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[0001] The present invention relates to a support apparatus for performing mammograms and breast biopsies during which the patient is in the decubitus position. More specifically, the present invention provides an apparatus and method for accurately repositioning a patent, maintaining the patient in the selected position for breast biopsy and preventing discomfort to the patients bottom arm and shoulder which are supporting the patient's weight during mammography performed in the decubitus position.
[0002] Advances in the field of mammography have enabled early detection and treatment of cancerous and precancerous tissues. When a mammogram is taken, it is analyzed by a radiologist. If suspicious images are found, a biopsy of the tissue is taken. Mammography typically has been performed with the patient in the standing position, and the breast positioned between two opposed plates which flatten the tissue and hold it in place. If suspicious tissue was observed in the mammogram the physician marked the precise area to be biopsied and a tissue sample was obtained. The procedure of marking the area for biopsy involved inserting a needle into the breast, and feeding of a wire through the needle which remains in place until the biopsy is performed.
[0003] In an improved method for performing breast biopsies, known as the core biopsy technique, the patient is placed in a standing or upright sitting position and the biopsy is taken by positioning the patient's breast between the opposed plates of a mammography device. Then, using a medical instrument known as a “breast tissue sampler,” a core of tissue is cut at the position indicated by the mammogram. This procedure represents a significant advance, in that the patient is not required to remain with a wire projecting from her breast or move to a remote location for the surgical biopsy. Instead, the biopsy can be performed in the same location as the initial mammogram.
[0004] However, during the performance of the core biopsy, it is possible for the patient to move slightly, or worse to faint. Either reaction presents significant problems both for the patient and the technician or radiologist. In one instance a sample from the wrong area is taken, and in the other an incorrect sample can be taken and the patient can be injured by falling. One solution to this problem is to support the patient during core breast tissue sampling by using an examination table having a central, surrounded and not laterally accessible opening therein. With such an examination table, the patient lies in a prone position with her breasts hanging downwardly through the opening. This type of support table, known as a “prone table” or “Parker table.” The Parker table is large and not readily repositionable, making access to the breast region difficult. The Parker table also presents a problem in attempting to locate tumors when the patient is small breasted or the suspected tumor is adjacent the chest wall, i.e., the rib cage area.
[0005] Thus it would be beneficial if the patient could have mammograms, needle localizations and core biopsies performed when laying on her side. This is known as the decubitus position, wherein the patient's breast is oriented toward the mammogram—preferably with the upper breast positioned for mammography or biopsy, but sometimes with the lower breast examined. The patient may thus be positioned in a left lateral decubitus (left side of patient down) or right lateral decubitus (right side of patient down) to present her breast to for examination. This may require the patient to position her head at either end of the support, or to rotate longitudinally (with feet and head remaining at the same relative ends of the bed) to present the breast in the proper position. The patient must be adequately supported and this support must be provided without giving the patient a sense of anxiety about failing off the support. Additionally, the support must permit access by the technician and access to the mammography and core biopsy machine to enable performance of the mammogram and/or biopsy procedure.
[0006] Prior art patient supports are perhaps best shown in U.S. Pat. Nos. 5,184,363 and 5,461,739 to Falbo, Sr., and 5,950,262 to Smoler et al., the disclosures of which are incorporated herein by reference. Such supports are beneficially configured with drop-out sections to permit access by the technician to the patient. However, these patient supports are not configured to meet the peculiar demands of decubitus breast mammography and biopsy. For example the U.S. Pat No. 5,184,363 patent discloses a support bed useful for cardiac sonography having two drop-out sections, the first to permit sonographic diagnosis of a patient lying on the bed, the second to accommodate the legs or other aspect of a person performing the diagnosis. However, the openings do not admit access by a mammography and core biopsy device, nor is the table particularly configured to permit alternate positioning of the patient on either the left or right side. Moreover, a mammography device often must be tilted in which case a bulky portion of the device must lie adjacent the patient's head and below the top surface of the table, which is not possible with the aforementioned support bed. The U.S. Pat. No. 5,461,739 support apparatus is also designed for performing cardiac sonography, but with the patient in a supine position (resting on the back) and accommodating a pedaling device. It also teaches the use of one, or alternatively two, patient drop-out, sections, but is not configured to admit into the openings a mammography and core biopsy device, nor to allow the patient to rest in a variety of different positions to present the breast for examination.
