WO2013165564A1

WO2013165564A1 - Passive artificial sphincter

Info

Publication number: WO2013165564A1
Application number: PCT/US2013/030361
Authority: WO
Inventors: John R. Frigstad; Amanda J. HEYS; William A. STUROS; Daniel R. PARKS; Natalie A. BORGOS; James R. Mujwid; Benjamin Y. Arcand
Original assignee: Ams Research Corporation
Priority date: 2012-05-04
Filing date: 2013-03-12
Publication date: 2013-11-07

Abstract

Embodiments of a passive artificial sphincter (100) configured for implantation in an individual to assist in occluding a lumen (104) of the individual include a cuff member (102), a reservoir (109) containing fluid, and a passageway (110) fluidically coupling the cuff member to the reservoir. The artificial sphincter has a quiescent state, in which the cuff member is inflated by the fluid pressurized by the reservoir. The artificial sphincter does not include a pump. In a method of selectively occluding a lumen (104) of an individual, a cuff member (102) is implanted around the lumen, and a reservoir (109) is implanted in the individual. Fluid in the reservoir is pressurized using the reservoir. The cuff member is inflated by driving fluid from the reservoir into the cuff member through a passageway (110) in response to the pressurizing of the fluid in the reservoir. The lumen is occluded in response to inflating the cuff member.

Description

PASSIVE ARTIFICIAL SPHINCTER

BACKGROUND

[0001] Artificial sphincters are devices that are implanted in individuals to assist in occluding lumens of the individual to control a flow of material through the lumen. For instance, artificial sphincters have been implanted around the urethra to treat urinary incontinence.

[0002] Conventional artificial sphincters are "active" artificial sphincters that operate to provide a desired constrictive force to occlude a lumen of an individual responsive to input from the individual. Typical active artificial sphincters comprise the cuff, a reservoir, and a pump. The cuff that is wrapped around the lumen, the reservoir is implanted in an abdominal cavity, and the pump is implanted at a location that may be actuated by the individual, such as in the scrotum of the individual. Tubing connects the reservoir, pump and cuff. The reservoir pressurizes fluid in the system and maintains the cuff in an inflated state, in which a constrictive force is applied to the lumen to occlude the lumen. Actuation of the pump drives fluid out of the cuff and back into the reservoir to deflate the cuff. This removes the constrictive force on the lumen and allows the passage of material through the lumen and past the cuff.

[0003] The implantation of such an active artificial sphincter can be quite invasive due to the number and volume of the components. Additionally, the control of the artificial sphincter requires input from the individual, which may be difficult for some individuals.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] FIGS. 1 and 2 are simplified drawings respectively illustrating an artificial sphincter formed in accordance with embodiments of the invention in a closed and open position.

[0005] FIG. 3 is a simplified block diagram of an artificial sphincter in accordance with embodiments of the invention.

[0006] FIG. 4 is a simplified side view of an artificial sphincter in accordance with embodiments of the invention implanted in an individual.

[0007] FIGS. 5 and 6 are simplified top views of an artificial sphincter in accordance with embodiments of the invention in open and closed states, respectively.

[0008] FIGS. 7 and 8 are side cross-sectional views of an artificial sphincter respectively in open and closed states, in accordance with embodiments of the invention. [0009] FIGS. 9 and 10 are cross-sectional views of the artificial sphincter of FIGS. 5 and 6 implanted around a lumen of an individual.

[0010] FIGS. 11 and 12 are charts that illustrate exemplary responses of an artificial sphincter to internal pressure within a lumen of an individual.

[0011] FIG. 13 is a simplified side view of an exemplary valve of a flow restrictor, in accordance with embodiments of the invention.

[0012] FIG. 14 is a simplified front view of an exemplary valve member of FIG. 13 in a closed state.

[0013] FIG. 15 is a simplified side view of the valve of FIG. 13 during a deflation stage.

[0014] FIG. 16 is a simplified front view of a valve member of FIG. 15 in an open state.

[0015] FIGS. 17 and 18 respectively are simplified top views of a cuff member of an artificial sphincter in closed and open states, in accordance with embodiments of the invention.

