WO2015195263A1 - Sphincter oesophagien artificiel - Google Patents

Sphincter oesophagien artificiel Download PDF

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Publication number
WO2015195263A1
WO2015195263A1 PCT/US2015/031661 US2015031661W WO2015195263A1 WO 2015195263 A1 WO2015195263 A1 WO 2015195263A1 US 2015031661 W US2015031661 W US 2015031661W WO 2015195263 A1 WO2015195263 A1 WO 2015195263A1
Authority
WO
WIPO (PCT)
Prior art keywords
outer ring
implant
sheath
arms
flexible shaft
Prior art date
Application number
PCT/US2015/031661
Other languages
English (en)
Inventor
Timothy S. Bedard
Frederick E. Shelton, Iv
Original Assignee
Ethicon Endo-Surgery, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Publication of WO2015195263A1 publication Critical patent/WO2015195263A1/fr

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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A61F5/0079—Pyloric or esophageal obstructions
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044—Oesophagi or esophagi or gullets
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the present artificial sphincter relates in general to surgical devices and
  • the insufflated cavity is
  • Surgical access devices are often used to facilitate surgical
  • trocars are often used to provide a port through which endoscopic
  • Trocars generally have an instrument seal,
  • Endoscopic surge ry may also be performed in the
  • 25 may be performed in the absence of insuffiatory gas, as the rib cage provides
  • the present disclosure concerns apparatus and methods for improving the function of biological passages.
  • the ability of biological passages to expand and contract actively or passively to regulate the flow of solids, liquids, gases, or combinations thereof, may be compromised by defects or disease.
  • Gastro Esophageal Reflux Disease hereinafter, "GERD " ), which effects the esophagus.
  • Other bod passages that may be subject to dysfunction, defect, and disease include, but are not limited to, a fallopian tube, a urethra (for example, in the case of incontinence), and a blood vessel (for example, in the case of an aneurysm). GERD and esophageal dysfunction will be further described herein for the sake of illustration.
  • the normal healthy esophagus is a muscular tube that carries food from the mouth through the chest cavity and into the upper part of the stomach.
  • a smali--valved opening in the distal esophagus called the lower esophageal sphincter (hereinafter, "LES"), regulates the passage of food into the stomach.
  • the LES muscle presents a barrier to the reflux of acid or food back into the esophagus.
  • the LES also regulates the stomach intra-gastric pressures, regulating acidic gases from refiuxing from the stomach back into the esophagus.
  • the LES when functioning properly, will open to allow gases to be vented from the stomach.
  • a healthy LES at rest can resist, pressure from stomach gases that, are at least. 10 mm Hg greater than normal intragastric pressure. This pressure difference can regulate the amount of acidic fluid that refluxes from the stomach into the esophagus.
  • the LES is controlled largely by two components.
  • the primary component is intrinsic smooth muscle of the distal esophagus wall.
  • the second component is the skeletal muscle of the crural diaphragm or esophageal hiatus.
  • the diaphragm is a muscle separating the stomach from the chest. Studies have shown that the diaphragm may act as a sphincter around the lower end of the esophagus.
  • the esophageal hiatus is the opening in the diaphragm where the esophagus attaches to the stomach.
  • GERD esophageal reflux
  • Normally occurring mechanisms that diminish or prevent GERD include peristaltic squeezing by the esophageal body, gravity (when a person is in an upright position), and neutralization by saliva.
  • Drugs may be required to manage symptoms of the damage and medical intervention, including surgical or endoscopic procedures, may be required to repair the damage.
  • the lining of the esophagus is called mucosa. Chronic exposure to stomach gases may cause the mucosa to become inflamed or ulcerated.
  • inilamed or ulcerated mucosa may lead to problems tha may require medical intervention.
  • Hiatal hernias are often associated with GERD. If the esophageal hernia becomes enlarged (herniated), the LES function may be compromised and the risk of GERD increased. (A hiatal hernia occurs when the upper portion of the stomach moves up through an opening in the diaphragm.)
  • Barrett's Esophagus is a disease of the esophagus that may compromise esophageal function. This disease may occur when the tissue that ordinarily lines the esophagus migrates away from the lower part of the esophagus to avoid exposure to the acidic fluids against the sensitive mucosa. Barretts Esophagus is often a. precursor to esophageal cancer.
