WO2013165563A1

WO2013165563A1 - Artificial sphincter

Info

Publication number: WO2013165563A1
Application number: PCT/US2013/030348
Authority: WO
Inventors: John R. Frigstad; Amanda J. Heys; William A. Sturos; Daniel R. Parks; Natalie A. Borgos; Paul J. Gindele; Jessica E. Felton; Danielle E. STEFFENS; Joshua P. SCHUMACHER
Original assignee: AMS Research LLC
Current assignee: AMS Research LLC
Priority date: 2012-05-04
Filing date: 2013-03-12
Publication date: 2013-11-07
Anticipated expiration: 2014-11-04

Description

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 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.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIGS. 1 and 2 are simplified front views of a cuff member of an artificial sphincter in accordance with embodiments of the invention implanted around a lumen of an individual, and respectively in closed and open states.

[0004] FIGS. 3 and 4 are simplified diagrams of an artificial sphincter in accordance with embodiments of the invention.

[0005] FIGS. 5 and 6 are simplified views of an artificial sphincter in accordance with embodiments of the invention including a top cross-sectional view of a cuff member, which is implanted around a lumen and is respectively in closed and open states.

[0006] FIGS. 7 and 8 are simplified side cross-sectional views of a cuff member of an artificial sphincter in accordance with embodiments of the invention, which is implanted around a lumen and is respectively in closed and open states.

[0007] FIG. 9 is a simplified diagram of a cuff member of an artificial sphincter implanted around a lumen of an individual, in accordance with embodiments of the invention. [0008] FIGS. 10 and 11 are cross-sectional views of embodiments of the cuff member of FIG. 9 taken generally along line A-A in open and closed states, respectively.

[0009] FIGS. 12 and 13 are cross-sectional views of embodiments of the cuff member of FIG. 9 taken generally along line A-A in open and closed states, respectively.

SUMMARY

[0010] Embodiments of the invention are directed to an artificial sphincter and methods of using the artificial sphincter to occlude a lumen of an individual. In some embodiments, the artificial sphincter includes a cuff member, a reservoir containing fluid and a passageway. Embodiments of the cuff member include a bladder, an anvil member, and a hammer member. The passageway fluidically couples the bladder to the reservoir. Inflation of the bladder drives the hammer member toward the anvil member.

[0011] In some embodiments, the artificial sphincter has a quiescent closed state in which the bladder is inflated by the fluid pressurized by the reservoir.

[0012] In some embodiments, the hammer member is attached to a surface of the bladder member. In some embodiments, the anvil member is attached to a surface of the bladder member.

[0013] In some embodiments, the anvil member includes a depression. In some embodiments, the depression comprises a groove in the anvil member. In some embodiments, the hammer member conforms to the depression.

[0014] In some embodiments, the anvil member is formed of a conformable or malleable material.

[0015] In some embodiments, the artificial sphincter includes a pump configured to drive fluid from the bladder to the reservoir.

[0016] In some embodiments, the artificial sphincter includes a flow restrictor configured to restrict fluid flow through the passageway between the bladder and the reservoir. In some embodiments, the flow restrictor comprises a bleed valve or a slit valve.

[0017] 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 comprising positioning an anvil member and a hammer member on opposing sides of the lumen, and implanting a reservoir in the individual. Fluid is pressurized in the reservoir using the reservoir. A bladder of the cuff member is inflated by driving fluid from the reservoir into the bladder through a passageway in response to the pressurized fluid in the reservoir. The lumen is pinched between the hammer member and the anvil member in response to inflating the bladder, which occludes the lumen.

[0018] In some embodiments of the method, fluid is driven from the bladder to the reservoir through the passageway. The occlusion of the lumen is released in response to driving the fluid from the bladder. In some embodiments, fluid is driven from the bladder to the reservoir through the passageway by increasing internal pressure within the lumen. In some embodiments, fluid is driven from the bladder to the reservoir through the passageway using a pump.

[0019] In some embodiments of the method, positioning of the anvil member and the hammer member on opposing sides of the lumen comprises aligning a depression of the anvil member with the lumen. The lumen is pinched between the hammer member and the depression of the anvil member to occlude the lumen.

[0020] In some embodiments of the method, positioning of the anvil member and the hammer member on opposing sides of the lumen comprises misaligning a depression of the anvil member with the lumen. The lumen is pinched between the hammer member and the depression of the anvil member to occlude the lumen.

