This disclose relates generally to patient securement devices to stabilize the patient on the surgical table for the Trendelenburg and other positions.
Keeping the patient from sliding off of a surgical table when the table is tilted into a steep, head-down (Trendelenburg) position, is a constant challenge for surgical personnel and a danger for the patient. This problem has gotten worse in recent years with the advent of laparoscopic surgery and particularly with the advent of robotic surgery. In both of these instances, the patients are regularly placed into the steep Trendelenburg position so that gravity can move the internal organs out of the way of the laparoscopes. Depending on the angle or steepness of the head-down Trendelenburg positioning, the patient's weight, and the make-up of the support surface (e.g., bed sheets), patients can be at risk of sliding off of the head end of the surgical table in the Trendelenburg position. This is especially true for pelvic surgery (e.g. rectal, gynecological, and urological), where the head of the surgical table may be tilted as much as 45° downward in order to use gravity to move the bowels and other internal organs away from the pelvis to improve the view of the surgical site.
Types of patient securement devices have been tried over the years. In general, there are several categories of securement devices, including: straps and tape; shoulder bolsters; foam surgical table overlays; bean bags that mold around the patient; and gel pads that stick to the patient. Straps and tape across the chest have proven to not be secure. Straps over the shoulders have resulted in stretch injuries to the nerves of the brachial plexus. Similarly, bolsters of foam or bean bags at the patient's shoulders that are secured to the side rails of the bed have also resulted in stretch injuries to the nerves of the brachial plexus and are not recommended by the Association for Operating Room Nurses. Gel pads are cold and messy because everything sticks to them.
Foam surgical table overlays have become the standard securement devices. The foam is generally sized to cover the section of the surgical table that supports the patient's torso and head. Irrespective of the foam's coefficient of friction against the patient's skin, the smooth surface of the surgical mattress usually creates a lower coefficient of friction between the foam and the mattress than the coefficient of friction between the foam and the patient. Therefore, unwanted slipping is most likely to occur between the mattress and the foam surgical table overlay. In order to improve the connection between the mattress and the foam surgical table overlay, the foam overlay is typically taped or strapped to the side rails of the surgical table. However, tape sticking to a foam surgical table overlay or straps glued to a foam surgical table overlay as described by Pigazzi in U.S. Pat. No. 8,464,720, for example, have a significant risk of becoming unattached when the weight of a 400 pound patient is applied at a 45° head-down angle. Either the adhesive fails or the top layer of foam pulls away from the foam surgical table overlay while still being adhered to the tape.
Some known devices, as described in U.S. Pat. No. 10,045,902 for example, advocate for the use of thicker foam pads, such as viscoelastic pads having a thickness in the range of from three-fourths of an inch to three inches or greater to permit formation of a depression having a depth sufficient to assist in holding a patient on the pad. In the present disclosure, we refer to the formation of a depression having a depth sufficient to assist in holding a patient on the pad as a “bolster effect.” The disadvantage of any securement device relying wholly or in part on a bolster effect is that bolster-type securement can be overpowered by excessive weight and rounded shaped shoulders that are common with obesity. Therefore, securement devices that rely in part on a bolster effect must provide instructions for use that limit both the weight of the patient and the angle of decline.
It would be desirable to provide reliable, safe, and convenient patient securement devices to stabilize the patient on the surgical table for the Trendelenburg and other unusual positions.
The underbody support mattresses and blankets of this disclosure are intended for use in medical settings generally. These include the operating room, the emergency room, the intensive care unit, hospital rooms, nursing homes, and other medical treatment locations.
Various embodiments include flexible and conformable heated underbody supports including mattresses, mattress overlays, and pads for providing therapeutic warming to a person, such as to a patient in an operating room setting. In various embodiments, the heated underbody support is maximally flexible and conformable allowing the heated surface to deform and accommodate the person without reducing the accommodation ability of any underlying mattress, for example.
In some embodiments, a sheet of fabric or other material that has been at least partially coated on both sides with friction-enhancing elements, such as high-friction plastic or rubber, may be interposed between the patient and the underbody support in order to increase the coefficient of friction therebetween. An example of such friction-enhancing elements may be a PVC foam or silicone rubber applied as a pattern of three-dimensional raised dots onto a sheet of fabric. Another example of such friction-enhancing elements may be a foam layer attached to a fabric layer.
In some embodiments, a sheet of fabric that is at least partially coated or laminated with friction enhancing elements is secured to the side rails of the surgical table by fabric or film or fabric reinforced film side securement flaps. The side securement flaps may be secured to the side rails by buttons attached to a side rail adaptor, or by hooks, or by straps. Irrespective of the attachment mechanism, the side securement flap material is contiguous between at least two adjacent attachment points to minimize the downhill shift that naturally occurs during Trendelenburg positioning or the distraction (pulling) of the leg during postless orthopedic hip surgery.
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical illustrations for implementing various exemplary embodiments. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of skill in the field. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized.
