WO2009035581A1 - Catheter a ballonnets intra-aortiques multiples permettant d'ameliorer la perfusion coronaire et viscerale - Google Patents

Catheter a ballonnets intra-aortiques multiples permettant d'ameliorer la perfusion coronaire et viscerale Download PDF

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Publication number
WO2009035581A1
WO2009035581A1 PCT/US2008/010519 US2008010519W WO2009035581A1 WO 2009035581 A1 WO2009035581 A1 WO 2009035581A1 US 2008010519 W US2008010519 W US 2008010519W WO 2009035581 A1 WO2009035581 A1 WO 2009035581A1
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WIPO (PCT)
Prior art keywords
balloon
abdominal
proximal
balloons
thoracic
Prior art date
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PCT/US2008/010519
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English (en)
Inventor
Ziad Anwar Ali
Ayyaz Anwar Ali
Original Assignee
Ziad Anwar Ali
Ayyaz Anwar Ali
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Application filed by Ziad Anwar Ali, Ayyaz Anwar Ali filed Critical Ziad Anwar Ali
Publication of WO2009035581A1 publication Critical patent/WO2009035581A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation

Definitions

  • This invention is in the field of devices used to augment or replace the pumping capacity or other flow capabilities of the cardiovascular system.
  • the invention is directed to an improved method and means of intra-aortic circulatory assist, and more particularly to a novel arrangement of balloons for substantially increasing blood flow to the coronary arteries and also the intra-abdominal and intra-pelvic organs.
  • This invention is in the field of devices which may be inserted using minimally invasive techniques, such as percutaneous, into the cardiovascular system to augment the pumping capabilities of the cardiovascular system.
  • a common approach to augmenting the pumping capabilities of the heart has been to provide cardiac assistance by introducing a balloon into the circulatory system, commonly the thoracic aorta, and causing the balloon to inflate during the diastolic portion of the natural cycle to increase coronary blood flow and deflate during the systolic portion of the natural cycle to augment the left ventricle's natural pumping action; known in the art as "counterpulsation”.
  • This device known in the art as an intra-aortic balloon pump (IABP) is a mechanical device that is used to decrease myocardial oxygen demand while at the same time increasing the pumping effect of the heart (increasing cardiac output). By increasing cardiac output it also increases coronary blood flow and therefore myocardial oxygen delivery.
  • the heart In the cardiovascular system, in some instances the heart is unable to maintain adequate circulation of blood. Circulatory support is required in patients with conditions such as myocardial infarction, physical trauma, cardiomyopathy, infection or any cause of cardiogenic shock (the inability of the heart to maintain perfusion, adequate flow, to organs). In addition, following cardiac surgery some patients remain hemodynamically unstable peri- operatively and require augmentation of the cardiac output. Without additional support mortality in these sets of patients is high, and as such according to the AHA/ACC 1999 guidelines IABP therapy is a class I indication for these patients.
  • CAD cardiac assist device
  • Postoperative renal dysfunction is defined as a decrease in creatinine clearance, a conventionally used marker of renal function, by 25% from baseline or a value less than 40 ml/min. It results from postoperative low circulating volume, anemia and importantly decreased renal blood flow and low cardiac output. In many of these patients such injury is mild and results in transient decrease in urine production with elevation in serum creatinine, a marker for worsening renal function, but usually followed by recovery. A subset of patients however progress to renal failure, some requiring dialysis. The mortality in these patients with renal failure ranges between 40 and 50%.
  • An intra-arterial multi-balloon balloon catheter device is provided, and methods for its use, wherein the device is capable of compartmentalizing and pressurizing the abdominal aorta, thereby augmenting abdominal and pelvic visceral perfusion.
  • the present invention is5 designed for augmenting flow to both the coronary arteries, and thus the heart, and the intra- abdominal/pelvic organs.
  • the present invention also includes a method of inserting and using the new catheter to meet these aims.
  • Apparatus embodiments of the present invention include catheter-mounted pumping balloons configured to be positioned within the cardiovascular system to propel directly blood through the cardiovascular system0 augmenting coronary, abdominal and pelvic visceral perfusion.
