Insufflation retention device with balloon

Abstract

To provide an insufflation retention device that promotes the retention of an insufflation material within a body cavity even when a body aperture has sustained structural damage that blocks formation of an effective seal with a probe.SOLUTION: A probe may be inserted through a body aperture that is naturally occurring or man-made, intentionally or by accident. The body aperture may form a seal encircling the probe so that an insufflation device may be effectively retained in the body cavity so that an operator can perform the interventions. However, there may be leakage of the insufflation material. The insufflation retention device is configured to form an effective seal contactingly adjacent the body aperture and to provide a passageway for the introduction of the probe into the body cavity, such that a diagnostic intervention or therapeutic intervention or both may be performed.SELECTED DRAWING: Figure 48

Description

Brief Description of the Drawings

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[0002] (DETAILED DESCRIPTION) There is a technique that enables an operator to introduce a probe, such as a medical scope, into a body cavity for diagnostic intervention, therapeutic intervention, or both. When introducing the probe, it may be necessary for the operator to expand the body cavity to perform the intervention. Using an insufflation technique, the operator can introduce an insufflation material to expand the body cavity, so the operator can perform the intervention. , more working space and better visibility can be obtained within the body cavity. For example, "Technology Status Evaluation Report: Methods of luminal distension for colonoscopy, Gastrointestinal Endoscopy, Volume 77, No. 4, 2013, pages 519-525" is incorporated herein by reference in its entirety. The insufflation substance can be air, carbon dioxide, water, or other suitable materials.

[0003] The operator starts the probe from outside the body and advances the probe through the human tissue. , and the probe can be introduced into a cavity of the body, i.e., the body cavity. The probe can be advanced through the tissue via a body opening, i.e., a naturally occurring orifice such as the anus or a wound such as a surgical incision or trauma. The body opening has elasticity such that its size and shape can be restored after being deformed by the probe advancing through the body opening into the body cavity, and can effectively seal the outside of the body from the body cavity. Thereafter, the insufflation substance introduced into the body cavity can be retained within the body cavity, and when the outside of the body is effectively sealed from the body cavity and the operator can intervene, it helps to promote the expansion of the body cavity.

[0004] However, in some cases, the insufflation substance may not be effectively retained within the body cavity. . For example, the body opening or nearby structures have a congenital malformation, or the body opening or nearby structures have scar tissue formation after abscess formation, surgical trauma, birth-related injuries, etc. , there is a possibility that the body opening has suffered a structural damage that inhibits the formation of an effective seal with the probe.

[0005] When the insufflation substance is not effectively retained, the operator cannot secure the time, location, or visibility for operating within the body cavity. For example, a probe such as an endoscope is inserted through anus or other body openings. It can be introduced into the body cavity such as the rectum or the large intestine through the body opening, but the elasticity of the body opening may not effectively form a seal adjacent to the probe in contact with it, and may not promote the retention of the insufflation substance in the body cavity. As will be described in more detail, the present disclosure describes an insufflation retention device that promotes the retention of the insufflation substance in the body cavity.

[0006] Figure 1 shows an insufflation retention device (also known as IRD100 in this specification) advanced from outside the body 102 into the body cavity 104 through a body opening 106, also known as an orifice. The IRD100 can typically include an inner buttress 108, an intermediate portion 110, and an outer buttress 112. The inner buttress 108 is at the first end 114 of the IRD100, and the outer buttress 112 is on the opposite side, between the second end 1 16 of the IRD100 and the intermediate portion 110. In other words, the intermediate portion 110 is disposed between the inner buttress 108 and the outer buttress 112.

[0007] As shown in Figure 1, the width 111 of the inner buttress 108 may be substantially larger than the width 1 13 of the outer buttress 112. Alternatively, the width 111 of the inner buttress 108 may be substantially equal to the width 113 of the outer buttress 112, as shown in later figures. Further more, the width 111 of the inner buttress 108 may be substantially smaller than the width 113 of the outer buttress 112, as also shown in later figures. The width 111 of the inner buttress 108 may be substantially parallel to the width 113 of the outer buttress 112.

[0008] The inner buttress 108 may be configured to have a non-expanded configuration so that an operator can introduce the IRD1 00 into the body cavity 104 through the body opening 106. The non-expanded configuration of the inner buttress 108 may be smaller than the expanded configuration of the inner buttress 108 shown in Figure 1 。The non-expanded configuration of the inner baffle 108 is configured to facilitate the entry of the IRD 100 from the exterior 118 of the body 102. In other words, in the contracted state, the inner baffle 108 can be configured to be inserted into the body cavity 104 of the body 102 through the body opening 106 of the body 102.

[0009] The expanded configuration of the inner baffle 108 is configured to prevent the IRD 100 from being removed from the body cavity 104. When the IRD 100 moves towards the exterior 118 of the body 102, the expanded configuration of the inner baffle 108 contacts and engages with the body cavity 104 or the body opening 106 or both, preventing the IRD 100 from being removed from the body cavity 104. In other words, in the expanded state, the inner baffle 108 can be configured to prevent the inner baffle 108 from being removed from the body cavity 104 through the body opening 106.

[0010] The inner baffle 108 in the non-expanded configuration or the contracted state can be sized to the expanded configuration or the expanded state by introducing an expanding substance supplied by a source into the inner cavity of the inner baffle 108. The expanding substance can be broadly considered to be a fluid. Examples of the expanding substance may include, but are not limited to, liquids such as water, and gases such as oxygen, air, compressed air, and carbon dioxide.

[0011] The inner baffle 108 can be configured to form a body inner baffle seal 105 between the body cavity 104 and the inner baffle 108. The inner baffle 108 is typically shown as a donut shape, but other shapes can be considered depending on the patient's body 102 and the needs of the operator. The shape of the inner baffle 108 can be selected to be a predetermined shape so as to effectively form a body inner baffle seal 105 between the body 102 and the inner baffle 108. When the air supply substance is retained within the body cavity 104, the effectiveness of the body inner baffle seal 105 occurs, thus enabling the operator to perform an intervention and also enabling the operator to secure the time, location, or field of view for working within the body cavity 104.

[0012] The outer buttress 112 may be considered to be in a non-expanded configuration or a contracted state. On the other hand, the non-expanded configuration of the outer buttress 112 is not required. The reason for not requiring the non-expanded configuration of the outer buttress 112 is that the outer buttress 112 is configured to prevent the IRD 100 from being introduced into the body cavity 104. For example, the outer buttress 112 may have a non-expanded configuration that is not configured to prevent the introduction of the IRD 100 into the body cavity 104. In this example, the user or operator can deform or transition the non-expanded configuration of the outer buttress 112 to an expanded configuration of the outer buttress 112 to prevent the IRD 100 from being introduced into the body cavity 104. In other words, the outer buttress 112 can be configured to prevent the outer buttress 112 from advancing through the body opening 106 into the body cavity 104 .

[0013] Similar to the inner buttress 108, the outer buttress 112 in the non-expanded configuration can be sized to an expanded configuration or an expanded state by introducing an expanding substance supplied by a source into the inner cavity of the outer buttress 112. Similarly in this case, the expanding substance can be considered to be broadly a fluid. The expanding substances used for the expansion of the inner buttress 108 and the outer buttress 112 may be the same or different in a given situation.

[0014] However, since the outer buttress 112 does not need to be introduced through the body opening 106, the outer buttress 112 does not need to have a smaller or non-expanded configuration. Therefore, the outer buttress 112 can be substantially the same size and configuration before and after the introduction of the IRD 100 into the body 102, and the outer buttress 112 can be substantially the same size and configuration before, during, and after the use of the IRD 100 in the body 102. However, for other practical considerations, it may be convenient to make the non-expanded configuration of the outer buttress 112 smaller. For example, the outer buttress 112 in the non-expanded configuration may fit more easily in a medical kit or package.

[0015] The outer buttress 112 can be configured to form a body-external buttress seal 107 between the body 102 and the outer buttress 112. The outer buttress 112 is typically shown as conical, but other shapes are conceivable considering the patient's body 102 and the needs of the operator. The shape of the outer buttress 112 can be selected to have a predetermined shape so as to effectively form the body-external buttress seal 107 between the body 102 and the outer buttress 112. When the insufflation substance is held within the body cavity 104, the effectiveness of the body-external buttress seal 107 occurs, and thus the operator can perform the intervention, and the operator can secure the time, location, or visibility for working within the body cavity 104.

[0016] The intermediate portion 110 is configured to connect the inner buttress 108 and the outer buttress 112. The intermediate portion 110 is configured to contact and engage the wall 120 of the body opening 106.

