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
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0089—Instruments for placement or removal
• • 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
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands

Definitions

• the present invention relates to the general field! impanancial medical devices, and more particularly in the field of implantable medical devices which comprise a flexible band intended to be pjaaée around a member to enclose the latter.
• the present invention relates in particular to devices of the surgical ring type, and in particular sphincters or gastric rings intended to be implanted around the stomach or the esophagus in a treatment of obesity.
• the head rings can be placed either around the intact stomach to achieve a direct gasiropjasty, out after a 'hy-pass' operation during which the stomach was surgically remodeled to create a pocket of reduced size, to prevent the
• S is known to intro quiz the gastric ring in open and loose form, in order to allow its passage through retro-gastric tissues.
• This operation is however delicate, insofar as it is necessary to open a passage by dissection blind in the (retragastric), then to introduce a grasping instrument through a passage, for then come to grasp the end of the gastric band with said grasping instrument and exercise a pull on the latter, in order to recall the instrument through the passage by towing the ring after it.
• the grasping instrument must, on the other hand, be positioned well in advance and, usually, remain in place during the major period of time. part of the intervention.
• this instrument Since this instrument must be controlled by a proximate portion located outside the patient, a portion of this instrument passes permanently through the abdominal wall via a catheter. This transcutaneous communication constitutes a vanishing point by which the gas which is used to inflate the abdominal cavity p ⁇ tid ⁇ rt Ifatervenîj ⁇ n escapes. The intervention then requires a flow rate and / or a relatively high supply pressure and leads to overconsumption of inflation gas.
• the objects assigned to the present invention therefore seek to overcome the drawbacks enumerated above and to propose a new implantable medical device intended to be placed around an organ to grip the latter which is particularly simple and easy to adjust, in particular by eceBoscopy.
• Another object of the invention is to provide a novel implantable medical device which facilitates the surgical procedure necessary for its operation.
• Another objective assigned to the invention is to provide an impiantable medical device which substantially reduces the risk of per-operative accidents,
• Another object assigned to the invention is to propose a new medical device tmpfantabie that is versatile and capable of being adapted case by case to the anatomical configuration of the patient operated.
• Another object assigned to the invention is to propose a new impiantabte medical device presenting good ergonomics which facilitates its
• Another object assigned to the invention is to propose a new impiantable medical device which is particularly simple in design and
• Another object of the invention is to provide a new impiantable medical device having good stability in an implanted manner.
• Another object assigned to the invention is to provide a novel medical device great suitable for the treatment of obesity.
• an implantable medical device comprising a strap adapted to be placed around an organ for gripping the latter, said medical device being characterized in that it comprises a means laying method provided with a curved stiffening element which has a rigidity greater than ceK ⁇ of the flexible strip, said laying means being designed to be engaged around the member in order to substantially materialize the path of placement of said flexible band around of said body.
• Figure 1 illustrates an exploded perspective view of an embodiment of an implantable medical device according to the invention.
• FIG. 2 illustrates, in a side view with sagittal sectional view
• FIG. 3 illustrates, in a side view with sagittal section partSe, a second embodiment of implantable medical device according to the invention.
• the present invention generally relates to an impenant medical device 1 which comprises a flexible band 2 intended to be placed around a member (not shown) to grip the latter.
• the device 1 according to the invention is intended to be placed around a body forming a pocket or a conduit so as to limit or reduce the passage section of the latter.
• said device 1 can be arranged to form a sphincter for the regulation of blood MUK or the treatment of urinary or faecal incontinence.
