Balloon-based insufflation maintenance device

Abstract

The present invention provides a pneumoperitoneum maintenance device that facilitates the retention of air-filled material within a body cavity. [Solution] According to various embodiments, a probe can be inserted into a body cavity to perform a diagnostic intervention, a therapeutic intervention, or both. The probe can be inserted through a naturally occurring or artificial, intentional, or accidental body opening. The body opening can form a seal surrounding the probe, thus effectively holding the insufflation device within the body cavity and allowing the operator to perform the intervention. However, there may be leakage of the insufflated material. The insufflation holding device is configured to contact and form an effective seal adjacent to the body opening, providing a passage for introducing the probe into the body cavity, thus enabling a diagnostic or therapeutic intervention, or both.

Description

Brief Description of the Drawings

[0001] [Figure 1] FIG. 1 shows a partial cross-sectional view of a pneumoperitoneum retention device passing through a body opening according to various embodiments. [Figure 2] FIG. 2 shows a cross-sectional view of the pneumoperitoneum retention device of FIG. 1 according to various embodiments. [Figure 3] FIG. 3 shows a cross-sectional view of the pneumoperitoneum retention device of FIG. 1 according to various embodiments. [Figure 4] FIG. 4 shows a cross-sectional view of the pneumoperitoneum retention device of FIG. 1 according to various embodiments. [Figure 5] FIG. 5 shows a partial cross-sectional view of an intermediate portion of a pneumoperitoneum retention device extending as an internal buttress portion and an opposing external buttress portion according to various embodiments. [Figure 6] FIG. 6 shows a partial cross-sectional view of an intermediate portion of a pneumoperitoneum retention device extending as an internal buttress portion and an opposing external buttress portion according to various embodiments. [Figure 7] FIG. 7 is a partial cross-sectional view of an internal buttress inflow valve in fluid communication with an expansion material conduit according to various embodiments. [Figure 8] FIG. 8 is a partial cross-sectional view of an internal buttress inflow valve in fluid communication with an expansion material conduit and an external buttress separate from an external buttress inflow valve according to various embodiments. [Figure 9] FIG. 9 shows a plan view of a first body component and a second body component according to various embodiments. [Figure 10] FIG. 10 shows a plan view of a first body component connected to a second body component via a hinge portion or a pivot portion according to various embodiments. [Figure 11] FIG. 11 shows an end view of an internal buttress connected to an open body component biased to a closed state according to various embodiments. [Figure 12]Figure 12 shows end views of internal buttresses connected to an open main body component, biased to a closed state by fasteners on the main body component, according to various embodiments. [Figure 13] Figure 13 shows partial cross-sectional views of probes passing through body openings in various embodiments. [Figure 14] Figure 14 shows end views of probes passing through body openings according to various embodiments. [Figure 15] Figure 15 shows a partial cross-sectional view of a probe passing through a deformed body opening. [Figure 16] Figure 16 shows an end view of a probe passing through a deformed body opening. [Figure 17] Figure 17 shows partial cross-sectional views of probes passing through a deformable body opening and probes passing through a pneumoperitoneum holding device according to various embodiments. [Figure 18] Figure 18 shows end views of probes passing through a deformable body opening and probes passing through a pneumoperitoneum holding device according to various embodiments. [Figure 19] Figure 19 shows a transparent view of a pneumoperitoneum retention device according to various embodiments. [Figure 20] Figure 20 shows end views of the insufflation support device of Figure 19 according to various embodiments. [Figure 21] Figure 21 shows side views of the insufflation retention device of Figure 19 according to various embodiments. [Figure 22] Figure 22 shows cross-sectional views of the insufflation retention device of Figure 22 according to various embodiments. [Figure 23] Figure 23 shows a side view opposite to the side view of the insufflation apparatus shown in Figure 21, according to various embodiments. [Figure 24] Figure 24 shows cross-sectional views of the insufflation retention device of Figure 23 according to various embodiments. [Figure 25] Figure 25 shows a perspective view of a passage structure used in a pneumoperitoneum retention device according to various embodiments. [Figure 26] Figure 26 shows a perspective view of the external compression member in the open state, and the external compression member is used together with the insufflation retention device shown in Figure 25. [Figure 27] Figure 27 shows a perspective view of the closed external compression member used in conjunction with the insufflation retention device shown in Figure 25. [Figure 28] Figure 28 shows a transparent view of the insufflation support device of Figure 25 according to various embodiments. [Figure 29] Figure 29 shows a transparent view of the insufflation support device and probe passing through the passage shown in Figure 25, according to various embodiments. [Figure 30] Figure 30 shows partial cross-sectional views of the insufflation retention device and probe according to various embodiments. [Figure 31] Figure 31 shows partial cross-sectional views of the insufflation retention device, O-ring type structure, and probe according to various embodiments. [Figure 32] Figure 32 shows partial cross-sectional views of a pneumoperitoneum holding device and multiple O-ring type structures and probes according to various embodiments. [Figure 33] Figure 33 shows a probe that can be used with a pneumoperitoneum retention device according to various embodiments. [Figure 34(A)] Figure 34(A) shows a continuous internal buttress having only a closed state and a discontinuous internal buttress having both an open and a closed state, according to various embodiments. [Figure 34(B)] Figure 34(B) shows a continuous internal buttress having only a closed state and a discontinuous internal buttress having both an open and a closed state, according to various embodiments. [Figure 34(C)] Figure 34(C) shows a continuous internal buttress having only a closed state and a discontinuous internal buttress having both an open and a closed state, according to various embodiments. [Figure 35] Figure 35 shows perspective views of pneumoperitoneum holding devices according to various embodiments. [Figure 36] Figure 36 shows perspective views of other insufflation devices according to various embodiments. [Figure 37] Figure 37 shows isometric views of other insufflation devices according to various embodiments. [Figure 38] Figure 38 shows isometric views of other insufflation devices according to various embodiments. [Figure 39] Figure 39 shows a cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 40] Figure 40 shows a cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 41] Figure 41 shows a cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 42] Figure 42 shows a partial isometric view of a pneumoperitoneum holding device according to various embodiments. [Figure 43] Figure 43 shows a partial cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 44] Figure 44 shows a partial isometric view of a pneumoperitoneum holding device according to various embodiments. [Figure 45] Figure 45 shows an isometric view of a pneumoperitoneum holding device according to various embodiments. [Figure 46] Figure 46 shows an isometric view of a pneumoperitoneum holding device according to various embodiments. [Figure 47] Figure 47 shows a partial cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 48] Figure 48 shows a partial cross-sectional view of a pneumoperitoneum holding device according to various embodiments. [Figure 49(A)] Figure 49(A) shows a partial cross-sectional view of a pneumoperitoneum holding device of one size configured to accommodate probes of multiple sizes according to various embodiments. [Figure 49(B)] Figure 49(B) shows a partial cross-sectional view of a pneumoperitoneum holding device of one size configured to accommodate probes of multiple sizes according to various embodiments. [Figure 50] Figure 50 shows a cross-sectional view of another pneumoperitoneum holding device according to various embodiments. [Figure 51] Figure 51 shows a perspective view of the pneumoperitoneum holding device shown in Figure 50 according to various embodiments. [Figure 52(A)] Figure 52(A) shows a cross-sectional view of another pneumoperitoneum holding device according to various embodiments. [Figure 52(B)]Figure 52(B) shows cross-sectional views of other insufflation devices according to various embodiments. [Figure 53] Figure 53 shows cross-sectional views of insufflation retention devices according to various embodiments. [Figure 54] Figure 54 shows perspective views of the insufflation device shown in Figure 53, according to various embodiments. [Figure 55] Figure 55 shows cross-sectional views of insufflation retention devices according to various embodiments. [Figure 56] Figure 56 shows perspective views of the insufflation device shown in Figure 55, according to various embodiments. [Figure 57] Figure 57 shows cross-sectional views of other insufflation retention devices according to various embodiments. [Figure 58] Figure 58 shows cross-sectional views of insufflation retention devices according to various embodiments. [Figure 59] Figure 59 shows plan views of some of the insufflation retention devices shown in Figure 58, according to various embodiments. [Figure 60(A)] Figure 60(A) shows plan views of pressure cuff pumps, valves, and expansion material lines according to various embodiments. [Figure 60(B)] Figure 60(B) shows an enlarged view of the valve shown in Figure 60(A) according to various embodiments. [Figure 61(A)] Figure 61(A) shows isometric views of other insufflation devices according to various embodiments. [Figure 61(B)] Figure 61(B) shows cross-sectional views of the insufflation retention device shown in Figure 60(A) according to various embodiments.

