ANGIOPLASTY, SELF-EXPANDING, STENT CATHETER WITH LOW PRESSURE ANCHOR AND/OR MARKER BALLOON ASSEMBLY AND METHOD

Abstract

An angioplasty apparatus and method, with a self-expanding stent, for facilitating accurate placement of the self-expanding stent for dilating a patient's blood lumen stenosis, the apparatus includes arcuate, low pressure, balloon segment(s) connected at a distal end of a deployment catheter assembly with axial gap(s) to facilitate continuous blood flow during a stenting procedure.

Claims

1. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site, said angioplasty self-expanding stent catheter apparatus comprising: a deployment catheter sheath having a proximal end and a distal end and being operable to be extended over a guide wire during a patient stenting procedure; a self-expanding catheter stent connected generally at a distal end of said deployment catheter sheath, said self-expanding catheter stent having, a generally cylindrical wire mesh stent operable for elf-expansion deployment at a stenotic site within a patient's blood lumen, a generally cylindrical stent deployment cover coaxially extending over said self-expanding wire mesh stent, said stent deployment cover being operable to be axially withdrawn from engagement with said self-expanding wire mesh stent to permit said self-expanding stent to expand within a patient's stenotic blood lumen site; at least one of a low pressure anchor and marker balloon assembly connected to said deployment catheter sheath generally at a distal end of said sheath, said balloon assembly including, at least one of an inflatable, low pressure, arcuate balloon segment and inflatable, low pressure, arcuate balloon segments, said at least one of an inflatable, low pressure, arcuate balloon segment and inflatable, low pressure, arcuate balloon segments having a total circumferential extent less than or equal to three hundred forty degrees extending about said deployment catheter sheath, and said at least one of an inflatable, low pressure, arcuate balloon segment and inflatable, low pressure, arcuate balloon segments being generally axially located on said deployment catheter sheath at a distal end of said generally cylindrical self-expanding wire mesh stent; and at least one independent, low pressure, inflation conduit connected to said deployment catheter sheath and to said at least one of a low pressure, balloon segment and low pressure, balloon segments and being operable to be connected to a low pressure inflation source at a proximal end of said deployment catheter sheath for selective delivery of fluid under low pressure to said at least one, low pressure, balloon segment and low pressure, balloon segments.

2. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least one of an arcuate shaped balloon segment and arcuate shaped balloon segments mounted at a distal end of said low pressure, balloon assembly subtends an arc of at least approximately twenty degrees.

3. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least one of an arcuate shaped balloon segment and arcuate shaped balloon segments mounted at a distal end of said low pressure, balloon assembly subtends an arc of at least approximately sixty degrees.

4. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least one of an arcuate shaped balloon segment and arcuate shaped balloon segments mounted at a distal end of said low pressure, balloon assembly subtends an arc of at least approximately one hundred and twenty degrees.

5. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least one of an arcuate shaped balloon segment and arcuate shaped balloon segments mounted at a distal end of said low pressure, balloon assembly subtends an arc of at least approximately three hundred and forty degrees.

6. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least one low pressure fluid conduit connected to and generally co-extensive with said deployment catheter sheath and one conduit extending to each of said at least one arcuate shaped balloon segment and arcuate shaped balloon segments generally at a distal end of said deployment catheter sheath and being operable at a proximal end of said deployment catheter sheath for each low pressure fluid conduit to be connection to a source of low pressure fluid for selectively inflating said at least one arcuate shaped, low pressure, balloon segment and arcuate shaped, low pressure, balloon segments.

7. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least two independent and symmetrically opposing arcuate shaped, low pressure balloon segments mounted generally at a distal end of said deployment catheter sheath.

8. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 7 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said two independent and symmetrically opposing arcuate shaped, low pressure, balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately one hundred twenty degrees.

9. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 7 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said two independent and symmetrically opposing arcuate shaped low pressure balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately sixty degrees.

10. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 7 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said two independent and symmetrically opposing arcuate shaped low pressure balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately twenty degrees.

11. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 7 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: two, low pressure, fluid conduits generally co-extensive with said deployment catheter sheath and one fluid conduit independently extending to each of said two arcuate shaped, low pressure, balloon segments generally at a distal end of said deployment catheter sheath and being operable at a proximal end of said deployment catheter sheath for connection to a source of low pressure fluid for selectively and independently inflating each of said two arcuate shaped, low pressure, anchor balloon segments.

12. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least three independent and symmetrically opposing arcuate shaped, low pressure, balloon segments mounted generally at a distal end of said deployment catheter sheath.

13. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 12 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said three independent and symmetrically opposing arcuate shaped, low pressure, balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately one hundred degrees.

14. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 12 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said three independent and symmetrically opposing arcuate shaped, low pressure, balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately sixty degrees.

15. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 12 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: each of said three independent and symmetrically opposing arcuate shaped, low pressure, balloon segments mounted generally at the distal end of said deployment catheter sheath subtends an arc of at least approximately twenty degrees.

16. An angioplasty self-expanding stent catheter apparatus including at least one of a low pressure anchor and marker balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 1 wherein said low pressure, balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: three, low pressure, fluid conduits generally co-extensive with said deployment catheter sheath and one fluid conduit independently extending to each of said three arcuate shaped, low pressure, balloon segments generally at a distal end of said deployment catheter sheath and being operable at a proximal end of said deployment catheter sheath for connection to a source of low pressure fluid for selectively and independently inflating each of said three arcuate shaped, low pressure, balloon segments.

17. An angioplasty self-expanding stent catheter apparatus including a low pressure balloon anchor balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site, said angioplasty self-expanding stent catheter apparatus comprising: a deployment catheter sheath having a proximal end and a distal end and being operable to be extended over a guide wire during a patient stenting procedure; a self-expanding catheter stent connected generally at a distal end of said deployment catheter sheath, said self-expanding catheter stent having, a generally cylindrical wire mesh stent operable for self-expansion deployment at a stenotic site within a patient's blood lumen, and a generally cylindrical stent deployment cover extending coaxially over said self-expanding wire mesh stent, said stent deployment cover being operable to be axially withdrawn from engagement with said self-expanding wire mesh stent to permit said self-expanding stent to expand within a patient's stenotic blood lumen site; a low pressure anchor balloon assembly connected to said deployment catheter sheath generally at a distal end of said sheath, said anchor balloon assembly including, at least one of a selectively inflatable, low pressure, arcuate, anchor balloon segment and inflatable, low pressure, anchor balloon segments each being located at generally a distal end of said deployment catheter sheath, and said at least one of an inflatable, low pressure, arcuate, anchor balloon segment and inflatable, low pressure, arcuate, anchor balloon segments each having a total circumferential extent less than or equal to three hundred forty degrees extending about said deployment catheter sheath; and an independent, low pressure, inflation conduit connected to each of said at least one low pressure, anchor balloon segment and low pressure, anchor balloon segments and each conduit being operable to be connected to a low pressure inflation source at a proximal end of said deployment catheter sheath for selective delivery of fluid under low pressure to said at least one, low pressure, inflatable, anchor balloon segment and low pressure, inflatable, anchor balloon segments.

18. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 17 wherein said at least one of a selectively inflatable, low pressure, anchor balloon segment, and inflatable, low pressure, arcuate, anchor balloon segments comprises: at least two independent and symmetrically opposing, arcuate shaped, anchor balloon segments mounted generally at a distal end of said deployment catheter sheath.

19. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 18 wherein said at least two independent and symmetrically opposing, arcuate shaped, anchor balloon segment, and inflatable, low pressure, arcuate, anchor balloon segments comprises: each of said two independent and symmetrically opposing, arcuate shaped, anchor balloon segments mounted at a distal end of said deployment catheter assembly subtends an arc of at least one hundred and twenty degrees.

20. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly for facilitating accurate placement of the self-expanding stent within a patient's stenotic lumen site as defined in claim 19 wherein said low pressure, anchor balloon assembly having at least one low pressure inflation conduit comprises: two, low pressure, fluid conduits connected to and generally co-extensive with said deployment catheter sheath and one fluid conduit independently extending to each of said two, arcuate shaped, balloon segments generally at a distal end of said deployment catheter sheath and being operable at a proximal end of said deployment catheter sheath for connection to a source of low pressure fluid for selectively and independently inflating each of said two arcuate shaped, low pressure, anchor balloon segments.

21. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 17 wherein said at least one of a selectively inflatable, low pressure, anchor balloon segment, and inflatable, low pressure, arcuate, anchor balloon segments comprises: at least three independent and symmetrically opposing, arcuate shaped, anchor balloon segments mounted generally at a distal end of said deployment catheter sheath.

22. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly for facilitating accurate placement of a self-expanding stent within a patient's stenotic lumen site as defined in claim 21 wherein said at least one independent and symmetrically opposing, arcuate shaped, anchor balloon segment, and inflatable, low pressure, arcuate shaped, anchor balloon segments comprises: each of said three independent and symmetrically opposing arcuate shaped anchor balloon segments mounted at a distal end of said deployment catheter assembly subtends an arc of at least sixty degrees.

23. An angioplasty self-expanding stent catheter apparatus including a low pressure anchor balloon assembly having at least one of an inflatable, anchor balloon segment and anchor balloon segments for facilitating accurate placement of the self-expanding stent within a patient's stenotic lumen site as defined in claim 22 wherein said low pressure, anchor balloon assembly having at least one low pressure inflation conduit comprises: three, low pressure, fluid conduits generally co-extensive with said deployment catheter sheath and one fluid conduit independently extending to each of said three, arcuate shaped, anchor balloon segments generally at a distal end of said deployment catheter sheath and being operable at a proximal end of said deployment catheter sheath for connection to a source of low pressure fluid for selectively and independently inflating each of said three, arcuate shaped, low pressure, anchor balloon segments.

24. A method for dilating a stenosis segment with a self-expanding stent within a human circulatory system, said method comprising the steps of: inserting percutaneously a deployment catheter assembly carrying a collapsed self-expanding wire mesh stent, and being covered with a retention collar, the self-expanding stent being connected generally at a distal end of said deployment catheter assembly and at least one collapsed, low pressure, anchor balloon segment mounted upon said deployment catheter assembly distally of said self-expanding stent; inserting an angioplasty guide wire coaxially through said deployment catheter assembly and through a patient's stenotic site to be treated; drawing back the deployment catheter assembly carrying the covered self-expanding wire mesh stent to a position where the self-expanding stent is located at the stenotic site to be treated; inflating, with a low pressure fluid, the at least one of an anchor balloon segment and anchor balloon segments having a total circumferential extent less than or equal to three hundred and forty degrees, connected at a distal end of the deployment catheter assembly to anchor the self-expanding stent in a location of the stenotic site to be treated while concomitantly permitting a flow of blood through the patients lumen during the stenting procedure; drawing back the self-expanding stent cover retaining the self-expanding stent in a collapsed posture to permit the self-expanding stent to radially expand and compress outwardly the stenotic site to be treated; collapsing the at least one, low pressure, anchor balloon segment and low pressure anchor balloon segments; and withdrawing the deployment catheter assembly including the at least one collapsed, anchor balloon segment and anchor balloon segments and guide wire percutaneously from the patient.

25. A method for dilating a stenosis segment with a self-expanding stent within a human circulatory system as defined in claim 24 wherein said at least one, low pressure, anchor balloon segment and anchor balloon segments at a distal end of said guide catheter comprises: two opposed, arcuate, anchor balloon segments with each having a circumferential extent of approximately one hundred and twenty degrees and inflating each arcuate, anchor balloon segment independently with a low pressure fluid to conform the anchor balloon segments generally at a distal end of said deployment catheter assembly to approximately a coaxial posture of the distal end of the guide catheter with a stenosis lumen to be treated.

