WO2025128141A1

WO2025128141A1 - System and device for a self-adjusting gastric band having a compliant reservoir

Info

Publication number: WO2025128141A1
Application number: PCT/US2024/016467
Authority: WO
Inventors: Janel A. Birk
Original assignee: Reshape Lifesciences Inc
Current assignee: Vyome Holdings Inc
Priority date: 2023-12-13
Filing date: 2024-02-20
Publication date: 2025-06-19
Anticipated expiration: 2026-06-13

Abstract

Methods, systems, and devices for a compliant tube system for use with a gastric band. The compliant tube system may include a first compliant reservoir configured to receive fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band. The first compliant reservoir may have a first end and a second end opposite the first end. The first compliant reservoir may further have a central inner fluid channel between the first end and the second end. The compliant tube system may be configured such that when a positive pressure is applied to a stoma created by the gastric band the fluid may flow from the gastric band and pass into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

Description

SYSTEM AND DEVICE FOR A SELF-ADJUSTING GASTRIC BAND HAVING A COMPLIANT RESERVOIR

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit and priority of United States Provisional Application Serial Number 63/609,574, filed December 13, 2023, entitled “SYSTEM AND DEVICE FOR A SELF-ADJUSTING GASTRIC BAND HAVING A COMPLIANT RESERVOIR,” the contents of which are herein incorporated by reference in its entirety.

BACKGROUND

[0002] 1. Field

[0003] This application relates to systems, devices, and methods for a self-adjusting gastric band having a compliant reservoir.

[0004] 2. Description of Related Art

[0005] Gastric band systems may control satiety levels for a patient by creating a constriction around a portion of the patient’s stomach. Some gastric band systems are adjustable through an access port and an access port needle, that allows a physician to add or remove fluid from the system to control the amount of constriction. If the level of pressure created by the gastric band is too high, the patient will feel some discomfort while eating since large and/or firm pieces of food will not be able to pass the constriction caused by the gastric band. However, a pressure that is too low (i.e., the gastric band is too loose around the patient’s stomach) will result in low satiety levels for the patient and cause hunger and overeating. Even if the constriction caused by the gastric band is appropriate and provides satiety, there may be times when the patient swallows a large bolus of food that is firm, such as steak, and is not fully chewed. In this event, the large bolus of food may not be able to pass the constriction. Therefore, the patient will likely experience discomfort as peristaltic forces increase trying to push the food through the gastric band or the patient may regurgitate the food back up.

[0006] Accordingly, there is a need for systems, methods, and devices for a self-adjusting gastric band.

SUMMARY

[0007] In general, one aspect of the subject matter described in this disclosure may be embodied in a compliant tube system for use with a gastric band. The compliant tube system may include a first compliant reservoir configured to receive fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band. The first compliant reservoir may have a first end and a second end opposite the first end. The first end may be configured to connect to a first tube and the second end may be configured to connect to a second tube. The first compliant reservoir may further have a central inner fluid channel between the first end and the second end. The compliant tube system may be configured such that when a positive pressure is applied to a stoma created by the gastric band the fluid may flow from the gastric band and pass into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

[0008] In another aspect, the subject matter described in this disclosure may be embodied in a compliant reservoir for a self-adjusting gastric band. The compliant reservoir may include a central tube configured to hold fluid. The central tube may have a first end and a second end opposite the first end, with the first end configured to connect to a first tube and the second end configured to connect to a second tube. The central tube may further include an inner surface between the first end and the second end, with the inner surface being defined by a central passageway with at least three channels extending from the central passageway for the passage of the fluid. The central tube may further include an outer surface having at least three elongated convex sections and an elongated concave section formed between adjacent convex sections. The elongated concave sections may be expandable outward when the central passageway receives the fluid and the fluid exerts an amount of pressure on the inner surface of the central tube.

[0009] In another aspect, the subject matter described in this disclosure may be embodied in a compliant gastric band system. The compliant gastric band system may include a gastric band configured to be placed around a portion of a patient’s stomach and form a stoma. The compliant gastric band system may further include a first tube connected to the gastric band. The compliant gastric band system may further include a first compliant reservoir configured to receive fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band. The compliant reservoir may have a first end connected to the first tube and a second end opposite the first end. The compliant reservoir may further have a central inner fluid channel between the first end and the second end. The compliant gastric band system may be configured such that when a positive pressure is applied to a stoma created by the gastric band the fluid may flow from the gastric band and pass into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Other systems, methods, features, and advantages of the present disclosure will be apparent to one skilled in the art upon examination of the following figures and detailed description. Component parts shown in the drawings are not necessarily to scale and may be exaggerated to better illustrate the important features of the present disclosure. In the drawings, like reference numerals designate like parts throughout the different views.