Each of the following US patents is hereby incorporated by reference in its entirety: U.S. Pat. Nos. 10,765,580; 10,575,784; 10,959,675; 10,980,694; 10,993,866; 11,103,188; and 11,278,463.
In some embodiments, as shown in
Mattress overlay embodiments may be similar, or identical, to pad embodiments, with the only difference being whether or not they are used on top of a mattress. Furthermore, the difference between pad embodiments and mattress embodiments may be the amount of support and accommodation they provide, and some pads may be insufficiently supportive to be used alone like a mattress. As such, the various aspects which are described herein apply to mattresses, mattress overlay and pad embodiments, even if only one type of support is shown in the specific example.
While there is repeated reference to “heated underbody supports” in this disclosure, skilled artisans will appreciate that the heat feature is not a necessary component of every embodiment. Non-heated underbody support embodiments are also anticipated.
In some embodiments, the heated underbody support includes a heater assembly and a layer of compressible material. The heater assembly may include a heating element including a sheet of conductive fabric having a top surface, a bottom surface, a first edge, an opposing second edge, a length, and a width. The conductive fabric may include threads separately and individually coated with an electrically conductive or semi-conductive material, with the coated threads of the fabric being able to slide relative to each other such that the sheet is flexible and stretchable. In some embodiments, the conductive fabric may be made with threads that are conductive such as carbon fiber. In some embodiments, the sheet is made with conductive ink applied to a polymeric film such as polyester film and is therefore not made with conductive fabric. In some embodiments, the heater is made of conductive film such as carbon or graphite-loaded plastic film.
The heater assembly may also include a first bus bar extending along the entire first edge of the heating element and adapted to receive a supply of electrical power, a second bus bar extending along the entire second edge of the heating element, and a temperature sensor. The layer of compressible material may be adapted to conform to a person's body under pressure from a person resting upon the support and adapted to return to an original shape when pressure is removed. It may be located beneath the heater assembly and may have a top surface and an opposing bottom surface, a length, and a width, with the length and width of the layer being approximately the same as the length and width of the heater assembly.
In some embodiments, the bus bars may be braided wire. In some embodiments, it may be desirable to coat the bus bars with a flexible rubber material such as silicone rubber, during construction of the heater. While braided wire is relatively tolerant of repeated flexion, if the flexion occurs enough times at the same spot, even braided wire bus bars can fracture and fail. Coating the bus bars with silicone rubber can significantly increase the durability of the bus bars to survive repeated flexion.
In some embodiments, the conductive or semi-conductive material is polypyrrole. In some embodiments, the compressible material includes a foam material, and in some embodiments it includes one or more air filled chambers. In some embodiments, the heated underbody support also includes a water resistant shell encasing the heater assembly, including an upper shell and a lower shell that can be sealed together along their edges to form a bonded edge, with the heater assembly attached to the shell only along one or more edges of the heater assembly. In some embodiments, the heating element has a generally planar shape when not under pressure. The heating element is adapted to stretch into a three-dimensional compound curve without wrinkling or folding while maintaining electrical conductivity in response to pressure, and may return to the same generally planar shape when pressure is removed.
In some embodiments, the heated underbody support includes a heater assembly including a flexible heating element comprising a sheet of conductive fabric having a top surface, a bottom surface, a first edge and an opposing second edge, a length, and a width, a first bus bar extending along the first edge of the heating element and adapted to receive a supply of electrical power, a second bus bar extending along the second edge of the heating element, and a temperature sensor. The underbody support may further include a layer of compressible support material located beneath the heater assembly, which conforms to a patient's body under pressure and returns to an original shape when pressure is removed.
In some such embodiments, the heating element includes a fabric coated with a conductive or semi-conductive material, which may be a carbon or metal containing polymer or ink, or may be a polymer such as polypyrrole. In some embodiments, the heated underbody support also includes a shell including at least two sheets of flexible shell material surrounding the heater assembly, the shell being a water resistant plastic film or fiber reinforced plastic film with the at least two sheets sealed together near the edges of the heater assembly. In some embodiments, the heated underbody support also includes a power supply and controller for regulating the supply of power to the first bus bar.
In some such embodiments, the compressible material is a foam material. The heater assembly may be attached to the top surface of the layer of compressible material. In some embodiments, the heated underbody support includes a water resistant shell encasing the heater assembly and having an upper shell and a lower shell that are sealed together along their edges to form a bonded edge. In some such embodiments, one or more edges of the heater assembly may be sealed into the bonded edge. In some embodiments, the heater assembly is attached to the shell only along one or more edges of the heater assembly. In some embodiments, the heater assembly is attached to the compressible foam material layer. In some embodiments, the heated underbody support also includes an electrical inlet, wherein the inlet is bonded to the upper shell and the lower shell and passes between them at the bonded edge. In some embodiments, the heated underbody support also includes an electrical inlet, wherein the inlet is bonded to the side wall of the shell.
