US20080065008A1

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Publication number: US20080065008A1
Application number: US11/941,872
Authority: US
Inventors: Denise Barbut; Jonathan Root; Giovanni Pastrone; Tracy Maahs; Ross Tsugita
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-05-14
Filing date: 2007-11-16
Publication date: 2008-03-13
Also published as: US20040158276A1; CA2254831C; WO1997042879A1; EP0897288A1; US6589264B1; US6090097A; US6231544B1; CA2254831A1; EP0897288A4; AU3122197A; US6592546B1; US7306575B2

Abstract

A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Description

This application is a continuation of Barbut et al., U.S. application Ser. No. 08/854,806, filed May 12, 1997, which is a continuation-in-part of U.S. application Ser. No. 08/645,762, filed May 14, 1996, now abandoned, the contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to blood filter devices having an associated balloon occluder for temporary placement in a blood vessel, and more particularly to a cannula device, having an associated blood filter and balloon occluder, for placement in a blood vessel to carry blood to an artery from a bypass-oxygenator system and to capture embolic material in the vessel. The invention also relates to catheters having a balloon occluder and associated filter to capture embolic material. More particularly, the invention relates to a blood filter device to be placed in the aorta during cardiac surgery, the device further having a balloon occluder which, when deployed, reduces or eliminates the need for aortic cross-clamping. The present invention also relates to methods for temporarily filtering blood to capture and remove embolic material, and to methods for protecting a patient from embolization which may be caused by the balloon occluder having dislodged atheromatous material from the artery

BACKGROUND OF THE INVENTION

Currently, the most common method of temporarily occluding the ascending aorta during open heart surgery utilizes a mechanical cross clamp. Once the chest cavity has been opened, access to the heart and to the adjacent vessels is provided. The ascending aorta is partially dissected from the surrounding tissue and exposed. Arterial and venous cannulas are inserted and sutured into place. The cannulas are connected to the cardiopulmonary bypass machine, and bypass blood oxygenation is established.

At this point, the heart must be arrested and isolated from the rest of the circulatory system. A mechanical cross clamp is positioned between cardioplegia cannula and the aortic cannula and actuated. The aorta is completely collapsed at the clamp site, thus stopping flow of blood between the coronary arteries and the innominate artery the oxygenated bypass blood is shunted around the heart. Once the vessel occlusion has been completed, cardioplegia solution is introduced through the cardioplegia cannula to arrest the heart. The surgeon may now proceed with the desired operation.

Other less common means of occluding the aorta include percutaneous balloon catheter occlusion, direct aortic balloon catheter (Foley) occlusion, aortic balloon occluder cannula, and an inflating diaphragm occluder (Hill—occlusion trocar). The percutaneous balloon catheter is inserted typically from the femoral artery feed through the descending aorta, across the aortic arch into position in the ascending aorta. Once in the ascending aorta, the balloon occluder is inflated and flow stopped.

As a simple replacement for the mechanical cross clamp, a Foley catheter may be placed through an additional incision site near the standard cross clamp site. Once inserted, the Foley catheter balloon is inflated and flow is stopped. Similarly, an aortic balloon occluder cannula is placed directly into the aorta. This occluder cannula replaces the standard aortic cannula by delivering the CPB blood back to the arterial circulatory system The occluder balloon is located on the cannula proximal to CPB blood exit port on the cannula. It may also replace the need for a cardioplegia cannula with an additional infusion port proximal to the occluder balloon. The occlusion trocar is described to offer similar features as the aortic balloon occluder cannula and would be used in place of the standard aortic cannula. However, it relies on an inflatable diaphragm to occlude the vessel.

The use of a balloon to occlude an artery has been disclosed by Gabbay, U.S. Pat. No. 5,330,451 (this and all other references cited herein are expressly incorporated by reference as if fully set forth in their entirety herein). The Gabbay device included a perfusion cannula having a proximal balloon occluder and a distal intra-aortic balloon to divert blood to the carotid arteries. The Gabbay perfusion cannula is disclosed for use during open heart surgery in order to prevent complications associated therewith.

Moreover, Peters, U.S. Pat. No. 5,433,700, discusses a method for inducing cardioplegic arrest using an arterial balloon catheter to occlude the ascending aorta. The Peters method includes the steps of maintaining systemic circulation using peripheral cardiopulmonary bypass, venting the left side of the heart, and introducing a cardioplegic agent into the coronary circulation. This procedure is said to prepare the heart for a variety of surgical procedures. Disclosures of similar endovascular occlusion catheters can be found in Machold et al., U.S. Pat. No. 5,458,574, Stevens, International Application No. PCT/US93/12323, and Stevens et al., International Application No. PCT/US94/12986.

There are a number of known devices designed to filter blood. The vast majority of these devices are designed for permanent placement in veins, in order to trap emboli destined for the lungs. For example, Kimmell, Jr., U.S. Pat. No. 3,952,747, discloses the so-called Kimray-Greenfield filter. This is a permanent filter typically placed in the vena cava comprising a plurality of convergent legs in a generally conical array, which are joined at their convergent ends to an apical hub. Each leg has a bent hook at its end to impale the internal walls of the vena cava.

Cottenceau et al., U.S. Pat. No. 5,375,612, discloses a blood filter intended for implantation in a blood vessel, typically in the vena cava. This device comprises a zigzagged thread wound on itself and a central strainer section to retain blood clots. This strainer section comprises a meshed net and may be made from a biologically absorbable material. This device is also provided with attachment means which penetrate into the wall of the vessel.

Gunther et al., U.S. Pat. No. 5,329,942, discloses a method for filtering blood in the venous system wherein a filter is positioned within a blood vessel beyond the distal end of a catheter by a positioning means guided through the catheter. The positioning means is locked to the catheter, and the catheter is anchored to the patient. The filter takes the form of a basket and is comprised of a plurality of thin resilient wires. This filter can be repositioned within the vessel to avoid endothelialization within the vessel wall.

There are various problems associated with permanent filters. For example, when a filter remains in contact with the inner wall of the vena cava for a substantial period of time, endothelialization takes place and the filter will subsequently become attached to the vena cava. This endothelialization may cause further occlusion of the vessel, thereby contributing to the problem the filter was intended to solve. Except for the Gunther device, these prior art filters do not address this problem.

A temporary venous filter device is disclosed in Bajaj, U.S. Pat. No. 5,053,008. This device treats emboli in the pulmonary artery which, despite its name, is in fact a vein. The Bajaj device is an intracardiac catheter for temporary placement in the pulmonary trunk of a patient predisposed to pulmonary embolism because of hip surgery, stroke or cerebral hemorrhage, major trauma, major abdominal or pelvic surgery, neurosurgery, neoplasm, sepsis, cardiorespiratory failure or immobilization.

The Bajaj device includes an umbrella made from meshwork which traps venous emboli before they reach the lungs. This device can also lyse emboli with a thrombolytic agent such as tissue plasminogen activator (TPA), destroy emboli with high velocity ultrasound energy, and remove emboli by vacuum suction through the lumen of the catheter. This very complex device is designed for venous filtration and is difficult to justify when good alternative treatments exist.

There are very few intravascular devices designed for arterial use. A filter that functions not only in veins, but also in arteries must address additional concerns because of the hemodynamic differences between arteries and veins. Arteries are much more flexible and elastic than veins and, in the arteries, blood flow is pulsatile with large pressure variations between systolic and diastolic flow. These pressure variations cause the artery walls to expand and contract. Blood flow rates in the arteries vary from about 1 to about 5 L/min.

Ginsburg, U.S. Pat. No. 4,873,978, discloses an arterial device. This device includes a catheter that has a strainer device at its distal end. This device is normally used in conjunction with non-surgical angioplastic treatment. This device is inserted into the vessel downstream from the treatment site and, after the treatment, the strainer is collapsed around the captured emboli, and the strainer and emboli are removed from the body. The Ginsburg device could not withstand flow rates of 5 L/min. It is designed for only small arteries and therefore could not capture emboli destined for all parts of the body. For example, it would not catch emboli going to the brain.

Ing. Walter Hengst GmbH & Co, German Patent DE 34 17 738, discloses another filter which may be used in the arteries of persons with a risk of embolism. This filter has an inherent tension which converts the filter from the collapsed to the unfolded state, or it can be unfolded by means of a folding linkage system. This folding linkage system comprises a plurality of folding arms spaced in parallel rows along the longitudinal axis of the conical filter (roughly similar to branches on a tree). The folding arms may be provided with small barbs at their projecting ends intended to penetrate the wall of the blood vessel to improve the hold of the filter within the vessel.

Moreover, da Silva, Brazil Patent Application No. PI9301980A, discusses an arterial filter for use during certain heart operations where the left chamber of the heart is opened. The filter in this case is used to collect air bubbles in addition to formed particles such as platelet fibrin clots not removed on cleaning the surgical site.

Each of the existing methods of blocking aortic blood flow carries with it some undesired aspects. The mechanical cross clamp offers simplicity and reliably consistent operation. However, the physical clamping action on the vessel has been linked to may adverse body responses. Barbut et al. noted the majority of embolic events (release) is associated with the actuation and release of the cross clamp during coronary bypass graph surgery. The clamping action may be responsible for breaking up and freeing atherosclerotic buildup on the vessel walls. In addition, the potential for vascular damage, like aortic dissections, may also incur during the clamp application.

The percutaneous balloon catheter occluder has a distinct drawback in that it must be placed with visionary assistance. Fluoroscopy is typically used to position the device in the aorta. This added equipment is not always readily available in the surgical suite. In addition, the catheter placement up to the aorta may also create additional vascular trauma and emboli generation.

The use of a Foley catheter to occlude the aorta requires an additional incision site to place the device. This extra cut is an additional insult site and requires sutures to close. Generation of emboli and the potential of aortic dissection directly associated with just the incision may potentially outweigh the benefits of using the balloon occlusion technique.

The aortic balloon occluder cannula addresses many of the deficiencies of the previous devices. Placement is easy to visualize and no extra cuts are required. With the cardioplegia port included, this design offers a complete package while potentially reducing the number of incision sites and removing the need for the potentially traumatic cross clamp. However, this “all-in-one” design possesses several deficiencies. First, there is one inherent drawback with using a balloon to occlude a vessel. Balloons are always susceptible to failure (e.g., popping, leaking). In addition, the cannula has a limited placement region. It must be inserted sufficiently proximal to the innominate artery to allow room for occlusion balloon to seat within the vessel and not occlude or block the innominate artery. This cannula design has at least two critical functions (three with the cardioplegia port). A balloon failure means either replacing the cannula (stopping the CPB and cardioplegia), or immediately placing the cross clamp and inserting a cardioplegia cannula. Life support, occlusion, and cardioplegia depend on one device. This situation is less than optimal. The risks associated to a failure are multiplied when one device is used for more than one critical operation.

A need exists for an arterial cannula having both a balloon occluder, which reduces or eliminates the need for aortic cross-clamping, a major contributor to atheromatous embolization, and an associated filter which captures any embolic material dislodged during balloon occlusion. Existing devices are inadequate for this purpose.

SUMMARY OF THE INVENTION

The present invention relates to arterial medical devices, and particularly cannulas and catheters having an occlusion balloon and optionally a blood filter device, and to methods of using the devices during cardiac surgery. The devices of the present invention may be adapted to filter embolic material from the blood. Embolic material or foreign matter is any constituent of blood, including gaseous material and particulate matter, which may cause complications in the body if allowed to travel freely in the bloodstream. This matter includes but is not limited to atheromatous fragments, fat, platelets, fibrin, clots, or gaseous material.

In one embodiment, the device includes a blood cannula having a balloon occluder at a distal region of the blood cannula. In another embodiment, the device includes an intravascular catheter having a balloon occluder at a distal region of the catheter. The balloon occluder may consist of a flexible material surrounding a chamber which is expandable between a deflated, contracted condition and an inflated, enlarged condition. The balloon occluder may be circumferentially disposed about a distal region of the catheter or blood cannula, or may be attached to the catheter or blood cannula at a specific radial position about the distal region of the catheter or blood cannula. The balloon occluder, when in the contracted condition, is closely associated with the distal region of the catheter or blood cannula, while the balloon occluder expands upon inflation to occupy an area which may occlude blood flowing within an artery.

