WO2021224719A1 - Manchon de sphincter urétral artificiel - Google Patents

Manchon de sphincter urétral artificiel Download PDF

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Publication number
WO2021224719A1
WO2021224719A1 PCT/IB2021/053438 IB2021053438W WO2021224719A1 WO 2021224719 A1 WO2021224719 A1 WO 2021224719A1 IB 2021053438 W IB2021053438 W IB 2021053438W WO 2021224719 A1 WO2021224719 A1 WO 2021224719A1
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WO
WIPO (PCT)
Prior art keywords
cuff
inflatable chamber
main wall
side walls
walls
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2021/053438
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English (en)
Inventor
Emanuele Luigi Carniel
Chiara Giulia FONTANELLA
Arturo Nicola NATALI
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Universita degli Studi di Padova
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Universita degli Studi di Padova
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Filing date
Publication date
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Publication of WO2021224719A1 publication Critical patent/WO2021224719A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness

Definitions

  • the present invention relates to the field of medical devices. Indeed, the present invention relates to a device for the treatment of urinary incontinence, with particular reference to male subjects. Specifically, the present invention proposes a cuff for making an artificial urethral sphincter device.
  • Urinary incontinence is a disease that affects an increasing percentage of the world's population, also in light of the continuous increase in average age.
  • the pathology determines a drastic reduction in the quality of life, with reference to the physical, psychological, social and work contexts.
  • the socio-economic costs associated with this disease can be extremely significant.
  • the clinical-surgical practice provides different methodologies for the treatment of urinary incontinence.
  • the artificial sphincter is a prosthetic device that, by interacting with the urethra as a result of activation by the user, prevents the flow of urine through the urethra itself.
  • urine flow may occur, allowing urination to occur.
  • the prevention of the flow generally occurs by occlusion of the urethral lumen, induced through the application of a mechanical stress that tends to crush the urethra.
  • the most common type of artificial sphincter comprises a cuff, which is suitably placed around the urethra during surgery. Specifically, the cuff is wrapped around a section of the patient's urethral duct. The cuff is also connected to a tank by means of a mechanically or electro-mechanically activated pump, which allows the introduction and removal of a fluid within the cuff itself. The introduction of the fluid leads to the swelling of the cuff and the consequent mechanical occlusive action of the urethral duct wrapped by it.
  • the swelling of the cuff leads to the interaction between a cuff wall and the surface of the urethral duct through mechanical actions. These actions result in the crushing of the duct and subsequent occlusion of the lumen.
  • the Applicant has found that in such artificial sphincters, the mechanical stress exerted by the cuff on the urethral tissues appears to have a non-uniform distribution; that is, with reference to the surface of interaction between the cuff wall and the urethral duct, the cuff acts on the duct through a non-uniform distribution of mechanical actions.
  • the operation of wrapping the cuff around the urethra and the subsequent introduction of fluid result in the formation of loops, i.e., there are phenomena of warping of the cuff as a result of the operations of wrapping around the duct, amplified by the subsequent swelling.
  • This non-homogeneity of mechanical actions results in regions of the urethral duct where low mechanical stress is experienced and in regions of the urethral duct where high mechanical stress is experienced.
  • This lack of uniformity in the mechanical actions applied to the urethral duct results in excessive deformation and tension in some regions of the urethral duct.
  • biological tissues can undergo degenerative processes, such as inflammation, atrophy and/or stiffening, which are the basis of vasoconstriction phenomena, the formation of shrinkages and erosion processes.
  • FR 2929843 describes an implantable surgical ring, which allows for modification of the cross-sectional area of an organ, particularly a patient's stomach.
  • the ring comprises a bearing structure, a first and a second clamping pocket supported by the bearing structure.
  • the clamping pockets are designed to be filled with a filling fluid.
  • the first and second clamping pockets are separated from each other by an intermediate cavity isolated from the clamping pockets and bounded by a bridge connecting the clamping pockets.
