clamping force, oriented axially to the rod-shaped assembly tool 13, which clamps the alternating sequence of contact ring elements 6 and sealing rings 7 in a force-fit with, or against, each other, it is necessary to rotate the assembly tool 13 relative to the fastening means 15, for example by completely screwing the assembly tool-side external thread into the internal thread of the fastening means 15, as a result of which a defined clamping force acting along the contact ring elements 6 and sealing rings 7 seated on the assembly tool 13 is established.

[0038] The axial stacking arrangement 14 shown in FIG. 4 represents a semi-finished product that can be handled separately, which is inserted into a casting mold 17 as shown in FIG. 5 after appropriate electrical contacts have been established between the electrical conductor structures 8 and the electrical contact ring elements 6. The casting mold 17 is, as in the case of the casting process according to FIG. 3, partially bounded by the fixing plate 4, which is integrally connected to the casting compound on the supply section-side, i.e. the upper face 4′ of the fixing plate 4 closes off the rest of the casting mold 17 in a manner impermeable to fluids. The casting process takes place in the same manner, with the use of the same solidifiable casting compound, as that with which the fixing plate 4 and the cast body of the supply section 3 are made.

[0039] After the head section-side casting compound has solidified, the medical implant 1 can be removed from the casting mold 17, and the assembly tool 13 can be separated from the fastening means 15 by rotation. The clamping force prevailing axially between the contact ring elements 6 and the sealing rings 7 is supported and conserved by the head section-side solidified casting compound. As an alternative to the procedure as explained above, it is also possible to carry out the casting procedure shown in FIG. 5 before, or at the same time as, the casting procedure for the production of the supply section 3 shown in FIG. 3.

LIST OF REFERENCE SIGNS

[0040] 1 Medical implant [0041] 2 Head section [0042] 3 Supply section [0043] 4 Fixing plate [0044] 4′ Plate upper face [0045] 4″ Plate lower face [0046] 5 Blind hole-type recess [0047] 6 Electrically conductive contact element, contact ring element [0048] 7 Sealing ring [0049] 8 Electrical conductor structure [0050] 9 Microcontroller [0051] 10 Electrical energy source, battery [0052] 11 Mechanical fastener [0053] 12 Casting mold [0054] 13 Assembly tool [0055] 14 Stacking arrangement [0056] 15, 16 Fastening means [0057] 17 Casting mold