[0021] In some embodiments of the method, the cuff member is implanted around the lumen by creating a folded section in the lumen, and placing the folded section between the anvil member and the hammer member. The lumen is occluded by pinching the folded section between the anvil member and the hammer member.

[0022] In accordance with another method of selectively occluding a lumen of an individual, an artificial sphincter is implanted in the lumen by creating a folded section in the lumen, and implanting a cuff member around the folded section. Additionally, a reservoir is implanted in the individual. Fluid in the reservoir is pressurized using the reservoir. A bladder of the cuff member is inflated by driving fluid from the reservoir into the bladder through a passageway in response to the pressurized fluid in the reservoir. The folded section of the lumen is pinched in response to the inflation of the bladder. The lumen is occluded in response to pinching the folded section of the lumen.

[0023] In some embodiments of the method, the folded section of the lumen is pinched between an anvil member and a bladder member in response to the inflation of the bladder.

[0024] In some embodiments of the method, fluid is driven from the bladder to the reservoir through the passageway. The occlusion of the lumen is released in response to driving the fluid from the bladder. [0025] 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

[0026] Embodiments of the invention are directed to an artificial sphincter that is configured to apply a constrictive force to a lumen of an individual to occlude the lumen. The constrictive force may be overcome using a pump requiring input from the individual, or in a passive manner through the generation of internal pressure within the lumen by the individual.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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. 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.

[0033] The cuff member 102 has a closed state (FIG. 1), in which the cuff member 102 is configured to apply a constrictive force to the lumen 104 to occlude the lumen 104. In some embodiments, the constrictive force applied by the cuff member 102 to the lumen 104 pinches the lumen 104, or pinches a corresponding sphincter muscle, between two components of the cuff member 102, rather than radially squeezing the lumen 104 in accordance with conventional artificial sphincters. In some embodiments, the constrictive force reduces an internal diameter 106 of the lumen 104, and reduces or prevents the passage of material through the lumen 104 and past the cuff member 102, as shown in FIG. 1. [0034] The cuff member 102 also has an open state (FIG. 2), in which the constriction of the lumen 104 is substantially relieved. This allows material to pass through the lumen 104 and past the cuff member 102, as indicated by arrows 107.

[0035] FIGS. 3 and 4 are simplified diagrams of an artificial sphincter 100 in accordance with embodiments of the invention. In addition to the cuff member 102, some embodiments of the artificial sphincter 100 include a reservoir 108 and a fluid pathway 110. In some embodiments, the material forming the reservoir 108 is flexible and is always in a state of tension (i.e., expanded like a balloon) due to the volume of fluid in the artificial sphincter 100. As a result, the reservoir 108 pressurizes the fluid in the artificial sphincter 100. This drives a volume of fluid into a bladder of the cuff member 102 and biases the cuff member 102 in the closed state without the need for a pump. That is, the quiescent state of the artificial sphincter 100 places the cuff member 102 in the closed state (FIG. 1) due to the pressurization of the fluid by the reservoir 108. Exemplary materials that may be used to form the reservoir 108 include polyethylene, polypropylene, and polyvinyl acetate.

[0036] When it is desired to relieve the occlusion of the lumen 104 by transitioning the cuff member from the closed state to the open state (FIG. 2), the inflated bladder within the cuff member 102 is deflated by transferring fluid from the bladder back to the reservoir 108 through the fluid pathway 110. This substantially relieves the constriction of the lumen 104 generated by the cuff member 102 and allows the lumen 104 to open, as shown in FIG. 2.

[0037] In some embodiments, the artificial sphincter 100 includes a pump 112 (FIG. 3) that is used to transition the cuff member 102 from the closed state (FIG. 1) to the open state (FIG. 2). The pump 112 is a conventional pump that drives fluid from the bladder of the cuff member 102 back to the reservoir 108. The pump 112 may be a manual pump, which is activated by squeezing a bulb of the pump 112 by hand, or the pump may be an electric pump, which is activated using magnets or through the transmission of a signal to the pump 112.

