CA2114927A1 - X-ray visible tissue replacement device - Google Patents
X-ray visible tissue replacement deviceInfo
- Publication number
- CA2114927A1 CA2114927A1 CA002114927A CA2114927A CA2114927A1 CA 2114927 A1 CA2114927 A1 CA 2114927A1 CA 002114927 A CA002114927 A CA 002114927A CA 2114927 A CA2114927 A CA 2114927A CA 2114927 A1 CA2114927 A1 CA 2114927A1
- Authority
- CA
- Canada
- Prior art keywords
- implant
- array
- ray
- replacement device
- tissue replacement
- 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.)
- Abandoned
Links
- 230000005855 radiation Effects 0.000 claims abstract description 3
- 230000000903 blocking effect Effects 0.000 claims description 6
- 238000012544 monitoring process Methods 0.000 claims description 2
- 239000002344 surface layer Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 abstract description 3
- 239000007943 implant Substances 0.000 description 52
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 25
- 229910052791 calcium Inorganic materials 0.000 description 25
- 239000011575 calcium Substances 0.000 description 25
- 229920001296 polysiloxane Polymers 0.000 description 20
- 210000001519 tissue Anatomy 0.000 description 18
- 235000014443 Pyrus communis Nutrition 0.000 description 5
- 210000000038 chest Anatomy 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 210000000988 bone and bone Anatomy 0.000 description 4
- 238000011976 chest X-ray Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 206010028980 Neoplasm Diseases 0.000 description 3
- 238000003491 array Methods 0.000 description 3
- 210000000481 breast Anatomy 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 238000010276 construction Methods 0.000 description 2
- 229910001385 heavy metal Inorganic materials 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 208000012260 Accidental injury Diseases 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- 201000010001 Silicosis Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 201000007741 female breast cancer Diseases 0.000 description 1
- 201000002276 female breast carcinoma Diseases 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 235000012771 pancakes Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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 and implants
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Prostheses (AREA)
Abstract
An array of masses composed of an compound which will block, diffract, deflect, or absorb X-rays, is to be placed with in the layer of the encapsulating shell of an internal artificial tissue replacement device which when bombarded by X-ray radiation will be reproduced on an X-ray detecting medium.
Description
~2 1 1 4927 5 - 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.
The need for an individual to introduce an artificial device into one's 10 body can arise from the desire to improve one's appearance, or from circumstances beyond one's control. Accidental injury is a common source of circumstance which may require artificial tissue replacement. In the past decade the treatment of cancerous tissue has become a large source for the need of tissue replacement operations.
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. To overcome the loss of tissue, 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 20 structural integrity of the device.
For example in cases of breast cancer, a mastectomy causes a noticeable loss of tissue. When it is desired to undergo reconstructive mammaplasty to replace to tissue lost from the mastectomy operation, it is I~A21 14927 common to use 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.
Currently the most effective way to monitor the integrity of the implant is with Magnetic Nuclear Resonance Imaging (MRI). MRI is a reliable method for diagnosing the intactness of the mammary prosthesis. MRI
requires on average an hour to perform a complete examination. Purchase of MRI equipment for institutions is expensive, and highly trained staff are required to operate the machines. Currently there are over one million ~A21 1~27 american women with an internal mammary prosthesis, and this figure is increasing due to the higher rate of female breast cancer. MRI is not a practical method to continuously monitor all of the women who have a mammary prosthesis. An intermediate system for diagnosing the status of 5 an mammary prosthesis is required.
One of the reasons that MRI is successful in monitoring the implant is that this method is able to isolate the silicone gel and display data relating to the presence of only silicone. A more conventional method would be to have a more identifiable material placed in an precise pattern on the surface 10 of the encapsulating shell.
If X-ray diffracting, absorbing, deflecting, diffracting, or blocking masses were to be placed in a precise pattern within the encapsulating shell of the implant, the implant would be viewable with a standard chest X-ray machine.
These chest X-ray machines are accessible in health care institutions in 15 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.
With the assistance of computer imaging, the data from the X-ray can be used to construct a three dimensional representation of the implant, with ~A21 14927 ~ossible 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.
