WO1996036269A2 - Methods and apparatus for treating abdominal aortic aneurysms - Google Patents
Methods and apparatus for treating abdominal aortic aneurysms Download PDFInfo
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- WO1996036269A2 WO1996036269A2 PCT/US1996/006436 US9606436W WO9636269A2 WO 1996036269 A2 WO1996036269 A2 WO 1996036269A2 US 9606436 W US9606436 W US 9606436W WO 9636269 A2 WO9636269 A2 WO 9636269A2
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- iliac
- graft
- mandril
- patient
- aortic
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Classifications
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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
- 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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- 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
- A61F2/95—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
- A61F2/02—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
- 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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Definitions
- the present invention relates to the field of intra-vascular surgery and, in particular, intra-aortic surgery and methods for accomplishing same as well as devices to assist in the delivery of bifurcated grafts.
- BACKGROUND ART There are several medical conditions which currently require surgery and/or the use of an abdominal aortic graft. These conditions include: abdominal aortic aneurysms, aortic and iliac occlusive disease following balloon angioplasty and aorta-distal arterial embolization.
- An aneurysm is defined as a sac formed by localized dilatation of the aorta. Aneurysms can lead to occlusion and more notably rupture of the arterial wall and thus unconfined bleeding into the abdomen. If left untreated, the patient may die of internal bleeding.
- Another technique involves the insertion of a graft of material within the existing aorta and anchoring the graft in place such that it acts to carry blood through the afflicted portion of the aorta. This is analogous to fixing a leaking pipe by placing another pipe of smaller diameter within the existing pipe and, in essence, bypassing the afflicted area of the aorta.
- the technique does have some problems, including difficulty in accurately sizing and delivering the graft in a bifurcated blood vessel.
- One problem for example, is that until surgery begins, it is often difficult to know exactly the length of a graft which will actually be required to reach from the affected area of the aorta just below the renal arteries down to and through the iliac arteries.
- a graft which is too long may buckle or kink once flow is restored. If, on the other hand, the graft is too short then when a stent is released to anchor the graft in place, it may expand in an already weakened portion of the aortic or iliac arteries and cause rupture, leakage or other complications.
- the other guide wire is fed in through the same leg and crosses over from one iliac artery into the other iliac artery and out through an incision in the common femoral artery of the other leg. See, for example, Figs. 9 through 12, and the accompanying text of Baron et al . , U.S. Patent
- the loose guide wire is used to guide the entire stent and graft assembly into the abdominal aorta above the iliac divide.
- the aortic or proximal end of the graft is exclusively fed through the femoral artery with the two iliac ends of the graft trailing behind.
- the second guide wire which is looped up through both iliac ends of the graft, is used to help try to position the crossover iliac end into proper position in the iliac artery of the other leg.
- Baron et al. also discloses insertion of an apparatus intraluminally to the aorta and in particular, to a ruptured aneurysm, through the axillary artery in the patients arm. See, for example Figs. 13 and 14.
- this method and device appear limited to use in connection with ruptured aneurysms and Baron, et al . does not disclose the ability to accommodate a bifurcated graft. Palmaz, et al . , U.S. Patent No. 5,316,022 disclosing inserting two individual grafts, rather than one bifurcated graft, through the individual femoral and iliac arteries up into the aorta.
- the present invention overcomes all of the disadvantages of the prior art by allowing for a simple, straight forward, surgical protocol which allows for complete control of the upper and lower ends of a bifurcated graft.
- the present invention allows the surgeon control of the graft from outside the body even while the graft is within the body.
- the present invention also allows a surgeon to dynamically adjust the length of the graft during surgery to provide for a perfect fit.
- the present invention further provides methods which can be primarily undertaken through the common femoral artery or through the supraclavicular subclavian artery.
- the present invention accomplishes same by the use of surgical techniques which involve three incisions, one to allow access to each of the common femoral and iliac arteries and another to allow access to, in particular, the supraclavicular left subclavian artery.
- Other arteries such as, for example, the axillary arteries or the common carotids may also be used.
- the present invention takes advantage of the use of uniquely designed delivery assemblies which allow for complete control of the placement of the graft.
- a method of implanting an abdominal aortic graft into the body of a patient which includes a number of steps.
- access is provided through an access point or access port to the interior of the first and second iliac arteries of the patient. This can be done through an incision, puncture or the like.
- access is provided through an access point to the interior of the abdominal aorta above the iliac divide and above the junction between the aorta and the renal arteries of the patient.
- a bifurcated graft having an abdominal end, a first iliac end and a second end is introduced into the abdominal aorta and the iliac arteries through one of the access points previously described.
- the graft is fixed into place such that blood can flow therethrough.
- the bifurcated graft is delivered through the access point to the interior of the abdominal aorta above the iliac divide and above the junction between the aorta and the renal arteries.
- the bifurcated graft can be introduced through the access point to the interior of one of the first or second iliac arteries of the patient.
- the abdominal aortic surgical methods can include steps of stringing one or more guide wires through the patient's body. This can include stringing at least one guide wire through both the access point to the interior of the abdominal aorta and the access point to the interior of the first iliac artery such that both ends of the guide wire protrude from the body of the patient.
- a method of implanting an abdominal aortic graft into the body of a patient which includes the step of providing access through an access point to the interior of the abdominal aorta above the iliac divide and above the junction of the aorta and the renal arteries of the patient as previously described.
- a bifurcated mandril assembly having an aortic end, a first iliac end and a second iliac end which includes a bifurcated graft is introduced into the abdominal aorta by inserting the first iliac end and the second iliac end of the mandril assembly into the abdominal aorta through the access point discussed above.
- the mandril assembly is then manipulated into place such that the first iliac end of the bifurcated mandril is disposed in the first iliac artery of the patient, the second iliac end of the bifurcated mandril is disposed in the second iliac artery of the patient and the aortic end of the mandril assembly is disposed in the abdominal aorta below the junction of the aorta and the renal arteries. Finally, the graft which is carried by the assembly is fixed in place.
- the mandril assembly can be withdrawn through the access point.
- the mandril assembly allows one to independently manipulate the first iliac end the and second iliac end, as well as the aortic end of the mandril assembly through the single access port.
- a method of implanting an abdominal aortic graft in the body of a patient which includes the steps of providing access through an access point to the interior of the first and the second iliac arteries of the patient to the abdominal aorta therethrough.
- a bifurcated mandril assembly having an aortic end, a first iliac end and a second iliac end and including a bifurcated graft is then introduced into the first iliac artery by inserting the aortic end and the second iliac end of the mandril assembly into the first iliac artery before introducing the first iliac end of the mandril assembly into same.
- the bifurcated mandril is manipulated by manipulating at least the first and the second iliac ends of the mandril assembly into place in the first and second iliac arteries respectively. This can be done in such a way so as to position the aortic end of the mandril assembly in the abdominal aorta below the junction of the abdominal aorta and the renal arteries. This, in turn, means that the bifurcated graft is in the proper place for fixation. Finally, the graft is fixed in place.