• said device 1 constitutes a gastric ring for the treatment of obesity, designed to be positioned on the esophagus or on the fesfomac, and in particular constitutes a gastric ring specifically adapted to be placed on the pocket stomach resulting from a bypass surgery to oppose the postoperative dilation of said stomach pocket.
• the strip supple 2 forms a sort of seite intended to partially surround the member concerned
• said flexible strip 2 will preferably be long enough to content substantially any fa perimeter of said organ, and in particular to be closed on itself substantially at its ends 3, 4 so as to be able to form a dose of dose surrounding the organ,
• the flexible strip is preferably provided with locking means 5, 6 designed to keep it in a closed configuration, such locking means comprising, for example, male elements such as ergot for cooperating, for example by packaging, with a conjugated female element 6, such as a sleeve.
• the locking means are reversible to alternatively allow the closure or opening of the ring formed by the flexible band.
• the locking means 5, 6 can advantageously be designed to allow adjustment of the length of the inner perimeter of the flexible strip, and in particular to comprise a succession of male elements 5 aligned in a row so as to form several possible notches for closing, as shown in Figures 1 to 3.
• the inner face 2i of the flexible band 2 which is intended to come into contact with the body, may comprise one or more inflatable pockets designed to be filled by a filling fluid, such as air or physiological saline, in order to ensure an adjustable con ⁇ triction of the organ.
• a filling fluid such as air or physiological saline
• the device 1 can compotier an annular clamping bag which extends substantially along its length of ia the flexible band so as to ensure a substantially radial centripetal constriction of this organ.
• the device 1 may comprise one or more gripping tongues 7, 8 intended to facilitate the handling of said device, in particular during its implantation, and / or to enable the locking means to be provided.
• the device 1 comprises a laying means 10 which is provided with a curved stiffener element 11 which has a rigidity greater than that of the hollow strip 2, since the laying means is designed to be engaged. around the organ in order to substantially materialize the trajectory of setting pfece said soupie band 2 around
• the device 1 has an on-board laying means 10, which is carried by the device 1 and is an integral part of said device tors intervention, and is intended to be fully introduced under the skin, for example, in the abdominal cavity, integrally with the compression band, so that the device and particularly the endgraphic device of its laying means can be manipulated flexibly inside the body, in the vicinity of the body.
• the junction of the laying means 10 with the remainder of the dispositti authorizes Debattem ⁇ nt captive, amplitude limited by oottstrucUo ⁇ , dudit laying means 10 relative to the rest of the device 1, said laying means is preferably attached to the device, for example to the flexible strip, so as to form with the latter a unitary assembly which is advantageously tmpîantabte and mantpufabie in one piece under the skin.
• the laying means 10 according to the invention is designed to be introduced into the tissues, in particular into the retro-gastric tissues, so as to bypass the organ until it reappears at the level of the visible face of the latter. Which allows the practitioner to determine and pre-visualize the position that the flexible band will occupy around the organ, before actually engaging the latter around the organ.
• the curvature of the stiffener element 11, and consequently that of the laying means 10 is advantageously chosen in such a way that allowing said laying means to initiate a sharp turn around the organ as it is introduced into the tissues, thereby easily bypassing said organ without the risk of perforating the underlying tissues.
• the reamer element 11 advantageously has sufficient rigidity to allow the insertion of the laying means 10 and not to be deformed unexpectedly when said laying means is threaded and maneuvered in your tissues by the practitioner.
• the device 1 facilitates ('introduction and introduction of the flexible band 2, elfe-even too flaccid to be introduced frontally into your tissues, while allowing the device to retain, when The laying then after installation, the flexibility necessary for its closure around the body and its normal operation.
• the delivery means 10 includes a penetrating means 12 which is designed to be able to create a passage in the vicinity of the organ by perforating the tissue.
• the laying means 10, and more generally the device 1 is advantageously adapted to be able to incise and / or tear of itself the biological tissues ions of its establishment, and in particular the healthy biological tissues which surround the organ,