In another embodiment, the blood cannula or catheter will further include filtration means disposed about the distal region of the catheter or blood cannula. Several designs for blood filtration cannulas are disclosed in Barbut et al., U.S. application Ser. No. 08/553,137, filed Nov. 7, 1995, Barbut et al., U.S. application Ser. No. 08/580,223, filed Dec. 28, 1995, Barbut et al., U.S. application Ser. No. 08/584,759, filed Jan. 9, 1996, and Barbut et al., U.S. application Ser. No. 08/640,015, filed on Apr. 30, 1996, and Barbut et al., U.S. Application Serial No. [attorney docket no. 224/194], filed Apr. 16, 1997, and the contents of each of these prior applications are incorporated herein by reference in their entirety. Thus, in one embodiment, the balloon aortic cannula as disclosed herein will include a filtration means having an expandable member, such as an inflation seal, disposed about the distal end of the blood cannula, which is expandable between a deflated, contracted condition and an inflated, enlarged condition. The filtration means will further include a mesh having an edge attached to the expansion means. The mesh may optionally include a second edge which is closely associated with the outer surface of the blood cannula, or the mesh may be continuous and unbroken at its distal region. The filtration means will generally be disposed about the distal end of the blood cannula and the balloon occluder at a region proximal of the mesh, so that the balloon occluder expands upon inflation to substantially occlude an artery upstream of the mesh. For those embodiments using an intravascular catheter, the balloon occluder is typically upstream of the filtration means, or with reference to the catheter, distal the filtration means.

In another embodiment, a cannula with filtration means further includes a blood flow diffuser. The blood flow diffuser may be located inside or outside of the blood cannula. In both the intra-cannula and extra-cannula diffuser embodiments, the flow diffuser can be located either proximal or distal to the filtration means. The diffuser may be similarly used for intravascular catheter embodiments of the device.

In another embodiment, a cannula with attached filtration means includes a sleeve which, when unrolled, captures the filtration means thereby closely securing the filter components against the cannula wall during insertion and retraction. The sleeve may be similarly used for intravascular catheter embodiments of the device. In another embodiment, a cannula is made of an elastomeric material which collapses along part of the cannula length so as to absorb the filtration means during cannula insertion and retraction.

In an alternate embodiment, a blood cannula includes a conduit to provide a solution, such as cardioplegia solution, to the heart side of an aortic balloon occluder while providing oxygenated blood into the arterial circulation of the systemic side of the occluder.

The methods of the present invention include protecting a patient from embolization during cardiac surgery by using a balloon aortic cannula as described above or other intravascular or intra-arterial procedure resulting in distal embolization. The distal end of the arterial cannula is inserted into a patient's aorta while the filtration and expansion means is in the contracted condition. The expansion means, including associated mesh, is inflated to expand and thereby achieve contact with the inner wall of the artery, preferably the aorta. Once the filtration means are in place and deployed, the balloon occluder is activated by inflating to occlude the artery, preferably the aorta, in a region upstream of the mesh. In other embodiments, the balloon occluder may be inflated before the expansion means is inflated. During balloon occlusion, certain embolic material may be dislodged from the artery, and thereafter captured by the deployed filtration system. The cannula is used to supply blood to the aorta from a bypass-oxygenator machine. A surgical procedure may then be performed on the heart, aorta, or vasculature upstream of the deployed filtration system. During this procedure, further embolic material may be dislodged and enter the circulation, and thereafter be captured by the deployed filtration mesh. After the surgery is performed, the balloon occluder is deflated, and further embolic material may be dislodged and captured by the filtration system. The expansion means of the filtration system is then contracted by deflating to resume a small shape, and the arterial cannula with captured embolic material is removed from the aorta.

In a preferred method, balloon occlusion occurs, and blood is filtered during cardiac surgery, in particular during cardiac bypass surgery, to protect a patient from embolization. In this method, the mesh is positioned in the aorta where it filters blood before it reaches the carotid arteries, brachiocephlalic trunk, and left subclavian artery.

The present invention was developed, in part, in view of a recognition of the occurrence of embolization during cardiac surgery. Emboli are frequently detected in cardiac surgery patients and have been found to account for neurologic, cardiac and other systemic complications. Specifically, embolization appears to contribute significantly to problems such as strokes, lengthy hospital stays and, in some cases, death. Of the patients undergoing cardiac surgery, 5-10% experience strokes and 30% become cognitively impaired. In addition, it has been recognized that embolization is often the result of procedures performed on blood vessels such as incising, clamping, and cannulation, wherein mechanical or other force is applied to the vessel. See, for example, Barbut et al., “Cerebral Emboli Detected During Bypass Surgery Are Associated With Clamp Removal,” Stroke 25(12):2398-2402 (1994), which is incorporated herein by reference in its entirety. These procedures are commonly performed in many different types of surgery including cardiac surgery, coronary artery surgery including coronary artery bypass graft surgery, aneurysm repair surgery, angioplasty, atherectomy, and endarterectomy, including carotid endarterectomy. It has also been recognized that reintroducing blood into blood vessels with a cannula or catheter during these procedures can dislodge plaque and other emboli-creating materials as a result of blood impinging upon the vessel wall at high velocities. See, for example, Cosgrove et. al., Low Velocity Aortic Cannula, U.S. Pat. 5,354,288.

Finally, it has been found that the occurrence of embolization is more likely in certain types of patients. For example, embolization occurs more frequently in elderly patients and in those patients who have atheromatosis. In fact, atheromatous embolization, which is related to severity of aortic atheromatosis, is the single most important contributing factor to perioperative neurologic morbidity in patients undergoing cardiac surgery.

Embolic material, which has been detected at 2.88 mm in diameter, will generally range from 0.02 mm (20 μm) to 5 mm, and consists predominantly of atheromatous fragments dislodged from the aortic wall and air bubbles introduced during dissection, but also includes platelet aggregates which form during cardiac surgery. See Barbut et al., “Determination of Embolic Size and Volume of Embolization During Coronary Artery Bypass Surgery Using Transesophageal Echocardiography,” J. Cardiothoracic Anesthesia (1996). These emboli enter either the cerebral circulation or systemic arterial system. Those entering the cerebral circulation obstruct small arteries and lead to macroscopic or microscopic cerebral infarction, with ensuing neurocognitive dysfunction. Systemic emboli similarly cause infarction, leading to cardiac, renal, mesenteric, and other ischemic complications. See Barbut et al., “Aortic Atheromatosis And Risks of Cerebral Embolization,” Journal of Cardiothoracic and Vascular Anesthesia 10(1):244-30 (1996), which is incorporated herein by reference in its entirety.

Emboli entering the cerebral circulation during coronary artery bypass surgery have been detected with transcranial Doppler ultrasonography (TCD). TCD is a standard visualization technique used for monitoring emboli in the cerebral circulation. To detect emboli using TCD, the middle cerebral artery of a bypass patient is continuously monitored from aortic cannulation to bypass discontinuation using a 2 MHZ pulsed-wave TCD probe (Medasonics-CDS) placed on the patient's temple at a depth of 4.5 to 6.0 cm. The number of emboli is determined by counting the number of embolic signals, which are high-amplitude, unidirectional, transient signals, lasting less than 0.1 second in duration and associated with a characteristic chirping sound.

TCD is useful in analyzing the relationship between embolization and procedures performed on blood vessels. For example, the timing of embolic signals detected by TCD have been recorded along with the timing of procedures performed during open or closed cardiac surgical procedures. One of these procedures is cross-clamping of the aorta to temporarily block the flow of blood back into the heart. It has been found that flurries of emboli are frequently detected after aortic clamping and clamp release. During the placement and removal for the clamps, atheromatous material along the aortic wall apparently becomes detached and finds its way to the brain and other parts of the body. Similarly, flurries of emboli are also detected during aortic cannulation and inception and termination of bypass.

Transesophageal echocardiography (TEE), another standard visualization technique known in the art, is significant in the detection of conditions which may predispose a patient to embolization. TEE is an invasive technique, which has been used, with either biplanar and multiplanar probes, to visualize segments of the aorta, to ascertain the presence of atheroma. This technique permits physicians to visualize the aortic wall in great detail and to quantify atheromatous aortic plaque according to thickness, degree of intraluminal protrusion and presence or absence of mobile components, as well as visualize emboli within the vascular lumen. See, for example, Barbut et al., “Comparison of Transcranial Doppler and Transesophageal Echocardiography to Monitor Emboli During Coronary Bypass Surgery,” Stroke 27(1):87-90 (1996) and Yao, Barbut et al., “Detection of Aortic Emboli By Transesophageal Echocardiography During Coronary Artery Bypass Surgery,” Journal of Cardiothoracic Anesthesia 10(3):314-317 (May 1996), and Anesthesiology 83(3A):A126 (1995), which are incorporated herein by reference in their entirety. Through TEE, one may also determine which segments of a vessel wall contain the most plaque. For example, in patients with aortic atheromatous disease, mobile plaque has been found to be the least common in the ascending aorta, much more common in the distal arch and most frequent in the descending segment. Furthermore, TEE-detected aortic plaque is unequivocally associated with stroke. Plaque of all thickness is associated with stroke but the association is strongest for plaques over 4 mm in thickness. See Amarenco et al., “Atherosclerotic disease of the aortic arch and the risk of ischemic stroke,” New England Journal of Medicine 331:1474-1479 (1994).

Another visualization technique, intravascular ultrasound, is also useful in evaluating the condition of a patient's blood vessel. Unlike the other techniques mentioned, intravascular ultrasound visualizes the blood vessel from its inside. Thus, for example, it may be useful for visualizing the ascending aorta overcoming deficiencies of the other techniques. In one aspect of the invention, it is contemplated that intravascular ultrasound is useful in conjunction with devices disclosed herein. In this way, the device and visualizing means may be introduced into the vessel by means of a single catheter.

Through visualization techniques such as TEE epicardial aortic ultrasonography and intravascular ultrasound, it is possible to identify the patients with plaque and to determine appropriate regions of a patient's vessel on which to perform certain procedures. For example, during cardiac surgery, in particular, coronary artery bypass surgery, positioning a probe to view the aortic arch allows monitoring of all sources of emboli in this procedure, including air introduced during aortic cannulation, air in the bypass equipment, platelet emboli formed by turbulence in the system and atheromatous emboli from the aortic wall. Visualization techniques may be used in conjunction with a blood filter device to filter blood effectively. For example, through use of a visualization technique, a user may adjust the position of a blood filter device, and the degree of actuation of that device as well as assessing the efficacy of the device by determining whether foreign matter has bypassed the device.

It is an object of the present invention to eliminate or reduce the problems that have been recognized as relating to embolization. The present invention is intended to capture and remove emboli in a variety of situations, and to reduce the number of emboli by obviating the need for cross-clamping. For example, in accordance with one aspect of the invention, blood may be filtered in a patient during procedures which affect blood vessels of the patient. The present invention is particularly suited for temporary filtration of blood in an artery of a patient to capture embolic debris. This in turn will eliminate or reduce neurologic, cognitive, and cardiac complications helping to reduce length of hospital stay. In accordance with another aspect of the invention, blood may be filtered temporarily in a patient who has been identified as being at risk for embolization.

As for the devices, one object is to provide simple, safe and reliable devices that are easy to manufacture and use. A further object is to provide devices that may be used in any blood vessel. Yet another object is to provide devices that will improve surgery by lessening complications, decreasing the length of patients' hospital stays and lowering costs associated with the surgery. See Barbut et al., “Intraoperative Embolization Affects Neurologic and Cardiac Outcome and Length of Hospital Stay in Patients Undergoing Coronary Bypass Surgery,” Stroke (1996).

The devices disclosed herein have the following characteristics: can withstand high arterial blood flow rates for an extended time; include a mesh that is porous enough to allow adequate blood flow in a blood vessel while capturing mobile emboli; can be used with or without imaging equipment; remove the captured emboli when the operation has ended; will not dislodge mobile plaque; and can be used in men, women, and children of varying sizes.

