This invention relates to orthopaedic splints or supports.
In the field of hardenable orthopaedic splints and supports, the splints are normally rectangular in shape and are held on to the anatomy by a finishing tape of some kind wrapped along the entire length of the splint. To function properly, both the splint and finishing tape are soft and supple in order to conform to the contours of the anatomy. During application of the splint, it is necessary that the limb be held in a variety of positions. Frequently, lengthy splints must be used to properly immobilize the injured limb, and gravity causes one end or the other of the splint to fall away from the anatomy or merely shift away from the proper position. If one person is attempting to apply the splint, it is difficult to maintain the appropriate position for each particular injury during application. Usually it is necessary to ask for additional assistance to ensure proper application. More particularly, an extra set of hands is required to keep the splint in the desired location on the patient's anatomy until the outer securing or immobilization means has been applied.
In accordance with the present invention a splint, blank, or main support is provided with primary tacking arrangements to help hold the splint, blank, or main support in place, allowing the physician or technician the use of two free hands for quickly and easily adjusting the position of the splint, blank, or main support if necessary without removing or loosening the primary tacking arrangements. The physician or technician then applies a secondary, more supportive securing arrangements to effectively hold the splint, blank, or main support to the injured part of the patient's anatomy.
In accordance with one illustrative implementation of the invention, the primary tacking arrangements may include mating hook and loop type material such as VELCRO® type inserts or pads, or hook type patches used with a splint covering of unbroken loop (UBL) or other hook receivable material on the surface of the splint. In this regard the entire hook receivable surface acts as the loop portion of the hook and loop fastening arrangements.
In addition, with the splint or support normally being longitudinal in extent, laterally extending securing extensions may be provided with hook and loop, adhesive or other securing arrangements at the outer ends thereof. These lateral extensions may be formed as part of the hardenable portion of the splint, or as part of one layer thereof, or may be separate straps or the like, secured to the splint blank.
The secondary or “functional” securing arrangements may be in the form of a stretchable wrap such as an ACE® bandage, or may be straps, where the said arrangements are of sufficient strength to firmly hold the splint to the injured part of the anatomy during regular usage for extended periods of time.
Other features which may be included in implementation of the invention may involve the following:
1. The use of “spacer” type double knit material for the splint.
2. The use of an outer or secondary support such as an exo-skeleton type support, with associated straps serving as the functional securing arrangements.
3. The use of non-rectangular splints, with laterally extending areas forming the primary securing arrangements.
4. The use of a roll of splinting material, with lateral extensions spaced along its length.
5. The use of splint blanks with a thumbhole or another web space locater forming a part of the assembly.
In the field of splinting it is normally desirable to fully secure the splint or cast so that it will not come off or shift location during the normal course of daily activities. The primary holding or splint locating arrangements in the present invention are used when the splint blank is flexible and is being initially applied. These primary securing arrangements may be considered to be temporary “tacking” or locating arrangements, as they permit easy adjustment of the splint position, and are usually of insufficient strength to rigidly immobilize the splint for long term use by the patient.
Accordingly, when the term “tacking” is used in the present specification and claims, reference is being made to the primary holding arrangements which are of insufficient strength to fully secure the splint; and subsequent securing arrangements are normally required in addition to the “tacking.” The “tacking” may be implemented, for example, by hook and loop fastening arrangements, by adhesive, by snaps, by hooks or any other suitable arrangement; and functional securing of the splint may be accomplished by lamination of the layers when the edges of hardenable material are overlapped, by wrapping with flexible tape, such as an ACE® bandage tape, by straps, or by any other securing arrangement of sufficient strength to properly immobilize the splint to the injured portion of the anatomy.
It is further noted that the use of a layer of UBL or hook-receivable material has the additional advantage of restricting the flow of the hardenable material, as set forth in, for example, U.S. Pat. No. 6,824,522 (Henderson, et al.), titled “Hardenable Orthopaedic Supports,” whose entire contents are hereby incorporated by reference.
In accordance with a method illustrating certain aspects of the invention, a splint or support is formed with sheet material impregnated with hardenable material, and with one or more primary laterally extending tacking extensions. The hardenable material is activated and the splint or support is held to the anatomy by engaging the laterally extending extensions; and the position and/or configuration of the impregnated sheet material is adjusted prior to the hardening of the hardenable sheet material while it is being loosely held by the tacking extensions; and the adjusted position is maintained while the hardening is accomplished.
Other objects, features and advantages will become apparent from a consideration of the following detailed description and the accompanying drawings.
