JP2021522928A - Pneumoperitoneum retention device using a balloon - Google Patents

Abstract

According to various embodiments, the probe can be inserted into the body cavity to perform diagnostic and / or therapeutic interventions. The probe can be inserted through a naturally occurring or artificial, intentional or accidental body opening. The body meatus can form a seal surrounding the probe, thus allowing the pneumoperitoneum device to be effectively held within the body cavity and the operator to perform the intervention. However, there may be leaks of air supply material. The pneumoperitoneum retention device is configured to contact the body meatus to form an adjacent effective seal and provide a passage for introducing the probe into the body cavity, thus providing a diagnostic or therapeutic intervention. , Or both.
[Selection diagram] FIG. 48

Description

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

(Detailed explanation)
There are techniques that allow an operator to introduce a probe, such as a medical scope, into the body cavity for diagnostic and / or therapeutic interventions. When introducing the probe, the operator may need to dilate the body cavity for intervention. Using insufflation technology, the operator can introduce insufflation material to dilate the body cavity, allowing the operator to have more work space and better visibility in the body cavity to perform the intervention. Can be done. For example, "Technology Status Evaluation Report: Methods of luminal distension for colonoscopy, Gastrointestinal Endoscopy, Volume 77, No. 4, 2013, pages 519-525" is incorporated by reference in its entirety. The insufflation material can be air, carbon dioxide, water, or other suitable material.

The operator can start the probe from outside the body, and the operator can advance the probe through human tissue and introduce the probe into the cavity of the body, that is, the body cavity. The probe can be advanced through the tissue through a body opening, i.e., a naturally occurring orifice, such as an anus or wound, such as a surgical incision or trauma. The body opening has the elasticity to allow the probe to recover its size and shape after being deformed by being propelled into the body cavity through the body opening, effectively sealing the outside of the body from the body cavity. can do. The insufflation material introduced into the body cavity can then be retained in the body cavity, effectively sealing the outside of the body from the body cavity and facilitating dilation of the body cavity when the operator is able to intervene. Useful for.

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

If the insufflation material is not effectively retained, the operator will not have the time and place to operate in the body cavity, or visibility. For example, a probe such as an endoscope 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 makes contact with the probe and an adjacent seal. It may not form effectively and may not promote retention of air-feeding material in the body cavity. As described in more detail, the present disclosure describes a pneumoperitoneum retention device that promotes retention of air-feeding material in the body cavity.

FIG. 1 shows a pneumoperitoneum retention device (also known herein as IRD100) that is advanced from outside the body 102 into the body cavity 104 through a body opening 106, also known as an orifice. The IRD 100 can typically include an internal buttress 108, an intermediate 110, and an external buttress 112. The inner buttress 108 is at the first end 114 of the IRD 100 and the outer buttress 112 is on the opposite side between the second end 116 of the IRD 100 and the middle 110. In other words, the intermediate portion 110 is arranged between the inner buttress 108 and the outer buttress 112.

As shown in FIG. 1, the width 111 of the inner buttress 108 may be substantially larger than the width 113 of the outer buttress 112. Alternatively, the width 111 of the inner buttress 108 may be substantially equal to the width 113 of the outer buttress 112, as shown in the later figure. Further, the width 111 of the inner buttress 108 may be substantially smaller than the width 113 of the outer buttress 112, as will be shown in a later figure. The width 111 of the inner buttress 108 may be substantially parallel to the width 113 of the outer buttress 112.

The internal buttress 108 may be configured to have a non-expanding configuration to allow the operator to introduce the IRD 100 into the body cavity 104 through the body opening 106. The non-expanded configuration of the internal buttress 108 may be smaller than the expanded configuration of the internal buttress 108 shown in FIG. The non-expanded configuration of the internal buttress 108 is configured to facilitate the entry of the IRD 100 from the external 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.

The extended configuration of the internal buttress 108 is configured to prevent the IRD 100 from being removed from the body cavity 104. When the IRD 100 moves towards the outer 118 of the body 102, the extended configuration of the internal buttress 108 contacts and engages with the body cavity 104, the body opening 106, or both, preventing the IRD 100 from being removed from the body cavity 104. In other words, in the expanded state, the 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.

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

The internal buttress 108 may be configured to form a body internal 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 conceivable, taking into account the patient's body 102 and according to the operator's needs. The shape of the internal buttress 108 may be chosen to be a predetermined shape so as to effectively form the body internal buttress seal 105 between the body 102 and the internal buttress 108. When the insufflation material is retained in the body cavity 104, the effectiveness of the buttress seal 105 inside the body arises, thus allowing the operator to perform the intervention and the time for the operator to work in the body cavity 104. And place or visibility can be secured.

The external buttress 112 may also be considered in a non-expanded or contracted state. On the other hand, the non-expanded configuration of the external buttress 112 is not required. The reason why the non-expanded configuration of the external buttress 112 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-expanding configuration that is not configured to prevent the introduction of the IRD 100 into the body cavity 104. In this example, the user or operator can transform or transition the non-expanded configuration of the external buttress 112 to the expanded configuration of the external buttress 112 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 through the body opening 106 into the body cavity 104.

Similar to the internal buttress 108, the external buttress 112 in the non-expanded configuration can be expanded in size to the expanded or expanded state by introducing the expanding material supplied by the source into the internal cavity of the external buttress 112. .. Similarly, in this case, the expanding material can be widely considered to be a fluid. The dilators used to dilate the inner buttress 108 and the outer buttress 112 may be the same or different in certain circumstances.

However, the external buttress 112 does not need to have a smaller or non-expanding configuration, as the external buttress 112 does not need to be introduced through the body opening 106. Thus, the external buttress 112 can be substantially the same size and configuration before and after introduction into the IRD 100 on the body 102, and the external buttress 112 is substantially the same size and configuration before, during and after use of the IRD 100 on the body 102. Can be of the same size and configuration. However, for other practical considerations, it may be more convenient to reduce the non-expanded configuration of the external buttress 112. For example, the non-expanded external buttress 112 may be easily accommodated by a medical kit or package.

The external buttress 112 may be configured to form an external buttress seal 107 between the body 102 and the external buttress 112. The external buttress 112 is usually shown as a conical shape, but other shapes are conceivable, taking into account the patient's body 102 and according to the operator's needs. The shape of the external buttress 112 may be chosen to be a predetermined shape so as to effectively form the external buttress seal 107 between the body 102 and the external buttress 112. When the insufflation material is retained in the body cavity 104, the effectiveness of the extracorporeal buttress seal 107 arises, thus allowing the operator to perform the intervention and the time for the operator to work in the body cavity 104. And place or visibility can be secured.

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

The intermediate portion may be configured to form a body intermediate portion seal 109 between the body opening 106 and the intermediate portion 110. The intermediate portion 110 is usually shown as a cylinder, but other shapes may be considered, depending on the operator's needs, taking into account the patient's body 102. The shape of the intermediate portion 110 may be selected to be a predetermined shape so as to effectively form the body intermediate portion seal 109 between the body 102 and the intermediate portion 110. When the insufflation material is retained in the body cavity 104, the effectiveness of the body intermediate seal 109 arises, thus allowing the operator to perform the intervention and the time for the operator to work in the body cavity 104. And place or visibility can be secured.

FIG. 2 shows a cross section of the internal buttress of the IRD100 of the embodiment shown in FIG. The outer circumference 130 of the inner buttress 108 may be extensible from the non-expandable configuration shown. The inner circumference 132 of the inner buttress 108 may be configured to be relatively rigid compared to the outer circumference 130. The relatively rigid inner circumference 132 of the internal buttress 108 means that when the operator performs the intervention, the probe is introduced into the IRD100 and the probe moves back and forth and rotates inside the IRD100. The IRD100 can help maintain its configuration and size.

