WO2000054829A2

WO2000054829A2 - Catheter having varying resiliency balloon

Info

Publication number: WO2000054829A2
Application number: PCT/US2000/006855
Authority: WO
Inventors: Mitta Suresh; Jill W. Giannoble
Original assignee: Chase Medical Inc.
Priority date: 1999-03-16
Filing date: 2000-03-16
Publication date: 2000-09-21
Also published as: AU3749400A; WO2000054829A3

Abstract

A catheter (10, 40, 49, 53, 60, 90) having a balloon (24, 42, 50, 55, 74, 92) with a varying resiliency. A catheter body (16, 68) having a fluid delivery lumen (20, 62) extending therethrough is provided, with the balloon preferably being located at the distal portion. The balloon is securely attached to the catheter body at a first portion (30) and has a second portion (28) having a varying resiliency. A mid-section of the balloon having a lower resiliency (26) is more elastic than the second portion having the higher resiliency (28). The varying resiliency balloon may be achieved with varying durometer materials, or by varying the thickness of the balloon including increasing the thickness of the second portion. The varying resiliency balloon allows the catheter tip to self-align within a body vessel when the balloon is inflated to prevent impinging delivered fluid upon a vessel wall, and also preventing obstruction other extending body vessels. A flange (84) aids in positioning of the catheter within the body vessel, and a rigid member (70) allows for ease of insertion and positioning within a body vessel. The less resilient middle portions of the balloon may be angled with respect to the catheter body to further self-align the catheter within a body vessel.

Description

CATHETER HAVING VARYING RESILIENCY BALLOON

CROSS REFERENCE TO RELATED APPLICATIONS

The following U.S. Patent application is commonly assigned and is incorporated herein by reference:

FIELD OF THE INVENTION The present invention is generally related to medical catheters, and more particularly to catheters including balloon aortic perfusion catheters and the like that need to be precisely oriented in a body vessel.

BACKGROUND OF THE INVENTION In modern heart surgery, minimally invasive procedures are being employed whereby a balloon catheter is inserted into a body vessel, with the balloon being inflated to occlude a desired portion of the body vessel. These balloon catheters may also be utilized to infuse a fluid into the body vessel, sometimes at a high pressure and fluid rate. One challenge surgeons face during surgery while utilizing catheters in body vessels, such as arteries, is the difficulty of positioning the balloon and properly directing the infused fluid in the body vessel. It is important that the infused fluid not be directed against or impinge the inner walls of the body vessel, commonly referred to as "sand blasting", which impinging fluid may result in damage to the body vessel, or may dislodge body vessel lining substances such as plaque, resulting in a stroke or embolism elsewhere in the patient's body. It is therefore desired that the catheter infuse the fluid substantially parallel with the length of the body vessel. However, with prior art catheters, the balloon may not be centered in the body vessel, or may easily rotate after insertion and positioning, whereby the infused fluid may be directed at the body vessel wall.

Another problem presented by prior art catheters with inflatable balloons is that upon inflation, the balloon radially expands and exerts a force on a body vessel, such as an aorta. When the balloon is further inflated, the balloon expands along the area of least resistance which is longitudinally along the length of the catheter, which may result in obstruction of undesired regions of the body vessel including laterally extending vessels.

There is desired an improved balloon catheter having the ability to be effectively oriented in a body vessel, which catheter may be adapted to align itself in the body vessel, to reduce "sandblasting" a vessel wall during fluid infusion. Also desired is a balloon catheter adapted to being selectively inflatable within a body vessel while preventing obstruction of undesired regions.

SUMMARY OF THE INVENTION

The present invention achieves technical advantages as a balloon catheter that can be conveniently oriented in a body vessel to prevent sandblasting the vessel wall without obstructing an extending vessel. In a first embodiment, the balloon catheter includes a balloon having a varying resiliency. The catheter includes a catheter body having a proximal portion and a distal portion, and a first lumen extending between the proximal portion and the distal portion of the catheter body. The catheter further has an expandable balloon having a first portion securingly attached to the catheter body and an expandable second portion, the second portion having a varying resiliency proximate the first portion. The catheter also preferably includes a second lumen coupled to the balloon. To provide the varying resiliency balloon, the second portion of the balloon may have a varying thickness, with thin areas being more inflatable than the thick areas. The second portion is thicker proximate the first portion to reduce inflation of the balloon proximate the catheter body. The balloon may include a support member secured to parts of the exterior or interior surface of a balloon member to provide additional thickness to the balloon and reduce the elasticity of the balloon second portion.

