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
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
• • 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
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
  • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining

Definitions

• the present invention relates generally to structures or devices for
• graft assembly having a length of graft conduit (autologous or synthetic)
• Vascular stenosis is a major problem in health care worldwide, and is
• thombolytics clot-dissolving drugs
• Thromolytics are typically administered in high doses. However, even with
• thrombolytics fail to restore blood flow in the affected vessel in
• these drugs can also dissolve beneficial clots or
• Interventional procedures include angioplasty, atherectomy, and laser
• PTCA Percutaneous transluminal coronary angioplasty
• balloon angioplasty is a treatment for coronary vessel stenosis.
• typical PTCA PTCA
• a guiding catheter is percutaneously introduced into the cardiovascular
• a balloon catheter is advanced over the guide wire to the treatment
• the balloon is then expanded to reopen the artery.
• Restenosis is believed to be a natural healing reaction to the injury of the arterial wall
• the healing reaction begins with the clotting of blood at the site of the injury.
• transluminal coronary angioplasty (PTCA) procedure are destined to require a repeat procedure.
• the patient faces an impact on his or her tolerance and well being, as
• a stent is typically composed of a biologically compatible material (biomaterial) such as a biocompatible metal wire of tubular shape or metallic
• the stent should be of sufficient strength and rigidity to maintain its
• the deployment procedure involves advancing
• the balloon is inflated to expand the stent radially to a
• stents has constituted a beacon in avoidance of the complication, risks, potential
• reducing in-stent restenosis involves coating the stent with a biocompatible, non-
• This thin coating on a metallic stent may be used to release drugs
• hirudin a platelet inhibitor such as prostacyclin (PGI.sub.2), a prostaglandin. Both of these drugs are effective to inhibit proliferation
• coating acts to prevent the adhesion of thrombi to the biomaterial or the coating
• Blood components such as
• albumin, adhesive proteins, and thrombocytes can adhere to the surface of the biomaterial, if at all, for only very limited time because of the continuous cleansing
• drugs incorporated therein include synthetic and naturally occurring aliphatic and
• polyhydroxybutyrates such as polyhydroxybutyrates, polyhydroxyvaleriates and blends, and polydioxanon, modified starch, gelatine, modified cellulose, caprolactaine polymers, acrylic acid
• Anti-proliferation substances may be incorporated into the coating carrier to
• Such substances include corticoids and dexamethasone, which prevent local
• relaxation of a vessel can be achieved by inclusion of nitrogen monoxide (NO) or other drugs that release NO, such as organic nitrates or molsidomin, or SDMI, its
• the active period of the coated stent may be adjusted by varying the thickness of the coating, the specific type of biodegradable material
• the biodegradable coating may also be applied to the stent in multiple layers,
• the layer to provide a desired response during a particular period following implantation of the coated stent. For example, at the moment the stent is introduced into the coated stent.
• the same substance as was present or a different substance from that in the top layer might be selected for use in the application of the same substance as was present or a different substance from that in the top layer might be selected for use in the application of the same substance as was present or a different substance from that in the top layer might be selected for use in the application of the same substance as was present or a different substance from that in the top layer might be selected for use in the application of the same substance as was present or a different substance from that in the top layer might be selected for use in the application of the
• Hirudin for example, can be effective against both
• a still further technique for preventing restenosis involves the use of
• percutaneous insertion catheter for purposes of enhancing luminal dilatation
• angioplasty or atherectomy which incorporates or is plated with a radioisotope to
• stent may be made radioactive by irradiation or by incorporating a radioisotope into
• radioisotope at the core of the tubular stent or to plate the radioisotope onto the surface of the stent.
• the patent also teaches, aside from the provision of radioactivity
• embodiments disclosed in summary fashion in the patent include a steel helical stent which is alloyed with a metal that can be made radioactive, such as phosphorus (14.3
• beta radiation emitter with a penetration depth of about 3 millimeters is clearly visible
• radioactive wire inserted into the coronary arteries or into arteriosclerotic vessels of
• radioactivity level may have decayed to a point
• Another technique for preventing in-stent restenosis involves providing stents
• the cells were therefore able to be delivered to the vascular wall where
• fibrin can be used to produce a
• polyurethane is combined with fibrinogen and cross-linked with thrombin and then
• artificial blood vessel, catheter or artificial internal organ is made from a polymerized protein such as fibrin.
