APPARATUS FOR POSITIONING PAΗENTS
RELATED APPLICATION:
This application claims priority to United States provisional patent application Serial No. 60/048,417 entitled APPARATUS FOR POSITIONING PAΗENTS DURING CERTAIN MEDICAL PROCEDURES filed June 3, 1997. By this reference, the full disclosure, including the drawings, of United States provisional patent application Serial No 60/048,417 is incorporated herein
TECHNICAL FIELD
The present invention relates to apparatus intended to support patients dunnε medical procedures More specifically, the present invention relates to apparatus intended to support patients during procedures involving the application of nuclear medicine, whereby both patient comfort and examination accuracy may be increased.
BACKGROUND ART:
23 million mammography examinations are administered each year in the United States for the early detection of breast cancers While traditionally a mammogram is obtained by compressing the breast and X-raying the anatomical structure mterior thereto, a new diagnostic procedure called scmtimammography is gaining widespread acceptance for use in cases where the conventional mammogram is indeterminate or hard to read. In scmtimammography, a radionuclide having an affinity for the breast, such as technetium (Tc), is administered to the patient and the resulting distribution of radioactivity in the breast is recorded with a scintillation camera, preferably a gamma camera. Because approximately 30% of mammogram examinations may be categorized as indeterminate or difficult to read,
scintimammography represents an important step in reducing inaccurat§Ξ@nd-
? ineffecfiw examinations.
Unlike conventional mammogram protocol, however, scintimammography calls for the breasts to hang freely while the gamma camera records focal areas of radioisotope activity such as are indicative of malignant lesions. In the examining position, however, it is common for both breasts to be obtained within the gamma camera's field of view. As a result, a lesion image in one breast may interfere with the image formed in the other breast. This phenomenon, called cross talk, will usually present the analyst with an inaccurate or ambiguous view. Although cross talk presents a serious limitation to the efficacy of scintimammography technology, the present inventors know of no available apparatus designed specifically to combat the phenomenon. In many cases, the patient is simply told to lie at an angle on an examination table with one breast suspended off the table's side. The other breast is then compressed against the top surface of the table, substantially removing it from the camera's field of view. Not only is this technique extremely uncomfortable for the patient during the lengthy procedure, it also places the nuclear medicine technician at sigmficant risk due to the fact that the technician is required to remain proximal the radionuclide source in order to safely support the patient on the table.
It is therefore a primary objective of the present invention to improve over the prior art by providing an apparatus through which a scintimammography patient may be properly and comfortably positioned without unnecessarily subjecting the nuclear medicine technician to the harmful effects of radioisotopes.
It is a further object of the present invention to provide such an apparatus wherein the patient's position may be readily adjusted prior to or during an examination in order to obtain oblique images of the breast regions, all the while maintaining patient comfort, stability and safety.
It is yet a further object of the present invention to provide the foregoing apparatus with features for the reduction or minimization of cross talk and its effects.
It is yet another object of the present invention to provide to foregoing apparatus in a lightweight, durable and otherwise easily and rapidly transportable package.
These and other objects will be more apparent to those of ordinary skill in the relevant arts upon review of the foregoing discussion in light of the following disclosure of the invention, best mode for carrying out the invention and ie appended claims. In no case, however, should these objects be a limitation of the scope of the present invention, which is limited only be the claims appended hereto.
DISCLOSURE OF THE INVENTION:
The purpose of the described apparatus is to improve both the accuracy of the examination and the comfort of the patient during scintimammography, while alleviating the above-described problems. The apparatus allows the breast to be suspended in a natural position and untouched. By rotating the patient along the longitudinal axis, the ability of the examining camera to detect a tumor in the breast is greatly increased. Placing the patient in a prone position will help to increase the effectiveness of the examination by suspending the breasts and increasing patient comfort.
