Patent Application
20110034844
The invention generally relates to the field of orthopedic or prosthetic devices and more specifically to a cervical collar arranged to accommodate a variety of wearer sizes including height and circumferential width adjustment, improve patient comfort and adjust or set the collar for different medical indications.
Cervical collars are used in the treatment, stabilization, and therapy of cervical trauma. Some collars are intended to provide support for whiplash and other such injuries where support for the head and neck is needed. Other collars are intended for near complete immobilization of the head and neck, such as in an EMS pre-hospital setting.
There is often a rush to apply these collars onto the wearer due to the acute nature of cervical injuries. The collar must be selected to accommodate the wearer's size in a quick manner for effective stabilization and immobilization of the neck of the wearer.
Known cervical collars restrict spine flexion, extension and rotation to promote wearer recovery. Such known collars also include a trachea opening allowing for healthcare clinicians the ability to perform quick carotid pulse monitoring and emergency tracheotomies while providing cervical immobilization.
A drawback to known collars is that they are individually sized for a variety of standard wearer sizes. It follows that there is a need to store many different sized collars in inventory which significantly adds to the cost for using such collars. In the event there is an emergency, and the proper sized collar is not available, the caregiver is given little option other than to apply a poorly fitting collar on the wearer since many known collars provide minimal size adjustment.
Proper sizing is critical for wearer immobilization and comfort. While there are a variety of different standard sizes, the wearer may have dimensions which fall outside of the standard sizes, and thus wear a poorly fitting collar that insufficiently immobilizes the wearer's neck. Such poor fitting may also cause significant discomfort to the wearer.
Over time, swelling of the wearer's neck may reduce which further complicates the sizing of the collar. This may lead to the need for disposing the initially selected collar and replacing it with a new collar. This may lead to waste and an increase in cost.
When sizing a cervical collar, the first notable dimension concerns the height. The height is measured by the vertical distance from the tip of the chin to the sternum; the other key dimension concerns the circumference of the wearer's neck.
In addition to sizing, proper application of the collar is necessary for immobilization and wearer comfort. A typical collar consists of front and rear components which are packaged as a set according to the size of the wearer.
When applying a collar to the wearer, the rear component of the collar is applied to the back of the wearer's neck. Once the back wearer is positioned appropriately, the front component of the collar is positioned against the front or anterior portion of the neck so that a chin support is placed against the chin. The front component is centered to secure neutral alignment. The front component overlaps the rear component to ensure effective immobilization and comfort. Straps are then tightened to the collar with a bilateral adjustment which secures the wearer's cervical region in neutral alignment.
The present invention provides a cervical collar having height and circumferential adjustment in order to accommodate a wide variety of sizes of different wearers and to accommodate size changes caused by increased or decreased swelling of the affected anatomical portions of the wearers.
According to an embodiment of the cervical collar, the cervical collar includes a front component formed from a compressible foam material and defines a recess forming a portion of a tracheal opening, and a height adjustment mechanism secured to the front component and forming a rigid border to the tracheal opening. The height adjustment mechanism selectively connects the front component to a sternum pad at a permanently locked position among a plurality of predefined distances.
In accordance with this disclosure, “permanently locked” is defined as once the height adjustment mechanism is placed at a particular height setting among a plurality of predefined height settings, it can be permanently locked at such height setting; no further adjustment of the height of the collar is possible.
The cervical collar may include a rear component connecting to the front component, and have a plurality of lateral breakaway sections formed at side portions of the rear component. The breakaway sections are arranged to be removed without the benefit of a tool such that removal of one of the breakaway sections reduces a circumference of the collar formed by the combination of the front and rear components. The rear component may be resiliently contoured in a generally arcuate shape such that the front and rear components form from their arcuate shapes a circumferential configuration for securing about a wearer's neck.
The rear component may be formed from compressible foam, and include a reinforcement support arranged to support a wearer's spine and an elongate strap arranged to secure to the front component. A rear gap may be formed between a top portion of the reinforcement support and the rear component. This gap may allow for expansion of the wearer's neck without reducing the circumference of the collar.