[0002] (Detailed explanation) There are techniques that allow an operator to introduce a probe, such as a medical scope, into a body cavity for diagnostic, therapeutic, or both interventions. When introducing the probe, the operator may need to expand the body cavity to perform the intervention. Using air insufflation techniques, the operator can introduce an air-filled substance to expand the body cavity, thereby providing the operator with more workspace and a better view within the body cavity to perform the intervention. For example, "Technology Status Evaluation Report: Methods of luminal distension for colonoscopy, Gastrointestinal Endoscopy, Volume 77, No. 4, 2013, pages 519-525" describes this. The entire structure is incorporated by reference. The air supply material may be air, carbon dioxide, water, or other suitable material.

[0003] The operator can start the probe from outside the body, advance it through body tissue, and introduce it into a body cavity, or body cavity. The probe can be advanced through 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 that allows it to recover its size and shape after being deformed by the probe being advanced into the body cavity through the opening, and can effectively seal the outside of the body from the body cavity. Subsequently, the insufflated material introduced into the body cavity can be retained within the body cavity, and the outside of the body is effectively sealed from the body cavity, which helps to promote the expansion of the body cavity when the operator is able to perform the intervention.

[0004] However, in some cases, the insufflated material may not be effectively retained within the body cavity. For example, the body opening or nearby structure may have a congenital malformation, or the body opening or nearby structure may have structural damage that prevents the body opening from forming an effective seal with the probe, such as scar tissue formation after abscess formation, surgical trauma, or birth-related injury.

[0005] If the insufflated material is not effectively retained, the operator may not have the time, space, or visibility to perform the operation within the body cavity. For example, an endoscope probe can be introduced into a body cavity such as the rectum or large intestine through a body opening such as the anus, but the elasticity of the body opening does not effectively form an adjacent seal in contact with the probe, thus hindering the retention of the insufflated material within the body cavity. This may not always be the case. As will be explained in more detail, this disclosure describes a pneumoperitoneum retention device that facilitates the retention of air-sufflated material within a body cavity.

[0006] Figure 1 shows a pneumoperitoneum retainer (also known herein as IRD100) advanced from outside the body 102 into the body cavity 104 through a body opening 106, also known as an orifice. The IRD100 may typically include an internal buttress 108, an intermediate section 110, and an external buttress 112. The internal buttress 108 is located at the first end 114 of the IRD100, and the external buttress 112 is located on the opposite side, between the second end 116 and the intermediate section 110 of the IRD100. In other words, the intermediate section 110 is positioned between the internal buttress 108 and the external buttress 112.

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

[0008] The internal buttress 108 may be configured to have a non-expandable configuration so that an operator can introduce the IRD 100 into the body cavity 104 through the body opening 106. The non-expandable configuration of the internal buttress 108 may be smaller than the expanded configuration of the internal buttress 108 shown in Figure 1. The non-expandable configuration of the internal buttress 108 is configured to facilitate the entry of the IRD 100 from outside 118 of the body 102. In other words, in the contracted state, the internal buttress 108 may 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 extended configuration of the internal buttress 108 is configured to prevent the IRD 100 from being removed from the body cavity 104. If the IRD 100 moves toward the outside 118 of the body 102, the extended configuration of the internal buttress 108 will contact and engage 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 extended state, the internal buttress 108 may be configured to prevent the internal buttress 108 from being removed from the body cavity 104 through the body opening 106.

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

[0011] The internal buttress 108 may be configured to form an internal body buttress seal 105 between the body cavity 104 and the internal buttress 108. The internal buttress 108 is usually shown as a donut shape, but other shapes are possible depending on the patient's body 102 and the operator's needs. The shape of the internal buttress 108 may be selected to be a predetermined shape so as to effectively form an internal body buttress seal 105 between the body 102 and the internal buttress 108. When the insufflated material is held within the body cavity 104, the effectiveness of the internal body buttress seal 105 arises, and thus the operator can perform the intervention and have the time, space, or field of view to work within the body cavity 104.

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

[0013] Similar to the internal buttress 108, the external buttress 112, which is in a non-expandable configuration, can be enlarged to an expanded configuration or expanded state by introducing an expanding material supplied by a source into the internal cavity of the external buttress 112. In this case as well, the expanding material can be broadly considered to be a fluid. The expanding material used to expand the internal buttress 108 and the external buttress 112 may be the same or different under certain circumstances.

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

[0015] The external buttress 112 may be configured to form an external body buttress seal 107 between the body 102 and the external buttress 112. The external buttress 112 is usually shown as conical, but other shapes are possible depending on the patient's body 102 and the operator's needs. The shape of the external buttress 112 may be selected to be a predetermined shape so as to effectively form an external body buttress seal 107 between the body 102 and the external buttress 112. When the insufflated material is held within the body cavity 104, the effectiveness of the external body buttress seal 107 arises, and thus the operator can perform the intervention and have the time, place, or view to work within the body cavity 104.

[0016] The intermediate section 110 is configured to connect the internal buttress 108 and the external buttress 112. The intermediate section 110 is configured to contact and engage with the wall 120 of the body opening 106.

[0017] The intermediate portion may be configured to form a body intermediate seal 109 between the body opening 106 and the intermediate portion 110. The intermediate portion 110 is usually shown as a cylinder, but other shapes are possible depending on the patient's body 102 and the operator's needs. The shape of the intermediate portion 110 may be selected to be a predetermined shape so as to effectively form a body intermediate seal 109 between the body 102 and the intermediate portion 110. When the insufflated material is held within the body cavity 104, the effectiveness of the body intermediate seal 109 arises, and thus the operator can perform the intervention and have the time, place, or view to work within the body cavity 104.

[0018] Figure 2 shows a cross-section of the internal buttress of the IRD100 in the embodiment shown in Figure 1. The outer circumference 130 of the internal buttress 108 may be configured to be expandable from the illustrated non-expandable configuration to an expandable configuration. The inner circumference 132 of the internal buttress 108 may be configured to be relatively rigid compared to the outer circumference 130. Being rigid helps the IRD100 maintain its configuration and size when the operator performs an intervention, as the probe is introduced into the IRD100 and moves back and forth and rotates inside the IRD100.

[0019] Figure 3 shows a cross-section of the intermediate portion of the IRD100 in the embodiment shown in Figure 1. Within the body 140 of the intermediate portion 110, there may be an expansion material conduit 142 that can be used by an operator to introduce expansion material into the internal cavity of the internal buttress 108. As shown in the figure, the outer surface 144 of the intermediate portion 110 may be substantially circular, and therefore, when an operator inserts the IRD100 into the body opening 106, performs an intervention, or removes the IRD100 from the body opening 106, the IRD100 can rotate relatively freely clockwise or counterclockwise within the body opening 106. Similarly, the inner surface 146 of the intermediate portion 110 may be substantially circular, and therefore, when an operator inserts a probe into the IRD100, performs an intervention, removes the probe from the IRD100, or attaches a probe to the IRD100, the IRD100 can rotate relatively freely clockwise or counterclockwise around the probe. The outer surface 144 of the intermediate portion may be substantially parallel to the inner surface 146 of the intermediate portion. In other words, the intermediate portion 110 may be cylindrical.

[0020] The inner surface 146 of the intermediate section 110 can be considered a sleeve that surrounds the probe when the intermediate section 110 is in use. As shown, the sleeve is substantially circular and may be symmetrically positioned within the body 140 of the intermediate section 110. Alternatively, the sleeve may be asymmetrically positioned within the body 140 of the intermediate section 110.