26. A method for dilating a stenosis segment with a self-expanding stent within a human circulatory system as defined in claim 24 wherein said at least one, low pressure, anchor balloon at a distal end of said guide catheter comprises: three opposed arcuate anchor balloon segments with each having a circumferential extent of approximately at least twenty degrees and inflating each arcuate anchor balloon segment independently with a low pressure fluid to conform the anchor balloon segments generally at a distal end of said deployment catheter assembly to approximately a coaxial posture of the distal end of the guide catheter with a stenosis lumen to be treated.

27. A method for dilating a stenosis segment with a self-expanding stent within a human circulatory system as defined in claim 24 wherein said at least one, low pressure, anchor balloon at a distal end of said guide catheter comprises: three opposed arcuate anchor balloon segments with each having a circumferential extent of approximately at least one hundred and twenty degrees and inflating each arcuate anchor balloon segment independently with a low pressure fluid to conform the anchor balloon segments generally at a distal end of said deployment catheter assembly to approximately a coaxial posture of the distal end of the guide catheter with a stenosis lumen to be treated.

28. A method for dilating a stenosis segment with a self-expanding stent within a human circulatory system as defined in claim 24 and further comprising the step of: injecting a marker media into at least one of said anchor balloon segment and anchor balloon segments to facilitate identification of the physical location of the self-expanding stent within a patient's blood lumen.

Description

THE DRAWINGS

[0016] Numerous advantages of the present invention will become apparent from the following detailed description of an illustrative embodiment taken in conjunction with the accompanying drawings wherein:

[0017] FIG. 1 is a human silhouette, front view, including basic illustrative components of a human heart and vascular system with an ipsilateral insertion of a self-expanding stent deployment sheath into a patient's left common femoral artery to address a patient's stenotic lesion above the point of insertion such as the junction of a patient's left iliac artery and base of the aorta;

[0018] FIG. 1A is an enlargement bubble disclosing detail of the ipsilateral insertion, in the general direction of arrow “A”, of a self-expanding, stent catheter with an anchor and/or marker balloon assembly positioned at a junction of the base of a patient's aorta and the left iliac artery;

[0019] FIG. 2 is a cross-sectional, detail view of a nose portion of a deployment sheath carrying a self-expanding stent which is held in a collapsed posture by a concentric release collar or sheath;

[0020] FIG. 3 is an axial view, taken in the general direction of arrow “B” in FIG. 1A of a patient's stenotic lumen with a self-expanding stent and an anchor and/or marker balloon segment, taken in partial cross-section with a distal to proximal perspective, disclosing one embodiment of the invention including a single low pressure anchor and/or marker balloon arcute segment of approximately 340° with a circumferential gap of 20° to permit a continuous flow of blood and/or contrast media past the deployed low pressure, anchor and/or marker balloon assembly during a stenting procedure. In this view and in the views of FIGS. 4 and 5 cross-sectional components of a self-expanding, metal stent are shown in full line view, for purposes of illustration, even though one of skill in the art will recognize that portions of these components are operably behind low pressure, anchor and/or marker balloon segment(s);

[0021] FIG. 4 is a view similar to FIG. 3 disclosing an alternative preferred embodiment of the invention with a pair of opposing anchor balloon segments with each segment subtending an arc of approximately 120° to provide opposing axial passages of approximately 60° degrees to facilitate a continuous flow of blood and/or contrast media past the anchor balloon segments during a stenting procedure;

[0022] FIG. 5 is a view similar to FIGS. 3 and 4 disclosing yet another preferred embodiment of the invention where three generally equal anchor balloon arcuate segments of approximately 60° are illustrated positioned about a self-expanding stent deployment sheath to advantageously maintain lumen blood and/or contrast media flow during a stenting procedure;