[0017] The intermediate portion can be configured to form a body-intermediate portion seal 109 between the body opening 106 and the intermediate portion 110. The intermediate portion 110 is typically shown as cylindrical, but other shapes are conceivable considering the patient's body 102 and the needs of the operator. The shape of the intermediate portion 110 can be selected to have a predetermined shape so as to effectively form the body-intermediate portion seal 109 between the body 102 and the intermediate portion 110. When the insufflation substance is held within the body cavity 104, the effectiveness of the body-intermediate portion seal 109 occurs, and thus the operator can perform the intervention, and the operator can secure the time, location, or visibility for working within the body cavity 104.

[0018] Figure 2 shows a cross-section of the inner buttress of the IRD 100 of the embodiment shown in Figure 1. The outer periphery 130 of the inner buttress 108 is configured to be expandable from the illustrated non-expanded configuration to an expanded configuration This may also be the case. The inner circumference 132 of the inner buttress 108 can be configured to be relatively rigid compared to the outer circumference 130. The fact that the inner circumference 132 of the inner buttress 108 is relatively rigid can help the IRD 100 maintain its configuration and size when a probe is introduced into the IRD 100 and the probe moves back and forth and rotates inside the IRD 100 when an operator performs an intervention.

[0019] FIG. 3 shows a cross-section of the middle portion of the IRD 100 of the embodiment shown in FIG. 1. Inside the main body 140 of the middle portion 110, there may be an expansion material conduit 142 that can be used by an operator to introduce an expansion material into the internal cavity of the inner buttress 108. As shown in the figure, the outer surface 1 44 of the middle portion 110 can be substantially circular, and thus, when an operator inserts the IRD 100 into the body opening 106, performs an intervention, or removes the IRD 100 from the body opening 106, the IRD 100 can rotate relatively freely clockwise or counterclockwise inside the body opening 106. Similarly, the inner surface 146 of the middle portion 110 can be substantially circular, and thus, when an operator inserts a probe into the IRD 100, performs an intervention, removes the probe from the IRD 100, or attaches the probe to the IRD 100, the IRD 100 can rotate relatively freely clockwise or counterclockwise around the probe. The outer surface 144 of the middle portion may be substantially parallel to the inner surface 146 of the middle portion. In other words, the middle portion 110 may be cylindrical.

[0020] The inner surface 146 of the middle portion 110 can be regarded as a sleeve that surrounds the probe when the middle portion 110 is in use. As shown, the sleeve is substantially circular and can be symmetrically arranged inside the main body 140 of the middle portion 110. Alternatively, the sleeve may be asymmetrically arranged inside the main body 140 of the middle portion 1 10.

[0021] Figure 4 shows a cross-section of the external sheath 112 of the IRD100 of the embodiment shown in Figure 1. The outer periphery 150 of the external sheath 112 may be configured to be expandable from a non-expanded configuration to an expanded configuration. The inner surface 152 of the external sheath 112 may be configured to be relatively rigid compared to the outer periphery 150. The relatively rigid inner surface 152 of the external sheath can help the IRD100 maintain its configuration, so that when the operator performs an intervention, a probe can be introduced into the IRD100, and the probe can move back and forth and rotate inside the IRD100.

[0022] The IRD100 may be made of one or more biocompatible materials. The biocompatible material may be a polymer such as silicone or latex. The same polymer may be used for the inner sheath 108 and the external sheath 112, or different polymers may be used for the inner sheath 108 and the external sheath 112. The same polymer used for the inner sheath 108 and the external sheath 112 may be used for the intermediate portion 110, or different polymers may be used for the intermediate portion 110, the inner sheath 108, and the external sheath 112. The intermediate portion 110 may be integrally formed with the inner sheath 108 and the external sheath 112, or the intermediate portion 110 may be formed from parts different from the inner sheath 108 and the external sheath 112. Also, the inner sheath 108 and the external sheath 112 may be formed of a plurality of different parts. When a plurality of different parts are used to form the IRD100, the parts can be joined using laser welding or the like.

[0023] Figure 5 shows a cross-section of an embodiment of the IRD100 in which the internal cavity 160 of the inner sheath 108 is in fluid communication with the internal cavity of the external sheath 112 through the expansion material conduit 14 2. The expanded state is shown. An inflow valve 164 for the expansion material is shown connected to the external sheath 112. The operator can introduce the expansion material through the inflow valve 164 into the internal cavity 162 of the external sheath 112, the expansion material conduit of the intermediate portion 110 It is introduced into the inner cavity 160 of the tube 142 and the inner buttress 108 using a gas tube, syringe, or other suitable source of the expanding substance.

[0024] FIG. 6 shows a cross-sectional view of another embodiment of the IRD 100 in which the inner cavity 160 of the inner buttress 108 is in fluid communication with the inner cavity 162 of the outer buttress 112 via the expanding substance conduit 142 of the intermediate portion 110. The expanded state is shown. The inflow valve 164 for the expanding substance is shown connected to the outer buttress 112 via an expanding substance line 166 connected to the outer buttress 112. The expanding substance line 166 may be rigid, flexible, or any combination of flexible and rigid. In the case of flexibility, the expanding substance line 166 can assume an appropriate direction and arrangement during use. In the case of rigidity, the expanding substance line can maintain a predetermined direction and configuration before, during, and after use. The operator introduces the expanding substance through the inflow valve 164 into the expanding substance line 166, the inner cavity 162 of the outer buttress 112, the expanding substance conduit 142 of the intermediate portion 110, and the inner cavity 1 08 of the inner buttress.

[0025] FIGS. 5 and 6 show the intermediate portion 110 extending as an inner buttress portion 168 and an opposing outer buttress portion 172. The inner buttress 108 is part of the inner buttress portion 168, and the outer buttress 112 is part of the opposing outer buttress portion 172. The inner buttress 108 may extend substantially shorter than, approximately equal to, or substantially beyond the first end 174 of the inner buttress portion 168. The inner buttress 108 is shown approximately equal to the first end 174 of the inner buttress portion 168. The outer buttress 112 may extend substantially shorter than, approximately equal to, or substantially beyond the second end 176 of the outer buttress portion 172. The outer buttress 112 is shown approximately equal to the second end 176 of the outer buttress portion 172.

[0026] The diluent conduit 142 of the middle portion 110 can take any shape. FIG. 5 shows that the diluent conduit 142 starts substantially perpendicular to the inner buttress 108 and the outer buttress 112, while FIG. 6 shows that the diluent conduit 142 starts in a substantially curvilinear direction with respect to the inner buttress 108 and the outer buttress 112. Further, one or more pressure relief valves of the IRD 100 can be configured to control when the expansion of the outer buttress 112 and the inner buttress 108 occurs with respect to the introduction of the diluent. The pressure relief valve can be of any suitable construction and is not shown.

[0027] FIG. 7 shows a cross-sectional view of another embodiment of the IRD 100 in which the inner buttress inlet valve 180 is in fluid communication with the diluent conduit 142 from the middle portion 110 to the inner buttress 108, while the outer buttress 112 is not in fluid communication with the inner buttress inlet valve 180. The inner buttress 108 is shown in a non-expanded state. Of course, although not shown, the inner buttress inlet valve 180 may be in direct fluid communication with the inner buttress 108 without passing through the intervening diluent conduit 142.

[0028] FIG. 8 shows a cross-sectional view of another embodiment of the IRD 100 in which the inner buttress inlet valve 180 is in fluid communication with the diluent conduit 142 such that the introduction of the diluent through the diluent line 166 expands the inner buttress 108. Further, the outer buttress inlet valve 182 is in fluid communication with the outer buttress 112 such that the introduction of the diluent expands the outer buttress 112. In this embodiment of the IRD 100, the inner buttress inlet valve 180 and the outer buttress inlet valve 182 are through the introduction and removal of the diluent through the inner buttress inlet valve 180 and the outer buttress inlet valve 182 , can be independently operated by an operator or user so as to expand and contract the inner buttress 108 and also so as to expand and contract the outer buttress 112. The inner buttress 108 is shown in an expanded state by an expanding substance supplied from an expanding substance source 184. is shown.

[0029] The outer buttress 112 is shown to have a rectangular shape, in contrast to other buttresses already shown in a donut shape, conical shape, etc. Any suitable shape can be used for the inner buttress 108 or the outer buttress 112.

[0030] Furthermore, the intermediate portion 110 can have an outer surface 190 that is not substantially flat. In other embodiments, the outer surface 190 of the intermediate portion 110 may be substantially flat. In this embodiment shown in FIG. 8, the outer surface 190 of the intermediate portion 110 has a contour that is not substantially flat. The contour can be selected by the operator based on the anatomical form of the body opening 106 (see FIG. 1) and other features. The contour can help to achieve and maintain an effective seal for the IRD 100 to hold the insufflation substance. The shape and size of the contour can depend on the presence or absence of the expanding substance. As shown in FIG. 8, the contour can have an expanding substance introduced via an expanding substance line 166 that supplies the expanding substance to the inner buttress 108. Of course, the contour can have an expanding substance introduced via an independent expanding substance line different from the expanding substance line 166 that supplies the expanding substance to the inner buttress 108.

