WO2020188525A1

WO2020188525A1 - Cannula seal assembly

Info

Publication number: WO2020188525A1
Application number: PCT/IB2020/052563
Authority: WO
Inventors: Assaf Pesach; Hagay Weisbrod; Ofer Arnold
Original assignee: Gordian Surgical Ltd
Priority date: 2019-03-20
Filing date: 2020-03-19
Publication date: 2020-09-24

Abstract

It is provided in accordance with a preferred embodiment of the present subject matter, a seal assembly for a cannula having a cannula seal housing with a circular inner surface through which various sized objects having a diameter that is smaller than a threshold diameter and having a diameter that is larger than a threshold diameter, are inserted and extracted, the seal assembly comprising: a centralizer comprising a plurality of members, wherein an end of each member of the plurality of members is connected along a circumference of the circular inner surface wherein an opposite end facing substantially a center of the housing of each member of the plurality of members form together a passage having substantially threshold diameter adapted to accommodate and embrace at least one of the various sized objects and centralize the objects having a diameter that is smaller than the threshold diameter.

Description

CANNULA SEAL ASSEMBLY

FIELD OF INVENTION

[001] The present subject matter relates to medical devices. More particularly, the present subject matter relates to cannula sealing.

BACKGROUND

[002] During surgical interventions, for example, during laparoscopic surgeries, a tube-like device, termed hereinafter“cannula”, is inserted into an internal cavity of the body, for example, the abdominal cavity, through a hole made in the skin and outer tissue, for example in the abdominal wall. This allows the insertion and withdrawal, through the cannula, of tools and objects into and out of the cavity to perform the surgical procedure.

SUMMARY OF THE INVENTION

[003] It is provided in accordance with a preferred embodiment of the present subject matter, a seal assembly for a cannula having a cannula seal housing with a circular inner surface through which various sized objects having a diameter that is smaller than a threshold diameter and having a diameter that is larger than a threshold diameter, are inserted and extracted, the seal assembly comprising:

a centralizer comprising a plurality of members, wherein an end of each member of the plurality of members is connected along a circumference of the circular inner surface

wherein an opposite end facing substantially a center of the housing of each member of the plurality of members form together a passage having substantially threshold diameter adapted to accommodate and embrace at least one of the various sized objects and centralize the objects having a diameter that is smaller than the threshold diameter.

[004] It is provided in accordance with another preferred embodiment, each member of the plurality of members comprising a first leaf connected to a second leaf by a curved zone, wherein said each member of the plurality of members is connected along a circumference of the inner surface by a fixed end of the second leaf, and wherein the opposite end facing the center of the housing is the curved zone. [005] It is provided in accordance with another preferred embodiment, the seal assembly further comprising a reducer.

[006] In accordance with yet another preferred embodiment of the present subject matter, a reducer comprising:

a cylinder- shaped elastic sleeve;

a first rigid frame connected to one end of the sleeve;

a second rigid frame connected to an opposite end of the sleeve; and an elastic aperture formed at a center of the sleeve by rotating the first rigid frame and the second rigid frame in opposite directions.

[007] It is also provided in accordance with yet another preferred embodiment, a seal assembly for a cannula through which various sized objects are inserted and extracted, the seal assembly comprising:

a cannula seal housing having a circular inner surface; and the reducer of claim 4 connected inside the inner surface of the housing wherein the elastic aperture embraces at least one of the various sized objects.

[008] It is provided in accordance with another preferred embodiment, the seal assembly further comprising the reducer previously indicated.

[009] It is provided in accordance with another preferred embodiment, the seal assembly further comprising an elastomer ring for binding the plurality of members, wherein the ring is mounted in a concave side of the curved zone, and wherein the ring is configured to control the diameter of the passage while embracing the object during insertion and extraction of the object.

[010] It is provided in accordance with another preferred embodiment, the ring is connected to the concave side of the curved zone by a connecting element.

[Oi l] It is provided in accordance with another preferred embodiment, at least one member of the plurality of members comprising at least one rib positioned in an orientation that facilitates directing the object towards the passage during insertion and further allows for smooth extraction of the object.

[012] It is provided in accordance with another preferred embodiment, each member of the plurality of members comprising an extension protruding from the first leaf of each member towards the passage, wherein each extension of each member of the plurality of members together provide additional strength and rigidity to the passage.

[013] It is provided in accordance with another preferred embodiment, the first leaf and the second leaf and the curved zone have identical thickness. [014] It is provided in accordance with another preferred embodiment, the curved zone a thickness is different than a thickness of the first leaf and the second leaf, thereby contributing to an elasticity of the member.

[015] It is provided in accordance with another preferred embodiment, the fixed end of the second leaf of each member of the plurality of members is connected along a circumference of the inner surface by an elastic member.

[016] It is provided in accordance with another preferred embodiment, the centralizer further comprises a sealing element configured to seal gaps between the plurality of members.

[017] It is provided in accordance with another preferred embodiment, the sealing element further comprises an inner rim that extends toward the passage, wherein the inner rim is configured to embrace an object having a diameter substantially similar or smaller than a diameter of the passage.

[018] It is provided in accordance with another preferred embodiment, each member has a pivot point situated substantially next to the end of the second leaf, wherein the pivot point allows for bending the second leaf downward as a result of an axial force exerted during object insertion.

[019] It is provided in accordance with another preferred embodiment, the pivot point of each member allows for bending the second leaf of each member upwards and sliding a free end of the first leaf of each member upwards as a result of an axial force exerted during object extraction.

[020] It is provided in accordance with another preferred embodiment, the elastic aperture of the reducer has a diameter that is smaller than a diameter of the object inserted through the elastic aperture, and wherein the elastic aperture embraces the object.

[021] It is provided in accordance with another preferred embodiment, the elastic aperture embraces the object while the object moves sideways in the cannula seal assembly.

