Occlusal cuff and implantable occlusal system comprising said cuff

Abstract

The invention relates to an occlusion collar (1) for selectively blocking an anatomical duct (2), comprising: a band (10) suitable for encircling the anatomical duct (2) and provided with a locking device suitable for keeping the band wound around itself along a predetermined length (L10), and an inflatable reservoir (11) disposed on an inner face of the band (10), the collar being characterized in that the inflatable reservoir (11) extends only over a portion (L13) of the length (L10) of the band (10), and another portion (L13) of the length (L10) defines a free inner surface (13) of the band that is configured to form a stop zone for the anatomical duct such that, when the band (10) is kept wound around itself by the locking device, the inflatable reservoir (11) is opposite the free inner surface (13) of the band.

Description

DOMAINE DE L'INVENTION

[0001] The present invention relates to an occlusive cuff intended to selectively occlude an anatomical conduit, such as a urethra or bladder neck, as well as an implantable occlusive system comprising such a cuff. ETAT DE LA TECHNIQUE

[0002] Implantable occlusive systems exist for selectively blocking an anatomical passage, for example, to treat incontinence (as with artificial urinary and anal sphincters) or to limit the entry of food into the stomach (as with gastric bands). The occlusion of the anatomical passage is achieved by the compression exerted by a cuff wrapped around it.

[0003] Among the cuffs, this text focuses on those based on fluidic technology (the cuff comprising an inflatable reservoir coupled to a fluidic circuit allowing the selective filling or emptying of said reservoir, depending on the compression to be exerted on the anatomical conduit).

[0004] Among occlusal systems, some are manual, meaning that a user (for example, the patient themselves) controls the compression applied by the cuff. Other systems are automatic, meaning that they include one or more sensors, an actuator, and a control unit that commands the actuator to apply a specific compression to the anatomical canal via the cuff, without requiring user intervention.

[0005] Document WO 2016 / 083428 describes an automatic implantable occlusive system. This system includes a fluidic circuit comprising: an inflatable occlusive sleeve containing a variable volume of a fluid, intended to surround at least part of a natural conduit to be occluded, a container with a variable volume filled with a fluid, said container comprising a fixed part and a movable part, a fluidic connection between the container and the occlusive sleeve,

[0006] Furthermore, this system includes an actuator mechanically coupled to the moving part of the container so as to linearly move said moving part relative to the fixed part to adjust the volume of the container.

[0007] Also, document WO 2013 101 764 describes: an occlusive cuff comprising: a band adapted to surround an anatomical conduit, provided with a closure device adapted to keep the band wound on itself over a determined length, an inflatable reservoir arranged on an inner face of the band, and a connector arranged at one end of the band to ensure a fluidic connection between the reservoir and a tube.

[0008] The actuator and the variable volume container are arranged in a sealed housing containing a gas.

[0009] THE figures 1A et 1B are views of an occlusive cuff 1' usable in this system, respectively in the free state (before implantation), and once implanted around the anatomical conduit 2 to be obturated.

[0010] The cuff comprises a band 10 adapted to surround the anatomical conduit, and an inflatable reservoir 11' arranged on one face of the band 10, substantially along its entire length. The inflatable reservoir 11 comprises at one of its ends a connector 12 for ensuring a fluid connection between the interior of the reservoir 11 and a tube 3 connected to the container.

[0011] At its opposite end to said connector 12, the band has an oblong opening 14, which is intended to be engaged on the connector 12 in order to keep the cuff in a wrapped position around the anatomical conduit 2.

[0012] In this text, the "length" of the cuff refers to the inner circumference of the cuff when it is in its closed position. This length is denoted L 10 on the figure 2A Depending on the cuff closure device, this length is therefore generally less than the total length of the band.

[0013] There are cuffs of different lengths, depending on the applications and patients targeted.

[0014] The length of the occlusive cuff is chosen by the surgeon, based on the circumference of the anatomical canal at the location intended for the cuff.

[0015] In the case of artificial urinary sphincters, the cuff is generally implanted in women around the bladder neck, which has a significant circumference. Typically, the cuff length for such an application is around ten centimeters.

[0016] However, using a cuff of this size poses a number of problems for the installation and operation of the system.

[0017] A primary drawback of such a cuff is its bulk. Implanting such a cuff around the bladder neck is delicate because there is little space around the neck for insertion. Furthermore, the cuff is positioned very close to the vaginal wall, which the surgeon must be careful not to perforate during implantation.

[0018] On the one hand, given the significant volume of the cuff, the fluid container must be sized accordingly to provide sufficient compression of the anatomical conduit by the cuff. This implies an increase in the size of the housing containing said container.

[0019] Furthermore, the variation in the volume of the container, which is implemented with a significant amplitude, also leads to a reduction in the autonomy of the energy source that powers the actuator, when it is also arranged in the housing.