[0031] In addition to transitioning from a contracted or non-expanded state with less expanding substance to an expanded state with more expanding substance, typically the intermediate portion 110 and the contour can be substantially rigid, as a non-limiting specific example. In embodiments having a substantially rigid contour, the intermediate portion 110 does not substantially deform during use of the IRD 100 from the direction and configuration of the IRD 100 before or after use of the IRD 100.

[0032] FIG. 9 shows another embodiment of the IRD 100. In this embodiment, the IRD 100 is the first It has a first body part 200 and a second body part 202. The first body part 200 is connected to the second body part 202 and is configured to form a usable IRD 100. The operator can use such two body parts when the probe is already in the body opening 106, or when it is in both the body opening 106 and the body cavity 104 (see FIG. 1). When the probe is in this position in the body opening 106 or the body cavity 104, it may be difficult for the operator to insert the probe through the IRD 100 or slide the IRD 100 onto the probe. On the other hand, the operator can connect the first body part 200 to the second body part 202 around the probe staying at the position of the body opening 106, or both the body opening 106 and the body cavity 104. The first body part 200 can be connected to the second body part 202 via one or more pairs of any suitable type of fastener 204, such as but not limited to snaps, clips, etc. Of course, this embodiment can also be used before the probe is in the body opening 106 or the body cavity 104 or both.

[0033] As shown in this embodiment, the first body part 200 and the second body part 202 can have substantially parallel walls configured to effectively form a sleeve providing a passage for the probe when the first body part 200 can be connected to the second body part 202. In this embodiment, the first internal buttress part 207 and the second internal buttress part 209 may be supplied with the expanding substance through different introductions of the expanding substance. In other words, the first internal buttress part 207 and the second internal buttress part 209 may not be in fluid communication.

[0034] Similarly, different introduction of the expanding substance may supply the expanding substance to the first external buttless component 211 and the second external buttless component 213, because the first external buttless component 211 and the second external buttless component 213 may not be in fluid communication. In this embodiment having the first main body component 200 and the second main body component 202, it may be inconvenient to fluidly communicate the buttless components. Of course, one or more various buttless components not shown may be in fluid communication.

[0035] FIG. 10 shows another embodiment of the IRD 100. In this embodiment, at the first hinge side 226 of the first main body component 2 20 and the second hinge side 228 of the second main body component 222, the first main body component 220 is connected to the second main body component 2 22 via the hinge portion 224 or a flexible member. The hinge portion 224 may be configured such that an operator can operate it with one hand to change the IRD1 00 from the open configuration shown in FIG. 10 to a closed configuration not shown. One or more pairs of fasteners 204 can connect the first opening edge portion 230 of the first main body component 220 to the second opening edge portion 232 of the second main body component 222. The fastener 204 can extend beyond the first main body component 220 and the second main body component 222 shown in FIG. 10, or , can be within the perimeter of the first main body component 200 and the second main body component 202 shown in FIG. 9.

[0036] In the configuration shown in FIG. 10, it may be convenient for an internal buttless (not shown) to surround and fluidly communicate the first main body component 220 and the second main body component 222, in other words, it may be convenient to fluidly communicate substantially the entire main body component as in some other embodiments. Further, as in some other embodiments, it may be convenient for an external buttless (not shown) to substantially surround and fluidly communicate the first main body component 220 and the second main body component 222. The internal buttless 108 and the external buttless 112 are not shown in FIG. 1 for simplicity It is not shown in 0 and would be understood to be on the surface of the IRD100 on the back of the figures that are shown.

[0037] Figures 11-12 show cross-sections within the internal buttress 108 in other embodiments of the IRD100. In these embodiments, the internal buttress 108 can be connected to the internal buttress body part 240 via laser welding, adhesion, or other suitable means. Or, the internal buttress 108 can be one object with the internal buttress body part 240. The internal buttress body part 240 can have a bias to a closed state to form a sleeve sized and dimensioned to fit around a probe used by an operator. The internal buttress body part 240 is shown in an open state in Figure 11. When the IRD100 is in the body cavity 104, at the body opening 106, or both, and the internal buttress body part 240 is in an open state, or when the IRD100 is not in the body cavity 104, not at the body opening 106, or not both (see Figure 1), the operator can place the IRD100 around the probe. Further, Figure 12 shows the internal buttress body part 240 with a first fastener 242 and a second fastener 244. The first fastener 242 is configured to connect with the second fastener 244 to form a sleeve sized and dimensioned to fit around the probe.

[0038] Furthermore, the internal buttress 108 can overlap the body part 240 as shown and help form an effective seal for retaining the insufflation substance. Alternatively, although not shown, the internal buttress 108 may not overlap the internal buttress body part 240 and can still achieve an effective seal for retaining the insufflation substance.

[0039] Similarly, although not shown, the external buttress may or may not overlap with a similar external buttress body part to form an effective seal for the insufflation substance.

[0040] FIG. 13 shows a side cross-sectional view of the probe 250 passing through the body opening 106, and FIG. 14 shows an end view. The body opening 106 forms an effective body probe seal 252 with the probe 250 inserted through the body opening 106 and , effectively forms a body probe seal 252. Further, a layer of lubricant 254 is typically lathered onto the probe 250 before entering through the body opening 106. . A layer of lubricant 254 disposed between the body opening 106 and the probe 250 further aids in forming the body probe seal 252 between the body opening 106 and the probe 250. The lubricant 254 can be of any suitable type for reducing friction between the body opening 106 and the probe 250.

[0041] FIG. 15 shows a side cross-sectional view of the probe 25 0 passing through the body opening 106 having an abnormality 256, and FIG. 16 shows an end view. The body opening 106 cannot effectively form a body probe seal 252 with the probe 250 inserted into the body opening 106 having the abnormality 256. For some reason such as congenital deformity, tumor, previous tumor, muscle relaxation, etc., the body opening 106 cannot effectively form a body probe seal 25 2 with the probe 250 passing through the body opening 106.

[0042] FIG. 17 shows side cross-sectional views of the probe 250 passing through the body opening 106 having an abnormality 256 and the probe 250 passing through the IRD 100 according to various embodiments, and FIG. 18 shows an end view. Similar to the configuration of a window in a house, the IRD 100 can effectively form a seal with the body 102 to facilitate retention of the air supply material within the body cavity 104. Further, the IRD 100 can provide a sleeve of a predetermined configuration and size according to the probe to effectively form a seal with the probe and further facilitate retention of the air supply material within the body cavity 104.

[0043] Of course, the IRD100 can be used with the probe 250 at the body opening 106 where the deformation 256 does not exist. However, even when the IRD100 is used with the probe 250 at the body opening 106 having the deformation 256, the IRD100 is configured to promote the retention of the insufflated substance inserted into the body cavity 104 during the time effective for the operator to perform diagnostic intervention, therapeutic intervention, or both, which is superior to the retention of the insufflated substance achievable using the probe 250 without the IRD100. The probe passage seal 260, the body intermediate seal 109, and the body internal buttress seal 105 can be configured to cooperate with the probe 250 to promote the retention of the insufflated substance inserted into the body cavity 104 during the time effective for the operator to perform diagnostic intervention, therapeutic intervention, or both. On the other hand, the passage 264 may be open without the probe 250 present therein, and thus the insufflated substance may not be retained in the body cavity 104.

[0044] The IRD100 can form an effective seal with the body intermediate seal 109 between the intermediate portion 110 and the wall 120 of the body opening 106, the body external buttress seal 107 between the external buttress 112 and the wall 120 of the body opening 106, and the body internal buttress seal 105 between the internal buttress 108 and the body cavity 104 or the body 102, which is possible even when the deformation 2 56 exists. As shown in FIG. 17, the intermediate portion 110 may be integrated with the external buttress 112 or be operationally proximate, and both functions prevent the forward movement of the IRD100 into the body cavity 104 during operation.

[0045] Furthermore, the IRD100 can effectively form the probe passage seal 260 when the probe 250 is inserted into the IRD100. The passage 26 4 through the intermediate portion 110 of the IRD100 can be configured to form the probe passage seal 260 between the probe 250 and the passage 264. The passage 264 is at the first end 174 and the second end 176 of the IRD100 (FIG. extends beyond (refer to FIGS. 5 and 6), and thus the probe 250 extends widely through the IRD 100.

[0046] Furthermore, the outer surface 190 of the intermediate portion 110 may be configured to provide a contour feature 266 that engages with the deformation 256 to provide an effective seal. Of course, the contour feature 26 6 may be a protrusion, indentation ), or a combination of both that engages with the deformation 256 to provide an effective seal. Further, the contour feature portion 266 may be formed from the outer buttress 112, or both the intermediate portion 110 and the outer buttress 112. Additionally, the inner buttress 108 may have a contour feature, and other shapes may be considered as described above, taking into account the patient's body 102 and the needs of the operator.