[022] It is provided in accordance with another preferred embodiment, the reducer is configured to allow smooth movement of object through it.

[023] It is provided in accordance with another preferred embodiment, the reducer and the centralizer are made of a material having a low friction coefficient.

[024] It is provided in accordance with another preferred embodiment, the reducer and the centralizer are coated with a material having a low friction coefficient.

[025] It is provided in accordance with another preferred embodiment, the seal assembly further comprises a reducer as discussed herein before and wherein the elastic aperture embraces at least one of the objects having a diameter larger than the threshold diameter while at least one of the objects moves sideways in the cannula seal assembly and the centralizer centralizes objects having a diameter that is smaller than the threshold diameter.

[026] It is provided in accordance with another preferred embodiment, the elastic aperture embraces at least one object having a diameter larger than a threshold diameter while the at least one object moves sideways in the cannula seal assembly and the centralizer centralizes objects having a diameter that is smaller than the threshold diameter.

BRIEF DESCRIPTION OF THE DRAWINGS

[027] Embodiments are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the embodiments. In this regard, no attempt is made to show structural details in more detail than is necessary for a fundamental understanding, the description taken with the drawings making apparent to those skilled in the art how several forms may be embodied in practice.

In the drawings:

[028] Figure 1 schematically illustrates a cross-sectional perspective view of a cannula seal assembly, according to an exemplary embodiment.

[029] Figure 2A schematically illustrates a perspective view of a part of a centralizer, according to an exemplary embodiment.

[030] Figure 2B schematically illustrates a perspective view of a part of a centralizer, according to another exemplary embodiment.

[031] Figure 3 schematically illustrates a cross-sectional perspective view of a cannula seal assembly, according to another exemplary embodiment.

[032] Figure 4 schematically illustrates a cross-sectional perspective view of a centralizer, according to another exemplary embodiment.

[033] Figure 5 schematically illustrates a cross-sectional perspective view of a centralizer, according to another exemplary embodiment.

[034] Figure 6 schematically illustrates a cross-sectional perspective view of a centralizer, according to another exemplary embodiment.

[035] Figure 7 schematically illustrates a cross-sectional perspective view of a centralizer, according to another exemplary embodiment. [036] Figure 8 A schematically illustrating a cross-sectional side view of a member in a resting state, according to another exemplary embodiment.

[037] Figure 8B schematically illustrating a cross-sectional side view of a cannula seal assembly in a resting state, according to an exemplary embodiment.

[038] Figure 9A, schematically illustrating a cross-sectional side view of a member experiencing a radial force, according to another exemplary embodiment.

[039] Figure 9B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience a radial force, according to an exemplary embodiment.

[040] Figure 10A, schematically illustrating a cross-sectional side view of a member experiencing an axial downward force, according to another exemplary embodiment.

[041] Figure 10B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience an axial downward force when a tool is just inserted through the centralizer, according to an exemplary embodiment.

[042] Figure IOC, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein the tool is already inserted through the centralizer.

[043] Figure 11 A, schematically illustrating a cross-sectional side view of a member experiencing an axial upward force, according to another exemplary embodiment.

[044] Figure 11B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience an axial upward force, according to an exemplary embodiment.

[045] Figures 12A-C schematically illustrating front perspective views of some exemplary embodiments of components of a reducer.

[046] Figures 13A-C schematically illustrating a front perspective view of stages of producing a reducer, according to an exemplary embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[047] Before explaining at least one embodiment in detail, it is to be understood that the subject matter is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The subject matter is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. In discussion of the various figures described herein below, like numbers refer to like parts. The drawings are generally not to scale.

[048] For clarity, non-essential elements were omitted from some of the drawings.

[049] The term“tool” as described herein relates to any type of instrument for performing a surgical procedure in a cavity of a body of a patient - human or animal. An exemplary tool is a medical instrument used in laparoscopic surgery and the like. The tool is configured to be inserted into the cavity through a cannula and extracted from the cavity through the cannula.

[050] The term“object” as described herein relates to any type of object, that is not a tool, that is to be inserted into a cavity of a body of a patient - human or animal, through a cannula, or extracted from the cavity through the cannula. Some examples of an object include a gauze, tissue or part of a tissue, an organ or part of an organ, and the like.

[051] The present subject matter provides a cannula seal assembly 10 configured to be installed over an outer opening of a cannula. According to one embodiment, the cannula seal assembly is provided separately to the cannula. According to another embodiment, the cannula seal assembly is provided as part of the cannula.

[052] During medical procedures involving the use of a cannula, there are cases in which the cavity in a body of a treated patient is inflated with a gas, for example, carbon dioxide, in order to allow convenient manipulation by the operating surgeon. However, the inflating gas can leak out the cavity through the cannula that is inserted into the cavity. Gas can be leaked when the cannula is empty. Currently, there are solutions for this problem, for example, usage of a duckbill check valve that is part of a cannula seal assembly that is installed over an outer opening of the cannula. Such problems and solutions are not dealt with in the present subject matter. Another challenge is leakage of gas when a tool or object is inserted into the cannula, present inside the cannula and extracted from the cannula, through the cannula seal assembly.

[053] One arm of the present subject matter is to provide a cannula seal assembly 10 that is configured to prevent leakage of gas when a tool is inserted, present and extracted from the cannula, regardless of the size of the tool that is used.

