Resorbable implantable device for the reconstruction of the orbit of the human skull

• US 5,383,931 A
• Filed: 01/03/1992
• Issued: 01/24/1995
• Est. Priority Date: 01/03/1992
• Status: Expired due to Term

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Hehli, Markus, Gogolewski, Sylwester, Perren, Stephan M.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Brittingham, Debra
• Application Number:
  US07/817,472
• Time in Patent Office: 1,117 Days
• Field of Search: 623/4, 623/16, 623/18
• US Class Current: 623/17.18
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2878 for orbital repair
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30708 Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2002/3071 Identification means; Administration of patients
• CPC Class Codes: A61F 2002/3096 trimmed or cut to a customised size
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0084 Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2250/0089 : coded with symbols, e.g. dots, numbers, letters, words
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A device for the reconstruction of the orbit of the skull is described. The device is produced from biocompatible polymeric preferably from resorbable polymers having a shape of nonporous and/or microporous plates, membranes or films. The device is preshaped into a three-dimensional element to fit into the orbit of the human skull. Fixation elements with holes being integral part of the device, allow attachment of the device to the skull. Anatomical cuts in the body of the device allow through the nerves and vessels of the eye. An oblong shape of the edges of the anatomical cuts, protects the nerves and vessels from being damaged when the nerves and vessels rub against the edge surface.

Claims

1. An implantable device for reconstructing an orbit of a human skull comprising:

a. a flat flexible element having a shape which is approximately the shape of a developed curved surface of a frustum of a cone, said surface having a circularly curved bottom rim and a smaller circularly curved top rim;

b. said element having an indentation in the top rim adapted to receive eye vessels and muscles;

c. said element being made of a material selected from the group consisting of a biocompatible polymeric material and a biocompatible polymeric-ceramic material; and

d. said element being three dimensionally shapable and trimmable to form a longitudinally slit curved surface for implantation and adaptation into the skull orbit to be reconstructed.

2. A device according to claim 1 in which said material is resorbable.

3. A device according to claim 2 in which said material is a polylactide.

5. A device according to claim 1 in which said material has pores in a size range of 0.1 to 500 μ

m, and a porosity below 85%.

6. A device according to claim 5 in which the pore size is 5 to 50 μ

m.

7. A device according to claim 1 in which said material has:

a molecular weight in a range of 15,000 to 1,000,000 and;

a polydispersity in a range of 1.0 to 100 .

8. A device according to claim 1 having a tensile strength at break of 20 MPa to 5 GPa.

9. A device according to claim 1 in which said element has a thickness of 0.1 to 3.0 mm.

10. A device according to claim 11 in which said material carries bone morphogenetic protein.

11. A device according to claim 1 in which said material is degradable.

12. A device according to claim 11 in which said material has a molecular weight of 150,000 to 400,000 and a polydispersity 1.1 to 4.5.

13. A device according to claim 1, wherein said material has a resorption rate of at least four months.

14. A device of claim 1, wherein said material has a resorption rate of at least 7 months.

15. A device according to claim 1 having a tensile strength at break of 50 MPa to 600 MPa.

16. A device according to claim 1 in which the element has a thickness of 0.2 to 2.0 mm.

17. A device according to claim 1 in which said material is selected from the group consisting of non-oriented polymers, oriented polymers having uniaxial orientation and oriented polymers having biaxial orientation.

18. A device according to claim 1 in which said material carries antibacterial drugs.

4. A device according to claim 4 in which said bottom rim is provided with straps of the same material as said element having holes for receiving fixation devices.