Apparatus for modifying the exit of a satiation pouch

Field of invention

The present invention generally relates to the field of devices and methods for achieving human weight loss, more specifically to implantable in the stomach of the human body, either to regulate the sensation of hunger or to limit food intake, or Regarding the use of the device for both.

Background of the invention

An anatomical chart of the human stomach S and related features is shown in Figure 1A. Esophagus E sends food from the mouth to the stomach S. The z-line or gastroesophageal junction Z is the irregularly shaped boundary between the thin tissue of the esophagus and the thick tissue of the gastric wall. The gastroesophageal junction region G is the region surrounding the terminal of the esophagus E, the z-line, and the base of the stomach S.

The stomach S contains a fundus F at its base and a pyloric sinus A at its end. Pyloric antrum A enters pylorus P, which attaches to duodenum D in the proximal region of the small intestine. Inside the pylorus P is the sphincter, which prevents the return of food from the duodenum to the stomach. The intermediate region of the small intestine located at the end of the duodenum D is the jejunum J.

The artificial organs used to control obesity are shown and described below. That is, U.S. Patent Application No. 09 / 940,110 (filed August 27, 2001), U.S. Patent Application No. 10 / 118,289 (filed April 8, 2002), and U.S. Provisional Patent Application No. 60 / 379,306 (2002). (Application on May 10). These applications are in the name of the assignee of the present application, and the disclosures thereof are incorporated herein by reference. A particular form of these devices relates to the positioning of the artificial pouch at the base of the stomach as shown in FIG. 1B. The pouch 2 includes a base opening 4 and a small diameter end opening 6 to form a small reservoir for collecting chewed food from the esophagus, thus limiting the amount of food that can be consumed at one time. The pouch swells as it is filled with food, exerting pressure on the upper stomach and lower esophageal sphincter, causing the patient to experience a feeling of fullness. This pouch additionally or alternatively acts as a limiter, limiting the amount of food consumed. The pouch is secured in place at a mooring point around the periphery of the base opening 4 using clips, sutures, suitable adhesives or other means 8.

Food intake to be restricted varies from patient to patient. Therefore, it is desirable that the amount of food that the patient can ingest can be increased or decreased by selecting an appropriate diameter of the terminal orifice of the pouch. The small orifice slows the descent of food from the pouch to the stomach more slowly than the large pouch, thus limiting the amount of food a patient consumes at one time.

Saturated pouches may be available for multiple terminal orifice sizes (and / or multiple pouch sizes) to allow the practitioner to choose the appropriate size for the target food intake for the patient. Alternatively, the saturated pouch may be configured to allow the size of its end opening to be increased or decreased. This allows the practitioner implanting such a device to have the patient size the terminal opening appropriately. In some cases, it also allows the practitioner to adjust the terminal opening after the device has been implanted. For example, if the patient has not been given the desired rate of weight loss, the practitioner reduces the size of the terminal opening so that the food from the pouch to the stomach is emptied more slowly. Alternatively, the practitioner may increase the size of the terminal opening if necessary, which either causes the weight loss to progress too quickly or the patient suffers from vomiting and the pouch is opened to ease the patient. If you need to be able to vomit. The present application describes various saturated pouches that have an adjustable terminal orifice size and provide the practitioner with improved adjustment beyond the degree of food consumption the patient consumes at one time.

<u style="single">Outline of the invention</u> The present invention includes an artificial organ that can be placed within the gastroesophageal junction region of the patient, the artificial organ including a base opening and a terminal orifice, the terminal orifice being sized prior to, after, or both of the implant. It is possible. During use, the prosthesis is attached to the tissue of the patient's gastroesophageal junction, and the device allows food ingested by the patient to pass from the esophagus through the base opening into the prosthesis's inner chamber, eventually ending. It is located to exit the prosthesis through an opening.