  • the catheter of the present invention is a multi-lumen catheter bearing a number of inflatable and deflatable balloons.
  • the balloons are mounted in tandem on the catheter shaft.
  • the present invention is designed for compatibility with existing and commercially5 available guidewires and balloon pump controller systems, with at most, minimal modification of those existing systems.
  • the mode of action of IABP catheter and controller are described in US patent 3,585,983 and herein incorporated by reference in its entirety.
  • the balloons utilized in the present invention must maintain their predetermined precise diameter and original configuration under inflation pressures without significant or0 undue stretch or deformation; (b) the material used to construct the balloon must have a high tensile strength and not rupture during repeated inflation; (c) the balloon must be inflatable and deflatable repeatedly under external control of an operator or balloon pump device, known in the art; (d) the cross-sectional profile of the balloon should be low (less than about 0.035", less than about 0.200", or less in diameter) when it is deflated with negative pressure5 so that it does not significantly increase the thickness of the catheter device; and (e) the material must be flexible as well as resilient.
  • the catheter device of the invention comprises a balloon in the proximal descending aorta, hereafter described as the distal intra-thoracic balloon, and one or more balloons in the distal aorta, iliac or femoral arteries, on a single intra-arterial catheter. Inflation of these balloons, compartmentalizes and pressurizes the abdominal aorta, augmenting abdominal and pelvic visceral perfusion.
  • the distal intra-thoracic balloon in this position is already known in the prior art and forms part of the present invention only in association with the other proximal intra-abdominal balloon or balloons forming part of the invention.
  • balloon pump controller By balloon pump controller, it is understood that an inflation device, often a microprocessor/microcontroller based system, inflates the intra-vascular balloons on a single catheter acting as an occlusive/semi-occlusive device to pressurize the vasculature between balloons.
  • balloon is used as it is known in the art, to refer to an inflatable device which can be expanded, when desired, in a lumen of a vessel or organ in the body. The device is useful to augment blood flow to abdominal and pelvic viscera.
  • an intra-aortic multi balloon catheter suitable for insertion into the human arterial tree is provided.
  • the first balloon is situated in the descending aorta below the left subclavian artery, and a second balloon is situated in the distal descending aorta, for example but not limited to below the inferior mesenteric artery, thus compartmentalizing and pressurizing the abdominal and thoracic aortic segments during inflation.
  • the first balloon is situated in the descending aorta distal to the left subclavian artery, and second and third balloons are situated in the common iliac arteries, thus compartmentalizing and pressurizing the abdominal and thoracic aortic segments.
  • the first balloon is situated in the descending aorta distal to the left subclavian artery, and second and third balloons are situated in the superficial femoral arteries, thus compartmentalizing and pressurizing the abdominal and thoracic aortic segment.
  • two pressurized compartments are created between the ascending aorta and the first balloon improving coronary perfusion, and between the first balloon and the second (or additional balloon(s)) improving abdominal and pelvic visceral perfusion.
  • a volume of blood substantially equivalent to the volume of the inflated balloons is displaced.
  • the first balloon is situated in the descending aorta distal to the left subclavian artery, a second balloon is placed in the descending aorta proximal to the superior mesenteric artery, and a third balloon is situated in the distal descending aorta below the inferior mesenteric artery, thus compartmentalizing and pressurizing the descending thoracic aortic segments and separately the abdominal aortic segment in segments.
  • the first balloon is situated in the descending aorta distal to the left subclavian artery, a second balloon is placed in the descending aorta proximal to the superior mesenteric artery, and third and fourth balloons are situated in the common iliac arteries, thus compartmentalizng and pressurizing the descending thoracic aortic segment and separately the abdominal aortic segment in segments.
  • the first balloon is situated in the descending aorta distal to the left subclavian artery, a second balloon is placed in the descending aorta proximal to the superior mesenteric artery, and third and forth balloons are situated in the superficial femoral arteries, thus compartmentalizing and pressurizing the descending thoracic aortic segment and separately the abdominal aortic segment.
