CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U. S. C. § 119(e) of U.S.

Provisional Application No. 61/102,561 filed on October 3, 2008, the contents of which are incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

[0002] The present invention relates to a positioning and stabilizing device for supporting a patient's head and face during prone surgical procedures, and more particularly to a system that can be positioned and fixed with three-dimensional variability and video monitoring capabilities during the surgical procedure.

Description of the Related Art

[0003] It is widely accepted that pre-operative positioning in the operating room is a crucial step in any operation. Errors in pre-operative positioning can have devastating consequences. Typically, a patient undergoing prone surgery, such as spinal surgery, is intubated in the supine position and then rolled into the prone, face down position. The patient's head extends beyond the top edge of the OR table and just after rolling into the prone position, the patient's head is initially supported manually by the anesthesiologist and positioned into an anatomically natural position.

[0004] Prone facial support systems have advanced slowly over the past several decades. In the beginning, a patient's forehead rested on a saline bag wrapped in a blue surgical towel placed directly on the OR table. The next development was a blue foam block with a T shaped hole for eyes, nose, and mouth and a side hole to accommodate the endotrachial tube. The foam is more supportive, but the device lacks any direct visualization or manual access, and also rests directly on the OR table. The most recent development was the Prone View ^® , by Dupaco, Inc. of Oceanside, CA, which utilizes a foam insert that rests in a plastic moulding that rests on a mirror, also placed directly on the OR table. This device has the advantage of providing visual access via the mirror, but lacks manual access to the oral and nasal tubing and lacks multidimensional positioning capabilities. [0005] Another head stabilizing device, the Mayfield ^® head clamp, by Integra Life

Services of Plainsboro, NJ, is used for prone neurosurgical procedures that provides an open environment and has a multi-dimensional position capability. This device is typically used for posterior, cervical spine or posterior fossa surgeries where head fixation and immobility are required. The downside is that the Mayfield ^® head clamp utilizes sharp metal pins that pierce the scalp and skull at 60 lbs. of pressure throughout the surgery. While the Mayfield ^® clamp is necessary for certain procedures, the majority of prone surgeries, lumbar and thoracic, do not require rigid fixation

[0006] These existing devices for supporting the head of a patient during prone surgical operations do not enable the pressure to be distributed properly and do not allow for positioning and variability. Such devices are also cumbersome and allow little if any access to the patient's airway. U.S. Published Patent Application No. 2006/0053556 teaches a headrest for a patient during prone surgery. However, the device does not enable medical professionals to adjust the position of the patient's head once the mask is positioned. Likewise, U.S. Patent No. 5,220,699 teaches a surgical face support mask that is fixed or with limited adjustability and U.S. Patent No. 5,520,623 discloses a face support device for sleeping that cushions the face in a prone position.

[0007] Adjustable headrest devices for surgery are known. However, head supports with mobility typically do not provide for a head in a prone position. See, U.S. Patent No. 6,594,839 and U.S. Published Patent Application Nos. 2008/0072381 and 2008/0078031. [0008] U.S. Published Patent Application No. 2006/0288484 discloses a prone headrest assembly for a massage table that is adjustable. However, the support device does not provide the support that is required to prevent serious operative complications. [0009] Accordingly, there is a need for an adjustable support device that not only prevents harmful pressure to the face and spine during prone surgical procedures, but allows manual access to the face, and visual access throughout the surgery via video recording.

SUMMARY OF THE INVENTION

[0010] The present invention relates to a variable position, head support and facial protection system for patients undergoing prone surgery. The invention combines several basic structural and technologic components to provide the next generation of patient safety for prone surgical procedures. The head support and facial protection components are a combination of a disposable custom soft foam insert that fits within a sturdy wire frame support. The mask prevents pressure on the patient's eyes, allows direct and video visualization of the patient's face, and provides manual access by anesthesiologists to oral and nasal tubes. The mask can be accommodated to any position to allow maximal security for a patients face through a solid connection to a universal three dimensional positioning arm. The system provides direct video monitoring of the patient' s face by the anesthesiologists during surgery.

[0011] The head support and facial protection system of the present invention provides a safe and secure environment for a patient's face and head while undergoing prone surgery. More specifically, the system creates the ability to position a patient's head in an anatomically neutral, natural, and stress free position through a positioning system that allows variability in pitch, roll, and yaw. The open mask design promotes safety by providing a pressure-free environment for the eyes and direct manual access to oral and nasal tubes by anesthesiologists. Furthermore, the open design provides a clear path for video monitoring allowing the anesthesiologist to monitor the patient's position and condition throughout the case and create a video record for documentation purposes.

