US20030083541A1 - Medical grafting methods and apparatus - Google Patents

Abstract

Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient's existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient's existing tubular body organ structure. This avoids the need for any significant surgery on the patient.

Description

• This is a division of U.S. patent application Ser. No. 09/712,968, filed Nov. 15, 2000, which is a continuation of U.S. patent application Ser. No. 09/287,941, filed Apr. 7, 1999 (now U.S. Pat. No. 6,186,942), which is a continuation of U.S. patent application Ser. No. 08/844,992, filed Apr. 23, 1997 (now U.S. Pat. No. 6,120,432). All of these prior applications are hereby incorporated by reference herein in their entireties.[0001]
BACKGROUND OF THE INVENTION
• This invention relates to medical grafting methods and apparatus, and more particularly to methods and apparatus for installing tubular bypass grafts intralumenally.[0002]
• Goldsteen et al. U.S. Pat. No. 5,976,178 shows, among other things, methods and apparatus for installing tubular bypass grafts intralumenally. (The Goldsteen et al. reference is hereby incorporated by reference herein in its entirety.) The Goldsteen et al. reference shows methods and apparatus in which each end of the graft site is approached separately and intralumenally, penetrated, and then a longitudinal structure (e.g.,[0003]element150 in the Goldsteen et al. reference) is established between the ends of the graft site. This longitudinal structure may extend intralumenally all the way out of the patient's body from both ends of the graft site. The graft is fed into the patient's body intralumenally along the longitudinal structure until it is in the desired position extending from one end of the graft site to the other. Each end of the graft is then secured at respective end of the graft site and the longitudinal structure is withdrawn from the patient.
• It may not be necessary or desirable in some cases to separately approach both ends of the graft site.[0004]
• It is therefore an object of this invention to provide improved methods and apparatus for intralumenal installation of bypass grafts.[0005]
• It is a more particular object of this invention to provide methods and apparatus for intralumenally installing bypass grafts which do not require both ends of the graft site to be separately approached intralumenally.[0006]
SUMMARY OF THE INVENTION
• These and other objects of the invention are accomplished in accordance with the principles of the invention by providing methods and apparatus for allowing a longitudinal structure to be extended intralumenally to one end of a graft site. At that end of the graft site the longitudinal structure passes out of the body structure lumen and extends extralumenally to the other end of the graft site. At the other end of the graft site, the longitudinal structure re-enters the body structure lumen. The graft is introduced intralumenally along the longitudinal structure until it passes out of the body structure lumen at the first end of the graft site and extends to the second end of the graft site. Both ends of the graft are then secured at the respective opposite ends of the graft site, and the longitudinal structure is axially withdrawn from the patient.[0007]
• Further features of the invention, its nature and various advantages will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments.[0008]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a simplified sectional view showing a portion of an illustrative procedure and related apparatus in accordance with this invention.[0009]
• FIG. 2 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of the FIG. 1 apparatus in more detail.[0010]
• FIG. 3 is a simplified elevational view of a portion of the FIG. 2 apparatus, but with the depicted elements in a different physical relationship to one another.[0011]
• FIG. 4 is a simplified longitudinal sectional view of an alternative embodiment of one component of the FIG. 2 apparatus.[0012]
• FIG. 5 is a simplified longitudinal sectional view of an alternative embodiment of another component of the FIG. 2 apparatus.[0013]
• FIG. 6 is a simplified elevational view of another alternative embodiment of the component shown in FIG. 5.[0014]
• FIG. 7 is a simplified elevational view of an alternative embodiment of still another component shown in FIG. 2.[0015]
• FIG. 8 is a simplified elevational view of an alternative embodiment of yet another component shown in FIG. 2.[0016]
• FIG. 9 is a simplified longitudinal sectional view similar to a portion of FIG. 1 showing a later stage in the illustrative procedure depicted in part by FIG. 1.[0017]
• FIG. 10 is a simplified sectional view of the apparatus shown in FIG. 9 without the associated tissue structure being present.[0018]
• FIG. 11 is a simplified cross sectional view of an illustrative embodiment of further illustrative apparatus in accordance with this invention.[0019]
• FIG. 12 is a view similar to FIG. 1 showing an even later stage in the illustrative procedure depicted in part by FIG. 9, together with related apparatus, all in accordance with this invention.[0020]
• FIG. 13 is a view similar to FIG. 12 showing a still later stage in the illustrative procedure depicted in part by FIG. 12.[0021]
• FIG. 13[0022]ais a simplified elevational view of an illustrative embodiment of structural details that can be included in apparatus of the type shown in FIGS.11-13.
• FIG. 14 is a view similar to FIG. 13 showing an even later stage in the illustrative procedure depicted in part by FIG. 13.[0023]
• FIG. 15 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of still further illustrative apparatus in accordance with this invention.[0024]
• FIG. 15[0025]ais a simplified elevational view of a structure which can be used to provide part of the apparatus shown in FIG. 15.
• FIG. 15[0026]bis a view similar to FIG. 15ashowing more of the structure of which FIG. 15ais a part.
• FIG. 15[0027]cis a view similar to FIG. 15bshowing the FIG. 15bstructure in another operational condition.
• FIG. 15[0028]dis a simplified elevational view of an alternative structure which can be used to provide part of the apparatus shown in FIG. 15.
• FIG. 15[0029]eis a view similar to FIG. 15dshowing the FIG. 15dstructure in another operational condition.
• FIG. 15[0030]fis a simplified longitudinal sectional view of another alternative structure which can be used to provide part of the apparatus shown in FIG. 15.
• FIG. 15[0031]gis a view similar to FIG. 15fshowing the FIG. 15fstructure in another operational condition.
• FIG. 16 is a simplified elevational view of an illustrative embodiment of one component of the FIG. 15 apparatus.[0032]
• FIG. 17 is a simplified longitudinal sectional view of an illustrative embodiment of another portion of the FIG. 15 apparatus.[0033]
• FIG. 18 is a view similar to a portion of FIG. 14 showing an even later stage in the illustrative procedure depicted in part by FIG. 14.[0034]
• FIG. 19 is a view similar to FIG. 18 showing a still later stage in the FIG. 18 procedure.[0035]
• FIG. 20 is a view similar to FIG. 19 showing an even later stage in the FIG. 19 procedure.[0036]
• FIG. 21 is a view similar to another portion of FIG. 14 showing a still later stage in the FIG. 20 procedure.[0037]
• FIG. 22 is a view similar to FIG. 21 showing an even later stage in the FIG. 21 procedure.[0038]
• FIG. 22[0039]ais a view similar to FIG. 22 showing a still later stage in the FIG. 22 procedure.
• FIG. 22[0040]bis a view similar to FIG. 22ashowing an even later stage in the FIG. 22aprocedure.
• FIG. 23 is a view similar to FIG. 22[0041]bshowing a still later stage in the FIG. 22bprocedure.
• FIG. 24 is a view similar to FIG. 23 showing an even later stage in the FIG. 23 procedure.[0042]
• FIG. 25 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of more apparatus in accordance with this invention.[0043]
• FIG. 26 is a view similar to FIG. 20 showing a later stage in the FIG. 24 procedure.[0044]
• FIG. 27 is a view similar to FIG. 26 showing a still later stage in the FIG. 26 procedure.[0045]
• FIG. 28 is a view similar to FIG. 24 showing an even later stage in the FIG. 27 procedure.[0046]
• FIG. 29 is a view similar to FIG. 28 showing a still later stage in the FIG. 28 procedure.[0047]