Many other features, objects and advantages of the present invention will be apparent to those of ordinary skill in the relevant arts, especially in light of the foregoing discussions and the following drawings, exemplary detailed description and appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS:
Although the scope of the present invention is much broader than any particular embodiment, a detailed description of the preferred embodiment follows together with illustrative figures, wherein like reference numerals refer to like components, and wherein:
Figure 1 shows the examination table to which the apparatus is attached;
Figure 2 shows an exploded isometric view of the apparatus;
Figure 3 depicts an overhead view of a first preferred embodiment of the apparatus;
Figure 4 shows a side view of the body support, specifically the right oblique bag 54, flexible overlay board 56, inflatable air bags 57, 58, 59, rigid overlay board 50, polyethylene filled bag 11, and body foam 12;
Figure 5 shows the front view of the body support, specifically the left and right oblique bags 54, 55, flexible overlay board 56, inflatable air bags 57, 58, 59, rigid overlay board 50, polyethylene filled bag 11, and body foam 12; Figure 6 shows the top view of rigid overlay board 50 or the flexible overlay board 56
(same top view);
Figure 7 shows a perspective cutaway view of the head and arm support platform 53 to show the two table attachment bags 13, 14;
Figure 8 is a frontal view looking rearward into the head and arm support platform 53. The attaching table 10 is shown squeezed by the two table attachment bags 13, 14;
Figure 9 is an overhead illustration depicting placement of the attaching table 10 through the head and arm support platform 53;
Figure 10 shows a detailed drawing of a side support rail 19;
Figures 11 and 12 show a side view of the apparatus in normal operation. Figure 11 depicts a patient in the prone examination position at a time when the air mattresses are not inflated. Figure 12 shows the apparatus when inflated;
Figure 13 shows an elevated perspective view of the second preferred embodiment of the apparatus;
Figure 14 shows a cutaway view looking forward into the 1 — 14 plane of Figure 13; Figure 15 shows a cutaway view looking rearward into the 15 — 15 plane of Figure 13; and
Figure 16 shows a cutaway view looking rearward into the 16 — 16 plane of Figure 13.
BEST MODE FOR CARRYING OUT THE INVENTION:
Although those of ordinary skill in the art will readily recognize many alternative embodiments, especially in light of the illustrations provided herein, this detailed description is exemplary of the preferred embodiment of the present invention - an improved apparatus for positioning patients during nuclear medicine examination procedures, the scope of which is limited only by the claims appended hereto. The present invention generally comprises an examination table 10. as typically depicted in Figure 1. having attached thereto a head and arm support 52, 73 and a body support 51, 74 In each preferred embodiment, a space is formed between the head and arm support 52, 73 and body support 51, 74. This space defines an open region between the supports for freely receiving a patient's breasts.
In a first preferred embodiment, as generally depicted in Figure 2, the head and arm support 52 comprises an open-ended head and arm support platform 53 having integrated therewith a plurality of independently inflatable table attachment bags 13, 14 as will be detailed further herein. In this first preferred embodiment, the body support 51 generally comprises a multi-layered structure of inflatable bags and interposed overlay boards.
In a second preferred embodiment, as generally depicted in Figure 13, the head and arm support 73 may also comprise a multi-layered structure of inflatable bags. In this second embodiment, the body support 74 may be adapted to more specifically support the patient's abdominal region, thereby more comfortably supporting the patient in a prone position.
Referring now to Figure 2, the first preferred embodiment is generally shown in exploded view to comprise an examination table 10 having mounted thereon a multi-layered body support 51 and a head and arm support 52. As shown from the side in Figure 4 and from the head end in Figure 5, the multi-layered body support 51 comprises a plurality of inflatable air bags 57. 58 and 59 primarily intended to adjust the overall height of the body support 51
and a plurality of independently inflatable oblique bags 54 and 55 primarily intended to impart rotation capability to the body support 51. As particularly shown in Figures 2 and 3, a left side support rail 19 and a right side support rail 20 are provided to ensure patient safety. These side rails 19, 20 may be augmented by straps to further secure the patient on the apparatus of the present invention. Finally, a blower box 67 is shown to provide pressurized fluid, through pressure hose 66, to the inflatable components of the body support 51 and side rails 19 and 20. As is known to those of ordinary skill on the art, there are many available blower units capable of delivering pressure sufficient to support a patient under normal operating conditions.