  • the fixing pockets are dilated by introducing filling fluid so as to narrow an inner diameter of the ring and thus the diameter of the portion of the stomach surrounded by the ring.
  • the Applicant has noted that the double-pocket conformation produces a non-uniform ring surface along an axial direction of the ring. This leads to non-homogeneity or, in any case, to a concentration of the mechanical actions exerted on the organ clamped by the ring, which entails negative effects similar to those highlighted above.
  • Asymmetry of mechanical stress by itself, or combined with one of the undesirable processes just mentioned, can lead to a partial functioning or even failure of the prosthetic system. This results in the need to re-operate the patient to remove and possibly replace the artificial sphincter with consequent discomfort for the patient and additional socioeconomic costs.
  • An object of the present invention is to overcome the disadvantages of the prior art.
  • a further object of the present invention is to propose a cuff for an artificial urethral sphincter having an annular contact surface that is substantially continuous, i.e., substantially free of warping when inflated to constrain a portion of the urethral duct.
  • the present invention is directed to a cuff of an artificial urethral sphincter.
  • This cuff comprises: an inflatable chamber comprising a pair of opposite main walls and two side walls, and a constraint arrangement comprising a pair of matching fastening elements.
  • first end portions of the main walls and side walls form a first end of the inflatable chamber
  • second end portions of the main walls and side walls form a second end of the inflatable chamber opposite the first end.
  • fastening elements are formed at opposite ends of the inflatable chamber.
  • the constraint arrangement is configured to maintain the cuff in a closed configuration when the fastening elements are engaged with each other and allowing an open configuration of the cuff when the fastening elements are disengaged.
  • opposite ends of the inflatable chamber are in contact with each other, and an inner main wall of said pair of main walls of the inflatable chamber defines an annular contact surface configured to contact a portion of a urethral duct, and, in the open configuration, opposite ends of the inflatable chamber are spaced apart one from the other.
  • said main walls have membrane stiffness greater than the membrane stiffness of the side walls.
  • membrane stiffness refers to the ability of a wall to oppose the extension of the wall as a result of the pressure action exerted by the fluid insufflated within the inflatable chamber. This membrane stiffness is determined by the stiffness of the constituent material, which can be expressed by its Young's modulus, and by the thickness of the wall itself. Membrane stiffness is generally calculated as the product of wall thickness and Young's modulus of the constituent material.
  • the cuff is made of one or more materials selected from: elastomeric materials, of thermoplastic or thermosetting nature.
  • the cuff is made, at least partially, of silicone rubber.
  • the material(s) of which the cuff is made should be biocompatible.
  • the inner main wall maintains a substantially annular conformation, or at least free of folds or warping, when the inflatable chamber is inflated by introducing a fluid therein.
  • the expansion of the inflatable chamber in a radial direction with respect to the annular surface results substantially uniform in case the inflatable chamber is expanded without wrapping a portion of urethral duct. Any nonuniformity in expansion when the cuff is wrapped around a portion of the urethral duct is due to the specific conformation of the urethral duct itself. Consequently, it is possible to obtain a substantially uniformly distributed pressure in the radial directions with respect to the urethral duct. This allows to obtain a reliable closure of the urethral duct and to minimize the phenomena of excessive deformation and tension applied to the urethral duct.
  • the inner main wall and the outer main wall have different membrane stiffness characteristics.
  • the inner main wall generally has a lower membrane stiffness than the stiffness of the outer main wall.
  • the inner main wall of the inflatable chamber has a membrane stiffness comprised between 1.1 and 7 times, preferably comprised between 2 and 5 times, the membrane stiffness of the side wall.
  • This difference in membrane stiffness may be achieved by differences in wall thickness, differences in the mechanical properties of the constituent materials, or a combination of both.
  • the membrane stiffness of the inner main wall is uniform.
