Synthetic tissue structures for electrosurgical training and simulation

• US 10,081,727 B2
• Filed: 07/13/2016
• Issued: 09/25/2018
• Est. Priority Date: 05/14/2015
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Felsinger, Natasha, Chehayeb, Sam, Bolanos, Eduardo
• Primary Examiner(s): Fernstrom, Kurt
• Application Number:
  US15/208,873
• Publication Number:
  US 20160355676A1
• Time in Patent Office: 804 Days
• Field of Search: 434262, 434267, 434268, 434272, 434273, 434274
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: B29C 39/003 characterised by the choice of material
• CPC Class Codes: B29K 2005/00 Use of polysaccharides or derivatives as moulding material
• CPC Class Codes: B29K 2033/26 Polymers of acrylamide or methacrylamide
• CPC Class Codes: C08J 2333/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: C08J 2405/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08J 5/122 using low molecular chemically inert solvents, swelling or softening agents
• CPC Class Codes: C08L 33/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: G09B 23/30 Anatomical models G09B23/281 - G09B23/288 take precedence

Abstract

A surgical simulator for electrosurgical training and simulation is provided. The surgical simulator includes one or more simulated tissue structures made substantially of a hydrogel comprising a dual interpenetrating network of ionically cross-linked alginate and covalently cross-linked acrylamide. Combinations of different simulated tissue structures define procedural-based models for the practice of various electrosurgical procedures including laparoscopic total mesorectal excision, transanal total mesorectal excision, cholecystectomy and transanal minimally invasive surgery. Methods of making the simulated tissue structures are also provided.

Claims

1. A method of making a surgical simulator, comprising the steps of:

providing an acrylamide polymer;

providing alginate polymer;

providing water;

mixing the water with the acrylamide and alginate to form a solution;

adding ammonium persulfate to the solution;

adding N,N-methylenebisacrylamide to the solution;

adding calcium sulfate after the steps of adding ammonium persulfate and adding N,N-methylenebisacrylamide to the solution;

casting the solution into a shape representative of an anatomical structure; and

curing the solution to form a simulated electrosurgery model made of hydrogel for practicing and simulating electrosurgery.

2. The method of claim 1 including the step of adding N,N,N′

,N′

-tetramethylethylenediamine in the amount of approximately 0.3 percent acrylamide by weight to the solution;

wherein the step of adding ammonium persulfate includes adding ammonium persulfate in the amount of approximately 0.3 percent acrylamide by weight to the solution;

wherein the step of adding N,N-methylenebisacrylamide includes adding N,N-methylenebisacrylamide in the amount of approximately 0.06 percent acrylamide by weight to the solution; and

wherein the step of adding calcium sulfate includes adding calcium sulfate in the amount of approximately 13.6 percent alginate by weight to the solution.

3. The method of claim 1 further including the step of flushing the solution with argon gas.

4. The method of claim 1 including the step of dry mixing the acrylamide polymer and alginate polymer prior to the step of mixing the water.

5. The method of claim 1 wherein the steps of:

forming a first layer of hydrogel having a first ratio of acrylamide to alginate by weight; and

overmolding a second layer of hydrogel having a second ratio of acrylamide to alginate by weight.

6. The method of claim 1 further including the steps of:

providing a colorant selected for a synthetic tissue structure; and

mixing the colorant with the water;

wherein the step of mixing the colorant with the water is performed prior to the step of mixing the water with the acrylamide and alginate to form a solution.

7. The method of claim 1 wherein the step of adding ammonium persulfate includes adding ammonium persulfate in the amount of approximately 0.3 percent acrylamide by weight to the solution.

8. The method of claim 1 wherein the step of adding N,N-methylenebisacrylamide includes adding N,N-methylenebisacrylamide in the amount of approximately 0.06 percent acrylamide by weight to the solution.

9. The method of claim 1 wherein the step of adding calcium sulfate includes adding calcium sulfate in the amount of approximately 13.6 percent alginate by weight to the solution.

10. The method of claim 1 wherein the step of providing acrylamide includes providing approximately 8 parts by weight acrylamide and the step of providing alginate includes providing approximately 3 parts by weight alginate.

11. The method of claim 1 wherein the step of providing acrylamide includes providing approximately 8 parts by weight acrylamide and the step of providing alginate includes providing approximately 1 part by weight alginate.

12. The method of claim 1 wherein the step of providing water includes providing approximately 86% total weight by water of the simulated electrosurgery model.

13. A surgical simulator for surgical training comprising:

a synthetic tissue structure substantially formed of a hydrogel including an ionically cross-linked alginate network cross-linked with a covalently cross-linked acrylamide network;

the synthetic tissue structure includes a first layer formed of the hydrogel having a first ratio of acrylamide to alginate by weight; and

a second layer formed of the hydrogel having a second ratio of acrylamide to alginate by weight;

the second layer being adjacent to the first layer.

14. The surgical simulator of claim 13 wherein the first ratio is approximately 8:

3 and the second ratio is approximately 8;

3.

15. The surgical simulator of claim 13 wherein the first ratio is approximately 8:

1 and the second ratio is approximately 8;

1.

16. The surgical simulator of claim 13 wherein the first ratio is approximately 8:

1 and the second ratio is approximately 8;

3.

17. The surgical simulator of claim 13 further including a synthetic tissue structure embedded between the first layer and the second layer;

wherein the embedded synthetic tissue structure is glued to the first layer using adhesive.

18. The surgical simulator of claim 13 further including an electrosurgical unit having a proximal end and an operable distal end configured to deliver energy at the distal end and controlled with a handle at the proximal end;

wherein contact of the distal end of the electrosurgical unit with the hydrogel simulates electrosurgery.

19. The surgical simulator of claim 13 further including a simulated prostate system including one or more of an artificial prostate, artificial seminal vesicles, simulated bladder, simulated urethra, and simulated vas deferens;

the simulated prostate system being located between the first layer and the second layer.

20. The surgical simulator of claim 13 wherein the first ratio and the second ratio are the same.