US20020128598A1 - Blood vessel occlusion device - Google Patents

Blood vessel occlusion device Download PDF

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Publication number
US20020128598A1
US20020128598A1 US09/845,624 US84562401A US2002128598A1 US 20020128598 A1 US20020128598 A1 US 20020128598A1 US 84562401 A US84562401 A US 84562401A US 2002128598 A1 US2002128598 A1 US 2002128598A1
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Prior art keywords
balloon member
balloon
blood vessel
aorta
blood
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US09/845,624
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Anthony Nobles
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Priority to US09/845,624 priority Critical patent/US20020128598A1/en
Priority to US10/237,569 priority patent/US20050203564A1/en
Publication of US20020128598A1 publication Critical patent/US20020128598A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons

Definitions

  • the present invention relates generally to occlusion devices and methods of use thereof. More specifically, the present invention relates to balloon occlusion devices for performing cardiac bypass or other vascular procedures.
  • Coronary artery diseases are often caused by atherosclerosis or narrowing of the small arteries between the aorta and the heart muscles.
  • There are several ways to provide blood flow around occluded segments of arteries or veins however, the known methods commonly cause a large amount of trauma to the patient.
  • One method is to perform an “open heart surgery,” which involves cracking open the chest and exposing the heart and treating the vessel directly.
  • the large incision and surgically cut sternum take a long time to heal.
  • a section of the saphenous vein, or a suitable substitute is grafted, usually between the ascending aorta just above the heart and one or more of the coronary arteries beyond the points of blockage.
  • the bypass operation is performed with the patient connected to a heart-lung machine and the heart is stopped. Because the heart is stopped, the heart-lung bypass can damage blood cells. Additionally, the patient's internal body temperature is reduced while on a heart-lung bypass to reduce basil metabolism and then the body temperature is increased to normal when the procedure is over. This thermal change to a person's body can cause damage to the intestinal track as well as causing additional stress to the patient.
  • the aorta is typically partially clamped along its axis to create an area of blood stasis and a small channel for blood flow.
  • clamping the aorta can cause injury to the aorta and can also cause plaque formations to break off into the blood stream and cause severe disorders such as strokes and emboli.
  • occlusion balloons are inserted through the femoral artery up to the blood vessel to be occluded. Both clamps and existing occlusion devices commonly cause damage to the internal blood vessel walls and the introduce plaque into the patient's blood stream. Existing balloons are also likely to move longitudinally along the catheter while in the blood vessel, and thus are likely to move into the heart or interfere with blood flow.
  • the present invention relates to a direct-access device with a balloon for occluding blood vessels, and methods of use thereof.
  • the invention also relates generally to the design and manufacturing of this occlusion device.
  • the occlusion device is ideally suited for occluding a patient's aorta during stopped-heart cardiac procedures.
  • a preferred embodiment of the present device comprises a flexible balloon member which is attached to the exterior of a tubular member to form an inflatable balloon.
  • the tubular member includes an inflation lumen which can be used to inflate and deflate the thin-profile balloon. Together, the balloon member and tubular member occlude a blood vessel.
  • the balloon member is preferably attached near the distal end of the tubular member. The width of the outer peripheral contact area of the balloon member, which comes in contact with the inner wall of the blood vessel, is substantially narrower than the balloon member's diameter. The contact area between the balloon member and the inner blood vessel wall is thus reduced over prior designs.
  • the balloon member is preferably made of a low compliance material, which limits the expansion of the balloon member to expanding 1% to 40% radially and 1 % to 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape.
  • the low compliance material limits the expansion of the balloon member to expanding 10% to 33% radially and 10% to 40% longitudinally.
  • the low compliance material comprises polyurethane.
  • the tubular member preferably comprises a blood flow lumen which carries blood between the patient and an external medical device, such as a heart-lung machine.
  • the tubular member preferably has other lumens to measure blood pressure and introduce a cardioplegia solution and/or drugs.
  • the tubular member is bent near the distal end to allow the balloon member to conveniently be directly introduced into and positioned within the blood vessel.
  • the inflated balloon member has a thin profile at its periphery.
  • the balloon member produces a longitudinal contact distance which is less than 50% of (and preferably 20-30% of) the inner diameter of the blood vessel.
  • the thin-profile balloon member contacts only a narrow segment of the blood vessel when the balloon member is inflated. Because the surface area of contact is reduced, the potential damage to the blood vessel commonly caused by such contact is also reduced.
  • Another benefit of using a thin-profile balloon member is that the balloon member is less likely to move longitudinally along the catheter while in the blood vessel, and thus less likely to move into the heart or interfere with the device's blood flow port.
  • the present device can be used to occlude the aorta without the need clamps, and thus reduces the likelihood of plaque being introduced into the blood stream.
  • the limited compliance of the balloon member reduces longitudinal stretching and maintains a small peripheral surface area which comes in contact with the internal blood vessel wall. This prevents the balloon member from blocking the distal end of the tubular member or the opening of a branching blood vessel, such as the innominate artery.
  • the limited compliance also limits radial stretching, and thus reduces potential damage to the blood vessel wall.
  • the limited compliance reduces the likelihood of dissections and breakoffs of the inflatable balloon member, and reduces the risk of the balloon bursting.
  • the balloon is inserted in the aorta
  • another advantage of the thin-profile of the balloon is that it allows the physician to move the balloon closer to the innominate artery (brachiocephalic artery). This creates more working space in the aorta for anastomosis.
  • the balloon member comprises at least one pair of internal ribs which support the structure of the balloon member (maintain its thin profile) and prevent the balloon member from expanding by more than 1% to 50% after the balloon member is initially inflated.
  • the internal ribs limit the longitudinal expansion of the balloon member even further than the limited compliance material. These internal ribs interconnect the proximal and distal walls of the balloon member. In one configuration of balloon member, the ribs overlap one another and are bonded together.
  • the balloon member with internal ribs may be formed by dipping a mandrel, with grooves or channels formed therein, a number of times into liquid polyethylene, polyurethane or other material with similar properties.
  • the internal ribs feature may be used to limit or control the expansion of other types of occlusion balloons, such as angioplasty balloons.
  • the balloon member comprises at least one indent or bump along the peripheral edge of the balloon member. These indents or bumps help to maintain the position of the balloon member within the blood vessel, prevent the balloon member from slipping, and reduce the contact area between the balloon and the internal wall of the blood vessel.
  • FIG. 1 is a perspective view of a direct-access blood vessel occlusion device in accordance with the invention, with the balloon of the device shown in an inflated state.
  • FIG. 2 is a partially cut-away perspective view of the occlusion device of FIG. 1.
  • FIG. 3 is a side view of the occlusion device, with three of the device's five lumens shown in dashed lines.
  • FIG. 4 is a top view of the occlusion device taken from the line 4 - 4 of FIG. 3, with three lumens shown in dashed lines.
  • FIG. 5 illustrates the use of the occlusion device to occlude the aorta of a patient, and illustrates one type of connector that may be provided at the proximal end of the device.
  • FIG. 6 illustrates how two of the occlusion devices may be used to achieve a state of cardiopulmonary bypass.
  • FIG. 7 is a perspective view of a mandrel that may be used to form the flexible balloon member of the occlusion device.
  • FIG. 8 is a partially cut-away perspective view of an alternative embodiment of the occlusion device, wherein internal ribs are provided within the balloon member to limit the longitudinal expansion of the balloon.
  • FIG. 9 is a perspective view of a mandrel which may be used to form a balloon member of the type shown in FIG. 8.
  • FIG. 10 is a cross sectional view taken along the line 10 - 10 of FIG. 9.
  • FIG. 11 is a perspective view of another type of mandrel which may be used to generate balloon members of the type shown in FIG. 8.
  • FIG. 12 is a cross sectional view taken along the line 12 - 12 of FIG. 11.
  • FIGS. 13A and 13B are cross sectional side views of other configurations of the balloon member.
  • the present invention provides a direct-access blood vessel occlusion device 30 ideally suited for use during a stopped-heart cardiac procedure.
  • the device 30 comprises a flexible balloon member 32 which is attached to the outer surface of a multi-lumen tube 34 to form a balloon 36 .
  • the balloon 36 may be inflated and deflated using an inflation lumen 40 which extends axially from a proximal end 44 of the tube to port 40 ′ within the interior of the balloon 36 .
  • a main lumen 46 extends axially through the center of the tube 34 and is used to carry blood between the patient's circulatory system and a heart-lung machine (not shown).
  • a bend (preferably ninety degrees) is formed in the multi-lumen tube 34 proximal to the balloon 36 to allow the balloon 36 to easily be directly introduced into, and positioning within, the blood vessel to be occluded.
  • the multi-lumen tube 34 is straight without a bend.
  • FIG. 6 illustrates how two such devices may be used to achieve cardiopulmonary bypass, such as during an aortocoronary bypass procedure.
  • the first device 30 a is used to occlude and draw blood from the patient's superior vena cava 50 .
  • a conventional non-occluding canula may alternatively be used for this purpose, in which case cardiopulmonary bypass is achieved without occluding the vena cava 50 .
  • the blood that is withdrawn using the first device 30 a is passed through a heart-lung machine (not shown) for re-oxygenation.
  • the second device 30 b is used to occlude, and to reintroduce oxygenated blood into, the patient's aorta 54 .
  • the procedure by which the devices 30 a, 30 b are introduced into the blood vessels and used to achieve cardiopulmonary bypass is described below.
  • the inflated balloon 36 has a thin profile at its periphery, and thus contacts only a narrow segment of the blood vessel (vena cava or aorta) when the balloon is inflated.
  • existing balloon occlusion devices commonly produce a longitudinal contact distance (the longitudinal distance over which the inflated balloon contacts the inner wall of the blood vessel) which exceeds the inner diameter of the blood vessel.
  • the device 30 described herein produces a longitudinal contact distance which is less than 50% (and preferably 20-30%) of the inner diameter of the blood vessel. Because the area of contact is reduced, the potential damage commonly caused by such contact is also reduced.
  • the balloon member 32 is preferably substantially disk-shaped as shown in FIGS. 1 and 2.
  • the shape of the balloon member 32 may resemble a spinning top.
  • the shape of the balloon member 32 may be designed in various configurations, but the width of the outer peripheral contact area, which contacts the inner wall of the blood vessel, remains less than 50% (and preferably 20-30%) of the inner diameter of the blood vessel.
  • Another benefit of using a thin-profile balloon is that the balloon is less likely to move longitudinally along the tube 34 (or catheter) while in the blood vessel, and thus less likely to move into the heart or interfere with the device's blood flow port.
  • the balloon 36 B is inserted in the aorta 54 , another advantage is the thin-profile of the balloon 36 B allows the physician to move the balloon 36 B closer to the innominate artery (brachiocephalic artery) 120 , and thus create more working space (labelled ‘W’ in FIG. 5) in the aorta 54 for anastomosis. This is shown in FIG. 5.
  • a longer segment of tube is provided distal to the bend, and two balloons 36 (both of the same general construction as in the single-balloon configuration) are spaced apart from one another along this tube segment.
  • the two balloons are preferably fluidly coupled to a common inflation lumen of the tube 34 .
  • the spacing between the two balloons is sufficient to form a working area for performing an anastomosis between the two inflated balloons.
  • the use of two balloons in this manner prevents blood from flowing in the region of the anastomosis site during the anastomosis procedure, as described generally in U.S. provisional application No. 60/046,977 filed May 19, 1997.
  • the multi-lumen tube 34 includes the blood flow lumen 46 , the inflation lumen 40 , a proximal blood pressure lumen 60 , a distal blood pressure lumen 62 , and a cardioplegia lumen 64 .
  • Each lumen extends axially from the proximal end 44 of the tube 34 .
  • the blood flow lumen 46 and the distal blood pressure lumen 62 extend to the tapered, distal end 70 of the tube 34 .
  • the proximal blood pressure lumen 60 and the cardioplegia lumen 64 extend to respective openings 60 ′, 64 ′ in the outer surface of the tube 34 proximal to the balloon 36 .
  • the inflation lumen 40 extends to an opening 40 ′ which coincides in position with the interior of the balloon 36 .
  • a standard barbed fitting 76 is provided at the proximal end of the multi-lumen tube 34 to enable other tubes and connectors to be fluidly coupled to each of the five lumens.