In an embodiment of the height adjustment mechanism, the height adjustment mechanism includes an upper part secured to the front component, and a lower part secured to the sternum pad and bordering the lower portion of the tracheal opening. The lower part defines a first arm bordering a side of the tracheal opening and the upper part defines a retainer through which the arm slides. The retainer is only located at a bottom portion of the upper part, such that when inserted through the retainer, the arm extends past the retainer and toward a top portion of the upper part. The location of the retainer permits the arms to be securely connected to the upper part at the first point of engagement as well as throughout the length of the height adjustment of the collar.
The first retainer may form a window and the arm may form a series of location identifiers representing a plurality of distance settings of the front component relative to the sternum pad. Preferably, an individual one of the location identifiers may be arranged to be placed in register with the window when the arm is inserted into the retainer. A lip may be formed around each of the location identifiers, a lip corresponding to the location identifier in the window engaging edges of the window. This window allows for the clinician to quickly compare the height of the lower part relative to the upper part, assuring that both sides are positioned at the same height.
According to a variation of the cervical collar, the upper part forms an elongate recess arranged to accommodate the arm. A variable gap is defined between the uppermost section of the arm relative to the recess thereby permitting some adjustment of the uppermost section of the arm relative to the upper part.
In order to permanently lock the upper part relative to the lower part of the height adjustment mechanism, according to an embodiment of the height adjustment mechanism, the lower part includes a pin fixedly securable to at least one of a series of locking elements formed along the upper part. The locking element into which the pin is secured corresponds to the location identifier located in the window.
In a variation of the lower part, the lower part forms a central tab connected to the sternum pad. The central tab has a living hinge adapted to bias the tab and sternum pad to a remainder of the lower part. Also, the lower part may form a side tab corresponding to the arm, and the side tab may have a living hinge adapted to bias the side tab relative to the sternum pad.
These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings.
It should be noted that the drawing figures are not necessarily drawn to scale, but instead are drawn to provide a better understanding of the components thereof, and are not intended to be limiting in scope, but rather to provide exemplary illustrations. It should further be noted that the figures illustrate exemplary configurations of a cervical collar having height and circumferential adjustment and the respective components thereof, and in no way limit the structures or configurations of a cervical collar and components thereof according to the present disclosure.
Embodiments of an orthopedic device are provided for use in stabilizing and supporting anatomical portions of a wearer, for example, the neck and head of a wearer.
Although the embodiments of the disclosure are adapted for supporting and stabilizing anatomical portions of a large number of wearers having various anatomical shapes and sizes, the embodiments of the disclosure may also be dimensioned to accommodate different types, shapes and sizes of anatomical portions.
For ease of understanding the disclosed embodiments of an orthopedic device, the front or anterior, and rear or posterior portions of the orthopedic device are described independently. It will be recognized that the anterior and posterior portions of the orthopedic device function together to form a supporting and stabilizing collar that encompasses the anatomical portions of the wearer.
The term “posterior” also has its ordinary meaning and refers to a location that is behind or to the rear of another location. Lastly, the term “anterior” has its ordinary meaning and refers to a location that is ahead of or to the front of another location.
The terms “rigid,” “semi-rigid,” “flexible,” and “compressible” may be used herein to distinguish characteristics of portions of certain features of the orthopedic device. The term “rigid” is intended to denote that an element of the device is generally devoid of flexibility. Within the context of support members or shells that are “rigid,” it is intended to indicate that they do not lose their overall shape when force is applied, and in fact they may break if bent with sufficient force. As for the term “semi-rigid,” this term is used to connote properties of support members or shells that provide support and are free-standing; however such support members or shells may have some degree of flexibility or resiliency.
On the other hand, the term “flexible” is intended to denote that features are capable of repeated bending such that the features may be bent into retained shapes or the features do not retain a general shape, but continuously deform when force is applied. The term “compressible” is used to qualify such structural features as being capable of being reduced in size or volume due to the exertion of force applied to the structural feature.
The cervical collar described herein includes front and rear components constructed from flexible and compressible foam. Anterior and posterior rigid plastic reinforcement supports are applied to the front and rear components, respectively, to limit movement of the front and rear components. Adjustable hook and loop fasteners couple the front and rear components to one another, and secure to the anterior and posterior reinforcement supports.
The front component 102 is arranged to secure to a rear component 140 by a strap system 114 secured to strap loops 122 formed on the upper mechanism part 108, and strap slots 156 connected to the rear component 140.