FIG. 3 shows a cross section of an intermediate portion of the IRD100 of the embodiment shown in FIG. Within the body 140 of the intermediate portion 110 may be an expansion material conduit 142 that can be used by the operator to introduce the 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 can be substantially circular, so that the operator inserts the IRD 100 into the body opening 106 to perform an intervention, or the IRD 100 from the body opening 106. Upon removal, the IRD 100 can rotate relatively freely clockwise or counterclockwise within the body opening 106. Similarly, the inner surface 146 of the intermediate 110 can be substantially circular, so when the operator inserts the probe into the IRD100, performs an intervention, removes the probe from the IRD100, or attaches the probe to the IRD100. In addition, the IRD100 is relatively free to rotate 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.

The inner surface 146 of the intermediate portion 110 can be considered as a sleeve surrounding the probe when the intermediate portion 110 is in use. As shown, the sleeves are substantially circular and can be symmetrically placed within the body 140 of the intermediate portion 110. Alternatively, the sleeves may be asymmetrically arranged within the body 140 of the intermediate portion 110.

FIG. 4 shows a cross section of the external buttress 112 of the IRD100 of the embodiment shown in FIG. The outer circumference 150 of the external buttress 112 may be configured to be expandable from a non-expandable configuration to an expanded configuration. The inner surface 152 of the outer buttress 112 may be configured to be relatively rigid compared to the outer circumference 150. The relative rigidity of the inner surface 152 of this outer buttress can help the IRD100 maintain its configuration, so when the operator performs the intervention, the probe can be introduced into the IRD100 and the IRD100. The probe can move back and forth inside the and rotate.

The IRD100 may be made of one or more biocompatible materials. The biocompatible material may be a polymer such as silicone or latex. The same polymer may be used for the inner buttress 108 and the outer buttress 112, or different polymers may be used for the inner buttress 108 and the outer buttress 112. The same polymer used for the inner buttress 108 and the outer buttress 112 may be used for the intermediate portion 110, or a different polymer may be used for the intermediate portion 110, the inner buttress 108 and the outer buttress 112. The intermediate portion 110 may be formed integrally with the inner buttress 108 and the outer buttress 112, or the intermediate portion 110 may be formed from parts different from the inner buttress 108 and the outer buttress 112. Further, the inner buttress 108 and the outer buttress 112 may be formed of a plurality of different parts. When a plurality of different parts are used to form the IRD 100, the parts can be joined by using laser welding or the like.

FIG. 5 shows a cross section of an embodiment of the IRD 100 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 portion 110. The extended state is shown. An inflow valve 164 for expansion material is shown connected to an external buttress 112. The operator passes the expansion material through the inflow valve 164 into the internal cavity 162 of the external buttress 112, the expansion material conduit 142 of the intermediate portion 110, and the internal cavity 160 of the internal buttress 108, in addition to the gas pipe, syringe, or expansion material. Introduce using a suitable source of.

FIG. 6 shows a cross-sectional view of another embodiment of the IRD 100 in which the internal cavity 160 of the internal buttress 108 fluidizes through the internal cavity 162 of the external buttress 112 and the expansion material conduit 142 of the intermediate portion 110. The extended state is shown. The inflow valve 164 for the dilating material is shown to be connected to the external buttress 112 via an dilating material line 166 connected to the external buttress 112. The expansion material line 166 may be rigid, flexible, or any combination of flexibility and stiffness. In the case of flexibility, the expansion material line 166 can be properly oriented and positioned during use. In the case of rigidity, the expanding material line can maintain a predetermined direction and composition before, during and after use. The operator introduces the expansion material through the inflow valve 164 into the expansion material line 166, the internal cavity 162 of the external buttress 112, the expansion material conduit 142 of the intermediate portion 110, and the internal cavity 160 of the internal buttress 108.

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

The expansion material conduit 142 of the intermediate portion 110 can take any shape. FIG. 5 shows that the expansion material conduit 142 begins substantially at right angles to the inner buttress 108 and the outer buttress 112, while FIG. 6 shows that the expansion material conduit 142 starts at the inner buttress 108 and the outer buttress. It shows that it starts substantially in the curved direction with respect to 112. In addition, one or more pressure release valves in the IRD 100 may be configured to control when expansion of the external buttress 112 and internal buttress 108 occurs with respect to the introduction of the expanding material. The pressure release valve may be of any suitable construction and is not shown.

In FIG. 7, the internal buttress inflow valve 180 is in fluid communication with the extension material conduit 142 from the intermediate portion 110 to the internal buttress 108, while the external buttress 112 is not in fluid communication with the internal buttress inflow valve 180. A cross-sectional view of another embodiment is shown. The internal buttress 108 is shown in the non-expanded state. Of course, although not shown, the internal buttress inflow valve 180 may communicate directly with the internal buttress 108 without the intervening dilator conduit 142.

FIG. 8 is a cross-sectional view of another embodiment of the IRD 100 in which the internal buttress inflow valve 180 is in fluid communication with the expansion material conduit 142 so as to expand the internal buttress 108 by introducing the expansion material through the expansion material line 166. Is shown. Further, the external buttress inflow valve 182 is in fluid communication with the external buttress 112 so as to expand the external buttress 112 by introducing an expanding substance. In this embodiment of the IRD100, the internal buttress inflow valve 180 and the external buttress inflow valve 182 extend the internal buttress 108 through the introduction and removal of the dilator through the internal buttress inflow valve 180 and the external buttress inflow valve 182. And to contract, and to expand and contract the external buttress 112, it can be operated independently by the operator or user. The internal buttress 108 is shown in an expanded state by the expansion material supplied from the expansion material source 184.

The external buttress 112 has been shown to have a rectangular shape, as opposed to other buttresses already shown in donut shape, conical shape and the like. Any suitable shape can be used for the inner buttress 108 or the outer buttress 112.

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

In addition to transitioning from a contracted or non-expanded state with less dilated material to an expanded state with more dilated material, the intermediate 110 and contours are usually substantially rigid, as a specific example, but not limited. could be. In an embodiment having a substantially rigid contour, the intermediate portion 110 does not substantially deform during the use of the IRD 100 from the orientation and configuration of the IRD 100 with respect to the IRD 100 before or after use.

FIG. 9 shows another embodiment of the IRD100. In this embodiment, the IRD 100 has a first body component 200 and a second body component 202. The first body component 200 is configured to be connected to the second body component 202 to form a usable IRD 100. The operator can use two such body components if the probe is already in the body opening 106, or in both the body opening 106 and the body cavity 104 (see FIG. 1). When the probe is at this position in the body opening 106 or body cavity 104, it can be difficult for the operator to insert the probe through the IRD 100 or slide the IRD 100 onto the probe. On the other hand, the operator may connect the first body component 200 to the second body component 202 around a probe that remains at both the body opening 106 or both the body opening 106 and the body cavity 104. can. The first body component 200 may 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, clips, etc. Of course, this embodiment can also be used before the probe is in the body opening 106 and / or body cavity 104.

As shown in this embodiment, the first body component 200 and the second body component 202 are sleeves that provide a passage for the probe when the first body component 200 can be connected to the second body component 202. Can have substantially parallel walls configured to effectively form. In this embodiment, the first internal buttress component 207 and the second internal buttress component 209 may be supplied with the expanding material via different introductions of the expanding material. In other words, the first internal buttress component 207 and the second internal buttress component 209 do not have to be fluid communication.