[054] Another aim of the present subject matter is to provide a cannula seal assembly 10 that is adapted to any type and diameter of the tool currently known in the art. Furthermore, the cannula seal assembly 10 of the present subject matter is adapted to any type and diameter of tool that can be used in surgical interventions in general. [055] As described hereinafter in detail, the cannula seal assembly 10 comprises a centralizer 16, or a reducer 18, or a centralizer 16 and a reducer 18. One aim of the reducer 18 is to embrace a tool while present in the cannula seal assembly 10 and prevent leakage of gas. Some embodiments of the centralizer 16, as described hereinafter, also allow the centralizer 16 to embrace a tool while present in the cannula seal assembly 10 and prevent leakage of gas. Another aim of the centralizer 16 is to centralize a tool in order to improve the embracing of the tool by the reducer 18 and thus improve the prevention of gas leakage by the reducer 18 when a tool is inserted therein. This embodiment of the centralizer 16 is particularly important when a tool, embraced by the reducer 18, is radially moved, for example by a user of a tool during a surgical operation. Without the centralizer 16, such radial movement of the tool can cause the formation of a gap between the tool and the reducer 18, a gap through which gas can leak. However, when the tool is also held by the centralizer 16, the centralizer 16 centralizes the tool and prevents the radial movement of the tool, despite radial forces that are exerted on the tool, for example by a user. As a result, no gap is formed between the tool and the reducer 18, and leakage of gas is prevented.

[056] According to one embodiment, the cannula seal assembly 10 is configured to allow the insertion of a tool into the cannula through the cannula seal assembly 10. According to another embodiment, the cannula seal assembly 10 is configured to allow extraction of a tool or an object out of the cannula through the cannula seal assembly 10. According to yet another embodiment, the cannula seal assembly 10 is configured to allow the insertion of a tool or an object into the cannula through the cannula seal assembly 10. According to still another embodiment, the cannula seal assembly 10 is configured to allow extraction of an object out of the cannula through the cannula seal assembly 10. According to a further embodiment, the cannula seal assembly 10 is configured to be adjustable to the size of a tool passed through the cannula seal assembly. In other words, the cannula seal assembly 10 is configured to allow passage of tools in various sizes, while still preventing leakage of gas when the tool is either inserted into the cannula or withdrawn from the cannula.

[057] The following embodiments are illustrated, for example, in Figure 1. According to one embodiment, the cannula seal assembly 10 comprises a centralizer 16. According to another embodiment, the cannula seal assembly 10 comprises a reducer 18. According to yet another embodiment, the cannula seal assembly 10 comprises a centralizer 16 and a reducerl8. According to a further embodiment, the cannula seal assembly 10 is configured to prevent passage of gas when a tool is inserted into the cannula through the cannula seal assembly 10. According to yet a further embodiment, the cannula seal assembly 10 is configured to prevent passage of gas when a tool is extracted from the cannula through the cannula seal assembly 10. It should be noted that there are cases where withdrawal of an object that is not symmetric or has an amorphic shape, may cause momentary leakage of gas. However, this situation is tolerable in the current practice.

[058] It should be further noted that as mentioned above, the cannula seal assembly 10 as described above cannot prevent passage of gas when the cannula is empty. For this purpose, any element known in the art that is configured to prevent passage of gas when the cannula is empty can be added to the cannula seal assembly 10, for example, a duckbill check valve that as known in the art can be positioned, for example, under the reducer 18 (not shown). Nevertheless, the elements configured to prevent passage of gas when the cannula is empty are out of the scope of the present subject matter.

[059] It is provided in accordance with a preferred embodiment of the present subject matter, a seal assembly for a cannula having a cannula seal housing with a circular inner surface through which various sized objects having a diameter that is smaller than a threshold diameter and having a diameter that is larger than a threshold diameter, are inserted and extracted, the seal assembly comprising:

[060] Reference is now made to Figure 1 illustrating a cross-sectional perspective view of a cannula seal assembly 10, according to an exemplary embodiment. A cannula seal assembly 10 is provided. According to one embodiment, the cannula seal assembly 10 comprises a seal housing 12 having a passage for inserting objects or tools into the cannula through the passage, and extracting objects or tools from the cannula through the passage.

[061] According to one embodiment, the cannula seal assembly 10 comprises a centralizer 16. According to another embodiment, the cannula seal assembly 10 comprises a reducer 18. According to yet another embodiment, the cannula seal assembly 10 comprises a centralizer 16, and a reducer 18 underneath the centralizer 16. The reducer 18 is occasionally referred to hereinafter as“aperture adjuster 18”. According to a preferred embodiment, the reducer 18 is flat, as described hereinafter. However, any type of reducer 18 known in the art can be used in combination with the centralizer 16.

[062] According to one embodiment, a diameter of the passage of the cannula seal assembly 10 is defined by the diameter of a passage of the centralizer 16, termed hereinafter“centralizer passage 14”. According to another embodiment, a diameter of the passage of the cannula seal assembly 10 is defined by a diameter of a passage of the reducer 18, termed hereinafter“elastic aperture 17”.

[063] According to one embodiment, the centralizer 16 is assembled in a circular inner surface of the cannula seal assembly 10 and configured to hold a tool, or an object, inserted through the cannula seal assembly 10. According to another embodiment, the centralizer 16 comprises a plurality of members 20 that are disposed within the housing 12. According to yet another embodiment, the members 20 are arranged in a circular arrangement over a circumference of the housing 12. According to one embodiment, the member 20 comprises two leaf-like elements, a first leaf 21 and a second leaf 23, in which one end of the first leaf is connected to one end of the second leaf by a curved zone 22. Where the curved zone 22 have a convex side, which is internally directed towards a centralizer passage 14. According to an additional embodiment, the member second leaf 23 comprises a fixed end 24 pivotally connected to the housing 12, and the first leaf 21 comprises a free end 28.

