# US 5,700,479 A · Surgical element and method for selective tissue regeneration

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- Number: US 5,700,479 A
- Document ID: US5700479A
- Status: Granted
- Kind: A
- Application number: 08/337,652
- Filed: 1994-11-10
- Granted: 1997-12-23
- Earliest claimed: 1988-12-23
- Assignees: Guidor AB
- Inventors: Dan Lundgren
- Web page: https://patentgrep.com/patent/US5700479A

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61C 8/00: Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools (fastening of peg-teeth in the mouth A61C13/30)
- A61C 8/0006: {Periodontal tissue or bone regeneration (support means for endoprosthetic bone substitute or bone graft implants A61F2/2846)}
- A61C 8/0009: {Consolidating prostheses or implants, e.g. by means of stabilising pins (A61C8/0031 takes precedence)}
- A61F 2/0059: {Cosmetic or alloplastic implants (A61F2/10 - A61F2/16, A61F2/28 take precedence)}
- A61F 2/2846: {Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006)}
- A61F 2/30907: {Nets or sleeves applied to surface of prostheses or in cement}
- A61K 6/50: Preparations specially adapted for dental root treatment
- A61L 31/10: Macromolecular materials
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61F 2/30724: {Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity}
- A61F 2/30749: {Fixation appliances for connecting prostheses to the body}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30909: {Nets}
- A61F 2002/30914: {Details of the mesh structure, e.g. disposition of the woven warp and weft wires}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2002/30971: {Laminates, i.e. layered products}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2240/001: Designing or manufacturing processes
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/414: Growth factors
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2430/12: for dental implants or prostheses
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A surgical element for guided and controlled tissue regeneration and method for selective tissue regeneration. The elements disclosed include embodiments containing protrusions on at least one side of a sheet of element material for separating the implanted element from an adjacent surface, and other embodiments comprising multiple layers of element material with internal spacer means separating the layers. Also disclosed is a method for treating supporting tissues adjacent to teeth and dental implants, the method comprising the use of a surgical element for selected influence on the growth of alveolar bone and periodontal ligament tissues.

## Claims

### Claim 1

An article adapted for selectively-guided tissue regeneration in the treatment of a periodontal defect adjacent to the root of a tooth, said article comprising
(a) an element comprising a first sheet portion and a second sheet portion, said first portion having a first surface adapted to face towards said root, and having an outer surface, said first portion being adapted to be disposed adjacent said root at the site of said defect, said first portion having a coronal end and an apical end;
(b) said second portion having an inner surface and an outer surface, said inner surface being opposite and essentially parallel to said outer surface of said first portion;
(c) at least one of said portions comprising a plurality of perforations;
(d) said element further comprising first spacing means located between said outer surface of said first portion and said inner surface of said second portion, said first spacing means being adapted to maintain said first portion and said second portion in essentially parallel relationship, thereby creating a first space, said first space being adapted to permit ingrowth of new connective tissue thereinto through said perforations; and
(e) said element further comprising second spacing means, said second spacing means being adapted to create and maintain a second space between said root and said first surface, said second space having sufficient width perpendicular to the longitudinal axis of said root to permit ingrowth into said second space of periodontal ligament tissue.

### Claim 2 (depends on 1)

The article of claim 1 further comprising tightly applying means adapted to permit the coronal end of said inner surface to be tightly applied to the surface of said root.

### Claim 3 (depends on 2)

The article of claim 2, wherein said tightly applying means comprises a hollow channel extending across the width of said first portion near its coronal end, said channel having an outer boundary and being adapted to have disposed therein an anchoring ligature, said ligature being adapted when under tension to compress said inner surface tightly against the surface of said root.

### Claim 4 (depends on 3)

The article of claim 3, wherein said ligature is displaceable longitudinally in said channel.

### Claim 5 (depends on 1)

The article of claim 1, wherein said first portion has a variable stiffness.

### Claim 6 (depends on 1)

The article of claim 1, wherein said second portion has a variable stiffness.

### Claim 7 (depends on 1)

The article of claim 1, wherein said first spacing means comprises spacers having the shape of a truncated cone.

