ANGIOPLASTY ANCHOR AND/OR MARKER BALLOON STENT CATHETER APPARATUS AND METHOD

Abstract

An angioplasty apparatus and method including a balloon stent, for facilitating accurate placement of a lumen stent for dilating a stenotic site, the apparatus includes arcuate, low pressure, anchor and/or marker and guide balloon segment(s) connected to a stent deployment catheter at at least one of a proximal and distal end of a wire mesh stent with circumferential gaps in the anchor and/or marker balloon segment or segments to facilitate blood flow and contrast media during a stenting procedure. Optimal positioning of a stent at a stenotic lumen site is facilitated by selective injection of marker fluid into one or more low pressure, anchor and/or marker balloon segment(s).

Claims

1. An angioplasty balloon stent catheter apparatus for facilitating accurate placement of a balloon stent within a patient's stenotic lumen site, said angioplasty balloon 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 balloon catheter stent connected generally at a distal end of said deployment catheter sheath, said balloon catheter stent having, a generally cylindrical wire mesh stent operable for deployment and expansion at a stenotic site within a human blood lumen, a generally cylindrical high pressure balloon mounted generally at a distal end of said deployment catheter sheath and extending coaxially within the interior of said generally cylindrical wire mesh stent, said high pressure balloon being operable to radially expand said wire mesh stent within a patient's stenotic blood lumen site; a low pressure anchor and guide balloon assembly connected to said deployment catheter sheath, said anchor and guide 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 at least one of a distal end and a proximal end but slightly axially separate from said generally cylindrical wire mesh stent; and at least one low pressure inflation conduit connected to said deployment catheter sheath and said at least one of a low pressure anchor and guide balloon segment and anchor and guide 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 inflatable balloon segment and balloon segments.

2. An angioplasty balloon stent catheter apparatus as defined in claim 1 wherein said anchor and guide balloon assembly having at least one of an inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: an arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath, said arcuate shaped balloon segment subtends an arc of at least approximately twenty degrees.

3. An angioplasty balloon stent catheter apparatus as defined in claim 2 wherein said arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath is mounted on said deployment catheter sheath: at a generally proximal end of said balloon catheter stent.

4. An angioplasty balloon stent catheter apparatus as defined in claim 2 wherein said arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath is mounted on said deployment catheter sheath: at a generally distal end of said balloon catheter stent.

5. An angioplasty balloon stent catheter apparatus as defined in claim 1 wherein said balloon assembly having at least one inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: an arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath, said arcuate shaped balloon segment subtends an arc of at least approximately three hundred forty degrees.

6. An angioplasty balloon stent catheter apparatus as defined in claim 5 wherein said arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath is mounted on said deployment catheter sheath: at a generally proximal end of said balloon catheter stent.

7. An angioplasty balloon stent catheter apparatus as defined in claim 5 wherein said arcuate shaped balloon segment mounted generally at a distal end of said deployment catheter sheath is mounted on said deployment catheter sheath: at a generally distal end of said balloon catheter stent.

8. An angioplasty balloon stent catheter apparatus as defined in claim 1 wherein said anchor and guide balloon assembly having at least one inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: a plurality of arcuate shaped balloon segments mounted generally at a distal end of said deployment catheter sheath, each of said plurality of arcuate shaped balloon segments subtends an arc of at least approximately twenty degrees.

9. An angioplasty balloon stent catheter apparatus as defined in claim 8 wherein said anchor and guide balloon assembly having at least one inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least two independent and symmetrically opposing arcuate shaped balloon segments mounted on said deployment catheter sheath.

10. An angioplasty balloon stent catheter apparatus as defined in claim 9 wherein: each of said two independent and symmetrically opposing arcuate shaped segments mounted generally at the distal end of said catheter assembly subtends an arc of at least approximately one hundred degrees.

