RELATED APPLICATION

The present application claims the benefit of priority to Indian complete Patent Application no. 202221060191 filed on Oct 20, 2022 and the entire complete specification.

FIELD OF INVENTION

The present invention relates to orthopedic scaffold plaster for immobilizing, supporting and protecting the body parts. In particular, the present invention relates to adjustable orthopaedic scaffold device for immobilizing broken or fracture bones so as to keep bone aligned and to protect the fracture site.

BACKGROUND OF INVENTION

Currently, fractured skeletal structure or diseased joints are immobilized using casts and splints which helps in faster healing. Doctors adjusted the fracture to align the broken bone and to stabilize it, they apply cast or splint. Casts and splints hold the bones in place during healing and further unite them. They also help to reduce pain, swelling and muscle spasm. In some instances, after surgery, splints and casts are applied to immobilize bone or joints.

Splints are non-circumferential immobilizers that accommodate swelling. This quality makes splints ideal for the management of a variety of acute musculoskeletal conditions in which swelling is anticipated, such as acute fractures, sprains or for initial stabilization of reduced, displaced, or unstable fractures before orthopedic intervention. A splint is like a partial cast, a section of hard material that is held in place with an elastic bandage or Velcro straps. Splints usually have a soft cotton layer inside. The outer layer of a splint made from the same materials as a cast or it can be a pre-made piece of stiff metal or plastic surrounded by strong fabric. Casting is the most common form and it is used for a wide array of bone and soft- tissue injuries. Casts are circumferential immobilizers and because of this, casts provide superior immobilization however is less forgiving, having higher complication rates and generally reserved for complex and/or definitive fracture management. There are several different kinds of plaster casting material available, the choice depends on the particular injury. In a stable fracture the cast is usually needed to protect the bone from further injury and limit movement a little at the fracture site. Hence molding and fitting is not critical. It is also possible to make a removable cast or use pre-made splints. In an unstable fracture treated with a cast, the plaster cast is critical in holding the bone ends in a good position where the fitting and molding is very important.

In the current treatments following types of plaster cast are used: back slab, Plaster of paris (POP), synthetic cast (hard and soft cast) and swimming cast. Each type of plaster cast has some advantages and disadvantages. Back slab is used in acute fracture swelling but are usually temporary and used for a few days. They usually do not last longer than 2 weeks. Plaster of paris (POP) is often used in acute, fresh fractures. Although setting takes only a few minutes, drying may take many hours or days, especially if the atmosphere is moist and cool. Such impacts on the plaster while it is setting may cause weakening of the material and also it cannot be used in water. Another type of cast is synthetic casts known as fiber glass casts, this is a slight misnomer, not all synthetic casts are made of fiber glass and some are made of polyester. There are two main synthetic casting groups, standard synthetic casts (hard) and standard synthetic casts (Soft). Soft casts are used mostly for support or stable fractures in kids. Benefits of soft cast include the ability to remove the soft cast by unwrapping or cutting off the cast without the need for a plaster saw. It is also possible to manufacture a "swimming cast" using soft cast. The problem with swimming soft casts is that the skin will become soggy and macerate.

Accordingly, there is a need exists to eliminate at least a part of the disadvantages of the prior art and to provide a novel plaster having all the advantages in one, which is lightweight having strength and provides immobilization at the fracture site, compact, comfortable, both able to be applied on inflamed fracture site and also act as a long-term cast, easy to apply, adjustable during use, can be used in water, should be recyclable and economical. In addition to this physician may wish to check on the healing process via x-ray or other scanning techniques so cast is also needed to be compatible with x-rays and/or other scanning techniques.

The publication number US5857988, US5857989, W02006027763, W02006134343, US20080066272; US20080060168; US20080060167, W02008157738,

W02008078105, W02008041215, US20100249682, W02010103186,

W02010103187, US20120101417, US20130102940, W02014082502, US2015008077 and WO2015048265 disclosed the different type of plasters.

Thus, the inventors of the present invention have successfully addressed the drawbacks of the available literatures by providing an adjustable orthopedic scaffold device which ameliorates the above-mentioned drawbacks.