  • the proximal end 44 of the multi-lumen tube 34 is in the form of a female connector.
  • the female connector enables the device 30 to be coupled to the heart-lung machine, pressure sensors, and injection valves via a single connection.
  • the device 30 is instead provided with a standard barbed connector 76 for coupling the blood-flow lumen 46 to the heart-lung machine, and is provided with four standard valved luer fittings 78 for providing access to the smaller lumens 40 , 46 , 62 , 64 . Any of a variety of other types of connectors can be used.
  • the inflation lumen 40 may serve an additional purpose: to prevent over-inflation of the occlusion balloon 36 .
  • the proximal end of the inflation lumen 40 is attached to a flexible tube 118 , as shown in FIG. 5.
  • the proximal end of the flexible tube 118 is attached to an over-inflation balloon (not shown).
  • the over-inflation balloon is attached to a luer connector, which is attached to a luer fitting.
  • a one-way, syringe-activated valve is built inside the luer connector.
  • the over-inflation balloon provides a space for sliding the distal part of the valve.
  • the over-inflation balloon is a ‘Pilot’ balloon made by Mallinckrodt Medical, Inc.
  • the occlusion balloon 36 begins to inflate, there is no resistance on the balloon 36 as it expands, and there is no back pressure in the inflation lumen 40 . But when the occlusion balloon 36 comes in contact with the inner walls of the blood vessel, the walls of the blood vessel create resistance on the expanding balloon 36 . This creates back pressure in the inflation lumen 40 , and the over-inflation check balloon begins to inflate or bulge. This provides a direct signal to the physician that the inflated occlusion balloon 36 has contacted the internal walls of the blood vessel.
  • the threshold pressure level needed to inflate the over-inflation balloon may also be produced by attempts to inflate the balloon 36 beyond its maximum diameter, even though the balloon 36 may not be in contact with the vessel walls.
  • some other pressure indicating device such as a pressure meter, may be used to indicate that the desired pressure level has been reached within the occlusion balloon 36 .
  • This pressure indicating device is fluidly coupled to the occlusion balloon 36 .
  • the over-inflation check balloon or other pressure indicating device is coupled to separate lumen (not shown) which runs parallel with the inflation lumen 40 along the tubular member 34 and extends to an opening which coincides in position with the interior of the balloon 36 , similar to the opening 40 ′.
  • the thin-profile balloon member 32 is preferably formed from a limited compliance material, such as polyethylene, polyurethane, other polymers or any other material with similar properties.
  • the balloon member 32 may comprise a mixture of materials.
  • the material of the balloon member 32 is not fully compliant, like silicone or latex.
  • the compliance of the material is preferably selected such that the balloon may stretch from 1% to 40% radially and from 1% to 50% longitudinally after it is initially inflated under ambient pressure to its normal, unstretched shape.
  • the low compliance material limits the expansion of the balloon member to expanding 10% to 33% radially and 10% to 40% longitudinally. During such expansion, the balloon 32 does not lose its overall shape.
  • the width L (FIG.
  • the balloon member 32 preferably never expands to be more than 50% (and preferably 20-30%) of the length of its diameter D.
  • the use of a limited compliance material for this purpose reduces longitudinal stretching, and thus maintains a small peripheral surface area which contacts the internal wall of the blood vessel.
  • the limited compliance also prevents the balloon member 32 from blocking the distal tip of the tube 34 or blocking the opening of a branching blood vessel, such as the innominate artery.
  • the limited compliance also reduces the likelihood of dissections and breakoffs of the inflatable balloon 32 .
  • the limited compliance material also reduces the risk of the balloon bursting, which is common for silicone or latex balloons.
  • the balloon member 32 is made of a sufficiently thick material to be resistant to calcified lesions on the inner wall of the blood vessel.
  • the diameter D of the balloon 36 is approximately three to five times the peripheral length or thickness L of the balloon.
  • the diameter D of the inflated balloon 36 is preferably at least twice the diameter of the tube 34 .
  • the angle A of the balloon is approximately 40 degrees.
  • the multi-lumen tube 34 is preferably formed of a semi-rigid, translucent material using a conventional extrusion process. Polyethylene may be used for this purpose, in which case the balloon member 32 may be bonded to the exterior of the tube 34 using a solvent bonding process.
  • a ninety degree bend 74 is formed in the tube 34 proximal to the balloon 36 . As depicted by FIG. 4, the curvature and position of this bend 74 are such that the straight, proximal portion of the tube 34 is perpendicular to the blood vessel 54 when the balloon 36 is properly oriented within the blood vessel.
  • the bend 74 is preferably formed within the tubing 34 using a heat mandrel which is inserted within the blood flow lumen 46 .
  • the multilumen tube 34 is straight without a bend.
  • the physician performs a thoracotomy, sternotomy or other procedure to obtain access to the patient's vena cava 50 and aorta 54 .
  • the physician selects devices 30 a, 30 b having balloons 36 A, 36 B which correspond in diameter to the vena cava 50 and the aorta 54 (respectively) of the particular patient, and fluidly couples these devices 30 a, 30 b to the heart-lung machine and the various instruments to be used during the procedure.
  • Incisions are then made in the vena cava 50 and the ascending aorta 54 , and the distal ends of the devices 30 a, 30 b are advanced into the respective blood vessels to position the balloons.
  • the balloons are maintained in an uninflated, collapsed state during the insertion process.
  • the heart-lung machine is activated such that blood is withdrawn from the vena cava 50 and perfused into the aorta 54 .
  • Each balloon 36 a, 36 b is then inflated by introducing an appropriate substance into the interior thereof via the respective inflation lumen 40 (FIGS. 3 and 4).
  • the balloons 36 a, 36 b are preferably inflated with saline solution or any other suitable fluid. Locking syringes or syringes coupled to one-way valves may be used to inflate the balloons 36 a, 36 b.
  • the balloons 36 a, 36 b expand in diameter by about 1% to 40% (preferably 10% to 33%) from their initial inflated state during the inflation process. As illustrated by FIG. 5 for the aorta 54 , the balloons 36 a, 36 b press outward against the inner walls of their respective blood vessels 50 , 54 by a sufficient degree to cause the blood vessel walls to bulge outward slightly. Such bulging helps to maintain the inflated balloons in position.
  • a cardioplegia solution is introduced into the heart to stop the heart from beating.
  • the cardioplegia solution is preferably introduced via the cardioplegia lumen 64 (FIG. 3) of the aortic occlusion device 30 b, although the cardioplegia lumen of the vena cava occlusion device 30 a may additionally be used for this purpose.
  • the proximal and distal pressure lumens 60 , 62 may be used to monitor the pressure on the proximal and distal sides of the inflated balloons 36 a, 36 b.
  • These lumens 60 , 62 may additionally or alternatively be used for other purposes, such as to introduce drugs into the heart and/or the circulatory system.
  • FIG. 7 illustrates a mandrel 90 which may be used to manufacture the thin-profile balloon members 32 .
  • the mandrel is preferably composed of 304 (or higher) stainless steel which is electropolished after machining.
  • the diameter of the mandrel ranges from 1.0 to 1.5 cm in embodiments that are used for aortic occlusion. In one preferred embodiment, the diameter is equal to 1.102 cm, and in another preferred embodiment, the diameter is equal to 1.416 cm.
  • the balloon member 32 is subsequently removed from the mandrel, and the tubular segments (not shown) which extend away from balloon portion in opposite directions are trimmed away. An appropriate powder may be applied to the balloon material to prevent the balloon walls from sticking together. Finally, the balloon member 32 is positioned over and bonded to the multi-lumen tube 34 .
  • the balloon member 32 may be provided with pairs of internal ribs 94 (one pair visible in FIG. 8) that interconnect the proximal and distal walls of the balloon.
  • the use of such ribs 94 impedes the longitudinal expansion of the balloon 36 during inflation, and thus helps to maintain the thin profile of the balloon 36 .
  • the internal ribs limit the longitudinal expansion of the balloon 36 even further than the limited compliance material. For example, if the limited compliance material prevents the balloon 36 from expanding longitudinally by more than 50%, the internal ribs may further limit longitudinal expansion up to only 10%.
  • the two ribs 94 that are visible overlap one another and are bonded together. At least three pairs of attached ribs of the type shown in FIG. 8 are preferably provided within the balloon member 32 , with the pairs spaced at equal angular intervals.
  • the internal ribs feature may be used to limit or control the expansion of other types of occlusion balloons, such as angioplasty balloons.
  • FIGS. 9 and 10 illustrate one embodiment of a mandrel 90 ′ that can be used to form a balloon member 32 of the type shown in FIG. 8.
  • Each face of the mandrel (only one face visible in FIG. 9) has eight grooves or channels 96 formed therein to form eight pairs of ribs. These channels 96 become filled during the dipping process to form the ribs.
  • each pair of ribs 94 is formed using a pair of overlapping channels 96 that are angularly offset from one another.
  • the corresponding ribs 94 are manually glued together.
  • a mandrel that produces non-overlapping ribs can alternatively be used, in which case the proximal and distal walls of the balloon member 32 are squeezed towards one another during the gluing process to cause the ribs to overlap.
  • FIGS. 11 and 12 illustrate an alternative mandrel configuration which can be used to form the ribbed balloon member 32 .
  • the channels of the mandrel 90 ′ of FIGS. 9 and 10 are replaced with corresponding protrusions 98 which extend longitudinally outward from each face of the mandrel 90 ′′.
  • the mandrel 90 ′′ is initially dipped in a liquid polyethylene, polyurethane or other solution to form a balloon member 32 having ribs which extend outward from the outer surface of the balloon member.
  • This balloon member is then inverted (turned inside out) so that these ribs reside within the balloon member.
  • the corresponding ribs are then glued together, and the inverted balloon member is bonded to the multi-lumen tube 34 .
  • FIGS. 13A and 13B illustrate two alternative configurations of the flexible, inflatable balloon member in accordance with the present invention.
  • the balloon member 100 has a channel, groove or indent 106 formed circumferentially around the balloon's perimeter to form two ridges or peaks 104 , 108 .
  • This indent 106 may be formed by using a mandrel with a desired indent formed therein. A solvent or adhesive may be applied in the indent 106 to hold the indent 106 in place after the balloon member 100 is removed from the mandrel. Alternatively, the indent 106 may be formed by manually pushing the balloon member 100 inward and applying a solvent or adhesive in the indent 106 to hold the indent 106 in place.
  • the inner edges of the two peaks 104 , 108 are held together by the adhesive, but the whole balloon member 100 remains flexible for inflation and deflation.
  • the angle labelled ‘B’ of the indent 106 is preferably 20 degrees.
  • the angle labelled ‘C’of the two peaks 104 , 108 is preferably 30 degrees.
  • the configuration in FIG. 13B is similar to the one in FIG. 13A except the peaks contain internal ribs 110 , 112 , 118 , 120 which preferably extend around the circumference of the balloon 102 .
  • the configurations in FIG. 13A and 13B are used in generally the same manner as the configurations described above.
  • the indent in balloons 100 , 102 as shown in FIGS. 13A and 13B may extend around the entire peripheral edge of the balloon 100 , 102 , i.e. 360 degrees.
  • the indent may be provided in select places around the outer peripheral contact area.
  • the indents may be from 30 to 60 degrees, from 120 to 150 degrees, from 210 to 240 degrees, and from 300 to 330 degrees.
  • the indents along the outer peripheral contact area are not evenly distributed.
  • the indents may be a series of bumps, zig-zags, or cross-hatches on the outer peripheral contact area.
  • indents do not divide the outer peripheral contact area into two distinct peaks, but these indents may serve some of the same purposes as the indent and two peaks configuration.
  • Any other indent pattern may be used, such that the pattern preferably does not interfere with occlusion of the blood vessel, i.e. interfere with the seal created by the outer peripheral contact area against the inner wall of the blood vessel.
  • These configurations may be made by a mandrel with a series of bumps, zig-zags or cross-hatches along the peripheral edge.
  • One purpose for the indent shown in FIGS. 13A and 13B is to hold the balloon member 100 , 102 in position within the blood vessel and prevent the balloon member from sliding within the blood vessel.
  • the two peripheral edges provide a better distribution of forces. In other words, when one peak 104 starts to slide, the other peak 108 compensates and holds the balloon member in place. Thus, the two peripheral edge configuration tends to maintain the position of the balloon member within the blood vessel better than a single peripheral edge.
  • Another purpose of the indent is to maintain the thin profile of the balloon 100 , 102 . Another purpose is to limit the compliance of the balloon 100 . Another purpose is to reduce the surface area of the peripheral edge of the balloon 100 , 102 which comes in contact with the internal blood vessel wall. In the embodiments described herein, the peripheral contact area produced by the indented balloon members 100 , 102 is less than the contact area produced by the unindented balloon member 32 . Reducing the contact surface area reduces the risk of damage to the blood vessel.