[0011] FIG. 1 A is a perspective view of an example self-adjusting (or compliant) gastric band system including a gastric band, a subcutaneous access port, and a compliant tube system according to an aspect of the disclosure.

[0012] FIG. IB is a perspective view of an example self-adjusting (or compliant) gastric band system including a gastric band, a subcutaneous access port, and a compliant tube system according to an aspect of the disclosure.

[0013] FIG. 1 C is a perspective view of an example self-adjusting (or compliant) gastric band system including a gastric band, a subcutaneous access port, and a compliant tube system according to an aspect of the disclosure. [0014] FIG. 2 is a perspective view of an example compliant (or flexible) tube system that includes a first compliant reservoir and a second compliant reservoir according to an aspect of the disclosure.

[0015] FIG. 3 is a schematic sectional view of a portion of the second compliant reservoir of FIG. 2 according to an aspect of the disclosure.

[0016] FIG. 4 is a schematic sectional view of a portion of the second compliant reservoir of FIG. 3 according to an aspect of the disclosure.

[0017] FIG. 5A is a schematic cross-sectional view of a portion of the second compliant reservoir of FIG. 2 in an unexpanded state according to an aspect of the disclosure.

[0018] FIG. 5B is a schematic cross-sectional view of a portion of the second compliant reservoir of FIG. 2 in an expanded state according to an aspect of the disclosure.

[0019] FIG. 6 is an example graph illustrating different gastric band system designs (or previous Lap-Band designs) having different pressure profiles and different maximum fluid fill volumes (MFFVs) according to an aspect of the disclosure.

[0020] FIG. 7 is an example graph illustrating how the example compliant tube system of FIG. 2 lowers an internal system pressure (or intraband pressure) response associated with a large, firm food bolus passing through a constriction created by a gastric band according to an aspect of the disclosure.

[0021] FIGS. 8A and 8B are example graphs illustrating the intraband pressure response of an example gastric band system, the Lap-Band AP Small (APS), and an example self-adjusting gastric band system, the Lap-Band APS with compliant tube system (w/CTS), in a simulated solid food swallowing test at different fluid fill volumes according to an aspect of the disclosure.

[0022] FIG. 9 is an example graph illustrating how examples of self-adjusting gastric band systems, the Lap-Band APS w/CTS and AP Large (APL) w/CTS, are able to maintain the same range of band stomas as gastric band systems that do not include the compliant tube system according to an aspect of the disclosure. DETAILED DESCRIPTION

[0023] Disclosed herein are systems, methods, and devices for a self-adjusting gastric band system that provides a more consistent and appropriate level of pressure around a patient’s stomach and that can adapt to pressure from peristalsis. A gastric band, such as the Lap-Band®, is placed around the upper stomach to cause a constnction and apply compression to the stomach. The bands inner diameter or stoma can be adjusted by adding and removing fluid from the system. The self-adjusting gastric band system allows the gastric band to temporarily dilate the stoma to reduce the constriction around the stomach to allow large, firm and/or unchewed pieces of food to more easily pass through the patient’s gastric band. Without the self-adjustment, large boluses could become lodged at the level of the gastric band and cause discomfort to the patient or cause the patient to regurgitate the bolus back up. The self-adjusting gastric band also allows the fluid to return to the gastric band quickly and safely to return the system to its original pressure prior to the large bolus event.

[0024] FIGS. 1A, IB, and 1C illustrate a self-adjusting (or compliant) gastric band system 100a, a self-adj usting (or compliant) gastric band system 100b, and a self-adjusting (or compliant) gastric band system 100c, respectively. The self-adjusting gastric band system 100a, the self- adjusting gastric band system 100b, and the self-adjusting gastric band system 100c include a compliant tube system 102a, a compliant tube system 102b, and a compliant tube system 102c, respectively. The self-adjusting gastric band systems lOOa-c further include a gastric band 103 and a subcutaneous access port 101. The gastric band 103 is fluidly coupled to the subcutaneous access port 101 via the compliant tube system 102a-c. The gastric band 103 may include a circular ring 104 and/or an inflatable portion 105.

