First entry model

• US 10,026,337 B2
• Filed: 12/06/2016
• Issued: 07/17/2018
• Est. Priority Date: 07/24/2013
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Black, Katie, Poulsen, Nikolai, Holmes, Heidi, Felsinger, Natasha, Breslin, Tracy, Pravongviengkham, Kennii, Pravong, Boun, Bolanos, Eduardo, Falkenstein, Zoran, Hart, Charles C., Talwar, Tina
• Primary Examiner(s): Fernstrom, Kurt
• Application Number:
  US15/370,231
• Publication Number:
  US 20170084204A1
• Time in Patent Office: 588 Days
• Field of Search: 434262, 434267, 434268, 434269, 434272
• CPC Class Codes: B29C 39/026 characterised by the shape of the surface
• CPC Class Codes: B29K 2083/005 LSR, i.e. liquid silicone rubbers, or derivatives thereof
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G09B 5/02 with visual presentation of the material to be studied, e.g. using film strip

Abstract

A simulated abdominal wall model that is ideal for practicing laparoscopic first entry surgical techniques is provided. The model includes a simulated abdominal wall portion captured between two frame elements of a support. The support is connectable to a surgical trainer. When connected to the trainer, the model provides a penetrable abdominal tissue portion for accessing an internal cavity of the trainer. The simulated abdominal wall includes a plurality of layers including a skin layer, a fabric posterior rectus sheath layer, a simulated fat layer of low-resilience polyurethane foam and at least two layers that provide distinctive haptic feedback upon penetration of the simulated transversalis fascia and muscle layers. The simulated abdominal wall includes a simulated umbilicus across several layers of simulated tissue.

Claims

1. A method for manufacturing a simulated skin layer for a simulated abdominal wall, comprising the steps of:

providing a mold defining a cavity having a first depth and a first well inside the cavity having a second depth greater than the first depth;

the mold having a core located inside the first well;

pouring a silicone mixture into the mold cavity and first well;

curing the silicone inside the mold to form a simulated skin layer having a top surface and a bottom surface and a tubular structure extending from the top surface;

the tubular structure having a lumen defining an opening in the layer at the proximal end and an opening at a distal end; and

inverting the tubular structure by passing the distal end of the tubular structure through the opening.

2. The method of claim 1 further including the step of forming a thicker portion circumferentially around the first well.

3. The method of claim 1 further including the step of providing a mold having a circumferential well extending around the first well;

the circumferential well having a third depth that is less than the second depth; and

forming thicker portion in the layer around the first well.

4. The method of claim 1 further including the step of sealing the opening at the proximal end closed.

5. The method of claim 1 further including the step of forming a plurality of cuts in the tubular structure;

each cut extending from the distal end toward the proximal end.

6. A simulated tissue structure, comprising:

a simulated skin layer having a top surface and a bottom surface and an elongated tubular structure extending from the top surface;

the tubular structure having a proximal end and a distal end;

the tubular structure having a lumen defining an opening in the simulated skin layer;

wherein the tubular structure is inverted by passing the distal end of the tubular structure through the opening such that the tubular structure depends from the bottom surface.

7. The simulated tissue structure of claim 6 further including a plurality of simulated tissue layers located below the bottom surface of the simulated skin layer;

the plurality of simulated tissue layers and the simulated skin layer forming a simulated abdominal wall.

8. The simulated tissue structure of claim 7 wherein each simulated tissue layer includes an opening;

the openings in the simulated tissue layers are aligned and the tubular structure extends through the openings in the plurality of simulated tissue layers.

9. The simulated tissue structure of claim 6 wherein the opening at the top surface is closed with adhesive.

10. The simulated tissue structure of claim 6 wherein the tubular structure has an elliptical cross-section.

11. The simulated tissue structure of claim 7 wherein the distal end of the tubular structure includes cuts extending toward the proximal end;

the distal end of the tubular structure being connected to one of the plurality of simulated tissue layers.

12. The simulated tissue structure of claim 7 wherein the plurality of simulated tissue layers and the simulated skin layer are captured within a frame.

13. The simulate tissue structure of claim 6 wherein a portion of the simulated skin layer surrounding the opening has an increased thickness relative to the rest of the simulated skin layer.

14. The simulated tissue structure of claim 8 wherein the plurality of simulate tissue layers includes:

a first layer having a top surface and a bottom surface;

a second layer having a top surface and a bottom surface;

the bottom surface of the first layer overlaying the top surface of the second layer;

a third layer having a top surface and a bottom surface;

the bottom surface of the second layer overlaying the top surface of the third layer;

a fourth layer having a top surface and a bottom surface;

the bottom surface of the third layer overlaying the top surface of the fourth layer;

a fifth layer having a top surface and a bottom surface;

the bottom surface of the fourth layer overlaying the top surface of the fifth layer;

a sixth layer having a top surface and a bottom surface;

the bottom surface of the fifth layer overlaying the top surface of the sixth layer;

a seventh layer having a top surface and a bottom surface;

the bottom surface of the sixth layer overlaying the top surface of the seventh layer;

an eighth layer having a top surface and a bottom surface;

the eighth layer being located under the seventh layer.

15. The simulated tissue structure of claim 14 wherein the openings of the second layer, third layer, fourth layer and fifth layer are elongate openings substantially in alignment with each other and having a length and a width;

the length extending along a longitudinal axis.

16. The simulated tissue structure of claim 14 wherein the fourth layer and the seventh layer are made of polyethylene foam.

17. The simulated tissue structure of claim 14 wherein the first layer is made of cellular foam.

18. The simulated tissue structure of claim 14 wherein the first layer is made of memory foam.