[0038] In some embodiments, fluid is automatically returned to the cuff member 102 from the pressurized reservoir 108 through a return fluid pathway (not shown) to transition the cuff member 102 from the open state back to the closed state. In some embodiments, the artificial sphincter 100 includes a conventional valve (not shown) that is actuated by the individual to open the return fluid pathway. Fluid is driven back to the bladder of the cuff member 102 from the reservoir 108 due to the pressure difference between the fluid in the reservoir 108 and the bladder of the cuff member 102. In accordance with another embodiment, a flow restrictor, such as a bleed valve, slit valve or other suitable flow restrictor, is placed in line with the return fluid pathway to provide an automatic slow return of the fluid in the reservoir 108 back to the cuff member 102 responsive to the pressure difference between the reservoir 108 and the bladder of the cuff member 102.

[0039] In accordance with another embodiment, the artificial sphincter 100 does not include a pump, as shown in FIG. 4. The cuff member 102 is transitioned from the closed state to the open state through sustained pressure within the lumen 104 of the cuff member 102 by the individual. This sustained pressure counteracts the constrictive force applied by the cuff member 102 to the lumen 104, and causes the bladder within the cuff member 102 to discharge fluid to the reservoir 108 through the fluid pathway 110. The deflation of the bladder within the cuff member 102 transitions the cuff member 102 to the open state, and allows material to flow past the cuff member 102, as shown in FIG. 2.

[0040] In some embodiments, the artificial sphincter 100 includes a flow restrictor 115 in line with the fluid pathway 110. In some embodiments, the flow restrictor 115 allows fluid to flow between the cuff member 102 and the reservoir 108, but restricts the flow of fluid in one or both directions. Embodiments of the flow restrictor 115 include one or more bleed valves, slit valves, or other suitable flow restrictors. The flow restrictor 115 is particularly useful when the artificial sphincter lacks a pump, as shown in FIG. 4.

[0041] In some embodiments, the flow restrictor 115 restricts the flow of fluid from the cuff member 102 to the reservoir 108 through the passageway 110 by slowing the response of the fluid transfer from the bladder of the cuff member 102 to the reservoir 108 in response to the sustained increase in the internal pressure of the lumen 104 by the individual. This prevents significant deflation of the cuff member 102 in response to transient changes to the internal pressure within the lumen 104 caused by, for example, coughing, sneezing, jumping, and the like. Thus, the restrictor 115 may operate to "filter" such transient pressure events and prevent significant deflation of the cuff member 102 in response to such events.

[0042] In some embodiments, the flow restrictor 115 restricts the flow of fluid from the reservoir 108 to the cuff member 102 through the passageway 110. This 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.

[0043] FIGS. 5 and 6 are simplified views of an artificial sphincter 100 formed in accordance with embodiments of the invention. A top cross-sectional view of the cuff member 102 implanted around a lumen 104 of an individual is illustrated in FIGS. 5 and 6, with the cuff member 102 respectively in closed and open states. The pump 112 and the flow restrictor 115 are not shown in FIGS. 5 and 6 in order to simplify the illustrations.

[0044] In addition to the bladder 118 mentioned above, some embodiments of the cuff member 102 include an anvil member 120, a hammer member 122 and a sleeve 126. In some embodiments, the anvil member 120 and the bladder member 122 are positioned on opposing sides of the lumen 104. In some embodiments, the hammer member 122 is attached to an interior surface 130 of the bladder 118 that faces the anvil member 120. In some embodiments, the bladder 118 and the anvil member 120 are attached to an interior surface 132 of the sleeve 126.

[0045] In some embodiments, the sleeve 126 is configured to secure the bladder 118, anvil member 120, and hammer member 122 around the lumen 104. In some embodiments, the sleeve 126 comprises a strap having ends that are joined together using a conventional fastener.

[0046] In some embodiments, the anvil member 120 is conformable to the exterior surface of the hammer member 122. For example, the anvil member 120 may comprise a gel- filled bladder or other conformable or malleable material. In some embodiments, the anvil member 120 includes a depression 134, which can have a desired shape, such as one that generally conforms to the exterior surface of the hammer member 122 or the lumen 104, for example. In some embodiments, the depression 134 comprises a groove that is generally aligned with a longitudinal axis of the lumen 104. That is, the depression 134 extends along the length of the lumen 104 to align the depression 134 with the lumen 104.

