CN112804930A

CN112804930A - Insufflation retention device with balloon

Info

Publication number: CN112804930A
Application number: CN201980046456.2A
Authority: CN
Inventors: R·M·霍尔布鲁克; R·汉森; J·芬特雷斯; J·兹格涅戈; P·史密斯; A·沙弗斯
Original assignee: Biandou Co ltd
Current assignee: Biandou Co ltd
Priority date: 2018-05-11
Filing date: 2019-05-13
Publication date: 2021-05-14
Also published as: CA3099666A1; JP2021522928A; EP3773133A1; KR102572599B1; WO2019216960A1; KR20210008388A; EP3773133A4

Abstract

A probe may be inserted into a body lumen to perform diagnostic intervention(s), therapeutic intervention(s), or both. The probe may be inserted through a body orifice that is naturally occurring or intentionally or unintentionally artificial. The body orifice may form a seal around the probe so that the insufflation retaining material may be effectively retained in the body cavity so that the operator may perform the intervention(s). However, there may be leakage of blown material. The insufflation retention device is configured to form an effective seal in contact adjacent the body orifice and provide a pathway for introducing the probe into the body cavity so that diagnostic or therapeutic intervention, or both, may be performed.

Description

Insufflation retention device with balloon

Drawings

Figure 1 illustrates, in partial cross-sectional view, an insufflation retention device through a body orifice and in a body lumen in accordance with various embodiments.

Figure 2 illustrates the insufflation retention device of figure 1 in cross-section in accordance with various embodiments.

Figure 3 illustrates, in cross-section, the insufflation retention device of figure 1 in accordance with various embodiments.

FIG. 4 illustrates, in cross-section, the insufflation retention device of FIG. 1 in accordance with various embodiments.

Figure 5 illustrates, in partial cross-sectional view, a middle portion of an insufflation retention device according to various embodiments extending into an inner buttress portion and an opposing outer buttress portion.

Figure 6 illustrates, in partial cross-sectional view, a middle portion of an insufflation retention device according to various embodiments extending into an inner buttress portion and an opposing outer buttress portion.

Fig. 7 illustrates, in partial cross-sectional view, an internal buttress input valve in fluid communication with a distended material conduit, according to various embodiments.

Fig. 8 illustrates, in partial cross-sectional view, an internal buttress input valve in fluid communication with a distended material conduit, and an external buttress with a separate external buttress input valve, according to various embodiments.

Fig. 9 illustrates, in plan view, a first body member and a second body member in accordance with various embodiments.

Fig. 10 illustrates, in plan view, a first body portion coupled to a second body portion via a hinge or pivot portion, in accordance with various embodiments.

Fig. 11 illustrates, in an end view, an internal support coupled to a body portion in an open state, the internal support biased to a closed state, in accordance with various embodiments.

Fig. 12 illustrates, in an end view, an internal support coupled to a body portion with a fastener on the body portion in an open state, the internal support biased to a closed state, in accordance with various embodiments.

Fig. 13 illustrates, in partial cross-sectional view, a probe through a body orifice according to various embodiments.

Fig. 14 illustrates, in an end view, a probe through a body hole according to various embodiments.

Fig. 15 shows in partial cross-sectional view a probe through a body orifice with an anomaly (abnormality).

Figure 16 shows in end view a probe through a body hole having an anomaly.

Figure 17 illustrates, in partial cross-sectional view, a probe through a body hole having an anomaly and through an insufflation retention device in accordance with various embodiments.

Figure 18 shows, in an end view, a probe through a body hole having an anomaly and through an insufflation retention device according to various embodiments.

FIG. 19 illustrates in perspective view an insufflation retention device in accordance with various embodiments.

FIG. 20 shows the insufflation retention device of FIG. 19 in end view according to various embodiments.

FIG. 21 illustrates the insufflation retention device of FIG. 19 in side view in accordance with various embodiments.

FIG. 22 illustrates, in cross-section, the insufflation retention device of FIG. 22 in accordance with various embodiments.

FIG. 23 shows, in side view, opposite sides of the side of the insufflation apparatus of FIG. 21 in accordance with various embodiments.

FIG. 24 illustrates, in cross-section, the insufflation retention device of FIG. 23 in accordance with various embodiments.

Figure 25 illustrates a perspective view of a passageway structure used in an insufflation retention device in accordance with various embodiments.

FIG. 26 shows a perspective view of an outer compression member in an open state, wherein the outer compression member is used in conjunction with the insufflation retention device of FIG. 25.

FIG. 27 shows a perspective view of an outer compression member in a closed state, as used in conjunction with the insufflation retention device of FIG. 25.

FIG. 28 shows a perspective view of the insufflation retention device of FIG. 25 in accordance with various embodiments.

FIG. 29 shows a perspective view of the insufflation retention device of FIG. 25 with a probe passing through the passageway in accordance with various embodiments.

Figure 30 illustrates, in partial cross-sectional view, an insufflation retention device with a stylet in accordance with various embodiments.

FIG. 31 illustrates, in partial cross-sectional view, an insufflation retention device with a stylet and having an O-ring type configuration in accordance with various embodiments.

FIG. 32 illustrates, in partial cross-sectional view, an insufflation retention device having a stylet and having a plurality of O-ring type structures in accordance with various embodiments.

Figure 33 illustrates a probe that can be used with an insufflation retention device in accordance with various embodiments.

Fig. 34(a) - (C) illustrate a continuous internal support having only a closed state and a discontinuous internal support having both an open state and a closed state, according to various embodiments.

FIG. 35 illustrates in perspective view an insufflation retention device in accordance with various embodiments.

FIG. 36 illustrates, in perspective view, another insufflation retention device in accordance with various embodiments.

Figures 37-38 show isometric views of another insufflation retention device in accordance with various embodiments.

Figure 39 shows an insufflation retention device in cross-section in accordance with various embodiments.

Figure 40 illustrates in cross-section an insufflation retention device in accordance with various embodiments.

Figure 41 shows a blown-in retention device according to various embodiments in cross-section.

Figure 42 illustrates an isometric view of a portion of an insufflation retention device in accordance with various embodiments.

Figure 43 illustrates, in partial cross-section, a portion of an insufflation retention device in accordance with various embodiments.

Figure 44 illustrates an isometric view of a portion of an insufflation retention device in accordance with various embodiments.

Figure 45 illustrates an isometric view of an insufflation retention device in accordance with various embodiments.

Figure 46 illustrates an isometric view of an insufflation retention device in accordance with various embodiments.

Figure 47 illustrates, in partial cross-section, an insufflation retention device in accordance with various embodiments.

Figure 48 illustrates, in partial cross-section, an insufflation retention device in accordance with various embodiments.

49(A) - (B) illustrate, in partial cross-section, one size of insufflation retention device configured to accommodate multiple sizes of probes in accordance with various embodiments.

Figure 50 illustrates, in cross-section, another insufflation retention device in accordance with various embodiments.

FIG. 51 illustrates the insufflation retention device of FIG. 50 in perspective view in accordance with various embodiments.

Figures 52(a) - (B) show another insufflation retention device in cross section in accordance with various embodiments.

FIG. 53 illustrates in cross-section an insufflation retention device in accordance with various embodiments.

FIG. 54 illustrates the insufflation retention device of FIG. 53 in perspective view in accordance with various embodiments.

Figure 55 shows a blown-in retention device according to various embodiments in cross-section.

FIG. 56 illustrates the insufflation retention device of FIG. 55 in perspective view in accordance with various embodiments.

Figure 57 illustrates, in cross-section, another insufflation retention device in accordance with various embodiments.

Figure 58 illustrates in cross-section an insufflation retention device in accordance with various embodiments.

FIG. 59 shows a portion of the insufflation retention device of FIG. 58 in plan view in accordance with various embodiments.

Fig. 60(a) illustrates, in plan view, a pressure cuff pump, a valve, and an inflation material line, in accordance with various embodiments.

Fig. 60(B) illustrates the valve of fig. 60(a) in close-up, in accordance with various embodiments.

Figure 61(a) shows an isometric view of another insufflation retention device in accordance with various embodiments.

Figure 61(B) shows the insufflation retention device of figure 60(a) in cross-section in accordance with various embodiments.

Detailed Description

There are techniques that allow an operator to introduce a probe (e.g., a medical scope) into a body cavity for diagnostic or therapeutic intervention or both. When introducing the probe, it may be necessary to dilate the body cavity for the operator to perform the intervention(s). Using insufflation techniques, the operator can introduce insufflation material to dilate the body cavity, so the operator can have more working space and better visibility in the body cavity to perform the intervention(s). For example, please refer to "technical status assessment report" in gastrointestinal endoscopy "2013, 4 th, 77 th, 519-525: methods of luminal dilation for colonoscopy (Methods of luminal dilation) "which are incorporated herein by reference in their entirety. The blowing material may be air, carbon dioxide, water, or other suitable material.

