Tissue containment device for use in surgical procedures

• US 11,253,239 B2
• Filed: 06/18/2017
• Issued: 02/22/2022
• Est. Priority Date: 06/16/2016
• Status: Active Grant

• Current Assignee: Ark Surgical Ltd.
• Original Assignee: Ark Surgical Ltd.
• Inventors: Bar-Yoseph, Gill, Bleicher, David
• Primary Examiner(s): Yabut, Diane D
• Assistant Examiner(s): Byrd, Brigid K
• Application Number:
  US16/310,435
• Publication Number:
  US 20190328376A1
• Time in Patent Office: 1,710 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/0809 Indication of cracks or breakages
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/08 Accessories or related features not otherwise provided for
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags

Abstract

A tissue containment device (10) for isolating tissue from surrounding tissue during a surgical procedure to remove the tissue includes a bag (12) formed by one or more walls (14) defining a containment compartment (16) and an opening (18) for accessing the containment compartment. Each wall (14) is formed from at least two layers including an inner layer (20) facing the containment compartment and an outer layer (22) facing outwards from bag (12). The layers define between them one or more inflatable volumes (24). Layers (20) and (22) are interconnected at spaced-apart connection regions (28) that are arranged such that, when a fluid is introduced into the inflatable volumes (24), regions of the at least two layers between the connection regions form wall cavity regions surrounding an internal volume of the containment compartment.

Claims

1. A tissue containment device for isolating tissue from surrounding tissue during a surgical procedure to remove the tissue, the device comprising:

(a) a bag comprising one or more walls, defining a containment compartment and an opening for accessing said containment compartment, wherein said one or more walls are formed from at least two layers and define at least one inflatable volume;

wherein a first layer of said at least two layers is an inner layer facing an internal volume of said containment compartment, and a second layer of said at least two layers is an outer layer facing outwards from said bag, and wherein said device further comprises at least one intermediate layer interconnecting said inner layer and said outer layer at spaced-apart connection regions, and

(b) at least one inflation port in fluid connection with said at least one inflatable volume for introducing and removing a fluid to and from said at least one inflatable volume,

wherein said at least one inflatable volume comprises two or more inflatable regions on both sides of said at least one intermediate layer, said connection regions being configured such that, when the fluid is introduced to said at least one inflatable volume, said two or more inflatable regions are inflated to form two or more wall cavity regions on both sides of said at least one intermediate layer, said two or more wall cavity regions on both sides of said at least one intermediate layer substantially surrounding said internal volume of said containment compartment.

2. The device of claim 1, wherein said at least two layers are implemented as initially flat sheets of material that are selectively interconnected at said connection regions.

3. The device of claim 1, wherein at least one layer of said at least two layers is implemented as a layer having an increased resistance to flexing compared to a different layer of said at least two layers.

4. The device of claim 1, wherein at least one layer of said at least two layers differs from a different layer of said at least two layers in at least one property selected from the group consisting of:

shear strength, burst limit and puncture resistance.

5. The device of claim 1, wherein said spaced apart connection regions between said first layer and said at least one intermediate layer are interspaced between s aid spaced apart connection regions between said second layer and said at least one intermediate layer.

6. The device of claim 1, wherein at least one of said inner layer and said outer layer of said at least two layers is implemented with preformed inflatable pockets between said connection regions.

7. The device of claim 1, wherein said bag assumes a compact state in which a first region of said one or more walls is adjacent to a second region of said one or more walls, and wherein said spaced-apart connection regions define elongated inflatable deployment cavities extending within said first and second regions such that, on said introducing of said fluid to said at least one inflatable volume, said inflatable deployment cavities press against each other so as to tend to force apart said first and second regions, thereby opening up said internal volume of said containment compartment.

8. The device of claim 1, wherein said one or more walls are configured to form at least two inflatable volumes of said at least one inflatable volume, said at least two inflatable volumes being independently inflatable.

9. The device of claim 1, wherein said connection regions are deployed so as to define elongated inflatable boundary cavities extending so as to circumscribe a majority of said opening such that, on inflation of said at least one inflatable volume, said inflatable boundary cavities tend to open said opening.

10. The device of claim 1, wherein said connection regions are deployed such that, on inflation of said at least one inflatable volume, at least part of said one or more walls presents an array of inflated bulges in a facing relation to said internal volume of said containment compartment.

11. The device of claim 1, wherein said one or more walls comprise two walls interconnected at a peripheral seal such that said bag is formed from at least four of said at least two layers in overlying relation.

12. The device of claim 1, wherein said bag further comprises at least one loop element deployed on an external surface of the bag, said loop element being located to facilitate rolling of said bag by insertion of an instrument through said at least one loop element and rotation of the instrument.

13. The device of claim 1, further comprising a pressure indicator in fluid interconnection with said at least one inflatable volume, said pressure indicator being configured to generate a visible and/or audible indication when a pressure within said inflatable volume decreases or falls below a reference pressure value.

14. The device of claim 1, wherein said bag further comprises at least one instrument insertion branch implemented as a flexible access tube communicating with said containment compartment and allowing instrument access via an incision in a direction angularly spaced from said opening of said bag.

15. The device of claim 1, wherein said containment compartment comprises an elongated containment compartment.

16. A method for surgical removal of tissue from a body, the method comprising:

introducing the device of claim 1 into a body cavity through an incision or a body orifice;

inflating the at least one inflatable volume with the fluid;

inserting through said opening into the bag a tissue to be removed from the body;

reducing said tissue located within said bag;

deflating said device while said reduced tissue is within the bag;

removing said device from said body through said incision or said body orifice.

17. The method of claim 16, wherein said reducing comprises reducing said tissue located within said bag while said body cavity is insufflated.

18. The device of claim 1, wherein said two or more wall cavity regions extend over at least 97% of a surface of said one or more walls facing said internal volume of said containment compartment as projected towards a centroid of the internal volume of said containment compartment.

19. The device of claim 1 wherein, between adjacent wall cavity regions of said two or more wall cavity regions, there is disposed a portion of said at least one intermediate layer, said portion extending between said inner layer and said outer layer.

20. The device of claim 1, further including at least one check valve connected to said at least one inflatable volume, said at least one check valve configured to maintain a pressure in said at least one inflatable volume.