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Last Updated: March 28, 2024

Claims for Patent: 8,535,062


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Summary for Patent: 8,535,062
Title:Cutaneous surgical training model of the head, neck and shoulders
Abstract: The present invention relates to a high-fidelity three-dimensional surgical training model for demonstrating or practicing surgical techniques. The three-dimensional surgical training model simulates human tissues of the head, neck and shoulders. The three-dimensional surgical training model may comprise a wide variety of defects, including but not limited to various cutaneous defects. The present invention also relates to methods of building and utilizing a three-dimensional surgical training model.
Inventor(s): Nguyen; Keoni (Dayton, OH)
Assignee: SimSkin, LLC (Chicago, IL)
Application Number:12/646,887
Patent Claims:1. A three-dimensional surgical training model for demonstrating or practicing surgical techniques, comprising: a skeleton-simulating structure comprising a skull-simulating structure which approximates the shape of a human skull; cartilage-simulating structures disposed upon and adjacent to the skeleton-simulating structure, wherein the cartilage-simulating structures comprise nasal cartilage-simulating structures and auricular cartilage-simulating structures; a muscle-simulating layer disposed upon and adjacent to the skeleton-simulating structure, wherein the muscle-simulating layer comprises superficial muscle-simulating structures of the head and neck; and a high fidelity skin-simulating layer disposed upon and adjacent to the muscle-simulating layer, wherein the high fidelity skin-simulating layer comprises: an epidermis-simulating layer, wherein the epidermis-simulating layer comprises a mixture of a platinum polysiloxane derivative, a silicone rubber, and a polysiloxane softener; an upper dermis-simulating layer disposed upon and adjacent to the epidermis-simulating layer, wherein the upper dermis-simulating layer comprises a mixture of a silicone rubber and a polysiloxane softener; a lower dermis-simulating layer disposed upon and adjacent to the upper dermis-simulating layer, wherein the lower dermis-simulating layer comprises a plurality of layers of polyamide mesh; and a subcutaneous-simulating layer disposed upon and adjacent to the lower dermis-simulating layer, wherein the subcutaneous-simulating layer comprises a mixture of a platinum polysiloxane derivative and a polysiloxane softener, and wherein the high fidelity skin-simulating layer comprises a tensile strength of from about 16 MPa to about 20 MPa, an elongation at break point of from about 65% to about 75%, and a durometer hardness of from about 4 to about 6.

2. The three-dimensional surgical training model of claim 1, wherein the skeleton-simulating structure further comprises a periosteum-simulating layer disposed upon and adjacent to the skeleton-simulating structure.

3. The three-dimensional surgical training model of claim 1, wherein the skeleton-simulating structure further comprises a galea aponeurotica-simulating structure disposed upon and adjacent to the skeleton-simulating structure.

4. The three-dimensional surgical training model of claim 1, wherein the superficial muscle-simulating structures of the head and neck comprise at least one of the frontal, occipital, procerus, orbicularis oculi, transverse nasalis, levator labii superioris alaeque nasi, levator labii superioris, zygomaticus minor, zygomaticus major, orbicularis oris, buccinator, depressor anguli oris, depressor labii inferioris, mentalis, and platysma muscles.

5. The three-dimensional surgical training model of claim 1, wherein the muscle-simulating layer further comprises nerve-simulating structures disposed upon the muscle-simulating layer, artery-simulating structures disposed upon the muscle-simulating layer, and a superficial musculoaponeurotic system-simulating layer disposed upon and adjacent to the muscle-simulating layer.

6. The three-dimensional surgical training model of claim 1, wherein the cartilage-simulating structures are laminated onto the skeleton-simulating structure, the muscle-simulating layer is laminated onto the skeleton-simulating structure, and the high fidelity skin-simulating layer is laminated onto the muscle-simulating layer.

7. The three-dimensional surgical training model of claim 1, wherein: the epidermis-simulating layer further comprises a polyfiber layer, the epidermis-simulating layer has a thickness of from about 0.5 mm to about 1.0 mm, a tensile strength of from about 1 MPa to about 3.4 MPa, and an elongation at break point of from about 700% to about 1100%; the epidermis-simulating layer comprises the platinum polysiloxane derivative and the silicone rubber in the epidermis-simulating layer in a ratio of 1:1, the upper dermis-simulating layer further comprises a polyfiber layer, the upper dermis-simulating layer and the lower dermis-simulating layer have a combined thickness of from about 1.5 mm to about 2.5 mm, a combined tensile strength of from about 15 MPa to about 20 MPa, and a combined elongation at break point of about 75% to about 100%; and the subcutaneous-simulating layer has a thickness of from about 1 mm to about 10 mm.

8. The three-dimensional surgical training model of claim 1, wherein the lower dermis-simulating layer further comprises blood vessel-simulating structures disposed therein.