• the practitioner can thus directly use the laying means 10 to drill a thunder? by animating tedH means of laying a movement, in advance F under constraint which drives it into said tissues by gradually dissociating the mass Hssuiaire.
• the delivery means 10 may advantageously open a passageway by frontal penetration into the tissues, and does not necessarily require the prior embodiment of a passage suitable for the purpose of a separate surgical instrument.
• aut ⁇ -f ⁇ rant laying means 10 gives the device 1 a certain autonomy during the installation and simplifies the surgeon's gesture by eliminating the dissection step prior to this phase of rî ⁇ isrvsnti ⁇ n.
• the laying means 10, and more particularly the stiffening element 11, are sufficiently rigid, that is to say sufficiently resistant to buckling, to substantially maintain the initial shape, and in particular the predetermined curvature, by means of pose 10 when it is introduced to
• the penetrating means 12 is formed by a blunt or rounded tip, as illustrated in FIGS. 1 to 3.
• such an arrangement reduces the peroperative risks, head that the accidental perforation of the wall of the organ, and limits the extent of the trauma suffered by the tissues tors of (a creation of the passage,
• said ravening element 11 is preferably configurable in such a way that it allows the adjustment of the geometry of the laying means before it is reengaged. around the organ.
• the raklisseur element 11 may advantageously adopt and maintain a more or less pronounced curvature, which may be modified at will by the practitioner according to whether the latter will bend or contrains plastically straighten the laying means 10.
• the mistrustful man will be able to determine the material or materials constituting the stiffening element 11, as well as its geometry and dimensions of - last to meet the dual requirement of buckling resistance lof "of the penetration into your tissues and plastic flexibility allowing modeling of the laying means on sue, and in particular in the abdominal cavity, before "insertion behind the organ.
• the stiffener element 11 can be made using shape memory materials or superelastic materials, so that said stiffening element can alternatively adopt a rectified configuration, substantially sectiligne, oerrnfettant its passage in a transeutantric trocar trocar, and a recurved functional configuration.
• the basalization of one configuration to the other may advantageously take place spontaneously, depending on the case, either owing to the effect of a change of temperature, and in particular of a heating at body temperature (for a shape), either under the effect of the relaxation of the mechanical straightening stress exerted during the introduction under the skin by the trocar or any accessory (for a super-elastic material).
• the laying means 10 comprises a rigid or semi-rigid core 15 which engages the stiffening element 11, said core 15 being housed in a sheath 16 made of flexible biocompatible material.
• the laying means 10 may be in the form of a coated needle, that is to say a composite structure in which the stiffening element or elements are covered with a flexible coating and
• the blade may be made of plastic material of the ABS or polypropylene type, or of any other non-brittle plastic having an appropriate resistance to wrinkling and rigidity.
• the core 15 may be made of titanium, stainless steel, or any other ductile material, sufficiently easy to conform piastically but having a good stiffness and by
• the sheath 16 can, for its part, be produced in a SiHeone-type, EPDM, polyurethane-beta or other flexible material and
• the means 4e pose 10 is preferably arranged so as to allow its clearance from the vicinity of the body in a forward movement F in the same sense that the movement that allows its engagement around said body for the pose of the flexible band 2.
• the extraction of the laying means 10 outside the operating zone, while said laying means is always under the skin may advantageously be carried out by continuing the movement initiated during the introduction of this method. last in the tissues and bypassing the organ, without it being necessary to turn back at
• the laying means 10 is preferably connected to one of the ends 3, 4 of the flexible strip 2 and protrudes from said flexible strip 2 substantially in the longitudinal extension thereof.
• the longitudinal direction of the band corresponds to that which joins the first end 3 to the second end 4 of said baiHfe SCHJj ⁇ and which st ⁇ sensitive ⁇ supple when it substantially marries the outer wall of Forgaoe that encloses it.
• the depositing means 10 is advantageously arranged so as to extend from the first end 3 of the strip 2 beyond the inner face 21 of the latter, and to oppose the second