There are some restrictions based on the condition of the patient and 5 the shape and size of the artificial tissue replacement device which will have an effect of the accuracy of the information obtained on an individual. 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 10 information about the structure of the implant.
Nature and Terms;
Since the invention can undertake an amorphous shape, in order to illustrate the invention the drawings will describe an pear shaped implant 15 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 "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 ~ A 2 1 1 ~927 3riented 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 rib cage of the patient.
In the drawings which illustrate the embodiments of the invention, 5 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", and Figure 4 is a cross 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 10 shell A which encapsulates the silicone gel contents C of the implant. The cross-linked silicone shell A can also be composed of 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, 15 and are placed over the entire cross-linked silicone shell A in the grid like array as 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 ~A21 14927 -sensitive medium. The fact that these calcium spheres 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. When 5 the implant is first put in place a chest X-ray shortly afterwards will result in a reference X-ray 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 10 call for further tests to verify the presence of a 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 15 the calcium spheres B, the array can be distinctly identified with some interference from the bones of the patient.
In figures 2 and 3 it can be shown that the "front" and "back" halves of the breast implant have the grid array of calcium spheres B offset by half of the distance between the calcium spheres B. In figure 2 line 2,2 ~A21 14927 -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 5 sections along the side of the implant.
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 implant. Thus the 10 loss of a calcium sphere B could be caused by exposure by a rupture on the outer surface of the shell surrounding the calcium sphere B, but not deep enough to continue through to the silicone gel C of the implant. If this situation occurs it is possible that the cross-linked encapsulating shell A
could potentially rupture at this point at a later time and the implant may 15 need to be replaced before a rupture occurs as a preventative action. There are no calcium spheres B on the bottom section of the implant in figure 4 as they are offset and not in the plane of line 1,1 in figure 1.
Since figures 1, 2 ,3, and 4 illustrate a pear shaped implant, the implant should not flip from top to bottom once inside the patient. The pear ~A 2 I 14927 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 all times and the same surface as the 5 back at all times. By offsetting the array of calcium spheres B between the front and back grids it will make the resulting X-ray picture more valuable as the front and back arrays of calcium spheres B will be offset and not on top of each other. With implants which have a rounder shape it may not be feasible to offset the front and back array of calcium spheres B as the 10 orientation once inside can not be predicted, and the implant may move around once inside due to the shape of the implant.
Figures 5, 6, and 7 illustrate how the array could be placed on a pancake shaped implant. Figure 5 represents the "front" surface of the implant with D representing oval rather than round masses in a horizontal 15 orientation. Figure 6 represents the "back" surface of the implant with E
representing the oval masses in a vertical orientation. Figure 7 represents the view taken of both arrays superimposed-on one another. As it is represented in Figure 7 the "front" and "back" arrays are individually visible due to the orientation and shape of each array. This can add more ~A21 14927 Information as rotation of oval masses D or E can be used as a factor to indicate possible rupture of the encapsulating envelope of the implant. The use of oval masses D or E can have the disadvantage of causing a rupture by poking through the surface of the implant where a fold or sharp curve in 5 the encapsulating shell occurs.
As noted earlier 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 10 material for use in the array are as follows:
Biocompatible Biodegradable Diffract, block, deflect, or absorb X-rays Non reactive to silicone gel or cross-linked shell Non reactive during cross linking silicone process Can be produced in specific size and shape Show up on an X-ray differently than the bones of the patient ~A21 1 4~27 - Heavy metals can be put into compounds which meet the above requirements, but may not be practical in the day to day operations 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 around the lung area.
In situations where a rupture causes the shell's surface to contract rather than expand, 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. In some circumstances the calcium spheres B will interfere with other objects which need to be viewed by a chest X-ray.
In current use are multiple chamber tissue replacement devices. These multi chamber devices are in use to better control the shape and size of an implant. The array may be placed within the chambers of the implant to monitor the position or integrity of these inner chambers. As time continues and technology advances the complexities of the construction of internal artificial tissue replacement devices will increase. An attempt to include the unknown direction of the implant construction will be addressed in the claims ~ A21 1 4927 ,D~llowing the conclusion of the description of the invention.