In a second embodiment, the balloon catheter has an extended reinforced distal end to allow the catheter distal end to bend without kinking while infusing fluid into a body vessel along the vessel inner wall. The catheter includes a catheter body having a proximal portion and a distal portion, a first lumen extending between the proximal portion and the distal portion of the catheter body, and an expandable balloon disposed proximate the distal portion. The balloon has a first portion securingly attached to the catheter body and an expandable second portion, the second portion having a varying resiliency proximate the first portion. The catheter also includes a reinforcement member disposed about the first lumen proximate the distal portion and located distal of the balloon to allow the catheter distal end to bend without kinking while infusing fluid into a body vessel along the vessel inner wall.

The present invention also is a method of using a catheter in a body vessel, including the steps of inserting said catheter into the body vessel and expanding the balloon to occlude a region of the body vessel. The catheter has a proximal portion and a distal portion with a first lumen extending therebetween. The catheter has an expandable balloon proximate the distal portion, with the balloon having a first portion securingly attached to the catheter body and an expandable second portion, where the second portion has a varying resiliency proximate the first portion. The second portion of the balloon has a higher resiliency and expands less than said second portion having a lower resiliency. The catheter may have an extended distal end to bend without kinking while infusing fluid into a body vessel along the vessel inner wall.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a cross-sectional view of a balloon catheter of the prior art; Figure 2 is an illustration of a prior art balloon catheter in use during surgery;

Figure 3 is a cross-sectional view of a balloon catheter according to a first preferred embodiment of the present invention having a balloon with a varying resiliency attached to the catheter body;

Figure 4 is a cross-sectional view of the catheter shown in Figure 3 after inflation of the balloon;

Figure 5 is a cross-sectional view of a second embodiment of the present invention where the balloon member has an annular support member secured proximate the exterior wall of each balloon member ends;

Figure 6 is a cross-sectional view of the catheter shown in Figure 5 after inflation of the balloon;

Figure 7 is a cross-sectional view of a third embodiment of the present invention where the member has an annular support member secured to the interior wall of the balloon member proximate the balloon member ends;

Figure 8 illustrates the catheter of Figure 3 in use during a surgical operation with a distal catheter portion extending distal of the balloon member and being reinforced proximate the balloon to prevent kinking when bent against the vessel wall such as an aorta;

Figure 9 illustrates a fourth embodiment of the present invention having a middle portion with lower resiliency angled with respect to the catheter body, in use during a surgical operation;

Figure 10 is a cross-sectional view of a fifth embodiment of the present invention having a variable thickness balloon, a reinforcement member at the distal end of the catheter and a laterally extending flange adapted to position the catheter and balloon within a body vessel;

Figure 11 illustrates a cross-sectional view of a sixth embodiment of the present invention where the balloon has a higher resiliency at the distal portion of the balloon; and

Figure 12 illustrates the catheter of Figure 10 in use in a surgical operation, where the varying resiliency member facilitates securely positioning the catheter distal end within a body vessel close to a laterally extending vessel without obstructing the laterally extending body vessel.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring first to Figure 1 , therein is shown a prior art catheter having a balloon.

The balloon has the same resiliency along the length of the balloon, such that the balloon uniformly expands radially upon inflation. Figure 2 illustrates the prior art catheter of Figure 1 in use during a surgical operation in a body vessel. There are several problems with such prior art catheters. There is nothing to prevent perfusing a liquid directly against the interior walls of the body vessel, as shown. The catheter body may be flimsy, allowing the catheter tip to scrape and damage the inner walls of the body vessel. Furthermore, because the balloon member expands equally across the inflating surface, undesired areas of the body vessel may be inadvertently blocked. These problems with prior art catheters will be discussed further herein and are solved with the novel variable resiliency balloon catheter of the present invention.

Referring to Figure 3, there is generally shown at 10 an improved catheter according to a first preferred embodiment of the present invention. Catheter 10 is preferably comprised of a catheter body 16 extending from a proximal end portion 12 to a distal end portion 14. Extending within catheter body 16 is a first flow lumen 20 extending from the proximal portion 12 to the distal portion 14 and terminating at a lumen distal port 22. Flow lumen 20 preferably has a diameter sufficient to infuse oxygenated blood into an aorta at a suitable flow rate and flow pressure to perfuse a human body. Catheter body 16 is preferably comprised of an elastomeric material, such as silicone, which is a rather soft material having the advantage that it does not readily cause trauma to body vessels when inserted therewithin. Catheter body 16 is seen to be reinforced along a proximal section to a location short of the distal portion 14 by a semirigid support member 18 comprising a coil or spring. The wire forming support member 18 has a relatively small cross-sectional diameter and longitudinally extends within the catheter body 16 about flow lumen 20. Support member 18 is preferably integrated into the catheter body 16 during a manufacturing extrusion process forming the catheter body 16.