  • three pressurized compartments are created between the ascending aorta and the first balloon improving coronary perfusion, between the first balloon and the second balloon improving thoracic visceral perfusion, and between the second balloon and the third (and fourth balloon) improving abdominal and pelvic visceral perfusion.
  • the device is designed, in any combination and number of balloons to augment intra abdominal/pelvic visceral perfusion.
  • the invention also provides a method for monitoring the pressure within each compartment created by balloon inflation, the method comprising the incorporation of a pressure transducer within the catheter distal to each balloon, so that the effect of compartmentalizing the aorta can be monitored.
  • Apparatus and methods for transduction of arterial pressure in relation with an IABP catheter is described in US patent 4, 733, 652 and is hereby incorporated by reference in its entirety.
  • the catheter has hollow fluid filled lumens associated with each of the pressurized compartments allowing pressure measurement from each of the separate compartments.
  • Any suitable film-forming material capable of withstanding bursting or deformation, when formed into a thin walled balloon may be used.
  • Materials commonly used in balloon construction include but are not limited to; polyurethane, polyvinylchloride, silicone, latex, nylon, polyester, polyethylene.
  • Biocompatible materials such as polyurethane have been commonly utilized for balloon construction as outlined in US patent 3,585,983 and 4,733,652 are herein incorporated by reference in their entirety.
  • the distal thoracic balloon of the invention is at least about 10 cm in length, usually about 30 cm in length, and not more than about 50 cm in length, and may be around 25 cm in length.
  • the proximal abdominal balloon when placed in the descending aorta below the inferior mesenteric artery is at least 2cm, usually 5cm and not more than about 12cm in length.
  • the proximal abdominal balloon when placed in the common iliac arteries should be at least 1cm, usually 5cm and not more than 8cm in length.
  • the proximal abdominal balloon when placed in the superficial femoral arteries should be at least 1cm, usually 5cm and not more than 8cm in length.
  • the distal thoracic balloon is inflated with at least 5cc, usually 35cc, and not more than 70cc of an inert gas, such as helium to allow compartmentalization of the proximal vascular segment (thoracic aortic segment).
  • an inert gas such as helium to allow compartmentalization of the proximal vascular segment (thoracic aortic segment).
  • the proximal abdominal balloon is inflated with at least 5cc, usually 20cc, and not more than 40cc of an inert gas, such as helium to allow compartmentalization of the distal vascular segment.
  • the balloons are inflated with liquid instead of an inert gas. In these embodiments, the balloon is inflated to fill at least 10%, usually 85%, and up to 100% of the diameter of the vascular segment.
  • the catheter size ranges from 3F-14F, and usually 9.5F.
  • the balloon is inflated during diastole and deflates in systole by a timed proprietary balloon pump controller, which may be responsive to the electrocardiogram, arterial pressure waveform, or pressure volume loop as indicators of different phases of the cycle of the heart including systole and diastole, known to those in the art.
  • Fig.1 is a longitudinal view of the catheter.
  • Fig.2 is a longitudinal close up view demonstrating contiguous tandem bonding.
  • Fig.3 is a partly cutaway cross sectional view of the distal thoracic aortic balloon portion of the catheter.
  • Fig.4 is a partly cutaway cross sectional view of the area the non balloon portion of the catheter joins the distal thoracic aortic balloon portion of the catheter.
  • Fig.5 is a partly cutaway cross sectional view of the non balloon portion of the catheter.
  • Fig.6 is a partially cutaway longitudinal close-up view of the proximal abdominal aortic balloon.
  • Fig.7 is a partly cutaway cross sectional view of the proximal abdominal balloon portion of the catheter.
  • Fig.8 is a view of the catheter placed in vivo into the aorta compartmentalizing and pressurizing the thoracic and abdominal aortic segments.
  • Fig.9 is a longitudinal view of a IAMBC of sliding design which is a variation of the IAMBC shown in Fig.1 allowing variable anatomical placement of the proximal abdominal aortic balloon via a sliding and locking mechanism.
