US20030105486A1 - Cannula with flow diversion mechanism and methods of use - Google Patents

Abstract

A cannula is described that includes a diverter mechanism in the form of a diffusion surface deployable from within the lumen of the cannula and retractable from the lumen of the cannula. The diffusion surface may take the form of a planar surface, a curved surface, a membrane mounted on a wire ring, or a conical sleeve, or any other suitable shape. In use, the cannula is inserted in a vessel, the diffusion surface is deployed in the lumen of the cannula beyond the distal end of the cannula, and blood flow is passed through the cannula and against the diffusion surface. Alternative devices and methods are also described.

Description

• This is a continuation of U.S. patent application Ser. No. 09/846,309, filed Apr. 30, 2001, now U.S. Pat. No. 6,508,826, which is expressly incorporated herein by reference in its entirety.[0001]
FIELD OF THE INVENTION
• The present invention relates generally to medical devices useful for cannulation of a vascular tissue, such as the aorta, and for protecting against distal embolization during cardiovascular procedures. More particularly, the devices minimize plaque dislodgement and damage to a vessel wall during delivery of blood to the vessel.[0002]
BACKGROUND OF THE INVENTION
• Aortic cannulation is commonly employed during various conventional or minimally invasive surgeries, such as coronary artery bypass grafting, heart valve repair or replacement, septal defect repair, pulmonary thrombectomy, atherectomy, aneurysm repair, aortic dissection repair, and correction of congenital defects, to establish cardiopulmonary bypass. After circulatory isolation of the coronary blood flow from the peripheral vascular system is established, a cannula is usually inserted in the ascending aorta to deliver oxygenated blood from a bypass-oxygenator to maintain blood flow to the peripheral organs, e.g., the brain and kidneys. It is well recognized that one of the complications associated with cardiovascular procedures is the dislodgement of embolic materials generated during manipulation of the aorta or the heart, thereby causing occlusion of the vessels downstream from the aorta causing ischemia or infarct of the organs, e.g., stroke. To minimize embolic complication, an arterial filter is often temporarily deployed in the aorta distal to the aortic cannula to capture embolic debris.[0003]
• However, when oxygenated blood is delivered to the aortic cannula through the bypass-oxygenator, blood exits the cannula with a very high velocity, similar to a jet-like profile. When this jet is directed toward the aortic wall, it may damage the aorta causing aortic dissection or aneurysm. Furthermore, the jet may dislodge plaque on the aortic wall, causing distal embolization and peripheral organ infarction. When oxygenated blood is allowed to flow into a filter, the jet may cause turbulent flow in the filter, thereby washing out the emboli caught in the filter. As a result of the swirling action by the jet, the emboli may escape around the edges of the filter to cause distal embolization and result in damage to peripheral organs, or may travel upstream to reach a coronary artery and cause myocardial infarction.[0004]
• New devices and methods are thus needed in aortic cannulation to minimize embolic dislodgement and vascular wall damage due to delivery of oxygenated blood to the aorta during cardiovascular surgeries.[0005]
SUMMARY OF THE INVENTION
• The invention provides devices and methods for reducing the jet-like profile of blood delivered through a cannula and the swirling of the blood within a filter. It will be understood that, although the present invention is most useful in aortic cannulation during cardiovascular surgeries, the devices and methods can be used in any surgeries where delivery of fluid or blood through a cannula can potentially damage the body tissue.[0006]
• In a first embodiment, the cannula is an elongate tubular member having a proximal end, a distal end, and a lumen therebetween. A blast plate deployable from within the lumen of the elongate tubular member is provided. The blast plate is retractable into the lumen of the elongate tubular member after use. In certain cases, the cannula is angled at its distal end, generally at a 90° angle to the axis of the lumen at a proximal end. In other cases, the cannula will further include a filter deployable from the distal end of the cannula. The filter may be mounted on the distal end of the cannula, or the filter can be mounted on a separately insertable member, such as a guidewire. In other cases, the cannula has more than one lumen extending from its proximal to its distal end. In still other cases, the cannula further comprises an occlusion member such as a balloon occluder, deployable from the distal end of the cannula. As with the filter, the occluder can be mounted on the cannula, or provided on a separately insertable member, such as an occlusion catheter.[0007]