[0025] The ring 104 may be located at least partially or completely within the inflatable portion 105 and/or may be coupled to an outer surface of the inflatable portion 105. The ring 104 may provide structure and support to the inflatable portion 105 and facilitate implanting the gastric band 103 around the patient’s stomach. The ring 104 may be made from and/or of the same material as the inflatable portion 105 and may be a unitary piece or integrated with the inflatable portion 105. For example, the ring 104 may be a thicker portion that is integrated into an outer portion of the inflatable portion 105. The ring 104 may include internal wires or be made of a flexible, harder plastic or rubber material to provide structural support. Alternatively, the gastric band 103 may not include the ring 104 and instead include an alternative inflatable portion or an outer shell portion that may be made of a more rigid material, may include internal and/or external stiffening structures such as ribs and/or wires, and/or may include more or thicker material than the inflatable portion 105 to form a more rigid structure such that the ring 104 is not needed.

[0026] The inflatable portion 105 may be fluidly coupled to the compliant tube system 102a- c and/or the subcutaneous access port 101 and may be filled and drained with afluid (e.g., a saline solution) via the compliant tube system 102a-c. For example, the compliant tube system 102a-c may be fluidly coupled to the subcutaneous access port 101 for filling and draining the inflatable portion 105 via subcutaneous injections. The compliant tube system 102a-c may be in-line with and fluidly between the inflatable portion 105 and the subcutaneous access port 101. The inflatable portion 105 is configured to create a constriction around a portion of the patient's stomach. When more fluid is introduced in the inflatable portion 105, the constriction around the stomach generally becomes tighter. Correspondingly, when less fluid is present, the constriction loosens and/or opens up.

[0027] The subcutaneous access port 101 may be sutured onto a rectus muscle sheath or any other accessible muscle of the patient. The rectus muscle sheath provides a secure surface on which to attach the subcutaneous access port 101.

[0028] The compliant tube system 102a-c is fluidly coupled to the subcutaneous access port

101 and/or the inflatable portion 105 of the gastric band 103 and is configured to receive, hold, and/or expel fluid to facilitate automatic adjustment of the inflatable portion 105, and the constriction around the patient’s stomach that the inflatable portion 105 causes, when a large bolus attempts to pass through the constriction. As the gastric band 103 is adjusted to add fluid to the inflatable portion 105 to reach satiety for the patient, fluid will also pass into the compliant tube system 102a-c and be held there. When a large bolus attempts to pass through the top portion of the stomach and the gastric band 103, the bolus of food exerts pressure on the inflatable portion 105 and causes fluid to pass from the inflatable portion 105 into the compliant tube system 102a- c (e.g., into one or more compliant reservoirs). That is. the compliant tube system 102a-c may receive and temporarily hold fluid from the inflatable portion 105 by expanding to relieve the constriction of the inflatable portion 105 when the large bolus passes through the constriction and may expel the fluid back to the inflatable portion 105 after the large bolus has passed to return to the original pressure around the stomach.

[0029] FIG. 2 illustrates an example of a compliant (or flexible) tube system 200 that includes a first compliant reservoir 201 and/or a second compliant reservoir 202. With combined reference to FIGS. 1A-1C and 2, the first compliant reservoir 201 and/or the second compliant reservoir 202 can each be fluidly coupled and/or connected to a first tubing section 220, a second tubing section 222. and/or a third tubing section 224. The compliant tube system 200 may act as the compliant tube system 102a-c in the self-adjusting gastric band systems lOOa-c of FIGS. 1A-1C. In an example, the compliant tube system 200 may include only one compliant reservoir and one or more (e.g., two) tubing sections (as shown in FIG. 1A). In an example, the compliant tube system 200 may include two compliant reservoirs and one or more (e.g., three) tubing sections (as shown in FIGS. IB and 2). In another example, the compliant tube system 200 includes three or more compliant reservoirs and four or more tubing sections.

[0030] The first tubing section 220 may include a first end portion 210 configured to couple to the gastric band 103 and a second end portion 211 opposite the first end portion 210. The second tubing section 222 may include a first end portion 212 and a second end portion 213 opposite the first end portion 212. The third tubing section 224 may include a first end portion

214 and a second end portion 215 opposite the first end portion 214, the second end portion 215 is configured to couple to the subcutaneous access port 101. The tubing sections 220, 222, and 224 are configured to receive, carry, and/or provide the fluid from/to the subcutaneous access port 101, the first compliant reservoir 201, the second compliant reservoir 202, and/or the gastric band 103. The second tubing section 222 fluidly couples the first compliant reservoir 201 to the second compliant reservoir 202 and may be 0.5-10 inches in length, with a preferred length being about 2 inches to maintain a compact size but being long enough to prevent the second tubing section 222 from kinking and restricting fluid flow when the compliant tube system 200 is bent. [0031] The compliant reservoirs 201 and 202 may be (or include) an extruded tube (or central tube) defining an outer circumference and having a length of between about 1.5-2.5 inches and a maximum diameter of about 0.2-0.5 inches and a preferred length and maximum diameter of about 2.05 inches and 0.35 inches, respectively, in a natural (or unexpanded) state to maintain a low profile to facilitate implanting of the compliant tube system 200 while maintaining an optimal fluid capacity.