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Abstract

A direct-access device with a thin-profile balloon member is used to occlude a blood vessel. The device is ideally suited for occluding a patient's aorta during stopped-heart cardiac procedures. The device comprises a flexible, thin-profile balloon member which forms a balloon in combination with a tubular member, which inflates the thin-profile balloon member. Together, the balloon member and tubular member occlude a blood vessel. The balloon member is attached near the distal end of the tubular member. The width of the balloon member's outer peripheral contact area, which contacts the inner wall of the blood vessel, is substantially narrower than the balloon member's diameter. The balloon member is made of a low compliance material which prevents the balloon member from expanding by more than 40% radially and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape. The balloon member comprises at least one pair of internal ribs which support the structure of the balloon member and prevent the balloon member from expanding longitudinally by more than 50%. The balloon member with internal ribs may be formed by dipping a mandrel, with grooves or channels formed therein, a number of times into liquid polyethylene, polyurethane or other similar material. The tubular member comprises a first lumen which carries blood between the patient and an external medical device. Another lumen is used to inflate and deflate the thin profile balloon member. Other lumens are used to measure blood pressure, introduce cardioplegia solution or drugs, and/or compensate for over-inflation of the balloon member. The tubular member is preferably bent near the distal end to allow the balloon member to be directly introduced into the blood vessel.