11. An angioplasty balloon stent catheter apparatus as defined in claim 9 wherein: each of said two independent and symmetrically opposing arcuate anchor and guide balloon segments generally at the distal end of said catheter assembly subtends an arc of at least approximately one hundred and twenty degrees.

12. An angioplasty balloon stent catheter apparatus as defined in claim 8 wherein said balloon assembly having at least one inflatable arcuate balloon segment and inflatable arcuate balloon segments comprises: at least three independent and symmetrically opposing arcuate shaped balloon segments mounted on said deployment catheter sheath generally at a distal end of said balloon catheter stent.

13. An angioplasty balloon stent catheter apparatus as defined in claim 12 wherein: each of said three independent and symmetrically opposing arcuate shaped balloon segments mounted at a distal end of said balloon catheter stent subtends an arc of at least twenty degrees.

14. An angioplasty balloon stent catheter apparatus as defined in claim 12 wherein: each of said at least three independent and symmetrically opposing arcuate shaped balloon segments mounted on said deployment catheter sheath generally at the distal end of said balloon catheter stent subtends an arc of at least sixty degrees.

15. An angioplasty balloon stent catheter apparatus as defined in claim 12 wherein: each of said three independent and symmetrically opposing arcuate shaped balloon segments mounted on said deployment catheter sheath generally at the distal end of said balloon catheter stent subtends an arc of at least one hundred degrees.

16. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent for dilating a patient's stenotic site, said angioplasty apparatus comprises: a percutaneous deployment catheter sheath having a proximal end and a distal end, wherein said distal end is operable to be threaded over a guide wire positioned within a patient's lumen to be treated; a balloon, wire mesh, stent assembly mounted generally at a distal end of said deployment catheter sheath, said balloon, wire mesh, stent assembly including, an expandable wire mesh stent, and a high pressure, generally cylindrical balloon mounted concentrically within said expandable wire mesh stent for selectively expanding said wire mesh stent at a stenotic site within a patient's lumen; and a balloon assembly mounted upon said percutaneous deployment catheter sheath generally at at least one of a distal end and a proximal end of said balloon, wire mesh, stent, said anchor and guide balloon assembly including, at least one of an inflatable low pressure, inflatable balloon segment and low pressure, inflatable balloon segments, said anchor and guide balloon segment and balloon segments having a total circumferential extent less than or equal to three hundred and forty degrees for facilitating blood flow through a patient's lumen during a stenting procedure.

17. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a patient's stenotic site as defined in claim 16 wherein said anchor and guide balloon assembly having at least one of a low pressure, inflatable balloon segment and low pressure, inflatable balloon segments comprises: at least two independent and symmetrically opposing low pressure arcuate balloon segments mounted generally at a distal end of said deployment catheter sheath, and each of said balloon segments subtends an arc of at least twenty degrees.

18. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a stenotic site as defined in claim 17 wherein said balloon assembly having at least one of a low pressure inflatable balloon segment and low pressure, inflatable balloon segments includes: an independent low pressure inflation conduit connected to each of said low pressure balloon segments to independently inflate said at least two low pressure balloon segments to facilely conform said inflated balloon segments to a stenotic lumen site.

19. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a stenotic site as defined in claim 18 wherein said balloon assembly having at least one of a low pressure inflatable balloon segment and low pressure balloon segments further comprises: each of said two independent and symmetrically opposing arcuate balloon segments mounted at the distal end of said deployment catheter assembly subtends an arc of at least approximately one hundred and twenty degrees.

20. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a stenotic site as defined in claim 16 wherein said balloon assembly having at least one of a low pressure inflatable balloon segment and low pressure balloon segments further comprises: at least three independent and symmetrically positioned, low pressure, arcuate balloon segments mounted generally at a distal end of said deployment catheter sheath wherein each of said arcuate balloon segments subtends an arc of at least approximately sixty degrees.

21. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a lumen stenotic site as defined in claim 20 wherein said balloon assembly having at least one low pressure inflatable balloon segment and low pressure, inflatable segments includes: an independent low pressure inflation conduit connected to each of said low pressure balloon segments to independently inflate said at least three low pressure anchor and guide balloon segments to facilely conform said inflated balloon segments at a stenotic lumen site.

22. An angioplasty apparatus, with balloon stent, for facilitating accurate placement of a lumen stent and dilating a lumen stenosis as defined in claim 21 wherein said balloon assembly having at least one low pressure, inflatable balloon segment and low pressure, inflatable balloon segments comprises: each of said at least three independent and symmetrically opposing arcuate balloon segments mounted generally at the distal end of said deployment catheter assembly subtends an arc of at least approximately one hundred degrees.

23. A method for dilating a lumen, stenotic segment, site within a human circulatory system, said method comprising the steps of: inserting percutaneously a guide wire into a patient's blood lumen to and through a stenotic site to be treated; inserting percutaneously, coaxially along the guide wire, a deployment catheter stent assembly having at least one low pressure, balloon segment connected to a generally distal end of said deployment catheter stent assembly; selectively inflating, with a low pressure fluid, at least one of said at least one balloon segment and balloon segments connected at a distal end of said deployment catheter sheath to expand the at least one balloon segment and balloon segments to a degree larger than a stenotic site of interest to position and anchor said balloon catheter stent at the stenotic site; expanding an internal, cylindrical, stent balloon within a wire mesh stent with a high pressure fluid to radially expand the wire mesh stent outwardly and radially enlarge the stenosis at the lumen stenotic site being treated; collapsing said high pressure stent balloon; collapsing said at least one low pressure, balloon stent, balloon segment and balloon segments; and withdrawing the collapsed stent balloon, the at least one collapsed balloon segment and balloon segments, the deployment catheter and the guide wire percutaneously from a patient being treated.

24. A method for dilating a lumen, stenotic segment, site within a human circulatory system as defined in claim 23 wherein said at least one balloon segment and segments at a distal end of said deployment catheter comprises: two opposed, low pressure, balloon segments with each having a circumferential extent of approximately one hundred and twenty degrees and selectively inflating each of said two opposed, low pressure, balloon segments, independently, with a low pressure fluid to conform the balloon segments generally at a distal end of said deployment catheter with a lumen stenosis site to be treated.

25. A method for dilating a lumen, stenotic segment, site within a human circulatory system as defined in claim 23 wherein said at least one low pressure, balloon comprises: at least three, low pressure, balloon segments with each segment having a radial extent of approximately sixty degrees; and inflating each balloon segment, independently, with a low pressure fluid, to conform the balloon segments generally at a distal end of said deployment catheter to a stenosis lumen to be treated.

26. A method for dilating a lumen, stenosis segment, site within a human circulatory system as defined in claim 23 said method comprising the steps of: injecting percutaneously a marker fluid within at least one of said at least one balloon segment and balloon segments for identifying the location of said at least one balloon segment and balloon segments within a patient's circulatory system.

27. A method for dilating a lumen, stenotic segment, site within a human circulatory system as defined in claim 23 wherein said step of selectively inflating said at least one low pressure balloon segment and balloon segments comprises: inflating said at least one low pressure balloon segment and balloon segments at approximately a proximal end of said wire mesh stent carried by said deployment catheter.

28. A method for dilating a lumen, stenotic segment, site within a human circulatory system as defined in claim 23 wherein said step of selectively inflating said at least one low pressure balloon comprises: inflating said at least one low pressure balloon segment and low pressure balloon segments approximately at a distal end of said wire mesh stent carried by said deployment catheter.