• the laying means 10, and more particularly the reducing element 11, are advantageously coupled to the strip, upstream of the strip and of the non-overlapping bottle, in order to allow successive engagement of the laying means 10 in succession. of the flexible band 2 in your tissues.
• the laying means 10 is integrally sttuated on one side of the flexible strip, and particularly preferably at the end of the ⁇ -dish, substantially centered with respect to its traftsver ⁇ e section.
• the laying means 10 may be formed by a rod 20 which extends between a foot 21 connected to the flexible band 2 and a head 22 free which carries the means of penetration 12.
• the foot 21 is connected to the head 22 by means of an intermediate section 23 which contains or is formed by the stiffening member 11, so that a penetration force exerted on the foot 21 pmit be transmitted by tedrt intermediate section to the head 22 which bears against the tissues.
• the laying means 10 is advantageously designed to be grasped, manipulated and guided by its foot 21, which forms a kind of handle, when i' ⁇ n drives its head 22, remained free, in the tissues.
• the arrangement of the laying means 10 in accordance with the invention allows the practitioner to first insert the tie 20 substantially from the head 22 to the foot 21 into the tissues surrounding the organ, until the said emerge head 22 on the side of the member opposite the input side of said rod, then to exert in a second time a traction on the emerging part of the head 22 so that the rod 20 is progressively extracted from the passage it formed to be replaced progressively by the flexible strip 2, the latter thus penetrating the passage following the laying means 10 which preceded you.
• the rigidity of the intermediate ring 23 and the foot 21 allow the gripping and manipulation of the laying means 10 itself, but also, preferably, of the flexible band 2 to which it is attached.
• the rod 20 is cylindrical and circular section, preferably substantially constant, which gives it a little traumatizing vis-à-vis the tissues when circulating in contact of these.
• the laying means 10 is integral with the flexible strip 2
• the foot 21 of the rod 20, and more particularly the sheath 16 may be formed in one piece with a tip 30, preferably cylindrical, which extends the flexible band 2 and forms the end of the male locking means 5.
• the laying means 10 then has, at its junction with the flexible band 2, a preferentially separating zone 31, of the sorting zone type, which is designed "to facilitate the separation of the laying means 10 and". the flexible band 2 after the laying of the latter.
• the preferential separation zone 31 may consist of a constricted or thinned portion forming a preferential fracture or cutting point which allows the practitioner to remove, by ablation, the stem 20 after the latter has been removed. served to introduce Ja
• the device 1 After its establishment and its locking around the body, the device 1 has almost no sa partiesanfes parts and residual space is particularly reduced, which limits the risk of post-operative complications and improves patient comfort .
• the laying means 10 is provided with reversible fixing means 32 designed to allow alternately, under the control of the practitioner, its connection to the device 1 and its separation of said device 1.
• the fastening means 32 advantageously confer on the laying means 10, and more particularly on the freeze 20, a removable character, and the device 1 a modular character.
• Said reversible fixing means 32 may, for example, comprise a serrated protrusion extending foot 21 from the opposite side of the head 22, and intended to co-operate by packaging with a crenellated housing provided for this purpose at the end. end of the tip 30 to allow the assembly of the device 1, te! that this is illustrated in Figures 1 and 2.
• the rod 20, and more generally the means ⁇ e pose 10 will thus be able to form a sort of adaptable rostrum at the end of the flexible band 1 r and can be fixed, preferably substantially centrally, in the extension of said band flexible 2.
• the invention also relates to the removable laying means 10 as such, and in particular to the rod 20 provided with the core 15, to the sheath 16, and to the reversible fastening means thereof. .
• the means for fixing such a laying means 10 are designed such that the latter can be assembled directly out of the end of the flexible strip 2, that is to say into the 30, that is, if the device is provided with an inflation pouch connected to a filling catheter for placing said pouch in communication with an implant-site fluid reservoir at the free end of said catheter.
• the device 1 is provided with a filling catheter connected to or intended to be connected to the flexible band 2 substantially at one end of the latter, the laying means 10, and more particularly the stiffening element 11, can project, and preferably arise, at the other end of the device 1,