• FIG. 30 is a view similar to FIG. 29 showing an even later stage in the FIG. 29 procedure.[0048]
• FIG. 31 is a view similar to FIG. 14 showing the end result of the procedure depicted in part by FIG. 30.[0049]
• FIG. 32 is a simplified longitudinal sectional view showing an end result similar to FIG. 31 but in a different context.[0050]
• FIG. 33 is a simplified longitudinal sectional view showing a possible alternative construction of portions of the apparatus showing in FIG. 15.[0051]
• FIG. 34 is a simplified elevational view (partly in section) showing another possible alternative construction of portions of the FIG. 15 apparatus.[0052]
• FIG. 35 is a simplified longitudinal sectional view of the FIG. 34 apparatus in another operating condition.[0053]
• FIG. 36 is a simplified elevational view of apparatus which can be used as an alternative to certain apparatus components shown in FIGS. 15 and 17.[0054]
• FIG. 37 is a simplified elevational view (partly in section) showing additional components with the FIG. 36 apparatus.[0055]
• FIG. 38 is a simplified longitudinal sectional view showing still another possible alternative construction of portions of the FIG. 15 apparatus.[0056]
• FIG. 39 is a simplified elevational view showing in more detail a possible construction of a portion of the FIG. 38 apparatus.[0057]
• FIG. 40 is a simplified elevational view of illustrative apparatus that can be used as an alternative to certain apparatus shown in other FIGS.[0058]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• A typical use of this invention is to provide a bypass graft around a narrowing in a coronary artery. Thus FIG. 1 shows a patient's[0059]aorta30 with acoronary artery20 branching off from the aorta. A narrowing22 incoronary artery20 is obstructing blood flow fromaorta30 to downstream portions of the coronary artery, thereby preventing the patient's heart from receiving all the blood it needs for normal operation. To remedy this condition, a bypass graft around narrowing22 is needed, and one way to provide such a bypass is to add a graft conduit from aorta30 (e.g., at location34) to a downstream portion of coronary artery20 (e.g., at location24).
• In order to provide such a graft conduit in accordance with this invention,[0060]elongated instrumentation200 is introduced into the patient's circulatory system, preferably from a location remote fromaorta30. For example,instrumentation200 may be introduced into the patient's circulatory system from a femoral artery, a brachial artery, or any other suitable location. From theinsertion point instrumentation200 passes intralumenally along the patient's circulatory system until adistal portion204 ofinstrumentation200 is adjacent one end (e.g.,34) of the desired graft site. Undepicted proximal portions ofinstrumentation200 always remain outside the patient adjacent the point of introduction of the instrumentation so that the physician (a term which includes any technicians or other assistants) can control the instrumentation from outside the patient's body. In particular, the depicted distal portions ofinstrumentation200 are controlled remotely by the physician from outside the patient. Radiologic markers such as206 may be provided oninstrumentation200 to aid the physician in properly locating the instrumentation in the patient.
• It will be understood that the[0061]particular location34 shown in FIG. 1 for one end of the bypass graft is only illustrative, and that any other suitable location may be chosen instead.
• An illustrative construction of[0062]instrumentation200 is shown in more detail in FIG. 2. This FIG. shows the distal portions ofelements220,230,240, and250 telescoped out from one another and from the distal end ofouter member210 for greater clarity. It will be understood, however, that all of these elements are initially inside of one another and insideouter member210. Indeed,member210 may be initially positioned in the patient without any or all ofelements220,230,240, and250 inside, and these elements may then be inserted intomember210. Moreover, the number of members like220,230, etc., may be more or less than the number shown in FIG. 2, depending on the requirements of a particular procedure.
• [0063]Outer member210 may be a catheter-type member. The distal portion ofcatheter210 may carry two axially spacedannular balloons212 and214.Proximal balloon212 is inflatable and deflatable viainflation lumen216 incatheter210.Distal balloon214 is inflatable and deflatable via inflation lumen218 incatheter210.Lumens216 and218 are separate from one another so thatballoons212 and214 can be separately controlled.Balloons212 and214 are shown substantially deflated in FIG. 2. The distal end ofcatheter210 may be tapered as shown at211 in FIG. 4 to facilitate passage ofcatheter210 through an aperture inaorta30 as will be described below.
• Coaxially inside[0064]catheter210 istubular sheath member220.Sheath220 is longitudinally movable relative tocatheter210. The distal portion ofsheath220 may be tapered as shown at222 in FIG. 5, and/or externally threaded as shown at224 in FIG. 6. Either or both offeatures222 and224 may be provided to facilitate passage ofsheath220 through an aperture inaorta30 as will be described below. Ifthreads224 are provided, thensheath220 is rotatable (either alone or with other components) about the longitudinal axis ofinstrument200 in order to enablethreads224 to engage the tissue of the aorta wall and help pullsheath220 through the aorta wall.
• Coaxially inside[0065]sheath member220 ispower steering tube230.Tube230 is longitudinally movable relative tosheath220.Tube230 may also be rotatable (about the central longitudinal axis of instrument200) relative tosheath220, and the distal end oftube230 may be threaded on the outside (as shown at232 in FIG. 7) for reasons similar to those for which threading224 may be provided onsheath220.Tube230 is preferably controllable from its proximal portion (outside the patient) to deflect laterally by a desired amount to help steer, push, ortwist instrument200 to the desired location in the patient. Examples of illustrative steering techniques are discussed in more detail below in connection with FIGS.11-13.
• Coaxially inside[0066]tube230 istube240.Tube240 is longitudinally movable relative totube230, and may be metal (e.g., stainless steel) hypotube, for example.Screw head242 is mounted on the distal end oftube240 and is threaded (as indicated at244) on its distal conical surface.Tube240 is rotatable (about the central longitudinal axis ofinstrument200, either alone or with other elements) in order rotatehead242 and thereby usethreads244 in engagement with the tissue of the aorta wall to help pullhead242 through that wall as will be more fully described below. Becausetube240 is hollow, it can be used for passage of fluid or pressure into or out of the patient.
• Coaxially inside[0067]tube240 islongitudinal structure250.Longitudinal structure250 is longitudinally movable relative totube240.Structure250 may also be rotatable (about its longitudinal axis) relative totube240 and/or other elements.Structure250 may be a wire with adistal end portion252 that is resiliently biased to deflect laterally to one side.Wire portion252 is kept relatively straight when it is insidetube240 as shown in FIG. 2. But whenwire portion252 is pushed axially out the distal end oftube240, it curves to one side as shown in FIG. 3. As an alternative or addition to the above-described resilient lateral deflection, the distal portion ofstructure250 may be threaded as shown at254 in FIG. 8 to help structure250 thread its way through the wall ofaorta30.
• All of[0068]components210,220,230,240, and250 are controlled from outside the patient's body as is described in general terms above.
• When the distal portion of[0069]catheter210 is at the desiredlocation34,proximal balloon212 is inflated. Even when inflated,proximal balloon212 is not large enough to blockaorta30.
• After[0070]proximal balloon212 has been inflated,wire250 is pushed distally so that its distal portion emerges from the distal end oftube240 and penetrates the wall ofaorta30 atlocation34. This anchors the distal portion ofinstrument200 to the aorta wall at the desired location. Because of its operation to thus anchorinstrument200,wire250 is sometimes referred to as an anchor wire. The rotatability ofwire250, as well as its resilient lateral deflection (FIG. 3) and/or threads254 (FIG. 8), may be used to help get the distal end of the wire to the desiredlocation34 and firmly into the aorta wall at that location in order to achieve the desired anchoring ofinstrument200.