[0016] FIG. 19 is a simplified side view of a cuff member of an artificial sphincter, in accordance with embodiments of the invention.

SUMMARY

[0017] Embodiments of the invention are directed to a passive artificial sphincter configured for implantation in an individual to assist in occluding a lumen of the individual, and methods of selectively constricting a lumen of an individual using the passive artificial sphincter. In some embodiments, the artificial sphincter comprises a cuff member, a reservoir containing fluid, and a passageway fluidically coupling the cuff member to the reservoir. The artificial sphincter has a quiescent state in which the cuff member is inflated by the fluid, which is pressurized by the reservoir. The artificial sphincter does not include a pump.

[0018] In some embodiments, the cuff member is configured to form a ring. In some embodiments, the reservoir surrounds the cuff member. In some embodiments, the reservoir forms a ring around the cuff member.

[0019] In some embodiments, the reservoir comprises a first bladder positioned adjacent a first side of the cuff member. In some embodiments, the reservoir comprises a second bladder positioned adjacent a second side of the cuff member. In some embodiments, the first and second sides of the cuff member are displaced from each other along a longitudinal axis of the cuff member. [0020] In some embodiments, the artificial sphincter comprises a flow restrictor in line with the passageway. The flow restrictor is configured to restrict a flow through the passageway from the cuff member to the reservoir. In some embodiments, the flow restrictor comprises a first one-way valve configured to restrict a flow of fluid through the passageway from the cuff member to the reservoir.

[0021] In some embodiments, the first one-way valve comprises a housing, a valve member, and a bladder. The valve member is supported by the housing and has an open state, in which a flow of fluid may travel through the passageway from the cuff member to the reservoir, and a closed state, in which fluid flow through the passageway from the cuff member to the reservoir is blocked. The bladder is supported by the housing and has a low pressure state, in which the valve member remains in the closed position, and a high pressure state, in which the bladder drives the valve member to the open state. In some embodiments, the bladder is in fluid communication with the cuff member.

[0022] In some embodiments, the flow restrictor includes a second one-way valve configured to restrict a flow of fluid through the passageway from the reservoir to the cuff member. In some embodiments, the first and second one-way valves comprise a bleed valve.

[0023] In some embodiments, the cuff member comprises a plurality of fluid pockets and tubing fluidically coupling the fluid pockets together. The fluid pockets are configured to inflate with the fluid pressurized by the reservoir.

[0024] In some embodiments, the cuff member comprises a plurality of openings.

[0025] In some embodiments of the method of selectively occluding a lumen of an individual, an artificial sphincter is implanted in the individual by implanting a cuff member around the lumen and implanting a reservoir in the individual. Fluid in the reservoir is pressurized using the reservoir. The cuff member is inflated by driving fluid from the reservoir into the cuff member through a passageway in response to the pressurizing of the fluid in the reservoir. The lumen is then occluded in response to inflating the cuff member.

[0026] In some embodiments, fluid is driven from the cuff member to the reservoir through the passageway in response to an increase in internal pressure within the lumen. The occlusion of the lumen is released in response to driving fluid from the cuff member.

[0027] In some embodiments, flow of fluid from the cuff member to the reservoir is restricted using a flow restrictor.

[0028] In some embodiments, the reservoir is positioned around the lumen. In some embodiments, the reservoir is positioned around the cuff member. [0029] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not indented to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in the Background.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0030] Embodiments of the invention are directed to an artificial sphincter that is configured to passively apply a constrictive force to a lumen of an individual without a control input from the individual, as required by active artificial sphincters. Additionally, embodiments of the artificial sphincter require fewer components to be installed in the individual thereby reducing the invasiveness of the implantation, the complexity of the installation, and the likelihood of component failure. Some applications of the passive artificial sphincter, such as to prevent fecal incontinence, allow the individual to control the artificial sphincter in a natural manner making the implantation highly inconspicuous, as compared to conventional active artificial sphincters.

[0031] Embodiments of the invention are described more fully hereinafter with reference to the accompanying drawings. The various embodiments of the invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Elements that are identified using the same or similar reference characters refer to the same or similar elements.

[0032] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. [0033] It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, if an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present. Embodiments of the invention include both interpretations unless stated otherwise.

