US20060069422A9 - Intraluminal prosthesis attachment systems and methods - Google Patents
Intraluminal prosthesis attachment systems and methods Download PDFInfo
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- US20060069422A9 US20060069422A9 US10/307,226 US30722602A US2006069422A9 US 20060069422 A9 US20060069422 A9 US 20060069422A9 US 30722602 A US30722602 A US 30722602A US 2006069422 A9 US2006069422 A9 US 2006069422A9
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- applier
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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
- A61F2/02—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
- 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
- A61B17/064—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
- 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
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
-
- 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
- A61F2/89—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 comprising two or more adjacent rings flexibly connected by separate members
-
- 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
-
- 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
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
- This application claims the benefit of co-pending U.S. patent application Ser. No. 10/271,334, filed Oct. 15, 2002. This application also claims the benefit of co-pending U.S. Provisional Application Serial No. 60/333,937 filed 28 Nov. 2001.
- The invention relates generally to the attachment of a vascular prosthesis to a native vessel, and in particular, to a method and system of devices for the repair of diseased and/or damaged sections of a vessel.
- The weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture.
- For example, aneurysms of the aorta primarily occur in abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality.
- Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture. In this procedure, the diseased or damaged section of vessel is removed and a prosthetic graft, made either in a straight of bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthetic grafts for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The grafts are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel. However, these procedures require a large surgical incision and have a high rate of morbidity and mortality. In addition, many patients are unsuitable for this type of major surgery due to other co-morbidities.
- Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular prosthesis, which is placed intraluminally. Typically these prosthetic grafts for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These grafts are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel. Unlike open surgical aneurysm repair, intraluminally deployed grafts are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the graft in position. These graft attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.
- The invention provides systems and methods for implanting prostheses in the body. The systems and methods provide permanent attachment of the prosthesis in the body. The prosthesis can comprise, e.g., an endovascular graft, which can be deployed without damaging the native blood vessel in either an arterial or a venous system. The endovascular graft can comprise, e.g., a radially expanding vascular stent and/or a stent-graft. The graft can be placed in the vasculature, e.g., to exclude or bridge an aneurysm, for example, an abdominal aortic aneurysm. The graft desirably adapts to changes in aneurysm morphology and repairs the endovascular aneurysm. The fastening system and methods are deployed through the vasculature and manipulated from outside the body, to deliver a fastener to attach the graft to the vessel wall.
- One aspect of the invention provides a fastener applier for a prosthesis. The applier comprises a drive mechanism sized and configured to be releasably coupled to the fastener to deploy the fastener into the prosthesis. The applier also includes an actuator for the drive mechanism including a sensing mechanism that enables operation of the drive mechanism in response to at least one of (i) a force sensed at or near the fastener, and (ii) contact sensed with a surface at or near the distal end of the fastener body.
- Another aspect of the invention provides a fastener sized and configured for deployment in tissue. The fastener includes a fastener body having a distal end for penetrating tissue in response to a force. The fastener body also has a proximal end for releasably coupling the fastener body to a force applier. The fastener includes a stop structure associated with the proximal end to prevent over-penetration of the fastener body into tissue. In one embodiment, the stop structure couples the fastener body to the force applier, e.g., by a magnetic or mechanical coupling. On one embodiment, the fastener body can comprise, e.g., a helical coil.
- Another aspect of the invention provides a fastener sized and configured for deployment in tissue. The fastener comprises a fastener body having a distal end for penetrating tissue in response to a force. The fastener body also has a proximal end for releasably coupling the fastener body to a force applier. A tracking wire is coupled to the proximal end to guide the force applier into operative contact with the fastener.
- Another aspect of the invention provides a prosthesis comprising a prosthesis body and a fastener assembly integrally carried by the prosthesis body. The fastener assembly includes at least one fastener deployable into tissue in response to force applied by a force applier. A tracking wire is coupled to the fastener to guide the force applier into operative contact with the fastener.
- Another aspect of the invention provides a prosthesis comprising a prosthesis body and a fastener assembly integrally carried by the prosthesis body. The assembly includes at least one fastener deployable into tissue in response to non-rotational force applied by a force applier.
- The invention will be understood from the following detailed description of preferred embodiments, taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is a perspective view of one embodiment of an endovascular graft delivery device shown positioned within an abdominal aortic aneurysm; -
FIG. 2 is a perspective view of one embodiment the deployment of an endovascular graft within the aneurysm ofFIG. 1 ; -
FIG. 3 is a perspective view of a fully deployed straight endovascular graft ofFIG. 2 ; -
FIG. 4 is a perspective view of a fully deployed bifurcated endovascular graft broken away to show an anchoring scaffold at one end; -
FIG. 5 is a perspective view similar toFIG. 5 showing an alternative scaffold structure; -
FIG. 6 is a perspective view showing one embodiment of a device for directing the fastener applier; -
FIG. 7 is a perspective view showing the device ofFIG. 6 upon insertion within the deployed endovascular graft ofFIG. 3 with both the graft and scaffolding broken away; -
FIG. 8 is a perspective view of the device ofFIG. 6 showing activation of one embodiment of a stabilizing device attached to the directing device; -
FIG. 9 is a perspective view of the control assembly inFIG. 8 articulating the directing device ofFIG. 6 ; -
FIG. 10 is a perspective view of an alternative embodiment of the stabilization device ofFIG. 8 ; -
FIG. 11 is a perspective view showing the activation of the alternative stabilization device ofFIG. 10 ; -
