WO2013152283A1 - Procédé et appareil pour occlure un vaisseau sanguin - Google Patents

Procédé et appareil pour occlure un vaisseau sanguin Download PDF

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Publication number
WO2013152283A1
WO2013152283A1 PCT/US2013/035435 US2013035435W WO2013152283A1 WO 2013152283 A1 WO2013152283 A1 WO 2013152283A1 US 2013035435 W US2013035435 W US 2013035435W WO 2013152283 A1 WO2013152283 A1 WO 2013152283A1
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WIPO (PCT)
Prior art keywords
component
occluder
hollow structure
distal portion
proximal portion
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PCT/US2013/035435
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English (en)
Inventor
Arnold Miller
Avraham Rami Lore
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Amsel Medical Corporation
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Publication of WO2013152283A1 publication Critical patent/WO2013152283A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982—General structural features
    • A61B2017/00986—Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • This invention relates to surgical methods and apparatus in general, and more particularly to surgical methods and apparatus for the occlusion of blood vessels and the treatment of varicose veins.
  • This invention also relates to a minimally invasive means for fastening mechanical structures to tissues or blood vessels, for example, for drug delivery.
  • Veins lie within all tissues. Veins return blood to the heart. When muscles in the leg contract, blood is pumped back to the heart. Valves inside the veins direct the flow of blood back to the heart.
  • the veins are relatively weak tubes. Under the skin there is no support for these veins, so that when the pressure in the veins is elevated, areas of weakness occur and the veins enlarge, both in size and length. In some cases the veins can become twisty and bulge significantly. This condition is commonly referred to as varicose veins.
  • Very small varicose veins are sometimes called spider veins. Unlike the larger varicose veins, these spider veins lie in the skin.
  • the cause of the increased pressure in the veins is due to the occurrence of "leaky” valves within the veins.
  • the main valve is in the groin region, i.e., in the great sapheous vein near the sapheno-femoral junction. See Fig. 1, which shows a leg 5 of a patient, the femoral vein 10, the great saphenous vein 15, the sapheno-femoral junction 20, and the main valve 25 in the great saphenous vein near the
  • the problem is primarily cosmetic.
  • the veins bulge and look unsightly.
  • varicose veins Treatment of varicose veins is undertaken for relief of the symptoms, i.e., the removal of the unsightly veins and the prevention of the discomfort and late-stage manifestations described above.
  • the simplest treatment is a non-surgical
  • fitted elastic stockings strong enough to overcome the increased pressure caused by the "leaky” valves, are used.
  • the aim of the surgical/interventional treatment is (i) the elimination of the cause of the high venous pressure (i.e., the "leaky” valves at the groin); and
  • a sclerosant i.e., a substance irritating to the tissues
  • a sclerosant i.e., a substance irritating to the tissues
  • Venous ablation for varicose veins can be any type of vein
  • Percutaneous laser treatment is primarily an
  • a special laser or radio-frequency (RF) catheter is introduced, with local anesthesia, through a needle puncture into the main superficial vein (i.e., the saphenous vein) of the leg. Entry is made in the region around the knee, and the catheter is passed up towards the groin, advancing to the site where the saphenous vein joins the deep veins at the site of the main "leaky” valves.
  • RF radio-frequency
  • the laser light or radio-frequency (RF) energy heats up the wall of the vein, endoluminally coagulating the proteins and destroying the lining surface of the vein.
  • RF radio-frequency
  • RF radio- frequency
  • anesthesia either in an operating room or a
  • the disadvantages of endovenous laser/radio- frequency (RF) therapy include: (i) generally, only one leg is done at a time; (ii) the procedure
  • the aim of open surgery is to eliminate the
  • saphenous vein which, in 50-60% or more of varicose vein patients, is not involved in the varicose vein process and is otherwise normal and hence usable for other procedures (such as a bypass graft in the heart or limbs ) .
  • the surgery is performed in the operating room under light general or regional (spinal or epidural) anesthesia.
  • An incision e.g., 1-2 inch
  • the wound is closed with absorbable sutures from within.
  • small (e.g., 2-4 mm) stab wounds are made over any unsightly varicose veins (these veins are marked out just prior to the surgery with the patient standing) and the varicose veins are completely removed.
  • the small stab wounds associated with removal of the marked-out veins are generally so small that they typically do not require any stitches to close them.
  • the leg is wrapped in elastic bandages (e.g., Ace wraps).
  • the dressings and Ace wraps are usually changed in the doctor's office at the first post-operative visit, typically within 24 hours of the open surgical procedure.
  • the patient and a family member or friend is instructed on proper care of the wounds.
  • a simple dressing is applied to cover the small wounds in the legs for the next 2-3 days. After 2-3 days no further treatment is generally required. Recovery is generally rapid, with the patient returning to work within 5-7 days.
  • the wounds are minimal, with minimal discomfort which is easily managed with oral analgesics (i.e., pain medicine); (iv) the results are generally
  • varicose veins present a significant problem for many patients which must be addressed, and all of the current procedures for treating varicose veins suffer from a number of significant disadvantages.
  • the present invention provides a new and improved approach for treating varicose veins and other blood vessels .
  • a novel occluder which is used to occlude a vein (e.g., the proximal saphenous vein, the small saphenous vein, tributaries, the perforator veins, etc.) so as to restrict blood flow through the vein and thereby treat varicose veins below the point of occlusion.
  • a vein e.g., the proximal saphenous vein, the small saphenous vein, tributaries, the perforator veins, etc.
  • the novel occluder is configured to be deployed using a minimally-invasive approach (i.e., either
  • visualization apparatus e.g., CT, MRI , X-ray etc.
  • the novel treatment can be provided in a doctor's office, with minimal local anesthetic, and effectively no post-operative care.
  • apparatus for occluding a blood vessel comprising:
  • an occluder the occluder being configured so that at least a portion of the occluder may assume (i) a diametrically-reduced configuration for
  • a method for occluding a blood vessel comprising:
  • providing apparatus comprising:
  • an occluder the occluder being configured so that at least a portion of the occluder may assume (i) a diametrically-reduced configuration for
  • apparatus for delivering a substance to a location adjacent to a blood vessel comprising:
  • a carrier configured so that at least a portion of the carrier may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a
  • the substance will be disposed adjacent to the blood vessel.