• When[0071]instrument200 is sufficiently anchored bywire250,tubes230 and240 are moved in the distal direction relative to wire250 so thatscrew head242 begins to followwire250 into and through the aorta wall. During this motion, atleast tube240 is rotated about its longitudinal axis so thatthreads244 help to pullhead242 into and through the aorta wall. The distal portion oftube230 followshead242 through the aorta wall. If provided,threads232 and rotation oftube230 may facilitate transfer of the aorta wall tissue fromhead242 totube230.
• When[0072]tube230 is through the aorta wall,sheath220 is moved distally relative totube230 so that a distal portion ofsheath220 followstube230 through the aorta wall. If provided, the distal taper222 and/orthreads224 and rotation ofsheath220 help the distal portion ofsheath220 through the aorta wall. Thencatheter210 is advanced distally relative tosheath220 so that a distal portion ofcatheter210 followssheath220 through the aorta wall. Again, thedistal taper211 of catheter210 (if provided) helps the distal portion of the catheter through the aorta wall. Inflatedproximal balloon212 prevents more than just the portion ofcatheter210 that is distal ofballoon212 from passing through the aorta wall.
• It should be mentioned that each time another, larger one of[0073]elements240,230,220, and210 is pushed through the aorta wall, the previously extended elements can be and preferably are either held stationary or pulled back proximally to prevent them from damaging body tissues outside the aorta. It should also be mentioned that threading such as254,244,232, and224 is entirely optional and can be omitted if the associated elements are made sharp enough and can be pushed distally sufficiently strongly to penetrate the aorta wall without the aid of threading and rotation.
• When the distal portion of[0074]catheter210 is through the aorta wall,distal balloon214, which is now outside the aorta, is also inflated. The axial spacing betweenballoons212 and214 is preferably small enough so that the aorta wall is clamped between these two balloons as shown in FIG. 9. For example, ifballoons212 and214 were inflated without the presence of the aorta wall, their appearance might be as shown in FIG. 10. The close spacing ofballoons212 and214, as well as their resilient bias toward one another, helps to anchorcatheter210 through the aorta wall and also to seal the aorta wall around the catheter.Balloons212 and214 may be inflated by liquid or gas, and they may be specially coated to help improve the seal betweencatheter210 and the aorta wall.
• After the condition of[0075]catheter210 shown in FIG. 9 has been reached, all ofcomponents220,230,240, and250 can be withdrawn from the patient by pulling them out ofcatheter210 in the proximal direction.
• The next step in the illustrative procedure being described is to insert an elongated, steerable,[0076]endoscopic instrument300 lengthwise intocatheter210. A simplified cross sectional view of an illustrative steerableendoscopic instrument300 is shown in FIG. 11. As shown in that FIG.,instrument300 includes one or more sheath structures such as310aand310bthat are operable by the physician to steer the instrument by curvilinearly deflecting it laterally by a desired, variable amount. In lieu of or in addition to steeringsheaths310aand310b, any other conventional steering elements may be provided and used. Other examples of suitable steering structures are shown in Bachinski et al. U.S. patent application Ser. No. 08/842,391, filed Apr. 23, 1997 (published as WO 98/19732), which is hereby incorporated by reference herein. Withinsheaths310 are such other components as (1) afiber optic bundle320 for conveying light from outside the patient to the distal end ofinstrument300 in order to provide illumination beyond the distal end of the instrument, (2) anotherfiber optic bundle330 for conveying an image from beyond the distal end of the instrument back to optical and/or video equipment outside the patient and usable by the physician to see what is beyond the distal end of the instrument, and (3) alumen340 with a longitudinal structure150 (i.e., a wire) inside of it. Additional lumens such as360 may be provided for such purposes as (1) introducing fluid that may help to clear the distal ends of fiber optic bundles320 and330, (2) introducing fluid for irrigating and/or medicating the patient, (3) suctioning fluid from the patient, etc.
• As shown in FIG. 12, the distal portion of steerable[0077]endoscopic instrument300 is extended distally beyond the distal end ofcatheter210 and steered by the physician until it is adjacent to the exterior ofcoronary artery portion24. The endoscopic features ofinstrument300 are used by the physician to help steer the distal end of the instrument to the desired location.Instrument300 may also be provided with radiologic markers (likemarkers206 oninstrument200 in FIG. 1) to additionally help the physician get the distal end ofinstrument300 to the desired location.
• The next step in the illustrative procedure being described is to extend[0078]longitudinal structure150 from the distal end ofinstrument300 so that it passes through the wall ofcoronary artery20 atlocation24 and into the lumen of the artery as shown in FIG. 13. To facilitate penetration of the coronary artery wall, the distal end oflongitudinal structure150 may be sharply pointed. The distal portion oflongitudinal structure150 may also be threaded (analogous to thethreads254 shown on the distal portion oflongitudinal structure250 in FIG. 8) andlongitudinal structure150 may be rotated about its longitudinal axis so that the threads engage the coronary artery wall tissue and pulllongitudinal structure150 into and through the coronary artery wall. The distal portion oflongitudinal structure150 is preferably pushed sufficiently far down into the lumen ofcoronary artery20 so that it does not inadvertently come out of the coronary artery.
• FIG. 13[0079]ashows alternative apparatus that may be used to introduce the distal portion oflongitudinal structure150 intocoronary artery20 atlocation24. This apparatus includes ahypotube370 that extends distally from the distal end ofinstrument300.Hypotube370 may have a fixed amount of extension frominstrument300, or it may be selectively extendable frominstrument300.Hypotube370 has a sharply pointeddistal tip portion372, the purpose of which will be described below. An illustrative size forhypotube370 is about0.015 inches in diameter.
• [0080]Longitudinal structure150 is disposed coaxially insidehypotube370 and is axially and rotatably movable relative tohypotube370. The proximal portion150aofstructure150 may be a wire having a diameter of about 0.009 inches. Adistal portion150bof wire150amay be ground down to produce a safety ribbon insidewire coil150c. An illustrative size for the wire ofcoil150cis about 2 mils. The proximal end ofcoil wire150cis secured to wire150a. The distal end ofcoil wire150cis secured todistal tip150d, which is also secured to the distal end ofsafety ribbon150b.Elements150b,150c, and150dcooperate to give longitudinal structure150 a highly flexible distal portion.
• Prior to use of sharply pointed[0081]cutter tip372 as described below, the distal portion oflongitudinal structure150 may be distally extended from the distal portion ofhypotube370. This protectscutter tip372 and also protects nearby tissue from the cutter tip.