In some embodiments, the temperature sensor is adapted to monitor a temperature of the heating element and is located in contact with the heating element in a location upon which a patient would be placed during normal use of the support. In some embodiments, the heated underbody support also includes a power supply and a controller for regulating a supply of power to the first bus bar. Some embodiments of heating pads and mattresses have been disclosed in U.S. Pat. Nos. 8,604,391; 9,962,122; and 10,206,248, the entire disclosures of which are incorporated by reference into the present disclosure.
The steep Trendelenburg position is often used during urological, gynecological and colorectal surgery, especially if the surgery is done with robotic or laparoscopic techniques. As shown in
The underbody support 16 may include elements for anchoring the underbody support 16 to the surgical table 4. In some embodiments, the elements for anchoring may be a Velcro attachment between the upper surface of the surgical table 4 and the lower surface of the underbody support 16. The lower surface may also be called the table interface surface.
In some embodiments, the elements for anchoring the underbody support 16 may be a strap attachment between the side of the surgical table 4 and the durable shell of the underbody support 16. As shown in
In some embodiments, the shell material of the underbody support 16 may be reinforced with a mesh of fibers such as nylon embedded in the shell material during the shell material extrusion process. The fiber reinforcement may be included in the lower shell layer, the upper shell layer, or in both shell layers. The reinforcing fibers prevent the shell material from stretching and deforming when a heavy patient is placed in the steep Trendelenburg position, creating a sliding force between the layers of the underbody support or between the underbody support 16 and the surgical table mattress 30 or the surgical table top 64. This reinforced construction of the underbody support 16 in conjunction with the reinforced construction of the strap attachment protrusions 22 of the underbody support 16 together with the reinforced construction of the straps 18A, 18B connected to the side rails 20 of the surgical table 4, or Velcro attachment to the surgical table top 64, assures that the underbody support 16 will remain stable and not shift or slide when the patient is placed in the steep Trendelenburg position. In some embodiments, the durable construction of this underbody support 16 prevents deformation and stretching in any direction parallel to the plane of the support, thus preventing slippage between the underbody support 16 and the surgical table 4. The stability and inability to deform in response to the weight of the patient pulling the patient down the slope of the surgical table 4 provided by this construction, is in contrast to the relatively fragile and flexible construction of conventional disposable securement pads. As shown in
Additionally, as shown in
In some embodiments, as shown in
In some embodiments, a sheet of fabric 32 is interposed between the upper surface of the underbody support 16 and the back of the patient 2 in order to increase the coefficient of friction between these two surfaces. The sheet of fabric 32 may be either woven or non-woven and may be made of any durable fiber such as polyester, rayon, nylon or cotton. Other fibers for the sheet of fabric 32 are also anticipated. In some embodiments, if a fluid impervious layer is desirable, the sheet of fabric 32 in this disclosure may be made of plastic film or plastic film coated or laminated onto one or both sides of a sheet of fibrous fabric. The plastic film layer may be made of polyethylene, polypropylene, PVC, urethane or other suitable films.
In some embodiments, the sheet of fabric 32 is partially coated on at least its upper surface 36 with friction-enhancing elements 34. The friction-enhancing elements 34 can be a plastic or rubber three-dimensional friction-enhancing elements, such as a three-dimensional raised pattern of circular, square, rectangular or oblong elements. In some embodiments, the friction-enhancing elements 34 are between 0.1 inches and 0.5 inches in diameter or cross section. The friction-enhancing elements 34 include but are not limited to: PVC foams, viscoelastic PVC foams, silicone, viscoelastic polyurethane foams, other viscoelastic polymeric foams, urethane, PVC, as well as other polymers and rubbers.
In some embodiments, as shown in
In some embodiments, as shown in
In some embodiments, as shown in
In some embodiments, the area of one hole 40 may advantageously be less than the area of one of the friction-enhancing elements 34. In some embodiments, the area of one of the holes 40 may advantageously be less than 0.1875 square inches. Holes 40 that are larger than 0.1875 square inches disadvantage both the area of skin supporting the weight of the patient's body and the natural tackiness between the friction-enhancing elements 34 and the skin. Further, holes 40 that are larger than 0.1875 inches square may create a hydrostatic pressure gradient within the patient's skin protruding into the hole 40 resulting in a pattern of petechiae or bruising.
In some embodiments, as shown in
Where the friction-enhancing elements 34 are foamed PVC three-dimensional friction-enhancing elements, flattening these friction-enhancing elements 34 in a heat laminator process also alters the surface characteristic of the foamed PVC material, making it substantially stickier. The heating and compression process disrupts the normal “skin” that forms on the surface of foam as it cures. Disrupting the surface “skin” exposes the “stickier” inner foam. The stickier PVC foam further increases the coefficient of friction between the underbody support 16 and the patient 2. The “stickier” PVC foam may stick to the patient better than the skinned foam but it does not stick as well to adhesives. The exposed plasticizer in the foam interferes with the adhesion of adhesives. Therefore, if pieces of the sheet of fabric 32 are intended to be adhesively bonded to the draw sheet 76 or other materials, it may be advantageous to adhesively bond to the non-compressed side of the sheet of fabric 32. The original “skin” characteristic of the foamed PVC material on the lower surface 38 helps with adhesive bonding. The stickier foam PVC in the presence of heat from the underbody support 16 and pressure from the weight of the patient 2, may leave an unsightly residue of foam adhered to the underbody support 16. In some embodiments, this adhesion residue may be prevented by heating and flattening the friction-enhancing elements 34 on the upper surface 36 of the sheet of fabric 32, while leaving the original “skin” characteristic of the foamed PVC material on the lower surface 38 substantially unchanged and less sticky. The original “skin” characteristic of the foamed PVC material on the lower surface 38 helps to prevent the residue of foam from adhering to the underbody support 16.