[064] According to one embodiment, the members 20 of the centralizer 16 define a centralizer passage 14 having a certain diameter that represent a certain threshold diameter. Any diameter of the centralizer passage 14 is under the scope of the present subject matter. For example, the diameter of the centralizer passage 14 is substantially 5 mm. Accordingly, some tools have a diameter smaller than, or substantially similar to the threshold diameter, which is the diameter of the centralizer passage 14, for example, tools that have a diameter smaller than, or substantially similar to, substantially 5 mm. Furthermore, some tools have a diameter that is larger than the threshold diameter, which is the diameter of the centralizer passage 14, for example, tools that have a diameter larger than substantially 5 mm. It should be noted that the diameter of the centralizer passage 14, of substantially 5 mm, is only exemplary, and should not be considered as limiting the scope of the present subject matter.

[065] According to one embodiment, the member 20 is configured to move relative to a pivot point 26 between the member 20 and the housing 12. The pivot point 26 is adjacent to the fixed end 24. According to another embodiment, an orientation of the members 20 relative to the housing 12 is in control of the extent of available centralizer passage 14, as will be described hereinafter. [066] Reference is now made to Figures 2 A and 2B, schematically illustrating perspective views of a part of a centralizer 16, according to an exemplary embodiment. According to one embodiment, the centralizer 16 comprises a plurality of members 20. Any number, above one, of members 20 is under the scope of the present subject matter. According to one embodiment, the curved zones 22 of the members 20 are adjacent one to the other. According to another embodiment, the curved zones 22 of the members 20 are in a substantially close to one another. Both aforementioned embodiments regarding the positions of the curved zones 22 are to ensure that a centered centralizer passage 14 is defined between the curved zones 22. For example, according to the exemplary embodiment illustrated in Figure 2A, the centralizer 16 comprises six members 20, while according to the exemplary embodiment illustrated in Figure 2B, the centralizer 16 comprises four members 20.

[067] According to one embodiment, illustrated for example in Figures 2A and 2B, member 20 is curved. According to another embodiment, the member 20 has a substantially V-shape or a substantially U-shape. The curved zones 22 of all the members 20 define an actual centralizer passage 14 available for inserting and withdrawing tools and objects through the cannula (the cannula is not shown in Figures 2 A and 2B). According to one embodiment, the fixed end 24 of the member 20 is connected to the housing 12 (In Figure 2A only a small portion of the housing 12 is shown). According to another embodiment, the free end 28 of the member 20 is free and is positioned above the fixed end 24. According to yet another embodiment, the free end 28 of the member 20 tends to be pressed against the housing 12. According to still another embodiment, the free end 28 of the member 20 is configured to slide on the surface of the housing 12.

[068] According to one embodiment, the member 20 is relatively rigid. According to this embodiment, the member 20 can be made of a relatively rigid material. According to another embodiment, the member 20 has relatively low elasticity. According to this embodiment, the member 20 can be made of a material that is relatively rigid and has relatively low elasticity. According to yet another embodiment, the member 20 can comprise portions that have different types of rigidity and elasticity. For example, the curved zone 22 can have more elasticity than other parts of the member 20 to allow the first leaf 21 and the second leaf 23 of the member 20 to get easily close and distant one from the other.

[069] Reference is now made to Figure 3, schematically illustrating a cross-sectional perspective view of a cannula seal assembly 10, according to another exemplary embodiment. Figure 3 illustrates a cannula seal assembly 10 provided with a centralizer 16 and a reducer 18 disposed within a housing 12. The shape and characteristics of the members 20 are similar to the shape and characteristics of the members 20 shown in Figure 1. However, it should be noted that the members can have any shape known in the art, according to the embodiments described herein, and that the shape illustrated in the Figures should not be considered as limiting the scope of the present subject matter.

[070] According to one embodiment, in order to assure the close fitting between the members 20, especially in the curved zones 22 that define the centralizer passage 14 therebetween, an elastomer ring 52 is mounted in a concave side of the curved zones 22 for binding the plurality of members 20. According to another embodiment, the elastomer 52, as shown in Figure 3, is an O-ring that is configured to change its diameter while moving along the centralizer passage 14 when the orientation of the members 20 is changed. This feature is elaborated hereinafter.

[071] Reference is now made to Figure 4, schematically illustrating a cross-sectional perspective view of a centralizer 16, according to another exemplary embodiment. According to one embodiment, the member 20 further comprises an extension 212 of the first leaf 21 that protrudes towards the centralizer passage 14 formed by the members 20. According to another embodiment, the extension 212 is configured to provide additional strength and rigidity that can be needed, for example, when a relatively large tool is inserted into the cannula through the cannula seal assembly 10, or when a large tool is withdrawn from the cannula through the cannula seal assembly 10, as described hereinafter. The extension 212 can have any structure known in the art. Figure 4 illustrates an exemplary embodiment in which the extension 212 is curved and confers a Y-shape to the member 20. It should be noted though, that the Y-shape of the member 20 that is illustrated in Figure 4 is only exemplary, and that any shape of the member 20 is under the scope of the present subject matter.

[072] Reference is now made to Figure 5, schematically illustrating a cross-sectional perspective view of a centralizer 16, according to another exemplary embodiment. According to embodiments illustrated in Figures 1-5, the thicknesses of the first leaf 21, the second leaf 23 and the curved zone 22 were substantially similar. In other words, the thickness of the member 20 is uniform. According to another embodiment, the thickness of the member 20 is not uniform. In other words, different parts of the member 20 can have different thicknesses. According to the embodiment illustrated in Figure 5, the thickness of the curved zone 22 is smaller than the thickness of the first leaf 21 and the second leaf 23. This embodiment can contribute to the elasticity of the member 20, and improve the movement of the first leaf 21 relatives to the second leaf 23.

[073] Reference is now made to Figure 6, schematically illustrating a cross-sectional perspective view of a centralizer 16, according to another exemplary embodiment. As mentioned above, the member 20 of the centralizer 16 has relatively low elasticity. According to the embodiment illustrated in Figure 6, the member 20 further comprises an elastic member 70, configured to confer elasticity to the member 20. For example, the elastic member 70 is in the form of a spring 70 that is attached to the member 20. According to another embodiment, the spring 70 can also be anchored in the housing 12 as illustrated in Figure 6. It should be noted though, that the embodiment of the elastic member 70 illustrated in Figure 6 is exemplary only, and should not be considered as limiting the scope of the present subject matter. Any type of elastic element 70 known in the art is under the scope of the present subject matter.