• [0082]Instrument300 is controlled as described above in connection with FIG. 12 to positioncutter tip372 adjacentcoronary artery portion24.Longitudinal structure150 is then retracted proximally to exposecutter tip372. Next,cutter tip372 is advanced to make a slit throughcoronary artery portion24. Withcutter tip372 still in this slit,longitudinal structure150 is moved distally relative to hypotube370 so that the distal portion ofstructure150 passes through the above-mentioned slit into the lumen ofcoronary artery20. Once inside the coronary artery lumen, the distal portion oflongitudinal structure150 can be pushed farther down along that lumen.Wire coil150ccan be used to threadedly engage the interior of the coronary artery where the coronary artery narrows down (farther along its length) to help releasably anchor the distal portion ofstructure150 in the coronary artery. This threaded engagement can be produced by rotatinglongitudinal structure150 about its longitudinal axis when the longitudinal structure begins to encounter resistance to further distal pushing along the coronary artery. Of course, this threaded engagement is reversible by rotatinglongitudinal structure150 in the direction opposite to the direction which produces the threaded engagement.
• After the distal portion of[0083]longitudinal structure150 is satisfactorily in place in the lumen ofcoronary artery20 as described above in connection with FIG. 13 and/or FIG. 13a, the next step is to withdraw instrument300 (including hypotube370 if provided) from the patient by pullinginstrument300 back out throughcatheter210. Onlylongitudinal structure150 frominstrument300 is left in the patient as shown in FIG. 14. If desired,longitudinal structure150 may be provided withradiologic markers154 equally spaced along the length of its distal portion to help the physician determine by radiologic observation the actual length betweenlocation24 andlocation34. This enables the physician to determine the exact length of the graft tubing needed to connectlocations24 and34.
• The next phase of the illustrative procedure being described is to install a new length of tubing between[0084]regions24 and34. The new length of tubing may be either an artificial graft, natural body organ tubing harvested from the patient's body, or a combination of artificial and natural tubing (e.g., natural tubing coaxially inside artificial tubing). In the following discussion it is assumed that the new tubing is to be natural tubing (e.g., a length of the patient's saphenous vein that has been harvested for this purpose) inside an artificial conduit. When such a combination of natural and artificial conduits is used, both conduits can be delivered and installed simultaneously, or the outer artificial conduit can be delivered and installed first, and then the inner natural conduit can be delivered and installed. The following discussion initially assumes that the latter technique is employed.
• In accordance with the above-stated assumptions, the next step in the procedure is to use[0085]catheter210 and longitudinal structure150 (hereinafter referred to for convenience and simplicity of terminology as wire150) to deliver an artificial conduit so that it extends betweenregions24 and34. The distal portion of anillustrative assembly400 for doing this is shown in FIG. 15. (Several alternative constructions of this portion of the apparatus are shown in later FIGS. and described below.) As shown in FIG. 15assembly400 includes a threaded, conical,distal tip412 mounted on a tubular member410 (e.g., metal hypotube) through whichwire150 can freely pass. Additional details regarding various possible constructions oftip412 are provided later with reference to FIGS. 15a-15g, but it should be mentioned here that in thisembodiment tip412 is selectively collapsible to facilitate its withdrawal from the patient after it has served its purpose. Anothertubular member420 is disposed concentrically aroundtubular member410. Aninflatable balloon422 is mounted on the distal end oftubular member420.Tubular member420 includes an axially extending lumen (not shown in FIG. 15) for use in selectively inflating and deflatingballoon422.Balloon422 is shown deflated in FIG. 15.
• Coaxially around[0086]tubular member420 is anartificial graft conduit430. An illustrative embodiment of asuitable conduit430 is shown in FIG. 16 and includes a tube formed of aframe432 of a first highly elastic material (such as nitinol) with a covering434 of a second highly elastic material (e.g., a rubber-like material such as silicone) substantially filling the apertures in the frame. Additional information regarding this possible embodiment ofconduit430 and other suitable artificial graft structures is provided in the Goldsteen et al. reference which is first mentioned above (see also Bachinski et al. U.S. patent application Ser. No. 08/839,080, filed Apr. 23, 1997 (published as WO 98/19632), which is also hereby incorporated by reference herein). Here it will suffice to say that this structure is extremely elastic, flexible, pliable, and resilient. For example, it can be stretched to a small fraction of its original diameter, and it thereafter returns by itself to its original size and shape without damage or permanent deformation of any kind. In addition, this structure is distensible so that it may pulsate very much like natural circulatory system tubing in response to pressure waves in the blood flow. This helps keep the conduit open, especially if it is used by itself as the final graft conduit. At its distal end, extensions offrame432 are flared out to form resilient hooks orbarbs436, the purpose of which will become apparent as the description proceeds. Near the proximal end ofconduit430 two axially spacedresilient flaps438aand438bwith hooks orbarbs439 are provided. The purpose and operation ofelements438 and439 will also become apparent as the description proceeds.
• In assembly[0087]400 (see again FIG. 15, and also FIG. 17), hooks436 and flaps438 are compressed radially inwardly and confined withinconduit delivery tube440, which coaxially surroundsconduit430. Indeed,conduit430 may be somewhat circumferentially compressed bytube440.
• The portion of[0088]assembly440 at which the proximal end ofconduit430 is located is shown in FIG. 17. There it will be seen how flaps438 are confined withinconduit delivery tube440. FIG. 17 also shows howtubes410,420, and440 extend proximally (to the right as viewed in FIG. 17) from the proximal end ofconduit430 so that the physician can remotely control the distal portion ofassembly400 from outside the patient.
• To install[0089]artificial graft conduit430 in the patient betweenregions24 and34,assembly400 is fed into the patient alongwire150 throughcatheter210. Whentip412 reachescoronary artery portion24,tip412 is threaded into and through the coronary artery wall by rotatingtube410 and therefore tip412. The passage oftip412 through the coronary artery wall opens up the aperture previously made bywire150 in that wall. Aftertip412 passes through the artery wall, that wall seals itself against the outside of the distal portion ofconduit delivery tube440 as shown in FIG. 18.
• The next step is to push[0090]tube410 andtip412 distally relative todelivery tube440, which is held stationary.Conduit430 is initially moved distally withcomponents410 and412. This may be done by inflatingballoon422 so that it engagesconduit430, and then movingtube420 distally withcomponents410 and412. Distal motion ofconduit430 moves hooks436 beyond the distal end ofdelivery tube440, thereby allowing the hooks to spring out insidecoronary artery20 as shown in FIG. 19. This prevents the distal end ofconduit430 from being pulled proximally out of the coronary artery. Ifballoon422 was inflated during this phase of the procedure, it may be deflated before beginning the next phase.
• The next step is to pull[0091]delivery tube440 back slightly so that it is withdrawn fromcoronary artery20. Thentube420 is moved distally so thatballoon422 is radially inside the annulus ofhooks436.Balloon442 is then inflated to ensure thathooks436 are firmly set incoronary artery20. Conditions are now as shown in FIG. 20. Cross sections ofballoon422 may be L-shaped when inflated (one leg of the L extending parallel to the longitudinal axis ofconduit430, and the other leg of the L extending radially outward from that longitudinal axis immediately distal of hooks436). This may further help to ensure thathooks436 fully engage the wall ofcoronary artery20.
• The next step is to deflate[0092]balloon422. Thendelivery tube440 is withdrawn proximally untilflap438a(but notflap438b) is distal of the distal end of the delivery tube. This allowsflap438ato spring radially out as shown in FIG. 21.Tube420 is then withdrawn untilballoon422 is just distal offlap438a. Then balloon422 is inflated, producing the condition shown in FIG. 21.