The front collar has a vein clearance configuration 143 as particularly described in pending U.S. patent application Ser. No. 12/729,536, filed on Mar. 23, 2010, and incorporated herein by reference.
The sternum pad 104 is preferably constructed from a compressible and flexible foam or a similar material of any type described herein. The lower mechanism part 110 defines a central tab 116 which may be connected to the remainder of the lower mechanism part 110 via a central living hinge 118 so as to accommodate the movement and anatomy of a wearer of the collar. Side tabs 130 straddle the central tab 116 and are spaced from the central tab 130 by a clearance 138. The side tabs 130 may optionally include a living hinge 182 to likewise accommodate movement and anatomy of a wearer. The sternum pad 104 may be secured to the lower mechanism part 110 via fasteners 120.
The adjustability of the height adjustment mechanism allows for selective positioning of the sternum pad 104 relative to the front component 102. In order to know the settings of the location of the sternum pad 104 relative to the front component 102, windows 128 are formed on opposed side of the upper mechanism part 108 which encircle or identify indicia 126 indicating certain predetermined heights of the front component 102 relative to the sternum pad 104. The upper mechanism part 108 defines grooves 128 located at opposed sides of the trachea opening 112 and are arranged to accommodate the arms 124 of the lower mechanism part 110.
The rear component 140 has side portions 142 that preferably outwardly overlap side portions 141 of the front component 102. While shown in the preferred configuration, the cervical collar can be configured so that the side portions 141 of the front component outwardly overlap the side portions 142 of the rear component 140.
A posterior reinforcement support 144 is secured along a midline 146 of the rear component 140. The reinforcement support 144 defines a middle section 148, an uppermost section 150 and a lowermost section 152. The middle section 148 and the lowermost section 152 are preferably mounted flush to the rear component 140. The uppermost section 150 protrudes outwardly from the rear component 140 so as to form a gap 158 therebetween. The gap 158 allows for a slight expansion of the rear component 140 relative to the reinforcement support 144 so as to accommodate additional sizing of the wearer's neck. The middle and lowermost sections 150, 152 however are adapted to firmly restrain the wearer's spine regardless of any additional sizing of the wearer's neck, particularly since the fasteners are located along these sections of the reinforcement support.
The reinforcement support 144 is secured to the rear component 140 via a plurality of fasteners 154, and the strap system 114 secures to the rear component 140 by slots 156 formed by the reinforcement support 144. The reinforcement support is configured to have a cervical arch support so as to maintain neutral alignment of the cervical spine.
The rear component 140 has a pattern of openings 136 extending through the thickness of the rear component to provide for a circulation of air between the wearer and outside of the cervical collar, thereby reducing heat and moisture for the wearer due to wearing the collar. According to this embodiment, the rear component includes a series of notches 132 located at opposed end portions of upper and lower sections of the front component. At least one elongate opening 134 is defined between each set of upper and lower notches 132 to facilitate removing a section of the front component in order to reduce the width of the collar. The opening 134 may extend in part through the front component or extend through the entirety of the front component.
In reference to
The upper part 108 of the height adjustment mechanism 110 defines a chin portion 164 generally protruding outwardly from the front component 102 so as to form a gap 168. The gap 168 is variable in that the wearer can adjust the chin slightly while the neck is immobilized. There are preferably no fasteners mounted near the uppermost portion of the upper part, thereby allowing for some adjustability for the wearer of the collar. It will be noted that the chin portion 164, as with the remainder of the height adjustment mechanism, is substantially rigid, therefore the variability of the gap is due at least in part to the compressibility and flexibility of the front component relative to the chin portion.
As shown in
Each window is formed by a retainer 127 belonging to the upper part 108. The retainers 127 allow for the arms of the lower part to be inserted therethrough such that the arms extend past the retainers 127 and into an elongate recess 192 of the upper part. The retainer is preferably located at a bottom portion of the upper part, such that when the arm is inserted through the retainer, the arm extends past the retainer and toward a top portion of the upper part.