  • Fig.10 is a partly cutaway cross sectional view of the area the non balloon portion of the sliding catheter joins the proximal abdominal balloon portion of the sliding catheter.
  • Fig.11 is a partly cutaway cross sectional view of the non balloon portion of the sliding catheter
  • the present invention is directed towards improving perfusion to abdominal/pelvic viscera in patients with hypotension secondary to low cardiac output syndrome. It utilizes on a modification of conventional IABP counterpulsation technology.
  • the conventional IABP utilizes a single balloon which is inflated with helium. This balloon lies just distal to the left subclavian artery. On inflation the balloon expands to occupy almost the entire lumen of the descending thoracic aorta.
  • the current invention utilizes a second balloon which is sited proximal to the conventional balloon in the abdominal aorta preferably just below the inferior mesenteric artery. This balloon is also inflated with helium gas and its volume when fully inflated will occupy almost the entire lumen of the abdominal aorta. This second balloon inflates synchronously, or near synchronously, and in-phase with the distal thoracic balloon.
  • the abdominal aorta and blood supply to all the major abdominal/pelvic viscera lie between the thoracic aortic balloon and abdominal aortic balloon. In this manner a visceral aortic compartment is created between the two balloons. As both balloons inflate the pressure within this compartment is augmented substantially thereby propelling blood flow to the intra-abdominal/pelvic organs.
  • the distal thoracic balloon is sited just below the left subclavian artery as in the conventional IABP. Inflation of this distal thoracic balloon augments coronary perfusion in the same manner as the conventional IABP, by retrograde flow. However in the current invention antegrade flow is directed towards the inflated intra- abdominal balloon. As blood flows antegrade the inflated intra-abdominal balloon directs blood to paths of lower resistance, namely into the arteries supplying the intra-abdominal and pelvic viscera.
  • the invention provides a means of improving both coronary and visceral perfusion in patients with hypotension and low cardiac output. This is advantageous as low cardiac output leads to failure and injury of all organs and the heart should not be addressed in isolation by counterpulsation.
  • augmentation of both coronary and visceral perfusion the incidence of ischemic coronary, renal, intestinal and hepatic injury is dramatically reduced.
  • the components of the present invention may be fabricated from conventional commercially available polymers, but may also utilize improved materials in as they become available in the future.
  • the balloon segments of the present invention may be shaped or blown using well known hot water bath, heat torch, or thermal oven methods but construction is not limited to these methods.
  • the balloon joint bonding processes that may be used include heat bonding, vulcanization bonding, solvent bonding, ultrasonic welding, laser bonding, and glue bonding but construction is not limited to these methods.
  • the intra-aortic multi-balloon catheter (IAMBC) 1 consists of a distal thoracic balloon 2 and proximal abdominal balloon 5 mounted on a catheter shaft 4.
  • Inert gases such as carbon dioxide or helium, or liquid, inflate the proximal abdominal balloon 5 and distal thoracic balloon 2 traveling through the catheter shaft 4 and the inflate/deflate tube 9 connected to the external balloon pump controller 30.
  • Fig. 2 shows a simple tandem bonding joint between two balloons.
  • the distal thoracic balloon 2 and proximal abdominal balloon 5 are provided on the catheter shaft 4. Between the balloons is a central attachment site 26 to which the proximal end of the distal thoracic balloon 2 and the distal end of the proximal abdominal balloon 5 are attached.
  • the distal thoracic balloon 2 and proximal abdominal balloon 5 are made from a single, continuous piece of balloon material. When the balloons 2, and 5 are blown from this single piece of material, and are shaped to have the desired diameters, a narrow waist 27 is formed in the balloon material having a lesser diameter than either of the balloons 2, 5.
  • This narrow waist 27 is bonded to the catheter shaft 4 at the central attachment site 26.
  • This construction is referred to as contiguous tandem construction because the balloons 2, 5 are formed from a single, continuous piece of balloon material and they are mounted in tandem on the catheter shaft. In another embodiment the balloons 2, 5 are formed of separate pieces of balloon material and mounted on the catheter shaft 4 in tandem, one next to the other. This is referred to herein as separate tandem bonding.