OBJECTIVE OF INVENTION

An object of the present invention is to provide an orthopedic scaffold device for fixing fractured bone.

An object of the present invention is to provide an orthopedic scaffold device which is adjustable according to the size of the body parts to be supported.

Another object of the invention is to provide an orthopedic scaffold device which is light weight having strength and provides immobilization at the fracture site.

Yet another object of the invention is to provide an orthopedic scaffold device which can be used in water.

Yet another object of the invention is to provide an orthopedic scaffold device which can be applied on target limbs with ease without trained personal. Yet another object of the invention is to provide an orthopedic scaffold device which is transparent to X-ray radiation.

Yet another object of the invention is to provide an orthopedic scaffold device which is ventilated.

Yet another object of the invention is to provide an orthopedic scaffold device which is recyclable and economical.

SUMMARY OF THE INVENTION

In accordance with one aspect the invention relates to an adjustable orthopedic scaffold device for fixing bone comprising: at least two unit of an elongated support base having a first layer and a second layer, wherein the first layer and the second layer are irremovably connected forming plurality of cavity defining a locking mechanism along at least a portion of the length of the elongated support base. The elongated support base is rigid and non-collapsible. an elongated strap extending from at least one surface of the elongated support base comprising a locking groove along at least a portion of the length of the strap, wherein the series of locking grooves are unidirectionally fixes into the locking mechanism. The elongated strap is flexible in nature and comprises a series of surface grooves along at least a portion of the length of the elongated strap. Further, the elongated strap comprises a series of aperture along at least a portion of the length of the elongated strap, wherein at least plurality of elongated straps externally surrounding fractured bone site is fastened by unidirectionally pulling the elongated strap through the cavity of the locking mechanism characterized in that providing support and immobilize the fractured bone.

According to one embodiment of the present invention, wherein said orthopedic scaffold device comprises at least two elongated support bases characterized in that the locking grooves of the first elongated strap fixes into the locking mechanism of second elongated support base, the locking grooves of second elongated strap fixes into the locking mechanism of the first elongated support base forming a non-releasable loop enclosing fracture site.

According to another embodiment of the present invention, the cavity comprises a series of surface groove for securely engaging a portion of the series of locking groves of the elongated strap.

According to another embodiment of the present invention, wherein the cavity comprises a pawl for securely engaging a portion of the series of ratchet teeth of the elongated strap.

According to another embodiment of the present invention, the orthopedic scaffold device further comprises a support member having first end and second end, removably attached to the elongated support base, characterized in that first end of support member is engaged with at least one end of the first elongated support base and second end of the support member is engaged with at least one end of the second elongated support base, wherein support member ensures stability of the adjustable orthopedic scaffold device.

In certain embodiment, the present invention provides, the elongated strap of the orthopedic scaffold device is prepared using a polymer, which is selected from but not limited to polyvinyl chloride (PVC), polypropylene, polyvinylidene chloride, polyesters and derivatives thereof.

In certain embodiment, the present invention provides, the elongated support base of the orthopedic scaffold device is prepared using a polymer, which is selected from including but not limited to PVC, polypropylene, polycarbonate, high molecular weight polyethylene and derivatives thereof. In certain embodiment, the present invention provides orthopedic scaffold device of appropriate kit type prepared according to the patient age and size of the body part to be supported.

In accordance with another aspect, the invention relates to orthopedic scaffold device for immobilizing broken or fracture bones, supporting and protecting the body part.

While several embodiments have been described in detail, it will be apparent to those skilled in the art that the disclosed embodiments may be modified. Therefore, the foregoing description is to be considered exemplary rather than limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 : Illustrates perspective view a unit of orthopaedic scaffold device according to one embodiment.

Figure 2: Illustrates an expanded view of inbuilt locking mechanism on elongated support base.

Figure 3(a): Illustrates top view of a unit of alternative orthopaedic scaffold device according to one embodiment.

Figure 3(b): Illustrates side view of a unit of alternative orthopaedic scaffold device.

Figure 3(c): Illustrates expanded side view of inbuilt locking mechanism on elongated support base of alternative orthopaedic scaffold device.

Figure 4(a): Illustrates two unit of orthopaedic scaffold device.