In some embodiments, as shown in
In some embodiments, the sheet of fabric 32 with friction-enhancing elements 34 (which can be foamed PVC three-dimensional friction-enhancing elements) and having uncoated spaces or holes 40 therebetween, can be flattened and thinned by running it through a heated compression process. The heated compression process may advantageously produce a patient securement device with very little thickness (compared to conventional thick foam pad securement devices) yet retain most of the gripping characteristics.
In some embodiments, the underbody support 16 may also serve as a capacitive coupling electrosurgical grounding electrode. Effective capacitive coupling requires that the two electrical conductors be separated by only a thin dielectric (electrical insulator). Capacitive coupling of RF electrical energy is most efficient and effective when the patient's skin is separated from the grounding antenna by a thin dielectric or electrical insulating material. A thick dielectric, for example greater than 0.5 inches, will prevent effective capacitive coupling electrosurgical grounding. The friction-enhancing elements 34 (which can be three-dimensional friction-enhancing elements) on the sheet of fabric 32 of the present disclosure create a thin dielectric. The thickness of this dielectric may be further decreased by heating and compressing the friction-enhancing elements 34 between two rollers as described above in order to form flattened friction-enhancing elements 50, which further enhances the effectiveness of the capacitive coupling. In some embodiments, the thin nature of the sheet of fabric 32 of the instant invention (such as less than 0.125 inches thick), allows effective capacitive coupling electrosurgical grounding. The capacitive coupling may be even further enhanced by the holes or uncoated spaces 40 that are formed between the friction-enhancing elements 34, 50, where there is no added electrical insulating (dielectric) properties caused by the sheet of fabric 32. The invention of this disclosure is uniquely suited for use with capacitive coupling electrosurgical grounding. In contrast, the conventional (e.g., thick foam) securement pads 26 prevent effective capacitive coupling from occurring.
In some embodiments, the total thickness of each of the (e.g., three-dimensional) friction-enhancing elements 34 on both the upper 36 and lower 38 surfaces of the sheet of fabric 32 is less than 0.25 inches. In some embodiments, as shown in
In some embodiments, minimizing or even eliminating any weight-limited patient securing bolster effect in the patient securement overlay 54 by limiting the thickness to less than 0.75 inches, results in a patient securing effectiveness that is determined nearly exclusively by the coefficient of friction between the patient and the patient securement overlay 54. Coefficient of friction is by definition, independent of the patient's weight. In some embodiments, due to the physical properties of the coefficient of friction, the effectiveness of this patient securement device is independent of the patient's weight and is only limited by the angle of the decline. Therefore, due to the physical properties of the coefficient of friction, the patient securement device of the instant disclosure can accommodate patients of any size or weight, without limitation. The instructions for use of this device may only limit the angle of decline. Most known bolster-type patient securement devices are limited to certain weights, usually 300-400 pounds. The instructions for use of bolster-type devices limit both the angle of decline and weight of the patient.
In some embodiments, as shown in
As shown in
In some embodiments, the perineal cutout 14 of the underbody support 16 may be a tapering 3-6 inch recess in the foot end of the underbody support 16 that may be 10-20 inches wide at the open side of the recess and 4-12 inches wide at the closed side of the recess.
In some embodiments, as shown in
In some embodiments, the width of the foot end extension 58 is less than the width of the patient securement overlay 54. In some embodiments, the width of the foot end extension 58 is advantageously approximately equal to the width of the closed side of the recess of the perineal cutout 14 of the surgical table mattress 30 or the underbody support 16. In some embodiments, the width of the foot end extension 58 may be between 4 and 20 inches. In some embodiments, the width of the perineal cutout 14 of the underbody support 16 may be greater than a width of the perineal cutout 14 of the surgical table mattress 30. When the perineal cutout 14 of the underbody support 16 is wider than the width of the perineal cutout 14 of the surgical table mattress 30, this may advantageously allow a wider and thus stronger foot end extension 58 of the sheet of fabric 32 to wrap around the perineal cutout 14 of the underbody support 16 and still fit within the perineal cutout 14.
In some embodiments, the patient securement overlay 54 is advantageously anchored to at least a portion of the head end 62 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso, by a head end extension 60 of the sheet of fabric 32 that wraps around at least a portion of the head end 62 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso and is secured under the surgical table mattress 30 or underbody support 16. In some embodiments, the head end extension 60 for anchoring the head end of the patient securement overlay 54 is a separate sheet of fabric that is added as an extension to the sheet of fabric 32.
