US20040153142A1 - Expandable coil endoluminal prosthesis - Google Patents
Expandable coil endoluminal prosthesis Download PDFInfo
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- US20040153142A1 US20040153142A1 US10/731,737 US73173703A US2004153142A1 US 20040153142 A1 US20040153142 A1 US 20040153142A1 US 73173703 A US73173703 A US 73173703A US 2004153142 A1 US2004153142 A1 US 2004153142A1
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- stent
- graft
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- balloon
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- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- 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
- A61F2002/065—Y-shaped blood vessels
-
- 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
- A61F2002/065—Y-shaped blood vessels
- A61F2002/067—Y-shaped blood vessels modular
-
- 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
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
-
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
-
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
Description
- This is a continuation of U.S. patent application Ser. No. 09/834,145 filed 12 Apr. 2001, now U.S. Pat. No. 6,660,032, which is a continuation of U.S. patent application Ser. No. 09/400,955 filed 22 Sep. 1999, now U.S. Pat. No. 6,645,237, which is a continuation-in-part of U.S. patent application Ser. No. 09/258,542 filed 26 Feb. 1999, now U.S. Pat. No. 6,248,122. This is related to U.S. patent application Ser. No. 09/400,952 entitled Catheter With Controlled Release Endoluminal Prosthesis and Method For Placing, filed 22 Sep. 1999, now U.S. Pat. No. 6,238,430.
- The present invention provides devices and methods for the endoluminal placement of prostheses, particularly within the vascular system for the treatment of cardiovascular disease, such as vascular stenoses, dissections, aneurysms, and the like. The apparatus and methods, however, are also useful for placement in other body lumens, such as the ureter, urethra, biliary tract, gastrointestinal tract and the like, for the treatment of other conditions which may benefit from the introduction of a reinforcing or protective structure within the body lumen. The prostheses will be placed endoluminally. As used herein, “endoluminally” will mean placement by percutaneous or cutdown procedures, wherein the prosthesis is transluminally advanced through the body lumen from a remote location to a target site in the lumen. In vascular procedures, the prostheses will typically be introduced “endovascularly” using a catheter over a guidewire under fluoroscopic guidance. The catheters and guidewires may be introduced through conventional access sites to the vascular system, such as through the femoral artery, or brachial and subclavian arteries, for access to the target site.
- An endoluminal prosthesis typically comprises at least one radially expansible, usually cylindrical, body segment. By “radially expansible,” it is meant that the body segment can be converted from a small diameter configuration (used for endoluminal placement) to a radially expanded, usually cylindrical, configuration which is achieved when the prosthesis is implanted at the desired target site. The prosthesis may be non-resilient, e.g., malleable, thus requiring the application of an internal force to expand it at the target site. Typically, the expansive force can be provided by a balloon catheter, such as an angioplasty balloon for vascular procedures. Alternatively, the prosthesis can be self-expanding. Such self-expanding structures are provided by a temperature-sensitive superelastic material, such as Nitinol, which naturally assumes a radially expanded condition once an appropriate temperature has been reached. The appropriate temperature can be, for example, a temperature slightly below normal body temperature; if the appropriate temperature is above normal body temperature, some method of heating the structure must be used. Another type of self-expanding structure uses resilient material, such as a stainless steel or superelastic alloy, and forming the body segment so that it possesses its desired, radially-expanded diameter when it is unconstrained, e.g., released from radially constraining forces a sheath. To remain anchored in the body lumen, the prosthesis will remain partially constrained by the lumen. The self-expanding prosthesis can be delivered in its radially constrained configuration, e.g. by placing the prosthesis within a delivery sheath or tube and retracting the sheath at the target site. Such general aspects of construction and delivery modalities are well-known in the art and do not comprise part of the present invention.
- The dimensions of a typical endoluminal prosthesis will depend on its intended use. Typically, the prosthesis will have a length in the range from 0.5 cm to 10 cm, usually being from about 0.8 cm to 5 cm, for vascular applications. The small (radially collapsed) diameter of cylindrical prostheses will usually be in the range from about 1 mm to 10 mm, more usually being in the range from 1.5 mm to 6 mm for vascular applications. The expanded diameter will usually be in the range from about 2 mm to 42 mm, preferably being in the range from about 3 mm to 15 mm for vascular applications.
- One type of endoluminal prosthesis includes both a stent component and a graft component. These endoluminal prostheses are often called stent grafts. A stent graft is typically introduced using a catheter with both the stent and graft in contracted, reduced-diameter states. Once at the target site, the stent and graft are expanded. After expansion, the catheter is withdrawn from the vessel leaving the stent graft at the target site.
- Grafts are used within the body for various reasons, such as to repair damaged or diseased portions of blood vessels such as may be caused by injury, disease, or an aneurysm. It has been found effective to introduce pores into the walls of the graft to provide ingrowth of tissue onto the walls of the graft. With larger diameter grafts, woven graft material is often used. In small diameter vessels, porous fluoropolymers, such as PTFE, have been found useful.
- Coil-type stents can be wound about the catheter shaft in torqued compression for deployment. The coil-type stent can be maintained in this torqued compression condition by securing the ends of the coil-type stent in position on a catheter shaft. The ends are released by, for example, pulling on wires once at the target site. See, for example, U.S. Pat. Nos. 5,372,600 and 5,476,505. Alternatively, the endoluminal prosthesis can be maintained in its reduced-diameter condition by a sleeve; the sleeve can be selectively retracted to release the prosthesis. A third approach is the most common. A balloon is used to expand the prosthesis at the target site. The stent is typically extended past its elastic limit so that it remains in its expanded state after the balloon is deflated. One balloon expandable stent is the PALMAZ-SHATZ stent available from the CORDIS Division of Johnson & Johnson. Stents are also available from Arterial Vascular Engineering of Santa Rosa, Calif. and Guidant Corporation of Indianapolis, Ind.