  • the Applicant has identified that this relationship between the membrane stiffnesses of the inner main and side walls allows a substantially annular conformation to be maintained during the expansion of the inflatable chamber and, thus, to exert substantially uniform pressure on the urethral duct portion in a particularly effective manner.
  • the inner main wall is characterized by a thickness comprised between 0.1 mm and 0.8 mm, more preferably comprised between 0.2 and 0.6 mm, and is made of a material having an initial stiffness that can be expressed by a Young's modulus value comprised between 0.5 and 10 MPa, more preferably comprised between 1 and 5 MPa.
  • Young's modulus is equal to 2.4 MPa.
  • the Applicant has identified that such structural features allow making a cuff capable of expanding uniformly and maintaining the most continuous annular contact surface possible.
  • the inner main wall comprises a plurality of first elongated portions having a first membrane stiffness and a plurality of second elongated portions having a second membrane stiffness, wherein the first elongated portions and the second elongated portions extend along the inner main wall in a direction substantially transverse to the opposite side walls of the inflatable chamber and are arranged alternately with each other, preferably along a longitudinal direction of the annular contact surface.
  • first elongated portions and the second elongated portions extend along the inner main wall in a direction substantially parallel to the opposite side walls of the inflatable chamber and are arranged alternately with each other, preferably, transverse to a longitudinal direction of the contact surface.
  • first elongated portions and the second elongated portions are made of the same material having different thicknesses.
  • first elongated portions and the second elongated portions are made of materials having a different stiffness.
  • first elongated portions and the second elongated portions are formed both with materials having different stiffnesses and have different thicknesses.
  • the Applicant has determined that such inner main wall conformations effectively allow maintaining continuity of the annular contact surface both at rest and during expansion of the inflatable chamber.
  • the elongated portions having less membrane stiffness are deformed so as to define the annular contact surface substantially in its entirety, overlying the elongated portions having greater membrane stiffness.
  • the ends of the pair of opposite ends of the inflatable chamber are shaped in a complementary manner in such a way to overlap each other, when the constraint arrangement maintains the cuff in the closed configuration, thereby maintaining substantially continuous the annular contact surface even at the contact region between the two ends.
  • each of the opposite ends comprises: an elongated portion, and an abutment portion, wherein an edge of the elongated portion of one end is configured to contact the abutment portion of the other end.
  • the elongated portion of a first end of said pair of ends defines a portion of said annular contact surface and wherein the elongated portion of a second end of said pair of ends is adjacent to the elongated portion of said first end in a radial direction with respect to the annular contact surface.
  • the elongated portion of the first end has a lower overall depth in the radial direction than the overall depth of the elongated portion of the second end.
  • This structure allows to effectively minimize the formation of discontinuities in the annular contact surface of the cuff, even when the inflatable chamber is inflated by introducing a fluid inside it.
  • a first end portion of the inner main wall and first end portions of the side walls are shaped so as to define the elongated portion and the abutment portion of the first end, and in which a second end portion of the inner main wall and second end portions of the side walls are shaped so as to define the elongated portion and the abutment portion of the second end.
  • the elongated portion of both ends of the inflatable chamber has a main length parallel to a main longitudinal direction of the inflatable chamber. Further, the abutment portion of both ends of the inflatable chamber is transverse to the main longitudinal direction of the inflatable chamber.
  • the cuff further comprising a support strip.
  • the support strip is coupled to an outer main wall of the pair of main walls of the inflatable chamber.
  • the support strip itself forms at least part of the outer main wall of the inflatable chamber.
  • the support strip has a curvature defined by a non-zero radius of curvature, in particular substantially constant, in an open configuration of the cuff in which the fastening elements of the constraint arrangement are disengaged.
  • the support strip keeps the cuff curved even at rest, i.e., in an open configuration, when the constraint arrangement is not engaged. This reduces a deformation of the cuff and in particular of the inner main wall of the inflatable chamber associated with the passage from the open to the closed configuration.
