Endoscope sheath.

The endoscope sheath with a deformable chamber and fluid control system addresses inefficiencies and damage risks in existing sheaths by enabling controlled dilation and retraction, improving procedural efficiency and safety.

FR3170248A1Pending Publication Date: 2026-06-26MARCHAL FRANCIS

Patent Information

Authority / Receiving Office
FR · FR
Patent Type
Applications
Current Assignee / Owner
MARCHAL FRANCIS
Filing Date
2024-12-23
Publication Date
2026-06-26

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Abstract

Endoscope sheath (10) comprising: - at least one first chamber (101; 101a, 101b) extending over at least 30%, or even over at least 50%, or even over at least 80%, of the length (L10) of the sheath or extending over all or substantially all of the length (L10) of the sheath, - a first deformable wall (102), in particular elastically deformable, defining at least partially a boundary of the at least one first chamber (101; 101a, 101b), - a second wall (104) intended to surround an insertion tube (3) of an endoscope (100) and constituting a passage channel (103) for an insertion tube (3) of an endoscope (100), and - at least one opening (106) for the inlet and / or outlet of fluid into the at least a first chamber (101; 101a, 101b). Figure for the abridged version: 1
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Description

Title of the invention: Sheath for endoscope. Technical field of the invention

[0001] The invention relates to the medical field, particularly medical examinations or surgical procedures. The invention relates to a sheath for an endoscope. The invention also relates to an endoscope device comprising an endoscope and such a sheath. Prior art

[0002] In various surgical procedures, it is necessary to dilate ducts in the human body. This is particularly the case in procedures aimed at treating strictures. It is sometimes also necessary to dilate a duct over a significant length, or even along its entire length. This dilation is then known to be performed by successive insertions and withdrawals of an endoscope into the duct, with a sheath of a different size being placed on the endoscope's insertion tube between each withdrawal and insertion. This dilation technique has certain drawbacks: it requires time and manipulation due to the successive mounting and dismounting of the sheaths on the endoscope. Furthermore, the repeated passages of the sheaths through the duct to be explored and / or treated can cause damage to the duct wall through friction. Presentation of the invention

[0003] The invention relates to an endoscope sheath that provides a solution to the problems mentioned above and improves upon known prior art sheaths. In particular, the invention offers a simple, reliable, and practical endoscope sheath that can be used easily and with minimal risk of injury to the patient's organs. Summary of the invention

[0004] According to the invention, an endoscope sheath comprises: - at least one first chamber extending over at least 30%, or even over at least 50%, or even over at least 80%, of the length of the duct, or extending over the entire or substantially the entire length of the duct, - a first deformable wall, in particular elastically deformable, defining at least partially a boundary of at least one first chamber, - a second wall intended to surround an insertion tube of an endoscope and constituting a passage channel for an insertion tube of an endoscope, and - at least one fluid inlet and / or outlet opening in at least one first chamber.

[0005] At least one first chamber may have an annular cross-section.

[0006] The second wall can be rigid and intended to surround an insertion tube of an endoscope with a gap intended to constitute a rinsing channel.

[0007] The sheath may have several chambers distributed around the passage channel of the insertion tube.

[0008] The sheath may have one or more working channels distributed around the passage channel of the insertion tube.

[0009] The sheath can be made of transparent material.

[0010] The first wall and the second wall can be made of transparent material.

[0011] According to the invention, a sheath device comprises: - a sheath defined previously, and - a device for injecting fluid into at least one first chamber and / or removing fluid from at least one first chamber.

[0012] According to the invention, an endoscope system comprises: - a previously defined sheath or sheath device, and - an endoscope.

[0013] According to the invention, a method for dilating a duct in the body of an animal, in particular the body of a human, comprises the following steps: - mounting a previously defined sheath onto an endoscope, in particular onto an endoscope insertion tube, - insertion of the endoscope and sheath into the canal, - injection of a pressurized fluid into the chamber to expand the sheath and conduit accordingly, - possibly, removing at least part of the fluid from the chamber in order to retract the sheath, - Removal of the duct sheath.

[0014] According to the invention, a method for placing an endoprosthesis in a duct of an animal's body, in particular a human body, comprises the following steps: - mounting a previously defined sheath onto an endoscope, in particular onto an endoscope insertion tube, - mounting an endoprosthesis onto the sheath, - initial inflation of the sheath to hold the endoprosthesis in place on the sheath, - insertion of the endoprosthesis into the duct, - a second inflation of the sheath to bring the endoprosthesis into the desired configuration, - deflation of the sheath, - Removal of the sheath and endoscope from the canal. Presentation of the figures

[0015] Other advantages and features will become clearer from the following description of different embodiments of an endoscope system and the accompanying figures in which:

[0016] Fig. 1 is a schematic view of a first embodiment of an endoscope system, the endoscope sheath being in a first inflated configuration.