• the laying means 10, and more particularly the stiffener 11 may advantageously be mounted or originate near this "of the ends 3, 4 of your flexible band 2 which has the smallest space, that is to say, 3a section where the transverse dimension i less extensive, and more particularly be fixed to the first end 3 which carries the element male 5 means of functionalorrouitiage, upstream of the latter in consideration of the pievu direction of the advance movement F.
• a te! This arrangement makes it possible to drive the soup band 2 in the third retro-gastric passage in a direction of introduction that is relatively more traumatic, that is to say, to make "travel" through the said retro-gastric passageway, since the laying of the device 1, that the first end 3 which is ia less bulky, and therefore ia least traumatic, while the second end 4 opposite, pfus cumbersome, remains recessed without engaging in said passage.
• the fabrics of the duct are only forced into the mesura just necessary and sufficient for placing the device in the room.
• the laying means 10 preferably has a transverse section smaller than that of the flexible band 2.
• the stem Q will preferably have a diameter smaller than the smallest overall transverse dimension of the flexible strip 2, as measured perpendicularly to the direction
• the laying means 10 does not have an excess thickness with respect to the band, so that it does not dig unnecessarily an oversized tunnel with respect to the capacity necessary to accommodate the band.
• transition zone between the laying means 10 and the flexible strip 2 may advantageously comprise spacer means 400 facilitating the eeartement of the tissues that delimit the passage during the insertion of the flexible strip 2.
• the intermediate means 40 may advantageously be constituted by the inclined faces of the lugs 5 originating on the end piece 30 and forming the matt locking means.
• the laying means 10 has a length substantially equal to that of the stiffening element 1.1.
• the length of the laying means 10, and / or that of the grinding element 11, is moreover preferably substantially between 50% and 100% of the length of the flexible strip, and particularly preferably between 60% and 70% of the length of said flexible strip, the length of the flexible strip being here considered as the length of its contact zone, that is to say substantially the value of the perimeter of the member.
• the length of the laying means is greater than the outer perimeter of the member around which the flexible band is to be implanted.
• the laying means 10 is preferably, when in the operating configuration, curved substantially over its entire length, prefer ⁇ ntieltement continuously in a curvature of the same sign.
• the laying means is integrally located projecting from the flexible strip 2 and has an invariant length extension compared to
• the outer diameter of the sheath 16 is preferably between 2 mm and 5 mm, while the diameter of the stiffener 1, which is preferably in the form of a rod or a rope, is as for him substantially between 1, 5 mm and 3 mm.
• the present invention also relates to a surgical method of implanting a medical device, which will now be described in more detail with reference to the preferred embodiment of device 1 illustrated in Figures 1 and 2.
• said surgical method preferably comprises a step (a) of mounting, during which the practitioner integrates the laying means 10 to the device 1 by connecting and fixing the rod 20, preferably by interlocking means of 32, at one of the ends 3 of the flexible band 2, or, if appropriate, at the free end of the catheter connected to
• said method then comprises a step (b) of adjustment, during which the practitioner plastically deforms the rod 20, and more parifculierement the stiffener element 11, to shape the laying means 10 and give it a geometry , and in particular a curvature,
• the practitioner may in particular use the plasticity medium raldisseuF 11 exerting a bending force on the intermediate portion 23 to curl, or conversely straighten it.
• the adjustment step (b) can be performed either directly manually or indirectly, when the device 1 is completely under the skin, in particular in the abdominal cavity, using ocelioscopy instruments.
• step (C) of engagement during which the practitioner penetrates the laying means 10 in the tissues contiguous to the organ, and in particular in the tissues behind the said tissue. member, and advances the delivery means 10 through said tissue so as to bypass the organ until the head 22 emerges tissuedes, substantially opposite the insertion side of the laying means 10 relative to the organ.