Figure 4(b): Illustrates two unit of orthopaedic scaffold device engaged with each other forming a non-releasable loop.

Figure 4(c): Illustrates two unit of orthopaedic scaffold device engaged with each other forming a non-releasable loop on upper limb of the body.

Figure 5: Illustrates top view of a unit of alternative orthopaedic scaffold device with releasable elongated strap according to one embodiment. Figure 6(a): Illustrates a support member held on lower base between thumb and index finger, attached to the orthopedic scaffold device applied on forearm.

Figure 6(b) shows placement of support member applied on elbow joint.

Figure 6(c) shows placement of support member applied on knee joint. Figure 6(d) shows placement of support member applied on ankle joint.

DETAILED DESCRIPTION OF THE INVENTION

In the description that follows, a number of terms are used, the following definitions are provided to facilitate understanding of various aspects of the disclosure.

The terms and words used in the following description are not limited to the bibliographical meanings, but, are merely used to enable a clear and consistent understanding of the disclosure. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present disclosure are provided for illustration purpose only and not for the purpose of limiting the disclosure as defined by the appended claims and their equivalents.

In describing the embodiment of the invention, specific terminology is chosen for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that such specific terms include all technical equivalents that operate in a similar manner to accomplish a similar purpose. As used herein, reference to an element by the indefinite article “a” or “an” does not exclude the possibility that more than one of the elements is present, unless the context clearly requires that there is one and only one of the elements.

Before any embodiments of the disclosure are explained in detail, it is to be understood that the embodiments may not be limited in application per the details of the structure or the function as set forth in the following descriptions or illustrated in the figures. Different embodiments may be capable of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of terms such as “including,” “comprising,” or “having” and variations thereof herein are generally meant to encompass the item listed thereafter and equivalents thereof as well as additional items. Further, unless otherwise noted, technical terms may be used according to conventional usage. It is further contemplated that like reference numbers may describe similar components and the equivalents thereof.

Definition

The term ‘Plaster’ as used herein is a device used to assist or restrict body movement for immobilizing, supporting and protecting the body parts.

The term ‘cast’ as used herein is a protective shell of material molded to protect a broken bone or fractured limb as it heals.

The term ‘splint’ as used herein is a medical device for immobilizing or stabilizing an injured bone, joint, limb, or spine.

The term ‘elongated straps’ as defined herein, are strips prepared from polymer.

A better understanding of different embodiments of the disclosure may be understood from the following description read with the accompaying drawing in which like reference characters refer to like elements.

The present invention discloses an adjustable orthopedic scaffold device which covers and supports the fracture site and also provides required strength and immobilization to the fracture site. It is a polymer-based scaffold which adjusts according to the fracture area of patient wherein, same scaffold can applicable to different body parts having different dimensions.

In one aspect, the present invention relates to an adjustable orthopedic scaffold device (100) for fixing fractured bone when applied externally on the fractured bone body site of a patient. In accordance with an embodiment of the present disclosure and reference to FIG. 1 and FIG. 2, an adjustable orthopedic scaffold device (100) is provided which includes an elongated support base (10) having a first layer (12) and a second layer (14), wherein the first layer (12) and the second layer (14) are irremovably connected forming plurality of cavity (32) defining a locking mechanism (30) along at least a portion of the length of the elongated support base (10).

In one embodiment, the present invention provides an elongated strap (20) extending from surface of at least one layer of the elongated support base (10) comprising a locking groove (22) along at least a portion of the length of the strap, wherein the series of locking grooves (22) are unidirectionally fixes into the locking mechanism (30). In one embodiment, the elongated strap is flexible.

In one embodiment, the elongated straps (20) extend from surface of at second layer (14) of the elongated support base (10) comprising a locking groove (22) along at least a portion of the length of the strap, wherein the series of locking grooves (22) are unidirectionally fixes into the locking mechanism (30);

Typically, the number of locking mechanism (30) within elongated support base is proportional to the number of expanses of the elongated straps (20). In a preferred embodiment, the number of locking mechanism (30) within elongated support base is equal to the number of expanses of the elongated straps (20).