- The present invention is directed to an endoluminal prosthesis configured to help avoid trauma to a patient's tissue.
- One aspect of the invention is directed to a coiled stent having a coiled stent body with a main body portion and end portions. The end portions are substantially less stiff than the body portion to help prevent tissue trauma.
- The main body portion may include a ladder-like stent having edge elements separated by connector elements. The end portions may have inwardly-tapering portions with blunt tips. The inwardly-tapering portions may have lengths greater than the widths. The main body portion may also be designed to have longitudinal sections with different radial stiffnesses.
- A graft material may be used to cover at least the main body portion to create a coiled stent graft in which adjacent turns have gaps defined therebetween to create a generally helical gap. The generally helical gap helps to promote a helical pattern of tissue ingrowth so that even if substantial tissue ingrowth occurs, the vessel will be much less likely to be sealed off than if the exposed tissue defined a circular pattern. The use of the generally helical gap may help speed up healing because the generally helical gap may help cells to proliferate more evenly between the coils and may enhance non-turbulent flow to help reduce restenosis.
- Further aspects of the invention relates to an endoluminal prosthesis having a body with side elements separated by connector elements and a placement method therefore. The body is placeable in a contracted, reduced diameter state and a relaxed, expanded state. The connector elements are generally parallel to the axis of the body when placed in the contracted, reduced-diameter state, typically surrounding a placement catheter.
- According to another aspect of the invention the endoluminal prosthesis includes a coiled body having first and second ends and a main portion therebetween. The main portion has an average cross-sectional dimension of x. At least one of the first and second ends has a maximum cross-sectional dimension of about 5×to25× and a blunt tip to avoid trauma to the patient's tissue. The tip typically has a flattened, generally oval shape while the main body portion typically has a rectangular cross-sectional shape.
- Other features and advantages of the invention will appear from the following description in which the preferred embodiments have been set forth in detail in conjunction with the accompanying drawings.
- FIG. 1 is an overall view of a catheter assembly using a straight stent embodiment;
- FIG. 1A is an enlarged cross-sectional view taken along line1A-1A of FIG. 1;
- FIG. 1B is an enlarged simplified partial cross-sectional view of the distal portion of the catheter of FIG. 1, with the addition of a general tubular external graft, to illustrate the relative relationship between the various components;
- FIG. 2A illustrates the catheter of FIG. 1A introduced into a blood vessel at a target site after the sheath has been pulled back to expose the stent and balloon at the target site, the graft of FIG. 1B being omitted from FIGS.2A-2G for clarity of illustration;
- FIG. 2B is similar to FIG. 2A with the distal portion of the balloon partially inflated to cause the first, distal stent portion to disengage from the first stent portion holder;
- FIG. 2C is similar to FIG. 2B but after the balloon has been deflated which permits the distal portion of the stent to spin relatively freely and thus expand to press against the inside wall of the blood vessel;
- FIG. 2D illustrates the balloon fully reinflated and showing the second, proximal end of the stent disengaged from the second stent end holder;
- FIG. 2E is similar to FIG. 2D but with the balloon fully deflated;
- FIG. 2F shows the stent in its second, expanded-diameter state after withdrawal of the distal portion of the catheter shaft;
- FIG. 3A is an enlarged view illustrating a push wire extending along the catheter shaft, passing through a push wire tube to permit the second, proximal end of the stent to be disengaged from the catheter shaft;
- FIG. 3B illustrates the first stent end holder and the first, distal end of the stent which slidably engages an opening formed in the first stent end holder;
- FIG. 4A illustrates the stent of FIG. 2G with the external graft of FIG. 1B surrounding the stent and held against the inner wall of the blood vessel by the stent;
- FIG. 4B illustrates the stent of FIG. 2G with an internal graft;
- FIG. 4C illustrates fastening an internal graft to an external stent using strips of graft material creating pathways for the stent;
- FIG. 4D illustrates an alternative coil-type stent in which the stent comprises a pair of spaced-apart coiled stent wires;
- FIG. 4E illustrates a stent graft in which parallel stent wires are kept in a spaced-apart relationship by spacers, the coiled stent wires being covered on both the inside and the outside by graft material, only a portion of the stent of FIG. 4A shown covered by the graft material to illustrate the arrangement of the coiled stent wires and spacers;
- FIG. 5 shows a bifurcated version of the catheter and balloon allowing for deployment of a bifurcated prosthesis, the prosthesis not shown;
- FIG. 6 illustrates a bifurcated stent;
- FIG. 7 shows the bifurcated stent of FIG. 6 loaded onto the bifurcated catheter of FIG. 5 with the balloon deflated;
- FIG. 7A is an enlarged cross sectional view taken along line7A-7A of FIG. 7;
- FIG. 8 shows the bifurcated stent of FIG. 7 deployed in a bifurcated vessel with the balloon inflated;
- FIG. 9 shows the stent of FIG. 8 deployed in the vessel and the withdrawal of the catheter;
- FIG. 10 shows a bifurcated catheter with a spring member used to keep the catheter shaft arms apart;
- FIG. 11 illustrates a stent blank used to create a coiled stent similar to that shown in FIG. 4E;
- FIG. 12 illustrates a stent blank similar to that of FIG. 11 but having different thickness along its length;
- FIG. 13 illustrates a stent graft in a radially expanded condition, the stent graft including a stent similar to that shown in FIG. 11 covered with a sleeve of porous graft material, the stent graft having a central turn with a greatly increased pitch for placement at a branching intersection;