Description

    PRIORITY CLAIM
  • This application is a division of application No. Ser. 09/121,443, filed Jul. 23, 1998 and claims the benefit of provisional application No. 60,075,024 filed Feb. 18, 1998.[0001]
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention [0002]
  • The present invention relates generally to occlusion devices and methods of use thereof. More specifically, the present invention relates to balloon occlusion devices for performing cardiac bypass or other vascular procedures. [0003]
  • 2. Brief Description of the Related Art [0004]
  • Coronary artery diseases are often caused by atherosclerosis or narrowing of the small arteries between the aorta and the heart muscles. There are several ways to provide blood flow around occluded segments of arteries or veins, however, the known methods commonly cause a large amount of trauma to the patient. One method is to perform an “open heart surgery,” which involves cracking open the chest and exposing the heart and treating the vessel directly. However, the large incision and surgically cut sternum take a long time to heal. [0005]
  • In the bypass operation, a section of the saphenous vein, or a suitable substitute, is grafted, usually between the ascending aorta just above the heart and one or more of the coronary arteries beyond the points of blockage. The bypass operation is performed with the patient connected to a heart-lung machine and the heart is stopped. Because the heart is stopped, the heart-lung bypass can damage blood cells. Additionally, the patient's internal body temperature is reduced while on a heart-lung bypass to reduce basil metabolism and then the body temperature is increased to normal when the procedure is over. This thermal change to a person's body can cause damage to the intestinal track as well as causing additional stress to the patient. [0006]
  • If the patient is not placed on a heart-lung bypass, the aorta is typically partially clamped along its axis to create an area of blood stasis and a small channel for blood flow. However, clamping the aorta can cause injury to the aorta and can also cause plaque formations to break off into the blood stream and cause severe disorders such as strokes and emboli. [0007]
  • Sometimes, occlusion balloons are inserted through the femoral artery up to the blood vessel to be occluded. Both clamps and existing occlusion devices commonly cause damage to the internal blood vessel walls and the introduce plaque into the patient's blood stream. Existing balloons are also likely to move longitudinally along the catheter while in the blood vessel, and thus are likely to move into the heart or interfere with blood flow. [0008]
  • SUMMARY OF THE INVENTION
  • The present invention relates to a direct-access device with a balloon for occluding blood vessels, and methods of use thereof. The invention also relates generally to the design and manufacturing of this occlusion device. The occlusion device is ideally suited for occluding a patient's aorta during stopped-heart cardiac procedures. [0009]
  • A preferred embodiment of the present device comprises a flexible balloon member which is attached to the exterior of a tubular member to form an inflatable balloon. The tubular member includes an inflation lumen which can be used to inflate and deflate the thin-profile balloon. Together, the balloon member and tubular member occlude a blood vessel. The balloon member is preferably attached near the distal end of the tubular member. The width of the outer peripheral contact area of the balloon member, which comes in contact with the inner wall of the blood vessel, is substantially narrower than the balloon member's diameter. The contact area between the balloon member and the inner blood vessel wall is thus reduced over prior designs. [0010]
  • The balloon member is preferably made of a low compliance material, which limits the expansion of the balloon member to expanding 1% to 40% radially and [0011] 1% to 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape. In one embodiment, the low compliance material limits the expansion of the balloon member to expanding 10% to 33% radially and 10% to 40% longitudinally. In one embodiment, the low compliance material comprises polyurethane.
  • In addition to the inflation lumen, the tubular member preferably comprises a blood flow lumen which carries blood between the patient and an external medical device, such as a heart-lung machine. The tubular member preferably has other lumens to measure blood pressure and introduce a cardioplegia solution and/or drugs. In one embodiment, the tubular member is bent near the distal end to allow the balloon member to conveniently be directly introduced into and positioned within the blood vessel. [0012]
  • A significant advantage of the present device is that the inflated balloon member has a thin profile at its periphery. In a preferred embodiment, the balloon member produces a longitudinal contact distance which is less than 50% of (and preferably 20-30% of) the inner diameter of the blood vessel. Thus, the thin-profile balloon member contacts only a narrow segment of the blood vessel when the balloon member is inflated. Because the surface area of contact is reduced, the potential damage to the blood vessel commonly caused by such contact is also reduced. Another benefit of using a thin-profile balloon member is that the balloon member is less likely to move longitudinally along the catheter while in the blood vessel, and thus less likely to move into the heart or interfere with the device's blood flow port. [0013]
  • Another substantial advantage is the present device can be used to occlude the aorta without the need clamps, and thus reduces the likelihood of plaque being introduced into the blood stream. [0014]
  • Another important advantage results from the limited compliance of the balloon member. The limited compliance of the balloon member reduces longitudinal stretching and maintains a small peripheral surface area which comes in contact with the internal blood vessel wall. This prevents the balloon member from blocking the distal end of the tubular member or the opening of a branching blood vessel, such as the innominate artery. The limited compliance also limits radial stretching, and thus reduces potential damage to the blood vessel wall. In addition, the limited compliance reduces the likelihood of dissections and breakoffs of the inflatable balloon member, and reduces the risk of the balloon bursting. [0015]
  • If the balloon is inserted in the aorta, another advantage of the thin-profile of the balloon is that it allows the physician to move the balloon closer to the innominate artery (brachiocephalic artery). This creates more working space in the aorta for anastomosis. [0016]
  • In one embodiment, the balloon member comprises at least one pair of internal ribs which support the structure of the balloon member (maintain its thin profile) and prevent the balloon member from expanding by more than 1% to 50% after the balloon member is initially inflated. In one embodiment, the internal ribs limit the longitudinal expansion of the balloon member even further than the limited compliance material. These internal ribs interconnect the proximal and distal walls of the balloon member. In one configuration of balloon member, the ribs overlap one another and are bonded together. The balloon member with internal ribs may be formed by dipping a mandrel, with grooves or channels formed therein, a number of times into liquid polyethylene, polyurethane or other material with similar properties. In other embodiments of the invention, the internal ribs feature may be used to limit or control the expansion of other types of occlusion balloons, such as angioplasty balloons. [0017]
  • In another configuration, the balloon member comprises at least one indent or bump along the peripheral edge of the balloon member. These indents or bumps help to maintain the position of the balloon member within the blood vessel, prevent the balloon member from slipping, and reduce the contact area between the balloon and the internal wall of the blood vessel.[0018]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of a direct-access blood vessel occlusion device in accordance with the invention, with the balloon of the device shown in an inflated state. [0019]
  • FIG. 2 is a partially cut-away perspective view of the occlusion device of FIG. 1. [0020]
  • FIG. 3 is a side view of the occlusion device, with three of the device's five lumens shown in dashed lines. [0021]
  • FIG. 4 is a top view of the occlusion device taken from the line [0022] 4-4 of FIG. 3, with three lumens shown in dashed lines.
  • FIG. 5 illustrates the use of the occlusion device to occlude the aorta of a patient, and illustrates one type of connector that may be provided at the proximal end of the device. [0023]
  • FIG. 6 illustrates how two of the occlusion devices may be used to achieve a state of cardiopulmonary bypass. [0024]
  • FIG. 7 is a perspective view of a mandrel that may be used to form the flexible balloon member of the occlusion device. [0025]
  • FIG. 8 is a partially cut-away perspective view of an alternative embodiment of the occlusion device, wherein internal ribs are provided within the balloon member to limit the longitudinal expansion of the balloon. [0026]
  • FIG. 9 is a perspective view of a mandrel which may be used to form a balloon member of the type shown in FIG. 8. [0027]
  • FIG. 10 is a cross sectional view taken along the line [0028] 10-10 of FIG. 9.
  • FIG. 11 is a perspective view of another type of mandrel which may be used to generate balloon members of the type shown in FIG. 8. [0029]
  • FIG. 12 is a cross sectional view taken along the line [0030] 12-12 of FIG. 11.
  • FIGS. 13A and 13B are cross sectional side views of other configurations of the balloon member.[0031]
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • The present invention provides a direct-access blood [0032] vessel occlusion device 30 ideally suited for use during a stopped-heart cardiac procedure. In a preferred embodiment, as depicted by FIGS. 1-5, the device 30 comprises a flexible balloon member 32 which is attached to the outer surface of a multi-lumen tube 34 to form a balloon 36. The balloon 36 may be inflated and deflated using an inflation lumen 40 which extends axially from a proximal end 44 of the tube to port 40′ within the interior of the balloon 36. A main lumen 46 extends axially through the center of the tube 34 and is used to carry blood between the patient's circulatory system and a heart-lung machine (not shown). In a preferred configuration, a bend (preferably ninety degrees) is formed in the multi-lumen tube 34 proximal to the balloon 36 to allow the balloon 36 to easily be directly introduced into, and positioning within, the blood vessel to be occluded. In another configuration (ideally suited for occluding the superior vena cava), the multi-lumen tube 34 is straight without a bend.