[0023] FIG. 6 is a partial, cross-sectional, view of an illustrative stenosis site within a patient's left iliac artery at the junction with the base of the patient's aorta showing insertion of a collapsed anchor and/or marker balloon segment(s) and an outer sheath covering a self-expanding stent; and

[0024] FIG. 7 is a partial, cross-sectional, view similar to FIG. 6 illustrating initial deployment of a self-expanding stent, by withdrawing on site a retention collar with a low pressure, anchor and/or marker balloon assembly deployed at a position adjacent a bifurcation stenosis site to be treated.

DETAILED DESCRIPTION

[0025] In this description and in the claims the expressions “approximately” or “generally” are intended to mean at or near but not always exactly such that an exact dimension or location is not considered critical in contexts where those expressions appear, unless specifically stated otherwise. In this description focus will be directed to a vascular, self-expanding stent mounted upon a deployment catheter sheath with a low pressure, anchor and/or marker balloon segment or segments for angioplasty stenting at a stenotic bifurcation location at the base of a patient's aorta. The term low pressure means generally one to two atmospheres of fluid pressure as opposed to nine to eighteen atmospheres of pressure which is often used in some stent, expansion balloon, angioplasty contexts and procedures.

[0026] Referring initially to FIGS. 1 and 1A there is shown a front silhouette view of a human FIG. 10 with a generalized and illustrative outline of basic components of a human circulatory system 12 including a heart 14, an ascending aorta 16 connected to a left ventricle of the heart, an aorta arch 18 and a descending central abdominal aorta 20. The human body has a number of arteries stemming from the aorta but for purposes of this description only the left 22 and right 24 iliac arteries descending into a patient's legs are depicted as being representative.

[0027] In addition to the left and right iliac arteries 22 and 24 FIGS. 1 and 1A generally depict left and right common femoral arteries extending into a patient's lower extremities; as well as left 26 and right 28 brachial arteries in the figure's arms.

[0028] One percutaneous entry site for angioplasty, with stenting, can be a patient's left leg common femoral artery at approximately location 30 shown in FIGS. 1 and 1A. Other entry sites are contemplated by the subject invention and sites 30 is intended for purposes of illustration and not limitation. Briefly, in this, entry from the common femoral artery 26, up against the flow of blood (called a retrograde approach) can be used to address an ipsilateral lesion in the iliac artery 22, for example. There is a different illustrative approach when the insertion from the common femoral artery is pointing down (ante-grade approach) to fix a lesion downstream in the same leg.

[0029] Referring now specifically to FIG. 1A a common femoral site 30 is shown that receives a deployment entry sheath 32 that projects a relatively short distance via a patient's common femoral artery and includes a one way check valve operable to receive a stent catheter but will block an outward flow of blood from the percutaneous entry site. A stent deployment catheter 34 is inserted through the entry sheath 32 and is axially fed over a guide wire 36. The guide wire 36 is shown extending upward in the general direction of arrow “A” within a patient's common femoral artery and through a plaque stenosis 38 to be treated, noted FIGS. 6 and 7. A wire mesh, self-expanding stent 40 is carried by the deployment catheter sheath 34 in a contracted posture for deployment at a stenotic site 38.

[0030] Turning now to FIG. 2 the deployment catheter sheath 34 terminates with an insertion head 42 which is operable to facilitate deployment of a distal end of the deployment catheter sheath 34 over the guide wire 36 and through a patient's artery 22 such as depicted in FIG. 1A. The anchor and/or marker balloon assembly 44 is operably attached to the deployment catheter sheath 34 and is fitted with a fluid delivery conduit 46 as shown extending through the deployment catheter sheath 34 to deliver low pressure fluid, such as saline solution and/or marker media, into the anchor balloon assembly 44. Although a separate conduit 46 is illustrated that extends within a central passage of the deployment catheter sheath 34 the subject invention also includes creation of a passage(s) within the side wall of the deployment catheter sheath 34 or fluid passage(s) mounted on an exterior surface of the deployment catheter sheath 34 as alternate forms of selectively delivering saline and/or marker media into the interior of individual balloon segment or segments comprising the anchor and/or marker balloon assembly 44.