• The next steps are (1) to deflate[0093]distal balloon214, (2) to proximally withdraw catheter210 a short way, (3) to proximally withdrawtube420 to pressflap438aagainst the outer surface of the aorta wall, and (4) to proximally withdrawdelivery tube440 by the amount required to allowflap438bto spring out against the interior ofcatheter210, all as shown in FIG. 22. As a result of the above-described proximal withdrawal oftube420, the hooks orbarbs439 onflap438aare urged to enter the aorta wall tissue to help maintain engagement betweenflap438aand the wall of the aorta.Inflated balloon422 helps to set hooks orbarbs439 in the tissue whentube420 is tugged proximally.
• The next step is to insert the distal portion of[0094]delivery tube440 into the proximal end ofconduit430 as shown in FIG. 22a. The distal end ofconduit440 may be inserted all the way to the proximal end of balloon422 (see FIG. 23 for a depiction of this). A purpose of this step is to subsequently help control the rate at which blood is allowed to begin to flow throughconduit430.
• The next step is to proximally withdraw[0095]catheter210 by the amount required to releaseflap438bto spring out against the interior of the wall ofaorta30 as shown in FIG. 22b.Catheter210 may be subsequently pushed back againstflap438bas shown in FIG. 23 to help securely engage that flap against the aorta wall.
• [0096]Artificial graft conduit430 is now fully established betweenaorta region34 andcoronary artery region24. The next steps are therefore to deflateballoon422 and proximally withdrawtube420, to collapsetip412 and proximally withdrawtube410, and to proximally withdrawdelivery tube440. The proximal end ofconduit430 is now as shown in FIG. 24. As possible alternatives to what is shown in FIG. 24, the distal end ofcatheter210 could be left pressed up againstproximal flap438band/or the distal portion ofdelivery tube440 could be left inside the proximal portion ofconduit430. If the latter possibility is employed, then delivery of the natural graft conduit (described below) can be throughtube440.
• Several illustrative embodiments of[0097]collapsible tips412 are shown in FIGS. 15a-15g. In the first embodiment (shown in FIGS. 15a-15c) a frame of wire struts412aextends radially out and proximally back from the distal end of hypotube410 (see especially FIG. 15a). This frame is covered with a somewhatelastic polymer cover412b(FIG. 15b) which is provided with threads as indicated at412c. For example,threads412cmay be made of one or more spirals of nitinol wire or other metal. When it is desired to collapsetip412, another hypotube410a(which is disposed around hypotube410) is shifted distally relative to hypotube410 to invert andcollapse tip412 as shown in FIG. 15c.
• In the alternative embodiment shown in FIGS. 15[0098]dand15e,tip412 has a centralmain portion412eattached tohypotube410. Around the proximal portion ofmain portion412eare a plurality of triangular shapedportions412f, each of which is connected tomain portion412eby ahinge412g. The outer surface of the tip is threaded as indicated at412h. For example, in thisembodiment tip412 may be made of a plastic polymer material, and hinges412gmay be so-called “living” hinges between the various masses of the polymer. As soon astriangular portions412fmeet any resistance astip412 is withdrawn proximally, they pivot about theirhinges412gto the positions shown in FIG. 15e, thereby greatly reducing the circumferential size of the tip.
• In the further alternative embodiment shown in FIGS. 15[0099]fand15g, metal struts412jare attached to the distal end ofhypotube410 so that they extend radially out and proximally back. Although not shown in FIGS. 15fand15g, struts412jare covered with a cover and threads like thecover412bandthreads412cshown in FIG. 15band described above. Awire412kconnects a proximal portion of eachstrut412j, through an aperture inhypotube410, to the distal end of anotherhypotube410bwhich is disposed insidehypotube410. Whenwires412kare relaxed as shown in FIG. 15f, struts412jextend radially out beyond the circumference ofdelivery tube440. When it is desired to collapsetip412, hypotube410bis pulled back proximally relative to hypotube410 as shown in FIG. 15g. This causeswires412kto pullstruts412jin so that the outer circumference oftip412 is much smaller than the circumference ofdelivery tube440.
• Again, it should be mentioned that the use of a threaded,[0100]collapsible tip412 as described above is only one of several possibilities. Other alternatives are discussed below after completion of the discussion of the illustrative procedure which is being described and which will now be further considered with reference to FIG. 25 and subsequent FIGS.
• As has been mentioned, the illustrative procedure being described assumes that natural body conduit (e.g. a length of the patient's saphenous vein that has been harvested for this purpose) is installed inside[0101]artificial conduit430 after installation of the latter conduit. Anillustrative assembly500 for delivering a length of natural body conduit to installedconduit430 is shown in FIG. 25.
• As shown in FIG. 25,[0102]assembly500 includes atube510 disposed aroundwire150 so thattube510 is freely movable in either direction alongwire150.Tube510 has an inflatable annular balloon512anear its distal end and another inflatableannular balloon512bspaced in the proximal direction from balloon512a.Tube510 includes separate inflation lumens (not shown) for each of balloons512 so that the balloons can be separately inflated and deflated. An annular collar structure or ring520ais disposed concentrically around balloon512a, and a similar annular collar structure orring520bis disposed concentrically aroundballoon512b. Balloons512 may be partly inflated. Each of rings520 may have radially outwardly extending hooks orbarbs522. A length of natural body conduit530 (e.g., saphenous vein as mentioned earlier) extends fromring520ato ring520baround the intervening portion oftube510. Hooks orbarbs522 may extend through the portions ofconduit530 that axially overlap rings520. Adelivery tube540 is disposed aroundconduit530. In use,tubes510 and540 extend proximally (to the right as viewed in FIG. 25) out of the patient to permit the physician to remotely control the distal portion ofassembly500.
• Although not shown in FIG. 25,[0103]assembly500 may include a spring coil (similar tocoil450 in FIG. 36) extending between rings520 inside ofconduit530 to help holdconduit530 open and out againstdelivery tube540 or subsequently out againstconduit430. Instead of balloons512 being both in thesame tube510, balloon512amay be on a relatively small first tube, whileballoon512bis on a larger second tube that concentrically surrounds the proximal portion of the first tube. The first and second tubes are axially movable relative to one another, thereby allowing the distance between balloons512 to be adjusted forgrafts530 of different lengths. Illustrative apparatus of this kind is shown in Goldsteen et al. U.S. Pat. No. 5,931,842, which is hereby incorporated by reference herein.
• [0104]Assembly500 is employed by placing it onwire150 leading intocatheter210.Assembly500 is then advanced distally alongwire150 throughcatheter210 and then intoconduit430 until the distal end ofconduit530 is adjacent the distal end ofconduit430 and the proximal end ofconduit530 is adjacent the proximal end ofconduit430. The condition of the apparatus at the distal end ofassembly500 is now as shown in FIG. 26. The condition of the apparatus at the proximal end ofconduit530 is as shown in FIG. 28.
• The next step is to proximally withdraw[0105]delivery tube540 so that the distal portion ofconduit530 and distalbarbed ring520aare no longer inside the distal portion ofdelivery tube540. Then distal balloon512ais inflated to circumferentially expandring520aand to set hooks orbarbs522 throughconduit530 into the surrounding portion ofconduit430 and coronaryartery wall portion24. This provides a completed anastomosis of the distal end ofconduit530 tocoronary artery20. FIG. 27 shows the condition of the apparatus at this stage in the procedure.
