Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
1997-10-20
2001-01-30
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C600S595000
Reexamination Certificate
active
06179790
ABSTRACT:
BACKGROUND
This invention relates to examining tissue with pressure sensors.
All women are at risk for breast cancer. This risk increases as a woman ages. Women are generally considered to be at increased risk for developing breast cancer if they have one or more of the following risk factors: a family history of breast cancer, a previous diagnosis of a malignant breast tumor or other gynecological cancers, hormonal factors, or not having had any children or having a first child later in their child bearing years. Even so, the majority of all breast cancers occur in women who apparently do not have identifiable risk factors.
Although breast cancer currently cannot be prevented, it can be detected at an early, treatable stage when the tumor is small and has not spread beyond the breast. Women who are treated at this early stage have a much higher survival rate than women who are treated at more advanced stages of the disease. However, not all breast cancers are currently detected at this early stage. Therefore, the importance of screening for breast cancer has become a critical a aspect in the overall management of this disease.
The methods currently used in the United States to screen for breast cancer and other breast conditions include monthly Breast self examination (BSE), mammography, and clinical breast examination.
Breast self examination is manual examination of a woman's breast tissue by the woman herself. During such examinations, a woman should examine her breasts at the same time each month, 7-10 days after the first day of her last menstrual cycle. She should report to her physician anything she feels that is new or that has changed since her prior exam.
Breast self examinations are important for the early detection of breast cancer. However, many women do not perform these examinations. When questioned about this, most women explain that they are not comfortable with their level of skill in doing such examinations. Products which help to remove the obstacles that prevent women from examining their breasts regularly would clearly be beneficial. Ideally, these products would increase the quality of such examinations without requiring extensive technical skill from their users.
Several devices designed to assist the user and clinicians in performing breast self examination are described in commonly-owned U.S. patent application Ser. No. 08/757,466, entitled “Tissue Examination” (hereinafter, “the '466 application), incorporated herein by reference. These devices include an array of sensors each of which produces a signal in response to the pressure imposed thereon as the sensor is pressed against tissue. The pressure varies in accordance with properties of different types of underlying tissue structures. Processing tests are performed on the signals to discern the characteristics of underlying tissue structures and thus discriminate between different types of underlying tissue (e.g., potentially foreign structures such as cysts or solid masses, and normal structures such as a nipple, a rib, or a ligament). Accordingly, the devices can alert the user to the presence of suspicious or indeterminate discrete and dominate structures in breast tissue.
Many of the processing tests performed by the devices described in the '466 application search for small differentials in the outputs of the pressure sensors. Random or patterned faults, due e.g. to surface abrasions or small tissue structures near the surface, may produce erroneous test results, thereby potentially leading to “false positive” indications of potentially foreign tissue structures. Moreover, if some of the sensors respond unduly weakly to imposed pressure, due e.g. to sensors being damaged, the device may fail to detect an underlying structure (particularly if the weakened sensors are concentrated together in the array).
SUMMARY
This invention concerns examining a tissue using pressure sensors and disposing a layer of material on the sensors during examination. In one general aspect, the invention features an apparatus that includes a tissue examination device and a layer of material. The tissue examination device has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensors as the sensors are pressed against tissue. The device also has a processor for processing those signals to detect whether an underlying tissue structure is present in the tissue being examined. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner.
In another general aspect, the invention features an apparatus that includes a tissue examination device and a layer of material. The tissue examination device has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensors as the sensors are pressed against tissue. The device also has a processor for processing the signals to generate an image representative of the underlying tissue structure, and a display for displaying that image. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner.
In yet another general aspect, the invention features a layer of material to be used with a tissue examination device. The tissue examination device has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensors as the sensors are pressed against tissue. The device also has a processor for processing those signals to detect whether an underlying tissue structure is present in the tissue being examined. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner.
In another general aspect, the invention features a layer of material to be used with a tissue examination device. The tissue examination device has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensors as the sensors are pressed against tissue. The device also has a processor for processing the signals to generate an image representative of the underlying tissue structure, and a display for displaying that image. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner.
In another aspect, the invention relates to a method of examining tissue. A tissue examination device is provided. The tissue examination device includes a plurality of pressure sensors that produce signals in response to pressure imposed on the sensors as the sensors are pressed against tissue. A layer of material is disposed over the sensors to distribute the imposed pressure in a selected manner. The sensors are then pressed against the tissue to examine the tissue.
Preferred embodiments may include one or more of the following features.
The layer of material distributes the pressure imposed on a sensor to an adjacent sensor, which may be one of the surrounding sensors. The sensors can have a top layer and the layer of material is configured to reduce a deflection of the top layer in response to the imposed pressure.
The imposed pressure is shear stress imposed by the tissue on the sensors when the sensors are moved over the tissue. In that case, the layer of material distributes the shear stress to reduce the shear stress imposed on the sensors. The sensors can have a top and a bottom layer, the top layer being capable of moving relative to the bottom layer in response to the shear stress. The layer of material is configured to reduce a movement of the top layer relative to the bottom layer caused by the shear stress. A lubricant is disposed between the top layer of the sensors and the layer of material which can assist with reducing the movement of the top layer relative to the bottom layer.
The tissue examination device has a housing which is made up of a sensor head on which the sensors are installed and a neck connected to the sensor head. The layer of material distributes the stress imposed on the layer of material
Cundari Michael Anthony
Roberts Troy William
West Alan Irving
Assurance Medical Inc.
Fish & Richardson P.C.
Hindenburg Max
Wingood Pamela L.
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