[0031] The self-expanding stent 40, per se, is of a conventional commercial design, and is carried generally upon a distal end of the deployment catheter sheath 34 in a collapsed condition. The self-expanding stent 40 is held in a collapsed state by a surrounding, pull back, stent retention collar 48 at a location proximal to the anchor and/or marker balloon assembly 44. An exterior, pull-back, actuation sheath 50 is integral with a proximal end of the stent retention collar 48 and extends coaxially throughout the length of the deployment catheter sheath 34. The exterior actuation sheath 50 terminates with a pullback handle 74, note FIG. 1A, for selectively withdrawing the retention collar 48 to permit the self-expanding stent 40 to radially deploy at a patient's stenotic lumen site.

[0032] FIG. 3 is an illustration of one embodiment of the anchor balloon(s) assembly 44 generally viewed in the direction of arrow “B” in FIG. 1A. In this embodiment a single low pressure, arcuate, anchor and/or marker balloon 50 is shown that preferably extends approximately three hundred and forty degrees around a distal end of the guide catheter sheath 34. The low pressure, anchor and/or marker balloon segment 50 has a small, low pressure line 52 that extends along or within the guide catheter sheath 34 and is used to selectively inflate the anchor balloon segment 50. At a location exterior to a patient's vascular system an interventional physician is able to inject low pressure fluid such as a saline solution and/or radiopaque marker media with one or two atmospheres of pressure into anchor balloon segment 50 by injection, for example, with a hand syringe (not shown). The anchor balloon will then be gently expanded into engagement with a peripheral site of a surrounding artery wall axially adjacent to a stenotic lumen site to be treated.

[0033] The anchor balloon segment 50 preferably occupies an arcuate expanse of approximately three hundred and forty degrees and there is a peripheral gap of at least approximately twenty degrees enabling blood or marker media to flow past the anchor balloon segment 50 during a stenting procedure. Although three hundred and forty degrees is one preferred embodiment of the arcuate extent of the anchor balloon segment 50 a degree of operative advantage can be realized from the subject invention where the arcuate extent of the single marker balloon segment 50 shown in FIG. 3 is as little as approximately forty-five degrees with generally three hundred and fifteen degrees of passage space around the distal end of the deployment catheter sheath 34.

[0034] FIG. 4 is a view similar to FIG. 3 but discloses an alternate preferred embodiment of the invention disclosing a low pressure anchor and/or marker balloon assembly 44 composed of two arcuate, low pressure, anchor and/or marker balloon segments 54 and 56 positioned in an opposing posture at a distal end of the guide catheter sheath 34. This balanced arrangement of arcuate, low pressure, balloon segments 54 and 56, provides an ability for an interventional physician to selectively control the amount of pressure within each balloon segment. This enhances a physician's ability to establish an approximately coaxial placement of the guide catheter sheath 34 with a patient's branch artery. In this embodiment each of the two balloon segments subtends an arc of at least one hundred degrees but less than one hundred and forty degrees and preferably one hundred and twenty degrees. The substantial combined open region of approximately eighty to one hundred and sixty degrees provides a relatively unobstructed flow of blood and/or contrast media through the patient's stenotic site during a stenting procedure.

[0035] Each of the anchor balloon arcuate segments is shown in FIG. 4, for purposes of illustration, with an independent thin tube 58 and 60 extending through, or operably along, or embedded within the side wall of the guide catheter sheath 34, as previously noted, for use in separately and selectively filling the low pressure marker balloon segments 54 and 56 respectively with a saline or radiopaque fluid by using for example a hand operated syringe. The capacity to separately inflate each anchor balloon segments enables a physician to selectively orient the end of the guide catheter sheath 34 with respect to a branch artery as necessary or desirable to facilitate a normal, or near normal, positioning of the distal end of a guide catheter sheath 34 with respect to placement at a desired branch lumen.