[0012] Thus, one aspect of the present invention is to provide a variable positioning device that stabilizes and positions a patients head during prone surgical procedures. [0013] Another aspect of the present invention is to provide a prone surgery facial support device that provides an even distribution of pressure along the forehead and face and that enables the head to rest in an anatomically neutral position.

[0014] Yet another aspect of the present invention is to provide a prone surgery facial support device that eliminates any pressure application to the patient's eyes and removes stressful forces on the cervical spine.

[0015] Still another aspect of the present invention is a prone surgery facial support devices that allows direct access to the patient's eyes for visualization and examination of the patient's eyes by an anesthesiologists. Furthermore, the device enables endotracheal and oropharyngeal accessibility for direct inspection and manipulation, as well as video monitoring capability for documentation and visual access to the face. [0016] The present invention provides a prone surgical facial support device that incorporates a soft foam insert that supports the patients' face in a prone position. The face support insert, which is disposable, integrates into the rigid wire mask and evenly distributes pressure about the forehead, chin and periphery of the face. An adjustment mechanism connects the facial support system to an operating room table via a three dimensional universal arm. [0017] In accomplishing these and other aspects of the present invention there is provided a prone surgical facial support device having a face support for supporting a patient's face in a prone position. The face support includes a support mechanism for evenly distributing pressure about the forehead, chin and periphery of the face. An adjustment mechanism rotatably and moveably connects the face mask to an operating table. [0018] These and other features, aspects, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiment relative to the accompanied drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Fig. 1 is a front view of a prone surgery facial support mask of the present invention.

[0020] Fig. 2 is a cross-sectional view of the mask of Fig. 1 taken along line I-I.

[0021] Fig. 3 is a front view of another embodiment of a prone surgery facial support mask of the present invention.

[0022] Fig. 4 is a front view of a support of the mask of Fig. 3.

[0023] Fig. 5 is a front view of an insert of the mask of Fig. 3.

[0024] Fig. 6 is a front view of another insert used in conjunction with the support of

Fig. 4.

[0025] Fig. 7 is a side view of the prone surgery facial support device of the present invention.

[0026] Fig. 8 is a perspective view of another embodiment of the adjustment mechanism of the present invention .

[0027] Figs. 9-11 are perspective views of the device of the present invention with video monitoring.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0028] Referring to Fig. 1, the present invention relates to a prone surgery facial support device 10 that includes a face support mask 12. Mask 12 is preferably made from a substantially rigid plastic material or metal wire. It should be appreciated that the mask can be made of other suitable materials. Mask 12 includes an outer support 14 that has an oval shape to correspond with the shape of the patient's face. A plurality of longitudinal struts 16 and interconnecting horizontal struts 18 along with outer support 14 encompass the support structure for mask 12. Struts, 16, 18 are shaped to conform to the contour of the face. The struts and outer support can be formed of a single unitary molded piece or separate interconnected pieces. The support structure can be made of a sterilizable or disposable material.

[0029] As shown in Figs. 1 and 2, in one embodiment mask 12 includes a plurality of cushions 20 attached between struts 16, 18 and support 14. Cushions 20 provide a soft, stable support for the patient's face. The cushion(s) can be made of a flexible, plastic material, although cloth or any other suitable material, such as foam, can be used. Moreover, the material can be sterilizable, reusable or disposable. If reusable, the cushions should be made of a material that does not easily absorb fluids.

[0030] Referring again to Fig. 1, cushions 20 are disbursed about the entire periphery of the face to better support and conform to the weight and shape of the patient' s face. The cushions can be separately attached to apertures 22 of the support of the mask or can be a unitary, quilted piece that is attached to the structure. Conventional attachment means such as

Velcro ^® , or adhesive can be used to permanently or removably attach the cushion(s) to the mask.

[0031] The support structure of struts 16, 18 and cushion(s) 20 are provided along the entire temple area of the patient, as well as the chin and each side of the face to provide maximum pressure distribution and weight support.