While the specification describes particular embodiments of the present invention, those of ordinary skill can devise variations of the present invention without departing from the inventive concept.
Referring more particularly to the drawings,
The splint location is subsequently immobilized by wrapping the flexible, resilient tape 30 around the forearm and splint. This tape 30 may be of the type sold under the ACE® trademark.
In various embodiments, relative to the hook receivable type material underlying the hook type patches 26, it may either be in the form of hook receivable type patches secured to the splint 12 in selected areas; or alternatively, the entire splint may be covered with a layer of unbroken loop (UBL) or other hook receivable material, so that the hook type patches will engage and secure to the splint 24 at any convenient location.
Furthermore, instead of VELCRO® type fasteners, adhesive, snaps, or hooks, for example, could be employed for tacking the straps 18, 20 and 22 in place.
The hardenable layer 42 is preferably impregnated with a water activatable material such as urethane. The layer of hook receivable or UBL material 44 may inhibit the transfer of the water activatable material to the outer surface of the splint.
The preferred splint roll configuration is an inner activatable material of at least one layer with an outer covering material on one side and a padding layer on the other. The outer covering is preferably made from a hook receivable material, such as a UBL material, and the padding may consist of at least one layer of either a double knit spacer material, foam, or a nonwoven material. Throughout the length of the splint are tacking arrangements spaced at equal intervals. The extensions may have hook type arrangements on both ends so that they would be removable and movable with respect to the splint assembly. It is also preferable that the tacking arrangements be made of a stretchable material and have a configuration that would ensure proper securing yet not cause any discomfort to the end user. An acceptable material to use would be a nonwoven because of its cost effectiveness and low profile. The splint can be cut to usable lengths prior to packaging or may be provided in long lengths and may be cut to the appropriate size immediately prior to application.
In the case of all of the embodiments as disclosed in this specification, the construction and alternatives as disclosed herein may be used in each of the constructions intended for specific application. Thus, for example, after cutting off a length of the splint roll 52, activating it, and tacking it in place, the splint may be wrapped with a flexible wrap, to functionally secure the splint.
In
In
The splint blank of
Referring now to
As shown to advantage in
Shown in dashed lines are the strips 178′ and 184′ in an unfolded configuration, to extend around a portion of the anatomy such as a forearm or lower leg, for example. The hook material 180′ engages the lower surface of the unfolded hook receivable strip 184′ to hold the base member 176 onto the desired part of the anatomy. This arrangement permits tacking of the base strip 176 in place while the physician or medical technician is adjusting the position of the splint or support. As shown in
As shown in
The assembly as shown in
The embodiment of
With the outer surface being covered with a UBL or other hook receivable material, an anti-flexing strap 158 may be utilized. The anti-flexing strap 158 may have hook type patches 160 and 162 at its ends, to mate with hook receivable type material on the body 150 of the splint. During application, the anti-flexing strap 158 aids in securing the arm and limiting the ability of the arm and splint to flex until it has hardened. After hardening, it will help reinforce the splint and keep the elbow at a ninety degree angle. If desired, the anti-flexion strap 158 may be permanently secured to splint 150 at one end thereof. As shown, the anti-flexion strap is used to help stabilize an elbow. However, it may also be used to stabilize other necessary portions of the anatomy such as the ankle.
An additional feature shown in
After the splint 142 is properly mounted in place, the entire splint assembly may be wrapped with a secondary, flexible, resilient tape such as an ACE® type wrap, to functionally secure the splinting arrangements.
In regard to the materials used for fabricating the various layers of the above mentioned splinting assemblies, the primary tacking arrangements are preferably made from a nonwoven material. Nonwoven materials are typically very inexpensive and may be made to be hydrophobic which is very advantageous. The tacking materials may also be made of a knitted material, woven fabric, or foam. It is also beneficial if the primary tacking arrangements are low profile, stretchable and tearable. The activatable layer can be composed of a double knit spacer material, multiple layers of a single knit material, foam laminate, nonwoven material, woven material, or any suitable material that will achieve sufficient strength upon hardening.
As seen in the exemplary embodiments of
The primary holding material should preferably be made from a material that is porous to ambient air so that it is breathable and thus comfortable to the patient. To achieve a good balance of air porosity versus hold strength and fabric integrity, the density of the primary holding material preferably falls within a range of 25-110 g/m2 and more preferably 50-65 g/m2, including all values at and within the specified outer limits.