In the Trendelenburg position, the force vector of the patient's weight is applied parallel to the direction of the sheet of fabric 32 that wraps around at least a portion of the foot end 10 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso. In some embodiments, the anchoring mechanism at the foot end extension 58 of the sheet of fabric 32 that wraps around at least a portion of the foot end 10 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso and is secured under the surgical table mattress 30 or underbody support 16, is applying a force vector that is directly opposite the direction of the force applied by the patient's weight when the patient is in the Trendelenburg position. The positive coupling provided by the foot end extension 58 of the sheet of fabric 32 that wraps around at least a portion of the foot end 10 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso and is secured under the surgical table mattress 30 or underbody support 16 does not stretch or flex and therefore substantially limits (e.g., does not allow) slippage or deformation between the patient securement overlay 54 and the surgical table mattress 30 or underbody support 16. In some embodiments, the anchoring mechanism at the foot end 10 of the section 12 of the surgical table mattress 30 or underbody support 16 that supports the patient's torso, creates an anchoring force vector that is advantageously directly opposite the force vector of the patient sliding down the incline of the surgical table 4 in the Trendelenburg position. This is in contrast to known securement pads 26 where the anchoring force vector is sideways or perpendicular to the force vector of the patient sliding down the incline of the surgical table 4 in the Trendelenburg position. A perpendicular force vector to prevent sliding is not nearly as secure as a parallel force vector.
In some embodiments, wrapping the anchoring the sheet of fabric 32 around the foot end of the surgical table mattress 30, creates a substantially vertical anchor segment at the foot end of the mattress, that is oriented perpendicular to the force vector of the weight of the patient sliding down the incline of a surgical table in the Trendelenburg position. In the instance of the mattress not being adequately secured to the table, or any slippage between the layers of materials that form the mattress, or crushing and dislocation of the foam of the mattress, the perpendicular orientation of the anchoring the sheet of fabric 32 around the foot end of the surgical table mattress 30 cannot prevent the patient from moving down the inclined surgical table. In some embodiments, the problem with anchoring the sheet of fabric 32 around the foot end of the surgical table mattress 30, is that under a heavy load (such as >300 lbs.) in a steep Trendelenburg position (such as >35°), the force of the patient's weight pulling on the anchoring the sheet of fabric 32 around the foot end of the surgical table mattress 30, crushes the foam of the upper foot edge of a 3 or 4 inch thick surgical mattress pad, until the sheet of fabric 32 at the foot end of the surgical table mattress 30 reaches an angle of approximately 45-55° relative to the surgical table top. At this angle the force vector is adequate to prevent further sliding, however, the patient will have slid 3-4 inches down the inclined surgical table before stabilizing. A 3-4-inch slide is unacceptable if it occurs mid-surgery.
In some embodiments, the foot end extension 58 and head end extension 60 of the sheet of fabric 32 for respectively wrapping around at least a portion of the foot end 10 and head end 62 of the surgical table mattress 30 or underbody support 16, includes one or more elements that improve the friction bond between the foot end extension 58 and head end extension 60 and either or both of the underside of the underbody support 16, the section 12 of the surgical table mattress 30 that supports the patient's torso and/or the surgical table top 64. In some embodiments, the one or more elements that improve this friction bond include a low tack adhesive or three-dimensional friction-enhancing elements, that can be plastic or rubber, applied to the foot end extension 58 and head end extension 60 of the sheet of fabric 32.
Any low tack adhesives known in the art can be used to improve this friction bond, including but not limited to those adhesives used on Post-it Notes® (available from 3M Corporation), for example. Plastic or rubber three-dimensional friction-enhancing elements that can be used include but are not limited to: silicone, viscoelastic polyurethane foams, viscoelastic PVC foams, other viscoelastic polymeric foams, urethane, PVC, as well as other polymers and rubbers. The friction-enhancing elements 34, which can be three-dimensional friction-enhancing elements, may be applied to foot end extension 58 and head end extension 60 of the sheet of fabric 32, or may be a separate piece of fabric that is adhesively bonded, heat bonded, or sewn to the sheet of fabric 32 forming foot end extension 58 and head end extension 60.
In some embodiments, the neck 70 of the sheet of fabric 32 or the foot end extension 58 at the foot end of the sheet of fabric 32 that joins the foot end of the sheet of fabric 32 to the anchor 66 (which can be plastic, metal, fiberboard, or other suitable materials) may be strengthened by melting and compressing the friction-enhancing elements, such as PVC foams, viscoelastic PVC foams, viscoelastic polyurethane foams, or polyurethane foams into the form of a film. Compressing these materials in a heated press or RF press will collapse the foam structure and convert the material to resemble a film. The film-like structure is stronger than the foam structure and may, in some applications, be a superior configuration for wrapping around the end of the surgical table mattress 30 or underbody support 16.