[0047] FIGS. 19 - 25 show various views of an IRD 100 according to another embodiment. The IRD 100 may have an inner buttress 108 and an outer buttress 112, with an intermediate portion 110 therebetween. The IRD 100 may be made with a seam 2 92 that extends along the length of the IRD 100 as shown, or a portion thereof. The seam 292 may essentially be a gap or crack between the surfaces of the material that is folded upon itself to form the IRD 100. If the surfaces of the material are folded upon themselves to bring the IRD 100 into contact with each other, the seam 292 may not be present. The outer buttress 112 has a tapered surface 294 that is substantially conical to facilitate an effective seal with the body 102 (refer to FIG. 1).

[0048] The internal bias member 290 having a bias tension cooperates with the remaining bias tension of the IRD 100 to keep the IRD 100 in a closed state during operation. The internal bias member 290 may be substantially in the same plane as the inside of the IRD 100, or the internal bias member 290 may not be substantially in the same plane as the inside of the IRD 100. On the other hand, when the probe 250 is in the body opening 106, the body cavity 104, or both, the shown IRD 100 can be opened to enclose the probe 250, and the IRD can be inserted into the body opening 106 through the body opening 106. The internal bias member 290 is configured for single-handed or two-handed operation.

[0049] The access port 298 of the external buttress 112 may be configured to have a diameter larger than the diameter of the passage 264, and the diameters are substantially parallel to each other. By having a diameter of the access port 298 larger than the diameter of the passage 264, the operator may have a larger target for inserting the probe 250 into the passage 264. The diameter of the passage 264 can be configured and sized to fit snugly around the diameter of the probe 250, and thus, a probe passage seal between the passage and the probe can be more easily achieved. In this case as well, these diameters are substantially parallel to each other. The internal taper 296 of the external buttress 112 may have an internal taper 296 such that the diameter of the access port 298 can taper down to a smaller diameter of the passage 264. The internal taper 296 is shown as substantially straight in FIG. 22 resulting in a conical structure, but any suitable shape that facilitates the operator's manipulation of the probe 250 into the passage 264 is conceivable. 64 than when it is substantially the same size as the diameter of the passage 264, the operator may have a larger target for inserting the probe 250 into the passage 264. The diameter of the passage 264 can be configured and sized to fit snugly around the diameter of the probe 25 0, and thus, a probe passage seal between the passage and the probe can be more easily achieved. In this case as well, these diameters are substantially parallel to each other. The internal taper 296 of the external buttress 112 may have an internal taper 296 such that the diameter of the access port 298 can taper down to a smaller diameter of the passage 264. The internal taper 296 is shown as substantially straight in FIG. 22 resulting in a conical structure, but any suitable shape that facilitates the operator's manipulation of the probe 250 into the passage 264 is conceivable.

[0050] This embodiment is shown as a solid structure, and when the internal buttress 108 is a compressible material (e.g., foam by way of example and limitation), the IRD 100 can be a solid structure, and thus, the internal buttress 108 can be pushed through the body opening 106 in a contracted state and, once inside the body cavity 104, can expand to an expanded state. Of course, this similar structure, such as the access port 298 having the internal taper 296, can exist with features from other embodiments including an internal buttress 108 expandable by an expanding substance.

[0051] Figures 25 - 29 show various views of the IRD 100 according to another embodiment. The internal buttress 108 and the external buttress 112, although not shown, can be in fluid communication through the intermediate portion 110 via a substantially rectangular balloon, also known herein as the passage structure 300. The intermediate portion 110 can be compressed by an external compression member 302 that essentially biases the fluid within the passage structure 300 towards the internal buttress 108 and the external buttress 112. The external compression member 302 can contact and be adjacent to the outer surface of the passage structure 300. The external compression member 302 in the closed position can push or not push substantially all of the fluid, i.e., the expanding substance from the intermediate portion 110 of the IRD 100 that is ready for use by the operator. The passage structure 300 is actually shown and is considered to be rectangular and symmetric during operation, but other suitable sizes and dimensions can be considered in view of the patient's body 102 and the user's needs.

[0052] The external compression member 302 can have an internal bias member 304 that is internally in a rolled state relative to an external bias member 306 of the external compression member 302 in the closed position shown in Figures 27 - 29. Further, the external compression member 302 is shown to overlap the external bias member 306 that overlaps the internal bias member 304, but the external compression member 302 itself may not overlap, and the internal bias member 304 itself may not overlap. The external compression member 302 is configured to be operable with one hand or both hands from the open position, and the external compression member 30 The IRD 100 in the open position can be arranged to surround the probe 250, and the IRD 100 in the closed position can be maintained around the probe 250.

[0053] The external compression member 302 is shown outside the balloon forming part of the inner buttress 108, the outer buttress 112, and the middle part 1 10, but it is quite conceivable that the external compression member 302 may be inside the passage structure 300.

[0054] Figures 30 - 32 show cross-sectional views of the cut IRD 100 with an O-ring type structure 280, or a plurality of O-ring type structures 280, according to various embodiments. The IRD 100 cooperates with the probe 2 50 to form a probe passage seal 260, which is an effective seal between the IRD 100 and the probe 250. Further, the layer of lubricant 25 4 between the IRD 100 and the probe 250 can help or promote the effectiveness of the probe passage seal 260 between the IRD 100 and the probe 250.

[0055] Furthermore, the O-ring type structure 280 along the sleeve can help promote the seal between the IRD 100, for example, between the middle part 1 10 and the probe 250. The O-ring type structure 280 is fixed to the sleeve at the first O-ring end 282, and the opposite second O-ring end 28 4 may be movable. The O-ring type structure 280 can be one of the plurality of O-ring type structures 280. The O-ring type structure 280 can be rigid, but there may be advantages in making the O-ring type structure 280 flexible, so that when the probe 250 advances, the opposite second O-ring end 284 is drawn into the body cavity 104, and when the probe 250 retracts, the opposite second O-ring end 284 is drawn out of the body cavity 104.

[0056] As described in various embodiments, when the probe is within body opening 106 or body cavity 104, the operator will not be able to insert the probe through IRD 100 into its interior or slide IRD 100 over the probe. In contrast, in other embodiments, the operator can connect IRD 100 around the probe that remains in a position within body opening 106, or within both body opening 106 and body cavity 104.

[0057] One of ordinary skill in the art will understand that the probe may be, by way of non-limiting example, an endoscope. Commercially available endoscopes have a light source configured to illuminate the lumen of the colon, such as body cavity 104, and an integrated air pump configured to supply air to the lumen of the colon to expand it during a colonoscopy. Additionally, one of ordinary skill in the art will understand that the endoscope may be configured to use CO2, water, or other suitable substances for aspiration of the lumen of the colon.

[0058] One of ordinary skill in the art will understand that in a colonoscopy, the quality of bowel preparation greatly affects the success of the colonoscopy. Numerous bowel preparations are available to adequately clean the bowel. For example, "Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization, Ann Gastroenterol 2016; 29 (2): 137-146", which is hereby incorporated by reference in its entirety.

[0059] Furthermore, FIG. 33 shows a commercially available endoscope 350 with which one of ordinary skill in the art is familiar. The commercially available endoscope 3 50 has three main parts: a connector portion 352, a control portion 354, and an insertion tube 356. 。The connector portion 352 is for attaching the endoscope 350 to a system 358 including a display, an image processing device, a light source and a power source, and a supply source of water, air, CO2 or other suitable substances. The control unit 354 is attached to the connector portion 352. The control unit 354 is held by an operator to control a dial that deflects the tip 360 of the insertion tube 356 up, down, left, and right. The control unit 354 may have individual buttons for suction, aspiration, and imaging. Finally, the control unit 354 may have an access port for inserting an accessory into the body cavity 104 through the conduit of the insertion tube 356. Many endoscopes have additional control functions. The insertion tube 356 is a flexible shaft attached to the control unit 354. The insertion tube 356 may include one or more conduits for accessories, washing water, aspiration, etc. The insertion tube 356 may include an angle-forming actuator for bending the tip 360 of the insertion tube 356. The tip 360 of the insertion tube 356 may include an image generation device, an illumination system, an aspiration opening, an objective lens, and a water jet for cleaning the lens. The length, diameter, and flexibility of the insertion tube 356 vary depending on the type and manufacturer of the endoscope, and the diameter ranges from about 4.9 mm to about 12.9 mm. For example, "Report on Emerging Technology: GI Endoscopes, Gastrointestinal Endoscopy, Volume 74, No. 1, 2011, pages 1-6" is hereby incorporated by reference in its entirety.