The operator may begin with the probe outside the body, and the operator may advance the probe through the tissue of the body to introduce the probe into a cavity (i.e., a body cavity) of the body. The probe may be advanced through tissue via a hole of the body (i.e., a body orifice, which is a naturally occurring orifice (e.g., the anus) or a wound (e.g., a surgical incision or trauma)). The body orifice may have an elasticity that allows the body orifice to recover its size and shape after any deformation due to advancement of the probe through the body orifice into the body cavity to effectively seal the exterior of the body from the body cavity. Thereafter, insufflation material introduced into the body cavity may be retained in the body cavity to help facilitate expansion of the body cavity while effectively sealing the exterior of the body from the body cavity to allow an operator to perform the intervention(s).

However, in some cases, the insufflation material may not be effectively retained in the body cavity. For example, the body orifice or nearby structures may have congenital malformations or may have suffered structural damage, such as scar tissue formed after abscess formation, surgical trauma, childbirth-related injuries, and the like, which inhibits the body orifice from forming an effective seal with the probe.

If the insufflation material is not effectively retained, the operator will not have visibility of the time and space or operation of work in the body cavity. For example, a probe (such as an endoscope) may be introduced into a body cavity (such as the rectum and large intestine) through a body orifice (such as the anus), and the elasticity of the body orifice may not be effective to form a seal contactingly adjacent the probe to facilitate retention of insufflation material in the body cavity. As will be described in further detail, the present disclosure describes an insufflation retention device that facilitates retention of insufflation material in a body cavity.

Fig. 1 shows the apparatus as an insufflation retention device (also referred to herein as IRD 100) that has been advanced from outside of body 102 through body orifice 106 (also referred to as an orifice) into body cavity 104. IRD 100 may generally include an inner support 108, a middle portion 110 and an outer support 112. The inner support 108 is at a first end 114 of the IRD 100 and the outer support 112 is at an opposite second end 116 of the IRD 100 with the intermediate portion 110 therebetween. In other words, the intermediate portion 110 is disposed between the inner support 108 and the outer support 112.

As shown in fig. 1, the width 111 of the inner support 108 may be substantially greater than the width 113 of the outer support 112. Alternatively, as shown in later figures, the width 111 of the inner support 108 may be substantially equal to the width 113 of the outer support 112. Furthermore, as shown in later figures, the width 111 of the inner support 108 may also be substantially less than the width 113 of the outer support 112. The width 111 of the inner support 108 may be substantially parallel to the width 113 of the outer support 112. The width of the middle portion 110 may be substantially less than the width 111 of the inner support 108. The width of the middle portion 110 may be substantially less than the width 113 of the outer support 112. The width of the middle portion 110 may be substantially parallel to the width 111 of the inner support 108. The width of the middle portion 110 may be substantially parallel to the width 113 of the outer support 112.

The internal support 108 may be configured to have an unexpanded configuration such that an operator may introduce the IRD 100 into the body lumen 104 through the body orifice 106. The unexpanded configuration of the internal struts 108 may be smaller than the expanded configuration of the internal struts 108 shown in fig. 1. The unexpanded configuration of the inner support 108 is configured to facilitate entry of the IRD 100 from an exterior 118 of the body 102. In other words, in the collapsed state, the internal support 108 can be configured for insertion into the body cavity 104 of the body 102 through the body orifice 106 of the body 102.

The expanded configuration of the internal buttress 108 is configured to prevent removal of the IRD 100 from the body lumen 104. If the IRD 100 is moved toward the exterior 118 of the body 102, the expanded configuration of the internal support 108 will contactingly engage the body lumen 104 or the body orifice 106 or both to prevent removal of the IRD 100 from the body lumen 104. In other words, in the expanded state, the internal buttress 108 may be configured to inhibit removal of the internal buttress 108 from the body lumen 104 through the body orifice 106.

The inner support 108, in an unexpanded or contracted state, can be increased in size to an expanded configuration or state by introducing an expandable material into the lumen of the inner support 108 supplied by a source. The expandable material may be broadly considered as a fluid. By way of example and not limitation, examples of the expandable material may be a liquid (e.g., water) and a gas (e.g., oxygen, air, compressed air, carbon dioxide).

The internal support 108 can be configured to form a body internal support seal 105 between the body lumen 104 and the internal support 108. When the body cavity 104 is part of the lower alimentary system, the body internal support seal 105 may or may not include the wall of the rectum between the body cavity 104 and the internal support 108. The body internal support seal 105 may or may not include all walls of the rectum between the body cavity 104 and the internal support 108. The inner support 108 is shown generally in the shape of a doughnut; however, other shapes are contemplated depending on the needs of the operator in view of the patient's body 102. The shape of the inner support 108 can be selected to be a predetermined shape to effectively form a body inner support seal 105 between the body 102 and the inner support 108. The effectiveness of the body internal buttress seal 105 occurs when insufflating material is held in the body cavity 104 so that the operator can perform the intervention(s) and the operator will have visibility of the time and space or operation of work in the body cavity 104.

The outer support 112 can also be considered to have an unexpanded configuration or a contracted state. However, the unexpanded configuration of the outer support 112 is not required. The reason that the unexpanded configuration of the outer support 112 is not required is that the outer support 112 is configured to prevent the IRD 100 from being introduced into the body lumen 104. For example, the outer support 112 may have an unexpanded configuration that is not configured to prevent introduction of the IRD 100 into the body lumen 104. In this example, the user or operator may then transform or transition the unexpanded configuration of the outer support 112 to the expanded configuration of the outer support 112 to prevent the IRD 100 from being introduced into the body lumen 104. In other words, the outer support 112 can be configured to inhibit advancement of the outer support 112 through the body orifice 106 into the body lumen 104.

As with the inner support 108, the outer support 112 in the unexpanded configuration can be increased in size to an expanded configuration or state by introducing an expandable material into the lumen of the outer support 112 supplied by the source. The expandable material may again be broadly considered as a fluid. The expansion material used to expand the inner 108 and outer 112 struts may be the same or different in any given situation.

However, the outer support 112 need not have a smaller or unexpanded configuration, as the outer support 112 need not be introduced through the body aperture 106. Thus, the external buttress 112 may have substantially the same size and configuration before and after the IRD 100 is introduced into the body 102, and the external buttress 112 may have substantially the same size and configuration before, during, and after use of the IRD 100 in the body 102. However, for other practical considerations, it may be convenient for the outer support 112 to have a smaller unexpanded configuration. For example, the outer support 112 in an unexpanded configuration may be more easily assembled in a medical kit or package.

The outer support 112 can be configured to form a body outer support seal 107 between the body 102 and the outer support 112. The outer support 112 is shown generally as being conical in shape; however, other shapes are contemplated depending on the needs of the operator in view of the patient's body 102. The shape of the outer support 112 can be selected to be a predetermined shape to effectively form a body outer support seal 107 between the body 102 and the outer support 112. The effectiveness of the body external buttress seal 107 occurs when insufflating material is held in the body cavity 104 so that the operator may perform the intervention(s) and the operator will have visibility of the time and space or operation of work in the body cavity 104.

The middle portion 110 is configured to couple the inner support 108 to the outer support 112. The intermediate portion 110 is configured to contactingly engage a wall 120 of the body aperture 106.

The middle portion can be configured to form a body middle portion seal 109 between the body aperture 106 and the middle portion 110. The middle portion 110 is shown generally as a cylinder; however, other shapes are contemplated depending on the needs of the operator in view of the patient's body 102. The shape of the intermediate portion 110 may be selected to be a predetermined shape to effectively form a body intermediate portion seal 109 between the body 102 and the intermediate portion 110. The effectiveness of the mid-body seal 109 occurs when the insufflation material is held in the body cavity 104 so that the operator can perform the intervention(s) and the operator will have visibility of the time and space or operation of work in the body cavity 104.

Fig. 2 shows in cross-section the internal support of the IRD 100 of the embodiment shown in fig. 1. The outer perimeter 130 of the inner support 108 can be configured to be expandable from an unexpanded configuration to the expanded configuration shown. The inner perimeter 132 of the inner support 108 may be configured to be relatively rigid compared to the outer perimeter 130. This relative rigidity of the inner perimeter 132 of the inner support 108 may help the IRD 100 maintain its configuration and size as the probe is introduced into the IRD 100 and the probe moves back and forth and rotates within the IRD 100 as the operator performs the intervention(s).

Fig. 3 shows in cross-section a middle portion of the IRD 100 of the embodiment shown in fig. 1. Within the body 140 of the intermediate portion 110, there may be a distention material conduit 142 that an operator may use to introduce distention material into the lumen of the internal support 108. As can be seen, the outer surface 144 of the intermediate portion 110 may be substantially circular such that when an operator inserts the IRD 100 into the body bore 106, performs an intervention(s), or removes the IRD 100 from the body bore 106, the IRD 100 may rotate relatively freely clockwise or counterclockwise within the body bore 106. Likewise, the interior surface 146 of the intermediate portion 110 may be substantially circular such that when an operator inserts a stylet into the IRD 100, performs an intervention(s), removes a stylet from the IRD 100, or attaches the IRD 100 to a stylet, the IRD 100 may be relatively free to rotate clockwise or counterclockwise about the stylet. The outer surface 144 of the middle portion may be substantially parallel to the inner surface 146 of the middle portion. In other words, the middle portion 110 may be a cylinder. As shown in fig. 1, the middle portion 110 may be a right circular hollow cylinder or a cylindrical shell.