[074] According to an additional embodiment, the member 20 further comprises at least one rib 25. According to yet an additional embodiment, the member 20 further comprises one rib 25. According to one embodiment, at least one of the members 20 of the cannula seal assembly comprises at least one rib 25. According to another embodiment, all the members 20 of the cannula seal assembly 10 comprise at least one rib 25. According to a further embodiment, the rib 25 is configured to direct the insertion of a tool towards the centralizer passage 14 defined by the curved zones 22 of the members 20. This embodiment is, for example, useful when a thin tool is inserted into the cannula seal assembly 10. Since the user cannot see exactly where he inserts the tool, the ribs 25 direct the tool towards the centralizer passage 14 in case the tool is not inserted centrally. According to this embodiment, the rib 25 has a wedge-like structure, as illustrated for example in Figure 6, positioned in an orientation that directs the tool towards the centralizer passage 14. According to yet a further embodiment, the rib 25 is configured to allow smooth extraction of a tool through the centralizer 16, for example when the diameter of the tool is larger than the diameter of the centralizer passage 14. According to an additional embodiment, the rib 25 is configured to provide additional strength to the member 20 to withstand forces exerted on the member 20, for example during the transfer of tools or objects through the cannula seal assembly 10. It will be appreciated that member 20 must not fail (mechanically) during the transfer of objects through the cannula seal assembly 10. For example, the member 20 can undergo buckling when relatively strong forces are exerted on it, for example when an object, like a gauze, is withdrawn through the cannula seal assembly 10. The at least one rib 25 is configured to prevent this mechanical failure of the members 20.

[075] Reference is now made to Figure 7, schematically illustrating a cross-sectional perspective view of a centralizer 16, according to another exemplary embodiment. According to one embodiment, the elastomer 52 is connected to the curved zone 22 of at least one member 20 of the centralizer 16 with a connecting element 80. Any type of connecting element 80 known in the art is under the scope of the present subject matter. According to one exemplary embodiment, illustrated in Figure 7, the connecting element 80 is part of the elastomer 52 that is positioned there since it is over-molded or pressed over the members 20 during production. According to another exemplary embodiment, the connecting element 80 is a snapping button 80 that is configured to be embedded into the curved zone 22 of the member 20 and then into the elastomer 52 so that the elastomer 52 is connected to the curved zone 22.

[076] According to one embodiment, the centralizer 16 further comprises a sealing element 40 configured to seal gaps between the members 20, but let the centralizer passage 14 to be open. Any type of sealing element 40 known in the art is under the scope of the present subject matter. For example, the sealing element 40 can be a plurality of elastic sheets, when each elastic sheet is configured to attach to the second leaf 23 of at least two adjacent members 20 and seal the gap in between them. According to another exemplary embodiment, illustrated in Figure 7, the sealing element 40 is an elastic sheet 40 that covers the entire area occupied by the members 20. According to one embodiment, the elastic sheet 40 is configured to cover the entire area of the second leaves 23 of all the members 20 of the centralizer 16 and the gaps between them. According to another embodiment, the elastic sheet 40 is configured to cover the entire area of the first leaves 21 of all the members 20 of the centralizer 16 and the gaps between them. According to yet another embodiment, the elastic sheet 40 is configured to cover the entire area between the first leaves 21 and the second leaves 23 of all the members 20 of the centralizer 16 and the gaps between them. As can be appreciated by a person skilled in the art, the sealing of the centralizer 16 with the elastic sheet 40, according to the embodiments described above, negates the usage of a reducer 18 in the cannula seal assembly 10.

[077] According to an exemplary embodiment illustrated in Figure 7, the elastic sheet 40 further comprises an inner rim 42 that extends into the centralizer passage 14. According to one embodiment, the inner rim 42 of the elastic sheet 40 is configured to embrace a tool having a diameter substantially similar to, or smaller than, the diameter of the centralizer passage 14, and by this prevent leakage of gas. According to another embodiment, when a tool having a diameter larger than the diameter of the centralizer passage 14 is inserted through the centralizer 16, an area adjacent to the curved zone 22 of the member 20 embraces the tool and thus prevents leakage of gas.

[078] Figures 8-11 hereinafter, illustrate the mechanism with which the centralizer 16 centralizes an object, or a tool, in the cannula seal assembly 10, while dealing with objects, or tools, in various sizes or diameters.

[079] Reference is now made to Figure 8A, schematically illustrating a cross-sectional side view of a member in a resting state, and to Figure 8B, schematically illustrating a cross- sectional side view of a cannula seal assembly in a resting state, according to an exemplary embodiment.

[080] According to one embodiment, the cannula seal assembly 10, including the members 20 of the centralizer 16, can be in a resting state. In the resting state, no tool or object is transferred through the centralizer passage 14, as illustrated in Figure 8B, or a tool or object having a diameter smaller than the diameter of the centralizer passage 14 is transferred through the centralizer passage 14 (not shown). As a result, during the resting state, no external forces are exerted on the members 20 of the centralizer 16. As illustrated in Figure 8 A, in the resting state, the member 20 is in a default state, in which the free end 28 of the first leaf 21 barely touched the housing.

[081] Reference is now made to Figure 9A, schematically illustrating a cross-sectional side view of a member experiencing a radial force, and to Figure 9B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience a radial force, according to an exemplary embodiment.