FIG. 12 is a perspective view showing another embodiment of the stabilization device ofFIG. 8 ; -
FIG. 13 is a perspective view showing activation of the stabilization device ofFIG. 12 ; -
FIG. 14 is one embodiment of the fastener applier; -
FIG. 14A is an enlarged view of the distal end of the fastener applier shown inFIG. 14 , showing the details of the fastener drive mechanism; -
FIG. 14B is a section view of the interior of the handle of the fastener applier shown inFIG. 14 ; -
FIG. 15 is a perspective view of the fastener applier ofFIG. 14 being positioned within directing device ofFIG. 6 ; -
FIG. 16 is an enlarged cross-sectional view of one embodiment of the fastener applier ofFIG. 14 ; -
FIG. 17 is an enlarged cross-sectional view of the attachment applier showing one embodiment of the proximal end of the helical fastener and the drive mechanism; -
FIG. 18 is a enlarged perspective view of one embodiment of the helical fastener ofFIG. 16 ; -
FIG. 19 is an enlarged view of the attachment applier showing one embodiment of the control assembly that activates the fastener applier; -
FIG. 20 is an enlarged view of the attachment applied activated with a fastener implanted into the graft and vessel wall; -
FIG. 21 is an enlarged view of the completed attachment of the proximal graft ofFIG. 3 to the vessel wall with fasteners; -
FIG. 22 is a perspective view of the graft ofFIG. 4 completely attached to the vessel; -
FIG. 23 is an enlarged section view of the drive mechanism of the fastener applier shown inFIG. 14 , showing a contact/force sensing assembly that disables the applier in the absence of desired contact between the fastener and a targeted tissue region; -
FIG. 24 is an enlarged section view of the drive mechanism of the fastener applier shown inFIG. 14 , showing the contact/force sensing assembly enabling use of the applier in response to desired contact between the fastener and the targeted tissue region; -
FIGS. 25A and 25B are enlarged views of the distal end of a fastener applier showing the details of an alternative embodiment of the fastener drive mechanism; -
FIG. 26A is an enlarged section view of the drive mechanism of the fastener applier shown inFIGS. 25A and 25B showing a contact/force sensing assembly that disables the applier in the absence of desired contact between the fastener and a targeted tissue region; -
FIGS. 26B and 26C are enlarged section views of the drive mechanism of the fastener applier shown inFIGS. 25A and 25B , showing the contact/force sensing assembly enabling use of the applier in response to desired contact between the fastener and the targeted tissue region; -
FIG. 27 is a perspective view of a helical fastener that can be used in association with the fastener applier shown inFIGS. 14, 23 , and 24; -
FIG. 28A is a perspective view of a helical fastener that can be used in association with the fastener applier shown inFIGS. 25A and 25B ; -
FIG. 28B is perspective view of a helical fastener that can be used in association with the fastener applier shown inFIGS. 26A to 26C; -
FIG. 29 is an enlarged side view, partially in section, of a fastener applier having an angled applicator end that can be used to deploy the helical fastener shown inFIG. 27 without use of a separate directing device; -
FIG. 30 is an enlarged side view, partially in section, of an alternative embodiment of an angled fastener applier that can be used to deploy the helical fastener shown inFIG. 27 without use of a separate directing device; -
FIG. 31 is an enlarged side view, partially in section, of an alternative embodiment of an angled fastener applier that can be used to deploy the helical fastener shown inFIG. 27 without use of a separate directing device, the fastener applier having an articulating applicator end; -
FIG. 32 is a perspective view of an endovascular prosthesis shown positioned within an abdominal aortic aneurysm, the prosthesis including an integrated fastener assembly; -
FIG. 33 is a perspective view of the endovascular prosthesis shown inFIG. 32 , with an intraluminal tool deployed to operatively interact with the integrated fastener assembly, to temporarily or permanently anchor the prosthesis to the wall of the vessel; -
FIG. 34 is a side view of a fastener that forms a part of the integrated fastener assembly shown inFIG. 33 , the fastener having a stem, which is shown in a normally spread-apart condition before its association with the integrated fastener assembly; -
FIG. 35 is a side view of the fastener shown inFIG. 34 , the fastener stem now being shown in a closed condition and housed within a grommet that forms a part of the integrated fastener assembly; -
FIGS. 36 and 37 are side views showing the use of the intraluminal tool shown inFIG. 33 to apply force to drive the fastener from its position shown inFIG. 35 and through the vessel wall; -
FIG. 38 is the integrated fastener assembly after deployment to anchor a prosthesis to a vessel wall; -
FIG. 39 is a side view showing the use of a tracking wire to guide a intraluminal tool into contact with a fastener, so that force can be applied to drive the fastener through the vessel wall; -
FIG. 40 is an embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including an array of stabilization struts to help hold the prosthesis in position against the flow of blood; -
FIG. 41 is another embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including an array of inverted stabilization struts to help hold the prosthesis in position against the flow of blood; and -
FIG. 42 is another embodiment of a prosthesis delivery catheter for a prostheses in which the stent structure covers only a portion of the prosthesis, the catheter including a stabilization basket to help hold the prosthesis in position against the flow of blood. - I. Delivering a Prosthesis
-
FIG. 1 depicts an endovasculargraft delivery catheter 10 as it is being positioned over aguidewire 12 in a body lumen. Thecatheter 10 carries a prosthesis 14 (seeFIG. 2 ), which is placed at a targeted site, e.g., by radial expansion of the prosthesis 14 (seeFIG. 3 ). After expansion of theprosthesis 14, one or more fasteners 28 (seeFIGS. 15 and 16 ) are introduced by a fastener attachment assembly to anchor theprosthesis 14 in place. - For the purposes of illustration,
FIG. 1 shows the targeted site as being within an abdominalaortic aneurysm 11. The targeted site can be elsewhere in the body. In the illustrated arrangement, theprosthesis 14 takes the form of an endovascular graft. -
FIG. 2 depicts the initial stage of graft deployment at the targeted site. While the deployment method can vary, in the illustrated embodiment, thedelivery catheter 10 has amovable cover 13, which overlays thegraft 14. When thecover 13 is pulled proximally, thegraft 14 is free to radially expand, thereby enlarging to contact the internal walls of the blood vessel. Thegraft 14 is shown to be self-expanding. Alternatively, thegraft 14 can utilize an expanding member, such as a balloon or mechanical expander. - The process of graft deployment is continued, until the
graft 14 is fully deployed within the vessel. Thegraft 14 can be sized and configured to be either straight or bifurcated form.FIG. 3 depicts a completely deployedstraight graft 14.FIG. 4 depicts a completely deployedbifurcated graft 15. - A. The Prosthesis
- The