[0017] Figure 2 is a schematic view of the first embodiment of the system of the endoscope, the endoscope sheath being in a second deflated configuration.

[0018] Fig. 3 is a schematic cross-sectional view, along plane AA of Fig. 1, of the first embodiment of the endoscope system, the sheath being in an inflated configuration.

[0019] Figure 4 is a schematic view of a cross-section along plane AA of the [Fig.l], of a second embodiment of an endoscope system, the sheath being in an inflated configuration.

[0020] Fig. 5 is a schematic cross-sectional view, along plane AA of Fig. 1, of a third embodiment of an endoscope system, the sheath being in an inflated configuration. Detailed description

[0021] A first embodiment of an 800 endoscope system is described below with reference to figures 1 to 3.

[0022] The 800 endoscope system comprises: - a 100 endoscope and a 10 sheath.

[0023] The endoscope 100 mainly comprises a housing 1 and an insertion tube 3. The insertion tube 3 is, for example, made of a biocompatible material, in particular stainless steel, titanium, synthetic material, and / or plastic. The insertion tube 3 may be flexible so as to be able, in particular, to follow the curves of the channels being examined or the curves of the insertion tube. The insertion tube has: - a proximal end 140 fixed or attached to the housing, and - a distal end 130 at which is arranged an optical system enabling the production, formation or transmission of images of objects or structures facing it. The insertion tube, particularly the distal end of the insertion tube, is intended to be inserted into a canal or duct or cavity of an animal or human body in order to explore that canal or cavity.

[0024] In the figures, the insertion tube is shown in a configuration extending straight along an axis B. However, the insertion tube may have any form of curvature to facilitate the exploration and / or treatment of a duct of an animal body, in particular a human body.

[0025] The endoscope 100 may also include a viewing device, such as, for example, an oculus or a peephole or any other optical interface, connected to the optical system, via a first optical fiber conductor.

[0026] The endoscope 100 may also include a light source. The light source emits light and conducts it via a second optical fiber conductor. The light beams illuminate objects or structures located in front of the optical system.

[0027] The endoscope 100 includes a conformation 15 intended to receive a tip 109 of the sheath 10.

[0028] The sheath 10 can be assembled onto the endoscope 100 using any mechanical fastening method, such as helical connections, in particular Luer Lock type connections or others. In any case, preferably, the sheath 10 can be detached from the endoscope.

[0029] The sheath 10 is preferably made of plastic. The sheath is preferably single-use. The sheath may be made of rigid material so as to maintain the shape of the insertion tube 3 when the sheath 10 is mounted on the insertion tube 3. Alternatively, the sheath may have a flexible structure, i.e., it may conform to the shape of the insertion tube 3 onto which it is mounted or threaded.

[0030] The sheath 10 may include: - a first channel 103 extending substantially from the proximal end 140 to the distal end 130 and allowing the conveyance, up to the distal end 130, of a rinsing liquid, and / or - a second channel 107 extending substantially from the proximal end 140 to the distal end 130 and allowing to be conveyed, up to the distal end 130, a tool or an instrument for intervention in the body.

[0031] Channels 103 and 107 are shown schematically. The rinsing channel 103 may in particular be formed by a gap or space between an internal surface of the sheath 104 and an external surface of the insertion tube 3. The channel 103 and / or 107 therefore passes through the sheath along its entire length.

[0032] The sheath 10 comprises: - a first chamber 101 extending over at least 30%, or even over at least 50%, or even over at least 80%, of the length (L10) of the duct or extending over the entire or substantially the entire length (L10) of the duct, - a first deformable wall 102, in particular elastically deformable, defining at least partially a limit of the first chamber 101, - a second wall 104 intended to surround the insertion tube 3 of the endoscope 100 and constituting a passage channel 103 of an insertion tube 3 of the endoscope 100, and - an opening 106 for the admission and / or evacuation of fluid into at least a first chamber 101.

[0033] The first chamber 101 extends over a length L101. The ratio of lengths L101 / L10 is therefore greater than 0.3, or even greater than 0.5, or even greater than 0.8, or even equal to or substantially equal to one.

[0034] The endoscope 100 can be threaded into the passage channel 103.

