Element for implantation in body tissue, particularly bone tissue

• US 4,330,891 A
• Filed: 02/28/1980
• Issued: 05/25/1982
• Est. Priority Date: 03/07/1979
• Status: Expired due to Term

• Current Assignee: Bo Thuresson Af Ekenstam, Per I. Branemark
• Original Assignee: Bo Thuresson Af Ekenstam, Per I. Branemark
• Inventors: Branemark, Per I., Thuresson af Ekenstam, Bo
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US06/125,654
• Time in Patent Office: 817 Days
• Field of Search: 3/1.9-1.913, 3/1, 128/92 C, 128/92 CA, 128/92 G
• US Class Current: 623/23.61
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/30107 using materials or accessories for preventing galvanic or electrolytic corrosion
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30838 Microstructures
• CPC Class Codes: A61F 2210/0009 using materials or accessories for preventing galvanic or electrolytic corrosion
• CPC Class Codes: A61L 2300/214 Amino acids
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

In an element for implantation in body tissue, particularly bone tissue, consisting of a biologically flawless material with a micro-pitted surface, the pores in the surface have a diameter many times smaller than has been previously known in order to permit the occurrence of such a tight and extensive boundary zone around the implanted element that this achieves reinforced and inextricable anchoring in the tissue. The pore diameter may be as little as about 10 nm and as large as a few multiples of the normal diameter of the cells in the tissue, preferably no larger than the cell diameter, i.e. about 1000 nm. Optimal results are obtained with pore diameters equal to or smaller than about 300 nm and a finely pored rutile layer has been found to give a particularly strong and durable joint with the growing tissue. Preferably at least one deposit of an agent facilitating and/or accelerating the growing-together process is arranged on or in the element. The element may be shaped with grooves, corrugations, channels etc. and be provided with an opening for tissue to grow through. The element is extremely suitable as anchoring device for a prosthesis or partial prosthesis and may be made integral therewith.

Claims

1. An element intended for implantation in bone tissue consisting of a biologically flawless material selected to avoid the occurrence of unsuitable electrical potential differences and galvanic currents in the implantation region, said element having a, micro-pitted surface intended to face the tissue in the implantation region of a patient, said micro-pitted surface has pits with a diameter in the range of from about 10 nm up to about 1000 nm.

2. An element according to claim 1, wherein said element includes at least one depot of at least one agent beneficial to the healing process of the body tissue on the element, said agent containing at least one of whole blood and plasma of said patient into whom the element is to be implanted by surgery.

3. An element according to claim 1, wherein said material is titanium having a decreasing oxygen content from a titanium dioxide micro-pitted surface inwardly.

4. An element according to claim 2, wherein said at least one depot is within said element beneath the surface thereof.

5. An element according to claim 2, wherein said agent is selected from a group consisting of substances having membrane effects, mineral substances, blood vessel-dilating substances, coagulation-regulating substances, vitamins and growth-promoting hormones.

6. An element according to claim 1, 2 or 3, wherein the pit diameter is up to about 300 nm.

7. An element according to any one of claims 1 to 3, wherein the surface consists substantially of a fine-pitted rutile layer.

8. An element according to any one of claims 1 to 3, wherein the surface has at least one groove, corrugation, channel or recess roughening the surface.

9. An element according to any one of claims 1 to 3, wherein at least one through opening is provided for tissue to grow through, said opening arranged in the element and being many times greater than the pit diameter.