[0032] The first compliant reservoir 201 includes a first end portion 205 and a second end portion 206 opposite the first end portion 205. The first end portion 205 of the first compliant reservoir 201 couples to the second end portion 211 of the first tubing section 220. The second end portion 206 of the first compliant reservoir 201 couples to the first end portion 212 of the second tubing section 222. The second compliant reservoir 202 includes a first end portion 225 and a second end portion 226 opposite the first end portion 225. The first end portion 225 of the second compliant reservoir 202 couples to the second end portion 213 of the second tubing section 222. The second end portion 226 of the second compliant reservoir 202 couples to the first end portion 214 of the third tubing section 224.

[0033] FIG. 3 illustrates a sectional view of the second compliant reservoir 202 and FIG. 4 illustrates a portion of FIG. 3. With combined reference to FIGS. 2-4, in examples, the first compliant reservoir 201 may include all of the features of the second compliant reservoir 202. In other examples, the first compliant reservoir 201 may include some of the features of the second compliant reservoir 202. The first end portion 205 and the second end portion 206 of the first compliant reservoir 201 may include a first cavity and a second cavity, respectively, with the first cavity configured to receive the second end portion 211 of the first tubing section 220 and the second cavity configured to receive the first end portion 212 of the second tubing section 222. The first end portion 225 and the second end portion 226 of the second compliant reservoir 202 may include a first cavity 301 and a second cavity 302, respectively, with the first cavity 301 configured to receive the second end portion 213 of the second tubing section 222 and the second cavity 302 configured to receive the first end portion 214 of the third tubing section 224. The cavities of the first compliant reservoir 201 and the cavities 301 and 302 of the second compliant reservoir 202 may each measure about 0.1 -0.2 inches in length with a diameter of about 0. 1-0.2 inches, with a preferred length and diameter of about 0. 175 inches and 0. 135 inches, respectively, to securely couple and prevent kinking of the tubing sections 220, 222, and 224 and to create a passageway for the fluid that is large enough to allow fluid to easily flow therethrough.

[0034] The first end portions 205 and 225 of the compliant reserv oirs 201 and 202 and the second end portions 206 and 226 of the compliant reservoirs 201 and 202 may each have a tapered surface. For example, a first diameter (or width) 402 of the second compliant reservoir 202 may gradually reduce down to a second diameter 403 of the second compliant reservoir 202. In examples, an edge of the first end portion 205 and an edge of the second end portion 206 of the first compliant reservoir 201, and an edge of the first end portion 225 and an edge 404 of the second end portion 226 of the second compliant reservoir 202 may each have about 25-45 degree and 0.005-0.015 inches deep chamfers, with the preferred chamfers being about 30 degrees and about 0.01 inches deep, with the tapered surfaces and the chamfered edges having the benefit of (1) preventing the tubing sections 220, 222, and 224 from kinking and restricting fluid flow when the compliant tube system 200 is bent, (2) facilitating insertion into the patient, and (3) reducing the potential to cause a foreign body response with a smooth tapered surface that will not abrade tissue. [0035] Referencing FIGS. 2-4, 5 A, and 5B, the compliant reservoirs 201 and 202 may further include one or more raised edges 208 running a first length 230 and one or more valleys 207 running a second length 232. The one or more raised edges 208 may be (or form) one or more elongated convex sections along the first length 230. The one or more valleys 207 may be (or form) one or more elongated concave sections between the one or more raised edges 208. The first length 230 and the second length 232 may be over half the length of the compliant reservoirs 201 and 202 with the first length 230 being less than the second length 232 because a taper transitions the ends 205, 206, 213 and 214 to facilitate implanting the compliant tube system 200 and to prevent the patient’s body from rejecting the compliant tube system 200 due to friction and irritation by a sharper transition. The one or more raised edges 208 may be parallel with, and alternate with, the one or more valleys 207 on an outer surface 240 of the compliant reservoirs 201 and 202 such that the one or more raised edges 208 are each adjacent to two valleys 207. The compliant reservoirs 201 and 202 may preferably include five raised edges 208 and five valleys 207 and may have a cross section similar in appearance to a pentagon having smooth points and sides that slope inward, as shown in FIG. 5A, to facilitate the ability of the compliant reservoirs 201 and 202 to rapidly intake fluid from and expel fluid to the gastric band 103 when the large bolus passes through the constriction (e.g., intake fluid and expel the fluid back to the gastric band 103 rapidly in less than 5 seconds or in less than 2 seconds).

