USRE34037E - Support for biomedical implant device - Google Patents
Support for biomedical implant device Download PDFInfo
- Publication number
- USRE34037E USRE34037E US07/642,582 US64258291A USRE34037E US RE34037 E USRE34037 E US RE34037E US 64258291 A US64258291 A US 64258291A US RE34037 E USRE34037 E US RE34037E
- Authority
- US
- United States
- Prior art keywords
- implant device
- biomedical implant
- recited
- cuff
- drug
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
Definitions
- the present invention relates to a support for retaining biomedical implant devices such as a catheter for peritoneal dialysis, an extracorporeal shunt for hemodialysis, a tube for an ascites recirculation circuit, a drain tube, an air tube for an artificial heart, an electric circuit tube, and drug reservoir to be implanted under the skin.
- biomedical implant devices such as a catheter for peritoneal dialysis, an extracorporeal shunt for hemodialysis, a tube for an ascites recirculation circuit, a drain tube, an air tube for an artificial heart, an electric circuit tube, and drug reservoir to be implanted under the skin.
- the present invention relates to a support for such biomedical implant devices that manifests enhanced biocompatibility and which allows them to be retained in the body over a prolonged period without permitting bacterial ingress.
- a cuff which is used with a catheter for peritoneal dialysis.
- a catheter 1 is inserted through the skin 10 of the patient, the subcutaneous layer of fat 11, the fascia 12, the muscular tunic 13 and the peritoneum 14.
- the catheter 1 is retained in the body so as to permit injection or discharging of a dialyzing solution through the catheter 1.
- a cuff 2 attached to the catheter 1 is used as a support for functionally retaining the catheter 1 in the body over an extended period and is generally sutured in living tissues at the end of a surgical operation.
- the cuff 2 is typically made of such materials as knitted or unknitted fabrics of synthetic or natural fibers, plastic or plastic film.
- a reservoir 15 is implanted below the skin layer 10 and is composed of a drug cell 16. Holes 17 on projections guide a retaining thread (suture). The intended drug is injected into the cell 16 through a silicone or synthetic rubber wall 18.
- a silicon tube 19 serves as a passage for introducing the drug into the affected site of part of the body such as a blood vessel or muscle. Stability of the retained reservoir 15 is required for a prolonged period in order to allow for periodic supply of the drug into the reservoir through the wall 18 with syringe.
- a general object of the invention is to eliminate the above described problems in a biomedical implant device.
- a particular object, therefore, of the present invention is to provide a support for biomedical implant device that affords enhanced adhesion to tissues and allows the implanted biomedical device to be retained stably in the body without permitting bacterial ingress.
- Another object of the present invention is to provide a support which, in addition to the enhanced adhesion to surrounding tissues, permits the tissue to be anchored in the support, with subsequent increase in the stability of the support in the body.
- a further object of the present invention is to provide a support possessed of increased strength and enhanced adhesion to the biomedical implant device.
- a biomedical implant device having a support made of a biocompatible calcium phosphate compound as the material of the surface layer.
- the calcium phosphate material may be porous, thereby allowing anchoring of the tissue.
- the support is made in multiple layers.
- the porous or solid support may have in its surface many recesses formed by etching, ion milling or other techniques.
- FIG. 1 is a sketch of a conventional catheter with a cuff in the implanted state.
- FIG. 2 is a sketch of a conventional drug reservoir in the subcutaneously implanted state.
- FIGS. 3, 7, 8A and 8B and 9 are cross-sectional views of cuffs according to four embodiments of the present invention.
- FIGS. 4 to 6 are pictorial representations of supports for biomedical implant device in the state where they adhere to surrounding tissues.
- FIG. 10 is a sketch showing a cross section of the surface layer of a cuff according to a fifth embodiment of the present invention.
- FIGS. 11A and 11B are a plan and a cross-sectional view, respectively, of a drug reservoir to be implanted under the skin according to a sixth embodiment of the present invention.
- FIG. 3 shows a cuff 2 prepared in accordance with one embodiment of the present invention.
- a catheter 1 made of a plastic or some other suitable material is connected to the cuff 2 that is formed of a biocompatible calcium phosphate material such as sintered hydroxyapatite, bioglass or sintered tricalcium phosphate (TCP).
