THERMOPLASTIC ORTHOPEDIC DEVICES

Abstract

A formable orthopedic device having at least one first configuration and at least one second configuration, the second configuration being adapted to provide support to at least one limb, the device being made of a thermoplastic polymeric material selected to have an elastic modulus of at least about 1500 MPa when measured according to ASTM D638, a glass transition temperature (Tg) of between about 65 C. and about 120 C., and elongation to break of at least 75% when measured according to ASTM D638, the device being capable to be formed into the second configuration by heating the device to said Tg.

Claims

1. A formable orthopedic device having at least one first configuration and at least one second configuration, the at least one second configuration being adapted to provide support to at least one limb, the formable orthopedic device being made of a thermoplastic polymeric material selected to have an elastic modulus of at least about 1500 MPa when measured according to ASTM D638, a glass transition temperature (Tg) of between about 65 C. and about 120 C., and elongation to break of at least 75% when measured according to ASTM D638, the formable orthopedic device being capable to be formed into the second configuration by heating the device to said Tg.

2. (canceled)

3. The formable orthopedic device of claim 1, wherein the thermoplastic polymeric material has a glass transition temperature (Tg) of the thermoplastic polymer material that is between about 70 C. and about 105 C.

4. The formable orthopedic device of claim 1, being re-formable upon heating to the Tg.

5. The formable orthopedic device of claim 1, wherein the thermoplastic polymeric material is recyclable.

6. (canceled)

7. The formable orthopedic device of claim 1, wherein the thermoplastic polymeric material having has a total light transmittance of at least 88% when measured according to ASTM D1003.

8. The formable orthopedic device of claim 1, wherein the thermoplastic material has a deflection temperature of the thermoplastic that is at least 65 C. at 0.455 MPa when measured according to ISO 75.

9. The formable orthopedic device of claim 1, wherein the thermoplastic polymeric material includes at least one of polyesters, thermoplastic polyurethanes, blends thereof, or copolymers thereof.

10. The formable orthopedic device of claim 9, wherein the thermoplastic polymeric material includes a glycol-modified polyethylene terephthalate (PETG).

11. (canceled)

12. The formable orthopedic device of claim 1, wherein the at least one first configuration of the formable orthopedic device is a planar formed sheet and the at least one second configuration of the device is a non-planar 3-dimensional device.

13. (canceled)

14. (canceled)

15. The formable orthopedic device of claim 1, having an edge defining a contour of the device, the edge being filleted.

16. The formable orthopedic device of claim 15, wherein the filleted edge has at least one portion with a curvature radius of between about 0.8 and about 2 mm.

17. (canceled)

18. (canceled)

19. (canceled)

20. The formable orthopedic device of claim 1, wherein said at least one first configuration is obtained by injection molding of the thermoplastic polymeric material.

21. (canceled)

22. (canceled)

23. (canceled)

24. (canceled)

25. The formable orthopedic device of claim 1, being a splint.

26. (canceled)

27. (canceled)

28. A method of forming an orthopedic device, the method comprising: heating a device having a first configuration to a temperature of between about 65 C. and about 140 C., thus obtaining a malleable pre-formed device, the malleable pre-formed device being made of a thermoplastic polymeric material selected to have an elastic modulus of at least about 1500 MPa when measured according to ASTM D638, a glass transition temperature (Tg) of between about 65 C. and about 120 C., and elongation to break of at least 75% when measured according to ASTM D638; bringing the malleable pre-formed device into direct or indirect contact with a body limb requiring support; forming the malleable pre-formed device into a second configuration matching the form of said body limb thus obtaining a malleable formed device; and permitting the malleable formed device to cool and harden, thus obtaining said orthopedic device.

29. (canceled)

30. (canceled)

31. The method of claim 28, wherein said heating is carried out by immersing the device in boiling water.

32. (canceled)

33. (canceled)

34. The method of claim 28, wherein indirect contacting the malleable pre-formed device with the body limb includes at least partially wrapping the body limb requiring support with a thermally protective sheet closely following the contours of the body limb, and bringing the malleable pre-formed device into contact with the protective layer.

35. A kit comprising a first device according to claim 1 and at least one fastening strip, the first device being configured for receiving said at least one fastening strip.

36. (canceled)

37. (canceled)

38. (canceled)

39. The kit of claim 35, further comprising at least one second device of claim 1 being configured for receiving said at least one fastening strip, said first and second devices being connected to one another by the fastening strips for encasing a body limb in need of support.

40. The kit of claim 35, further comprising at least one orthopedic device of claim 1 configured for receiving at least one fastening strip or other connectors, to form a prosthesis device.