[0021] Figure 4 shows a cross-section of the external buttress 112 of the IRD100 in the embodiment shown in Figure 1. The outer circumference 150 of the external buttress 112 may be configured to be expandable from a non-expandable configuration to an expandable configuration. The inner surface 152 of the external buttress 112 may be configured to be relatively rigid compared to the outer circumference 150. This relative rigidity of the inner surface 152 of the external buttress can help the IRD100 maintain its configuration, and therefore, when an operator performs an intervention, a probe can be introduced into the IRD100 and move back and forth and rotate within 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 internal buttress 108 and the external buttress 112, or different polymers may be used for the internal buttress 108 and the external buttress 112. The same polymer used for the internal buttress 108 and the external buttress 112 may be used for the intermediate section 110, or different polymers may be used for the intermediate section 110, the internal buttress 108 and the external buttress 112. The intermediate section 110 may be formed integrally with the internal buttress 108 and the external buttress 112, or the intermediate section 110 may be formed from different parts than the internal buttress 108 and the external buttress 112. It may also be formed from multiple different parts than the internal buttress 108 and the external buttress 112. When multiple different parts are used to form the IRD100, the parts can be joined together 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 internal buttress 108 is in fluid communication with the internal cavity of the external buttress 112 through the expansion material conduit 142 of the intermediate section 110. The expanded state is shown. An inlet valve 164 for the expansion material is shown connected to the external buttress 112. The operator introduces the expansion material through the inlet valve 164 into the internal cavity 162 of the external buttress 112, the expansion material conduit 142 of the intermediate section 110, and the internal cavity 160 of the internal buttress 108 using a gas pipe, syringe, or other suitable source of the expansion material.

[0024] Figure 6 shows a cross-sectional view of another embodiment of the IRD100 in which the internal cavity 160 of the internal buttress 108 is in fluid communication with the internal cavity 162 of the external buttress 112 via the expansion material conduit 142 of the intermediate section 110. The expanded state is shown. An inlet valve 164 for the expansion material is shown to be connected to the external buttress 112 via an expansion material line 166 connected to the external buttress 112. The expansion material line 166 may be rigid, flexible, or any combination of flexible and rigid. If flexible, the expansion material line 166 can take on an appropriate orientation and configuration during use. If rigid, the expansion material line can maintain a predetermined orientation and configuration before, during, and after use. The operator introduces the expanding material through the inlet valve 164 into the expanding material line 166, the internal cavity 162 of the outer buttress 112, the expanding material conduit 142 of the intermediate section 110, and the internal cavity 160 of the inner buttress 108.

[0025] Figures 5 and 6 show an intermediate section 110 that extends as an internal buttress section 168 and an opposing external buttress section 172. The internal buttress 108 is part of the internal buttress section 168, and the external buttress 112 is part of the opposing external buttress section 172. The internal buttress 108 may extend substantially shorter than, approximately equal to, or substantially beyond the first end 174 of the internal buttress section 168. The internal buttress 108 is shown as being approximately equal to the first end 174 of the internal buttress section 168. The external buttress 112 may extend substantially shorter than, approximately equal to, or substantially beyond the second end 176 of the external buttress section 172. The external buttress 112 is shown as being approximately equal to the second end 176 of the external buttress section 172.

[0026] The expansion material conduit 142 in the intermediate section 110 can take any shape. Figure 5 shows that the expansion material conduit 142 begins substantially perpendicular to the internal buttress 108 and external buttress 112, while Figure 6 shows that the expansion material conduit 142 begins substantially curved relative to the internal buttress 108 and external buttress 112. Furthermore, one or more pressure relief valves in the IRD 100 may be configured to control when the expansion of the external buttress 112 and internal buttress 108 occurs with respect to the introduction of the expanding material. The pressure relief valves may be of any suitable structure and are not shown.

[0027] Figure 7 shows a cross-sectional view of another embodiment of the IRD100 in which the internal buttress inlet valve 180 is in fluid communication with the expanding mass conduit 142 from the intermediate section 110 to the internal buttress 108, while the external buttress 112 is not in fluid communication with the internal buttress inlet valve 180. The internal buttress 108 is shown in its non-expanded state. Of course, although not shown, the internal buttress inlet valve 180 may be in direct fluid communication with the internal buttress 108 without going through the intermediate expanding mass conduit 142.

[0028] Figure 8 shows a cross-sectional view of another embodiment of the IRD100 in which the internal buttress inlet valve 180 is in fluid communication with the expansion material conduit 142 to expand the internal buttress 108 by introducing expansion material through the expansion material line 166. Furthermore, the external buttress inlet valve 182 is in fluid communication with the external buttress 112 to expand the external buttress 112 by introducing expansion material. In this embodiment of the IRD100, the internal buttress inlet valve 180 and the external buttress inlet valve 182 can be independently operated by an operator or user to expand and contract the internal buttress 108 and the external buttress 112 through the introduction and removal of expansion material via the internal buttress inlet valve 180 and the external buttress inlet valve 182. The internal buttress 108 is shown expanded by the expansion material supplied from the expansion material source 184.

[0029] The external buttress 112 has been shown to have a rectangular shape, in contrast to the other buttresses already shown to be donut-shaped or conical. Any suitable shape can be used for the internal buttress 108 or the external buttress 112.

[0030] Furthermore, the intermediate section 110 may have a substantially non-flat outer surface 190. In other embodiments, the outer surface 190 of the intermediate section 110 may be substantially flat. In this embodiment shown in Figure 8, the outer surface 190 of the intermediate section 110 has a substantially non-flat contour. The contour may be selected by the operator based on the anatomical form of the body opening 106 (see Figure 1) and other features. The contour can help the IRD 100 achieve and maintain an effective seal for holding the air supply material. The shape and size of the contour may depend on the presence or absence of expansion material. As shown in Figure 8, the contour may have expansion material introduced via an expansion material line 166 that supplies the expansion material to the internal buttress 108. Naturally, the contour may have expansion material introduced via an independent expansion material line separate from the expansion material line 166 that supplies the expansion material to the internal buttress 108.

[0031] In addition to the transition from a contracted or non-expanded state with less expanded material to an expanded state with more expanded material, the intermediate portion 110 and contour can be substantially rigid in specific, non-limiting examples. In embodiments having a substantially rigid contour, the intermediate portion 110 does not substantially deform during use of the IRD 100 from its orientation and configuration relative to the IRD 100 before or after use.

[0032] Figure 9 shows another embodiment of the IRD100. In this embodiment, the IRD100 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 to form a usable IRD100. The operator can use the two body parts if the probe is already in the body opening 106, or in both the body opening 106 and the body cavity 104 (see Figure 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 pass the probe through to the IRD100 and insert it, or to slide the IRD100 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 that remains in the body opening 106, or in both the body opening 106 and the body cavity 104. The first body component 200 can be connected to the second body component 202 via one or more pairs of any suitable type of fastener 204, such as but not limited to snaps and clips. Naturally, this embodiment can also be used before the probe is in a body opening 106 or a body cavity 104 or both.

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

[0034] Similarly, the first external buttress component 211 and the second external buttress component 213 may be supplied with expansion material through different introductions of expansion material, since the first external buttress component 211 and the second external buttress component 213 do not need to be in fluid communication. In this embodiment having a first body component 200 and a second body component 202, it may be inconvenient to have the buttress components in fluid communication. Of course, one or more different buttress components not shown may be in fluid communication.

[0035] Figure 10 shows another embodiment of the IRD100. In this embodiment, the first body part 220 is connected to the second body part 222 via a hinge portion 224 or a flexible member at the first hinge side 226 of the first body part 220 and the second hinge side 228 of the second body part 222. The hinge portion 224 may be configured to allow an operator to change the IRD100 from an open configuration, as shown in Figure 10, to a closed configuration, which is not shown, with one hand. One or more pairs of fasteners 204 can connect the first opening edge 230 of the first body part 220 to the second opening edge 232 of the second body part 222. The fastener 204 may extend beyond the first body part 220 and the second body part 222 shown in Figure 10, or it may be located within the periphery of the first body part 200 and the second body part 202 shown in Figure 9.