[0020] Therefore, the use of a large cuff implies both a greater complexity of the implantation operation, an increase in the volume of the implantable device and a decrease in the autonomy of the system. EXPOSE DE L'INVENTION

[0021] One aim of the invention is therefore to design an occlusive cuff that can be easily implanted around an anatomical canal with a large circumference, without causing the aforementioned problems.

[0022] To this end, the invention proposes an occlusive cuff for selectively closing an anatomical duct, comprising: a band adapted to surround said anatomical conduit, provided with a closure device adapted to keep the band rolled up on itself over a determined length, and an inflatable reservoir arranged on an inner face of the band.

[0023] The said cuff is characterized in that the inflatable reservoir extends over only a portion of the length of the band, another portion of said length defining a free inner surface of the band configured to form a support area for the anatomical conduit, so that when the band is held rolled up by the closure device, the inflatable reservoir is opposite said free inner surface of the band.

[0024] In accordance with its common meaning, the term "free" in this text means that the inner surface of the band does not support any additional element which could potentially come between the band and the anatomical canal.

[0025] In this text, the term "inner" refers to the side of the cuff that, when the cuff is closed, is intended to come into direct contact with the anatomical canal. The term "outer" refers to the opposite side.

[0026] In a particularly advantageous manner, the length of the reservoir is chosen such that when the band is wound around the anatomical conduit and the reservoir is inflated, the anatomical conduit is compressed between the wall of the reservoir and the free surface of the band, the reservoir exerting a pushing force on the anatomical conduit against said free surface of the band.

[0027] The inflatable tank preferably extends over a length less than or equal to 75% of the length of the band.

[0028] The length of the band can be between 30 and 110 mm, preferably between 70 and 110 mm.

[0029] In one embodiment, the band is made of a textile coated with a biocompatible elastomer. The inflatable reservoir can be made of a biocompatible elastomer. In one embodiment, said biocompatible elastomer is silicone.

[0030] Advantageously, the sleeve also includes a connector arranged at one end of the band to ensure a fluidic connection between the reservoir and a tube.

[0031] According to one embodiment, the closure device includes an opening provided at one end of the band and adapted to engage around the connector to keep the band wound on itself.

[0032] Alternatively, the closure device comprises a surface with notches at one end of the band and a fastening device including a slot for inserting said end, configured to lock the notches against an extraction force on said end. Preferably, these notches are arranged on the outer face of the band.

[0033] Another object of the invention relates to an implantable occlusive system comprising a cuff as described above and an implantable housing comprising a pump in fluidic connection with the cuff to vary the volume of fluid in the inflatable reservoir.

[0034] According to a particular application of the invention, the occlusive system is an artificial urinary sphincter. DESCRIPTION DES FIGURES

[0035] Other features and advantages of the invention will become apparent from the detailed description that follows, with reference to the accompanying drawings in which: there figure 1A is a schematic view of a known type of occlusal cuff, as provided to the surgeon for implantation; the figure 1B is a schematic view of the cuff of the figure 1A , after implantation around the anatomical canal (represented as not exerting compression on said canal); the figure 2A is a schematic view of an occlusive cuff according to an embodiment of the invention, as provided to the surgeon for implantation; the figure 2B is a schematic view of the cuff of the figure 2A , after implantation around the anatomical canal (represented as not exerting compression on said canal); the figure 2C is a schematic view of the cuff of the figure 2A , after implantation around the anatomical canal, in a configuration that obturates said canal; the figure 3 illustrates a variant of the occlusal cuff closure system; the figure 4A illustrates a finite element simulation of the compressive stress generated in a bladder neck by the compression exerted by a cuff as illustrated on the figure 1A ; there figure 4B illustrates a finite element simulation of the compressive stress generated in the bladder neck by the compression exerted by a cuff according to an embodiment of the invention; the figure 5 illustrates an implantable occlusive system comprising a cuff according to an embodiment of the invention.

[0036] Identical reference symbols from one figure to another designate identical elements or at least elements fulfilling the same function. DESCRIPTION DETAILLEE DE MODES DE REALISATION DE L'INVENTION

[0037] Compared to known occlusive cuffs, the invention proposes to reduce the length of the inflatable reservoir.

[0038] THE figures 2A-2C schematically illustrate a sleeve 1 according to an embodiment of the invention, respectively in the free state, in the closed state without exerting compression on the conduit and in a configuration of closure of said conduit.

[0039] The inflatable reservoir 11 extends over less than 75% of the length L 10 of the band, preferably less than 60% of the band length, and even more preferably less than 50% of the band length. The length of the inflatable reservoir is denoted L 11.

[0040] Thus, for example, for a cuff 10 cm long, the length of the inflatable reservoir is 4.5 cm.