As for methods of use, an object is to provide temporary occlusion and filtration in any blood vessel and more particularly in any artery. A further object is to provide a method for temporarily filtering blood in an aorta of a patient before the blood reaches the carotid arteries and the distal aorta. A further object is to provide a method for filtering blood in patients who have been identified as being at risk for embolization. Yet a further object is to provide a method to be carried out in conjunction with a blood filter device and visualization technique that will assist a user in determining appropriate sites of filtration. This visualization technique also may assist the user in adjusting the blood filter device to ensure effective filtration. Yet a further object is to provide a method for filtering blood during surgery only when filtration is necessary. Yet another object is to provide a method for eliminating or minimizing embolization resulting from a procedure on a patient's blood vessel by using a visualization technique to determine an appropriate site to perform the procedure.

Another object is to provide a method for minimizing incidence of thromboatheroembolisms resulting from cannula and catheter procedures by coordinating filtration and blood flow diffusion techniques in a single device. Another object is to provide a method of inserting or retrieving a cannula or catheter with attached filtering means from a vessel while minimizing the device's profile and diameter.

Thus, we disclose herein each of the individual designs listed below which are grouped into three categories.



DESIGN	ADVANTAGE

Aortic cannula based:

Mechanical Occluder

1.

No additional holes/incisions required.

1.	Basket withdam	2.	Reliable actuation mechanism.
2.	Basket with dam and	3.	Non-migrating positioning seal. Stability.
	inflatable seal	4.	Rugged design; will not burst (except #2)
3.	Basket with removable	5.	No fluoroscopy required.
	dam	6.	Potentially less traumatic to vessel than
4.	Expandable wire basket		mechanical cross clamps.

Inflatable Occluder

1.

No additional holes/incisions required

1.	Balloon with adhesive		(except #4).
	seal	2.	Conforming seal; adjusts to any shape.
2.	Self-inflating balloon	3.	Potentially less traumatic to vessel than
3.	Self-inflating balloon		mechanical cross clamps.
	on acollapsible cannula	4.	Adhesive seal reduces potential for leakage and adds
4.	Balloon catheter		to occluder stability.
5.	Balloon catheter with	5.	Self-inflating units are self-sealing occluder.
	aortic cannula	6.	Catheter systems decoupled from cannula.
	introducer		Units can be inserted to desired location
6.	Balloon catheter with		independent of cannula position.
	aortic cannula	7.	No fluoroscopy required.
	introducer and guide

Cardioplegia cannula based:

Inflatable Occluder

1.

Same as other inflatable occluders (listed

1.	Balloon cannula		above).
2.	Balloon catheter	2.	Occlusion device separate from aortic
	through cannula		cannula. Reduces complexity of critical
3.	Port access occluder		device.
		3.	Port access design does not require partial or full
			sternotomy.
		4.	No fluoroscopy required.

BRIEF DESCRIPTION OF DRAWINGS

Reference is next made to a brief description of the drawings, which are intended to illustrate balloon aortic cannula and catheter devices for use herein. The drawings and detailed description which follow are intended to be merely illustrative and are not intended to limit the scope of the invention as set forth in the appended claims.

FIG. 1 is a longitudinal view of a balloon aortic cannula according to one embodiment having the filter deployed and the balloon occluder in the contracted condition;

FIGS. 2A, 2B, and2C are cross-sectional views through section line2-2 of the device depicted inFIG. 1, showing the balloon occluder at successive degrees of inflation;

FIG. 3 is a longitudinal view of the balloon aortic cannula depicted inFIG. 1, showing the balloon occluder in the fully expanded condition and disposed circumferentially about the blood cannula;

FIG. 4 is a longitudinal view of a balloon aortic cannula according to another embodiment, showing the filter deployed and the balloon occluder in the contracted condition at a radial position about the distal region of the balloon aortic cannula;

FIG. 5 is a longitudinal view of the balloon aortic cannula according toFIG. 4, showing the balloon occluder and filter deployed after insertion of the cannula into the aorta;

FIG. 6 is a longitudinal view of a balloon aortic cannula according to another embodiment;

FIG. 7 is a longitudinal view of a balloon aortic cannula according to another embodiment, wherein the filter mesh is continuous;

FIG. 8 is a longitudinal view of a balloon aortic cannula according to another embodiment;

FIG. 9 is a longitudinal view of a balloon aortic cannula according to another embodiment;

FIG. 9A is a cross-sectional view through section line A-A of the device depicted inFIG. 9;

FIG. 10 is a longitudinal view of a balloon aortic cannula according to another embodiment; and

FIG. 11 is a longitudinal view of an arterial balloon catheter disposed within the aorta and having a balloon occluder and filter deployed therein.

FIG. 12 is a longitudinal view of a balloon aortic cannula according to another embodiment, wherein a flow diffuser is included at a location distal to the filter;

FIG. 12ais a detail of the flow diffuser ofFIG. 12;

FIG. 13 is a longitudinal view of a balloon aortic cannula according to another embodiment, wherein a flow diffuser is included at a location distal to the filter;

FIG. 13ais a detail of the flow diffuser ofFIG. 13;

FIG. 14 is a longitudinal view of a balloon aortic cannula according to another embodiment, wherein a flow diffuser is included at a location proximal to the filter.

FIG. 15 is a longitudinal view of a balloon aortic cannula according to another embodiment, wherein a flow diffuser is included at a location proximal to the filter.

FIG. 16 is a longitudinal view of a balloon aortic cannula according to another embodiment wherein the cannula includes a condom-like filter sleeve shown in a rolled back position.

FIG. 17 is a longitudinal view of the balloon aortic cannula ofFIG. 16 wherein the unrolled filter sleeve has captured the filter means.

FIG. 18 shows detail of an unrolled filter sleeve and accompanying control lines.

FIG. 19 is a three-dimensional drawing of a balloon aortic cannula with a filter sleeve in the rolled up position.

FIG. 19A shows the cannula ofFIG. 19 in use.

FIG. 20 is a longitudinal view of a balloon aortic cannula including a sleeve deployable by virtue of a pulley mechanism.

FIG. 21 is a longitudinal view of a balloon aortic cannula wherein the cannula has a collapsible section which can accommodate the lip of the filter.

FIG. 22 is a longitudinal view of a balloon aortic elastic cannula wherein the cannula's outer diameter and filter profile are reduced by introduction of a stylet in the cannula's central lumen.

FIG. 23 is a longitudinal view of a balloon aortic elastic cannula wherein the elastic cannula is in a relaxed state.

FIG. 24 is a longitudinal view of a cannula wherein the expander is proximal to the collapsible portion of the distal cannula.

FIG. 25 is a longitudinal view of a cannula wherein the expander has been inserted into the collapsible portion of the distal cannula.

FIGS. 26 and 26cdepict a cannula wherein the filter has an elastomeric compliant edge which conforms to vessel irregularities.

FIGS. 26a, 26band26dshow other views of the cannula depicted inFIG. 26c.

FIG. 27 shows a cannula having an open-ended sleeve disposed within the aorta.

FIG. 28 is a longitudinal view of a balloon aortic cannula wherein the filter and balloon are of integrated construction.

FIG. 29 is a longitudinal view of a balloon aortic cannula wherein the balloon occluder contains a conduit for delivery of solutions to the heart side of the occluder.

FIG. 30 is a longitudinal view of a catheter as inFIG. 11 wherein the catheter contains openings and lumens for delivery of solutions to the heart side of the balloon occluder.

FIG. 31 is a longitudinal view of a cannula with blocking dam.

FIGS. 32 and 32A are longitudinal views of a balloon occluder on catheter.

FIGS. 33 and 33A are longitudinal views of a cannula with self-expanding balloon.

FIG. 34 is a longitudinal view of an adhesive coated balloon cannula.

FIGS. 35 and 35A are longitudinal views of an expandable wire occluder.

FIG. 36 is a longitudinal view of a cannula introducer.

FIG. 37 is a longitudinal view of an integrated occlusion cape.

FIG. 38 is a longitudinal view of a cardioplegia occlusion cannula in use.

FIG. 39 is a longitudinal view of a cannula with occluder guide.

FIG. 40 is a depiction of the sternum and aorta of a patient having an occlusion cannula in use.

FIG. 41 is a longitudinal view of an L-shaped single-piece occluder.

FIG. 42 is a longitudinal view of a J-shaped single-piece occluder.

FIG. 43 is a depiction of a multiple component port access aortic occluder.

FIG. 44 is a longitudinal view of a balloon aortic cannula in use.

FIG. 45 is a longitudinal view of a cardioplegia cannula and balloon catheter in use.

FIG. 46 is a longitudinal view of a cardioplegia balloon cannula in use.

DETAILED DESCRIPTION

To filter blood effectively, i.e., to capture embolic material, without unduly disrupting blood flow, the mesh must have the appropriate physical characteristics, including area (A_M), thread diameter (D_r), and pore size (S_P). In the aorta, the mesh40 must permit flow rates as high as 3 L/min or more, more preferably 3.5 L/min or more, more preferably 4 L/min or more, more preferably 4.5 L/min or more, more preferably 5 L/min or more preferably 5.5 L/min or more, and most preferably 6 L/min or more at pre-filter pressures (proximal to the mesh) of around 120 mm Hg or less.

In order to capture as many particles as possible, mesh with the appropriate pore size must be chosen. The dimensions of the particles to be captured is an important factor in this choice. In the aorta during cardiac surgery, for example, individual particle diameter has been found to range from 0.27 mm to 2.88 mm, with a mean diameter of 0.85 mm, and individual particle volume has been found to range from 0.01 mm³to 12.45 mm³, with a mean particle volume of 0.32 mm³. Approximately 27 percent of the particles have been found to measure 0.6 mm or less in diameter. During cardiac bypass surgery in particular, the total aortic embolic load has been found to range from 0.57 cc to 11.2 cc, with a mean of 3.7 cc, and an estimated cerebral embolic load has been found to range from 60 mm³to 510 mm, with a mean of 276 mm³.

By way of example, when a device as disclosed herein is intended for use in the aorta, the area of the mesh required for the device is calculated in the following manner. First, the number of pores N_Pin the mesh is calculated as a function of thread diameter, pore size, flow rate, upstream pressure and downstream pressure. This is done using Bernoulli's equation for flow in a tube with an obstruction:

\frac{P_{1}}{ρ * g} + \frac{V_{1}^{2}}{2 * g} = \frac{P_{2}}{ρ * g} + \frac{V_{2}^{2}}{2 * g} * A

In this equation, P is pressure, ρ is density of the fluid, g is the gravity constant (9.8 m/s²), V is velocity, K represents the loss constants, and f is the friction factor. Thenumbers 1 and 2 denote conditions upstream and downstream, respectively, of the filter.

The following values are chosen to simulate conditions within the aorta:
P₁=120 mm Hg;
P₂=80 mm Hg;
K_entry=0.5;
K_exit=1.0;
K=K_entry+K_exit; and

{[\frac{D_{T}}{S_{P}}]}_{Equiv} is 30.

Assuming laminar flow out of the mesh filter, f is given as
64/Re
where Re is the Reynold's number and the Reynold's number is given by the following equation:

Re = \frac{(ρ * Q * S_{P})}{(μ * N_{P} * A_{h})}

where μ is the kinematic viscosity of the fluid and A_his the area of one hole in the mesh given by S_P*S_P.

Conservation of the volume dictates the following equation:

N_{P} * V_{2} * A_{h} = Q OR V_{2} = \frac{Q}{(N_{P} * A_{h})}

where Q is the flow rate of the blood. In addition, V₁is given by:

V_{1} = \frac{Q}{A_{vessel}}

where A_vesselis the cross-sectional area of the vessel. Substitution and manipulation of the above equations yields N_p.

Next, the area of the mesh is calculated as a function of the number of pores, thread diameter and pore size using the following equation:
A_M−N_P*(D_T+S_P)²

The calculation set forth above has been made with reference to the aorta. It will be understood, however, that blood flow parameters within any vessel other than the aorta may be inserted into the equations set forth above to calculate the mesh area required for a blood filter device adapted for that vessel.

To test the mesh under conditions simulating the conditions within the body, fluid flow may be observed from a reservoir through a pipe attached to the bottom of the reservoir with the mesh placed over the mouth of the pipe through which the fluid exits the pipe. A mixture of glycerin and water may be used to simulate blood. Fluid height (h) is the length of the pipe in addition to the depth of the fluid in the reservoir, and it is given by the following equation:

h = \frac{P}{(ρ * g)}

where ρ is given by the density of the glycerin-water mixture, and g is given by the gravity constant (9.8 ms²).