  • the support strip comprises an end protruding beyond the abutment portion of the first end of the inflatable chamber. This protruding end acts as a stop region for the elongated portion of the second end of the chamber.
  • This structure facilitates the cuff closure procedure by preventing over-distancing of the two ends of the cuff while an operator engages the constraint element.
  • the support strip provides thickness comprised between 0.6 and 1.5 mm and is made of a material having an initial stiffness that can be expressed by a value of Young's modulus comprised between 1 and 10 MPa. Thanks to this structure it is possible to shape the cuff so as to maintain a curved configuration, with a predefined and substantially constant curvature, even in rest conditions.
  • the support strip comprises at least one fold portion having a thickness less than the average thickness of the rest of the support strip.
  • said fold portion is shaped as a depression or groove facing the external environment and having a development parallel to an axis of the annular contact surface.
  • This structure makes it possible to facilitate and guide a flexion of the cuff in order to move the opposite ends of the inflatable chamber apart during the application of the cuff around a portion of the urethral duct.
  • a different aspect of the present invention relates to an artificial urethral sphincter device comprising: a cuff according to any of the above described embodiments; a pump with possible fluid tank, and a conduit.
  • the fluid conduit hydraulically connects the pump to the inflatable chamber of the cuff.
  • the urethral sphincter system therefore allows a more proper mechanical stress on the urethral tissues, thus limiting the onset of degenerative processes of the tissues and the consequent failure of the prosthetic system.
  • Figure 1 is an axonometric view of a cuff for an artificial urethral sphincter according to the present invention
  • Figure 2 is a schematic side view of a detail of a cuff for an artificial urethral sphincter according to the present invention showing two opposite ends of an inflatable chamber of the cuff;
  • Figure 3 is an axonometric cross-sectional view along a plane P of the cuff of Figure 1 ;
  • Figure 4 schematically illustrates an artificial urethral sphincter device comprising a cuff according to an embodiment of the present invention
  • Figure 5 illustrates a cuff in accordance with a first alternative embodiment of the present invention
  • Figure 6 illustrates a cuff in accordance with a second alternative embodiment of the present invention
  • Figure 7 illustrates a cuff in accordance with a third alternative embodiment of the present invention.
  • Figure 8 illustrates a cuff in accordance with a fourth alternative embodiment of the present invention
  • Figure 9 illustrates a cuff in accordance with a fifth alternative embodiment of the present invention.
  • the cuff comprises an inflatable chamber 10, a support strip 20, and a constraint arrangement 30. Additionally, a connection mouth 40 connectable to a pipe or other conduit is provided to allow a flow of fluid to and from the inflatable chamber 10.
  • the cuff 1 is made of one or more biocompatible materials selected from elastomeric materials of the thermoplastic or thermosetting type.
  • the cuff 1 is made at least partially of a silicone rubber.
  • the inflatable chamber 10 is delimited by four walls, in particular there are two main walls 11 (inner main wall) and 13 (outer main wall) separated laterally by two side walls 15.
  • the two main walls 11 and 13 have an extension substantially greater than the dimension of the side walls 15, in particular, the width dimension of the two main walls 11 and 13 is substantially greater than the width dimension of the side walls 15 which separate these main surfaces 11 and 13.
  • the inner main wall 11 defines an annular contact surface of the cuff 1 that delimits a cavity A intended to contact a portion of a urethral duct (not illustrated).
  • the main walls 11 and 13 substantially form a ring, which is closed at opposite sides by the side walls 15.
  • a first end portion 11a of the inner main wall 11 is coupled to a corresponding first end portion 13b of the outer main wall 13 of the main walls 11 and 13.
  • a second end portion 11 b of the main wall 11 is coupled to a corresponding second end portion 13b of the outer main wall 13 at a second end 17 of the inflatable chamber 10 opposite the first end 16.
  • a respective pair of end portions 15a and 15b of the side walls 15 are coupled to the first end portions 11a, 13a of the main walls 11 and 13 and to the second end portions 11b, 13b of the main walls 11 and 13, respectively.