graft 14 desirably incorporates a support frame orscaffold 16. Thescaffold 16 may be elastic, e.g., comprised of a shape memory alloy elastic stainless steel, or the like. For elastic scaffolds, expanding typically comprises releasing the scaffolding from a constraint to permit the scaffold to self-expand at the implantation site. In the illustrated arrangement, thecover 13 serves as a radial constraint. Alternatively, placement of a tubular catheter, delivery sheath, or the like over thescaffold 16 can serve to maintain the scaffold in a radially reduced configuration. In this arrangement, self-expansion of thescaffold 16 is achieved by pulling back on the radial constraining member, to permit thescaffold 16 to assume its larger diameter configuration. - Alternatively, the
scaffold 16 may be constrained in an axially elongated configuration, e.g., by attaching either end of the scaffold to an internal tube, rod, catheter or the like. This maintains thescaffold 16 in the elongated, reduced diameter configuration. Thescaffold 16 may then be released from such axial constraint in order to permit self-expansion. - Alternatively, the
scaffold 16 may be formed from a malleable material, such as malleable stainless steel of other metals. Expansion may then comprise applying a radially expansive force within the scaffold to cause expansion, e.g., inflating a scaffold delivery catheter within the scaffold in order to affect the expansion. In this arrangement, the positioning and deployment of the endograft can be accomplished by the use of an expansion means either separate or incorporated into the deployment catheter. This will allow the endograft to be positioned within the vessel and partially deployed while checking relative position within the vessel. The expansion can be accomplished either via a balloon or mechanical expansion device. Additionally, this expansion stabilizes the position of the endograft within the artery by resisting the force of blood on the endograft until the endograft can be fully deployed. - The
graft 14 may have a wide variety of conventional configurations. It can typically comprise a fabric or some other blood semi-impermeable flexible barrier which is supported by thescaffold 16, which can take the form of a stent structure. The stent structure can have any conventional stent configuration, such as zigzag, serpentine, expanding diamond, or combinations thereof. The stent structure may extend the entire length of the graft, and in some instances can be longer than the fabric components of the graft. Alternatively, the stent structure can cover only a small portion of the prosthesis, e.g., being present at the ends. The stent structure may have three or more ends when it is configured to treat bifurcated vascular regions, such as the treatment of abdominal aortic aneurysms, when the stent graft extends into the iliac arteries. In certain instances, the stent structures can be spaced apart along the entire length, or at least a major portion of the entire length, of the stent-graft, where individual stent structures are not connected to each other directly, but rather connected to the fabric or other flexible component of the graft. - One illustrative embodiment of the
graft scaffold 16 or stent structure is illustrated in the area broke away inFIG. 4 . Here, the stent structure is in the form of a simple zigzag pattern, however it is contemplated that the stent design could involve morecomplex patterns 17 as depicted inFIG. 5 . Although only one stent structure within the graft is depicted, inFIGS. 4 and 5 , it is contemplated that multiple independent stent structures could be incorporated into the graft, as previously described. -
FIG. 40 shows an embodiment of aprosthesis delivery catheter 600 for aprostheses 14 in which thestent structure 16 covers only a portion of the prosthesis, e.g., being present only at the ends. As shown inFIG. 40 , the prosthesis delivery catheter 600 (which is shown deployed over a guidewire 610) includes an array of stabilization struts 612 that are releasably coupled to thestent structure 16 at the end of theprosthesis 14, e.g., by sutures that can be released by pulling on a drawstring (not shown) that passes through a lumen in thecatheter 600. The stabilization struts 612 hold the self-expandingstent structure 16 in position against thevessel wall 34, while the remainder of theprosthesis 14 is being deployed (by withdrawal of a delivery sheath 614). Thestruts 612 support the stent structure 16 (and thus the overall prosthesis 14) against the force of blood flow through the vessel during prosthesis deployment. Thecatheter 600 can also include anose cone 618 at its distal end to diffuse blood flow toward the vessel wall, to aid in supporting theprosthesis 14 during its deployment. Upon, deployment of theprosthesis 14, thestruts 612 can be detached from thestent structure 14 by pulling upon the drawstring to release the sutures, and thecatheter 600 is withdrawn over theguidewire 610 through the delivery sheath 614 (thestruts 612, freed from thestent structure 16, fold back upon thecatheter 600 during passage through the delivery sheath 614). -
FIG. 41 shows an alternative embodiment of aprosthesis delivery catheter 700 for aprostheses 14 in which thestent structure 16 covers only a portion of the prosthesis, e.g., being present at the ends. As shown inFIG. 40 , the prosthesis delivery catheter 700 (which is also shown deployed over a guidewire 710) includes an array of inverted stabilization struts 712 that are releasably coupled to thestent structure 16 at the end of theprosthesis 14, e.g., by sutures that can be released by pulling on a drawstring (not shown) that passes through a lumen in thecatheter 700. The inverted stabilization struts 712, like thestruts 612 shown inFIG. 40 , hold the self-expandingstent structure 16 in position against thevessel wall 34, while the remainder of theprosthesis 14 is being deployed (by withdrawal of a delivery sheath 714). Like thecatheter 600 inFIG. 40 , thecatheter 700 can also include anose cone 718 at its distal end to diffuse blood flow toward the vessel wall. Upon, deployment of theprosthesis 14, thestruts 712 are detached from thestent structure 14 by pulling upon the drawstring not shown), and thecatheter 700 is withdrawn over theguidewire 710 through the delivery sheath 714 (thestruts 612, freed from thestent structure 16, fold back upon thecatheter 600 during passage through the delivery sheath 614). -
FIG. 42 shows another alternative embodiment of aprosthesis delivery catheter 800 for aprostheses 14 in which thestent structure 16 covers only a portion of the prosthesis, e.g., being present at the ends. As shown inFIG. 42 , the prosthesis delivery catheter 800 (which is also shown deployed over a guidewire 810) includes a self-expandingstabilization basket 812. Thestabilization basket 812 holds the self-expandingstent structure 16 in position against the vessel wall, while the remainder of theprosthesis 14 is being deployed (by withdrawal of a delivery sheath 814). Like thecatheters FIGS. 40 and 41 , thecatheter 800 can also include anose cone 818 at its distal end to diffuse blood flow toward the vessel wall. Upon, deployment of theprosthesis 14, the stabilization basket is placed into a collapsed condition by withdrawal through thedelivery sheath 814, as thecatheter 800 is withdrawn over theguidewire 810. - In all of the just-described embodiments, the
guidewire prosthesis 14, as will be described in greater detail next. - II. Fastening the Prosthesis
- In a desired embodiment, a fastener attachment assembly is provided that makes possible intraluminal fastener attachment. The attachment assembly can be variously constructed.