[0034] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a first element could be termed a second element without departing from the teachings of the present invention.

[0035] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0036] FIGS. 1 and 2 are simplified diagrams of an artificial sphincter 100 comprising a cuff member 102 that is implanted around a lumen (i.e., a passageway) 104 of an individual. Exemplary embodiments of the lumen 104 include the urethra, the anal canal, the esophagus, a lumen of an ostomy, or other lumen of an individual. In some embodiments, the cuff member 102 may be implanted directly around the lumen 104, such as upstream or downstream of a sphincter muscle (e.g., anal sphincter) controlling flow through the lumen 104. Alternatively, the cuff member 102 may be implanted around a sphincter muscle corresponding to the lumen 104 to reinforce the sphincter muscle and assist in occluding the lumen. Accordingly, embodiments of positioning, placing or implanting the cuff member 102 around a lumen 104 of the individual include the implantation of the cuff member 102 around a sphincter muscle corresponding to the lumen 104.

[0037] The cuff member 102 is configured to apply a constrictive force to the lumen 104 to circumferentially occlude the lumen 104. In some embodiments, the constrictive force applied by the cuff member 102 to the lumen 104 is a substantially uniform force applied around the circumference of the lumen 104. In some embodiments, the constrictive force closes the lumen 104, or assists another sphincter to close the lumen 104, to prevent or reduce the passage of material through the lumen 104 and past the artificial sphincter 100, as shown in FIG. 1. That is, the constrictive force of the cuff member 102 results in the internal diameter 106 of the artificial sphincter 100 and the outer diameter of the lumen 104 to reach a closed state where the lumen 104 is closed or substantially closed to the passage of material through the lumen 104 and past the cuff member 102, as shown in FIG. 1.

[0038] In some embodiments, the cuff member 102 may be transitioned to an open state (FIG. 2), in which material may pass through the lumen 104 and past the artificial sphincter 100. In some embodiments, the cuff member 102 transitions from the closed state to the open state in response to sustained pressure within the lumen 104 on the upstream side 107 of the cuff member 102 relative to the normal flow of material through the lumen represented by arrows 108. This pressure counteracts the constrictive force applied by the artificial sphincter 100 and causes the internal diameter 106 of the cuff member 102 to expand radially, as shown in FIG. 2. This expansion of the cuff member 102 allows material to flow through the lumen 104 and past the cuff member 102, as indicated by arrows 108 in FIG. 2.

[0039] For instance, when the cuff member 102 is implanted around the anal canal of the individual, the cuff member 102 constricts the anal canal, or assists the anal sphincter in constricting the anal canal, under normal abdominal conditions to prevent fecal incontinence, as illustrated in FIG. 1. When the individual wishes to have a bowel movement, the individual increases abdominal pressure in a natural manner to increase the pressure within the lumen 104 on the upstream side 107 of the cuff member 102, which causes the cuff member 102 to radially expand and allow the bowel movement to occur, as shown in FIG. 2.

[0040] In addition to the cuff member 102, some embodiments of the artificial sphincter 100 include a reservoir 109 and a fluid pathway 110, as shown in the simplified block diagram of FIG. 3. In some embodiments, the cuff member 102 is inflated by fluid pressurized by the reservoir 109 to place the artificial sphincter 100 in the closed state and occlude the lumen 104 (FIG. 1). In some embodiments, the material forming the reservoir 109 is flexible and is always in a state of tension, which causes the reservoir 109 to pressurize the fluid in the artificial sphincter 100. That is, the reservoir 109 is expanded like a balloon due to the volume of fluid in the system. Exemplary materials that may be used to form the reservoir include polyethylene, polypropylene, and polyvinyl acetate. The pressurization of the fluid by reservoir 109 biases the cuff member 102 in the inflated state. That is, the quiescent state of the artificial sphincter places the cuff member 102 in the inflated condition due to the pressurization of the fluid by the reservoir 109. Thus, some embodiments of the artificial sphincter 100 do not include a pump for inflating the cuff member 102. [0041] When the lumen 104 needs to open for a material passage, fluid from the cuff member 102 is delivered to the reservoir 109 through the fluid pathway 110 in response to internal pressure within the lumen 104, which overcomes the pressure induced by the reservoir 109. This deflates the cuff member 102, inflates the reservoir 109, and allows the lumen 104 to open, as shown in FIG. 2. When the internal pressure within the lumen 104 is relieved, the inflated reservoir 109 automatically drives fluid back into the cuff member 102 to inflate the cuff member 102 and occlude the lumen 104. Thus, some embodiments of the artificial sphincter do not include a pump for deflating the cuff member 102.