Detailed description of the drawing The accompanying drawings show a number of examples of saturated pouches that have the characteristic of allowing the size of the end or outlet orifice to be varied before, after, or both of the implant. The term "exit orifice" is used to describe the smallest orifice through which food flow from the inner chamber of the pouch to the stomach. When referring to the step of resizing the end or outlet orifice of a device, the term "size" is used to mean a dimension, and when it is changed, the food ingested through the orifice. Flow rate changes.

For the purposes of this application, the term "saturated device" or "saturated pouch" is used to mean an artificial organ containing a pouch intended to induce weight loss by at least one of a variety of techniques. These include, but are not limited to: That is, physically limiting the amount of food that can be ingested and / or exerting pressure on parts of the human body (eg, stomach, esophagus, esophageal sphincter, etc.) to cause the patient to experience satiety and / or Affecting the level of substances in the human body that regulate or affect the sensation of hormones or hunger, and / or the amount of food ingested by humans.

The pouch described in each embodiment may be formed from a flexible material that prevents the passage of food through its sides. Examples of such materials include polyesters (eg, Dacron polyester), ePTFE fabrics (eg, GoreTex trademark fabrics, etc.), polyurethanes (eg, ChronoFlex polyurethanes, nylon fabrics, silicones, other polymeric materials, and in vivo. Includes, but is not limited to, absorbent materials such as PLLA, PGA, PCL, poly-amihydrides, etc. This material is of flexible, semi-flexible and / or non-flexible material. Can be formed from the composition, these provide separate areas of the pouch with different degrees of flexibility to allow or limit the expansion of the pouch at various locations, eg, a pouch with a sufficiently flexible outlet port. It is desirable to give and prevent blockage when a large piece of food is ingested and / or control the outlet pressure of the food from the pouch, while the base end of the pouch is stiff to prevent swelling. You may build varying degrees of flexibility into the pouch by varying the cross-sectional thickness of the pouch in individual areas of the pouch. The material is a lubricious, biocompatible, chemically inert material. , For example, may be coated with pararain to reduce friction with the substrate, which helps prevent the adhesion and deposition of food on the device.

The flexible pouch material may be constructed or supported by being reinforced by a support member, such as a soft mesh, cage structure, ribs, rings and the like. The support member may be formed of stainless steel, a polymer, a shape memory material (eg, nitinol, shape memory alloy, or shape memory polymer), or a thick region of pouch material. The pouch may be configured to be self-expandable so that the pouch pops radially and opens open when ejected from the deploying device or catheter.

Implants of the devices described above are preferably performed endoscopically by passing the device through the esophagus, preferably under endoscopic visualization. Alternatively, the device may be implanted using surgical or peritoneal procedures.

During the implant, the pouch is secured to the gastroesophageal junction region G using sutures, clips, glue, stents or stent-like structures, or other suitable means. One suture attachment device that has proven useful for making sutures between pouches and tissues is the "Sew-Right" suture device available from LSI Solutions, JVC, NY. The pouch may be attached to the esophageal tissue, but more preferably sutures / clips under the Z-line to allow attachment to the thick tissue of the stomach wall.

Each of the pouches described includes a proximal opening and an distal exit port (see openings 4 and 6 in FIG. 1B, respectively). Due to its small volume (a volume of about 2 cc to 300 cc, preferably in the range of 10 to 30 cc), the pouch functions to limit the amount of food that can be consumed at one time. Over time, the food in this storage chamber descends into the stomach through the outlet port of the pouch.

First Example A first embodiment of a saturated pouch with a variable size orifice is shown in FIGS. 2A-3C. The pouch 10 includes a proximal opening 12, a distal opening 14, and a passage extending between the proximal opening and the distal opening. Inserts 16a, 16b are provided for attachment to the pouch 10. Such inserts 16a, 16b are preferably given two or more, each having a different size terminal orifices 18a, 18b. For example, the integration of inserts may be provided with terminal orifices, each with a different diameter in the range of 6-14 mm (for circular orifices) . Each insert includes a proximal opening 20 surrounded by a rim 22. The rim 22 is sized to sit in a recess 24 (FIG. 3A) formed in the inner wall of the pouch 10 when the insert 16a is located inside the pouch and the orifice 18a extends endward. (See Figures 2B and 3C). If it is necessary to ensure a snug fit between the insert and the pouch, the rim 22 may be structurally reinforced with ring-shaped nitinol, stainless steel, thick silicone or the like. Good.

