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WO1995021581A1 - Dispositif interne de remplacement de tissu visible au rayon-x - Google Patents

Dispositif interne de remplacement de tissu visible au rayon-x Download PDF

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Publication number
WO1995021581A1
WO1995021581A1 PCT/CA1995/000050 CA9500050W WO9521581A1 WO 1995021581 A1 WO1995021581 A1 WO 1995021581A1 CA 9500050 W CA9500050 W CA 9500050W WO 9521581 A1 WO9521581 A1 WO 9521581A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
array
ray
replacement device
calcium
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.)
Ceased
Application number
PCT/CA1995/000050
Other languages
English (en)
Inventor
Douglas Diethard Wing Wendler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to AU15303/95A priority Critical patent/AU1530395A/en
Publication of WO1995021581A1 publication Critical patent/WO1995021581A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • This invention relates to the design of internal artificial tissue replacement devices and particularly to the placement of an X-ray identifiable array on the inner surface of the encapsulating shell of an internal artificial tissue replacement device.
  • Cancer treatment can include the removal of tissue which contain cancer cells.
  • the loss of tissue due to cancer treatment can be functionally and aesthetically displeasing.
  • artificial devices may be placed internally to offset the effects of tissue loss. Once in place however, it is difficult to monitor the position within the body or the structural integrity of the device.
  • a mastectomy causes a noticeable loss of tissue.
  • reconstructive mammaplasty to replace to tissue lost from the mastectomy operation
  • an artificial device to replace the tissue below the skin.
  • Silicone gel filled implants are often used for this purpose. Saline filled and multi-chamber implants are examples of other devices also used in reconstructive mammaplasty.
  • the artificial devices in reconstructive mammaplasty are often filled with silicone gel, as silicone is generally thought to be biocompatible inside the human body. Once the implant is inside a person, it is difficult to monitor the integrity of the outer cross- linked silicone shell which encapsulates the implant. Rupture of this cross-linked silicone outer shell can enable the silicone gel contents of the implant to move freely through the body.
  • the specific side effects of free silicone gel inside the body are unknown, and are still under study, but never the less this situation must be avoided if possible.
  • the implant would be viewable with a standard chest X-ray machine.
  • chest X-ray machines are accessible in health care institutions in metropolitan and rural locations. Chest X-ray machines and technicians are widely available, less expensive, and take less time to obtain data on a patient with implants.
  • the data from the X- ray can be used to construct a three dimensional representation of the implant, with possible ranges of the current shape of the outer cross linked shell. If the computer image is compared to data recorded from the initial installation of the implant the accuracy of a diagnoses can be enhanced.
  • MRI provides a proven ability to diagnose silicone gel mammary prosthesis.
  • the level of success obtainable by the array is unknown at this time, but information provided by the array is useful in that it can provide timely information about the structure of the implant.
  • the drawings will describe an pear shaped implant placed on the chest of a patient outside the ribcage and below the skin tissue layer.
  • the small end of the implant will be place closest to the head of the patent and will be labelled as the 90 "top” of the implant.
  • the wide end of the implant will be placed closest to the feet of the patient and be labelled “bottom” for the orientation of the implant.
  • the length of the pear will be oriented from top to bottom with the "front” being the surface farthest away from the ribcage of the patient, and the "back” being the surface closest to the 95 rib cage of the patient.
  • Figure 1 is the "front” view of an implant
  • Figure 2 is a “side” view of the implant across the “bottom” of an implant
  • Figure 3 is a “side” view from “top” to “bottom”
  • Figure 4 is a cross 00 sectional view along line 1 ,1 in Figure 1.
  • Figures 5, 6, and 7 illustrate a different embodiment of the array.
  • the breast implant illustrated consists of a cross-linked silicone outer shell A which encapsulates the silicone gel contents C of the implant.
  • the cross-linked silicone shell A can also be composed of 05 a different compound, but should have the properties to keep the silicone gel from leaking out, be biocompatible and have some flexibility to move with the body of the patient.
  • Calcium spheres B are embedded in the cross-linked silicone outer shell A, and are placed over the entire cross-linked silicone shell A in the grid like array as 10 shown in figures 1 , 2, and 3.
  • the calcium spheres B can be composed of other materials which block, diffract, or absorb X-rays.
  • the purpose of the calcium spheres B are that they, when bombarded by X-ray radiation, will individually show up on an X-ray detecting or sensitive medium.
  • the fact that these calcium spheres 15 B will be displayed on the X-ray detecting medium will allow the outer shell of the breast implant to be evaluated for integrity.
  • the resulting display of the calcium spheres B gives a physician more information about the integrity of the implant.
  • a chest X-ray shortly afterwards will result in a reference X-ray 20 of the intact implant which can be used as a reference point to compare future X-ray examinations. If for instance it is apparent that there is a calcium sphere B missing, or that there is more space between two adjacent calcium spheres B than there should be, than the physician can call for further tests to verify the presence of a 25 rupture in the outer shell A of the implant.
  • the calcium spheres B will show up white on an X-ray.
  • the bones of the patient are also composed of calcium, but they tend to appear grey on an X-ray. Due to the different contrast between the bones of the patient an the calcium spheres B, the array can be
  • figure 2 line 2,2 represents the line dividing the top and bottom sections of the implant. As it can be seen in figure 2 the array of calcium spheres B in the top section are offset from the array of calcium spheres B in the bottom section. Similarly in Figure 3 line 3,3 represents the division of the top and bottom sections along the side
  • Figure 4 is a cross section through line 1 ,1 of figure 1.
  • the cross section illustrated by figure 4 shows that the calcium spheres B are contained within the cross-linked encapsulating shell A of the implant and do not come in direct contact with the silicone gel C of
  • the pear shaped implant generally is also designed with a flat or shallow convex back side which will keep the implant in a consistent front, back orientation once inside the patient. This consistent orientation of the pear shape implant will have the same surface as the front at
  • Figures 5, 6, and 7 illustrate how the array could be placed on a pancake shaped implant.
  • Figure 5 represents the "front" surface of
  • Figure 7 represents the view taken of both arrays superimposed on one another. As it is represented in Figure 7 the "front” and "back"
  • the X-ray blocking, diffracting, deflecting, or absorbing spheroid masses are depicted as being the calcium spheres B.
  • Calcium is a good example of a material to be used in the array as it has all of the properties required of a material for this purpose.
  • the properties of a material for use in the array are as 190 follows:
  • Heavy metals can be put into compounds which meet the above requirements, but may not be practical in the day to day operations 200 of the patient. Day to day examples such as airport metal detectors may discourage the use of heavy metals.
  • the disadvantages of the array in general are that if the patient has silicosis, or another lung condition which causes the lungs to show up as a white cloud, the array will not show through the cloud 205 around the lung area.
  • the calcium spheres B will move closer together, and it will be difficult to tell if the closeness of spheres is caused by a fold or a rupture.
  • the calcium spheres B will interfere with other objects which need to be 210 viewed by a chest X-ray.
  • This invention is designed to be integrated into the production of artificial tissue replacement devices.
  • This invention could be used in artificial hearts, mammary prosthesis, and other such tissue replacement devices as they become available.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