[0042] In some embodiments, the artificial sphincter 100 includes a flow restrictor 112 in line with the fluid pathway 110. In some embodiments, the flow restrictor 112 allows fluid to flow between the cuff member 102 and the reservoir 109. In some embodiments, the flow of fluid between the cuff member 102 and the reservoir 109 is restricted in one or both directions.

[0043] In some embodiments, the reservoir 109 becomes pressurized with the fluid as the cuff member 102 deflates. The pressurization of the reservoir 109 drives the fluid back to the cuff member 102 through the fluid pathway 110 to inflate the cuff member 102 after the pressurization of the lumen 104 is released.

[0044] In some embodiments, the cuff member 102 is implanted around the lumen 104 and the reservoir 109 is implanted nearby, as shown in the simplified side view of FIG. 4.

[0045] In some embodiments, the artificial sphincter is formed as a compact, unitary component, as shown in FIGS. 5 and 6, which are simplified top views of an artificial sphincter 100 respectively in an open state, in which the cuff member 102 is deflated and the reservoir 109 is inflated, and a closed state, in which the cuff member 102 is inflated with fluid from the reservoir. The fluid pathway 110 extends between the cuff member 102 and the reservoir 109. In some embodiments, the reservoir 109 is formed as a second cuff (i.e., ring) around the cuff member 102, as shown in FIGS. 5 and 6. This places the reservoir 109 around the lumen 104 when the artificial sphincter is implanted in an individual.

[0046] In some embodiments, the reservoir 109 may comprise one or more bladders 118 positioned adjacent a side or edge 120 and/or a side or edge 121 of the cuff member 102, as shown in FIGS. 7 and 8, which are simplified side cross-sectional views of an artificial sphincter 100 in accordance with embodiments of the invention. In some embodiments, the bladders 118 are ring-shaped. In some embodiments, the side or edges 120 and 121 are displaced along a longitudinal axis 122 of the cuff member 102 that is generally aligned with a longitudinal axis of the lumen 104. The deflation of the cuff member 102 then inflates the one or more bladders 118 to place the artificial sphincter 100 in an open state around a lumen 104 (shown in phantom), as shown in FIG. 7. The deflation of the one or more bladders 118 inflates the cuff member 102 to place the artificial sphincter 100 in an open state, as shown in FIG. 8.

[0047] The cuff member 102 provides the inflatable pillow portion that creates the occlusion of the lumen 104 when inflated (FIGS. 6 and 8). In some embodiments, a strap or band 114 surrounds the cuff member 102 to provide resistance to the radial expansion of the cuff member 102, and directs the expansion of the cuff member 102 toward the lumen 104 to constrict the lumen 104 upon inflation of the cuff member 102. In some embodiments, ends of the strap or band 114 are attached together using a suitable connector 123, such as a clasp.

[0048] In some embodiments, a second band or housing 124 may surround the reservoir 109 and other components of the artificial sphincter 100, as shown in FIGS. 5 and 6. In some embodiments, ends of the second band or housing 124 are attached together using a suitable connector 125.

[0049] FIGS. 9 and 10 are cross-sectional views of the artificial sphincter 100 of FIGS. 5 and 6 implanted around a lumen 104 of an individual. When in its quiescent state, the inner cuff member 102 is inflated and occludes the lumen 104 and the outer cuff or reservoir 109 is deflated, as shown in FIG. 9. As pressure within the lumen 104 increases, fluid within the inner cuff member 102 is driven through the fluid passageway 110 and into the outer cuff or reservoir 109 to deflate the cuff member 102. This opens the lumen 104 and allows for the passage of material, as shown in FIG. 10. As the pressure within the lumen 104 decreases, fluid flows back to the cuff member 102 through the fluid passageway 110.