- the present invention also provides an apparatus for placing a bifurcated graft having a first, second and third end, into a body of a patient.
- the apparatus comprises a first member, a second member and a third member, each member having a first end and a second end.
- the second end of the first member is connected to the second end of the second member and the second end of the third member is connected to the second end of the first member.
- the first, second and third members each include graft deployment means for retaining the first, second and third ends of a graft respectively and for deploying a graft into the body.
- the bifurcated mandril of the present invention may include recesses, balloons, sheaths and/or other structures which will allow it to retain the stents which are attached to the various ends of a bifurcated graft until those stents are deployed.
- the first, second and/or third members also referred to as the aortic, first iliac and second iliac ends of the bifurcated mandril assembly, may be separated from one another such that each portion of the mandril assembly may be removed through a different access point in the body.
- an aortic graft delivery system provides a surgeon with the ability to manipulate all ends of the bifurcated graft, dynamically, both before and after the graft enters the body. This allows the surgeon unmatched control over the movement and placement of the graft by directly manipulating each end of the graft through the vessel into which it will be delivered.
- the supraclavicular left subclavian artery is used as the primary approach for delivery of the graft.
- a first and a second guide wire are inserted through the subclavian artery down into the abdominal aorta. Then one of each wires is run through each of the iliac arteries and out of the body of the patient through the common femoral arteries in the groin region of each leg. The first guide wire is then fed or threaded through the opening in the first iliac end of the graft and then fed through and out of the opening in the proximal or aortic end of the graft.
- the second guide wire is fed or threaded through the opening in the second iliac end of the graft and then out through the aortic end thereof.
- the graft can then be pushed and pulled into the abdominal aorta through the subclavian artery and moved into place exactly where desired. Because of the use of guide wires running into each of the iliac arteries and through each of the iliac ends of the graft, when the graft is advanced along the wires, it will naturally take up the necessary position in the aorta and in both of the iliac arteries. Moreover, because control over the top and bottom ends of the graft can be maintained at all times, simultaneously, the stents which are used to anchor the graft into place can be positioned exactly where desired.
- the former can be accomplished with the use of a bifurcated mandril as described in detail herein.
- the latter can be accomplished using a bifurcated mandril assembly for a bifurcated graft which, in essence, eliminates the need for the use of guide wires.
- the assembly were long enough, its iliac ends (those carrying the iliac ends of the bifurcated graft) could be inserted directly into the subclavian artery, down into the aorta and into each of the iliac arteries and then pulled out of the body through the common femoral arteries in each leg.
- the graft could remain out of the body even while the lower ends of the assembly protrude from the common femoral arteries. This would also allow a surgeon to control the exact placement of the graft by allowing the graft to be pushed and pulled into proper position by manipulating the three ends of the assembly alone.
- Hybrid devices are also contemplated which include built-in guide wires.
- the graft and mandril assembly could be coupled to a guide wire such that pulling on the guide wire will assist in placement of the graft. In another embodiment in accordance with the methods of the present invention, the same three incisions are made.
- the graft will be inserted through the iliac arteries via the common femoral arteries.
- only one guide wire is fed from the subclavian out through one of the femoral arteries.
- a second cross-over wire is fed from the femoral artery through which the first guide wire is threaded, up through and over the divide of the aorta into the iliac arteries and back again out through the common femoral artery in the other leg, the non- insertion leg.
- the aortic end, and the cross-over iliac portions, or second iliac end of the graft which are disposed on a bifurcated mandril assembly are both fed into the first femoral artery then into the first iliac artery and finally up into the aorta and second iliac artery by pushing and pulling the graft and the assembly, the first iliac end of the assembly is thereby carried into the first iliac artery.
- the upper end of the graft is naturally manipulated into a position below the renal arteries.
- the cross-over leg or second iliac end of the graft follows the cross-over guide wire directly into place in the non-insertion or second iliac artery. Because control is maintained over each end of the graft during insertion, it is possible to insure the correct placement of the graft and its stents.
- the invention has been described in terms of a method and apparatus utilizing guide wires.
- a single incision can be made in the subclavian and a bifurcated mandril including a bifurcated graft may be fed through the subclavian access down into the abdominal aorta and the iliac arteries.
- the device used will allow for some measure of control over the distal ends of the bifurcated mandril and graft to assist in ensuring that the first and second iliac ends of the graft are properly placed in the respective iliac arteries.
- This can be accomplished through the use of guide wires (including guides wires which do not protrude through the groin of the patient) and/or the use of an iliac stent containing mandril whose position can be influenced while inside the body.
- the iliac ends of the mandril can be combined with tips which are essentially moveable and curved so as to influence the steering of the mandril or the iliac ends of the mandril can include, for example, floatation catheters.
- the invention also allows for the use of lighter gauge, more flexible guide wires and in some cases, the elimination of guide wires altogether. This in turn allows for the use of smaller and smaller graft delivery devices minimizing stress to the vessels during surgery. In addition, lower profile devices make access options more easily available. Moreover, the resulting increase in flexibility allows for negotiating various turns in blood vessels. Thus, other blood vessels may be used as introduction points. Of course, ultimately, percutaneous access is the goal.
- the ability to control the graft, coupled with its small size and great flexibility minimizes contact between the prosthesis and the vessel wall during insertion thereby reducing the likelihood of plaque or thrombus dislodgment. Because of the ease of surgery using the present invention, operating time is reduced as is the cost of performing application. The need for further surgery due to a graft which is improperly sized or deployed can also be virtually eliminated.
- the present invention also relates to an entry device which may be used in accordance with the surgical methods and devices described herein and, indeed, any form of endo-vascular surgery.
- the device allows for quick and easy deployment of other devices into blood vessels, retards bleeding and provides for collection of blood which may accumulate during surgery for return to the patient.
- an apparatus for introducing second apparatus into the body of a patient and for collecting blood includes a hollow sheath having a longitudinal axis extending between a first and second end, a hollow housing defining a housing chamber communicating with the first end of the hollow sheath and a first valve means disposed within the housing chamber.
- the first valve means for allowing insertion of the second apparatus into the housing chamber and through the sheath but substantially retarding blood from exiting the housing chamber.
- a blood removal means is connected to the housing chamber for removing blood from the housing chamber.
- the present invention further relates to a self-expanding stent which is designed to be used either for graft fixation in a blood vessel such as the aorta or iliac arteries or for adjunctive use following balloon angioplasty in the aorta-iliac region.
- the construction of the stent provides great residual radial force throughout the entire anticipated expansion range.
- the looping of the stent construction wires and the ends helps retain the memory and the springiness of the wire while also assisting in locking the stent in place.
- the loops also help retard metal fatigue.
- three levels of contact or friction points are provided in each stent at each ends of the device and in the middle where loops of material are present.
- a self-actuating stent in accordance with one aspect of the present invention there is provided a self-actuating stent.
- the stent includes a first and a second wire.
- the first and second wires lie in a generally cylindrical surface having open ends.
- the first wire joins the second wire at a plurality of points between the open ends. At those points, the first wire includes a loop for accepting the second wire.