The interior surface 146 of the middle portion 110 can be considered a sleeve that surrounds the probe when the middle portion 110 is in use. As shown, the sleeve may be substantially circular and symmetrically disposed within the body 140 of the intermediate portion 110. Alternatively, the sleeve may be asymmetrically disposed within the body 140 of the intermediate portion 110.

Fig. 4 shows in cross-section the outer support 112 of the IRD 100 of the embodiment shown in fig. 1. The outer perimeter 150 of the outer support 112 can be configured to be expandable from an unexpanded configuration to an expanded configuration. The inner surface 152 of the outer support 112 can be configured to be relatively rigid compared to the outer perimeter 150. This relative rigidity of the interior surface 152 of the external support may help the IRD 100 maintain its configuration such that when the operator performs an intervention(s), the stylet may be introduced into the IRD 100 and the stylet moved back and forth and rotated within the IRD 100.

IRD 100 may be made of one or more biologically compatible materials. The biocompatible material may be a polymer, such as silicone or latex. The same polymer may be used for the inner support 108 and the outer support 112, or different polymers may be used for the inner support 108 and the outer support 112. The same polymer as the inner support 108 and the outer support 112 may be used for the middle portion 110, or a different polymer may be used for the middle portion 110, the inner support 108, and the outer support 112. The middle portion 110 and the inner and

outer supports

108, 112 may be formed from one piece, or the middle portion 110 and the inner and

outer supports

108, 112 may be formed from different pieces. The inner support 108 and the outer support 112 may also be formed from different pieces. If different parts are used to form IRD 100, laser welding or the like may be used to join the parts together.

Fig. 5 illustrates an embodiment of IRD 100 in cross-section wherein the inner lumen 160 of inner buttress 108 is in fluid communication with the inner lumen 162 of outer buttress 112 via the expansile material conduit 142 of intermediate portion 110. The expanded state is shown. An input valve 164 of distending material is shown coupled to the outer support 112. The operator introduces the distending material into the inner lumen 162 of the outer support 112, the distending material conduits 142 of the intermediate portion 110, and the inner lumen 160 of the inner support 108 through the input valve 164 using a gas line, syringe, or other suitable source of distending material.

Fig. 6 illustrates another embodiment of IRD 100 in cross-section, wherein the inner lumen 160 of inner buttress 108 is in fluid communication with the inner lumen 162 of outer buttress 112 via the expansile material conduit 142 of intermediate portion 110. The expanded state is shown. The expandable material input valve 164 is shown coupled to the outer support 112 via an expandable material conduit 166 coupled to the outer support 112. The inflation material conduit 166 may be rigid, flexible, or some combination of flexible and rigid. When flexible, the inflation material conduit 166 may assume any suitable orientation and configuration during use. When rigid, the expansile material conduits may maintain a predetermined orientation and configuration before, during, and after use. The operator introduces the expandable material through the input valve 164 into the expandable material conduit 166, the lumen 162 of the outer support 112, the expandable material conduit 142 of the intermediate portion 110, and the lumen 160 of the inner support 108.

Fig. 5 and 6 show intermediate portion 110 extending into an inner support portion 168 and an opposing outer support portion 172. Inner support 108 is part of inner support portion 168 and outer support 112 is part of opposing outer support portion 172. Inner support 108 may extend substantially shorter than, approximately flush with, or substantially beyond first end 174 of inner support portion 168. Inner support 108 is shown approximately flush with first end 174 of inner support section 168. Outer support 112 extends substantially short of, approximately flush with, or substantially beyond a second end 176 of outer support portion 172. Outer support 112 is shown approximately flush with second end 176 of outer support section 172.

The expandable material conduit 142 of the intermediate section 110 may take any shape.

Fig. 5 shows the distending material conduits 142 beginning at a substantially right angle to the inner support 108 and the outer support 112, while fig. 6 shows the distending material conduits 142 beginning at a substantially curved orientation relative to the inner support 108 and the outer support 112. Further, one or more pressure relief valves in IRDs 100 may be configured to control when expansion of outer support 112 and inner support 108 occurs relative to the introduction of expandable material. The pressure relief valve may have any suitable configuration and is not shown.

Fig. 7 illustrates, in cross-section, another embodiment of the IRD 100 wherein the inner buttress input valve 180 is in fluid communication with the expansile material conduit 142 of the intermediate portion 110 to the inner buttress 108, while the outer buttress 112 is not in fluid communication with the inner buttress input valve 180. The inner support 108 is shown in an unexpanded state. Inner support 108 can expand outwardly or away from inner support portion 168 (see fig. 5-6). Of course, the internal buttress input valve 180 may be in direct fluid communication with the internal buttress 108 without intervening the distending material conduit 142, which is not shown.

FIG. 8 illustrates another embodiment of the IRD 100 in cross-section, wherein an internal buttress input valve 180 is in fluid communication with a scaffolding conduit 142 via a scaffolding conduit 166 to augment the internal buttress 108 via the introduction of a scaffolding. Further, an external buttress input valve 182 is in fluid communication with the external buttress 112 to expand the external buttress 112 via introduction of an expansion material. In this embodiment of the IRD 100, the internal buttress input valve 180 and the external buttress input valve 182 are independently operable by an operator or user to expand and contract the internal buttress 108 and to expand and contract the external buttress 112 by introducing and removing an expandable material via the internal buttress input valve 180 and the external buttress input valve 182. The inner support 108 is shown expanded by an expanding material supplied by an expanding material source 184.

The outer support 112 is shown as having a rectangular shape, as opposed to other support shapes previously shown in the shape of a doughnut, a cone, etc. Any suitable shape may be used for the inner support 108 or the outer support 112.

Additionally, the intermediate portion 110 may have a substantially non-planar outer surface 190. In other embodiments, the outer surface 190 of the middle portion 110 may be substantially flat. In the embodiment shown in fig. 8, the outer surface 190 of the intermediate portion 110 is contoured, which is substantially non-planar. The contour may be selected by the operator based on the anatomy and other features of the body bore 106 (see fig. 1). The profile may help the IRD 100 achieve and maintain an effective seal for holding insufflation material. The profile shape and size may be responsive to the presence or absence of the distending material. As shown in fig. 8, the profile may have an expandable material introduced through an expandable material conduit 166 that supplies the expandable material to the inner support 108. Of course, the profile may have the expandable material introduced through some expandable material conduit that is different and independent from the expandable material conduit 166 supplying the expandable material to the inner support 108. As a non-limiting specific example, the intermediate portion 110 may be generally and contoured to be substantially rigid, except for changing from a contracted or unexpanded state with less expanded material to an expanded state with more expanded material. In embodiments having a substantially rigid profile, intermediate portion 110 is substantially undeformed from its orientation and configuration relative to IRD 100 prior to or after use of IRD 100 during use of IRD 100.

Fig. 9 shows another embodiment of IRD 100. In this embodiment, the IRD 100 has a first body member 200 and a second body member 202. The first body member 200 is configured to be coupled to the second body member 202 to form the IRD 100 in operable use. An operator may wish to use such a two-body component system when the probe is already in the body orifice 106 or in both the body orifice 106 and the body cavity 104 (see fig. 1). When the probe is in this position in the body orifice 106 or body cavity 104, the operator may not be able to insert the probe into the IRD 100 and pass through the IRD 100 or slide the IRD 100 over the probe. On the other hand, the operator will be able to couple the first body member 200 to the second body member 202 around a probe held in place in the body bore 106 or in place in both the body bore 106 and the body cavity 104. The first body member 200 may be coupled to the second body member 202 via one or more pairs of fasteners 204 of any suitable type, such as, but not limited to, snaps, clips, and the like. Of course, this embodiment may also be used before the probe is located in the body orifice 106 or the body cavity 104 or both.

As shown in this embodiment, the first and

second body members

200, 202 may have substantially parallel walls configured to effectively form a sleeve that provides a passageway for the probe when the first body member 200 may be coupled to the second body member 202. In this embodiment, the first and second

inner support members

207, 209 may be supplied with the expandable material via different introductions of the expandable material.

In other words, the first inner support member 207 and the second inner support member 209 may not be in fluid communication. Similarly, the first and second

outer support members

211, 213 can be supplied with the expansion material via different introductions of the expansion material, as the first and second

outer support members

211, 213 may not be in fluid communication.

In this embodiment having a first body member 200 and a second body member 202, it may be inconvenient to place the buttress members in fluid communication.

Of course, one or more of the various buttress components may be in fluid communication, which is not shown.

Fig. 10 shows another embodiment of IRD 100. In this embodiment, the first body portion 220 is coupled to the second body portion 222 via a hinge portion 224 or flexible member at a first hinged side 226 of the first body portion 220 and a second hinged side 228 of the second body portion 222. Hinge portion 224 may be configured to allow an operator to bring IRD 100 from the open configuration shown in fig. 10 to a closed configuration not shown by a one-handed operation. One or more pairs of fasteners 204 may couple a first opening edge 230 of the first body portion 220 to a second opening edge 232 of the second body portion 222. The fastener 204 may extend beyond the first and

second body portions

220, 222, as shown in fig. 10, or within the perimeter of the first and

second body members

200, 202, as shown in fig. 9.