In this first preferred embodiment of the present invention, radiolucent layer of body foam 12 is provided at the top of the body support 51 and above a polyethylene filled bag 11. Although other similar materials, as are known to those of ordinary skill in the art, are suitable, this bag 11 is preferably filled with polyethylene beads, which are free to move about the bag 11 when it is filled with air through pressure hose 66. Prior to therapy, the patient lies upon the body foam 12 and the polyethylene filled bag 11 while the bag 11 is filled with air. In this state, the patient's shape permeates through the conformable foam 12, stabilizing the polyethylene beads within the bag 11. At this point, the air within bag 11 may be evacuated through provided valves leaving bag 11 rigidly in the shape of the patient's body. Because the body foam 12 is conformable to both the patient's body and the rigid bag 11, the personalized imprint left on the bag 11 serves to provide a comfortable patient supporting surface. Referring now to Figures 4 and 5, a rigid overlay board 50 and a flexible overlay board 56, each comprising radiolucent polyethylene, are shown as preferably interposed between the various layers of the body support 51. These overlay boards 50, 56 serve to provide structural support for the body support 51. As shown in Figure 6, each overlay board 50, 56 may comprise a plurality of apertures through which patient restraints and the like may be attached. The ultimate result of this multi-layered structure is that body support 51 provides a stable mechanism for patient elevation and positioning.
Oblique bags 54, 55 not only provide the foundation of the body support 51 but also may be independently inflated, allowing the upper layer 12 to be rotated to the left and right of the patient's centerline. On the other hand, the simultaneous inflation of oblique bags 54, 55 results in these bags being utilized to elevate the patient from the generally horizontal plane of the attaching table 10. This horizontal elevation may be further effected by inflation of height adjusting bags 57, 58 and 59. By inflating rotation adjusting bags 54 and 55 and height adjusting bags 57, 58 and 59 to an appropriate degree, the patient's body may be placed in a desired examination position prior to or during a scintimammography examination. In order to control the inflation of the various air bags, appropriate pressure valves known to those of ordinary skill in the art are provided.
Referring now to Figures 7. 8 and 9, the head and arm support 52 is described in detail. The head and arm support 52 generally comprises and open-ended head and arm support platform 53. This open-ended construction allows the head and arm support 52 to slide over the examination table 10. The head and arm support platform 53, as depicted in Figure 7, is preferably fashioned from radiolucent polyethylene or similar material. As shown in Figure 8, two independently inflatable table attachment bags 13, 14 having a length and width equal to or less than that of the length and width of the head and arm support platform 53 are inflatable through the pressure hose 66.
In use, the examination table 10 is positioned through the head and arm support platform 53 and between the inflatable table attachment bags 13, 14, as shown in Figure 8. The bags 13, 14 are then inflated against the examination table 10 to immobilize the head and arm support 52 in its operable position, as depicted in Figure 9.
As detailed in Figure 10, two side support boards 23, 24 form the base of the left side support rail 19 and are joined in such fashion as to provide for swivel the movement along the adjoining edges. Trademark VELCRO straps 68, 69 or similar attachment means are suitable to form this joint. One independently inflatable side support bag 25, 26 is secured to each side
support board 23. 24 In the preferred embodiment of the present invention, the lower side support board 23 is secured to a vmyl base 21 with Trademark VELCRO stπps This vinyl base 21 is then secured to the examination table 10 as well as the vinyl base of the πght side support rail 20, also suitably with trademark VELCRO stπps or other similar mateπal In normal operation of the apparatus of the present mvention, the patient lays upon the examination table 10 a prone position This allows the patient's breast to fall into the empty volume between the head and arm support 52 and a body support 51, a shown in Figure 11 Because it is important that the breast be freely suspended duπng examination from the gamma camera, which as is understood by those of ordinary skill in the art may be located at either side of the examination table 10 and is generalh focused in a transverse direction to the table 10, the body support 51 may be elevated as has been descnbed hereinabove and as is depicted in Figure 12
Referring now to Figure 13, there is shown the second of the two preferred embodiments of the apparatus of the present mvention The bed includes an upper baseboard 72 to which is attached a head and arm support 73, and a lower baseboard 71 to which is secured an abdominal support 74 and a lower body support 75 A body restramt 76 is anchored to the abdominal support 74 and can be secured to the head and arm support 73 to provide patient stability A table attachment 77 is secured to the underside of the upper baseboard 72 and two table attachments 78, 79 are secured to the underside of the lower baseboard 71 to provide the examination bed with varvmg degrees of immobility relative to the attached table A blower box 110 maintains desired inflation of all mflatable components by delivering air through the pressure hose 109
The head and arm support 73 or the lower body support can be secured against the attaching table exclusively or in addition to the previously descnbed means with a buckle or zip table attachment 96
The head and arm support 73 includes a head height adjustment 81. allowing the height of a patient's head to be adjusted relative to the general horizontal plane of the upper baseboard 72. A head and arm shielding curtain 98 may be secured to the head and arm support 73 to eliminate cross talk during the imaging procedure. An abdominal shielding curtain 84 may be secured to minimize cross talk, the disadvantages of which have been discussed hereinabove.