- Fig. 1 is a cross-sectional view of a bifurcated mandril assembly in accordance with the present invention including a bifurcated graft which is retained by a plurality of sheaths.
- Fig. 2 is a view of a threaded lower or iliac mandril assembly.
- Fig. 3 is a view of the mandril assembly of
- Fig. 2 further comprising a housing and a recess for retaining a stent.
- Fig. 4. is a view of the mandril of Fig. 3 further illustrating a self-expanding stent.
- Fig. 5 is a partial cross-section of a mandril assembly, graft and sheath for a fixed length graft.
- Fig. 6 is a view, in partial cross-section of a bifurcated mandril including balloon expandable stents and slidable lower mandrils.
- Fig. 7 is a view of an aneurysmal aorta illustrating the insertion of guide wires through a balloon expandable universal access sheath.
- Fig. 8 illustrates the insertion of a bifurcated mandril assembly over guide wires.
- Fig. 9 illustrates the final placement of a bifurcated mandril in accordance with the present invention in the area of aneurysm.
- Fig. 10 illustrates the deployment of the aortic stent.
- Fig. 11 illustrates a bifurcated mandril for delivering a bifurcated graft including balloon expandable stents.
- Fig. 12 is a view of the bifurcated mandril of Fig. 11 illustrating the expansion of balloons and the expansion of a balloon expandable stent.
- Fig. 13 illustrates another preferred embodiment of threading guide wires for a distal mandril assembly.
- Fig. 14 illustrates a bifurcated mandril assembly for a distal insertion application having self- expandable stents.
- Fig. 15 illustrates a bifurcated mandril for a distal insertion method including both self-expandable and balloon expandable stents.
- Fig. 16 is an illustration of a self-expanding stent.
- Fig. 17 is a view, in partial cross-section, of a balloon expandable universal access sheath.
- Fig. 18 is a view, in partial cross-section, of a balloon inflation device for use in conjunction with a balloon expandable access sheath.
- Fig. 19 is an illustration, in partial cross- section, of a distal mandril including an inflation balloon disposed beneath a self expanding stent which can be inflated from outside of the body of the patient.
- Fig. 20 is an illustration, in partial cross- section of a balloon tipped device useful for occluding blood flow in a blood vessel while, at the same time, allowing work to be conducted therethrough.
- Fig. 21 is an illustration, in cross-section, of the proximal end of the device shown in Fig. 20.
- Fig. 22 is an illustration, in cross-section, of a catheter insert which fits inside of the balloon occlusion device and which is removable to reveal a cavity.
- a graft carrying assembly is used to carry a bifurcated graft to an aneurysm.
- Fig. 1 which along with the other figures is not to scale, illustrates one graft carrying mandril assembly 10 in accordance with the present invention.
- Assembly 10 is intended for insertion into a patient, and the elements of assembly 10 are generally described as being “proximal” or “distal” depending on their relative position with respect to the head and feet of the patient.
- proximal or “upper” portion shall generally refer to the portion closest to patient's head and the “distal” or “lower” portion shall generally refer to the portion closest to the patient's feet.
- proximal distal
- distal distal
- Assembly 10 includes upper mandril 20, and two lower mandrils 30, 30'.
- Upper mandril 20 is generally cylindrical, and extends from a proximal end 21 to a distal end 22.
- the upper mandril also has two channels 33, 33' extending from the proximal end to the distal end, and the channels are sufficiently large enough to accept guide wires 11, 12 respectively. Although not shown, a single channel large enough to accommodate both wires may also be used.
- the upper mandril 20 also has a recess 24 which extends around the outer surface of the mandril.
- the recess holds a cylindrical self-actuating or self expandable aortic stent 50, and the edges 26 of recess 24 prevent the axial movement of the stent, i.e. movement parallel to the longitudinal axis of the mandril.
- coupling means 25 comprises screw threads on the outer surface of the proximal end 31 of lower mandril 30, and cooperating threads in channel 33 at the distal end 22 of upper mandril 20.
- detachable coupling means 25 may also include a different threaded assembly, a detachable pressure coupling, a slidable coupling member, a series of perforations, or other similar means.
- Lower mandril 30 also includes a hollow channel 37 extending from its proximal end 31 to distal end 32.
- Lower mandril 30 is generally cylindrical, but preferably narrower in diameter than upper mandril 20.
- Channel 37 is cooperatively disposed relative to channel
- a housing 34 is disposed on the outer surface of the lower mandril, and extends from raised edge 39 below the proximal end 31 until near the distal end 32. Housing 34 is preferably fixed in place such that it is not capable of axial movement with respect to the length of mandril 30, but is freely rotatable about the mandril's longitudinal axis. In other words, the housing 30 cannot move up and down the mandril, but can rotate about it. Housing 30 also defines a recess 35 on its outer surface for holding a self-actuating or self expanding cylindrical iliac stent 60.
- Lower mandril 30' is also detachably engaged with the distal end 22 of the upper mandril.
- Lower mandril 30' has the same structure as lower mandril 30, including a channel for accepting guide wire 12, and a rotatable housing with a recess for holding an iliac stent 60' .
- Figs. 2-4 offer a perspective view of alternative lower mandrils with a somewhat different coupling structure than the lower mandril shown in Fig. 1.
- Fig. 2 shows a mandril 30 with channel 33 through which a guide wire may be passed.
- Fig. 2 also shows an alternative coupling means 25 whereby the threaded receiving member of the lower mandril has a wider inside diameter than the corresponding threaded member at distal end 22 of upper mandril 20.
- Fig. 3 illustrates the same alternative lower mandril 30 but contained in housing member 34.
- the housing member 34 starts at raised edge 39 and ends at or near the distal end 32 and is freely rotatable around mandril 30. As shown in Fig.
- iliac stent 60 is disposed and retained in recess 35.
- the actual distance between the proximal ends and distal ends of the various mandrils or members are preferably quite large compared to the mandrils' diameter.
- the length of upper mandril 20 may be 100cm while the diameter is 5mm.
- All of the mandrils should be of a material sufficiently flexible for being threaded through the arteries of a patient, such as hollow, helically coiled wire or molded plastic.
- a bifurcated graft 70 is attached to stents 50, 60, and 60'.
- the graft is pant- shaped or "Y" shaped having an open proximal or aortic end 71 and two open distal or iliac ends 72,72'.
- Proximal end 71 is preferably attached midway between the ends of aortic stent 50 in nearly any manner known in the art.
- the graft is sutured to the stents, using for example, interrupted, non-absorbable sutures.
- Each distal end 72,72' of the graft 70 is attached midway between the ends of the corresponding iliac stents 60,60' of lower mandrils 30,31'.
- the Y-shaped graft 70 is fitted over assembly 10 at the junction between the upper mandril and the lower mandrils and is attached at its ends to the middle of the stents.
- stents A wide variety of stents are known and can be used. In such cases, the graft 70 may not be attached to the stents in the manner just described. Rather, attachment will be dictated by the stent itself.
- a number of commercially available bifurcated grafts 70 may be used.
- the Bard Velex graft available from CR. Bard, Inc. may be used.