In the configuration shown in fig. 10, it may be convenient for an internal support, not shown, to be in fluid communication around the first and second body portions 220, 222 (in other words, substantially the entire body portion), as is present in some other embodiments. Further, it may be convenient for an external support, not shown, to be in fluid communication substantially around the first body portion 220 and the second body portion 222, as is present in some other embodiments. For simplicity, the inner support 108 and outer support 112 are not shown in fig. 10 and will be understood to be located on the surface of the IRD 100 in the rear of the view shown.

Fig. 11-12 show cross-sections through the internal support 108 in another embodiment of the IRD 100. In these embodiments, the inner support 108 may be coupled to the inner support body portion 240 via laser welding, adhesives, or other suitable means. Alternatively, the inner support 108 may be one material with the inner support body portion 240. The inner support body portion 240 can have a bias to a closed state to form a sleeve sized and dimensioned to fit around a probe to be used by an operator. The inner support body portion 240 is shown in an open state in fig. 11. When the internal buttress body portion 240 is in an open state, when the IRD 100 is in the body cavity 104, body aperture 106 or both, or when the IRD 100 is not in the body cavity 104, body aperture 106 or both, the operator may position the IRD 100 (see fig. 1) around the probe. Further, fig. 12 shows an inner support body portion 240 having a first fastener 242 and a second fastener 244. The first fastener 242 is configured to couple to the second fastener 244 to form a sleeve sized and dimensioned to fit around the probe.

Additionally, as shown, the inner support 108 may overlap the body portion 240 to help form an effective seal for retaining the insufflation material.

Alternatively, as not shown, the inner support 108 may not overlap the inner support body portion 240 and still achieve an effective seal for retaining the insufflation material.

Similarly, the outer support may or may not partially overlap with a similar outer support body to form an effective seal for retaining insufflation material, which is not shown.

Fig. 13 shows the probe 250 through the body hole 106 in a cross-sectional side view and fig. 14 in an end view. The body aperture 106 and the probe 250 that has been inserted through the body aperture 106 effectively form a body probe seal 252. In addition, a lubricant layer 254 is typically bubbled through the probe 250 prior to entering through the body aperture 106. A lubricant layer 254 disposed between the body aperture 106 and the probe 250 further assists in forming a body probe seal 252 between the body aperture 106 and the probe 250. The lubricant layer 254 may be of any suitable type to reduce friction between the body bore 106 and the probe 250.

Fig. 15 shows a probe 250 in cross-sectional side view and fig. 16 shows in end view through a body hole 106 having an anomaly 256. The body aperture 106 cannot effectively form a body probe seal 252 with a probe 250 that has been inserted through the body aperture 106 having an anomaly 256. For any reason, such as congenital malformations, abscesses, previous abscesses, muscle relaxation, etc., the body orifice 106 does not effectively form a body probe seal 252 with the probe 250 passing through the body orifice 106.

Fig. 17 shows a stylet 250 through the body orifice 106 with the anomaly 256 and the stylet 250 through the IRD 100 in cross-sectional side view and fig. 18 in end view, in accordance with various embodiments. Similar to framing windows in a house, the IRD 100 may effectively form a seal with the body 102 to facilitate retention of insufflation material in the body cavity 104.

Additionally, the IRD 100 may provide a sleeve having a predetermined configuration and size in response to the stylet to effectively form another seal with the stylet to further facilitate retention of the insufflation material in the body lumen 104.

Of course, the IRD 100 may be used with the probe 250 in a body hole 106 where the anomaly 256 is not present. However, when the IRD 100 is used with the probe 250 in the body bore 106 having the anomaly 256, the IRD 100 is configured to facilitate retention of the insufflating material inserted into the body lumen 104 for a time effective for the operator to perform the diagnostic intervention, the therapeutic intervention, or both, which is better than the retention of the insufflating material achievable using the probe 250 without the IRD 100. The probe access seal 260, mid-body portion seal 109, external-body buttress seal 107, and internal-body buttress seal 105 may be configured to cooperate with the probe 250 to facilitate retention of insufflating material inserted into the body cavity 104 for a time effective for an operator to perform diagnostic intervention, therapeutic intervention, or both. On the other hand, the passageway 264 may be open without the probe 250 in the passageway 264, such that insufflation material may not be retained in the body cavity 104. Fig. 17 shows that even when the inner support 108 is expanded and the outer support 112 is expanded, the passageway 264 may be open without the probe 250 in the passageway 264.

The IRD 100 can effectively form a seal: a body mid-section seal 109 is formed between the mid-section 110 and the wall 120 of the body orifice 106, a body outer support seal 107 is formed between the outer support 112 and the wall 120 of the body orifice 106 and the exterior of the body orifice 106, and a body inner support seal 105 is formed between the inner support 108 and the body cavity 104 or body 102 even in the presence of the anomaly 256. As shown in FIG. 17, the intermediate portion 110 may be cooperatively or operatively associated with the outer support 112 to both function to inhibit advancement of the IRD 100 into the body lumen 104 during operation.

Further, when probe 250 is inserted into IRD 100, IRD 100 may effectively form a probe access seal 260. The passageway 264 through the intermediate portion 110 of the IRD 100 may be configured to form a stylet passageway seal 260 between the stylet 250 and the passageway 264. Passageway 264 extends beyond first end 174 and beyond second end 176 of IRD 100 (see fig. 5 and 6) such that stylet 250 extends all the way through IRD 100. Those skilled in the art will appreciate that for probe 250, passageway 264 has a corresponding first opening near first end 174 and a second opening near second end 176.

Additionally, the outer surface 190 of the intermediate portion 110 may be configured to provide a contour feature 266 to engage the anomaly 256 to provide an effective seal. Of course, the profile feature 266 may be a protrusion, a depression, or a combination of both to engage the anomaly 256 to provide an effective seal.

Further, the contour feature 266 may be formed by the outer support 112 or by both the intermediate portion 110 and the outer support 112. Additionally, the inner support 108 may have contoured features as the previously discussed shapes are contemplated depending on the needs of the operator in view of the patient's body 102.

Fig. 19-24 show various views of IRD 100 according to another embodiment. The IRD 100 may have an inner support 108 and an outer support 112 with a middle portion 110 therebetween. IRD 100 may be formed with seam 292 extending along the length (as shown) of IRD 100 or a portion thereof. Seam 292 may be substantially a gap or break between surfaces of material that is folded upon itself to make IRD 100. Seam 292 may not be present if the surfaces of the material folded upon itself to make IRD 100 abut each other. The outer support 112 has a tapered surface 294 that is substantially conical to facilitate an effective seal with the body 102 (see fig. 1).

An internal biasing member 290 having a biasing tension cooperates with the biasing tension of the remainder of the IRD 100 to keep the IRD 100 closed during operation. The internal biasing member 290 may be substantially flush with the interior of the IRD 100 or the internal biasing member 290 may be substantially non-flush with the interior of the IRD 100. On the other hand, when the stylet 250 is in the body orifice 106, the body lumen 104, or both, the IRD 100 shown may be opened to wrap around the stylet 250 and then inserted into the body orifice 106 and through the body orifice 106. The inner biasing member 290 is configured for one-handed or two-handed operation.

The access port 298 in the outer support 112 may be configured to have a diameter that is wider than the diameter of the passageway 264, wherein the diameters are substantially parallel to each other. By making the diameter of entry port 298 wider than the diameter of passageway 264, the operator will have a larger target for inserting probe 250 into passageway 264, then if the diameter of entry port 298 is substantially the same size as the diameter of passageway 264. The diameter of the passageway 264 may be configured and sized to fit closely around the diameter of the probe 250 so that the probe passageway seal between the passageway and the probe may be more easily achieved, and wherein the diameters are again substantially parallel to each other. An internal taper 296 may be present in the outer support 112 such that the diameter of the access port 298 may taper to the smaller diameter of the passageway 264. While the internal taper 296 is shown as being substantially linear, resulting in the conical configuration of FIG. 22, any suitable shape is contemplated to facilitate manipulation of the probe 250 into the passageway 264 by an operator.

This embodiment is shown as a solid structure that the IRD 100 may be if the internal buttress 108 is a compressible material (e.g., foam, by way of example and limitation), such that the internal buttress 108 may be pushed through the body aperture 106 in a collapsed state, and then the internal buttress 108 may expand to an expanded state once inside the body lumen 104. Of course, such similar structures (e.g., an access port 298 having an internal taper 296) may exist in combination with features from other embodiments that include an internal buttress 108 that is expandable by a expandable material.

Fig. 25-29 show various views of IRD 100 according to another embodiment. The inner support 108 and the outer support 112 may be in fluid communication through the intermediate portion 110, not shown, via an effectively rectangular balloon (also referred to herein as a channel structure 300). The intermediate portion 110 may be compressed by an outer compression member 302 that substantially biases fluid within the pathway structure 300 toward the inner support 108 and the outer support 112. The outer compression member 302 may be contactingly adjacent an outer surface of the pathway structure 300. The outer compression member 302 in the closed position may or may not push substantially all of the fluid (i.e., distending material) from the intermediate portion 110 in the IRD 100 that the operator is ready to use.