[0047] As mentioned above, the pressurized reservoir 108 biases the cuff member 102 in the closed position by inflating the bladder 118 with fluid, as shown in FIG 5. The inflation of the bladder 118 and the position of the anvil member 120 are constrained by the sleeve 126, which forces the bladder 118 to expand toward lumen 104 and the anvil member 120. This pinches the lumen 104 between the hammer member 122 and a portion of the anvil member 120, which occludes the lumen 104. In some embodiments, the lumen 104 is pinched between the hammer member 122 and the depression 134 of the anvil member 120, as shown in FIG. 5.

[0048] The artificial sphincter 100 may be transitioned from the closed state (FIG. 5) to the open state (FIG. 6) by driving fluid from the bladder 118 to the reservoir 108 through the passageway 110. In some embodiments, the fluid is driven out of the bladder 118 using a pump 112, or through an increase in internal pressure of the lumen 104 generated by the individual, as discussed above. The reservoir 108 inflates with the fluid driven from the bladder 118, as shown in FIG. 6. The deflation of the bladder 118 displaces the hammer member 122 from the anvil member 120, and allows the lumen 104 to expand for material passage past the cuff member 102, as shown in FIG. 6.

[0049] FIGS. 7 and 8 are simplified side cross-sectional views of a cuff member 102 of an artificial sphincter 100 in accordance with embodiments of the invention, respectively in closed and open states. The cuff member 102 is shown implanted around a lumen 104 of an individual. The reservoir 108, fluid pathway 110, pump 112/flow restrictor 115 are not shown in order to simplify the illustrations. Embodiments of the cuff member 102 include a bladder 118, an anvil member 120, a hammer member 122, and a sleeve 126, which generally operate as described above with reference to FIGS. 5 and 6. In some embodiments, the anvil member 122 includes a depression 134 that does not conform to the lumen 104. In some embodiments, the depression 134 comprises a groove, which extends in a direction that is transverse to the longitudinal axis 136 of the lumen 104, as shown in FIG. 8. Thus, in some embodiments, the depression 134 is misaligned with the lumen 104.

[0050] When the bladder 118 is inflated with fluid, the cuff member 102 is in a closed position, and the hammer member 122 pinches the lumen 104 against the anvil member 120 to occlude the lumen 104, as shown in FIG. 7. In some embodiments, the lumen 104 is pinched between the hammer member 122 and the depression 134.

[0051] When fluid from the bladder 118 is driven back to the reservoir 108 in accordance with one of the techniques described above, the hammer member 122 is displaced from the anvil member 120, as shown in FIG. 8. This places the cuff member 102 in an open position and relieves the lumen 104 of the occlusion.

[0052] FIG. 9 is a simplified side view of a cuff member 102 implanted in an individual to occlude a lumen 104 of the individual in accordance with embodiments of the invention. In some embodiments, the cuff member 102 is secured around a folded section 140 of the lumen 104. The cuff member 102 operates to pinch the folded section 140 of the lumen 104 to occlude the lumen 104. In some embodiments, the cuff member 102 includes a cup section 142 that receives the folded section 140 of the lumen 104.

[0053] FIGS. 10 and 11 are cross-sectional views of embodiments of the cuff member 102 of FIG. 9 taken generally along line A- A when the cuff member 102 is in open and closed states, respectively. In some embodiments, the cuff member 102 is formed in accordance with the cuff member 102 illustrated in FIGS. 5 and 6, but sized to accommodate the folded section 140 of the lumen 104, as shown in FIGS. 10 and 11. In some embodiments, the cuff member 102 includes a sleeve or strap 126 that secures components of the cuff member 102 to the folded section 140 of the lumen 104.

[0054] When the bladder 118 is sufficiently deflated of fluid, the cuff member 102 is placed in the open state, and the anvil member 120 is displaced from the hammer member 122, as shown in FIG. 10. This allows material to flow through the folded section 140 of the lumen 104.

[0055] Inflation of the bladder 118 transitions the cuff member 102 to the closed state (FIG. 11), in which the folded section 140 of the lumen 104 is pinched between the bladder 118 and the anvil member 120. In some embodiments, the folded section 140 is positioned between the anvil member 120 and a hammer member 122, which pinch the folded section 140 when the bladder 118 is inflated. In some embodiments, the anvil member 120 includes a depression 134 that receives a portion of the folded section 140 of the lumen 104, as shown in FIG. 11. The pinching of the folded portion 140 by the cuff member 102 occludes the lumen 104 and prevents material from passing through the folded portion 140.