[0041] In other words, the inner face of the band 10 is divided into a region of length L 11 on which the reservoir 11 is arranged, and a region of length L 13 which forms a free surface, i.e. without a reservoir, and which constitutes a support area for the anatomical conduit.

[0042] When the cuff is in the closed position, the wall of the reservoir 11 is therefore opposite the free surface 13 of the band (the anatomical conduit 2 being interposed between these two surfaces, as shown in the figure 2B ).

[0043] On the contrary, in a cuff of a known type such as that depicted on the figures 1A et 1B The two ends of the reservoir are joined when the cuff is closed. Although a slight gap may remain between these two ends, particularly to accommodate the change in reservoir volume during inflation, the corresponding area of ​​the band does not provide support for the anatomical conduit.

[0044] Returning to the invention, when the reservoir 11 is inflated, it pushes the anatomical conduit against the free surface 13 of the band, thus progressively closing the conduit (cf. figure 2C ). Thus, the anatomical conduit is compressed between, on the one hand, the reservoir 11 and, on the other hand, the free surface 13.

[0045] Advantageously, the surgeon is provided with a range of cuffs of varying lengths, from which they can choose the most suitable one for the patient and the planned implantation site. Within this range, the cuff length is generally between 3 and 11 cm.

[0046] For short sleeves (i.e. typically less than 7 cm), the inflatable reservoir can be arranged along the entire length of the sleeve.

[0047] From a certain cuff length (for example, 7 cm), the length of the inflatable reservoir can be fixed (for example, around 4.5 cm). This allows the same pump to be used for all cuff sizes, thus avoiding the need for multiple pump housings.

[0048] Such a cuff can be made in the following way.

[0049] On the one hand, the band is made of a textile coated with a biocompatible elastomer. Advantageously, the textile is a biocompatible polyester fabric, known in particular as DACRON™, and the elastomer is silicone. The band can be cut, for example by water jet cutting, from a large sheet. The resulting band has the advantage of being smooth, not becoming embedded in anatomical tissues (thus allowing for possible explantation of the cuff), and not being stretchable.

[0050] On the other hand, the reservoir is made of a biocompatible elastomer, for example silicone, preferably by dipping in order to ensure a perfectly smooth surface condition to ensure flexible contact with the anatomical conduit.

[0051] The tank is glued onto the strip.

[0052] The connector is molded and glued onto the side of the band opposite the reservoir, passing through the band to ensure a fluid connection between the reservoir and the tubing which is fitted onto the connector.

[0053] According to one embodiment, illustrated on the figure 2A , the cuff closure device 1 includes an oblong opening 14 intended to engage with the connector 12.

[0054] According to another embodiment, illustrated on the figure 3 The strip has at one end a plurality of notches 15 and at its other end, preferably at the connector 12, a fastening device 16 comprising a slot adapted to allow insertion of the first end and equipped with a retention system that only permits movement of the strip 10 in the direction of insertion (the notches resisting any pulling movement intended to remove the strip from the slot). Advantageously, the notches 15 are located on the outer face of the strip 10, so as not to risk eroding the compressed portion of the conduit. The notches may be an integral part of the strip or manufactured by molding and then bonded to the strip.

[0055] Naturally, a person skilled in the art could choose any other closing device without departing from the scope of the present invention.

[0056] Reducing the length of the inflatable tank has three main beneficial effects.

[0057] A primary benefit is a reduction in the cuff's bulk, facilitating its implantation in areas where space is limited. In its deflated state prior to implantation, the cuff is a thin strip, which can therefore be inserted relatively easily into the dissected area around the bladder neck. This contrasts with the cuff described in WO 2013 / 165563, which uses an anvil attached to the inner surface of the strip and a hammer attached to the reservoir to compress the anatomical duct. Because the anvil and hammer are relatively rigid, they present a significant bulk in the implantation area. In contrast, in the present invention, as clearly shown in the diagrams... figures 2B et 2C , when the cuff is implanted around the anatomical conduit, said conduit is in direct contact with the reservoir 11 and with the free surface 13 of the band which are flexible parts, which helps to minimize the thickness of the cuff and reduce the risk of erosion of anatomical tissues.

[0058] A second advantageous effect of the invention is a reduction in the volume of fluid needed to inflate the reservoir in order to seal the anatomical conduit.

[0059] Therefore, the volume of the variable volume container contained in the case remains limited, and the autonomy of the power source is not penalized.

[0060] A third effect is a modification of the mode of action of the cuff on the anatomical conduit.

[0061] There figure 4A presents the result of a finite element simulation of the compressive stresses applied to the bladder neck by a cuff according to the prior art, as illustrated on the figure 1A For a fluid pressure of 120 cm H₂O in the cuff, the curvature of the cuff, combined with reservoir expansion, divides the reservoir 11' into four pockets, each extending over approximately one-quarter of the cuff's inner circumference. The bladder neck is pinched between two adjacent pockets and, in these pinched areas P, is subjected to local mechanical stresses far exceeding those experienced by the rest of the neck. These localized stresses are likely to damage the bladder neck, for example, by causing atrophy.