[0060] Accordingly, those skilled in the art will understand that in all embodiments, the probe 250 can be inserted into the IRD 100 when the IRD 100 is outside the body cavity 104 or body opening 106, but when the IRD 100 is inside the body cavity 104 or body opening 106, the probe 250 can be inserted into the IRD 100 only in some of the embodiments. For example, referring to FIG. 1, the internal buttress 108 is the probe 25 Since it is configured seamlessly around 0, the internal bezel 108 is configured to have only a closed state. The probe 250 can be inserted into the seamless internal bezel 108 only when the IRD 100 is outside the body cavity 104 or the body opening 106. On the other hand, referring to FIG. 11, since the internal bezel 108 is configured to have a cut around the probe 250, the internal bezel 108 is configured to have a closed state and an open state. When the internal bezel 108 has a cut, the operator can place the IRD 100 around the probe when the IRD 100 is inside the body cavity 104 , the body opening 106, or both, and the internal bezel 108 is in the open state, or when the IRD 100 is not inside the body cavity 104, the body opening 106, or both.

[0061] FIG. 34 shows, as will be understood by those skilled in the art, an end view showing the relationship between an embodiment showing the seamless structure of the internal bezel 108 around the probe and the structure of the internal bezel 108 around the probe 250 having a cut. The probe 250 is shown substantially as a cylinder and the internal bezel 108 is shown as a ring, but other shapes (e.g., oval, etc.) can also be employed and are disclosed herein.

[0062] FIG. 34(A) shows the probe 25 0 outside the seamless structure of the internal bezel 108. In the seamless structure of the internal bezel 108, as shown in the upper right figure, the only way to place the internal bezel 108 around the probe 250 is to position the probe 250 inside the internal bezel 108 and slide the internal bezel 108 relative to the probe 250 so that it is surrounded by the internal bezel 108. In this state In this embodiment, the probe 250 extends through the passageway 264. If the internal buttress 108 has a continuous structure and the probe 250 is within the body opening 106 or cavity 104, the internal buttress 108 will not be able to slide over the probe 250. For example, if the probe is a colonoscope, the probe will only be able to slide at one end into the internal buttress 108. In such an example, the colonoscope 350 will be fitted with a probe 250 that is inserted into the passageway 264. 50. However, the insertion tube 356 is configured to slide over the insertion tube 3 56 may have disposed at a first end thereof a control portion 354, a connector portion 352, and a system 358 that may prevent the insertion tube 356 from sliding over the internal buttress 108 at the first end. The colonoscope 350 has a tip 360 at a second end of the insertion tube 356 that is configured to slide into the internal buttress 108. However, when the tip 360 is within the body orifice 106 or body cavity 104, the tip 360 is not available for sliding into the internal buttress 108.

[0063] Figure 34(B) shows, from left to right, the internal buttress biased into a closed position. 108, the probe 250 is shown outside the unitary structure of the internal buttress 108 in an open configuration, and the probe 250 is shown within the internal buttress 108 and surrounded by the internal buttress 108 in a closed configuration. In manufacturing the IRD 100 as a single semi-rigid member having a seam 292 along the entire length of its sides, it may be difficult to facilitate sliding the IRD 100 over the probe after it has been placed within the body opening 106, body cavity 104, or both. Therefore, as discussed elsewhere herein, it may be necessary to include a bracket 656 or other fastener to bring the edges of the seam 292 closer together so that the IRD 100 can improve retention of the pneumoperitoneum.

[0064] FIG. 34(C) shows, in order from left to right, the probe 250 outside the two structures of the internal buttress 108, the probe 250 within the open internal buttress 108, and the probe 250 located within the internal buttress 108 and surrounded by the closed internal buttress 108.

[0065] FIG. 35 shows a perspective view of another embodiment of the IRD100. As shown , the outer buttress 112, the intermediate portion 110, and the internal buttress portion 168 may be integrally formed. Alternatively, as shown in other embodiments, the outer buttress 112, the intermediate portion 110, and the internal buttress portion 168 may be formed from two or more members. The combined outer buttress 112, intermediate portion 110, and internal buttress portion 168 are referred to herein as the handle or base member 400.

[0066] The internal buttress 108 may be fixed to the base member 400 by heat staking / welding, laser welding, inductive coupling, RF welding, impact sealing, adhesives, or other suitable methods. Similarly, the balloon may be formed by various processes such as dip molding, thermoforming, welding of extruded films, or other suitable methods. The base member 400 may be formed by injection molding, compression molding, transfer molding, liquid silicone rubber molding, or other suitable methods. All materials are biocompatible.

[0067] The base member 400 may be semi-rigid and have greater rigidity than the internal buttress in the expanded state. The internal buttress may be a balloon having a non-expanded state and an expanded state (as shown). The balloon may be configured to connect onto itself in the expanded state and snap closed. The balloon may be thermally formed such that when the balloon expands from the non-expanded state to the expanded state, the first end 402 of the internal buttress 108 engages the second end 404 of the internal buttress 108 to form a seal between the two ends of the balloon portion of the internal buttress 108. By doing so, the balloon in the expanded state forms an internal buttress 108 that forms an effective seal for holding the inhaled substance.

[0068] In the non-expanded state, the internal buttress is in an open state. In the expanded state, the internal buttress 108 is in a closed state. In the non-expanded state of the internal buttress 108, the base member 400 may be in an open state having a seam 292 along its entire length. Internal buttress 1 08. In the expanded state, the base member 400 may be in a closed state. In the open state of the internal buttress 1 08 and the base member 400, when the probe is inside a body opening, body cavity, or both a body opening and a body cavity, the seam 292 is substantially open, so the IRD 100 can be placed around the probe. In the closed state of the internal buttress 108 and the base member 400, when the probe is inside a body opening, body cavity, or both a body opening and a body cavity, the seam 292 is substantially closed, so the IRD 100 cannot be placed around the probe. However, in the closed state of the internal buttress 108 and the base member 400, when the probe is not inside a body opening, body cavity, or both a body opening and a body cavity, the IRD 100 can be slid onto the probe. This is because the passage 264 for the probe is open so that the inhaled substance does not continue to be held when the probe is not present.

[0069] As shown, the inner buttress 108 is not configured to engage the probe, and thus the inflated balloon of the inner buttress 108 does not contribute to the seal between the IRD 100 and the probe. Alternatively, the inner buttress 108 may be configured to engage the probe to contribute to the seal between the IRD 100 and the probe.

[0070] Figure 36 shows a perspective view of another embodiment of the IRD 100. As shown , the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be integrally formed. The inner buttress 108 may be a balloon having a non-inflated state (not shown). The inner buttress 108 may be a balloon having an inflated state as shown. The inner buttress 108 may be attached to the base member 400. The base member 400 may be semi-rigid having greater rigidity than the inflated inner buttress 108. The user may wrap the inner buttress 108 around the base member 400 when the inner buttress 108 is in the non-inflated state. Then, the user inserts the IRD 100 into the patient and inflates the inner buttress 108 from the non-inflated state to the inflated state.

[0071] As described above, in the non-inflated state, the inner buttress 108 is in an open state. In the inflated state, the inner buttress 108 is in a closed state. In the non-inflated state of the inner buttress 108, the base member 400 may have an open state (not shown) with a seam 292 along its entire length. In the inflated state of the inner buttress, the base member 400 may be in a closed state. In the open state of the inner buttress 108 and the base member 400, when the probe is inside a body cavity, a body opening, or both a body cavity and a body opening, the seam 29 Since 2 is substantially open, the IRD 100 can be disposed around the probe. In the closed state of the internal buttress and the base member 400, when the probe is inside the body cavity, body opening, or both the body cavity and the body opening 106, the seam 292 is substantially closed, so the IRD 100 cannot be disposed around the probe. However, in the closed state of the internal buttress 108 and the base member 400, when the probe is not inside the body cavity, body opening, or both the body cavity and the body opening, a passage for the probe is open, so the IRD 100 can be slid onto the probe.

[0072] As shown, the balloon portion of the internal buttress 108 is configured not to engage the probe when the probe is present, and thus the expanding internal buttress 108 does not contribute to the seal between the IRD 100 and the probe.

[0073] As shown, the internal buttress portion may have a chamfered portion 406 or an end with an inclined edge, which facilitates entry of the IRD 100 into the body cavity through the body opening. Alternatively, as shown in other embodiments, the internal buttress 108 may have an end with a rounded edge.

[0074] Figures 37-38 show cross-sectional views of other embodiments of the IRD 100. The external buttress 112 , the intermediate portion 110, and the internal buttress portion 168 are referred to as the base member 400 and may be formed from two or more members or components. For example, the external buttress 112, the intermediate portion 110, and the internal buttress portion 168 may be formed by combining a first body component 200 and a second body component 202. The first body component may have a first body external buttress 112, a first body intermediate portion 110, and a first body internal buttress portion 168. The second body component may have a second body external buttress 112, a second body intermediate portion 110, and a second It may also have an internal buttless portion 168 inside the body 2. When the first body component and the second body component are combined, the first body component and the second body component form the external buttless 112, the intermediate portion 110, and the internal buttless portion 168 of the IRD 100.