[0056] FIGS. 12 and 13 are cross-sectional views of additional embodiments of the cuff member 102 of FIG. 9 taken generally along line A- A. FIG. 12 illustrates the cuff member 102 in an open state, and FIG. 13 illustrates the cuff member 102 in a closed state. In some embodiments, the cuff member 102 comprises a bladder 118 and a sleeve or strap 126 configured to secure the bladder 118 either completely or partially around the folded section 140 of the lumen 104.

[0057] The cuff member 102 is in an open state when the bladder 118 is deflated, as shown in FIG. 12. This allows material to pass through the folded section 140 of the lumen 104. The cuff member 102 transitions to the closed state by inflating the bladder 118 with fluid from the reservoir 108, as discussed above. The inflation of the bladder 118 is constrained by the strap 126, which forces the bladder 118 to expand toward the folded section 140 of the lumen 104. This constricts the folded section 140 and places the cuff member 102 in the closed state (FIG. 13), in which material is prevented from passing through the folded section 140 of the lumen 104.

[0058] Additional embodiments are directed to a method of occluding a lumen 104 of an individual using the artificial sphincter 100 formed in accordance with one or more embodiments described above. In some embodiments, the artificial sphincter 100 comprises a cuff member 102 that is secured to the lumen 104 using a sleeve or strap 126, and is formed in accordance with one or more of the embodiments described above with reference to FIGS. 5-8. In some embodiments, the cuff member 102 includes a bladder 118, an anvil member 120, and a hammer member 122. In some embodiments, the anvil member 120 includes a depression 134. In some embodiments, the depression 134 is configured to conform to a portion of the lumen 104, as shown in FIGS. 5 and 6. In some embodiments, the depression 134 comprises a groove that is oriented transversely to the longitudinal axis 136 of the lumen 104 (i.e., misaligned with the lumen 104), as shown in FIGS. 7 and 8.

[0059] In some embodiments of the method, fluid in a reservoir 108 is pressurized due to an expansion of the reservoir 108. The bladder 118 is inflated by driving fluid from the reservoir 108 into the bladder 118 through a passageway 110 in response to the pressurizing of the fluid in the reservoir 108. The lumen 104 is occluded in response to inflating the bladder 118 of cuff member 102, as shown in FIGS. 5 and 7. In some embodiments, the occlusion of the lumen 104 involves pinching the lumen 104 between the hammer member 122 and the anvil member 120, as described above.

[0060] In some embodiments of the method, the cuff member 102 is transitioned from the closed state (FIGS. 5 and 7) to the open state (FIGS. 6 and 8) by driving fluid from the bladder 118 back to the reservoir 108. In some embodiments, fluid is driven from the bladder 118 to the reservoir 108 using a pump 112 (FIG. 3). In accordance with other embodiments, fluid is driven from the bladder 118 to the reservoir 108 through the passageway 110 in response to an increase in internal pressure within the lumen 104 generated by the individual. The cuff member 102 is placed in the open state, and the occlusion of the lumen 104 is released in response to driving fluid from the bladder 118 to the reservoir 108, as shown in FIGS. 2, 6 and 8.

[0061] In some embodiments of the method, a folded section 140 is formed in the lumen 104 and received within the cuff member 102 of the artificial sphincter 100, as shown in FIGS. 9-13. In some embodiments, a sleeve or strap 126 secures components of the cuff member 102 to the folded section 140. In some embodiments, a bladder 118 of the cuff member 102 is inflated by driving fluid from a reservoir 108 through a passageway 110 and into the bladder 118 to place the cuff member 102 in a closed state, as discussed above. The folded section 140 of the lumen 104 is pinched in response to the inflation of the bladder 118, as illustrated in FIGS. 11 and 13, which occludes the lumen 104. In some embodiments, the folded section is pinched between an anvil member 120 and a hammer member 122 in response to the inflation of the bladder 118, as shown in FIG. 11. [0062] In some embodiments, the cuff member 102 is transitioned from the closed state to an open state by driving fluid from the bladder 118 to the reservoir 108, as shown in FIGS. 10 and 12. Embodiments of this driving step include driving the fluid from the bladder 118 using a pump 112 (FIG. 3), or driving fluid from the bladder 118 to the reservoir 108 in response to an increase in internal pressure within the lumen 104 generated by the individual. In some embodiments, the fluid driven from the bladder 118 is also driven through a flow restrictor 115 before returning to the reservoir 108, as discussed above. The resultant deflation of the bladder 118 allows material to flow through the folded section 140 of the lumen 104.