Further, the primary holding material may be treated to be hydrophobic, and as mentioned above, may be nonwoven to keep down expense. Specifically, the nonwoven materials are typically made from polyester, rayon, or polypropylene fabrics. Alternatively, sheets or strips of natural rubber, latex, thermoplastic rubber (TPE) such as SANTOPRENE, HYDREL, KRAYTON, or the like may be used. Most of these materials are inherently hydrophobic. In addition, the nonwoven materials can optionally be treated, for example, with Scotchguard or a Teflon coating to enhance hydrophobic properties.
The primary holding material is preferably not made entirely of the aforementioned materials, but rather such materials are incorporated into the nonwoven fabric to give it stretch properties. Most stretchable nonwoven materials are not just one layer of fabric but some type of laminated structure to allow for stretchability. It is therefore preferable that the primary holding material be a laminate of stretchable nonwoven materials selected from one or any combination of the foregoing listed materials. The nonwoven material can either be stretchable throughout its entire length or only have certain sections that are stretchable and other sections that are not stretchable. A region of the primary holding material may further be stretchable in one direction yet non-stretchable in another direction, such as longitudinally versus transversely. The non-stretchable sections or regions help keep the primary holding material or strap from “necking down” when it is stretched and wrapped around the patient's anatomy. The “necking down” of the primary holding material leads to the unwanted turniquette effect.
Exemplary width dimensions for the primary holding material ranges from about 1 inch to 6 inches wide, including all sizes therebetween. To enable tacking the primary support material to the splint support body, brace, or blank, the former may be made from hook receivable material, UBL, or napped fabric, or include patches of the hook or loop portion from a hook and loop type fastener such as VELCRO®.
Alternatively, a means for tacking may be used to attach the primary holding material to the splint support body, brace, or blank. For example, the means for tacking 26 shown in
Preferably, the primary holding material is stretchable, where its length under a tensile load L may increase up to about 50% or greater of its unstretched, initial length. This amount of stretch may be measured on the basis of the entire structure or only a portion thereof. Conventional stretchable materials used with hook and loop type fasteners can only stretch up to about 40% of its initial length. The stretching is measured from the percent of elastic increase from its unstretched, initial length, where the stretched length is achieved just prior to any plastic or permanent deformation, or failure in the material in the form of tearing.
In addition, the primary holding material exhibits limited rebound, i.e., resistance to stretch. This feature prevents a turniquette effect on the wearer patient, which would otherwise impede circulation or movement of the limb, joint, or body part. Therefore, it is preferable that the primary holding material can be stretched under tensile load L to an increase in length of about 2 inches or 30% of its initial unstretched length under a tensile force of about 1.5 lbf. (6.7 N); in alternative embodiments, that tensile load L may be about 1.3 lbf. (6 N) down to 1.0 lbf. (4.5 N), or even less to achieve a 30% stretch. When the primary holding material is tested by stretching it 100% and held for about 5 minutes, the final length is about 30% or greater than the initial, unstretched length.
Furthermore, the primary holding material is designed to tear before causing the turniquette effect. To achieve this behavior, the primary holding material has an ultimate tensile strength of about 10 lbf. (44.5 N) or less (but greater than 0 lbf., of course), and more preferably of about 3 lbf. (13.4 N), including all values therebetween, when tearing is initiated. The primary holding material can resist complete detachment or separation into two discrete pieces from the tensile loads L that are less than about 10 lbf. (44 N) and more preferably about 3 lbf. (13.4 N). In addition, the tearing when the ultimate tensile strength is exceeded may be designed to occur anywhere in the primary holding material, or could be purposely designed to propagate at precise tear regions. These tear regions may even have optional perforations or have precuts at the edge, for example. Empirical observations have found that the foregoing stretch and tear characteristics are effective for minimizing and virtually eliminating the unwanted turniquette effect.
It is to be understood that the foregoing detailed description and the embodiments shown in the drawings are illustrative embodiments of the invention. Various alternatives and modifications may be made without departing from the spirit and scope of the invention. Thus, by way of example and not of limitation, in most of the embodiments shown herein, and specifically the embodiments of
While the specification describes particular embodiments of the present invention, those of ordinary skill can devise variations of the present invention without departing from the inventive concept.
This is a continuation-in-part application of co-pending parent application Ser. No. 10/828,744, filed Apr. 20, 2004, whose entire contents are hereby incorporated by reference.
Number | Date | Country | |
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Parent | 10828744 | Apr 2004 | US |
Child | 11153013 | Jun 2005 | US |