In one embodiment, first layer (12) and second layer (14) of the elongated support base (10) are rigid and non-collapsible which are placed above each other such that a cavity defining a locking mechanism (30) for engaging elongated straps (20) with elongated support base (10) forming a non- releasable loop.

Typically, the series of locking grooves are unidirectionally fixes into the locking mechanism of located between first layer (12) and second layer (14) of elongated support base of at least another unit of orthopedic scaffold device (100) In one embodiment, the cavity (32) defining a locking mechanism (30) along at least a portion of the length of the elongated support base (10) comprises a series of surface groove (34) for securely engaging a portion of the series of locking groves (22) of the elongated strap (20). Typically, the locking grooves engaging with the surface grooves of the elongated strap is unidirectionally. In preferred embodiment, the non-releasable loop can be unidirectionally fastened by pulling the elongated strap (20) through the locking mechanism (30) present in the elongated support base (10) based on the requirements. More specifically, the individual member of elongated strap (20) can be fastened independently.

In one embodiment of the present invention and accordance to the FIG.3a-3c, the cavity defining a locking mechanism (30) along at least a portion of the length of the elongated support base (10) comprises a pawl (42) for securely engaging a portion of the series of ratchet teeth (44) of the elongated strap (20). Typically, the pawl (42) engaged with ratchet teeth (44)form a unidirectional locking mechanism forming a non-releasable loop. In preferred embodiment, the non-releasable loop can be unidirectionally fastened by pulling the elongated strap (20) through the locking mechanism (30) present in the elongated support base (10) based on the requirements. More specifically, the individual member of elongated strap (20) can be fastened independently.

In one embodiment of the present invention, at least a plurality of elongated straps externally surrounding fractured bone site is fastened by unidirectionally pulling the elongated strap through the cavity of the locking mechanism (30)of the other elongated support base (10) characterized in that providing support and immobilize the fractured bone. Typically, the elongated straps (20)

According to one embodiment of the present invention and accordance to the FIG. 4a- 4c, the orthopedic scaffold device (100) comprises at least two elongated support bases characterized in that the locking grooves (22) of the first elongated strap (42a) fixes into the locking mechanism (30) of second elongated support base (40b), the locking grooves (22) of second elongated strap (42b) fixes into the locking mechanism (30) of the first elongated support base (40a) forming a non-releasable loop enclosing fracture site. Typically, the orthopedic scaffold device comprises at two elongated support bases characterized in that the locking grooves (20) of the first elongated strap (42a) fixes into the locking mechanism of second elongated support base(40b), the locking grooves of second elongated strap (42b) fixes into the locking mechanism of the first elongated support base (40a)forming a non-releasable loop enclosing fracture site.

In another embodiment, the number of adjustable orthopedic scaffold device surrounding the fracture site of the body is directly proportional to the size of the limb.

In another embodiment, the elongated straps (20) of adjustable orthopedic scaffold device (100) includes apertures (24) along at least a portion of the length of the elongated strap. Typically, the size of aperture (24) ensures a proper ventilation for respiration of skin surface pores.

According to one embodiment of the present invention, the locking mechanism (30) formed by engaging elongated straps (20) and elongated support base (10) is at least one including but not limited standard zip-tie, push-in, ball, double locking, beaded, hookloop, ratchet, rivets, pinlocks and grip auto-lock.

In one embodiment and accordance to the FIG. 5, the adjustable orthopedic scaffold device (50) comprises at reversible locking system engaging the elongated strap and elongated support base. The elongated strap once attached to the elongated support base can be moved bidirectionally with help of reversible locking mechanism. In preferred embodiment the grooves on elongated strap are reversibly attached to the elongated support base through a locking mechanism characterized in that at least grooves (52) are release by unlocking a release button (54) position on the elongated support base. More specifically, at least two release buttons are unlocked simultaneously for the reverse movement of the elongated strap. Once the elongated strap the adjusted reversibly, the release button is moved to its original engaged position with the elongated support base. In another embodiment, the unlocking of the release button (54) positioned on the elongated support base is performed by at least one selected from pushing or pulling the release button (54). In preferred embodiment, the release button is pulled to disengage the elongated strap with the elongated support base. This mechanism allows user to adjust the scaffold device as per the circumferential length of the limb subject to the support treatment. In one embodiment, the user can remove the elongated straps engaged with the elongated support base, once the requirement orthopedic scaffold device is completed.