In summery, the above representation of the invention is attempting by means of words to describe an array of masses which will block, diffract, or absorb X-rays to be placed within the encapsulating layer of a tissue 5 replacement device in such a manner as to be recorded on an X-ray recording media and that the resulting picture or data recorded will provide a medical doctor with information which can assist in the diagnosis of the intactness of an the internal tissue replacement device.
The need for an individual to introduce an artificial device into one's 10 body can arise from the desire to improve one's appearance, or from circumstances beyond one's control. Accidental injury is a common source of circumstance which may require artificial tissue replacement. In the past decade the treatment of cancerous tissue has become a large source for the need of tissue replacement operations.
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. To overcome the loss of tissue, 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 20 structural integrity of the device.
For example in cases of breast cancer, a mastectomy causes a noticeable loss of tissue. When it is desired to undergo reconstructive mammaplasty to replace to tissue lost from the mastectomy operation, it is I~A21 14927 common to use 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.
Currently the most effective way to monitor the integrity of the implant is with Magnetic Nuclear Resonance Imaging (MRI). MRI is a reliable method for diagnosing the intactness of the mammary prosthesis. MRI
requires on average an hour to perform a complete examination. Purchase of MRI equipment for institutions is expensive, and highly trained staff are required to operate the machines. Currently there are over one million ~A21 1~27 american women with an internal mammary prosthesis, and this figure is increasing due to the higher rate of female breast cancer. MRI is not a practical method to continuously monitor all of the women who have a mammary prosthesis. An intermediate system for diagnosing the status of 5 an mammary prosthesis is required.
One of the reasons that MRI is successful in monitoring the implant is that this method is able to isolate the silicone gel and display data relating to the presence of only silicone. A more conventional method would be to have a more identifiable material placed in an precise pattern on the surface 10 of the encapsulating shell.
If X-ray diffracting, absorbing, deflecting, diffracting, or blocking masses were to be placed in a precise pattern within the encapsulating shell of the implant, the implant would be viewable with a standard chest X-ray machine.
These chest X-ray machines are accessible in health care institutions in 15 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.
With the assistance of computer imaging, the data from the X-ray can be used to construct a three dimensional representation of the implant, with ~A21 14927 ~ossible 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.
There are some restrictions based on the condition of the patient and 5 the shape and size of the artificial tissue replacement device which will have an effect of the accuracy of the information obtained on an individual. 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 10 information about the structure of the implant.
Nature and Terms;
Since the invention can undertake an amorphous shape, in order to illustrate the invention the drawings will describe an pear shaped implant 15 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 "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 ~ A 2 1 1 ~927 3riented 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 rib cage of the patient.
In the drawings which illustrate the embodiments of the invention, 5 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", and Figure 4 is a cross 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 10 shell A which encapsulates the silicone gel contents C of the implant. The cross-linked silicone shell A can also be composed of 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, 15 and are placed over the entire cross-linked silicone shell A in the grid like array as 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 ~A21 14927 -sensitive medium. The fact that these calcium spheres 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. When 5 the implant is first put in place a chest X-ray shortly afterwards will result in a reference X-ray 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 10 call for further tests to verify the presence of a 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 15 the calcium spheres B, the array can be distinctly identified with some interference from the bones of the patient.
In figures 2 and 3 it can be shown that the "front" and "back" halves of the breast implant have the grid array of calcium spheres B offset by half of the distance between the calcium spheres B. In figure 2 line 2,2 ~A21 14927 -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 5 sections along the side of the implant.
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 implant. Thus the 10 loss of a calcium sphere B could be caused by exposure by a rupture on the outer surface of the shell surrounding the calcium sphere B, but not deep enough to continue through to the silicone gel C of the implant. If this situation occurs it is possible that the cross-linked encapsulating shell A
could potentially rupture at this point at a later time and the implant may 15 need to be replaced before a rupture occurs as a preventative action. There are no calcium spheres B on the bottom section of the implant in figure 4 as they are offset and not in the plane of line 1,1 in figure 1.