• The next step is to continue to proximally withdraw[0106]delivery tube540 until the proximal end ofconduit530 andproximal ring520bare no longer inside tube540 (see FIG. 29). Thenproximal balloon512bis inflated to circumferentially expandring520band thereby set hooks orbarbs522 throughconduit530 into the surrounding portion ofconduit430 and aorta wall portion34 (see FIG. 30). This provides a completed anastomosis of the proximal end ofconduit530 toaorta30.
• The next step is to deflate[0107]balloons512aand512band proximally withdrawtube510 anddelivery tube540 from the patient viacatheter210. Then wire150 is withdrawn from the patient by pulling it proximally fromcatheter210. Lastly,catheter210 is proximally withdrawn from the patient to conclude the procedure. The bypass that is left in the patient is as shown in FIG. 31. This bypass extends fromaorta30 atlocation34 tocoronary artery20 atlocation24. The bypass includesnatural body conduit530 insideartificial graft conduit430. One end of the bypass is anchored and anastomosed tocoronary artery20 byhooks436 and ring520a. The other end of the bypass is anchored and anastomosed to aorta30 byflaps438 andring520b.
• The particular uses of the invention that have been described in detail above are only illustrative of many possible uses of the invention. Other examples include same-vessel bypasses in the coronary area and vessel-to-vessel and same-vessel bypasses in other portions of the circulatory system (including neurological areas, renal areas, urological areas, gynecological areas, and peripheral areas generally). A same-vessel bypass is a bypass that extends from one portion of a vessel to another axially spaced portion of the same vessel. In FIG. 32, bypass[0108]620 is a same-vessel bypass around a narrowing612 invessel610. For ease of comparison to previously described embodiments, the various components ofbypass620 are identified using the same reference numbers that are used for similar elements in FIG. 31. The invention is also applicable to procedures similar to any of those mentioned above, but for non-circulatory systems such as urological tubing.
• It has been mentioned that the collapsible tip structures shown, for example, in FIGS.[0109]15-15gare illustrative of only one of several possible approaches to providing a structure that can penetrate the wall ofcoronary artery20 from outside the artery. Another example of a suitable structure is shown in FIG. 33. To facilitate comparison to FIG. 15, FIG. 33 uses reference numbers with primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15.
• In the embodiment shown in FIG. 33[0110]distal tip412′ hasexternal threads414 for helping to grip and dilate tissue such as the wall ofcoronary artery20 astip412′ is rotated aboutwire150 by rotation of proximally extendingtubular shaft410′.Threads414 continue asthreads442 on the exterior of the distal portion oftube440′.Threads414 also threadedly engage withthreads444 on the interior of the distal portion oftube440′. Thus when both ofstructures410′ and440′ are rotated together,threads414 and442 tend to pulltip412′ and then the distal portion oftube440′ into and through the wall ofcoronary artery20. In the course of this,threads412′ transfer the tissue tothreads442. Thereafter,structure410′ can be removed fromstructure440′ by rotatingstructure410′ in the direction relative to structure440′ that causesthreads414 and444 to cooperate to shifttip412′ proximally relative to structure440′. Whentip412′ has thus shifted proximally beyondthreads444,elements410′ and412′ can be pulled proximally out of the patient.Tube440′, which remains in place through the coronary artery wall, can thereafter be used as a guide tube for delivery of a graft structure (such as430 (FIGS.15-17)) and associated instrumentation (such as structure420 (e.g., FIGS. 15 and 17)) to the operative site.
• Another illustrative alternative embodiment of some of the instrumentation shown in FIG. 15 is shown in FIGS. 34 and 35. Once again, to facilitate comparison to FIG. 15, FIGS. 34 and 35 use reference numbers with primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15. In the embodiment shown in FIGS. 34 and 35[0111]struts436′ are connected to the distal end of aserpentine ring439 which is connected in turn to the distal end offrame432′.Struts436′ are initially held in the form of a distally pointed cone byyieldable bands437a,437b,437c, and437d. As elsewhere alonggraft conduit430′, the spaces betweenstruts436′ are substantially filled by a highly elastic material such as silicone rubber. Bands437 may be made of a polymeric or other suitable yieldable material. Alternatively, bands437 could be serpentine metal members that yield by becoming straighter. Bands437 are initially strong enough to preventstruts436′ from flaring radially outward fromconduit430′ as the struts are resiliently biased to do. However, bands437 can be made to yield by inflatingballoon422′ (on the distal end oftube420′) inside the annulus ofstruts436′.
• [0112]Struts436′ can be forced through tissue such as the wall ofcoronary artery20 in their initial cone shape. Sufficient pushing force can be applied to the cone ofstruts436′ in any of several ways. For example,tube420′ may be metal (e.g., stainless steel) hypotube which can transmit pushing force to the cone ofstruts436′ by inflatingballoon422′ to trap the base of the cone betweenballoon422′ andtube440. Additional pushing force may then also be applied viatube440 itself.
• When a sufficient portion of the height of the cone of[0113]struts436′ is through the coronary artery wall,balloon422′ is inflated inside the cone as shown in FIG. 35 to cause bands437 to yield. This allows struts436′ to flare radially outward inside the coronary artery, thereby anchoring the distal end ofconduit430′ to the artery. Bands437 may be made progressively weaker in the distal direction to facilitate prompt yielding of distal bands such as437aand437bin response to relatively little inflation ofballoon422′, whereas more proximal bands such as437cand437ddo not yield until somewhat later in response to greater inflation ofballoon422′. This progression of yielding may help ensure that the annulus of struts flares out in the desired trumpet-bell shape of hooks inside the coronary artery.
• FIGS. 34 and 35 illustrate the point that if the structure used to enlarge the initial hole (made by wire[0114]150) through the wall ofcoronary artery20 is sufficiently sharp, it may not be necessary to provide threads on and rotation of the structure. Instead, the hole-enlarging structure can simply be pushed through the coronary artery wall. This same principle applies to all embodiments of structures for penetrating the coronary artery wall and subsequently enlarging the opening in that wall (e.g., as in FIGS.13,15-15g,33, and36-39).
• FIGS. 36 and 37 illustrate another possible use of a cone structure like that shown in FIGS. 34 and 35, as well as illustrating other possible aspects of the invention. These FIGS. illustrate a structure that can be used to deliver an artificial graft conduit, or a natural graft conduit, or both an artificial graft conduit and a natural graft conduit simultaneously (e.g., with the natural conduit coaxially inside the artificial conduit). In the particular case shown in FIGS. 36 and 37 it is assumed that only natural graft conduit is being delivered, but it will be readily apparent that artificial graft conduit could be substituted for or added outside the natural graft conduit.[0115]
• In the embodiment shown in FIGS. 36 and 37 the cone of[0116]struts436′ is mounted on the distal end of a highlyelastic coil spring450. The proximal end ofcoil450 is attached to ring460. The cone ofbarbs436′ is provided with additional, relatively short, radially outwardly projecting hooks orbarbs436″ near the proximal base of the cone. As shown in FIG. 37, hooks orbarbs436″ extend into and/or through the distal portion of a length ofgraft tubing530, which (as has been mentioned) is assumed in this case to be natural body organ tubing such as saphenous vein.Ring460 is similarly provided with radially outwardly extending hooks orbarbs462 which extend into and/or through the proximal portion ofgraft conduit530.Ring460 also includes resilient radially outwardly extendingannular flaps438aand438bwith hooks orbarbs439, all similar to correspondingly numbered elements in FIG. 16.Spring450, which is insideconduit530 between the cone ofbarbs436′ andring460, helps to support and hold open the graft conduit.Structure420′ (similar to structure420′ in FIGS. 34 and 35 and includingballoon422′ as shown in those FIGS.) is disposed aroundwire150 insidestructures436′,450,460, and530.Delivery tube440 is disposed aroundconduit530.