  • a method for delivering a substance to a location adjacent to a blood vessel comprising:
  • providing apparatus comprising:
  • a carrier configured so that at least a portion of the carrier may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a
  • apparatus for percutaneously occluding a hollow structure comprising: an occluder, said occluder comprising a first component and a second component, wherein said first component is configured so that it may assume (i) a diametrically-reduced configuration for disposition within the lumen of a hollow tube, and (ii) a
  • diametrically-expanded configuration for disposition adjacent to the hollow structure, whereby to occlude the hollow structure, and further wherein said second component percutaneously connects said first component to a site remote from said first component.
  • a method for percutaneously occluding a hollow structure comprising:
  • providing apparatus comprising:
  • an occluder comprising a first component and a second component, wherein said first component is configured so that it may assume
  • an occluder for occluding a hollow structure, wherein the occluder is configured to be
  • the occluder percutaneously delivered to an internal site and thereafter expanded so as to cause complete or partial occlusion of the hollow structure, and further wherein the occluder is configured so that the expansion of the occluder may thereafter be reversed in full or in part so as to completely or partially restore the hollow structure to its original condition.
  • a method for occluding a hollow structure wherein an occluder is percutaneously delivered to an internal site and thereafter expanded so as to cause complete or partial occlusion of the hollow structure, and further wherein the occluder is configured so that the expansion of the occluder may thereafter be reversed in full or in part so as to completely or partially restore the hollow structure to its original condition.
  • apparatus for occluding a hollow structure wherein the apparatus comprises an occluder, a device for percutaneously delivering the occluder to an internal site and deploying the occluder so that it completely or partially occludes the hollow structure, and a device for removing some or all of the occluder so as to completely or partially restore the hollow structure to its original condition.
  • a method for treating a patient comprising percutaneously delivering an occluder to an internal site so that it completely or partially occludes the hollow structure, and further wherein the method comprises thereafter removing some or all of the occluder so as to completely or partially restore the hollow structure to its original condition.
  • Fig. 1 is a schematic view showing various aspects of the venous system of the leg
  • FIGs. 2-4 are schematic views showing an occluder occluding a blood vessel in accordance with one form of the present invention
  • FIG. 5 is a schematic view showing one possible construction for the occluder shown in Figs. 2-4;
  • Figs. 6 and 7 are schematic views showing an exemplary syringe-type inserter which may be used to deploy the occluder shown in Figs. 2-4;
  • Figs. 8-10 are schematic views showing an
  • FIGs. 11-14 are schematic views showing an occluder occluding a blood vessel in accordance with still another form of the present invention.
  • Figs. 15-17 are schematic views showing other possible constructions for the occluder of the present invention.
  • Figs. 18-20 are schematic views showing the occluders of the types shown in Figs. 15-17 occluding a blood vessel in accordance with yet another form of the present invention.
  • Figs. 21-24 are schematic views showing an occluder occluding a blood vessel in accordance with another form of the present invention.
  • Figs. 25-27 are schematic views showing an occluder occluding a blood vessel in accordance with still another form of the present invention.
  • Figs. 28 and 29 are schematic views showing an occluder occluding a blood vessel in accordance with yet another form of the present invention.
  • Figs. 30 and 31 are schematic views showing an occluder occluding a blood vessel in accordance with another form of the present invention
  • Figs. 32 and 33 are schematic views showing an occluder occluding a blood vessel in accordance with still another form of the present invention
  • Figs. 34 and 35 are schematic views showing a drug/cellular delivery body being attached to a blood vessel in accordance with one form of the present invention
  • Figs. 36 and 37 are schematic views showing a drug/cellular delivery body being attached to a blood vessel in accordance with another form of the present invention.
  • Figs. 38 and 39 are schematic views showing a drug/cellular delivery body being attached to a blood vessel in accordance with still another form of the present invention.
  • Figs. 40 and 41 are schematic views showing a drug/cellular delivery body being attached to a blood vessel in accordance with yet another form of the present invention.
  • Figs. 42-48 are schematic views showing a two- part occluder formed in accordance with another form of the present invention.
  • Figs. 49-58 are schematic views showing
  • Figs. 59-82 are schematic views showing the two- part occluder of Figs. 42-48 being deployed across a blood vessel using the installation apparatus of Figs. 49-58;
  • Figs. 83-86 are schematic views showing another two-part occluder formed in accordance with the present invention.
  • Figs. 87-90 are schematic views showing still another two-part occluder formed in accordance with the present invention.
  • Figs. 91-94 are schematic views showing yet another two-part occluder formed in accordance with the present invention.
  • Figs. 95-100 are schematic views showing another two-part occluder formed in accordance with the present invention.
  • Figs. 101-103 are schematic views showing a temporary occluder formed in accordance with the present invention.
  • Figs. 104-107 are schematic views showing another temporary occluder formed in accordance with the present invention.
  • Figs. 108-124 are schematic views showing still another temporary occluder formed in accordance with the present invention.
  • Figs. 125 and 126 are schematic views showing yet another temporary occluder formed in accordance with the present invention
  • Figs. 127-142 are schematic views showing another temporary occluder formed in accordance with the present invention.
  • Figs. 143-148 are schematic views showing still another temporary occluder formed in accordance with the present invention.
  • Fig. 149 is a schematic view showing yet another temporary occluder formed in accordance with the present invention.
  • Fig. 150 is a schematic view showing another temporary occluder formed in accordance with the present invention.
  • the present invention provides a new and improved approach for treating varicose veins and other blood vessels .
  • a novel occluder which is used to occlude a vein (e.g., the proximal saphenous vein, the small saphenous vein, tributaries, the perforator veins, etc.) so as to restrict blood flow through the vein and thereby treat varicose veins below the point of occlusion.
  • a vein e.g., the proximal saphenous vein, the small saphenous vein, tributaries, the perforator veins, etc.
  • the novel occluder is configured to be deployed using a minimally-invasive approach (i.e., either
  • the novel treatment can be provided in a doctor's office, with minimal local anesthetic, and effectively no post-operative care.
  • the occluder is delivered by percutaneously advancing the occluder through the skin, through intervening tissue and then across some or all of the blood vessel (e.g., the great saphenous vein near the sapheno-femoral
  • the occluder is configured to occlude the vein by compressing the vein and closing down its lumen; and in another form of the invention, the occluder is configured to occlude the vein by
  • the occlusion of the lumen may be complete or partial If the occlusion is partial, some blood may continue to flow in the vein. Such partial occlusion can act to relieve some of the pressure on the valve, thereby improving its function. In some applications, an occlusion of 70% or greater of the lumen may be desired and realized based on the current invention. In other applications, an occlusion of 80% or greater of the lumen may be desired and realized based on the current invention. In one embodiment, the occlusion pressure applied may be greater than 40 mm of mercury. In another embodiment of the present invention, the occlusion pressure may be greater than the pressure of the typical blood flow in the vein.