  • FIG. 6 illustrates how two such devices may be used to achieve cardiopulmonary bypass, such as during an aortocoronary bypass procedure. For convenience, the reference characters “a” and “b” are appended to the FIG. 6 reference numbers to distinguish between the two devices. The [0033] first device 30 a is used to occlude and draw blood from the patient's superior vena cava 50. A conventional non-occluding canula may alternatively be used for this purpose, in which case cardiopulmonary bypass is achieved without occluding the vena cava 50. The blood that is withdrawn using the first device 30 a is passed through a heart-lung machine (not shown) for re-oxygenation. The second device 30 b is used to occlude, and to reintroduce oxygenated blood into, the patient's aorta 54. The procedure by which the devices 30 a, 30 b are introduced into the blood vessels and used to achieve cardiopulmonary bypass is described below.
  • An important feature of the [0034] device 30 is that the inflated balloon 36 has a thin profile at its periphery, and thus contacts only a narrow segment of the blood vessel (vena cava or aorta) when the balloon is inflated. By way of background, existing balloon occlusion devices commonly produce a longitudinal contact distance (the longitudinal distance over which the inflated balloon contacts the inner wall of the blood vessel) which exceeds the inner diameter of the blood vessel. In contrast, the device 30 described herein produces a longitudinal contact distance which is less than 50% (and preferably 20-30%) of the inner diameter of the blood vessel. Because the area of contact is reduced, the potential damage commonly caused by such contact is also reduced. The balloon member 32 is preferably substantially disk-shaped as shown in FIGS. 1 and 2. Alternatively, the shape of the balloon member 32 may resemble a spinning top. The shape of the balloon member 32 may be designed in various configurations, but the width of the outer peripheral contact area, which contacts the inner wall of the blood vessel, remains less than 50% (and preferably 20-30%) of the inner diameter of the blood vessel.
  • Another benefit of using a thin-profile balloon is that the balloon is less likely to move longitudinally along the tube [0035] 34 (or catheter) while in the blood vessel, and thus less likely to move into the heart or interfere with the device's blood flow port.
  • If the balloon [0036] 36B is inserted in the aorta 54, another advantage is the thin-profile of the balloon 36B allows the physician to move the balloon 36B closer to the innominate artery (brachiocephalic artery) 120, and thus create more working space (labelled ‘W’ in FIG. 5) in the aorta 54 for anastomosis. This is shown in FIG. 5.
  • In another embodiment (not illustrated) of the invention, a longer segment of tube is provided distal to the bend, and two balloons [0037] 36 (both of the same general construction as in the single-balloon configuration) are spaced apart from one another along this tube segment. The two balloons are preferably fluidly coupled to a common inflation lumen of the tube 34. The spacing between the two balloons is sufficient to form a working area for performing an anastomosis between the two inflated balloons. The use of two balloons in this manner prevents blood from flowing in the region of the anastomosis site during the anastomosis procedure, as described generally in U.S. provisional application No. 60/046,977 filed May 19, 1997.
  • The general construction of the [0038] device 30 will now be described in further detail with reference to FIGS. 1-5. As best shown by FIGS. 3 and 4, the multi-lumen tube 34 includes the blood flow lumen 46, the inflation lumen 40, a proximal blood pressure lumen 60, a distal blood pressure lumen 62, and a cardioplegia lumen 64. Each lumen extends axially from the proximal end 44 of the tube 34. The blood flow lumen 46 and the distal blood pressure lumen 62 extend to the tapered, distal end 70 of the tube 34. The proximal blood pressure lumen 60 and the cardioplegia lumen 64 extend to respective openings 60′, 64′ in the outer surface of the tube 34 proximal to the balloon 36. The inflation lumen 40 extends to an opening 40′ which coincides in position with the interior of the balloon 36. A standard barbed fitting 76 is provided at the proximal end of the multi-lumen tube 34 to enable other tubes and connectors to be fluidly coupled to each of the five lumens.
  • In the embodiment illustrated in FIGS. [0039] 1-4, the proximal end 44 of the multi-lumen tube 34 is in the form of a female connector. The female connector enables the device 30 to be coupled to the heart-lung machine, pressure sensors, and injection valves via a single connection. In the embodiment shown in FIG. 5, the device 30 is instead provided with a standard barbed connector 76 for coupling the blood-flow lumen 46 to the heart-lung machine, and is provided with four standard valved luer fittings 78 for providing access to the smaller lumens 40, 46, 62, 64. Any of a variety of other types of connectors can be used.
  • One or more of the lumens (or additional lumens) may, of course, be used for other purposes. For example, the [0040] inflation lumen 40 may serve an additional purpose: to prevent over-inflation of the occlusion balloon 36. In a preferred embodiment, the proximal end of the inflation lumen 40 is attached to a flexible tube 118, as shown in FIG. 5. The proximal end of the flexible tube 118 is attached to an over-inflation balloon (not shown). The over-inflation balloon is attached to a luer connector, which is attached to a luer fitting. A one-way, syringe-activated valve is built inside the luer connector. The over-inflation balloon provides a space for sliding the distal part of the valve. In a preferred embodiment, the over-inflation balloon is a ‘Pilot’ balloon made by Mallinckrodt Medical, Inc.
  • When the physician inserts a syringe into the luer fitting and the valve to inflate the [0041] occlusion balloon 36, a component inside the valve moves distally to allow the syringe to insert the inflation fluid. If the physician pulls the inflation syringe out, the valve closes (the component inside moves proximally) and prevents the occlusion balloon 36 from losing its inflation. To deflate the balloon 36, the physician inserts the syringe into the valve and withdraws the fluid.
  • When the [0042] occlusion balloon 36 begins to inflate, there is no resistance on the balloon 36 as it expands, and there is no back pressure in the inflation lumen 40. But when the occlusion balloon 36 comes in contact with the inner walls of the blood vessel, the walls of the blood vessel create resistance on the expanding balloon 36. This creates back pressure in the inflation lumen 40, and the over-inflation check balloon begins to inflate or bulge. This provides a direct signal to the physician that the inflated occlusion balloon 36 has contacted the internal walls of the blood vessel. The threshold pressure level needed to inflate the over-inflation balloon may also be produced by attempts to inflate the balloon 36 beyond its maximum diameter, even though the balloon 36 may not be in contact with the vessel walls.
  • Alternatively, in addition to an over-inflation balloon, some other pressure indicating device, such as a pressure meter, may be used to indicate that the desired pressure level has been reached within the [0043] occlusion balloon 36. This pressure indicating device is fluidly coupled to the occlusion balloon 36.
  • In another embodiment, the over-inflation check balloon or other pressure indicating device is coupled to separate lumen (not shown) which runs parallel with the [0044] inflation lumen 40 along the tubular member 34 and extends to an opening which coincides in position with the interior of the balloon 36, similar to the opening 40′.
  • The thin-[0045] profile balloon member 32 is preferably formed from a limited compliance material, such as polyethylene, polyurethane, other polymers or any other material with similar properties. The balloon member 32 may comprise a mixture of materials. The material of the balloon member 32 is not fully compliant, like silicone or latex. The compliance of the material is preferably selected such that the balloon may stretch from 1% to 40% radially and from 1% to 50% longitudinally after it is initially inflated under ambient pressure to its normal, unstretched shape. In one embodiment, the low compliance material limits the expansion of the balloon member to expanding 10% to 33% radially and 10% to 40% longitudinally. During such expansion, the balloon 32 does not lose its overall shape. The width L (FIG. 3) of the balloon member 32 preferably never expands to be more than 50% (and preferably 20-30%) of the length of its diameter D. The use of a limited compliance material for this purpose reduces longitudinal stretching, and thus maintains a small peripheral surface area which contacts the internal wall of the blood vessel. The limited compliance also prevents the balloon member 32 from blocking the distal tip of the tube 34 or blocking the opening of a branching blood vessel, such as the innominate artery. The limited compliance also reduces the likelihood of dissections and breakoffs of the inflatable balloon 32.
  • The limited compliance material also reduces the risk of the balloon bursting, which is common for silicone or latex balloons. The [0046] balloon member 32 is made of a sufficiently thick material to be resistant to calcified lesions on the inner wall of the blood vessel.
  • With reference to FIG. 3, when the [0047] balloon 36 is inflated in free air, the diameter D of the balloon 36 is approximately three to five times the peripheral length or thickness L of the balloon. The diameter D of the inflated balloon 36 is preferably at least twice the diameter of the tube 34. In a preferred configuration, the angle A of the balloon is approximately 40 degrees.
  • The [0048] multi-lumen tube 34 is preferably formed of a semi-rigid, translucent material using a conventional extrusion process. Polyethylene may be used for this purpose, in which case the balloon member 32 may be bonded to the exterior of the tube 34 using a solvent bonding process. In a preferred embodiment, as best illustrated by the side view of FIG. 3, a ninety degree bend 74 is formed in the tube 34 proximal to the balloon 36. As depicted by FIG. 4, the curvature and position of this bend 74 are such that the straight, proximal portion of the tube 34 is perpendicular to the blood vessel 54 when the balloon 36 is properly oriented within the blood vessel. The bend 74 is preferably formed within the tubing 34 using a heat mandrel which is inserted within the blood flow lumen 46. In another configuration (ideally suited for occluding the superior vena cava), the multilumen tube 34 is straight without a bend.
