Laparoscopic tissue containment device
The laparoscopic tissue containment device with an expandable wall and radial stiffening members addresses the challenge of maintaining a stable surgical workspace within the body cavity by folding and expanding to resist intra-abdominal pressures, ensuring effective surgical access and visibility.
Patent Information
- Application Number
- JP2023536819
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-12-17
- Filing Date
- 2021-12-16
- Publication Date
- 2026-01-16
- Estimated Expiration
- 2041-12-16
AI Technical Summary
Existing laparoscopic tissue containment devices struggle to maintain a stable workspace within the body cavity while accommodating the intra-abdominal pressures and providing sufficient space for surgical manipulation.
A laparoscopic tissue containment device with an expandable wall comprising multiple segments and radial stiffening members that can fold through a small passageway and expand within the body cavity, resisting collapse due to intra-abdominal forces and maintaining a stable workspace.
The device provides a stable and expandable workspace within the body cavity, allowing for effective surgical manipulation while withstanding internal pressures, and includes visualization channels for enhanced surgical visibility.
Smart Images

Figure 0007801345000001 
Figure 0007801345000002 
Figure 0007801345000003
Abstract
Description
[Technical Field]
[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 126,640, filed December 17, 2020, the entire contents of which are incorporated herein by reference. [Background technology]
[0002] The present invention, in some embodiments thereof, relates to laparoscopic tissue containment devices, such as laparoscopic workspace devices, and more particularly, but not exclusively, to inflatable laparoscopic tissue containment devices.
[0003] Workspace devices, such as laparoscopic tissue containment devices, are used to isolate certain tissues and / or organs from other body tissues within a body cavity, such as the abdominal cavity. Summary of the Invention
[0004] Some examples of some embodiments of the present invention are described below. Of course, features of one example can be used together with features of other examples.
[0005] Example 1. A workspace device having a body that can be folded to a collapsed state to fit through a laparoscopic passageway in a body cavity wall and can be expanded to an expanded state within a body cavity through which the passageway extends, comprising: a workspace body having a plurality of expandable segments defining a lumen and a plurality of radial stiffening members disposed within said wall; In the expanded state, the workspace device extends defining a workspace axis and has an opening to the interior volume; The plurality of expandable segments stiffen the workspace body to resist collapse due to intra-abdominal forces, and the plurality of radially extending stiffening members disposed within the wall resist radial forces.
[0006] Example 2. The device of Example 1, wherein the workspace wall comprises at least one expandable chamber comprising the radial stiffening member, the radial stiffening member dividing the expandable chamber into the plurality of expandable segments fluidly connected to one another.
[0007] Example 3. The device of any one of Examples 1 or 2, wherein in the expanded state, the radial stiffening members are less than the width of the workspace wall.
[0008] Example 4. The device of Example 1, wherein in the expanded state, adjacent expandable segments push laterally against at least one radial stiffening member of the plurality of radial stiffening members.
[0009] Example 5. The device of any one of the preceding examples, wherein the workspace wall includes at least one inner layer of sheet material that forms the inner surface facing the lumen of the workspace device in the expanded state, and at least one outer layer of sheet material that forms the outer surface of the workspace wall, and wherein the two or more radial stiffening members interconnect the at least one inner layer and the at least one outer layer.
[0010] Example 6. The device of Example 5, wherein the plurality of radial stiffening members are formed by the at least one inner layer of sheet material and / or the at least one outer layer of sheet material.
[0011] Example 7. The device of Example 6, wherein the radial stiffening member comprises a portion of the at least one inner layer and / or a portion of the at least one outer layer.
[0012] Example 8. A device described in any one of Examples 5-7, comprising at least one additional layer of bendable sheet material attached to the inner layer and the outer layer to form the plurality of radial stiffening members.
[0013] Example 9. A device described in any one of Examples 5 to 8, wherein the expandable segments are separated by at least one radial stiffening member of the plurality of radial stiffening members, and the length of the radial stiffening member disposed between two adjacent expandable segments is at least 2 cm.
[0014] Example 10. A device described in any one of Examples 5 to 9, wherein each of the radial stiffening members defines a sidewall of at least one expandable segment of the plurality of expandable segments.
[0015] Example 11. The device of any one of Examples 5-10, wherein in the expanded state, two adjacent expandable segments press against each other along an interface region having a length greater than 0.3 cm.
[0016] Example 12. A device described in any one of Examples 5 to 11, wherein in the expanded state, the at least one inner layer and the at least one outer layer are smooth.
[0017] Example 13. The device described in Example 12, wherein in an expanded state, the at least one inner layer and the at least one outer layer comprise one or more bulges having a radius of curvature of less than 10 mm.
[0018] Example 14. A device described in any one of Examples 5 to 11, wherein in the expanded state, one of the at least one inner layer and the at least one outer layer is smoother than the other layer.
[0019] Example 15. A device described in any one of Examples 5 to 11, wherein in an expanded state, the at least one inner layer is smoother than the at least one outer layer, and the expandable segment extends radially outward from the lumen a distance of more than 2 cm.
[0020] Example 16. A device described in any one of Examples 5 to 11, wherein in an expanded state, the at least one outer layer is smoother than the at least one inner layer, and the expandable segment extends radially inward into the at least one inner lumen of the workspace device to a distance of more than 2 cm from the at least one outer layer.
[0021] Example 17. A device described in any one of Examples 5 to 16, wherein in an expanded state, the radial stiffening member is perpendicular to a tangent to at least one or both of the at least one inner layer and the at least one outer layer.
[0022] Example 18. A device described in any one of Examples 5 to 16, wherein in an expanded state, the radial stiffening member is positioned at an angle relative to a tangent to at least one or both of the at least one inner layer and the at least one outer layer.
[0023] Example 19. A device described in any one of Examples 1 to 5, wherein the expandable segment is a ring-shaped expandable segment surrounding the lumen and arranged along the workspace axis, and the interface region between two adjacent ring-shaped expandable segments includes at least one radial stiffening member of the plurality of radial stiffening members.
[0024] Example 20. A device described in Example 19, wherein in an expanded state, the height of each of the ring-shaped expandable segments is less than the length of the interface region between adjacent ring-shaped expandable segments.
[0025] Example 21. A device described in any one of the preceding examples, comprising one or more inflation channels configured to supply inflation fluid to the workspace device body and the expandable segment to expand the workspace body to the expanded state.
[0026] Example 22. A device according to any one of the preceding examples, wherein the workspace body includes one or more visualization channels extending at least 1 cm into the lumen through an opening in the exterior surface of the body, the one or more visualization channels being sized to receive an end of a visualization tool.
[0027] Example 23. The device of Example 22, wherein the minimum diameter of the one or more visualization channels is at least 5 mm.
[0028] Example 24. The device described in Example 22, wherein the ends of the one or more visualization channels within the lumen are closed, and the one or more visualization channels are at least partially transparent so that the internal volume can be visualized by the visualization tool from a close distance.
[0029] Example 25. A device described in any one of Examples 22 to 24, wherein the one or more visualization channels enter the lumen through an opening in the workspace wall located between or within the expandable segments.
[0030] Example 26. A device described in any one of Examples 22 to 24, wherein the one or more visualization channels enter the lumen through an opening within at least one radial stiffening member or between two adjacent radial stiffening members of the plurality of radial stiffening members.
[0031] Example 27. A device described in any one of Examples 22 to 24, which in an expanded state comprises a tool insertion channel connecting the opening of the workspace device to a body opening, and wherein the one or more visualization channels enter the lumen through the opening of the tool insertion channel.
[0032] Example 28. A device according to any one of the preceding examples, wherein the passage is smaller than 15 mm and the workspace device fits within the passage in a collapsed state.
[0033] Example 29. A device according to any one of the preceding examples, wherein in the expanded state, the workspace device extends axially in a proximal to distal direction defining the workspace axis.
[0034] Example 30. A device as described in Example 29, wherein the expandable segment is a vertically expandable segment oriented along the workspace axis and arranged around the lumen.
[0035] Example 31. A device described in any one of Examples 1 to 29, wherein in the expanded state, the workspace device extends laterally and the opening to the lumen is an opening in the workspace wall.
[0036] Example 32. The device described in Example 31, wherein the opening is an opening within or between one or more expandable segments.
[0037] Example 33. The device of any one of the preceding examples, wherein the body cavity comprises an abdominal cavity and the body cavity wall comprises an abdominal cavity wall.
[0038] Example 34. A workspace device having a body that can be folded to a collapsed state to fit through a laparoscopic passageway in a body cavity wall and can be expanded to an expanded state within a body cavity through which the passageway extends, comprising: a workspace body having a workspace wall including a plurality of expandable segments defining a lumen; In the expanded state, the workspace device extends defining a workspace axis and has an opening to the interior volume; A workspace device wherein the plurality of expandable segments contact each other along an interface region formed between two adjacent expandable segments having a length of at least 2 cm, and the plurality of expandable segments extend inward into the lumen or outward from a smooth surface opposite the wall a distance of more than 2 cm, stiffening the workspace body to resist collapse due to intra-abdominal forces.
[0039] Example 35. A device as described in Example 34, wherein the workspace wall comprises an expandable chamber including the expandable segments, and the expandable segments are fluidly connected to the expandable chamber and to each other.
[0040] Example 36. A device described in any one of Examples 34 or 35, wherein in the expanded state, the workspace device extends axially from proximal to distal direction defining the workspace axis, and the expandable segments are vertically expandable segments oriented along the workspace axis and disposed along the circumference of the lumen.
[0041] Example 37. A device described in any one of Examples 34 to 36, wherein in an expanded state, the outer surface of the workspace body is smoother than the inner surface of the body, and the expandable segment extends inward into the interior volume.
[0042] Example 38. A device described in any one of Examples 34 to 36, wherein in an expanded state, the inner surface of the workspace body is smoother than the outer surface of the body, and the expandable segment extends outward from the interior volume.
[0043] Example 39. A device described in any one of Examples 34 to 38, wherein the workspace wall comprises at least one inner layer of sheet material and at least one outer layer of sheet material attached to one another to form the expandable segment therebetween.
[0044] Example 40. A device as described in Example 39, comprising a plurality of ribs, wherein the at least one inner layer and the at least one outer layer are attached to the plurality of ribs, and at least one of the plurality of ribs forms the interface region between adjacent expandable segments.
[0045] Example 41. A device described in any one of Examples 34 to 40, wherein the passage is smaller than 15 mm and the workspace device fits within the passage in a collapsed state.
[0046] Example 42. A device described in any one of Examples 34 to 41, wherein the body cavity comprises an abdominal cavity and the body cavity wall comprises an abdominal cavity wall.
[0047] Example 43. A workspace device having a body that can be folded to a collapsed state to fit within a laparoscopic passageway in a body cavity wall and can be expanded to an expanded state within the body cavity through which the passageway extends, a workspace body including an expandable workspace wall defining an internal cavity, the workspace body being expandable such that expansion of the expandable wall increases the internal volume within the body cavity to an expanded state; one or more visualization channels having openings in the workspace body shaped to receive visualization tools; The workspace device, wherein in the expanded state, the one or more visualization channels extend into the lumen a distance of more than 1 cm from an inner surface of the workspace body facing the lumen.
[0048] Example 44. A device described in Example 43, wherein the ends of the one or more visualization channels within the lumen are closed, and the one or more visualization channels are at least partially transparent.
[0049] Example 45. A device described in any one of Examples 43 or 44, wherein the workspace device body, in an expanded state, comprises a tool insertion channel connecting an opening of the workspace device to a body opening in the body cavity wall, and the one or more visualization channels enter the lumen through the opening of the tool insertion channel.
[0050] Example 46. A device described in any one of Examples 43 or 44, wherein the one or more visualization channels enter the lumen through an opening in the expandable wall.
[0051] Example 47. A device as described in Example 46, wherein the expandable wall includes a plurality of expandable segments, and the one or more visualization channels enter the lumen through openings in the expandable wall located between adjacent expandable segments.
[0052] Example 48. The expandable wall comprises a plurality of radial stiffening members contacting and / or defining the expandable segments, and two adjacent expandable segments are separated between at least one radial stiffening member, and The device of Example 47, wherein the one or more visualization channels enter the lumen through an opening in the at least one radial stiffening member.
[0053] Example 49. A device described in any one of Examples 43 to 48, wherein the minimum diameter of the one or more visualization channels is at least 5 mm.
[0054] Example 50. A workspace device having a body that can be folded to a collapsed state to fit through a laparoscopic passageway in a body cavity wall and can be expanded to an expanded state within the body cavity through which the passageway extends, a workspace body having a workspace wall including a plurality of vertically expandable segments defining an interior volume; In the expanded state, the workspace device extends axially in a proximal to distal direction defining the workspace axis; and The workspace device, wherein the plurality of vertically expandable segments are oriented along the workspace axis and stiffen the workspace body to resist collapse due to intra-abdominal forces.
[0055] Example 51. A device described in Example 50, wherein the workspace wall comprises at least one inflatable chamber comprising the plurality of vertically expandable segments, and the plurality of vertically expandable segments are fluidly connected to each other.
[0056] Example 52. A body orifice port, a rim shaped and sized to contact an outer surface of the skin surrounding the body opening; a flexible cylindrical body defining a channel, connected to the rim, and configured to pass through the body opening into a body cavity; a cylindrical tube slidable within the channel, wherein sliding of the cylindrical tube within the channel secures the port within the body opening.
[0057] Example 53. An expandable anchor connected to the flexible cylindrical body configured to move between a collapsed state and an expanded state, wherein in the expanded state, the anchor expands and secures the port within the body opening; 53. The port of claim 52, wherein the anchor is expanded to an expanded state by sliding the cylindrical tube within the flexible cylindrical body.
[0058] Example 54. A port described in Example 52, wherein the flexible cylindrical body is at least partially folded when inserted through the body opening, and the flexible cylindrical body is unfolded by sliding the cylindrical tube within the flexible cylindrical body.
[0059] Example 55. A body orifice port, comprising: a rim shaped and sized to contact an outer surface of the skin surrounding the body opening; a cylindrical body insertable into a body lumen through the body opening, the cylindrical body having a proximal end connected to the rim and a distal end disposed within the body; an expandable anchor connected to the cylindrical body near the distal end, the expandable anchor configured to expand and secure the port within the body opening, the expandable anchor including an opening or channel shaped to receive a visualization tool.
[0060] Example 56. A method of manufacturing an expandable segment of an expandable wall of a workspace device, comprising: disposing a plurality of ribs between at least one first layer of sheet material and at least one second layer of sheet material; and welding the at least one first layer of sheet material and the at least one second layer of sheet material to two opposite ends of each rib of the plurality of ribs to form an expandable segment, each expandable segment being formed between two adjacent ribs.
[0061] Example 57. The method of Example 56, wherein the positioning includes aligning each rib of the plurality of ribs so that it is perpendicular to the at least one first layer and the at least one second layer, or perpendicular to a tangent to the at least one first layer and a tangent to the at least one second layer, before the welding.
[0062] Example 58. The method of Example 56, wherein the positioning includes aligning at least a portion of the plurality of ribs so that they are at an angle relative to a tangent to the at least one first layer and a tangent to the at least one second layer before the welding.
[0063] Example 59. The method of Example 56, comprising molding at least one or both of the at least one first layer and the at least one second layer, and wherein the placing comprises placing the plurality of ribs between one or both of the molded at least one first layer and the at least one second layer.
[0064] Example 60. A body orifice port, a rim shaped and sized to contact an outer surface of the tissue surrounding the body opening; a tubular body insertable into a body lumen through the body opening, the tubular body defining a lumen and having a proximal end connected to the rim and a distal end disposed within the body; an internal expandable anchor connected to the tubular body at the distal end, the expandable anchor configured to expand and secure the port within the body opening; The body opening port.
[0065] Example 61. A port described in Example 60, wherein the inner expandable anchor has at least two wings, the at least two wings being configured to move between a folded state in which the at least two wings face each other and an expanded state in which the at least two wings extend laterally from the tubular body, and the two wings being configured to extend laterally when the inner expandable anchor is in a relaxed state.
[0066] Example 62. A port described in Example 61, wherein the at least two wings are arranged on opposite sides of the tubular body, and in the folded state, the inner expandable anchor bends inward toward the lumen, positioning the at least two wings at a distance of less than 2 cm from each other.
[0067] Example 63. A port as described in Example 62, wherein the tubular body has at least two slot cuts at the distal end, defining a bending axis between the slot cuts along which the inner expandable anchor bends in the collapsed state, and each of the slot cuts is positioned circumferentially on either side of the distal end of the tubular body between the at least two wings.
[0068] Example 64. A port described in any one of Examples 61 to 63, wherein the tubular body has at least two openings, each opening of the at least two openings being positioned between each of the at least two wings and the proximal end of the tubular body.
[0069] Example 65. A port described in any one of Examples 60 to 64, wherein the rim is part of an external bolster shaped and sized to contact the outer surface of the skin, and the external bolster is provided with a cutting guide having a length corresponding to the target incision length that needs to be made in the skin to introduce the distal end of the tubular body into the body lumen.
[0070] Example 66. A port described in any one of Examples 60 to 65, wherein the rim and the inner expandable anchor are integral with the tubular body.
[0071] Example 67. A port described in any one of Examples 60 to 66, wherein the body opening port is elastic.
[0072] Example 68. A port described in any one of Examples 60 to 67, wherein the inner expandable anchor comprises an opening or channel shaped to receive a visualization tool.
[0073] Example 69. An introducer for a laparoscopic workspace device, comprising: an elongate outer tubular body having a lumen with a distal opening and a proximal opening; an inner member shaped and sized to slide within the lumen and extend out through the distal opening, the inner member including an elongate body having a distal end and a proximal end; an expandable workspace device holder coupled to a distal end of the elongate body, the expandable workspace device holder configured to move between an expanded state in which the holder extends out of the lumen and a collapsed state in which the holder is positioned within the lumen; the expandable workspace device holder comprising at least two elastic members coupled to one another by at least one rigid spacer configured to maintain a desired distance between the at least two elastic members when the holder is in a collapsed state within the lumen; The introducer.