  • first end portions 11a, 13a, 15a, and the second end portions 11b, 13b, 15b of the main walls 11 and 13, and of the side walls 15 define two mutually opposite ends 16 and 17, respectively, of the inflatable chamber 10 - along a circumferential direction C of the cuff 1, corresponding to a main longitudinal direction of the inflatable chamber.
  • the opposite ends 16 and 17 are configured to match to each other.
  • said ends 16 and 17 are shaped in a complementary manner in such a way to overlap each other, when the cuff is in a closed configuration - obtained by engaging the constraint arrangement 30, as described below.
  • each of the opposite ends 16 and 17 comprises an elongated portion - substantially parallel to the circumferential direction C -, and an abutment portion - aligned along a direction substantially radial to the circumferential direction C.
  • the first end portion 11a from the inner main walls 11 and the end portions 15a of the side walls 15 are shaped so as to define the elongated portion and the abutment portion of the first end 16.
  • the second end portion 11b from the inner main wall 11 and the end portions 15b of the side walls 15 are shaped so as to define the elongated portion - substantially parallel to the circumferential direction C - and the abutment portion - aligned along a direction substantially radial to the circumferential direction C - of the second end 17.
  • the ends 16 and 17 have a 'step' conformation, configured to match each other, particularly when the inflatable chamber 10 is inflated.
  • an edge of the elongated portion of each end 16, 17 is configured to contact the abutment portion of the opposite end.
  • surfaces facing each other of the elongated portion of each end 16, 17 - substantially parallel to the circumferential direction C - are configured to contact each other.
  • the elongated portion of the (first) end 16 defines a portion of said annular contact surface and wherein the elongated portion of the other (second) end 17 is adjacent to the elongated portion of said first end in a radial direction relative to the annular contact surface.
  • the elongated portion of the first end 16 has a lower overall depth in the radial direction than the overall depth of the elongated portion of the second end 17.
  • depth 1 means a dimension along a radial direction with respect to the annular contact surface.
  • the inflatable chamber 10 further comprises an opening 19 in fluid communication with the mouth 40 through the support strip 20.
  • the main walls 11 and 13 have membrane stiffness greater than the membrane stiffness of the side walls 15.
  • membrane stiffness refers to the ability of a wall to oppose the extension of the wall as a result of the pressure action exerted by the fluid insufflated within the inflatable chamber. This membrane stiffness is determined by the stiffness of the constituent material, which can be expressed by its Young's modulus, and by the thickness of the wall itself. In particular, membrane stiffness is generally calculated as the product of wall thickness and Young's modulus of the constituent material.
  • the inner main wall 11 is characterized by a thickness comprised between 0.1 mm and 0.8 mm, more preferably comprised between 0.2 mm and 0.6 mm, for example the thickness corresponds to 0.5 mm, and is made at least partially of a first elastomeric material having a Young's modulus comprised between 0.5 MPa and 10 MPa, preferably comprised between 1 MPa and 5 MPa, for example preferably equal to 2.4 MPa.
  • the side walls 15 have a membrane stiffness between 1.1 and 7 times, preferably between 2 times and 5 times, less than the membrane stiffness of the inner main wall 11.
  • the side walls 15 have a membrane stiffness 3 times less than the membrane stiffness of the inner main wall 11.
  • the outer main wall 13 is made of a material corresponding to the material of the inner main wall 11 and having a similar thickness. However, there is nothing to prevent other embodiments from comprising an outer main wall 13 having a membrane stiffness different from the membrane stiffness of the inner main wall 11 , for example greater.
  • the support strip 20 has substantially similar dimensions and shape to the inflatable chamber 10 and is coupled to the outer main wall 13 of the inflatable chamber 10 by a respective main wall.
  • the support strip 20 itself at least partially constitutes the outer main wall 13 of the inflatable chamber 10.