• The embodiment shown in FIGS. 36 and 37 illustrates a structure which can be used to deliver and install natural body organ conduit without any full length artificial graft conduit being used. In a manner similar to what is shown in FIGS. 34 and 35, the structure shown in FIG. 37 is delivered to the operative site via[0117]wire150. The cone ofstruts436′ is forced through the wall ofcoronary artery20 and then flared radially outward inside the coronary artery to anchor the distal end of the graft conduit to that artery. The distal end ofdelivery tube440 is pulled back as needed to aid in attachment of the distal end of the graft structure. Attachment of the proximal end of the graft structure to the wall ofaorta30 is performed similarly to what is shown in FIGS.21-24. Accordingly, withdistal flap438ajust outside the wall ofaorta30,delivery tube440 is pulled back proximally to expose that flap.Flap438ais thereby released to spring out and engage the outer surface of the aorta wall. After that has occurred,proximal flap438bis adjacent the inner surface of the aorta wall.Tube440 is pulled back proximally even farther to exposeflap438bso that it can spring out and engage the inner surface of the aorta wall. Naturalbody organ graft530 is now fully installed in the patient.Structures436′,450, and460 remain in place in the patient to help anchor the ends ofgraft conduit530 and to help hold open the medial portion of that conduit.
• In embodiments like FIGS. 36 and 37,[0118]coil450 is optional. Ifcoil450 is used, its ends may or may not be attached tostructures436 and/or460.
• A coil like[0119]coil450 can be used in other embodiments of the invention. For example, a coil like450 could be used betweenrings520aand520bin embodiments like that shown in FIG. 25 to help holdopen graft conduit530 in that embodiment.
• Still another illustrative alternative embodiment of some of the instrumentation shown in FIG. 15 is shown in FIG. 38. To facilitate comparison to FIG. 15, FIG. 38 uses reference numbers with double primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15. In the embodiment shown in FIG. 38, the distal end of[0120]artificial graft conduit430″ is attached toexpandable ring430a. Elongated struts436″ extend distally from the distal end ofring430a. The distal ends ofstruts436″ are turned back in the proximal direction and extend just far enough into the distal end oftube420″ to be releasably retained by that tube.Struts436″ are resiliently biased to extend radially outward fromring430a, but are initially restrained from doing so by the presence of their distal end portions in the distal end oftube420″. Thus struts436″ initially form a distally pointing cone that can be pushed through tissue such as the wall ofcoronary artery20 in the same manner that has been described above in connection with FIGS.34-37.Structure420″, which may be metal (e.g., stainless steel) hypotube with an inflatableannular balloon422″ near its distal end, may be used to help push the cone through the tissue.
• After the distal portion of the cone of[0121]struts436″ has been pushed through the wall ofcoronary artery20,tube420″ is shifted proximally relative to the struts to release the distal end portions of the struts. This allows struts436″ to spring radially outward fromring430ainsidecoronary artery20, thereby anchoring the distal end of the graft conduit in the coronary artery.Ring430acan then be circumferentially expanded to increase the size of the connection betweencoronary artery20 and the distal portion of the graft conduit. If desired, each ofstruts436″ may be twisted 180° as shown in FIG. 39 before it enters the distal end oftube420″. This promotes turning of the extreme distal end portions of the struts toward the coronary artery wall when the struts are released fromtube420″.
• [0122]Ring430aand struts436″ may be made of any suitable material such as any 300-series stainless steel (e.g., 316L stainless steel). Another material that may be suitable forstruts436″ is nitinol. As in previously described embodiments, theelastic cover434 that forms part ofconduit430″ preferably extends toregions430aand436″.
• The structures shown herein and described above for penetrating existing body organ tissues and for connecting and/or fastening graft structures to existing body organ tissues are only illustrative of structures that can be used. Other examples of such structures are shown in Bachinski et al. U.S. Pat. No. 6,036,702, which is hereby incorporated by reference herein.[0123]
• Although it has been said that it is not necessary in accordance with and for purposes of this invention to intralumenally approach more than one end of the graft site, it is not inconsistent with this invention to also use other instrumentation to intralumenally approach the other end of the graft site. For example, it may be desirable to introduce a catheter into[0124]coronary artery20 during the procedure described above that includes FIG. 1 and related FIGS. in order to medicate the coronary artery, to introduce radiologic (e.g., fluroscopic) liquids into the coronary artery, etc.
• FIG. 40 shows a[0125]structure700 that may be used as an alternative to an inflatable balloon for radially enlarging a surrounding structure such as a connector between a natural or artificial graft and a patient's body tissue. For example, structures likestructure700 may be used in place of one or more of balloons422 (FIGS. 15 and 18-23),512a/512b(FIGS.25-30),422′ (FIG. 35), or422″ (FIG. 38), or wherever else a generally similar radially enlargeable structure is needed.
• [0126]Structure700 includes an outer tube710 (e.g., of metal hypotube). Near the distal end oftube710pivotable members720aand720bare pivotally mounted on apin730 which extends transversely acrosstube710. The proximal portions of members710aand710bare pivotally connected tolinks740aand740b, respectively. The proximal ends of links740 are pivotally connected to the distal end ofwire750.Axially extending slots760 are formed in diametrically opposite sides oftube710 to allow members720 and740 to extend radially out oftube710, for example, as shown in FIG. 40. The distal ends of members720 can be brought together by pullingwire750 proximally relative totube710. Alternatively, that portion ofstructure700 can be radially enlarged (i.e., the distal portions of members720 can be spread apart) by pushingwire750 distally relative totube710.Structure700 is therefore another example of a selectively radially enlargeable structure that can be used in accordance with this invention.
• If desired, one or more selectively[0127]inflatable balloons780 may be disposed onstructure700. Eachsuch balloon780 preferably extends annularly aroundstructure700. (For greater clarity FIG. 40 only shows the rear half ofannular balloon780.)Balloon780 and/or similar balloons may be used for such purposes as helping to hold a graft in position aroundstructure700 during use ofstructure700 to transport the graft.Balloon780 or like balloons may be selectively inflated via an inflation lumen which extends proximally from the balloon alongcomponent710.
• As an alternative to pushing[0128]wire750 to spread the distal portions of members720 apart, links740 can start out more nearly partly overlapping the proximal portions of members720. Then whenwire750 is pulled proximally relative totube710, the distal portions of members720 will be spread apart.
• It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, the order of some steps in the procedures that have been described are not critical and can be changed if desired. The manner in which radiologic elements and techniques are used for observation of the apparatus inside the patient may vary. For example, radiologic fluids may be injected into the patient through various lumens in the apparatus to help monitor the location of various apparatus components in the patient, and/or radiologic markers (of which the above-described markers such as[0129]154 and206 are examples) may be provided anywhere on the apparatus that may be helpful to the physician.