- a thinner version of such a graft could also be used as the graft is being used endo-luminally i.e. inserted within an already existing vessel.
- an expandable PTFE graft manufactured by Impra of Scottsdale, Arizona may be used.
- graft 70 is adjustable in terms of length.
- the iliac and/or aortic portion of the graft may be constructed using accordion-type folds or pleats (crimped) which, when pulled, will expand allowing for the adjustment of the length of the graft and, in particular, the placement of the iliac stents.
- the actual size of the graft is chosen by the surgeon based on the particular needs of the patient. For example, a 16 x 8 graft 70 will have a 16 millimeter opening at upper end 71 and 8 millimeter openings at distal ends 72,72'.
- the graft 70 itself is made of a flexible material which may stretch to accommodate vessel growth, and/or to allow the graft to be used over a wide range of lengths.
- the assembly 10, including the graft 70, is then encased in a removable sheath.
- the sheath may be a single integral unit, but is preferably three separate sheaths 81,82,82', covering the stents on the upper mandril and the lower mandrils, respectively.
- Sheath 81 extends from approximately the proximal end 21 of upper mandril 20 to the distal end 22.
- sheaths 82,82' extend from approximately the proximal ends of lower mandrils 30,30' to the distal ends of the lower mandrils.
- the sheaths are sized to tightly fit over the mandrils, stents and graft to prevent the stents from expanding.
- the device just described may be used as follows. First, the patient is prepped from neck to knees and draped in a fashion to expose the left of the neck above the clavicle and both groins. The patient is laid supine with the neck hyper-extended and turned to the right. General or local anesthetic, the latter with a sedative, may be administered.
- a transverse skin incision is made above the left clavicle and the lateral third of the left sternocleidomastoid muscle is divided and retracted medially.
- the internal jugular vein is also retracted medially exposing the scalenus anticus muscle.
- the phrenic nerve runs along the antero-lateral border of the scalenus anticus muscle and injury must be avoided during the procedure.
- the scalenus anticus muscle is then divided to expose the subclavian artery 1
- the subclavian artery 1 is encircled and mobilized circumferentially, taking care not to enter the pleural cavity.
- the branches of the subclavian artery are controlled with loops of 2-0 silk.
- a puncture is made into the subclavian 1 and a Balloon Expandable Universal Access Sheath ("BEUAS") 2000 or some other, conventional, access port is inserted (the BEUAS 2000 is illustrated in Figs. 17 and 18).
- BEUAS 2000 is illustrated in Figs. 17 and 18.
- a large bolus of Heprin is given.
- a first guide wire 11 is then inserted through the BEUAS.
- the guide wire may be guided through the body with a guide catheter, the wire is preferably passed within a floatation catheter 13.
- the use of a flotation catheter takes advantage of blood flow for placement and minimizes the contact between the guide wire and the arterier wall.
- Guide wire 11 is fed down through subclavian 1, past renal arteries 2, through the abdominal aorta 3 and past the aneurysm 6 to be treated, into and through iliac artery 4, and finally out a small transverse arteriotomy 105 made in the common femoral artery 5 of the patient's leg.
- a second guide wire 12 is fed into the subclavian 1 and out another incision 105' in the common femoral artery 5* of the other leg.
- both guide wires 11, 12 protrude from the patient's body, one end of each wire protruding from each leg and the other ends both protruding from the subclavian.
- Sufficient wire il, 12 is left protruding from the body to allow for easy manipulation.
- the guide wires 11, 12 may be as much as 12 feet in length, or even longer.
- the guide wire should be sufficiently long to allow for control of both ends to be maintained, even when the graft is put into place.
- the guide wire must be sufficiently long to accommodate and allow access thereto even when the full length of the mandril is exposed through the patient's legs.
- the portions of wires 11,12 extending out of subclavian 1 are then fed into and through the appropriate channels 37, 37' of the lower mandrils and then channels 33, 33' of the upper mandril. (see Fig. 1) .
- the two distal ends 32,32' of the sheathed assembly 10 are inserted into the subclavian 1 through the BEUAS 2000 and fed through the patient's body until the ends 32,32' protrude from the incisions in the common femoral arteries 5, 5' (Figs. 8-9).
- the assembly can be releasably attached to the guide wires 11, 12 such that the assembly can be pulled into place by pulling on the guide wires.
- graft 70 is ready to be introduced into the body and positioned. Graft 70 in combination with the mandril assembly 10 are advanced along guide wires 11,12 and moved to aneurysm 6 by manipulating the protruding portions of the mandrils, i.e. by pulling and pushing on lower ends 32, 32' and upper end 21 (Fig. 9). While feeding the graft through the patient, care must be taken to ensure the sheaths 81, 82, 82' remain in place in order to prevent premature deployment of the stents.
- the graft is correctly positioned within the aneurysm 6 when the aortic stent 50 is in position below the junction with the renal arteries 2 (Fig. 9) .
- the graft and stents will be completely within the patient's body, while portions of the guide wires 11, 12, mandrils 20, 30, 30', housing 34, 34' and sheaths 81, 82, 82' will all extend out of the patient.
- the position of the graft 70 can be confirmed by reference to an angiogram which is taken using a pigtail catheter and an operating table having a radio-opaque ruler at the beginning of the procedure.
- the graft is deployed by removing the individual sheaths.
- the aortic stent 50 is deployed by removing the sheath 81 by pulling the sheath back through the subclavian artery 1 (Fig. 10) .
- the sheath 81 is tightly disposed around the graft 70 and upper mandril 20, it is not so tight that it can not be pulled off the upper mandril, especially when the lower mandrils 30 are held in place.
- the self- actuating stent 50 will expand out of recess 24 and push the proximal end 71 of the graft against the walls of the aorta 3 above the aneurysm 6. This fixes the upper end 71 of the graft 70 into place in the aorta 3.
- the lower mandrils 30 are detached from the upper mandril 20.
- the upper end 21 of the upper mandril 20 and the housing 34 of the lower mandril 30 are grasped and prevented from rotating.
- lower mandril 30 is rotated by rotating the lower end 32.
- the screw coupling 25 will come undone and the lower mandril will be detached from the upper mandril.
- housing 34 is prevented from rotating, the lower mandril 30 will be able to spin within housing 34 without twisting the iliac leg of the graft 70, stent 60 or sheath 82.
- the lower mandril 30 is detached from the upper mandril assembly, the lower mandril is manipulated to a position such that the lower end 72 of graft 70 is the correct position within iliac artery 4. In other words, the graft 70 is pulled and stretched to the appropriate length.
- the housings 34 and mandril 30 are kept steady while sheath 82 is retracted through the common femoral artery, thereby deploying the iliac stent 60 and fixing the distal end 72 of graft 70 in place in iliac artery 4.
- the two legs are done sequentially.
- the other iliac stent is deployed in the other leg in the same manner described in connection with the foregoing stent.
- a structure which helps prevent the premature deployment of stents 50, 60, 60' by inadvertent removal of sheaths 81, 82 and 82. This can be accomplished by the use of a collapsible structure at each end of the mandril assembly which will protrude from the patients body. The structure stretches the sheath in the localized area thereof making it difficult to move the sheath axially relative to the housing, mandril and/or other structures.