  • the outer wall 13 of the inflatable chamber 10 coupled to the support strip 20, or the support strip 20 alone when the latter operates from the outer wall 13, define a containment wall delimiting the inflatable chamber 10.
  • the support strip 20 is shaped so as to maintain the cuff 1 in a substantially circular arrangement in an open configuration of the cuff 1 , i.e., when the constraint arrangement is not engaged. More generally, the support strip 20 has a curvature defined by a non-zero radius of curvature in an open configuration of the cuff. Preferably, the radius of curvature in the open condition of the cuff 1 can be approximated to a constant radius of curvature, which defines the circumference of the annular contact surface of the cuff 1 in the closed condition thereof. In this configuration, the ends 16 and 17 of the inflatable chamber result substantially in contact in the resting condition along the circumferential direction C.
  • the support strip 20 has a membrane stiffness greater than the membrane stiffness of the inner main wall 11.
  • the support strip 20 is made of the same material as the main walls.
  • said containment wall has an overall thickness comprised between 0.3 mm and 2 mm, for example the thickness of the containment wall has a thickness of 1.2 mm.
  • the support strip 20 comprises an end 21 configured to go into abutment with a corresponding opposite end - along the circumferential direction C of the cuff 1 - of the support strip 20 in the closed configuration of the cuff 1.
  • the end 21 protrudes beyond the abutment portion of the first end 16 of the inflatable chamber 10 so as to act as a stop region for the elongated portion of the second end 17 of the inflatable chamber 10.
  • the constraint arrangement 30 comprises at least one pair of corresponding fastening elements, in the example considered, a tab 31 and an anchoring element 33, configured to be mechanically coupled to each other, preferably in a releasable manner and are configured to bring the opposite ends 16 and 17 of the inflatable chamber 10 into contact with each other and, preferably, the opposite ends of the support strip 20.
  • the tab 31 and the anchoring element 33 protrude from an outer surface 23 of the support strip 20 near opposite ends thereof.
  • the tab 31 comprises an opening 35 shaped and adapted to deform to receive the anchoring element 33 when the tab is pulled toward the anchoring element 33 in order to couple the tab 31 to the anchoring element 33.
  • the walls of the tab delimiting the opening 35 prevent the anchoring element from escaping and keep the opposite ends 16 and 17 of the inflatable chamber 10 and the opposite ends of the support strip 20 clamped together.
  • the anchoring element 33 has substantially a T shape radially protruding from the surface 23 of the support strip and is integrated into the mouth 40.
  • the tab 31 , the anchoring element 33 and, thus, the mouth 40 are formed as a piece with the support strip 20.
  • these elements are overmolded or mechanically coupled.
  • the cuff 1 is integrated into an artificial urethral sphincter 5 shown schematically in Figure 3.
  • the artificial urethral sphincter 5 comprises a conduit 51 that places the inflatable chamber 10 in fluid connection with a pump 53.
  • the conduit is fixed to the mouth 40.
  • the cuff 1 is inserted around a portion of the urethral duct U and brought into the closed configuration it is possible to block, or allow, a flow of fluid through the urethral duct U by pumping a fluid volume into, or out of, the inflatable chamber 10.
  • the annular contact surface presses substantially uniformly against the portion of the urethral duct U avoiding the creation of excessive stresses in the tissues of the urethral duct and, at the same time, ensuring an effective obstruction of the urethral duct U.
  • the difference in membrane stiffness between the inner main wall and the side walls of the inflatable chamber can be obtained with different conformations thereof.
  • the inner main wall and the side walls of the inflatable chamber are made of the same material.
  • the inner main wall has a thickness greater than the thickness of the side walls, preferably constant.
  • the thickness of the inner main wall is comprised between 1.1 and 7 times, preferably between 2 and 5 times the thickness of the side walls.
  • the support strip 20a of the cuff 2 comprises at least one groove, three grooves 25 in the example considered, each defining a portion with thickness less than the average thickness of the rest of the support strip 20.