  • Occluder 30 comprises an elastic filament 35 which, in an unconstrained condition, comprises a generally
  • non-linear configuration e.g., a coiled mass
  • a linear configuration e.g., in the narrow lumen 40 of a needle 45, or where the filament is formed out of a shape memory material, by appropriately controlling its temperature and hence its shape
  • elastic filament 35 will return to its generally non-linear configuration, whereby to provide enlarged masses for occluding the vein .
  • the occluder is formed out of a shape memory material (e.g., a shape memory alloy such as Nitinol, or a shape memory polymer) , with the shape memory material being
  • the occluder 30 is installed in the narrow lumen 40 of a needle 45 (Fig. 2), the needle is introduced percutaneously and advanced across the vein which is to be occluded
  • a first length of the occluder is extruded from the needle on the far side of the vein so that a portion of the occluder is restored to a coiled mass configuration 50 on the far side of the vein (Fig. 3), the needle is withdrawn back across the vein, and then the remainder of the occluder is extruded on the near side of the vein (Fig. 4), whereupon the remainder of the occluder is restored to a coiled mass configuration 55, with a portion 57 of the occluder extending across the lumen
  • the occluder on the far and near sides of the vein i.e., the coiled masses 50 and 55, respectively
  • the portions of the occluder on the far and near sides of the vein i.e., the coiled masses 50 and 55, respectively
  • occluder 30 may be formed out of a shape memory material (e.g., a shape memory alloy such as Nitinol, or a shape memory polymer, etc.), with the shape memory material being configured to provide superelasticity, or temperature-induced shape changes, or both) .
  • a shape memory material e.g., a shape memory alloy such as Nitinol, or a shape memory polymer, etc.
  • occluder 30 is formed out of a single elastic filament 35, and a shape transition (i.e., from substantially linear to a pair of opposing coiled masses 50, 55) is used to cause occlusion of the target blood vessel.
  • a shape transition i.e., from substantially linear to a pair of opposing coiled masses 50, 55
  • the aforementioned coiled masses 50, 55 may comprise substantially random turns of the elastic filament arranged in a substantially three-dimensional
  • the coiled masses 50, 55 may comprise highly reproducible structures such as loops, coils, etc., and these loops, coils, etc. may or may not assume a substantially planar structure. See, for example, Fig. 5, where coiled masses 50, 55 comprise highly reproducible loops and coils.
  • Figs. 6 and 7 show an exemplary syringe-type inserter 65 which may be used to deploy the novel occluder of the present invention.
  • the syringe-type inserter 65 may contain one occluder 30 or multiple pre-loaded occluders 30, e.g., where syringe-type inserter 65 comprises multiple occluders 30, the occluders may be disposed serially within the syringe-type inserter 65.
  • occluder 30 is shown occluding the vein by compressing the vein between the two coiled masses 50, 55, whereby to close down its lumen 60.
  • the vein in Figs. 2-4, occluder 30 is shown occluding the vein by compressing the vein between the two coiled masses 50, 55, whereby to close down its lumen 60.
  • occluder 30 can be used to occlude the vein without compressing the vein. This is done by depositing a coiled mass within the lumen of the vein, whereby to restrict blood flow through the lumen of the vein. More particularly, and looking now at Figs. 8-10, in this form of the invention, the needle 45 is passed into the interior of the vein 15 and one coiled mass 50 of the occluder 30 is extruded into the lumen 60 of the vein (Fig. 8) so as to occlude the lumen of the vein, the needle 45 is withdrawn to the near side of the vein (Fig. 9), and then another coiled mass 55 is disposed on the near side of the vein (Fig.
  • portion 57 of the occluder extending through the side wall of the vein so as to stabilize the occluder relative to the vein (i.e., so as to attach the occluder to the vein and prevent the occluder from moving relative to the vein) .
  • Figs. 11-14 show another approach where a coiled mass of the occluder 30 is deposited within the interior of the blood vessel so as to obstruct blood flow through the vessel. More particularly, in this form of the invention, the needle 45 is passed
  • a coiled mass 50 of the occluder is deposited on the far side of the vein (Fig. 12), the needle is withdrawn into the interior of the vein where another coiled mass 55 of the occluder is deposited (Fig. 13), and then the needle is withdrawn to the near side of the vein where another coiled mass 70 of the occluder 30 is deposited (Fig. 14) .
  • coiled mass 55 resides within the lumen 60 of the vein and
  • Figs. 15 and 16 show occluders 30 formed out of a single strand of elastic filament.
  • the occluder 30 comprises a relatively ordered coil where the turns 72 of the coil are unidirectional.
  • the occluder 30 comprises another relatively ordered coil but where the turns rotate in opposite directions on different sides of a midpoint 75.
  • occluder 30 can be constructed so as to form a
  • relatively disordered coil i.e., where the strand of the filament follows a relatively random pattern (see, for example, the disordered coils illustrated in Figs.
  • the mass of the reformed coil itself provide a flow obstruction (e.g., where the reformed coil is disposed intraluminally so as to impede blood flow through the vein)
  • the elastic filament reform into a relatively disordered coil having a relatively random disposition, since this can provide a denser filament configuration.
  • Fig. 17 shows an occluder 30 formed out of multiple strands of elastic filaments 35. In one form of the invention, these multiple strands are joined together at a joinder 80. Again, the coils (e.g., the aforementioned coiled masses 50, 55, 70) formed by these multiple strands can be relatively ordered or relatively disordered.
  • Figs. 18 and 19 show how the multistrand occluder of Fig. 17 can be used to occlude a vein by forming coiled masses 50, 55 to compress the side wall of the vein inwardly so as to restrict blood flow through the vein.
  • Fig. 20 shows how the multi- strand occluder 30 of Fig.
  • a number of the elastic filaments 35 are shown piercing the side wall of the vein so as to hold the coiled mass 55 in position within the lumen of the blood vessel.
  • Figs. 21-24 show another form of occluder 30 where the occluder is formed by structures other than a filament.
  • the occluder 30 may comprise a transluminal section 85, a far side lateral projection 90 and a near side lateral projection 95, with the far side lateral projection 90 and the near side lateral projection 95 being held in opposition to one another so as to close down the lumen 60 of the vein 15.
  • Such an arrangement may be provided by many different types of structures, e.g., such as the "double T-bar" structure shown in Figs. 25-27 where the transluminal section 85 of the
  • occluder 30 is formed out of an elastic material which draws the two opposing T-bars 90, 95 of the occluder together so as to provide vessel occlusion.