[0062] On the figures 4A And 4BThe levels of constraints represented with dark colors correspond to the high constraints on the color scale shown to the right of each simulation.

[0063] There figure 4B presents the result of a finite element simulation of the compressive stresses applied to the bladder neck by a cuff according to an embodiment of the invention, as illustrated in the figure 2A For a fluid pressure in the cuff of 120 cm H₂O, it is observed that reducing the length of the inflatable reservoir 11 eliminates areas of compression of the bladder neck, and consequently removes excessive stress locally on the bladder neck. The bladder neck is therefore less susceptible to damage.

[0064] There figure 5 This illustrates an implantable occlusive system comprising an implantable housing with a pump and an occlusive cuff as described above, in fluidic connection with the pump. The pump is advantageously one of the devices described in document WO 2016 / 083428.

[0065] The housing 4 contains the variable-volume container, the actuator, and the electronic module(s) and, where applicable, the power source. The housing contains a gas, for example, air. The housing must be leak-proof to prevent any transfer of fluid or gas to or from the intracorporeal environment. The housing is made of a biocompatible material and may, for example, be made of implantable titanium and sealed by laser welding. A leak test may be performed, in particular, using helium (for example, a leak rate less than 10⁻⁹ mbar·L / s of helium) to ensure the housing remains completely leak-proof for the duration of the system's implantation.

[0066] The variable volume container is connected to the cuff 1 by the tubing 3.

[0067] Advantageously, the housing includes, in a wall delimiting the variable volume container, a puncture port 5 that can be pierced by a needle and is capable of closing hermetically after the removal of the needle, allowing the injection or removal of fluid from the container. REFERENCES

[0068] WO 2016 / 083428 WO 2013 / 165563

Claims

1. Occlusive cuff (1) for selectively occluding an anatomical duct (2), comprising: - a band (10) suited to surrounding said anatomical duct (2), provided with a closing device suited to maintaining the band wound upon itself over a determined length (L10), - an inflatable reservoir (11) arranged on an inner face of the band (10), and - a connector (12) arranged at one end of the band to ensure a fluid connection between the reservoir (11) and a tubing (3), said cuff being characterised in that the inflatable reservoir (11) extends over only a part (L11) of the length (L10) of the band (10), another part (L13) of said length (L10) defining a free inner surface (13) of the band configured to form a bearing zone for the anatomical duct, such that when the band (10) is maintained wound upon itself by the closing device, the inflatable reservoir (11) is opposite said free inner surface (13) of the band.

2. Cuff according to claim 1, wherein the length (L11) of the reservoir (11) is chosen such that when the band is wound upon itself around the anatomical duct (2) and when the reservoir (11) is inflated, the anatomical duct is compressed between the wall of the reservoir (11) and the free surface (13) of the band, the reservoir (11) exerting a push force of the anatomical duct (2) against said free surface (13) of the band.

3. Cuff according to one of claims 1 or 2, wherein the inflatable reservoir (11) and the free inner surface (13) of the band are configured to be in direct contact with the anatomical duct when the band is wound around said anatomical duct (2).

4. Cuff according to one of claims 1 to 3, wherein the inflatable reservoir (11) extends over a length (L11) less than or equal to 75% of the length (L10) of the band.

5. Cuff according to one of claims 1 to 4, wherein the length of the band is comprised between 30 and 110 mm, preferably between 70 and 110 mm.

6. Cuff according to one of claims 1 to 5, wherein the band (10) is formed of a textile coated with a biocompatible elastomer.

7. Cuff according to one of claims 1 to 6, wherein the reservoir (11) is made of a biocompatible elastomer.

8. Cuff according to one of claims 6 or 7, wherein said biocompatible elastomer is silicone.

9. Cuff according to one of claims 1 to 8, wherein the closing device comprises an opening (14) formed at one end of the band (10) and able to engage around the connector (12) to maintain the band wound upon itself.

10. Cuff according to one of claims 1 to 9, wherein the closing device comprises a surface provided with teeth (15) at one end of the band (10) and an attachment device (16) comprising a slot for the insertion of said end, configured to block the teeth against an extraction force of said end.

11. Cuff according to claim 10, wherein the teeth (15) are arranged on the outer face of the band (10).

12. Implantable occlusive system comprising an implantable housing comprising a pump, and an occlusive cuff according to one of claims 1 to 11, in fluid connection with the pump to vary the volume of fluid in the inflatable reservoir.

13. System according to claim 12, consisting of an artificial urinary sphincter.

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