- FIG. 14 illustrates a stent graft similar to that of FIG. 13 but in which one end of the stent graft has much greater radially expanded diameter than the other portion to accommodate a vessel having different internal diameters;
- FIG. 15 illustrates an alternative embodiment to the stent graft of FIG. 13 in which the stent graft has a large expanded diameter and also has the one turn with the greater pitch at one end of the stent graft;
- FIG. 15A shows a stent graft similar to that of FIG. 13 but with generally evenly-spaced turns;
- FIG. 16A is an overall view of the distal end of a three-shaft deployment catheter used to deploy the stent grafts of FIGS.13-15;
- FIG. 16B is an end view of the shafts of16A;
- FIG. 16C is an embodiment similar to the catheter of FIG. 16A but including only inner and outer shafts;
- FIG. 16D illustrates a proximal end adapter mounted to the proximal end of the catheter of FIG. 16C;
- FIG. 16E illustrates an alternative embodiment of the catheter of FIG. 16C;
- FIGS. 16F and 16G are simplified side and cross-sectional views of a further alternative embodiment of the catheter of FIGS. 16A and 16B;
- FIG. 17A illustrates the stent graft of FIG. 13 tightly wrapped about the distal end of the catheter of FIGS. 16A and 16B and placed within a vessel with the intermediate portion of the stent graft at the intersection of the main and branching vessels;
- FIG. 17B illustrates the release of the proximal half of the stent graft;
- FIG. 17C illustrates the release of the distal half of the stent graft prior to the removal of the catheter shafts;
- FIGS. 18 and 19 illustrate the placement of radiopaque marks at different positions along a coiled ladder-type stent having a central turn with a greatly increased pitch;
- FIG. 20 illustrates one example of a radiopaque marker shaped to permit the determination of the orientation of the prosthesis as well as its location; and
- FIG. 21 illustrates a coiled prosthesis having enlarged blunt ends to help prevent tissue trauma.
- FIG. 1 illustrates a catheter assembly2 including broadly a catheter 4 extending from a
proximal end adaptor 6, the catheter having anintroducer sheath 8 slidably mounted over the catheter.Proximal end adaptor 6 includes abody 10 to which apush wire manipulator 14 is slidably mounted.Proximal end adaptor 6 also includes aninflation port 16, to permit a balloon, discussed below, to be inflated and deflated during use, and aguidewire port 17. - Catheter4 includes
elongate catheter shaft 18 defining three lumens therein. FIG. 1A illustrates aninflation lumen 20, coupled toinflation port 16, aguidewire lumen 22 housing aguidewire 24, the proximal end of the guidewire passing throughguidewire port 17. Thecatheter shaft 18 also includes apush wire lumen 26 housing apush wire tube 28, apush wire 30 being housed withinpush wire tube 28. Pushwire 30 is connected to pushwire manipulator 14 and is pushed and pulled throughpush wire tube 28 by the movement ofmanipulator 14. Pushwire tube 28 is used to help preventpush wire 30 from buckling, which may occur during use due to the relatively thin diameter of the push wire, typically about 0.10 to 76 mm (0.004 to 0.030 inch). The distal end ofguidewire 24, not shown, is positioned near thetip 32 ofcatheter shaft 18 and is used to help guidetip 32 through the body, typically through blood vessels, as is conventional. During the typically percutaneous introduction of thedistal portion 34 of catheter 4 into the vasculature,sheath 8 is in the distal position shown in FIG. 1 to cover up theballoon 36,stent 38, andgraft 40 as shown in FIG. 1B. - Once in position at the
target site 42 inblood vessel 44, see FIG. 2A, handle 46 ofintroducer sheath 8 is pulled in a proximal direction to exposegraft 40,stent 38, andballoon 36. Note that in FIGS. 2A-2F,graft 40 is not shown for clarity of illustration. -
Stent 38 is a coil-type of stent typically made of 0.10 to 0.76 mm (0.004 to 0.030 inch) diameter Nitinol wire.Stent 38 may be made of other materials including stainless steel, Elgiloy®, a cobalt-chromium-nickel alloy made by Elgiloy Inc., and polymers.Stent 38, when in a relaxed state, typically has a diameter of about 2 to 30 mm to accommodateblood vessel 44 having an internal diameter of about 2 to 30 mm. The wire diameter, coil diameter, and other properties ofstent 38 may vary according to the particular body region to be accessed and the procedure to be conducted. In FIGS. 1B and 2A,balloon 36 is in a deflated condition whilestent 38 is in a first, reduced-diameter state with the coil-type stent 38 in torqued compression ontocatheter shaft 18 andballoon 36.Stent 38 includes aproximal end 48, shown also in FIG. 3A, which is housed within a hollow interior of astent end holder 50.Proximal end 48 ofstent 38 can be selectively dislodged from proximalstent end holder 50 by the distal movement ofpush wire 30 throughpush wire tube 28. In this embodiment, proximalstent end holder 50 is an extension ofpush wire tube 28 as suggested in FIG. 3A. Instead ofpush wire 30,push wire tube 28 could be pulled intocatheter shaft 18 to releaseproximal end 48 ofstent 38. - It may be desired that the length of
stent 34 be about the same when in the reduced-diameter state as when in the relaxed, enlarged-diameter state. This is desirable to minimize shifting of the stent at the target site during deployment. The use of a coil-type stent helps to achieve this by permitting the appropriate spacing the turns of the stent onto the balloon-covered catheter shaft when in a reduced-diameter state. For example,stent 38 having a relaxed diameter of 6 mm, a relaxed length of 5 cm and 10 turns in a relaxed state, can be wound onto the balloon-covered catheter shaft to assume a reduced-diameter state with about 30 turns, a diameter of about 2.5 mm and the same length of about 5 cm. The results will vary depending on various factors, such as the pitch of the coil. - A
proximal end 52 ofballoon 36 is spaced-apart fromstent end holder 50 by a distance sufficient to permit at least one turn, and preferably one-and-a-half to two turns, ofstent 38 to be wrapped directly aroundcatheter shaft 18 without any ofballoon 38 being betweenstent 38 andcatheter shaft 18. The purpose of this is to inhibit the dislodgment ofproximal end 48 fromstent end holder 50 upon the initial inflation ofballoon 36 as will be discussed in more detail below. Thus, the initial turn or turns ofstent 38 are in effective contact withcatheter shaft 18 because there is no portion ofballoon 36 between the turn or turns of the stent and the catheter shaft. - The