While the access structure 300 is indeed shown and contemplated as being rectangular and symmetrical in operation, other suitable sizes and dimensions are contemplated based on the needs of the user in view of the patient's body 102.

The outer compression member 302 may have an inner biasing member 304 that is inside an outer biasing member 306 of the outer compression member 302 in a coiled configuration in the closed position shown in fig. 27-29.

Further, while outer compression member 302 is shown overlapping outer biasing member 306 overlapping inner biasing member 304, outer compression member 302 may not overlap itself as inner biasing member 304 may not overlap itself. The outer compression member 302 is configured for one-handed or two-handed operation from an open position, wherein the IRD 100 can be positioned around the stylet 250 with the outer compression member 302 in the open position, and can be maintained around the stylet 250 with the outer compression member 302 in the closed position.

While the outer compression member 302 is shown outside of the balloon forming the inner support 108, the outer support 112, and a portion of the intermediate portion 110, it is fully contemplated that the outer compression member 302 may be inside the access structure 300.

Fig. 30-32 show cut-away side views of IRDs 100 having an O-ring type structure 280 or a plurality of O-ring type structures 280 according to various embodiments. IRD 100 may cooperate with probe 250 to form a probe access seal 260, which is an effective seal between IRD 100 and probe 250. Further, a lubricant layer 254 between IRD 100 and probe 250 may assist or promote the effectiveness of probe path seal 260 between IRD 100 and probe 250.

Further, an O-ring type structure 280 along the sleeve may further assist in facilitating a seal between the IRD 100 (e.g., middle portion 110) and the probe 250. The O-ring type structure 280 may be fixed to the sleeve at a first O-ring end 282 and movable at an opposite second O-ring end 284. The O-ring type structure 280 may be one of a variety of O-ring type structures 280. While the O-ring type structure 280 may be rigid, it may be beneficial to: the O-ring type structure 280 is made flexible such that when the probe 250 is advanced, the opposing second O-ring end 284 is drawn inwardly toward the body cavity 104, and when the probe 250 is retracted, the opposing second O-ring end 284 is drawn outwardly away from the body cavity 104.

As discussed in various embodiments, the operator may not be able to insert a probe into the IRD 100 and through the IRD 100 or slide the IRD 100 over the probe while the probe is in the body orifice 106 or body cavity 104. On the other hand, in other embodiments, the operator may be able to couple the IRD 100 around a stylet held in place in the body bore 106 or in place in both the body bore 106 and the body lumen 104.

Those skilled in the art will appreciate that the probes are by way of example and not limitationMay be an endoscope. Commercially available endoscopes will have a light source configured to provide light in a lumen of the colon (such as body lumen 104), and an integrated air pump configured to provide air in the lumen of the colon for luminal dilation during colonoscopy. Further, those skilled in the art will appreciate that the endoscope may be configured to use CO₂Water or other suitable material for insufflation into the lumen of the colon.

For colonoscopy, one skilled in the art will appreciate that the quality of bowel preparation may affect the success of the colonoscopy. Many bowel preparations are available to achieve adequate bowel cleanliness. For example, optimizing bowel preparation for colonoscopy: a guide to improve visualization quality, Ann Gastroenterol 2016; 29 (2): 137-146, which is incorporated herein by reference in its entirety.

Additionally, fig. 33 shows a commercially available endoscope 350 as understood by those skilled in the art. Commercially available endoscope 350 has three main parts: a connector section 352, a control section 354, and an insertion tube 356. The connector section 352 attaches the endoscope 350 to systems 358, which may include a display, an image processor, a light source and power source, and water, air, CO₂Or other suitable material. The control section 354 is attached to the connector section 352. The control section 354 is held by the operator to control dials that may deflect the tip (tip) 360 of the instrument tip of the insertion tube 356 up/down and left/right. The control section 354 may have separate buttons for suction, insufflation and imaging. Finally, the control section 354 may have an access port for inserting the accessory through the passage of the insertion tube 356 into the body cavity 104. Many endoscopes also have additional controls. The insertion tube 356 is a flexible shaft that is attached to the control section 354. The insertion tube 356 may include one of a plurality of channels for accessories, flush water, insufflation, and the like. The insertion tube 356 may include a goniometric actuator for deflecting the tip 360 of the insertion tube 356. The tip 360 of the insertion tube 356 may contain an image generating device, an illumination system, an opening for insufflation, an objective lens, and a water jet to clean the objective lens.

The length, diameter, and flexibility of the insertion tube 356 vary among endoscope types and manufacturers, with a diameter in the range of about 4.9 mm to about 12.9 mm. For example, please refer to "gastrointestinal endoscopy" 2011, vol.1, vol.74, pages 1-6, "new technical reports: GI endoscope ", which is incorporated herein by reference in its entirety.

Thus, it will be understood that while the probe 250 may be inserted into the IRD 100 of all embodiments when the IRD 100 is outside of the body cavity 104 or body orifice 106, the probe 250 may be inserted into the IRD 100 in only some embodiments when the IRD 100 is in the body cavity 104 or body orifice 106.

See, for example, fig. 1, where the inner support 108 is configured to be continuous around the probe 250 such that the inner support 108 is configured to have only a closed state. When the IRD 100 is outside of the body cavity 104 or body orifice 106, the stylet 250 may simply be inserted into the continuous inner support 108. On the other hand, see example fig. 11, where the inner support 108 is configured to be discontinuous around the probe 250 such that the inner support 108 is configured to have a closed state and an open state. When the internal buttress body portion 108 is discontinuous, the operator may position the IRD 100 around the stylet when the internal buttress 108 is in an open state, when the IRD 100 is in the body lumen 104, the body orifice 106, or both, or when the IRD 100 is not in the body lumen 104, the body orifice 106, or both.

Fig. 34 illustrates, in an end view, the relationship between embodiments that show the relationship between embodiments of a continuous structure of the inner support 108 around the probe and discontinuous structures of the inner support 108 around the probe 250 as would be understood by one skilled in the art. Although the probe 250 is shown as being substantially cylindrical and the inner support 108 is shown as a ring, other shapes (e.g., oval, etc.) are contemplated and disclosed throughout this specification.

Fig. 34(a) shows the probe 250 outside the continuous structure of the inner support 108. In a continuous structure of the inner support 108, as shown in the top right drawing, the only way to position the inner support 108 around the probe 250 is to slide the inner support 108 relative to the probe 250 so that the probe 250 is located within the inner support 108 and surrounded by the inner support 108.

In this case, the probe 250 will pass through the passage 264. When the inner support 108 has a continuous structure, the inner support 108 may not slide onto the probe 250 when the probe 250 is in the body orifice 106 or the body cavity 104. For example, the probe may have only one end that can be slid into the inner support 108, such as when the probe is a colonoscope. In such an example, the colonoscope 350 has an insertion tube 356 that can be configured to slide onto the probe 250. However, at the first end of the insertion tube 356, there may be a control section 354, a connector section 352, and a system 358 that will prevent the insertion tube 356 from sliding onto the inner support 108 at the first end. The colonoscope 350 has a pointed end 360 at the second end of the insertion tube 356 that is configured to slide into the inner support 108.

However, when the tip 360 is in the body orifice 106 or the body lumen 104, the tip 360 cannot slide into the inner support 108.

Fig. 34(B) shows the following from left to right: a probe 250 external to the one-piece construction of the inner support 108, the inner support biased to a closed position; a probe 250 within the inner support 108, the inner support being in an open state; and a probe 250 positioned within the inner support 108 and surrounded by the inner support 108, the inner support being in a closed state. There may be challenges in manufacturing the IRD 100 as one semi-rigid piece with a seam 292 along the length of the sides of the IRD 100 to facilitate sliding of the IRD 100 over the stylet after it is positioned in the body bore 106, body cavity 104, or both. For this reason, it may be necessary to have brackets 656 or other fasteners to more closely approximate the edges of the seam 292 so that the IRD 100 may facilitate retention of blown-in retention material, as discussed elsewhere.

Fig. 34(C) shows the following from left to right: a two-piece construction of the outer probe 250 at the inner support 108; a probe 250 within the inner support 108, the inner support being in an open state; and a probe 250 positioned within the inner support 108 and surrounded by the inner support 108, the inner support being in a closed state.

Fig. 35 shows a perspective view of another embodiment of IRD 100. As shown, the outer support 112, the intermediate portion 110, and the inner support portion 168 may be formed from one piece. Alternatively, as shown in other embodiments, the outer support 112, the intermediate portion 110, and the inner support portion 168 may be formed of two or more pieces. The combined outer support 112, intermediate portion 110, and inner support portion 168 may be referred to herein as a handle or base member 400.

The inner support 108 may be affixed to the base member 400 by heat staking/welding, laser welding, induction bonding, RF welding, impulse sealing, adhesives, or other suitable methods. The balloon may also be formed using various methods: dip molding, thermoforming, welding extruded films, or other suitable methods. The base member 400 may be formed via injection molding, compression molding, transfer molding, liquid silicone rubber molding, or other suitable methods. All materials are biocompatible.