Description

THE DRAWINGS

[0021] Numerous advantages of the present invention will become apparent from the following detailed description of preferred embodiments taken in conjunction with the accompanying drawings wherein:

[0022] FIG. 1A is a generalized anatomic, silhouette, front view of basic components of a human with certain internal components of a circulatory system disclosed including a human heart and basic vascular bed with an illustrative insertion of a balloon stent deployment sheath into a patient's left leg common femoral artery to address an illustrative stenotic lesion at a junction of a patient's left external iliac artery and the base of the patient's aorta;

[0023] FIG. 1B is a bubble view of a balloon stent inserted into a patient's left common femoral artery to address a stenotic site at the junction of the patient's left iliac artery and the base junction with the patient's aorta as depicted in FIG. 1A;

[0024] FIG. 2 is an illustrative detail view of a patient's blood lumen having a stenotic segment and introduction of a guide catheter carrying a guide wire and a surrounding balloon stent with a proximal low pressure anchor and/or marker balloon segment or segments;

[0025] FIG. 3 is an illustrative detail view similar to FIGS. 2 and 1B of a human blood lumen wherein the proximal low pressure anchor and/or marker balloon segment or segments has been expanded to axially secure a balloon stent and an internal high pressure stent balloon that has been radially expanded to deploy a wire mesh stent against a stenotic site to enlarge the axial passage and facilitate a flow of blood through the lumen;

[0026] FIG. 4 is a cross-sectional detail view of a wire mesh stent and deployment catheter with a low pressure anchor and/or marker balloon segment(s) carried by the stent deployment catheter generally at a proximal end of the wire mesh stent;

[0027] FIG. 5A is a partial detail view of an illustrative segment of a patient's aorta and lateral extending renal artery branch where a stenotic lesion has formed at the junction and with initial introduction of a balloon stent and an anchor and/or marker balloon mounted at a proximal end of the stent;

[0028] FIG. 5B is a bubble detail view of the stent depicted in FIG. 5A where the anchor and/or marker balloon segment has been expanded and the stent 64 has also been expanded against a stenotic site to enlarge the junction opening of the renal artery from the patient's aorta;

[0029] FIG. 6 is an illustrative detail view, similar to FIG. 2 of a human blood lumen having a stenotic segment and introduction of a guide catheter carrying a guide wire and a surrounding balloon stent with a distal low pressure anchor and/or marker balloon segment or segments;

[0030] FIG. 7 is an illustrative detail view similar to FIG. 3 of a human blood lumen wherein the low pressure anchor and/or marker balloon segment or segments at a distal end of a stent has been expanded to axially secure the balloon stent and an internal high pressure stent balloon has been radially expanded to deploy a wire mesh stent against a stenotic site to enlarge the site for axial passage to facilitate blood flow through the lumen;

[0031] FIG. 8 is a view similar to FIG. 4 disclosing a cross-sectional detail view of a wire mesh stent and deployment catheter with a low pressure anchor and/or marker balloon segment(s) carried by the deployment catheter generally at a distal end of the wire mesh stent;

[0032] FIG. 9 is an end and partial cross-sectional view taken in the direction of arrow “A” in FIG. 3, arrow “B” in FIG. 5B and “C” in FIG. 7 disclosing one embodiment of an anchor and/or marker balloon assembly;

[0033] FIG. 10 is an end and partial cross-sectional view similar to FIG. 9 disclosing another embodiment of the invention where two opposing and generally equally angular anchor and/or marker balloon segments of approximately one hundred and twenty degrees are illustrated positioned about a balloon stent deployment sheath to advantageously maintain blood flow during a stenting procedure; and

[0034] FIG. 11 is a view similar to FIGS. 9 and 10 disclosing yet another embodiment of the invention where three generally symmetrically disposed and opposing anchor and/or marker balloon segments of approximately sixty degrees each are illustrated positioned about a balloon stent deployment catheter to advantageously maintain blood flow during a stenting procedure.

DETAILED DESCRIPTION

[0035] In this description the expression “approximately” or “generally” is intended to mean at or near but not always exactly such that an exact dimension or location is not considered critical in those contexts where those expressions appear. In this description focus will be directed to a vascular balloon stent mounted upon a deployment catheter sheath with an anchor and/or marker low pressure balloon segment or segments for angioplasty, with high pressure balloon stenting, at stenotic locations within a patient's vascular system. The terms “high” and “low” as used in this disclosure are mutually relative expressions. In a preferred embodiment “low” means approximately a pressure of one or two atmospheres while “high” means a pressure of nine to eighteen atmospheres, however, other relative pressures are within the scope of the subject disclosure.