Bernoulli's equation (as set forth above) may be solved in order to determine (D_t/S_P)_Equiv. V₁is given by the following equation:

V_{1} = \frac{Q}{A_{1}}

where Q is the flow rate which would be measured during testing and A₁is the cross-sectional area of the pipe. V₂is given by the following equation:

V_{2} = \frac{Q}{(N * A_{2})}

where N is the number of pores in the mesh and A₂is the area of one pore. Further, P₁=120 mm Hg and P₂=0 m Hg and S_Pis the diagonal length of the pore. Reynold's number (Re) is given by the following equation:

Re = \frac{(ρ * V_{2} * D)}{μ}

where ρ and μ are, respectively, the density and kinematic viscosity of the glycerin-water mixture.

Once appropriate physical characteristics are determined, suitable mesh can be found among standard meshes known in the art. For example, polyurethane meshes may be used, such as Saati and Tetko meshes. These are available in sheet form and can be easily cut and formed into a desired shape. In a preferred embodiment, the mesh is sonic welded into a cone shape. Other meshes known in the art, which have the desired physical characteristics, are also suitable. Anticoagulants, such as heparin and heparinoids, may be applied to the mesh to reduce the chances of blood clotting on the mesh. Anticoagulants other than heparinoids also may be used, e.g., monoclonal antibodies such as ReoPro (Centocore). The anticoagulant may be painted or sprayed onto the mesh. A chemical dip comprising the anticoagulant also may be used. Other methods known in the art for applying chemicals to mesh may be used.

In an embodiment of the devices suited for placement in the aorta, the expansion means, upon deploymnent, has an outer diameter of approximately 100 Fr., more preferably 105 Fr., more preferably 110 Fr., more preferably 115 Fr., more preferably 120 Fr., and most preferably 125 Fr., or greater, and an inner diameter of approximately 45 Fr. (1 Fr.=0.13 in.) when fully inflated. The dimensions of the expansion means may be adjusted in alternative embodiments adapted for use in vessels other than the aorta. Alternatively, expandable members other than a balloon also may be used with this invention. Other expandable members include the umbrella frame with a plurality of arms as described in U.S. application Ser. Nos. 08/533,137, 08/580,223, 08/584,759, 08/640,015, [attorney docket no. 224/194], and [attorney docket no. 222/133].

All components of this device should be composed of materials suitable for insertion into the body. Additionally, sizes of all components are determined by dimensional parameters of the vessels in which the devices are intended to be used. These parameters are shown by those skilled in the art.

By way of purely illustrative example, the operational characteristics of a filter according to the invention and adapted for use in the aorta are as follows:



	Temperature Range	25-39 degrees C.
	Pressure Range	50-150 mmHg
	Flow Rate	usually up to 5 L/min., can be
		as high as 6 L/min.
	Duration of single use	up to approximately 5 hours
	Average emboli trapped	5-10,000
	Pressure gradient range	(100-140)/(50-90)

Modification of the operational characteristics set forth above for use in vessels other than the aorta are readily ascertainable by those skilled in the art in view of the present disclosure. An advantage of all embodiments disclosed herein is that the blood filter will capture emboli which may result from the incision through which the blood filter is inserted. Another advantage is that both the balloon occluder and the filter means enter the vessel through the same incision created for the blood cannula, and therefore the devices and methods herein economize on incisions made in the blood vessel, often the aorta.

In addition, use of visualization techniques is also contemplated in order to determine which patients require filtration (identify risk factors), where to effectively position a blood filter device to maximize effectiveness, when to adjust the device if adjustment is necessary, when to actuate the device and appropriate regions for performing any procedures required on a patient's blood vessel.

In accordance with one aspect of the invention, a visualization technique, such as TCD, is used to determine when to actuate a blood filter device. For example, during cardiac bypass surgery, flurries of emboli are detected during aortic cannulation, inception, and termination of bypass and cross-clamping of the aorta. Therefore, a mesh may be opened within a vessel downstream of the aorta during these procedures and closed when embolization resulting from these procedures has ceased. Closing the mesh when filtration is not required helps to minimize obstruction of the blood flow.

According to another embodiment, a visualization technique is used to monitor emboli entering cerebral circulation to evaluate the effectiveness of a blood filter device in trapping emboli. Also, a visualization technique is useful to positioning a device within a vessel so that it operates at optimum efficiency. For example, a user may adjust the position of the device if TCD monitoring indicates emboli are freely entering the cerebral circulation. In addition, a user may adjust a mesh of a blood filter device to ensure that substantially all of the blood flowing in the vessel passes through the mesh.

According to yet another embodiment, a visualization technique, such as intravascular ultrasonography, TEE, and epicardial aortic ultrasonography, is used to identify those patients requiring blood filtration according to the present invention. For example, these visualization techniques may be used to identify patients who are likely to experience embolization due to the presence of mobile plaque. These techniques may be used before the patient undergoes any type of procedure which will affect a blood vessel in which mobile plaque is located.

Additionally, visualization techniques may be used to select appropriate sites on a blood vessel to perform certain procedures to eliminate or reduce the occurrence of embolization. For example, during cardiac bypass surgery, the aorta is both clamped and cannulated. According to methods disclosed herein, the step of clamping may be replaced by deployment of a balloon occluder. These procedures frequently dislodge atheromatous material already present on the walls of the aorta. To minimize the amount of atheromatous material dislodged, a user may clamp or cannulate a section of the aorta which contains the least amount of atheromatous material, as identified by TEE, epicardial aortic ultrasonography or other visualization technique such as intravascular ultrasonography.

Procedures other than incising and clamping also tend to dislodge atheromatous material from the walls of vessels. These procedures include, but are not limited to, dilatation, angioplasty, and atherectomy.

Visualization techniques also may be used to select appropriate sites for filtering blood. Once atheromatous material is located within a vessel, a blood filter device may be placed downstream of that location.

Visualization techniques, other than those already mentioned, as are known to those skilled in the art, are also useful in ascertaining the contours of a blood vessel affected by surgical procedure to assess a variety of risk of embolization factors, and to locate appropriate sections of a vessel for performing certain procedures. Any suitable visualization device may be used to evaluate the efficacy of a device, such as those disclosed herein, in trapping emboli.

In one embodiment, a balloon aortic cannula with associated filter is provided as depicted inFIG. 1. The balloon aortic cannula may include a pressurizingcannula50 having a proximal region, a distal region, and an intermediate region which connects the proximal and distal regions. The pressurizingcannula50 is typically a rigid or semi-rigid, preferably transparent tube having a first substantially cylindrical lumen which extends from the proximal region to the distal region and is shaped to receiveblood supply cannula10 or an additional side port (not shown). The pressurizingcannula50 may further include asecond lumen60 in fluid communication withballoon occluder65 disposed about the distal region of pressurizingcannula50. With reference toFIG. 1,balloon occluder65 is shown in the deflated, contracted condition, having a minimal cross-sectional diameter for entry through an incision inaorta99.Lumen60 is adapted to inflateballoon occluder65 by use of a gas, or preferably saline, under pressure. The proximal end of thecannula50 may include any of the features disclosed in U.S. application Ser. Nos. 08/553,137, 08/580,223, and 08/584,759.

Blood supply cannula

10 may have certain features in common with a standard arterial cannula and is generally a substantially cylindrical, semi-rigid, and preferably transparent tube. The blood cannula is slidable within the pressurizing cannula, and the blood cannula will typically include a fitting or molded joint at its proximal end (not shown) which is adapted for coupling to a bypass-oxygenator system, and may have any of the features disclosed in U.S. application Ser. Nos. 08/553,137, 08/580,223, and 08/584,759.Blood cannula10 is adapted to carry blood to the aorta from the bypass-oxygenator system.

With reference toFIG. 1, the distal region of pressurizingcannula50 is shown with blood filtration means deployed in the ascending region of ahuman aorta99. The distal region of pressurizingcannula50 includes a plurality of spokes or holdingstrings55 made from Dacron® or other suitable material. Holding strings55 connect the distal region of the pressurizingcannula50 to an expansion means70, preferably an inflation seal which comprises a continuous ring of thin tubing attached to filtermesh75 on its outer side.Filter mesh75 is bonded at its distal end around the circumference ofblood cannula10, preferably at a cross-sectional position near the distal end ofblood cannula10.

Inflation seal

Chamber

71 is in fluid communication with a firsttubular passage56 and a secondtubular passage57 which permitchamber71 to be inflated with gas, or preferably a fluid such as saline.Passage57 is in fluid communication with a third lumen of pressurizing cannula50 (not shown), whilepassage56 is ill fluid communication with a fourth lumen of pressurizing cannula50 (not shown).

Passages

56 and57 therebyinterconnect chamber71 with the third and fourth lumens, respectively, of pressurizingcannula50.

In certain embodiments,inflation seal70 will include a septum (not shown) which blocks the movement of fluid in one direction aroundchamber71. If the septum is positioned in close proximity to the fluid entry port, then the injection of fluid will push all gas inchamber71 aroundinflation seal70 and out throughpassage56. In one embodiment, the entry port and the exit port are positioned in close proximity, with the septum disposed between the entry and exit port. In this case, injection of fluid will force virtually all gas out ofinflation seal70.

Filter mesh

In certain embodiments, the pressurizingcannula50 will be provided with an additional lumen (not shown) in fluid communication withballoon occluder65. A system having two lumens in communication withballoon occluder65 can be used to enter saline into the balloon occluder and purge all gas therefrom to prevent the formation of an air embolism in a patient's circulation should the balloon occluder rupture during use. Thus, if pressurized saline is advanced throughlumen60, the gas present inballoon occluder65 will be forced out through the additional lumen in communication with the balloon occluder. A septum may be included in the balloon occluder and disposed between entry and exit ports to ensure that all gas is purged on entry of saline.

It will also be understood for this cannula apparatus that blood flow to the patient is maintained by blood passage throughblood cannula10, and not throughmesh75. Thus, the cannula must have an inner diameter which allows blood throughput at a mean flow rate of at least 3.0 L/min., more preferably 3.5 L/min., more preferably 4 L/min., more preferably at least 4.5 L/min., more preferably at least 5 L/min., and more. Of course, flow rate call vary intermittently down to as low as 0.5 L/min. Therefore, the inner diameter ofblood supply cannula10 will typically be at least 9 F (3.0 mm), more preferably 10 F, more preferably 11 F, more preferably 12 F (4 mm), more preferably 13 F, more preferably 14 F, more preferably 15 F (5 mm), and greater. Depending on the inner diameter and thickness of the tubing, the outer diameter ofblood cannula10 is approximately 8 mm. Meanwhile, the pressurizingcannula50 may have an outer diameter of approximately 10.5 mm. The foregoing ranges are intended only to illustrate typical device parameters and dimensions, and the actual parameters may obviously vary outside the stated ranges and numbers without departing from the basic principles disclosed herein.

In use, the balloon aortic cannula with associated filter is provided, and saline is injected into both the balloon occluder and the inflation seal until saline exits from the exit ports and exit lumens, thereby purging substantially all gas from the inflation seal, the balloon occluder, and dual lumen systems associated with each. Cardiac surgery can then be conducted in accordance with procedures which employ standard cannula insertion, as discussed more fully herein. Themesh75,inflation seal70, andballoon occluder65 are maintained in a deflated, fully contracted condition about the pressurizing cannula and/or blood cannula. The cannula is introduced into the aorta, preferably the ascending aorta, of a patient through an incision, and the incision may be tightened about the cannula by use of a “purse string” suture. Cardiopulmonary bypass occurs throughblood cannula10.

With the cannula in place, the filter is ready for deployment. The filtration means are first exposed by removing a handle or enclosure which may cover the expansion means and mesh. Then, saline or gas is advanced under pressure throughlumen57 to expand the inflation seal. The inflation seal expands to ensure contact with the inside of the aorta at all points along the circumference of the lumen, as depicted inFIGS. 1 and 2C. The inflation system for the expansion means is then locked in place to prevent inflation or depressurization of the inflation seal during use.