  • Still other arrangements for connecting and drawing together a far side lateral projection 90 and a near side lateral projection 95 will be apparent to those skilled in the art in view of the present disclosure.
  • far side lateral projection 90 and near side lateral projection 95 may be connected together by a loop of suture, with the loop of suture being lockable in a reduced size configuration (i.e., so as to maintain occlusion) with a sliding locking knot.
  • multiple occluders 30 may be used on a single blood vessel or tissue to occlude the blood vessel more completely, or to occlude a blood vessel in multiple regions, or to attach a material (e.g., a drug or cellular delivery element) in multiple places to the blood vessel.
  • the occluders may be coated with a drug-eluting compound, or the occluders may be electrically charged to enhance or prevent clotting or to deliver a desired compound or agent to the blood vessel, etc. If desired, the location of the
  • occluding or attachment element may be precisely controlled to deliver the desired compound or agent at a specific anatomical location.
  • the occluder 30 is delivered to the occlusion site by endoluminally advancing the occluder up the vein using a catheter, and then deploying the occluder in the vein, with the occluder acting to occlude the vein and thereby treat varicose veins.
  • the occluder is preferably passed through one or more side walls of the vein so as to stabilize the occluder relative to the vein.
  • the occluder is configured to occlude the vein by depositing a mass within the lumen of the vein so as to restrict blood flow through the lumen of the vein; and in another form of the invention, the occluder is configured to occlude the vein by compressing the vein and closing down its lumen.
  • a catheter 100 is used to endoluminally advance the occluder 30 up the interior of the vein 15 to a deployment site. Then one end of the occluder is passed through the side wall of the vein so as to deposit a coiled mass 50 of the occluder 30 outside the vein, and the remainder of the occluder is
  • a coiled mass 55 of the occluder is deposited within the interior of the vein so as to restrict blood flow through the vein and thereby treat varicose veins.
  • Figs. 30 and 31 show how two separate occluders 30, each used in the manner shown in Figs. 28 and 29, can be used to increase the coiled mass of occluder contained within the lumen of the vein, whereby to increase the extent of occlusion of the lumen of the vein .
  • Figs. 32 and 33 show how an occluder 30 can be delivered endoluminally and used to compress the outer walls of the vein so as to occlude blood flow through the lumen of the vein. More particularly, in this form of the invention, the occluder 30 is advanced endoluminally through the vein to the deployment site, one end of the occluder is passed through one side wall of the vein so as to deposit a coiled mass 50 on one side of the vein and the other end of the occluder is passed through the other side wall of the vein so as to deposit another coiled mass 55 on the other side of the vein, with the two coiled masses being connected together by the intermediate portion 57 of the occluder and with the two coiled masses being drawn toward one another under the coiling force inherent in the elastic filament so as to apply compressive opposing forces on the two sides of the vein, whereby to compress the vein and close down its lumen .
  • the novel occluder of the present invention can be used in conjunction with the removal of the large varicose veins (i.e., phlebectomy) .
  • the phlebectomy can be done at the same time as the occlusion of the vein or at another time. For this surgical procedure, minimal local anesthetic is needed .
  • novel occluder of the present invention can also be used to occlude tubular structures for purposes other than treating varicose veins.
  • novel occluder of the present invention can be used to occlude other vascular structures (e.g., to occlude arteries so as to control bleeding) , or to occlude other tubular structures within the body (e.g., phallopian tubes, so as to induce infertility), etc .
  • the occluder 30 may be modified so as to allow
  • the device functions as a drug/cellular delivery stabilizer, and may or may not function as an occluder. See, for example, Figs. 34 and 35, where an elastic filament
  • Figs. 36 and 37 show a similar arrangement where a catheter 130 is used to deliver the device endoluminally.
  • Figs. 38 and 39 show another arrangement wherein the device is delivered percutaneously so that the coiled mass is disposed inside lumen 125 of the blood vessel and the
  • Figs. 40 and 41 show how the device is delivered endoluminally so that the coiled mass is disposed inside lumen 125 of the blood vessel and the drug/cellular delivery body 105 is disposed outside the blood vessel.
  • delivery devices may be passive or active polymers or silicon-based or micro- and nanotechnology devices, or matrices of materials, etc.
  • FIG. 42 there is shown a
  • Two-part occluder 200 formed in accordance with the present invention.
  • Two-part occluder 200 generally comprises a distal implant 205 and a proximal implant 210.
  • Distal implant 205 is shown in further detail in Figs. 43-46.
  • Distal implant 205 comprises a distal implant body 215 and a distal implant locking tube 220.
  • Distal implant body 215 comprises a tube 225 having a distal end 226, a proximal end 227, and a lumen 230 extending therebetween.
  • Tube 225 is slit intermediate its length so as to define a plurality of legs 235.
  • a set of inwardly-pro ecting tangs 240 are formed in tube 225 between legs 235 and proximal end 227.
  • a set of windows 245 are formed in tube 225 between inwardly-pro ecting tangs 240 and proximal end 227.
  • Distal implant body 215 is preferably formed out of an elastic material (e.g., a shape memory material having superelastic properties such as Nitinol or superelastic polymers, including superelastic
  • tube 225 normally project laterally away from the longitudinal axis of tube 225 (e.g., in the manner shown in Figs.
  • legs 235 can be constrained inwardly (e.g., within the lumen of a delivery needle, as will hereinafter be discussed) so that distal implant body 215 can assume a substantially linear disposition. See, for example, Fig. 46, which shows legs 235 moved inwardly relative to the position shown in Figs. 43 and 44. However, when any such constraint is removed, the elastic nature of the material used to form distal implant body 215 causes legs 235 to return to the position shown in Figs. 43 and 44.
  • Distal implant locking tube 220 (Fig. 45)
  • a generally tubular structure having a distal end 250, a proximal end 260 and a lumen 262 extending therebetween.
  • a set of windows 265 are formed in the distal implant locking tube 220, with windows 265 being disposed distal to proximal end 260.
  • Distal implant locking tube 220 is disposed within lumen 230 of distal implant body 215.
  • distal implant locking tube 220 terminates well short of tangs 240 of distal implant body 215, so that the proximal end 227 of distal implant body 215 can move longitudinally relative to distal end 226 of distal implant body 215.
  • proximal end 227 of distal implant body 215 is moved distally a sufficient distance to allow full radial expansion of legs 235 (see Fig.