• the practitioner can advantageously grasp the rod 20 by its foot 21 and exert on said rod "a thrust force which is transmitted to the head 22 by the intermediate section 23, so that the head 22 compresses the tissue and force a passage through these, according to an advance movement F.
• step (c) of engagement is simultaneously accompanied by a sub-step (d) of perforation, during which the practitioner pierces and dissociates the tissue seated ahead of the head 22, to help the penetrating means 12, in the direction of the advance movement F, as the rod 20 progresses, in order to clear a passage in the sinter mass.
• the practitioner can advantageously directly introduce the means of laying 10 into force in your tissues to thread said laying means 10 around the Romanesque, and possibly guide it by trial and error.
• the rigidity of the rakfesseur element allows ⁇ last to maintain durably the conformation of the laying means 10 chosen by the practitioner, in particular to meet the buckling forces that translate the him
• the practitioner can control Visu ⁇ iiern & nt that f position of the laying means relative to the body substantially corresponds to your configuration in which U wishes to place the flexible band around dudft body.
• the length of the medium cf0 poses 10 is sufficient for the latter substantially materializes the entire trajectory of implementation of the flexible band around the hidden portion, that is to say, not apparent, the perimeter of the organ.
• the practitioner can maneuver the laying means, or even at least partially to brush it back to reintroduce thereafter around the organ and bring it, iterations, to a position it considers appropriate.
• the extraction of the laying means 10 causes a mechanical "call" of the rest of the device 1, by pulling on the end of the flexible strip 2, either directly at the end 30 or indirectly via catheter that acts as a fraction cable.
• the soup band 2 is at the entrance of the passage dug by the laying means in which it penetrates, the spacer means 40 deforming said passage to widen it and facilitate (progression ID in succession of the rest of the flexible band 2.
• Said flexible strip 2 is thus pulled by the laying means 10 and guided by the passage in the wake of said laying means until the latter has substantially circumnavigated the member and its first end 3 emerges from the passage.
• the extraction step (d) is thus accompanied by a sub-step of progressive substitution of the flexible band 2 by means of laying 10 in the passage prefonmê by the latter.
• the second end 4 of the flexible strip 2 is not engaged in the passage and remains permanently emerging on the 0 side of the member where said strip has been introduced.
• the practitioner can then proceed to a separation step e) during which he disengages and moves away from the laying means 10 of the device 1, and more particularly from the flexible band 2, by unlocking the fastening means 32 or, as the case may be, appropriate, by sectioning the junction between the means of laying 10 and your flexible strip 2 at the preferential separation zone 31.
• your flexible band 2 is held in place around the organ during this separation step, thanks to the elastic stress exerted against it by the tissues which constitute the wall of the passage, said flexible band 2 being thus sheathed by a natural holder sleeve and vascuiarisô.
• the practitioner can use the laying means 10, and more particularly the clutch in the sleeve forming the female locking means ⁇ , in order to engage the male locking means 5 in the latter and thus close the device 1 by blocking in position around the body.
• the delivery means When the delivery means is attached to the catheter, it can then be disconnected from the catheter and replaced by the exciting site.
• this closing step of the ring can also, as the case may be, be performed after the step (e) of separation.
• the impenetrable medical device according to the invention advantageously forms an autonomous device, which can be set up simply and safely by its own means, requiring a minimum of surgical gestures, which contributes to reducing the difficulty, the duration, and the risks of the intervention.
• the device 1 according to the invention advantageously has a slit, compact and substantially alumina structure.

Applications Claiming Priority (2)

Publications (1)

Family

ID=41056716

Family Applications (1)

Country Status (5)

Families Citing this family (4)

Family Cites Families (8)

• 2009
  • 2009-01-28 FR FR0950530A patent/FR2941366B1/fr not_active Expired - Fee Related
• 2010
  • 2010-01-27 WO PCT/EP2010/050946 patent/WO2010086335A1/fr active Application Filing
  • 2010-01-27 EP EP10705315A patent/EP2391313A1/de not_active Withdrawn
  • 2010-01-27 BR BRPI1006886A patent/BRPI1006886A2/pt not_active IP Right Cessation
  • 2010-01-27 US US13/146,109 patent/US20120022320A1/en not_active Abandoned

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events