Since figures 1, 2 ,3, and 4 illustrate a pear shaped implant, the implant should not flip from top to bottom once inside the patient. The pear ~A 2 I 14927 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 all times and the same surface as the 5 back at all times. By offsetting the array of calcium spheres B between the front and back grids it will make the resulting X-ray picture more valuable as the front and back arrays of calcium spheres B will be offset and not on top of each other. With implants which have a rounder shape it may not be feasible to offset the front and back array of calcium spheres B as the 10 orientation once inside can not be predicted, and the implant may move around once inside due to the shape of the implant.
Figures 5, 6, and 7 illustrate how the array could be placed on a pancake shaped implant. Figure 5 represents the "front" surface of the implant with D representing oval rather than round masses in a horizontal 15 orientation. Figure 6 represents the "back" surface of the implant with E
representing the oval masses in a vertical orientation. Figure 7 represents the view taken of both arrays superimposed-on one another. As it is represented in Figure 7 the "front" and "back" arrays are individually visible due to the orientation and shape of each array. This can add more ~A21 14927 Information as rotation of oval masses D or E can be used as a factor to indicate possible rupture of the encapsulating envelope of the implant. The use of oval masses D or E can have the disadvantage of causing a rupture by poking through the surface of the implant where a fold or sharp curve in 5 the encapsulating shell occurs.
As noted earlier 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 10 material for use in the array are as follows:
Biocompatible Biodegradable Diffract, block, deflect, or absorb X-rays Non reactive to silicone gel or cross-linked shell Non reactive during cross linking silicone process Can be produced in specific size and shape Show up on an X-ray differently than the bones of the patient ~A21 1 4~27 - Heavy metals can be put into compounds which meet the above requirements, but may not be practical in the day to day operations 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 around the lung area.
In situations where a rupture causes the shell's surface to contract rather than expand, 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. In some circumstances the calcium spheres B will interfere with other objects which need to be viewed by a chest X-ray.
In current use are multiple chamber tissue replacement devices. These multi chamber devices are in use to better control the shape and size of an implant. The array may be placed within the chambers of the implant to monitor the position or integrity of these inner chambers. As time continues and technology advances the complexities of the construction of internal artificial tissue replacement devices will increase. An attempt to include the unknown direction of the implant construction will be addressed in the claims ~ A21 1 4927 ,D~llowing the conclusion of the description of the invention.
In summery, the above representation of the invention is attempting by means of words to describe an array of masses which will block, diffract, or absorb X-rays to be placed within the encapsulating layer of a tissue 5 replacement device in such a manner as to be recorded on an X-ray recording media and that the resulting picture or data recorded will provide a medical doctor with information which can assist in the diagnosis of the intactness of an the internal tissue replacement device.
Claims (2)
1. The invention claimed is an array of X-ray blocking, diffracting, deflecting, or absorbing masses, to be placed within the surface layer of the encapsulating shell of an internal artificial tissue replacement device, which when exposed to X-ray radiation will record on an X-ray detecting media the array of X-ray blocking, diffracting, deflecting, or absorbing masses in such a manner that the array of masses are mappable for the purpose providing information to assist in the determination of the integral status of the encapsulating shell an internal tissue replacement device.