[0007] A bed or examination table which allows the patent to be positioned on her side is the subject of U.S. patent application Ser. No. 09/712,475. This patent application teaches the use of an examination table or bed in which the patient may be positioned in a left lateral decubitus or right lateral decubitus position to present her breast to for examination and biopsy. While the bed or table of U.S. patent application Ser. No. 09/712,475 provides substantial benefits to the patient, additional improvements and embodiments of the examination table or bed have been discovered which can further increase patient comfort while in the decubitus position, and which can increase the accuracy of the biopsy procedure.
[0008] It will be appreciated by those skilled in the art that while a patient is in the decubitus position (
[0009] An additional embodiment of the examination table or bed of U.S. patent application Ser. No. 09/712,475 is provided in the present application and which reduces or eliminates the discomfort caused to a patient from being positioned in the left lateral decubitus or right lateral decubitus position for a period of time. While in the left lateral decubitus or right lateral decubitus position much of the patient's weight is resting on the patient's downward arm and shoulder. If the patient is required to remain in the lateral decubitus position for a time the patient can experience pain or the local loss of feeling in the arm or shoulder which is in contact with the examination table. Therefore, a means for reducing the pressure of the patient's body weight on the patient's downward arm and shoulder would be beneficial.
[0010] A further problem associated with positioning a patient in either the left lateral decubitus or right lateral decubitus position occurs when a removable filler panel as described in U.S. patent application Ser. No. 09/712,475 is removed and the patient attempts to allow their arm to drop below the surface of the table. In this instance the patient's arm is simply left to dangle downwardly and can contribute to the patient feeling unstable and can contribute to a tendency for the patient to roll forward into the mammography or biopsy device. Therefore, it would be beneficial if an examination table which allows the patient to be positioned in the left or right lateral decubitus positions were to provide a stabilizing means for the patent while the patient's arm is hanging below the table surface.
[0011] Yet another advantage could be obtained for the radiologist or technologist using the device of U.S. patent application Ser. No. 09/712,475 if a limited degree of movement of the patent's breast in the lateral plane—a plane parallel to the surface of the bed or table—could be achieved. In a biopsy procedure it may be necessary to take a biopsy from more than one location in a breast, or it may be necessary to shift a patient to place the area to be biopsied more centrally under the biopsy needle. In these cases, presently, the radiologist or technologist must either adjust the position of the patient by directing the patient to move their body slightly, or by readjusting the breast within the biopsy device, or by repositioning the biopsy device. These options do not provide the radiologist or technologist with the fine degree of control which would be beneficial in achieving biopsy accuracy. Therefore it would be of great benefit to a radiologist or technologist if a means were available which would allow the repositioning of a patient, or patients breast with respect to a breast biopsy device.
[0012] A further problem is associated with examination tables which position a patient in the left or right lateral decubitus position. If the patient is short in stature, the patient's head will not extent to the end of the table where it can be supported at a different level of height from the table surface. In such cases the patient cannot be shifted toward the headrest as then the patient would not be aligned with the filler section openings. Therefore, it would be beneficial if a headrest for use with left or right lateral decubitus position breast biopsy examination tables were known which would allow the head of a short patient to be supported at a level above the height of the examination table surface.
[0013] These needs have largely been achieved by the method and apparatus of the present invention which in one embodiment provides a method and apparatus of bracing the patient to prevent forward and rearward movement of the patient with respect to a core biopsy device and which in another embodiment provides a method and apparatus for reducing the pressure placed on the downward arm and shoulder of a patient while in the decubitus position and which in another embodiment provides a method and apparatus for adjusting the position of a patient and/or the patient's breast, while the patient is in the decubitus position.
[0014] The method and apparatus of bracing the patient to prevent forward and rearward movement of the patient with respect to a core biopsy device comprises the bracing of a patient's rear shoulder area by positioning of a pad against the patient's upper back and shoulder area to prevent rearward movement and to provide a reference point for the patient to press against to assist in preventing forward rolling movement of the patient.
[0015] The method and apparatus for reducing the pressure placed on the downward arm and shoulder of a patient while in the decubitus position comprises the provision of a recess or depression in the examination bed or table adjacent the location of the patient's shoulder on the examination table. This recess or depression allows the patient to extend the arm downwardly and to shift the patient's body weight from the downward arm and shoulder and onto the patient's chest wall area.
[0016] The method and apparatus for providing a stabilizing means for the patent while the patient's arm is hanging below the table surface comprises a patient support which can be grasped by the patient's downwardly hanging arms and which allows the patient to hold themselves in position and prevent forward rotation of their body toward the biopsy or mammography apparatus while providing the patient with a sense of security and control over their body position.