• The blast plate typically comprises a generally flat or curved surface, and may comprise a membrane mounted on a flexible wire ring. The membrane generally comprises a semi-permeable material. In certain cases the member is a mesh material. In still other cases, the membrane is made of an impermeable material. While in certain cases the blast plate is formed in the shape of a planar surface defined by a wire ring, in other cases the blast plate is a cone-shaped sleeve. The sleeve can be made of an elastomeric material. The blast plate may also take the form of a substantially flat surface mounted at the distal end of a flexible or an inflexible elongate member. For example, the blast plate may be fixed to the end of a wire. The blast plate will be angled relative to the elongate member, and the angle may be selected from a 45° angle, a 50° angle, a 55° angle, a 60° angle, a 65° angle, a 70° angle, a 75° angle, an 80° angle, an 85° angle, or a 90° angle.[0008]
• In use, the surgeon inserts the cannula into a body cavity, e.g., a blood vessel. It will be understood that the cannula may comprise a standard commercially available cannula, or any of the novel cannula described herein. The surgeon will then advance a blast plate or dispersion mechanism through the lumen of the cannula and beyond the distal end of the cannula. The surgeon then flows a stream of fluid, e.g., blood, through the lumen of the cannula. The blood flow hits the blast plate, and the blood stream is diffused and dispersed by the blast plate without jetting against the wall of the aorta. After the infusion procedure is complete, the surgeon retracts the blast plate into the lumen of the cannula.[0009]
• It will be understood that the methods of use have particular application where the body cavity is a blood vessel, where the blood vessel is an artery, and where the artery is the aorta. It will further be understood that there are several advantages to using the diffusion-diversion devices and methods described herein. For example, by dispersing the stream of blood flow, the devices and methods (1) avoid “sand blasting” embolic debris from the lumen of the vessel, (2) avoid the swirling of blood that may carry embolic debris upstream during CABG to the coronary arteries, where myocardial ischemia can occur, (3) avoid turbulence that can force embolic debris around the periphery of a deployed filter to cause distal embolization which can results in stroke, renal failure, or other organ damage.[0010]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A depicts a cannula having a blast plate deployed within an artery.[0011]
• FIG. 1B depicts an end view of the artery and cannula of FIG. 1A.[0012]
• FIG. 1C depicts a cannula with blast plate deployed within an artery, and a separately deployed filter through a second cannula.[0013]
• FIG. 1D depicts a cannula having a filter and a blast plate deployed through separate lumens of the cannula.[0014]
• FIG. 1E depicts removal of the blast plate of FIG. 1D.[0015]
• FIG. 2A depicts a blast plate comprising a membrane mounted on a flexible wire ring.[0016]
• FIG. 2B depicts an end view of the artery and cannula of FIG. 2A.[0017]
• FIG. 3A depicts a diverter that comprises a cone-shaped sleeve.[0018]
• FIG. 3B depicts the diverter of FIG. 3A deployed within a filter.[0019]
• FIG. 3C depicts an end view of the diverter and filter of FIG. 3B.[0020]
• FIG. 3D depicts an oblique view of the diverter and filter of FIG. 3B.[0021]
• FIG. 4A depicts a standard cannula and filter without a diverter.[0022]
• FIG. 4B depicts a filter and cannula having a windsock embolic trap incorporated in the filter.[0023]
• FIG. 4C depicts the use of the device of FIG. 4B in the ascending aorta.[0024]
DETAILED DESCRIPTION
• A first cannula with flow diverter is depicted in FIG. 1A.[0025]Cannula10 havingdistal end11 is deployed through an incision invessel99, in certain cases the aorta.Blast plate20 is fixed to elongatewire21 atbond22.Blast plate20 is deployed throughlumen13 ofcannula10. Blood flow exitscannula10,impacts blast plate20, and is scattered as shown by the arrows surroundingblast plate20. FIG. 1B depicts an end view of the diverter and cannula of FIG. 1B. As shown in FIG. 1A,blast plate20 is not necessarily flat but can take on a curvilinear configuration.
• FIG. 1C shows a cannula and diverter deployed within[0026]vessel99, and a separate filter cannula.Filter cannula30 carries separately insertableelongate member43 havingexpansion frame41 andmesh40 disposed at a distal end ofelongate member43.Expansion frame41 is attached to elongatemember43 throughactive anchor wire42. It will be understood thatanchor wire42 allowsexpansion frame41 to expand to fill the lumen ofvessel99.Mesh40 is attached at an edge toexpansion frame41. In other devices,expansion frame41 may be directly connected to elongatemember43. In this manner, the filter mechanism is separately insertable throughcannula30, which is introduced as a separate stick onvessel99.