41. (canceled)

42. The kit of claim 35, further comprising instructions for use.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0069] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0070] FIG. 1A is a perspective view of the orthopedic device in the form of a splint, according to one embodiment of the presently disclosed subject matter, in which the splint is in its first flat configuration;

[0071] FIG. 1B is a front, top and side views of the splint of FIG. 1A;

[0072] FIG. 1C is a perspective view of the splint of FIG. 1A, in which the splint is in its second bent configuration;

[0073] FIG. 1D is a perspective view of the splint of FIG. 1A, in which the splint is in its third bent configuration; and

[0074] FIG. 2 is a schematic illustration of method of using a kit including the splint of FIG. 1A, and in particular of forming the splint.

DETAILED DESCRIPTION OF EMBODIMENTS

[0075] Reference is now made to FIGS. 1A-1D, illustrating one example of an orthopedic device according to the presently disclosed subject matter, in the form of a functional volar splint, generally designated as 1. The splint 1 in FIGS. 1A and 1B is shown in its first flat configuration, in FIG. 1C in its second bent configuration, and in FIG. 1D in its third bent configuration. The splint 1 is shaped to fit a patient's forearm and wrist in order to provide support to the wrist, for example, in the second bent configuration. The splint 1 according to the particular example of FIGS. 1A-1D is made of glycol-modified polyethylene terephthalate (PETG), having the following characteristics: a Tg of between about 90 C. and about 105 C., an elastic modulus of about 2200 MPa when measured according to ASTM D638, an elongation to break of about 150% when measured according to ASTM D638, and a total light transmittance of about 91% when measured according to ASTM D1003. The splint 1 is pre-shaped by injection molding.

[0076] The splint 1 is configured to be easily and quickly tailored to the patient's anatomical features, without using expensive equipment and without requiring specialization in splinting for properly fitting the splint to the patient. Further, the splint 1 is mechanically stable, such that once shaped and customized into the desired spatial configuration, e.g., the second bent configuration and the third bent configuration, and hardened, the splint 1 provides proper support to the injured limb. Further, the splint 1 is formable and shapeable without the need of specialized equipment, thus making the splint 1 suitable for providing treatment to populations in poor or developing countries, as well as in disaster areas. The material of the splint 1 allows heating it to its polymer's Tg without using special heating equipment, and may be carried out by boiling water to the desired temperature. This is of particular importance for utilization of the splint 1 in disaster areas or developing countries, where no access to sophisticated equipment is available. For example, the splint 1 may be heated to its Tg to permit forming by merely immersing the splint 1 (in its first configuration) in a boiling water pot including water with a temperature of about 100 C. This is of importance as, in field conditions, the bubbling of boiling water is a straightforward visual indicator to a practitioner that a suitable temperature is obtained to permit immersion of the splint 1.

[0077] The third bent configuration of FIG. 1D is provided in the drawings, to illustrate how the splint 1 can be reshaped from the second bent configuration of FIG. 1C to a different bent 3D shape, thus permitting reusing and retailoring the splint 1 to a different patient once the splint 1 is no longer in use by a previous patient.

[0078] Such formability, along with a desired strength and stability, is obtained by utilizing the above described thermoplastic polymeric material of splint 1 having the above mentioned defined set of characteristics.

[0079] Once the splint 1 needs to be reshaped or reformed, either due to a need to fine-tune the fit to the patient's anatomical shape or when requiring adjusting the splint 1 to a different patient, a practitioner needs to merely heat the splint 1 to the Tg and the softening of the polymeric material enables reshaping of the splint 1 to another desired second configuration (e.g., the second bent configuration of FIG. 1C, or the third bent configuration of FIG. 1D).

[0080] The transparency of the splint 1 is advantageous when the splint 1 is intended for closely contacting or fitting onto the limb. Such close fitting may often apply pressure on the tissue beneath the splint 1, which may result in lack of comfort to the patient (and hence lack of compliance) at least, or even development of pressure-sores and development of necrotic tissue in a different extreme situation. Thus, the transparency of the splint 1 may on the one hand help the practitioner to fine tune the fitting of the splint 1 onto the limb during the shaping process, as well as assist the patient and the practitioner after fitting (and during treatment) to identify development of undesired damage to the tis sue.

[0081] Reference is now made particularly to FIG. 1B, and in which the splint 1 is shown from its front view, from its top view 2 when viewed from direction 2 (above the splint 1), and from its side view 3 when viewed from direction 3 (right to the splint 1).