Similarly, the first external buttress component 211 and the second external buttress component 213 may be supplied with the expanding material via different introductions of the expanding material, because the first external buttress component 211 and the first external buttress component 211 and the first. This is because the external buttress component 213 of 2 does not have to communicate with the fluid. In this embodiment having the first body component 200 and the second body component 202, it may be inconvenient to allow the buttress components to communicate fluidly. Of course, one or more buttress components not shown may be fluid communication.

FIG. 10 shows another embodiment of the IRD100. In this embodiment, in the first hinge side 226 of the first main body component 220 and the second hinge side 228 of the second main body component 222, the first main body component 220 has a hinge portion 224 or flexibility. It is connected to the second main body component 222 via a member. The hinge portion 224 may be configured so that the operator can operate the IRD 100 from an open configuration as shown in FIG. 10 to a closed configuration (not shown) by one-handed operation. One or more pairs of fasteners 204 may connect the first opening edge 230 of the first body component 220 to the second opening edge 232 of the second body component 222. The fastener 204 may extend beyond the first body component 220 and the second body component 222 shown in FIG. 10, or the first body component 200 and the second body component 202 shown in FIG. Can be within the perimeter of.

In the configuration shown in FIG. 10, it may be convenient for an internal buttress (not shown) to surround the first body component 220 and the second body component 222 for fluid communication, in other words, some other embodiments. As present in, it can be convenient to have fluid communication through substantially the entire body component. Further, as present in some other embodiments, it may be convenient for an external buttress (not shown) to substantially surround the first body component 220 and the second body component 222 for fluid communication. .. The inner buttress 108 and the outer buttress 112 are not shown in FIG. 10 for convenience and will be understood to be on the surface of the IRD 100 on the back of the shown figure.

11-12 show cross sections within the internal buttress 108 in another embodiment of the IRD100. In these embodiments, the internal buttress 108 may be connected to the internal buttress body component 240 via laser welding, gluing, or other suitable means. Alternatively, the internal buttress 108 can be an object with the internal buttress body component 240. The internal buttress body component 240 may have a bias to the closed state to form a sleeve of a size and size that fits around the probe used by the operator. The internal buttress body component 240 is shown in the open state in FIG. The IRD 100 is in the body cavity 104, in the body opening 106, or both, and the internal buttress body part 240 is open, or the IRD 100 is not in the body cavity 104 and is in the body opening. If not in 106, or both (see FIG. 1), the operator can place the IRD 100 around the probe. Further, FIG. 12 shows an internal buttress body component 240 with a first fastener 242 and a second fastener 244. The first fastener 242 is configured to connect with the second fastener 244 to form a sleeve of suitable size and size around the probe.

In addition, the internal buttress 108 can overlap the body component 240 as shown, helping to form an effective seal for the retention of air-feeding material. Alternatively, although not shown, the internal buttress 108 does not have to overlap the internal buttress body component 240 and may still provide an effective seal for retaining the air-feeding material.

Similarly, although not shown, the external buttress may or may not overlap with similar external buttress body components to form an effective seal of air-feeding material.

FIG. 13 shows a side sectional view of the probe 250 passing through the body opening 106, and FIG. 14 shows an end view. The body opening 106 effectively forms the body probe seal 252 with the probe 250 inserted through the body opening 106. In addition, the layer of lubricant 254 is usually lathered onto the probe 250 before entering through the body opening 106. The layer of lubricant 254 disposed between the body opening 106 and the probe 250 further aids in the formation of the body probe seal 252 between the body opening 106 and the probe 250.
Lubricant 254 can be any suitable type for reducing friction between the body opening 106 and the probe 250.

FIG. 15 shows a side sectional view of the probe 250 passing through the body opening 106 having an abnormality 256, and FIG. 16 shows an end view. The body opening 106 is unable to effectively form the probe 250 and the body probe seal 252 inserted into the body opening 106 having the variant 256. For some reason, such as congenital malformations, tumors, previous tumors, muscle relaxation, etc., the body opening 106 does not effectively form the probe 250 and the body probe seal 252 through the body opening 106.

FIG. 17 shows side sectional views of the probe 250 passing through the body opening 106 having the variant 256 and the probe 250 passing through the IRD 100 according to various embodiments, and FIG. 18 shows an end view. Similar to the construction of the windows of the house, the IRD 100 can effectively form a seal with the body 102 to facilitate the retention of air-feeding material within the body cavity 104. In addition, the IRD 100 can provide sleeves of a predetermined configuration and size depending on the probe in order to effectively form the probe and other seals and further promote retention of the insufflation material in the body cavity 104.

Not surprisingly, the IRD 100 can be used with the probe 250 of the body opening 106 in the absence of variant 256. However, even when the IRD 100 is used with the probe 250 in a body opening 106 with a variant 256, the IRD 100 remains in the body cavity 104 for a period of time effective for performing diagnostic, therapeutic, or both of the operator's diagnostic and therapeutic interventions. It is configured to facilitate retention of the insufflation inserted within, which is superior to the retention of the insufflation that can be achieved using the probe 250 without the IRD 100. The probe passage seal 260, the midbody seal 109 and the internal buttress seal 105 work in conjunction with the probe 250 and are within the body cavity 104 for a period of time effective for the operator to perform diagnostic, therapeutic and / or both. It may be configured to promote retention of the insufflation material inserted into the. On the other hand, the passage 264 may be open without the probe 250 present in the passage, and therefore the insufflation material may not be retained in the body cavity 104.

The IRD 100 includes a body intermediate seal 109 between the intermediate 110 and the wall 120 of the body opening 106, an external buttress seal 107 between the external buttress 112 and the wall 120 of the body opening 106, and an internal buttress 108. An effective seal can be formed with the buttress seal 105 inside the body between the body cavity 104 or the body 102, even in the presence of the variant 256. As shown in FIG. 17, the intermediate portion 110 may be integrated with the external buttress 112 or may be operational close, both functions advancing the IRD 100 into the body cavity 104 during the operation. Stop.

Further, the IRD 100 can effectively form the probe passage seal 260 when the probe 250 is inserted into the IRD 100. The passage 264 through the intermediate portion 110 of the IRD 100 may 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 IRD 100 (see FIGS. 5 and 6), and thus the probe 250 extends widely through the IRD 100.

Further, the outer surface 190 of the intermediate portion 110 may be configured to provide contour features 266 that engage with the variant 256 to provide an effective seal. Of course, the contour feature 266 may be a protrusion, indentation, or a combination of both that engages with the variant 256 to provide an effective seal. Further, the contour feature portion 266 may be formed from the outer buttress 112, or both the intermediate portion 110 and the outer buttress 112. Further, the internal buttress 108 may have contour features, may take into account the patient's body 102, and may have other shapes as described above, depending on the operator's needs.

19-25 show various diagrams of the IRD100 according to another embodiment. The IRD 100 may have an internal buttress 108 and an external buttress 112 with an intermediate portion 110 between them. The IRD100 can be made of seams 292, or parts thereof, extending along the length of the IRD100, as shown. The seam 292 can basically be a gap or crevice between the surfaces of the material that is folded by itself to make the IRD100. If the surfaces of the material are folded by themselves to bring the IRD 100s into contact with each other, the seams 292 may not be present. The external buttress 112 has a tapered surface 294 that is substantially conical to facilitate effective sealing with the body 102 (see FIG. 1).

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

The entry port 298 of the outer buttress 112 may be configured to have a diameter wider than the diameter of the passage 264, which diameters are substantially parallel to each other. By having the diameter of the entry port 298, which is wider than the diameter of the passage 264, the operator inserts the probe 250 into the passage 264 than if the diameter of the entry port 298 is substantially the same size as the diameter of the passage 264. Can have a larger target. The diameter of the passage 264 can be configured and sized to fit snugly around the diameter of the probe 250, thus a probe passage seal between the passage and the probe can be achieved more easily, again. As before, these diameters are substantially parallel to each other. An internal taper 296 of the external buttress 112 may be provided so that the diameter of the entry port 298 can be tapered to a smaller diameter of the passage 264. The internal taper 296 is shown in FIG. 22 as a substantially straight line resulting in a conical structure, but any suitable shape is conceivable that facilitates the operator manipulating the probe 250 into the passage 264.