  • The process by which the [0049] device 30 is used during a cardiac bypass procedure will now be described with reference to FIGS. 5 and 6. For purposes of this description, it will be assumed that the same type of device is used to occlude both the vena cava and the aorta.
  • Initially, the physician performs a thoracotomy, sternotomy or other procedure to obtain access to the patient's [0050] vena cava 50 and aorta 54. The physician then selects devices 30 a, 30 b having balloons 36A, 36B which correspond in diameter to the vena cava 50 and the aorta 54 (respectively) of the particular patient, and fluidly couples these devices 30 a, 30 b to the heart-lung machine and the various instruments to be used during the procedure. Incisions are then made in the vena cava 50 and the ascending aorta 54, and the distal ends of the devices 30 a, 30 b are advanced into the respective blood vessels to position the balloons. The balloons are maintained in an uninflated, collapsed state during the insertion process.
  • Once the [0051] devices 30 a, 30 b are positioned within the superior vena cava 50 and the ascending aorta 54, the heart-lung machine is activated such that blood is withdrawn from the vena cava 50 and perfused into the aorta 54. Each balloon 36 a, 36 b is then inflated by introducing an appropriate substance into the interior thereof via the respective inflation lumen 40 (FIGS. 3 and 4). The balloons 36 a, 36 b are preferably inflated with saline solution or any other suitable fluid. Locking syringes or syringes coupled to one-way valves may be used to inflate the balloons 36 a, 36 b.
  • The [0052] balloons 36 a, 36 b expand in diameter by about 1% to 40% (preferably 10% to 33%) from their initial inflated state during the inflation process. As illustrated by FIG. 5 for the aorta 54, the balloons 36 a, 36 b press outward against the inner walls of their respective blood vessels 50, 54 by a sufficient degree to cause the blood vessel walls to bulge outward slightly. Such bulging helps to maintain the inflated balloons in position.
  • Once the [0053] balloons 36 a, 36 b have been inflated, a cardioplegia solution is introduced into the heart to stop the heart from beating. The cardioplegia solution is preferably introduced via the cardioplegia lumen 64 (FIG. 3) of the aortic occlusion device 30 b, although the cardioplegia lumen of the vena cava occlusion device 30 a may additionally be used for this purpose. During the subsequent bypass or other cardiac procedure, the proximal and distal pressure lumens 60, 62 (FIGS. 3 and 4) may be used to monitor the pressure on the proximal and distal sides of the inflated balloons 36 a, 36 b. These lumens 60, 62 may additionally or alternatively be used for other purposes, such as to introduce drugs into the heart and/or the circulatory system.
  • FIG. 7 illustrates a [0054] mandrel 90 which may be used to manufacture the thin-profile balloon members 32. The mandrel is preferably composed of 304 (or higher) stainless steel which is electropolished after machining. The diameter of the mandrel ranges from 1.0 to 1.5 cm in embodiments that are used for aortic occlusion. In one preferred embodiment, the diameter is equal to 1.102 cm, and in another preferred embodiment, the diameter is equal to 1.416 cm. During the manufacturing process, the mandrel 90 is appropriately dipped in a liquid polyethylene, polyurethane or other solution a sufficient number of times to produce a wall thickness of approximately 0.4 mils to 0.7 mils (where 1 mil=0.001 inches). The balloon member 32 is subsequently removed from the mandrel, and the tubular segments (not shown) which extend away from balloon portion in opposite directions are trimmed away. An appropriate powder may be applied to the balloon material to prevent the balloon walls from sticking together. Finally, the balloon member 32 is positioned over and bonded to the multi-lumen tube 34.
  • An optional feature of the [0055] balloon member 32 will now be described with reference to FIGS. 8-12. As illustrated by FIG. 8, the balloon member 32 may be provided with pairs of internal ribs 94 (one pair visible in FIG. 8) that interconnect the proximal and distal walls of the balloon. The use of such ribs 94 impedes the longitudinal expansion of the balloon 36 during inflation, and thus helps to maintain the thin profile of the balloon 36. In one embodiment, the internal ribs limit the longitudinal expansion of the balloon 36 even further than the limited compliance material. For example, if the limited compliance material prevents the balloon 36 from expanding longitudinally by more than 50%, the internal ribs may further limit longitudinal expansion up to only 10%. In the embodiment shown in FIG. 8, the two ribs 94 that are visible overlap one another and are bonded together. At least three pairs of attached ribs of the type shown in FIG. 8 are preferably provided within the balloon member 32, with the pairs spaced at equal angular intervals.
  • In other embodiments of the invention, the internal ribs feature may be used to limit or control the expansion of other types of occlusion balloons, such as angioplasty balloons. [0056]
  • FIGS. 9 and 10 illustrate one embodiment of a [0057] mandrel 90′ that can be used to form a balloon member 32 of the type shown in FIG. 8. Each face of the mandrel (only one face visible in FIG. 9) has eight grooves or channels 96 formed therein to form eight pairs of ribs. These channels 96 become filled during the dipping process to form the ribs. As illustrated by the cross-sectional view of FIG. 10 for a single channel pair, each pair of ribs 94 is formed using a pair of overlapping channels 96 that are angularly offset from one another. After the balloon member 32 is removed from mandrel 90′, the corresponding ribs 94 are manually glued together. A mandrel that produces non-overlapping ribs can alternatively be used, in which case the proximal and distal walls of the balloon member 32 are squeezed towards one another during the gluing process to cause the ribs to overlap.
  • FIGS. 11 and 12 illustrate an alternative mandrel configuration which can be used to form the [0058] ribbed balloon member 32. In this configuration, the channels of the mandrel 90′ of FIGS. 9 and 10 are replaced with corresponding protrusions 98 which extend longitudinally outward from each face of the mandrel 90″. To form a balloon 36 of the type shown in FIG. 8, the mandrel 90″ is initially dipped in a liquid polyethylene, polyurethane or other solution to form a balloon member 32 having ribs which extend outward from the outer surface of the balloon member. This balloon member is then inverted (turned inside out) so that these ribs reside within the balloon member. The corresponding ribs are then glued together, and the inverted balloon member is bonded to the multi-lumen tube 34.
  • FIGS. 13A and 13B illustrate two alternative configurations of the flexible, inflatable balloon member in accordance with the present invention. The [0059] balloon member 100 has a channel, groove or indent 106 formed circumferentially around the balloon's perimeter to form two ridges or peaks 104, 108. This indent 106 may be formed by using a mandrel with a desired indent formed therein. A solvent or adhesive may be applied in the indent 106 to hold the indent 106 in place after the balloon member 100 is removed from the mandrel. Alternatively, the indent 106 may be formed by manually pushing the balloon member 100 inward and applying a solvent or adhesive in the indent 106 to hold the indent 106 in place. The inner edges of the two peaks 104, 108 are held together by the adhesive, but the whole balloon member 100 remains flexible for inflation and deflation. The angle labelled ‘B’ of the indent 106 is preferably 20 degrees. The angle labelled ‘C’of the two peaks 104, 108 is preferably 30 degrees. The configuration in FIG. 13B is similar to the one in FIG. 13A except the peaks contain internal ribs 110, 112, 118, 120 which preferably extend around the circumference of the balloon 102. The configurations in FIG. 13A and 13B are used in generally the same manner as the configurations described above.
  • The indent in [0060] balloons 100, 102 as shown in FIGS. 13A and 13B may extend around the entire peripheral edge of the balloon 100, 102, i.e. 360 degrees. Alternatively, the indent may be provided in select places around the outer peripheral contact area. For example, in one configuration, the indents may be from 30 to 60 degrees, from 120 to 150 degrees, from 210 to 240 degrees, and from 300 to 330 degrees. In other embodiments (not shown), the indents along the outer peripheral contact area are not evenly distributed. For example, the indents may be a series of bumps, zig-zags, or cross-hatches on the outer peripheral contact area. These indents do not divide the outer peripheral contact area into two distinct peaks, but these indents may serve some of the same purposes as the indent and two peaks configuration. Any other indent pattern may be used, such that the pattern preferably does not interfere with occlusion of the blood vessel, i.e. interfere with the seal created by the outer peripheral contact area against the inner wall of the blood vessel. These configurations may be made by a mandrel with a series of bumps, zig-zags or cross-hatches along the peripheral edge.
  • One purpose for the indent shown in FIGS. 13A and 13B is to hold the [0061] balloon member 100, 102 in position within the blood vessel and prevent the balloon member from sliding within the blood vessel. The two peripheral edges provide a better distribution of forces. In other words, when one peak 104 starts to slide, the other peak 108 compensates and holds the balloon member in place. Thus, the two peripheral edge configuration tends to maintain the position of the balloon member within the blood vessel better than a single peripheral edge.
  • Another purpose of the indent is to maintain the thin profile of the [0062] balloon 100, 102. Another purpose is to limit the compliance of the balloon 100. Another purpose is to reduce the surface area of the peripheral edge of the balloon 100, 102 which comes in contact with the internal blood vessel wall. In the embodiments described herein, the peripheral contact area produced by the indented balloon members 100, 102 is less than the contact area produced by the unindented balloon member 32. Reducing the contact surface area reduces the risk of damage to the blood vessel.
  • While embodiments and applications of this invention have been shown and described, it will be apparent to those skilled in the art that various modifications are possible without departing from the scope of the invention. It is, therefore, to be understood that within the scope of the appended claims, this invention may be practiced otherwise than as specifically described. [0063]