[0035] The opening 106 allows fluid to be added to or removed from the first chamber 101. This addition and removal of fluid allows control of the duct's dimensions, in particular its transverse dimensions, due to the deformation of chamber 101. The deformation of chamber 101 can be achieved by controlling the volume of fluid introduced into chamber 101 and / or by controlling the pressure of the fluid introduced into chamber 101. The fluid can be a gas or a liquid. The opening 106 may include a valve, flap, or tap to prevent exchanges between the inside and outside of chamber 101 and thus ensure that the transverse dimensions of the duct 10 are maintained over time.In other words, the sheath includes a system that can be configured in a sealed state in which exchanges between the inside of the first chamber 101 and the outside of the first chamber are prohibited. This allows the sheath to maintain its shape defined by the pressure of the fluid that fills it.

[0036] In order to introduce or remove fluid from chamber 101, a fluid injection device 110 is connected to the opening 106. This device 110 also allows control of the removal of fluid from chamber 101.

[0037] In the first embodiment of the sheath 10, the first chamber 101 has an annular cross-section as shown in [Fig.3].

[0038] In a second embodiment of a sheath 10 shown in cross-section perpendicular to axis B in Figure 4, the sheath 10 differs from the sheath described in the first embodiment in that it comprises several chambers arranged around the insertion tube 3. For example, the sheath 10 may comprise a first chamber 101a and a second chamber 101b, the first and second chambers being arranged coaxially. Each chamber comprises an outer wall 102a, 102b and an inner wall 104a, 104b. The inner wall 104a and the outer wall 102b may be a single wall or two walls placed against each other. These two walls 104a and 102b may be fixed to each other, free from each other, or separated from each other. In the case where these walls are free, they can nevertheless be mounted tightly on each other in the event that one and / or the other of the first chamber 101a and second chamber 101b is inflated.

[0039] In this embodiment, the sheath comprises two independent and sealed systems for managing fluid exchange between the interiors of the chambers and an external environment.

[0040] Such a coaxial chamber sheath 10 configuration allows for the placement of an inflatable tube structure within a conduit. For example, the first and second chambers can be placed on the insertion tube 3, and chamber 101b can be slightly inflated to hold chamber 101a, which is in its deflated configuration, around it. The insertion tube can then be inserted into the body conduit with the sheath 10 positioned on the insertion tube. Chamber 101a can then be inflated and chamber 101b deflated. At this point, the endoscope can be withdrawn with chamber 101b, and the first chamber 101a, in its inflated configuration, can remain in the conduit. Alternatively, both chambers 101a and 101b can remain positioned within the conduit.This allows for surgical interventions within the passage formed by the tubular shape of the first chamber 101a, or even within the passage formed by the tubular shape of the second chamber 101b. Alternatively, or in addition, this allows for diagnostic interventions from within the passage channel 103 formed by the tubular shape of the first chamber 101a, or even within the passage formed by the tubular shape of the second chamber 101b. Alternatively, the inflated chamber 101a can serve as an endoprosthesis for the duct. Finally, the inflated chamber 101a can allow for the placement of a plastically deformable endoprosthesis, such as a stent or mesh support, this endoprosthesis being intended to remain within the duct.

[0041] In a third embodiment of a sheath 10 shown in [Fig.5] in cross-section perpendicular to axis B, the sheath 10 differs from the sheath described in the first embodiment in that it comprises several chambers arranged around the insertion tube 3. The sheath 10 has, for example, one or more working channels 107 distributed around the passage channel 103 of the insertion tube 3 and several chambers 101a, 101b distributed around the passage channel 103 of the insertion tube 3.

[0042] In this embodiment, the sheath comprises two independent and sealed systems for managing fluid exchange between the interiors of the chambers and an external environment.

[0043] Preferably, in the embodiments shown, the first chamber 101; 101a, 101b extends over the entire length L10 of the duct 10 or extends substantially over the entire length L10 of the duct 10.

[0044] Preferably, regardless of the embodiment and variant, the second wall 104 is designed to surround an insertion tube 3 of an endoscope 100 with a gap intended to form a rinsing channel 105. The second wall 104 may be flexible or rigid. A rinsing fluid can thus be introduced between the sheath and the insertion tube at the proximal end 140 of the sheath 10, travel along the axis B between the sheath 10 and the insertion tube, and escape at the distal end 130 of the sheath 10.