- A. Two Component Fastener Guide and Attachment Assembly
- In one arrangement, the fastener attachment assembly comprises a fastener guide or directing
component 18 and afastener applier component 27. Theguide component 18 desirably has a steerable or deflectable distal tip, which is initially deployed over theguidewire 12. In use, theguidewire 12 that is used to deliver and position theprosthesis 14 desirably remains within the vessel for subsequent deployment of thefastener guide component 18. - Optionally, the
guide component 18 includes a stabilizer for holding, following removal of theguidewire 12, the deflected tip against a location in theprosthesis 14, to which afastener 28 for theprosthesis 14 is to be applied. - In this arrangement, the
applier component 27 is desirably deployed through theguide component 18. Thefastener applier 27 carries at least onefastener 28 and afastener drive mechanism 100 for advancing thefastener 28, so that it penetrates theprosthesis 14 and underlying vessel wall, to thereby anchor theprosthesis 14 firmly in place. - 1. Fastener Directing Component
-
FIG. 6 depicts one embodiment of the directing orguide component 18 that forms a part of the fastener attachment assembly. Thecomponent 18 takes the form of a directingdevice 18. Thedevice 18 has anobturator 19 positioned within a lumen of the directingdevice 18, which extends past the distal of the tip of the directing device. Theobturator 19 has a lumen to allow for delivery of the directingdevice 18 over theguidewire 12, as shown inFIG. 7 . - The directing
device 18 desirably includes an integrated stabilizingdevice 20, which aids in maintaining position of the directingdevice 18 within the vessel upon removal of theguidewire 12. In one embodiment, the stabilizingdevice 20 is spring-loaded and is positioned for deployment when theobturator 19 and guidewire 12 are removed (seeFIG. 8 ). - In the illustrated embodiment (see
FIG. 8 ), the directingdevice 18 includes acontrol assembly 21. In one embodiment thecontrol assembly 21 features a movable wheel orlever 22, which operate interior steering wires in a conventional fashion to deflect thedistal tip 23 of the directingdevice 18 toward a desired location, as seen inFIG. 9 . It is contemplated that the control assembly for the directingdevice 18 could be activated mechanically, electrically, hydraulically or pneumatically. Thecontrol assembly 21 has a through lumen to allow for the passage of theobturator 19 andapplier component 27. -
FIG. 10 depicts an alternative embodiment, in which the stabilizingdevice 20 takes the form of amovable strut assembly 24. Themovable strut assembly 24 can be activated, e.g., through alever 25 on the control assembly (seeFIG. 11 ). In both embodiments (FIGS. 7 and 10 ) the stabilizingdevice 20 is distal to the end of the directing device. - In another alternative embodiment (see
FIG. 12 ), the stabilizingdevice 20 takes the form of anexpandable member 26 adjacent to the distal tip of the directing device. As shown inFIG. 13 , theexpandable member 26 can be activated, e.g., through alever 25 on thecontrol assembly 21. However it also contemplated that this type of stabilizingdevice 20 could also be inflatable. In all embodiments the stabilizing device could be use to stabilize the directingdevice 18 either concentrically or eccentrically within the vessel. - In another embodiment, a separate stabilization device could be used in cooperation with the directing
device 18 and to access the vessel. This separate stabilization device could incorporate the forms of the stabilizing devices described above, or some other form of stabilization mechanism. - 2. Fastener Applier Component
-
FIG. 14 shows one embodiment of theapplier component 27 that forms a part of the fastener attachment assembly. Thecomponent 27 takes the form of afastener applier 27.FIG. 15 depicts thefastener applier 27 being deployed through a lumen of the directingdevice 18 to the site where afastener 28 will be installed. - Located at the distal end of the fastener applier 27 (see
FIG. 14 ) is afastener drive mechanism 100. In the illustrated embodiment (seeFIG. 14A ), thedrive mechanism 100 includes adriver 29 that is coupled to acarrier 102. The coupling between thedriver 29 andcarrier 102 can take different forms—e.g., magnets, graspers, or other suitable mechanical connection. In the embodiment illustrated inFIG. 14A , thedriver 29 andcarrier 102 are integrally connected as a single unit. - The
carrier 102 is sized and configured to engage a selectedfastener 28. InFIG. 14A , the fastener takes the form of a helical fastener of the type shown inFIGS. 18 and 27 . As best shown inFIG. 27 , and as will be described in greater detail later, thehelical fastener 28 inFIG. 26 is anopen coil 148 with a sharpened leadingtip 142. Theproximal end 144 of thefastener 28 includes an L-shapedleg 146. The L-shape leg 146 desirably bisects the entire interior diameter of thecoil 148; that is, the L-shapedleg 146 extends completely across the interior diameter of thecoil 148, asFIG. 27 shows. The L-shapedleg 146 serves to engage thecarrier 102 of thefastener applier 27, which rotates the helical fastener to achieve implantation. The L-shapedleg 146 also serves as a stop to prevent the helical fastener from penetrating too far into the tissue. - The
carrier 102 inFIG. 14A includes aslot 180, which receives the L-shapedleg 146 to couple thefastener 28 for rotation with thecarrier 102. The turns of thecoil 148 rest in complementaryinternal grooves 32 that surround thecarrier 102. Thegrooves 32 could be positioned along the entire length of thefastener 28 or within a portion of its length. - The actuation of the
drive mechanism 100 can, of course, be accomplished in various ways, e.g., mechanical (i.e., manual or hand-powered), electrical, hydraulic, or pneumatic. In the illustrated embodiment (seeFIG. 14B ), adrive cable 30 couples thefastener driver 29 to anelectric motor 106 carried in theapplier handle 108. Thedrive cable 30 is desirably made of a suitable material that allows for both bending and rotation. Driven by the motor 106 (which is, in turn, under the control ofmotor control unit 31, as will be described later), thedrive cable 30 rotates thedriver 29 and, with it, thecarrier 102. Thecarrier 102 imparts rotation and torque to thehelical fastener 28 for implantation in tissue. -
FIG. 16 is an enlarged cross-sectional view offastener applier 27 and directingdevice 18.FIG. 17 is an enlarged cross-sectional view of thefastener applier 27 with a cross-section of thefastener driver 29 depicting the engagement between thefastener driver 29 andhelical fastener 28.FIG. 19 depicts thefastener applier 27 during activation of thefastener drive mechanism 100. Activation of thedrive mechanism 100 rotates, as a unit, thedrive shaft 30, thedriver 29, thecarrier 102, andhelical fastener 28. This rotation causes thehelical fastener 28 to travel within theinternal grooves 32 of the fastener applier and into theprosthesis 14 and vessel wall 34 (seeFIG. 20 ).FIG. 21 illustrates a completedhelical fastener 28 attachment of thegraft 14 to thevessel wall 34. - In use, the