distal end 54 ofballoon 36 is positioned near the distalstent end holder 56. Accordingly, when thedistal stent end 58 is engaged within distalstent end holder 56,stent 38 quickly starts wrapping aroundballoon 36. Thus, upon inflation ofballoon 36,distal stent end 58 is pulled fromdistal end holder 56 as shown in FIG. 2B. Note that in FIG. 2B,balloon 36 is only partly inflated. Inflation ofdistal end 54 ofballoon 36 is aided in this embodiment by somewhat more loosely wrappingstent 38 around the balloon atdistal end 54 than over the remainder of the balloon. This reduces the resistance to inflation of the balloon atdistal end 54 thus permitting the expansion of the distal end ofstent 38 before expansion at its proximal end. Other ways to promote this initial expansion ofdistal end 54 ofballoon 36, such as makingdistal end 54 easier to expand than the remainder of the balloon or only partially retractingsleeve 8 or using a balloon with separately inflatable proximal and distal portions, can be used. - After this partial expansion of
balloon 36, the balloon is deflated as shown in FIG. 2C. This permitsstent 38 to more freely expand withinblood vessel 44 so that a greater portion of the stent is in its expanded state in FIG. 2C than in FIG. 2B. FIG. 2D illustratesballoon 36 after having been fully inflated and the dislodgment ofproximal end 48 ofstent 38 from proximalend stent holder 50 by movingpush wire 30 distally through the manipulation ofpush wire manipulator 14. This dislodgment ofproximal end 48 preferably occurs after the full inflation ofballoon 36; it could also occur before the full inflation of the balloon as well. - FIG. 2E illustrates
balloon 36 deflated leavingstent 38 in its expanded-diameterstate pressing graft 40, not shown in FIGS. 2A-2F but shown in FIG. 4A, against the inner wall ofblood vessel 44. Though not always necessary, it may be desired to movesheath 40 in a distal direction to coverballoon 36 prior to removing the distal portion of the catheter shaft. FIG. 2F illustratesstent 38 in its expanded-diameter state after removal ofcatheter shaft 18 andsheath 8. It can be noted that in FIGS. 1B and 4A the length ofgraft 40 is shorter than the length ofstent 38; this helps to ensure that the ends ofgraft 40 are pressed against the interior ofblood vessel 44. - In use, the user introduces
distal portion 34 of catheter 4 into, for example, asuitable blood vessel 44 and directstip 32 ofcatheter shaft 18 to atarget site 42 using guidewire manipulator 12 and appropriate visualization techniques as is conventional.Balloon 36 is partially inflated throughinflation port 16 to the condition of FIG. 2B causingdistal stent end 58 to be dislodged from distalstent end holder 56.Balloon 36 is then deflated to permit a distal portion ofstent 38 to more fully expand withinblood vessel 44.Balloon 36 is then fully expanded as shown in FIG. 2D and pushwire 30 is extended by movingpush wire manipulator 14 in a distal direction causingproximal end 48 ofstent 36 to be dislodged from proximalstent end holder 50; alternatively,push wire 30 could be extended to first dislodgeproximal end 48 ofstent 38B from proximalend stent holder 50 and then balloon 36 could be fully expanded. The inflation ofballoon 36 also expandsgraft 40.Balloon 36 is then deflated as shown in FIG. 2E and withdrawn intosheath 8. A distal portion ofcatheter shaft 18 andballoon 36 therewith are then withdrawn fromtarget site 42 in blood vessel 44 (see FIG. 2F) leavingstent 38 andgraft 40, which together constitute astent graft 59, in place as shown in FIG. 4A. - FIG. 4B illustrates an alternative embodiment in which
graft 40A is an internal graft coupled tostent 38. One method of couplinginternal graft 40A tostent 38 is through the use of one ormore strips 60 of graft material. Pockets, not shown, are created betweenstent 40A and strips 60 to permitstent 38 to pass between the two. The gaps are relatively large to preventgraft 40A from being overly deformed during the deployment of the stent and graft. - FIG. 4D illustrates a
stent 38A made up of a pair of spaced-apart coiled stent wires joined together at their ends. To permit the ends ofstent 38 to be secured tocatheter shaft 18, the stent end holders could, for example, be modified to accommodate the generally U-shaped ends or the ends could be squeezed together or otherwise made to form a pointed end as suggested by the dashed lines at one end ofstent end 38A. - FIG. 4E illustrates a presently preferred embodiment in which a
stent 38B is made up of a pair ofcoiled stent wires 62 joined together and maintained in a spaced-apart relationship by spacer wires 64 to create a ladder-like stent 38B. Astrip 66 of graft material is secured to coiledstent wire 62 to form aspiral graft 40 B surrounding stent 38B to lie on both the inside and the outside of the stent. Only a portion ofstent 38B is covered withstrip 66 to illustrate the construction of the stent.Strip 66 of graft material can be adhered tostent 38B in a variety of ways including use of an adhesive, heat welding, or makingstrip 66 in the form of a tube or a double-sided strip with a hollow interior which encases coiledstent wires 62. It can be seen that only one of the twocoiled stent wires 62 extend outwardly at each end ofstent 38B to form the proximal end 48B and the distal end 58B ofstent 38B. - Ladder-
like stent 38B could also be made from a tube or sheet of stent material by, for example, stamping, laser cutting, waterjet cutting or other suitable processes. It is expected that processes which do not overly heat the stent material, such as waterjet cutting, may be preferred. The graft material can be in the form of a tube of graft material which is slid over ladder-like stent 38B and secured in place by, for example, suturing the ends of the graft material. - FIG. 5 shows a