In some embodiments, as shown in
In some embodiments, the layer of flexible foam material 52 may be any type of suitable foam material. In some embodiments, the layer of flexible foam material 52 may be a viscoelastic urethane foam or a urethane upholstery foam. Other foam materials including other viscoelastic foam materials are anticipated and can be used as the layer of flexible foam material 52. The layer of flexible foam material 52 may have any thickness between about 0.25 inches and about 3 inches. In some embodiments, the layer of flexible foam material 52 can be less than 0.5 inches thick.
In some embodiments, a method of supporting and restricting a sliding motion of a patient 2 on a surgical table 4 is provided. The method can include the steps of: (i) providing an underbody support 16 configured to support the patient 2 on the surgical table 4, the underbody support 16 including a compressible material layer having an upper surface configured to face the patient 2 opposite a base layer having a lower surface configured to face the surgical table 4; (ii) coupling the underbody support 16 to the surgical table 4; (iii) placing a sheet of fabric 32 between the upper surface of the underbody support 16 and the patient 2, the sheet of fabric 32 comprising friction-enhancing elements 34 on one or both sides of the sheet of fabric 32, wherein the sheet of fabric 32 is configured to grip both the underbody support 16 and the patient 2 to prevent the patient from inadvertently slipping off of the underbody support 16; and (iv) positioning the patient 2 on the underbody support 16.
In some embodiments, it may be advantageous to secure the sheet of fabric 32 or other securement overlay, to the side rails 20 of the surgical table 4. Securing to the side rails 20 of the surgical table 4 is not a new idea—for example Pigazzi discloses securing a patient securement device by straps to the side rails 20, in U.S. Pat. No. 8,464,720. We disclose securing a mattress overlay device by straps to the side rails 20, in U.S. Pat. No. 10,765,580. In both of these prior art examples, the device was secured to the side rails 20 by straps 18.
As shown in
As shown in
We tested under the severe conditions of a 400 lb. “patient” on a 45° incline with the mattress 12 unsecured to the top of surgical table 4 as would be the case if the Velcro that normally secures a mattress 12 to the surgical table 4 was old and damaged. Under these severe conditions, independent straps 1818A and 1818B secured to the four corners of the sheet of fabric 32 will allow the mattress 12 to slip approximately 4 in. down the table (mattress movement 1870), before stopping the sliding motion.
We tested under the severe conditions of a 400 lb. “patient” on a 45° incline and with the mattress 12 unsecured to the top of surgical table 4. Under these conditions, side flaps 72 secured to each side of the sheet of fabric 32 near the foot end and attached to the side rails of the surgical table 4 at attachment points 1974A and 1974B, allowed the mattress 12 to slip approximately 2 in. down the table (mattress movement 1970), before stopping the sliding motion. 2 in. of mattress movement 1970 is exactly half of the 4 in. of mattress movement 1870 observed with straps 1818A and 1818B.
We tested under the severe conditions of a 400 lb. “patient” on a 45° incline and with the mattress 12 unsecured to the top of surgical table 4. Under these conditions, side flaps 76 secured to each side of the sheet of fabric 32 near the foot end and attached to the side rails of the surgical table 4 at attachment points 2074A, 2074B and 2074C, allowed the mattress 12 to slip approximately 1 in. down the table (mattress movement 2070), before stopping the sliding motion. 1 in. of mattress movement 2070 is exactly ¼ of the 4 in. of mattress movement 1870 observed with straps 1818A and 1818B.
We tested under the severe conditions of a 400 lb. “patient” on a 45° incline and with the mattress 12 unsecured to the top of surgical table 4. Results of this testing are shown below at Table 1. Under these conditions, side flaps 78 secured to each side of the sheet of fabric 32 near the foot end and attached to the side rails of the surgical table 4 at attachment points 2174A, 2174B, 2174C and 2174D, allowed the mattress 12 to slip approximately ½ in. down the table (mattress movement 2170), before stopping the sliding motion. ½ in. of mattress movement 2170 is exactly ⅛ of the 4 in. of mattress movement 1870 observed with straps 1818A and 1818B.
As shown in
In some examples, the advantage of smaller retaining force vector angles can be summarized in
In some examples as shown in
In some examples as shown in
In some examples as shown in
In some examples, the sheet of fabric 32 can be made of a wide variety of woven and non-woven fabrics including but not limited to polyester, polypropylene, rayon and cotton. The friction enhancing elements have been previously discussed in this disclosure. It is also anticipated that the sheet of fabric 32 can be made of plastic film such as PVC or polyurethane. It is also anticipated that the sheet of fabric 32 can be made of plastic film such as PVC or polyurethane that has been reinforced with a woven or non-woven fabric layer.
In some examples, the sheet of fabric 32 may be coated with foam bumps, silicone bumps or other friction enhancing elements 34 that help to secure the patient 2 to the sheet of fabric 32. In some examples as shown in
In some examples, such as when the sheet of fabric 32 is coated with foam bumps, silicone bumps or other friction enhancing elements 34, the sheet of fabric 32 may be sized to cover most or all of the torso section of the surgical table mattress 12. In some examples, the sheet of fabric 32 may extend beyond the ends or sides of the torso section of the surgical table mattress 12. In these examples, the side flaps 72, 76, 78 and 82 may be made of a different material such as fabric-reinforced plastic film for example and the side flaps 72, 76, 78 and 82 may be attached to the sheet of fabric 32 along the side edges.