  • locking tangs 240 of distal implant body 215 will be received within windows 265 of distal implant locking tube 220, whereby to lock distal implant 205 in its radially-expanded condition (i.e., with legs 235 projecting laterally away from the longitudinal axis of tube 225, e.g., in the manner shown in Figs. 43 and 44) .
  • Spot welds applied via openings 270 formed in the distal end 226 of distal implant body 215 serve to lock distal implant locking tube 220 to distal implant body 215, whereby to form a singular structure (see Fig. 43 and 46) .
  • proximal implant 210 comprises a tube 275 having a distal end 280, a proximal end 285, and a lumen 290 extending
  • Tube 275 is slit at its distal end so as to define a plurality of legs 295.
  • a set of inwardly-pro ecting tangs 300 are formed in tube 275 between legs 295 and proximal end 285.
  • Proximal implant 210 is preferably formed out of an elastic material (e.g., a shape memory material having
  • proximal implant 210 can assume a substantially linear disposition. See, for example, Fig. 48, which shows legs 295 moved inwardly relative to the position shown in Fig. 47. However, when any such constraint is removed, the elastic nature of the material used to form proximal implant 210 causes legs 295 to return to the position shown in Fig. 47.
  • distal implant 205 and proximal implant 210 are configured and sized so that tube 225 of distal implant body 215 can be received in lumen 290 of proximal implant 210, with the expanded legs 235 of distal implant 205 opposing the expanded legs 295 of proximal implant 210 (see, for example, Fig. 82), whereby to impose a clamping action on the side wall of a blood vessel (e.g., vein) disposed therebetween and thereby occlude the blood vessel, as will hereinafter be discussed in further detail (or, as an alternative, the opposing expanded legs of the proximal and distal implants could
  • distal implant 205 and proximal implant 210 are configured and sized so that they may be locked in this position, inasmuch as inwardly- projecting tangs 300 of proximal implant 210 will project into windows 245 of distal implant 205.
  • Two-part occluder 200 is intended to be deployed using associated installation apparatus. This
  • associated installation apparatus preferably comprises a hollow needle 305 (Fig. 49) for penetrating tissue, a distal implant delivery tube 310 (Fig. 50) for delivering distal implant 205 through hollow needle 305 to the far side of the blood vessel which is to be occluded, a composite guidewire 315 (Figs. 51-56) for supplying support to various components during
  • a push rod 320 (Fig. 57) for delivering various components over composite guidewire 315
  • a proximal implant delivery tube 330 (Fig. 58) for delivering proximal implant 210 for mating with distal implant 205, as will hereinafter be discussed .
  • Hollow needle 305 (Fig. 49) comprises a distal end 335, a proximal end 340 and a lumen 345 extending therebetween. Distal end 335 terminates in a sharp point 350. In one preferred form of the invention, hollow needle 305 comprises a side port 355 which communicates with lumen 345.
  • Distal implant delivery tube 310 (Fig. 50) comprises a distal end 360, a proximal end 365 and a lumen 370 extending therebetween.
  • Composite guidewire 315 (Figs. 51-56) comprises a guidewire rod 370 and a guidewire sheath 380.
  • Guidewire rod 370 comprises a distal end 385 and a proximal end 390.
  • Distal end 385 terminates in an enlargement 395.
  • Guidewire sheath 380 comprises a distal end 400, a proximal end 405 and a lumen 410 extending therebetween.
  • the distal end 400 of guidewire sheath 380 comprises at least one, and preferably a plurality of, proximally-extending slits 415.
  • Proximally-extending slits 415 open on the distal end of guidewire sheath 380 and allow the distal end of guidewire sheath 380 to radially expand somewhat.
  • guidewire rod 370 and guidewire sheath 380 are configured and sized so that guidewire rod 370 can be received in lumen 410 of guidewire sheath 380.
  • the proximally-extending slits 415 in guidewire sheath 380 allow the distal end of the guidewire sheath 380 to expand somewhat so as to receive at least some of the enlargement 395 formed on the distal end of guidewire rod 370. As this occurs, the distal end of guidewire sheath 380 will expand radially .
  • Push rod 320 (Fig. 57) comprises a distal end 420, a proximal end 425 and a lumen 430 extending therebetween.
  • Proximal implant delivery tube 330 (Fig. 58) comprises a distal end 435, a proximal end 440 and a lumen 445 extending therebetween.
  • installation apparatus are preferably used as follows.
  • hollow needle 305 (carrying distal implant delivery tube 310 therein, which in turn contains the composite guidewire 315 therein, upon which is mounted distal implant 205) is passed through the skin of the patient, through intervening tissue, and across the blood vessel (e.g., vein 450) which is to be occluded. See Figs. 59-61. As this is done, any blood flowing out side port 355 can be monitored - excessive or pulsatile blood flow can indicate that hollow needle has accidentally struck an artery.
  • blood vessel e.g., vein 450
  • hollow needle 305 is retracted, leaving distal implant delivery tube 310 extending across the blood vessel. See Fig. 62.
  • distal implant delivery tube 310 is
  • composite guidewire 315, push rod 320 and distal implant 205 are all moved distally, so as to advance the distal ends of composite guidewire 315 and the distal implant 205 out of the distal end of distal implant delivery tube 310. As this occurs, legs 235 of distal implant 205 are released from the constraint of distal implant delivery tube 310 and expand
  • hollow needle 305, distal implant delivery tube 310 and push rod 320 may be removed (Fig. 67), leaving distal implant 205 mounted on composite guidewire 315, with the legs 235 fully deployed on the far side of the blood vessel and the proximal end of distal implant 205 extending into the interior of the blood vessel (Fig. 68) .
  • proximal implant 210 (carrying proximal implant 210 therein) is advanced down composite guidewire 315, until the distal end of proximal implant delivery tube 330 sits just proximal to the blood vessel (Figs. 69-72).
  • push rod 320 is used to advance the distal end of proximal implant 210 out of the distal end of proximal implant delivery tube 330. As this occurs, legs 295 are released from the constraint of proximal implant delivery tube 330 and open radially. See Figs. 73-76.
  • proximal implant 210 is pushed distally as distal implant 205 is pulled proximally using composite guidewire 315.
  • guidewire rod 370 is pulled proximally, which causes enlargement 395 on the distal end of guidewire rod 370 to expand guidewire sheath 380 to a size larger than lumen 262 in distal implant locking tube 220, which causes guidewire sheath 380 to move proximally, which causes proximal movement of distal implant 205.