The base member 400 may be semi-rigid, with a rigidity greater than the internal support in the expanded state. The internal support may be a balloon having an unexpanded state and an expanded state as shown. The balloon may be configured to interlock and snap closed upon itself in the expanded state. The balloon may be thermoformed in this manner as follows: when the balloon is inflated from the unexpanded state to the expanded state, the first end 402 of the inner support 108 and the second end 404 of the inner support 108 lock together to create a seal between the two ends of the balloon portion of the inner support 108. In doing so, the balloon in the expanded state forms an internal support 108 that creates an effective seal for retaining the insufflation material.

In the unexpanded state, the internal support has an open state. In the expanded state, the inner support 108 has a closed state. In the unexpanded state of the internal support 108, the base member 400 may have an open state with the seam 292 along the entire length of the base member 400. In the expanded state of the internal support 108, the base member 400 may have a closed state. In the open state of the internal support 108 and base member 400, the IRD 100 may be placed around the probe when the probe is in a body cavity, body orifice, or both, because the seam 292 is substantially open. In the closed state of the inner support 108 and the base member 400, the IRD 100 may not be placed around the probe when the probe is in the body cavity, the body orifice, or both the body cavity and the body orifice because the seam 292 is substantially closed. However, in the closed state of the internal support 108 and base member 400, when the probe is not in the body cavity, body orifice, or both the body cavity and body orifice, the IRD 100 can slide the IRD 100 past the probe because the passageway 264 for the probe is open so that insufflation material is not retained when the probe is not present.

As shown, the internal support 108 is not configured to engage the stylet, and thus the inflated balloon of the internal support 108 may not contribute to the seal between the IRD 100 and the stylet. Alternatively, the internal support 108 may be configured to engage the stylet to facilitate a seal between the IRD 100 and the stylet.

Fig. 36 shows a perspective view of another embodiment of IRD 100. As shown, the outer support 112, the intermediate portion 110, and the inner support portion 168 may be formed from one piece. The internal support 108 may be a balloon having an unexpanded state, not shown. The internal support 108 may be a balloon having an expanded state as shown. The inner support 108 may be affixed to the base member 400. The base member 400 may be semi-rigid, with a rigidity greater than the internal support 108 in the expanded state. When the inner support 108 is in the unexpanded state, the user may coil the inner support 108 around the base member 400 into a coil (coil). The user then inserts the IRD 100 into the patient and inflates the internal support 108 from the unexpanded state to the expanded state.

Again, in the unexpanded state, the internal support 108 has an open state. In the expanded state, the inner support 108 has a closed state. In the unexpanded state of the internal support 108, the base member may have an open state with a seam 292 along the entire length of the base member 400, which seam is not shown. In the expanded state of the internal support, the base member 400 may have a closed state. In the open state of the internal support 108 and base member 400, the IRD 100 may be placed around the probe when the probe is in a body cavity, body orifice, or both, because the seam 292 is substantially open. In the closed state of the internal support and base member 400, the IRD 100 may not be placed around the probe when the probe is in the body cavity, body orifice, or both the body cavity and body orifice 106, because the seam 292 is substantially closed. However, in the closed state of the internal support 108 and base member 400, when the probe is not in the body cavity, body orifice, or both the body cavity and the body orifice, the IRD 100 may slide the IRD 100 past the probe because the access for the probe is open.

As shown, the balloon portion of the internal support 108 is configured to not engage the stylet when present, and thus the expanded internal support 108 does not facilitate a seal between the IRD 100 and the stylet.

As shown, the inner buttress portion may have an end portion with a chamfer 406 or beveled edge, which may facilitate passage of the IRD 100 through a body orifice into a body cavity. Alternatively, as shown in other embodiments, the inner support 108 may have an end portion with a blunt edge.

Fig. 37-38 show isometric views of other embodiments of IRD 100. Outer support 112, intermediate portion 110, and inner support portion 168 are referred to as base member 400 and may be formed of two or more pieces or components. For example, the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be formed by bringing the first and

second body members

200, 202 together. The first body member may have a first body outer support 112, a first body intermediate portion 110, and a first body inner support portion 168. The second body member may have a second body outer support 112, a second body intermediate portion 110, and a second body inner support portion 168. When the first and second body components are combined, the first and second body components may form the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 of the IRD 100. The inner support 108 may be affixed to the base member 400 by welding, adhesive, or other suitable method. The first and second body members may be semi-rigid, with a rigidity greater than the inner struts 108 in the expanded state. The internal support 108 may be a balloon having an unexpanded state and an expanded state as shown. The balloon of the first body member 200 may be separate and isolated from the balloon of the second body member. The first body member 200 may have a inflation material conduit 166 in fluid communication with a first inflation material conduit in fluid communication with the first lumen of the first balloon. The second body member 202 may have a second inflation material conduit 466 in fluid communication with a second inflation material conduit in fluid communication with the second lumen of the second balloon. Although the first and second balloons may be inflated independently in a sequential manner by one source or simultaneously by 2 sources, the first and second inflation material lines may be connected by a Y-valve so that the user can still use a single source to inflate both the first and second balloons simultaneously.

By way of example and not limitation, the first and second body members may have fasteners, such as snaps 205 and snap receptacles 206. Further, by way of example and not limitation, the first and

second body members

200, 202 may have guides, such as locating pins 208 and locating holes 210. The fasteners on the first body member 200 may be positioned to engage the fasteners on the second body member 202. The guide on the first body member 200 may be positioned to engage the guide on the second body member 202. For any configuration of IRD 100, because the first and second body members are opposite mirror images of each other, the actual components that are the first and second body members may be used interchangeably after manufacture.

As shown in fig. 38, the first and

second body members

200 and 202 may be connected by a hinge 225 between the first body outer support 112 of the first body member 200 and the second body outer support 112 of the second body member 202. As shown, the flared portion of the inner support 108 may be configured to not engage the stylet 250, and thus the flared portion of the inner support 108 does not facilitate a seal between the IRD 100 and the stylet. The internal struts 108 are configured to extend peripherally from the IRD 100 as the internal struts 108 expand.

Fig. 39, 40 and 41 show further embodiments of IRD 100 in cross-section. The outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be formed of two or more pieces or body members. For example, the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168 may be formed by bringing together a first body member and a second body member. The first body component may have a first body outer support, a first body intermediate portion, and a first body inner support portion. The second body member may have a second body outer support, a second body intermediate portion and a second body inner support portion. When the first and second body components are combined, the first and second body components may form the body components of the outer buttress, the middle portion, and the inner buttress portion, which are also referred to herein as base components.

The body member shown in fig. 39 is complementary to the body member shown in fig. 40 or 41. In other words, outer support 112, intermediate portion 110, and inner support portion 168 may be complementary. As shown, the outer support 112, the intermediate portion 110, and the inner support portion 168 may be formed from one piece. The passageway 264 extends along the entire length of one side of the IRD 100 from the inner support 108 through the intermediate portion 110 to the outer support 112. The passageway 264 may be defined by a passageway structure extending from the inner support 108 to the outer support 112.

The complementary features of the body member may be reversed as desired. As shown, the dilation material conduit 166 for the IRD 100 may be present on only one of the first or second body members. As shown in phantom, the inflation material conduit 142 may extend through the body member from the inflation material conduit 166 to the lumen of the existing balloon such that the inflation material conduit is in fluid communication with the lumen. The first body member may be in fluid communication with the second body member through a valve 600, such as, by way of example and not limitation, a male valve/snap as shown in fig. 39 that mates with a female valve/snap in fig. 40 or 41. In other words, the 2 components snap together to create a continuous air path to allow inflation from one inflation material line 166 and source. Thus, while the balloons are isolated in the sense that one balloon is formed and attached to the first body member and the other balloon is formed and attached to the second body member, the balloons may be in fluid communication with the inflation material conduit 166 and a source that is the same for both balloons.

Additionally, as shown in the inner buttress portion, the body members may have fasteners or position guides, such as male/female locating features (214 and 216, respectively), to facilitate alignment of the first and second body members and assembly of the IRD 100.

As with other embodiments, the inner surface 344 of the passageway 264 may support one or more O-ring type structures (also referred to herein as a gasket or sphincter). One passageway may have O-ring type structures 280 of different diameters so that probes of different diameters may be positioned in the interior of the passageway to form a probe O-ring type structure seal. If there is more than one O-ring structure 280, the larger diameter may be toward the outer support 112 and the smaller diameter may be toward the inner support 108, but the opposite is contemplated.

As shown, the internal support 108 may be a balloon. The balloon may have a variable thickness 610 to facilitate inflation for expansion with insertion of a dilatation material. The balloon may be thinner toward first end 174 of inner support portion 168 to facilitate expansion of the balloon toward inner support portion 168.

Different balloon arrangements are shown and contemplated. Fig. 39 shows the balloon extending from the outer periphery of the inner support portion to the first end 174 of the inner support portion 168. The balloon in the expanded state may be configured to engage the probe (when present) through the passageway 264 to form a seal between the balloon and the probe. The balloon may be configured not to engage the stylet through the passage 264 (when a stylet is present) so that no seal is formed between the balloon and stylet, in which case other features would form a seal between the IRD 100 and the stylet in the passage 264. In either case of certain embodiments, the balloon in the expanded state is not closed, and thus the IRD 100 cannot hold insufflation material without a probe in the IRD 100.