- the cuff 2 which is formed of sintered hydroxyapatite can be prepared from a hydroxyapatite powder by the following procedure.
- a hydroxyapatite powder comprising irregularly shaped particles of 0.1-1 ⁇ m in average size is blended with a hydroxyapatite powder comprising spherical particles of 2-20 ⁇ m in average size.
- the blend is intimately mixed with water and a blowing agent.
- the mix is expanded and dried in a thermostatic dryer.
- a suitable blowing agent is an aqueous solution of hydrogen peroxide or egg albumin.
- the so prepared porous hydroxyapatite is machined into a cuff-shaped structure which is fired at a temperature of 1,000°-1,250° C. to produce the intended cuff 2.
- the cuff has a porosity of 5-60%, preferably 20-40%, with the pore size being adjusted to 0.5-500 ⁇ m, preferably 5-200 ⁇ m.
- the value of the porosity is determined by comparing the density of the solid material with that of the porous material. The percentage difference is the porosity and represents generally the volume percentage of voids.
- the cuff 2 is then joined to a catheter 1 which is implanted in the body.
- Such a cuff exhibits good biocompatibility while it is being gradually fused to surrounding tissues with time. Any bacterial ingress that might occur via the outer surface of the catheter is completely prevented at least by the cuff 2, with the result that the catheter 1 can be stably retained in the body over a prolonged period.
- Adjustment of the porosity and pore size of the cuff to the above-specified values ensures spontaneous formation of small voids in its surface with the result that the effective surface area of the cuff 2 is sufficiently increased to provide enhanced adhesion to the surrounding tissues. If the porosity of the cuff is less than 5%, strong adhesion to the surrounding tissues is not attained. If the porosity exceeds 60%, the strength of the cuff 2 is drastically decreased. If the pore size of the cuff is less than 0.5 ⁇ m, tissue cells are unable to enter the cuff through voids. If the pore size exceeds 500 ⁇ m, the desired anchoring of tissues in the porous structure of the cuff cannot be attained.
- FIGS. 4, 5 and 6 show that the adhesion between the cuff and surrounding tissues increases as the porosity of the cuff increases. As can be seen from the comparison of FIG. 4 (20% porosity), FIG. 5 (30% porosity) and FIG. 6 (56% porosity), strong adhesion is imparted by the tissues (colored portion) penetrating into the sintered hydroxy apatite (white portion).
- FIGS. 7 shows a cuff according to a second embodiment of the present invention.
- a catheter 1 is connected to a cuff 2.
- the surface of the cuff 2 is provided with small projections 3 (5-1,000 ⁇ m in height) that are formed by cutting or some other machining technique.
- the cuff 2 having such small projections 3 on its surface serve as a brake or impediment resisting movement when it is implanted in the body. Therefore, the cuff 2 with the projections 3 allows the catheter 1 to be securely fixed in the body right after it has been implanted by a surgical operation.
- FIGS. 8A and 8B show a cuff according to a third embodiment of the present invention.
- a catheter 1 is connected to a cuff 2 that is provided with holes 3 for facilitating post-operational suturing. Two variations of such a cuff 2 are shown in the two drawings.
- FIG. 4 shows a cuff according to a fourth embodiment of the present invention.
- a catheter 1 is connected to a cuff 2 that is composed of a surface-layer portion 4 and an inner-layer portion 5.
- the surface-layer portion 4 is formed of a biocompatible calcium phosphate material having a comparatively high porosity.
- the inner-layer portions 5 is formed of a biocompatible calcium phosphate material having a comparatively low porosity.
- the inner-layer portion 6 may be formed on other materials such as titanium, alumina and plastics and, if plastic materials are used, greater facility is ensured when connecting the cuff 2 to the catheter 1.
- the advantage of this fourth embodiment is that the inner-layer portion 6 imparts a greater strength to the cuff 2 so that the catheter 1 can be stably retained within the body.
- FIG. 10 shows a cuff according to a fifth embodiment of the present invention.
- a catheter 1 is connected to a cuff 2 that is prepared from sintered hydroxyapatite which is surface-treated by etching or ion milling to form recesses 7 in its surface having diameters of 0.5-500 ⁇ m.