[0036] In the configuration shown in Figure 10, it may be convenient for internal buttresses (not shown) to surround and fluidize the first body component 220 and the second body component 222, or in other words, to fluidize substantially the entire body component, as is present in some other embodiments. Furthermore, as is present in some other embodiments, it may be convenient for external buttresses (not shown) to substantially surround and fluidize the first body component 220 and the second body component 222. The internal buttresses 108 and 112 are not shown in Figure 10 for simplicity and will be understood to be on the surface of the IRD 100 on the back of the shown figure.

[0037] Figures 11-12 show cross-sections within the internal buttress 108 in other embodiments of the IRD 100. In these embodiments, the internal buttress 108 may be connected to the internal buttress body component 240 by laser welding, bonding, or other suitable means. Alternatively, the internal buttress 108 may be a single object with the internal buttress body component 240. The internal buttress body component 240 may have a bias towards a closed state in order to form a sleeve of a size and dimensions that fits around a probe used by an operator. The internal buttress body component 240 is shown in an open state in Figure 11. When the IRD 100 is in a body cavity 104, in a body opening 106, or both, and the internal buttress body component 240 is in an open state, or when the IRD 100 is not in a body cavity 104, not in a body opening 106, or not in either (see Figure 1), the operator can position the IRD 100 around the probe. Furthermore, Figure 12 shows an internal buttress body component 240 comprising 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 of a size and dimensions that fits around the probe.

[0038] Furthermore, the internal buttress 108 may overlap with the main body component 240 as shown in the figure, which helps to form an effective seal for retaining the air supply material. Alternatively, although not shown, the internal buttress 108 does not have to overlap with the internal buttress main body component 240, and an effective seal for retaining the air supply material can still be achieved.

[0039] Similarly, although not shown, the external buttresses may or may not overlap with similar external buttress body components to form an effective seal for the air supply material.

[0040] Figure 13 shows a side cross-sectional view of the probe 250 passing through the body opening 106, and Figure 14 shows an end view. The body opening 106 effectively forms a body probe seal 252 with the probe 250 inserted through the body opening 106. Furthermore, a layer of lubricant 254 is usually lathered on the probe 250 before it enters through the body opening 106. The layer of lubricant 254 placed between the body opening 106 and the probe 250 further helps in the formation of a body probe seal 252 between the body opening 106 and the probe 250. The lubricant 254 may be any suitable type for reducing friction between the body opening 106 and the probe 250.

[0041] Figure 15 shows a probe 25 passing through a body opening 106 having an abnormality 256. Figure 16 shows a side cross-sectional view of body 0, and Figure 16 shows an end view. The body opening 106 cannot effectively form a probe 250 and a body probe seal 252 inserted into the body opening 106 which has deformation 256. Due to any reason such as congenital malformation, tumor, previous tumor, muscle relaxation, etc., the body opening 106 cannot effectively form a probe 250 and a body probe seal 252 passing through the body opening 106.

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

[0043] Naturally, the IRD100 can be used with the probe 250 in a body opening 106 where deformation 256 is absent. However, even when the IRD100 is used with the probe 250 in a body opening 106 with deformation 256, the IRD100 is configured to facilitate the retention of the insufflated material inserted into the body cavity 104 for a period of time that is effective for the operator to perform a diagnostic intervention, a therapeutic intervention, or both, which is superior to the retention of the insufflated material that can be achieved using the probe 250 without the IRD100. The probe passage seal 260, the mid-body seal 109, and the internal body buttress seal 105 may work in conjunction with the probe 250 to facilitate the retention of the insufflated material inserted into the body cavity 104 for a period of time that is effective for the operator to perform a diagnostic intervention, a therapeutic intervention, or both. On the other hand, the passage 264 may be open when the probe 250 is not present in the passage, and therefore the insufflated material may not be retained in the body cavity 104.

[0044] The IRD100 can form effective seals with the intermediate body seal 109 between the intermediate section 110 and the wall 120 of the body opening 106, the external body buttress seal 107 between the external buttress 112 and the wall 120 of the body opening 106, and the internal body buttress seal 105 between the internal buttress 108 and the body cavity 104 or body 102, even in the presence of deformation 256. As shown in Figure 17, the intermediate section 110 may be integrated with the external buttress 112 or be operationally close to it, and both functions prevent the IRD100 from advancing into the body cavity 104 during operation.

[0045] Furthermore, the IRD100 can effectively form a probe passage seal 260 when the probe 250 is inserted into the IRD100. The passage 264 passing through the middle section 110 of the IRD100 can be configured to form a probe passage seal 260 between the probe 250 and the passage 264. The passage 264 extends beyond the first end 174 and the second end 176 of the IRD100 (see Figures 5 and 6), so that the probe 250 extends broadly through the IRD100.

[0046] Furthermore, the outer surface 190 of the intermediate portion 110 may be configured to provide contour features 266 that engage with the deformation 256 to provide an effective seal. Naturally, the contour features 266 may have protrusions, indentations, etc., to engage with the deformation 256 to provide an effective seal. ), or a combination of both. Furthermore, the contour feature portion 266 may be formed from the external buttress 112, or from both the intermediate portion 110 and the external buttress 112. Furthermore, the internal buttress 108 may have contour features, and other shapes can be considered as described above, depending on the patient's body 102 and the operator's needs.

[0047] Figures 19–25 show various diagrams of the IRD100 according to another embodiment. The IRD100 may have an internal buttress 108 and an external buttress 112, with an intermediate section 110 between them. The IRD100 can be made of a seam 292, or a portion thereof, extending along the length of the IRD100, as shown. The seam 292 can be essentially a gap or crack between surfaces of material that fold themselves to make the IRD100. If the surfaces of the material fold themselves to bring the IRD100 into contact with each other, the seam 292 may not be present. The external buttress 112 has a tapered surface 294 that is substantially conical to facilitate an effective seal with the body 102 (see Figure 1).

[0048] The internal bias member 290, having bias tension, works in conjunction with the remaining bias tension of the IRD 100 to keep the IRD 100 closed during operation. The internal bias member 290 may or may not be substantially coplanar with the interior of the IRD 100. On the other hand, if the probe 250 is in a body opening 106, a body cavity 104, or both, the indicated IRD 100 can open to enclose the probe 250, and the IRD can be inserted through the body opening 106 into the body opening 106. The internal bias member 290 is configured for one-handed or two-handed operation.

[0049] The entry port 298 of the external buttress 112 may be configured to have a diameter wider than the diameter of the passage 264, such that the diameters are substantially parallel to each other. Having an entry port 298 with a diameter wider than the diameter of the passage 264 allows the operator to have a larger target for inserting the probe 250 into the passage 264 than if the diameter of the entry port 298 were substantially the same size as the diameter of 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 the probe passage seal between the passage and the probe can be achieved more easily, and in this case as before, these diameters are substantially parallel to each other. The external buttress 112 may have an internal taper 296 so that the diameter of the entry port 298 tapers to a smaller diameter of the passage 264. The internal taper 296 is shown as a substantially straight line in Figure 22, resulting in a conical structure, but any suitable shape is possible that facilitates the operator in maneuvering the probe 250 into the passage 264.

[0050] This embodiment is shown as a solid structure, and if the internal buttress 108 is made of a compressible material (e.g., foam, as an 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, the internal buttress 108 can expand into an expanded state. Naturally, similar structures such as an entry port 298 having an internal taper 296 may exist together with features from other embodiments that include an internal buttress 108 expandable by an expandable material.

[0051] Figures 25-29 show various diagrams of the IRD100 according to another embodiment. The internal buttresses 108 and external buttresses 112, not shown, can communicate with fluid through the intermediate section 110 via a substantially rectangular balloon also known herein as a passage structure 300. The intermediate section 110 can be compressed by an external compression member 302 that essentially biases the fluid in the passage structure 300 toward the internal buttresses 108 and external buttresses 112. The external compression member 302 may be adjacent to the outer surface of the passage structure 300 in contact with it. The external compression member 302 in the closed position may push substantially all of the fluid, i.e., the expanded material from the intermediate section 110 of the IRD100 that is ready for use by the operator. It is not necessary to proceed. The passage structure 300 is actually shown and is thought to be rectangular and symmetrical during operation, but other appropriate sizes and dimensions can be considered depending on the user's needs, taking into account the patient's body 102.