[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. For instance, the positions of the anvil member and the hammer member could be reversed.

Claims

WHAT IS CLAIMED IS:

1. An 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) comprising:

a bladder (118);

an anvil member (120); and

a hammer member (122);

wherein inflation of the bladder drives the hammer member toward the anvil member;

a reservoir (108) containing fluid; and

a passageway (110) fluidically coupling the bladder to the reservoir.

2. An artificial sphincter according to claim 1, wherein the artificial sphincter has a quiescent closed state in which the bladder is inflated by the fluid pressurized by the reservoir.

3. An artificial sphincter according to any of claims 1-2, wherein the hammer member is attached to a surface (130) of the bladder member.

4. An artificial sphincter according to any of claims 1-3, wherein the anvil member includes a depression (134).

5. An artificial sphincter according to claim 4, wherein the depression comprises a groove in the anvil member.

6. An artificial sphincter according to claim 4, wherein the hammer member conforms to the depression.

7. An artificial sphincter according to any of claims 1-3, wherein the anvil member is formed of a conformable or malleable material.

8. An artificial sphincter according to any of claims 1-7, comprising a pump (112) configured to drive fluid from the bladder to the reservoir.

9. An artificial sphincter according to any of claims 1-7, comprising a flow restrictor (115) configured to restrict fluid flow through the passageway between the bladder and reservoir.

10. An artificial sphincter according to claim 9, wherein the flow restrictor comprises a bleed valve or a slit valve.

11. A method of selectively occluding a lumen (104) of an individual comprising:

implanting an artificial sphincter (100) in the individual comprising:

implanting a cuff member (102) around the lumen comprising positioning an anvil member (120) and a hammer member (122) on opposing sides of the lumen; and

implanting a reservoir (108) in the individual;

pressurizing fluid in the reservoir using the reservoir;

inflating a bladder (118) of the cuff member comprising driving fluid from the reservoir into the bladder through a passageway (110) in response to pressurizing fluid in the reservoir;

pinching the lumen between the hammer member and the anvil member in response to inflating the bladder; and

occluding the lumen in response to pinching the lumen.

12. A method according to claim 11, further comprising:

driving fluid from the bladder to the reservoir through the passageway; and

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

13. A method according to claim 12, wherein driving fluid from the bladder to the reservoir through the passageway comprises:

increasing internal pressure within the lumen; and

driving fluid from the bladder in response to increasing internal pressure within the lumen.

14. A method according to claim 12, wherein driving fluid from the bladder to the reservoir through the passageway comprises driving fluid from the bladder to the reservoir using a pump (112).

15. A method according to any of claims 11-14, wherein:

positioning an anvil member and a hammer member on opposing sides of the lumen comprises aligning a depression (134) of the anvil member with the lumen; and pinching the lumen between the hammer member and the anvil member comprises pinching the lumen between the hammer member and the depression of the anvil member.

16. A method according to any of claims 11-14, wherein:

positioning an anvil member and a hammer member on opposing sides of the lumen comprises misaligning a depression (134) of the anvil member with the lumen; and

pinching the lumen between the hammer member and the anvil member comprises pinching the lumen between the hammer member and the depression of the anvil member.

17. A method according to any of claims 11-16, wherein implanting a cuff member around the lumen comprises creating a folded section (140) in the lumen, and placing the folded section between the anvil member and the bladder member.

18. A method of selectively occluding a lumen (104) of an individual comprising:

implanting an artificial sphincter (100) in the individual comprising:

creating a folded section (140) in the lumen;

implanting a cuff member (102) around the folded section; and

implanting a reservoir (108) in the individual;

pressurizing fluid in the reservoir using the reservoir;

pinching the folded section of the lumen responsive to inflating the bladder; and occluding the lumen in response to pinching the folded section of the lumen.

19. A method according to claim 18, wherein pinching the folded section of the lumen comprises pinching the folded section of the lumen between an anvil member (120) and a bladder member (122) responsive to inflating the bladder.

20. A method according to claim 18, further comprising:

driving fluid from the bladder to the reservoir through the passageway; and