[0036] Turning initially now to FIG. 1 there is shown a front view 10 of a human figure with outline images of generalized and basic components of a human vascular circulatory system including a heart 14, a briefly ascending aorta 16 stemming from to a left ventricle of the heart, and a descending abdominal aorta 18 with renal branch arteries 20 and 22 extending to left and right kidneys 24 and 26 respectively. As indicated above, the human body has a number of arteries stemming from the aorta but for purposes of this description only the renal arteries going to a patient's kidneys are depicted as being representative.

[0037] In addition to lateral left and right renal arteries extending from a patient's aorta to a human's kidneys, FIG. 1 generally depicts left and right carotid arteries 28 and 30 as well as left and right iliac arteries 32 and 34 which terminate at the common femoral arteries 40 which bifurcate to superficial femoral and profunda arteries which are illustrative of an artery bed in a human's lower vascular system. FIG. 1 also depicts left 36 and right 38 brachial arteries in the human figure's arms.

[0038] A conventional percutaneous entry site for angioplasty, with stenting, is in a patient's common femoral artery at approximately location 40 shown in FIG. 1 or in a brachial arm artery at approximately site 42 also depicted in FIG. 1.

[0039] As shown in FIG. 1B, if a stenosis 52 develops at the junction of a patient's left iliac artery with the base of the patient's aorta a guide wire 58 carrying a collapsed stent 64 may be operably inserted through the stenosis and the stent is brought into registry with the stenosis 52. The anchor and/or marker balloon segment(s) 66 is shown in an inflated posture to anchor the stent in position prior to radially deploying the stent by pressurizing an internal high pressure, cylindrical stent balloon. In addition marker media may be injection into the balloon segment(s) 66 to assist in accurately positioning the stent scaffolding 64.

[0040] Turning now to FIGS. 2-4 one preferred embodiment of the subject invention is depicted in further detail to address an issue of a stenosis site 52 within an artery lumen 54 of a human vascular bed. The specific site is not identified in FIGS. 2-3 and is intended to be generally illustrative of a number of stenosis locations that might develop within a human vascular bed. In FIG. 2 a catheter deployment sheath 56 is inserted into a patient's vascular lumen, via illustrative insertion sites 40 or 42 (note again FIG. 1). The deployment catheter 56 includes an entry check valve to enable a guide wire 58 and collapsed stent to be delivered into the patient's vascular system without permitting a back flow of blood from the entry site. The angioplasty guide wire 58 is trained through the catheter deployment sheath 56 and is further extended through the stenotic accumulation 52 to be treated.

[0041] A stent deployment sheath 60 is extended through the catheter deployment sheath 56, generally concentrically along the guide wire 58, to deliver a wire mesh stent 64, in a collapsed condition, into the heart of the stenotic site 52. An anchor and/or marker balloon segment 66, or segments, are mounted on the stent deployment sheath 60 generally at a proximal end 74 of the stent 64. The wire mesh stent 64 and anchor and/or marker balloon segment 66 (or segments) is delivered to a proximal end of the stenotic site to be treated through the catheter deployment sheath 56 in a collapsed condition as illustrated in FIG. 2.

[0042] On a stenotic site, FIG. 3 illustrates deployment of the low pressure, anchor and/or marker balloon segment 66 (or segments) via a low pressure inflation line 46 which can be an independent line, as illustrated in FIG. 4, or a line imbedded within the side wall of the stent deployment sheath 60. Axial positioning of the collapsed wire mesh stent 64 can be facilitated by registry of a radiopaque marker band 72 located generally at a proximal end of the stent 64, note as an example FIG. 2, or by injecting radiopaque dye through the axial opening provided by the stent guide balloon segment 66 or (segments).