  • the grooves 25 develop on the outer surface 23 of the support strip 20a parallel (facing the outer environment) with a development parallel to an axis X of the annular contact surface.
  • These grooves 25 define guide elements in the opening operations of the cuff necessary for its application around the urethral duct.
  • the ends may have a different shape.
  • the inflatable chamber 10 of the cuff 3 illustrated in Figure 6 comprises two ends 16a and 17a having substantially the same length along the circumferential direction C and substantially the same depth in the radial direction
  • the inflatable chamber 10 of the cuff 4 illustrated in Figure 7 comprises two ends 16b and 17b having substantially the same length along the circumferential direction C substantially less than the length of the ends 16, 17, 16a and 17a considered in the previous embodiments.
  • the length of the ends of the inflatable chamber along the circumferential direction C is comprised between 0.05 and 0.2 times, more preferably between 0.125 and 0.17 times, the circumference of the annular surface defined by the inner main wall of the cuff.
  • the length is selected so as to achieve a desired compromise between ease of application of the cuff - with shorter end lengths - and better structural hold of the cuff, with longer end lengths.
  • the depth of the ends of the inflatable chamber in the radial direction with respect to the annular surface is comprised between 0.2 and 0.8 times, more preferably between 0.3 and 0.7 times, the depth of the inflatable chamber in a resting condition.
  • the inner main wall 11X of the inflatable chamber 10 comprises a plurality of first elongated portions 111 having a first membrane stiffness and a plurality of second elongated portions 112 having a second membrane stiffness different from the first membrane stiffness.
  • Both the first elongated portions 111 and the second elongated portions 112 are elongated along, i.e., parallel to, the circumferential direction C of the annular contact surface - corresponding to a longitudinal direction of the inflatable chamber 10.
  • the first elongated portions 111 and the second elongated portions 112 are alternated with each other, preferably, along a transverse direction, preferably perpendicular, to the circumferential direction C.
  • a different cuff 6, according to an alternative embodiment provides that the inner main wall 11 Y comprises first elongated portions 113 and second elongated portions, on the inner main wall, along the longitudinal direction of the annular contact surface and alternated along the circumferential direction thereof. Furthermore, the first elongated portions - of greater stiffness - have a width much less - for example, by 5 or more times - than the width of the second elongated portions.
  • the lobes have a substantially radial arrangement around the urethral duct and allow to obtain a substantially homogeneous pressure on the urethral duct, although without defining a continuous annular contact surface.
  • first elongated portions 111 and 113, and the second elongated portions 112 and 114 may be made of the same material having different thicknesses.
  • first elongated portions 111 and 113, and the second elongated portions 112 and 114 are made of materials having a different stiffness.
  • both the first elongated portions 111 and 113 and the second elongated portions 112 and 114 have a membrane stiffness greater than the membrane stiffness of the side walls 15.
  • the mouth and the constraint arrangement may be formed from separate elements.
  • the constraint arrangement may comprise different fastening elements, such as one or more hooks and slots or a snap lever.