A balloon 24 in accordance with the present invention is attached to the catheter body 16 at balloon ends 30. The balloon 24 has a varying resiliency, namely, the resiliency of the balloon is not uniform along the length of the balloon. As shown in Figure 3, the varying resiliency balloon 24 may be achieved by providing a varying thickness balloon member, with annular thicker areas 28 being defined near the ends 30 of the balloon 24, and a thinner area 26 being located therebetween at the middle of the balloon 24. The balloon 24 is inflatable via an inflation lumen 36. which lumen terminates at a balloon inflation port 34 opening into a balloon cavity 32.

According to the first embodiment of present invention, the distal portion of the catheter shown at di extends distal the balloon 24 by a predetermined distance, preferably at least an inch, and more preferably an inch and a half. The support member 18 preferably extends to a point distal the balloon 24, and preferably extends to a point at least ^lA an inch distal the balloon 24, and more preferably, ^lΛ an inch, shown as distance d₂. The advantages of these features will be discussed in more detail shortly in reference to Figure 6. Referring now to Figure 4, therein is shown the improved catheter 10 according to the first embodiment of present invention with balloon 24 being inflated. It can be seen that the thicker end portions 28 of the balloon 24, for a given inflation pressure, do not expand as much as the thinner middle portion 26. This results in the balloon walls being inflated substantially perpendicular from the catheter body 16, as shown. This balloon design is advantageous because the balloon member 24 is prevented from rolling and repositioning within the vessel during surgery. The thicker portions 28 are also advantageous as an increase in inflation pressure increases pressure to the middle portion 26, improving occlusion of the body vessel without causing the thicker portions 28 to expand proximal and distally along the catheter body 16.

Figure 5 shows a second embodiment of the present invention as catheter 40 having a balloon 42 including a balloon member 44 comprising an elastic sleeve and a less elastic annular support member 48 at both ends of the balloon 42 proximate the balloon ends 46 that are secured to the catheter body 16. Specifically, the support members 48 are comprised of a higher resiliency material than the material comprising balloon member 44. In this embodiment, the varying resiliency of the balloon 42 is accomplished with the support members 48 secured to the exterior surface of the balloon member 44. Also shown in this embodiment is the support member 18 extending throughout the entire distal portion 14 along the length di of the catheter body

16, to the distal port opening 22. Figure 6 shows the catheter 40 with inflated balloon 42, with the unsupported middle portion of balloon member 44 inflating more than the end areas of balloon member 44 having support members 48. Again, the balloon 42 inflates from the catheter body 16 at the mid-section substantially perpendicular from the catheter body, due to the increased resiliency of the balloon 42 near the ends 46.

Figure 7 illustrates a third embodiment of the present invention as catheter 49 having a balloon 50 comprising an elastic balloon member 44 and a less elastic annular support member 51 attached at each end of the balloon member 44 proximate the balloon member ends 46. In this embodiment, the support members 51 are secured to the interior surface of the balloon member 44, to provide increased resiliency end portions. Upon inflation, not shown, the balloon 50 extends at the mid-section thereof and substantially perpendicular from the catheter body 16, such as shown in Figures 4 and 6.

Referring now to Figure 8, therein is illustrated the catheter 10 of Figure 3 of the present invention in use during a surgical procedure. A body vessel 52, such as an ascending aorta, is illustrated and is selectively occluded by and perfused by the catheter 10 as will now be discussed.