[0074] Example 70. An introducer as described in Example 69, wherein the at least two elastic members are coupled to the distal end of the elongate body via at least two spaced hinge connectors configured to allow rotational movement of each of the at least two elastic members relative to the distal end of the elongate body when the expandable workspace device holder is expanded.
[0075] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
[0076] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings and images. While specific reference will now be made in detail to the drawings, it is emphasized that the details shown are for the purpose of illustrating and discussing embodiments of the present invention by way of example. In this regard, the description taken in conjunction with the drawings will make apparent to those skilled in the art how embodiments of the present invention may be practiced. [Brief explanation of the drawings]
[0077] [Figure 1-1] FIG. 1A is a general process for forming an expandable segment of a workspace device having radial stiffening members, according to some exemplary embodiments of the present invention. [Figure 1-2] 1B and 1C are schematic illustrations of workspace devices with radial stiffening members, according to some exemplary embodiments of the present invention. [Figure 1-3] 1D is a detailed flowchart of a process for producing expandable segments with ribs therebetween, according to some exemplary embodiments of the present invention. [Figure 2]2A and 2B are schematic diagrams of a laparoscopic workspace device having walls formed from two layers of sheet material, with the outer layer having a length greater than the inner layer, according to some exemplary embodiments of the present invention; and FIG. 2C is a schematic diagram showing the layers of FIGS. 2A and 2B interconnected by multiple ribs in an unfolded state, according to some exemplary embodiments of the present invention. [Figure 3-1] FIG. 1A is a schematic diagram showing the walls of a laparoscopic workspace device in an expanded state having perforated interconnected radial ribs according to some exemplary embodiments of the present invention; and FIG. 1B is a schematic diagram showing the walls of a laparoscopic workspace device in an expanded state having interconnected radial ribs formed from a single layer according to some exemplary embodiments of the present invention. [Figure 3-2] C is a schematic diagram showing the walls of a laparoscopic workspace device in an expanded state having interconnected radial ribs perpendicular to the layers forming the wall, according to some exemplary embodiments of the present invention; D is a schematic diagram showing the walls of a laparoscopic workspace device in an expanded state having interconnected ribs arranged at an angle to the layers forming the wall, according to some exemplary embodiments of the present invention; E and F are schematic diagrams showing the walls of a laparoscopic workspace device in an expanded state having interconnected radially extending ribs with spaced apart walls, according to some exemplary embodiments of the present invention. [Figure 4-1] 1A and 1B are schematic illustrations of a laparoscopic workspace device in an expanded state, where the wall of the device comprises a plurality of ribs within an inflatable chamber, according to some exemplary embodiments of the present invention. [Figure 4-2] C is a schematic diagram of a laparoscopic workspace device in an uninflated state, according to some exemplary embodiments of the present invention; and D is a schematic diagram of a laparoscopic workspace device in an expanded state, according to some exemplary embodiments of the present invention. [Figure 5]1A and 1B are schematic diagrams of a laparoscopic workspace device in an expanded state, in which the walls of the device are formed from circumferentially expandable segments separated by stiffening discs, in accordance with some exemplary embodiments of the present invention; and FIG. 1C and 1D are schematic diagrams of stiffening discs, in accordance with some exemplary embodiments of the present invention. [Figure 6] 6A-6C are schematic illustrations of a laparoscopic workspace device in an expanded state having walls with inwardly extending expandable segments separated by ribs, according to some exemplary embodiments of the present invention; and FIG. 6D is a schematic illustration of the layers forming the walls of FIGS. 6A-6C in an unfolded state, according to some exemplary embodiments of the present invention. [Figure 7] FIG. 7A is a schematic diagram illustrating the walls of a laparoscopic workspace device formed from two layers of sheet material in an unfolded state interconnected by an axially elongated rib, according to some exemplary embodiments of the present invention; and FIGS. 7B-D are schematic diagrams illustrating the formation of a laparoscopic workspace device from the walls of FIG. 7A, according to some exemplary embodiments of the present invention. [Figure 8] 1A and 1B are schematic diagrams illustrating a laparoscopic workspace device having walls formed from circumferential rings separated by radial stiffening members, according to some exemplary embodiments of the present invention; and FIG. 1C and FIG. 1D are schematic diagrams illustrating the ratio between the height of an expandable segment and the length of a radial stiffening member located between adjacent expandable segments, according to some exemplary embodiments of the present invention. [Figure 9] 1A-C are schematic illustrations of a laparoscopic workspace device having walls with outwardly extending vertically expandable segments, according to some exemplary embodiments of the present invention. [Figure 10] 1A-C are schematic illustrations of a laparoscopic workspace device having walls with inwardly extending vertically expandable segments, according to some exemplary embodiments of the present invention. [Figure 11] 10A-10C are schematic diagrams of unfolded assemblies between flat and curved layers bent to form the expandable segments shown in FIGS. 9A-9C and 10A-10C, according to some exemplary embodiments of the present invention. [Figure 12] 1A and 1B are schematic cross-sectional views of a wall of a laparoscopic workspace device having interconnected internal expandable segments, according to some exemplary embodiments of the present invention. [Figure 13-1] 1A-C are schematic illustrations of a laparoscopic workspace device formed from vertically expandable segments and horizontally expandable segments, according to some exemplary embodiments of the present invention. [Figure 13-2] 13A-13C in an unfolded state, according to some exemplary embodiments of the present invention. [Figure 14] 1A and 1B are schematic diagrams of a port including a foldable portion, according to some exemplary embodiments of the present invention. [Figure 15] 1A-D are schematic illustrations of ports including deployable anchors, according to some exemplary embodiments of the present invention. [Figure 16] 1A-C are schematic illustrations of ports formed from overlapping portions, according to some exemplary embodiments of the present invention. [Figure 17-1] 1A is a schematic diagram of a port with a visualization opening, according to some exemplary embodiments of the present invention. FIG. [Figure 17-2] 1B and 1C are schematic illustrations of a laparoscopic workspace device with visualization openings and channels, according to some exemplary embodiments of the present invention. [Figure 17-3] DF are schematic illustrations of ports with expandable distal ends, according to some exemplary embodiments of the present invention. [Figure 17-4] GH are schematic diagrams illustrating the interaction between a port having an expandable distal end and a clamp used to collapse the distal end of the port, according to some exemplary embodiments of the present invention; I is a schematic diagram illustrating the use of the port and clamp when inserting the port through an incision in a body wall into a laparoscopic workspace device positioned within a body cavity, according to some exemplary embodiments of the present invention. [Figure 17-5]10A-10M are schematic illustrations of ports with cutting guides, according to some exemplary embodiments of the present invention. [Figure 18] 1A-D are schematic illustrations of laparoscopic workspace devices having one or more side openings, eg, tool insertion side openings, according to some exemplary embodiments of the present invention. [Figure 19] 1A and 1B are schematic diagrams of a planar rib aligner, according to some example embodiments of the present invention. [Figure 20-1] 1A and 1B are schematic diagrams of a welding assembly according to some exemplary embodiments of the present invention, and FIG. 1C is a schematic diagram of a planar rib aligner connected to a rib and a layer according to some exemplary embodiments of the present invention. [Figure 20-2] FIG. 1D is a schematic illustration of an electrode array attached to a radially extending stiffening member, eg, a rib, according to some exemplary embodiments of the present invention. [Figure 21] 1A and 1B are schematic diagrams of a welding assembly including a layer former, according to some exemplary embodiments of the present invention. [Figure 22-1] 1A and 1B are schematic diagrams of a rotary welding assembly, according to some example embodiments of the present invention. [Figure 22-2] 22C is a schematic diagram of a circular rib aligner according to some exemplary embodiments of the present invention, and FIG. 22D is a schematic diagram of the circular rib aligner of FIG. 22C coupled to a rotary welding assembly according to some exemplary embodiments of the present invention. [Figure 23-1] 1A-C are schematic illustrations of an introducer of a workspace device, according to some exemplary embodiments of the present invention. [Figure 23-2] 10D and 10E are schematic illustrations of an introducer of a workspace device, according to some exemplary embodiments of the present invention. [Figure 23-3] 1F is a schematic diagram showing an introducer holder surrounding an opening of a workspace device, with the holder in an expanded state forcing the workspace device open, according to some exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0078] The present invention, in some embodiments thereof, relates to laparoscopic tissue containment devices, and more particularly, but not exclusively, to inflatable laparoscopic tissue containment devices.
[0079] A broad aspect of some embodiments of the present invention relates to a workspace device that can be inserted into a body (e.g., a body cavity such as the abdominal cavity) and used to manipulate body tissue within the body, for example, as described in WO 2019 / 049152, the entire contents of which are incorporated herein by reference. In some embodiments, the body of the workspace device is formed from an expandable wall that defines an internal lumen of the device and includes multiple expandable segments and one or more stiffening members, e.g., radially extending stiffening members, e.g., radial stiffening members. In some embodiments, the expandable wall comprises at least one inflatable chamber comprising multiple expandable segments and a radial stiffening member. Optionally, the radial stiffening member divides the at least one inflatable chamber into the multiple expandable segments. Additionally or optionally, the multiple expandable segments are fluidly connected to one another, e.g., allowing fluid to flow between the fluidly connected expandable segments of the inflatable chamber when the inflatable chamber is inflated. In some embodiments, the multiple expandable segments can resist collapse of the device body due to intra-abdominal forces caused, for example, by intra-abdominal gas used for pneumoperitoneum. Additionally, the radial stiffening members can resist radial forces applied, for example, to the outer surface of the expandable wall.
[0080] According to some embodiments, the body of the workspace device with the expandable wall is configured to fold into a folded state to fit within a laparoscopic passageway in a body cavity wall, such as, for example, the abdominal cavity wall. In some embodiments, the workspace device body is configured to fold to fit within a laparoscopic passageway having an interior width of less than 20 mm, e.g., less than 15 mm, less than 10 mm, or any width therebetween, smaller, or larger. As used herein, laparoscopic passageway refers to any opening through a body wall, including natural orifices optionally used or created in laparoscopic surgical procedures.
[0081] According to some embodiments, the body of the workspace device comprising the expandable wall is configured to expand to an expanded state within a body cavity, for example the abdominal cavity, into which a laparoscopic passageway extends from a bodily opening in the body cavity wall.
[0082] According to some embodiments, when the workspace device body is in an expanded state, one or both of the inner and outer surfaces of the expandable wall are smooth. In some embodiments, the term "smooth" refers to an optionally curved surface having a surface texture including bulges having a radius of curvature of less than 0.1 mm, e.g., less than 0.05 mm, less than 0.01 mm, or any value therebetween, smaller, or larger. Alternatively or additionally, the term "smooth" refers to an optionally curved surface including elements having a radius of curvature of less than 2 cm, e.g., less than 1 cm, less than 0.5 cm, or any value therebetween, smaller, or larger. Alternatively or additionally, the term "smooth" in some embodiments relates to an optionally curved surface optionally including bulges or other elements extending from the surface having a radius of curvature of less than 20%, e.g., less than 10%, less than 5%, less than 1%, or any percentage value therebetween, smaller, or larger, from the thickness of the expandable wall in the expanded state.
[0083] According to some exemplary embodiments, a wall, e.g., an expandable wall of a workspace device, is fluidly connected to one or more inflation channels or tubes configured to inflate at least one inflatable chamber within the wall. Alternatively or additionally, the one or more inflation channels or tubes are configured to inflate at least one, e.g., two or more, expandable segments of the wall.
[0084] Certain aspects of some embodiments relate to walls of a workspace device, e.g., a laparoscopic workspace device including at least one expandable segment, e.g., two, three, four, or any greater number of expandable segments. In some embodiments, the walls of the workspace device comprise two or more radial stiffening members. It should be understood that "rigid" does not mean stiff. Rather, stiffness means being sufficiently stiff to resist radial forces applied to the body of the workspace device, optionally as expected during operation. For example, the radial stiffening members may mean being sufficiently stiff to maintain the shape of the device body with less than a 10% volumetric change in an ambient environment having a pressure that exceeds the pressure of the device, e.g., the pressure within the lumen of the device used to process tissue, such as 5 mmHg, 10 mmHg, 20 mmHg, 30 mmHg, or pressures therebetween or higher. In some embodiments, the two or more radial stiffening members are configured to increase the stiffness of the wall to resist radial pressure within an insufflated body cavity.
[0085] According to some embodiments, at least some of the radial stiffening members are optionally located adjacent to or between the expandable segments forming the wall. In some embodiments, at least some of the radial stiffening members are optionally disposed within the expandable segments. In some embodiments, at least some of the radial stiffening members include spaced apart elements that are not connected to one another. Alternatively, at least some of the radial stiffening members include spaced apart elements that are interconnected, for example, by at least one connecting portion. In some embodiments, the radial stiffening members and at least some of the connecting portions are integrated into a sheet material layer. In some embodiments, at least some of the radial stiffening members are part of one or more layers that form the expandable segments of the wall. In some embodiments, at least some or all of the radial stiffening members are perforated, for example, to allow fluid flow between adjacent expandable segments separated by the radial stiffening members. Alternatively, at least some of the radial stiffening members are sealed, for example, to maintain the structural integrity of the wall in the event that one or more of the expandable segments that contact the radial stiffening members are perforated.
[0086] According to some embodiments, the radial stiffening member includes a rib, e.g., a thin rib. In some embodiments, the rib has a thickness in the range of 20-150 microns (μm), e.g., 20-50 μm, 40-80 μm, 70-120 μm, or any range of values therebetween, smaller, or larger, and is disposed between adjacent expandable segments of the wall. In some embodiments, one or more of the ribs define an expandable segment. Optionally, a single rib is shared by two adjacent expandable segments of the wall. In some embodiments, each rib is welded to at least one inner layer of sheet material and at least one outer layer of sheet material, e.g., to form at least one expandable segment. Optionally, at least some or all of the expandable segments are defined by at least two ribs welded to at least one inner layer and at least one outer layer.
[0087] According to some exemplary embodiments, at least some or all of the ribs in the workspace device walls are fluidly sealed, e.g., to create expandable segments that are sealed against fluid flow between each other. Alternatively, at least some or all of the ribs in the workspace device walls are perforated, e.g., to allow fluid flow between adjacent expandable segments. In some embodiments, the ribs are, e.g., radially rigid.
[0088] According to some exemplary embodiments, at least some or all of the ribs in the walls of the workspace device are spaced apart. Alternatively, the ribs are connected to one another. In some embodiments, the ribs in the walls of the workspace device are formed from a preformed single layer of sheet material. In some embodiments, in the expanded state of the walls, at least some or all of the ribs are perpendicular to a tangent to the inner layer and / or a tangent to the outer layer. Alternatively, in the expanded state of the walls, the ribs are disposed at an angle relative to the inner and outer layers of the walls.
[0089] According to some exemplary embodiments, the ribs include rings disposed between circumferentially expandable segments that surround the interior volume of the workspace device. Alternatively, the rings divide the lumen between the inner and outer layers of the wall of the workspace device into circumferentially expandable segments. Optionally, the ring-shaped rings are perforated, for example, to allow fluid flow between adjacent expandable segments.
[0090] According to some exemplary embodiments, the expandable segment of the wall is formed from at least one curved layer of sheet material preformed to form the wall of the expandable segment. In some embodiments, the curved portion of the at least one curved layer forming the wall is a radial stiffening member. Alternatively, the radial stiffening member between adjacent expandable segments is formed by attaching the walls of the adjacent expandable segments, for example, by welding or gluing the walls together.
[0091] According to some exemplary embodiments, ribs connected to the at least one inner layer and the at least one outer layer define vertically expandable segments of the walls of the workspace device. In some embodiments, when expanded, the vertically expandable segments lie around the lumen of the workspace device. Alternatively, ribs connected to the at least one inner layer and the at least one outer layer define circumferentially expandable segments. In some embodiments, when expanded, the circumferentially expandable segments surround the interior volume of the workspace device.
[0092] An aspect of some embodiments relates to workspace devices having walls with elastic expandable segments, e.g., inwardly or outwardly extending expandable segments. In some embodiments, in an expanded state, e.g., when the elastic expandable segments are inflated, the elastic expandable segments press against one another. In some embodiments, the elastic expandable segments press against one another to define and expand a lumen of the workspace device.
[0093] According to some embodiments, the walls of adjacent elastic expandable segments are optionally attached to one another, for example, by welding, to form radial stiffening members upon expansion. In some embodiments, the length of each radial stiffening member is greater than 50% of the wall thickness, e.g., greater than 60%, greater than 80%, greater than 90% of the wall thickness, or any percentage value therebetween, lesser, or greater.
[0094] According to some exemplary embodiments, the walls of the workspace device comprise at least one smooth curved surface and at least one undulating surface formed by the extensible expandable segment.
[0095] According to some embodiments, the workspace device comprises a wall having inwardly extending expandable segments. In some embodiments, the wall of the workspace device has a smooth outer surface and an undulating inner surface formed by the inwardly extending expandable segments. In some embodiments, when expanded, the inwardly extending expandable segments extend into the lumen of the workspace device. Optionally, in the expanded state, each inwardly extending segment presses against an adjacent inwardly extending segment.
[0096] According to some embodiments, the workspace device comprises a wall having outwardly extending expandable segments. In some embodiments, the wall of the workspace device has a smooth inner surface and an undulating outer surface formed by the outwardly extending expandable segments. In some embodiments, when expanded, the outwardly extending elastic expandable segments extend into a body cavity, for example, an insufflated body cavity. Optionally, in the expanded state, each outwardly extending segment presses against an adjacent outwardly extending segment.
[0097] According to some embodiments, the expandable segments, eg, the inwardly extending expandable segments or the outwardly extending expandable segments, are elongated vertical segments that are optionally disposed around the periphery of the wall.