• FIG. 1D depicts[0027]cannula10 havingfirst lumen13 andsecond lumen12.First lumen13 is adapted for insertion ofdiverter mechanism20.Second lumen12 is adapted to receive and pass a separately insertable filter disposed at the distal end of an elongate member. FIG. 1E depictsblast plate20 being withdrawn throughlumen13 ofcannula10.
• In certain alternative embodiments,[0028]diverter20 or alternately the filter/diverter may be stored inlumen13 through which blood flows, so that the onset of flow causesdiverter mechanism20 and/or the filter to move distally and deploy once ejected from the tip of the cannula. The mechanism may be tethered to the cannula and may be removed with the cannula or withdrawn back intolumen13 using a wire.
• FIG. 2A shows an alternative construction of a diverter mechanism and filter protection device. The diverter comprises[0029]wire ring23 fixed to elongatemember21 atbond22. An impermeable orsemi-permeable material24covers wire ring23 and acts as a blast plate for existing blood flow.Filter40 includesexpansion frame41 andcantilever42. The reader is referred to Ambrisco et al., U.S. Pat. No. 6,007,557, incorporated as if set forth in its entirety herein, for details on the design of a cantilever-based expansion frame. FIG. 2B depicts an end view of a membrane blast plate as shown in FIG. 2A.
• FIG. 3A shows[0030]cannula10 having angleddistal end11 disposed withinvessel99.Diverter20 takes the form of cone-shapedsleeve25 formed of an impermeable or semi-permeable material.Sleeve25 is open atproximal end26 for receiving blood flow fromarterial return cannula10.Sleeve25 disperses the jet stream of blood as shown by thearrows surrounding sleeve25. FIG. 3B showssleeve25 used withfilter40 mounted onexpansion frame41. FIG. 3C depicts an end view of the filter with the cone-shaped sleeve of FIG. 3B.Sleeve25 is connected to elongatemember28 bystruts27.Elongate member28 andsleeve25 are separately insertable throughcannula10.Filter40 andexpansion frame41 may be separately insertable or may be mounted on the distal region ofcannula10. FIG. 3D shows an oblique view of the cannula, cone-shaped diverter sleeve, and filter of FIG. 3B.
• FIG. 4A depicts[0031]standard cannula10 andfilter50, without diverter capabilities. Unscattered blood flow fromcannula10 creates turbulence withinfilter50 that may cause emboli to escape downstream, and may carry other emboli upstream where they can become lodged in the coronary arteries, resulting in myocardial ischemia or infarct. FIG. 4B shows a filter construction that traps emboli to prevent movement within turbulent blood flow.Expansion frame41 is attached to filtermesh60 that includes reservoir tip61 (in the shape of a windsock) for retaining captured emboli. This design will immobilize emboli and minimize the opportunity for proximal and distal embolization.
• FIG. 4C shows the use of a filter with reservoir tip in the ascending aorta.[0032]Expansion frame41 is deployed throughcannula10 upstream the takeoff for rightbrachiocephalic artery96, left commoncarotid artery97, and leftsubclavian artery98.Filter60 includesreservoir tip61. Afterfilter60 is deployed, arterial return is provided throughcannula10. After termination of arterial return flow,expansion frame41 andfilter60 are removed throughcannula10 before removingcannula10. These devices will find application in any surgeries that can make use of arterial cannulation and/or filter protection, including coronary artery bypass grafting, heart valve repair or replacement, septal defect repair, pulmonary thrombectomy, atherectomy, aneurysm repair, aortic dissection repair, and correction of congenital defects.
• The length of the cannula will generally be between 15 and 60 centimeters, preferably approximately between 25 and 40 centimeters. The inner diameter of the cannula lumen will generally be between 0.5 and 1.5 centimeters, preferably between 0.5 and 1.0 centimeters. The diameter of the expanded filter will generally be between 0.3 and 3.0 centimeters, preferably approximately 2.0 and 2.5 centimeters for use in the aorta. The foregoing ranges are set forth solely for the purpose of illustrating typical device dimensions. The actual dimensions of a device constructed according to the principles of the present invention may obviously vary outside of the listed ranges without departing from those basic principles.[0033]
• Although the foregoing invention has, for the purposes of clarity and understanding, been described in some detail by way of illustration and example, it will be obvious that certain changes and modifications may be practiced which will still fall within the scope of the appended claims. For example, the devices and methods of each embodiment can be combined with or used in any of the other embodiments.[0034]