During use, the distal end of catheter 10 may be inserted through an incision created at 56 in body vessel 52 such as an aorta, whereby the catheter extends at an angle A with respect to the body vessel 52 such that the balloon 24 is generally laterally positioned within the vessel 52. The angle A is preferably about 30 degrees, but may be 30 degrees +/-10 degrees, for example. The catheter distal end portion 14 engages the inner wall of vessel 52 and responsively bends at portion d₂, thereby extending distal end portion 14 parallel to and within the vessel 52. Upon inflation of balloon 24, via inflation lumen 36 the vessel 52 is properly occluded by balloon 24, whereby the coil reinforcing member 18 at d₂ bends without kinking and anchors the catheter to prevent the balloon from rolling within vessel 52. Oxygenated blood can be perfused into the ascending aorta via opening 22 without impinging the lining of body vessel 52, thereby avoiding damage to the vessel lining. The oxygenated blood is delivered at a suitable pressure and flow rate adequate to perfuse the human body. It is only necessary that the distal end 14 be reinforced proximate and distal the balloon 24 a predetermined distance, and not necessarily the entire length of the distal end portion 14. It is only necessary that the portion of the catheter that bends, such as where reinforced at d₂, is reinforced to prevent kinking. The length di of distal end 14 is sufficient to permit bending when inserted at an angle in the vessel 52 such that the distal end 14 is parallel to the vessel 52. The unreinforced distal portion 14 is soft to prevent trauma to the vessel 52 during insertion and use. The method achieves technical advantages whereby distal end portion 14 extending distal of the balloon 24 has a predetermined length di sufficient to allow the distal end 14 to bend within the body vessel 52 and extend parallel to the vessel 52, thereby providing the perfusion of oxygenated blood via opening 22 along the inner wall of vessel 52, and not against the inner wall of vessel 52 which might otherwise cause damage to the lining. The balloon 24 has sidewalls or end portions 28 that have a higher resiliency and are less resilient than the middle section 26 such that the end portions 28 expand less than middle section 26 for a given inflation pressure. Upon inflation, balloon 24 primarily radially expands at middle section 26 to securingly engage the vessel wall and occlude the vessel. The less resilient end portions 28 reduce expansion longitudinally along the catheter body 16 which prevents obstruction of laterally extending vessels, such as Brachiocephalic artery 54.

The higher resiliency balloon ends 28 may comprise of the balloon wall being increased in thickness, as described. Alternatively, the balloon member may have uniform thickness with balloon ends 28 having less resiliency or a higher durometer than middle section 26 of the balloon 24 to inhibit expansion. For instance, the middle section 24 of the balloon 26 may comprise of a material having a durometer of 35 Shore A, and end portions 28 may comprise of a material having durometer of 60 Shore A.

In the three embodiments shown, both ends of the balloons 24, 42 and 50 have an increased resiliency with respect to the mid-section of the balloon. However, according to the present invention only one end of the balloon may comprise an increased resiliency. Furthermore, the decreased resiliency mid-section may be angled with respect to the catheter body, as shown in a fourth embodiment in Figure 9. Catheter 53 has a balloon 55 comprising a mid-section 57 that is less resilient than and disposed between two end sections 58. The mid-section 57 may be angled as shown at angle B with respect to the catheter body 16, rather than being substantially perpendicular to catheter body 16, as shown in previous embodiments. When inflated, mid-section 57 is less resilient and expands more than more resilient end sections 58. The variance in resiliency may be accomplished by varying the thickness of the balloon, securing support members to the interior or exterior of the balloon, or by having a varying durometer material for the balloon, as described above. Angling the mid- section 57 provides the ability to selectively inflate the balloon 55, prevents the balloon

55 from rolling within the body vessel 52, and gives the surgeon more precise positioning capability. Preferably, the balloon inflates perpendicular to the body vessel 52, at an angle B to the catheter body. When the balloon inflates perpendicular to the walls that also reduces the effects of friction in occluding the aorta. Angle B is preferably greater than 90 degrees and less than 170 degrees, for example. Preferably,

Angle B is 90 degrees + the angle of insertion A. The balloon 55 is also preferably symmetric around the mid-section 57 within the body vessel 52 upon inflation, yet asymmetric with respect to the catheter body 16.

Figure 10 shows a catheter 60 according to a fifth embodiment of the present invention having a first lumen 62 extending between a proximal portion 64 and a distal portion 66 of a catheter body 68. The catheter 60 includes a malleable rigid tip member 70 having a 90 degree bend at 72 securely attached within the first lumen 60 of the catheter body 68. The 90 degree bend 72 is located proximate the distal end 66 of the catheter body 68 and within an inflatable balloon 74. Balloon 74 comprises thicker end regions 76 and thinner middle region 78 which define a balloon cavity 80 inflatable by inflation lumen 82. The varying resilience of the balloon 74 may also be accomplished with a varying durometer material, or support members, as described herein. The catheter 60 further comprises a laterally extending annular flange 84 slightly spaced away from a distance d₃ and proximal the balloon 74. The spacing d₃ between the balloon 74 and the flange 84 is preferably equal to the thickness of the body vessel the catheter is to be inserted into, thus, the flange 84 assists in proper positioning the catheter 60 within the body vessel.