[0050] As mentioned above, the flow of fluid between the cuff member 102 and the reservoir 109 may be restricted in one or both directions by the flow restrictor 112. In some embodiments, the flow restrictor provides a slow response or viscous reaction to the pressurization of the fluid within the reservoir and/or cuff member 102 to restrict the flow of fluid through the passageway 110. FIGS. 11 and 12 are charts that illustrate the response of the artificial sphincter 100 to internal pressure within the lumen 104.

[0051] With reference to FIG. 11, from time t₀-ti, the cuff member 102 is inflated placing the artificial sphincter 100 in a closed state (FIG. 1) around the lumen 104, which constricts the lumen and prevents or restricts the passage of material through the lumen 104, and past the cuff member 102. During time ti-t₂ (deflation stage), the individual increases internal pressure within the lumen 104 through, for example, an increase in abdominal pressure, and sustains the pressure for a period of time. This deflates the cuff member 102 by driving fluid from the cuff member 102 to the reservoir 109 through the passage 110.

[0052] In some embodiments, the flow restrictor 112 includes a one-way valve 130, such as a bleed valve or other suitable mechanism, which restricts the flow of fluid from the cuff member 102 to the reservoir 109 through the passageway 110. The valve 130 slows the response of the fluid transfer from the cuff member 102 to the reservoir in response to the sustained increase in the internal pressure of the lumen 104. One objective of the valve 130 is to prevent significant deflation of the cuff member 102 in response to transient changes to the internal pressure within the lumen 104, as shown in FIG. 12. For instance, the valve 130 prevents transient high pressure abdominal events caused by coughing, sneezing, jumping, and the like, which may generate a brief spike to the internal pressure within the lumen 104, from driving a large volume of fluid from cuff member 102 to the reservoir 109 through the passageway 110. Thus, the valve 130 operates to "filter" such transient pressure events and prevent significant deflation of the cuff member 102 in response to such events. Instead, deflating the cuff member 102 requires sustained abdominal pressure that is purposefully applied by the individual, as indicated in FIG. 11.

[0053] At time t₂, the artificial sphincter 100 is in the open state due to the deflation of the cuff member 102, and material is allowed to travel through the lumen 104 and past the cuff member 102. In some embodiments, the flow restrictor 112 includes a one-way valve 132, such as a bleed valve or other suitable mechanism, which restricts the flow of fluid from the reservoir 109 to the cuff member 102 through the passageway 110. The flow restriction produced by the valve 132 reduces or eliminates the need for the individual to continuously generate the internal pressure required to deflate the cuff member 102 and open the passageway through the lumen 104. Thus, when the internal pressure within the lumen 104 produced by the individual is released at time t₃, the valve 132 ensures that fluid does not rush back into the cuff member 102, as shown in FIG. 11. Instead, fluid is slowly returned to the cuff member 102 through the valve 132 causing a gradual inflation of the cuff member 102 to time t₄, where it again reaches the fully inflated, closed state. This is useful, for example, when the cuff member 102 is implanted around the anal canal of the individual. Once the individual increases the internal pressure to drive fluid from the cuff member 102 to the reservoir 109 and open the artificial sphincter 100, the individual may defecate without having to continuously generate the pressure required to initially deflate the cuff member 102.

[0054] An exemplary valve 130 configured to restrict the flow of fluid traveling from the cuff member side 134 to the reservoir side 136 through the passageway 110 will be described with reference to FIGS. 13-16. FIG. 13 is a simplified side view of the valve 130 while the cuff member 102 is inflated and prior to a sustained increase in internal pressure within the lumen 104 caused by the individual. In some embodiments, the valve 130 includes a slit or duckbill valve member 138 inline with the fluid passageway 110, as shown in FIG. 13. FIG. 14 is a simplified front view of the valve 134 of FIG. 13. Initially, an opening 140 of the valve 134 is closed to prevent the passage of fluid from the inflated cuff member 102 to the reservoir 109, as shown in FIG. 14.