• the fibrin is said to be highly nonthrombogenic and tissue
• the present invention is directed at a method and apparatus for maintaining
• the present invention solves the above-identified drawbacks with the prior
• a graft assembly which includes a length of graft conduit
• the first deployment assembly includes an
• the second deployment assembly includes
• the elastomeric sheaths may comprise
• Each sheath is coupled or anchored to the exterior surface of one end
• the stent rings may start out in a contracted, crimped, or partially expanded
• balloon-expandable dictates the type of delivery mechanism for transporting the
• the balloon-expandable variety it is preferred to crimp the stent rings in position on the balloon of a balloon catheter such that only the elastomeric sheaths are disposed
• graft conduit is maintained in between the stent rings during delivery into a patient
• the elastomeric sheaths are
• the sheaths will contract in length and cause the
• ends of the graft conduit to be drawn generally equal to or past the outer ends of the stent rings and into a generally mating relationship with the inside of the blood
• the elastomeric sheaths must be stretched around the stent rings such that the
• graft material resides in between the stent rings during delivery.
• the elastomeric sheaths will automatically contract in an effort to
• Figure 1 is a graft assembly according to an illustrative embodiment of the
• Figure 2 is a cross-sectional view of the graft assembly of the present invention.
• Figure 3 is a cross-sectional view illustrating a first step in the manufacture of
• Figure 3 is a cross-sectional view illustrating a first step in the manufacture of
• Figure 4 is a cross-sectional view illustrating a second step in the manufacture
• Figure 5 is a cross-sectional view illustrating a third step in the manufacture
• Figure 6 is a cross-sectional view illustrating a fourth step in the manufacture
• Figure 7 is a cross-sectional view illustrating a fifth step in the manufacture
• Figure 8 is a side view illustrating a graft assembly and a dual-balloon
• Figure 9 is a partial sectional view illustrating the placement of the graft
• Figure 10 is a partial sectional view illustrating the deployment of the graft
• Figure 11 is a cross-sectional view illustrating the graft assembly of Figure 8.
• Figure 12 is a cross-sectional view illustrating the graft assembly of Figure 8.
• Figure 13 is a partial sectional view illustrating a graft assembly of a second
• Figure 14 is a partial sectional view illustrating a graft assembly of a third
• Figure 15 is a partial sectional view illustrating a graft assembly of a fourth
• Figure 16 is a cross-sectional view of the graft assembly, delivery catheter,
• Figure 17 is a partial sectional view illustrating a graft assembly of a fifth
• Figure 18 is a partial sectional view illustrating the deployment of the graft assembly of Figure 17 in a partially occluded blood vessel via the single-balloon
• Figure 19 is a cross-sectional view illustrating the graft assembly of Figure 17
• FIGS. 1 and 2 illustrate a graft assembly 10 according to one aspect of the
• graft conduit 12 autologous or synthetic
• the graft conduit 12 is equipped with a first deployment assembly
• assembly 14 includes an elastomeric sheath 18 and a first anchor member 20.
• second deployment assembly 16 includes an elastomeric sheath 22 and a second
• each elastomeric sheath 18, 22 is coupled or anchored to the exterior surface of one end of the graft
• conduit 12 while the remaining length of the sheaths 18, 22 are dimensioned to
• the graft assembly 10 reestablishes or maintains sufficient flow through
• the graft assembly 10 also provides a means for treating or preventing diseases or occluded regions within a blood vessel.
• Anchor members 20, 24 may comprise any number of self-deployable and/or
• balloon-deployable structures or devices including but not limited to stents or stent-
• the anchor members 20, 24 may start out in the generally contracted state
• stent type and/or delivery mechanism i.e. self- expanding and or balloon-expandable.