[0045] Regardless of the embodiment or variant, the sheath 10 is advantageously disposable. It is supplied sterile, in packaging, mounted on the insertion tube 3, and then discarded after the medical examination or surgical procedure. Regardless of the embodiment or variant, the sheath 10 may be non-disposable and sterilizable.

[0046] Regardless of the embodiment and variant, the sheath 10 is advantageously made of transparent material(s). At least the first wall(s) 102a, 102b and the second wall(s) 104a, 104b can advantageously be made of transparent material. This transparency must be sufficient to allow endoscopic observation of the inner surface of the conduit from the access channel 103. The inflation pressure can be adjusted to obtain optimal deformation of the inner surface of the conduit for observation. Preferably, it is possible to move the endoscope within the access channel 103 to observe the inner surface of the conduit along its entire length. The endoscope used for this observation may have an optical system, in particular a wide-angle optical system, whose optical axis is parallel to that of the insertion tube.Alternatively, the endoscope used for this observation may have an optical system whose optical axis is at an angle, in particular an angle of approximately 90°, with that of the insertion tube.

[0047] Regardless of the embodiment and variant, the sheath 10 is advantageously made of a flexible and resistant material such as silicone, latex, nylon, polyethylene terephthalate, or polyvinyl chloride. The chamber(s) can be inflated to a pressure of up to 10 bar, or even 15 bar.

[0048] Regardless of the embodiment and variant, the fluid pressure in the chamber or chambers defines the shape of the duct and / or the dimensions of the duct.

[0049] Several methods can be implemented using the sheath solutions described above.

[0050] For example, a first method allows for the dilation of a duct in an animal's body, particularly a human body. The method comprises the following steps: - mounting a sheath 10 as described above on an endoscope 100, in particular on an insertion tube 3 of an endoscope 100, - insertion of the endoscope 100 and the sheath 10 into the conduit, - injection of a pressurized fluid into the chamber so as to expand the sheath 10 and the conduit accordingly, this expansion being the consequence of the inflation of a chamber 101; 101a, 101b by the fluid, - removal of the sheath from the conduit.

[0051] Preferably, the method includes, after the injection step and before the step of removing the sheath 10 from the conduit, a step of removing at least part of the fluid from the chamber so as to retract the sheath 10 while minimizing the friction of the sheath on the wall of the conduit in order to limit the risk of injury.

[0052] In another example, a second method allows for the placement of an endoprosthesis within the duct in order to maintain or ensure a certain cross-sectional area of ​​the duct, for example, to treat a stenosis. The endoprosthesis may be a tube or pipe, for example, of the stent type, or made of a deformable mesh. The endoprosthesis may be resorbable or non-resorbable.

[0053] In this second method, in a first step, a sheath 10 can be placed according to a solution described above on an insertion tube 3 of an endoscope 100, and then the endoprosthesis can be positioned around the sheath 10.

[0054] Then, in a second step, a chamber 101; 101a, 101b of the sheath 10 can be slightly inflated so that the endoprosthesis is slightly tight around the sheath 10.

[0055] Then, in a third step, the endoprosthesis, the sheath 10, and the insertion tube 3 can be introduced into the conduit. The endoprosthesis can be guided and positioned precisely within and along the conduit due to its retention on the sheath 10 by the slight tightening mentioned previously.

[0056] Then, in a fourth step, the sheath 10 can be inflated to deploy the endoprosthesis, in the case where this endoprosthesis is of the plastically deformable type. This deployment can be ensured along the entire length of the conduit because the sheath 10 has a chamber extending along the entire length of the conduit. When the sheath has been sufficiently inflated for the endoprosthesis to have reached its desired shape, the chamber 101, 101a, 101b can be deflated, thus significantly reducing the transverse dimension of the sheath 10.

[0057] Then, in a fifth step, the endoscope 100 and the sheath 10 can be removed. The endoprosthesis then remains in position in the conduit.