[0098] Certain aspects of some embodiments relate to securing a port configured to be placed within a body opening, e.g., a surgically formed or anatomical body opening, by moving at least one element through a channel defined by the port. In some embodiments, the at least one element includes a surgical tool, e.g., a morcellator. Alternatively, the port comprises an outer portion and an inner portion slidable within the outer portion. In some embodiments, the port is secured within the body opening by sliding the inner portion, e.g., a rigid portion, within the outer portion, e.g., a flexible portion, of the port. In some embodiments, the inner and outer portions of the port are cylindrical.
[0099] According to some embodiments, the anchor expands by sliding the inner portion within the outer portion of a port already positioned within the body opening. In some embodiments, the anchor is part of the outer portion of the port. Alternatively, the anchor is part of the inner portion of the port. In some embodiments, the anchor reversibly expands and collapses when the inner portion is removed from the outer portion of the port.
[0100] According to some embodiments, the outer portion of the port is introduced into the body opening in a collapsed state. In some embodiments, sliding the inner portion within the outer portion deploys the outer portion. In some embodiments, deployment of the outer portion secures the port within the body opening.
[0101] An aspect of some embodiments relates to visualizing the lumen of the workspace device from outside the body. In some embodiments, the expandable wall of the workspace device comprises one or more openings or channels shaped and sized to receive a visualization tool, e.g., the end of an endoscope. In some embodiments, the ends of the channels within the lumen are closed, e.g., to prevent a visualization tool from entering the lumen through the expandable wall. Additionally, at least a portion of the channels located within the lumen of the workspace device are transparent, e.g., to allow visualization of the lumen from within the channel.
[0102] According to some embodiments, the workspace device comprises one or more channels that enter the lumen of the workspace device through an expandable wall or through a sleeve connecting the lumen of the workspace device and the body opening. In some embodiments, the one or more channels are open channels, for example, to allow entry of a visualization tool, such as an endoscope, into the lumen of the workspace device. Alternatively, the opening or end of the one or more channels facing the lumen is closed, for example, to maintain separation between the contents of the lumen and the body cavity contents.
[0103] According to some exemplary embodiments, one or more openings or channels in the expandable wall are formed between adjacent radial stiffening members, or alternatively, one or more openings or channels are formed within the radial stiffening members.
[0104] Alternatively or additionally, the lumen of the workspace device is visualized through an opening in a port disposed in the body orifice, the opening of the workspace device including at least one opening shaped and sized to receive a visualization tool. In some embodiments, the opening is shaped and sized to allow entry of a visualization tool into the lumen. Alternatively, the opening is an opening in an entry channel having at least one end.
[0105] An aspect of some embodiments relates to a workspace device having an expandable wall and a sleeve connecting a body opening and an internal lumen of the workspace device through the expandable wall. In some embodiments, the sleeve is connected to an opening in the expandable wall located between or through an expandable segment of the wall. In some embodiments, the sleeve is connected to one or more, for example, two, radial stiffening members of the expandable wall.
[0106] An aspect of some embodiments relates to a rib aligner configured to align a plurality of ribs with two or more layers of sheet material during formation of a wall of a workspace device. In some embodiments, the rib aligner secures the position of the rib when attaching the rib to at least two layers, e.g., when attaching each side of the rib to a different layer. In some embodiments, the rib aligner secures the position of the rib during welding of the layers to the rib, e.g., radio frequency (RF) welding, heat welding, or ultrasonic welding.
[0107] According to some embodiments, the rib aligner comprises a plurality of spaced-apart spacers configured to hold, e.g., reversibly hold, the ribs during installation, e.g., during a welding process. In some embodiments, the length of the spacers is determined according to a desired or pre-planned distance between two layers forming a wall, e.g., a desired thickness of the wall. In some embodiments, the distance between adjacent spacers is determined according to a desired or pre-planned distance between adjacent ribs of the wall. Optionally, the distance between adjacent ribs defines the size and / or volume of the expandable segment. In some embodiments, the spacers of the rib aligner are conductive.
[0108] According to some embodiments, the rib aligner can be planar, e.g., at least one planar sheet attached to the ribs, or it can be circular, e.g., a cylindrical sheet attached to the ribs.
[0109] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
[0110] General Process for Forming the Walls of a Laparoscopic Workspace Device Reference is now made to FIG. 1A, which depicts a process for forming a wall of a laparoscopic workspace device comprising one or more radial stiffening members, according to some exemplary embodiments of the present invention.
[0111] According to some exemplary embodiments, two or more sheets of material are provided at block 102. In some embodiments, at least one of the sheets is flexible, e.g., formed from a flexible material. Optionally, at least one of the sheets is elastic, e.g., formed from an elastic material. In some embodiments, the sheets have a maximum thickness of 200 microns (μm), e.g., a maximum thickness of 100 μm, 50 μm, 10 μm, or any value therebetween, smaller, or larger.
[0112] According to some exemplary embodiments, at least one of the sheets is shaped at block 104. In some embodiments, shaping the sheet includes bending or bending the sheet into a desired shape or pattern, such as a curved or wavy pattern. In some embodiments, the shaped sheet is fixed in the desired shape.
[0113] According to some exemplary embodiments, an expandable segment is created at block 106. In some embodiments, the expandable segment, e.g., inflatable segment, is created by connecting two or more of the provided sheets. In some embodiments, two or more sheets are connected, e.g., welded, to one another at specific locations to form the expandable segment. In some embodiments, at least one of the sheets formed at block 104 is connected, e.g., welded, to a smooth or flat sheet at specific locations to form the expandable segment. Alternatively or additionally, two formed sheets are connected, e.g., welded, to one another to form the expandable segment.
[0114] According to some exemplary embodiments, radial stiffening members are formed between the expandable segments at block 108. In some embodiments, the radial stiffening members are formed between adjacent segments. In some embodiments, the radial stiffening members are formed during creation of the expandable segments. Alternatively, the radial stiffening members are formed subsequent to creation of the expandable segments.
[0115] According to some exemplary embodiments, a radial stiffening member is formed between adjacent expandable segments by attaching, e.g., welding, two opposing walls of the adjacent expandable segments to one another along a large surface area, forming a radially rigid interface. In some embodiments, the radially rigid interface has a length greater than the length of the expandable segment walls that contact the interface. In some embodiments, the interface between adjacent expandable segments is stiffened, e.g., radially, by forming it from two or more sheet layers attached to one another.
[0116] According to some exemplary embodiments, in the expanded state, two adjacent expandable segments press against each other, hi some embodiments, the two adjacent expandable segments press against each other along an interface area having a length greater than 0.2 cm, e.g., greater than 0.2 cm, greater than 0.3 cm, greater than 0.5 cm, or any length therebetween, lesser, or greater.
[0117] According to some exemplary embodiments, the radial stiffening member is formed by placing a stiffening rib between two or more sheets during creation of the expandable segment. In some embodiments, the expandable segment is formed by connecting two or more layers of sheets to a rib, for example, connecting each layer to opposite sides of a rib. In some embodiments, when the layers are connected to the ribs, each expandable segment is defined by two layers and two ribs, each rib separating adjacent segments. In some embodiments, the expandable segment is created by welding two sheets to either side of a rib at block 106. In some embodiments, the two sheets are welded to the rib simultaneously or sequentially.
[0118] Exemplary Wall with Interlayer According to some exemplary embodiments, the walls of the workspace device comprise one or more radial stiffening members, for example, to resist inward collapse of the workspace device. In some embodiments, the one or more radial stiffening members are disposed between or adjacent to the expandable segments of the wall. Optionally, the one or more radial stiffening members at least partially define one or more of the expandable segments. Reference is now made to FIG. 1B, which depicts a radial stiffening member formed from a layer of sheet material within a wall, according to some exemplary embodiments of the present invention.
[0119] According to some exemplary embodiments, the workspace device body comprises a wall, e.g., wall 120, which defines an internal lumen 122 of the device. In some embodiments, the wall of the workspace device comprises one or more expandable segments that allow the workspace space device body to move between a collapsed state, e.g., when the workspace device body is delivered into a body cavity, and an expanded state, when the device body is deployed within the body cavity. In some embodiments, during deployment of the workspace device, the one or more expandable segments are expanded, e.g., by inflation.
[0120] According to some exemplary embodiments, wall 120 is formed from at least one inner layer 124 facing lumen 122 and at least one outer layer 125 facing the body cavity. In some embodiments, at least one or both of inner layer 124 and outer layer 125 are pre-formed to obtain a selected shape or pattern, such as a curved or wavy pattern. In some embodiments, at least one or both of inner layer 124 and outer layer 125 are formed from a flexible material that allows flexing of the layers and / or wall, for example, in an expanded state.
[0121] Additionally, the wall comprises at least one intermediate layer of sheet material, e.g., intermediate layer 126, disposed between inner layer 124 and outer layer 125. In some embodiments, intermediate layer 126 is connected, e.g., welded, to inner layer 124 and outer layer 125 at specific locations, e.g., locations 128, 130, 132, and 134, to define multiple expandable segments.
[0122] According to some exemplary embodiments, when the expandable segments are expanded, the portion of the middle layer 126 connecting the inner layer 124 and the outer layer 125 forms a radial stiffening member portion. In some embodiments, the radial stiffening member portion is disposed between and contacts two adjacent expandable segments. Optionally, a single radial stiffening member portion is shared and / or defines two adjacent expandable segments.
[0123] According to some exemplary embodiments, the connection portion of the intermediate layer 126 to at least one of the inner layer 124 and the outer layer 125 has a length similar to the length of the radial stiffening member portion between the inner and outer layers, or alternatively, the connection portion of the intermediate layer 126 has a length greater than the length of the radial stiffening member portion extending between the inner and outer layers.
[0124] According to some exemplary embodiments, intermediate layer 126 is pre-formed, e.g., bent into a desired shape to form the radial stiffening member portions and connecting portions, before connecting intermediate layer 126 to inner layer 124 and / or outer layer 125. In some embodiments, the thickness of intermediate layer 124 is greater than the thickness of each or at least one of inner layer 124 and outer layer 125. Alternatively, the radial stiffening member portions of intermediate layer 126 are thicker than the connecting portions of the intermediate layer. In some embodiments, the thickness of each layer is in the range of 0.2 μm to 200 μm, e.g., 0.2 μm to 10 μm, 8 μm to 30 μm, 20 μm to 70 μm, 100 μm to 200 μm, or any range of values therebetween, smaller, or larger.
[0125] Exemplary Wall with Radial Stiffening Members According to some exemplary embodiments, the walls of a workspace device are formed by inner and outer layers connected to one another. In some embodiments, the walls comprise a plurality of expandable segments defined by the inner and outer layers. In some embodiments, the connections between the expandable segments include radial stiffening members that enable the walls to resist collapse due to, for example, external pressure within a body cavity in which the device is deployed, when the expandable segments expand. Reference is now made to FIG. 1C, which depicts a wall of a workspace device comprising a plurality of radial stiffening members, according to some exemplary embodiments of the present invention.
[0126] According to some exemplary embodiments, a wall of the workspace device, e.g., wall 138, comprises an inner layer of sheet material 142 and an outer layer of sheet material 140. In some embodiments, inner layer 142 is connected to outer layer 140 at specific locations to define, e.g., multiple expandable segments. In some embodiments, the multiple expandable segments expand as the wall expands, e.g., when the device is deployed within a body cavity. In some embodiments, the connection points between the two layers form radial stiffening members when the expandable segments are expanded.
[0127] According to some exemplary embodiments, a radial stiffening member is formed between two adjacent expandable segments. In some embodiments, the radial stiffening member is formed by the connecting walls of the two adjacent expandable segments. In some embodiments, the two interconnected walls are two portions of the same layer that, together with at least one different layer, define the expandable segment, for example, when at least one layer is bent or shaped into a curved or wavy pattern. In some embodiments, the expandable segment is formed from two pre-shaped layers, e.g., curved layers, connected to each other. Alternatively, at least one of the layers is curved and at least one different layer is smooth.
[0128] According to some exemplary embodiments, as shown in FIG. 1C , at least one inner layer 142 and at least one outer layer 140 are connected to one another by radial stiffening members, such as ribs 144, 146, 148, and 150. In some embodiments, each layer is connected to a different end of the rib. In some embodiments, the layers are connected to the rib by welding, gluing, or the use of a solvent that dissolves one or both of the layers and the rib.
[0129] According to some exemplary embodiments, the rib, or at least one of the ribs, becomes radially stiffer when the expandable segment is expanded and / or when the workspace device is in an expanded state. In some embodiments, the thickness of each rib is greater than the thickness of each layer. In some embodiments, the maximum thickness of the rib is in the range of 0.2 μm to 80 μm, e.g., 0.2 μm, 20 μm, 10 μm to 30 μm, 15 μm to 50 μm, or any range of values therebetween, smaller, or larger. In some embodiments, the ribs, e.g., ribs 144, 146, 148, and 150, and / or one of the sheet material layers, are optionally formed from at least one of polyurethane, polyurethane with a plastic coating, polyurethane-coated fiber-reinforced nylon, and a polyurethane layer attached to a metal film.
[0130] According to some exemplary embodiments, a distance 145 between two adjacent ribs, e.g., ribs 144 and 146, is determined according to, for example, a distance 147 between inner layer 142 and outer layer 140. Alternatively, distance 145 is determined according to the length of one or both of the ribs, e.g., ribs 144 and 146. In some embodiments, distance 145 between two adjacent ribs is greater than the length of one or both of the ribs, e.g., ribs 144 and 146. In some embodiments, the distance between two adjacent ribs defines the length of the expandable segment. In some embodiments, the length of the ribs defines the width or thickness of the expandable segment. A potential advantage of having distance 145 greater than the length of the ribs may be increased radial stiffness of the workspace wall.
[0131] According to some exemplary embodiments, the length of one or more radial stiffening members, e.g., ribs 144 and 146, is optionally less than the thickness or axial length, e.g., the length from the proximal to distal end, of wall 138, e.g., the expandable wall. In some embodiments, having radial stiffening members that are less than the axial length of the wall or workspace device in the expanded state allows, for example, fluid flow between two or more expandable segments of the wall. In some embodiments, the length of each radial stiffening member is at least 2 cm, e.g., at least 3 cm, at least 4 cm, or any length therebetween, shorter, or longer.
[0132] According to some exemplary embodiments, in the expanded state of the workspace device, at least some or all of the ribs in the workspace device walls, e.g., ribs 144 and 146, are perpendicular to at least one of inner layer 142 and outer layer 140. Alternatively or additionally, at least some of the ribs, e.g., ribs 148 and 150, are disposed at an angle relative to inner layer 142 and outer layer 140.
[0133] According to some exemplary embodiments, in the expanded state of the workspace device, adjacent expandable segments press against one another, such as expandable segments 141 and 143. In some embodiments, in the expanded state of the workspace device, adjacent expandable segments press against radial stiffening members, such as ribs, disposed therebetween.
[0134] According to some exemplary embodiments, in the expanded state of the workspace device, at least one or both of the inner and outer layers of the workspace space device are smooth. In some embodiments, at least one of the layers is curved, e.g., radially extending. In some embodiments, in the expanded state, at least one of the layers extends inward or outward.
[0135] According to some exemplary embodiments, in the expanded state, at least some of the expandable segments extend radially outward from the lumen of the workspace device a distance of more than 1 cm, e.g., more than 2 cm, more than 4 cm, more than 5 cm, more than 6 cm, or any distance between, less than, or greater than 1 cm. Alternatively or additionally, in the expanded state, at least some of the expandable segments extend radially inward into the lumen of the workspace device a distance of more than 1 cm, e.g., more than 2 cm, more than 4 cm, more than 5 cm, more than 6 cm, or any distance between, less than, or greater than 1 cm. According to some exemplary embodiments, at least some or all of the radial stiffening members, e.g., ribs, are connected to one another. Alternatively, at least some or all of the ribs are decoupled from one another.
[0136] Exemplary Process for Generating Ribbed Walls of a Workspace Device According to some exemplary embodiments, the walls of the workspace device comprise a plurality of radial stiffening members, e.g., ribs. In some embodiments, the ribs are disposed between the inner and outer layers of the wall. Optionally, the ribs are connected to both layers to increase the stiffness of the wall, e.g., against radial forces, when the wall is expanded and when the device is in the expanded state. Alternatively or additionally, the ribs may, for example, allow radial forces applied to the outer surface of the device to be distributed laterally toward the inner surface and / or toward other ribs. Reference is now made to FIG. 1D, which depicts a process for producing a workspace device wall comprising a plurality of ribs, according to some exemplary embodiments of the present invention.
[0137] According to some exemplary embodiments, a plurality of radial stiffening members, e.g., ribs, are provided at block 150. In some embodiments, the ribs are provided before, during, and / or after providing two or more sheets of material used to form at least one inner layer and at least one outer layer of the wall.
[0138] According to some exemplary embodiments, at block 152, at least one of the sheets is pre-formed into a desired shape or pattern. In some embodiments, at least one of the sheets of material is bent or curved into a desired shape or pattern, such as a corrugated shape. Optionally, two sheets of material forming the inner and outer layers of the wall are pre-formed into a desired shape or pattern. In some embodiments, at least one of the sheets is pre-formed using a former. In some embodiments, the former is configured to hold at least one sheet in a desired shape before and during securing the formed sheet to a rib or another sheet.
[0139] According to some exemplary embodiments, at block 154, the ribs are aligned with one or more of the sheets. In some embodiments, at least one or both of the sheets are aligned with the ribs. Optionally, at least one or both of the sheets are placed in contact with at least one or all of the ribs. In some embodiments, at least one or all of the ribs are aligned with one or more of the sheets using an aligner. In some embodiments, the aligner positions at least some of the ribs at a predetermined distance from each other. Alternatively or additionally, the aligner holds at least one of the ribs in a predetermined position with respect to at least one sheet of material.