  • distal implant 205 and proximal implant 210 move together, their legs 235, 295
  • Distal implant 205 and proximal implant 210 continue moving together until inwardly-pro ecting tangs 300 of proximal implant 210 enter windows 245 of distal implant 205, thereby locking the two members into position relative to one another. See Fig. 77.
  • composite guidewire 315 is removed. This is done by first advancing guidewire rod 370 distally (Fig. 79), which allows the distal end of guidewire sheath 380 to relax inwardly, thereby reducing its outer diameter to a size smaller than lumen 262 in distal implant locking tube 220. As a result, guidewire sheath 380 can then be withdrawn proximally through the interior of two-part occluder 200. See Fig. 80. Then guidewire rod 370 can be withdrawn proximally through the interior of two-part occluder
  • Figs. 83-86 illustrate another two-part occluder
  • Two-part occluder 200A having a distal implant 205A and a proximal implant 210A.
  • Two-part occluder 200A is generally similar to the aforementioned two-part occluder 200, except that distal implant 205A utilizes a unibody construction .
  • Figs. 87-90 illustrate another two-part occluder
  • Two-part occluder 200B is generally similar to the aforementioned two-part occluder 200A, except that distal implant 205B utilizes a friction fit to lock distal implant 205B to proximal implant 210B.
  • Figs. 91-94 illustrate another two-part occluder
  • Two-part occluder 200C having a distal implant 205C and a proximal implant 210C.
  • Two-part occluder 200C is generally similar to the aforementioned two-part occluder 200, except that distal implant 205C comprises a tube 225C which receives and secures the proximal ends of legs
  • FIG. 95-100 illustrate another two-part occluder 200D having a distal implant 205D and a proximal implant 210D.
  • Two-part occluder 200D is generally similar to the aforementioned two-part occluder 200, except that distal implant 205D comprises a tube or rod 225D which receives and secures the proximal ends of legs 235D.
  • Legs 235D are preferably coils formed out of a superelastic shape memory material so as to provide the legs 235D with the desired degree of elasticity.
  • composite guidewire 315 for use in delivering distal implant 205 and proximal implant 210 to the anatomy.
  • composite guidewire 315 is formed from two parts, i.e., a guidewire rod 370 and a guidewire sheath 380.
  • composite guidewire 315 can have its distal diameter enlarged or reduced as desired so as to permit composite guidewire 315 to bind to distal implant 205, or be separable from the distal implant 205, respectively.
  • composite guidewire 315 can have its distal diameter enlarged or reduced as desired so as to permit composite guidewire 315 to bind to distal implant 205, or be separable from the distal implant 205, respectively.
  • composite guidewire 315 can be replaced by an alternative guidewire which includes a mechanism for releasably binding the alternative guidewire to distal implant 205.
  • an alternative guidewire may include screw threads, and distal implant 205 may include a screw recess, so that the alternative guidewire can be selectively secured to, or released from, the distal implant 205, i.e., by a screwing action.
  • an occlusion device may be implanted and then, at a later time (e.g., days, months, years), may be removed.
  • temporary occlusion devices include reversible occlusion of fallopian tubes, temporary occlusion of the saphenous vein during pregnancy and subsequent removal of the occlusion device at the conclusion of pregnancy so as to restore blood flow through, etc.
  • the present invention also envisions deployment of temporary occlusion devices that can be left in the body permanently.
  • the present invention also provides a novel temporary occlusion device (hereinafter sometimes referred to as a "temporary occluder”) that can be deployed percutaneously to temporarily occlude major blood vessels (e.g., arteries) until specialized care can be obtained to surgically control massive
  • temporary occluder a novel temporary occlusion device that can be deployed percutaneously to temporarily occlude major blood vessels (e.g., arteries) until specialized care can be obtained to surgically control massive
  • novel temporary occluder of the present invention may be used as an alternative to a conventional tourniquet to control major extremity bleeding following trauma, providing a more effective, reliable and highly targeted method to control major blood vessel
  • the temporary occluder of the present invention may be used even in the presence of soft tissue injury with minimal patient discomfort. Once deployed, minimal post-deployment supervision is required during the time required to transport the patient to the specialized care required to surgically repair the damaged blood vessel.
  • the invention requires accessing the damaged blood vessel (e.g., major artery) with a needle or other device, but this is typically within the level of expertise expected of the average military medic or civilian emergency medical technician.
  • the utilization of ultrasound to identify and access the damaged blood vessel significantly simplifies the temporary
  • Deployment comprises passing a portion of the temporary occluder across the blood vessel (e.g., artery) so that a distal portion of the temporary occluder bears against the outside surface of the blood vessel on the far side of the blood vessel, and positioning a proximal portion of the temporary occluder against the outside surface of the blood vessel on the near side of the blood vessel, or against the outside surface of the skin, whereby to establish an occluding compression across the blood vessel.
  • the blood vessel e.g., artery
  • a proximal portion of the temporary occluder against the outside surface of the blood vessel on the near side of the blood vessel, or against the outside surface of the skin, whereby to establish an occluding compression across the blood vessel.
  • hemostasis of the punctures caused by deployment of the temporary occluder across the blood vessel may be obtained with standard manual compression of the blood vessel, thus minimizing the need for further blood vessel repair.
  • other means such as cauterization of the tissue, deploying a polymeric sealant, or deploying gauze or a pad, or positioning a coated stent in the vessel, may be used to arrest blood flow.
  • Temporary occluder 500 may be used percutaneously to temporarily occlude a blood vessel 505 disposed beneath the surface of skin 510, wherein intervening tissue 512 is disposed between the surface of skin 510 and blood vessel 505.
  • Temporary occluder 500 generally comprises a distal portion 515 and a proximal portion 520.
  • Distal portion 515 generally comprises a cylindrical body 525 having a plurality of laterally-expandable legs 530 connected thereto.
  • distal portion 515 may be formed out of a Nitinol cylinder having distal slits formed therein, whereby to form cylindrical body 525 and laterally- expandable legs 530.
  • Proximal portion 520 generally comprises a cylindrical body 535 having a plurality of laterally-expandable legs 540 connected thereto.
  • proximal portion 520 may be formed out of a Nitinol cylinder having proximal slits formed therein, whereby to form
  • each laterally-expandable leg 530, 540 is designed with an appropriate length to minimize penetration into any tissues which may reside adjacent to the blood vessel. In one embodiment, each laterally-expandable leg 530, 540 is less than about 20 mm in length. In one embodiment, the cylindrical bodies 525, 535 are both less than about 18 gauge.