The upper and lower parts 108, 110 form a border to the trachea opening 112 of the cervical collar. Specifically, the upper part 108 defines the uppermost arch 176 and size portions 172, 174 of the trachea opening 112, while an uppermost arch 177 of the lower part forms the lowermost arch of the trachea opening 112. The combination of these portions of the upper and lower parts allows for the trachea opening to be maintained regardless of the height adjustment of the collar.
Each of the arms 124 defines a pin 184 that extends inwardly toward the front component and is fixedly securable to at least one of a series of locking elements 186 formed along the upper part. Each of the locking elements 186 includes a plurality of fingers 188 which securely and lockingly engage the pin so that the pin 188 cannot be withdrawn from the locking element 186 once it is pressed thereinto.
As shown in
In accordance with the embodiments described herein, the front and rear components, as well as the sternum pad are preferably constructed from PLASTAZOTE or similar foam material. PLASTAZOTE itself is well known in the art of cervical collars, and is distinguished as being compressible and flexible. Specifically, PLASTAZOTE is a polyethylene foam and is considered as having excellent cushioning properties, thereby rendering the front and rear components and the sternum pad as compressible and flexible. In accordance with the embodiments shown herein, the front and rear components conform to the shoulder, and the front component has a mandible contour allowing for superior stability and comfort.
In the embodiments herein, the strap system is provided in combination with the compressible foam based front and rear components to provide sufficient support to immobilize the neck of the wearer. Specifically, the arrangement of the front and rear components restricts cervical spine flexion, extension and rotation to promote patient recovery. Moreover the use of PLASTAZOTE allows for the front and rear components to be latex-free, non-toxic and hypoallergenic.
The height adjustment mechanism and the reinforcement support are substantially rigid components, particularly provided to limit movement of the wearer's neck. The two piece design of the front and rear components enhance patient comfort and compress and flex about the wearer's neck whereas the rigid height adjustment mechanism and reinforcement support remain rigid when worn by the wearer, and when the strap system is tensioned about the neck of the wearer.
Of particular note, while the height adjustment mechanism allows for an adjustment in height of the collar, the height adjustment mechanism remains rigid so as to provide anterior support for the user. The height adjustment mechanism borders the trachea opening thereby providing a substantially rigid border about the trachea opening. This allows for a large trachea opening, regardless of the height setting, and permits for quick access to the carotid pulse monitoring and emergency tracheotomies. It will also be noted that the variable gap between the gap between the chin portion of the height adjustment mechanism and the front component makes the cervical collar maneuverable for assisting in airway management of the cervical collar for the wearer.
According to this embodiment, the locking of the height adjustment mechanism is arranged to be permanently locked at one of the predetermined heights defined by the indicia so that the wearer cannot change the height setting once it has been locked. The benefit of this embodiment is that the height adjustment mechanism is more secure, with less risk of accidentally unlocking it. There is also a reduction in the risk that of the patient changing the setting. However, the embodiments herein are not to be limited to permanent locking elements, and it is within the scope of the invention to make the locking elements adjustable and not permanent.
In operation, the rod 206 is provided in the largest configuration, as exemplified by “XL.” Should the wearer have a shorter height, the break according to the wearer's size is snapped so that the rod 206 is reduced in height and inserted into the receptacle 208. The fitting contour 212 is configured in a manner such that there is a frictional fit with the lowermost end of the rod 206 when inserted therein.
The bottom part 224 includes a slider 232 which extends through and engages the slot 228, and an arm 94 laterally extending from a side of the bottom part 224 and generally in alignment with the slider 232. The arm 234 carries a head 236 having a fastening element 238, such as a rivet or a locking pin, which is adapted to engage one of the locking recesses 230. The locking recesses 230 are arranged in a pattern which corresponds to different height settings of the collar.
In operation, the caregiver moves the slider in the slot so that it is aligned with one of the locking recesses. Once aligned at the proper setting, the arm is turned over the edge of the top and bottom parts. The fastening element is then pressed into the locking recesses whereat it engages and effectively maintains the desired collar height.
The fastening element may be arranged to permanently lock into one of the locking recesses. By permanently locking, the collar cannot be tampered with by the wearer, the tampering of which can result in improper alignment and lack of immobilization for the wearer.
Of course, a variety of other adjustment mechanisms are available, and the adjustment mechanism can be modified in a manner to accommodate such other adjustment mechanisms.