This embodiment is shown as a solid structure, where the IRD100 can be a solid structure if the internal buttress 108 is a compressible material (eg, foam as an example and limitation), thus the internal buttress 108 Once pushed through the body opening 106 in the contracted state and once inside the body cavity 104, the internal buttress 108 can expand into the expanded state. Of course, this similar structure, such as the entry port 298 with an internal taper 296, may be present with features from other embodiments that include an internal buttress 108 that is expandable by the extendable material.

25-29 show various diagrams of the IRD100 according to another embodiment. Although not shown, the inner buttress 108 and the outer buttress 112 allow fluid communication through the intermediate portion 110 via a substantially rectangular balloon, also known herein as the passage structure 300. The intermediate portion 110 may be compressed by an external compression member 302 that essentially biases the fluid in the passage structure 300 towards the internal buttress 108 and the external buttress 112. The external compression member 302 may be in contact with and adjacent to the outer surface of the passage structure 300. The external compression member 302 in the closed position may or may not push virtually any fluid, that is, the extension material from the intermediate 110 of the IRD 100 ready for use by the operator. .. The passage structure 300 is actually shown and is as rectangular as possible and is considered symmetrical during operation, but with the patient's body 102 in mind and other suitable sizes as needed by the user. Dimensions are possible.

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 at the closed position shown in FIGS. 27 to 29. Further, although the external compression member 302 is shown to overlap the external bias member 306 that overlaps the internal bias member 304, the external compression member 302 itself does not have to overlap the internal bias member 304 itself. Do not have to overlap. The external compression member 302 is configured for one-handed or two-handed operation from the open position, and the IRD100 with the external compression member 302 in the open position can be arranged so as to surround the probe 250 and the IRD100 in the closed position. Can be maintained around the probe 250.

Although the external compression member 302 is shown outside the balloon forming the internal buttress 108, the external buttress 112, and the intermediate portion 110, the external compression member 302 may be inside the passage structure 300. Is fully conceivable.

30-32 show cut side views of an O-ring structure 280 or an IRD 100 with a plurality of O-ring structures 280 according to various embodiments. The IRD 100 works with the probe 250 to form a probe passage seal 260, which is an effective seal between the IRD 100 and the probe 250. In addition, a layer of lubricant 254 between the IRD 100 and the probe 250 may help or facilitate the effect of the probe passage seal 260 between the IRD 100 and the probe 250.

In addition, the O-ring structure 280 along the sleeve can help facilitate the seal between the IRD 100, eg, the intermediate 110 and the probe 250. The O-ring structure 280 may be fixed to the sleeve at the first O-ring end 282 and movable at the opposite second O-ring end 284. The O-ring type structure 280 can be one of a plurality of O-ring type structures 280. Although the O-ring structure 280 can be rigid, it can be advantageous to allow the O-ring structure 280 to be flexible and therefore a second contralateral side when the probe 250 advances. When the O-ring end 284 is pulled into the body cavity 104 and the probe 250 retracts, the opposite second O-ring end 284 is pulled out of the body cavity 104.

As described in various embodiments, when the probe is within the body opening 106 or body cavity 104, the operator inserts the probe through the IRD 100 into it or slides the IRD 100 onto the probe. You won't be able to. In contrast, in other embodiments, the operator can connect the IRD 100 around a probe that remains in position within both the body opening 106, or both the body opening 106 and the body cavity 104.

Those skilled in the art will appreciate that the probe may be an endoscope, as a non-limiting example. Commercially available endoscopes have a light source configured to illuminate the lumen of the colon, such as the body cavity 104, and air to the lumen to dilate the colon during colonoscopy. It has an integrated air pump configured. In addition, one of ordinary skill in the art will appreciate that the _{endoscope may be configured to use CO 2} , water, or other suitable substance for inhalation of the lumen of the colon.

Those skilled in the art will appreciate that in colonoscopy, the quality of intestinal regulation has a significant impact on the success of colonoscopy. Numerous intestinal preparations are available to adequately clean the intestines. For example, "Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization, Ann Gastroenterol 2016; 29 (2): 137-146" is incorporated herein by reference in its entirety.

In addition, FIG. 33 shows a commercially available endoscope 350 that is familiar to those skilled in the art. The commercially available endoscope 350 has three main parts: a connector part 352, a control part 354, and an intubation tube 356. The connector section 352 is for attaching the endoscope 350 to a system 358 including a display, an image processor, a light source and a power source, and a source of water, air, CO ₂ or other suitable substance. The control unit 354 is attached to the connector unit 352. The control unit 354 is held by the operator in order to control the dial that deflects the tip 360 of the intubation tube 356 up, down, left and right. The control unit 354 may have separate buttons for suction, inhalation, and imaging. Finally, the control unit 354 may have an entry port for inserting an appendage into the body cavity 104 via the conduit of the intubation tube 356. Many endoscopes have additional control functions. The intubation tube 356 is a flexible shaft attached to the control unit 354. The intubation 356 may include one or more conduits for appendages, wash water, inhalation, etc. The intubation 356 may include an angle forming actuator for bending the tip 360 of the intubation 356. The tip 360 of the insertion tube 356 may include an image generator, a lighting system, a suction aperture, an objective lens, and a water ejector for cleaning the lens. The length, diameter, and flexibility of the intubation 356 will vary depending on the type and manufacturer of the endoscope, with diameters ranging from about 4.9 mm to about 12.9 mm. For example, "Report on Emerging Technology: GI Endoscopes, Gastrointestinal Endoscopy, Volume 74, No. 1, 2011, pages 1-6" is incorporated herein by reference in its entirety.

Thus, one of ordinary skill in the art can insert the probe 250 into the IRD 100 in all embodiments when the IRD 100 is outside the body cavity 104 or body opening 106, but the IRD 100 is inside the body cavity 104 or body opening 106. It will be appreciated that the probe 250 can be inserted into the IRD 100 only in some of the embodiments. For example, referring to FIG. 1, since the internal buttress 108 is seamlessly constructed around the probe 250, the internal buttress 108 is configured to have only a closed state. The probe 250 can be inserted into the unbroken internal buttress 108 only when the IRD 100 is outside the body cavity 104 or body opening 106. On the other hand, referring to FIG. 11, since the internal buttress 108 is configured to have a cut around the probe 250, the internal buttress 108 is configured to have a closed state and an open state. When the internal buttress 108 has a cut, the operator can say that the IRD 100 is inside the body cavity 104, the body opening 106, or both, and the internal buttress 108 is in the open state, or the IRD 100 is in the body cavity 104, the body. The IRD 100 can be placed around the probe when not inside the opening 106, or both.

FIG. 34, as will be appreciated by those skilled in the art, relates to an embodiment showing a continuous structure of the internal buttress 108 around the probe and a cut structure of the internal buttress 108 around the probe 250. It is shown by the end view which shows. Although the probe 250 is shown as substantially a cylinder and the internal buttress 108 is shown as a ring, other shapes (eg, ellipse, etc.) can also be employed, which are also disclosed herein. NS.