  • Fig. 3 is a partly cutaway cross sectional view corresponding to dashed line 1-1 in Fig.1 of the balloon portion of the catheter (more generally depicted as distal thoracic balloon 2 in Fig. 1) showing that the distal thoracic balloon 2 consists of an outer membrane 10, a gas filled cavity of the balloon 11, and an inner liquid containing lumen 12 within a semicircular liquid containing tube 38, which optionally contains a guidewire 13.
  • the gas containing lumen 14 (shown in Fig. 4) is not present as it has terminated in the area where the non-balloon portion of the catheter joins the balloon portion of the catheter.
  • Fig. 4 is a partly cutaway cross sectional view of the area where the non-balloon portion of the catheter joins the balloon portion of the catheter (more generally depicted as the area the non-balloon portion of the catheter joins the balloon portion of the catheter depicted as 2-2 in Fig. 1) showing the outer membrane 10, the gas filled cavity of the balloon 11 and the gas containing lumen 14 within a semi-circular gas containing tube 39, the liquid containing lumen 12 within a semi-circular liquid containing tube 38, which may or may not contain a guidewire 13 within the central catheter shaft 4.
  • Fig. 4 is a partly cutaway cross sectional view of the area where the non-balloon portion of the catheter joins the balloon portion of the catheter (more generally depicted as the area the non-balloon portion of the catheter joins the balloon portion of the catheter depicted as 2-2 in Fig. 1) showing the outer membrane 10, the gas filled cavity of the balloon 11 and the gas containing lumen 14 within a semi-circular gas containing tube 39
  • FIG. 5 is a partly cutaway cross sectional view of the non-balloon portion of the catheter (more generally depicted as the non-balloon portion of the catheter shaft 4 depicted as 3-3 in Fig. 1) showing the gas containing lumen 14 within a semi-circular gas containing tube 39, the liquid containing lumen 12 within a semi-circular liquid containing tube 38, which may or may not contain a guidewire 13 within the central catheter shaft 4.
  • Fig.6 is a close up of the proximal abdominal balloon 5 showing the catheter shaft 4 ending at the proximal segment of proximal abdominal balloon 5.
  • the gas containing lumen 14 within the semi-circular gas containing tube 39 and the liquid containing lumen 12 within a semi-circular liquid containing tube 38 pass through the proximal abdominal balloon 5 centrally without coverage from the catheter shaft 4.
  • the semi-circular gas containing tube 39 has numerous perforations or apertures 28 allowing passage of gas to and from the gas filled cavity of the balloon 11.
  • the outer membrane 10 is bonded to the catheter shaft 4 at the proximal and distal ends of the proximal abdominal balloon 5.
  • the semi-circular gas containing tube 39 and the semi-circular liquid containing tube 38 are bonded at the midpoint of the proximal abdominal balloon 5 by a radio-opaque marker 29. These radio-opaque markers, made of metal or other radio-opaque material, are preferentially located at the distal and proximal tip of each balloon such that the exact placement of the balloons may be identified by imaging modalities.
  • Fig. 7 is a partly cutaway cross sectional view of the proximal abdominal balloon 5 (more generally depicted as proximal abdominal balloon 5 depicted as 4-4 in Fig. 1) showing the outer membrane 10, the gas filled cavity of the balloon 11 and the semi-circular gas containing tube 39 with perforations or apertures 28 to allow passage of gas/liquid, and the liquid containing lumen 12 within a semi-circular liquid containing tube 38, which may or may not contain a guidewire 13 within the central catheter shaft 4.
  • Fig. 8 is a view of the arterial vascular tree showing the IAMBC 1 , connected to the balloon pump controller 30, inserted into the femoral artery 16 with the proximal intraabdominal balloon 5 sited just below the inferior mesenteric artery 25 and the distal thoracic balloon 2 compartmentalizing the abdominal aortic segment 21 designed to augment perfusion to the celiac artery 22, renal arteries 23 and superior mesenteric artery 24. Also the distal thoracic balloon 2 sited just below the left subclavian artery 19 compartmentalizes the thoracic aortic segment 17 of the aorta 18 augmenting perfusion to the coronary arteries 20.