### Claim 8 (depends on 1)

The article of claim 1, wherein said second spacing means comprises second spacers having a rectangular ross-section.

### Claim 9 (depends on 8)

The article of claim 8, wherein said second spacers are located in a uniform pattern.

### Claim 10 (depends on 1)

The article of claim 1, wherein said second spacing means comprises second spacers having a rectangular cross-section, and said first spacing means comprises first spacers having the shape of a truncated cone.

### Claim 11 (depends on 10)

The article of claim 10, wherein a majority of said first spacers and said second spacers are centered opposite one another.

### Claim 12 (depends on 1)

The article of claim 1, wherein said perforations are in said second portion and are rectangular.

### Claim 13 (depends on 1)

The article of claim 1 wherein both of said portions have a plurality of perforations.

### Claim 14 (depends on 13)

The article of claim 13, wherein the perforations in said first portion are circular.

### Claim 15 (depends on 13)

The article of claim 13, wherein the cross-sectional area of individual perforations in said first portion is uniform and smaller than the cross-sectional area of individual perforations in said second portion.

### Claim 16 (depends on 1)

The article of claim 1, wherein said first portion and said second portion are integral.

### Claim 17 (depends on 3)

The article of claim 3, wherein said first spacing means comprises first spacing members having the shape of a truncated cone, and at least one of said first spacing members comprises a portion of said boundary of said hollow channel.

### Claim 18 (depends on 3)

The article of claim 3, wherein said first portion further comprises a rib extending longitudinally across the width of said inner surface of said first portion near the coronal end thereof, and said rib defining a portion of said outer boundary of said hollow channel.

### Claim 19 (depends on 3)

The article of claim 3 wherein the coronal end of said first surface further comprises a rib extending across the width of said first surface, said rib being adapted to be, in use, positioned against the surface of said root slightly apical to the cervix of said tooth.

### Claim 20 (depends on 19)

The article of claim 19, wherein said rib is continuous.

### Claim 21 (depends on 1)

The article of claim 1, wherein said element is biodegradable.

### Claim 22 (depends on 1)

The article of claim 1, wherein said further element comprises at least one biofunctional substance.

### Claim 23 (depends on 1)

A method of providing selective influence on tissue regeneration in the vicinity of a periodontal defect, said method comprising the steps of
(a) separating soft tissue from at least a portion of the surface of a root of a tooth located at said defect, said portion comprising that area of said root surface located adjacent said defect; and
(b) affixing to said root surface an article as defined in claim 1, said article being affixed near or slightly apical to the cervix of said root, and tightly affixing said article to prevent the growth in an apical direction of soft tissue along said root surface.

### Claim 24

An article adapted for selectively-guided tissue regeneration in the treatment of a periodontal defect adjacent to the root of a tooth, said article comprising: an element comprising a first sheet portion and a second sheet portion, said first sheet portion having a first surface adapted to face towards said root, and having an outer surface, said first sheet portion being adapted to be disposed adjacent said root at the site of said defect, said first portion having a coronal and an apical end; said second sheet portion having an inner surface and an outer surface, said inner surface being opposite and essentially parallel to said outer surface of said first sheet portion; at least one of said portions comprising a plurality of perforations; said element further comprising a plurality of first spacers located between said outer surface of said first sheet portion and said inner surface of said second sheet portion, said first spacers being adapted to maintain said first sheet portion and said second sheet portion in essentially parallel relationship, thereby creating a first space, said first space being adapted to permit ingrowth of new connective tissue thereunto through said perforations; and said element further comprising a plurality of second spacers affixed to said inner surface of said first sheet portion and adapted to create and maintain a second space between said root and said first surface, said second space having sufficient width perpendicular to the longitudinal axis of said root to permit ingrowth into said second space of periodontal ligament tissue.

### Claim 25 (depends on 24)

The article of claim 24, wherein at least a portion of said first spacers are affixed to or integral with said outer surface of said first sheet portion.

### Claim 26 (depends on 24)

The article of claim 24 wherein the length and/or the cross-sectional area of individual members of said first spacers differ from the length and/or cross-sectional area of individual members of said second spacers.