[0082] As clearly seen in top view 2, the splint 1 has a variable thickness profile along a cross-section (not shown) taken perpendicularly to the longitudinal axis X of the splint 1, and being parallel to top view 2 of the splint 1. The variable thickness profile seen in the top view 2 is expressed by a thickness D1 at the center of the profile, which is larger compared to a thickness D2 at the edges of the profile. Such variability in thickness may assist the practitioner to shape and form the edges of the splint 1 more accurately without substantially deforming the central segments of the splint 1, such that the edges are bent to fit the patient's anatomical features, while the central segments of the splint 1 provide mechanical support due to their larger thickness.

[0083] As seen in FIGS. 1A and 1B, the splint 1 has a filleted edge 7 that defines a contour thereof. The filleted edge 7 is configured to provide a smooth edge finish and prevent sharp edges from contacting the limb to prevent applying pressure on the tissue beneath the splint 1. The filleted edge 7 has a curvature radius of about 1.5 mm.

[0084] The splint 1 also has a plurality of through-holes 8 that extend between a first face and a second, opposite face of the splint 1. The through-holes 8 provide for aeration to the tissue beneath the splint 1, one applied onto the limb. The through-holes 8 have varying sizes and are arranged as a semi-ordered array formation. Each of the through-holes 8 also has a filleted hole edge, with a curvature radius of about 0.5 mm.

[0085] In order to allow customization of the splint 1, in its second bent configuration, onto the forearm, the lower portion 6 of the splint 1 is configured with two pairs of slits 9 and 10. Each of the slits 9 and 10 extends in proximity to the edge 7 has an elongate structure configured for receiving a respective end portion of a fastening strip 20 (as detailed below with respect to FIG. 2). Each fastening strip 20 can be made with or without Neoprene, and with hook and loop Velcro connectors for connecting the strip 20 to its respective slit 9 and 10. The strips 20 can be disconnected from the splint 1, are replaced with other (e.g., new) strips 20. In addition, the slits 9 and 10 of the splint 1 can be easily cleaned, for example, during usual maintenance or when the splint 1 is reused for another patient.

[0086] Reference is now made to FIG. 2, in which a kit 100 including the splint 1 of FIG. 1A, is shown together with illustration of method steps for using the kit 100.

[0087] The kit 100 includes the following elements: the splint 1, four fastening strips 20, a pair of heat-insulating gloves 25, a thermally protective sheet 30, a pot 35 for boiling water, tongs 40.

[0088] As shown in FIG. 2, the method of using the kit 100 for forming the splint 1 comprises the following steps:

[0089] step 101: providing the kit 100, including the splint 1 in its first flat configuration;

[0090] step 102: plunging the splint 1 in its first flat configuration into the pot 35 and exposing the splint 1 to a temperature of about 100 C.;

[0091] step 103: waiting for a period of time of about 50 seconds to soften the splint 1, however without melting, thus obtaining a malleable pre-formed splint 1, and extracting the malleable pre-formed splint 1 from the pot 35;

[0092] step 104: wrapping a patient's forearm and wrist requiring support with the thermally protective sheet 30 and bringing the malleable pre-formed splint 1 into contact with the patient's forearm and wrist;

[0093] step 105: application force on various areas of the splint 1 in order to fit the splint 1 to the anatomical shape of the patient's forearm and wrist, and thereby forming the malleable pre-formed splint 1 into a second configuration matching the form of said forearm and wrist, and obtaining a malleable formed splint 1;

[0094] step 106: permitting the malleable formed splint 1 to cool to room temperature of about 24 C. along about 3 minutes, for example, by using cold water, thus obtaining said splint 1 in its second bent configuration;

[0095] step 107: introducing each one of the strips 20 to their respective slits 9 and 10, and connecting the hook and loop Velcro connectors of each of the strips, thereby obtaining the splint 1 in its second bent configuration ready for use; and

[0096] step 108: attaching the splint 1 to patient's forearm, for providing support to his wrist, and observing the fixed area through the transparent splint 1 for receiving visual indication to pressure points and for correcting the customization of the splint 1 to the pressured area at the point of care.

[0097] As is clear from the above description, utilizing the kit 100 and the above method, the entire process of forming the splint 1 from its first flat configuration until obtaining the second bent configuration is relatively short and simple, taking often up to 5 minutes.

[0098] Although not shown in the drawings, the kit 100 can further comprise a splint configured to be connected to the splint 1 by fastening strips for encasing a body limb in need of support. Such kits may be used to fit two or more splints of this disclosure around a limb to be supported, either to provide segmented support or to encase the limb by supporting splints (obtaining a fixation similar to that obtained by a cast).