  • Fig. 8 is a view of the arterial vascular tree showing the IAMBC 1 , connected to the balloon pump controller 30, inserted into the femoral artery 16 with the proximal intraabdominal balloon 5 sited just below the inferior mesenteric artery 25 and the distal thoracic balloon 2 compartmentalizing
  • FIG. 9 illustrates a longitudinal view of an intra-aortic multi-balloon catheter of sliding design indicated generally by the reference numeral 35 in Fig. 9.
  • the intra-aortic multi- balloon catheter (IAMBC) of sliding design 35 consists of a distal thoracic balloon 2 mounted on a catheter shaft 4.
  • the sliding proximal abdominal balloon 5 is mounted proximally to a separate sliding catheter 31 and distally to a separate sliding circular tube 32.
  • Inert gases such as carbon dioxide or helium, or liquid, inflate the proximal abdominal balloon 5 traveling through the sliding catheter 31 and the separate inflate/deflate tube 33 connected to the external balloon pump controller 30.
  • the sliding proximal abdominal balloon 5 slides through the sliding balloon port 37, which has a locking device, not shown but well known in the art, to stabilize the balloon once it is in the desired position.
  • Fig. 10 is a partly cutaway cross sectional view corresponding to dashed line 5-5 in
  • Fig.9 of the balloon portion of the intra-aortic multi-balloon catheter of sliding design 35 showing that the proximal abdominal balloon 5 when of sliding design consists of an outer gas containing membrane 10, which surrounds a gas filled cavity.
  • a sliding circular tube 32 is designed to slide over the fixed catheter shaft 4 which allows for the sliding mechanism of the proximal abdominal balloon 5. By exploiting the sliding mechanism of proximal abdominal balloon 5 it can be advanced to within a variable distance of the distal thoracic balloon 2 located at the end of the catheter shaft 4.
  • the sliding circular tube 32 contains a liquid containing channel 40 which will communicate with arterial blood within the lumen of the aorta in the abdominal aortic segment 21 (Fig. 8).
  • the catheter shaft 4 of the distal aortic balloon is comprised of the gas containing lumen 14 within a semi-circular gas containing tube 39, the liquid containing lumen 12 within a semi-circular liquid containing tube 38.
  • the gas containing lumen 36 (shown in Fig. 11) within the sliding catheter 31 is not present as it has terminated in the area where the non balloon portion of the catheter joins the balloon portion of the catheter in the intra-aortic multi-balloon catheter of sliding design 35.
  • Fig. 11 is a partly cutaway cross sectional view corresponding to dashed line 6-6 in Fig.9 of the non balloon portion of the intra-aortic multi-balloon catheter of sliding design 35 showing (from the outside in), sliding catheter 31 , gas containing lumen 36, sliding circular tube 32, liquid containing channel 40, over fixed catheter shaft 4.
  • the sliding circular tube 32 is designed to slide over fixed catheter shaft 4.
  • Fig 1-11 Prior to insertion of the IAMBC 1 , the semi-circular liquid containing tube 38 of the catheter shaft 4 is flushed with heparinized saline through the Y-fitting 8 (Figs.1 , 9).
  • the inflate/deflate tube 9 is connected to the balloon pump controller 30.
  • a needle is advanced into the femoral artery 16, and a guidewire 13 advanced through the needle into the lumen of the artery.
  • This method of percutaneous insertion of intra-aortic balloon catheter via the Seldinger technique is outlined in US patent 4,733,652, herein specifically incorporated by reference.
  • the IAMBC 1 is placed into the lumen of the femoral artery 16 by advancing the semi-circular liquid containing tube 38 over the guidewire 13 according to the Seldinger technique.