Prior to implanting the pouch 10, the practitioner selects an insert with a diameter suitable for the patient. That is, the practitioner selects an insert with a terminal orifice size that lowers food from the stomach at the desired rate. The practitioner then passes the insert through the proximal opening 12 of the pouch 10 and pushes the rim of the insert to engage the pouch recess 24. It will be necessary to widen the end opening 14 of the pouch to allow the rim 22 to sit in the recess 24.

The end face of the rim 22 may include a ridge 26 as shown in FIG. 3B. When the pouch is inserted and attached, these ridges 26 urge the base end face of the rim against the top surface of the recess (Fig. 3C), so if this is not the case, the base end face and recess of the rim Accumulation of ingested food in the space between the upper surface is prevented. The connection between the pouch and the insert may be reinforced with sutures or other means if desired. After the pouch and insert are assembled, the pouch is implanted in the gastroesophageal junction area.

Note that the assembly of the pouch and insert may optionally be performed after the pouch has been implanted. Hole 28 (FIG. 3) facilitates gripping the insert with tweezers or other instruments during assembly.

After the practitioner (eg, hours, days, weeks, months or even years later), inserts with different orifice sizes are more suitable for a particular stage of the patient's treatment. If so, remove the insert 16a from the pouch 10 (eg by grasping the insert with tweezers and pulling it out of the proximal opening 12) and replace it with another pouch.

The pouch 10 is shown to have a proximal opening 12 that is larger than the distal opening 14, but this pouch has a large distal opening, including a distal opening that is equal to or larger than the proximal opening. It may be provided. Such examples are used, for example, in patients who want to recover the patient from the initial implant and / or who want to adjust the presence of the implanted pouch before shrinking the exit orifice. .. After an appropriate recovery / adjustment period (eg, at least one day and at most about two weeks to restore the suture / locking attachment point), individual treatments are performed on the insert or other flow-restricting component, preferably the stomach. It is performed to add to pouch 10 by passing the esophagus down toward. It is desirable that some food material that may accumulate in the recess 24 does not block the pouch between implants of the insert or other part. Note that if a recovery / adjustment period is intended, the pouch design may be slightly modified to minimize the chance of food material accumulating in the recess 24.

Another variant of the additional concept of flow limiting components after the initial adjustment period is for the initial implant of the base device in the gastroesophageal junction region, where the base device does not require a saturated pouch, but during the recovery / adjustment period. It is the base to which the pouch is then attached. For example, the base may take the form of an annular ring or other device that is secured to the gastroesophageal junction region with sutures, clips, staples, or the like. The ring can be formed from a variety of materials, including those listed above for use in forming pouches. After the recovery / adjustment period, the saturated pouch can be attached to the base using screws, snaps, sutures, clips, staplers, or other fasteners.

Various modifications of the first embodiment are possible and are considered to be within the scope of the applicant's disclosure. For example, the insert may be replaced with another type of compatible component that attaches a larger or smaller orifice to the pouch. For example, an example of such a component is the same as the inserts 16a and 16b, but may be attached to the outer surface of the pouch instead of being seated in the inner chamber of the pouch. The insert or alternative component may also be attachable to the pouch using other means, such as sutures, clips, adhesives and the like.

Second Example FIG. 4A shows a second embodiment of the saturated pouch 30. The pouch 30 includes a terminal orifice 32, which has a size that can be increased or decreased prior to or subsequent to the implant. The ductile ring 34 is located at the end of the pouch near the end orifice 32. The ring is preferably made of a malleable, ductile material (eg, annealed stainless steel, copper or other metal, or plastic). It may be in the form of a spring as shown, or it may have a stent-like or other form. The ring 34 may be located on the inner or outer surface of the pouch 30 or may be embedded in the pouch material.