  • Distal portion 515 is sized to be concentrically received within proximal portion 520 (see Fig. 101) . In one preferred form of the invention, cylindrical body 535 of proximal portion 520 is approximately aligned with the distal ends of laterally-expandable legs 530 of distal portion 515, and cylindrical body
  • distal portion 515 is approximately aligned with the proximal ends of laterally-expandable legs 540 of proximal portion 520.
  • Temporary occluder 500 also comprises a flexible filament 545 having a distal end 550 and a proximal end 555 (Fig. 103) .
  • Distal end 550 of flexible filament 545 is secured to cylindrical body 525 of distal portion 515.
  • Temporary occluder 500 is intended to be deployed using a needle 560, or other tubular element. Needle
  • Needle 560 comprises a distal end 565, a proximal end 570 and a lumen 575 extending therebetween. Needle 560 is sized to slidably receive temporary occluder 500 within its lumen 575.
  • needle 560 carrying temporary occluder 500 therein, with flexible filament 545 extending from proximal end 570 of needle
  • distal portion 515 of temporary occluder 500 is pushed out of needle 560 so that laterally-expandable legs 530 of distal portion 515 deploy on the far side of blood vessel 505.
  • cylindrical body 525 of distal portion 515 is set so that it is approximately aligned with cylindrical body 535 of proximal portion 520.
  • needle 560 is withdrawn proximally, allowing laterally-expandable legs 540 of proximal portion 520 to deploy on the near side of blood vessel 505, with laterally-expandable legs 530 of distal portion 515 cooperating with laterally- expanding legs 540 of proximal portion 520 so as to occlude blood vessel 505 (Fig. 102) .
  • Needle 560 may then be completely removed, leaving flexible filament 545 extending from the occlusion site up to the surface of the skin 510.
  • proximal end 555 of flexible filament 545 (which extends above the surface of skin 510) is pulled proximally, whereby to pull distal portion 515 of temporary occluder 500 free of proximal portion 520 of temporary occluder 500, and thereby restore normal blood flow through blood vessel 505 (Fig. 103) .
  • laterally-expandable legs 530, 540 may be replaced by resilient (e.g., polymer) disks or umbrella
  • temporary occluder 500 omits the aforementioned flexible filament 545, and instead provides an introducer 580 for deploying temporary occluder 500 out of needle 560 (Figs. 104 and 105) .
  • introducer 580 is withdrawn with needle 560, leaving the deployed temporary occluder 500 isolated at the occlusion site.
  • a guidewire 585 is passed down the lumen 590 of blood vessel 505 and through the deployed temporary occluder 500.
  • an appropriately-sized, non-compliant balloon 595 e.g., an angioplasty balloon
  • balloon 595 is advanced, in its deflated state, over guidewire 585 until balloon 595 spans temporary occluder 500.
  • balloon 595 is expanded (Fig. 106) so as to separate distal portion 515 of temporary occluder 500 from proximal portion 520 of temporary occluder 500, thereby restoring normal blood flow through blood vessel 505.
  • balloon 595 and guidewire 585 are withdrawn (Fig. 107) .
  • the balloon 595 may also be made out of an elastomer, e.g., latex or silicone.
  • the balloon 595 may be filled with water or a compound of higher molecular weight than air.
  • the balloon 595 may also be inflated with a polymer that hardens in situ, for applications where it is desirable to permanently maintain occlusion of the blood vessel.
  • balloon 595 may be inflated with a polymer that hardens in situ and thereafter bio- degrades over time.
  • Temporary occluder 600 generally comprises a filament
  • Distal portion 610 comprises a plurality of laterally-expanding legs 620 secured to distal portion 610.
  • Temporary occluder 600 is intended to be deployed using a needle, e.g., the aforementioned needle 560 (Fig. 109) .
  • filament 605 is loaded into lumen 575 of needle 560 so that distal portion 610 of temporary occluder 600 has its laterally-expanding legs 620 contained within distal end 565 of needle 560. This may be accomplished by feeding the proximal end 625 (Fig. 108) of filament 605 into distal end 565 of needle 560, advancing proximal end 625 of filament 605 out of proximal end 570 of needle 560, and then pulling on proximal end 625 of filament 605 so that laterally- expanding legs 620 are drawn into distal end 565 of needle 560. Then needle 560, carrying filament 605 and distal portion 610 therein, is advanced through skin 510 (Fig. Ill), through intervening tissue 512 (Fig.
  • needle 560 is retracted, and proximal portion 615 of temporary occluder 600 is advanced distally along needle 560 and filament 605 so that proximal portion 615 of temporary occluder 600 presses against the outer surface of the skin 510, whereby to compress blood vessel 505 and the intervening tissue 512 (Figs. 115 and 116) .
  • proximal portion 615 of temporary occluder 600 is locked or secured in place (Fig. 117) .
  • needle 560 may be completely withdrawn, leaving blood vessel 505 occluded (Fig. 118) .
  • proximal portion 615 of temporary occluder 600 is removed (Fig. 119), needle 560 is advanced back down filament 605 (Fig. 120), through skin 510, through intervening tissue 512, through blood vessel 505 (Fig. 121) and then over laterally-expanding legs 620 (Fig. 122), causing laterally-expanding legs 620 to enter the interior of needle 560, collapsing laterally- expanding legs 512 in the process. Then needle 560 is withdrawn (Fig. 123), carrying filament 605 and distal portion 610 of temporary occluder 600 with it (Fig. 124) .
  • Figs. 125 and 126 show a temporary occluder 625 which comprises another form of the invention.
  • Temporary occluder 625 is substantially the same as the two-part occluder 200A shown in Figs. 83-86, except that (i) temporary occluder 625 comprises a distal implant 630 having a distal implant body 635 of increased length sufficient to protrude above the surface of skin 510, and a proximal implant 640 having a proximal implant body 645 of increased length sufficient to protrude above the surface of skin 510, and (ii) temporary occluder 625 comprises fingers 650 on proximal implant body 645 allowing proximal implant 640 to be unlocked from distal implant 630 when desired .
  • Temporary occluder 655 which comprises another form of the invention.
  • Temporary occluder 655 is substantially the same as the two-part occluder 200A shown in Figs. 83-86, i.e., it comprises a distal implant 660 and a proximal implant 665, etc., except that in this form of the invention, the
  • proximal end of distal implant 660 is threaded (not shown) as will hereinafter be discussed.