On place un réseau de masses (B) constituées d'un composé bloquant, diffractant, défléchissant ou absorbant les rayons-X, dans la couche de l'enveloppe capsulaire (A) d'un dispositif interne artificiel de remplacement de tissu, lequel, lorsqu'il est bombardé par des rayons-X, est reproduit sur un support de détection de rayons-X.
PCT/CA1995/000050 1994-02-08 1995-01-31 Dispositif interne de remplacement de tissu visible au rayon-x Ceased WO1995021581A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU15303/95A AU1530395A (en) 1994-02-08 1995-01-31 The x-ray visible internal tissue replacement device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CA2,114,927 1994-02-08
CA002114927A CA2114927A1 (fr) 1994-02-08 1994-02-08 Dispositif de remplacement tissulaire radio-opaque

Publications (1)

Publication Number Publication Date
WO1995021581A1 true WO1995021581A1 (fr) 1995-08-17

Family

ID=4152854

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA1995/000050 Ceased WO1995021581A1 (fr) 1994-02-08 1995-01-31 Dispositif interne de remplacement de tissu visible au rayon-x

Country Status (3)

Country Link
AU (1) AU1530395A (fr)
CA (1) CA2114927A1 (fr)
WO (1) WO1995021581A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014127132A1 (fr) * 2013-02-14 2014-08-21 Allergan, Inc. Procédés pour augmenter ou reconstruire un sein humain

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0177288A2 (fr) * 1984-10-03 1986-04-09 Baylor College of Medicine Prothèse mammaire avec marquage et méthodes pour détecter et prédire la rupture de la prothèse
US4863470A (en) * 1985-03-19 1989-09-05 Medical Engineering Corporation Identification marker for a breast prosthesis
DE3902249A1 (de) * 1989-01-26 1990-08-02 Bodenseewerk Geraetetech Verfahren zur festlegung der lage von vorgegebenen stellen im menschlichen koerper
WO1994023649A1 (fr) * 1993-04-13 1994-10-27 Mallinckrodt Medical, Inc. Particules traitees contenant du calcium/des oxyanions pour l'imagerie medicale diagnostique

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0177288A2 (fr) * 1984-10-03 1986-04-09 Baylor College of Medicine Prothèse mammaire avec marquage et méthodes pour détecter et prédire la rupture de la prothèse
US4863470A (en) * 1985-03-19 1989-09-05 Medical Engineering Corporation Identification marker for a breast prosthesis
DE3902249A1 (de) * 1989-01-26 1990-08-02 Bodenseewerk Geraetetech Verfahren zur festlegung der lage von vorgegebenen stellen im menschlichen koerper
WO1994023649A1 (fr) * 1993-04-13 1994-10-27 Mallinckrodt Medical, Inc. Particules traitees contenant du calcium/des oxyanions pour l'imagerie medicale diagnostique

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014127132A1 (fr) * 2013-02-14 2014-08-21 Allergan, Inc. Procédés pour augmenter ou reconstruire un sein humain

Also Published As

Publication number Publication date
CA2114927A1 (fr) 1995-08-09
AU1530395A (en) 1995-08-29

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