- the multiple recesses 7 help increase the surface area of the cuff 2 so as to provide further enhanced adhesion to surrounding tissues.
- the concept of this embodiment is applicable not only to the case where the cuff 2 has a solid structure but also to the case where it is made of a porous structure.
- the resulting cuff 2 provides not only good adhesion to surrounding tissues but also effective anchoring of the issue in the porous surface of the cuff 2, thereby ensuring greater stability of the catheter in the body.
- FIGS. 11A and 11B shows a drug reservoir to be implanted under the skin according to a sixth embodiment of the present invention.
- Components which are the same as those shown in FIG. 2 are identified by like numerals.
- the reservoir 15 is surrounded by a casing 20 that has holes 17 for suturing.
- the casing 20 is formed of a biocompatible calcium phosphate material. Any of the techniques employed in the above-described first to fifth embodiments is applicable to the casing 20 so that it will display sufficient biocompatibility and adhesion to the surrounding tissues to ensure that the reservoir 15 is stably retained in the body over a prolonged period.
- the support for biomedical implant device of the present invention is made of a biocompatible calcium phosphate material either entirely or at least in the part which is to contact surrounding tissues when the device is implanted in the body.
- the support has improved adhesion to the living tissues and allows the implanted biomedical device to be stably retained in the body without permitting bacterial ingress.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Abstract
Description
Claims (19)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP61-131570 | 1986-06-06 | ||
JP61131570A JPS6346171A (en) | 1986-06-06 | 1986-06-06 | Support of medical device stayed in living body |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/059,445 Reissue US4798585A (en) | 1986-06-06 | 1987-06-08 | Support for biomedical implant device |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE34037E true USRE34037E (en) | 1992-08-18 |
Family
ID=15061148
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/059,445 Ceased US4798585A (en) | 1986-06-06 | 1987-06-08 | Support for biomedical implant device |
US07/642,582 Expired - Lifetime USRE34037E (en) | 1986-06-06 | 1991-01-17 | Support for biomedical implant device |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/059,445 Ceased US4798585A (en) | 1986-06-06 | 1987-06-08 | Support for biomedical implant device |
Country Status (6)
Country | Link |
---|---|
US (2) | US4798585A (en) |
JP (1) | JPS6346171A (en) |
CA (1) | CA1261699A (en) |
DE (1) | DE3718963A1 (en) |
FR (1) | FR2599627B1 (en) |
GB (1) | GB2194151B (en) |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
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US5308338A (en) * | 1993-04-22 | 1994-05-03 | Helfrich G Baird | Catheter or the like with medication injector to prevent infection |
US5643278A (en) * | 1995-04-06 | 1997-07-01 | Leocor, Inc. | Stent delivery system |
US5690643A (en) * | 1996-02-20 | 1997-11-25 | Leocor, Incorporated | Stent delivery system |
US5707387A (en) * | 1996-03-25 | 1998-01-13 | Wijay; Bandula | Flexible stent |
US5741293A (en) * | 1995-11-28 | 1998-04-21 | Wijay; Bandula | Locking stent |
US5824059A (en) * | 1997-08-05 | 1998-10-20 | Wijay; Bandula | Flexible stent |
US5984967A (en) | 1995-03-27 | 1999-11-16 | Sdgi Holdings, Inc. | Osteogenic fusion devices |
US6203569B1 (en) | 1996-01-04 | 2001-03-20 | Bandula Wijay | Flexible stent |
US6206922B1 (en) | 1995-03-27 | 2001-03-27 | Sdgi Holdings, Inc. | Methods and instruments for interbody fusion |
US6340366B2 (en) | 1998-12-08 | 2002-01-22 | Bandula Wijay | Stent with nested or overlapping rings |