  • Dyspepsia The most common symptom of GERD is dyspepsia (commonly known as "heartburn”).
  • Dyspepsia may be defined as an acute burning sensation in the chest area typically, behind the sternum.
  • Other symptoms of GERD may include hemorrhage, pulmonary disorders, chronic cough, intermittent wheezing, ulcers, Barrett's esophagus, and esophageal cancer.
  • GERD GERD
  • This highly invasive procedure is often initially successful, but has a high risk of morbidity including esophageal tears, tears of the spleen, subphrenic abcess, dysphagia, inability to vomit or belch, epigastric distension and persistent esphagitis.
  • GERD GERD
  • suturing may be performed endoscopically using a suturing device on the end of an endoscope inserted into the esophagus through the mouth. Endoscopic procedures are less invasive than open surgery, but still require surgical incisions and great skill.
  • Surgical procedures may relocate and affix existing tissue of the stomach, esophagus, or both to add support and structure to the LES.
  • LES strength is increased by the added support, thus reducing the incidence of reflux.
  • Fig. 1 depicts is a sectional view of an illustrative biological passage
  • Fig, 2 is an illustrative view of a human esophago -gastric junction
  • 1 Fig, 3 is an cross-sectional view of an artificial sphincter implant
  • Fig. 4 is a cross-sectional, view of a petal from the Fig. 3 implant ;
  • FIG. 5 is a partial cut-away view of the Fig. 3 sphincter
  • Fig. 6 is an isometric view of one expression of an artificiai sphincter implant ;
  • Fig. 7A is an isometric view of an artificial sphincter implant loaded onto an
  • Fig. 7B is a partial cross sectional view of the Fig. 7 A implant on a deployment
  • Fig. 7C is a cross sectional view of an artificial sphincter implant deployment
  • 10 Fig. 7D is a cross sectional view of anchor deployment
  • FIG. 7E is an isometric cut-away view of the Fig. 7A artificial sphincter
  • Fig. 8A is a close-up cross sectional view of implant placement before anchor
  • Fig. 8B is a close-up cross sectional view of anchor deployment
  • FIG. 8C is a close-up cross sectional view of anchors deployed into a biological
  • Fig. 9A is an isometric view of another expression of an artificial sphincter
  • Fig. 9B is an isometric view of another expression of an artificial sphincter
  • Fig. 9C depicts the Fig. 9B implant in a closed state
  • FIG. 10A, 10B and IOC depict an artificiai sphincter prior to implantation
  • FIG. 11A, 1 1B and l lC depict a substance passing through one expression of
  • Figs. I2A and 12B depict a substance passing through another expression of
  • the devices and methods disclosed herein relate to providing an artificial sphincter apparatus and method for placing the same in a body lumen.
  • the device may be used in a variety of biological lumens, including, but not limited to, the alimentary canal, particularly the distal esophagus.
  • Some expressions of the artificial sphincter may include an annular body that defines a central axis. (The axis may follow an approximately central path through the body and in some expressions may not be a straight line.) The central axis may define an axial, or longitudinal, direction. A plane
  • an axial plane perpendicular to or nearly perpendicular to the central axis.
  • At least one anchor may be coupled to the body.
  • anchor may refer to a single barb or quill or, anchor may refer to a plurality of barbs or quills as a collective anchor.
  • the anchor may be configured to engage a portion of the passage, for example, a portion of a passage wall.
  • the anchor may be configured to engage a portion of a passage inner wall.
  • the body may include an elastic material.
  • the body may include an inert material.
  • the body may include a mo!dahle material.
  • a material that is biocompatible and resistant to reaction with biochemical solids, liquids, and gases may be an inert material.
  • Stainless steel, nickel titanium alloy, tantalum and other non- reactive metals may be inert.
  • Polymers such as PTFE, polyurethane, polyamide, and those sold under the trademark PEBAX by Elf Atochem North America may be inert. Medical grade metals and polymers ma be inert.
  • the anchor may extend radially away from the axis and in some expressions is oriented normal to an outer surface of the band portion of the artificial sphincter.
  • the anchor may extend in a non-radial direction away from the axis.
  • the anchor may extend in a curved path away from the axis.
  • the anchor may be pushed radially outward into the inner wall.
  • the anchor may be twisted or rotated about the axis to engage the inner wall.