  • the IAMBC 1 is advanced into the aorta 17 until the distal thoracic balloon 2 is just distal to the left subclavian artery 19 according to radio-opaque markers 29, present in the distal thoracic balloon 2 and the proximal abdominal balloon 5, which may be visualized easily by x-ray.
  • a sheath apparatus 6 is advanced over the redundant portion of the catheter that remains outside of the patient for purposes of sterility.
  • the catheter may be fixed to the skin a suture at suture site 7.
  • the proximal balloon 5 sits beneath the inferior mesenteric artery 25.
  • the guidewire 13 is removed from the semi-circular liquid containing tube 38 through the Y-fitting 8.
  • the Y fitting 8 is then connected to a three-way tap allowing injection of fluid and withdrawal of blood through the semi-circular liquid containing tube 38, which may also be used for pressure transduction.
  • the balloon pump controller 30, is activated such that the unit alternates inflation of the balloon during diastole (the relaxation period of the heart) with rapid deflation just before systole (the ejection period of the heart) in a manner well known in the art.
  • the proximal abdominal balloon 5 is inflated displacing blood retrograde towards the distal thoracic balloon 2 and antegrade into the lower limbs.
  • the distal thoracic balloon 2 inflates displacing blood retrograde to the coronary arteries 20, thus pressurizing the thoracic aortic segment 18 and improving coronary perfusion.
  • the distal thoracic balloon 2 inflates blood is displaced antegrade towards the inflated proximal abdominal balloon 5, thus pressurizing the abdominal aortic compartment 21.
  • Blood therefore takes the path of least resistance improving perfusion via the celiac artery 22, renal arteries 23, superior mesenteric artery 24, and inferior mesenteric artery 25 to the abdominal and pelvic viscera.
  • the distal thoracic balloon 2 is at least about 10 cm in length, usually at least about 30 cm in length, and not more than about 50 cm in length, and may be around about 25 cm in length.
  • the proximal balloon when placed in the descending aorta below the inferior mesenteric artery is at least 2cm, usually 5cm and not more than 10cm in length.
  • the distal thoracic balloon 2 and proximal abdominal balloon 5 are inflated to fill at least 10%, usually 85%, and up to 100% of the diameter of the vascular segment.
  • the proximal abdominal balloon 5 may be of a sliding design such that it may be preferentially placed throughout the aorta at a desired distance from the distal thoracic balloon 2, as shown in Figs 9-11.
  • the distal thoracic balloon 2 is mounted on the catheter shaft 4 as described above.
  • the proximal abdominal balloon 5 is bonded proximally to a separate sliding catheter 31 and distally to a separate sliding circular tube 32.
  • the sliding catheter 31 has a separate inflate/deflate tube 33, similar to the inflate/deflate tube 9 of the fixed catheter shaft 4.
  • the sliding catheter 31 has a separate Y- fitting 34, similar to the Y-fitting 8 of the fixed catheter shaft 4.
  • the inflate/deflate tube 33 of the sliding catheter 31 and the inflate/deflate tube 9 of the fixed catheter may be inflated and deflated separately (synchronously) through separate balloon pump controllers 30.
  • the inflate/deflate tube 33 of the sliding catheter 31 and the inflate/deflate tube 9 of the fixed catheter may be inflated and deflated in sequence through a single balloon pump controller modified to be able to provide synchronous inflation/deflation.
  • the inflate/deflate tube 33 of the sliding catheter 31 and the inflate/deflate tube 9 of the fixed catheter shaft 4 may be inflated and deflated simultaneously by connecting them to a Y- connector, not shown but well known in the art, through a single balloon pump controller or by connecting each inflate/deflate tube separately to separate controllers.
  • the invention may be modified replacing the proximal abdominal balloon 5 with an occlusive device achieving the same goal of pressurizing the thoracic aortic component 18 and abdominal aortic compartment 21 increasing perfusion to the coronary arteries and visceral abdominal/pelvic organs.
  • the invention may be modified replacing the proximal abdominal balloon 5 with multiple balloons achieving the same goal of pressurizing the thoracic aortic component 18 and abdominal aortic compartment 21 increasing perfusion to the coronary arteries and visceral abdominal/pelvic organs.