[0043] As further illustrated in FIGS. 3-4, once the wire mesh stent 64 is axially positioned within a stenotic site 52 to be treated an internal, coaxial, cylindrical balloon 68, note particularly FIG. 4, is injected with a high pressure fluid in a range of nine to eighteen atmospheres via an independent high pressure line 74, or a line embedded within the sidewall of the deployment sheath 60, to radially expand the surrounding wire mesh stent 64 outward to open the stenotic site 52 and restore an open lumen 54 for normal blood circulation. Following deployment the wire mesh stent 64 will remain within a patient's lumen 54 as a scaffolding to keep an open flow channel through the stenotic site.

[0044] Turning to FIGS. 5A and 5B a stenotic site 52 is shown as an accumulation at a junction location of a patient's aorta 18 and right renal artery 22. At this illustrative stenotic damaged site a guide catheter 56 is used to introduce a collapsed balloon stent 64 carried by a guide wire 58 into and through the stenosis 52. Once generally positioned anchor and/or marker balloon segment(s) 66 are expanded by the introduction of a relatively low pressure saline or marker fluid as illustrated in FIG. 5B. The expanded anchor and/or marker balloon segment(s) 66 serve to abut against the junction site and a proximal end of the stenosis and effectively assist in properly positioning the balloon stent 64 axially within the stenosis 52. Once axially positioned the internal cylindrical, high pressure, stent balloon is deployed and the stent 64 is radially expanded against the stenosis to open the site and create a scaffolding structure to keep the site opened to facilitate blood flow into the renal artery.

[0045] Referring now to FIGS. 6-8 there is illustrated another preferred embodiment of the invention where a guide balloon segment 66 (or segments) is mounted on the deployment catheter 60 generally at a distal location 78 of the wire mesh stent 64. In a manner similar to the description of the stent 64 illustrated and described in connection with FIGS. 2-4 the anchor and/or marker balloon segment 66 (or segments) positioned at a distal end of the wire mesh stent 64 is operable to anchor, guide and locate the wire mesh stent 64 within a stenotic site 52 for deployment and radial expansion of the stent to enlarge the stenotic site 52 and restore a flow of blood through a partially occluded blood lumen. The difference between FIGS. 2-4 and FIGS. 5-7 is the axial location of the anchor and/or marker balloon segment 66 or segments with respect to the stent 64. In this, FIGS. 2-4 depict the anchor and/or marker balloon segment(s) in as posture proximal to the stent 64 while FIGS. 6-8 disclose the anchor and/or marker balloon segment(s) distal to the stent 64.

[0046] Referring specifically to FIGS. 6-7, once the wire mesh stent 64 is axially positioned with respect to a stenotic site 52 the low pressure anchor and/or marker balloon segment 66 (or segments) is expanded via a low pressure inflation line 46 in FIGS. 4 and 70 in FIG. 8 to secure the stent 64 axially in an optimum posture. Then high pressure fluid is injected via line 74 in FIGS. 4 and 76 in FIG. 8 into the cylindrical, expansion balloon 68 to radially deploy the wire mesh stent 64 radially outward as illustrated in FIGS. 3 and 7.

[0047] Viewed in the direction of arrow “A” in FIG. 3, “B” in FIG. 5B and similarly “C” in FIG. 7, FIG. 9 depicts one preferred embodiment of the low pressure, anchor and/or marker balloon segment 66. More specifically, a single low pressure, arcuate, anchor and/or marker balloon 80 that preferably extends approximately three hundred and forty degrees around a distal end of the stent deployment sheath 60. The single low pressure, anchor and guide balloon segment 80 has a small, low pressure line 46, 70 that extends along or within the stent deployment sheath 60 and is used to inflate the anchor and/or guide balloon segment 80. At a location exterior to a patient's vascular system a physician is able to inject low pressure (one or two atmospheres) radiopaque media into anchor and/or marker balloon segment 80 by injection from a hand syringe (not shown). Although the exterior surface of the anchor and/or marker and guide balloon 80 is illustrated with a smooth exterior surface in certain instances it is contemplated that elevated transverse ridges, cross-hatching ridges or dimples can be formed on the exterior surface of the balloon segment 80 to facilitate the anchor function of the low pressure balloon segment.