FIG. 34 (A) shows the probe 250 outside the seamless structure of the internal buttress 108. In the seamless structure of the internal buttress 108, the only way to place the internal buttress 108 around the probe 250, as shown in the upper right figure, is for the probe 250 to be located within the internal buttress 108 and surrounded by the internal buttress 108. The internal buttress 108 is slid relative to the probe 250 so as to. In this state, the probe 250 penetrates the passage 264. When the internal buttress 108 has a seamless structure and the probe 250 is within the body opening 106 or body cavity 104, the internal buttress 108 will not be able to slide over the probe 250. For example, if the probe is a colonoscope, the probe will only be able to slide into the internal buttress 108 at only one end. In such an example, the colonoscope 350 has an intubation 356 configured to slide over the probe 250. However, at the first end of the intubation 356, a control unit 354, a connector unit 352, and a system 358 that may prevent the intubation 356 from sliding on the internal buttress 108 at the first end are arranged. It may be. The colonoscope 350 has a tip 360 at the second end of an intubation 356 configured to slide into the internal buttress 108. However, if the tip 360 is in the body opening 106 or body cavity 104, the tip 360 cannot be utilized for sliding into the internal buttress 108.

FIG. 34 (B) shows the probe 250 outside the integral structure of the internal buttress 108 biased to the closed position and the probe 250 inside the internal buttress 108 in the open state, in order from left to right. , A probe 250 located within the internal buttress 108 and surrounded by an internal buttress 108 in a closed state. In manufacturing the IRD100 as a single semi-rigid member with a seam 292 along the overall length of its sides, after the probe has been placed inside the body opening 106, body cavity 104, or both of the body. It is difficult to make it easy to slide the IRD100 over the probe. Therefore, as described elsewhere in the specification, brackets 656 or other fasteners to bring the edges of the seams 292 closer together so that the IRD100 can improve retention of pneumoperitoneum-retaining material. It may be necessary to prepare.

FIG. 34 (C) shows the probe 250 located outside the two structures of the internal buttress 108, the probe 250 inside the open internal buttress 108, and the probe 250 inside the internal buttress 108, in order from left to right. It shows a probe 250 surrounded by an internal buttress 108 in a closed state.

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

The internal buttress 108 may be secured to the base member 400 by thermal caulking / welding, laser welding, inductive coupling, RF welding, impact sealing, adhesives, or other suitable method. Similarly, balloons may be formed by various treatments such as dip molding, thermoforming, welding of extruded films, or other suitable methods. The base member 400 may be formed by injection molding, compression molding, transfer molding, liquid silicone rubber molding, or any other suitable method. All materials are biocompatible.

The base member 400 may be semi-rigid, having a higher rigidity than the expanded internal buttress. The internal buttress may be a balloon with a non-expanded state and an expanded state (as shown). The balloon may be configured to snap onto and snap onto itself in the expanded state. The balloon is such that the first end 402 of the internal buttress 108 forms a seal between the two ends of the balloon portion of the internal buttress 108 when the balloon is inflated from the non-expanded state to the expanded state. It may be thermoformed to bond with the second end 404 of the buttress 108. In doing so, the expanded balloon forms an internal buttress 108 that forms an effective seal for holding the inhaled material.

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 in the open state with a seam 292 along its entire length. In the expanded state of the internal buttress 108, the base member 400 may be in the closed state. In the open state of the internal buttless 108 and the base member 400, when the probe is inside the body opening, the body cavity, or both the body opening and the body cavity, the seam 292 is substantially open, so the IRD 100 is used for the probe. Can be placed around. In the closed state of the internal buttress 108 and the base member 400, when the probe is inside the body opening, the body cavity, or both the body opening and the body cavity, the seam 292 is substantially closed, so the IRD 100 is used for the probe. You won't be able to place it around. However, in the closed state of the internal buttress 108 and the base member 400, the IRD 100 can be slid onto the probe when the probe is not inside the body opening, body cavity, or both body opening and body cavity. This is because the passage 264 for the probe is open so that the inhaled material is not retained in the absence of the probe.

As shown, the internal buttress 108 is not configured to engage the probe, so the extended balloon of the internal buttress 108 does not contribute to the seal between the IRD 100 and the probe. Alternatively, the internal buttress 108 may be configured to engage the probe to contribute to the seal between the IRD 100 and the probe.

FIG. 36 shows a perspective view of another embodiment of the IRD100. As shown, the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be integrally formed. The internal buttress 108 may be a balloon having a non-expanded state (not shown). The internal buttress 108 may be a balloon with an expanded state, as shown. The internal buttress 108 may be attached to the base member 400. The base member 400 may be a semi-rigid member having a rigidity greater than that of the expanded internal buttress 108. The user may wrap the internal buttress 108 around the base member 400 when the internal buttress 108 is in the non-expanded state. The user then inserts the IRD 100 into the patient to expand the internal buttress 108 from the non-expanded state to the expanded state.

As described above, the internal buttress 108 is in the open state in the non-expanded state. 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 in the closed state. In the open state of the internal buttress 108 and the base member 400, when the probe is inside the body cavity, body opening, or both body cavity and body opening, the seam 292 is substantially open, so the IRD 100 is used for the probe. Can be placed around. When the probe is inside the body cavity, body opening, or both body cavity and body opening 106 in the closed state of the internal buttress and base member 400, the seam 292 is substantially closed and the IRD 100 is used for the probe. You won't be able to place it around. However, in the closed state of the internal buttress 108 and the base member 400, when the probe is not inside the body cavity, the body opening, or both the body cavity and the body opening, the passage for the probe is open and the IRD100 is used. It can be slid on the probe.

As shown, the balloon portion of the internal buttress 108 is configured so that it does not engage the probe in the presence of the probe, thus the expanding internal buttress 108 contributes to the seal between the IRD 100 and the probe. do not.

As shown, the internal buttress portion may have a chamfered portion 406 or an end with a sloping edge, which facilitates entry into the body cavity through the body opening of the IRD100. Alternatively, as shown in other embodiments, the internal buttress 108 may have an end with a rounded edge.

37-38 show cross-sectional views of other embodiments of the IRD100. The outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 are referred to as base members 400 and may be formed from two or more members or components. For example, the outer buttless 112, the intermediate portion 110, and the inner buttless portion 168 may be formed by combining the first main body component 200 and the second main body component 202. The first main body component may include a first main body external buttress 112, a first main body intermediate portion 110, and a first main body internal buttress portion 168. The second main body component may include a second main body external buttress 112, a second main body intermediate portion 110, and a second main body internal buttress portion 168. When the first body component and the second body component are combined, the first body component and the second body component form an external buttress 112 of the IRD 100, an intermediate portion 110, and an internal buttress portion 168.

The internal buttress 108 may be attached to the base member 400 by welding, adhesive, or other suitable method. The first main body component and the second main body component may be semi-rigid having a rigidity larger than that of the internal buttress 108 in the expanded state. The internal buttress 108 may be a balloon with a non-expanded state and an expanded state (as shown). The balloon of the first body component 200 is separate from and may be separated from the balloon of the second body component. The first body component 200 may have an expansion material line 166 that fluidly communicates with a first expansion material conduit that communicates fluidly with the first internal cavity of the first balloon. The second body component 202 may have a second expanding material line 466 that fluidly communicates with a second expanding material conduit that communicates fluidly with the second internal cavity of the second balloon. The first balloon and the second balloon may be inflated independently by one source in sequence, or may be inflated by two sources at the same time. Alternatively, the first expanding material line and the second expanding material line are connected by a Y valve, and the user can inflate both the first balloon and the second balloon at the same time using a single source. ..