2. The array of X-ray blocking, diffracting, deflecting, or blocking masses as in claim 1 wherein the array is be placed within chambers or structures contained within the internal artificial tissue replacement device for the additional purpose of monitoring positioning or integrity of the structures placed with in the internal artificial tissue replacement device.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002114927A CA2114927A1 (en) | 1994-02-08 | 1994-02-08 | X-ray visible tissue replacement device |
| AU15303/95A AU1530395A (en) | 1994-02-08 | 1995-01-31 | The x-ray visible internal tissue replacement device |
| PCT/CA1995/000050 WO1995021581A1 (en) | 1994-02-08 | 1995-01-31 | The x-ray visible internal tissue replacement device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002114927A CA2114927A1 (en) | 1994-02-08 | 1994-02-08 | X-ray visible tissue replacement device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2114927A1 true CA2114927A1 (en) | 1995-08-09 |
Family
ID=4152854
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002114927A Abandoned CA2114927A1 (en) | 1994-02-08 | 1994-02-08 | X-ray visible tissue replacement device |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU1530395A (en) |
| CA (1) | CA2114927A1 (en) |
| WO (1) | WO1995021581A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140228950A1 (en) * | 2013-02-14 | 2014-08-14 | Allergan, Inc. | Methods for augmenting or reconstructing a human breast |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0177288A3 (en) * | 1984-10-03 | 1986-08-13 | Baylor College of Medicine | Labeled breast prosthesis and methods for detecting and predicting rupture of the prosthesis |
| US4863470A (en) * | 1985-03-19 | 1989-09-05 | Medical Engineering Corporation | Identification marker for a breast prosthesis |
| DE3902249A1 (en) * | 1989-01-26 | 1990-08-02 | Bodenseewerk Geraetetech | Method of fixing the position of predetermined sites in the human body |
| US5407659A (en) * | 1991-10-22 | 1995-04-18 | Mallinckrodt Medical, Inc. | Treated calcium/oxyanion-containing particles for medical diagnostic imaging |
-
1994
- 1994-02-08 CA CA002114927A patent/CA2114927A1/en not_active Abandoned
-
1995
- 1995-01-31 AU AU15303/95A patent/AU1530395A/en not_active Abandoned
- 1995-01-31 WO PCT/CA1995/000050 patent/WO1995021581A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| AU1530395A (en) | 1995-08-29 |
| WO1995021581A1 (en) | 1995-08-17 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US9241773B2 (en) | Imaging fiducial markers and methods | |
| Abdel-Dayem et al. | Changes in cerebral perfusion after acute head injury: comparison of CT with Tc-99m HM-PAO SPECT. | |
| KR102537926B1 (en) | Low Profile Intracranial Device | |
| De Paredes | Atlas of mammography | |
| JP6702635B2 (en) | Implantable devices and techniques for oncoplastic surgery | |
| CN101371161A (en) | Improved indication of patient skin dose in radiology | |
| US20200054454A1 (en) | Bone reconstruction implant | |
| AU2017313453B2 (en) | Wearable medical device and systems derived therefrom | |
| US11298232B2 (en) | Cranial implant with dural window | |
| Sealy et al. | Progress in the use of iodine therapy for tumours of the eye | |
| Pecking et al. | SPECT–CT fusion imaging radionuclide lymphoscintigraphy: Potential for limb lymphedema assessment and sentinel node detection in breast cancer | |
| CA2114927A1 (en) | X-ray visible tissue replacement device | |
| Hardy et al. | Computer graphics with computerized tomography for functional neurosurgery | |
| JPS61100257A (en) | Labelled breast part filling appliance and detection and estimation of bursting of said filling appliance | |
| Mishra et al. | Medical imaging using signal processing: A comprehensive review | |
| Nia et al. | The mammographic appearance of the BioMonitor implantable loop recorder | |
| CN208808624U (en) | A kind of individuation bone defect filling metal internal fixation device | |
| Meisamy et al. | The Effects of Q Inside TM Safety Technology Micro Transponder on Routine Breast Implant Imaging | |
| Handel et al. | An in vivo study of the effect of various breast implant filler materials on mammography | |
| Ruot-Worley | Augmentation mammoplasty: implications for the primary care provider | |
| AU683223B2 (en) | Breast implant with radiolucent shell | |
| CN212971867U (en) | Protective helmet | |
| US20240225841A1 (en) | X-Ray Developable Identifying Element for Use in an Implant and Implant Comprising the Same | |
| Alanezi | Evaluation of the effect of breast implants on the accuracy of the CT attenuation Correction (CTAC) map for SPECT/CT myocardial perfusion imaging: a phantom study | |
| Ogura et al. | Clearer image of computed tomography by reconstruction analysis method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Dead |