applier 27 is advanced through the directingdevice 18 and into contact with the prosthesis. The operator actuates thecontrol unit 31 by contacting a control switch 110 (seeFIGS. 14 and 14 B). This action causes thehelical fastener 28 to be rotated off thecarrier 102 and through theprosthesis 14 and into thevessel wall 34. Themotor control unit 31 desirably rotates the drive cable 30 a specific number of revolutions with each activation command. This can be accomplished by incorporating a mechanical or electrical counter. - With the deployment of a
fastener 28, theapplier 27 is retrieved through the directingdevice 18, and anotherfastener 28 is loaded into thecarrier 102. The directingdevice 18 is repositioned and stabilized, and theapplier 27 is advanced again through the directingdevice 18 and into contact with theprosthesis 14. The operator again actuates thecontrol unit 31 by contacting thecontrol switch 110 to deploy anotherfastener 28. This process is repeated at both proximal and/or distal ends of theprosthesis 14 until theprosthesis 14 is suitably attached and sealed to thevessel wall 34. It is contemplated that from about two to about twelvefasteners 28 may be applied at each end of theprosthesis 14 to affect anchorage. Thefasteners 28 can be applied in a single circumferentially space-apart row, or may be applied in more than one row with individual fasteners being axially aligned or circumferentially staggered. -
FIG. 22 illustrates a perspective view of a graft prosthesis attached to the vessel wall both proximally and distally. It is contemplated that the present invention can be used for graft attachment of both straight and bifurcated grafts within the aorta and other branch vessels. - An alternative embodiment of the
drive mechanism 100 is shown inFIGS. 25A and 25B . In this embodiment, thedriver 29 is coupled to acarrier 150, which forms a part of thehelical fastener 28 itself, as also shown inFIG. 28A . As shown inFIG. 28A , thehelical fastener 28 is, like the fastener shown inFIG. 27 , anopen coil 148 with a sharpened leadingtip 142. Theproximal end 144 of thefastener 28 includes thecarrier 150. - The
carrier 150 includes aslot 182. Theslot 182 engages adrive flange 184 on the driver 29 (seeFIG. 25A ) to impart rotation of thedriver 29 to rotation of thehelical fastener 28 during the implantation process. Like the L-shaped leg of the fastener shown inFIG. 27 , thecarrier 150 also serves as a stop to prevent the helical fastener from penetrating too far into the tissue. - The coupling engagement between the
carrier 150 and thedriver 29 could be accomplished in various ways, e.g., by separate graspers or grippers, a magnetic couple, or any other suitable mechanical connecting means. In the illustrated embodiment, thedriver 29 is made of a magnetized material, and thecarrier 150 is made from a material that is magnetically attracted toward the magnetized material. Of course, a reverse arrangement of magnetized and magnetically attracted materials could be used. - In this arrangement, the
motor coupling 132 between thedrive cable 30 and themotor 106 accommodates axial displacement of the motor cable 30 (left and right inFIGS. 25A and 25B ) without interrupting the drive connection with themotor 106. With the distal tip of theapplier device 27 in contact with the prosthesis 14 (seeFIG. 25A ), the operator actuates thecontrol unit 31 by contacting acontrol switch 110. Thecontrol unit 31 commands themotor 106 to rotate thedrive cable 30 to impart rotation to thedriver 29 and the magnetically attachedhelical fastener 28. This action causes the magnetically attachedhelical fastener 28 to be rotated intoprosthesis 14 and the vessel wall 34 (seeFIG. 25B ). Due to the magnetic coupling, as thefastener 28 is deployed to the left inFIG. 25B , thedriver 29 moves in tandem with carrier 150 (also to the left inFIG. 25B ). Due to the magnetic coupling between thecarrier 150 and thedriver 29, the operator must exert a deliberate separation force to decouple the carrier 150 (and, with it, the fastener 28) from thedriver 29. This arrangement prevents inadvertent release of afastener 28. - As before described, with the deployment of a
fastener 28, theapplier 27 is retrieved through the directingdevice 18, and anotherfastener 28 is magnetically coupled to thedriver 29. The directingdevice 18 is repositioned and stabilized, and theapplier 27 is advanced again through the directingdevice 18 and into contact with theprosthesis 14. The operator again actuates thecontrol unit 31 by contacting acontrol switch 110 to deploy anotherfastener 28. This process is repeated at both proximal and/or distal ends of theprosthesis 14 until theprosthesis 14 is suitably attached and sealed to thevessel wall 34. - As indicated in the above description, the outer diameter of the
applier component 27 is desirably sized and configured to pass through the lumen of the directingcomponent 18, which can take the form of a suitable steerable guide catheter, to direct theapplier component 27 to the desired location. As also above described, theapplier component 27 is desirably configured to implant onefastener 28 at a time (a so-called “single fire” approach). This is believed desirable, because it reduces the complexity of the design and accommodates access of theapplier 27 through tortuous anatomy.Fastener appliers 27 which carry a single fastener can have a lower profile and may be more effective and less traumatic than fastener appliers which carry multiple fasteners. Still, in alternative embodiments, theapplier component 27 may, if desired, be configured to carry multiple fasteners. Moreover, thefastener applier 27 may simultaneously deploy multiple fasteners in the preferred circumferentially spaced-apart space pattern described above. - a. Prosthesis/Tissue Contact Sensing
- The
fastener applier 27 desirably incorporates a function that prevents actuation of themotor 106 until the tip of theapplier 27 is in a desired degree of contact with the prosthesis or tissue surface. This prevents inadvertent discharge of afastener 28 and/or separation of thefastener 28. This function can be implemented, e.g., using a contact or force sensor, which is either mechanical or electrical in design. - When the
fastener applier 27 is of the type shown inFIGS. 14A . 14B, and 14C (seeFIGS. 23 and 24 ), the contact or force sensing function can, e.g., utilize thedistal tip 120 of thecarrier 102 to transmit a contact force. This force can be transmitted to a force orcontact sensing switch 122 located, e.g., within thefastener applier handle 108. In this arrangement, theswitch 122 can be part of the electrical circuit between theactuator switch 110 and thecontrol unit 31. - In the illustrated embodiment, the