[082] According to one embodiment, the member 20 is configured to be in the state illustrated in Figure 9A and 9B, when it experiences a radial force exerted on the member 20. This embodiment occurs, for example, when a tool, having a diameter similar to, or smaller than, the diameter of the centralizer passage 14, is transferred through the centralizer passage 14, as illustrated in Figure 9B. For example, when a tool having a diameter of substantially 5 mm, or less, is transferred through a centralizer passage 14 having a diameter of substantially 5 mm. The radial force that, for example, can be caused due to manipulation exerted by a user of the tool, like a surgeon, is designated in Figure 9 A with arrow 902. The radial force 902 is exerted by the tool, for example, on the curved zone 22 of the member 20 in a radial direction towards the housing 12. As a result, the first leaf 21 is radially pushed towards the housing 12, and the free end 28 of the first leaf 21 radially presses the housing 12, while the housing 12 exerts a contradictory radial force, designated with arrow 904, on the free end 28 of the member 20. It should be noted that the radial force 902 is exerted on the member 20 regardless of the direction of movement of the tool. The same radial force 902 is exerted when the tool is inserted into or extracted from the cannula through the cannula seal assembly 10. According to one embodiment, at least one of the members 20 of the centralizer 16 experiences a radial force exerted on the member 20. According to another embodiment, one of the members 20 of the centralizer 16 experiences a radial force exerted on the member 20.

[083] According to one embodiment, illustrated for example in Figures 8A and 9A, the housing 12 comprises a blocking element 122, for example in the form of a negative slope in the wall of the housing 12, adjacent to a position of the free end 28 of the first leaf 21, when the member 20 is in a resting state (see Figure 8A). When a radial force 902 is exerted on the member, as described above and illustrated in Figure 9B, the contradictory radial force 904 exerted by the housing 12 has an axial component as well, due to the contact of the free end 28 of the first leaf 21 with the blocking element 122 of the housing 12. According to another embodiment, the blocking element 122 is configured to block the sliding of the free end 28 upwards when a radial force 902 is exerted on the member 20, as illustrated in Figure 9A.

[084] Reference is now made to Figure 10A, schematically illustrating a cross-sectional side view of a member experiencing an axial downward force, to Figure 10B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience an axial downward force when is tool is just inserted through the centralizer, according to an exemplary embodiment, and to Figure IOC, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein the tool is already inserted through the centralizer.

[085] According to one embodiment, the member 20 is configured to be in the state illustrated in Figures 10A and 10B, when it experiences an axial downward force exerted on the member 20. This embodiment occurs, for example, when a tool, having a diameter larger than the diameter of the centralizer passage 14, is just inserted into the centralizer passage 14 from above, as illustrated in Figure 10B. For example, when a tool having a diameter of substantially 12 mm is inserted into a centralizer passage 14 having a diameter of substantially 5 mm. The downward axial force, designated in Figure 10A with arrow 912, is exerted by the tool, for example, on the curved zone 22 of the member 20 in a downwards axial direction. As a result, the curved zone 22, together with the first leaf 21 and the second leaf 23 are pushed downwards and the free end 28 of the first leaf 21 is moved away from the housing 12. This movement downwards of the member 20 is achieved due to the pivot point 26 of the members, about which the second leaf 23 bent. As a result, the second leaf 23 exerts a force contradictory to the movement of the member 20, designated with arrow 914. After the tool is already inserted into the centralizer passage 14, the members 20 stay in the same orientation downwards, as illustrated in Figure 10B, but the downward axial force is now negligible.

[086] Reference is now made to Figure 11 A, schematically illustrating a cross-sectional side view of a member experiencing an upward axial force, and to Figure 11B, schematically illustrating a cross-sectional side view of a cannula seal assembly wherein members of the centralizer experience an upward axial force, according to an exemplary embodiment. [087] According to one embodiment, the member 20 is configured to be in the state illustrated in Figures 11A and 1 IB, when it experiences an upward axial force exerted on the member 20. This embodiment occurs, for example, when an object having a size larger than the diameter of the centralizer passage 14, is transferred upwards through the centralizer passage 14, as illustrated in Figure 11B. For example, when an object, for example, a piece of tissue, having a diameter larger than the diameter of the centralizer passage 14, is transferred upwards through the centralizer passage 14. The upward axial force, designated in Figure 11A with arrow 922, is exerted by the object, for example, on the curved zone 22 of the member 20 in an upwards axial direction. As a result, the curved zone 22, together with the first leaf 21 and the second leaf 23 are pushed upwards and the free end 28 of the first leaf 21 slides upwards, in the direction designated with arrow 924, on the surface of the housing 12. This movement of the member 20 upwards can be attributed to the elasticity of the member 20, for example, the elasticity of the entire member 20 or at least one component of the member 20. This movement of the member 20 upwards can also be attributed to the elasticity of the curved zone 22. According to the one embodiment, the curved zone 22 can be an axis about which the first leaf 21 and the second leaf 23 can swivel during the movement of the member 20 upwards. In case the object is large, the free end 28 continues to slide on the surface of the housing 12 until it reaches a rim 122 of the housing 12 and slides outside over the rim 122. This ensures a wide opening of the centralizer passage 14 in order to facilitate the movement of the large object outside through the centralizer passage 14. This movement upwards of the member 20 is achieved due to the pivot point 26 of the members, about which the second leaf 23 swivels. According to one embodiment, since the members, 20 are independent one from the other, and since the object can be amorphic, at least one of the members 20 can be lifted upwards as described above. According to another embodiment, only one member 20 can be lifted above by the object. According to yet another embodiment, all the members can be lifted above by the object.

[088] According to one embodiment, when an axial upwards force 922 is exerted on the member 20, as described above, this axial upwards force 922 is strong enough to overcome the blocking element 122 of the housing 12 and cause the free end 28 to slide upwards on the housing 12.