[0036] FIB. 5A illustrates a cross-section of the second compliant reservoir 202 with the second compliant reservoir being in an unexpanded (or natural) state (i.e., there is no fluid and/or not enough fluid to generate enough pressure within the second compliant reservoir 202 to cause the second compliant reservoir 202 to expand). FIB. 5B illustrates a cross-section of the second compliant reservoir 202 with the second compliant reserv oir 202 being in an expanded (or filled) state. The first compliant reservoir 201 may have a similar and/or the same cross-section as the second compliant reservoir 202. As shown by FIG. 5B, in operation, the compliant reservoirs

201 and 202 may expand with fluid by the one or more valleys 207 and the one or more raised edges 208 deforming, thereby changing the appearance of the outer perimeter and the maximum diameter of the compliant reservoirs 201 and 202. When the one or more valleys 207 deform and the compliant reservoirs 201 and 202 fill and expand with fluid, the one or more valleys 207 may change in shape from being concave to being flat or convex, and may increase the fluid capacity of the compliant reservoirs 201 and 202. In examples, when the compliant reservoirs 201 and 202 are in the expanded state, the outer surface 240 may become more circular in the cross sectional view as shown in FIG. 5B. In examples, the maximum diameter of the compliant reservoirs 201 and 202 in the expanded state may be l. lx-2x the maximum diameter of the compliant reservoirs 201 and 202 in the unexpanded state.

[0037] The compliant reservoirs 201 and 202 may include a central chamber/passageway (or central inner fluid channel) 509 with a diameter 510 of about 0.05-0.2 inches and a length of about 1-2 inches, with a preferred diameter and length being about 0.1 inches and 2.0 inches, respectively, to optimize size, weight, rate of pressure change, and fluid capacity of the compliant reservoirs 201 and 202.

[0038] The compliant reservoirs 201 and 202 may include the outer surface 240 and an inner surface 504 defining a wall 501 with varying thicknesses. For example, the inner surface 504 may extend between the first end portion 225 and the second end portion 226 of the second compliant reserv oir 202. The compliant reservoirs 201 and 202 may further include one or more channels (or outer channels) 401 having a width 512a (in the unexpanded state) of about 0.02- 0.04 inches, a variable w idth 512b (in the expanded state) that is greater than the width 512a, and a preferred width 512a of about 0.03 inches. The one or more channels 401 may extend substantially the length of the central chamber 509 of the compliant reservoirs 201 and 202. The one or more channels 401 may extend from and along the central chamber 509. The compliant reservoirs 201 and 202 preferably contain five channels 401 to optimize the fluid requirements (i.e., amount of fluid required to expand) of the compliant reservoirs 201 and 202 and to increase the speed of expansion of the compliant resen' oirs 201 and 202 when a large bolus passes through the constriction thereby expelling fluid from the gastric band 103 and into the compliant reservoirs 201 and 202 with the compliant reservoirs 201 and 202 expanding to receive the fluid. The central chamber 509 and the one or more channels 401 may combine to form a star shaped chamber within the compliant reservoirs 201 and 202. The star shape, created by the central chamber 509 and the one or more channels 401, as compared to other cross-sectional profiles allows a reduced amount of fluid to expand the complaint tube system 200 which also reduces the overall profile and subsequent weight of the device when expanded. The one or more channels 401 may extend from the central chamber 509 and may be equally spaced apart. The one or more channels 401 may be situated within the compliant reservoirs 201 and 202 such that a maximum wall thickness 505 is at a center of each of the one or more valleys 207 and a minimum wall thickness 506 is at a center of each of the one or more raised edges 208. The minimum wall thickness 506 being about 0.015-0.035 inches and the maximum wall thickness 505 being about 0.05-0.15 inches, with a preferred minimum wall thickness and maximum wall thickness being about 0.025 inches and about 0.07-0.115 inches, respectively, to increase the speed at which the compliant reservoirs 201 and 202 intake fluid from and expel fluid to the gastric band 103 when a large bolus passes through the constriction. For example, thin sections of the wall 501 near the one or more raised edges 208 increases the compliance of the compliant reservoirs 201 and 202 and thus increases the speed at which the compliant reservoirs 201 and 202 expand with fluid from the gastric band 103, while thick sections of the wall 501 near the one or more valleys 207 increases the rigidity of the compliant reservoirs 201 and 202 and thus increases the speed at which the compliant reservoirs 201 and 202 return to their original shape thereby returning the fluid to the gastric band 103. Thus, the combination of the thin and thick sections of the wall 501 may result in the compliant reservoirs 201 and 202 having a sensitive spring action, meaning that the compliant reservoirs 201 and 202 are compliant but also spring back to their original shape quickly.