[0048] The anchor and/or marker balloon segment 80 preferably occupies an arcuate expanse of approximately three hundred and forty degrees so that there is a minimal gap of at least approximately twenty degrees past the anchor and guide balloon 80 for passage of blood or contrast media through an artery during a stenting procedure. Although three hundred and forty degrees is preferred for the arcuate extent of the anchor and/or marker balloon segment 80 a degree of operative advantage can be realized by the subject invention where the arcuate extent of the single anchor and/or marker balloon segment 80 shown in FIG. 9 is as little as forty five degrees.

[0049] FIG. 10 is a view similar to FIG. 9 but discloses an alternate preferred embodiment of the invention disclosing a low pressure anchor and guide balloon system 66 including placement of two, arcuate, low pressure anchor and guide balloon segments 82 and 84 positioned in an opposing posture at a proximal (FIGS. 2 and 5A) or distal (FIG. 6) end of the wire mesh stent 64. This balanced arrangement of arcuate marker balloon segments, which can be independently inflated with marker fluid, enhances an ability to establish approximately coaxial placement of the opening of a wire mesh stent 64 within a stenotic site 52. In this embodiment each of the two balloon segments subtends an angle of at least one hundred degrees but less than one hundred and forty degrees and preferably one hundred and twenty degrees. The substantial open regions of approximately eighty to one hundred and sixty degrees provides relatively unobstructed blood and contrast media flow past the anchor and/or marker and guide balloon segments 82 and 84 during a stenting procedure.

[0050] Each of the marker balloon arcuate segments is fitted with an independent thin tube 86 and 88 extending through the stent deployment sheath 60 for use in independently inflating the low pressure anchor and/or marker balloon segments 82 and 84 with a radiopaque or saline fluid by using a syringe. The capacity and capability to separately inflate each anchor and/or marker balloon segment 82 and 84 enables a physician to selectively orient and guide the end of the stent deployment sheath 60 within a patient's lumen.

[0051] FIG. 11 discloses yet another preferred embodiment of the anchor and/or marker balloon segments 66. In this embodiment three approximately uniform, arcuate, anchor and/or marker and guide balloon segments are composed of low pressure balloons 90, 92, and 94 and independent corresponding inflation lines 96, 98, and 100. This enables transmission of a low pressure radiopaque marker media or saline solution via a syringe to the anchor and/or marker balloon segments generally at a proximal end (note FIGS. 2 and 5A) or distal end (note FIG. 6) but in each instance separate from the high pressure, stent deployment balloon 68. The anchor and/or marker balloon segments 90, 92, and 94 each extend peripherally around the stent deployment sheath 60 at least approximately twenty degrees but less than one hundred degrees and preferably sixty degrees around the stent deployment sheath 60. In this embodiment it is preferred that there is symmetric positioning of the anchor and/or marker balloon segments. This preferred anchor and/or marker balloon spacing concomitantly provides at least approximately sixty degrees of open space for blood and contrast media flow during a stenting procedure and with three independent pressure zones a capacity for enhanced positioning capability of a of the stent deployment by appropriate selection of pressure within each anchor and/or marker and guide balloon segment 90, 92 and 94.

[0052] In operation, a syringe is preferably used to inflate the low pressure anchor and/or marker balloon segment 66 (or segments) with a radiopaque marker media or saline solution. A balloon stent 64 is slid over the guide wire 58 extending generally coaxially within the interior of the guide catheter 56. A radiopaque marker band 72 is positioned in the region of a lumen stenosis 52 to be treated, as illustrated in FIGS. 2, 5A and 6.