[0058] According to another aspect of the invention, objects are defined by the following propositions: 1. Endoscope sheath (10) comprising: - at least one first chamber (101; 101a, 101b), - a first deformable wall (102), in particular elastically deformable, defining at least partially a boundary of the at least one first chamber (101; 101a, 101b), - a second wall (104) intended to surround an insertion tube (3) of an endoscope (100) and constituting a passage channel (103) for an insertion tube (3) of an endoscope (100), and - at least one opening (106) for the intake and / or discharge of fluid in at least one first chamber (101; 101a, 101b), the sheath (10) being made of transparent material and / or the first wall (102) and the second wall (104) being made of transparent material. 2. Sheath (10) for endoscope according to proposition 1, characterized in that at least one first chamber (101; 101a, 101b) has a cross-section of annular shape. 3. Sheath (10) for endoscope according to proposal 2, characterized in that the second wall (104) is rigid and intended to surround an insertion tube (3) of an endoscope (100) with a gap intended to constitute a rinsing channel (105). 4. Sheath (10) for endoscope according to one of propositions 1 to 3, characterized in that the sheath (10) has several chambers (101; 101a, 101b) distributed around the passage channel (103) of the insertion tube (3). 5. Sheath (10) for endoscope according to one of propositions 1 to 4, characterized in that the sheath (10) has one or more working channels (107) distributed around the passage channel (103) of the insertion tube (3). 6. Sheath (10) for endoscope according to any one of propositions 1 to 5, characterized in that at least one first chamber (101; 101a, 101b) extends over at least 30%, or even over at least 50%, or even over at least 80%, of the length (L10) of the sheath or extends over the whole or substantially over the whole length (L10) of the sheath. 7. Sheath device (10) comprising: - a sheath (10) according to one of the propositions 1 to 6, and - a device (110) for injecting fluid into at least one first chamber (101; 101a, 101b) and / or removing fluid from at least one first chamber (101; 101a, 101b). 8. Endoscope system (800) comprising: - a sheath (10) according to one of proposals 1 to 6 or a sheath device according to proposal 7, and - an endoscope (100). 9. A method for dilating a duct in the body of an animal, in particular the body of a human, comprising the following steps: - mounting a sheath (10) according to one of proposals 1 to 6 on an endoscope (100), in particular on an insertion tube (3) of an endoscope (100), - insertion of the endoscope (100) and the sheath (10) into the conduit, - injection of a pressurized fluid into the chamber so as to expand the sheath (10) and the conduit accordingly, - possibly, removal of at least part of the fluid from the chamber so as to retract the sheath (10), - Removal of the duct sheath. 10. A method for placing an endoprosthesis in a duct of an animal's body, in particular a human body, comprising the following steps: - mounting a sheath (10) according to one of proposals 1 to 6 on an endoscope (100), in particular on an insertion tube (3) of an endoscope (100), - mounting of an endoprosthesis on the sheath (10), - first inflation of the sheath (10) so as to hold the endoprosthesis on the sheath (10), - insertion of the endoprosthesis into the duct, - second inflation of the sheath (10) to bring the endoprosthesis into the desired configuration, - deflation of the sheath (10), - removal of the sheath (10) and the endoscope (100) from the conduit.

Claims

Demands

1. Endoscope sheath (10) comprising: - at least one first chamber (101; 101a, 101b) extending over at least 30%, or even over at least 50%, or even over at least 80%, of the length (L10) of the sheath or extending over all or substantially all of the length (L10) of the sheath, - a first deformable wall (102), in particular elastically deformable, defining at least partially a boundary of the at least one first chamber (101; 101a, 101b), - a second wall (104) intended to surround an insertion tube (3) of an endoscope (100) and constituting a passage channel (103) for an insertion tube (3) of an endoscope (100), and - at least one inlet and / or outlet opening (106) of fluid in at least one first chamber (101; 101a, 101b).

2. Sheath (10) for endoscope according to the preceding claim, characterized in that at least one first chamber (101; 101a, 101b) has an annular cross-section.

3. Sheath (10) for endoscope according to the preceding claim, characterized in that the second wall (104) is rigid and intended to surround an insertion tube (3) of an endoscope (100) with a gap intended to constitute a rinsing channel (105).

4. Sheath (10) for endoscope according to any one of the preceding claims, characterized in that the sheath (10) has several chambers (101; 101a, 101b) distributed around the passage channel (103) of the insertion tube (3).

5. Sheath (10) for endoscope according to any one of the preceding claims, characterized in that the sheath (10) has one or more working channels (107) distributed around the passage channel (103) of the insertion tube (3).

6. Sheath (10) for endoscope according to any one of the preceding claims, characterized in that the sheath (10) is made of transparent material and / or characterized in that the first wall (102) and the second wall (104) are made of transparent material.

7. Sheath device (10) comprising: - a sheath (10) according to any one of the preceding claims, and

8. - a device (110) for injecting fluid into at least one first chamber (101; 101a, 101b) and / or removing fluid from at least one first chamber (101; 101a, 101b). Endoscope system (800) comprising: - a sheath (10) according to any one of claims 1 to 6 or a sheath device according to the preceding claim, and - an endoscope (100).