[0032] The size, number and shape of the cushions can be varied to support different sized patients. For example, the cushions can be varied in thickness and width to allow for a variety of different sized patients using the same support structure. Alternatively, by varying the size of cushion(s) 20, the size and location of apertures 22 and/or the support structure, a variety of different sized patients can be fitted to wear mask 12 with optimal support and maximum distribution of pressure and weight about the entire periphery of the face to prevent injury to the eyes, nerves and skin.

[0033] Mask 12 has an inner access opening 24 that is free of struts 16, 18 and cushions 20. The access opening enables medical staff to monitor the patient's eyes during surgery and allows access to patient's face. Access 24 also allows for the passage of conventional life support tubes 4.

[0034] Mask 12 can also include fastening means for attaching the mask to the patient. Thus, the mask can be fitted on the patient prior to surgery and the patient can then be rolled over from a supine position to the prone position. As will be described further herein, the present invention also enables the patient' s head to be rotated while in the prone position.

[0035] Figs. 3-5 illustrate another embodiment of the face mask 12 of the present invention. Mask 12 includes a wire support 54 and a disposable custom soft foam insert 56. Insert 56 can be a unitary piece shaped to conform to support 54. Insert 56 has an aperture 58 shaped to allow access to the patient's eyes, nose and mouth. As described above, the mask is constructed and arranged to prevent pressure on a patient's eyes and to allow direct and video visualization of the face.

[0036] Fig. 6 is an internal view of another embodiment of an insert 60 to be used with the support 54. Insert 60 includes an opening 62 shaped to accommodate the patient's face.

[0037] Referring to Fig. 7, the present invention includes an adjustment mechanism

30 that enables the patient's head to be positioned and fixed with 3-dimensional variability during prone surgical procedures. Adjustment mechanism 30 can be a universal positioning arm that includes a support 32 removably attachable to an operating table 26 or other surface. Support 32 can be at least one bracket or rod, and is adjustable to change the position of mask 12 with respect to table 26. Support 32 can be telescopic or have some other position adjusting means.

[0038] Adjustment mechanism 30 includes a lower arm 34, a middle arm 36 and an upper arm 38. A joint 40 is located at one end of upper arm 38 and is rotatably connected to a flange 26 (Fig. 2) of mask 12. Joint 40 can be a ball joint or other known rotatable connection means. By attaching mask 12 to assembly 30 via rotatable joint 40, the patient's head can be rotated while in the prone position. Joint 40 may also include locking means 41, such as a knob 41, to lock the joint in the desired position once the patient's head has been positioned correctly.

[0039] As shown in Fig. 7, middle arm 36 and upper arm 38 are connected via a pivot

42. It should be appreciated that another type of rotatable connection means can be used. Pivot 42 allows arms 36 and 38 to be adjusted at different vertical positions. Arms 34, 36 and 38 can also be telescopic to adjust the lengths therebetween. Lower arm 34 and middle arm 36 are connected via a pivot 44 and the position therebetween can be locked via an easily accessible handle 46. Joint 48 attaches the other end of lower arm 34 with support 32. Thus, the vertical position of lower arm 34 can be adjusted with respect to table 26. Joint 48 can be a ball joint, pivot or other rotatable connection means with locking means. [0040] Fig. 8 illustrates another embodiment of an adjustment mechanism 30 in use with the mask and support of Figs. 3-6. Support 54 includes a connector 64 located at the top of the support. Upper arm 38 can be attached to connector 64. Middle arm 36 and support 32 can be telescopic to adjust the mechanism 30 as described above.

[0041] Due to the above-described adjustment mechanism 30, the position of mask 12 with respect to table 26 can be adjusted with a three-dimensional path of movement. Thus, different sized patients can be easily accommodated. Most importantly, the position of mask 12 can be adjusted to meet the needs of the patient, minimizing the danger of injury by allowing the surgical staff to monitor the patient and prevent the patient from being subject to pressure at a point on the face that can cause optical or other nerve damage while in the prone surgical position.

[0042] In use the face mask with a disposable custom insert is applied directly to the patient's face while the patient is in the anatomically natural position and again supported manually. The facemask is then connected to the universal arm and locked into place. As shown in Figs. 9-11 a video camera 70 can be connected to the adjustment mechanism 30 and directed at the patient's face. The video camera connects to any computer through a USB port and captures continuous, real time video during the procedure. [0043] It should be appreciated that the device has the ability to interact with a commercially available positioning arm. A separate connector arm, and indeed the device is not restricted to being only interactive with the disclosed arm.

[0044] Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.