[0140] According to some exemplary embodiments, at block 156, at least one of the sheets is secured to at least one of the ribs. In some embodiments, the ribs are secured to two or more sheets simultaneously, simultaneously, or sequentially. In some embodiments, at least one sheet is secured to at least one rib by welding, adhesive, or solvent. In some embodiments, attaching the sheets of material to the ribs creates expandable segments of the wall. In some embodiments, adjacent expandable segments are separated by at least one rib.
[0141] According to some exemplary embodiments, the aligner is optionally removed at block 158 .
[0142] According to some exemplary embodiments, the former is optionally removed at block 160 .
[0143] According to some exemplary embodiments, the ribs and at least two sheets of material that together form a wall are optionally bent at block 162. In some embodiments, the wall, including the ribs and sheets of material, is bent to form a cylinder. Alternatively, the at least two sheets are provided as two closed cylinders, and the ribs are aligned to one or both of the cylinders at block 154.
[0144] According to some exemplary embodiments, at least one inflation tube is connected to the wall at block 164. In some embodiments, the expandable segments of the formed wall are fluidly connected and at least one inflation tube is used to inflate all of the expandable segments of the wall. Alternatively, at least a portion of the expandable segments of the wall are fluidly connected and two or more inflation tubes are connected to the wall.
[0145] According to some exemplary embodiments, the two ends of the wall that form the cylinder are connected to one another at block 166. In some embodiments, the two ends of the wall are connected to one another, for example, by welding or gluing, to form a sealed cylinder.
[0146] According to some exemplary embodiments, at least one opening of the sealed cylinder is closed at block 168. In some embodiments, the at least one opening is closed to form a closed bottom of the workspace device. In some embodiments, the opening is closed using at least one additional layer.
[0147] Exemplary Workspace Devices with Smooth Inner and Outer Surfaces Reference is now made to Figures 2A and 2B, which depict workspace devices having smooth inner and outer layers of sheet material at least partially connected by radial stiffening members, according to some exemplary embodiments of the present invention.
[0148] According to some exemplary embodiments, a workspace device, such as device 200, comprises an expandable workspace device body 201 formed from a wall 203 having at least one expandable segment. In some embodiments, body wall 203 defines a lumen within which a bodily organ or tissue is disposed and optionally treated.
[0149] According to some exemplary embodiments, body 201 comprises a distal base 210 formed from at least one layer. In some embodiments, base 210 is formed from two or more layers. Optionally, base 210 is expandable, for example, by inflating at least one expandable segment of the base.
[0150] According to some exemplary embodiments, the wall is formed from two or more layers of sheet material, e.g., at least one inner layer 202 and at least one outer layer 204. In some embodiments, the at least one inner layer 202 and the at least one outer layer 204 are interconnected by a plurality of radial stiffening members, e.g., ribs 208 and 209. In some embodiments, the ribs 208 and 209 divide the lumen between the two layers into two or more expandable segments. Optionally, at least some or all of the expandable segments are fluidly interconnected, e.g., allowing for inflation of the expandable segments using a single inflation channel.
[0151] According to some exemplary embodiments, body 201 includes a channel 206, e.g., a cylindrical channel including opening 212, connected to wall 203. In some embodiments, the channel is disposed within the body opening and is shaped and sized to define a sealed passageway between the lumen of the wall and body 203 and the exterior of the body. In some embodiments, the passageway is sized and shaped to allow insertion of a tissue processing device, e.g., a manual or powered morcellator, into the lumen of body 203 from the exterior of the body. In some embodiments, channel 206 is flexible and optionally formed from one or more additional layers of sheet material. Alternatively, the channel is formed from an extension of one or more layers of sheet material used to form wall 203, e.g., an extension of inner layer 202 and / or an extension of outer layer 204.
[0152] According to some exemplary embodiments, as shown in, for example, FIG. 2B , body 201 comprises at least one inflation tube, e.g., inflation tube 211. In some embodiments, inflation tube 211 is fluidly connected to wall 203, e.g., one or more expandable segments of wall 203. Alternatively, inflation tube 211 or at least one additional inflation tube is fluidly connected to outer layer 204.
[0153] Reference is now made to FIG. 2C, which depicts wall 203 in a preform state, according to some exemplary embodiments of the present invention.
[0154] According to some exemplary embodiments, wall 203 is formed from inner layer 202 and outer layer 204. In some embodiments, as shown, for example, in FIG. 2C , outer layer 204 has a length greater than the length of inner layer 202 when the layers are in an unfolded, preformed state. In some embodiments, as shown, for example, in FIGS. 2A and 2B , wall 203 has an outer perimeter that is greater than the inner perimeter, optionally due to a difference in length between the inner and outer layers. Further, as shown, for example, in FIG. 2C , the preformed inner and outer layers of sheet material are connected to one another by a plurality of spaced ribs, such as ribs connected at weld lines 208 and 209.
[0155] According to some exemplary embodiments, as shown in, for example, FIG. 2C , the channel 206, e.g., the tool insertion channel, is an integral part, e.g., an extension of the sheet material of the inner layer 202. In some embodiments, the extension is a portion of the inner layer 202 that extends beyond the portion of the inner layer 202 that is connected to the outer layer 204. Alternatively, the channel, e.g., the tool insertion channel, is an integral part of the outer layer sheet material. In some embodiments, the channel is a portion of the outer layer that extends beyond the portion of the outer layer that is connected to the inner layer.
[0156] Exemplary Radially Extending Stiffening Members According to some exemplary embodiments, radial stiffening members are at least partially connected to at least one inner layer and at least one outer layer of the expandable wall of the workspace device. In some embodiments, the radial stiffening members are configured to provide radial stiffness to the wall of the workspace device in the expanded state. Reference is now made to Figures 3A-3F, which depict different types of radial stiffening members, according to some exemplary embodiments of the present invention.
[0157] According to some exemplary embodiments, as shown in, for example, Figure 3A, wall 300 comprises at least one inner layer 304 of sheet material and an outer layer 302 of sheet material interconnected by a plurality of spaced ribs, e.g., ribs 306 and 308. In some embodiments, as shown in, for example, Figure 3A, in the expanded state, inner layer 304 and outer layer 302 are smooth and do not include protrusions or extensions across and / or extending from the surface at a distance greater than 8 mm, e.g., greater than 7 mm, greater than 6 mm, greater than 4 mm, or any distance therebetween, less than, or greater than the portion of the surface having a smallest diameter.
[0158] According to some exemplary embodiments, the radial stiffening members, e.g., ribs, are perforated and include openings, e.g., openings 310 and 312, as shown in, for example, FIG. 3A. In some embodiments, the openings are large enough to allow fluid pathways between different expandable segments of the wall. Additionally, the openings are small enough so as not to reduce the radial stiffness generated by the ribs. In some embodiments, the total area of the openings in a single radial stiffening member, e.g., rib, is at most 50%, e.g., at most 40%, at most 30%, at most 20% of the total surface area of the rib.
[0159] According to some exemplary embodiments, as shown in, for example, FIG. 3B , a wall, e.g., wall 320, comprises radial stiffening members, e.g., radial stiffening members 326 and 327, formed from at least one additional layer disposed between inner layer 324 and outer layer 322 of wall 320. In some embodiments, the at least one additional layer is bent to form radially extending stiffening portions 326 and 327 located in the radial direction and connecting portions, e.g., connecting portions 328 and 329. In some embodiments, the connecting portions are portions where the at least one additional layer is attached, e.g., interchangeably, to the inner and outer layers. Optionally, the connecting portions include openings, e.g., to reduce the amount of material needed to create the connecting portions or the layers used to form the connecting portions.
[0160] According to some exemplary embodiments, the radial stiffening member portion of at least one additional layer is thicker and / or stiffer than the connecting portion of the at least one additional layer. In some embodiments, the length of the connecting portion attached to the inner or outer layer, such as connecting portion 328, is similar to or longer than the length of the radial stiffening member portion.
[0161] According to some exemplary embodiments, at least some or all of the radial stiffening member segments are solid. Optionally, the solid radial stiffening member segments define sealed expandable segments between adjacent radial stiffening member segments. Alternatively, at least some or all of the radial stiffening member segments are perforated, e.g., to create fluidly connected expandable segments.
[0162] According to some exemplary embodiments, as shown in, for example, Figure 3C, workspace device wall 340 includes a plurality of radial stiffening members, e.g., outer layer 342 and inner layer 344, comprised of at least one additional layer of sheet material interconnected by radial stiffening member portions spaced apart by ribs 346 and 348. In some embodiments, as shown in, for example, Figure 3C, the plurality of radial stiffening members are perpendicular to inner layer 344 and / or outer layer 342 when wall 340 is in an expanded state, e.g., inflated. Optionally, the radial stiffening members are radial to the longitudinal axis of the laparoscopic workspace device.
[0163] According to some exemplary embodiments, as shown in, for example, FIG. 3D , in wall 360, a plurality of radially extending stiffening members, e.g., stiffening members 366 and 368, are disposed at an angle relative to a tangent to outer layer 362 and / or a tangent to inner layer 364. In some embodiments, the plurality of stiffening members 366 and 368 are disposed at an angle, for example, when wall 360 is in an expanded state.
[0164] Reference is now made to Figures 3E and 3F, which depict walls of a workspace device comprising multiple stiffening members formed from two or more walls, according to some exemplary embodiments of the present invention.
[0165] According to some exemplary embodiments, the wall 376 of the workspace device comprises an inner layer 380 of sheet material, an outer layer 378 of sheet material, and a plurality of radial stiffening members, e.g., ribs 382, disposed therebetween. In some embodiments, the ribs 382 are formed by bending at least one of the inner layer 380 or the outer layer 378. In some embodiments, the radial stiffening member formed by bending at least one of the layers is a double-walled radial stiffening member. In some embodiments, the double-walled radial stiffening member comprises an inner lumen. In some embodiments, the double-walled radial stiffening member extends outward from the outer layer 378 of the wall. In some embodiments, the double-walled radial stiffening member extends outward from the outer surface of the outer layer 378 a distance of up to 5 mm, e.g., up to 3 mm, up to 1 mm, or any distance therebetween, lesser, or greater.
[0166] According to some exemplary embodiments, each radial stiffening member is formed from a tubular member. In some embodiments, two walls of the tubular member interconnect the inner and outer layers and serve as ribs between the inner and outer layers. In some embodiments, two additional walls of the tubular member interconnecting the two ribs are attached to different layers of the inner and outer layers, for example, by welding. Optionally, at least some or each of the walls of the tubular member comprises an opening. In some embodiments, during manufacturing, for example, during assembly of the expandable wall, the tubular member is positioned between the inner and outer layers, and an electrode, for example, a welding electrode, is inserted into the lumen of the tubular member to weld each of the two additional walls to different layers of the inner and outer layers. In some embodiments, two radial stiffening members are formed from a single tubular member and introduced between the inner and outer layers. In some embodiments, each radial stiffening member is a wall of the tubular member.
[0167] Exemplary Workspace Device with Walls Formed by Bent Layers Reference is now made to Figures 4A and 4B, which depict cross-sectional views of a workspace device in an expanded state having walls formed by bending layers, according to some exemplary embodiments of the present invention.
[0168] According to some exemplary embodiments, workspace device 402 has a body configured to fold and expand. Additionally, workspace device body includes a wall, e.g., expandable wall 401. In some embodiments, the body of the workspace device is optionally foldable to pass through a passageway, e.g., a laparoscopic passageway, through a body cavity wall and into the body cavity. In some embodiments, the passageway includes a channel connecting the outer surface of the skin, e.g., a body opening in the outer surface of the skin, with the body cavity. Optionally, a port, e.g., ports 1402, 1412, 1502, 1602 shown in FIGS. 14A-14B, 15A-15D, and 16A-16C, is disposed within the passageway to, e.g., prevent damage to the body wall or channel 403 when a tool is inserted into the lumen of the workspace device through the body opening. In some embodiments, the passageway has a length of less than 40 mm, e.g., less than 30 mm, less than 15 mm, or less than 10 mm. In some embodiments, in the collapsed state, the workspace body and walls, eg, expandable walls, fit within the passageway.
[0169] According to some exemplary embodiments, the workspace body is expandable within a body cavity, e.g., the abdominal cavity, through which the passageway extends. In some embodiments, the workspace body is configured to expand to an expanded state within the body cavity. In some embodiments, when expanded, the workspace device extends axially, e.g., from a proximal to a distal direction, to define a workspace axis, e.g., workspace axis 434. As used herein, in some embodiments, the term “proximal” refers to being closer to the body opening, and the term “distal” refers to being closer to the body cavity. Alternatively, as shown in, for example, FIGS. 18C and 18D , the workspace device extends laterally in the expanded state, e.g., from side to side. In some embodiments, the workspace device extends laterally to optionally define a workspace axis at an angle greater than 35 degrees, e.g., greater than 45 degrees, greater than 50 degrees, greater than 80 degrees, or any angle therebetween, less than, or greater than, relative to the proximal-distal axis between the body opening and the body cavity.
[0170] According to some exemplary embodiments, in the expanded state, the wall, e.g., expandable wall 401, comprises at least one inflatable chamber. In some embodiments, the at least one inflatable chamber is connected to at least one inflation tube configured to inflate the at least one inflatable chamber to reach a desired pressure. In some embodiments, the wall and / or at least one inflatable chamber of the wall optionally surrounds an internal lumen of the workspace device, e.g., lumen 409. In some embodiments, wall 401 comprises multiple radial stiffening members, e.g., ribs 407 and 408. In some embodiments, the radial stiffening members at least partially interconnect an internal surface of wall 401 facing lumen 409 with an external surface of the wall. In some embodiments, multiple radial stiffening members are disposed within the at least one inflatable chamber. In some embodiments, the multiple radial stiffening members divide the at least one inflatable chamber into two or more, e.g., multiple expandable segments. In some embodiments, the multiple expandable segments are fluidly connected to each other within the at least one inflatable chamber.
[0171] According to some exemplary embodiments, the axial length 425 of at least some or all of the radial stiffening members, e.g., ribs 407, is shorter than the axial length of at least one expandable chamber 422 and / or the axial length of the wall, as shown in, for example, FIG. 4B. In some embodiments, having ribs that are shorter than the length of at least one expandable chamber or smaller in size than the cross-sectional size of at least one expandable chamber allows fluid flow, e.g., between expandable segments, e.g., adjacent expandable segments, e.g., proximal and / or distal to the ribs.
[0172] According to some exemplary embodiments, wall 401 of workspace device 402 comprises an inner layer 404 and an outer layer 406. In some embodiments, inner layer 404 and outer layer are connected to form at least one inflatable chamber 432. In some embodiments, at least one inflatable chamber is configured to be inflated by at least one inflation tube fluidly connected to at least one inflatable chamber 432. In some embodiments, at least one inflatable chamber is a chamber configured to maintain a predetermined pressure or range of pressure values sufficient to resist collapse due to pressure within a body cavity, such as an insufflated body cavity.
[0173] According to some exemplary embodiments, inner layer 404 and outer layer 406 are interconnected by a plurality of radial stiffening members, e.g., ribs 407 and 408. In some embodiments, ribs 407 and 408 are disposed within at least one expandable chamber 432. In some embodiments, for example, as shown in FIGS. 4A and 4B , a length 425, e.g., an axial length, of ribs is less than a length, e.g., an axial length, of wall 401 when the wall is in an expanded state, e.g., to allow fluid communication between expandable segments formed between adjacent ribs. In some embodiments, radial stiffening members, e.g., ribs 407 and 408, divide at least one expandable chamber into expandable segments. In some embodiments, the expandable segments are vertically expandable segments oriented along axis 434. Optionally, the vertically expandable segments are disposed around lumen 409, e.g., around the circumference of lumen 409. In some embodiments, wall 401 comprises at least one expandable chamber in which ribs and / or expandable segments are disposed.
[0174] According to some exemplary embodiments, wall 401 comprises at least one expandable distal ring near base 412 of workspace device. Alternatively, base 412 is formed from at least one additional layer connected to wall 401. In some embodiments, base 412 is formed from a single layer of sheet material. In some embodiments, at least one layer of sheet material forming base 412 is connected to one or both of at least one inner layer 404 and / or at least one outer layer 406. In some embodiments, wall 401 comprises at least one expandable proximal ring near channel 403. In some embodiments, channel 403, optionally a sleeve, connects the opening of lumen 409 with a body opening through which a device, e.g., 402, is introduced into the body cavity. In some embodiments, the channel is optionally formed from at least one additional layer of sheet material connected to wall 401. Alternatively, channel 403 is formed from one or both of at least one inner layer 404 and at least one outer layer 406. In some embodiments, a channel, e.g., channel 403, is optionally formed from a single layer of sheet material. In some embodiments, a channel, e.g., channel 403, is used to introduce a tool, e.g., a surgical tool, into the lumen of the device through a body orifice.
[0175] According to some exemplary embodiments, at least one inner layer 404 and at least one outer layer 406 are optionally welded or glued together, e.g., in a proximal region near channel 403 and / or in a distal region near base 412, to form, e.g., at least one inflatable chamber and / or expandable wall.
[0176] In some embodiments, the at least one expandable distal ring and / or the at least one expandable proximal ring are formed by bending at least one of the layers and connecting them to the same or a different layer, for example, inner layer 404 and / or outer layer 406 are connected to disk-shaped layer 414. In some embodiments, the at least one expandable distal ring and / or the at least one expandable proximal ring are circumferential rings that surround the lumen of the workspace device.
[0177] According to some exemplary embodiments, as shown in FIG. 4A , the base 412 of workspace device 402 is distal to at least one distal ring. In some embodiments, as shown in FIG. 4A , the base 412 is positioned distal to the wall 401. Alternatively, as shown in FIG. 4B , in workspace device 420, the distal ring is positioned distal to the base 412, for example, to push the base 412 away from internal organs within the body cavity. Alternatively, as shown in FIG. 4B , the base 412 is proximal to the wall 401. A potential advantage of having the base proximal to the wall may be to reduce contact between the base 412 and the surface that first contacts the distal portion of the wall.