[0052] The external compression member 302 may have an internal bias member 304 that is rolled inside the external bias member 306 of the external compression member 302 in the closed position shown in Figures 27 to 29. Furthermore, although the external compression member 302 is shown overlapping with the external bias member 306 which overlaps with the internal bias member 304, the external compression member 302 itself does not have to overlap, just as the internal bias member 304 itself does not have to overlap. The external compression member 302 is configured for one-handed operation or two-handed operation from the open position, and the IRD 100 with the external compression member 302 in the open position may be positioned to surround the probe 250, while the IRD 100 with the external compression member 302 in the closed position may be maintained around the probe 250.

[0053] Although the external compression member 302 is shown outside the internal buttress 108, the external buttress 112, and the balloon that forms part of the intermediate section 110, it is quite conceivable that the external compression member 302 may also be located inside the passage structure 300.

[0054] Figures 30-32 show cross-sectional side views of the IRD100 with an O-ring type structure 280, or with multiple O-ring type structures 280, according to various embodiments. The IRD100 works in conjunction with the probe 250 to form a probe passage seal 260, which is an effective seal between the IRD100 and the probe 250. Furthermore, a layer of lubricant 254 between the IRD100 and the probe 250 may contribute to or enhance the effectiveness of the probe passage seal 260 between the IRD100 and the probe 250.

[0055] Furthermore, the O-ring structure 280 along the sleeve may help facilitate sealing between the IRD 100, for example, the intermediate section 110 and the probe 250. The O-ring structure 280 may be fixed to the sleeve at a first O-ring end 282 and movable at a second O-ring end 284 on the opposite side. The O-ring structure 280 may be one of several O-ring structures 280. The O-ring structure 280 may be rigid, but there may be advantages to making the O-ring structure 280 flexible, so that when the probe 250 moves forward, the second O-ring end 284 on the opposite side is retracted into the body cavity 104, and when the probe 250 moves backward, the second O-ring end 284 on the opposite side is pulled out of the body cavity 104.

[0056] As described in various embodiments, if the probe is located inside a body opening 106 or a body cavity 104, the operator would not be able to insert the probe into it or slide the IRD 100 over the probe. In contrast, in other embodiments, the operator can connect the IRD 100 around a probe that remains inside the body opening 106, or both the body opening 106 and the body cavity 104.

[0057] Those skilled in the art will understand that the probe may, in a non-limiting example, be an endoscope. Commercial 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 to expand the lumen of the colon during a colonoscopy. Furthermore, those skilled in the art will understand that the endoscope may be configured to use CO2, water, or other suitable substance for aspirating the lumen of the colon.

[0058] Those skilled in the art will understand that the quality of bowel preparation significantly impacts the success of a colonoscopy. Numerous bowel preparations are available to adequately cleanse the bowel. For example, "Optimizing bowel preparation for colonoscopy: a guide to enhance qua "Lity of visualization, Ann Gastroenterol 2016; 29 (2): 137-146" is the entirety of This is incorporated herein by reference.

[0059] Furthermore, Figure 33 shows a commercially available endoscope 350 familiar to those skilled in the art. The commercially available endoscope 350 has three main parts: a connector section 352, a control section 354, and an insertion tube 356. The connector section 352 is for attaching the endoscope 350 to a system 358 which includes a display, an image processing device, a light source and power supply, and a source of water, air, CO2, or other suitable substance. The control section 354 is attached to the connector section 352. The control section 354 is held by the operator to control a dial that bends the tip 360 of the insertion tube 356 up, down, left, and right. The control section 354 may have separate buttons for suction, inhalation, and imaging. Finally, the control section 354 may have an entry 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 section 354. The insertion tube 356 may include one or more conduits for accessories, irrigation water, suction, 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 generating device, an illumination system, a suction 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, with the diameter ranging from approximately 4.9 mm to approximately 12.9 mm. For example, "Report on Emerging Technology: GI Endoscopes, Gastrointestinal Endoscopy, Volume 74, No. 1, 2011, pages 1-6" is cited in its entirety. It will be included in the detailed specifications.

[0060] Therefore, 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 in only some of the embodiments. For example, referring to Figure 1, the internal buttress 108 is constructed seamlessly around the probe 250, so the internal buttress 108 is configured to have only a closed state. The probe 250 can be inserted into the seamless internal buttress 108 only when the IRD 100 is outside the body cavity 104 or body opening 106. On the other hand, referring to Figure 11, the internal buttress 108 is constructed to have a gap around the probe 250, so the internal buttress 108 is configured to have both a closed state and an open state. If the internal buttress 108 has a slit, the operator can position 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 buttress 108 is open, or when the IRD 100 is not inside the body cavity 104, the body opening 106, or both.

[0061] Figure 34, as will be understood by those skilled in the art, is an end view showing an embodiment in which the internal buttresses 108 around the probe have a seamless structure, in relation to the internal buttresses 108 around the probe 250 having a split structure. The probe 250 is shown as substantially cylindrical and the internal buttresses 108 are shown as rings, but other shapes (e.g., elliptical) can also be employed and are also disclosed herein.

[0062] Figure 34(A) shows the probe 250 outside the seamless structure of the internal buttress 108. In the seamless structure of the internal buttress 108, as shown in the upper right figure, the only way to position the internal buttress 108 around the probe 250 is to slide the internal buttress 108 relative to the probe 250 so that the probe 250 is located inside the internal buttress 108 and surrounded by the internal buttress 108. In this state, the probe 250 penetrates the passage 264. When the internal buttress 108 has a seamless structure and the probe 250 is inside the body opening 106 or body cavity 104, The internal buttress 108 would not be able to slide on the probe 250. For example, if the probe is a colonoscope, only one end of the probe would be able to slide into the internal buttress 108. In such an example, the colonoscope 350 has an insertion tube 356 configured to slide on the probe 250. However, the first end of the insertion tube 356 may have a control unit 354, a connector unit 352, and a system 358 which could prevent the insertion tube 356 from sliding on the internal buttress 108 at that first end. The colonoscope 350 has a tip 360 at the second end of the insertion tube 356 configured to slide into the internal buttress 108. However, if the tip 360 is inside a body opening 106 or body cavity 104, the tip 360 cannot be used to slide into the internal buttress 108.

[0063] Figure 34(B) shows, from left to right, the probe 250 outside the integral structure of the internal buttress 108 biased to the closed position, the probe 250 inside the internal buttress 108 in the open position, and the probe 250 located inside the internal buttress 108 and surrounded by the internal buttress 108 in the closed position. When manufacturing the IRD 100 as a single semi-rigid member having a seam 292 along the entire length of its side, it is difficult to facilitate sliding the IRD 100 on the probe after the probe has been positioned inside the body opening 106, body cavity 104, or both. Therefore, as described in other parts of the specification, it may be necessary to provide a bracket 656 or other fastener to bring the edges of the seam 292 closer together so that the IRD 100 can improve the retention of the insufflation retaining material.

[0064] Figure 34(C) shows, from left to right, the probe 250 located on the outside of the two-part structure of the internal buttress 108, the probe 250 inside the open internal buttress 108, and the probe 250 located inside the internal buttress 108 and surrounded by the closed internal buttress 108.

[0065] Figure 35 shows a perspective view of another embodiment of the IRD100. As shown, the external buttress 112, the intermediate section 110, and the internal buttress section 168 may be formed integrally. Alternatively, as shown in the other embodiment, the external buttress 112, the intermediate section 110, and the internal buttress section 168 may be formed from two or more members. The combined external buttress 112, intermediate section 110, and internal buttress section 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 scribing / welding, laser welding, inductive coupling, RF welding, impact sealing, adhesive, or other suitable method. Similarly, the balloon may be formed by various processes such as dip molding, thermoforming, welding of extruded film, or other suitable method. The base member 400 may be formed by injection molding, compression molding, transfer molding, liquid silicone rubber molding, or other suitable method. All materials are biocompatible.