[089] According to one embodiment, when an axial upwards force 922 is exerted on the member 20, as described above, this axial upwards force 922 direction leads the tree end to slide upwards without even touching the blocking element 122. [090] According to one embodiment, after the movement of the member 20 radially towards the housing 12, as illustrated in Figures 9A and 9B, and after the movement of the member 20 axially downwards, as illustrated in Figures 10A and 10B, and after the movement of the member 20 axially upwards, as illustrated in Figures 11A and 11B, the member 20 is configured to return to the resting state, illustrated in Figures 8A and 8B. This embodiment can be achieved for example by the elasticity of the material of which the member 20 is made, or for example by the elastic member 70, illustrated in Figure 6.

[091] Reference is now made to Figures 12A-C schematically illustrating front perspective views of some exemplary embodiments of components of a reducer 18.

[092] The present subject matter further provides a reducer 18 configured to be positioned under the centralizer 16 in the cannula seal assembly 10. According to one embodiment, the reducer 18 is configured to prevent leakage of gas through the cannula seal assembly 10 when a tool is inserted into the cannula seal assembly 10. According to another embodiment, the reducer comprises a first frame 182, a second frame 184 and an elastic sleeve 186 connecting the first frame 182 and the second frame 184. According to one embodiment, the first frame 182, or the second frame 184, or both the first frame 182 and the second frame 184, are part of the elastic sleeve 186. This can be achieved, for example, by manufacturing the elastic sleeve 186 and at least one of the first frame 182 and the second frame 184 from a piece of material that is hardened at least one of the edges of the elastic sleeve 186. In other words, at least one of the first frame 182 and second frame 184 is a hardened edge of the elastic sleeve 186. According to another embodiment, at least one of the first frame 182 and the second frame 184 is separate from the elastic sleeve 186. For example, at least one of the first frame 182 and the second frame 184 can be a frame made of a rigid material, for example, plastic, that is configured to connected to an edge of the elastic sleeve 186. According to one embodiment, the first frame 182 and the second frame 184 have a substantially similar shape. According to another embodiment, the first frame 182 and the second frame 184 have a ring-like structure, as illustrated for example in Figures 12A-C. It should be noted that the ring-like structure of the first frame 182 and the second frame 184 is only exemplary, and should not be considered as limiting the scope of the present subject matter. The first frame 182 and the second frame 184 can have any closed structure known in the art.

[093] The elastic sleeve 186 can have an elongated structure known in the art, as long as it defines an interior space, like a tube. Some exemplary embodiments of the structure of the elastic sleeve 186 are shown in Figures 12A-C. According to one exemplary embodiment, the elastic sleeve 186 has a cylinder- shaped structure, as illustrated in Figure 12A. According to another exemplary embodiment, the elastic sleeve 186 has a cylinder-like structure shrunken substantially at the center, as illustrated in Figure 12B. According to yet another exemplary embodiment, the elastic sleeve 186 has a folded cylinder- like structure, as illustrated in Figure 12C.

[094] Reference is now made to Figures 13A-C schematically illustrating a front perspective view of stages of producing a reducer, according to an exemplary embodiment.

[095] According to one embodiment, the elastic sleeve 186 has an elongated tube-like structure having two ends, wherein one end is connected and the opposite end is connected, in a manner that the first frame 182 and the second frame 184 are connected by the elastic sleeve 186, as illustrated in Figure 13 A.

[096] In some exemplary embodiments, rotating the first frame 182, as illustrated in Figure 13B, and the second frame 184 in opposite directions in a manner that causes the elastic sleeve 186 to fold inward toward a longitude axis of the sleeve, thereby forming elastic aperture 17. Simultaneously, the first frame 182 and the second frame 184 are moved one towards the other until they kiss each other, as illustrated in Figure 13C, which allows for installing reducer 18 in the cannula seal assembly 10.

[097] In some exemplary embodiments, the folded sleeve 186, held by the first frame 182 and the second frame 184, forms at its center, an elastic aperture 17 adapted to hug the tool that is inserted through the elastic aperture 17, essentially sealing an opening the aperture by embracing the tool. According to one embodiment, the diameter of the elastic aperture 17 is smaller than the diameter of an inner part of the elastic sleeve 186 before the elastic sleeve 186 is folded, as illustrated in Figure 13B. According to this embodiment, even though the elastic sleeve 186 is produced with a diameter of the inner part that is larger than the diameter of some tools, the diameter of the elastic aperture 17 is smaller than the diameter of a tool, as described hereinafter. According to another embodiment, the diameter of the elastic aperture 17 is smaller than the diameter of a tool that is inserted through the elastic aperture 17. This embodiment ensures that any tool that is inserted through the elastic aperture 17 is embraced by the folded sleeve 186 in a manner that prevents leakage of gas between the tool and the folded sleeve 186. Furthermore, due to the elasticity of folded sleeve 186, a tool can be moved aside in the cannula seal assembly 10 while the folded sleeve 186 still embraces the tool and prevent the passage of gas. When the movement aside is above a certain level, a gap may form between the folded sleeve 186 and the tool, leading to leakage of gas. This can be prevented by the centralizer 16 that holds the tool at the center and prevents a substantial movement of the tool aside. [098] According to one embodiment, the reducer 18 is affixed to housing 12, as illustrated for example in Figure 1. According to another embodiment, the reducer 18 is configured to radially move in the cannula seal assembly 10. This embodiment allows adjustment of the position of the reducer 18 to a position of a tool in the cannula seal assembly 10, and seal leakage of gas also in cases when the tool is not centralized.