- the surgeon can grip the entire assembly, including the sheath, between that structure and the outer-most end of the mandril, without significant fear of inadvertently deploying the stent covered by that sheath.
- the sheath is made of a more rigid, slick, plastic material, then the assembly can be gripped above this structure without fear of inadvertent stent deployment as well.
- the sheath can be gripped above this structure and/or the device can be compressed or collapsed such that it no longer provides additional resistance.
- the structure could be a retaining band, a collapsible balloon, a spring loaded bearing or pad, a hook or latch, and the like.
- the various portions of the lower mandrils 30, 30' and housings 34, 34' are withdrawn through the femoral incisions and the upper mandril 20 is removed through the subclavian artery.
- a pigtail catheter is once again inserted into the surgical region to give a completion arteriogram.
- the guide wires 11, 12 are also removed. If satisfactory, each leg is flushed and femoral blood flow is restored after the arteriotomics are closed. The incisions are then closed and the wounds dressed.
- the housing 34 was allowed to freely rotate relative to the lower mandril 30 in order to allow the mandril 30 to be unscrewed without effecting the position of the housing 34 and, therefore, causing a twisting of the graft 70. If some other form of detachment means is used, it may not be necessary to include an independently rotatable housing 34. For example, if the lower mandrils 30, 30' are connected to the upper mandril 20 by a microperforation or by some form of pressure or snap coupling, then it may be possible to build the housing 34 and/or the recess 35 into the mandril 30 per se .
- guide wires 11, 12 could be eliminated by designing systems such that mandrils 20 and 30 are sufficiently long, sufficiently rigid, and sufficiently tapered so as to allow insertion directly through the subclavian 1 down into the aorta 3, through the iliac arteries 4 and out through the femoral arteries 5.
- long wiry mandrils themselves are used. Otherwise, however, the device can remain substantially unchanged.
- Such a system may be smaller than the embodiment shown in Fig. 1 by eliminating channels 33, 33', 37, 37'.
- a small upper mandril diameter may help reduce surgical trauma.
- a guide wire is permanently embedded in the mandril to provide a sufficient degree of rigidity and flexibility to allow the mandril to be properly placed with as little stress as possible upon the blood vessels.
- FIG. 5 illustrates another embodiment using an assembly which is particularly adapted for introducing grafts of a fixed length. Because it is not necessary to stretch a fixed-size graft, lower mandrils 230, 230' are permanently attached to and/or integral with the distal portion 222 of the upper mandril 220. In this embodiment, as in any embodiment which utilizes distal or lower mandrils 230, 230' which do not need to be rotated for removal, it is possible to eliminate the use of housing members 34, 34' by building recess 235' directly into the lower mandrils to retain the iliac stent 260'.
- the entire assembly including the upper and lower mandrils can be withdrawn through the subclavian 1 incision.
- Balloon-expandable aortic and iliac stents are, in turn, placed around the balloons.
- balloon 300 underneath the balloon expandable stent 350 in the aorta is inflated via inlet 390, thus increasing the size of the aortic stent and locking the proximal end 371 of the graft 370 in place.
- the balloon expandable iliac stents 360, 360' are then expanded so as to deploy the iliac stents 360, 365 and secure the distal ends of the graft. Thereafter, balloons 300, 301 301' are deflated and the entire mandril assembly 310 is removed through the subclavian 1.
- the lower mandrils 430, 430' of assembly 410 are slidably disposed within and through upper mandril 420.
- the lower mandrils slide through the upper mandril.
- Within upper mandril 420 are two channels 433, 433' extending from proximal end 421 to distal end 422.
- Lower mandrils 430, 430' extend through these tubes, such that the proximal end 431 of lower mandril 430 extends above the proximal end 421 of upper mandril 420, and distal end 432 of lower mandril 430 extends below the distal end 422 of upper mandril 420.
- the individual iliac stents 460, 460' are positioned by pushing and pulling on the proximal ends 431, 432, 432' which extend out of the body of the patient.
- This arrangement is that all of delicate work of carefully positioning the graft can take place in the same end of the patient, i.e., at the proximal end. It may be advisable for this arrangement to include a stop mechanism located a certain distance proximal to the upper end 421 of the upper mandril 420 to ensure that the lower mandrils 430, 430' are not pulled too far so as to rip the stent or withdraw the lower mandrils out of the upper mandril. On the other hand, the stop may be configured to allow for withdrawal of the lower mandrils 430, 430' through the femoral artery 5 when desired.
- Fig. 6 may be particularly useful in performing surgery without the use of incisions in the femoral arteries.
- an incision can be made in the subclavian as previously described and a bifurcated mandril assembly 410 inserted as previously described.
- the distal ends 432, 432' of the assembly 410 in one embodiment, will be attached to, embedded in or include floatation devices which will allow them to float independently into the two iliac arteries.
- the distal ends 432 and 432' of the lower mandrils 430 and 430' can be tapered and may include somewhat converging conical tips which form something of a claw shape when positioned in opposition to each other.
- the lower mandrils could be rotated from the proximal end of the assembly such that the tips 432, 432' diverge to assist in feeding the individual iliac ends of the graft into the respective iliac arteries.
- housings 434 and 434' would be anchored in some way to the body of the upper mandril 420 to prevent the graft 470 from rotating when mandrils 430, 430' are rotated.
- guide wires can be fed into the iliac and femoral arteries as previously described. However, no incisions are made to retrieve same through the legs. Thereafter, the mandril assembly 410 is threaded onto the guide wires 411 and 412 and, generally pushed into position from above. Once the graft 470 has been properly placed and fixed, both the mandril and the guide wires can be removed through the subclavian 1.
- Figure 6 also shows a combination of stent deployment methods. For example, a balloon is used to deploy the iliac stents 460, 460' and a self-expanding stent 70 is used in the aorta. Nearly any combination of stents is possible in accordance with the present invention.
- mandril assembly 510 is preferably used if a distal approach is selected. While the mandril assembly 510 used in a preferred aspect of the invention is very similar in structure to the mandril assembly 10 previously described, there are some differences. As illustrated in Figure 14, the graft carrying assembly 510 is placed on the guide wires 511, 512 so that subclavian guide wire 512 is fed through the aortic or proximal end 521 of the upper mandril 510 and through one of lower mandrils 530'. This lower mandril 530' is also referred to as the first iliac end. Thus, the guide wire 512 is fed through the aortic end of the graft 570 and out through the first iliac end thereof. As shown in Fig. 13, lower mandril
- cross-over or second guide wire 511 is fed into the "cross-over” or lower mandril 530 through its distal end
- Mandril 530 is also referred to herein as the second iliac end.
- the second guide wire 512 is fed though both iliac ends of graft 570.
- the distal assembly 510 is substantially the same as the proximal assembly 10 previously described.
- the upper assembly 520 may be, and preferably is, integrally formed with lower mandril 530' and is generally not detachable therefrom.