[0067] The base member 400 may be semi-rigid having greater rigidity than the internal buttress in its 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 to itself in its expanded state and to close with a snap. The balloon may be thermoformed such that the first end 402 of the internal buttress 108 connects with the second end 404 of the internal buttress 108 so as the balloon expands from its non-expanded state to its expanded state, forming a seal between the two ends of the balloon portion of the internal buttress 108. In this way, the expanded balloon forms the internal buttress 108 which forms an effective seal for holding inhaled material.

[0068] In the non-expanded state, the internal buttress is open. In the expanded state, the internal buttress 108 is closed. In the non-expanded state of the internal buttress 108, the base member 400 may be open, having a seam 292 along its entire length. In the expanded state of the internal buttress 108, the base member 400 may be closed. In the open state of the internal buttress 108 and the base member 400, when the probe is inside a body opening, body cavity, or both, the seam 292 is substantially open, so the IRD 100 can be positioned 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, the seam 292 is substantially closed, so the IRD 100 cannot be positioned around the probe. However, when the internal buttress 108 and base member 400 are closed, the IRD 100 can be slid on the probe when the probe is not inside a body opening, body cavity, or both. This is because the passage 264 for the probe is open so that inhaled substances are not retained when the probe is not present.

[0069] As shown in the diagram, the internal buttress 108 is not configured to engage with the probe, and therefore the expanded balloon of the internal buttress 108 does not contribute to sealing between the IRD 100 and the probe. Alternatively, the internal buttress 108 may be configured to engage with the probe in order to contribute to sealing between the IRD 100 and the probe.

[0070] Figure 36 shows a perspective view of another embodiment of the IRD100. As shown, the external buttress 112, the intermediate section 110, and the internal buttress section 168 are integrally formed. The internal buttress 108 may be a balloon having an unexpanded state (not shown). The internal buttress 108 may be a balloon having an expanded state, as shown. The internal buttress 108 may be attached to a base member 400. The base member 400 may be semi-rigid having greater rigidity than the internal buttress 108 in its expanded state. The user may wrap the internal buttress 108 around the base member 400 when the internal buttress 108 is in its unexpanded state. The user then inserts the IRD 100 into the patient and expands the internal buttress 108 from its unexpanded state to its expanded state.

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

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

[0073] As shown in the illustration, the internal buttress portion may have a chamfered portion 406 or an end with an inclined edge, which facilitates entry into the body cavity through the body opening of the IRD 100. 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 IRD100. The external buttresses 112, intermediate section 110, and internal buttress section 168 are referred to as the base member 400 and may be formed from two or more members or parts. For example, the external buttresses 112, intermediate section 110, and internal buttress section 168 may be formed by combining a first body part 200 and a second body part 202. The first body part may have a first body external buttress 112, a first body intermediate section 110, and a first body internal buttress section 168. The second body part may have a second body external buttress 112, a second body intermediate section 110, and a second body internal buttress section 168. When the first main body component and the second main body component are assembled, they form the external buttress 112, the intermediate section 110, and the internal buttress section 168 of the IRD100.

[0075] The internal buttress 108 may be attached to the base member 400 by welding, adhesive, or other suitable method. The first and second body components may be semi-rigid having greater rigidity than the internal buttress 108 in its expanded state. The internal buttress 108 may be a balloon having both an unexpanded state and an expanded state (as shown). The balloon of the first body component 200 may be separate from and separated from the balloon of the second body component. The first body component 200 may have a first expandable material conduit and an expandable material line 166 that are in fluid communication with the first internal cavity of the first balloon. The second body component 202 may have a second expandable material conduit and a second expandable material line 466 that are in fluid communication with the second internal cavity of the second balloon. The first and second balloons may be inflated sequentially and independently by one source, or they may be inflated simultaneously by two sources. Alternatively, the first and second expansion material lines can be connected by a Y-valve, allowing the user to inflate both the first and second balloons simultaneously using a single supply source.

[0076] The first and second body components may have fasteners such as snaps 205 and snap receivers 206, as an example, not limited to these. Furthermore, the first body component 200 and the second body component 202 may have guides such as positioning pins 208 and positioning holes 210, as an example, not limited to these. Fasteners on the first body component 200 may be arranged to engage with fasteners on the second body component 202. Guides on the first body component 200 may be arranged to engage with guides on the second body component 202. In any configuration of the IRD100, since the first and second body components are mirror images of each other, the actual parts that become the first and second body components may be interchangeable after manufacturing.

[0077] As shown in Figure 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 diagram, the extended portion of the internal buttress 108 may be configured not to engage with the probe 250, and therefore the extended portion of the internal buttress 108 does not contribute to sealing between the IRD 100 and the probe. The internal buttress 108 is configured to extend circumferentially from the IRD 100 as it expands.

[0079] Figures 39, 40, and 41 show cross-sectional views of other embodiments of the IRD100. External battery The buttress 112, intermediate section 110, and internal buttress section 168 may be formed from two or more members or body parts. For example, the external buttress 112, intermediate section 110, and internal buttress section 168 may be formed by combining a first body part and a second body part. The first body part may have a first body external buttress, a first body intermediate section, and a first body internal buttress section. The second body part may have a second body external buttress, a second body intermediate section, and a second body internal buttress section. When the first body part and the second body part are combined, the first body part and the second body part may form a body part consisting of an external buttress, an intermediate section, and an internal buttress section, which is also referred to herein as a base member.

[0080] The main body component shown in Figure 39 is complementary to the main body component shown in Figure 40 or Figure 41. In other words, the external buttress 112, the intermediate section 110, and the internal buttress section 168 may be complementary. As shown, the external buttress 112, the intermediate section 110, and the internal The buttress portion 168 may be formed integrally. The passage 264 extends along the entire length of the side surface of the IRD 100, 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 that extends from the internal buttress 108 to the external buttress 112.

[0081] The complementary features of the main body components may be reversed if necessary. As shown in the illustration, the expansion material line 166 for the IRD 100 may be provided in only one of the first or second main body components. As shown by the dotted line, the expansion material conduit 142 may extend throughout the main body component from the expansion material line 166 to the internal cavity of the balloon present therein, thereby providing fluid communication between the expansion material line and the internal cavity. The first main body component may be in fluid communication with the second main body component via a valve 600, such as the male valve / snap shown in Figure 39, which engages with the female valve / snap shown in Figure 40 or Figure 41, as a non-limiting example. In other words, these two components may snap together to form a continuous air passage to allow expansion from one expansion material line 166 and a supply source. Therefore, the balloons are separated in the sense that one is formed and attached to the first body component and the other is formed and attached to the second body component, but the balloons may be in fluid communication with an expansion material line 166 and a supply source common to both balloons.

[0082] Furthermore, the main body components may have fasteners or positioning guides, such as male / female positioning mechanisms (214 and 216, respectively), to facilitate the alignment of the first and second main body components and the assembly of the IRD100, as shown in the internal buttress section.

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

[0084] As shown in the figure, the internal buttress 108 may be a balloon. The balloon may have a variable thickness 610 to facilitate inflation for expansion by insertion of an expanding material. The balloon may thin towards the first end 174 of the internal buttress portion 168 to facilitate the expansion of the balloon toward the internal buttress portion 168.

[0085] The following shows different balloon arrangements that can be adopted. Figure 39 shows that the balloon extends from the outer circumference of the internal buttress portion around the first end 174 of the internal buttress portion 168. The expanded balloon may be configured to engage with the probe through the passage 264 to form a seal between the balloon and the probe when the probe is present. The balloon may also be configured not to engage with the probe through the passage 264 so as not to form a seal between the balloon and the probe when the 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 the particular embodiment, the expanded balloon is not closed and therefore the IRD 100 cannot hold inhaled material when the probe is not inside the IRD 100.