In some examples, such as when the sheet of fabric 32 is a base layer onto which a layer of foam has been bonded as shown in
In some examples, the sheet of fabric 32 may be made of the same material as the side flaps 72, 76, 78 and 82 or may even be cut from the same piece of material as the side flaps 72, 76, 78 and 82, eliminating the need of for bonding the sheet of fabric 32 to the side flaps 72, 76, 78 and 82. For example, the two-holed side flaps 72 shown in
In some examples, the side flaps 72, 76, 78 and 82, are made of fabric-reinforced plastic film. The reinforcing fabric may be made of a wide variety of woven and non-woven fabrics or scrims including but not limited to polyester, polypropylene, rayon, nylon and cotton. In some examples, it may be preferable to make the side flaps 72, 76, 78 and 82 out of a woven polyester fabric that has been extrusion coated with PVC or polyurethane film. The fabric reinforcement in conjunction with the film layers minimizes the diagonal stretching of the side flaps 72, 76, 78 and 82. The fabric layer strengthens and prevents tearing of the film layer while the film layers stabilize and prevent stretching, especially diagonal stretching of the fibrous layer. The fabric reinforcement in conjunction with the film layers also creates durable, minimally stretching and non-tearing attachment points 74—the entire side flap may become essentially a wide belt. Other fibrous reinforcing layer and film layer materials are anticipated. Multiple layers are also anticipated.
In some examples, the side flaps 72, 76, 78 and 82 may be attached to the sheet of fabric 32 using an RF welding process if the materials are similar. For example, a sheet of fabric 32 made of a PVC foam applied to a woven fibrous scrim can be RF welded to fiber-reinforced PVC film side flaps 72, 76, 78 and 82, creating a strong but inexpensive bond. Similarly, urethane foams can be RF welded or heat bonded to urethane films.
In some examples, the side flaps 72, 76, 78 and 82 may be attached to the sheet of fabric 32 using sewing or adhesives. Other attachment mechanisms are anticipated, including but not limited to: snaps, hooks, hook and loop (Velcro) and buttons.
In some examples, the side flaps 72, 76, 78 and 82 may be attached to a mattress overlay 16, a heated mattress overlay 16 or even a surgical table mattress 12, in order to secure the overlay 16 or mattress 12 to the surgical table 4. The securement method of this disclosure may be especially important in the case of surgical table mattresses 12 that are losing their attachment to the surgical table 4 because of failing Velcro. It is well-known that the repeated connection, disconnection and cleaning of the standard Velcro surgical table mattress 12 attachments can lead to Velcro failure, in which case the surgical table mattress 12 can slide freely off of the surgical table 4. The securement method of this disclosure can provide either a backup safety securement or primary securement of the mattress 12 or mattress overlay 16 to the surgical table 4.
In some examples as shown in
In some examples, attachment bracket 86 may be made of sheet metal such as stainless steel or aluminum. In some examples, attachment bracket 86 may be made of molded or die-cut plastic. In some examples, attachment bracket 86 may be made of carbon fiber or fiberglass reinforced plastic. The plastic attachment brackets 86 have the advantage of being radiolucent—they are invisible to x-ray. In some examples, attachment bracket 86 may be any shape and height that is suitable to bridge between two or more side rail standoff posts 84A, 84B and 84C (or corresponding side rail) and have two or more attachment points 74A, 74B and 74C.
In some examples, the attachment points 74A, 74B and 74C may be the side rail standoff posts 84A, 84B and 84C. In some examples, the attachment points 74A, 74B and 74C may be the side rails 20. In some examples, the attachment points 74A, 74B and 74C may be mounting brackets or clamps attached to the side rail standoff posts 84A, 84B and 84C. In some examples, the attachment points 74A, 74B and 74C may be mounting brackets or clamps attached to the side rails 20.
In some examples, side flaps 82 may include side flap holes 90A, 90B and 90C which may be buttonholes positioned to engage with the buttons or hooks mounted at attachment points 74A, 74B and 74C on the upper portion of attachment bracket 86. In some examples, the side flap holes 90A, 90B and 90C may be in a tear-drop shape for easy application to the buttons at attachment points 74A, 74B and 74C. In some examples, the tear-drop shaped holes may be positioned with the pointed end of the tear-drop shape aimed toward the force vector 80A, 80B and 80C that is directed at the attachment points 74A, 74B and 74C, and the stronger rounded end of the tear-drop shape positioned against the button, in order to minimize the possibility of the side flap 82 material tearing against the buttons or hooks.