Claims (20)

What is claimed is:

1. A surgical method, comprising the steps of:

inserting a cannula into a blood vessel, the cannula comprising an elongate tubular member having a proximal end, a distal end, and a lumen therebetween;

deploying an embolic protection filter through the elongate tubular member and within the blood vessel;

advancing a diffusion surface from the lumen of the elongate tubular member beyond the distal end of the elongate tubular member;

flowing a blood stream through the lumen of the elongate tubular member against the diffusion surface, wherein the blood stream is dispersed by the diffusion surface; and

retracting the diffusion surface into the lumen of the elongate tubular member.

2. The method ofclaim 1, wherein the blood vessel is an artery.

3. The method ofclaim 2, wherein the artery is the aorta.

4. The method ofclaim 1, wherein the elongate tubular member is angled at its distal end.

5. The method ofclaim 1, wherein the lumen is divided into more than one lumen.

6. The method ofclaim 1, further comprising an occlusion member deployable from the distal end of the elongate tubular member.

7. The method ofclaim 1, wherein the diffusion surface comprises a membrane mounted on a flexible wire ring.

8. The method ofclaim 7, wherein the membrane is semi-permeable.

9. The method ofclaim 8, wherein the membrane is a mesh.

10. The method ofclaim 7, wherein the membrane is impermeable.

11. The method ofclaim 1, wherein the diffusion surface is a cone-shaped sleeve.

12. The method ofclaim 11, wherein the sleeve is an elastomeric material.

13. The method ofclaim 1, wherein the diffusion surface comprises a substantially flat surface mounted at a distal end of a flexible elongate member.

14. The method ofclaim 13, wherein the flexible elongate member is a wire.

15. The method ofclaim 13, wherein the surface is attached to the flexible elongate member at substantially a 45° angle.

16. A cannula, comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen therebetween;

an attachment wire coupled to the distal end of the elongate tubular member; and

an expansion frame deployable from the distal end of the elongate tubular member and attached to the distal end of the attachment wire;

wherein during use, the distal end of the elongate tubular member is inserted into a vessel and the expansion frame is expanded to fill the vessel lumen.

17. The cannula ofclaim 16, further comprising a mesh attached to the expansion frame.

18. The cannula ofclaim 16, further comprising a diffusion surface deployable from within the lumen of the elongate tubular member and retractable into the lumen of the elongate tubular member.

19. The cannula ofclaim 18, wherein the diffusion surface comprises a substantially flat surface mounted at a distal end of a flexible elongate member.

20. The cannula ofclaim 16, wherein the lumen is divided into more than one lumen.

Images