Theballoon occluder65 is then deployed to occlude the aorta upstream of the filter. Saline or gas is advanced under pressure throughlumen60 to expand the balloon occluder, as shown inFIGS. 2A, 2B,2C, and3. Embolic material dislodged from the aorta is captured byfilter mesh75. The bypass-oxygenator system is then started to achieve cardiopulmonary bypass throughblood cannula10. Cardiac surgery is performed while the filter, inflation seal, and balloon occluder are maintained in place for a number of hours, typically 8 hours or less, more typically 7 hours or less, more typically 6 hours or less, more typically 5 hours or less, more typically 4 hours or less, more typically 3 hours or less, more typically 2 hours or less, and more typically 1 hour or less.

At the end of the cardiac surgery, the balloon occluder is depressurized, and any embolic material dislodged by this step is captured by the filter. The filter is then depressurized and removed from the ascending aorta. The syringe lock is released and saline is withdrawn from the balloon occluder, and then from the inflation seal. This will cause both the balloon occluder and inflation seal to contract to a deflated condition with minimum cross-sectional diameter, as the device was configured before deployment. Notably, embolic material collected in the filter is trapped under the contracted filter. Once the inflation seal, associated filter, and balloon occluder have been deflated, the cannula can be removed from the patient without damaging the aortic incision by using standard procedures.

The devices disclosed herein may optionally include a handle adapted to cover and enclose the inflation seal, mesh, and balloon occluder. Moreover, before deployment, the inflation system for either the balloon occluder, inflation seal, or both, may be carried by either the pressurizing cannula or the blood cannula. In certain embodiments, the blood cannula and pressurizing cannula will be integrally combined into a single unitary component, or the pressurizing cannula is eliminated and the inflation system may be carried either within or on the outside of the blood cannula.

In another embodiment, a balloon aortic cannula is provided as depicted inFIG. 4, withballoon occluder65 disposed at one radial position on a side of pressurizingcannula50. It will be understood thatFIG. 4 shares many features in common withFIGS. 1 and 3, and the numbering of apparatus components has been duplicated so that appropriate description can be found with reference toFIGS. 1 and 3. With reference toFIG. 4,balloon occluder65 is shown in the deflated, contracted state on a side of pressurizingcannula50 and disposed about the distal region thereof.Rotational orientation marker51 may be included in certain embodiments and disposed at a fixed radial position relative to the point of attachment ofballoon occluder65, e.g., at a radial position 180° fromballoon occluder65. The inclusion of a marker on the proximal region of the pressurizingcannula50 will enable rotation of the cannula once inserted in the aorta in order to ensure positioning ofballoon occluder65 so that expansion and balloon occlusion occurs upstream offilter75, and does not interfere withblood cannula10 and/or pressurizingcannula50. Alternatively, where the pressurizingcannula50 orblood cannula10 includes alumen60 which is visible on the exterior sheath, thelumen60 may be used as a rotational orientation marker.

Upon inflation,balloon occluder65 assumes a shape as depicted in FIGS.5 or6. With reference toFIG. 5, theocclusion chamber65 is shown connected to the cannula by way of atubular extension67 which distances tire balloon occluder from the cannula. Alternatively, as shown inFIG. 6, the chamber ofballoon occluder65 may be in close contact with pressurizingcannula50 orblood cannula10.

It will be understood that the balloon occluders as disclosed herein and depicted on balloon aortic cannulas may be used in combination with any of a number of arterial cannulas having associated filtration means as previously disclosed. Thus, the balloon occluders disclosed herein can be used in combination with any of the arterial cannulas disclosed in Barbut et al., U.S. application Ser. No. 08/584,759, filed Jan. 9, 1996, Barbut et al., U.S. application Ser. No. 08/580,223, filed Dec. 28, 1995, Barbut et al., U.S. application Ser. No. 08/553,137, filed Nov. 7, 1995, Barbut et al., U.S. application Ser. No. 08/640,015, filed Apr. 30, 1996, Barbut et al., U.S. Application Serial No. [attorney docket no. 224/194], filed Apr. 16, 1997, and Maahs et al., U.S. Application Serial No. [attorney docket no. 225/108], filed May 8, 1997, and any of the features disclosed in these applications can be used on the balloon aortic cannulas described herein. Accordingly, the entire disclosures of these prior applications are incorporated herein by reference, and it is noted that the devices, methods, and procedures disclosed in these applications can be used in combination with the balloon occluder and balloon aortic cannula disclosed herein.

In another embodiment, a cannula is provided as depicted inFIG. 7 with a continuous filter mesh which extends beyond and over the lumen of the blood cannula so that blood from the cannula passes through the mesh before circulating within the patient. The device may include a pressurizingcannula50, a blood cannula,inflation seal70,continuous mesh75, andballoon occluder65 which operates upstream ofmesh75. In still another embodiment, the continuous filter mesh is tethered from the distal end ofcannula50 by a plurality of holdingstrings55, as depicted inFIG. 8. It will be understood thatFIGS. 7 and 8 share many features in common withFIGS. 4 and 6, and the numbering of apparatus components has been duplicated so that appropriate description can be found with reference toFIGS. 4 and 6.

In anther embodiment, a balloon aortic cannula is provided as depicted inFIG. 9. The device includes a pressurizingcannula300 havingproximal region301,distal region302, and all intermediate region which connects the proximal and distal regions. The pressurizingcannula300 is typically a rigid or semi-rigid, preferably transparent tube having a first substantiallycylindrical lumen303 which extends from the proximal region and is shaped to receiveblood supply cannula350. The pressurizingcannula300 further includes at its proximal

region luer fittings

304 and305 which are shaped to receive a cap orseptum306 and asyringe307 filled with saline or gas and having alocking mechanism308 for locking thebarrel309 andplunger310 in a fixed position. The pressurizingcannula300 typically has a dual lumen to affect pressurization of the inflation seal. Thus,luer305 is connected topassage311 which is in fluid communication with asecond lumen312 which extends from the proximal to the distal end of pressurizingcannula300. Meanwhile,luer304 is connected topassage313 which is in fluid communication with athird lumen314 which extends from the proximal to the distal end of pressurizingcannula300. At its distal region, the pressurizingcannula300 includes ablood filtration assembly315.

Blood supply cannula

350 may have certain features in common with a standard cannula, and is generally a substantially cylindrical, semi-rigid, and preferably transparent tube which includes arib351 disposed about the circumference at a distal region thereof. The blood cannula is slidable within the pressurizing cannula, and in the proximal region, theblood cannula350 may be angled to adopt a shape which does not interfere withsyringe307. Moreover, the blood cannula will typically include a fitting or molded joint352 which is adapted for coupling to a bypass-oxygenator system.Blood cannula350 is adapted to carry blood to the aorta from the bypass-oxygenator system.

The pressurizing cannula may also include an inserting and retractinghandle380 comprising a substantially cylindrical tube disposed about the intermediate region of pressurizingcannula300. Handle380 will generally include a rigid or semi-rigid, preferably transparent tube with molded hand grip to facilitate holding and inserting. With reference toFIG. 9, handle380 is slidable relative to the pressurizingcannula300, and may include a sealingmember381 comprising a rubber washer or O-ring mounted in a proximal region of the handle and disposed between380 and pressurizingcannula300 to prevent leakage of blood therebetween. Handle380 may includecorrugation ribs382 in its proximal and intermediate regions, and a substantially flat or levelcollar insertion region383 adapted to fit tightly against vessel material at an aortic incision. In certain embodiments,collar insertion region383 will include a sealing ring or rib (not shown), having a width of about 5 mm and an outer diameter of about 13 mm, which serves as an anchor against the aorta to prevent the cannula assembly from slipping out during a surgical procedure. A “purse string” suture is generally tied around the circumference of the aortic incision, and this string will be tightened around the ring incollar region383 to prevent slippage of the cannula assembly.

Handle380 may also include anenlarged end region384 which encloses theblood filtration assembly315 as described in Barbut et al., U.S. application Ser. No. 08/640,015, filed Apr. 30, 1996. Thishousing enclosure384 is a particularly preferred component because it prevents inadvertent deployment of the blood filtration assembly and balloon occluder, and it provides a smooth outer surface to the cannula which facilitates entry through an incision in the aorta without tearing the aorta. In the absence of such housing enclosure, the balloon and filter are liable to scrape against the inner wall of a vessel, and thereby damage or rupture the vessel. At its distal end, handle380 may includeinverted cuff385 which bears againstrib351 ofblood cannula350 to form a seal when thefiltration assembly315 is enclosed byhandle380.

The distal region of pressurizingcannula300 is shown withblood filtration assembly315 deployed in the ascendingaorta399 of a human. Handle380 has been moved proximally to exposefilter assembly315. The distal region of pressurizingcannula300 includes a plurality of holdingstrings316 made from Dacron® or other suitable material. Holdingstrings316 connect the distal region of the pressurizingcannula300 toinflation seal317 as described above. The inflation seal is attached to filtermesh318 on its outer side.Filter mesh318 is bonded at is distal end around the circumference ofblood cannula350 preferably at a cross-sectional position which closely abutsrib351.

Chamber

319 is in fluid communication with a firsttubular passage320 and a secondtubular passage322 which permitchamber319 to be inflated with gas, or preferably a fluid such as saline.Passage320 is in fluid communication withsecond lumen312 of pressurizingcannula300, whilepassage322 is in fluid communication withthird lumen314 of pressurizingcannula300.

Passages

320 and322 therebyinterconnect chamber319 with the second and

third lumen

312 and314, respectively, of pressurizingcannula300.

In certain embodiments,inflation seal317 will include aseptum321 which blocks the movement of fluid in one direction aroundchamber319. Ifseptum321 is positioned in close proximity to the fluid entry port, then the injection of fluid will push all gas inchamber319 aroundinflation seal317 and out throughpassage322, as described above. In one embodiment, the entry port and the exit port are positioned in close proximity withseptum321 disposed between the entry and exit port. In this case, injection of fluid will force virtually all gas out ofinflation seal317.

With reference toFIG. 9, the pressurizingcannula300 may further includeballoon occluder65 operably attached at a distal region of pressurizingcannula300, and generally proximal to thefiltration assembly315.Balloon occluder65 will, upon inflation, expand upstream of the aortic incision andfiltration assembly315 to occlude a region of the ascending aorta as described above. In those embodiments which includehandle380,balloon occluder65 will pass through an opening inhandle380 in order to define a chamber which is in fluid communication with an additional, fourth lumen (not shown) of pressurizingcannula300. A cross-sectional view of pressurizingcannula300 and handle380 in the region of balloon occlude65 is depicted inFIG. 9A. With reference toFIG. 9A,balloon occluder65 passes throughopening386 inhandle380.

In yet another embodiment, a balloon aortic cannula is provided as depicted inFIG. 10. The device includesblood filtration system410 which comprisesinsertion tube420,umbrella frame430,end plate460,activation tube450,mesh440,adjustment device470, and handle480.Filtration assembly410 is introduced into a vessel throughmain port407 ofcannula405, and blood or other surgical equipment may be introduced intomain port407 ofcannula405 throughside port403. Thecannula405 andfiltration system410 will not interfere with placement of equipment which may be used during a surgical procedure.

Umbrella frame

430 comprises a plurality of arms432 (some of which are not shown), which may include 3 arms, more preferably 4 arms, more preferably 5 arms, more preferably 6 arms, more preferably 7 arms, more preferably 8 arms, more preferably 9 arms, and most preferably 10 arms.Socket434 may be connected toinsertion tube420 by welding, epoxy, sonic welding, or adhesive bonding. A further detailed description of the construction offiltration assembly410 can be found with reference to Barbut et al., U.S. application Ser. No. 08/584,759, filed Jan. 9, 1996, and other references cited herein.

End plate

460 comprises a one-piece injection molded component, made of plastic or metal.Arms432 are bonded toend plate460 atarm junctures461 spaced at equal increments along a circumference of a circle.Activation tube450 extends fromend plate460 throughinsertion tube420 toadjustment device470 housed inhandle480 as shown inFIG. 10.Adjustment device470 is a linear actuation device, comprisingthumb switch472 which is attached to guideframe474 which is in turn attached toactivation tube450 via a bond joint.Thumb switch472 comprisesbase476 andrachet arm478 which moves alongrachet slot482 along the top ofhandle480, locking in predetermined intervals in a manner known in the art. Slidingthumb switch472 away fromdistal end402 ofcannula405 retractsactivation tube450, which in turn drawsend plate460 towardhandle480. This movement causesarms432 ofumbrella frame430 to bend and causes mesh440 to open and ready to capture embolic material in the blood. Slidingthumb switch472 towarddistal end402 ofcannula405 pushesactivation tube450 in the direction ofmesh440.Activation tube450 then pushesend plate460 away fromhandle480, causingarms432 ofumbrella frame430 to straighten and mesh440 to close.