switch 122 includes a stationary switch element 128 (coupled to the interior of the handle 108) and a movable switch element 130 (carried by the drive cable 31). In this arrangement, themotor coupling 132 between thedrive cable 30 and themotor 106 accommodates axial displacement of the motor cable 30 (left and right inFIGS. 23 and 24 ) without interrupting the drive connection with themotor 106. Thedrive cable 30 is coupled by abearing 134 to themovable switch element 130, so that theswitch element 130 moves in response to movement of thedrive cable 30. Thestationary switch element 128 is not coupled to themovable drive cable 30, which slidably passes through theswitch element 130. - Due to this arrangement, axial displacement of the
drive cable 30 moves theswitch element 130 relative to theswitch element 128. More particularly, displacement of thedrive cable 30 to the left inFIG. 23 moves theswitch element 130 to the left, away from theswitch element 128. Conversely, displacement of thedrive cable 30 to the right inFIG. 23 moves theswitch element 130 to the right, toward theswitch element 128. - A
spring 126 normally biases theswitch elements actuating switch 110 does not serve to actuate thecontrol unit 31, as the electricallyopen switch 122 interrupts conveyance of the actuation signal to themotor control unit 31. When theswitch elements drive cable 30 is displaced to the left to position thecarrier tip 120 beyond thedistal tip 124 of thefastener applier 27. Thecarrier tip 120 therefore makes contact with theprosthesis 14 or tissue in advance of theapplier tip 124. - When the
carrier tip 120 contacts the surface of the prosthesis or tissue with sufficient force to compress thespring 126, thedrive cable 30 is displaced against the biasing force of the spring to the right inFIG. 23 . This moves theswitch element 130 to the right. Ultimately, contact between theswitch elements FIG. 24 . The contact establishes an electrically closed condition. In this condition, operation of theactuating switch 110 serves to actuate thecontrol unit 31. As shown inFIGS. 23 and 24 , acontact screw 136 can be provided to adjust the amount of displacement required to close theswitch elements - Upon removal of contact force, or in the absence of sufficient contact force, the
spring 126 urges theswitch elements carrier 102 is located distally beyond the distal tip of theapplier 27. - It should be appreciated that the translation of movement of the
carrier tip 120 to theswitch 122 need not occur along the entire length of thedrive cable 30. For example, theswitch 122 can be located in a translation space between thecarrier 102 and thedriver 29. In this arrangement, thedriver 29, coupled to thedrive cable 30 need not accommodate axial displacement. Instead, relative movement of thecarrier 102 toward thedriver 29 in response to contact with theprosthesis 14 will mechanically couple thecarrier 10 with the driver 29 (e.g., through a slot and flange connection similar to that shown inFIGS. 25A and 25B ), while also closing theswitch 122 to energize the circuit between theactuator switch 110 and themotor control unit 31. - When the
fastener applier 27 is of the type shown inFIGS. 25A and 25B (seeFIGS. 26A, 26B , and 26C), the contact or force sensing function can, e.g., utilize aforce sensing rod 190 that slidably passes through acentral passage 192 in thecarrier 150′ (thecarrier 150′ is shown inFIG. 28B ), thedriver 29 and thedrive cable 30. Therod 190 is coupled to themovable switch element 130. In this embodiment, theswitch element 130 translates left and right over thedrive cable 30, which rotates on abearing 134 within theswitch element 130. - As in the preceding embodiment, the
spring 126 normally biases theswitch elements switch elements force sensing rod 190 is displaced to the left beyond thedistal tip 124 of thefastener applier 27. Theforce sensing rod 190 therefore makes contact with theprosthesis 14 orscaffold structure 16 in advance of theapplier tip 124. - When the
rod 190 contacts the surface of the prosthesis or scaffold structure with sufficient force to compress thespring 126, therod 190 is displaced against the biasing force of thespring 126 to the right inFIG. 26A . This moves theswitch element 130 to the right. Ultimately, contact between theswitch elements FIG. 26B . The contact establishes an electrically closed condition. In this condition, operation of theactuating switch 110 serves to actuate thecontrol unit 31. This action causes thehelical fastener 28 to be rotated into thescaffold structure 16 and into the vessel wall 34 (seeFIG. 26C ). Due to the magnetic coupling between thedriver 29 andcarrier 150′, thedriver 29 is moved in tandem with attachedcarrier 150′ to the left inFIG. 26B , as thefastener 28 is deployed. Also, due to the magnetic coupling between thecarrier 150 and thedriver 29, the operator must exert a separation force to decouple the carrier 150 (and, with it, the fastener 28) from thedriver 29. As before described, this arrangement prevents inadvertent release of afastener 28. Acontact screw 136 can be provided to adjust the amount of displacement required to close theswitch elements - Upon removal of contact force, or in the absence of sufficient contact force, the
spring 126 urges theswitch elements rod 190 out beyond thedistal tip 124 of theapplier 27. - The contact or force sensing arrangements just described can also generate an audible and/or visual output to the operator, to indicate that sufficient contact force between the
applier device 27 and the prosthesis or tissue exists. - B. Angled Component Fastener Guide and Attachment Assembly
- In another arrangement (see
FIG. 29 ), the fastener attachment assembly comprises a unitary, angled fastener guide andapplier component 160. In this arrangement, thecomponent 160 includes afastener drive mechanism 162 that places thecarrier 164 holding thefastener 28 in a perpendicular or near perpendicular position with respect to the prosthesis or tissue. This configuration eliminates the need for a separatesteerable guide component 18 for thefastener component 27, previously described. - The
drive mechanism 162 can vary. In the illustrated embodiment (shown inFIG. 29 ), themechanism 162 includes abeveled drive gear 168 coupled to thedrive cable 30. Thedrive gear 168 operatively meshes with a transfer orpinion gear 170, which is coupled to thecarrier 164. The axes of rotation of thedrive gear 168 andpinion gear 170 are offset about ninety degrees, so that rotation of thedrive cable 30 along the axis of the vessel is translated into rotation of thecarrier 164 generally perpendicular to the wall of the vessel. The fastener guide andapplier component 160 can be positioned and stabilized within the vessel in various ways, e.g., through the use external spring loaded strut or the like (as shown in association with the directingcomponent 18 discussed above), or by use of an expandable member 166 (asFIG. 29 shows). Theexpansion member 166 can comprise either a balloon or mechanical expansion device. Theexpansion member 166 stabilizes the position of both the prosthesis and the fastener guide andapplier component 160 within the vessel by resisting the force of blood until the prosthesis can be anchored. - As