  • a removal device 670 is advanced through skin 510 and intervening tissue 512 until the distal tip 675 of removal device 670 contacts the proximal end of proximal implant 665 (Fig. 128) . Ultrasound guidance may be used to facilitate such docking. Then a shaft 680 is extended out of removal device 670 and threaded into distal implant 660 (Figs. 128 and 129) . Next, a pusher tube 685 is advanced over shaft 680 and
  • Pusher tube 685 itself latches onto proximal implant 665 using latching grooves 690 formed in pusher tube 685, which receive latches 695 of proximal implant 665 (Fig. 132) so as to effect the desired connection. Then shaft 680 is pulled
  • distal implant 660 proximally, pulling distal implant 660 through pusher tube 685 and out of the patient (Figs. 133-137) .
  • an external sheath 700 is extended down over pusher tube 685 (Fig. 138) whereby to capture proximal implant 665, within the external sheath, whereupon proximal implant 665 is removed from the surgical site by pulling pusher tube 685 out of the patient through external sheath 700 (Figs. 139 and 140) . Finally, external sheath 700 is removed from the patient (Figs. 141 and 142) . It should also be appreciated that various other means of attachment and securing the various elements will be apparent to those skilled in the art in view of the present disclosure.
  • a second balloon 505 is positioned (in its deflated condition) on the near side of blood vessel 505, and then needle 560, paying out inflation line 710 as it goes, is retracted out of the tissue (Fig. 147) .
  • inflation line 710 is used to inflate both balloons 705, whereby to occlude blood vessel 505 (Fig. 148) .
  • balloons 705 are deflated using inflation line 710, and then the two balloons are pulled free of the anatomy by pulling proximally on inflation line 710.
  • a balloon 705 may be positioned on the far side of the blood vessel, a cap 615 may be
  • balloon 705 may be inflated and then tension pulled between inflated balloon 705 and cap 615 so as to occlude blood vessel 505.
  • balloon 705 When temporary occlusion is to be withdrawn, balloon 705 is deflated using inflation line 710, and then balloon 705 is pulled free of the anatomy by pulling proximally on inflation line 710.
  • a balloon 705 may be
  • balloon 705 When temporary occlusion is to be withdrawn, balloon 705 is deflated using inflation line 710, and then balloon 705 is pulled free of the anatomy by pulling proximally on inflation line 710.
  • the balloon(s) 705 may be filled with air, water or a compound of higher molecular weight than air.
  • the balloon 705 may also be inflated with a polymer that hardens in situ, for applications where it is desirable to permanently maintain occlusion of the blood vessel.
  • balloon 705 may be inflated with a polymer that hardens in situ and thereafter bio-degrades over time.
  • the occluder may comprise a sealed tube having two regions that may be inflated into balloons. These balloon regions are expanded using air or liquid pressure .
  • the occluder may be positioned directly against a surface (e.g., an outer surface) of the hollow structure, or the occluder may be
  • an intervening structure or structures e.g., anatomical tissue
  • occluder applies a force to the intervening structure or structures, whereby to occlude the hollow structure which is to be occluded.
  • the temporary occluder of the present invention can also be used to occlude tubular structures other than blood vessels.
  • the temporary occluder of the present invention can be used to occlude other structures within the body (e.g., tubes such as fallopian tubes and/or vas deferens for temporary or permanent sterilization, ducts such as bile ducts and cystic ducts for cholecystectomy, lymphatic vessels, including the thoracic duct, fistula tracts, etc.).
  • tubes such as fallopian tubes and/or vas deferens for temporary or permanent sterilization
  • ducts such as bile ducts and cystic ducts for cholecystectomy
  • lymphatic vessels including the thoracic duct, fistula tracts, etc.

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Abstract

L'invention concerne un appareil pour occlure une structure creuse par voie percutanée. Ledit appareil comprend un occluseur, ledit occluseur comprenant un premier composant et un second composant. Ledit premier composant est configuré de façon à être apte à adopter (i) une configuration diamétralement réduite pour disposition à l'intérieur de la lumière d'un tube creux, et (ii) une configuration diamétralement dilatée pour être disposée adjacente à la structure creuse, pour occlure la structure creuse. Ledit second composant connecte par voie percutanée ledit premier composant un site à distance dudit premier composant.
PCT/US2013/035435 2012-04-05 2013-04-05 Procédé et appareil pour occlure un vaisseau sanguin WO2013152283A1 (fr)

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EP3151785A4 (fr) * 2014-06-08 2017-12-20 Eitan Konstantino Dispositifs et procédés de remodelage des vaisseaux sanguins

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EP2311381A1 (fr) * 1996-12-20 2011-04-20 Gore Enterprise Holdings, Inc. Dispositif d'obturation à auto-extension, appareil et procédé de fabrication
US8133242B1 (en) * 2007-04-27 2012-03-13 Q-Tech Medical Incorporated Image-guided extraluminal occlusion
WO2010127083A2 (fr) * 2009-04-30 2010-11-04 Mayo Foundation For Medical Education And Research Appareil et procédés pour l'occlusion d'une lumière corporelle
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WO2015134768A1 (fr) * 2011-01-11 2015-09-11 Amsel Medical Corporation Procédé et appareil pour occlure un vaisseau sanguin et/ou d'autres structures tubulaires
US9936955B2 (en) 2011-01-11 2018-04-10 Amsel Medical Corporation Apparatus and methods for fastening tissue layers together with multiple tissue fasteners
EP3151785A4 (fr) * 2014-06-08 2017-12-20 Eitan Konstantino Dispositifs et procédés de remodelage des vaisseaux sanguins
US9918719B2 (en) 2014-06-08 2018-03-20 Sano V Pte Ltd Devices and methods for reshaping blood vessels
AU2015274900B2 (en) * 2014-06-08 2019-08-22 Sano V Pte. Ltd. Devices and methods for reshaping blood vessels
US10499923B2 (en) 2014-06-08 2019-12-10 Sano V Pte Ltd Devices and methods for reshaping blood vessels
US11213296B2 (en) 2014-06-08 2022-01-04 Sano V Pte Ltd Devices and methods for reshaping blood vessels
US10524952B2 (en) 2015-06-05 2020-01-07 Sano V Pte Ltd Devices and methods for pressure-responsive reshaping of blood vessels
WO2017100221A1 (fr) 2015-12-07 2017-06-15 Sano V Pte Ltd Dispositifs et procédés pour un remodelage sensible à la pression de vaisseaux sanguins
EP3386435A4 (fr) * 2015-12-07 2019-11-13 Sano V Pte Ltd Dispositifs et procédés pour un remodelage sensible à la pression de vaisseaux sanguins

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