With reference toFIG. 10,filtration device410 further includesballoon occluder465 connected to a further lumen (not shown) oncannula405. Accordingly, the assembly providesballoon occluder465 at a distal region of cannula435 so that, upon deployment,balloon occluder465 expands upstream of the filtration assembly, which assembly captures embolic material dislodged upon deployment ofballoon465.

In another embodiment, an arterial balloon catheter is provided as depicted inFIG. 11. The catheter includes flexibleelongate member100 having an outer surface, adistal region101, and a proximal region. The catheter includesballoon occluder65 at the distal end of the elongate member. The catheter also includes at its distal region expansion means, such asinflation seal70,filter mesh75 attached toinflation seal70, and may optionally include holdingstrings55 which secure the inflation seal tocatheter100. The catheter may also include an inflation system (not shown) to operateinflation seal70, as described above for other embodiments.

In another embodiment, an arterial balloon cannula with associated filter and distal flow diffuser is provided as depicted inFIGS. 12 and 12a. In this embodiment the distal end of thecannula10, is closed with acap500 and the flow diffuser is arounded cone502 extending inside the lumen of the cannula. As shown inFIG. 12, the cap preferably has a rounded, hemispherical shape to facilitate the insertion of the distal end of the cannula into the vessel. The flow diffuser tapers towards the proximal end of thecannula10 starting from the end cap. The shape of the flow diffuser is preferably conical in order to avoid damaging the blood. However, other shapes, including pyramidal shapes, may be employed.

As shown inFIG. 12a, a plurality ofoutlet openings504 are formed in the sidewall of thecannula10 adjacent to its distal end. The openings may have an arched configuration, with thecurved portion506 of each arch oriented in the upstream direction. Although any number of openings are possible, a preferred embodiment has six openings. Preferably the total area of the openings is greater than the area of the distal end opening of a conventional catheter of the same diameter. The length of theopenings504 are also preferably greater than the length of theflow diffuser502.

In another embodiment, an arterial balloon cannula with filtration means is provided as depicted inFIGS. 13 and 13a. In this embodiment, the distal end of thecannula10 contains adiffuser602 with a helical configuration. Thediffuser602 can be held in place within the cannula by the tapering configuration of the distal end of the cannula, by adhesives, by ultrasonic welding, or by some other suitable means. The diffuser is preferably formed from a flat rectangular member with a single one-hundred-eighty degree twist. In this embodiment, the distal end of the cannula is partially blocked. Additionally, any number of outlet opening604 may be formed in the sidewall of the cannula.

The intra-cannula flow diffusers ofFIG. 12 andFIG. 13 may also be employed proximal to the filter by positioning the diffuser within the arterial balloon cannula ofFIG. 7. Other variations and details of intra-lumen flow diffusers may be found in Cosgrove et. al., Low Velocity Aortic Cannula, U.S. Pat. No. 5,354,288, which is incorporated by reference herein.

In another embodiment, an arterial balloon cannula is provided as inFIG. 14. In this embodiment the proximal end of aflow diffuser702 is connected to the distal end of thecannula10 by a plurality of structural supports30704. Thediffuser702 is preferably conical, although other shapes may be used. The distal end of theflow diffuser702 extends to the apex of thefilter706 by virtue of alinear shaft708 said shaft running through the center of the expanded filter. In this embodiment theflow diffuser702 diffuses blood flow proximal to thefilter706.

In another embodiment, an arterial balloon cannula is provided as inFIG. 15. In this embodiment theflow diffuser802 is contained within the distal end of theblood cannula10. In a preferred embodiment, thediffuser802 is the helical diffuser shown inFIG. 13 and13a. Theflow diffuser802 can be held in place by the tapering configuration of the distal end of the cannula, by adhesives, by ultrasonic welding, or by some other suitable means. Unlike the invention ofFIG. 13, the distal end of thediffuser802 is attached to the apex of thefilter806 by virtue of alinear shaft808 said shaft running through the center of the expanded filter. The shaft may be any shape which will not traumatize blood components, and preferably comprises a rounded surface which tapers outward in the distal direction. In this embodiment the flow diffuser diffuses cannula blood flow proximal to the filter. Thecannula10 optionally containsopenings803 in itsdistal end804 to further diffuse the cannula blood. In an alternate embodiment,blood diffuser802 is contained withincannula10 but is not connected to filter806 said filter being supported as disclosed inFIG. 7.

Although cannulas have been selected for purposes of example, the inventions ofFIG. 12-15 can be readily applied for use in arterial balloon catheters.

It is to be understood that flow diffusers such as those ofFIGS. 12-15 can be used in any blood filter device having a blood supply cannula and associated filter, including the devices depicted inFIG. 3 andFIG. 4. Furthermore, the diffuser ofFIG. 15 may be employed inside a cannula having a distal filter. Such as inFIG. 7, thus creating a blood filter device with two filters, one proximal to and one distal to the cannula opening.

In an alternative embodiment, shown inFIG. 16, an arterial balloon cannula and associatedfilter906 include a generallycylindrical filter sleeve908 disposed circumferentially about the distal end of the cannula and attached to four

control lines

902a,902b,904a,904b. Proximal force on

unroll control lines

904aand904bunrollsfilter sleeve908 from its depicted position so as to capture the filter resulting in the position shown inFIG. 17. In this embodiment, the manner of unrolling the filter sleeve is analogous to the unrolling of a latex condom. Although the sleeve may be any shape, provided it both encases the cannula and rolls up in response to the control lines, in a preferred embodiment the sleeve has a circular cross-section.

InFIG. 16 thefilter sleeve908 is rolled back distal to the filter, to allow the filter to be fully expanded.FIG. 16 shows a cross-sectional cut away of the sleeve. The full sleeve, not depicted, is a continuous piece surrounding the cannula about a 360 degree radius. In a preferred embodiment, a circular condom-like sleeve is attached at the outer-diameter of the cannula along the arc ofcircle910. The condom-like sleeve has a distal opening to permit exit of the cannula tip. In a preferred embodiment a pair of

control lines

902aand904aenter a control lumen at

points

928 and929 respectively and run insidecontrol lumen922 adjacent the cannula lumen until exiting the control lumen at a proximal point on the cannula (not shown). In the preferred embodiment, a second set of

control lines

902band904benter a second control lumen924 at

points

926 and927 respectively, said points located one-hundred eighty degrees from the first lumen along the cannula's outer diameter.

As shown inFIG. 17, unroll

control lines

904aand904bare attached tosleeve908 at

points

914 and916 said points located on the proximal end of the unrolled sleeve. Consequently, whensleeve908 is rolled-up as shown inFIG. 16, points914 and916 are rolled into the center of the nautilus-shaped lip ofsleeve908 while unroll control

lines

904aand904bare rolled-up alongside the sleeve.

In contrast, roll-up

control lines

902aand902bare attached to the cannula at

points

918 and920, respectively. Both

points

918 and920 are located onarc910. When the sleeve is rolled-up, as shown inFIG. 16, the roll-up

control lines

902aand902brun from their respective points of

attachment

918 and920, along the exposed side of the rolled-up sleeve, and enter the

control lumens

922 and924 at

points

926 and928 respectively. After entering the control lumens, the roll-up lines proceed through the control lumens until exiting at points (not shown) proximally located on the cannula.

FIG. 17 shows the same arterial balloon catheter and associated filter asFIG. 16 but with thesleeve908 fully unrolled and capturingfilter906. The unrolled sleeve provides a compact, smooth profile for the device's introduction to and retraction from a vessel. In order to unroll the sleeve from theFIG. 16 position, the

unroll lines

904aand904bofFIG. 17 have been pulled in a proximal direction, away from the cannula tip. Consequently, points914 and916 are positioned at the proximal end of unrolledsleeve908.

When the sleeve is in the unrolled state, the roll-up

control lines

902aand902brun from

points

918 and920 respectively, along the underside of thesleeve908, around the proximal end of the sleeve, and then distally along the outer side of the sleeve before entering the

control lumens

922 and924 at

points

926 and928 respectively. After entering at

points

926 and928, the roll-up

control lines

902aand902btravel through the control lumens until exiting the control lumens at points (not shown) located at the proximal region of the cannula. When the sleeve is in the unrolled position as shown inFIG. 17, the roll-up lines may be pulled in a proximal direction, away from the cannula tip. Pulling the roll-up lines causessleeve908 to roll-up until reaching the rolled-up state shown inFIG. 16. In a preferred method of use, thesleeve908 is unrolled prior to insertion of the cannula in a vessel, rolled up during mesh deployment and once again unrolled prior to cannula retraction.

FIG. 18 shows a cross-sectional detail of thesleeve908 in the unrolled state, with emphasis on the points of attachment for the control lines. In theFIG. 18 embodiment, the sleeve, which is a continuous about 360 degrees (not shown), is directly connected to the two roll-up

lines

902aand902bat

points

918 and920 respectively. Alternatively, the roll-up lines are attached directly to the cannula at points neighboring918 and920 located immediately distal to the distal end of the sleeve. Pulling the roll-up

lines

902aand902bin a proximal direction, as shown by the arrows inFIG. 18, causes the sleeve to roll-up like a condom. Accordingly, the sleeve material should be thin enough to avoid bunching and to provide smooth rolling in reaction to the proximal force exerted by the roll-up lines. In a preferred embodiment, the sleeve is made of latex, with a thickness of between 3 and 14 thousandths of an inch. In a more preferred embodiment, the sleeve is made of latex with a thickness of between 4 and 16 thousandths of an inch. The invention may also use silicone or another silastic, biocompatible material to construct the sleeve. Other materials as are known in the art may permit use of a sleeve with less than 4 thousandths of an inch provided the material gives suitable assurances against breaking or tearing.

FIG. 19 is a three-dimensional depiction of thecannula10,filter906 andsleeve908, withsleeve908 in the rolled-up state. In one embodiment thefilter906 is located distal to the cannula opening such that cannula output is filtered upon leaving the cannula. In another embodiment, the filter is located proximal to the cannula opening such that cannula output is downstream of the filter. The cannula opening may optionally have aplanar diffuser932.Filter906 is made of mesh which is contiguous with a sealingskirt930. With the exception ofentrance point933, both the rollup and unroll lines enter and exit the cannula at points not shown. In a preferred embodiment, the control lines attach to a control line actuating mechanism such as a capstan, ring or pulley (also not shown). In this embodiment, the structure adapted to open and close the filter may be an umbrella frame (not shown)) such as depicted inFIG. 10, or alternatively an inflation balloon (not shown), such as shown inFIG. 7 andFIG. 9. TheFIG. 19 embodiment may be used with any of the various means to actuate the structure as described herein. Pulling the

unroll control lines

904aand904bin a proximal direction causes the capture sleeve to roll out over the top of the filter. Subsequently pulling the roll-up

control lines

902aand902brolls-up the captured sleeve thereby permitting filter deployment. InFIG. 19 the unroll lines are oriented at an angle of 180 degrees from one another along the circumference of the filter (thus904bis not shown). The roll-up

lines

902aand902bare similarly oriented at an angle of 180 degrees from one another. However, as with the inventions ofFIGS. 16-18, this embodiment may employ any number of control lines spaced at varying distances around the outer diameter of the filter sleeve.Cannula10 is shown in use inFIG. 19A.Balloon occluder65 expands to engage the lumen ofaorta99.FIG. 19A also shows an expansion frame comprising an umbrella having a plurality ofprimary struts511 and a plurality ofsecondary struts512 which are connected to the primary struts at about the midpoint of the primary struts.

FIG. 20 shows an alternative embodiment wherein onecontrol ring936 controls rolling and unrolling of thesleeve934 with the assistance of a pulley mechanism. Thecontrol ring936 is movable in both the proximal and distal directions along the outer diameter of the cannula (not shown).Control ring936 is S directly attached to unroll

control lines

904aand904band attached to roll-up

control lines

902aand902bthroughpulley934. Proximal movement of the control ring causes thesleeve908 to unroll. Distal movement conversely causessleeve908 to roll up.