FIG. 30 shows, the fastener guide andapplier component 160 can, if desired, provide an angled deployment between thedrive cable 30 andcarrier 164 that is somewhat less than ninety-degrees, to aid in intraluminal manipulation of the carrier into perpendicular contact position against the wall of the vessel. AsFIG. 31 shows, the fastener guide andapplier component 160 can, if desired, be articulated between thedrive cable 30 andcarrier 164. In this arrangement, a remote control mechanism is desirable provided to move thecarrier 164 from a first, generally straight position (shown in phantom lines inFIG. 31 ) for deployment to the targeted site, to a second, articulated position (shown in solid lines inFIG. 31 ) for alignment of thecarrier 164 in contact against the vessel wall. - III. The Fasteners
- As illustrated and described thus far, introduction of the
fasteners 28 will typically be affected after theprosthesis 14 has been initially placed. That is, initial placement of theprosthesis 14 will be achieved by self-expansion or balloon expansion, after which theprosthesis 14 is secured or anchored in place by the introduction of a plurality of individual fasteners. Thefasteners 28 may be placed only through the fabric of theprosthesis 14, i.e., avoiding the scaffold structure. Alternately, thefasteners 28 can be introduced into and through portions of the scaffold structure itself. Theprosthesis 14 may include preformed receptacles, apertures, or grommets, which are specially configured to receive the fasteners. Thefasteners 28 may be introduced both through the fabric and through the scaffold structure. The fasteners can be introduced singly, i.e., one at a time, in a circumferentially spaced-apart pattern over an interior wall of theprosthesis 14. - In the exemplary embodiment, the
fasteners 28 are helical fasteners, so that they can be rotated and “screwed into” theprosthesis 14 and vessel wall. A desired configuration for the helical fastener 28 (seeFIGS. 27, 28A , and 28B) is anopen coil 148, much like a coil spring. This configuration allows thefastener 28 to capture a large area of tissue, which results in significantly greater holding force than conventional staples, without applying tissue compression, which can lead to tissue necrosis. - As
FIGS. 27, 28A , and 28B show, the leadingtip 142 of thehelical fastener 28 is desirable sharp to allow it to penetrate thought the artery wall and/or calcified tissue. Thisdistal tip 142 can be sharpened to cut a helical path through the tissue or it can be sharpened to a point to penetrate the tissue without cutting. - The
proximal end 144 of the fastener serves two design functions. The first function is to engage thecarrier 102 of thefastener applier 27, which rotates the helical fastener during the implantation process. The second function is to act as a stop to prevent the helical fastener from penetrating too far into the tissue. - In one embodiment (see
FIG. 27 ), theproximal end 144 of thehelical fastener 28 includes an L-shapedleg 146 of thecoil 148 bisecting the fastener diameter. Theleg 146 of thecoil 148 comes completely across the diameter to prevent the fastener from being an open coil and to control the depth of penetration into the tissue. In addition, theleg 146 of thecoil 148 can be attached to a previous coil to strengthen the entire structure and provide a more stable drive attachment point for the fastener applier. This attachment could be achieved via welding, adhesive or any other suitable means. - Alternatively (as shown in
FIGS. 28A and 28B ), theproximal end 144 of thefastener 28 could incorporate a separate cap orcarrier leg 146 of thecoil 148 inFIG. 27 . Thecarrier applier drive mechanism 100. These include separate graspers or grippers, a magnetic couple (as previously described), or any other suitable mechanical connecting means. InFIGS. 28A and 28B , thecarrier slot carrier - In
FIG. 28B , thecarrier 150′ also includes a passage 152 for holding the contact/force sensing rod 190 shown inFIGS. 26A, 26B , and 26C. - The
fasteners 28 shown inFIGS. 27, 28A , and 28B can be made from stainless steel or other types of implantable metal, however it is also envisioned that the fasteners in the above descriptions could be made from implantable polymers or from a biodegradable polymer or combinations of all materials thereof. Desirably, afastener 28 will have between 2 and 10 turns and will be between 1 mm and 10 mm long. The space between the individual coils will be between 0.25 mm and 3 mm. The diameter of thefastener 28 will be between 1 mm and 6 mm. - IV. Prosthesis with Integrated Fastener Assembly
-
FIG. 32 shows aprosthesis 500 that includes at least oneintegrated fastener assembly 502.FIG. 32 shows theprosthesis 500 deployed in a targeted intraluminal region, in particular, within an abdominalaortic aneurysm 504. Theprosthesis 500 can be deployed elsewhere in the body. - The
prosthesis 500 desirably includes a fabric material or the like carried by a support frame orscaffold 504, as previously described. Thescaffold 504 can be made, e.g., from an elastic material that self-expands radially during deployment from a sheath, or from a malleable material that expands radially in response to a radially expansive force applied within the scaffold by a balloon or a mechanical expansion device. - Following deployment of the
prosthesis 500 in the targeted region, theintegrated fastener assembly 502 on theprosthesis 500 is manipulated to anchor theprosthesis 500 to the vessel wall. In the illustrated embodiment, theprosthesis 500 carries twointegrated fastener assemblies 502, one in each end region of theprosthesis 500. - In the illustrated embodiment, each
fastener assembly 502 is imbedded in a reinforcedflange area 506 in the respective end region. Eachfastener assembly 502 comprises an array offasteners 508 circumferentially spaced about theflange 506. The number offasteners 508 in the array can vary, e.g., from about two to about twelve fasteners on eachflange area 506. The configuration of the array can also vary, e.g., in the circumferential array, thefasteners 508 can by axially spaced apart as well. - The
fasteners 508 can be formed of a metal or plastic material and can be variously constructed. In the illustrated embodiment, eachfastener 508 includes a disc-shapedhead 512 and astem 514 that is bifurcated into twowings material hinge region 520. The material of thehinge region 520 is formed with a resilient memory that biases thewings FIG. 34 shows). - Each