[0055] In some embodiments, the valve 130 includes a valve actuation bladder 142 that is fluidically coupled to the cuff member 102 through a low flow orifice 144. While the cuff member 102 is inflated and prior to a sustained increase in internal pressure by the individual, the bladder 142 is in a relatively deflated or low pressure state, and does not significantly deform the valve member 138 allowing the opening 140 to remain closed, as shown in FIG. 14.

[0056] FIG. 15 is a simplified side view of the valve 130 during deflation of the cuff member 102. As the individual increases internal pressure within the lumen 104 to deflate the cuff member 102, the lumen 104 expands and forces fluid out of the cuff member 102 and into the bladder 142 through the low flow orifice 144, as indicated by arrow 146. The pressurization of the bladder 142 in response to the fluid flow 146 causes the bladder 142 to reach a high pressure or inflated state, in which the bladder presses (represented by the arrows) against the valve member 138 and a housing 148 of the valve 130, which supports the valve member 138. The housing 148 constrains the expansion of the bladder 142 toward the valve member 138. The pressure imposed on the valve member 138 by the bladder 142 deforms the valve member 138, as shown in FIG. 16, which is a simplified front view of the valve member 138. The deformation of the valve member 138 breaks the seal of the opening 140 and allows fluid to flow from the cuff member 102, through the opening 140, and into the reservoir 109, as indicated by arrow 149. Thus, the high pressure state of the bladder 142 drives the valve member 138 to the open state.

[0057] In some embodiments, the cuff member 102 is designed to require less fluid than conventional cuffs while providing adequate occlusion of a lumen. FIGS. 17 and 18 respectively are simplified top views of a cuff member 102 of an artificial sphincter 100 in closed and open states, in accordance with embodiments of the invention. The fluid pathway 110, the reservoir 109, and other elements described above that may be used in combination with the cuff member 102 are not shown in order to simplify the illustrations. In some embodiments, the cuff member 102 utilizes a plurality of fluid pockets 150. The fluid pockets 150 may be fluidically coupled together by tubing 152. The fluid pockets 150 are each configured to fill with fluid and expand as shown in FIG. 17. This places the cuff member 102 and the artificial sphincter 100 in a closed position, in which the cuff member 102 occludes the desired lumen around which the cuff member 102 is implanted. The cuff member 102 may be transitioned to an open state by transferring fluid from the fluid pockets 150 to the reservoir 109 (not shown) in accordance with embodiments described above. This deflates the fluid pockets 150 and removes the constrictive force applied to the lumen.

[0058] In some embodiments, the cuff member 102 may be formed of distensible and non-distensible sections. The distensible sections define the fluid pockets 150, which are allowed to expand to constrict the lumen while the non-distensible sections maintain their shape and contain a consistent volume of fluid.

[0059] In accordance with another embodiment, the cuff member 102 includes openings 154, as shown in the simplified side view provided in FIG. 19. The openings 154 reduce the volume of fluid required to inflate the cuff member 102 and place the artificial sphincter in a closed state. As a result, the reservoir 109 may be formed smaller thereby reducing the overall size of the artificial sphincter 100.

[0060] Some embodiments of the invention are directed to methods of selectively constricting a lumen of an individual using the passive artificial sphincter 100 formed in accordance with one or more embodiments described above. In some embodiments, the artificial sphincter 100 is implanted in the individual by implanting the cuff member 102 around the lumen 104 and implanting a reservoir 109 in the individual, as generally illustrated in FIGS. 4 and 7-10. Fluid in the reservoir 109 is pressurized using the reservoir 109 due to the material forming the reservoir 109 being placed in tension. The cuff member 102 is inflated by driving fluid from the reservoir 109 into the cuff member 102 through a passageway 110 in response to the pressurizing of the fluid in the reservoir 109. The lumen 104 is then occluded in response to inflating the cuff member 102, as shown in FIGS. 2, 8 and 9. Embodiments of the lumen include the urethra, the anal canal, the esophagus, a lumen of an ostomy, or other lumen of an individual. Accordingly, embodiments of the method are directed to treating urinary incontinence and fecal incontinence.