- upper mandril 520 and lower 530 are detachable through some sort of detachable coupling as previously described.
- the upper mandril 520 and lower mandril 530' will be removed as a single unit through one of the iliac arteries as further described herein.
- a detachable coupling device is attached around the proximal end 531' of lower mandril 530' and the upper mandril will be removed through the subclavian with the lower mandril 530' being removed through the first iliac artery.
- Lower mandril 530 is preferably attached to the proximal end 531' of the first lower mandril 530'. However, as illustrated in Fig. 14, as upper mandril 520 and lower 530' are essentially one piece, lower mandril 530 may also be considered to be connected to the distal end 522 of upper mandril 520. Preferably, distal mandril 530 is attached to the remainder of the assembly 510 through a detachable coupling member 525 as previously described. In Fig. 14, the detachable coupling includes a threaded receiving member 525 and a threaded male member 525'.
- a flexible bridge member 575 is disposed to assist assembly 510 and in particular, cross-over mandril 530 in being properly positioned in the second iliac artery and in taking up the substantially "Y" shape required for proper placement of graft 570.
- a single wire 512 is run from the subclavian 1 to the leg through which the assembly will be inserted, i.e. common femoral artery 505'. Retrieval of the guide wire 512 is through a transverse arteriotomy as before.
- BEUAS 5200 is inserted into the common femoral artery 505' along the subclavian guide wire 512.
- a transverse arteriotomy is performed in the second or opposite common femoral artery 505 and a second guide wire 511 is passed through the BEUAS 5200 and out of the body through the other common femoral artery.
- guide wire 511 runs from the subclavian 1 to the first iliac artery and protrudes therefrom, guide wire 511 runs from the first iliac artery to and through the second iliac artery with one end of guide wire 511 protruding from each of the patient's legs.
- the reverse can also be accomplished with the end of the cross-over guide wire being snared and brought out through the BEUAS 5200.
- Guide wires 511 and 512 can be inserted in the reverse order as well.
- both the proximal end 521 of the upper mandril 520 and the distal end 532 of cross-over mandril 530 are advanced through the BEUAS 5200 until the upper end 521 emerges and protrudes from the subclavian 1 and the distal end 532 of the cross-over mandril 530 emerges and protrudes from the femoral artery.
- the junction of the upper and lower mandrils are not completely parallel to one another; rather, cross-over lower mandril 530 extends at an obtuse angle from the other lower mandril 530' and at an acute angle to upper mandril 520.
- This angled rest position enables the assembly to more easily conform to the arterial structure of the patient.
- the main portion of the assembly 510 including the graft 570 is fed into the first iliac artery 505' with both the aortic end 571 and second iliac end 572 of the graft being advanced ahead of the first iliac 572' end of the graft.
- the aortic stent 550 will be brought into place along guide wire 512 above aneurysm 506 and below the junction with the renal arteries 502.
- the distal assembly 530 will continue along guide wire 511 crossing over the iliac divide and entering the second iliac artery for placement therein.
- the first iliac end of the graft 572' housed on distal mandril 530' will be dragged essentially backwards into place in the iliac artery 505.
- FIG. 14 One possible detachable coupling means is shown in Figure 14 whereby a portion of detachable coupling means 525 is disposed at the proximal end 531 of cross-over mandril 530 while the other portion 525' is disposed at the proximal end 531' of lower mandril 530'.
- the aortic stent 550 is positioned first by manipulating the protruding ends of the mandrils. If a detachable mandril 520 is used for the upper portion of the graft 570, then the upper mandril 520 can be removed through the subclavian artery. Otherwise, mandril 520 is left in place. Next, by manipulating ends 532, 532' of the lower mandrils, the iliac stents 560, 560' are positioned in place. The cross-over mandril is then detached and removed through the femoral artery 505. It is also possible that the bifurcated mandril in accordance with the present invention be discontinuous. For example, mandril 530 could be totally independent of mandril 520 and mandril 530' essentially eliminating coupling member 525 and bridge
- proximal end 531 of distal mandril 530 will therefore be free, albeit disposed within graft 570. In essence, mandril 530 is retained in communication and cooperation with the remaining assembly 510 via graft
- graft 570 which is anchored, via stents 550, 560 and 560' as well as sheaths 581, 582 and 582'. Care should be taken to ensure that the distal end 532 of mandril 530 is carefully manipulated so that graft 570 is not twisted upon delivery. Discontinuous mandrils can also be used in the proximal approach as described herein previously.
- Fig. 15 which employs balloon expandable stents as there will be no need to employ a sheath around stent 550. If, however, a self expanding stent is used, a pre-split sheath will accommodate withdrawal over the crossover mandril. It is also possible to use balloon inflatable stents in the distal surgical procedure as well. As shown in Fig. 15, an assembly which is essentially of the same construction as that illustrated in Fig. 14 is provided.
- the aortic stent 850 and the iliac stent 860 which will be deployed in the insertion leg of the patient are balloon expandable stents which will be deployed by the input of air or a gas into inlets 890 and 891 respectively to inflate balloons 8100 and 8101 respectively.
- some form of sheath or outer covering may be desirable to ease insertion and minimize trauma.
- the cross-over stent remains as previously described with regard to the embodiment in Fig. 14 utilizing a self-expanding stent 860' and a removable sheath 882'.
- a self-expanding stent is generally preferred for the cross-over assembly because it is somewhat more complicated to inflate a balloon through the bend in the cross-over mandril 830'. Of course, it could be inflated through a valve disposed at the mandril's distal end 832'.
- distal or iliac mandril 830' is withdrawn through the femoral artery of one leg and the remaining assembly including upper mandril 820 and iliac mandril 830 are withdrawn through the femoral artery in the other leg.
- housing 3400 may be so constructed as to have a balloon 3700 within recess 3500 disposed underneath or inside of self expanding iliac stent 360.
- the balloon 3700 can communicate via an air inlet 3900 and passage way 3800 built into housing 3400 or mandril 3000 to a gas inlet 4000 near the distal end of mandril 3000.
- a sheath (not shown) is retracted, self expanding stent 3600 will expand and be deployed within the iliac artery essentially tacking the iliac end of a graft (not shown) in place.
- gas may be fed in through the inlet 4000 at the distal end of mandril 3000 which will inflate the balloon 3700 contained in recess 3500.
- the balloon 3600 can then expand and further expand stent 3600.
- balloon is deflated and surgery progresses as described herein.
- Such balloons can be used to assist the deployment of the other iliac stent and/or the aortic stent as need be.
- a long mandril can be fed through the BEUAS, up the femoral and iliac arteries, into the aorta and out through the incision in the subclavian artery.
- the second mandril this one attached to the cross-over leg as opposed to the upper portion of the graft, may be fed into the aorta just above the divide of the iliac arteries and snared through the incision in the common femoral artery of the other leg and pulled back therethrough.
- a device which employs one hollow mandril to accommodate a guide wire running from the subclavian out through one of the common femoral arteries in one of the legs as well as an elongated mandril attached to one of the bifurcated legs of the assembly carrying one of the bifurcated legs of the graft.
