IP Library Granted Patent US 12,211,394
Granted Patent B2
US 12,211,394 · App. 18/427,587 · Granted Jan 28, 2025

Simulated tissue models and methods

Inventors: Gregory K. Hofstetter (Lake Forest, CA); Tracy Breslin (Trabuco Canyon, CA); Nikolai Poulsen (Irvine, CA); Khodr Saleh (Rancho Santa Margarita, CA)
Assignee: Applied Medical Resources Corporation
G09B23/34B29C41/085B29C41/20B29C41/22G09B23/285G09B23/30B29K2083/00B29L2031/753
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Quick Facts
Patent No.
US 12,211,394
App. No.
18/427,587
Granted
Jan 28, 2025
Kind
B2
Abstract

Simulated tissue structures for practicing surgical techniques and methods of manufacturing those structures are provided. In particular, a realistic organ model or simulated tissue portion for practicing the removal of a tumor or other undesired tissue followed by suturing a remnant defect as part of the same surgical procedure is provided. The simulated tissue structures include a polyp simulation having a suturable mesh layer that is separable from a defect layer. A simulated colon model with interchangeable and suturable tissue pods is also provided as is a fully suturable rectum model and a rectum model with integrative suturable and removable polyp zones.

Claims (34)

1. A simulated tissue model, comprising:

a substantially cylindrical tube having an inner surface and an outer surface extending between a proximal end and a distal end and defining a central lumen having a longitudinal axis, wherein the cylindrical tube comprises:

a first layer made of silicone having a first tubular sidewall with an inner surface and an outer surface and at least one recess having a depth formed in the outer surface of the first tubular sidewall;

a second layer made of silicone having a substantially planar inner surface opposite a substantially planar outer surface defining a thickness therebetween; the second layer being sized and configured to fit inside the recess;

a third layer made of silicone having a second tubular sidewall with an inner surface and an outer surface; the second tubular sidewall being substantially uniform; the third layer and the first layer are adhered together such that the inner surface of the second tubular sidewall faces and contacts the outer surface of the first tubular sidewall and such that the second layer inside the recess is captured between the first layer and third layer.

2. The simulated tissue model of claim 1 wherein the inner surface and outer surface of the cylindrical tube correspond respectively to the inner surface of the first tubular sidewall and the outer surface of the second tubular sidewall.

3. The simulated tissue model of claim 1 wherein the second layer is placed inside the recess such that the substantially planar inner surface of the second layer faces the outer surface of the first layer.

4. The simulated tissue model of claim 1 further comprising a simulated tumor adhered to the inner surface of the first tubular sidewall in a location adjacent inwardly from the second layer.

5. The simulated tissue model of claim 4 wherein the simulated tumor protrudes into an interior of the cylindrical tube from the inner surface of the first layer.

6. The simulated tissue model of claim 4 wherein the first layer and second layer are selectively adhered in at least one or more regions of the recess.

7. The simulated tissue model of claim 6 wherein the at least one or more regions of the recess correspond to an area that is around the location of the simulated tumor on the inner surface of the first layer.

8. The simulated tissue model of claim 6 wherein the first layer and second layer are separable within a region of the recess that is located adjacent outwardly from the location of the simulated tumor on the inner surface of the first layer.

9. The simulated tissue model of claim 4 wherein the second layer is smaller in size than the first layer and the simulated tumor is smaller in size than the second layer.

10. The simulated tissue model of claim 4 wherein the second layer is configured to provide visual feedback to facilitate excision of the simulated tumor.

11. The simulated tissue model of claim 10 wherein the second layer is yellow in color while the third layer being clear or pink in color.

12. The simulated tissue model of claim 1 further comprising a mesh layer embedded in the first layer.

13. The simulated tissue model of claim 1 wherein the substantially cylindrical tube further comprising one or more transverse folds extending inwardly into the central lumen.

14. The simulated tissue model of claim 1 wherein the cylindrical tube represents a bowel section or colon having a plurality of simulated tumor adjoining a plurality of recesses and a plurality of second layers throughout the cylindrical tube.

15. A method for manufacturing a simulated tissue model, comprising the steps of:

providing an elongated mandrel having an outer surface with at least one depression;

rotating the mandrel;

applying a first layer of uncured silicone on the mandrel;

allowing the first layer to cure to form a substantially tubular structure having an inner surface and an outer surface and a well having a depth formed in the outer surface in the location of the depression;

providing a second layer of cured silicone having a shape substantially corresponding to the shape of the well and a thickness substantially corresponding to the depth of the well;

placing the second layer inside the well of the first layer;

applying a third layer of uncured silicone on the outer surface of the first layer and second layer; and

allowing the third layer to cure and adhere to the first layer and second layer to form a smooth outer surface.

16. The method of claim 15 further comprising the steps of:

providing a simulated tumor having a size smaller than the second layer; and

attaching the simulated tumor to the inner surface of the first layer in the location of the depression adjacent to the second layer.

17. The method of claim 16 further comprising the step of adhering the second layer to the outer surface of the first layer such that the second layer is adhered around the location of the tumor and not adhered in the location of the tumor.

18. The method of claim 15 further including the step of embedding a layer of mesh within the first layer.

19. The method of claim 15 wherein the step of providing an elongated mandrel comprises providing an elongated mandrel having an outer surface with at least one depression and at least one crevice.

20. The method of claim 19 wherein the at least one crevice is substantially perpendicular to a longitudinal axis of the elongated mandrel for forming transverse folds in the resulting simulated tissue model.