In one of the embodiment and accordance to the FIG. 6a-6d, the adjustable orthopedic scaffold device (100) further comprises a support member (60) having first end and second end, removably attached to the elongated support base, characterized in that first end of support member is engaged with at least one end of the first elongated support base and second end of the support member is engaged with at least one end of the second elongated support base, wherein support member ensures stability of the adjustable orthopedic scaffold device.

Referring to FIG. 6(a) the support member for (62) attached to proximal end elongated support base (10), positioned across the thumb to provide stability to the orthopedic scaffold device (100) providing support to the fractured limb, more specifically forearm.

Referring to FIG. 6(b) the support member for (64) attached to the elongated support base (10), positioned across the elbow to provide stability to the orthopedic scaffold device (100) providing support to the fractured limb, more specifically elbow.

Referring to FIG. 6(c) the support member for (66) attached to the elongated support base (10), positioned across the knee to provide stability to the orthopedic scaffold device (100) providing support to the fractured limb, more specifically knee.

Referring to FIG. 6(d) the support member for (68) attached to the elongated support base (10), positioned across the ankle joint to provide stability to the orthopedic scaffold device (100) providing support to the fractured limb, more specifically ankle joint. In one embodiment, the thickness and dimension of the orthopaedic scaffold device vary according to the patients’ requirements. The thickness of the elongated strap of the orthopaedic scaffold device for paediatric patient is ranging from 0.5 mm to 2mm, both inclusive; whereas thickness of the elongated strap of the orthopaedic scaffold device orthopaedic scaffold device for adult’s patient is ranging from 1 mm to 3 mm, both inclusive. Further, the thickness of the elongated support base of the orthopaedic scaffold device for paediatric patient is ranging from 1 mm to 3 mm, both inclusive; whereas thickness of the elongated support base of the orthopaedic scaffold device orthopaedic scaffold device for adult’s patient is ranging from 3 mm to 7 mm, both inclusive.

According to one embodiment of the present invention, the orthopedic scaffold sysytem is prepared using polymers which are selected from but not limited to polyvinyl chloride (PVC), polyvinylidene chloride, polyesters, polycarbonate, high molecular weight polyethylene, nylon, polyolefin (e.g. polyethylene (PE), polypropylene (PP), polymethylpentene (PMP), polybutene-1 (PB-1)), fluoropolymer (e.g. fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), kynar), polyesters, neoprene, rubber, silicon elastomer, viton and derivatives thereof.

In one embodiment of the present invention, the elasticty modulus of elonaged straps material (20) of the orthopedic scaffold device (100)is selected in the 600 MPa to 2500 MPa preferably 1500 Mpa. The elonaged straps (20) of the orthopedic scaffold device hereinabove is prepared from a polymer including but not limited to polypropylene, polyvinyl chloride (PVC), polyvinylidene chloride and polyesters. Particularly, preferredorthopaedic scaffold device polymer is having the properties of hardness with limited flexibility to achieve synchronized fastening mechanism.

In one embodiment of the present invention, the elasticty modulus of elonaged support base (10) of the orthopedic scaffold device (100)is selected in the 1200 MPa to 5000 MPa, preferably 3500 MPa. The elongated support base (10) as described herein above, is prepared form polymer including but not limited to Polypropylene, PVC, Polycarbonate or High molecular weight Polyethylene plastics.

In one embodiment of the present invention, the material for preparation of elongated strap (20) and elongated support base (10) is identical, however, flexibilty and rigidity of elongated strap (20) and elongated support base (10) is directly proportional to thickness of elonagted strap (20) and elongated support base (10) respectively. In preferred embodiment, the thickness of elonagted strap (20) is less than the thickness of elongated support base (10). Typically, the material is for preparing orthopedic scaffold device (100) is Polypropylene. The thickness of elongated strap (20) is 0.5-3 mm and the elongated support base (10) is 3-10 mm.

Various support members (50) are used to provide support to the fracture site during healing. The support members are selected from metal preferably aluminium or rigid plastic material.