[0039] Elastomeric materials may be used to construct the compliant reservoirs 201 and 202 which also aids in the spring action to allow the expansion and contraction of the compliant reservoirs 201 and 202. In examples, the compliant reservoirs 201 and 202 may be made of a variety of elastomeric materials, with silicone being the preferred material. In addition, the thickness of the wall 501 as described herein in combination with the one or more valleys 207 and the one or more raised edges 208 has the benefit of increasing the resistance of the compliant reservoirs 201 and 202 from kinking. When filled with positive fluid pressure, this pressure also reduces the potential of the compliant reservoirs 201 and 202 from kinking. The central chamber 509 and the one or more channels 401 combining to form a star shaped chamber within the compliant reservoirs 201 and 202 creates a geometric shape that, in the event that the compliant reservoirs 201 and 202 are folded onto themselves, would prevent a complete obstruction of fluid flow by having channels in different planes from the bend plane to allow fluid to continue to flow. [0040] FIG. 6 illustrates different gastric band system designs (or other Lap-Band designs) having different pressure profiles and different maximum fluid fill volumes (MFFVs). All pressures shown in FIG. 6 represent the internal system pressure or intraband pressure. FIG. 6 shows how the different designs increase in internal pressure at different rates when fluid is added to the gastric band systems. This is particularly true with the addition of the compliant tube system 200 (shown in FIG. 6 as “w/CTS” or “w/ compliant tube system”). As can be seen in FIG. 6, the pressure curve of APS as compared to the pressure curve of APS w/CTS has a lower maximum pressure and the increase in pressure per unit of fill volume is less. The rate of change of pressure for the gastric band system with the complaint tube system 200 is more gradual than without the compliant tube system 200. FIG. 6 demonstrates how it is advantageous to include the compliant tube system 200 to reduce the overall pressure, give a greater MFFV, and to allow greater adjustability' with gastric band adjustments with having a finer resolution of pressure increase between adjustments of volume. For example, a gastric band system with a noncompliant design, a low MFFV and no compliant tube system 200 (e.g., the 4 cc MFFV of the Lap-Band 9.75 and 10.0 gastric band systems in FIG. 6) wi 11 have a higher overall pressure and a faster rate of change of pressure per fill volume unit than the other gastric band systems with a more compliant design and higher MFFV (e.g., the 10 cc and the 14 cc MFFVs of the Lap- Band APS and APL gastric band systems, respectively, in FIG. 6). The less compliant gastric band system designs will make passing a large, unchewed, and/or firm boluses of food through the gastric band very uncomfortable or in some cases impossible for the patient. In addition, self- adjusting gastric band systems (e.g.. the Lap-Band APS w/CTS and APL w/CTS in FIG. 6) having the compliant tube system 200 have even lower pressure and a more gradual rate of pressure changes per fill volume than the APS and APL gastric band systems that do not have the compliant tube system 200. This demonstrates that the compliant tube system 200 increases the compliance of the system, and increases the MFFV from 10 cc to 13 cc for the APS gastric band system and from 14 cc to 20 cc for the APL gastric band system. However, size and weight concerns restrict the amount of fluid that can be contained within the self-adjusting gastric band systems. A self-adjusting gastric band system having a compliant tube system 200 with two compliant reservoirs 201 and 202 each having five channels 401, five raised edges 208, and/or five valleys 207 with the preferred dimensions disclosed above provides the optimal size, weight, fluid capacity relationship, and fluid dynamics.

[0041] FIG. 7 illustrates how the compliant tube system 200 lowers the internal system pressure (or intraband pressure) response associated with a large, firm food bolus passing through the constriction created by a gastric band. In FIG. 7, an example gastric band system, the Lap- Band APS, and an example self-adjusting gastric band system with the compliant tube system 200, the Lap-Band APS w/CTS, are locked around an inflatable tube which is expanded at two specific pressures, Pl and P2, to replicate bolus passage and then the intraband pressures of the two gastric band systems are monitored over time during the expansion. This testing is repeated at incrementally increasing fill volumes shown as 4cc, 5cc, 6cc, etc. As shown in FIG. 7, the pressure wave shows an increase of the intraband pressure when the inflatable tube is expanded and that when the expansion is removed, the pressure returns to the baseline pressure prior to the expansion. As shown in FIG. 7, the Lap-Band APS demonstrated a 22 mmHg increase when the inflatable tube expanded with a pressure increase Pl, and a 33 mmHg increase when the inflatable tube expanded with a pressure increase P2. In contrast, the Lap-Band APS w/CTS demonstrated a 7 mmHg increase when the inflatable tube expanded with the pressure increase Pl, and a 12 mmHg increase when the inflatable tube expanded with the pressure increase P2. This demonstrates that pressure response wave is reduced in the system with the compliant tube system 200.