US6478783B1 (en) | 2000-05-26 | 2002-11-12 | H. Robert Moorehead | Anti-sludge medication ports and related methods |
US6613091B1 (en) | 1995-03-27 | 2003-09-02 | Sdgi Holdings, Inc. | Spinal fusion implants and tools for insertion and revision |
US20040068228A1 (en) * | 2002-10-04 | 2004-04-08 | Jon Cunningham | Device and method for stabilizing catheters |
US20040244819A1 (en) * | 2002-11-04 | 2004-12-09 | Edelmann David Charles | Systems and methods for controlling warewasher wash cycle duration, detecting water levels and priming warewasher chemical feed lines |
US20080262406A1 (en) * | 2007-04-23 | 2008-10-23 | Edward Lee Wiener | Securement device for shunt catheter and implantation method therefor |
Families Citing this family (72)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6346171A (en) * | 1986-06-06 | 1988-02-27 | 旭光学工業株式会社 | Support of medical device stayed in living body |
JP2683750B2 (en) * | 1988-06-06 | 1997-12-03 | 住友電気工業株式会社 | Catheter balloon |
DE8808701U1 (en) * | 1988-07-04 | 1989-08-03 | Mecron Medizinische Produkte Gmbh, 1000 Berlin | Endoprosthesis |
US5176638A (en) * | 1990-01-12 | 1993-01-05 | Don Michael T Anthony | Regional perfusion catheter with improved drug delivery control |
US5314471A (en) * | 1991-07-24 | 1994-05-24 | Baxter International Inc. | Tissue inplant systems and methods for sustaining viable high cell densities within a host |
CA2070816A1 (en) * | 1990-10-31 | 1992-05-01 | James H. Brauker | Close vascularization implant material |
US5344454A (en) * | 1991-07-24 | 1994-09-06 | Baxter International Inc. | Closed porous chambers for implanting tissue in a host |
US5545223A (en) * | 1990-10-31 | 1996-08-13 | Baxter International, Inc. | Ported tissue implant systems and methods of using same |
US5713888A (en) * | 1990-10-31 | 1998-02-03 | Baxter International, Inc. | Tissue implant systems |
US6773458B1 (en) | 1991-07-24 | 2004-08-10 | Baxter International Inc. | Angiogenic tissue implant systems and methods |
US5453278A (en) * | 1991-07-24 | 1995-09-26 | Baxter International Inc. | Laminated barriers for tissue implants |
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US5534031A (en) * | 1992-01-28 | 1996-07-09 | Asahi Kogaku Kogyo Kabushiki Kaisha | Prosthesis for spanning a space formed upon removal of an intervertebral disk |
US6001103A (en) * | 1992-03-10 | 1999-12-14 | Asahi Kogaku Kogyo Kabushiki Kaisha | Bone connector |
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US6156305A (en) * | 1994-07-08 | 2000-12-05 | Baxter International Inc. | Implanted tumor cells for the prevention and treatment of cancer |
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US5830539A (en) * | 1995-11-17 | 1998-11-03 | The State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of The University Of Oregon | Methods for functionalizing and coating substrates and devices made according to the methods |
US5848987A (en) * | 1996-04-30 | 1998-12-15 | Medtronic, Inc. | Microtextured catheter and method for preventing catheter fluid reflux |
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US8251986B2 (en) | 2000-08-17 | 2012-08-28 | Angiodynamics, Inc. | Method of destroying tissue cells by eletroporation |
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US6949251B2 (en) * | 2001-03-02 | 2005-09-27 | Stryker Corporation | Porous β-tricalcium phosphate granules for regeneration of bone tissue |
US6695920B1 (en) * | 2001-06-27 | 2004-02-24 | Advanced Cardiovascular Systems, Inc. | Mandrel for supporting a stent and a method of using the mandrel to coat a stent |
US6673154B1 (en) * | 2001-06-28 | 2004-01-06 | Advanced Cardiovascular Systems, Inc. | Stent mounting device to coat a stent |
US6994706B2 (en) | 2001-08-13 | 2006-02-07 | Minnesota Medical Physics, Llc | Apparatus and method for treatment of benign prostatic hyperplasia |