[0036] FIG. 5 discloses yet another preferred embodiment of the invention comprising an anchor balloon assembly 44 composed of three arcuate, low pressure, anchor and/or marker balloon segments 62, 64, and 66 and associated independent fill lines 68, 70 and 72. The fill lines may be embedded within the side wall of the deployment catheter sheath 34 or deployed within the interior or affixed to the exterior of the sheath as operably desirable. This enables transmission of a low pressure saline or radiopaque marker media to be selectively injected into the individual anchor balloon segments with variable pressure via a hand syringe from a proximal end of the guide catheter sheath 34.

[0037] The anchor balloon segments 62, 64 and 66 each extend peripherally around a distal end of the deployment catheter sheath 34 at least approximately twenty degrees but less than approximately one hundred degrees and preferably sixty degrees. In this embodiment it is preferred, and as illustrated, there is symmetric positioning of the anchor and/or marker balloon segments. This preferred balloon segment spacing concomitantly provides a degree of open space for blood and contrast media flow during a stenting procedure. Moreover, with three independent pressure zones there is an enhanced positioning capability of a distal end of a guide catheter sheath 34 with respect to a branch artery by appropriate selection of pressure within each marker balloon segment. In addition, although symmetric placement of the anchor balloon segments 62, 64 and 66 is illustrated, in certain patient anatomic configurations the subject invention envisions asymmetric mounting of the anchor and/or marker balloons upon generally a distal end of the guide catheter sheath 34.

[0038] FIGS. 6 and 7 disclose a stenting procedure sequence in accordance with one preferred embodiment of the invention. In this, FIGS. 1, 1A and 6 depict an ipsilateral insertion of a deployment catheter sheath 34 via a patient's left common femoral artery and into the patient's iliac artery below a stenotic site to be treated. A guide wire 36 is coaxially extended through the deployment sheath 34 and through a patient's artery 22, past a stenotic site 38 to be treated. Insertion of the guide wire 36 is followed by extending the deployment catheter sheath 34 along the guide wire with a self-expanding stent 40, carried at a distal end of the deployment catheter sheath 34, in a collapsed posture, through the stenosis 38 to be addressed.

[0039] From the posture of the proximal end of the deployment catheter sheath 34, depicted in FIG. 6, one or more syringes are used to selectively inflate the low pressure anchor balloon segment or segments 50 with a saline solution and/or radiopaque marker media and the inflated anchor balloon segment or segments are then drawn back into a posture adjacent a distal end of a stenotic bifurcation site 38 to be treated.

[0040] As illustrated in FIGS. 1A and 7, when a distal end of the self-expanding stent 40 is anchored in position by expansion of the anchor balloon assembly 44 an interventional physician operably uses a handle 74 to draw back outer sheath 50 which is directly coupled to the stent retention collar 48. The self-expanding stent 40 then deploys and radially compresses the stenotic lesion 38 to restore an acceptable flow of blood through the patient's artery.

[0041] Once the stent 40 is fully deployed the anchor balloon assembly 44 is collapsed and the deployment catheter sheath 34, guide wire 36 and collapsed anchor balloon assembly 44 are withdrawn ipsi-laterally.

[0042] In certain instances the self-expanding stent 40 may not fully radially expand as intended. If that occurs a conventional balloon catheter may be independently inserted and inflated within the stent to assist in full radial expansion of the self-expanding stent, scaffolding, structure 40.

[0043] In describing the invention, reference has been made to preferred embodiments. Those skilled in the art however, and familiar with the disclosure of the subject invention, may recognize additions, deletions, substitutions, modifications and/or other changes which will fall within the scope of the invention as defined in the following claims.