[0178] Reference is now made to FIG. 4C, which depicts a workspace device in an unexpanded, eg, uninflated, state, according to some exemplary embodiments of the present invention.
[0179] According to some exemplary embodiments, workspace device 420 comprises an expandable wall 401 formed from an inner layer 404 and an outer layer 406, and a plurality of vertical stiffening members, e.g., ribs 408 and 407. In some embodiments, at least some of the ribs or all of the ribs are elongated ribs having a major axis and a minor axis. In some embodiments, the major axes of at least some of the ribs or all of the ribs are aligned along a major axis, e.g., longitudinal axis 434, of device 420. In some embodiments, the ribs interconnect inner layer 404 and outer layer 406. In some embodiments, the ribs are welded to each layer along weld lines formed in each layer.
[0180] According to some exemplary embodiments, the length of outer layer 406 is greater than the length of inner layer 404, and they are welded together by ribs to form an expandable wall, such that in the unexpanded state shown in FIG. 4A, both outer layer 406 and inner layer 404 have a smoothly deployed shape.
[0181] According to some exemplary embodiments, the ribs are distributed within the expandable wall 401 at equal or different distances from each other, separating the expandable wall 401 into multiple expandable segments. In some embodiments, the multiple expandable segments are fluidly connected to each other to allow inflation of the expandable wall 401, for example, through a single inlet. In some embodiments, in the unexpanded state of the device 420, the inner layer 404 forming the inner surface of the device 420 and the outer layer 406 forming the outer surface of the device 420 are smooth, optionally with a non-wavy shape, as shown, for example, in FIG. 4C .
[0182] According to some exemplary embodiments, expandable wall 401 comprises at least one fluid flow connector, such as connector 440. In some embodiments, connector 440 is a side connector, optionally comprising at least one valve. In some embodiments, connector 440 is connectable to an inflation tube having a proximal end connected to a fluid source and a distal end connected to connector 440.
[0183] According to some exemplary embodiments, expansion of expandable wall 401 via connector 440 causes expandable wall 401 and expandable segments 446 and 444, respectively, to expand and form inner and outer curves or bulges between two adjacent ribs, as shown, for example, in FIG. 4D. In some embodiments, expansion of expandable wall 401 causes upper ring 414 and lower ring 422 to form on wall 401, which is flat in the unexpanded state shown in FIG. 4A. In some embodiments, in the expanded state, expansion of the expandable segments causes inner layer 404 to form a wavy inner surface of device 420 and outer layer 406 to form a wavy outer surface of device 420, as shown, for example, in FIG. 4B.
[0184] Wall of an exemplary workspace device with a ring Reference is now made to Figures 5A and 5B, which depict a workspace device having walls with ring-shaped radial stiffening members, according to some exemplary embodiments of the present invention.
[0185] According to some exemplary embodiments, workspace device 502 comprises a wall 501 formed from at least one outer layer 502 of sheet material and at least one inner layer 504 of sheet material. In some embodiments, outer layer 502 and inner layer define at least one expandable segment in wall 501. In some embodiments, wall 501 comprises a plurality of radial stiffening members 506 shaped as rings interconnecting outer layer 502 and inner layer 504. In some embodiments, workspace device 500 further comprises a distal base 508 connected to wall 501 and a channel, e.g., a cylindrical channel 510, connected to wall 501 or at least one of outer layer 502 and inner layer 504. In some embodiments, the cylindrical channel is an extension of outer layer 502 or inner layer 504.
[0186] According to some exemplary embodiments, the ring-shaped radial stiffening member divides the lumen between the inner and outer layers into expandable segments, e.g., circumferentially expandable segments. In some embodiments, in the expanded state, e.g., when the wall 501 is inflated and expanded, the inner layer 504 and the outer layer are smooth. In some embodiments, in the expanded state, adjacent circumferentially expandable segments press against each other, e.g., press against each other axially along the vertical axis of the workspace device. In some embodiments, in the expanded state, adjacent circumferentially expandable segments press against the ring-shaped radial stiffening member disposed therebetween.
[0187] According to some exemplary embodiments, the ring-shaped radial stiffening member is made from polyurethane. In some embodiments, the ring-shaped radial stiffening member is solid and divides the walls of the workspace device into fluid-tight circumferentially expandable segments, as shown, for example, in FIG. 5C. Alternatively, the ring-shaped radial stiffening member is perforated and includes at least one opening, e.g., opening 512, configured to allow fluid flow between adjacent expandable segments, as shown, for example, in FIG. 5D.
[0188] Exemplary Workspace Device with Inner Folded Layer and Ribs According to some exemplary embodiments, a workspace device comprises a wall, e.g., an expandable wall, formed from an inner layer and an outer layer having similar perimeters. In some embodiments, in the expanded state, the outer layer is smooth and the inner layer is folded, e.g., into a wave-like pattern. Reference is now made to Figures 6A-6C, which depict a workspace device having a wall with a smooth outer surface and a folded inner surface connected by radial stiffening members, according to some exemplary embodiments of the present invention.
[0189] According to some exemplary embodiments, a workspace device, e.g., workspace device 612, comprises an expandable wall 602 that, in an expanded state, defines a lumen 603 of workspace space device 612. In some embodiments, wall 602 comprises an outer layer 604 and an inner layer 606 with a plurality of radial stiffening members, e.g., ribs 608 and 610, disposed therebetween. In some embodiments, ribs, e.g., ribs 608 and 610, interconnect inner layer 606 of sheet material with outer layer 604 of sheet material.
[0190] According to some exemplary embodiments, radial stiffening members, such as ribs 608 and 610, define a plurality of expandable segments, such as expandable segments 609 and 611. In some embodiments, in the expanded state, the inner surfaces of at least some of the expandable segments are curved and the outer surfaces of the expandable segments are smooth. In some embodiments, in the expanded state, the formed expandable segments are vertical segments that surround lumen 603.
[0191] According to some exemplary embodiments, in the expanded state, the expandable segment is connected to a distal base and a proximal channel, such as cylindrical channel 614 .
[0192] According to some exemplary embodiments, the wall is formed from two sheets of material that have similar lengths, for example, when the sheets are unfolded, as shown in Figure 6D. In some embodiments, the sheets are connected by spaced apart ribs 608 and 610. Optionally, the sheets that form the inner layer of the wall are pre-shaped, for example, shaped to obtain a curved or wavy pattern, before connecting the ribs.
[0193] According to some exemplary embodiments, the ribs are smaller than the maximum height of the walls, for example, as shown in FIG. 6C, thereby allowing fluid flow between the expandable segments.
[0194] Exemplary Flattened Workspace Device According to some exemplary embodiments, the workspace device has a flat, e.g., non-circular, shape. Reference is now made to Figures 7A-7D, which depict a workspace device having a flat shape, according to some exemplary embodiments of the present invention.
[0195] According to some exemplary embodiments, as shown, for example, in Figure 7A, at least two layers of sheet material, e.g., layer 704 and layer 706, are interconnected by a plurality of ribs, e.g., ribs 708 and 710. In some embodiments, in the unfolded state, as shown, for example, in Figure 7A, the sheet forming the inner layer of the wall, e.g., sheet 704, has a length that is greater than the length of the sheet forming the outer layer of the wall, e.g., sheet 706.
[0196] According to some exemplary embodiments, during fabrication of the wall, sheet 704 is connected to sheet 706, e.g., along the edges of sheet 706, to form, e.g., a closed expandable wall. In some embodiments, the formed expandable wall is bent, e.g., into a U-shape, to form expandable base 712 and side walls 711 and 713 of workspace device 702, as shown, e.g., in FIG. 7B . In some embodiments, the ends of side walls 711 and 713 are optionally connected, e.g., welded together, to form an enclosed planar body of the workspace device by connecting the rim / edge of wall 704 to adjacent rims of wall 704 and the rim of wall 706 to adjacent rims of wall 706, respectively, to allow fluid passage circumferentially to form channels and openings into the lumen of the workspace device.
[0197] According to some exemplary embodiments, wall 713 comprises a plurality of expandable segments that can be inflated, for example, to expand. In some embodiments, the multiple expandable segments are fluidly connected to one another, for example, to form a single expandable chamber. In some embodiments, the expandable segments are vertically expandable segments aligned along a vertical axis of the workspace device, as shown, for example, in FIG. 7D .
[0198] According to some exemplary embodiments, as shown, for example, in FIG. 7C , the formed wall 713 includes one or more weakened regions created along a desired bend line 715 surrounding the base 712 to, for example, facilitate bending of the wall at bend line 715. In some embodiments, the weakened regions are created by welding the wall at specific locations along bend line 715. In some embodiments, the bend line facilitates bending of the wall 713 at the base 712, for example.
[0199] Exemplary workspace device having walls with inner and outer radial stiffening members Reference is now made to Figures 8A and 8B, which depict a workspace device having a wall with a circumferential ring, according to some exemplary embodiments of the present invention.
[0200] According to some exemplary embodiments, the body of workspace device 802 comprises wall 804 formed from a plurality of ring-shaped expandable segments, e.g., interconnected segments 806 and 808. In some embodiments, each of the ring-shaped expandable segments is preformed by two ring-shaped layers of sheet material, e.g., layers 805 and 807, connected to each other along the inner periphery of the layers by at least one radial stiffening member, e.g., inner radial stiffening member 809. Additionally, layers 805 and 807 are connected to each other along the outer periphery of the layers by at least one additional radial stiffening member, e.g., outer radial stiffening member 811.
[0201] According to some exemplary embodiments, wall 804 is preformed by connecting ring-shaped expandable segments together, for example, by welding or adhesive bonding. In some embodiments, adjacent expandable segments are connected to each other along a large surface area of each layer. In some embodiments, the length 820 of the connection, e.g., interface between adjacent expandable segments, is similar to the height 822 of the expandable segments, as shown, for example, in FIG. 8C . Alternatively, the length 824 of the interface between adjacent expandable segments is greater than the height 826 of the expandable segments, as shown, for example, in FIG. 8D . A potential advantage of having an interface length greater than the height of the expandable segments may be increased radial stiffness of the expandable segments and / or wall.
[0202] According to some exemplary embodiments, in the expanded state of workspace device 802, as shown in, for example, Figures 8A and 8B, the expandable segments compress against each other in an axial direction 828, for example, to increase stiffness in a radial direction 830. In some embodiments, workspace device 802 comprises a proximal channel 832, e.g., a cylindrical proximal channel defining a passageway to the lumen of workspace device 802, and a distal base 834. In some embodiments, proximal channel 832 and / or distal base 834 are connected, e.g., welded or glued, to wall 804. Optionally, proximal channel 832 and / or distal base 834 are connected to inner radial stiffening member 809 and / or outer radial stiffening member 811.
[0203] According to some exemplary embodiments, inner radial stiffening member 809 and / or outer radial stiffening member 811 are formed from plates, discs, or rings of material, such as polyurethane.
[0204] Exemplary Workspace Device with Elastic Expandable Segments According to some exemplary embodiments, the workspace device comprises an expandable wall having expandable segments extending outward or inward that, in the expanded state, contact one another, e.g., define a radial stiffening member therebetween.
[0205] Reference is now made to Figures 9A-9C, which depict workspace devices having expandable walls with outwardly extending expandable segments, according to some exemplary embodiments of the present invention.
[0206] According to some exemplary embodiments, a workspace device, e.g., workspace device 902, comprises an expandable wall 904 that, in an expanded state, defines a lumen 905 of workspace space device 902. In some embodiments, the workspace device is configured to be placed in the expanded state within a body cavity, e.g., the abdominal cavity. In some embodiments, in the expanded state, wall 904 comprises an inner layer 906 that forms an inner, smooth surface facing the lumen. Further, in the expanded state, wall 904 comprises a plurality of outwardly extending expandable segments, e.g., segments 908 and 910. In some embodiments, segments 908 and 910 extend outward from a center of lumen 905, as shown, for example, in FIG. 9B .
[0207] According to some exemplary embodiments, the expandable segments, e.g., segments 908 and 910, are vertically expandable segments. In some embodiments, 908 and 910, e.g., vertically expandable segments, surround lumen 905. In some embodiments, in the expanded state, the outwardly extending expandable segments press against each other, e.g., laterally, as shown in, e.g., FIGS. 9B and 9C . In some embodiments, the outwardly extending expandable segments optionally have similar widths or similar diameters. Alternatively, at least some of the outwardly extending expandable segments optionally have different diameters or different widths.
[0208] According to some exemplary embodiments, the wall 904 is formed from at least one smooth inner layer 906 and at least one curved outer layer 912, as shown in FIG. 9B . In some embodiments, the at least one curved outer layer 912 is curved, e.g., by contacting the at least one smooth inner layer 906 at two or more locations along the circumference of the inner layer 906, to form at least one expandable segment. Alternatively, the at least one curved outer layer 912 is preformed to include a curved portion and a smooth portion. In some embodiments, the at least one curved outer layer 912 is attached to the smooth inner layer 906 such that the smooth portion is attached to the smooth inner layer 906 and the curved portion of the curved outer layer extends outward, away from the smooth inner layer 906, to form, e.g., expandable segments 908 and 910.
[0209] According to some exemplary embodiments, in the expanded state, as shown, for example, in FIG. 9C , the walls of two adjacent expandable segments, e.g., expandable segments 908 and 910, contact each other at an interface region 914. In some embodiments, the interface region 914 is spaced apart from the inner layer 906 or from a smooth region of the outer layer 912. Alternatively, the interface region between two adjacent expandable segments contacts the inner layer 906 or the smooth region of the outer layer 912.
[0210] According to some exemplary embodiments, interface region 914 is formed from at least two walls of adjacent expandable segments, each wall being a wall of a different expandable segment, that press together to stiffen, e.g., radially stiffen, interface region 914. In some embodiments, the two walls are fixedly attached to one another, e.g., by welding or adhesive bonding. In some embodiments, the expandable segment, in the expanded state, extends from the smooth inner layer 906 of wall 904 a maximum distance of 30 cm, e.g., a maximum of 25 cm, a maximum of 20 cm, or any distance therebetween, less, or greater.
[0211] According to some exemplary embodiments, each of the expandable segments has a tubular shape with closed ends in the expanded state. In some embodiments, at least some or all of the expandable segments, e.g., expandable segments 908 and 910, are fluidly connected to one another, e.g., to form a single inflatable segment. Alternatively, one or more of the expandable segments are fluidly isolated from other expandable segments of the wall. In some embodiments, in the expanded state, the outwardly extending expandable segments are flexible, e.g., to prevent damage to organs and tissues within the body cavity that contact wall 904.
[0212] Reference is now made to Figures 10A-10C, which depict workspace devices having expandable walls with inwardly extending expandable segments, according to some exemplary embodiments of the present invention.
[0213] According to some exemplary embodiments, a workspace device, e.g., workspace device 1002, comprises an expandable wall 1004 that, in an expanded state, defines a lumen 1005 of workspace space device 1002. In some embodiments, the workspace device is configured to be placed in the expanded state within a body cavity, e.g., the abdominal cavity. In some embodiments, in the expanded state, wall 1004 comprises an outer layer 1006 that forms a smooth outer surface facing the body cavity. Additionally, in the expanded state, wall 1004 comprises a plurality of inwardly extending expandable segments, e.g., segments 1008 and 1010. In some embodiments, segments 1008 and 1010 extend inward toward the center of lumen 1005, as shown, for example, in FIG. 10B .
[0214] According to some exemplary embodiments, the expandable segments, e.g., segments 1008 and 1010, are vertically elongated expandable segments. In some embodiments, 1008 and 1010, e.g., vertically expandable segments, surround lumen 1005. In some embodiments, in the expanded state, the inwardly extending expandable segments press against each other, e.g., laterally, as shown in Figures 10B and 10C.
[0215] According to some exemplary embodiments, the wall 1004 is formed from at least one smooth outer layer 1006 and at least one curved inner layer 1012, as shown in FIG. 10B . In some embodiments, the at least one curved inner layer 1012 is curved, e.g., by contacting the at least one smooth outer layer 1006 at two or more locations along the circumference of the outer layer 1006, to form at least one expandable segment. Alternatively, the at least one curved inner layer 1012 is preformed to include a curved portion and a smooth portion. In some embodiments, the at least one curved inner layer 1012 is attached to the smooth outer layer 1006 such that the smooth portion is attached to the smooth outer layer 1006 and the curved portion of the curved inner layer 1012 extends inward, away from the smooth outer layer 1006, to form, e.g., expandable segments 1008 and 1010.
[0216] According to some exemplary embodiments, in the expanded state, as shown, for example, in FIG. 10C , the walls of two adjacent expandable segments, e.g., expandable segments 1008 and 1010, contact each other at an interface region 1014. In some embodiments, the interface region 1014 is spaced apart from the outer layer 1006 or from a smooth region of the inner layer 1012. Alternatively, the interface region between two adjacent expandable segments contacts the outer layer 1006 or a smooth region of the inner layer 1012.
[0217] According to some exemplary embodiments, the interface region 1014 is formed from at least two walls of adjacent expandable segments, each wall being a wall of a different expandable segment, that press against one another to stiffen, e.g., radially stiffen, the interface region 1014. In some embodiments, the at least two walls are fixedly attached to one another, e.g., by welding or adhesive bonding. In some embodiments, the expandable segment, in the expanded state, extends from the smooth outer layer 1006 of the wall 1004 a maximum distance of 30 cm, e.g., a maximum of 25 cm, a maximum of 20 cm, or some distance therebetween, less than, or greater than the maximum distance.
[0218] According to some exemplary embodiments, each of the expandable segments has a tubular shape with closed ends in the expanded state. In some embodiments, at least some or all of the expandable segments, e.g., expandable segments 1008 and 1010, are fluidly connected to one another, e.g., to form a single inflatable segment. Alternatively, one or more of the expandable segments are fluidly isolated from other expandable segments of the wall. In some embodiments, in the expanded state, the inwardly extending expandable segments are flexible, e.g., to prevent damage to organs and tissues within the lumen that contact wall 1004.