US7074276B1 (en) * | 2002-12-12 | 2006-07-11 | Advanced Cardiovascular Systems, Inc. | Clamp mandrel fixture and a method of using the same to minimize coating defects |
US7622070B2 (en) * | 2005-06-20 | 2009-11-24 | Advanced Cardiovascular Systems, Inc. | Method of manufacturing an implantable polymeric medical device |
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- 1987-06-05 GB GB8713181A patent/GB2194151B/en not_active Expired - Lifetime
- 1987-06-05 DE DE19873718963 patent/DE3718963A1/en active Granted
- 1987-06-08 CA CA000539118A patent/CA1261699A/en not_active Expired
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Cited By (24)
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US5308338A (en) * | 1993-04-22 | 1994-05-03 | Helfrich G Baird | Catheter or the like with medication injector to prevent infection |
US6613091B1 (en) | 1995-03-27 | 2003-09-02 | Sdgi Holdings, Inc. | Spinal fusion implants and tools for insertion and revision |
US6206922B1 (en) | 1995-03-27 | 2001-03-27 | Sdgi Holdings, Inc. | Methods and instruments for interbody fusion |
US6695851B2 (en) | 1995-03-27 | 2004-02-24 | Sdgi Holdings, Inc. | Methods and instruments for interbody fusion |
US6471724B2 (en) | 1995-03-27 | 2002-10-29 | Sdgi Holdings, Inc. | Methods and instruments for interbody fusion |
US7621958B2 (en) | 1995-03-27 | 2009-11-24 | Warsaw Orthopedic, Inc. | Methods and instruments for interbody fusion |
US5984967A (en) | 1995-03-27 | 1999-11-16 | Sdgi Holdings, Inc. | Osteogenic fusion devices |
US20090043394A1 (en) * | 1995-03-27 | 2009-02-12 | Thomas Zdeblick | Spinal fusion implants and tools for insertion and revision |
US20040097928A1 (en) * | 1995-03-27 | 2004-05-20 | Thomas Zdeblick | Interbody fusion device and method for restoration of normal spinal anatomy |
US7238186B2 (en) | 1995-03-27 | 2007-07-03 | Warsaw Orthopedic, Inc. | Interbody fusion device and method for restoration of normal spinal anatomy |
US6645206B1 (en) | 1995-03-27 | 2003-11-11 | Sdgi Holdings, Inc. | Interbody fusion device and method for restoration of normal spinal anatomy |
US20050192669A1 (en) * | 1995-03-27 | 2005-09-01 | Thomas Zdeblick | Spinal fusion implants and tools for insertion and revision |
US7985258B2 (en) | 1995-03-27 | 2011-07-26 | Warsaw Orthopedic Inc. | Methods and instruments for interbody fusion |
US5643278A (en) * | 1995-04-06 | 1997-07-01 | Leocor, Inc. | Stent delivery system |
US5741293A (en) * | 1995-11-28 | 1998-04-21 | Wijay; Bandula | Locking stent |
US6203569B1 (en) | 1996-01-04 | 2001-03-20 | Bandula Wijay | Flexible stent |
US5690643A (en) * | 1996-02-20 | 1997-11-25 | Leocor, Incorporated | Stent delivery system |
US5707387A (en) * | 1996-03-25 | 1998-01-13 | Wijay; Bandula | Flexible stent |
US5824059A (en) * | 1997-08-05 | 1998-10-20 | Wijay; Bandula | Flexible stent |
US6340366B2 (en) | 1998-12-08 | 2002-01-22 | Bandula Wijay | Stent with nested or overlapping rings |
US6478783B1 (en) | 2000-05-26 | 2002-11-12 | H. Robert Moorehead | Anti-sludge medication ports and related methods |
US20040068228A1 (en) * | 2002-10-04 | 2004-04-08 | Jon Cunningham | Device and method for stabilizing catheters |
US20040244819A1 (en) * | 2002-11-04 | 2004-12-09 | Edelmann David Charles | Systems and methods for controlling warewasher wash cycle duration, detecting water levels and priming warewasher chemical feed lines |
US20080262406A1 (en) * | 2007-04-23 | 2008-10-23 | Edward Lee Wiener | Securement device for shunt catheter and implantation method therefor |
Also Published As
Publication number | Publication date |
---|---|
GB8713181D0 (en) | 1987-07-08 |
DE3718963A1 (en) | 1987-12-10 |
FR2599627A1 (en) | 1987-12-11 |
CA1261699A (en) | 1989-09-26 |
GB2194151B (en) | 1991-01-30 |
US4798585A (en) | 1989-01-17 |
FR2599627B1 (en) | 1992-09-04 |
JPS6346171A (en) | 1988-02-27 |
DE3718963C2 (en) | 1991-05-29 |
GB2194151A (en) | 1988-03-02 |
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