In some examples as shown in
In some examples as shown in
In some examples, when the side flaps 82 are secured to the side rail standoff posts 84 or side rails 20, the sheet of fabric 32 on the top of the mattress 12 is gently stretched and forcefully secured from side to side. This security may be advantageous when the patient is getting onto the surgical table 4 or being repositioned on the surgical table 4. Anything under the patient, especially if it has friction enhancing elements such as foam, can easily bunch up or wrinkle during positioning or repositioning. Anything under the patient that inadvertently bunches up or wrinkles and goes unnoticed for a prolonged period of time during surgery, can cause a pressure injury to the patient's skin. Securing the sheet of fabric 32 from side to side prevents bunching up or wrinkling and therefore reduces the risk of pressure injuries.
This disclosure has focused on patient securement in the Trendelenburg (head down) surgical position. It must be noted that the securement mechanism of this disclosure applies to other surgical positioning as well.
For example, it is anticipated in this disclosure that patients in the reverse Trendelenburg position (head up), which may be used during bariatric gastric surgery for example, can also be secured to the surgical table and prevented from sliding off the foot end of the surgical table. Similar to the Trendelenburg position, the patient lays on a sheet of fabric 32 that includes friction enhancing elements 34. In some examples, the sheet of fabric 32 may be secured to the surgical table by side flaps 82. In some examples, in contrast to the side flaps 82 in the Trendelenburg position, the side flaps 82 in the reverse Trendelenburg position may be attached near the head end of the sheet of fabric 32. The various options disclosed in this disclosure for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20, including the attachment brackets 86, can be used for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20 in the reverse Trendelenburg position.
Our experience has shown that the sheet of fabric 32 that includes friction enhancing elements 34 of this disclosure, can be too effective when engaging the skin of the buttocks of a patient in the reverse Trendelenburg position. As gravity pulls the patient toward the foot end in the reverse Trendelenburg position, the fat and skin of the buttocks engaged with the friction enhancing elements 34, can be rolled up and under the lower back when the patient shifts toward the foot end, which can cause damage to the skin of the buttocks. To prevent this from occurring, the friction enhancing elements 34 may be limited to the patients back (not buttocks), during reverse Trendelenburg positioning. In some examples, this can be accomplished by shortening the sheet of fabric 32 that includes friction enhancing elements 34 so that it ends above the buttocks, leaving the buttocks on the relatively slippery sheet normally covering the surgical table. In some examples, the buttocks can be protected by adding a layer of low friction material such as a non-woven fabric, over the portion of the sheet of fabric 32 that includes friction enhancing elements 34, in the area that would be expected to engage with the patient's buttocks.
In some examples, it is anticipated in this disclosure that patients on a substantially level surgical table experiencing leg distraction (forceful pulling on the leg), during certain hip and femoral orthopedic surgeries, can also be secured to the surgical table and prevented from sliding off the foot end of the surgical table. Traditionally, this sliding was prevented by placing a padded post in the patient's groin, between their legs.
However, the posts are frequently in the surgeon's way during surgery and can cause pressure injuries to the perineal nerve and genitals. There is a trend toward “postless” securement in orthopedics, using friction-based securement devices against the patient's back instead of a post between the legs.
Similar to the reverse Trendelenburg position, in some examples, the orthopedic patient lays on a sheet of fabric 32 that includes friction enhancing elements 34. In some examples, the sheet of fabric 32 may be secured to the surgical table by side flaps 82. In some examples, the side flaps 82 for postless orthopedic positioning may be attached near the head end of the sheet of fabric 32. The various options disclosed in this disclosure for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20, including the attachment brackets 86, can be used for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20 in postless orthopedic positioning. The securement device of this disclosure prevents the patient from slipping toward the foot end of the surgical table when a distraction force is applied to the leg.
In some examples, it is anticipated in this disclosure that patients undergoing robotic heart surgery or other surgeries requiring a sideways tilt, can benefit from using the securement device of this disclosure. Robotic heart surgery frequently requires that the patient be tilted sideways, usually to the right, in order for the robotic scopes and instruments to have a better entrance angle through the left chest wall. At steep tilt angles, patients may slip sideways on the surgical table if not properly secured.
Similar to the reverse Trendelenburg position, the cardiac surgery patient lays on a sheet of fabric 32 that includes friction enhancing elements 34. In some examples, the sheet of fabric 32 may be secured to the surgical table by side flaps 82. In some examples, the side flaps 82 for robotic cardiac surgery positioning may be attached near the head end of the sheet of fabric 32. The various options disclosed in this disclosure for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20, including the attachment brackets 86, can be used for attaching the side flaps 82 to the side rail standoff posts 84 or side rails 20 in robotic cardiac surgery positioning. The securement device of this disclosure prevents the patient from slipping toward the side of the surgical table when the table is tilted to the side.
In some examples, the securement device of this disclosure includes a perineal drape 106 as shown in
Whereas particular embodiments of the invention have been described for the purposes of illustration, it will be evident to those skilled in the art that numerous variations of the details may be made without departing from the invention as set forth in the embodiments described herein.
This application claims priority to U.S. provisional patent application No. 63/354,778, filed on Jun. 23, 2022.
Number | Date | Country | |
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63354778 | Jun 2022 | US |