The pouch 30 is provided with a tool for use in increasing or decreasing the diameter of the ring 34 to increase or decrease the size of the terminal orifice 32. For example, the expansion tool may take the form of a balloon dilator 36, which can be placed in the pouch and inflates to expand the ring 34 as shown in FIG. 4B. Another example is an expansion basket catheter. The reduction tool 38 may have an umbrella-like shape as shown in FIG. 4A. During use, the operating head 39 of the tool 39 is placed in its closed position and exits through the pouch to the terminal orifice 32. Upon exiting the terminal orifice, the head 39 bulges and is pulled out toward the proximal end to surround the ring 34 (FIG. 4C), move to the closed position and press the ring into a smaller diameter form. The tool 38 is then pulled out of the pouch.

In this embodiment and all the embodiments described herein, the modification of the outlet orifice size can be performed at various stages of the patient's treatment. For example, after a practitioner implants a pouch (eg, hours, days, weeks, months, or even years later), artificial organs with different orifice sizes are a particular stage of patient treatment. If determined to be more appropriate for the purpose, the necessary tools may be passed through the esophagus to change the orifice size. As another example, the pouch may be implanted from the beginning with a large (eg, as large as or larger than the proximal opening) outlet orifice. Then, after a suturing / fastening and other adjustment and / or recovery period on the implant side, a second procedure is performed to modify the exit orifice to the desired size.

Figures 20A and 20B show other pouches in which malleable material was used to allow the outlet orifice to be adjustable. The pouch 30a is provided with an outlet orifice 32a and an adjustment orifice 32b, which share a common wall 33. The pouch 30a is an outlet orifice 32a in which the expansion of an expansion tool (eg, balloon dilator 36) within the adjustment orifice 32b deforms a common wall 33 towards the outlet orifice 32a, for example, as shown in FIG. 20B. It is configured to reduce the size of. Similarly, the use of expansion tools within the outlet orifice 32a deforms the common wall 33 away from the outlet orifice, increasing the size of the outlet orifice. A portion of the pouch, such as the wall 33, or the ring / band surrounding the end and adjustment orifice, is malleable so that the adjusted size is retained unless the size of the outlet orifice 32a is further resized using an expansion tool. It is preferably formed from a material.

3rd and 4th Examples A modification of the second embodiment is the third embodiment shown in FIG. 5A. A third embodiment includes a pouch 40, which has an annular web 42 forming an outlet orifice 44 at its end. Examples of materials suitable for this web 42 include the materials listed above for use in pouches. The low yield strength ring 46 is connected to the outer circumference of the web. To increase the diameter of the orifice 44, an expansion tool such as the dilator 36 in FIG. 4A inflates through the orifice 44 to expand the ring. The expansion ring pulls the web radially outward, increasing the size of the orifice 44. The diameter of the orifice 44 may be reduced by compressing the ring to a smaller diameter size using a shrinking tool such as tool 38 in FIG. 4A.

The pouch 40a of the fourth embodiment works in the same manner as the third embodiment, as shown in FIG. 5B, but includes a web 42a and a ring 46a extending radially outward from the terminal orifice 44a.

5th and 6th Examples With reference to FIGS. 6A and 6B, a fifth embodiment of the pouch 50 may optionally be provided with a limiting ring 52, which surrounds the outer surface of the pouch in the immediate vicinity. Whether the ring 52 is expanded by applying a radial expansion force from within the inner diameter of the ring (eg, by using the dilator described above or by positioning the jaw of the gripper in the stomach and then separating the jaws). Or compress using the compressive force applied to the outside of the ring (eg, by positioning the ring between the jaws and closing the jaw slightly). This expansion / compression may be performed prior to the implant or after the pouch has already been implanted.