[0219] Reference is now made to FIG. 11, which depicts a wall of a workspace device in a preformed state having a smooth side and a curved opposing side, according to some exemplary embodiments of the present invention.
[0220] According to some exemplary embodiments, a wall of a workspace device, e.g., wall 1102, is formed from at least one smooth layer of sheet material, e.g., layer 1104, and at least one curved layer of sheet material, e.g., curved layer 1106. In some embodiments, in an unfolded state, smooth layer 1104 is planar, e.g., as shown in FIG. 11 . In some embodiments, the curved layer is formed to have a non-planar shape, e.g., a wavy shape, e.g., as shown in FIG. 11 . In some embodiments, curved layer 1106 is at least partially fixedly attached to smooth layer 1104, e.g., by welding or adhesive bonding. In some embodiments, a smooth portion, e.g., portion 1110 of curved layer 1106, is fixedly attached to smooth layer 1104, e.g., a planar layer in an unfolded state.
[0221] According to some exemplary embodiments, each expandable segment is at least partially formed from at least one smooth layer and at least one different curved, e.g., bent, layer, as shown, for example, in Figure 11. In some embodiments, in each expandable segment, the length of the curved layer defining the expandable segment is at least 1.3 times, e.g., at least 1.5 times, at least 2 times, or any value therebetween, less than, or greater than the length of the smooth layer defining the expandable segment.
[0222] Exemplary Workspace Device with Inner Expandable Segment Reference is now made to Figures 12A and 12B, which depict walls of a workspace device having an inner expandable segment, according to some exemplary embodiments of the present invention.
[0223] According to some exemplary embodiments, the workspace device comprises an expandable wall, e.g., wall 1202, which defines a lumen 1204 of the workspace device. In some embodiments, wall 1202 has a smooth outer surface and a plurality of inner expandable segments, e.g., segments 1208 and 1210 within lumen 1204. In some embodiments, the inner expandable segments surround the lumen when wall 1202 expands, e.g., inflates. Optionally, the inner expandable segments are vertical segments.
[0224] According to some exemplary embodiments, wall 1202 is formed from at least one smooth layer of sheet material having a smooth outer surface and an inner surface facing lumen 1204. In some embodiments, the expandable segments are formed from at least one additional curved layer 1212 of sheet material that is curved and / or bent to form multiple expandable segments. In some embodiments, the formed expandable segments are connected to the inner surface of the smooth layer at specific locations. In some embodiments, the expandable segments are connected to smooth layer 1206, for example, by welding or adhesive. Alternatively, the expandable segments are connected to smooth layer 1206 by extensions of the curved layer.
[0225] According to some exemplary embodiments, in the expanded state, the expandable segments, e.g., segments 1208 and 1210, are cylindrical. In some embodiments, in the expanded state, adjacent expandable segments contact each other and optionally press against each other. In some embodiments, wall 1202 comprises additional expandable segments, e.g., segments 1216 and 1218, defined between the inner expandable segment and smooth outer layer 1206. In some embodiments, segments 1216 and 1218 expand when the inner expandable segments, e.g., segments 1208 and 1210, are inflated.
[0226] According to some exemplary embodiments, at least some or all of the inner expandable segments, eg, expandable segments 1208 and 1210, are fluidly connected to one another, eg, to form a single inflatable segment.
[0227] According to some exemplary embodiments, the wall 1203 defining the lumen 1203 is formed by bending a single sheet of flexible material. In some embodiments, the single flexible sheet is bent to form the outer layer 1205, the expandable segments 1207 and 1209, and the inner layer 1211 that faces the lumen. In some embodiments, at least some or all of the expandable segments 1207 and 1209 are fluidly connected to one another, e.g., forming a shared inflatable chamber. In some embodiments, e.g., as shown in FIG. 12B , the expandable segments, e.g., expandable segments 1220 and 1220, are fluidly connected to one another, optionally by openings, e.g., openings 1224, formed in the walls of the expandable segments that contact one another. Alternatively or additionally, the openings, e.g., openings 1224, comprise channels that interconnect two or more of the expandable segments to form the inflatable chamber.
[0228] Exemplary workspace device walls with vertical and horizontal segments Reference is now made to Figures 13A-13C, which depict a workspace device having expandable walls with vertical and horizontal segments, according to some exemplary embodiments of the present invention.
[0229] According to some exemplary embodiments, a workspace device, e.g., workspace device 1302, comprises a body 1302 having an expandable wall 1304 that defines a lumen 1305 having an opening 1306, e.g., when the wall 1304 is expanded. In some embodiments, the body comprises a channel 1308, e.g., a cylindrical channel, connected to the wall 1304, defining a flow path between the opening 1306 and the lumen. Alternatively, the channel 1308 is integral with the wall 1304, e.g., with at least one layer of sheet material forming the wall 1304. In some embodiments, the body comprises a distal base 1310. In some embodiments, the distal base comprises at least one expandable segment, optionally formed from two or more layers of sheet material.
[0230] According to some exemplary embodiments, wall 1304 comprises multiple vertically expandable segments, e.g., segments 1312 and 1314, surrounding lumen 1305. In some embodiments, in the expanded state, adjacent vertically expandable segments contact one another. Optionally, the walls of adjacent vertically expandable segments are fixedly attached to one another, e.g., by welding or adhesive. Alternatively, in the expanded state, at least some or all of the vertically expandable segments are spaced apart from adjacent segments, e.g., segments 1312 and 1314, as shown, for example, in FIG. 13C . In some embodiments, adjacent segments are connected by a smooth wall portion 1316, e.g., a flat wall portion. In some embodiments, the smooth wall portion is formed from at least two layers forming the expandable segment. Alternatively, the smooth wall portion is formed from a single layer. In some embodiments, in the expanded state, smooth wall portion 1316 is stretched, e.g., stretched laterally between adjacent vertically expandable segments 1312 and 1314.
[0231] According to some exemplary embodiments, the vertically expandable segments are shaped as elongated cylinders, optionally closed at both ends. In some embodiments, at least some of the vertically expandable segments are fluidly connected to one another, for example, to form a single inflatable chamber. Alternatively, each or at least some of the vertically expandable segments are fluidly isolated from the other vertically expandable segments.
[0232] According to some exemplary embodiments, the body of the workspace device comprises at least one distal horizontal expandable segment 1318. In some embodiments, the distal horizontal segment 1318 comprises a base 1310. In some embodiments, in the expanded state, the at least one distal horizontal segment is shaped as a ring. In some embodiments, the base 1310 is fixedly connected to the distal horizontal segment 1318, for example, by welding or gluing. In some embodiments, the at least one distal horizontal segment is connected, for example, fixedly connected, to the wall 1304.
[0233] According to some exemplary embodiments, the body of the workspace device comprises at least one proximal horizontal expandable segment 1320. In some embodiments, in the expanded state, the at least one proximal horizontal segment is shaped as a ring. In some embodiments, the at least one proximal horizontal segment 1320 is connected, e.g., fixedly connected, to the wall 1304.
[0234] According to some exemplary embodiments, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 extend radially relative to the wall 1304. Optionally, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 are connected to vertically expandable segments, such as segments 1312 and 1314. In some embodiments, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 are perpendicular to the vertical segments.
[0235] According to some exemplary embodiments, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 are expandable segments. In some embodiments, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 are fluidly connected to the wall 1304, e.g., one or more of the vertical expandable segments of the wall. In some embodiments, at least one distal horizontal segment 1318 and / or at least one proximal segment 1320 are formed from at least two layers of sheet material welded together. In some embodiments, in the preformed, unfolded state, each of the at least two layers is shaped as a ring. In some embodiments, in the preformed, unfolded state, the inner diameter of one of the ring-shaped layers forming the horizontal segment has a larger inner diameter than the inner diameter of the second ring-shaped layer of the horizontal segment. Alternatively, in the preformed, unfolded state, each of the ring-shaped layers has the same inner diameter.
[0236] According to some exemplary embodiments, the body is formed from two layers of sheet material, each layer comprising a wall layer, i.e., a distal horizontal ring layer and a proximal horizontal ring layer, as shown in FIG. 13D . In some embodiments, in a preformed, unfolded state, a first body layer 1350 comprises a wall sheet material layer 1352, and two ring-like layers 1354 and 1356 are connected to either side of layer 1352. In some embodiments, two body layers, e.g., identical body layers, are attached to each other, e.g., fixedly attached to each other, to form the body of the workspace device. In some embodiments, the two body layers are fixedly attached to each other by welding or adhesive bonding.
[0237] Exemplary Ports Reference is now made to FIG. 14A, which depicts a port configured to define a flow path between a body lumen and an exterior skin surface, according to some exemplary embodiments of the present invention.
[0238] According to some exemplary embodiments, a port, e.g., port 1402, comprises an internal channel having at least two openings and is configured to be placed within a body opening, e.g., an anatomical body opening or a surgical body opening formed by an incision in a body wall. In some embodiments, port 1402 is configured to bridge a channel through body wall 1404 between body lumen 1408 and the outer surface of the skin.
[0239] According to some exemplary embodiments, as shown in, for example, FIG. 14B , the port 1412 comprises an outer cylinder 1414 and an inner cylinder 1420 slidable within the lumen of the outer cylinder 1414. In some embodiments, the outer cylinder 1414 comprises a proximal rim 1416 configured to be placed in contact with the outer surface of the skin and a folded body 1418. In some embodiments, the outer cylinder 1414, e.g., the folded body 1418, is flexible. In some embodiments, the folded body is formed from at least one flexible sheet. In some embodiments, the folded body 1418 comprises a groove having an opening facing the rim 1416.
[0240] According to some exemplary embodiments, inner cylinder 1420 comprises a proximal rim 1422 and a cylindrical body 1424. In some embodiments, inner cylinder 1420, e.g., cylindrical body 1424, is rigid. In some embodiments, the wall of the cylindrical body is shaped and sized to be inserted into a groove in the collapsed body. In some embodiments, the width of the wall of the cylindrical body is thinner than the width of the groove.
[0241] According to some exemplary embodiments, the optionally flexible outer cylinder 1414 is inserted through the body opening 1404 while the body 1418 is folded. In some embodiments, the inner cylinder 1420 then slides within a groove in the folded body through the body opening and into the body cavity 1408. In some embodiments, sliding the optionally rigid inner cylinder 1420 into the body cavity 1408 unfolds the folded body of the outer cylinder 1414. In some embodiments, the inner cylinder 1420 slides within the outer cylinder 1414 until the rim 1422 contacts the rim 1416. In some embodiments, once the inner cylinder 1420 is positioned within the outer cylinder 1414, the walls of the optionally rigid cylindrical body 1424 maintain the optionally flexible body 1418 in the unfolded state.
[0242] According to some exemplary embodiments, a port assembly, e.g., port 1402, includes at least one foldable outer portion and at least one inner portion slidable within the outer portion, as shown in, for example, FIG. 14B . In some embodiments, the at least one foldable outer portion is optionally cylindrical in a folded state. In some embodiments, the at least one foldable outer portion at least partially folds when inserted through a body orifice. Optionally, the at least one outer portion is optionally flexible. In some embodiments, the inner portion is optionally rigid. In some embodiments, sliding the at least one inner portion unfolds the at least one foldable outer portion within the body. Furthermore, the at least one inner portion secures the at least one foldable portion, e.g., within the body orifice. In some embodiments, the at least one inner portion is optionally shaped as a cylinder.
[0243] A potential advantage of having a port with a flexible outer cylinder may be to prevent damage to the body opening 1404 as the outer cylinder passes through the body opening and contacts the body wall 1406.
[0244] A potential advantage of having a port with a rigid inner cylinder may be to prevent closure of the passageway formed by the outer cylinder into the body cavity 1408. A further potential advantage of a rigid inner cylinder may be to prevent damage to the body wall 1408 when one or more surgical instruments are inserted into the body cavity through the inner cylinder.
[0245] Reference is now made to Figures 15A-15D, which depict a port having an intrabody cavity expandable anchor, according to some exemplary embodiments of the present invention.
[0246] According to some exemplary embodiments, the port assembly comprises an outer portion 1502 and an inner portion 1510 shaped and sized to fit within the outer portion 1502. In some embodiments, the outer portion 1502 comprises a body 1506 defining an internal lumen, a proximal annulus 1504 shaped and sized to be disposed outside the body, and a distal expandable anchor 1508, e.g., an inner expandable bolster. In some embodiments, the body 1506 is optionally cylindrical. In some embodiments, the body 1508 comprises a proximal opening and a distal opening. In some embodiments, the distal expandable anchor is configured to transition between closed states, e.g., upon entry into a body cavity through a body opening, as shown in FIGS. 15A and 15B . In some embodiments, in the closed state, the distal expandable anchor has a conical shape, optionally with a tapered end 1507. In some embodiments, in the closed state, the distal expandable anchor at least partially occludes the distal opening of the body 1506.
[0247] According to some exemplary embodiments, inner portion 1510 comprises a body 1512 insertable into a lumen of outer portion 1502. In some embodiments, inner portion 1510 is positioned outside the body and optionally comprises a proximal annulus shaped and sized to contact the proximal annulus of outer portion 1502. In some embodiments, inner portion body 1512 has a cylindrical shape and defines a lumen 1509.
[0248] According to some exemplary embodiments, sliding or inserting the inner portion body 1506 into the outer portion body 1506 expands the distal expandable anchor 1508, as shown in Figures 15C and 15D for example. In some embodiments, upon expansion, the anchor 1508 moves to an open state in which the anchor 1508 is positioned to contact the surface of the body cavity or the inner surface of the body wall, e.g., to prevent undesired dislodgement of the port. In some embodiments, expansion of the anchor 1508 opens the distal opening of the body 1506, e.g., to form a channel between the outer surface of the skin and the body cavity. In some embodiments, when the port is at least partially introduced into the workspace device, the port defines a channel between the outer surface of the skin and the inner lumen of the workspace device.
[0249] According to some exemplary embodiments, the expandable inner anchor comprises one or more movable protrusions, e.g., protrusions 1514, 1516, and 158, configured to move when the inner portion body 1510 is inserted or slid into the outer portion body 1506. In some embodiments, one or more outer portion bodies and / or the inner portion body 1506 have a cylindrical shape. In some embodiments, the outer portion 1502 of the port, e.g., body 1506, and / or the anchors are at least partially flexible or resilient when contacting the subject's body tissue, e.g., to prevent damage to at least one of the body cavity, body wall, and body opening. In some embodiments, the inner portion 1510 of the port, e.g., body 1512, is rigid, e.g., to ensure deployment of the anchor 1508 and / or to prevent contact or pressure between tools, e.g., surgical tools, entering the body cavity or workspace device through the lumen and the subject's body.
[0250] According to some exemplary embodiments, the anchor 1508 is configured to expand, e.g., reversibly expand, when the port inner portion 1510 slides into the outer portion 1502. In some embodiments, the anchor is configured to collapse to a closed state upon removal of the inner portion 1510 from the port outer portion 1502. Optionally, in a resting state, the anchor 1508 is collapsed.
[0251] According to some exemplary embodiments, the movable protrusion moves to an angle 1544 less than 100 degrees relative to the longitudinal distal-proximal axis 1540 of the port 1502, such as less than 95 degrees, less than 90 degrees, less than 80 degrees, or any angle therebetween, less than, or greater than. In some embodiments, the movable protrusion moves to contact the inner surface of the body cavity wall. In some embodiments, the protrusion is locked at the angle 1544 by positioning the inner portion 1510 within the outer portion 1502.
[0252] Reference is now made to Figures 16A-16C, which depict a body opening port formed from two or more overlapping arc-shaped flexible sheets, according to some exemplary embodiments of the present invention.
[0253] According to some exemplary embodiments, the port 1602 is configured to be placed within a body orifice, for example, an anatomical or surgical body orifice. In some embodiments, the port 1602 comprises an optionally elongate body 1602 defining a lumen 1616 having a distal opening and a proximal opening. In some embodiments, the port 1602 comprises an annulus 1604 surrounding the proximal opening, connected to the body 1606, and configured to be placed outside the body. In some embodiments, a smooth, optionally flat, surface of the annulus is configured to be placed in contact with the outer surface of the skin.
[0254] According to some exemplary embodiments, body 1602 comprises two or more sheets, optionally curved as arcs, e.g., in the form of plates 1610, 1612, and 1614, surrounding lumen 1616. In some embodiments, the curved sheets at least partially overlap one another, e.g., to form a closed channel. In some embodiments, the surface area of each curved sheet overlaps the surface area of an adjacent curved sheet by at least 5%, e.g., at least 10%, at least 20%, at least 30%, or any percentage value therebetween, lesser, or greater.
[0255] Exemplary Viewing Port According to some exemplary embodiments, a workspace device, e.g., a laparoscopic workspace device, includes at least one viewing port and / or at least one viewing channel to allow visualization of the lumen of the workspace device by an optical sensor, e.g., a camera. In some embodiments, the optical sensor is connected to an endoscope that can enter the lumen of the workspace device through the viewing channel and / or can be attached to a window in a wall or port of the workspace device.
[0256] Reference is now made to FIG. 17A, which depicts a viewing port of a port configured to be placed within a body orifice, according to some exemplary embodiments of the present invention.
[0257] According to some exemplary embodiments, as shown in FIG. 17A , for example, port 1702 comprises a body 1704, an outer annulus, e.g., an outer bolster 1706 configured to be positioned in contact with the outer surface of the skin, and an inner anchor, e.g., an inner anchor 1708 configured to contact the inner surface of a body cavity. In some embodiments, port 1702 comprises a viewing channel from outer bolster 1706 to inner anchor 1708. In some embodiments, the viewing channel comprises a viewing port 1710 at inner anchor 1708. In some embodiments, the viewing channel and viewing port 1710 are configured to receive an endoscope 1712 connected to an optical sensor. In some embodiments, viewing port 1710 comprises an opening shaped and sized to allow endoscope 1712 to pass through the viewing channel and into the lumen of the body cavity or workspace device. Alternatively, the viewing port comprises a transparent window into which the distal end of endoscope 1712 is positioned. In some embodiments, the transparent viewing port is shaped and positioned to allow a view into the body cavity and / or the lumen of the workspace device.