  • the anchor may include an elastic material.
  • the anchor may include a metal
  • the anchor may include an alloy.
  • the anchor may include a polymer.
  • the anchor may include inert material.
  • the anchor may be any suitable type of anchor, including any of the anchors described herein.
  • the anchor may be comprised of an absorbable material (e.g. polyglycolic acid, polyiactic acid, polydioxanone, PCL, organics - cellulose, collagen) and /or absorbable material that promotes tissue growth.
  • one or more anchors may be present in or near an axial plane of the body.
  • the axial plane may remain stationary or nearly stationary in the longitudinal direction when the body is deformed in the radial direction.
  • This feature may reduce stress on the passage wall near an anchor if the bod ⁇ ' deforms in connection with deployment in the passage.
  • the feature may reduce stress on the passage wall near the anchor if the body deforms in response to deformatio of the biological passage.
  • the biological passage may deform in response to muscular action, physiological processes, or any other processes.
  • the passage may deform in response to peristalsis, circulatory pumping, excretory processes, reproductive processes, or other physiological processes.
  • the anchor may be shaped like a barb or quill.
  • the anchor may be include a "catch".
  • a catch is a feature of an anchor that may be used to resist the withdrawal of the anchor from tissue.
  • a catch may be used to pinch or pin tissue.
  • a catch may hook into tissue (for example, as does a barb).
  • the anchor may include a staple.
  • the staple may be C-shaped.
  • the artificial sphincter may include a sheath that may be drawn over the body to protect the inner wall of a biological lumen from the anchors, for example, when the body is being inserted into the biological passage.
  • the sheath may deflect the anchor away from a direction extending radially away from the body axis. The sheath may be removed to engage the anchor with the inner wall.
  • Some expressions of the artificial sphincter may include a coating.
  • the coating may cover the entire surface of the body.
  • the coating may cover a portion of the body.
  • the coating may include an inert material.
  • the artificial sphincter may include a therapeutic substance.
  • the substance may be present in or on the body.
  • the substance may be present in the anchor, on the anchor, or both.
  • the substance may be present in or on the lining.
  • the substance may be embedded in a porous portion of the artificial sphincter.
  • the substance may elute from a portion of the artificial sphincter into the tissue of the biological passage.
  • the substance may include an agent configured to heal the tissue from a disease, defect, infection, inflammation, trauma, or any combination thereof.
  • the substance may include an agent configured to physically protect the tissue from acidic compounds.
  • the substance may act to neutralize an acidic compound.
  • the substance may be a drug.
  • the substance may include a steroid.
  • the substance may include an antibiotic.
  • Some expressions of the artificial sphincter may include anchor
  • the deployment means may be configured to apply force to the anchor to drive the anchor into the inner wall of the biological passage.
  • the anchor may have prongs and be shaped like a staple, a "C", a. "U”, a. barb or any other suitable form.
  • the deployment means may be used to drive the barbs or bend the prongs to engage the biological passage.
  • the deployment means may be used to secure the prongs to the biological, passage.
  • the anchor may be insert molded into a portion of the body.
  • the anchor may be wholly or partially embedded in the polymer.
  • the anchor may be made from a material that is less elastic than the polymer.
  • the body portion housing the anchor When the body is expanded away from the axis, the body portion housing the anchor may become thinner in the radial dimension. As the body portion thins, the anchor may protmde through and extend radially beyond the portion. This feature may permit the device to be inserted into the passage with the anchor in a retracted position. The feature may permit the anchor to be exposed or "activated" automatically as the body is expanded.
  • the body may include portions having different relative flexibilities. Some portions may have high flexibility. Some portions may have low flexibility. One or more anchors may be coupled to a low flexibility portion. One or more anchors may be coupled to a high flexibility portion. When the body expands, contracts, or otherwise deforms (for example, in response to peristalsis or other motion), the deformation may be concentrated in the portions having high relative flexibility.
  • An anchor or anchors coupled to a low flexibility 7 portion may be subject to less stress, less displacement, or both than if coupled, to a relatively high flexibility portion.
  • High flexibility portions may be, for example, thin, long, elastic, extensible, rotatable, or otherwise compliant.
  • Low flexibility portions may be, for example, thick, short, inelastic, fixed against rotation or shorter, or otherwise noncompliant.