[0042] In addition, FIG. 7 demonstrates the speed at which the compliant tube system 200 responds to the large bolus passing through the gastric band constriction by receiving fluid from the gastric band and then returning the fluid to the gastric band. For example, each of the pressure increases of 7 mmHg and 12 mmHg rapidly returned to baseline pressure in less than 5 seconds, or less than 2 seconds after the external pressure increase Pl and P2 was removed from the band stoma. The rapid change occurred with the disclosed preferred dimensions and/or quantities of the one or more channels 401, the one or more valleys 207, the wall 501, the one or more raised edges 208, and/or other features of the compliant reservoirs 201 and 202 as discussed above. Faster response speeds will increase patient comfort by allowing the bolus to pass more easily and quickly. Faster response speeds will allow the gastric band to modulate stomach contact pressure to maintain a satiety response.

[0043] FIGS. 8A and 8B illustrate the intraband pressure response of an example gastric band system, the Lap-Band APS, and an example self-adjusting gastric band system, the Lap-Band APS w/CTS, in a simulated solid food swallow test at different fluid fill volumes. In the test, internal system pressure or intraband pressure increases (shown in FIG. 8A) and the axial force (shown in FIG. 8B) required to propel solid food (simulated by solid stainless-steel balls measuring from 13 mm to 25 mm in diameter, in 1 mm increments) through the gastric band systems are measured over time. This test was performed for the same gastric band system with and without the compliant tube system 200. Lap-Band APS represents the system without the compliant tube system 200, and Lap-Band APS w/CTS represents the system with the compliant tube system 200. As shown in FIG. 8A, the maximum intraband pressure increase of approximately 200 mmHg of the Lap-Band APS is substantially higher than the approximate 47 mmHg pressure increase of the Lap-Band APS w/CTS for the maximum system fill volume and the largest stainless steel ball of 25 mm in diameter. As shown in FIG. 8B, the axial force required to force one or more balls through the band stoma is much lower with the Lap-Band APS w/CTS than the Lap-Band APS, demonstrating the reduction in resistance to allow the ball to pass. In FIG. 8A, it is of particular interest to note that the pressure response or pressure spike is rapid, and that the intraband pressure quickly returns to baseline after the solid food, in the form of a stainless-steel ball, has passed. In the bottom graph in FIG. 8A, the pressure spike is rapid and less than 5 seconds or 2 seconds or less showing that the intraband system response of the gastric band system with the compliant tube system 200 is rapid which incurs the benefits of a rapid system as previously discussed.

[0044] FIG. 9 illustrates an example of how the self-adjusting gastric band systems, the Lap- Band APS w/CTS and APL w/CTS, are able to maintain the same range of band stomas while having the advantages discussed above. Although the compliant tube system 200 of the Lap- Band APS w/CTS and APL w/CTS can modulate the band stoma during the swallowing of a large bolus of solid food as discussed above, the Lap-Band APS w/CTS and APL w/CTS are still able to achieve the same stoma range or gastric band inner diameter as the Lap-Band APS and APL and thus are able to maintain satiety in the patient.

[0045] Exemplary embodiments of the invention have been disclosed in an illustrative sty le. Accordingly, the terminology employed throughout should be read in a non-limiting manner. Although minor modifications to the teachings herein will occur to those well versed in the art, it shall be understood that what is intended to be circumscribed within the scope of the patent warranted hereon are all such embodiments that reasonably fall within the scope of the advancement to the art hereby contributed, and that that scope shall not be restricted, except in light of the appended claims and their equivalents.

Claims

CLAIMS What is claimed is:

1. A compliant tube system for use with a gastric band comprising: a first compliant reservoir configured to receive fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band, the compliant reservoir having: a first end and a second end opposite the first end. the first end configured to connect to a first tube and the second end configured to connect to a second tube, and a central inner fluid channel between the first end and the second end, wherein when a positive pressure is applied to a stoma created by the gastric band the fluid may flow from the gastric band and pass into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

2. The compliant tube system of claim 1, wherein the first compliant reservoir has at least three outer channels extending from and along the central inner fluid channel.