  • the catheter shaft may be constructed in any desired way to provide the requisite number of lumens terminating inside the desired balloons.
  • the actual number and size of the balloons in the form of the invention shown in Fig.1 may be varied as described above so as to meet the aims of the invention, to augment flow to the intra-abdominal and pelvic organs by intra-aortic circulatory assist.

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Abstract

L'invention concerne un cathéter à ballonnets intra-aortiques multiples servant à cloisonner et pressuriser l'aorte thoracique proximale pour améliorer la perfusion coronaire, et à cloisonner et pressuriser l'aorte abdominale pour améliorer la perfusion viscérale abdominale, par gonflement pendant la diastole et dégonflement pendant la systole. Le cathéter selon l'invention permet d'améliorer la fonction cardiaque en plus de protéger les organes abdominaux/pelviens principaux, tels que le foie, les reins et les intestins, contre les lésions causées par un faible débit cardiaque, l'instabilité hémodynamique et le choc.
PCT/US2008/010519 2007-09-10 2008-09-08 Catheter a ballonnets intra-aortiques multiples permettant d'ameliorer la perfusion coronaire et viscerale WO2009035581A1 (fr)

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US60/993,001 2007-09-10

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CN106924862A (zh) * 2017-03-29 2017-07-07 南方医科大学南方医院 主动脉腔内双水平球囊阻断加压输注系统
CN110353752A (zh) * 2019-06-28 2019-10-22 北京康瑞迪医疗科技有限公司 心脏冠状静脉血流阻断装置
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
WO2021137739A1 (fr) 2019-12-31 2021-07-08 Obshchestvo S Ogranichennoj Otvetstvennost'yu «Pandeks» Cathéter et procédé pour isoler une région dans un organe creux d'un mammifère, système à cathéter et utilisation du cathéter
US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
WO2023075634A1 (fr) 2021-11-01 2023-05-04 Pandx Ltd Cathéter de type stent pour isoler une région dans un organe creux d'un mammifère, et système basé sur le cathéter
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
WO2024033700A1 (fr) 2022-08-12 2024-02-15 Pandica Ltd Utilisation d'un cathéter pour isoler une région dans un organe creux d'un mammifère (variantes)
EP4327857A1 (fr) * 2022-08-23 2024-02-28 Fuwai Hospital of Chinese Academy of Medical Sciences Dispositif intra-aortique à double cathéter de pompe d'entraînement à ballonnet
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use

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US20040064091A1 (en) * 1999-01-11 2004-04-01 Gad Keren Apparatus and methods for treating congestive heart disease

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106924862A (zh) * 2017-03-29 2017-07-07 南方医科大学南方医院 主动脉腔内双水平球囊阻断加压输注系统
US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11717670B2 (en) 2017-06-07 2023-08-08 Shifamed Holdings, LLP Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11229784B2 (en) 2018-02-01 2022-01-25 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
CN110353752A (zh) * 2019-06-28 2019-10-22 北京康瑞迪医疗科技有限公司 心脏冠状静脉血流阻断装置
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
WO2021137739A1 (fr) 2019-12-31 2021-07-08 Obshchestvo S Ogranichennoj Otvetstvennost'yu «Pandeks» Cathéter et procédé pour isoler une région dans un organe creux d'un mammifère, système à cathéter et utilisation du cathéter
WO2023075634A1 (fr) 2021-11-01 2023-05-04 Pandx Ltd Cathéter de type stent pour isoler une région dans un organe creux d'un mammifère, et système basé sur le cathéter
WO2024033700A1 (fr) 2022-08-12 2024-02-15 Pandica Ltd Utilisation d'un cathéter pour isoler une région dans un organe creux d'un mammifère (variantes)
EP4327857A1 (fr) * 2022-08-23 2024-02-28 Fuwai Hospital of Chinese Academy of Medical Sciences Dispositif intra-aortique à double cathéter de pompe d'entraînement à ballonnet

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