Claims (10)

What is claimed:
1. A method of occluding a blood vessel comprising:
directly inserting a flexible balloon member and a tubular member through an incision in the blood vessel with the balloon member in an uninflated, collapsed state during insertion, said balloon member having an outer peripheral contact width which comes in contact with the inner wall of the blood vessel during occlusion, said outer peripheral contact width being substantially narrower than the diameter of the balloon member, said tubular member combining with the balloon member to form an inflatable balloon; and
inflating the balloon member inside the blood vessel to occlude the blood vessel such that the balloon member contacts the inner wall of the blood vessel along a longitudinal length which is substantially less than the diameter of the balloon member.
2. The method of claim 1, wherein the blood vessel is an aorta.
3. The method of claim 2, further comprising:
perfusing blood through the tubular member and into the patient.
4. The method of claim 1, further comprising:
monitoring blood pressure within the blood vessel using a lumen of the tubular member.
5. The method of claim 1 further comprising:
monitoring an amount of inflation within the balloon member using an external monitoring device.
6. The method of claim 5, wherein the external monitoring device indicates when the balloon member comes in contact with the inner wall of the blood vessel during occlusion.
7. A method of achieving cardiopulmonary bypass during an aortic coronary bypass procedure comprising:
inserting a balloon member attached to the distal end of a tubular member directly into an incision in a patient's aorta, said balloon member being maintained in an uninflated, collapsed state during insertion, said balloon member having an peripheral contact width which comes in contact with the inner wall of the aorta during occlusion, said outer peripheral contact width being substantially narrower than the diameter of the balloon member;
activating a heart-lung machine attached to the proximal end of the tubular member such that blood is perfused into the aorta; and
inflating the balloon member to occlude the aorta such that the balloon member contacts the inner wall of the aorta along a longitudinal length which is substantially less than the diameter of the balloon member.
8. The method of claim 7, further comprising:
inserting a second balloon member attached to the distal end of a second tubular member through an incision made in the patient's superior vena cava, said second balloon member being maintained in an uninflated, collapsed state during insertion.
9. The method of claim 7, further comprising:
introducing a cardioplegia solution into the patient's heart to stop the heart from beating; and
performing a bypass procedure on the aorta.
10. The method of claim 8, wherein the first and second balloon members are inflated with saline solution.
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Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040097997A1 (en) * 2002-09-04 2004-05-20 Corrado Di Cecco Ear duct cleaning device
US20050197668A1 (en) * 2004-03-02 2005-09-08 Scimed Life Systems, Inc. Occlusion balloon catheter with longitudinally expandable balloon
US20050203564A1 (en) * 1998-07-23 2005-09-15 Nobles Anthony A. Blood vessel occlusion device
US20110098672A1 (en) * 2008-01-24 2011-04-28 Cedars-Sinai Medical Center Balloon catheter and methods for pericardiocentesis and percutaneous pericardiotomy
US9642616B2 (en) 2005-06-20 2017-05-09 Nobles Medical Technologies, Inc. Method and apparatus for applying a knot to a suture
US9649106B2 (en) 2011-04-15 2017-05-16 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US9706988B2 (en) 2012-05-11 2017-07-18 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US10182802B2 (en) 2007-03-29 2019-01-22 Nobles Medical Technologies, Inc. Suturing devices and methods for closing a patent foramen ovale
US10194902B2 (en) 1999-07-02 2019-02-05 Quickpass, Inc. Suturing device
US10512458B2 (en) 2013-12-06 2019-12-24 Med-Venture Investments, Llc Suturing methods and apparatuses
US10687801B2 (en) 2016-04-11 2020-06-23 Nobles Medical Technologies Ii, Inc. Suture spools for tissue suturing device
US10828022B2 (en) 2013-07-02 2020-11-10 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US11166712B2 (en) 2008-05-09 2021-11-09 Scarab Technology Services, Llc Suturing devices and methods for suturing an anatomic valve
US11202624B2 (en) 2017-08-18 2021-12-21 Nobles Medical Technologies Ii, Inc. Apparatus for applying a knot to a suture
CN114191687A (en) * 2022-01-12 2022-03-18 郑州大学第三附属医院(河南省妇幼保健院) Blood flow blocking device for preventing lower limb necrosis for patient subjected to placenta implantation caesarean section
US11395658B2 (en) 2014-07-11 2022-07-26 Cardio Medical Solutions, Inc. Device and method for assisting end-to-side anastomosis
US11839370B2 (en) 2017-06-19 2023-12-12 Heartstitch, Inc. Suturing devices and methods for suturing an opening in the apex of the heart
US11957331B2 (en) 2017-06-19 2024-04-16 Heartstitch, Inc. Suturing systems and methods for suturing body tissue

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6475226B1 (en) 1999-02-03 2002-11-05 Scimed Life Systems, Inc. Percutaneous bypass apparatus and method
AU2001257546A1 (en) * 2000-05-09 2001-11-20 United States Endoscopy Group, Inc. Barrett's esophagus cytology device
US7108661B2 (en) 2001-05-07 2006-09-19 United States Endoscopy Group, Inc. Method and collection device for Barrett's esophagus cells
US6620159B2 (en) * 2001-06-06 2003-09-16 Scimed Life Systems, Inc. Conductive expandable electrode body and method of manufacturing the same
US6932828B2 (en) 2001-11-06 2005-08-23 Possis Medical, Inc. Guidewire occlusion system utilizing repeatably inflatable gas-filled occlusive device
US6942678B2 (en) * 2001-11-06 2005-09-13 Possis Medical, Inc. Gas inflation/evacuation system and sealing system for guidewire assembly having occlusive device
US20060064071A1 (en) * 2001-11-06 2006-03-23 Possis Medical, Inc. Gas inflation/evacuation system incorporating a reservoir and removably attached sealing system for a guidewire assembly having an occlusive device
US7169163B2 (en) * 2002-09-30 2007-01-30 Bruce Becker Transnasal method and catheter for lacrimal system
US20040106901A1 (en) * 2002-11-30 2004-06-03 Letson William W. Catheter having a balloon member invertedly attached thereto
US7124489B2 (en) * 2002-11-30 2006-10-24 Kimberly-Clark Worldwide, Inc. Process for producing a catheter
US7534224B2 (en) * 2002-11-30 2009-05-19 Kimberly-Clark Worldwide, Inc. Catheter with unitary component
US20040106899A1 (en) * 2002-11-30 2004-06-03 Mcmichael Donald J. Gastric balloon catheter with improved balloon orientation
US8114102B2 (en) * 2003-06-16 2012-02-14 St. Jude Medical Atg, Inc. Temporary hemostatic plug apparatus and method of use
US20050038381A1 (en) * 2003-08-11 2005-02-17 Kimberly-Clark Worldwide, Inc. Catheter having a balloon member recessedly attached thereto
US7468051B2 (en) * 2004-03-02 2008-12-23 Boston Scientific Scimed, Inc. Occlusion balloon catheter with external inflation lumen
US20060259066A1 (en) * 2005-04-28 2006-11-16 Euteneuer Charles L Bifurcated artery filter system
US8672990B2 (en) * 2005-05-27 2014-03-18 Boston Scientific Scimed, Inc. Fiber mesh controlled expansion balloon catheter
US7615031B2 (en) * 2005-09-01 2009-11-10 Medrad, Inc. Gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device
US9060802B2 (en) 2006-11-21 2015-06-23 Bridgepoint Medical, Inc. Endovascular devices and methods for exploiting intramural space
US11298511B2 (en) 2006-11-21 2022-04-12 Bridgepoint Medical, Inc. Endovascular devices and methods for exploiting intramural space
US20110144637A1 (en) * 2009-12-11 2011-06-16 Medtronic Cryocath Lp Vein Occlusion Devices and Methods for Catheter-Based Ablation
FR2955500B1 (en) * 2010-01-22 2012-04-20 Sayed Nour CARDIOVASCULAR DEVICE FOR SINGLE USE FOR MEDICAL AND SURGICAL INTERVENTION
EP2560722A2 (en) 2010-04-21 2013-02-27 The Regents of the University of Michigan Fluoroscopy-independent, endovascular aortic occlusion system
WO2012012660A2 (en) * 2010-07-21 2012-01-26 Accola Kevin D Prosthetic heart valves and devices, systems, and methods for deploying prosthetic heart valves
WO2014083559A1 (en) * 2012-11-30 2014-06-05 Hdh Medical Ltd Vascular occluding device and methods of use
US9474882B2 (en) 2013-02-26 2016-10-25 Prytime Medical Devices, Inc. Fluoroscopy-independent balloon guided occlusion catheter and methods
WO2015035393A1 (en) 2013-09-09 2015-03-12 Pryor Medical Devices, Inc. Low-profile occlusion catheter
US10232142B2 (en) 2014-06-10 2019-03-19 Prytime Medical Devices, Inc. Conduit guiding tip
AU2016232781B2 (en) 2015-03-19 2017-11-02 Prytime Medical Devices, Inc. System for low-profile occlusion balloon catheter
JP6408176B2 (en) 2016-06-02 2018-10-17 プリタイム・メディカル・デバイシーズ・インコーポレイテッドPrytime Medical Devices,Inc. System and method for low profile occlusion balloon catheter
CN110446523B (en) 2017-01-12 2022-06-10 加利福尼亚大学董事会 Intravascular perfusion enhancement for critical care
CN106725696B (en) * 2017-02-13 2019-07-19 中国医科大学附属盛京医院 It is a kind of for blocking the dual balloon catheter of common iliac blood flow
JP2020518329A (en) 2017-04-21 2020-06-25 ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア Aortic blood flow meter and pump for partial blockage of the aorta
CN107595343A (en) * 2017-10-20 2018-01-19 王刚 Previous anastomotic building mortion is aided in a kind of thin vessels Coronary Artery Bypass
CA3107489A1 (en) 2018-08-06 2020-02-13 Prytime Medical Devices, Inc. System and method for low profile occlusion balloon catheter
WO2021188602A2 (en) 2020-03-16 2021-09-23 Certus Critical Care, Inc. Blood flow control devices, systems, and methods and error detection thereof
WO2022197895A1 (en) 2021-03-18 2022-09-22 Prytime Medical Devices, Inc. Vascular occlusion catheter
CN115253036B (en) * 2022-08-11 2023-03-28 中国人民解放军陆军军医大学第二附属医院 Aorta blocking perfusion tube