The rigid member 70 of improved catheter 60 preferably comprises stainless steel and is fully contained within the catheter body 68. However, other materials may be used for the rigid member 70. Upon inflation, thicker areas 76 having a higher resiliency inflate less than thinner region 78 of the balloon member 74. Thicker areas 76 may be formed by a support member, as described for previous embodiments.

Figure 11 shows a sixth embodiment of the present invention, catheter 90 having a balloon 92 with a thicker portion 94 along approximately ^lA to 1/3 the distal end of the balloon 94. Thinner portions 96 inflate more than thicker portion 94 of the balloon 92. Catheter 90 has a fluid delivery lumen 98, an inflation lumen 100, inflation port 102, a balloon cavity 104, and flange 106.

Referring now to Figure 12, therein is shown a surgical procedure utilizing catheter 60 of Figure 10, according to a preferred embodiment of the present invention. Catheter 60 is adapted to be securely positioned within and occlude a body vessel 52, such as an aorta, and proximate a laterally extending vessel 54, such as a

Brachiocephalic artery. Catheter 60 is bent at approximately 90 degrees at 72 proximate distal end 66. Rigid member 70 is contained within and is securingly attached to the fluid delivery lumen 62, terminating at an opening 79 at the distal end 66. Disposed about and surrounding the bent portion 72 of the catheter body 68 is seen balloon 74 defining the balloon cavity 80 therewithin. Balloon 74 is selectively inflated with a fluid pressure provided via inflation lumen 82 extending through the catheter body 68 and an opening 83 in communication with cavity 80.

Catheter 60 is seen to have laterally extending flange 84 extending normal to the catheter body 68 and encompassing the catheter body 68. Flange 84 is spaced predetermined distance d from the balloon 74, as shown, this distance adapted to correspond to the thickness of a body vessel to be occluded, such as the aorta 52 as shown. Balloon 74 is particularly characterized as having the variable resiliency wall, as shown. The proximal and distal walls 76 are both seen to have a greater resiliency and thickness than the remaining portion of the balloon wall generally shown at 78. Increased resiliency walls 76 inhibit inflation of the balloon in the lateral direction in body vessel 52 and along the catheter distal end 66. This increased resiliency walls 76 reduce the lateral expansion of the balloon 74 upon inflation than if the balloon had a uniform resiliency wall. If the balloon had a uniform resiliency wall the balloon would more laterally inflate due to the vessel wall resistance as depicted by the phantom lines shown at 110. For a given fluid pressure provided to cavity 80, the fluid pressure will be equally directed against the balloon wall at all surface portions, including against the inner wall proximate the body vessel, shown as aorta 52, to occlude the body vessel as shown. However, the non-engaging balloon portions 76 will not extend laterally within the body vessel 52 so far as to encroach the opening 112 of the laterally extending vessel shown as 54.

For instance, during use, the catheter 60 may be inserted into the ascending aorta with the distal end 66 being directed upwardly into the ascending aorta. The catheter 60, including balloon 74, is positioned upwardly toward the Brachiocephalic artery 54, and closely proximate the opening 112. The small dimensions of the aorta and the extending body vessels including the Brachiocephalic artery 54 are particularly noted.

The present invention achieves technical advantages whereby the balloon 74 and the flange 84, in combination, secure the catheter 60 within the vessel 52, with the distal end 66 being centered within the body vessel 52, as shown. This allows for the perfusing of oxygenated blood upwardly into the ascending aorta within the center of the aorta 52, without directing fluid against the interior wall of the aorta 52 which could otherwise damage the lining wall. The balloon 74 is uniquely designed to stabilize and secure the catheter 60 within the body vessel 52, without extending laterally within the body vessel as depicted by the phantom lines 110. Thus, clearance is maintained from the opening 112 of the laterally extending vessel 54. The novel varying resiliency balloon 74 alone advantageously orients the catheter distal end 66 within the body vessel 52, but the flange 84 further stabilizes the balloon and catheter therewithin. The present invention derives technical advantages as a catheter having a variable resiliency balloon and a method of use thereof. In a preferred embodiment, the balloon of the present invention has varying thicknesses with thicker areas being more resilient and thus being less inflatable than thinner areas. This feature allows a surgeon to selectively inflate the balloon member of the catheter in order to occlude desired areas yet prevent obstructing other areas of a body vessel during surgery such as extending vessels. Further advantages include greater ease of guiding the catheter into the body, with the rigid member of the present invention. Another advantage includes better positioning of the catheter within the body vessel, provided by the 90-degree rigid tip member in conjunction with the positioning flange in accordance with the present invention. Angling the less resilient mid-section with respect to the catheter body provides better positioning ability within a body vessel and allows for selective inflation of the balloon.