distal portion 34D of a bifurcated catheter made according to the invention with like reference numerals referring to like elements.Catheter shaft 18D includes first andsecond arms second tips Balloon 36D is a bifurcated balloon having afirst portion 78 extending alongfirst arm 70 and asecond portion 80 extending alongsecond arm 72. Proximalstent end holder 50 is carried oncatheter shaft 50D while distalstent end holder 56D is positioned along first arm 70D. Thestent end holders stent end holders stent end holder 50 and proximally for distalstent end holder 56D. A second distalstent end holder 82 is carried alongsecond arm 72 and has a distally extending open-endedtube 84 corresponding to pushwire tube 28D in that it also extends in a distal direction and uses a push wire to disengage the end of a stent from within thepush wire tube 84. As discussed above, other methods for removing the ends of the stents frompush wire tubes - FIG. 6 illustrates a
bifurcated stent 38D having amain portion 86 and first andsecond arms catheter shaft 18D and first andsecond arms Arm 88 is an extension ofmain portion 86;arm 90 is joined toarm 88 andmain portion 86 atjunction 102.Proximal end 48D ofstent 38D corresponds toproximal end 48 ofstent 38 as shown in FIG. 3A whiledistal end 58D ofstent 38D corresponds todistal stent end 58 ofstent 38 shown in FIG. 3D. Proximal and distal ends 48D, 58D engage proximal and distalstent end holders distal end 92 ofsecond arm 90 may have a reverse bend. - As shown in FIG. 7A,
catheter shaft 18D defines three lumens,inflation lumen 20D,guidewire lumen 22D,housing tube guidewires 24D, one for eacharm push wire lumen 26D housingpush wire tubes push wires 30D slidingly passing within thepush wire tubes - FIG. 7 illustrates
distal catheter portion 34D withballoon 36D in a collapsed state,stent 38D wrapped around bothballoon 36D anddistal portion 34D, and showing the outline of abranched vessel 44D shown in dashed lines. Again, as with FIGS. 2A-2F, graft material is not shown for ease of illustration. However, as with the embodiments of FIGS. 1-4, graft material is typically used withstent 38D. Of course other types of stents, other than the coiled bifurcated stent shown in FIG. 6, could be used as well. The placement ofstent 38D occurs in substantially the same fashion as can occur with the straight stent described above. The main difference is that proximal ends 48D and 92 ofstent 38D are both released usingpush wires 30D whiledistal stent end 58D is released by the partial inflation ofballoon 36D. FIG. 8 illustrates the result of having gone through the stent end release cycle, that is typically partial inflation, which releasesstent end 58D, deflation and then the full inflation and release of stent ends 48D, 92. Afterstent 38D has been expanded,distal catheter portion 34D andballoon 36D therewith are removed from the bifurcated target site as suggested in FIG. 9. Again, graft material is not shown for clarity of illustration. As with the above embodiments, graft material may not be, but often is, used with the stent or other prosthesis. - FIG. 10 illustrates a
distal catheter portion 34E similar to that shown in FIG. 5 in which the first andsecond arms junction 94 by a biasingelement 96 which tends to separatearms element 96 helps to ensurearms vascular segments distal catheter portion 34E is typically housed withinsheath 8 until just above the target site. At that point,distal portion 34E is extended out through the open distal end ofintroducer sheath 8 permittingarms vascular segments guidewires 24D in addition to biasingelement 96. - Modifications and variation may be to the above-described catheter assembly and method may be made. For example, it may not be necessary to only partly inflate the balloon as indicated in FIG. 2B; rather, it may be desired to fully inflate the balloon to release distal stent end58 from distal
stent end holder 56. Also, it may not be necessary to deflate the balloon after the full or partial inflation of the balloon as shown in FIG. 2C. In a preferred embodiment, a coiled stent is placed in torqued compression onto the catheter shaft and balloon. Other types of radially expanding stents, which may or may not be self-expanding, can be used as well. For example, tubes of stent material having numerous axially extending slits which permit the tube to be expanded radially in a diamond-like pattern using the balloon can be used. The stent could also be made of a temperature-sensitive shape-memory material. In the preferred embodiment,balloon 36 is necessary to expandgraft 40 from its reduced-diameter state of FIG. 1B to its expanded-diameter state of FIG. 4A; graft material may be used which does not require a balloon to place it into its fully expanded condition. In the preferred embodiment,graft 40 is an expandable, porous PTFE graft material such as that available from IMPRA, Baxter, W. L. Gore or Atrium. Other types of graft material, such as polyester or polyurethane, can be used. Instead of mechanically releasingproximal end 48 ofstent 38, the proximal end can be held and selectively released by electrolytic methods as shown in U.S. Pat. No. 5,122,136 to Guglielmi, et al.Distal stent end 58 could be releasably coupled tocatheter shaft 18 for release by inflation ofballoon 36 by other thanholder 56, such as through a releasable or breakable tether, a clip or other fastener, adhesive or other releasable or breakable structure. The holding and selective release ofproximal stent end 48 could be by using a range of conventional or unconventional holders; for example, the distal end ofsheath 8 could be left to cover theproximal end 52 ofballoon 36 during the initial inflation of balloon and then pulled back to uncover the proximal balloon end for the subsequent inflation of the balloon. Pull or push wires could be used to actuate a catch to releaseproximal stent end 48. Conventional techniques, such as those shown in U.S. Pat. Nos. 5,372,600; 5,476,505; 5,683,451; 5,443,500; 4,913,141; 5,246,445; 5,360,401; 5,201,757; 4,875,480; 4,848,343; 4,732,152; and 4,665,918, and those shown in WO 97/07756 and WO 94/16629, may also be used to releaseproximal stent end 48. - Bifurcated embodiments have been shown illustrating use of a single balloon. If desired, a number of separate balloons could be used instead of a single balloon. For example, three separate balloons could be used, one for each branch of the stent. The three balloons could be all coupled to a single inflation lumen; in such case the three separate balloons would act similarly to the single balloon. However, if each balloon were separately inflatable, more than one of the stent ends could be released through the inflation of the various balloons.