[0053] When a stenotic site is at an origin of a blood vessel from the aorta, FIGS. 5A and 5B, the thin angioplasty guide wire 58 is advanced via the guide catheter 56, crossing the site of a stenosis into a downstream vessel. The stent 64 is then advanced over the guide wire 58 and into the stenotic site. When the stent is mostly inside the stenotic site, yet with the radiopaque marker band 72, still outside, the guide catheter tip is slightly pulled back into the aorta, the anchor and/or radiopaque marker balloon segments are inflated and gently advanced to face the opening of a blood vessel to be treated. Position is confirmed by tactile feedback and contrast media injection. The high pressure stent balloon 68 is then inflated and the stent 64 is radially deployed. After the stent 64 is set the anchor and/or marker balloon segment(s) and the stent balloon are deflated and the guide wire 58, anchor and/or marker balloon segment(s) 66, stent balloon 48 and stent catheter sheath 56 are all withdrawn.

[0054] When a lesion to be treated is downstream in the blood vessel FIGS. 2 and 3, and the radiopaque marker 72 or low pressure marker balloon segment 66 (or segments) containing a radiopaque fluid reaches a stenotic site a physician accurately knows that the stent 64 is in a proper posture for deployment. At this point the interior stent balloon 68, note FIG. 4, is inflated with approximately nine to eighteen atmospheres of pressure to expand the wire stent scaffolding 64 as shown in FIGS. 3 and 7. Once expanded the plaque stenosis 52 is pushed outwardly allowing the damaged site to be radially enlarged about the stent scaffolding to restore a flow of blood through the stenotic site.

[0055] The arcuate, anchor and/or marker, balloon segment gap(s) enables blood perfusion to through a diseased vessel during a stenting procedure and concomitantly allows contrast media flow to confirm final stent axial position before deployment.

[0056] When injecting radiopaque media through the guide catheter 56 radiopaque contrast media passes between the anchor and guide balloon segment(s) and into side branch lumens thus providing a view of the downstream side vessel geometry and confirming a desired position of the anchor and/or marker balloon segment (segments) and stent.

[0057] In general the low pressure anchor and guide balloon(s) will cover varying degrees of the blood vessel opening, and the degree of coverage and anchor and guide balloon pressure may vary to allow matching a branching angle, such as when positioning a stent at a bifurcation that is less than 90 degrees. This might occur at the bifurcation of the abdominal aorta into the iliac arteries and the bifurcation of the common femoral arteries. In these instances the interventional physician, may prefer an anchor and/or marker balloon extending less than one hundred and eight degrees, in a way that the marker balloon will fall on the shoulder of the bifurcation, rather in the lumen of the branching vessel.

[0058] The low pressure anchor and/or marker balloon segment or segments outer cross sectional diameter is larger than the diameter of the target vessel but smaller than the diameter of the application artery to allow proper inflation at a bifurcation FIG. 5B. When the stenosis is downstream with respect to a blood vessel the diameter will match the diameter of the target vessel, note FIGS. 3 and 7. Moreover the exterior of the anchor and/or marker and guide balloon segment (segments) 66 can be operable textured by a raised rib or pebble pattern to assist in an anchor function at a downstream stenotic site.

[0059] The advantages provided by a low pressure anchor and/or marker balloon segment or segments mounted on a proximal or distal end of a wire mesh stent facilitates, for example, accurate positioning of a stent within a patient's vascular system. In this context the low pressure balloon anchor and guide balloon segment or segments permits both a flow of blood during a stenting procedure and also a flow of radiopaque marker media to facilitate accurate placement of a stent at a stenosis site. Although the structure of a low pressure marker balloon segment (or segments) are depicted, for example, in FIGS. 9-11, it will be appreciated by those skilled in the art that the physical size of the arcuate anchor and/or marker balloon segment, and arcuate anchor and/or marker and guide balloon segments may be selected to suit the anatomy of a patient of interest.

[0060] 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.