[0061] In some embodiments, fluid is driven from the cuff member 102 to the reservoir 109 through the passageway 110 in response to an increase in internal pressure within the lumen 104. The occlusion of the lumen 104 is released in response to driving fluid from the cuff member 102, as illustrated in FIGS. 1, 7 and 10.

[0062] In some embodiments, a flow of fluid from the cuff member 102 to the reservoir 109 is restricted using a flow restrictor 112 formed in accordance with one or more embodiments described above.

[0063] Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

WHAT IS CLAIMED IS:

1. A passive artificial sphincter (100) configured for implantation in an individual to assist in occluding a lumen (104) of the individual, the artificial sphincter comprising:

a cuff member (102);

a reservoir (109) containing fluid; and

a passageway (110) fluidically coupling the cuff member to the reservoir;

wherein:

the artificial sphincter has a quiescent state in which the cuff member is inflated by the fluid pressurized by the reservoir; and

the artificial sphincter does not include a pump.

2. A passive artificial sphincter according to claim 1 , wherein the cuff member is configured to form a ring.

3. A passive artificial sphincter according to claim 2, wherein the reservoir surrounds the cuff member.

4. A passive artificial sphincter according to claim 3, wherein the reservoir forms a ring around the cuff member.

5. A passive artificial sphincter according to claim 1, wherein the reservoir comprises a first bladder (118) positioned adjacent a first side (120) of the cuff member.

6. A passive artificial sphincter according to claim 5, wherein the reservoir comprises a second bladder (118) positioned adjacent a second side (121).

7. A passive artificial sphincter according to claim 6, wherein the first and second sides are displaced from each other along a longitudinal axis (122) of the cuff member.

8. A passive artificial sphincter according to any of claims 1-7, further comprising a flow restrictor in line with the passageway, the flow restrictor configured to restrict a flow of fluid through the passageway from the cuff member to the reservoir.

9. A passive artificial sphincter according to claim 8, wherein the flow restrictor comprises a first one-way valve configured to restrict a flow of fluid through the passageway from the cuff member to the reservoir.

10. A passive artificial sphincter according to claim 9, wherein the first one-way valve comprises:

a housing;

a valve member supported by the housing and having an open state, in which a flow of fluid may travel through the passageway from the cuff member to the reservoir, and a closed state, in which fluid flow through the passageway from the cuff member to the reservoir is blocked; and

a bladder supported by the housing and having a low pressure state, in which the valve member remains in the closed position, and a high pressure state, in which the bladder drives the valve member to the open state.

11. A passive artificial sphincter according to claim 10, wherein the bladder is in fluid communication with the cuff member.

12. A passive artificial sphincter according to claims 9-11, wherein the flow restrictor includes a second one-way valve configured to restrict a flow of fluid through the passageway from the reservoir to the cuff member.

13. A passive artificial sphincter according to claim 12, wherein at least one of the first and second one-way valves comprises a bleed valve.

14. A passive artificial sphincter according to claims 1-13, wherein the cuff member comprises a plurality of fluid pockets (150) and tubing (152) fluidically coupling the fluid pockets, wherein the fluid pockets are configured to inflate with the fluid pressurized by the reservoir.

15. A passive artificial sphincter according to any of claims 1-14, wherein the cuff member comprises a plurality of openings.

16. A method of selectively occluding a lumen of an individual comprising:

implanting an artificial sphincter in the individual comprising:

implanting a cuff member around the lumen; and

implanting a reservoir in the individual;

pressurizing fluid in the reservoir using the reservoir; inflating the cuff member comprising driving fluid from the reservoir into the cuff member through a passageway in response to pressurizing fluid in the reservoir; and

occluding the lumen in response to inflating the cuff member.

17. A method according to claim 16, further comprising:

driving fluid from the cuff member to the reservoir through the passageway in response to an increase in internal pressure within the lumen; and

releasing the occlusion of the lumen in response to driving fluid from the cuff member.

18. A method according to any of claims 16-17, further comprising restricting the flow of fluid from the cuff member to the reservoir using a flow restrictor.

19. A method according to any of claims 16-18, wherein implanting a reservoir comprises positioning the reservoir around the lumen.

20. A method according to any of claims 16-19, wherein implanting a reservoir comprises positioning the reservoir around the cuff member.