The first main body component and the second main body component may have fasteners such as a snap 205 and a snap receiver 206, as a non-limiting example. Further, the first main body component 200 and the second main body component 202 may have guides such as a positioning pin 208 and a positioning hole 210, as a non-limiting example. The fastener on the first body component 200 may be arranged to engage the fastener on the second body component 202. The guide on the first main body component 200 may be arranged so as to engage with the guide on the second main body component 202. In the IRD100 having any configuration, since the first main body part and the second main body part are mirror image parts that are inverted with each other, the actual parts that become the first main body part and the second main body part are after manufacturing. It may be used interchangeably.

As shown in FIG. 38, the first main body component 200 and the second main body component 202 are 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. May be connected to and from via a hinge 225.

As shown, the extension of the inner buttress 108 may be configured so that it does not engage the probe 250, so the extension of the inner buttress 108 does not contribute to the seal between the IRD 100 and the probe. The internal buttress 108 is configured to extend in the peripheral direction from the IRD 100 as the internal buttress 108 expands.

39, 40 and 41 show cross-sectional views of other embodiments of the IRD100. The outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be formed from two or more members or body components. For example, the outer buttless 112, the intermediate portion 110, and the inner buttless portion 168 may be formed by combining a first main body component and a second main body component. The first main body component may include a first main body external buttress, a first main body intermediate portion, and a first main body internal buttress portion. The second main body component may have a second main body external buttress, an intermediate portion of the second main body, and an internal buttress portion of the second main body. When the first body component and the second body component are combined, the first body component and the second body component consist of an external buttress, an intermediate portion, and an internal buttress portion, also referred to herein as base members. A body component may be formed.

The main body component shown in FIG. 39 is complementary to the main body component shown in FIG. 40 or FIG. 41. In other words, the outer buttress 112, the intermediate 110, and the inner buttress portion 168 may be complementary. As shown, the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be integrally formed. The passage 264 extends from the inner buttress 108 to the outer buttress 112 through the intermediate portion 110 along the entire length of the side surface of the IRD 100. The passage 264 may be defined by a passage structure extending from the inner buttress 108 to the outer buttress 112.

Complementary features of the body component may be inverted if desired. As shown, the extension material line 166 for the IRD 100 may be provided in only one of the first body component or the second body component. As shown by the dotted line, the expanding material conduit 142 may extend throughout the body component from the expanding material line 166 to the internal cavity of the balloon present, whereby the expanding material line is with the internal cavity. Fluid communication. The first body component, as a non-limiting example, is via a valve 600 such as the male valve / snap shown in FIG. 39 that engages the female valve / snap shown in FIG. 40 or 41. , May be fluidly communicated with the second main body component. In other words, these two components may be snap-coupled to each other to form one expansion material line 166 and a continuous air passage to allow expansion from the source. Thus, 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, which is common to both balloons. There may be fluid communication with the extended material line 166 and the source.

Further, the body component is a male / female positioning mechanism (each It may have fasteners or positioning guides such as 214 and 216).

Similar to 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. One passage has an O-ring structure 280 of a different diameter so that probes of various diameters can be placed inside the passage and can form a seal on the O-ring structure of the probe. You may. When two or more O-ring type structures 280 are used, the one with a larger diameter may be arranged on the outer buttress 112 side and the one with a smaller diameter may be arranged on the inner buttress 108 side, or vice versa. May be adopted.

As shown, the internal buttress 108 may be a balloon. The balloon may have a variable thickness of 610 to facilitate expansion for expansion due to insertion of the expanding material. The balloon may be thinner towards the first end 174 of the inner buttress portion 168 to facilitate expansion of the balloon towards the inner buttress portion 168.

The different balloon arrangements that can be adopted are shown. FIG. 39 shows that the balloon extends from the outer circumference of the inner buttress portion around the first end 174 of the inner buttress portion 168. The expanded balloon, if present, may be configured to engage the probe through passage 264 to form a seal between the balloon and the probe. The balloon may be configured so as not to engage 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 by other features. A seal may be formed between the IRD 100 and the probe in passage 264. In any situation of the particular embodiment, the expanded balloon is not closed so that the IRD 100 is unable to hold the inhaled material in the absence of a probe within the IRD 100.

FIG. 40 shows that the balloon extends from the outer circumference of the inner buttress portion 168 through the circumference of the first end 174 of the inner buttress portion 168 into the passage 264. The depth of the balloon into the passage 264 is shown to be substantially similar to the depth of the balloon along the perimeter of the internal buttress 108, while the depth of the balloon into the passage 264 is the internal buttress. It may be substantially larger or smaller than the depth of the balloon along the outer circumference of 108. The expansion of the balloon in passage 264 has different diameters, such as a larger diameter 700, as shown in FIG. 49 (A), and a smaller diameter 702, as shown in FIG. 49 (B). A probe balloon encapsulation may be formed to accommodate the probe. A predetermined volume of dilator may be inserted into the internal cavity of the balloon while the probe is in the passage. Users using syringes, pressure cuff pumps, or other suitable sources of expansion material will feel resistance to further insertion of expansion material. In certain embodiments, the expanded balloon is not closed, so that the IRD 100 is unable to retain the inhaled material in the absence of a probe in passage 264.

FIG. 41 shows an inner balloon 632 in the passage 264 and a balloon outside the passage 264 and configured as an outer balloon 634 surrounding the passage. As shown, the inner balloon 632 and the outer balloon 634 are fluid communicating so that a single source of expanding material can be used to expand both balloons at the same time. Alternatively, the inner and outer balloons are not fluid-tight, thereby requiring the use of a single dilator source to stagger the expansion of multiple balloons. Alternatively, different dilator sources may be required to inflate multiple balloons at the same time.

In these embodiments, the internal buttress can be placed around the probe when the probe is inside the body opening, or both the body opening and the body cavity, and the IRD100 is in the open state. In terms of having a condition, it is considered to have a cut to the internal buttress. Further, the internal buttress in the embodiment has a closed state in which the internal buttress is closed around the probe when the probe is inside the body meatus, body cavity, or both.

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

42-49 show other embodiments of IRD100. The IRD100 does not have a two-piece structure composed of a first main body component and a second main body component as shown in FIGS. 39, 40 and 41, but has an external buttress 112, an intermediate portion 110 and an internal buttress portion 168. It has a base member 400 formed as an integral structure. Similar to these other embodiments, the internal buttress 108 may be a balloon that extends peripherally from the base member 400 when expanded.

As shown in FIGS. 42-49, the balloon may extend along the outer surface of the base member longer than the balloon extending along the interior of the base member in the passage, or vice versa. It may be. Further, the balloon may be extended along the outer surface of the base member to the same length as the balloon extending along the inside of the base member in the passage. The balloon inside the base member in the passage may engage with the probe to form a probe balloon seal to facilitate retention of inhaled material. The balloon on the outside of the base member may form a buttress seal inside the body to facilitate retention of inhaled material.

The IRD 100 has a seam 292 that extends along the overall length of the base member from the outer buttress to the inner buttress portion. The seam 292 is also present on the internal buttress balloon. The IRD 100 shown in FIGS. 42-49 may have an open state and a closed state due to the seam 292. The IRD 100 can be placed around the probe when the IRD 100 is in the open state and the probe is inside the body meatus, body cavity, or both. In addition, the internal buttress has a closed state in which the internal buttress is closed around the probe when the probe is inside the body meatus, body cavity, or both.

The outer 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.