Claims (12)

The Invention claimed is:

1. Apparatus for radially enlarging a structure used in a medical procedure comprising:

a first elongated component having axially spaced proximal and distal portions;

first and second members mounted for radial movement relative to the distal portion of the first component, the first and second members being movable along respective different radii of the first component; and

a second elongated component substantially parallel to the first component, the second component being operatively connected to the first and second members and movable relative to the first component to produce the radial movement of the first and second members.

2. The apparatus defined inclaim 1 further comprising:

a selectively inflatable balloon on the distal portion of the first component.

3. The apparatus defined inclaim 2 wherein the balloon extends annularly around the distal portion of the first component.

4. The apparatus defined inclaim 1 wherein the first and second members are pivotally mounted on the distal portion of the first component.

5. The apparatus defined inclaim 4 wherein the pivotal axis of each of the first and second members is transverse to the longitudinal axis of the first component.

6. The apparatus defined inclaim 1 wherein the second component is longitudinally movable relative to the first component to produce the radial movement of the first and second members.

7. The apparatus defined inclaim 1 wherein the first and second components are substantially concentric with one another.

8. The apparatus defined inclaim 1 further comprising:

first and second links operatively connected between the second component and the first and second members, respectively.

9. The apparatus defined inclaim 8 wherein each of the first and second links is pivotally connected to the second component and to the respective first or second member.

10. The apparatus defined inclaim 1 wherein the first component comprises a tubular member.

11. The apparatus defined inclaim 10 wherein the second component is disposed substantially coaxially in the tubular member.

12. The apparatus defined inclaim 11 wherein the second component comprises an elongated wire member.

Images