9. The three-dimensional surgical training model of claim 1, further comprising a rigid layer disposed upon and adjacent to the skeleton-simulating layer, wherein the rigid layer comprises a rigid foam capable of expansion.

10. The three-dimensional surgical training model of claim 1, further comprising gland-simulating structures disposed upon and adjacent to the muscle-simulating layer, wherein the gland-simulating structures comprise at least one of parotid gland-simulating structures and lacrimal gland-simulating structures.

11. The three-dimensional surgical training model of claim 1, further comprising cutaneous defect-simulating structures disposed within the high fidelity skin-simulating layer, wherein the cutaneous defect-simulating structures are selected from the group consisting of lesions, wounds, cysts, lymphomas and scars and combinations thereof, and wherein at least one of the cutaneous defect-simulating structures protrudes above an outer-most surface of the epidermis-simulating layer.

12. The three-dimensional surgical training model of claim 11, wherein the lesions comprise tumors and tumor margins.

13. The three-dimensional surgical training model of claim 1, wherein: the lower dermis-simulating layer comprises at least one blood vessel-simulating structure embedded therein, the lower dermis-simulating layer further comprises a silicone rubber, and the at least one blood vessel-simulating structure is provided as at least one channel defined by the silicone rubber, such that synthetic blood may be injected into the at least one channel to simulate bleeding upon demonstrating or practicing the surgical techniques.

14. The three-dimensional surgical training model of claim 1, wherein: the skeleton-simulating structure comprises gypsum cement, the cartilage-simulating structures comprise a mixture of a platinum polysiloxane derivative, gypsum cement, and alginate, the cartilage-simulating structures comprise a durometer hardness of about 20, the muscle-simulating layer comprises a mixture of a polysiloxane, a polysiloxane softener, and alginate, and the muscle-simulating layer comprises a durometer hardness of from about 10 to about 12.

15. The three-dimensional surgical training model of claim 1, wherein: the epidermis-simulating layer comprises about 42.5% by total volume of the platinum polysiloxane derivative and about 42.5% by total volume of the silicone rubber, the epidermis-simulating layer comprises about 10% by volume of the polysiloxane softener, the volume being the volume of the platinum polysiloxane derivative and the silicone rubber, the upper dermis-simulating layer comprises about 90% by total volume of the silicone rubber and about 10% by total volume of the polysiloxane softener, the lower dermis-simulating layer comprises a thickness of about 1.0 mm to about 1.5 mm, and the lower dermis-simulating layer comprises at least one blood vessel-simulating structure embedded therein, such that synthetic blood may be injected into the at least one blood vessel-simulating structure to simulate bleeding upon demonstrating or practicing the surgical techniques.

16. A method of building a three-dimensional surgical training model from a negative mold, comprising: laminating a high fidelity skin-simulating layer onto the negative mold, wherein the high fidelity skin-simulating layer comprises: an epidermis-simulating layer, wherein the epidermis-simulating layer comprises a mixture of a platinum polysiloxane derivative, a silicone rubber, and a polysiloxane softener, an upper dermis-simulating layer disposed upon and adjacent to the epidermis-simulating layer, wherein the upper dermis-simulating layer comprises a mixture of a silicone rubber and a polysiloxane softener, a lower dermis-simulating layer disposed upon and adjacent to the upper dermis-simulating layer, wherein the lower dermis-simulating layer comprises a plurality of layers of polyamide mesh, and a subcutaneous-simulating layer disposed upon and adjacent to the lower dermis-simulating layer, wherein the subcutaneous-simulating layer comprises a mixture of a platinum polysiloxane derivative and a polysiloxane softener, and wherein the high fidelity skin-simulating layer comprises a tensile strength of from about 16 MPa to about 20 MPa, an elongation at break point of from about 65% to about 75%, and a durometer hardness of from about 4 to about 6; laminating artery-simulating structures onto a muscle-simulating layer; laminating nerve-simulating structures onto the muscle-simulating layer; laminating a superficial musculoaponeurotic system-simulating layer onto the muscle-simulating layer; laminating cartilage-simulating structures onto a skeleton-simulating structure; laminating the muscle-simulating layer onto the skeleton-simulating structure; laminating the skeleton-simulating structure onto the high fidelity skin-simulating layer; and removing the negative mold.

17. The method of building a three-dimensional surgical training model of claim 16, wherein laminating the high fidelity skin-simulating layer onto the negative mold comprises laminating the epidermis-simulating layer onto the negative mold, laminating the upper dermis-simulating layer onto the epidermis-simulating layer, and laminating the lower dermis-simulating layer onto the upper dermis-simulating layer.

18. The method of building a three-dimensional surgical training model of claim 17, wherein the lower dermis-simulating layer is fabricated by laminating the lower dermis-simulating layer onto a negative mold and sectioning the lower dermis-simulating layer.