Closing system

There are number of closing system available in the prior art which required skill person to fastened and loose plaster. Some closing system are hook and loop fastener, cablereel, snaps, laces, toothed zip ties, ratchet lace systems, ratchet buckle system, ski boot type buckles and the like.

In one embodiment of the present invention, the locking system for elongated straps are reversible wherein elongated straps enaged with the locking mechanism can be adjusted to a desired length. In preferred embodiment, the elongated strap enagaged with the locking system can be pulled back by activating the release mechansim position on the locking system. In preferred embodiment, each member of the elongared strap engages with the individual locking member and function independently. This system provides a user to maintain the integrity of the orthopedic scaffold device during adjusting the elongated strap. In one embodiment of the present invention the adjustable orthopedic scaffold device containing plurality of elongated straps (20) are removably attached to locking mechanism (30) which is positioned in the elongated support base (10). In preferred embodiment, the desired elongated strap is reversibly locked in to the locking mechanism (30)

In another embodiment, the adjustable orthopedic scaffold device, the plurality of elongated straps (20) engaged with the locking mechanism (30) can be adjusted at different length of the said elongated straps (20). In a preferred embodiment, one elongated strap is adjusted by pulling back from reversible locking system to adjust according the size of the limb, thus, the length of the desired elongated strap is adjusted according the size of limbs. The size of the limbs keeps altering along the radial axis of the scaffold device. The rigidity of the elongated strap is selected to ideal range such that the integrity of the orthopedic scaffold device is maintained.

The invention disclosed the orthopedic scaffold system (100) does not necessarily require a technically skill person. After application of the padding material, two orthopedic scaffold devices applied around fracture site and passed through elongated support base (10) as shown in Figure 4 band 4c. This scaffold device was positioned properly to maximize the support to the fracture site followed adjustment of elongated strap (20) and tightens the same around the fracture site. This mechanism provides the use of the plaster on inflamed fracture site. The elongated strap (20) is adjusted accordingly to fit to the new size of the fracture site. The elongated strap (20) cuts using normal scissors and removed after the fracture healed (confirmed using X-ray taken along with orthopedic scaffold device (100).

While various configurations of the plaster material of the present invention have been illustrated and described herein, that other configurations and sizes are possible, and may be desirable for certain end uses. In the drawing and specification, there has been set forth embodiments of the invention, and although specific terms are employed, they are used in generic and descriptive sense only and not for purposes of limitation.

Examples Example 1 : Comparison of tensile strength between Plaster of Paris (POP) cast Plaster and Orthopaedic scaffold device

The tensile strength of the regular Plaster of Paris (POP) cast Plaster and orthopaedic scaffold device was compared using Texture analyser (Ubique Tensile Tester, Ubique enterprise, Pune, India). The tensile strength of the standard POP plaster with the thickness of 4cm was 145 N/m ² .

The tensile strength of the elongated strap (20) of the orthopaedic scaffold device was in the range of 30 to 100 N/m ² and elongated support base (10) was in the range of 80 to 250 N/m ² . Thus, the combined tensile strength of orthopaedic scaffold device was in the range of 110 to 350 N/m ² .

Thus, the orthopaedic scaffold device endures more than double the tensile strength compared to standard POP plaster.

Tablet. Comparison of Tensile strength between POP and Orthopaedic scaffold device

* Strength of plaster without padding material

Example 2: Weight comparison between Plaster of Paris (POP) cast Plaster and Orthopaedic scaffold device

An orthopaedic scaffold device is lighter in weight as compare to standard POP plaster. The comparison between POP and orthopaedic scaffold device as shown in Table 2

Table 2. Comparison of weight between POP and orthopaedic scaffold device

* Weight with padding material

TECHNICAL ADVANCEMENTS

The present invention provides the following technical advancements over the prior device or method for fixing fractured bones.

The advantages of the present invention include:

1. Applied on inflamed fracture site and adjustable;

2. Can be applied on fracture sites with wound;

3. Light weight with less components; 4. Not require skilled person for application;

5. Applied to the fractures on the site of accidents (regular fracture, natural calamities or used in emergencies);

6. Breathing and see-through plasters are possible;