3. The compliant tube system of claim 2, wherein the at least three outer channels are equally spaced apart.

4. The compliant tube system of claim 2, wherein the first compliant reservoir has: an inner surface defined by the central inner fluid channel and the at least three outer channels; and an outer surface having at least three elongated convex sections and an elongated concave section formed between adjacent convex sections, the elongated concave sections being expandable outward when the first compliant reservoir receives the fluid and the fluid exerts an amount of pressure on the inner surface of the first compliant reservoir.

5. The compliant tube system of claim 4, wherein the first compliant reservoir has a wall defined by an area between the inner surface and the outer surface, with portions of the wall that are between the at least three elongated convex sections and the inner surface having a smaller thickness than portions of the wall that are between the elongated concave sections and the inner surface.

6. The compliant tube system of claim 1, further comprising: the first tube connected to the first end of the first compliant reservoir and configured to connect to the gastric band; the second tube connected to the second end of the first compliant reservoir; a second compliant reservoir connected to the second tube and configured to receive the fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band; and a third tube connected to the second compliant reservoir and configured to connect to an access port.

7. The compliant tube system of claim 6, wherein when the positive pressure is applied to the stoma created by the gastric band the fluid may flow from the gastric band and pass through the first tube into the first compliant reservoir and pass through the second tube into the second compliant reservoir causing the first compliant reservoir and the second compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

8. The compliant tube system of claim 1, wherein when the positive pressure is applied to the stoma created by the gastric band the fluid may flow from the gastric band and pass into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 2 seconds.

9. The compliant tube system of claim 1 , wherein the first end and the second end of the first compliant reservoir have tapered outer surfaces.

10. A compliant reservoir for a self-adjusting gastric band comprising: a central tube configured to hold fluid and having: a first end and a second end opposite the first end. the first end configured to connect to a first tube and the second end configured to connect to a second tube, an inner surface between the first end and the second end, the inner surface being defined by a central passageway with at least three channels extending from the central passageway for the passage of the fluid, and an outer surface having at least three elongated convex sections and an elongated concave section formed between adjacent convex sections, the elongated concave sections being expandable outward when the central passageway receives the fluid and the fluid exerts an amount of pressure on the inner surface of the central tube.

11. The compliant reservoir of claim 10, wherein the central tube has a wall defined by an area between the inner surface and the outer surface, with portions of the wall between the at least three elongated convex sections and the inner surface having a smaller thickness than portions of the wall between the elongated concave sections and the inner surface.

12. The compliant reservoir of claim 10, wherein the at least three channels are equally spaced apart.

13. The compliant reservoir of claim 10, wherein the inner surface is defined by five channels extending from the central passageway for the passage of the fluid.

14. The compliant reservoir of claim 10, wherein the first end and the second end of the central tube have tapered outer surfaces.

15. A compliant gastric band system comprising: a gastric band configured to be placed around a portion of a patient's stomach and form a stoma; a first tube connected to the gastric band; and a first compliant reservoir configured to receive fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band, the compliant reservoir having: a first end connected to the first tube and a second end opposite the first end. and a central inner fluid channel between the first end and the second end, wherein when a positive pressure is applied to the stoma the fluid may flow from the gastric band and pass through the first tube into the first compliant reservoir causing the first compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.

16. The compliant gastric band system of claim 15, wherein the first compliant reservoir has at least three outer channels extending from and along the central inner fluid channel.

17. The compliant gastric band system of claim 16, wherein the first compliant reservoir has: an inner surface defined by the central inner fluid channel and the at least three outer channels; and an outer surface having at least three elongated convex sections and an elongated concave section formed between adjacent convex sections, the elongated concave sections being expandable outward when the first compliant reservoir receives the fluid and the fluid exerts an amount of pressure on the inner surface of the first compliant reservoir.

18. The compliant gastric band system of claim 17, wherein the first compliant reservoir has a wall defined by an area between the inner surface and the outer surface, with portions of the wall that are between the at least three elongated convex sections and the inner surface having a smaller thickness than portions of the wall that are between the elongated concave sections and the inner surface.

19. The compliant gastric band system of claim 15. further comprising: a second tube connected to the second end of the first compliant reservoir; a second compliant reservoir connected to the second tube and configured to receive the fluid from the gastric band, hold the fluid, expand by the fluid, and expel the fluid back to the gastric band; and a third tube connected to the second compliant reservoir and configured to connect to an access port.

20. The compliant gastric band system of claim 19, wherein when the positive pressure is applied to the stoma the fluid may flow from the gastric band and pass through the first tube into the first compliant reservoir and pass through the second tube into the second compliant reservoir causing the first compliant reservoir and the second compliant reservoir to expand temporarily before expelling the fluid back to the gastric band in less than 5 seconds.