Fig. 40 shows the balloon extending from the outer periphery of inner support portion 168 around and over (over) first end 174 of inner support portion 168 into passageway 264. Although the depth of the balloon into the passageway 264 is shown to be substantially similar to the depth of the balloon along the outer perimeter of the inner support 108, the depth of the balloon into the passageway 264 may be substantially greater or less than the depth of the balloon along the outer perimeter of the inner support 108. Inflation of the balloon in the passageway 264 can create a probe balloon seal that accommodates probes of different diameters, shown as having a larger diameter 700 as will be shown in fig. 49(a), and a smaller diameter 702 as will be shown in fig. 49 (B). With the probe positioned within the passageway, a predetermined volume of an expandable material may be inserted into the lumen of the balloon. The user may feel resistance to further insertion of the expandable material using a syringe, pressure cuff pump, or other suitable source of expandable material. In certain embodiments, the balloon in the expanded state is not closed, and thus the IRD 100 cannot hold insufflation material without a probe in the passageway 264.

Fig. 41 shows the balloons as an inner balloon 632 within the passageway 264 and an outer balloon 634 outside the passageway 264 and surrounding the passageway 264. As shown, the inner balloon 632 and the outer balloon 634 may be in fluid communication such that a single source of inflation material may be used to inflate both balloons simultaneously, or the inner balloon and the outer balloon may not be in fluid communication such that a single source of inflation material will need to be used to inflate the balloons at different times, or different sources of inflation material will need to be used to inflate the balloons at the same time.

These embodiments are considered discontinuous with respect to the internal support because these embodiments have an open state in which the internal support may be placed around the probe when the IRD 100 is in the open state, when the probe is in the body orifice, body cavity, or both. Further, the inner support in embodiments has a closed state, wherein the inner support is closable around the probe when the probe is in the body orifice, the 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 appropriate contact points 650 by heat welding or other suitable methods.

Fig. 42-49 illustrate another embodiment of IRD 100. Unlike the two-piece construction as the first and second body members shown in fig. 39, 40, and 41, the IRD 100 illustrates a one-piece construction of the base member 400 as the outer buttress 112, the intermediate portion 110, and the inner buttress portion 168. As with these other embodiments, the internal support 108 may be a balloon that extends peripherally from the base member 400 when expanded.

As shown in fig. 42-49, the balloon extends a distance along the exterior surface of the base member that is greater than the distance the balloon extends along the interior of the base member in the passageway, or vice versa. The length of the balloon extending along the exterior surface of the base member may also be substantially the same as the length of the balloon extending along the interior of the base member in the passageway. A balloon in the interior of the base member in the passageway may engage the probe to form a probe balloon seal to assist in retention of the insufflation material. The balloon on the exterior of the base member may form a body interior support seal to assist in retention of the insufflation material.

IRD 100 has seam 292 that extends all the way along the length of the base member from the outer support to the inner support portion. Seams 292 are also present in the balloon of the inner support. The IRD 100 shown in fig. 42-49 may have an open state and a closed state due to the seam 292. When the IRD 100 is in an open state, the IRD 100 may be placed around a probe when the probe is in a body orifice, a body cavity, or both. Further, the inner support has a closed state, wherein the inner support is closable around the probe when the probe is in the body orifice, the body cavity, or both.

The outer support 112 may have an outer surface 670 and an inner surface 672. The inner support 112 can have one or more support posts 674 on the inner surface 672. Fig. 50 illustrates, in cross-section and fig. 51 in perspective, another embodiment of the IRD 100 wherein the lumen 160 of the inner buttress 108 may extend circumferentially when expanded from the inner buttress portion 168 of the base member further including the intermediate portion 110 and the outer buttress 112. The passageway 264 configured for passage of a probe (when present) is shown as having two O-ring type structures 280, but it will be understood that it may have one or more O-ring type structures 280. An O-ring type structure 280 on the inner diameter of the base member allows a seal to be formed between the IRD 100 and the probe (when present). As shown, the O-ring type structure 280 may be surrounded by the outer support 112. One or more of the O-ring type structures 280 may also be surrounded by some combination of the intermediate portion 110 and the inner support portion 168. The O-ring type structure 280 may be used as a sphincter to allow sealing on probes of various diameters. IRD 100 has seam 292 along its length from first opening 420 to second opening 422. Because the internal support is discontinuous, IRD 100 has an open state and a closed state.

As shown in fig. 51, when IRD 100 is in the closed state, IRD 100 may have seam 292 which is not present through abutment of adjacent surfaces.

However, in a closed state where seam 292 is not absent, the stylet cannot slide through seam 292 into passageway 264 from outside IRD 100.

As shown, the inner support 108 in the expanded state is configured to not engage the stylet (when the stylet is present) to form a seal between the expanded inner support 108 and the stylet.

Fig. 52(a) and 52(B) show cross-sectional views of another embodiment of IRD 100. As in other embodiments, passageway 264 extends along a length from inner support 108 through middle portion 110 to outer support 112. The passageway 264 may be defined by a passageway structure 265 that extends from the inner support 108 to the outer support 112. The inner support 108 may surround and lay in contacting proximity to an outer surface 430 of the access structure 265 toward an insertion end 432 (otherwise referred to as a first end) of the access structure 265. The outer support 112 may surround and lay in contacting proximity with an outer surface 430 of the access structure 265 toward a handle 434 (otherwise referred to as a second end) of the access structure 265.

The inner support 108 may be made of an elastomeric material, such as a polymer or natural rubber. The outer support 112 may be made of a semi-rigid material that is more rigid than the elastomeric material of the inner support 108. The middle portion 110 may be made of a semi-rigid material and may also include an elastomeric material.

The first or insertion end 432 of the access structure 265 may include an internal support retention member 436. Inner support 108 may be positioned between intermediate portion 110 and inner support retention member 436.

An opposite second end or handle 434 of the access structure 265 may include an external buttress retention member 438. Outer support 112 may be positioned between intermediate portion 110 and outer support retaining member 438.

Inner support 108 may be fixed relative to inner support retaining member 436 at a first end 450 of inner support 108, and inner support 108 may be movable relative to inner support retaining member 436 at an opposite second end 452 of inner support 108. The inner support 108 may be biased toward the extension of the opposite second end 452 of the inner support 108 toward the outer support 112. Such biasing of the inner support 108 toward the outer support 112 may bias the outer support 112 toward the outer support retention member 438. Outer support retention member 438 may be configured to prevent outer support 112 from extending beyond handle 434 and out of access structure 265.

This embodiment may be considered to function in a manner similar to a well nut. The IRD 100 may have an inserted state and a held state. In the insertion position, the user may insert the IRD 100 into the body lumen 104 through the body orifice 106. The user may slide the outer support 112 relative to the outer surface 430 of the access structure 265 toward the inner support 108 while the inner support is in the body lumen 104. When the outer support 112 slides toward the inner support 108, the inner support 108 extends peripherally away from the access structure 265 when the IRD 100 is in the hold state. The internal buttress 108 may now prevent the IRD 100 from exiting the body lumen 104 and may facilitate retention of the insufflation material.

Further, IRD 100 may include latch 460 to maintain this retention state. In the inserted state, the latch 460 may be surrounded by the outer support 112. As the outer support 112 slides toward the inner support 108, the outer support 112 may no longer enclose the latch 460. The latch 460 may be biased to extend circumferentially from the access structure 265. When the outer support 112 no longer surrounds the latch 460, the latch 460 may extend peripherally from the access structure 265. The latch 460 may hold the outer support 112 and the inner support 108 in a retained state when the latch 460 extends peripherally from the access structure 265. The user may push the latch 460 centrally toward the access structure 265 such that the bias of the outer support 112 toward the outer support retention member 438 is no longer counteracted by the latch 460. Thus, the outer support 112 will slide towards the outer support retaining member 438 and the inner support 108 can move centrally towards the access structure 265 such that the inner support 108 can no longer prevent the IRD 100 from exiting the body cavity 104 and can no longer facilitate retention of the insufflation material. The IRD 100 has transitioned from the retention state back to the insertion state such that the IRD 100 may be removed from the body aperture 106 and the body cavity 104.

Fig. 53 shows another embodiment of IRD 100 in cross-section and fig. 54 in perspective view. Previously, embodiments have been shown having an O-ring type structure or sphincter inside the passageway. In this embodiment, the O-ring type structure is shown external to the access structure. This embodiment appears somewhat like a fir tree with one or more branches 470. Branches 470 of the tree may be shorter toward insertion end 432 of IRD 100 to act as a chamfered edge, and longer toward external support 112. Branches 470 may be made of an elastic material that may flex as IRD 100 is inserted and removed from the body lumen. For example, and not by way of limitation, branch 470 may be a soft rubber disk. One or more of branches 470 may extend into the body lumen during use of IRD 100, and one or more of branches 470 may remain in the body bore during use of IRD 100. As with other embodiments, lubricant may be applied to IRD 100, such as along branch 470.