fastener 508 is carried within agrommet 510 on the flange area 506 (seeFIG. 35 ). When thehinge region 520 is confined within the grommet 510 (asFIG. 35 shows), thewings FIG. 35 ), thewings grommet 510, and into and through the adjacent vessel wall (seeFIG. 36 ). Upon continued advancement, thehinge region 520 is freed from the confines of the grommet 510 (seeFIG. 37 ). As a result, thewings - In this arrangement, an intraluminal tool 522 (see
FIG. 33 ) is deployed into theprosthesis 500 to exert a pushing or punching force upon thehead 512 of a givenfastener 508. In the illustrated embodiment, thetool 522 comprises acatheter 524 that carries apunch member 526 at its distal end. In a desired arrangement, the distal end of thecatheter 524 is steerable, to aid in establishing point contact between thepunch member 526 and thehead 512 of the givenfastener 508. Thehead 512 can include arecess 528 to receive and stabilize the tip of thepunch member 526 with respect to thehead 512 during use (seeFIG. 34 ). - In use, the
punch member 526 is manipulated to apply a pushing or punching force upon the selectedfastener head 512. AsFIGS. 35 and 36 show, the application of the pushing force by thepunch member 526 forces thewings vessel wall 34. Thewings hinge region 520 is still confined within thegrommet 510. Theclosed wings hinge region 510 is freed from the grommet 510 (FIG. 37 ), thewings FIG. 38 ), thehead 512 and spread-apartwings prosthesis 500 against the vessel wall. In use, the physician locates and manipulates thepunch member 526 in succession against eachfastener 508, to complete the anchorage of theprosthesis 500 to the vessel wall. - In one embodiment (see
FIG. 39 ), eachfastener 508 can include atracking wire 530 that is releasably coupled to thehead 512. Thetracking wire 530 extends from thehead 512 outside the body for access outside the vessel. In this arrangement, thepunch member 526 includes a lumen to accommodate passage of thetracking wire 530. Thetracking wire 530 guides thepunch member 526 in an intraluminal path to therespective fastener 508. After thepunch member 526 is manipulated to drive thefastener 508 into the vessel wall, thepunch member 526 can be withdrawn over thetracking wire 530. Thetracking wire 530 can be released from the now-secured head 512, e.g., by applying a moderate pulling force upon thetracking wire 530. Thetracking wire 530 can then be withdrawn. Thepunch member 526 is sequentially guided over anothertracking wire 530 for interaction with another one of thefasteners 508, until a desired degree of anchorage is achieved. - In an alternative embodiment, an
integrated fastener assembly 502 on theprosthesis 500 can be used to temporarily tack theprosthesis 500 in place while a permanent anchoring technique is carried out. For example, in this arrangement, after using the integratedfastener assembly 502 to temporarily hold theprosthesis 500 in a desired location, the separatehelical fasteners 28 are deployed in the manner previously described, to permanently anchor theprosthesis 500 against the vessel wall. - It will be appreciated that the components and/or features of the preferred embodiments described herein may be used together or separately, while the depicted methods and devices may be combined or modified in whole or in part. It is contemplated that the components of the directing device, fastener applier and helical fastener may be alternately oriented relative to each other, for example, offset, bi-axial, etc. Further, it will be understood that the various embodiments may be used in additional procedures not described herein, such as vascular trauma, arterial dissections, artificial heart valve attachment and attachment of other prosthetic device within the vascular system and generally within the body.
- The preferred embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and sprit of the present disclosure.
Claims (46)
Priority Applications (35)
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US10/786,465 US8231639B2 (en) | 2001-11-28 | 2004-02-25 | Systems and methods for attaching a prosthesis within a body lumen or hollow organ |
US10/808,216 US20050177180A1 (en) | 2001-11-28 | 2004-03-24 | Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ |
US11/254,444 US7828838B2 (en) | 2001-11-28 | 2005-10-20 | Devices, systems, and methods for prosthesis delivery and implantation, including a prosthesis assembly |
US11/254,950 US7823267B2 (en) | 2001-11-28 | 2005-10-20 | Devices, systems, and methods for prosthesis delivery and implantation, including the use of a fastener tool |
US11/254,619 US9320503B2 (en) | 2001-11-28 | 2005-10-20 | Devices, system, and methods for guiding an operative tool into an interior body region |
US11/255,116 US7637932B2 (en) | 2001-11-28 | 2005-10-20 | Devices, systems, and methods for prosthesis delivery and implantation |
US11/365,056 US20060287661A1 (en) | 2001-11-28 | 2006-03-01 | Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ |
US11/488,305 US20070073389A1 (en) | 2001-11-28 | 2006-07-18 | Endovascular aneurysm devices, systems, and methods |
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US12/288,032 US20090112302A1 (en) | 2001-11-28 | 2008-10-16 | Devices, systems, and methods for endovascular staple and/or prosthesis delivery and implantation |
US12/288,034 US20090112303A1 (en) | 2001-11-28 | 2008-10-16 | Devices, systems, and methods for endovascular staple and/or prosthesis delivery and implantation |
US12/288,045 US20090138072A1 (en) | 2001-11-28 | 2008-10-16 | Devices, systems, and methods for endovascular staple and/or prosthesis delivery and implantation |
US12/288,031 US20090099650A1 (en) | 2001-11-28 | 2008-10-16 | Devices, systems, and methods for endovascular staple and/or prosthesis delivery and implantation |
US12/315,015 US20090082852A1 (en) | 2001-06-04 | 2008-11-26 | Catheter-based fastener implantation apparatus and methods |
US12/653,219 US20100094400A1 (en) | 2001-11-28 | 2009-12-10 | Devices, systems, and methods for prosthesis delivery and implantation |
US12/917,842 US8690897B2 (en) | 2001-11-28 | 2010-11-02 | Devices, systems, and methods for prosthesis delivery and implantation, including the use of a fastener tool |
US12/942,232 US20110087320A1 (en) | 2001-11-28 | 2010-11-09 | Devices, Systems, and Methods for Prosthesis Delivery and Implantation, Including a Prosthesis Assembly |
US13/157,242 US9023065B2 (en) | 2001-11-28 | 2011-06-09 | Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ |
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US14/210,683 US9808250B2 (en) | 2001-11-28 | 2014-03-14 | Systems and methods for attaching a prosthesis within a body lumen or hollow organ |
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