Stent 38D is shown withmain portion 86 and first andsecond arms common location 102. It may be desired to have, for example,second arm 90 be joined to a section ofstent 38D betweenmain portion 86 andfirst arm 88 by a sliding connection; this may be useful to help properly seat or orient the stent or a stent graft within the bifurcated vessel.First arm 88 is shown as a single continuous coil in FIG. 6. If desired,first arm 88 could include one or more separate sections of stent to create the first arm. Instead of having a single catheter split into two catheter arms,second arm 72 could actually be a separate catheter extending through the interior ofcatheter shaft 18D; this would facilitate inflating a balloon associated with the second arm separately from the one or more other balloons associated with the main portion of the catheter shaft and the first arm. It may also permit the second arm of the catheter shaft to move longitudinally relative to the main catheter shaft and the first arm of the catheter shaft. - FIG. 11 illustrates a stent blank104 used to create a coiled stent similar to that shown in FIG. 4E. Stent blank 104 includes a main body portion 106 and first and
second end portions 108. Main body portion 106 includes side edge orrail elements 110 connected by connector orrung elements 112.Rung elements 112 are, as shown in FIG. 11, at an angle to railelements 110 so that when stent blank 104 is formed into a coiled stent and tightly wrapped about an introducer catheter, such as in FIG. 17A,rung elements 112 are axially-extending so that they lie flat for a tighter wrap. -
End portions 108 are thinner and thus more flexible than main body portion 106. In addition,end portions 108 have an inwardly taperingportion 114 terminating at ablunt tip 115. The shape ofend portions 108 and the lessened stiffness of the end portions, compared to body portion 106, help to prevent tissue trauma during use. This type of coiled stent in which theend portions 108 are less stiff than the main body portion 106 can find particular utility in stabilizing a traumatic injury site within a patient, such as in the case of a dissection, flap or false lumen.End portion 108 could also be stiffer than main body portion; this embodiment may be useful, for example, when treating occlusive disease on either side of a branch vessel. - FIG. 12 illustrates a stent blank104A similar to stent blank 104 of FIG. 11 but in which
main body portion 106A has three different radial stiffnesses. That is,main body portion 106A has a first, centrallongitudinal section 116 of a first, greater stiffness, and second and thirdlongitudinal sections first section 116.Sections End portion 108A acts as the fourth longitudinal section with the least radial stiffness of any of the sections in this embodiment. Instead of a set of generally discrete radial stiffnesses, the radial stiffness could vary continuously along at least part of the length of stent blank 104A, and then along the resulting stent body. - In addition to providing less
traumatic end portions end portions - FIGS. 13, 14,15 and 15A illustrate four
stent graft embodiments Stent graft 122 includes a ladder-type coiled stent formed from stent blank 104 and covered withtubular graft material 124.Graft material 124 is preferably porous PTFE or ePTFE. The ends 126 ofgraft material 124 are sealed, or for example, by using an adhesive or by placing a suitable heat seal material, such as FEP (fluorinated ethylene propylene) or other thermoplastic materials, between the layers of thegraft material 124 and applying heat and pressure. The porous nature of the graft material permits sealing in this manner in spite of the inert nature of PTFE. In addition, a direct bond of the PTFE to itself, via a process known as sintering, may be employed. Other methods for sealing ends 126 could also be used.Coiled stent graft 122 includes a number of spaced apart turns 128 defining a generallyhelical gap 130 therebetween. The helical nature of thegap 130 is believed to help prevent restenosis in two ways. First, the helical nature ofstent graft 122 and ofgap 130 is expected to help induce a blood flow pattern which helps to reduce plaque build up. Second, if plaque build up does occur along the edges of helical gap 13, the helical nature of gap 13 is expected to help cells to proliferate more evenly betweenadjacent turns 128 and may enhance non-turbulent flow to help reduce restenosis. - The average width of
helical gap 130 is equal to about 0% to 1200% of the average width ofturns 128. More typically the average width of gap of 130 is about 50% to 800% of the average width ofturns 128 whenstent graft 122 is deployed. Also,stent graft 122 has a generally constant pitch except at its central region. The pitch of acentral turn 132 ofstent graft 122 is substantially greater than the pitch of itsadjacent turns 128 to accommodate placement ofstent graft 122 at the intersection of a main or first vessel and a branching vessel as will be discussed in more detail with reference to FIGS. 17A-17C. - FIG. 14 illustrates a
stent graft 122A in which acentral turn 132A also has an increased pitch as opposed toadjacent turns 128A. However, the turns on one side ofcentral turn 132A have a larger fully-expanded diameter than turns on the other side to accommodate transition between smaller and larger diameter vessels. - FIG. 15 illustrates a