The tightening bands stabilize the height adjustment mechanism such that when the collar is set in the lowest setting, the tightening bands are loose. When the height adjustment mechanism is in its tallest setting, the tightening bands are fully stretched and maintain the sternum pad in place against the wearer by urging forces 268 against the wearer.
Each of the side portions 284 has breakaway sections 286 corresponding to different lengths of the side portions 284. Removal of the breakaway sections 286 allow for the clinician to easily reduce the circumference of the rear component and hence the cervical collar. The breakaway sections 286 are delimited by areas of reduced thickness 290 at which locations the breakaway sections 286 are configured to be torn away from the base rear portion 282 according to a certain circumferential size of the wearer.
As an alternative to the areas of reduced thickness, the breakaway sections may be delimited by a line of perforations such that these perforations comprises a plurality of thin holes that permit easy tearing of the breakaway sections from the base rear portion.
The rear component 280 includes a plurality of openings 288 to provide ventilation to the wearer. Of particular note, certain of the openings 288 outside of the rear portion 282 may be confined within the breakaway sections 286 themselves so as to avoid uneven edges of the rear component 100.
Other configurations are available for constructing the breakaway sections which would be understood by the skilled person. It will be noted that the notched sections can have a thickness which withstand tearing, and instead, they merely serve as areas which facilitate the cutting of the side portions to accommodate a specific wearer's size.
Aside from the breakaway sections which are depicted as being adapted to adjust the circumference of the collar, other breakaway sections may be provided to modify the collar for different medical indications. For example, it has been found that the rear of the collar does not necessarily require adjustment in height. However, for patients that only require support for flexion, lowering the support in the back would increase breathability and comfort to the wearer.
In addition to the breakaway sections, the collar can be provided with a plurality of inserts for each of the openings. These inserts are arranged, including the configuration of reduced thickness, perforations or other means known to the skilled person, for easy detachment from the collar. Prior to adjustment, the collar has these openings filled with the inserts and the caregiver can adapt the collar by removing these inserts so that certain area have greater ventilation than other areas according to the demands of the wearer.
Turning to the embodiment 320 of
Because the interlocking removable segments are precut, they are readily separable from the front component and will include generally clean lines demarcating a portion of the periphery of the front component. The interlocking profile is preferably of a low profile allowing for interlocking of the parts, while minimizing contours of the interlocking profile so as to avoid a substantially jagged profile.
If it is desired to reduce the width of the collar, then one may pull apart the desired removable segment to form the new width of the front component. If in the event it is desired to add width to the collar, one may place the removed segment to the front component, or in the alternative, an extension segment 338 having an interlocking profile 340, as shown in
The sternum pad 330 may include removable segments 334, 336 having interlocking profiles 332 which are adapted to be added to or removed from the sternum pad. The embodiment in
By properly sizing the cervical collar using the height adjustment mechanism and sternum pad described herein,
It is particularly advantageous for a cervical collar to have excellent motion restriction so as to limit or prevent cervical pain, protect spinal instability, and protect the cervical spine in emergency situations. Cervical collars have also been found to provide benefits of proprioception and decreased loading to injured muscles or ligaments by increased support to the region. Moreover, it is likely that those cervical collars have the benefit of increasing local temperature of the soft tissue surrounding the cervical region by reducing heat loss and providing a placebo effect.
By having the ability to tailor the size of the collar both circumferentially and by height, and further including means for ventilating the collar and reducing foam size (such as by only including a sternum pad), the cervical collar of the invention allows for improved pain relief, immobilization, restraint against extreme neck motions, and rest of soft tissue surrounding the neck.
While the foregoing embodiments have been described and shown, it is understood that alternatives and modifications of these embodiments, such as those suggested by others, may be made to fall within the scope of the invention. Moreover, any of the principles described herein may be extended to any other orthopedic devices.
This application claims the benefit of U.S. provisional patent application 61/232,559, filed on Aug. 10, 2009, and U.S. provisional patent application 61/328,830, filed on Apr. 28, 2010. This application incorporates in its entirety the disclosure of U.S. provisional applications 61/232,559 and 61/328,830.
| Number | Date | Country | |
|---|---|---|---|
| 61232559 | Aug 2009 | US | |
| 61328830 | Apr 2010 | US |