[0258] Reference is now made to FIG. 17B, which depicts a workspace device with a side viewing port in a wall of the workspace device, according to some exemplary embodiments of the present invention.
[0259] According to some exemplary embodiments, workspace device 1720 comprises a body including a wall 1722, e.g., an expandable wall, that defines a lumen, and a sleeve 1723 connected to wall 1722 and defining a channel between the lumen and proximal opening 1724. In some embodiments, sleeve 1723 defines a channel between the outer surface of the skin and the lumen of workspace device 1720 when the wall is expanded within the body cavity.
[0260] According to some exemplary embodiments, wall 1722 includes an opening 1726, e.g., a side opening. In some embodiments, opening 1726 is shaped and sized to receive a visualization device, e.g., a laparoscope. In some embodiments, opening 1726 is the opening of a visualization channel that traverses wall 1722 and enters the lumen. Optionally, opening 1726 allows for entry of a visualization device into the lumen of the workspace device. In some embodiments, the channel extends at least 1 cm, e.g., at least 2 cm, e.g., at least 3 cm, at least 6 cm, into the lumen of the workspace device. In some embodiments, the end of the visualization channel within the lumen is closed, e.g., to prevent passage of material from the lumen through the visualization channel. In some embodiments, at least a portion of the visualization channel is optionally transparent. In some embodiments, the minimum diameter of the visualization channel is at least 3 mm, e.g., at least 4 mm, at least 5 mm, at least 7 mm, at least 9 mm, or any value therebetween, smaller, or larger.
[0261] In some embodiments, the workspace device comprises two or more openings, e.g., side openings in the wall. Optionally, at least a portion of the wall or an inner layer of the wall is transparent, e.g., allowing visualization of the lumen of the workspace device through opening 1726.
[0262] According to some exemplary embodiments, wall openings, such as opening 1726, are disposed between the radial stiffening members.
[0263] Reference is now made to FIG. 17C, which depicts a workspace device with one or more visualization channels, according to some exemplary embodiments of the present invention.
[0264] According to some exemplary embodiments, workspace device 1740 comprises a wall 1742, e.g., an expandable wall, that defines a lumen 1741, and a base 1745. Additionally, workspace device 1740 comprises a sleeve 1746 that defines a channel, e.g., a cylindrical channel connected to lumen 1741. Optionally, the channel is used to position an organ or tissue within lumen 1741. Alternatively or additionally, the channel is a tool channel that is shaped and sized to receive at least one tool within lumen 1741.
[0265] According to some exemplary embodiments, workspace device 1740 comprises at least one visualization channel, e.g., visualization channel 1744, that at least partially traverses wall 1742. In some embodiments, visualization channel enters lumen 1741 through wall 1742. Optionally, visualization channel 1744 terminates within lumen 1741. Alternatively or additionally, workspace device 1740 comprises at least one visualization channel, e.g., visualization channel 1748, that extends through sleeve 1746. In some embodiments, at least one of visualization channels 1748 and 1744 is shaped and sized to receive a visualization tool, e.g., an endoscope or endoscope tip. In some embodiments, visualization channels 1748 and 1744 are configured to allow visualization of lumen 1741 from a body cavity in which the workspace device, e.g., workspace device 1740, is deployed.
[0266] Exemplary Port with Expandable End According to some exemplary embodiments, the port is shaped and sized to enter a body cavity through an incision in the body wall, for example, to create a fluid path between the outer surface of the body wall and the body cavity. In some embodiments, during insertion of the port through the body wall, at least a portion of the port, e.g., the distal end of the port, folds over to form a narrow entry end of the port. In some embodiments, once the distal end of the port enters the body cavity, the distal end expands to secure the port within the body cavity. Reference is now made to Figures 17D-17I, which depict body ports having expandable distal ends, according to some exemplary embodiments of the present invention.
[0267] According to some exemplary embodiments, the port 1701 comprises a tubular body 1703 having a distal end 1705 configured to enter a body cavity and a proximal end 1707 shaped and sized to be disposed outside the body. In some embodiments, the tubular body 1703 defines a lumen 1709 having at least one distal opening at the distal end 1705 and at least one proximal opening at the proximal end 1707.
[0268] According to some exemplary embodiments, the port 1701 includes an external bolster 1711 shaped and sized to secure the proximal end 1707 of the port body 1703 to the outside of the subject's body. Optionally, the external bolster 1711 secures the port to the outer surface of the body. In some embodiments, the minimum width of the external bolster is greater than the maximum width of the incision made in the subject's body wall and / or the maximum width of the port tubular body 1703. In some embodiments, the width 1713 of the external bolster 1711 is in the range of 5 cm to 20 cm, e.g., 5 to 15 cm, 10 to 20 cm, or any range of values therebetween, smaller, or larger. In some embodiments, the surface of the external bolster 1711 is configured to contact the skin of the outer surface of the body. In some embodiments, the skin-contacting surface of the external bolster 1711 is flat, e.g., to prevent damage to the skin when the external bolster 1711 contacts the skin surface.
[0269] According to some exemplary embodiments, the external bolster 1711 is shaped as a rim. In some embodiments, the external bolster comprises a circular or semicircular plate that surrounds the proximal opening of the tubular body. In some embodiments, the external bolster 1711 is coupled or integral with the port body 1703 at the proximal end 1707 of the port body 1703.
[0270] According to some exemplary embodiments, the port 1701 comprises an internal bolster 1713 shaped and sized to secure the distal end 1705 of the port body 1703 within the subject's body cavity. In some embodiments, the internal bolster 1715 is coupled to or integral with the port body 1703 at the distal end 1707 of the port body 1703 or at the portion of the body 1703 that is located within the subject's body cavity.
[0271] According to some exemplary embodiments, the internal bolster 1715 is an expandable bolster configured to move between a collapsed state, as shown, for example, in FIGS. 17F-17H, and an expanded state, as shown, for example, in FIGS. 17D and 17E. In some embodiments, the internal bolster 1715 is expanded in a relaxed state. Optionally, at least a portion of the internal bolster is configured to move between the collapsed state and the expanded state. In some embodiments, the internal bolster 1715, or at least one expandable portion of the internal bolster 1715, is elastic. Optionally, the internal bolster 1715, or at least one expandable portion of the internal bolster 1715, is made from a flexible and / or elastic material.
[0272] According to some exemplary embodiments, internal bolster 1715 comprises at least two wings, e.g., wings 1717 and 1719. In some embodiments, the wings are distributed around the circumference of port body 1703 at distal end 1705. In some embodiments, the wings are configured to move between a collapsed state and an expanded state. In some embodiments, the wings are resilient and expand in a relaxed state.
[0273] According to some exemplary embodiments, in the folded state, as shown in, for example, FIG. 17F , the wings 1717 and 1719 face each other and are generally axially aligned along the longitudinal axis 1721 of the port 1701. In some embodiments, in the expanded, and optionally relaxed, state, the wings 1717 and 1719 extend laterally from the port body 1703.
[0274] In some embodiments, at least two wings 1717 and 1719 are located on opposite sides of port body 1703. In some embodiments, the port body includes at least two slot cuts, e.g., slot cut 1723, on opposite sides of distal end 1705 of the tubular body, with each slot cut located between wing 1717 and wing 1719. In some embodiments, the slot cuts define a bending axis 1725 passing through the center of each slot cut, which facilitates bending distal end 1705 and positioning the internal bolster in a folded state so that two wings 1717 and 1719 face each other, as shown, for example, in FIG.
[0275] According to some exemplary embodiments, in the collapsed state, the cross section of the distal end 1705 is narrower than the cross section of the proximal end 1707, allowing the distal end 1705 to easily enter a body cavity through an incision in a body wall. Optionally, with the internal bolster collapsed, the port body 1703 forms a converging structure at the distal end, optionally a conical structure, as shown, for example, in Figures 17G and 17H.
[0276] According to some exemplary embodiments, port body 1703 includes at least two side openings, such as openings 1727 and 1729 shown in FIG. 17E , located in the port body wall proximal to distal end 1705. Optionally, each side opening is disposed between one of at least two fingers 1717 and 1719 and proximal end 1707. In some embodiments, each side opening is shaped and sized to receive an end of a clamping member, such as the end of a scissor clamping member, introduced through the side opening via lumen 1709. Optionally, each of openings 1727 and 1729 is shaped as a slot.
[0277] According to some exemplary embodiments, as shown in, for example, Figures 17G and 17H, each elongate member, e.g., members 1727 and 1729 of clamp 1731, is pushed through a side opening, e.g., side opening 1729, and through the lumen of port 1701 to collapse wings 1717 and 1719. In some embodiments, clamp 1731, e.g., a scissors clamp, is used to introduce body port 1701 through body opening 1733 and into body cavity 1735 or the lumen of laparoscopic workspace device 1737, as shown in, for example, Figure 17I.
[0278] According to some exemplary embodiments, as shown in, for example, FIG. 17D , external bolster 1711 includes one or more openings, or at least two openings, e.g., openings 1757 and 1759, shaped and sized to receive two different fingers for holding and operating port 17-1 with one hand. In some embodiments, openings 1757 and 1759 traverse external bolster 1711. Alternatively or additionally, openings, e.g., openings 1757 and 1759, can reduce the contact area between the external bolster and the skin, for example.
[0279] According to some exemplary embodiments, the overall length of tubular body 1703 is within a range of 20 mm to 80 mm, e.g., 20 mm to 50 mm, 30 mm to 70 mm, 40 mm to 80 mm, or any range of values therebetween, smaller, or larger. In some embodiments, the inner diameter of tubular body is within a range of 20 mm to 80 mm, e.g., 20 mm to 50 mm, 30 mm to 70 mm, 40 mm to 80 mm, or any range of values therebetween, smaller, or larger.
[0280] Exemplary Cutting Guide According to some exemplary embodiments, during surgery, e.g., laparoscopic surgery, a surgeon makes an incision in the skin through the body wall to form a body opening that allows access to a subject's body cavity, e.g., the abdominal cavity. In some embodiments, the incision is made to allow for the introduction of a surgical tool, e.g., a laparoscopic tissue containment device, into the body cavity through the formed body opening. In some embodiments, the length of the incision is determined according to the maximum diameter of a port, e.g., the body of the port, to be placed within the body opening formed by the incision. Reference is now made to FIGS. 17J-17M, which depict a port having a cutting guide, according to some exemplary embodiments of the present invention.
[0281] According to some exemplary embodiments, port 1701 includes a cutting guide, such as cutting guide 1751, as also shown in FIGS. 17D-17I. In some embodiments, the cutting guide length provides an indication of the length of the incision that needs to be made to introduce a particular port through the body wall. Optionally, the cutting guide provides an indication of the length of the incision. In some embodiments, the cutting guide is used to guide the cutting edge of a blade, such as a scalpel, along the desired shape and / or length of the cut through the body wall. In some embodiments, the port includes a cutting guide shaped and / or sized according to the shape and / or size of the incision that needs to be made in the body wall to introduce a particular port.
[0282] According to some exemplary embodiments, the cutting guide of the port comprises a slot having the size and / or shape of a desired incision, e.g., a surgical incision, that needs to be made in the body wall. Optionally, the slot is placed at a selected cutting location on the skin, and a blade moves within the slot according to the length and / or curvature of the slot to make the desired incision in the body wall.
[0283] Alternatively, in some embodiments, the cutting guide is an edge of the port body or an edge of an internal or external bolster that has a length or contour that matches the desired incision length or shape. In some embodiments, for example, as shown in Figures 17J-17M, the cutting guide 1751 of the port 1701 is a linear, straight edge of the external bolster 1711 that has a length that matches the length of the desired incision in the body wall. In some embodiments, for example, as shown in Figures 17L and 17M, the length 1753 of the cutting guide 1751 is similar to the outer diameter 1755 of the port body 1703.
[0284] Exemplary Workspace Device with Tool Insertion Channel According to some exemplary embodiments, the tool insertion channel of the workspace device is connected to a side opening in a wall of the workspace device, hi some embodiments, the tool insertion channel bridges between the outer surface of the skin and an internal cavity defined by the wall.
[0285] According to some exemplary embodiments, the wall of the workspace device comprises at least one side opening, e.g., two, three, four, or any greater number of side openings, connected to a channel bridging the passage between the outer surface of the skin and the inner lumen of the workspace device.
[0286] Reference is now made to Figures 18A-18D, which depict workspace devices with side openings, eg, for tool insertion, according to some exemplary embodiments of the present invention.
[0287] According to some exemplary embodiments, a workspace device, e.g., workspace device 1802, comprises an expandable wall 1804. In some embodiments, the expandable wall comprises one or more, e.g., two, three, four, or any greater number of, expandable segments. In some embodiments, the expandable wall and / or one or more of the expandable segments, e.g., expandable segments 1808 and 1809, are configured to expand upon inflation. In some embodiments, the expandable wall 1804, when expanded, defines a lumen 1806. In some embodiments, the expandable wall 1804 comprises a plurality of radial stiffening members disposed or formed near and / or within the expandable segments. Alternatively or additionally, the radial stiffening members are disposed between adjacent expandable segments, e.g., between expandable segments 1808 and 1809. Optionally, the radial stiffening members are integral and define at least a portion of the expandable segments. In some embodiments, expandable segments, such as expandable segments 1808 and 1809, are expandable segments that extend inwardly facing lumen 1806.
[0288] According to some exemplary embodiments, device 1802, including wall 1804, is configured to expand to an expanded state within a body cavity. In some embodiments, the expansion of wall 1804, e.g., lateral expansion of the device, defines a workspace axis, e.g., workspace axis 1840. In some embodiments, workspace axis 1840 is disposed at an angle 1842 of at least 2 degrees, e.g., at least 20 degrees, at least 45 degrees, at least 80 degrees, or any value therebetween, less than, or greater than, relative to a proximal-distal axis 1844 between the body opening and lumen 1806 of device 1802. In some embodiments, angle 1842 is in the range of 2 degrees to 180 degrees, e.g., 10 degrees to 30 degrees, 30 degrees to 50 degrees, 45 degrees to 80 degrees, 45 degrees to 100 degrees, or any value therebetween, less than, or greater than, the range.
[0289] According to some exemplary embodiments, channel 1810, e.g., a tool insertion channel, is connected to a side opening in wall 1804. In some embodiments, a proximal portion of the channel including opening 1812, e.g., a proximal portion near the body wall, is configured to pass through a body opening, positioning channel opening 1812 outside the subject's body. In some embodiments, channel 1810 is formed from a flexible, optionally resilient, sleeve. In some embodiments, the sleeve is foldable, e.g., to allow passage of the sleeve through a narrow body opening.
[0290] According to some exemplary embodiments, when workspace device 1802 is deployed within body cavity 1820, the expandable wall expands to form lumen 1806, as shown in, for example, FIGS. 18C and 18D . In some embodiments, wall 1804 comprises a single opening, e.g., a single side opening connected to channel 1810. In some embodiments, channel 1810 defines a passageway between the outer surface of skin 1824 and body cavity 1820. In some embodiments, the defined passageway allows, for example, for insertion of a surgical tool 1822, e.g., a manual or powered morcellator, into body cavity 1820.
[0291] Exemplary Wall Formation According to some exemplary embodiments, the walls of the workspace device are formed, for example, by attaching at least two layers of sheet material to one another, for example, by welding. In some embodiments, the at least two layers are spaced apart by a plurality of spacers, for example, ribs. In some embodiments, the ribs are attached, for example, welded, to the at least two layers, for example, to define a plurality of expandable segments between the at least two layers.
[0292] 19A and 19B are now shown, depicting a rib aligner, according to some example embodiments of the present invention.
[0293] According to some exemplary embodiments, the rib aligner, e.g., electrode array 1902, includes a plurality of spaced-apart spacers, e.g., spacers 1906 and 1908. In some embodiments, the spacers are configured to reversibly hold a series of ribs, e.g., radial stiffening members, at a predetermined distance from one another. In some embodiments, the distance between adjacent spacers is fixed. Alternatively, the distance between at least some adjacent spacers is variable. In some embodiments, the spacers are electrodes used during welding, e.g., RF welding. Alternatively, the spacers are used to position the ribs during the bonding process.
[0294] Reference is now made to Figures 20A-20C, which depict a welding assembly for attaching at least two layers of sheet material to two opposing ends of a rib, according to some exemplary embodiments of the present invention.
[0295] According to some exemplary embodiments, a welding assembly, e.g., welding assembly 2002, includes an electrode array 1902, and at least some of the spacers of rib aligner 1902 are reversibly attached to the ribs. In some embodiments, a single spacer is attached to a single rib. Optionally, a single spacer is attached to two ribs, each on an opposite side of the spacer.
[0296] Additionally, at least one layer of sheet material, e.g., layers 2004 and 2006, is disposed on either side of rib aligner 1902. In some embodiments, layers 2004 and 2006 are both flat. In some embodiments, layers 2004 and 2006 have similar lengths. In some embodiments, assembly 2002 comprises a first outer plate 2008 and a second outer plate 2010, e.g., rigid plates. In some embodiments, each of the first outer plate and second outer plate is disposed to face a surface of the sheet material on either side of rib aligner 1902.
[0297] According to some demonstrative embodiments, each of the first and second outer plates presses a layer of sheet material against the rib aligner 1902, e.g., against a rib reversibly secured to a spacer of the rib aligner 1902. In some embodiments, during the welding process, an electric field is supplied through an electrode of the rib aligner to weld the rib held by the rib aligner to the layer of sheet material pressed against the rib. In some embodiments, the electric field is supplied through the electrode of the rib aligner 1902 and at least one electrode attached to each of the first outer plate, e.g., first welding plate 2008, and the second outer plate, e.g., second welding plate 2010.