Family Cites Families (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2473742A (en) * 1944-12-28 1949-06-21 Davol Rubber Co Inflation indicator for catheters
US3292627A (en) * 1963-03-25 1966-12-20 Pharmaseal Lab Catheter
US3394705A (en) 1965-10-22 1968-07-30 Daniel J. Abramson Drainage balloon catheter having means for antiseptic treatment of the urethra
US4119100A (en) 1977-03-18 1978-10-10 John William Stanley Rickett Surgical device for discharge of faecal matter from the colon
US4299237A (en) * 1978-07-21 1981-11-10 Foti Thomas M Closed flow caloric test device
DE2901701C2 (en) 1979-01-17 1982-06-03 Naučno-issledovatel'skij institut nejrochirurgii imeni Akademika N.N. Burdenko Akademii medicinskich Nauk SSSR, Moskva Device for closing vessels, in particular cerebral vessels
DE3235974A1 (en) 1981-11-24 1983-06-01 Volkmar Dipl.-Ing. Merkel (FH), 8520 Erlangen DEVICE FOR REMOVAL OR FOR THE EXPANSION OF CONSTRAINTS IN BODY LIQUID LEADING VESSELS
US4589868A (en) * 1984-03-12 1986-05-20 Dretler Stephen P Expandable dilator-catheter
US4734094A (en) 1986-06-09 1988-03-29 Jacob Erwin T Catheter and method for cholangiography
US4771776A (en) 1987-01-06 1988-09-20 Advanced Cardiovascular Systems, Inc. Dilatation catheter with angled balloon and method
US4861330A (en) 1987-03-12 1989-08-29 Gene Voss Cardiac assist device and method
US4796629A (en) * 1987-06-03 1989-01-10 Joseph Grayzel Stiffened dilation balloon catheter device
JPH0712626B2 (en) 1987-11-25 1995-02-15 日精エー・エス・ビー機械株式会社 Secondary injection molding machine for hollow molded products
GB8800447D0 (en) 1988-01-09 1988-02-10 Smiths Industries Plc Inflation indicators for cuffed tubes
AU615247B2 (en) 1988-01-27 1991-09-26 Kievsky Nauchno-Issledovatelsky Institut Neirokhirurgii Occluding device
US4932956A (en) 1988-05-10 1990-06-12 American Medical Systems, Inc. Prostate balloon dilator
WO1989011889A1 (en) * 1988-06-06 1989-12-14 Sumitomo Electric Industries, Ltd. Catheter
JP2736902B2 (en) * 1988-10-11 1998-04-08 テルモ株式会社 Tube body and blood perfusion device
US5090958A (en) 1988-11-23 1992-02-25 Harvinder Sahota Balloon catheters
US5116305A (en) 1990-02-01 1992-05-26 Abiomed, Inc. Curved intra aortic balloon with non-folding inflated balloon membrane
US5108369A (en) * 1990-03-15 1992-04-28 Diagnostic Devices Group, Limited Dual-diameter multifunction catheter
US5308320A (en) 1990-12-28 1994-05-03 University Of Pittsburgh Of The Commonwealth System Of Higher Education Portable and modular cardiopulmonary bypass apparatus and associated aortic balloon catheter and associated method
AR245376A1 (en) * 1991-02-25 1994-01-31 Liliana Rosa Grinfeld Y Robert Arterial profusion nozzle, for extra-corporal circulation and other uses.
US5433700A (en) 1992-12-03 1995-07-18 Stanford Surgical Technologies, Inc. Method for intraluminally inducing cardioplegic arrest and catheter for use therein
US5795325A (en) * 1991-07-16 1998-08-18 Heartport, Inc. Methods and apparatus for anchoring an occluding member
US5766151A (en) * 1991-07-16 1998-06-16 Heartport, Inc. Endovascular system for arresting the heart
US5458574A (en) 1994-03-16 1995-10-17 Heartport, Inc. System for performing a cardiac procedure
US5558644A (en) 1991-07-16 1996-09-24 Heartport, Inc. Retrograde delivery catheter and method for inducing cardioplegic arrest
JP2979804B2 (en) 1991-12-13 1999-11-15 株式会社ニッショー Aortic occlusion balloon catheter
US5382261A (en) 1992-09-01 1995-01-17 Expandable Grafts Partnership Method and apparatus for occluding vessels
US5370618A (en) 1992-11-20 1994-12-06 World Medical Manufacturing Corporation Pulmonary artery polyurethane balloon catheter
JP3394327B2 (en) * 1994-07-11 2003-04-07 テルモ株式会社 Tube inner surface treatment method
US5695468A (en) * 1994-09-16 1997-12-09 Scimed Life Systems, Inc. Balloon catheter with improved pressure source
US5697905A (en) * 1995-06-19 1997-12-16 Leo T. d'Ambrosio Triple-lumen intra-aortic catheter
US5591195A (en) 1995-10-30 1997-01-07 Taheri; Syde Apparatus and method for engrafting a blood vessel
US5688245A (en) * 1996-05-02 1997-11-18 Runge; Thomas M. Cannula system for a biventricular cardiac support system or a cardiopulmonary bypass system
US5797948A (en) * 1996-10-03 1998-08-25 Cordis Corporation Centering balloon catheter
US5868708A (en) * 1997-05-07 1999-02-09 Applied Medical Resources Corporation Balloon catheter apparatus and method
US5928192A (en) * 1997-07-24 1999-07-27 Embol-X, Inc. Arterial aspiration
EP0894475A1 (en) 1997-07-31 1999-02-03 Medtronic, Inc. Temporary vascular seal for anastomosis

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050203564A1 (en) * 1998-07-23 2005-09-15 Nobles Anthony A. Blood vessel occlusion device
US10194902B2 (en) 1999-07-02 2019-02-05 Quickpass, Inc. Suturing device
US7347865B2 (en) * 2002-09-04 2008-03-25 Corrado Di Cecco Ear duct cleaning device
US20040097997A1 (en) * 2002-09-04 2004-05-20 Corrado Di Cecco Ear duct cleaning device
US20050197668A1 (en) * 2004-03-02 2005-09-08 Scimed Life Systems, Inc. Occlusion balloon catheter with longitudinally expandable balloon
US7198632B2 (en) 2004-03-02 2007-04-03 Boston Scientific Scimed, Inc. Occlusion balloon catheter with longitudinally expandable balloon
US11744576B2 (en) 2005-06-20 2023-09-05 Scarab Technology Services, Llc Method and apparatus for applying a knot to a suture
US9642616B2 (en) 2005-06-20 2017-05-09 Nobles Medical Technologies, Inc. Method and apparatus for applying a knot to a suture
US10758223B2 (en) 2005-06-20 2020-09-01 Scarab Technology Services, Llc Method and apparatus for applying a knot to a suture
US11197661B2 (en) 2007-03-29 2021-12-14 Scarab Technology Services, Llc Device for applying a knot to a suture
US10182802B2 (en) 2007-03-29 2019-01-22 Nobles Medical Technologies, Inc. Suturing devices and methods for closing a patent foramen ovale
US20110098672A1 (en) * 2008-01-24 2011-04-28 Cedars-Sinai Medical Center Balloon catheter and methods for pericardiocentesis and percutaneous pericardiotomy
US8361016B2 (en) * 2008-01-24 2013-01-29 Cedars-Sinai Medical Center Balloon catheter and methods for pericardiocentesis and percutaneous pericardiotomy
US11166712B2 (en) 2008-05-09 2021-11-09 Scarab Technology Services, Llc Suturing devices and methods for suturing an anatomic valve
US10610216B2 (en) 2011-04-15 2020-04-07 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US10624629B2 (en) 2011-04-15 2020-04-21 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US9649106B2 (en) 2011-04-15 2017-05-16 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US9706988B2 (en) 2012-05-11 2017-07-18 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US10420545B2 (en) 2012-05-11 2019-09-24 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US11051802B2 (en) 2012-05-11 2021-07-06 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US10828022B2 (en) 2013-07-02 2020-11-10 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US10512458B2 (en) 2013-12-06 2019-12-24 Med-Venture Investments, Llc Suturing methods and apparatuses
US11779324B2 (en) 2013-12-06 2023-10-10 Med-Venture Investments, Llc Suturing methods and apparatuses
US11395658B2 (en) 2014-07-11 2022-07-26 Cardio Medical Solutions, Inc. Device and method for assisting end-to-side anastomosis
US10687801B2 (en) 2016-04-11 2020-06-23 Nobles Medical Technologies Ii, Inc. Suture spools for tissue suturing device
US11839370B2 (en) 2017-06-19 2023-12-12 Heartstitch, Inc. Suturing devices and methods for suturing an opening in the apex of the heart
US11957331B2 (en) 2017-06-19 2024-04-16 Heartstitch, Inc. Suturing systems and methods for suturing body tissue
US11202624B2 (en) 2017-08-18 2021-12-21 Nobles Medical Technologies Ii, Inc. Apparatus for applying a knot to a suture
CN114191687A (en) * 2022-01-12 2022-03-18 郑州大学第三附属医院(河南省妇幼保健院) Blood flow blocking device for preventing lower limb necrosis for patient subjected to placenta implantation caesarean section

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EP0977611A1 (en) 2000-02-09
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JP2001520566A (en) 2001-10-30
US6248121B1 (en) 2001-06-19

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