Extending through IRD 100 is a passageway 264 having a first opening 420 configured for entry of a stylet into IRD 100 and a second opening 422 configured for exit of a stylet from IRD 100. As shown, this embodiment of the IRD 100 may only have a closed state for sliding the stylet into the IRD 100 when the stylet is not in the body orifice or cavity.

Fig. 55 shows another embodiment of IRD 100 in cross-section and fig. 56 in perspective view. This embodiment shows an O-ring type structure 280 external to the access structure 265. The O-ring type structures 280 may be substantially the same length. The O-ring type structure 280 may be provided by an inner holder portion 168 that is externally affixed to the access structure 265. This embodiment may appear somewhat like a long "fur" collar, which in combination with a lubricant may form an effective seal. While the O-ring type structures 280 may extend substantially parallel to each other and substantially perpendicular to the via structures 265, the O-ring type structures 280 may extend diagonally and substantially non-perpendicular to the via structures 265. The orientation of the O-ring type structure 280 may facilitate retention of the blown-in retaining material. Of course, the O-ring type structure 280 may be flexible and change orientation when inserted and retracted from a body orifice or cavity.

Fig. 57 shows a cross-section of another embodiment of IRD 100. The winding path of the seam 292 between the first and

second body members

200, 202 may help align the first and

second body members

200, 202 when the user transitions the first and

second body members

200, 202 from the open state to the closed state. The passageway 264 extends through the combination of the first and

second body members

200, 202. The first body member 200 may have the inner lumen 160 of the inner strut 108 so that the inner strut 108 of the first body member 200 may expand from a contracted or unexpanded state upon introduction of an expansion material. The second body member 202 may have the inner lumen 160 of the inner strut 108 so that the inner strut 108 of the second body member 202 may expand from a contracted or unexpanded state upon introduction of an expanding material. In this embodiment, the lumen 160 of the inner strut 108 of the first body member 200 may not be in fluid communication with the lumen 160 of the inner strut 108 of the second body member 202.

Fig. 58 shows a cross-section of another embodiment of IRD 100. Any suitable material may be applied around the probe 250 and adhesive 490, such as an elastomeric material 488 (such as a thermoplastic elastomer or other elastomeric material), as shown in fig. 59, where an adhesive edge 492 may be used around the IRD 100 to place the IRD 100 in a closed state.

Fig. 60(a) shows an isometric view of a pressure cuff pump 500 that can serve as a source of inflation material through inflation material tubing 166 for inflating the inner or outer buttress lumens. The pressure cuff pump 500 is squeezed for inflation. One can pinch to open the one-way valve for deflation. A one-way duckbill valve 502 may be included as shown in figure 60 (B). The syringe may be used for inflation along with other sources contemplated by those skilled in the art. As previously shown, IRD 100 may require a valve to retain the expanded material after inflation of the inner buttress, outer buttress or intermediate portion.

Fig. 61(a) shows an isometric view of another embodiment of IRD 100. The soft thermoplastic elastomer 508 may be overmolded onto the rigid core 510. The rigid core 510 is more rigid than the soft thermoplastic elastomer 508. The rigid core 510 may be made of polypropylene or other suitable material. The soft thermoplastic elastomer 508 may have a rating of about 50A hardness or other suitable rating.

Fig. 61(B) shows IRD 100 in cross-section with probe 250 within rigid core 510. During use, when IRD 100 is inserted into a body orifice, body cavity, or both, the seam 292 seen between the surfaces may not be present. The IRD 100 may include an internal support, such as a balloon.

As shown in various embodiments throughout the present disclosure, in some embodiments, the inner support 108 and the outer support 112 are not configured to engage the stylet 250, and thus the inner support 108 and the outer support 112 may not contribute to the seal between the IRD 100 and the stylet 250. In other embodiments, the inner support 108 and the outer support 112 are configured to engage the stylet 250, and thus the inner support 108 and the outer support 112 may facilitate a seal between the IRD 100 and the stylet 250. Whether or not the inner support 108 and the outer support 112 engage the stylet 250, the inner support 108 and the outer support 112 may facilitate a seal between the IRD 100 and the body 102 (such as the body cavity 104, the body bore 106, and the wall 120 of the body bore 106).

Of course, care is taken to optimize the contact of the internal supports 108, external supports 112, and other parts of the IRD 100 with the body 102, body cavity 104, and body orifice 106, as well as other aspects of the patient, to minimize the risk of pressure necrosis (pressure necrosis) or other adverse side effects caused by use of the IRD 100. This may be accomplished by having a predetermined volume for the expandable material, which in turn will establish a predetermined pressure that the internal supports 108, external supports 112, etc. of the IRD 100 exert on the body 102, body cavity 104, body orifice 106, etc.

A method of using IRD 100 may include the following steps. At a first step, the IRD 100 is inserted into a body cavity 104 of the body 102 through a body orifice 106 of the body 102. At a second step, insufflation material is injected into the body cavity 104. At a third step, the user performs a diagnostic intervention, a therapeutic intervention, or both a diagnostic intervention and a therapeutic intervention using the probe. Additional steps are contemplated. For example, but not limited to, a probe may be inserted through the body orifice 106 before, after, or in conjunction with inserting an IRD through the body orifice 106.

It is to be understood that even though numerous characteristics and advantages of various embodiments of the present disclosure have been set forth in the foregoing description, together with details of the structure and function of various embodiments of the disclosure, this detailed description is illustrative only, and changes may be made in detail, especially in matters of structure and arrangement of parts within the principles of the present disclosure to the full extent indicated by the broad general meaning of the terms used in the appended claims. And changes may be made in detail, especially in matters of structure and arrangement of parts within the principles of the present disclosure to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

Claims

1. An insufflation retention device comprising:

an internal buttress configured to inhibit removal of the internal buttress from a body lumen through a body orifice of a body, wherein the internal buttress has an unexpanded state and an expanded state after introduction of an expandable material, and the internal buttress in the expanded state extends around an end of the insufflation retention device;

an outer buttress coupled to the inner buttress, the outer buttress configured to inhibit passage of the outer buttress through the body orifice into the body lumen, wherein the outer buttress has only an expanded state and no unexpanded state;

a passageway extending through the inner support and the outer support, the passageway configured for passage of a probe into contacting engagement with the body cavity, wherein the passageway is configured to be open in the absence of the probe in the passageway such that insufflation material introduced into the body cavity is not retained in the body cavity;

a seam extending from an exterior surface of the passageway to an interior surface of the passageway, wherein the seam extends from the interior support all the way to the exterior support.

2. The insufflation retention device of claim 1 wherein said internal support in said expanded state is configured to be contactingly adjacent said probe.

3. The insufflation retention device of claim 1 wherein said internal support in said expanded state is configured to be non-contactingly adjacent to said probe.

4. The insufflation retention device of claim 1 wherein the passageway is configured for passage of a probe therethrough from a first opening in the outer support to a second opening in the inner support.

5. The insufflation retention device of claim 1 wherein the seam is configured to extend from a first opening in the outer support to a second opening in the inner support such that the passageway has an open state that does not retain insufflation material when the probe is not present and a closed state that does retain insufflation material when the probe is in the passageway.

6. An insufflation retention device comprising:

a passageway extending through the inner support and the outer support, the passageway configured for passage of a probe into contacting engagement with the body lumen, wherein the passageway is configured to be open in the absence of the probe in the passageway such that insufflation material introduced into the body lumen is not retained in the body lumen, wherein the inner support in the expanded state extends into the passageway for contacting engagement with the probe;

7. The insufflation retention device of claim 6 wherein said internal support in said expanded state is configured to be contactingly adjacent said stylet.

8. The insufflation retention device of claim 6 wherein said internal support in said expanded state is configured to be non-contactingly adjacent to said probe.

9. The insufflation retention device of claim 6 wherein the passageway is configured for passage of a probe therethrough from a first opening in the outer support to a second opening in the inner support.

10. The insufflation retention device of claim 6 wherein the seam is configured to extend from a first opening in the outer support to a second opening in the inner support such that the passageway has an open state that does not retain insufflation material when the probe is not present and a closed state that does retain insufflation material when the probe is in the passageway.

11. An insufflation retention device comprising:

an internal buttress configured to inhibit removal of the internal buttress from a body lumen through a body orifice of a body, wherein the internal buttress has an unexpanded state and an expanded state after introduction of a bulking material;

a seam extending from an exterior surface of the passageway to an interior surface of the passageway, wherein the seam extends from the interior support all the way to the exterior support, wherein the interior support has a first balloon inside the passageway and a separate second balloon outside the passageway, and the first and second balloons are in fluid communication, but the first and second balloons do not walk around from an end of the interior support.

12. The insufflation retention device of claim 11 wherein said internal support in said expanded state is configured to be contactingly adjacent said stylet.

13. The insufflation retention device of claim 11 wherein said internal support in said expanded state is configured to be non-contactingly adjacent said probe.

14. The insufflation retention device of claim 11 wherein the passageway is configured for passage of a probe from a first opening in the outer support to a second opening in the inner support.

15. The insufflation retention device of claim 11 wherein the seam is configured to extend from a first opening in the outer support to a second opening in the inner support such that the passageway has an open state that does not retain insufflation material when the probe is not present and a closed state that does retain insufflation material when the probe is in the passageway.