[0017] The method and apparatus for adjusting the position of a patient and/or the patient's breast, while the patient is in the decubitus position comprises the mounting of the table frame on a system of dual, laterally shifting support surfaces which are independently moveable with respect to one another. The surfaces are positioned between the table frame and the upright support and, when released either separately or together, allow a user to shift the table and a patient thereon in two degrees of movement. The two degrees of movement allow movement in all direction in a plane which is parallel to the surface of the examination table. Once the patient is properly repositioned the table surface can be locked into position for the procedure.
[0018] The method and apparatus for supporting the shorter patient's head comprises a frame for use with a head support, the frame allowing the head support cushion to be shifted along the longitudinal axis of the examination table to allow the head support to be moved inwardly of the examination table frame to allow positioning of the head support under the head of the shorter stature patient.
[0019] The foregoing and other objects are intended to be illustrative of the invention and are not meant in a limiting sense. Many possible embodiments of the invention may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Various features and subcombinations of invention may be employed without reference to other features and subcombinations. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention.
[0020] Preferred embodiments of the invention, illustrative of the best modes in which the applicant has contemplated applying the principles, are set forth in the following description and are shown in the drawings and are particularly and distinctly pointed out and set forth in the appended claims.
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[0029] As required, detailed embodiments of the present inventions are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted a limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.
[0030] Referring now to the
[0031] While multiple embodiments are shown of the present invention, it is to be understood that all are sized and configured to support a human patient thereon, and to accommodate a mammography device and mammotome or an examiner or other member of the technical staff during mammography, needle localization or obtaining a tissue sample. Thus, while patient
[0032] In
[0033] In
[0034] Still referring to
[0035] The filler sections may be configured to be removably coupled to the frame
[0036] Referring now to
[0037] Deck support
[0038] The apparatus
[0039] In the method of the present invention, patient
[0040] However, support apparatus
[0041] The patient's breast
[0042] As previously mentioned, when a patient is in the right or left decubitus position,, the patient is lying on her side. In this position the downward arm is just in front of the patient and a substantial part of the patients weight is placed on the downward shoulder. Referring to
[0043] This need to remain in one position with a substantial amount of body weight on the shoulder frequently becomes quite uncomfortable for the patient. It is not uncommon for the patient to loose feeling the downward shoulder or arm during periods of lying in the right or left decubitus position. The present invention solves this problem by redistributing some of the patient's weight from resting on the patient's shoulder and shifting the weight to resting on the patients chest. This is accomplished by providing an indent or crescent-shaped depression in the rigid material or panel
[0044] Referring now to
[0045] The inclusion of Indent
[0046] Referring now to
[0047] Referring now to
[0048] In use, the patient is positioned on support apparatus
[0049] In yet another embodiment of the present invention patient
[0050] Referring now to FIGS.
[0051] Four-way movement means
[0052] When magnetic brake
[0053] To allow support apparatus to operate in both the medical mode for mammograms and biopsies and in the X-Y movement mode, it is necessary that frame
[0054] It will be appreciated by those skilled in the art that alternative embodiments of this principle can be applied to the present invention by substituting precision controlled motors to effect movement in the X-axis and the Y-axis in place of the rollers and track devices described previously. The object being to achieve repositioning of the area of interest on the breast without the patient moving their body with respect to the table surface.
[0055] During the mammography and biopsy procedure, it is preferred that the patient remain as immobile as possible. However, as previously described in current circumstances of patent positioning in the decubitus position it is possible for the patient to roll forward or rearward and disturb the positioning of the breast which was indicated by the mammography. To avoid this undesirable movement an embodiment of the present invention provides a back brace or support which can be position against a patient to assist in retaining a patient in the proper, selected position for a core breast biopsy.
[0056] Referring to
[0057] Clamp
[0058] In use, patient
[0059] Referring now to
[0060] As will be appreciated by examination of
[0061] Referring now to
[0062] In use, when a patient of shorter stature is positioned on support apparatus
[0063] In the foregoing description, certain terms have been used for brevity, clearness and understanding; but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such terms are used for descriptive purposes and are intended to be broadly construed. Moreover, the description and illustration of the inventions is by way of example, and the scope of the inventions is not limited to the exact details shown or described.
[0064] Certain changes may be made in embodying the above invention, and in the construction thereof, without departing from the spirit and scope of the invention. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not meant in a limiting sense.
[0065] Having now described the features, discoveries and principles of the invention, the manner in which the inventive biopsy bed is constructed and used, the characteristics of the construction, and advantageous, new and useful results obtained; the new and useful structures, devices, elements, arrangements, parts and combinations, are set forth in the appended claims.
[0066] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.