[0075] The internal buttless 108 may be attached to the base member 40 0 by welding, adhesive, or other suitable methods. The first body component and the second body component may be semi-rigid having greater rigidity than the internal buttless 108 in the expanded state. The internal buttless 1 08 may be a balloon having a non-expanded state and an expanded state (as shown). The balloon of the first body component 200 may be separate from and separable from the balloon of the second body component. The first body component 200 may have an expansion material line 166 that fluidly communicates with a first expansion material conduit that fluidly communicates with a first internal cavity of the first balloon. The second body component 202 may have a second expansion material line 466 that fluidly communicates with a second expansion material conduit that fluidly communicates with a second internal cavity of the second balloon. The first balloon and the second balloon may be inflated independently in sequence by one supply source or simultaneously by two supply sources. Alternatively, the first expansion material line and the second expansion material line may be connected by a Y-valve, and the user can also inflate both the first balloon and the second balloon simultaneously using a single supply source.

[0076] The first body component and the second body component may have fasteners such as snaps 205 and snap receivers 206, by way of non-limiting example. Further, the first body component 200 and the second body component 202 may have guides such as positioning pins 208 and positioning holes 210, by way of non-limiting example. The fasteners on the first body component 200 may be arranged to engage the fasteners on the second body component 202. The guides on the first body component 200 may be arranged to engage the guides on the second body component 202. For any configuration of the IRD 10 Even at 0, since the first main body component and the second main body component are mirror image components that are inverted with respect to each other, the actual components that become the first main body component and the second main body component may be used interchangeably after manufacture.

[0077] As shown in FIG. 38, the first main body component 200 and the second main body component 202 may be connected via a hinge 225 between the first main body external buttress 112 of the first main body component 200 and the second main body external buttress 112 of the second main body component 202.

[0078] As shown in the drawing, the extended portion of the internal buttress 108 may be configured not to engage with the probe 250, and thus the extended portion of the internal buttress 108 does not contribute to the sealing between the IRD10 0 and the probe. The internal buttress 108 is configured to extend radially from the IRD100 as the internal buttress 108 extends.

[0079] FIGS. 39, 40, and 41 show cross-sectional views of other embodiments of the IRD100. The external buttress 112, the intermediate portion 110, and the internal buttress portion 168 may be formed from two or more members or main body components. For example, the external buttress 112, the intermediate portion 110, and the internal buttress portion 168 may be formed by combining a first main body component and a second main body component. The first main body component may have a first main body external buttress, a first main body intermediate portion , and a first main body internal buttress portion. The second main body component may have a second main body external buttress, a second main body intermediate portion, and a second main body internal buttress portion. When the first main body component and the second main body component are combined, the first main body component and the second main body component may form a main body component composed of an external buttress, an intermediate portion, and an internal buttress portion, which is also referred to as a base member in this specification.

[0080] The body part shown in FIG. 39 is complementary to the body part shown in FIG. 40 or FIG. 41. In other words, the external buttress 112, the intermediate part 110, and the internal buttress part 168 may be complementary. As shown, the external buttress 112, the intermediate part 110, and the internal buttress part 168 may be integrally formed. The passage 264 extends from the internal buttress 108 through the intermediate part 110 to the external buttress 11 2 along the entire length of the side of the IRD 100. The passage 264 may be defined by a passage structure that extends from the internal buttress 108 to the external buttress 112.

[0081] The complementary features of the body part may be reversed if necessary. As shown , the diluent line 166 for the IRD 100 may be provided in only one of the first body part or the second body part. As shown by the dotted line, the diluent conduit 142 may extend throughout the body part from the diluent line 166 to the internal cavity of the balloon that is present, whereby the diluent line is in fluid communication with the internal cavity. The first body part may be in fluid communication with the second body part via a valve 600 such as the male valve / snap shown in FIG. 39 that engages the female valve / snap shown in FIG. 40 or FIG. 41, by way of non-limiting example. In other words, these two parts may be snap-coupled to each other to form a continuous air passage for enabling inflation from one diluent line 166 and a source. Thus, the balloons are separated in the sense that one is formed and attached to the first body part and the other is formed and attached to the second body part, but the balloons may be in fluid communication with a common diluent line 166 and a source for both balloons.

[0082] Furthermore, the body part may have a fastener or positioning guide, such as a male / female positioning mechanism (214 and 216, respectively), to facilitate alignment of the first and second body parts and assembly of the IRD 100, as shown in the internal buttress part.

[0083] As with other embodiments, the inner surface 344 of the passage 264 may support one or more O-ring type structures, also referred to herein as washers or sphincters. One passage may have O-ring type structures 280 of different diameters so that probes of various diameters can be placed inside the passage and a seal of the O-ring type structure of the probe can be formed. If two or more O-ring type structures 280 are used, the larger-diameter one may be arranged on the side of the outer buttress 112, and the smaller-diameter one may be arranged on the side of the inner buttress 108, or the reverse arrangement may be adopted.

[0084] As shown, the inner buttress 108 may be a balloon. The balloon may have a variable thickness 610 to facilitate inflation for expansion by insertion of an expanding substance. The balloon may be thinner towards the first end 174 of the inner buttress portion 168 to facilitate expanding the balloon towards the inner buttress portion 168. As shown in FIG. 39, which shows an alternative balloon arrangement that can be employed. FIG. 39 shows that the balloon extends from the outer periphery of the inner buttress portion around the first end 174 of the inner buttress portion 168. The expanded balloon may be configured to engage the probe through the passage 264 to form a seal between the balloon and the probe if a probe is present. The balloon may be configured not to engage the probe through the passage 264 so as not to form a seal between the balloon and the probe if a probe is present, in which case a seal may be formed between the IRD 100 and the probe within the passage 264 by other features. In any situation of a particular embodiment, the expanded balloon is not closed

[0085] and thus the IRD 100 cannot hold the inhaled substance when there is no probe within the IRD 100.

[0086] Figure 40 shows the balloon expanding into the passage 264 through the periphery of the inner buttless portion 168 and around the first end 174 of the inner buttless portion 1 68. The depth of the balloon into the passage 264 is shown to be substantially the same as the depth of the balloon along the outer periphery of the inner buttless 108, although the depth of the balloon into the passage 264 may be substantially greater or less than the depth of the balloon along the outer periphery of the inner buttless 108. The inflation of the balloon within the passage 264 may form a probe balloon seal that accommodates probes of different diameters, such as a larger diameter 700 as shown in FIG. 49(A) and a smaller diameter 702 as shown in FIG. 49(B). With the probe within the passage, a predetermined volume of inflation material may be inserted into the inner cavity of the balloon. The user using a syringe, pressure cuff pump, or other suitable source of inflation material will feel resistance to further insertion of the inflation material. In certain embodiments, the inflated balloon is not closed, and thus the IRD 100 cannot hold the inhaled material when there is no probe within the passage 264.

[0087] Figure 41 shows a balloon configured as an inner balloon 632 within the passage 264 and an outer balloon 634 outside and surrounding the passage 264. As shown, the inner balloon 632 and the outer balloon 634 may be in fluid communication, such that a single source of inflation material can be used to inflate both balloons simultaneously, or alternatively, the inner and outer balloons may not be in fluid communication, such that a single source of inflation material may be required to inflate the multiple balloons at different times, or different sources of inflation material may be required to inflate the multiple balloons simultaneously.

[0088] ​These embodiments are considered to have a break in the internal buttress in that when the probe is inside a body opening, body cavity, or both a body opening and a body cavity, and the IRD100 is in the open state, the internal buttress can be disposed around the probe in an open state. Further, the internal buttress in the embodiments has a closed state in which the internal buttress is closed around the probe when the probe is inside a body opening, body cavity, or both of them.

[0089] In these various embodiments, the balloon may be manufactured separately from the base member and then attached to the base member at an appropriate joint 650 by heat welding or other suitable method.

[0090] Figures 42 to 49 show other embodiments of the IRD100. The IRD100 is composed of two structural components as a first body component and a second body component as shown in Figures 39, 4 Rather than a structure, it has a base member 400 in which the external buttress 112, the intermediate portion 110, and the internal buttress portion 168 are formed as an integral structure. Similar to these other embodiments, the internal buttress 108 may be a balloon that expands in the peripheral direction from the base member 400 when expanded.

[0091] As shown in Figures 42 to 49, the balloon may extend longer than the balloon extending along the inner surface of the base member in the passage along the outer surface of the base member, or vice versa. Also, the balloon may extend for a length similar to that of the balloon extending along the inner surface of the base member in the passage along the outer surface of the base member. The balloon inside the base member in the passage may engage with the probe to form a probe balloon seal for promoting the retention of the inhaled substance. The balloon outside the base member may form a body internal buttress seal for promoting the retention of the inhaled substance.