- the present invention preferably allows control over all three ends of the graft (as compared to traditional approaches where one of the iliac ends is usually left to dangle during positioning of the other two ends) and preferably all three ends of the graft and mandril can be directly manipulated from outside of the body, the surgeon will have no trouble getting the both iliac ends into the appropriate position.
- wires in accordance with the present invention only act as tracks for the graft and various delivery assemblies, the wires can be much thinner than those traditionally used in similar operations. For example, wires ranging from a thickness of about 0.18 to about .020 may be used. (Currently, the thinnest wire used is about .038 gauge wire.)
- the stent is generally cylindrical, and is comprised of two interwoven metal or alloy wires 601 and 603.
- the wires are made of a material such as Titanium, stainless steel, or known memory materials, which returns to its original shape after reasonable deformation.
- Wire 601 is a closed loop which zigzags back and forth to define a generally hollow cylindrical boundary, wherein portions of the wire extend from one planar edge of the cylindrical boundary to the other planar edge of the cylindrical boundary, and wherein such portions of the wire are generally at an angle to the planes defined by such planar edges.
- wire 601 forms a set of consecutive triangles extending around the surface of a cylinder, with the apex 609 of alternating triangles reaching the top plane 605 of the cylinder and the opposing side of the triangles being open and at the bottom plane 607 of the cylinder.
- Stent 600 also includes a second wire 603 having a nearly identical structure to wire 601.
- the two wires 601 and 603 intersect one another midway between the top 605 and bottom 607 planes at a plurality of points 613.
- wire 601 remains straight and wire 603 loops around wire 601 in alternating directions forming a loop at midpoint 613.
- wire 601 may have a short portion which is parallel to the top and bottom planes 605, 607 level in order to facilitate the connection.
- the size of the loop should be sufficient to pass not only wire 601, but also to pass a suture thread.
- a surgeon can suture a graft to stent 600 by attaching the graft to the stent at midpoints 613.
- the apices 609, 611 preferably do not lie in the same cylindrical surface generally defined by the stent. Rather the apices extend farther outward and away from the center of the cylinder than the rest of the stent.
- the extended apices in the configuration shown allow for the elimination or minimization of metal fatigue or stress, particularly when compared to stents which may be formed with hard corners. This structure also helps to maintain dynamic tension over a longer periods of time. Rather than crimping the stent at the apices, it is preferable that the apices be somewhat bulbed shaped to aid the performance of the stent as it expands from its contracted position.
- BEUAS 2000 is a universal entry port which may be used in accordance with the surgical methods described herein, as well as any other type of surgical procedure which requires entry into a blood vessel such as an artery or a vein.
- the use of the BEUAS is certainly not limited to aortic grafting.
- BEUAS 2000 comprises a housing 2100 which can be of any shape and cross-section.
- the generally hollow housing includes an opening at its top into which is placed a diaphragm 2120 (preferably a silicon diaphragm) .
- Diaphragm 2120 preferably contains a central aperture 2140.
- a tricuspid valve 2160 also preferably of silicon or silicon rubber
- Valve 2160 is similar in construction to the tricuspid valve found in the heart. Of course, while a tricuspid valve is illustrated, a two part, four part or other multi-part valve, or its equivalent may also be used. In fact, any valve 2160 or diaphragm 2120 which can perform the functions described herein would be acceptable.
- a chamber 2180 is defined between diaphragm 2120 and tricuspid valve 2160. Preferably, access to chamber 2180 is provided via outlet 2200.
- a second chamber 2220, disposed below tricuspid valve 2160 is also defined.
- Attached and/or formed integrally with chamber 2220 is a balloon expandable sheath 2260.
- Sheath 2260 may be composed of a balloon expandable stent having sheath material sutured thereto. However, preferably, the sheath is composed of a weave of cloth and metal material which will expand when a balloon is inserted therein and expanded, just as a balloon expandable stent would.
- the stent material is disposed longitudinally within the fabric.
- BEUAS 2000 cooperates with a balloon insertion device 2300 illustrated in Fig. 18.
- Device 2300 comprises an air or gas inlet 2310 which feeds air into a handle 2320, down an elongated support rod 2330 and finally into an expandable, non-compliant balloon 2340 disposed around support rod 2330.
- the balloon 2340 is selected to have a predetermined size and shape upon inflation.
- balloon 2340 controls the resulting size of the access provided through access 2260 in BEUAS 2000.
- device 2300 is provided with an insertion tip 2350 which will make its insertion into the BEUAS 2000 and into the body easy, without the possibility of damaging various blood vessels. In operation, device 2300 is inserted into the
- BEUAS by inserting tip 2350 through aperture 2140 into and through chamber 2180 and into engagement with tricuspid valve 2160.
- Tricuspid valve 2160 will be pushed away or parted such that the balloon 2340 and stem 2330 of device 2300 can be inserted into expandable sheath 2260.
- Both devices are then inserted into a blood vessel such as an artery or vein through an incision. Gas is then fed through inlet 2310 through device 2300 and into balloon 2340 whereupon balloon 2340 expands to a predetermined shape and diameter. In so doing, the metal contained within sheath 2260 is deformed and expanded to increase its diameter.
- the external surface of sheath 2260 generally comes into contact with the walls of the access blood vessel and may stretch that vessels in diameter by up to about 20%.
- balloon 2340 is deflated and device 2300 is withdrawn from the BEUAS 2000.
- device 2300 is withdrawn from the BEUAS 2000.
- the sheath protects the blood vessel and also allows for the straight and uniform insertion and removal of devices, such as the mandril assemblies of the present invention.
- the device 2300 is hollow or is provided with a channel 2360 to allow it to be inserted over a guide wire (not shown) .
- the BEUAS may also be secured to the body through use of a suture hold 2240 or other similar structure.
- a balloon catheter can be used to occlude blood flow in, for example, the aorta.
- Such catheters are well-known.
- a mandril is used which must protrude above the junction of the abdominal aorta and the renal arteries.
- the conventional balloon would interfere therewith.
- the conventional type of balloon catheter would not be useful when the mandril is to be inserted through, for example, the subclavian as it would occlude the artery and prevent removal of the sheath from stent 50.
- any method or device which can temporarily interrupt blood flow to allow for the placement of self-expanding stents, which will not interfere with the operation of the apparatus of the present invention would be useful.
- One such apparatus is illustrated in Figs. 20-22.
- a balloon tipped occlusion device 5000 can be inserted into a blood vessel.
- the occlusion device 5000 is a hollow tube or sleeve 5010 having a proximal end 5021 and a distal end
- an access chamber 5020 may be disposed at the proximal end 5021 of the occlusion device 5000.
- the device 5000 and tube 5010 define a hollow cavity 5070 (see Fig. 21) which extends from the access chamber 5020 through to an aperture 5060 disposed at the distal end 5061 of the occlusion device 5000.
- Adjacent the proximal end 5021 of balloon tipped occlusion device 5000 is a gas inlet/outlet 5040 which is attached via tube 5030 to balloon 5050.
- at least a portion f tube 5030 is disposed within the wall of sleeve 5010.