  • embodiments comprising two or more of the following features may be provided: grooves at the outer main wall and/or of the support strip, inner main wall comprising first elongated portions and second elongated portions of different membrane stiffness alternated with each other.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un manchon (1 ; 2 ; 3 ; 4 ; 5 ; 6) de sphincter urétral artificiel comprenant : une chambre gonflable (10) comprenant une paire de parois principales opposées (11, 13) et deux parois latérales (15), des premières parties d'extrémité (11a, 13a, 15a) des parois principales (11, 13) et des parois latérales (15) formant une première extrémité (16) de la chambre gonflable (10) et des deuxièmes parties d'extrémité (11b, 13b, 15b) des parois principales (11, 13) et des parois latérales (15) formant une deuxième extrémité (17) de la chambre gonflable (10) opposée à la première extrémité (16), un agencement de contrainte (30) comprenant une paire d'éléments de fixation correspondants (31 ; 33) formée aux extrémités opposées (16, 17) de la chambre gonflable (10), ledit agencement de contrainte (30) étant en mesure de maintenir le manchon (1 ; 2 ; 3 ; 4 ; 5 ; 6) dans une configuration fermée lorsque les éléments de fixation sont mis en prise l'un avec l'autre, et permettant une configuration ouverte du manchon (1 ; 2 ; 3 ; 4 ; 5 ; 6) lorsque les éléments de fixation (31, 33) sont désengagés. Spécifiquement, dans la configuration fermée du manchon (1 ; 2 ; 3 ; 4 ; 5 ; 6), les extrémités opposées (16, 17) de la chambre gonflable (10) sont en contact l'une avec l'autre, et une paroi principale interne (11) de ladite paire de parois principales (11, 13) de la chambre gonflable (10) définit une surface de contact annulaire configurée pour entrer en contact avec une partie d'un canal urétral, et dans la configuration ouverte, les extrémités opposées (16, 17) de la chambre gonflable (10) sont espacées l'une de l'autre. Avantageusement, lesdites parois principales (11, 13) présentent une rigidité de membrane supérieure à la rigidité de membrane des parois latérales (15). Cela garantit que les parois latérales (15) subissent une déformation plus importante que les parois principales (11, 13) pendant un gonflage de la chambre gonflable (10) tout en maintenant uniforme la surface de contact annulaire définie par la paroi principale interne (11).
PCT/IB2021/053438 2020-05-04 2021-04-27 Manchon de sphincter urétral artificiel Ceased WO2021224719A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102020000009709 2020-05-04
IT102020000009709A IT202000009709A1 (it) 2020-05-04 2020-05-04 Cuffia per dispositivo sfinterico uretrale artificiale

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WO2021224719A1 true WO2021224719A1 (fr) 2021-11-11

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023101621A1 (fr) * 2021-11-30 2023-06-08 Lueleci Hueseyin Manchon urétral destiné à être utilisé dans des sphincters urinaires artificiels

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2907665A1 (fr) * 2006-10-31 2008-05-02 Cie Euro Etude Rech Paroscopie Dispositif medical implantable avec limiteur de pression
FR2929843A1 (fr) * 2008-04-14 2009-10-16 Cie Euro Etude Rech Paroscopie Anneau a poches multiples avec pont et cavite intermediaire
WO2013091730A1 (fr) * 2011-12-23 2013-06-27 Myopowers Medical Technologies Sa Dispositif médical comprenant une structure contractile artificielle

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Publication number Priority date Publication date Assignee Title
US2533924A (en) 1948-06-28 1950-12-12 Frederic E B Foley Artificial sphincter
US7011622B2 (en) 2000-03-15 2006-03-14 Ams Research Corporation Parylene coated components for artificial sphincters
US6432038B1 (en) 2001-02-15 2002-08-13 Ramesh Bakane Artificial urinary sphincter
US8696542B2 (en) 2008-12-23 2014-04-15 Ams Research Corporation Biased artificial sphincter cuff
US9375301B2 (en) 2013-06-06 2016-06-28 Coloplast A/S Artificial urinary sphincter having a multi-compartment cuff

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2907665A1 (fr) * 2006-10-31 2008-05-02 Cie Euro Etude Rech Paroscopie Dispositif medical implantable avec limiteur de pression
FR2929843A1 (fr) * 2008-04-14 2009-10-16 Cie Euro Etude Rech Paroscopie Anneau a poches multiples avec pont et cavite intermediaire
WO2013091730A1 (fr) * 2011-12-23 2013-06-27 Myopowers Medical Technologies Sa Dispositif médical comprenant une structure contractile artificielle

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023101621A1 (fr) * 2021-11-30 2023-06-08 Lueleci Hueseyin Manchon urétral destiné à être utilisé dans des sphincters urinaires artificiels

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