[0092] The IRD 100 has a seam 292 that extends along the entire length of the base member from the outer buttress to the inner buttress portion. The seam 292 is also present in the balloon of the inner buttress. The IRD 100 shown in Figures 42-49 may have an open state and a closed state due to the seam 292. The IRD 100 may be disposed around a probe when the IRD 100 is in an open state and the probe is within a body orifice, cavity, or both. Additionally, the inner buttress has a closed state in which the inner buttress is closed around the probe when the probe is within a body orifice, cavity, or both.

[0093] The outer buttress 112 may have an outer surface 670 and an inner surface 672. 12 may have one or more support posts 674 on the inner surface 672 .

[0094] FIG. 50 shows a cross-sectional view and FIG. 51 shows a perspective view of another embodiment of the IRD 100. The internal cavity 160 of the internal buttress 108 is formed within the internal buttress portion 16 of the base member. Upon expansion from the intermediate portion 11, the base member may expand in a circumferential direction. 0 and outer buttress 112. The passageway 264 configured to pass a probe, if present, is illustrated as having two O-ring type structures 280, but it will be apparent that it may have any number of O-ring type structures 280 greater than or equal to one. An O-ring type structure 280 on the inner diameter of the base member may be provided to allow passage of a probe, if present. , allowing a seal to form between the IRD 100 and the probe. As shown, the O-ring type structure 280 may be surrounded by the outer buttress 112. One or more O-ring type structures 280 may be surrounded by any combination of the middle section 110 and the inner buttress portion 168. The O-ring type structure 280 may act as a sphincter to allow a seal on probes having various diameters. The IRD 100 is configured to have a first opening at its It has a seam 292 that extends along the length from the first opening 420 to the second opening 422. Since the internal buttress has a cut, the IRD 100 has an open state and a closed state.

[0095] As shown in FIG. 51, the IRD 100 may have a seam 292 that disappears by the abutment of adjacent surfaces when it is in the closed state. However, in the closed state without the seam 292, the probe cannot slide from the outside of the IRD 100 through the seam 292 into the passage 264.

[0096] As shown, the expanded internal buttress 108 is configured not to engage with the probe so as to form a seal between the expanded internal buttress 108 and the probe when the probe is present.

[0097] FIGS. 52(A) and 52(B) show cross-sectional views of another embodiment of the IRD 100. Similar to the other embodiments, the passage 264 extends along a length reaching from the internal buttress 108 through the intermediate portion 110 to the external buttress 112. The passage 264 may be defined by a passage structure 265 that extends from the internal buttress 108 to the external buttress 112. The internal buttress 108 may surround the outer surface 430 of the passage structure 265 and be disposed adjacent in a contacting state toward the insertion end 432, also referred to as the first end, of the passage structure 265. The external buttress 112 may surround the outer surface 430 of the passage structure 265 and be disposed adjacent in a contacting state toward the handle 434, also referred to as the second end on the opposite side, of the passage structure 265.

[0098] The internal buttress 108 may be made of an elastomeric material such as a polymer or natural rubber. The external buttress 112 may be made of a semi-rigid material that is harder than the elastomeric material of the internal buttress 108. The intermediate portion 110 may also be made of a semi-rigid material or may include an elastomeric material.

[0099] The first end or insertion end 432 of the passage structure 265 may include an internal buttress retaining member 436. The internal buttress 108 may be disposed between the intermediate portion 110 and the internal buttress retaining member 436.

[0100] The second end or handle 434 on the opposite side of the passage structure 265 may include an external buttress retaining member 438. The external buttress 112 may be disposed between the intermediate portion 110 and the external buttress retaining member 43 8. The internal buttress 108 may be fixed to the internal buttress retaining member 436 at the first end 450 of the internal buttress 108, and further, the internal buttress 108 may be movable relative to the internal buttress retaining member 436 at the second end 452 on the opposite side of the internal buttress 108. The internal buttress 108 may be biased in a direction in which the second end 452 on the opposite side of the internal buttress 108 extends toward the external buttress 112. The internal buttress 1 08's bias in the direction toward the external buttress 112 may apply a bias toward the external buttress retaining member 438. The external buttress retaining member 438 may be configured to prevent the external buttress 112 from extending beyond the handle 434 and protruding from the passage structure 265. This embodiment is considered to function like a wing nut. The IRD 100 may have an inserted state and a retained state. In the inserted position state, the user may insert the IRD 100 into the body cavity 104 through the body opening 106. When the internal buttress is within the body cavity 104, the user may slide the external buttress 112 toward the internal buttress 108 side relative to the outer surface 430 of the passage structure 265. When the external buttress 112 slides toward the internal buttress 108 side when the IRD 100 is in the retained state, the internal buttress 108 expands in the peripheral direction away from the passage structure 265. Here, the internal buttress

[0101] 108 is biased in a direction in which the second end 452 on the opposite side of the internal buttress 108 extends toward the external buttress 112. When the external buttress 112 slides toward the internal buttress 108 side, the internal buttress 108 expands in the peripheral direction away from the passage structure 265. At this time, the internal buttress 108 can prevent the IRD100 from coming out of the body cavity 104 and can promote the retention of the inhaled substance.

[0102] Furthermore, the IRD100 may include a catch 460 to maintain the retention state. In the inserted state, the catch 460 may be surrounded by the outer buttress 112. When the outer buttress 112 slides toward the inner buttress 108 side, the outer buttress 112 no longer surrounds the catch 460. The catch 460 may be biased to extend circumferentially from the passage structure 265. When the outer buttress 112 no longer surrounds the catch 460, the catch 460 may extend peripherally from the passage structure 265. When the catch 460 extends peripherally from the passage structure 265, the catch 460 may hold the outer buttress 112 and the inner buttress 108 in a retained state. The user may push the catch 460 centrally toward the passage structure 265 so that the bias of the outer buttress 112 toward the outer buttress holding member 438 side is not canceled by the catch 460. Accordingly, the outer buttress 112 slides toward the outer buttress holding member 438 side, and the inner buttress 108 may move centrally toward the passage structure 265 such that the inner buttress 108 does not prevent the extraction of the IRD100 from the body cavity 104 and does not promote the retention of the inhaled substance. Since the IRD100 has been returned from the retained state to the inserted state, the IRD100 can be removed from the body opening 106 and the body cavity 104.

[0103] FIG. 53 shows a cross-sectional view of another embodiment of the IRD100, and FIG. 54 shows a perspective view thereof. In the above, the embodiment has been shown with an O-ring type structure or sphincter inside the passage. In this embodiment, the O-ring type structure is outside the passage structure. This embodiment ​、It has a shape like a pine tree with one or more branches 470. The branches 470 shorten toward the insertion end 432 of the IRD100 so as to act as inclined edges and lengthen toward the external buttress 112. The branches 470 may be made of an elastomeric material that curves as the IRD100 is inserted into and withdrawn from the body cavity. For example, the branches 470 may be, by way of non-limiting example, disc-shaped of soft rubber. One or more of the branches 470 may extend into the body cavity during use of the IRD100, and one or more of the branches 470 may remain within the body opening during use of the IRD100. As with other embodiments, a lubricant may be applied along the IRD100, for example, along the branches 470.

[0104] The passage 264 passes through the IRD100, and the first opening 420 is configured for entry of the probe into the IRD10 0, and the second opening 422 is configured for withdrawal from the probe's IRD100. As shown, the above-described embodiment of the IRD100 may have only a closed state for sliding the probe into the IRD100 when the probe is not present in the body opening or body cavity.

[0105] FIG. 55 shows a cross-sectional view of another embodiment of the IRD100, and FIG. 56 shows a perspective view thereof. In this embodiment, the O-ring type structure 280 is outside the passage structure 265. The plurality of O-ring type structures 280 may be of substantially the same length. The O-ring type structure 280 may be provided by an internal buttress portion 168 attached outside the passage structure 265. This embodiment has a shape like a long "fluffy" collar that forms an effective seal in combination with a lubricant. The O-ring type structures 280 extend substantially parallel to each other and substantially perpendicular to the passage structure 265, but the O-ring type structures The 280 may extend obliquely and substantially non-vertically with respect to the passage structure 265. The orientation of the O-ring type structure 280 may be an orientation that facilitates the retention of the pneumoperitoneum retaining substance. Of course, the O-ring type structure 280 may be flexible and may change its orientation when inserted into or withdrawn from a body opening or body cavity.