  • the artificial sphincter may have annular outer body with barbs protruding normally from the outer surface of the body.
  • the annular outer body and barbs may be coaled with a short term adhesive to promote fixation such as eyaiioaerylate, fibrin glue or oxidized regenerated cellulose.
  • the inner artificial sphincter body may have magnetic petals or leaves attached to or integrally formed into the inner surface of the body. The magnetic petals or leaves open as the biological lumen peristalses as will be more fully described herein.
  • the annular bod. ⁇ ' may be comprised of flexible, biocompatible material adapted for placement in a biological lumen.
  • the artificial sphincter may be entirely over molded in a biocompatible material where that biocompatible material has nano -features to promote tissue in- growth.
  • the artificial sphincter may include a deployment apparatus (e.g. a catheter) for inserting the body into the biological passage.
  • the body may be installed in the biological passage by placing the body in a portion of the passage, expanding the body, engaging the anchor or anchors with the passage inner wall, and allowing the body to relax.
  • the body may be expanded and the anchor or anchors secured in the inner wall using a balloon.
  • the body may be expanded sufficiently to partially engage the anchor or anchors with the wall.
  • a deployment means may be used to complete the engagement of the anchor or anchors with the wall.
  • the deployment means may be used to secure the anchor or anchors in the wall without previous partial engagement of the anchor or anchors.
  • the artificial sphincter may include a coating for a portion of the biological passage. Some of those expressions may include one or more anchors to secure the coating to the biological passage.
  • the coating may include a first plurality of anchors, a second plurality of anchors, and a sleeve. The sleeve may extend from the first plurality of anchors to the second plurality of anchors. The sleeve may be configured to conform to the inner wall of the biological passage.
  • the coating may include a polymer such as PTFE, polyurethane, polyamide, and PEBAX ⁇ .
  • the coating may include any suitable medical polymer.
  • the coating may include any suitable material that does riot readily react with biological fluids such as stomach acid, biological waste, or other materials that may be present in a biological passage.
  • FIGS. 1 and 2 show esophageal anatomy.
  • FIG. 1 shows health ⁇ ' esophagus 2, including distal esophagus 3 connected to stomach 4.
  • LES 6 is located at the junction of esophagus 2 and stomach 4 where esophagus 2 passes through hiatus 8 in hiatal diaphragm 10.
  • Sling fibers 12 in LES 6 are smooth muscle tissue that may regulate distal esophagus 3.
  • Hiatus 8 may externally support and regulate LES 6.
  • LES 6 is normally open at rest.
  • Implant 300 is annular in shape and is comprised of an outer retaining ring 310, an inner ring 320 and overlapping petals 330A--330D. Peta ls 330A-330D partially form an artificial valve.
  • the rings 310 and 320 as well as the petals 330A-D may he arranged annular ly around a central axis (not shown) .
  • Retaining ring 310 may be flexible in nature and may be comprised of any flexible polymer suitable for implant in a living bod ⁇ ' as is known and understood in the art.
  • Petals 330A-330D may be comprised of flexible bio -compatible polymer having embedded magnets with poles oriented in such a manner that the petals flex distally to permit passage of a substance e.g. food and return to the closed position.
  • the flexible petals provide for a variably-sized bore depending upon peristaltic force as well as the size and type of substance passing therethrough.
  • the petals 330A-330D may be comprised of a magnetic polymer where the magnet is formed from rare earth magnets NdFeB (Neodymium iron Boron), AINiCo (Aluminum Nickel Cobalt) SmCo (Samarium Cobalt), strontium ferrite and barium ferrite.
  • Paramagnetism materials like: Cr(NH3)6IBr3, K3[Cr(CN)6], K3[MoC16j , K4[V(CN)6], [Mn(NH3)6
  • Paramagnetism is a form, of magnetism, whereby certain materials are attracted by an externally applied magnetic field. In contrast with this behavior, diamagnetic materials are repelled by magnetic fields. Paramagnetic materials include most chemical elements and some compounds; they have a relative magnetic permeability greater than or equal to 1 (i.e. , a positive magnetic susceptibility) and hence are attracted to magnetic fields. Ferromagnets include iron, nickel, cobalt, and manganese, or their compounds (FE, CO, Ni, Cd, Dy, Cr02, MnAs, MnBi, EuO, NiO /Fe, Y3Fe5012, and others).