FIG. 7 shows a third alternative embodiment of the pouch 60 with an adjustable end opening. The embodiment of FIG. 7 is similar to the embodiment of FIG. 6A in that it depends on the expansion / contraction of the restriction ring 62. The restriction ring 62 is located inside the pouch near the terminal opening. A pair of opposing slots 64 are formed on the inner surface of the ring 62. The endoscopic control adjustment tool 66 includes a pair of extendable pins 68 at the end of the elongated shaft 70. Actuators 72a, 72b on the proximal end of the adjustment tool 66 control pin stretching between the degenerate position (FIG. 8A) and the stretching position (FIG. 8B). To adjust the diameter of the pouch 60, the tool inserts the pin 68 through the pouch in the degenerate position. Pin 68 is aligned with slot 64 in ring 62 and then stretched using actuator 72a. When these are stretched, the pin 68 slides into slot 64. The user then rotates the tool 70 around the vertical axis either clockwise or counterclockwise. The rotation of the tool expands or contracts the ring depending on the direction of rotation. After the ring size is adjusted, the actuator 72b is used to degenerate the pin 68 to remove the tool 66 from the pouch 62.

Seventh to ninth examples An expansion medium, such as gas or saline, may be used to influence the increase or decrease in terminal orifice size either before or after implanting the pouch. For example, in the seventh embodiment shown in FIG. 10, the pouch 80 includes an inflatable annular region 82 close to the terminal orifice 84. The endoscopic expansion / contraction tool 86 passes through the oral cavity into the pouch and ejects or withdraws the expansion medium using an expansion / contraction needle 88 that can be inserted into the expansion port in region 82. This region 82 is shown on the pouch 80a of the eighth embodiment shown in FIGS. 11A and 11B. FIG. 11A shows the ring being expanded and FIG. 11B shows the ring expanded enough to open the (additional) fold 89 on the pouch 80a.

The pouch 90 of the ninth embodiment (FIG. 12) includes a pair of annular expansion chambers 92,94, which are connected by a bidirectional valve 96, through which the expansion medium travels from one chamber to the other through the valve 96. I am trying to move. If it is desired to increase the diameter of the end orifice 98, an expansion tool (eg, tool 36 in FIG. 4A) is placed in the orifice 98 to inflate and the expansion medium in chamber 94 is passed through valve 96 to chamber 92. Therefore, the ingested food can more easily flow through the orifice 98. To reduce the diameter of the end orifice 98, the expansion tool is extended relative to the upper chamber 92 to pull the movement of the expansion medium to the lower chamber 94, thereby expanding the chamber 94 radially inward. Reduce the diameter of the orifice 98.

10th Example The pouch 100 of the tenth embodiment (FIG. 13) uses a zipper configuration (similar to that found in plastic storage bags) to increase or decrease the size of the terminal orifice. A vertical notch 102 is provided on the pouch wall. The zipper carriage 104 slides towards the proximal end along the notch separating the edges 106a, 106b to increase the size of the distal orifice 108. The movement of the carriage 104 in the terminal direction reduces the size of the terminal orifice 108 by connecting the edges 106a, 106b together.

Eleventh Example 14A and 14B show the end of the eleventh embodiment of the pouch 110. The end of the pouch 110 includes a diaphragm 112 that defines a terminal orifice 114. The diaphragm 112 is similar to a camera shutter in the sense that it includes the following movable piece 116, and the movable piece rotates so as to increase or decrease the terminal orifice 114 according to the rotation direction. Various mechanisms can be used for the rotation of the diaphragm, from a manually threaded actuator that can be engaged by an endoscopic tool that passes from the oral cavity to the pouch, or from an endoscopic accessory under direct visualization. Includes microelectromechanical motors that are activated or activated wirelessly from outside the patient's body.

12th Example According to a twelfth embodiment of the pouch 120, the pouch 120 includes a drawstring 122 that surrounds its end portion. The string may be held in place by passing it through a sleeve (eg, a case with a drawstring thread) or through a separate belt loop type loop. The size of the end orifice 124 is reduced by pulling on the free end 126 of the drawstring and tightening the pouch 120.

Cutting tool Another technique that can be used to increase the size of the terminal orifice of a saturated pouch is the use of a cutting tool that cuts out a larger opening in the pouch. If performed on a pouch located within the body, this tool is preferably an endoscopic tool that is guided to the pouch through the esophagus under visualization.