[0106] FIG. 57 is a cross-sectional view showing another embodiment of the IRD100. The spiral path between the first body part 200 and the second body part 202 of the seam 292 serves to align the first body part 200 and the second body part 202 when the user changes the first body part 200 and the second body part 202 from the open state to the closed state. The passage 264 passes through the combination of the first body part 200 and the second body part 202. The first body part 200 may have an internal cavity 160 of the internal buttress 108, whereby the internal buttress 108 of the first body part 200 may expand from a contracted or non-expanded state upon introduction of the expanding substance. The second body part 202 may have an internal cavity 16 0 of the internal buttress 108, whereby the internal buttress 108 of the second body part 202 may expand from a contracted or non-expanded state upon introduction of the expanding substance. In this embodiment, the internal cavity 160 of the internal buttress 108 of the first body part 200 may not be in fluid communication with the internal cavity 160 of the internal buttress 108 of the second body part 2 02. FIG. 58 shows a cross-section of another embodiment of the IRD100. As shown in FIG. 59, any suitable material such as an elastomeric material 488 such as a thermoplastic elastomer or other elastomeric material may be applied around the probe 250, and an adhesive 49 0 together with the adhesive edge 492 may be used to dispose the IRD100 around the IRD100 in the closed state.

[0107] FIG. 60(A) shows an isometric view of a pressure cuff pump 500 that functions as a source of an expanding substance via an expanding substance line 166 for expanding the internal cavity of an internal or external buttress. The pressure cuff pump 500 is compressed for expansion. The user may pinch it to open a one-way valve for contraction. As shown in FIG. 60(B), a one-way duckbill valve 502 may be provided. For expansion, a syringe may be used along with other sources that one of ordinary skill in the art may conceive. As described above, the IRD 100 is an internal buttress , an external buttress, or may require a valve to hold the expanding substance after expansion of the intermediate portion.

[0108] FIG. 61(A) shows a cross-sectional view of another embodiment of the IRD 100. A soft thermoplastic elastomer 508 may be molded onto a rigid core 510. The rigid core 510 is harder than the soft thermoplastic elastomer 508. The rigid core 510 may be made of polypropylene or other suitable material. The soft thermoplastic elastomer 508 may have a rating of about 50A durometer, or other suitable rating. FIG. 61(B) shows a cross-sectional view of the IRD 100, with the probe 250 being inside the rigid core 510. During use, the seam 292 visible between the surfaces may disappear when the IRD 100 is inserted into a body opening, body cavity, or both. The IRD 100 may include an internal buttress such as a balloon.

[0109] As shown throughout the disclosure of the various embodiments, in some embodiments, the internal buttress 108 and the external buttress 112 are not configured to engage with the probe 250, and thus, the internal buttress 108 and the external buttress 112 may not contribute to the seal between the IRD 100 and the probe 250. In other embodiments, the internal buttress 108 and the external buttress 112 are configured to engage with the probe 250, and thus, the internal buttress 108 and the external buttress 112 may contribute to the seal between the IRD 100 and the probe 250. Whether or not the internal buttress 108 and the external buttress 112 engage with the probe 250, the internal buttress 108 and the external buttress 112 may contribute to the seal between the IRD 100 and the body 102, such as the body cavity 104, the body opening 106, and the wall 120 of the body opening 106.

[0110] Of course, care is taken to optimize the contact between the internal buttress 108, the external buttress 112, and other parts of the IRD 100 and the body 102, the body cavity 104, the body opening 106, and other patient conditions, and to minimize the risk of compressive necrosis and other adverse side effects due to the use of the IRD 100. This care can be implemented by giving the expanding substance a predetermined volume, and then the internal buttress 108, the external buttress 112, etc. of the IRD 100 can establish a predetermined pressure applied to the body 102, the body cavity 104, the body opening 106, etc.

[0111] The method of using the IRD 100 can include the following steps. In a first step, the IRD 100 is inserted into the body cavity 104 of the body 102 through the body opening 106 of the body 102. In a second step, an insufflation substance is injected into the body cavity 104. In a third step, the user uses a probe to perform a diagnostic intervention, a therapeutic intervention, or both a diagnostic intervention and a therapeutic intervention. Further steps are conceivable. For example, by way of illustration and not limitation, the probe may be inserted through the body opening 106 before, after, or together with the IRD as the IRD is inserted through the body opening 106.

[0112] Numerous features and advantages of various embodiments of the present disclosure are described in the foregoing description along with details of the structure and function of the various embodiments of the present disclosure, but this detailed description is merely exemplary , and it should be understood that, particularly in matters of the structure and arrangement of parts within the principles of the present disclosure, changes may be made to the greatest extent shown by the broad general meaning of the terms as expressed in the appended claims.

Claims

1. an internal buttress configured to prevent escape from a body cavity through a bodily opening in the body; an internal buttress having a non-expanded state and an expanded state after introduction of an expansion substance, the internal buttress expanding around an end of the pneumoperitoneum device in the expanded state; an outer buttress coupled to the inner buttress, the outer buttress configured to prevent passage of the outer buttress through a body opening into a body cavity, the outer buttress having only an expanded state and not an unexpanded state; a passageway extending through the inner and outer buttresses, the passageway being configured to allow a probe to pass therethrough upon contacting engagement with the body cavity and configured to open in the absence of the probe within the passageway such that inhaled material introduced into the body cavity is not retained within the body cavity; a seam extending from an outer surface of the passageway to an inner surface of the passageway, the seam extending along the entire length from the inner buttress to the outer buttress.

2. The pneumoperitoneum device of claim 1 , wherein the internal buttress in the expanded state is configured to contact and abut the probe.

3. The pneumoperitoneum device of claim 1 , wherein the internal buttress in the expanded state is configured not to contact and abut the probe.

4. The pneumoperitoneum device of claim 1 , wherein the passageway is configured to allow passage of a probe from a first opening in the outer buttress to a second opening in the inner buttress.

5. 2. The pneumoperitoneum device of claim 1, wherein the seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, such that the passage has an open state that does not retain inhaled material when the probe is not present in the passage and a closed state that retains inhaled material when the probe is present in the passage.

6. an internal buttress configured to prevent escape from a body cavity through a bodily opening in the body; an internal buttress having a non-expanded state and an expanded state after introduction of an expansion substance, the internal buttress expanding around an end of the pneumoperitoneum device in the expanded state; an outer buttress coupled to the inner buttress, the outer buttress configured to prevent passage of the outer buttress through a body opening into a body cavity, the outer buttress having only an expanded state and not an unexpanded state; a passageway extending through the inner and outer buttresses, the passageway being configured to allow a probe to pass therethrough upon contacting engagement with the body cavity, the passageway being configured to open in the absence of the probe within the passageway such that inhaled material introduced into the body cavity is not retained within the body cavity, the inner buttress in its expanded state expanding into the passageway for contacting engagement with the probe; a seam extending from an outer surface of the passageway to an inner surface of the passageway, the seam extending along the entire length from the inner buttress to the outer buttress. 。

7. The pneumoperitoneum device of claim 6 , wherein the internal buttress in the expanded state is configured to contact and abut the probe.

8. The pneumoperitoneum device of claim 6 , wherein the internal buttress in the expanded state is configured not to contact and abut the probe.

9. The pneumoperitoneum device of claim 6 , wherein the passageway is configured to allow passage of a probe from a first opening in the outer buttress to a second opening in the inner buttress.

10. 7. The pneumoperitoneum device of claim 6, wherein the seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, such that the passage has an open state that does not retain inhaled material when the probe is not present in the passage and a closed state that retains inhaled material when the probe is present in the passage.

11. an internal buttress configured to prevent escape from a body cavity through a bodily opening in the body; an internal buttress having an unexpanded state and an expanded state after introduction of an expansion material; an outer buttress coupled to the inner buttress, the outer buttress configured to prevent passage of the outer buttress through a body opening into a body cavity, the outer buttress having only an expanded state and not an unexpanded state; a passageway extending through the inner and outer buttresses, the passageway being configured to allow a probe to pass therethrough upon contacting engagement with the body cavity and configured to open in the absence of the probe within the passageway such that inhaled material introduced into the body cavity is not retained within the body cavity; a seam extending from an outer surface of the passageway to an inner surface of the passageway, the seam extending along the entire length from the inner buttress to the outer buttress; The internal buttress includes a first balloon that is internal to the passageway and a second balloon that is external to the passageway. and a separate second balloon, wherein the first balloon and the second balloon are in fluid communication, but the first balloon and the second balloon do not orbit an edge of the internal buttress.

12. The pneumoperitoneum device of claim 11 , wherein the internal buttress in the expanded state is configured to contact and abut the probe.

13. The pneumoperitoneum device of claim 11 , wherein the internal buttress in the expanded state is configured not to contact and abut the probe.

14. The pneumoperitoneum device of claim 11 , wherein the passageway is configured to allow passage of a probe from a first opening in the outer buttress to a second opening in the inner buttress.

15. 12. The pneumoperitoneum device of claim 11, wherein the seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, such that the passage has an open state that does not retain inhaled material when the probe is not present in the passage and a closed state that retains inhaled material when the probe is present in the passage.

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