19. The method of building a three-dimensional surgical training model of claim 18, further comprising incorporating blood vessel-simulating structures into the lower-dermis simulating layer, wherein incorporating the blood vessel-simulating structures comprises laminating at least one filament onto the lower dermis-simulating layer and removing the at least one filament.

20. The method of building a three-dimensional surgical training model of claim 16, further comprising at least one of laminating gland-simulating structures onto the muscle-simulating layer, laminating a periosteum-simulating layer onto the skeleton-simulating structure, and laminating a galea aponeurotic-simulating structure onto the skeleton-simulating structure.

21. The method of building a three-dimensional surgical training model of claim 20, wherein the muscle-simulating layer, the artery-simulating structures, the cartilage-simulating structures, the skeleton-simulating structures, and the gland-simulating structures are fabricated in pre-fabricated molds.

22. A method of training medical practitioners, comprising: performing a surgical technique upon a three-dimensional surgical training model, wherein the three-dimensional surgical training model comprises: a skeleton-simulating structure, cartilage-simulating structures laminated on and adjacent to the skeleton simulating structure, a muscle-simulating layer laminated on and adjacent to the skeleton-simulating structure, and a high fidelity skin-simulating layer laminated on and adjacent to the muscle-simulating layer, wherein at least one cutaneous defect-simulating structure is laminated on the high fidelity skin-simulating layer, and wherein the high fidelity skin-simulating layer comprises: an epidermis-simulating layer, wherein the epidermis-simulating layer comprises a mixture of a platinum polysiloxane derivative, a silicone rubber, and a polysiloxane softener; an upper dermis-simulating layer disposed upon and adjacent to the epidermis-simulating layer, wherein the upper dermis-simulating layer comprises a mixture of a silicone rubber and a polysiloxane softener; a lower dermis-simulating layer disposed upon and adjacent to the upper dermis-simulating layer, wherein the lower dermis-simulating layer comprises a plurality of layers of polyamide mesh; and a subcutaneous-simulating layer disposed upon and adjacent to the lower dermis-simulating layer, wherein the subcutaneous-simulating layer comprises a mixture of a platinum polysiloxane derivative and a polysiloxane softener, and wherein the high fidelity skin-simulating layer comprises a tensile strength of from about 16 MPa to about 20 MPa, an elongation at break point of from about 65% to about 75%, and a durometer hardness of from about 4 to about 6.

23. The method of training medical practitioners of claim 22, wherein the surgical technique comprises removing the cutaneous defect-simulating structure and closing the wound.

24. The method of training medical practitioners of claim 22, wherein the surgical technique is selected from the group consisting of excisions, closures, resections, and cosmetic procedures.

25. The method of training medical practitioners of claim 24, wherein the closures are selected from the group consisting of flap closures, graft closures, and primary closures.

26. The method of training medical practitioners of claim 25, wherein the flap closures are selected from the group consisting of single advancement flap closures, double advancement flap closures, rotational flap closures, hinge flap closures, bilobed transpositional flap closures, forehead flaps, rhomboid flaps, Z-plasty flaps, nasolabial transpositional flap closures, and Estlander flaps.

27. The method of training medical practitioners of claim 25, wherein the graft closures are selected from the group consisting of island pedicle grafts and full thickness skin grafts.

28. The method of training medical practitioners of claim 24, wherein the resections comprise a wedge-shape resection.

29. The method of training medical practitioners of claim 24, wherein the cosmetic procedures are selected from the group consisting of facelifts, forehead lifts, scalp lifts, liposuction, injection therapies, blepharoplasty, facial implants, birthmark removal, mole removal, scar removal, and rhinoplasty.

30. The method of training medical practitioners of claim 29, wherein injection therapies are selected from the group consisting of Botox and fat injection.

31. The method of training medical practitioners of claim 22, wherein the lower dermis-simulating layer further comprises blood vessel-simulating structures disposed therein.

32. The method of training medical practitioners of claim 22, wherein the muscle-simulating layer further comprises nerve-simulating structures laminated on the muscle-simulating layer, artery-simulating structures laminated on the muscle-simulating layer, and a superficial musculoaponeurotic system-simulating layer laminated on and adjacent to the muscle-simulating layer.

33. The method of training medical practitioners of claim 22, wherein the three-dimensional surgical training model further comprises gland-simulating structures laminated on and adjacent to the muscle-simulating layer.

34. The method of training medical practitioners of claim 22, wherein the skeleton-simulating structure further comprises at least one of a periosteum-simulating layer laminated on and adjacent to the skeleton-simulating structure.

35. The three-dimensional surgical training model of claim 22, wherein the skeleton-simulating structure further comprises a galea aponeurotica-simulating structure laminated on and adjacent to the skeleton-simulating structure.

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