If the pouch is tapered towards its end, removing the end compartment will increase the orifice size. 16-19B show tools that can be used for this purpose.

FIG. 16 shows the pouch 2 located in the stomach S. By inserting the endoscope clamp 130 into the pouch 2 through the esophagus and using it to remove the end of the pouch 2, the size of the terminal orifice 6 is increased. In any of the cutting tool examples, the pouch 2 may include a marker 132 indicating where a cut should be formed to achieve various orifice diameters.

Referring to FIG. 17, the end of the pouch 2 may be opened using an endoscopic electrode, which is, for example, a bipolar or unipolar RF electrode wire 134, which is energized to melt the pouch material and of the pouch 2. Remove some. A variety of electrode configurations can be used, including a "bow" as shown, a wire with end tip electrodes, or a plurality of electrodes 134a configured in a basket-like arrangement as shown in FIG. Such a basket-shaped arrangement can be inflated to contact the pouch using a balloon 136. Alternatively, the wires are preformed in an extended position as shape memory alloy wires, which are housed in a sheath until they are placed in the pouch and then released into that extended position to perform a cutting operation.

Other forms of cutting tools may be used to increase the terminal orifice size in saturated pouches. For example, the pouch may be incised with a laser directed to the wall of the pouch, or with a jet of chemical selected to melt part of the pouch and to withstand the gastric mucosa and the patient well. May be good. In one embodiment, the pouch may be formed from a material that is not affected by the chemical and the pouch may have a cuff that is easily dissolved by the chemical. If the need to increase the orifice size arises, direct the chemical towards the cuff.

As another example, a cutting device similar to an aortic perforator used in cardiovascular procedures may be used to enlarge the terminal orifice of the saturated pouch. With reference to FIGS. 19A and 19B, the drilling device 138 includes a hollow elongated shaft 140 fluidly connected to the absorption port 142. A rod 144 extends through a shaft 140, which supports a perforated tip 146. The actuator 150 connected to the rod 144 moves the perforated tip 146 closer to and further from the end of the shaft 140.

During use, the instrument passes through the perforation and the perforation tip 146 extends from the terminal orifice of the pouch. The shaft 140 moves laterally so that a portion of the pouch surrounding the terminal orifice is trapped between the perforated tip 146 and the perimeter of the shaft 140. The cutting edge 148 slices the supplemented portion of the pouch by the user manipulating the actuator 150 to pull the perforation tip 146 towards the proximal end. When suction is applied to the suction port 142, the removed fragments of the pouch are removed from the operation side. This process is repeated until the terminal orifice is increased to the desired size.

Explaining the Use of Cutting Tools These tools cut along the circumference of the pouch so that the pouch has an increased end orifice size by simply forming a vertical notch close to its end. It may be.

Various embodiments of saturation devices and methods for expanding outlet orifices have been described herein. These examples are given by way of example and are not intended to limit the object of the present invention. Furthermore, it should be noted that the various features of the embodiments described above can be combined with a number of techniques for making a number of additional embodiments. Moreover, although various materials, dimensions, shapes, implant positions and the like have been described with reference to the disclosed examples, those other than those disclosed can also be used without exceeding the gist of the present invention. Finally, although the pouch was described for use in regulating the sensation of hunger, the shielding device described herein is similarly suitable for other artificial organs that can be placed within the body, which is the stomach. Includes artificial valves implanted in the lower esophagus or gastric base for the preparation of gastro-esophageal reflux disease (GERD).