[099] According to one embodiment, the cannula seal assembly 10 is configured to allow smooth movement of a tool through it. Therefore, according to one embodiment, the centralizer 16 is configured to allow smooth movement of a tool through it. According to another embodiment, the reducer 18 is configured to allow smooth movement of a tool through it. According to yet another embodiment, the centralizer 16 and the reducer 18 are configured to allow smooth movement of a tool through them. According to a further embodiment, the entire centralizer 16, or reducer 18, or centralizer 16 and reducer 18, is configured to allow smooth movement of a tool. According to yet a further embodiment, parts of the centralizer 16, or reducer 18, or centralizer 16 and reducer 18, that are in contact with a tool are configured to allow smooth movement of the tool. In order to allow smooth movement of a tool, according to an additional embodiment, the centralizer 16, or reducer 18, or centralizer 16 and reducer 18, or a part thereof that is in contact with a tool, is made of a material having a low friction coefficient. Any type of material having a low friction coefficient is under the scope of the present subject matter, for example, Teflon, a material undergone a surface treatment to reduce the friction coefficient of the material, and the like, is under the scope of the present subject matter. According to yet an additional embodiment, the centralizer 16, or reducer 18, or centralizer 16 and reducer 18, or a part thereof that is in contact with a tool, is coated with a material having a low friction coefficient, for example, oil, wax, grease and the like. Another advantage of coating the reducer 18 with a material having a low friction coefficient is that increases the sealing activity of the reducer 18, since the material having a low friction coefficient that coats the reducer 18, enters into tiny apertures that can be present in the reducer elastic sleeve 186 of the reducer 18, and seal them, especially when the material having low friction coefficient is viscous, for example, grease, wax and the like.

[100] It is appreciated that certain features of the subject matter, which 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 subject matter, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub combination. [101] Although the subject matter 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.

Claims

CLAIMS:

1. A seal assembly for a cannula having a cannula seal housing with a circular inner surface through which various sized objects having a diameter that is smaller than a threshold diameter and having a diameter that is larger than a threshold diameter, are inserted and extracted, the seal assembly comprising:

2. The seal assembly of claim 1, wherein each member of the plurality of members comprising a first leaf connected to a second leaf by a curved zone, wherein said each member of the plurality of members is connected along a circumference of the inner surface by a fixed end of the second leaf, and wherein the opposite end facing the center of the housing is the curved zone.

3. The seal assembly of any one of claims 1 or 2, further comprising a reducer.

4. A reducer comprising:

a cylinder- shaped elastic sleeve;

a first rigid frame connected to one end of the sleeve;

5. A seal assembly for a cannula through which various sized objects are inserted and extracted, the seal assembly comprising:

6. The seal assembly of claims 1 or 5, further comprising the reducer of claim 4.

7. The seal assembly of each one of claims 2-3 or 5-6, further comprising an elastomer ring for binding the plurality of members, wherein the ring is mounted in a concave side of the curved zone, and wherein the ring is configured to control the diameter of the passage while embracing the object during insertion and extraction of the object.

8. The seal assembly of claim 7, wherein the ring is connected to the concave side of the curved zone by a connecting element.

9. The seal assembly of each one of claims 1-3 or 5-6, wherein at least one member of the plurality of members comprising at least one rib positioned in an orientation that facilitates directing the object towards the passage during insertion and further allows for smooth extraction of the object.

10. The seal assembly of each one of claims 2-3 or 5-6, wherein each member of the plurality of members comprising an extension protruding from the first leaf of each member towards the passage, wherein each extension of each member of the plurality of members together provide additional strength and rigidity to the passage.

11. The seal assembly of each one of claims 2-3 or 5-6, wherein the first leaf and the second leaf and the curved zone have identical thickness.

12. The seal assembly of each one of claims 2-3 or 5-6, wherein the curved zone a thickness is different than a thickness of the first leaf and the second leaf, thereby contributing to an elasticity of the member.

13. The seal assembly of each one of claims 2-3 or 5-6, wherein the fixed end of the second leaf of each member of the plurality of members is connected along a circumference of the inner surface by an elastic member.

14. The seal assembly of each one of claims 1-3 or 5-6, wherein the centralizer further comprises a sealing element configured to seal gaps between the plurality of members.

15. The seal assembly of claim 14, wherein the sealing element further comprises an inner rim that extends toward the passage, wherein the inner rim is configured to embrace an object having a diameter substantially similar or smaller than a diameter of the passage.

16. The seal assembly of each one of claims 2-3 or 5-6, wherein each member has a pivot point situated substantially next to the end of the second leaf, wherein the pivot point allows for bending the second leaf downward as a result of an axial force exerted during object insertion.

17. The seal assembly of claim 16, wherein the pivot point of each member allows for bending the second leaf of each member upwards and sliding a free end of the first leaf of each member upwards as a result of an axial force exerted during object extraction.

18. The seal assembly of claims 5 or 6, wherein the elastic aperture of the reducer has a diameter that is smaller than a diameter of the object inserted through the elastic aperture, and wherein the elastic aperture embraces the object

19. The seal assembly of claims 5 or 6, wherein the elastic aperture embraces the object while the object moves sideways in the cannula seal assembly.

20. The seal assembly of claims 3 or any one of claims 5 and 6, wherein the reducer is configured to allow smooth movement of object through it.

21. The seal assembly of claims 3 or any one of claims 5 and 6, wherein the reducer and the centralizer are made of a material having a low friction coefficient.

22. The seal assembly of claims 3 or any one of claims 5 and 6, wherein the reducer and the centralizer are coated with a material having a low friction coefficient.

23. The seal assembly of claim 1 , further comprises a reducer of claim 4 and wherein the elastic aperture embraces at least one of the objects having a diameter larger than the threshold diameter while at least one of the objects moves sideways in the cannula seal assembly and the centralizer centralizes objects having a diameter that is smaller than the threshold diameter.

24. The seal assembly of claim 5 , wherein the elastic aperture embraces at least one object having a diameter larger than a threshold diameter while the at least one object moves sideways in the cannula seal assembly and the centralizer centralizes objects having a diameter that is smaller than the threshold diameter.