- Balloon 5050 is preferably disposed adjacent the distal and 5061 of occlusion device 5000.
- the placement of balloon 5050 is not important so long as it will rest in the intended blood vessel and stop the flow of blood when desired.
- a gas or liquid can be introduced through inlet/outlet 5040, through tube 5030 and into balloon 5050 to inflate same. Gas or liquid can also be withdrawn from balloon 5050 through tube 5030 and inlet/outlet 5040.
- Tube 5010 is generally made from a flexible polymer or cloth material. This allows occlusion device 5000 to conform to the shape of the vessels in question thereby reducing surgical trauma. However, it is difficult to deploy such a pliable device.
- insertion catheter 5100 may be used. As illustrated in Fig. 22, insertion catheter
- Insertion catheter 5100 comprises a body 5110 having a proximal end 5120 and a distal end 5130.
- the length of body 5110 is longer than the length of balloon occlusion device 5000.
- Insertion catheter 5100 is sized and shaped such that it can fit snugly within cavity
- proximal end 5130 of insertion catheter 5100 is tapered such that it will retain the distal end 5061 of occluding device
- Insertion catheter 5100 includes, at its proximal end 5120, a structure which allows it to nest and, preferably, substantially seal access chamber 5020. Insertion catheter 5100 also preferably includes one or more separate cavities, 5140 and 5150 through which may be fed guide wires 11 and 12 respectively. This allows the occlusion device 5000 to be inserted into a blood vessel over the very guide wires which the mandril will travel.
- the balloon tipped occlusion device 5000 is loaded onto insertion catheter 5100 such that the distal end 5130 of insertion catheter 5100 protrudes through the aperture 5060 at the distal end 5061 of the occlusion device 5000.
- Guide wires 11 and 12 are then threaded through cavities 5140 and 5150 such that their free ends protrude through the proximal end of both the insertion catheter 5100 and the occlusion device 5000.
- both the occlusion device 5000 and the insertion catheter 5100 are advanced along guide wires 11 and 12 into one or more blood vessels until such time as balloon 5050 is disposed in a position which will allow for the stoppage, or great reduction, of blood flow in the vessel in question.
- Placement of occlusion device 5000 also depends upon the disposition of aperture 5060 which must be positioned such that it is possible to deliver a bifurcated graft into the vessel in question therethrough.
- the balloon occlusion device 5000 may be inserted through the balloon expandable universal axis sheath as previously described. Then, insertion catheter 5100 can be withdrawn clearing aperture 5060 and passageway 5070 of the occlusion device 5000.
- a graft loaded on a bifurcated delivery mandril can then be inserted over the guide wires, through an opening in the proximal end 5020 in occlusion device 5000 and fed through hollow cavity 5070 and finally out of occlusion device 5000 through aperture 5060 in the distal end 5061 thereof.
- balloon 5050 can be expanded by the introduction of fluid or air through inlet/outlet 5040 such that blood flow is temporarily interrupted. Then, for example, a self expanding stent can be exposed such that it will expand radially, without any significant axially movement. Once the stent is lodged in the vessel, blood flow can be restored by deflating balloon 5050. These steps can then be repeated for a subsequent deployment of a stent, as necessary.
- the present invention finds applicability in the medical and surgical fields as well as in the health care industry. It provides methods and apparatus for bypassing faulty blood vessels including, without limitation, of the abdominal aorta and relates to various equipment designed to facilitate such operations.
- the principles, preferred embodiments and modes of operation of the present invention have been described in the foregoing specification.
- the invention which is intended to be protected herein, however, is not to be construed as limited to the particular embodiments disclosed, since these are to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit and scope of the invention.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU59189/96A AU5918996A (en) | 1995-05-09 | 1996-05-08 | Methods and apparatus for treating abdominal aortic aneurysm s |
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US43736195A | 1995-05-09 | 1995-05-09 | |
US43750295A | 1995-05-09 | 1995-05-09 | |
US08/437,361 | 1995-05-09 | ||
US08/437,393 | 1995-05-09 | ||
US08/437,393 US5662614A (en) | 1995-05-09 | 1995-05-09 | Balloon expandable universal access sheath |
US08/437,368 | 1995-05-09 | ||
US08/437,502 | 1995-05-09 | ||
US08/437,368 US5591228A (en) | 1995-05-09 | 1995-05-09 | Methods for treating abdominal aortic aneurysms |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1996036269A2 true WO1996036269A2 (en) | 1996-11-21 |
WO1996036269A3 WO1996036269A3 (en) | 1997-01-16 |
Family
ID=27503855
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1996/006436 WO1996036269A2 (en) | 1995-05-09 | 1996-05-08 | Methods and apparatus for treating abdominal aortic aneurysms |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU5918996A (en) |
WO (1) | WO1996036269A2 (en) |
Cited By (15)
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EP0891751A1 (en) * | 1997-07-18 | 1999-01-20 | Thomas Prof. Dr. Ischinger | Vascular stent for bifurcations, sidebranches and ostial lesions and an application catheter and method for implantation |
DE19732126A1 (en) * | 1997-07-25 | 1999-03-18 | Sulzer Vascutek Ltd | Insertion aid for a bifurcation prosthesis |
WO2005011528A3 (en) * | 2003-07-30 | 2005-04-28 | Scimed Life Systems Inc | Bifurcated stent delivery system |
EP1009325A4 (en) * | 1997-02-20 | 2006-08-23 | Endologix Inc | Bifurcated vascular graft and method and apparatus for deploying same |
WO2011159751A1 (en) * | 2010-06-18 | 2011-12-22 | Cook Medical Technologies Llc | Bifurcated stent introducer system |
US9636244B2 (en) | 2015-04-09 | 2017-05-02 | Mubin I. Syed | Apparatus and method for proximal to distal stent deployment |
WO2017074492A1 (en) * | 2015-10-30 | 2017-05-04 | Syed Mubin I | Apparatus and method for a bifurcated catheter for use in hostile aortic arches |
US10173031B2 (en) | 2016-06-20 | 2019-01-08 | Mubin I. Syed | Interchangeable flush/selective catheter |
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US5116318A (en) * | 1989-06-06 | 1992-05-26 | Cordis Corporation | Dilatation balloon within an elastic sleeve |
US5123917A (en) * | 1990-04-27 | 1992-06-23 | Lee Peter Y | Expandable intraluminal vascular graft |
US5360443A (en) * | 1990-06-11 | 1994-11-01 | Barone Hector D | Aortic graft for repairing an abdominal aortic aneurysm |
US5395349A (en) * | 1991-12-13 | 1995-03-07 | Endovascular Technologies, Inc. | Dual valve reinforced sheath and method |
US5507767A (en) * | 1992-01-15 | 1996-04-16 | Cook Incorporated | Spiral stent |
-
1996
- 1996-05-08 AU AU59189/96A patent/AU5918996A/en not_active Abandoned
- 1996-05-08 WO PCT/US1996/006436 patent/WO1996036269A2/en active Application Filing
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WO1996036269A3 (en) | 1997-01-16 |
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