  • magnets biocompatible they may be coated with or
  • non- absorbable plastic like PEEK, Polypropylene, high 1 density polyethylene, and polycarbonate. They could also be plated or
  • DLC diamond-like carbon
  • EPP expanded polypropylene
  • high density polyethylene high density polyethylene
  • elastomer ca be used e.g. isoprene or sanoprene.
  • the coatings of DLC or 10 bioglass can also be used for elastically deformable magnets.
  • petals 330A-330D are comprised of
  • a flexible magnet may be composed of a high-coercivity
  • 19 distance may be on the order of 5mm, but varies with, manufacturer and
  • the plastics can be PEEK, Polypropylene, high density
  • the pole - pole 21 polyethylene, polycarbonate or any other biocompatible polymer.
  • flat flexible magnets are made from composite materials and can have
  • FIG. 29 Figure 4 depicts a single petal 330C from implant 300. As is shown in
  • the petal 300C extends approximate! ⁇ ' 225° around an axis parallel to
  • the petals 330 in one expression, may have magnetic properties
  • FIG . 5 depicts another expression of implant 300.
  • petals 330A-330D where the lateral annular edge of each petal 330 10 is provided with an attachment means 540 that retain a filament 530.
  • I I Attachment means 540 may be a raised cut-out. defining an annulus or may be
  • Filament 530 is preferably
  • 16 filament 530 and petals 330 may be coated or extruded with a silicone coating
  • 18 filament 530 is attached to petals 330, an expandable, absorbable lattice
  • the lattice structure may be formed
  • the absorbable lattice 520 may be comprised of polyglycolic acid,
  • retainer 515 may be
  • 28 surface may further be provided with small cleats (approximately 100-250 ⁇
  • Retainer 515 is further provided
  • Anchors 510 penetrate the mucosa and into the muscularis of the lumen (e.g. 1 the esophagus) to anchor the implant 3(50 into position during tissue in-
  • Anchor 510 and barbs are preferably
  • Implant 300 may have a variety of petal geometries.
  • FIG. 6 depicts an
  • implant 300 is comprised of an outer retaining ring 615 A, Like the FIG. 5 10 expression, retaining rings 615 may be absorbable. Ring 615 is configured
  • Ring 615 is fixedly attached to band 660 and may be comprised of
  • rings 6 ISA and B and ring 660 may be one contiguous structure.
  • Petals 630 may each be configured with internal magnets to fix the petals 630
  • the petals 630 may be a polymer
  • FIG. 6 expression is
  • anchors 610 that serve to fix implant 300 in a hollow
  • anchors 610 are comprised of quills oriented
  • Rings 615A & B are
  • implant 300 is shown. In FIG. 7A, implant 300 is oriented about deployment
  • Deployment mechanism 700 is provided with an elongate shaft 705 of suitable 1 length to fit down an endoscope working channel.
  • a sheath 715 is disposed
  • a plurality of arms 720 are
  • FIG. 7 expression four arms 720 are provided but it is contemplated that as
  • the arms 720 may be staggered such that alternating arms
  • rings 615A and 615B are folded medially. Interior surface
  • rings 615A and 615B may be provided with annuli that mate with
  • depkryment arms 720 10 protrusions on depkryment arms 720, FIG. 7B.
  • deployment arms 720 10 protrusions on depkryment arms 720, FIG. 7B.
  • implant 300 expands to contact the interior lumen
  • a second deployment apparatus 730 is utilized to move rings
  • petals 19 orientation of petals 630, petals are biased back to a closed state as shown in
  • FIG. 7E after removal of deplo_yment mechanism 700.
  • deployer 700 may be used with the FIG. 3 expression as well.
  • FIG. 8A a close up view of rings 615A and 615B as well
  • rings 615A and 615B are show folded
  • 26 615B may be provided with annuli ⁇ not shown) that mate with projections on
  • balloons 730 may be provided with a pressure sensitive
  • anchors 610 are disposed about rings 615 in less than a normal orientation
  • rings 615A and 615B and ring 660 are of unitary construction. As discussed above, rings 615 and 660 may be discrete components or a unitary ring as is known and understood in the art.