• type of anchor structure i.e. self- expanding and or balloon-expandable
• delivery mechanism for
• the elastomeric sheaths 18, 22 must be stretched and expanded from the anchor point on
• anchor members 20, 24 are dimensioned such that, when anchor members 20, 24 are deployed (via self-
• the graft assembly 10 reestablishes sufficient flow through
• diseased or occluded regions and serves to isolate these diseased or occluded regions
• the design of the graft assembly 10 also facilitates ease of manufacture.
• the first step in manufacturing the graft assembly 10 involves
• the task of fixedly coupling the sheaths 18, 22 to the graft conduit 12 may be performed using any number of suitable
• conduit 12 Other than at the regions shown generally at 26, 28, the remainder of the
• elastomeric sheaths 18, 22 remain disposed along at least a portion of the exterior of
• FIG. 4 which involves folding the elastomeric sheaths 18, 22
• conduit 12 are left exposed, enabling the next manufacturing step shown in FIG. 5 -
• folding-trimming arrangement is that it allows a person preparing the graft assembly 10 (such as a surgeon or medical assistant) to tailor the length of the graft conduit 12
• This attachment or anchoring represented generally at 30, 32 in FIG. 2, may be performed using any number of suitable
• sheaths 18, 22 is an important feature of the present invention in that it
• the graft conduit 12 may thus be maintained in
• the various components forming the graft assembly 10 of the present invention may be formed of any number of suitable materials and dimensioned in any
• the graft conduit 12 may be
• graft conduit 12 may also comprise any number of synthetic materials (now existing
• the graft conduit 12 may be dimensioned having a length in the range of between 5 and 50
• the anchor members 20, 24 may be comprised of any material
• Anchor members 20, 24 may be dimensioned having a length in the range of between 0.5 mm and 50 mm (2.5 mm being preferred), a collapsed diameter
• the elastomeric sheaths 18, 22 may be comprised of any number of
• elastomeric materials including but not limited to silicone or any other polymers or compositions having contractility characteristics.
• the width of the elastomeric sheaths 18, 22 may range from
• the first and second deployment assemblies 14, 16 are equipped with balloon- expandable anchor members 20, 24.
• balloon-expandable As used herein, the term "balloon-expandable"
• One such device is a dual-balloon delivery catheter 40 of the type shown in FIG. 8.
• the dual-balloon delivery catheter 40 includes a catheter body 42 having a first
• the first and second balloons 42, 44 are identical to each other.
• the first and second balloons 42, 44 are identical to each other.
• the dual-balloon delivery catheter 40 is dimensioned to
• a flow restriction 52 (such as due to the build-up or deposit of fatty materials, cellular debris, calcium, and/or blood clots) capable of causing
• the dual-balloon delivery catheter 40 may be selectively positioned such
• first and second deployment assemblies 14, 16 are disposed on either side of
• balloon delivery catheter 40 may be dimensioned in any number of suitable fashions,
• the catheter body 42 having a diameter in the range of between
• the first and second balloons 44, 46 may be inflated
• this distention is advantageous in that it creates space within the vessel
• the balloons 44, 46 may be deflated and the catheter body 42 removed from the patient.
• the elastomeric sheaths 18, 22 are
• this contraction is sufficient to retract the elastomeric sheaths 18, 22
• the elastomeric sheaths 18, 22 are shown and described throughout as
• sheaths 18, 22 may be extended
• elastomeric sheaths 18, 22 be dimensioned so as to wrap the ends of the graft conduit
• the ends of the graft conduit 12 may be
• the blood flow is prevented from contacting the anchor members 20, 24, thereby
• In-stent restenosis occurs when a stent that has been previously deployed in a patient undergoes a subsequent build-
• the proactive step of preventing in-stent restenosis may be accomplished by
• the reactive step of eliminating or treating in-stent restenosis maybe
• invention may be employed in combination with current techniques for treating in-
• the graft assembly 10 maybe deployed following the
• the stent 56 is lined along its interior surface by the
• graft assembly 10 may be
• stenotic material would be sandwiched between the exterior surface of the graft conduit 12 and the interior surface of the stent 56. This would be
• a second main embodiment of the graft assembly 10 of the present invention will now be described with reference to FIG. 13. According to this embodiment,
• anchor member 20 of the first deployment assembly 14 is self-expanding, while
• anchor member 24 of the second deployment assembly 16 is balloon-expandable.
