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Title:
AN APPARATUS FOR POSITIONING PATIENTS DURING CERTAIN MEDICAL PROCEDURES
Document Type and Number:
WIPO Patent Application WO/1998/055013
Kind Code:
A2
Abstract:
A platform for supporting and positioning a patient on a standard examination table during medical procedures, especially procedures associated with the radiographic examination of a patient's breast. The platform includes a body support cushion having inflatable components capable of elevating the body of the patient as well as rotating the body of the patient clockwise or counterclockwise about a generally longitudinal axis. The platform futher includes a head and arm support independently positionable on the examination table adjacent the body support cushion. The head and arm support also includes air inflatable enclosures for elevating the patient's head during the examination. The body support and head and arm support cushions are positioned on the examination table using inflatable attachment means in a manner that defines a gap sufficient for allowing the breasts of the patient to fall freely beneath the patient when the patient is lying in a prone position on the platform. Appropriate side support and lower body support cushions are also provided.

Inventors:
KERR JERRY (US)
DIMITRIU DAN (US)
HICKS RONALD B (US)
LEININGER PETER A (US)
VRZALIK JOHN H (US)
Application Number:
PCT/US1998/011221
Publication Date:
December 10, 1998
Filing Date:
June 03, 1998
Export Citation:
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Assignee:
KINETIC CONCEPTS INC (US)
KERR JERRY (US)
DIMITRIU DAN (US)
HICKS RONALD B (US)
LEININGER PETER A (US)
VRZALIK JOHN H (US)
International Classes:
A61B6/04; A61G13/12; (IPC1-7): A61B/
Attorney, Agent or Firm:
Kammer, Mark A. (PLLC Suite 304, 750 E. Mulberr, San Antonio TX, US)
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Claims:
We claim:
1. A platform for supporting and positioning a patient on an examination table during a medical procedure, said platform comprising: a body support cushion having a length, a width, and a surface area suitable for the support of the body of said patient, said body support cushion removably positionable on said examination table, said body support cushion comprising: first and second inflatable oblique bags, said oblique bags each having a length approximately equal to said length of said body support cushion and a width approximately equal to onehalf said width of said body support cushion, said oblique bags positioned adjacent and parallel to each other so as to provide a foundation for said body support cushion on said examination table, wherein inflation of one of said oblique bags serves to rotate said body of said patient about a generally longitudinal axis; a flexible overlay board positioned and secured over said oblique bags, and sized so as to generally cover said oblique bags; a plurality of inflatable lift bags, said lift bags each having a length and a width approximately equal to said length and said width of said body support cushion, a first one of said inflatable lift bags positioned and secured over said flexible overlay board and the remainder of said inflatable lift bags positioned and secured in sequence over said first inflatable lift bag; a rigid overlay board positioned and secured over a last one of said inflatable lift bags, and sized so as to generally cover said lift bags; a formable filled bag positioned and secured over said rigid overlay board, said filled bag comprising a flexible shell and a plurality of beads within said shell such that upon evacuation of air from said shell, said beads become rigid and maintain a shape defined prior to said evacuation of air; a foam body layer positioned and secured over said formable filled bag and suitable for receiving said body of said patient thereon; a head and arm support cushion comprising: a support frame, said support frame having a first and a second horizontal wall and a first and a second vertical wall, said walls joined so as to form an openended enclosure, said support frame being dimensioned so as to receive said examination table through said openended enclosure; first and second inflatable table attachment bags, said table attachment bags secured to said support frame and positioned therein so as to receive said examination table between said attachment bags when said examination table is inserted through said openended support frame, wherein inflation of said attachment bags pushes against said examination table and provides stability and immobility for said head and arm support cushion; a side support cushion assembly comprising first and second pairs of side support boards, each of said side support boards having an inflatable side support bag, said first and second pairs of side support boards positioned longitudinally along said length of said body support cushion and serving to support said body of said patient from the side, said first and second pairs of side support boards each pivotally secured to a base sheet, said base sheet passing beneath said body support cushion and serving to hold said first and second pairs of side support boards in position adjacent said body support cushion; and an air delivery system comprising a blower box and a pressure hose, said pressure hose connecting said blower box to each of said inflatable bags in said body support cushion, said head and arm support cushion, and said side support cushion assembly.