  • implant 300 is located in an appropriate deployment, position in a biological lumen, arms 720 are deployed. Once arms 720 are deployed, implant 300 is biased against the lumen wail. Balloons 730 are then inflated as shown in FIG. 8B. As balloons 730 are filled with an appropriate substance e.g. saline via fill tubes 800, rings 615 move from a medial folded position to contact lumen wall 800. As rings 615 deploy, anchors 610 or quills 510 pierce the lumen wall sufficiently to retain implant in a fixed position relative to the lumen wall 810 as shown in FIG. 8C. As shown in FIG. 8C, quills or anchors 510, 6.10 may penetrate through the submucosa and into the muscularis 815.
  • an appropriate substance e.g. saline via fill tubes 800
  • rings 615 move from a medial folded position to contact lumen wall 800.
  • anchors 610 or quills 510 pierce the lumen wall sufficiently to retain implant in a fixed position relative
  • FIGS. 9A - 9C another expression of implant 300 is depicted as implant. 900.
  • the FIG. 9 implant has an outer ring 915 that may have outer rings as set forth in FIGS. 5 and 6 alo g with anchors or quills disposed about, ring 915's outer surface,
  • a plurality of magnets S)20 is oriented such that their poles are arranged end to end In an approximately annular arrangement about axis 950.
  • magnets 920 are encased in highly flexible silicone sheath 925 which permits the magnets to move toward and away from each other thereby pursing sheath 925.
  • Another plurality of magnets 930 may be arranged in the same manner as magnets 920 and are further enclosed in highly flexible silicone sheath 940 where the sheath permits the movement of magnets 930 toward each other but prevents magnets 930 from overlapping with magnets 920.
  • This arrangement of magnets 920 and 930 allows silicone 925 and 940 to bunch or purse thereby occluding a lumen forming a valve.
  • the magnetic force between magnets 920 and the force between 930 is not so sufficiently great that normal peristalsis cannot force a substance e.g. food or water through opening 960. As shown, opening 960 is in a partially opened state.
  • magnets 920 and 930 are arranged in an annular fashion about axis 950 where axis 950 defines a central lumen through implant 900. Magnets 920 and 930 may be organized in any fashion to accomplish the goal of permitting opening and closing of opening 960 through normal peristalsis as is known and understood in the art.
  • plurality of outer ring magnets 920 are embedded in a flexible biocompatible material e.g. silicone forming an outer magnetic ring.
  • a plurality of inner ring magnets 930 are embedded in flexible biocompatible material as well.
  • Polarity of rings 920 and 930 are arranged in such a fashion that ring 920 repels ring 930 thereby biasing implant to a closed state.
  • Ring 930 magnets are oriented with respect to each other such that they occlude opening 960.
  • the relative repulsion between rings 920 and 930 and the magnetic strength of ring magnets 930 are such that normal peristalsis forces individual magnets in rings 920 and 930 to move away from each other such that opening 960 is created permitting passage of food.
  • magnets 970 are generally spherical and are arranged about axis 950. Magnets 970 are spaced apart by spacers 975 and spacers 975 and magnets 970 are retained relative to one another by cord 980 where cord 980 passes through annuli in magnets 970 and spacers 975.
  • Cord 980, magnets 970 and spacers 975 are provided in a highly flexible silicone bag 980 such that when magnets 970 and spacers 975 are in a relaxed state, bag 980 occludes opening 960 (see FIG. 9C).
  • the FIG. 9B expression may be provided with rings 915 and anchors or quills as set forth above.
  • FIGS. 10A - 10B implant 300 is shown at various times after implantation.
  • FIG. 10A depicts implant 300 just after im.planta.fion where implant fixation is reliant upon holding strength of anchors or quills 510, 610.
  • FIG. 10B depicts ring 515, 615 beginning to break down thereby permitting and stimulating tissue in growth 1005, Ring 515, 615 may be comprised of materials that promote tissue growth such as in one expression the, ring 515, (515 can include both hydrophilic portions and hydrophobic portions to form a hydroph.ilic-h.ydroph.obic adjunct, material. The resulting combination can.
  • hydrophobic portions can be placed in contact with the tissue, while the hydrophobic portions can be oriented away from the tissue surface.
  • synthetic polymers used to form adjunct materials can be hydrophobic, such as polycapro lactone (PCL) and polylactic acid (PLLA). It is noted that "polymers" as used herein can include copolymers, Synthetic adjunct materials, however, can be treated or otherwise produced to be hydrophilic, as will be discussed herein.