Though the invention has been described with respect to specific preferred embodiments, many variations and modifications will become apparent to those skilled in the art upon reading the present application. For example, other means of providing variable resiliency balloons are contemplated, and limitation to the preferred embodiments is not to be inferred. It is therefore the intention that the appended claims be interpreted as broadly as possible in view of the prior art to include all such variations and modifications.

Claims

WE CLAIM

1. A catheter, comprising: a catheter body having a proximal portion and a distal portion; a first lumen extending between said proximal portion and said distal portion of said catheter body; and an expandable balloon having a first portion securingly attached to said catheter body and an expandable second portion, said second portion having a varying resiliency proximate said first portion.

2. The catheter as specified in Claim 1 wherein said balloon second portion extends from said first portion to a mid-section of said balloon, said second portion having a higher resiliency proximate said first portion than said balloon mid-section.

3. The catheter as specified in Claim 2 wherein said balloon second portion is angled with respect to said catheter body.

4. The catheter as specified in Claim 2 wherein said balloon second portion has a greater thickness proximate said first portion than said mid-section, said second portion being less elastic than said mid-section.

5. The catheter as specified in Claim 2 wherein said balloon comprises a third portion secured to said catheter body, wherein said balloon comprises a fourth portion extending from said third portion to a mid-section of said balloon, said fourth portion having a higher resiliency proximate said third portion than said mid-section.

6. The catheter as specified in Claim 5 wherein said second and fourth portions are angled with respect to said catheter body.

7 The catheter as specified in Claim 5 wherein said balloon fourth portion has a greater thickness proximate said third portion than said mid-section

8. The catheter as specified in Claim 1 wherein said catheter body further comprises a laterally extending flange disposed proximal said balloon adapted to position said catheter within a body vessel.

9. A catheter, comprising: a catheter body having a proximal portion and a distal portion; a first lumen extending between said proximal portion and said distal portion of said catheter body; an expandable balloon having a first portion securingly attached to said catheter body and an expandable second portion; and a support member extending between said proximal portion and said distal portion, said support member being enclosed within said catheter body wherein said support member extends distal of said balloon a predetermined distance.

10. The catheter as specified in Claim 9 wherein said support member extends at least ! ₄ of an inch distal of said balloon.

11. The catheter as specified in Claim 10 wherein said catheter body distal portion extends at least one inch distal of said balloon.

12. The catheter as specified in Claim 9 further comprising a rigid reinforcement member disposed about said catheter first lumen proximate said catheter body distal portion.

13. The catheter as specified in Claim 12 wherein said reinforcement member has a 90-degree bend.

14. The catheter as specified in Claim 9 wherein said second portion has a varying resiliency proximate said first portion.

15. A method of using a catheter in a body vessel, comprising the steps of: inserting said catheter having a body into the body vessel, said catheter body having a proximal portion and a distal portion and having a first lumen extending therebetween, said catheter having an expandable balloon proximate said distal portion, said balloon having a first portion securingly attached to said catheter body and an expandable second portion, said second portion having a varying resiliency proximate said first portion; and expanding said balloon to occlude a region of the body vessel, wherein said second portion of said balloon having a higher resiliency expands less than said second portion having a lower resiliency.

16. The method of Claim 15 wherein said vessel comprises an ascending aorta, further comprising the step of disposing said balloon proximate a Brachiocephalic artery, wherein said balloon does not obstruct the Brachiocephalic artery.

17. The method of Claim 16 further comprising the step of perfusing oxygenated blood upwardly into the ascending aorta via said first lumen, wherein said expanded balloon orients said catheter distal portion such that the oxygenated blood is directed from the first lumen into the aorta substantially parallel to the length of the aorta.

18. The method of Claim 15 wherein said balloon comprises opposing end sections and a middle section, at least one said end section having a higher resiliency than said middle section, wherein said expanding step includes expanding said middle section more than said end sections.

19. The method of Claim 18 wherein said middle section is angled with respect to said catheter body.

20. The method of Claim 15 wherein said catheter distal portion extends a first predetermined distance distal of said balloon, further comprising the step of inserting said distal portion upwardly into the aorta such that said distal portion engages said vessel and curves to an orientation parallel to the length of the vessel.