FIG. 50 shows a cross-sectional view of another embodiment of the IRD100, and FIG. 51 shows a perspective view thereof. The internal cavity 160 of the internal buttress 108 may expand in the peripheral direction when the base member is extended from the internal buttress portion 168, and the base member further comprises an intermediate portion 110 and an external buttress 112. The passage 264 configured to pass the probe, if present, is illustrated as having two O-ring structures 280, but any number of O-ring structures 280 of one or more. It will be clear that you can have. The O-ring structure 280 on the inner diameter of the base member makes it possible to form a seal between the IRD 100 and the probe in the presence of the probe. As shown, the O-ring structure 280 may be surrounded by an external buttress 112. One or more O-ring type structures 280 may be surrounded by some combination of an intermediate portion 110 and an internal buttress portion 168. The O-ring structure 280 may serve as a sphincter that allows sealing on probes of various diameters. The IRD 100 has a seam 292 that extends along the length from its first opening 420 to its second opening 422. Since the internal buttress has a cut, the IRD100 has an open state and a closed state.

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

As shown, the expanded internal buttress 108 does not engage the probe in the presence of the probe so as to form a seal between the expanded internal buttress 108 and the probe. It is composed of.

52 (A) and 52 (B) show cross-sectional views of other embodiments of the IRD100. As in other embodiments, the passage 264 extends along the length from the inner buttless 108 through the intermediate 110 to reach the outer buttless 112. The passage 264 may be defined by a passage structure 265 extending from the inner buttress 108 to the outer buttress 112. The internal buttress 108 may be arranged adjacent to the outer surface 430 of the passage structure 265 in a contacting state toward the insertion end 432, which is also called the first end of the passage structure 265. The outer buttress 112 may be arranged adjacent to the outer surface 430 of the passage structure 265 in contact with the handle 434, which is also called the second end on the opposite side of the passage structure 265.

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

The first end or insertion end 432 of the passage structure 265 may include an internal buttress holding member 436. The internal buttress 108 may be arranged between the intermediate portion 110 and the internal buttress holding member 436.

The second end or handle 434 on the opposite side of the passage structure 265 may include an external buttress holding member 438. The external buttress 112 may be arranged between the intermediate portion 110 and the external buttress holding member 438. The internal buttress 108 may be fixed to the internal buttress holding member 436 at the first end 450 of the internal buttress 108, and the internal buttress 108 is further located at the opposite second end 452 of the internal buttress 108. , May be movable relative to the internal buttress holding member 436.
The internal buttress 108 may be biased in a direction in which a second end 452 on the opposite side of the internal buttress 108 extends toward the external buttress 112. The bias of the inner buttress 108 toward the outer buttress 112 may be biased toward the outer buttress holding member 438 with respect to the outer buttress 112. The external buttress holding member 438 may be configured to prevent the external buttress 112 from extending beyond the handle 434 and popping out of the passage structure 265.

This embodiment is considered to function like a well nut. The IRD 100 may have an inserted state and a holding state. In the insertion position state, the user may insert the IRD 100 into the body cavity 104 through the body opening 106. When the inner buttless is in the body cavity 104, the user may slide the outer buttless 112 toward the inner buttless 108 with respect to the outer surface 430 of the passage structure 265. When the outer buttress 112 slides toward the inner buttress 108 while the IRD 100 is in the holding state, the inner buttress 108 expands in the peripheral direction away from the passage structure 265. Here, the internal buttless 108 can prevent the IRD 100 from exiting the body cavity 104 and promote retention of the inhaled substance.

In addition, the IRD 100 may include a latch 460 to maintain the holding state. In the inserted state, the latch 460 may be surrounded by an external buttress 112. When the outer buttress 112 slides toward the inner buttress 108, the outer buttress 112 no longer surrounds the latch 460. The latch 460 may be biased so as to extend in the circumferential direction from the passage structure 265. When the external buttress 112 no longer surrounds the latch 460, the latch 460 may extend from the passage structure 265 in the peripheral direction. When the latch 460 extends from the passage structure 265 in the peripheral direction, the latch 460 may hold the outer buttress 112 and the inner buttress 108 in a holding state. The user may push the stake 460 centrally towards the aisle structure 265 so that the bias towards the outer buttress holding member 438 side of the outer buttress 112 is not canceled by the stake 460. Therefore, the outer buttress 112 slides toward the outer buttress holding member 438, and the inner buttress 108 has a passage structure such that the inner buttress 108 does not interfere with the extraction of the IRD 100 from the body cavity 104 and does not promote the retention of inhaled material. You may move to the center towards 265. Since the IRD 100 has been returned from the holding state to the inserted state, the IRD 100 can be withdrawn from the body opening 106 and the body cavity 104.

FIG. 53 shows a cross-sectional view of another embodiment of the IRD100, and FIG. 54 shows a perspective view thereof. In the above, embodiments have been shown with an O-ring structure or sphincter inside the passage. In this embodiment, the O-ring structure is outside the aisle structure. This embodiment is shaped like a fir tree with one or more branches 470. The branch 470 is shortened towards the insertion end 432 of the IRD100 and elongated towards the outer buttress 112 to act as a sloping edge. The branch 470 may be of an elastomeric material that curves as the IRD100 is inserted into and withdrawn from the body cavity. For example, the branch 470 may be a disk-shaped soft rubber, as a non-limiting example. One or more of the branches 470 may extend into the body cavity during the use of the IRD100, and one or more of the branches 470 may remain in the body opening during the use of the IRD100. As in other embodiments, the lubricant may be applied along the IRD100, eg, branch 470.

The passage 264 penetrates the IRD100, the first opening 420 is configured for entry into the IRD100 of the probe, and the second opening 422 is configured for extraction from the IRD100 of the probe. As illustrated, the aforementioned embodiments of the IRD 100 may only have a closed state for sliding the probe into the IRD 100 when the probe is not present in the body opening or body cavity.

FIG. 55 shows a cross-sectional view of another embodiment of the IRD100, and FIG. 56 shows a perspective view thereof. In this embodiment, the O-ring structure 280 is outside the aisle structure 265. The plurality of O-ring type structures 280 may have 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. This embodiment is shaped like a long "fluffy" collar, which is combined with a lubricant to form an effective seal. The O-ring structure 280 extends substantially parallel to each other and substantially perpendicular to the passage structure 265, whereas the O-ring structure 280 is oblique and substantially perpendicular to the passage structure 265. It may be stretched non-vertically. The orientation of the O-ring structure 280 may be such that the retention of the pneumoperitoneum-retaining substance is facilitated. Of course, the O-ring structure 280 may be flexible and may change direction when inserted into or withdrawn from a body opening or cavity.

FIG. 57 is a cross-sectional view showing another embodiment of the IRD100. The circular path between the first body component 200 and the second body component 202 at the seam 292 causes the user to change the first body component 200 and the second body component 202 from the open state to the closed state. Sometimes it helps to align the first body component 200 and the second body component 202. The passage 264 penetrates a combination of the first main body component 200 and the second main body component 202. The first body component 200 may have an internal cavity 160 of the internal buttress 108, whereby the internal buttress 108 of the first body component 200 expands from a contracted or non-expanded state upon introduction of the expanding material. But it may be. The second body component 202 may have an internal cavity 160 of the internal buttress 108, whereby the internal buttress 108 of the second body component 202 expands from a contracted or non-expanded state upon introduction of the expanding material. But it may be. In this embodiment, the internal cavity 160 of the internal buttress 108 of the first main body component 200 does not have to communicate fluidly with the internal cavity 160 of the internal buttress 108 of the second main body component 202.
FIG. 58 shows a cross section of another embodiment of the IRD100. As shown in FIG. 59, any suitable material, such as elastomeric material 488, such as thermoplastic elastomer or other elastomeric material, may be applied around the probe 250 and the adhesive 490 with the adhesive edge 492. , May be used to place the IRD 100 around the IRD 100 in the closed state.