  • any method of creating a synthetic material having a hydrophilic portion and a hydrophobic portion can be used. In some embodiments, a surface of (or only half of) a. hydrophobic adjunct material is treated with an acid or base which can cause the formation of pockets or pits in the surface. Alternatively, the adjunct material can be formed by bonding a hydrophilic layer to a
  • an adjunct material can be treated such that the entire adjunct material becomes hydrophilic. Then this hydrophilic layer can be bound, such as by laminating, to a. second hydrophobic adjunct material layer creating a material that is hydrophobic and hydrophilic.
  • Various approaches can be used to create an adjunct material or matrix where a tissue contacting portion encourages cellular ingrowth while a non-tissue contacting portion discourages cellular ingrowth.
  • anchors 510, 610 and rings 5.15, 615 have been fully absorbed.
  • Mucosa 1010 is fully grown into scaffold 530, 635.
  • implant 300 After implanting, implant 300, as depicted in FIG. .11 A, Is situated in the esophagus 2 and is substantially located at the junction of the esophagus 2 and the stomach 4.
  • FIG. 1 IB implant 300 and petals 630 are depicted in an "open" state in response to esophageal peristalsis. A bolus of food is shown passing through the opening created by the expansion of implan 300 as well as the distal extension of petals 630. After the food passes through implant 300, petals 630 return to a closed state as shown in FIG. I I.C.
  • FIG. 12A a cross-section of the FIG. 5 expression of implant 300 is shown in an implanted state.
  • the overlapping nature of petals 330 is depicted.
  • implant 300 expands normal to axis 1200 (the direction of peristalsis and food movement) as shown in FIG. 12B. This normal expansion creates an opening about axis 1200 in petals 330 permitting passage of food past implant 300.

Abstract

L'invention concerne un implant chirurgical, un appareil de mise en place et un procédé d'insertion de ceux-ci dans une lumière biologique. L'implant comporte une bague extérieure présentant une paroi extérieure et une paroi intérieure, la bague extérieure étant placée autour d'un axe central. L'implant comporte en outre une bague intérieure adjacente à la paroi extérieure de la bague extérieure, placée autour de l'axe central et délimitant une ouverture annulaire. L'implant comporte un clapet fixé de manière flexible à la bague intérieure et placé autour de l'axe central, le clapet obturant sensiblement l'ouverture annulaire dans un premier état, et s'ouvrant élastiquement de manière à produire un trou de dimension variable, dans un second état, pour permettre le passage d'une substance à travers la lumière.
PCT/US2015/031661 2014-06-20 2015-05-20 Sphincter oesophagien artificiel WO2015195263A1 (fr)

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US14/310,329 2014-06-20

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113382697A (zh) * 2019-01-22 2021-09-10 利恩医疗技术有限公司 肥胖症治疗装置和方法

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US5151105A (en) * 1991-10-07 1992-09-29 Kwan Gett Clifford Collapsible vessel sleeve implant
US20010020190A1 (en) * 1997-12-09 2001-09-06 Taylor Thomas V. Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof
FR2828091A1 (fr) * 2001-07-31 2003-02-07 Seguin Jacques Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
US20040236406A1 (en) * 2003-05-20 2004-11-25 Scimed Life Systems, Inc. Mechanism to improve stent securement
US20050096750A1 (en) * 2002-11-01 2005-05-05 Jonathan Kagan Apparatus and methods for treatment of morbid obesity

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5151105A (en) * 1991-10-07 1992-09-29 Kwan Gett Clifford Collapsible vessel sleeve implant
US20010020190A1 (en) * 1997-12-09 2001-09-06 Taylor Thomas V. Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof
FR2828091A1 (fr) * 2001-07-31 2003-02-07 Seguin Jacques Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
US20050096750A1 (en) * 2002-11-01 2005-05-05 Jonathan Kagan Apparatus and methods for treatment of morbid obesity
US20040236406A1 (en) * 2003-05-20 2004-11-25 Scimed Life Systems, Inc. Mechanism to improve stent securement

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113382697A (zh) * 2019-01-22 2021-09-10 利恩医疗技术有限公司 肥胖症治疗装置和方法

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