[0086] Figure 40 shows that the balloon expands from the outer circumference of the internal buttress portion 168, around the first end 174 of the internal buttress portion 168, into the passage 264. 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 circumference of the internal buttress 108, but the depth of the balloon into the passage 264 may be substantially greater or less than the depth of the balloon along the outer circumference of the internal buttress 108. The expansion of the balloon into the passage 264 may form a probe balloon seal that accommodates probes of different diameters, such as a larger diameter 700 as shown in Figure 49(A) and a smaller diameter 702 as shown in Figure 49(B). With the probe in the passage, a predetermined volume of expansion material may be inserted into the internal cavity of the balloon. Users using a syringe, pressure cuff pump, or other suitable source of expansion material will experience resistance to further insertion of expansion material. In certain embodiments, the inflated balloon is not closed, and therefore, without a probe in the passage 264, the IRD100 cannot hold the inhaled substance.

[0087] Figure 41 shows an internal balloon 632 located within a passage 264, and an external balloon 634 located outside the passage 264 and surrounding it. As shown, the internal balloon 632 and the external balloon 634 may be in fluid communication, thereby allowing a single source of expanding material to inflate both balloons simultaneously, or the internal and external balloons may not be in fluid communication, thereby requiring a single source of expanding material to inflate multiple balloons at different times, or different sources of expanding material may be required to inflate multiple balloons simultaneously.

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

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

[0090] Figures 42-49 show other embodiments of the IRD100. The IRD100 is not a two-part structure consisting of a first and second body part as shown in Figures 39, 40, and 41, but rather has a base member 400 in which the external buttress 112, intermediate section 110, and internal buttress section 168 are formed as a single integrated structure. Similar to these other embodiments, The buttress 108 may be a balloon that expands outwards from the base member 400 when expanded.

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

[0092] The IRD100 has a seam 292 that extends along the entire length of the base member from the external buttress to the internal buttress portion. The seam 292 is also present in the balloon of the internal buttress. The IRD100 shown in Figures 42 to 49 may have an open state and a closed state due to the seam 292. The IRD100 can be positioned around the probe when the IRD100 is in the open state and the probe is inside a body opening, body cavity, or both. Furthermore, the internal buttress has a closed state in which the internal buttress closes around the probe when the probe is inside a body opening, body cavity, or both.

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

[0094] Figure 50 shows a cross-sectional view of another embodiment of the IRD100, and Figure 51 shows a perspective view thereof. The internal cavity 160 of the internal buttress 108 may expand peripherally when it expands from the internal buttress portion 168 of the base member, and the base member further comprises an intermediate portion 110 and an external buttress 112. The passage 264 configured to allow a probe to pass through if one is present is shown as having two O-ring-shaped structures 280, but it will be obvious that it may have one or any number of O-ring-shaped structures 280. The O-ring-shaped structures 280 on the inner diameter of the base member allow a seal to be formed between the IRD100 and the probe when a probe is present. As shown, the O-ring-shaped structures 280 may be surrounded by the external buttress 112. One or more O-ring-shaped structures 280 may be surrounded by any combination of the intermediate portion 110 and the internal buttress portion 168. The O-ring-shaped structures 280 may function as sphincters that allow a seal on probes of various diameters. The IRD100 has a seam 292 that extends along its length from the first opening 420 to the second opening 422. Since the internal buttress has a gap, the IRD100 has an open state and a closed state.

[0095] As shown in Figure 51, the IRD 100 may have a seam 292 that disappears when it is in a closed state due to contact with an adjacent surface. However, in a closed state without a seam 292, the probe cannot slide from the outside of the IRD 100 through the seam 292 into the passage 264.

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

[0097] Figures 52(A) and 52(B) show cross-sectional views of other embodiments of the IRD100. Similar to the other embodiments, the passage 264 extends along a length from the internal buttress 108 through the intermediate section 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 be positioned adjacent to the outer surface 430 of the passage structure 265, in contact with it, toward the insertion end 432, also known as the first end of the passage structure 265. The external buttress 112 may be positioned adjacent to the outer surface 430 of the passage structure 265, in contact with it, toward the handle 434, also known as the second end of the passage structure 265 on the opposite side.

[0098] The internal buttress 108 may be made from an elastomer material such as a polymer or natural rubber. The external buttress 112 may be made from a semi-rigid material that is harder than the elastomer material of the internal buttress 108. The intermediate section 110 may also be made from a semi-rigid material or may contain an elastomer 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 positioned 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 positioned between the intermediate section 110 and the external buttress retaining member 438. The internal buttress 108 may be fixed to the internal buttress retaining member 436 at its first end 450, and furthermore, the internal buttress 108 may be movable relative to the internal buttress retaining member 436 at its second end 452 on the opposite side. The internal buttress 108 may be biased so that its opposite second end 452 extends toward the external buttress 112. The bias of the internal buttress 108 toward the external buttress 112 may also be biased toward the external buttress retaining member 438 relative to the external buttress 112. 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.

[0101] This embodiment is considered to function like a well nut. The IRD 100 may have an inserted state and a retained state. In the inserted state, the user may insert the IRD 100 into the body cavity 104 through the body opening 106. When the internal buttress is in the body cavity 104, the user may slide the external buttress 112 toward the internal buttress 108 relative to the outer surface 430 of the passage structure 265. When the external buttress 112 slides toward the internal buttress 108 while the IRD 100 is in the retained state, the internal buttress 108 expands peripherally away from the passage structure 265. Here, the internal buttress 108 can prevent the IRD 100 from coming out of the body cavity 104 and promote retention of the inhaled substance.

[0102] Furthermore, the IRD100 may include a latch 460 to maintain the retained state. In the inserted state, the latch 460 may be surrounded by the external buttress 112. When the external buttress 112 slides toward the internal buttress 108, the external buttress 112 no longer surrounds the latch 460. The latch 460 may be biased to extend circumferentially from the passage structure 265. When the external buttress 112 no longer surrounds the latch 460, the latch 460 may extend circumferentially from the passage structure 265. When the latch 460 extends circumferentially from the passage structure 265, the latch 460 may hold the external buttress 112 and the internal buttress 108 in a retained state. The user may push the latch 460 towards the center toward the passage structure 265 so that the bias of the external buttress 112 toward the external buttress retaining member 438 is no longer canceled out by the latch 460. Therefore, the external buttress 112 slides toward the external buttress retaining member 438, and the internal buttress 108 does not obstruct the withdrawal of the IRD 100 from the body cavity 104, and the inhaled material It may move towards the center of the passage structure 265 so as not to promote quality preservation. Since the IRD 100 has been returned from the retained state to the inserted state, the IRD 100 can be withdrawn from the body opening 106 and the body cavity 104.

[0103] Figure 53 shows a cross-sectional view of another embodiment of the IRD100, and Figure 54 shows a perspective view thereof. In the above, embodiments have been shown with an O-ring-shaped structure or sphincter inside the passage. In this embodiment, the O-ring-shaped structure is outside the passage structure. This embodiment has a fir tree-like shape with one or more branches 470. The branches 470 are shorter toward the insertion end 432 of the IRD100 to act as inclined edges and are longer toward the external buttress 112. The branches 470 may be of an elastomer material that curves as the IRD100 is inserted into and withdrawn from the body cavity. For example, the branches 470 may be disc-shaped soft rubber, as an example not to limit. 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 in other embodiments, the lubricant may be applied along the IRD100, for example, the branch 470.

[0104] The passage 264 penetrates the IRD 100, with a first opening 420 configured for the probe to enter the IRD 100 and a second opening 422 configured for the probe to withdraw from the IRD 100. As shown in the illustration, the above embodiment of the IRD 100 may have only a closed state for sliding the probe into the IRD 100 when the probe is not in a body opening or body cavity.