FIG. 60 (A) shows an isometric view of the pressure cuff pump 500 that serves as a source of expansion material via the expansion material line 166 for expanding the internal cavity of the internal or external buttress. The pressure cuff pump 500 is squeezed for expansion. The user may pinch it to open the one-way valve for contraction. As shown in FIG. 60 (B), a one-way duck bill valve 502 may be provided. For swelling, syringes may be used with other sources that one of ordinary skill in the art can come up with. As mentioned above, the IRD100 may require a valve to hold the expansion material after expansion of the internal buttress, external buttress, or intermediate portion.

FIG. 61 (A) shows a cross-sectional view of another embodiment of the IRD100. The soft thermoplastic elastomer 508 may be molded onto the rigid core 510. The rigid core 510 is harder than the soft thermoplastic elastomer 508. The rigid core 510 may be made of polypropylene or other suitable material. The soft thermoplastic elastomer 508 may have a rating of about 50 A durometer, or any other suitable rating. FIG. 61B shows a cross-sectional view of the IRD 100, with the probe 250 inside the rigid core 510. During use, the seams 292 seen between the surfaces may disappear when the IRD100 is inserted into the body opening, body cavity, or both. The IRD100 may include an internal buttress such as a balloon.

As shown throughout the disclosure of the various embodiments, the internal buttress 108 and the external buttress 112 in some embodiments are not configured to engage the probe 250, thus the internal buttress 108 and the external buttress 112 , It does not have to contribute to the seal between the IRD 100 and the probe 250. In other embodiments, the inner buttress 108 and the outer buttress 112 are configured to engage the probe 250, so that the inner buttress 108 and the outer buttress 112 can contribute to the seal between the IRD 100 and the probe 250. .. Whether or not the internal buttless 108 and the external buttless 112 engage the probe 250, the internal buttless 108 and the external buttless 112 have an IRD 100 and a body cavity 104, a body opening 106, a wall 120 of the body opening 106, and the like. It can contribute to the seal between the body 102.

Not surprisingly, contact between the internal buttress 108, the external buttress 112, and other parts of the IRD 100 with the body 102, body cavity 104, body opening 106 and other patient conditions is also optimized. Care is taken to minimize the risk of pressure necrosis and other adverse side effects from the use of IRD100. This caution can be carried out by giving the expanding material a predetermined volume, and then the predetermined pressure exerted by the internal buttress 108, the external buttress 112, etc. of the IRD 100 on the body 102, the body cavity 104, the body opening 106, etc. Can be established.

The usage of IRD100 can include the following steps. In the first step, the IRD 100 is inserted into the body cavity 104 of the body 102 through the body opening 106 of the body 102. In the second step, the insufflation material is injected into the body cavity 104. In the third step, the user uses the probe to perform diagnostic, therapeutic, or both diagnostic and therapeutic interventions. Further steps are possible. For example, but not exclusively, the probe may be inserted through the body opening 106 before, after, or with the IRD being inserted through the body opening 106.

Although many features and advantages of the various embodiments of the present disclosure are described in the above description along with details of the structure and function of the various embodiments of the present disclosure, this detailed description is merely exemplary and in particular. It should be understood that in the matter of structure and placement of parts within the principles of the present disclosure, changes may be made to the maximum extent indicated by the broad general meaning of the terms expressed in the appended claims.

Claims (15)

An internal buttress configured to prevent exit from the body cavity through the body opening of the body, which has a non-expanded state and an expanded state after the introduction of the dilating substance, and in the dilated state, the end of the pneumoperitoneum holding device. With an internal buttress that extends around the
An external buttress connected to the internal buttress, the external buttress is configured so that the external buttress does not enter the body cavity through the body opening, has only an expanded state, and does not have a non-expanded state. ,
A passage extending through the inner buttress and the outer buttress, configured to allow the probe to pass through in contact engagement with the body cavity, with the probe absent in the passage. A passage configured to open so that the inhaled material introduced into the body cavity is not retained in the body cavity,
A pneumoperitoneum retention device comprising a seam extending from the outer surface of the passage to the inner surface of the passage, the seam extending along the entire length from the inner buttress to the outer buttress. The pneumoperitoneum retention device according to claim 1, wherein the internal buttress in the expanded state is configured to be in contact with and adjacent to the probe. The pneumoperitoneum retention device according to claim 1, wherein the internal buttress in the expanded state is configured so as not to be in contact with the probe and adjacent to the probe. The pneumoperitoneum retention device according to claim 1, wherein the passage is configured to allow the probe to pass from a first opening in the outer buttress to a second opening in the inner buttress. The seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, whereby the passage is inhaled when the probe is not present in the passage. The pneumoperitoneum retention device according to claim 1, which has an open state that does not hold a substance and a closed state that holds an inhaled substance when the probe is present in the passage. An internal buttress configured to prevent exit from the body cavity through the body opening of the body, which has a non-expanded state and an expanded state after the introduction of the dilating substance, and in the dilated state, the end of the pneumoperitoneum holding device. With an internal buttress that extends around the
An external buttress connected to the internal buttress, the external buttress is configured so that the external buttress does not enter the body cavity through the body opening, has only an expanded state, and does not have a non-expanded state. ,
A passage extending through the inner buttress and the outer buttress, which is configured to allow the probe to pass through in contact engagement with the body cavity, with the probe absent in the passage. A passage in which the inhaled material introduced into the body cavity is configured to open so as not to be retained in the body cavity, and the expanded internal buttress expands into the passage for contact engagement with the probe. When,
A pneumoperitoneum retention device comprising a seam extending from the outer surface of the passage to the inner surface of the passage, the seam extending along the entire length from the inner buttress to the outer buttress. The pneumoperitoneum retention device according to claim 6, wherein the internal buttress in the expanded state is configured to be in contact with and adjacent to the probe. The pneumoperitoneum retention device according to claim 6, wherein the internal buttress in the expanded state is configured to be in contact with the probe and not adjacent to the probe. The pneumoperitoneum retention device according to claim 6, wherein the passage is configured to pass a probe from a first opening in the outer buttress to a second opening in the inner buttress. The seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, whereby the passage is inhaled when the probe is not present in the passage. The pneumoperitoneum retention device according to claim 6, which has an open state that does not hold a substance and a closed state that holds an inhaled substance when the probe is present in the passage. An internal buttress that is configured to prevent it from exiting the body cavity through the body opening of the body and that has a non-expanded and dilated state after the introduction of the dilator.
An external buttress connected to the internal buttress, the external buttress is configured so that the external buttress does not enter the body cavity through the body opening, has only an expanded state, and does not have a non-expanded state. ,
A passage extending through the inner buttress and the outer buttress, configured to allow the probe to pass through in contact engagement with the body cavity, with the probe absent in the passage. A passage configured to open so that the inhaled material introduced into the body cavity is not retained in the body cavity,
A seam extending from the outer surface of the passage to the inner surface of the passage, including a seam extending along the entire length from the inner buttress to the outer buttress.
Although the internal buttress has a first balloon inside the passage and a separate second balloon outside the passage, the first balloon and the second balloon are in fluid communication. , The abdominal retention device in which the first balloon and the second balloon do not orbit the end of the internal buttress. The pneumoperitoneum retention device according to claim 11, wherein the internal buttress in the expanded state is configured to be in contact with and adjacent to the probe. The pneumoperitoneum retention device according to claim 11, wherein the internal buttress in the expanded state is configured to be in contact with the probe and not adjacent to the probe. The pneumoperitoneum retention device according to claim 11, wherein the passage is configured to allow the probe to pass from a first opening in the outer buttress to a second opening in the inner buttress. The seam is configured to extend from a first opening in the outer buttress to a second opening in the inner buttress, whereby the passage is inhaled when the probe is not present in the passage. The pneumoperitoneum retention device according to claim 11, which has an open state that does not hold a substance and a closed state that holds an inhaled substance when the probe is present in the passage.

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