stent graft 122B designed for placement with theend turn 134 having a substantially greater pitch than itsadjacent turn 128B.Stent graft 122B is used when one end of the stent graft is to be positioned at the intersection and main and branching vessels so that the stent graft extends to one side of the intersection as opposed to both sides as in the embodiments of FIGS. 13 and 14. FIG. 15A illustrates stent graft 122C, which may be used at locations other than bifurcations, having generally uniformly spaced turns 128C. - FIGS.16A-16B illustrate a
catheter 136 used for deploying the stent grafts of FIGS. 13 and 14.Catheter 136 includes outer, intermediate and inner rotating,telescoping shafts distal end prosthesis portion holder distal end Prosthesis portion holders pull wires lumens shafts gaps reinsertion openings wires stent graft 122 and secure those portions of the stent graft toshafts prosthesis portion holder 150B atdistal end 148 ofinner shaft 142 engages thedistal end 166 ofstent graft 122.Holders distal ends 144, 144A of outer andintermediate shafts proximal end 168 andcentral turn 132 ofstent graft 122, respectively. One or more ofshafts - FIG. 16C illustrates the distal end of a
catheter 136A including only two shafts,outer shaft 138A andinner shaft 142A.Catheter 136A is typically used when placing an endoluminal prosthesis of the type which does not have a central turn with an increased pitch, such as those of FIGS. 15 and 15A, and thus does not need a catheter with an intermediate shaft. - FIG. 16D illustrates, in a simplified form, a
proximal end adapter 170 mounted to the proximal end ofcatheter 136A of FIG. 16C.Proximal end adapter 170 includes distal andproximal portions 172, 176 through whichcatheter 136A passes.Proximal end adapter 170 provides for the rotation of either or bothshafts thumb wheel 174 mounted toportion 176. Aflip lever 175 extends from distal portion 172 and is movable between secured and released positions to eithersecure shafts shafts wires respective shafts deployment knobs deployment knobs wires appropriate holder - FIGS. 16F and 16G illustrate a further three-shaft embodiment of the invention similar to the three-shaft embodiment of FIGS. 16A and 16B. Instead of using
lumens 154 to house pullwires 152,tubular members shafts hypotubes gaps - FIG. 17A shows
stent graft 122 of FIG. 13 tightly wrapped aboutcatheter 136.Distal end 166,proximal end 168 andcentral turn 132 ofstent graft 122 are secured todistal ends intermediate shafts prosthesis portions holders 150.Stent graft 122 is housed within amain vessel 182 withcentral turn 132 aligned with theintersection 184 ofmain vessel 182 and branchingvessel 186. To help ensure proper placement ofcentral turn 132 atintersection 184,stent graft 122 has one or more remote visualization markers at or adjacent to turn 132.Radiopaque markers central turn 194 ofstent 196. Radiopaque markers may be shaped to provide information as to both location and orientation ofstent 196 on the catheter. For example, radiopaque marker 190A of FIG. 19 has a broad central portion 190B extending betweenrail elements 110 and arm portions 190C extending alongrail elements 110; this permits marker 190A to provide both location and orientation information about stent 196A. Orientation marker 190A is configured so that the viewer can determine whether the turn is facing the viewer or is away from the viewer based upon the marker's orientation. Various other marker shapes to provide both location and orientation can also be used. - Radiopaque markers may also be used on the placement catheter itself. For example,
radiopaque markers shafts respective holders Radiopaque marker 193 is shown to be configured as an orientation specific marker to help in the proper placement of the prosthesis. FIG. 20 illustrates the shape of an orientation-specificradiopaque marker 197 which could be placed, for example, onshafts holders 150 of the embodiments of FIGS. 16A, 16C and 16E. Radiopaque or other remote visualization markers may also be used at other positions along the endoluminal prosthesis, such as at each end, or along the placement catheter. - FIG. 17B illustrates the release of
proximal end 168 ofstent graft 122 while FIG. 17C illustrates the subsequent release ofdistal end 166 ofstent graft 122. It should be noted thatcentral turn 132 remains secured tointermediate shaft 140 while the distal and proximal ends 166, 168 ofstent graft 122 are released to ensure that the open region ofcentral turn 122 remains facingintersection 184 to help ensure substantially unrestricted fluid flow betweenmain vessel 182 and branchingvessel 186. It should also be noted that prior to releasing the stent graft, the number of turns can be increased or decreased by the relative rotation ofshafts stent graft 122 can be changed by the relative axial sliding motion among outer, intermediate andinner shafts proximal end 168 ofstent graft 122 to the position shown in FIG. 17B, it may be desired to rotate outer shaft relative tointermediate shaft 140, keeping intermediate andinner shafts stent graft 122 is properly positioned, especially with respect tocentral turn 132. If necessary or desired,intermediate shaft 140 could be, for example, rotated relative to outer andinner shafts central turn 132. - FIG. 17A also shows how by properly selecting the angle of
