Foam core sandwich splint

Patent metadata

Field	Value
Publication number	US-10285845-B2
Application number	US-201615082690-A
Country	US
Kind code	B2
Filing date	Mar 28, 2016
Priority date	Jul 31, 2012
Publication date	May 14, 2019
Grant date	May 14, 2019

Abstract

A multi-layered composite material suitable for use in orthopedics includes a foam core layer bonded between two layers of thermoformable polymer material. The thermoformable material is heat formable within a target temperature range allowing for rapid heating and application to a patient such as in the form of a splint. While within the target temperature range, the composite material includes a dwell time sufficiently long to enable proper fitment and adjustment, yet not overly long requiring extended periods of holding the composite material in place. The composite material is very light yet extremely rigid and easily conformable to patients.

First claim

What is claimed is:

1. A composite material, comprising:
a first layer of thermoformable material;
a second layer of thermoformable material; and
a foam layer disposed between, and bonded to, the first and second layers of thermoformable material,
wherein the first and second layers of thermoformable material are heat formable within a target temperature range and substantially rigid at room temperatures,
wherein the first and second layers of thermoformable material have a dwell time of about three to ten minutes, the dwell time being an amount of time during which the first and second layers of thermoformable, once heated to within the target temperature range, are at least partially shapeable, and
wherein the first and second layers of thermoformable material each have a thickness of about 0.03 to 0.075 inches, and wherein the foam layer has a thickness of about 0.04 to 0.12 inches.

2. The composite material of claim 1 , wherein the first and second layers of thermoformable material are at least partially rigid after a portion of the dwell time such that the first and second layers of thermoformable retain their shape after the portion of the dwell time.

3. The composite material of claim 2 , wherein the dwell time is greater than about five minutes and the portion of the dwell time is about five minutes.

4. The composite material of claim 1 , wherein the first and second layers of thermoformable material are substantially rigid at temperatures below a minimum formable temperature of about 130 degrees Fahrenheit.

5. The composite material of claim 1 , wherein the target temperature range is about 160-240 degrees Fahrenheit.

6. The composite material of claim 1 , wherein the target temperature range is about 190-225 degrees Fahrenheit.

7. A composite material, comprising:
a first layer of thermoformable material;
a second layer of thermoformable material; and
a foam layer disposed between, and bonded to, the first and second layers of thermoformable material, wherein density of the foam layer is about 150-300 kg/m3,
wherein the first and second layers of thermoformable material are heat formable within a target temperature range and substantially rigid at room temperatures,
wherein the first and second layers of thermoformable material have a dwell time of about three to ten minutes, the dwell time being an amount of time during which the first and second layers of thermoformable, once heated to within the target temperature range, are at least partially shapeable.

8. The composite material of claim 7 , wherein the first and second layers of thermoformable material have a density which is about three to five times greater than a density of the foam layer.

9. The composite material of claim 1 , further comprising:
an inner layer coupled to the first layer of thermoformable material; and
an outer layer coupled to the second layer of thermoformable material.

10. A splint, comprising:
a composite material including
a first layer of thermoformable material;
a second layer of thermoformable material; and
a foam layer disposed between, and bonded to, the first and second layers of thermoformable material,
wherein the first and second layers of thermoformable material are heat formable within a target temperature range and substantially rigid at room temperatures; and

a closure system attached to the composite material and configured to tighten the composite material around a body part.

11. The splint of claim 10 , wherein the closure system comprises:
one or more attachment members configured to releasably couple to composite material;
one or more guide elements affixed to the one or more attachment members;
an elongated flexible member configured to be routed through the one or more guide elements; and
a tensioning mechanism configured to be operable so as to engage the flexible member.

12. A method, comprising:
providing a composite material to a user, the composite material including:
a first layer of thermoformable material,
a second layer of thermoformable material, and
a foam layer disposed between, and bonded to, the first and second layers of thermoformable material,
wherein the first and second layers of thermoformable material are heat formable within a target temperature range and substantially rigid at below a minimum formable temperature,
wherein the first and second layers of thermoformable material have a dwell time of about three to ten minutes, the dwell time being an amount of time during which the first and second layers of thermoformable, once heated to within the target temperature range, are at least partially shapeable; and
providing instructions to the user for creating a splint with the composite material, the instructions including:
heating the composite material to within the target temperature range,
forming the composite material about a body part while the layers of thermoformable material are above the minimum formable temperature, and
allowing the composite material to cool in place for the dwell time such that the layers of thermoformable material are below the minimum formable temperature.

13. The method of claim 12 , wherein the instructions further comprise holding the composite material in place until expiration of the dwell time.

14. The method of claim 12 , wherein the first and second layers of thermoformable material are at least partially rigid after a portion of the dwell time such that the first and second layers of thermoformable retain their shape after the portion of the dwell time, and wherein the instructions further comprise holding the composite material in place for the portion of the dwell time.

15. The composite material of claim 14 , wherein the dwell time is greater than about five minutes and the portion of the dwell time is about five minutes.

16. The method of claim 12 , wherein heating the composite material to within the target temperature range comprises uses a dry heat source.

17. The method of claim 12 , wherein heating the composite material to within the target temperature range comprises uses a wet heat source.

18. The method of claim 12 , wherein the target temperature range being between 160-240 degrees Fahrenheit.

19. The method of claim 12 , wherein the target temperature range being between 190-225 degrees Fahrenheit.

20. The method of claim 12 , wherein the first and second layers of thermoformable material have a density which is about three to five times greater than a density of the foam layer.

Assignees

• Exos Llc
• Djo Llc

Inventors

• Joseph Mark

Classifications

• A61F5/01

  Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces · CPC title

• A61L15/14

  Use of materials characterised by their function or physical properties · CPC title

• A61F5/05825 Primary

  Strips of substantially planar form · CPC title

• B32B5/18

  characterised by features of a layer {of} foamed material · CPC title

• A61F5/0102

  specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations · CPC title