• self-expanding is meant to include any stent or scaffolding
• the delivery catheter 40 need only
• anchor member 20 requires a restraint mechanism to
• catheter 60 dimensioned to receive the graft assembly 10 and delivery catheter 40.
• Guide catheter 60 is shown in partial cross-section to illustrate the manner in which the wall 62 thereof cooperates to enclose and thereby restrain anchor member 20 of
• a guide wire (not shown) may first be advanced into the desired
• the guide catheter 60 may be advanced along the guide- wire by itself or with
• the delivery catheter 40 (carrying the graft assembly 10) disposed therein.
• the delivery catheter 40 must be capable of sliding through the inner lumen of the guide catheter
• the guide catheter 60 is first withdrawn past the
• the delivery catheter 40 may then be withdrawn from the guide catheter 60, after which point the guide catheter 60 is withdrawn to allow the self-
• the graft assembly 10 thus resides within the blood vessel 50 in generally the
• catheter 40 is shown disposed within the guide catheter 60 in FIG. 13, it is only necessary that the self-expanding first deployment assembly 14 be disposed therein
• FIG. 14 illustrates a third main embodiment of a graft assembly 10 of the
• anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both of the present invention. According to this embodiment, anchor members 20, 24 are both
• the guide catheter 60 is dimensioned to
• the delivery catheter 40 receives the graft assembly 10 and delivery catheter 40.
• the delivery catheter 40 receives the graft assembly 10 and delivery catheter 40.
• bill portion 48 has a generally tapered opening which is dimensioned to receive the
• first deployment assembly 14 at its proximal end and to abut a portion of the second
• the guide catheter 60 may be withdrawn over the delivery catheter 40.
• the deployment assembly 16 will deploy.
• the first deployment assembly 14 resides
• the graft assembly 10 resides within the blood vessel 50 in generally the same fashion as in the fully deployed state shown and described above with reference to
• FIGS. 15 and 16 illustrate a graft assembly 10 of a fourth main embodiment
• the anchor members 20, 24 are self-expanding as in the
• the guide catheter 60 is yet another type of delivery catheter 40.
• the guide catheter 60 is
• catheter 40 includes a catheter body 42 having a plurality of elongated rods 64
• the rods 64 cooperate
• rods 64 may be retracted into lumens formed within the wall of the catheter body 42 and, in so doing, release the second then first deployment assemblies 16, 14,
• the elongated rods 64 may be fixed in
• Nitonol or are pliable or controllable enough to allow the first and second
• the elongated rods 64 may permit the second deployment
• FIGS. 17-19 illustrate a graft assembly 10 of a fifth main embodiment of the
• the deployment assembly 14 is self-expanding.
• the second deployment assembly 16 is
• balloon-expandable although it employs a full stent 56 as opposed to the anchor
• first anchor member 20 comprises a modified delivery catheter 40 having an internal
• the delivery catheter 40 is
• the second deployment assembly 16 Once the delivery catheter 40 is positioned in the desired region within the blood vessel 50 (i.e. via a guide-wire), the balloon 66 is
• the balloon 66 may be deflated and the delivery catheter 40
• FIG. 19 The purchase created between the stent 56 and the vessel wall 50 is
• the graft assembly 10 is quite easy to deploy.
• Another benefit of this embodiment is that the use of the stent 56 allows a
• rigidity and expandability of the stent 56 provides the ability to position the graft
• stent 56 is sufficient to accommodate the elastomeric sheaths 18, 22, respectively, as they contract to bias the ends of the graft conduit 12 into a generally mating

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Transplantation (AREA)
• Vascular Medicine (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Animal Behavior & Ethology (AREA)
• Cardiology (AREA)
• Pulmonology (AREA)
• Gastroenterology & Hepatology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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Citations (3)

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• 2002
  • 2002-01-19 EP EP02724886A patent/EP1363560A4/de not_active Withdrawn
  • 2002-01-19 WO PCT/US2002/001845 patent/WO2002069842A2/en not_active Application Discontinuation
  • 2002-01-19 AU AU2002255486A patent/AU2002255486A1/en not_active Abandoned

Patent Citations (3)

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