In another embodiment of an arterial balloon cannula, shown inFIG. 21, the cannula contains a collapsible section such that it can accommodate thefilter seal907 and thefilter906 and any other components of the filtration means. Thecollapsible section938 is made out of an elastomeric material, such as latex. In another embodiment the collapsible section is a double walled balloon. In a preferred embodiment the section is made of a flexible material with built in memory such that the collapsible walls automatically return to their non-collapsed state when deployment force expands the filter. The collapsingsection938 begins just proximal to the site of thefilter seal907 when the filter is in the collapsed state. In the embodiment shown, the collapsing section has a length equal to the length of thefilter906 andfilter seal907. In an alternative embodiment, the collapsing section extends to the tip of the catheter from just proximal to the filter seal. The deformable section collapses radially inward when the filtration assembly is closed in order to produce a low-profile distal end to the cannula. Thus, a portion of the radial volume of the cannula is occupied by the filtration assembly when the filtration assembly is deployed; however, the blood flowing through the cannula subsequently blows the deformable cannula walls outwards to allow the flow of blood through the entire cannula diameter. It is to be understood this embodiment may be used in combination with the sleeve embodiments previously shown herein.

In another embodiment of an arterial balloon cannula, with associated filter shown inFIG. 22 and23, theblood cannula10 is composed of a medically acceptable elastic material, such as latex, silicone, rubber, and the like. As shown inFIG. 23, the blood cannula has an intrinsic length and diameter which characterizes the cannula when it is not under axial stress. The intrinsic length and diameter of the cannula varies according to vessel size. The cannula may be closed with a cap diffuser of the type disclosed inFIG. 12. Alternatively, the cannula may be only partially closed al the tip as inFIG. 13. As shown inFIG. 22, astylet944 is placed in thecannula10 and engages the cannula tip. In an alternative embodiment, the stylet engages a ring suspended at the opening of an open tip. When inserted fully into the cannula, thelengthy stylet944 engages the distal tip of the elastic cannula and axially stretches the cannula body. In this way the cannula is stretched so as to reduce cannula diameter upon introduction into the vessel. Afinger grip946 secured to the proximal end of the stylet includeslatch member948. The latch member engages arecess950, formed on aproximal fitting952 of the cannula, in order to maintain the cannula's stretched configuration After insertion in the vessel, the elastic cannula is radially expanded and shortened by depressinglatch member948 and withdrawing the stylet as inFIG. 23.

In this embodiment, thefilter908 is fixed to the outer diameter of the unexpanded elastic cannula by

tether lines

954 and956 such that, when the stylet is introduced, cannula expansion causes the tether lines to go taut, which in turn contours the filter to the cannula. Consequently, as shown inFIG. 23, when the stylet is withdrawn, the cannula shortens thereby permitting expansion of the filter. Although various biasing and filter opening mechanisms may be used, in one preferred embodiment, the filter itself is made of memory-wire biased to an open state.

In another embodiment shown inFIGS. 24 and 25, thedistal cannula portion960 upon which thefilter assembly962 is mounted is, at least in part, a radially flexible material or composite construction which is normally in a necked down, contracted position. This allows the contractedfilter assembly962 to create as small of a profile as possible for insertion into the blood vessel. The necked-downportion964 of the distal cannula is opened by inserting a closefitting expander966 through the necked-down portion. Theexpander966 has adistal end967. As a result of the expander insertion, thefilter assembly962 exhibits an extruding profile relative to the outer contours of the distal cannula. Optionally as shown inFIG. 24, thefilter assembly962 may be fully deployed by a deployment mechanism (not shown), as previously described herein. In bothFIGS. 24 and 25, the expander is fixed relative to theproximal cannula968. Both are moved distally relative to the distal cannula so as to insert the expander into the collapsible section. Alternatively, theexpander966 may move independent of theproximal cannula968.

In another embodiment shown isFIGS. 26 and 26A to26D,cannula350 includesfilter906 havingskirt970 disposed around its outermost edge.Skirt970 is an elastomeric strip of material (e.g., silicon or other suitable material) attached to the proximal edge of the filter mesh. Skirt970 forms a compliant edge which conforms to vessel lumen topography and gives a better seal with the vessel lumen when the filter is deployed. Moreover, thecompliant edge970 allows for changes in the vessel interior dimension as the vessel pulses from systole to diastole. Both unroll

control lines

904aand904b, as well as roll-up

control lines

902aand902b(not shown) are routed throughtube978 and then through the cannula housing atlocation971 and thereafter ride withintubing972 to the point where they are manipulated outside of the body. In addition to the roll-up and unroll control lines, a fifth control line is also carried throughtube972 andlocation971 for the purpose of operating the umbrella frame973 depicted inFIG. 26. This control line can ride either inside or outside oftube978. The umbrella frame consists of a series ofprimary struts974 extending from the distal to proximal end of the mesh and disposed circumferentially thereabout, and a series ofsecondary struts975.Struts975 connect at their proximal end tostruts974 and at their distal end are slidably connected to the axis of the conical filtration mesh.Secondary struts975 therefore operate to open and close the expansion frame between a radially expanded and radially contracted condition.

In another embodiment shown inFIG. 27,cannula350 includes on its distal end a “windsock” or open-endedsleeve976 which is either a porous mesh, a non-porous material (e.g., silicon), or a non-porous material with holes which allow some degree of lateral blood flow. InFIG. 27, the windsock cannula is shown deployed withinaorta99. As can be seen, embolic debris dislodged upstream of the cannula will be carried through thewindsock976 and will exit thedistal opening977.Sleeve976 thereby prevents passage of embolic material laterally in the region of the carotid arteries and thereby prevents or reduces the occurrence of embolic material reaching the brain. At the same time, however, the windsock apparatus overcomes difficulties associated with filter blockage due to blood clotting and buildup of debris by delivering a high volume of blood downstream of the carotid arteries without the need to pass laterally through the sleeve.

It is to be understood that the cannula devices ofFIG. 16-FIG. 27 may optionally employ a balloon occluder proximal to the filter, as disclosed inFIG. 1-FIG. 10.

In another embodiment of an arterial balloon cannula, as shown inFIG. 28, a filter and balloon occluder are integrated as onepiece987 and disposed concentrically about the cannula,10. As a result, the cannula employs a single inflation port988 for both occlusion of the vessel and deployment of the filter. In a preferred embodiment, a slide990 is used to collapse the filter-balloon unit via control lines (not shown) when passage of the device through the vessel is required.

In another embodiment of an arterial balloon cannula, as shown inFIG. 29, a cannula contains an opening992 proximal to theballoon occluder65 andfilter75. The opening is linked by a conduit991 which runs along the inside of the cannula and is isolated from the cannula blood flow. In a preferred embodiment the conduit carries a source of myocardial prevention solution, such as a cardioplegia solution, which is pumped into the heart side of the balloon-occluded aorta. Alternatively, the conduit may pump saline solution or a solution which facilitates pressure monitoring via the conduit. The construction and operation of the valve system to accommodate cardioplegia output on a perfusion cannula is explained in detail in Hill, U.S. Pat. Nos. 5,522,838, 5,330,498 (seeFIG. 6), and U.S. Pat. No. 5,499,996, incorporated herein by reference.

In an arterial balloon catheter embodiment, as shown inFIG. 30, a catheter similar to the catheter inFIG. 12 includes openings992 located proximal to the balloon so as to deliver oxygenated blood to the arterial side of the balloon occluder. Additionally, the arterial balloon catheter contains a fluid-isolated second lumen996 and opening998 at the distal end of thecatheter100 for delivery of cardioplegia solutions to the heart side of theballoon occluder65.

In another embodiment, a device for occluding arterial vessels is provided by a cannula having a dam or other impermeable structure as shown inFIG. 31.Cannula50 is equipped withmechanical dam structure513 at the distal end of the cannula,dam513 having a plurality of liftingarms551. The dam may optionally include aballoon seal514 disposed circumferentially and continuously about513.Balloon514 may be filled with saline, self-expanding foam, or a combination of both.Dam513 is constructed of any nonpermeable material, examples of which include silicon, urethan, or other occlusive barriers.

A balloon occluder on a catheter in accordance with another embodiment is depicted inFIGS. 32 and 32A. Referring toFIG. 32,catheter515 includesballoon occluder65 disposed about the distal region thereof. The catheter may be used as a standalone device or with a blood cannula.Cannula515 includes an inflation lumen for inflatingballoon65, and may optionally include a second lumen for delivery of fluids, such as cardioplegic solution. In use, the device is deployed as shown inFIG. 32A.Catheter515 may be deployed throughcannula50 and enter the aorta upstream ofcannula50.Catheter515 may optionally further includefilter75. In another embodiment,catheter515 is delivered throughcardioplegic cannula516. In this embodiment,catheter515 includes secondinner lumen517 for delivery of cardioplegia solution to the heart. Thus, the occlusion catheter can be delivered either through an additional lumen onperfusion cannula50 or through an entirely separatecardioplegic cannula516 which is inserted through the aorta upstream of theentry point450.

A cannula with a self-inflating balloon is shown inFIGS. 33 and 33

A. Cannula

50 includesballoon occluder65 disposed about a distal region thereof. The balloon is loaded with foam which is biased to expand radially outwardly. Vacuum is applied to the balloon inflation lumen to radially collapse theballoon occluder65 and thereby compressfoam518. When the cannula is in place within the aorta, the vacuum is released, andballoon occluder65 expands radially outwardly.FIG. 33A shows a self-expanding balloon occluder whereincannula50 includesrigid section524 anddeformable section523 which, upon balloon compression, collapses inwardly to economize on the cross-sectional area of the device.

An adhesive coated balloon cannula is shown inFIG. 34.Cannula50 includesballoon occluder65 at a distal region thereof.Balloon65 is equipped withadhesive coating519 on an outer radial surface thereof. Adhesive519 functions to grab and retain any embolic material dislodged from the vessel wall during a procedure.

An expandable wire occluder is shown inFIGS. 35 and 35

A. Wire

520 is preformed into a shape about the distal end of the cannula so that it will expand radially outwardly when longitudinally compressed. The device further includes pullingmember521 which is connected to the distal end ofwire520. When pulled,member521

causes expanding wire

520 to expand radially outwardly as shown inFIG. 35A. The expandingwire520 may optionally be further equipped with an impermeableelastic coating522.

A cannula introducer is shown inFIG. 36.Cannula50 includesbypass output port525 in one radial position, andpassage526 in another radial position, preferably 180° apart.Passage526 is adapted to receive aballoon catheter515 havingballoon occluder65 on a distal end thereof. This modular design allows theballoon catheter515 to be inserted and deployed and retracted independently of the cannula.

An integrated occlusion cape cannula is shown inFIG. 37.Cannula50 includesbypass output port525 at a first radial position, andocclusion cape528 at a second radial position, preferably substantially 180° from bypass output port. Also included on the distal end ofcannula50 aremesh75 andmechanical support structure527.Mesh filter75 is preferably equipped with an elastomeric skirt disposed circumferentially about the outer diameter of the mechanical support structure. The Support structure is typically outside ofmesh75.Cape528, once deployed, covers and lines meshfilter75 thereby blocking passage of fluids.Cape528, once retracted, is detached and withdrawn into a port incannula50 for removal from the aorta. The cape can be inverted to block fluid flow in the opposite direction.

The use of a balloon occluder catheter in conjunction with a cardioplegic catheter is depicted inFIG. 38.Bypass cannula50 is inserted downstream ofcardioplegic cannula520.Balloon occluder65 is disposed on acatheter553 which is insertable throughlumen530 oncardioplegic cannula529.Cannula529 is equipped with cardioplegiasolution exit port531 and optionally havingdiffuser ports552.Catheter553 may optionally includesolution ports532. The advantage of such a system over a cannula-based balloon occluder is that the occluder is independent of the bypass cannula. Therefore, this design is compatible with any bypass cannula design. Moreover, the bypass cannula is available for placement anywhere distal of the occluder.