A head and arm support cushion 80 is secured to the head height adjustment 81. As shown in Figure 14, the head and arm support cushion 80 is formed to the general contours of human upper body and arms when in a prone position and extended longitudinally along the bed. The patient's elbows rest in the valley of the head and arm support cushion 80 and the forearms lay on the inclined plane. The upper chest is supported by the crest of the head and arm support cushion 80, allowing free suspension of the breast from the body into the volume between the head and arms support 73 and the abdominal support 74.
The head height adjustment 81 is comprised of head height adjustment cushions 1, 92, 93, 94, 95, 195, 106, as shown in Figure 14. All of the cushions may be inflated independently by channeling air through the pressure hose 109, and the top four cushions, when inflated selectively, can rotate the head and upper chest of the patient up to approximately 30 degrees left or right to improve the angle of the examining gamma camera. For example, inflating head height adjustment cushions 91, 92 without inflating head height adjustment cushions 105, 106 would rotate the patient about the longitudinal axis approximately twenty to thirty degrees clockwise, resulting in a more accurate reading to the breast volume near the chest wall on patient's right side.
In order to minimize cross talk from the non-target breast, an upper body shielding curtain 98 is secured to the head and arm support cushion 80 with trademark VELCRO strips or similar methβds. Similarly, a lower body shielding curtain 84 is attached to the abdominal support 74. The curtains, fashioned from material opaque to the examining radiation, can be
adjusted to isolate one breast from the camera view while leaving the other exposed for examination.
Figure 15 details the abdominal support 74, which includes an abdominal support cushion 82 secured to an abdominal height adjustment 83. The abdominal height adjustment 83 can adjust the height of the abdominal support cushion 82 relative to the lower baseboard 71 and may include zero, one, or multiple abdominal support cushions 100, 101, 102, 103 and 104.
Figures 14, 15 and 16 show the table attachments 77, 78, 79 to comprise rectangular bag support curtains 85, 86, 87 secured to an inflatable bag 88, 89, 90 along the upper baseboard 72 or lower baseboard 71 edges parallel to the longitudinal axis of the respective baseboard edge and at some generally parallel and coplanar segment of the curtain. Inflating the bag exerts an upward force on the attaching table and exerts a downward force on the respective curtain, immobilizing the baseboard relative to the attaching table. The apparatus of the present invention, when used in normal and intended operation, has several beneficial characteristics: (a) increased patient comfort results from the prone position of the patient during examination; (b) the use of adjustable air bags that conform to the curvatures of the individual patients increases comfort and stabilizes the patient from normal movement, increasing the chance of a successful and rapid examination; (c) the apparatus may accommodate examinations of the oblique breast region by rotating the patient along a longitudinal axis while maintaining patient stability on the apparatus; the apparatus accommodates examination of one breast with minimal cross talk by allowing isolation of the non-target breast with material opaque to the examining gamma camera; and (d) the specific design of the device allows for easy transportation with regard to weight, durability, and rapidity. The device may be easily converted from and to a light and durable package for shipping.
While the foregoing description is exemplary of the preferred embodiments of the present invention, those of ordinary skill in the relevant arts will recognize the many variations, alterations, modifications, substitutions and the like as are readily possible, especially in light of this description, the accompanying drawings and the claims drawn hereto. For example, those of ordinary skill in the art will recognize that the above-described invention, or components thereof could readily be adapted to be used in conjunction with other procedures which require the patient to lay in the prone position for extended periods of time. Such procedures could include, but are by no means limited to, other imaging procedures, of the radiographic or magnetic resonance type, as well as certain surgical procedures.. In any case, because the scope of the present invention is much broader than any particular embodiment, the foregoing detailed description should not be construed as a limitation of the present invention, which is limited only by the claims appended hereto.
INDUSTRIAL APPLICABILITY: The present invention is applicable to the medical diagnostics industries. In particular, the invention is applicable within the field of nuclear medicine, specifically scintimammography.