2. A platform for supporting and positioning a patient on an examination table during a medical procedure, said platform comprising: an upper baseboard; a head and arm support, said head and arm support positioned and secured on said upper baseboard, said head and arm support having at least one inflatable cushion component; a lower baseboard; an abdominal support, said abdominal support positioned and secured on said lower baseboard, said abdominal support having at least one inflatable cushion component; a lower body support, said lower body support positioned and secured on said lower baseboard, adjacent said abdominal support, said lower body support having at least one inflatable cushion component; a body restraint strap, said restraint strap removably secured between said abdominal support and said head and arm support so as to provide patient stability when secured; and an air delivery system, said air delivery system providing inflation air to each of said inflatable cushion components of said head and arm support, said abdominal support, and said lower body support.
3. The platform of Claim 2 wherein said upper baseboard and said lower baseboard each further comprise inflatable attachment means for positioning and securing said upper baseboard and said lower baseboard to said examination table, said inflatable attachment means being inflatable by said air delivery system.
4. The platform of Claim 2 wherein said upper baseboard and said lower baseboard each further comprise strap attachment means positioning and securing said upper baseboard and said lower baseboard said examination table.
5. The platform of Claim 2 wherein said upper baseboard and said lower baseboard each further comprise zipper attachment means for positioning and securing said upper baseboard and said lower baseboard to said examination table.
6. The platform of Claim 2 wherein said head and arm support further comprises means for height adjustment, said height adjustment means allowing the head of said patient to be elevated above a general horizontal plane defined by said upper baseboard.
7. The platform of Claim 2 wherein said head and arm support further comprises a shielding curtain, said shielding curtain serving to reduce interferences during an imaging procedure carried out during said medical procedure.
8. The platform of Claim 2 wherein said abdominal support further comprises a shielding curtain, said shielding curtain serving to reduce interferences during an imaging procedure carried out during said medical procedure.
9. The platform of Claim 6 wherein said head and arm support further comprises a surface cushion, said surface cushion positioned and secured on said means for height adjustment, said surface cushion formed to follow the general contours of the upper body and arms of said patient when said patient is in a prone position extended longitudinally across said platform.
10. The platform Claim 9 wherein said surface cushion of said head and arm support further comprises a plurality of surface nodes, said surface nodes defining a valley within which the elbows of said patient may rest, said nodes further defining an inclined plane adjacent said valley, said inclined plane receiving the forearms of said patient when said patient is in a prone position, said nodes further defining a wall opposite said inclined plane, said wall serving to separate said arms and head of said patient from a chest area of said patient.
11. The platform of Claim 6 wherein said means for height adjustment for said head and arm support comprises a plurality of inflatable adjustment cushions, each of said adjustment cushions independently inflatable with air from said air delivery system.
12. The platform of Claim 11 wherein said means for height adjustment further comprises a plurality of inflatable rotation cushions, said rotation cushions serving to rotate said patient around a generally longitudinal axis upon inflation.
13. The platform of Claim 2 wherein said abdominal support further comprises means for height adjustment, said height adjustment means allowing the abdomen of said patient to be elevated above a general horizontal plane defined by said lower baseboard.
14. The platform of Claim 13 wherein said abdominal support means for height adjustment comprises a plurality of inflatable support cushions, each of said inflatable support cushions independently inflatable with air from said air delivery system.
15. The platform of Claim 3 wherein said inflatable table attachment means of said upper baseboard comprises an inflatable attachment bag, said attachment bag flexibly secured to said upper baseboard, so as to define an openended enclosure capable of receiving said examination table therethrough, said inflatable attachment bag serving to position and immobilize said head and arm support on said examination table upon inflation.
16. The platform of Claim 3 wherein said inflatable attachment means for said lower baseboard comprises first and second inflatable attachment bags, said first and second inflatable attachment bags flexibly secured to said lower baseboard, an enclosure capable of receiving said examination table therethrough, said inflatable attachment bags serving to position and immobilize said abdominal support and said lower body support on said examination table upon inflation.
Description:
Title: An Apparatus For Positioning Patients During Certain Medical Procedures Field of the Invention The field of this invention is that of apparatus which are intended to support patients during medical procedures, and in particular, those procedures performed in the field of nuclear medicine.