An aortic occluder with modular design is shown inFIG. 39.Cannula50 includesoccluder guide534 at a distal end thereof.Guide534 comprises a lumen adapted to receiveballoon occluder device533.Occluder533 includesballoon65 andfluid port535 as a conduit for cardioplegic solution.Guide534 is advantageous in that it directs or positions the occluder at a desired location rather than allowing the occluder to randomly position itself.

Human anatomy including the rib cage with deployed occluder is depicted inFIG. 40.Occluder cannula50 is disposed throughaccess port538 and thereafter enters the aorta behindsternum554. The rib cage is depicted generally bynumeral537.Occluder536 is shown deployed withinaorta99. The concept of port access allows a surgeon to enter the aorta via a port for a minimally invasive approach. By accessing the aorta directly, the device is deployed without the need for visual guidance, e.g., fluoroscopy, echocardiography. This device would obviate the need for a sternotomy procedure which is generally associated with conventional coronary artery bypass grafting surgery. In use, the aortic occluder passes through the access port to the aorta. Once positioned on the aorta, the occluder device is inserted into the vessel and the occluder is deployed. The occlusion device may comprise a single one-piece occluder cannula or multiple components. One simple design would utilize an inflation balloon on the end of a cannula. The shaft of the cannula could be flexible or stiff depending on whether the surgeon prefers to direct the occluder using a clamp or trocar or prefers a more steerable unit. The cannula may include one or more lumens for inflation and fluid passage.

A single-piece occluder is shown inFIG. 41.Occluder cannula50 includesocclusion balloon65 disposed on its distal end.Cannula50 is equipped withinfusion ports540 for passage of any appropriate fluid, e.g., cardioplegic solution.Cannula50 optionally includes seating bumps539 for additional sealing with the interior of the aorta. The L-shaped cannula may be preformed or flexible to allow for self-centering.

An alternate design for a single-piece occluder is depicted inFIG. 42.Cannula50 assumes a J-shape, and includesocclusion balloon65 on a distal end thereof.Infusion port541 allows passage of appropriate solution to the heart, e.g., cardioplegic solution. These single component occluders as shown inFIGS. 41 and 42 may be inserted through a pre-slit section of the aorta, or a trocar may be advanced through a lumen, and extended beyond the cannula tip. The trocar would be used to pierce the aorta wall. Once the trocar is in the vessel, the occluder is advanced and then the trocar removed.

A multiple component port access aortic occluder is depicted inFIG. 43. The system includestrocar555 having preshapedconfiguration542,sharp tip544, and position limiters543.Cannula50 includessuture plate548, kinkresistant shaft547,infusion port545, andhemostasis valve546.Occlusion catheter556 includes balloon occluder565, inflation port549, andinfusion lumen550.Occluder556 is shaped to receivefilter mesh75.Cannula50 is adapted to receivetrocar555 through theinfusion port545, and to receivecatheter556 throughhemostasis valve546. In use, a port access point or window is opened on the patient's chest. Tissue from the port to the aorta is dissected. The trocar and cannula are advanced to the aortic wall. A purse string suture(s) may be required to aid in wound closure and to secure the device. At the desired location, the trocar is advanced through the aortic wall and the cannula is pushed with the trocar. Once in the vessel, the cannula is secured and the trocar is removed. At this point, the occluder (and filter) may be advanced and deployed. Cardioplegia or other fluid may then be circulated through the infusion lumens.

An aortic balloon cannula is depicted inFIG. 44.Cannula50 is inserted throughaorta99 and includesballoon65 inflated to occlude the flow of blood in the aorta. The lumen ofbypass cannula50 releases oxygenated blood downstream ofoccluder65. In another embodiment, a balloon catheter is used for occlusion as shown inFIG. 45.Cardioplegia cannula529 penetratesaorta99 and allows deployment ofballoon catheter557 throughcannula529.Catheter557 includesocclusion balloon65 on a distal region thereof.Catheter557 is deployed through a lumen ofcardioplegia cannula529, wherein the lumen is optionally the same or a different lumen than the lumen which carries cardioplegia solution. In another embodiment, a cardioplegia balloon cannula is provided as depicted inFIG. 46.Cannula529 includesballoon65 mounted on a distal region thereof which is expandable withinaorta99 to occlude blood flow therein.Cannula529 further includesdistal port558 for delivery of cardioplegia solution to the heart.

In use, the arterial balloon catheter is deployed through the femoral artery while maintaining peripheral cardiopulmonary bypass as described in Peters, U.S. Pat. No. 5,433,700, Machold et al., U.S. Pat. No. 5,458,574, Stevens, International Application No. PCT/US93/12323, and Steven et al., International Application No. PCT/US94/12986. Thus, the catheters ofFIG. 12 andFIG. 30 may be used to induce cardioplegic arrest of a heart by the steps of maintaining systemic circulation with peripheral cardiopulmonary bypass, occluding the ascending aorta through percutaneous use of the arterial balloon catheter, introducing a cardioplegic agent into the coronary circulation, and venting the left side of the heart as discussed in the above-identified patents and applications. Moreover, the arterial balloon catheter can be used during open heart surgery or for any of a number of other procedures known in the art which involve the heart, aorta, or vasculature. Peripheral cardiopulmonary bypass is connected to a major vein, e.g., the femoral vein to withdraw blood, remove carbon dioxide, oxygenate the withdrawn blood, and return the oxygenated blood to the patient's arterial system through a major artery, e.g., the femoral artery. The catheters ofFIG. 12 andFIG. 30 may be introduced by subclavian delivery and induce cardioplegic arrest of the heart as disclosed in Sweezer, U.S. Pat. No. 5,478,309, herein incorporated by reference.

As a purely illustrative example of one of the methods of filtering blood as disclosed herein, the method will be described in the context of cardiac bypass surgery as described inManual of Cardiac Surgery,2d. Ed, by Bradley J. Harlan, Albert Sparr, Frederick Harwin, which is incorporated herein by reference in its entirety.

A preferred method of the present invention may be used to protect a patient from embolization during cardiac surgery, particularly cardiac bypass surgery. This method includes the following steps: introducing a mesh into an aorta of the patient; positioning the mesh to cover substantially all of the cross-sectional area of the aorta so that the mesh may capture embolic matter or foreign matter in the blood; adjusting the mesh to maintain its position covering substantially all of the cross-sectional area of the aorta; and removing the mesh and the captured foreign matter from the aorta. A variant comprises placing a cylindric mesh at the level of the take off of the cerebral vessel to divert emboli otherwise destined for the brain to other parts of the body.

During the cardiac surgery, the aorta is either clamped a number of times or occluded with a balloon occluder as disclosed herein. Because balloon occlusion and/or clamping the aorta dislodges atheromatous material from the walls of the aorta, which is released into the bloodstream, the mesh must be positioned within the aorta before clamping or balloon occlusion begins. Atheromatous material also accumulates behind the balloon occluder and/or clamps during the surgery and, because removal of the clamps and/or deflation of the balloon occluder releases this material into the bloodstream, the mesh must be maintained within the blood stream for about four to ten minutes after deflation of the occluder and/or removal of the clamps. Because the aorta is often a source of much of the atheromatous material that is eventually released into the bloodstream, it is preferable to place the mesh in the aorta between the heart and the carotid arteries. This placement ensures that foreign matter will be captured before it can reach the brain.

For illustration purposes, the method for balloon occlusion and filtering blood will be described in connection with the device depicted inFIGS. 4 and 5. After a patient has been anaesthetized and the patient's chest has been opened in preparation for the bypass surgery, thecannula10, ranging from about 22 to about 25 Fr. O.D. in size, is introduced into an incision made in the aorta. Thecannula10 is sutured to the aortic wall, and the heart is paralyzed. The balloon aortic cannula is stored in a closed position, in which theballoon occluder65 is deflated and folded in upon itself, and themesh75 is closed. Thecannula10 and its associated structures will not interfere with other equipment used in the surgical procedure.

Saline is introduced into theinflation seal70 through the actuation assembly (not shown) from an extracorporeal reservoir, and the inflation seal gradually assumes an open position in which theballoon70 is inflated in a donut-shape and themesh75 is opened to cover substantially all of the cross-sectional area of the vessel. In the opened position, the mesh is ready to capture foreign matter in the blood flow. By adjusting the amount of saline introduced into theballoon70, the surgeon may control the amount of inflation and consequently the degree to which themesh75 is opened. Saline is then introduced intoballoon occluder65 under pressure throughlumen60, and from an extracorporeal reservoir, and the balloon occluder gradually assumes an open position (seeFIG. 5) in which the balloon is opened to cover substantially all of the cross-sectional area of the vessel. In certain embodiments, the surgeon will dissect around the circumference of the aorta, and a cuff will be installed around the area of balloon occlusion to hold the aorta firmly against the balloon occluder. After the balloon aortic cannula has been thus actuated, blood from a bypass machine is introduced into the aorta through thecannula10.

It will be understood that balloon occlusion is used to block the flow of blood back into the heart. Balloon occlusion may dislodge atheromatous material from the walls of the aorta and releases it into the blood flow. Because balloon occlusion is performed upstream from thefilter75, the atheromatous material will be filtered from the blood bymesh75. While the aorta is occluded, the surgeon grafts one end of a vein removed from the patient's leg on to the coronary artery. In another embodiment, arterial grafting, such as internal mammary artery grafting, may be employed. After the surgeon checks the blood flow to make sure there is no leakage, the balloon occluder is deflated. Atheromatous material accumulates behind the balloon occluder and, when it is deflated, this material is released into the blood flow, which will be filtered bymesh75. The flow rate from the bypass machine is kept low to minimize embolization, and the heart is made to beat again.

During surgery, the position of the mesh may require adjustment to maintain its coverage of substantially all of the cross-sectional area of the aorta. To accomplish this, the surgeon occasionally palpates the outside of the aorta gently in order to adjustcannula10 so that themesh75 covers substantially all of the cross-sectional area of the aorta. The surgeon may also adjust the location ofcannula10 within the aorta.

The balloon aortic cannula may also be used in conjunction with TCD visualization techniques. Through this technique, the surgeon may actuate the inflation seal and mesh only when the surgeon expects a flurry of emboli such as during aortic cannulation, inception, and termination of bypass, balloon occlusion, deflation of an occlusive balloon, aortic clamping, and clamp release.

The surgeon then occludes and/or clamps the aorta longitudinally to partially close the aorta, again releasing the atheromatous material to be filtered by the mesh. Holes are punched into the closed off portion of the aorta, and the other end of the vein graft is sewn onto the aorta where the holes have been punched. The balloon occluder is deflated and/or the aortic clamps are removed, again releasing accumulated atheromatous material to be filtered from the blood by the mesh. The surgeon checks the blood flow to make sure there is no leakage. The heart resumes all the pumping, and the bypass machine is turned off, marking the end of the procedure.

The saline is then removed from the balloon occluder and the inflation seal via the actuation assembly, deflating the balloon occluder, inflation seal, and closing the mesh around the captured emboli. Finally, the balloon aortic cannula, along with the captured emboli, are removed from the body. Because the balloon aortic cannula is in place throughout the procedure, any material released during the procedure will be captured bymesh75.

When the balloon arterial cannula is used in conjunction with other invasive procedures, the dimensions of the device should be adjusted to fit the vessel affected. An appropriate mesh also should be chosen for blood flow in that vessel. In use, the device may be positioned so that it is placed downstream of the portion of the vessel that is affected during the procedure, by occlusion and/or clamping or other step in the procedure. For example, in order to capture emboli material in a leg artery, the cone-shaped filter can be placed such that the cone points toward the foot.

An advantage of the devices and methods of the present invention and the methods for filtering blood described herein is that it is possible to capture foreign matter resulting from the incisions through which the devices are inserted. Another advantage of the devices of the present invention is that the flexibility of the inflatable balloon allows it to conform to possible irregularities in the wall of a vessel.

While particular devices and methods have been described for filtering blood, once this description is known, it will be apparent to those of ordinary skill in the art that other embodiments and alternative steps are also possible without departing from the spirit and scope of the invention. Moreover, it will be apparent that certain features of each embodiment, as well as features disclosed in each reference incorporated herein, can be used in combination with devices illustrated in other embodiments. Accordingly, the above description should be construed as illustrative, and not in a limiting sense, the scope of the invention being defined by the following claims.