[0298] According to some exemplary embodiments, each of the welding plates 2008 and 2010 presses a layer of sheet material against the electrode array 1902 during welding. In some embodiments, each layer of sheet material, e.g., layers 2004 and 2006, is separately welded to a rib of the electrode array 1902, e.g., by applying an electric field through the electrode array and one of the welding plates 2008 and 2010. Alternatively, the two layers 2004 and 2006 are simultaneously welded to a rib in the rib aligner by simultaneously applying an electric field through both the welding plates 2008 and 2010, e.g., through electrodes attached to the welding plates 2008 and 2010.
[0299] According to some exemplary embodiments, after application of the electric field, as shown, for example, in Figures 20B and 20C, layers 2004 and 2006 are welded to ribs, e.g., ribs 2014 and 2016, of rib aligner 1902, which are reversibly connected to a spacer, e.g., spacer 2012. In some embodiments, each rib is connected, e.g., welded, to both layers of sheet material by, for example, two opposing welds 2016 and 2018. In some embodiments, once the welding is complete, the rib aligner is removed from the welded ribs and layers.
[0300] According to some exemplary embodiments, as shown in, for example, Figure 20D, electrode array 2030 comprises a plurality of electrodes 2032. In some embodiments, each of electrodes 2032 holds and fixes the position of a different rib, e.g., ribs 2034 and 2036, during the welding process. In some embodiments, each rib is bent at an end of the electrode, e.g., end 2038, to face a different layer during the welding process.
[0301] According to some exemplary embodiments, at least one of the layers of sheet material is pre-formed during welding to the rib, as shown, for example, in FIGS. 21A and 21B . In some embodiments, in an unfolded state, the pre-formed layer has a greater length than the planar layer. Optionally, at least one layer is pre-formed and another layer is planar. In some embodiments, layer 2104 is pre-formed into a wavy or curved shape before welding. In some embodiments, as shown, for example, in FIG. 21B , at least one former, or multiple formers, such as formers 2106 and 2108, are pressed against and held against layer 2104, simultaneously attaching layer 2104 to rib aligner 1902 during the welding process. In some embodiments, the multiple formers are separated from the pre-formed layer once welding is complete.
[0302] Reference is now made to Figures 22A-22D, which depict rotary welding assemblies according to some exemplary embodiments of the present invention.
[0303] According to some demonstrative embodiments, a welding assembly, e.g., welding assembly 2202, comprises a rotatable shaft 2203 and an electrode, e.g., cylindrical electrode 2204, connected to rotatable shaft 2203. In some embodiments, cylindrical electrode 2204 is configured to move simultaneously with, e.g., rotate and turn with, rotatable shaft 2203. In some embodiments, at least one inner cylindrical layer, e.g., layer 2208, of sheet material is attached to a surface of cylindrical electrode 2204. In some embodiments, a first inner surface of inner layer 2208 is attached to cylindrical electrode 2204. In some embodiments, inner layer 2208 is cylindrically formed.
[0304] According to some exemplary embodiments, two or more ribs are disposed about the periphery of the inner layer 2208 and contact the second outer surface of the inner layer 2208. In some embodiments, the two or more ribs are disposed between the first inner layer and the at least one cylindrical outer layer 2212.
[0305] According to some demonstrative embodiments, assembly 2202 includes at least one additional electrode, e.g., electrode 2206, configured to press at least one outer cylindrical layer 2212 against rib 2210 and at least one inner layer 2208. In some embodiments, during welding, an electric field is provided between electrode 2206 and cylindrical electrode 2204, e.g., as electrode 2206 presses at least one outer layer 2212 against rib 2210 and inner cylindrical layer 2208.
[0306] According to some exemplary embodiments, the cylindrical electrode 2204 optionally rotates continuously to place different ribs in front of the electrode 2206. In some embodiments, when the rotation of the cylindrical electrode 2204 stops, the electrode 2206 is pressed against the outer cylindrical layer while supplying an electric field, for example, to weld the ribs to the outer and inner cylindrical layers.
[0307] Reference is now made to Figures 22C and 22D, which depict a circular electrode array, according to some exemplary embodiments of the present invention.
[0308] According to some exemplary embodiments, the circular electrode array 2220 comprises a rim 2222 configured to hold multiple electrodes 2210. In some embodiments, ribs are attached to the electrodes 2210 during the welding process. Optionally, the rim 2222 comprises multiple slots disposed around the circumference of the rim 2222. In some embodiments, each of the slots is shaped and sized to receive a single electrode. In some embodiments, the slots are formed at predetermined distances around the circumference of the rim 2222, for example, according to a desired distance between the ribs.
[0309] According to some exemplary embodiments, as shown in Figure 22D, for example, a circular electrode array 2220 is positioned between an inner cylindrical layer 2208 and an outer cylindrical layer 2212 attached to a cylindrical electrode 2204. In some embodiments, once welding of the two layers to the ribs is complete, the circular rib aligner rim 2222 is removed.
[0310] Exemplary Laparoscopic Workspace Device Introducer According to some exemplary embodiments, laparoscopic workspace devices, such as devices 200, 402, and 420 shown in Figures 2A, 2B, and 4A-4D, are introduced into a body cavity using an introduction device. In some embodiments, the workspace device is introduced into a body cavity, such as the abdominal cavity, through a body opening created during a surgical procedure, such as a laparoscopic procedure, or through a natural opening, such as the birth canal.
[0311] According to some exemplary embodiments, after forming an incision through the skin and body wall, the distal end of the introducer passes through the incision and into the body cavity. In some embodiments, the introducer maintains the workspace device in a collapsed state as it passes through the introducer and into the body cavity. In some embodiments, once the workspace device is within the body cavity, the introducer expands an opening in the workspace device, e.g., to allow insertion of tissue or organs through the opening in the workspace device and into the lumen of the workspace device. In some embodiments, the introducer is operably coupled to a fluid source to control the expansion and / or contraction of the expandable wall of the workspace device.
[0312] Reference is now made to Figures 23A-23C, which depict an introducer of a laparoscopic workspace device, according to some exemplary embodiments of the present invention.
[0313] According to some exemplary embodiments, an introducer, e.g., introducer 2302, comprises an outer tubular body 2304 and an inner member 2306 configured to slide within the outer tubular body 2304. In some embodiments, the outer tubular body 2304 is a cylindrical body. In some embodiments, the outer tubular body 2304 is an elongate body having a distal end 2308 shaped and sized to enter through a body orifice, e.g., into a body cavity, and a proximal end 2310. In some embodiments, entry of the outer tubular body 2304 into the body cavity forms a channel between the body cavity and the outer surface of the skin. In some embodiments, a distal opening 2312 of the channel is located at the distal end 2308, and a proximal opening 2314 of the channel is located at the proximal end 2310. In some embodiments, the lumen of the outer tubular body 2304 defines the channel.
[0314] According to some exemplary embodiments, the introducer 2302 includes a gripping member 2316, e.g., a handle. In some embodiments, the gripping member 2316 is coupled to the outer tubular body 2304, e.g., between the distal end 2310 and the proximal end 2308. In some embodiments, the gripping member 2316 is coupled to the outer tubular body 2304 at the distal end 2310 or at a distance less than 35 cm from the distal end 2310, e.g., less than 30 cm, less than 25 cm, less than 20 cm, or any distance therebetween, less than, or greater than.
[0315] According to some exemplary embodiments, the inner member 2306 comprises an elongate body 2318, optionally a tubular body, having a distal end 2320 and a proximal end 2322. In some embodiments, the inner member comprises an expandable workspace device holder 2324 coupled to the distal end 2320 of the inner member elongate body 2318. In some embodiments, the inner member 2306 comprises at least one stop 2326 at the proximal end 2322 to limit the extension length of the inner member 2306 from the distal opening 2312. Optionally, the at least one stop 2326 is used as or includes a fastener, such as a latch, to secure the proximal end 2322 of the inner member 2306 to the outer tubular body 2304, e.g., the proximal end 2310 of the outer tubular body 2304.
[0316] According to some exemplary embodiments, as shown in Figures 23D and 23E, for example, the holder 2324 comprises at least two elongated elastic members 2328 and 2330. In some embodiments, the at least two elongated elastic members comprise elastic strips, such as elastic metal strips. Alternatively, the at least two elongated elastic members comprise elastic wires and / or elastic cables.
[0317] According to some exemplary embodiments, the distal end of each of the at least two elastic members 2328 and 2330 is coupled to at least one spacer 2332, e.g., a rigid spacer. In some embodiments, the spacer comprises a rigid metal strip, a rigid plastic strip, a rigid wire, or a rigid cable. In some embodiments, the length of the rigid member 2332 is less than the inner width, e.g., inner diameter, of the outer tubular body 2304.
[0318] According to some exemplary embodiments, each elastic member is optionally coupled to at least one spacer 2332 by a bending region, e.g., an elastic region, configured to allow bending of each elastic member, e.g., members 2328 and 2330, relative to at least one spacer 2332. In some embodiments, each elastic region comprises an elastic tube, a contraction, e.g., a plastic contraction. Alternatively, each end of at least one spacer 2332 comprises an elastic region connectable to elastic members of members 2328 and 2330. Optionally, at least one spacer comprises a plastic tube or strip with openings at each end to allow connection to elastic members 2328 and 2330.
[0319] According to some exemplary embodiments, the proximal end of each of the at least two elastic members is coupled to the distal end 2320 of the inner member body 2318 via at least one connector. In some embodiments, elastic member 2328 is coupled to the body 2318 by connector 2334, and elastic member 2330 is coupled to the body 2318 by connector 2336. In some embodiments, the at least two elastic members are coupled to the body 2318 at two spaced-apart connection regions. Optionally, each connector comprises a pin, and the proximal end of each elastic member comprises an opening, a hole, or is curved, e.g., as a hook, disposed around the pin. In some embodiments, each of connectors 2334 and 2336 comprises a hinge that allows rotation of the proximal end of each elastic member relative to the distal end 2320 of the inner member body 2318, e.g., when the holder is expanded.
[0320] According to some exemplary embodiments, as shown in FIG. 23F , for example, the expandable holder 2324 is coupled to the periphery 2340 of the workspace device opening 2342. Optionally, the expandable holder surrounds the workspace device opening 2328. In some embodiments, in the collapsed state, as shown in FIG. 23E , for example, the holder 2324 forms a frame 2346 by keeping the elastic members 2328 and 2330 spaced apart, for example, within a lumen, e.g., an interior channel, of the outer tubular body 2304. In some embodiments, the workspace device coupled to the holder 2324 is disposed within the frame 2346 between the elastic members in the collapsed state. In some embodiments, the frame formation can prevent pressure from the at least two elastic members on the collapsed workspace device, which could damage the workspace device, for example, during storage or delivery into a body cavity.
[0321] According to some exemplary embodiments, at least one spacer 2332 and / or spaced apart connectors are configured to keep the elastic members 2328 and 2330 spaced apart, e.g., a desired distance from each other, when the holder 2324 is collapsed within the outer tubular body 2304.
[0322] According to some exemplary embodiments, as shown in, for example, FIGS. 23D and 23F, when the holder 2324 is in an expanded state, e.g., a relaxed state, the elastic members 2328 and 2330 expand, causing the holder to assume a rim shape and forcing open the workspace device opening 2328, as shown in FIG. 23F.
[0323] As used herein in reference to an amount or value, the term "about" means "within ±10%."
[0324] The terms "comprises," "comprising," "includes," "including," "has," "having," and their cognates mean "including, but not limited to."
[0325] The term "consisting of" means "including and limited to."
[0326] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.
[0327] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include multiple compounds, including mixtures thereof.
[0328] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," etc., as well as individual numerical values within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
[0329] When a range of numerical values is given herein (e.g., "10-15," "10 to 15," or any pair of numerical values connected by these or other such range designations), it is meant to include any numerical value (fractional or integer) within the limits of the stated range, inclusive of the limits of the range, unless the context clearly dictates otherwise. The phrase "range / ranging / ranges between" a first stated numerical value and a second stated numerical value, and the phrase "range / ranging / ranges from" a first stated numerical value "to," "up to," "until," or "through" a second stated numerical value, are used interchangeably herein and are meant to include the first stated numerical value and the second stated numerical value, and all fractional and integer numbers therebetween.
[0330] Unless otherwise indicated, the numerical values used herein and any numerical ranges based thereon are approximations within reasonable measurement precision and rounding errors that one of ordinary skill in the art would understand.
[0331] As used herein, the term "method" refers to methods, means, techniques and procedures for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to practitioners of the chemical, pharmacological, biological, biochemical and medical arts, or those readily developed from known methods, means, techniques and procedures.
[0332] As used herein, the term "treating" includes preventing, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.
[0333] It will be understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as preferred in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiments cannot function without those elements.
[0334] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.
[0335] It is the intention of the applicants (applicants) that all publications, patents, and patent applications referenced herein be incorporated by reference in their entireties to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated by reference in their entireties.
Claims
1. 1. A workspace device having a body that can be folded to a collapsed state to fit through a laparoscopic passageway in a body cavity wall and can be expanded to an expanded state within a body cavity through which the passageway extends, comprising: a workspace body having a workspace wall defining an internal lumen, the workspace wall being formed from at least one inner layer and at least one outer layer of sheet material and having a plurality of vertically expandable segments and one or more stiffening members in the form of ribs disposed within the wall, the ribs interconnecting the at least one inner layer and the at least one outer layer, the one or more stiffening members including a plurality of spaced apart, discrete ribs dividing the wall into the plurality of vertically expandable segments; In the expanded state, the workspace device has a workspace longitudinal vertical axis and an opening to an interior volume; the vertically expandable segment is expanded and oriented along the workspace longitudinal vertical axis and disposed about the lumen; the vertically expandable segment stiffens the workspace body to resist collapse due to intra-abdominal forces; the plurality of spaced apart discrete ribs disposed within the wall are disposed within the wall to resist radial forces; The workspace device.
2. 10. The device of claim 1, wherein the plurality of spaced apart discrete ribs comprise radially extending ribs configured to extend radially in the expanded state to stiffen the workspace body and resist the radial forces.
3. 3. The device of claim 1, wherein the workspace wall comprises at least one expandable chamber, and the plurality of spaced apart, distinct ribs divide the at least one expandable chamber into the plurality of vertically expandable segments that are fluidly connected to one another.
4. A device according to any one of claims 1 to 3, wherein in an expanded state, the axial length of each rib of the plurality of spaced apart discrete ribs is less than the axial length of the workspace wall.
5. The device of claim 1 , wherein at least some or all of the plurality of spaced apart discrete ribs are perforated for fluid connection of the plurality of vertically expandable segments.
6. The device of any preceding claim, wherein the plurality of spaced apart discrete ribs comprise radially extending vertical ribs oriented along the longitudinal vertical axis.
7. 7. The device of claim 1, wherein in an expanded state, adjacent expandable segments press laterally against at least one of the plurality of spaced-apart, distinct ribs disposed therebetween.
8. 8. The device of claim 1, wherein the workspace wall comprises at least one horizontally expandable segment surrounding the lumen, and wherein in the expanded state, the at least one horizontally expandable segment is shaped as a ring.
9. 9. The device of claim 1, wherein the body comprises a distal base coupled to the wall and a proximal cylindrical sleeve extending from the body and defining a channel to the lumen, and in the expanded state, the vertically expandable segment is disposed between the proximal cylindrical sleeve and the distal base.
10. The device of any one of claims 1 to 9, wherein, in an unfolded state, the length of the at least one outer layer is greater than the length of the at least one inner layer.
11. The device of any one of claims 1 to 9, wherein in an unfolded state, the length of the at least one outer layer is similar to the length of the at least one inner layer.
12. 12. The device of claim 1, wherein in an expanded state, at least one of the spaced apart ribs is perpendicular to a tangent to at least one or both of the at least one inner layer and the at least one outer layer.
13. 12. The device of any one of claims 1 to 11, wherein in an expanded state at least one of the spaced apart ribs is disposed at an angle relative to a tangent to at least one or both of the at least one inner layer and the at least one outer layer.
14. A device according to any preceding claim, wherein the spaced apart ribs are formed by the at least one inner layer of sheet material and / or the at least one outer layer of sheet material.
15. The device of claim 14 , wherein the spaced apart ribs comprise a portion of the at least one inner layer and / or a portion of the at least one outer layer.
16. The device of any one of claims 1 to 15, wherein each rib of the spaced apart ribs defines a sidewall of at least one vertically expandable segment of the plurality of vertically expandable segments.
17. The device of any one of claims 1 to 16, wherein in the expanded state, two adjacent vertically expandable segments press against each other along an interface area having a length greater than 0.3 cm.
18. 18. The device of any one of claims 1-17, comprising one or more inflation channels configured to supply inflation fluid to a body of the workspace device and the vertically expandable segment to expand the workspace body to the expanded state.
19. the workspace body comprising one or more visualization channels extending at least 1 cm into the lumen through an opening in an exterior surface of the body, the one or more visualization channels sized to receive an end of a visualization tool; 19. The device of any one of claims 1-18, wherein the ends of the one or more visualization channels within the lumen are closed, and the one or more visualization channels are at least partially transparent to allow an internal volume to be visualized by the visualization tool from close range.
20. 20. The device of claim 19, comprising a tool insertion channel that, in an expanded state, connects the opening of the workspace device to a body orifice, the one or more visualization channels entering the lumen through an opening in the tool insertion channel.
21. The device of any preceding claim, wherein in the expanded state, the workspace device extends laterally and the opening to the lumen is an opening in the workspace wall.
22. The device according to any one of claims 1 to 21, wherein the body cavity comprises an abdominal cavity and the body cavity wall comprises an abdominal cavity wall.
Citation Information
Patent Citations
Inflatable surgical retraction device and method
JP2000505657A
Tissue containment device for use in surgical procedures
US20190328376A1
Multi-purpose medical devices
US4447227A