Background of the Invention Each year in the United States. 23 million mammographic examinations are done. About 30% of the women receiving a mammogram have breasts that are difficult to read, which can result in inaccurate or ineffective examinations. The main contributing factors to the inaccuracies in recording the scintimammogram include the phenomenon know as cross talk.

This is caused, for example, when recordino an image of the right breast. the left breast also contains a lesion which is a source of radiation. If the lesion in the left breast is within the field of view of the recording device. the image of the lesion in the left breast can interfere with the image formed of the right breast. thus presenting the analyst with an inaccurate or ambiguous image. One method employed to reduce cross talk is to have the patient lie at an angle with the target breast suspended off the side of the table, and the other breast compressed against the surface of the table, placing it substantially out of the field of view of the imaging device. This position is uncomfortable for the patient, since the procedure typically requires ten minutes per breast to complete. Further, the technologist administering the procedure must remain in close proximity to the patient in order to provide physical support for the patient.

Although this method is somewhat effective in the reduction of cross talk, it results in one of the biggest drawbacks to the procedure as it is performed today, that the nuclear medicine technologist must remain in close proximity to the patient during the entire procedure. Since the patient is a radioactive source, due to the isotopes which have been injected into their body, this results in significant exposure to the technologist during the course of the procedure.

Although scintimammography is gaining widespread acceptance by the medical community as a diagnostic and detection procedure for breast cancer, there are no known apparatus available which are specifically designed to provide for patient positioning and comfort during this particular procedure. Thus the present invention is believed to be unique to the field.

Scintimammography is a new diagnostic procedure that utilizes a radidonuclide, technetium 99 sestimibi, to detect breast cancer in patients with indeterminate or hard to read conventional mammoarams. Unlike a traditional mammogram, which compresses the breast and x-rays its anatomical structures, scintimammography allows the breast to hang free and uses a gamma camera to record focal areas of radioisotope activity, indication2 a alignant lesion.

SUMMARY 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.

BRIEF DESCRIPTION OF THE DRAWINGS 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 10, 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 10. polyethylene filled bag 11, and body foam 12.

Figure 6 shows the top view of rigid overlay board 10 or the flexible overlav 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 12,14.

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 A-A plane of Figure 13.

Figure 15 shows a cutaway view looking rearward into the B-B plane of Figure 13.

Figure 16 shows a cutaway view looking rearward into the C-C plane of Figure 13.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS (A) Figure 1 is an example of a typical examination table 10 to which the apparatus of the present invention can be attached. Although this specific table 10 is appropriate for the application, many other tables can be utilized.

Figure 2 depicts the exploded view of the apparatus. Arrows A and B indicate possible locations of the gamma camera required for the scintimammography examination. The figure shows the general assembly of the apparatus including relative positions to the attaching table 10

of the side support rails 19,20, and head and arm support 52, and the components of the body support 51. A blower box 67 delivers air through the pressure hose 66 to all inflatable components at a pressure capable of supporting a patient under normal operating conditions. The side support rails can be augmente by straps which secure the patient on the apparatus.

Referring to Figure 3, there is shown the side view of the apparatus according to the teachings of the present invention, namely a scintimammography examination table 10. The table 10 includes a body support 51, a head and arm support 52, and two side support rails 19, 20.

Shown in Figure 4 and Figure 5. the body support 51 includes multiple layers of materials to provide for patient elevation and stabilization. Two separately inflatable oblique bags 54, 55 provide the foundation of the body support 51, allowing for the patient's body to be rotated from 10 to 45 degrees clockwise or counterclockwise about a generally longitudinal axis. When inflated simultaneously, the oblique bags 54,55 can also elevate the patient from the generally horizontal plane of the attaching table. Each oblique bag 54,55 provides a pressure valve allowing for controlled inflation or deflation of the bag.