<figref num="1A">FIG. 1A is a schematic view of the human stomach and part of the small intestine.</figref><figref num="1B">FIG. 1B is a perspective view showing the saturated pouch located in the stomach.</figref><figref num="2A">FIG. 2A is a perspective view of a first embodiment of a saturated pouch containing a set of end inserts, each with a different end orifice size.</figref><figref num="2B">FIG. 2B is a perspective view of the saturated pouch of FIG. 2A having one of the terminal inserts connected to the pouch.</figref><figref num="3A">FIG. 3A is a side sectional view of the pouch of FIG. 2A.</figref><figref num="3B">FIG. 3B is a side sectional view of one of the terminal inserts of FIG. 2A.</figref><figref num="3C">FIG. 3C is a side sectional view showing the end portion of the pouch of FIG. 3A with the insert of FIG. 3B attached to the pouch.</figref><figref num="4A">FIG. 4A is a perspective view of a second embodiment of the saturated pouch shown with a device that increases or decreases the orifice diameter.</figref><figref num="4B">FIG. 4B is a perspective view of the pouch of FIG. 4A showing an expander used to increase the orifice size.</figref><figref num="4C">FIG. 4C is a perspective view of the pouch of FIG. 4A showing a reduction tool used to reduce the orifice size.</figref><figref num="5A">FIG. 5A is a perspective view of a third embodiment of the saturated device.</figref><figref num="5B">FIG. 5B is a perspective view of a fourth embodiment of the saturated device.</figref><figref num="6A">FIG. 6A is a vertical front view of a fifth embodiment of a saturated pouch having an alternative form of adjustable end opening.</figref><figref num="6B">FIG. 6B is a top plan view of the adjustable limiting ring of the pouch of FIG. 6A.</figref><figref num="7">FIG. 7 is a vertical side view of a sixth embodiment of a saturated pouch having other forms of adjustable end openings and tools that can be used to adjust the end openings.</figref><figref num="8A">FIG. 8A is a vertical side view showing the end of the tool shown in FIG. 7 in a degenerate position.</figref><figref num="8B">FIG. 8B is a vertical side view showing the end of the tool shown in FIG. 7 in the extended position.</figref><figref num="9A">FIG. 9A is a top plan view of the adjustable limiting ring of the pouch of FIG. 33 showing the ring in the expanded state.</figref><figref num="9B">FIG. 9B is a top plan view of the adjustable limiting ring of the pouch of FIG. 33 showing a degenerate ring.</figref><figref num="10">FIG. 10 is a perspective view showing a seventh embodiment of the saturation device along with the tools used to change the diameter of the terminal orifice.</figref><figref num="11">FIG. 11 is a perspective view of an eighth embodiment of the saturated device.</figref><figref num="12A">FIG. 12A is a perspective view of a ninth embodiment of the saturated device.</figref><figref num="12B">FIG. 12B is a perspective view of a ninth embodiment of the saturated device.</figref><figref num="13">FIG. 13 is a perspective view of a tenth embodiment of the saturated device.</figref><figref num="14A">FIG. 14A is a lower elevation view of the eleventh embodiment of the saturation device, showing the terminal orifice in reduced diameter form.</figref><figref num="14B">FIG. 14B is a lower elevation view of the eleventh embodiment of the saturation device, showing the terminal orifice in expanded diameter form.</figref><figref num="15A">FIG. 15A is a perspective view of a twelfth embodiment of the saturated device.</figref><figref num="15B">FIG. 15B is a perspective view of a twelfth embodiment of the saturation device, showing a pouch after reducing the size of the terminal orifice.</figref><figref num="16">FIG. 16 is a perspective view showing the terminal orifice of a saturated pouch that is expanded with various cutting tools.</figref><figref num="17">FIG. 17 is a perspective view showing the terminal orifice of a saturated pouch that is expanded using various cutting tools.</figref><figref num="18">FIG. 18 is a perspective view showing the terminal orifice of a saturated pouch that is expanded using various cutting tools.</figref><figref num="19A">FIG. 19A is a vertical side view of a cutting tool that extends the terminal orifice size of a saturated pouch.</figref><figref num="19B">FIG. 19B is an enlarged view of the area within the circle 19B-19B in FIG. 19A.</figref><figref num="20A">FIG. 20A is a cross-sectional perspective view of a saturated pouch with an adjustable orifice size.</figref><figref num="20B">FIG. 20B is a partially broken side perspective view of the pouch of FIG. 20A, which illustrates the adjustment of the orifice size.</figref>