connector elements 112 relative to sideelements 110 for a placement catheter of a particular outside diameter,connector elements 112, indicated by dashed lines in FIG. 17A, will lie generally parallel to the axis ofstent graft 122. This permitsconnector element 112 to lie closer tocatheter 136, to provide a much smoother wrap when in its contracted, reduced-diameter state, than would result if connector elements were not generally parallel to the axis in such a state. This axial orientation can be contrasted with the off-axis orientation ofconnectors 112 when in the expanded diameter state of FIG. 17C. The smoother outer surface ofstent graft 122 enhances the ease of insertion of the stent graft within a hollow body organ, such asblood vessel 182. - As discussed above with reference to FIGS. 11 and 12,
end portions main body portion 106, 106A, as well as having rounded,blunt tips 116, 116A. FIG. 21 illustrates acoiled prosthesis 198 in which themain body 200 has an average cross-sectional dimension of x while the enlarged blunt ends 202 have a maximumcross-sectional dimension 204 of 5x to 25x, and more preferably 5x to 10x. In one examplemain body 200 has a rectangular cross-sectional shape with a minimum width of 0.025 mm (0.001 in) and a maximum width of 1 mm (0.040 in); enlarged blunt end has a thickness of 0.025 mm (0.001 in) and a maximumcross-sectional dimension 204 of lcm (0.4 in). This configuration of theends 202 ofprosthesis 198 helps reduce trauma to the patient's tissue by making the ends of the prosthesis less stiff and also by providing a much greater surface area so to reduce the pressure exerted against the tissue, as opposed to what could be exerted by a coiled prosthesis having a constant cross-sectional dimension. The example of FIG. 21 could be modified so that ends 202, rather being solid, are made from loops of wire with open centers. - Modification and variation can be made to the above described inventions without departing from the subject of the inventions as defined in the following claims. For example,
connectors 112 could be oriented perpendicular to railelements 110,graft material 124 could be placed upon only a portion of the underlying stent or on only one side of the underlying stent.Placement catheter 136 could include fewer or additional telescoping rotatable shafts. The telescoping shafts may not need to be coaxial shafts slidable within or over one another; the telescoping shafts could be, for example, solid and/or tubular elongate members positioned side-by-side.Holders 150 could be constructed differently; for example, if the sequence of releasing the prosthesis is known it may be possible to use a single pull wire instead of three separate pull wires. - Any and all patents, applications, and printed publications referred to above are incorporated by reference.
Claims (8)
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US10/731,737 US20040153142A1 (en) | 1999-02-26 | 2003-12-09 | Expandable coil endoluminal prosthesis |
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US09/258,542 US6248122B1 (en) | 1999-02-26 | 1999-02-26 | Catheter with controlled release endoluminal prosthesis |
US09/400,955 US6645237B2 (en) | 1999-02-26 | 1999-09-22 | Expandable coiled endoluminal prosthesis |
US09/834,145 US6660032B2 (en) | 1999-02-26 | 2001-04-12 | Expandable coil endoluminal prosthesis |
US10/731,737 US20040153142A1 (en) | 1999-02-26 | 2003-12-09 | Expandable coil endoluminal prosthesis |
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US09/834,145 Continuation US6660032B2 (en) | 1999-02-26 | 2001-04-12 | Expandable coil endoluminal prosthesis |
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US20040153142A1 true US20040153142A1 (en) | 2004-08-05 |
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US09/258,542 Expired - Fee Related US6248122B1 (en) | 1999-02-26 | 1999-02-26 | Catheter with controlled release endoluminal prosthesis |
US09/400,955 Expired - Lifetime US6645237B2 (en) | 1999-02-26 | 1999-09-22 | Expandable coiled endoluminal prosthesis |
US09/400,952 Expired - Fee Related US6238430B1 (en) | 1999-02-26 | 1999-09-22 | Catheter assembly with controlled release endoluminal prosthesis and method for placing |
US09/834,145 Expired - Lifetime US6660032B2 (en) | 1999-02-26 | 2001-04-12 | Expandable coil endoluminal prosthesis |
US10/731,737 Abandoned US20040153142A1 (en) | 1999-02-26 | 2003-12-09 | Expandable coil endoluminal prosthesis |
Family Applications Before (4)
Application Number | Title | Priority Date | Filing Date |
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US09/258,542 Expired - Fee Related US6248122B1 (en) | 1999-02-26 | 1999-02-26 | Catheter with controlled release endoluminal prosthesis |
US09/400,955 Expired - Lifetime US6645237B2 (en) | 1999-02-26 | 1999-09-22 | Expandable coiled endoluminal prosthesis |
US09/400,952 Expired - Fee Related US6238430B1 (en) | 1999-02-26 | 1999-09-22 | Catheter assembly with controlled release endoluminal prosthesis and method for placing |
US09/834,145 Expired - Lifetime US6660032B2 (en) | 1999-02-26 | 2001-04-12 | Expandable coil endoluminal prosthesis |
Country Status (5)
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US (5) | US6248122B1 (en) |
AT (1) | ATE410977T1 (en) |
AU (1) | AU3246800A (en) |
DE (1) | DE60040525D1 (en) |
WO (1) | WO2000050116A1 (en) |
Cited By (12)
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Also Published As
Publication number | Publication date |
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US6660032B2 (en) | 2003-12-09 |
US6645237B2 (en) | 2003-11-11 |
US20010020182A1 (en) | 2001-09-06 |
US6248122B1 (en) | 2001-06-19 |
WO2000050116A1 (en) | 2000-08-31 |
DE60040525D1 (en) | 2008-11-27 |
US20010044621A1 (en) | 2001-11-22 |
US6238430B1 (en) | 2001-05-29 |
AU3246800A (en) | 2000-09-14 |
ATE410977T1 (en) | 2008-10-15 |
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