To provide support for the body support 51. a flexible overlay board 56 made from radiolucent polyethylene or similar radiolucent material is secured over the oblique bags 54,55.

The length and width of the flexible overlay board 56 are approximately or exactly equivalent to the length and width of the body support 51, respectively. An alternative embodiment shown in Figure 6 consists of four rectangular slits of sufficient length and width to be used for attachment to the other components of the body support are located along each longitudinal edge of the flexible overlay board 56.

As shown in Figures 4 and 5, the body support 51 includes one or multiple inflatable air bags 57,58 and 59 of length and width approximately or exactly equal to that of the flexible overlay board 56, which are inflatable to adjust the height of the patient. Each of the included inflatable air bags 57,58,59 provides a pressure valve to control the inflation of the device.

A rigid overlay board 50 of approximately or exactly equal length and width equal to the length and width of the flexible overlay board 56 and fashioned from radiolucent polyethylene or similar material is secured on top of the inflatable air bag 59 to provide a rigid base for a polyethylene filled bag 11. Shown in Figure 6. four rectangular slits approximately or equal to the dimensions of the slits in the flexible overlav board 56 to be used for attachment to the other components of the body support are located along each longitudinal edge of the rigid overlay board 50.

A polyethylene filled bag 11 is secured on top of the rigid overlay board 50. When the polyethylene beads inside the polyethylene filled bag 11 are stabilized and the contained air is evacuated through pressure valves, the polyethylene filled bag 11 becomes rigid and maintains shape providing the patient with a personalized imprint onto the bag. Secured on top of the polyethylene filled bag 11 is a layer of body foam 12 that conforms to both the polyethylene filled bag 11 and the patient.

The head and arm support 52 includes an open ended head and arm support platform 53, allowing the attaching table to slide through the head and arm support 52. The head and arm support platform 53, depicted in Figure 7, is fashioned from radiolucent polyethylene or similar material with width approximately equal to the width of the attaching table at the area of attachment. Shown in Figure 8 are two independently inflatable table attachment bags 13,14 of length and width equal to or less than that of the length and width of the head and arm support platform 53 respectively and are inflatable through the pressure hose 66. The table attachment bags 13,14 are secured to the platform along both the vertical faces of the platform. The attaching table is positioned through the head and arm support platform 53 and between the inflatable table attachment bags 13,14, as shown in Figure 8, allowing the bags to inflate against the attaching table and provide stability and immobility.

Figure 9 depicts the overhead view of the head and arm support platform 53 in relationship to the table 10.

Referring to Figure 10, two side support boards 23,24 form the base of the left side support rail 19 and are joined in such fashion to provide for swivel movement along the adjoining edge with Velcro straps 68,69 or similar attachment one independently inflatable side support bag 25,26 is secured to each side support board 23, 24. The lower side support board 23 is secured to a vinyl base 21 with Velcro strips. The vinyl base 21 is secured to the attaching table and the vinyl base of the right side support rail 20 with Velcro strips or similar material.

Normal operation of the apparatus requires the patient to lay on the invention in a prone position. allowing the breast to fall into the empty volume between the head and arm support 52 and the body support 51, as shown in Figure 11. This allows the breast to be freely suspended, increasing the effectiveness of the gamma camera when detecting abnormalities. The body support may be raised as in Figure 12 to prevent larger breasts from touching the table 10. This allows the device to accommodate different breast sizes.

Referring to Figure 13, there is shown the second of two preferred embodiments of the apparatus. 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 restraint 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 varying degrees of immobility relative to the attached table. A blower box 110 maintains inflation of all desired inflatable 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 described 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.

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 extended longitudinally across 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 91,92.

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 Velcro strips or similar methods. 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 103 and 104.

Figures 14,15 and 16 show the table attachments include 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 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, 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-taret 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.

From the above discussion, those skilled in the art will readily 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.




 
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