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

[0106] Figure 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 joint 292 helps 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 an open state to a closed state. The passage 264 passes through the combined first body part 200 and the second body part 202. The first body part 200 may have an internal cavity 160 of internal buttresses 108, thereby allowing the internal buttresses 108 of the first body part 200 to expand from a contracted or non-expanded state when expanding material is introduced. The second body part 202 may have an internal cavity 160 of internal buttresses 108, thereby allowing the internal buttresses 108 of the second body part 202 to expand from a contracted or non-expanded state when expanding material is introduced. In this embodiment, the internal cavity 160 of the internal buttress 108 of the first body part 200 is located within the second body part 2 The internal cavity 160 of the internal buttress 108 of 02 does not necessarily have to be in fluid communication with it. Figure 58 shows a cross-section of another embodiment of the IRD100. As shown in Figure 59, any suitable material such as the elastomer material 488, such as a thermoplastic elastomer or other elastomer material, may be applied around the probe 250, and the adhesive 490 together with the adhesive edge 492 may be used to position the IRD100 around the IRD100 in a closed state. That's good too.

[0107] Figure 60(A) shows an isometric view of a pressure cuff pump 500 that serves as a source of expansion material via an expansion material line 166 for expanding the internal cavity of an internal or external buttress. The pressure cuff pump 500 is compressed for expansion. For deflation, the user may pinch it to open a one-way valve. A one-way duckbill valve 502 may be provided, as shown in Figure 60(B). For expansion, a syringe may be used, along with other sources conceivable by those skilled in the art. As described above, the IRD100 may require a valve to retain the expansion material after expansion of the internal buttress, external buttress, or intermediate section.

[0108] Figure 61(A) shows a cross-sectional view of another embodiment of the IRD100. A flexible thermoplastic elastomer 508 may be molded onto a rigid core 510. The rigid core 510 is harder than the flexible thermoplastic elastomer 508. The rigid core 510 may be made of polypropylene or other suitable material. The flexible thermoplastic elastomer 508 may have a rating of about 50 A durometer, or other suitable rating. Figure 61(B) shows a cross-sectional view of the IRD100, where the probe 250 is inside the rigid core 510. The seam 292 visible between the surfaces during use may disappear when the IRD100 is inserted into a body opening, body cavity, or both. The IRD100 may include an internal buttress such as a balloon.

[0109] As shown throughout the disclosure of various embodiments, in some embodiments the internal buttress 108 and external buttress 112 are not configured to engage with the probe 250, and therefore the internal buttress 108 and external buttress 112 do not contribute to the seal between the IRD 100 and the probe 250. In other embodiments, the internal buttress 108 and external buttress 112 are configured to engage with the probe 250, and therefore the internal buttress 108 and external buttress 112 may contribute to the seal between the IRD 100 and the probe 250. Whether or not the internal buttress 108 and external buttress 112 engage with the probe 250, the internal buttress 108 and 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] Naturally, care is taken to optimize contact between the internal buttress 108, external buttress 112, and other parts of the IRD100 and the body 102, body cavity 104, body opening 106, and other patient conditions, and to minimize the risk of pressure necrosis and other adverse side effects from the use of the IRD100. This care may be carried out by giving the expandable material a predetermined volume, and then a predetermined pressure can be established on the body 102, body cavity 104, body opening 106, etc., by the internal buttress 108, external buttress 112, etc. of the IRD100.

[0111] The use of the IRD100 may include the following steps: In the first step, the IRD100 is inserted into the body cavity 104 of the body 102 through the body opening 106 of the body 102. In the second step, an insufflated substance is injected into the body cavity 104. In the third step, the user uses the probe to perform a diagnostic intervention, a therapeutic intervention, or both a diagnostic and therapeutic intervention. Further steps are possible. For example, the probe may be inserted through the body opening 106 before, after, or together with the IRD is inserted through the body opening 106, but not limited to these steps.

[0112] Many features and advantages of various embodiments of this disclosure, along with structural and functional details of various embodiments, are described in the preceding description; however, this detailed description is illustrative only, and in particular, regarding the structural and arrangement of components within the principles of this disclosure, the appended claims apply. Please understand that the terminology may be modified to the maximum extent indicated by its broader, more general meaning.

Claims

1. An internal buttress configured to prevent it from exiting the body cavity through a body opening, having a non-expanded state and an expanded state after the introduction of an expandable material, wherein in the expanded state, the internal buttress expands around the end of the insufflation retaining device, An external buttress connected to the internal buttress, configured so as not to enter the body cavity through a body opening, having only an expanded state and no non-expanded state, A passage that expands through the internal buttress and the external buttress, configured to allow a probe to pass through upon contact engagement with the body cavity, and configured to open so that inhaled substances introduced into the body cavity are not retained within the body cavity when the probe is not present in the passage; A pneumoperitoneal retention device comprising a joint extending from the outer surface of the passage to the inner surface of the passage, the joint extending along the entire length from the internal buttress to the external buttress.

2. The insufflation holding device according to claim 1, wherein the internal buttress in the expanded state is configured to contact and be adjacent to the probe.

3. The insufflation holding device according to claim 1, wherein the internal buttress in the expanded state is configured not to contact or be adjacent to the probe.

4. The insufflation holding device according to claim 1, wherein the passage is configured to allow a probe to pass from a first opening in the external buttress to a second opening in the internal buttress.

5. The insufflation retention device according to claim 1, wherein the joint is configured to extend from a first opening in the external buttress to a second opening in the internal buttress, so that the passage has an open state in which it does not retain inhaled material when the probe is not in the passage, and a closed state in which it retains inhaled material when the probe is in the passage.

6. An internal buttress configured to prevent it from exiting the body cavity through a body opening, having a non-expanded state and an expanded state after the introduction of an expandable material, wherein in the expanded state, the internal buttress expands around the end of the insufflation retaining device, An external buttress connected to the internal buttress, configured so as not to enter the body cavity through a body opening, having only an expanded state and no non-expanded state, A passage that expands through the internal buttress and the external buttress, configured to allow a probe to pass through upon contact engagement with the body cavity, and configured to open so that inhaled substances introduced into the body cavity are not retained within the body cavity when the probe is not present in the passage, and the expanded internal buttress expands into the passage for contact engagement with the probe, A pneumoperitoneal retention device comprising a joint extending from the outer surface of the passage to the inner surface of the passage, the joint extending along the entire length from the internal buttress to the external buttress.

7. The insufflation holding device according to claim 6, wherein the internal buttress in the expanded state is configured to contact and be adjacent to the probe.

8. The insufflation holding device according to claim 6, wherein the internal buttress in the expanded state is configured not to contact or be adjacent to the probe.

9. The insufflation holding device according to claim 6, wherein the passage is configured to allow a probe to pass from a first opening in the external buttress to a second opening in the internal buttress.

10. The insufflation retention device according to claim 6, wherein the joint is configured to extend from a first opening in the external buttress to a second opening in the internal buttress, so that the passage has an open state in which it does not retain inhaled material when the probe is not in the passage, and a closed state in which it retains inhaled material when the probe is in the passage.

11. An internal buttress configured to prevent it from exiting the body cavity through a body opening, and having a non-expanded state and an expanded state after the introduction of an expanding material, An external buttress connected to the internal buttress, configured so as not to enter the body cavity through a body opening, having only an expanded state and no non-expanded state, A passage that expands through the internal buttress and the external buttress, configured to allow a probe to pass through upon contact engagement with the body cavity, and configured to open so that inhaled substances introduced into the body cavity are not retained within the body cavity when the probe is not present in the passage; A joint extending from the outer surface of the passage to the inner surface of the passage, the joint extending along the entire length from the inner buttress to the outer buttress, An insufflation holding device wherein the internal buttress has a first balloon located inside the passage and a separate second balloon located outside the passage, and the first balloon and the second balloon are in fluid communication, but the first balloon and the second balloon do not orbit the end of the internal buttress.

12. The insufflation holding device according to claim 11, wherein the internal buttress in the expanded state is configured to contact and be adjacent to the probe.

13. The insufflation holding device according to claim 11, wherein the internal buttress in the expanded state is configured not to contact or be adjacent to the probe.

14. The insufflation retention device according to claim 11, wherein the passage is configured to allow a probe to pass from a first opening in the external buttress to a second opening in the internal buttress.

15. The insufflation retention device according to claim 11, wherein the joint is configured to extend from a first opening in the external buttress to a second opening in the internal buttress, so that the passage has an open state in which it does not retain inhaled material when the probe is not in the passage, and a closed state in which it retains inhaled material when the probe is in the passage.

Images