WO2002056955A1 - Arterial cannula with perforated filter lumen - Google Patents

Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/01—Filters implantable into blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/01—Filters implantable into blood vessels
  • A61F2/011—Instruments for their placement or removal
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
  • A61F2230/0004—Rounded shapes, e.g. with rounded corners
  • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0001—Catheters; Hollow probes for pressure measurement
  • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M2025/0286—Holding devices, e.g. on the body anchored in the skin by suture or other skin penetrating devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
  • A61M5/16804—Flow controllers
  • A61M5/16813—Flow controllers by controlling the degree of opening of the flow line

Definitions

• the present invention relates generally to medical devices for protecting a patient from embolization during cardiovascular procedures. More particularly, the devices comprise a filter insertable within a double-lumen cannula that is useful for arterial cannulation.
• Cardiopulmonary bypass and cardiac arrest are often required in both conventional and minimally invasive coronary artery bypass grafting surgeries, and other cardiovascular surgeries, such as ventricular septal defect repair, heart valve repair or replacement, ventricular myomectomy, aortic aneurysm repair, or aortic thrombectomy.
• cardiovascular surgeries such as ventricular septal defect repair, heart valve repair or replacement, ventricular myomectomy, aortic aneurysm repair, or aortic thrombectomy.
• cardioplegia solution can be infused to paralyze the heart without paralyzing the peripheral organs.
• Cardiopulmonary bypass is initiated to maintain peripheral circulation by withdrawing venous blood, passing the deoxygenated blood through a bypass-oxygenator, and infusing oxygenated blood into the aorta.
• embolic materials e.g., calcium, intimal debris, atheromatous plaque, thrombi, and/or air, generated during manipulation of the cardiovascular tissue, travel downstream and cause occlusion of the narrower vessels and ischemia or infarct of the organ that the vessel supplies.
• the organs typically at risk are the brain, the kidneys, the intestine, and the extremities.
• the arterial cannula accommodates a filter in its lumen.
• the lumen of the arterial cannula is sometimes occluded by the filter, causing impairment of arterial blood flow and pressure drop across the cannula.
• the present invention provides a cannula for placement in a patient's vessel.
• the cannula is most useful in performing cannulation in arteries, e.g., the aorta, the carotid artery, the iliac artery, and the femoral artery, it is also suitable for placement in veins, e.g., the inferior vena cava.
• the cannula comprises an elongate member having first and second lumens communicating with a proximal end and a distal end.
• the first lumen is adapted for perfusion of blood
• the second lumen is adapted to receive a filter wire.
• the effective diameter of the second lumen is smaller than that of the first lumen.
• the wall separating the first and second lumens is perforated to allow communication of blood flow between the two lumens.
• the proximal end of the cannula is adapted for attachment to a bypass-oxygenator machine.
• the distal end of the cannula is angled approximately 90° from the proximal end to facilitate positioning of the cannula inside a vessel.
• the angled distal region is flexible, so that the cannula assumes a linear configuration to facilitate its insertion into a vessel and returns to its preformed angled configuration after being positioned in the vessel.
• a suture flange may be mounted on a distal region of the cannula to secure the cannula onto a vessel.
• a hemostatic valve is included in the proximal end of the second lumen to prevent blood loss.
• the proximal end of the second lumen also includes a mechanism for adjusting blood flow in the second lumen.
• a manometer included in the distal end of the cannula measures blood pressure downstream the cannula and provides feedback to the mechanism for controlling blood flow to the vessel.
• the invention also provides methods for cannulation of a vessel and protecting a patient from embolization using the cannula described above.
• the filter or the occluding device is first placed in a collapsed state and inserted through an incision into the patient's aorta.
• the filter or the occluding device is expanded to capture embolic material, including air, thrombi, calcium, atheromatous plaque, and/or tissue debris.
• the distal end and the second lumen of the cannula is inserted over the filter wire and advanced into the aorta.
• Sutures may be placed on the suture flange to secure the cannula onto the aortic wall.
• the proximal end of the cannula may then be attached to a bypass-oxygenator and oxygenated blood is infused into the aorta through the first lumen of the cannula to establish cardiopulmonary bypass.
• Blood pressure downstream the cannula is measured by an optional manometer mounted on the distal end of the cannula.
• Blood flow to the aorta can be controlled by adjusting a flow-controlling mechanism that may be included in the proximal end of the cannula.
• an introducer is first inserted into the aorta.
• the filter in a collapsed state, is then inserted into the lumen of the introducer and advanced into the aorta. After expansion of the filter, the introducer is removed from the aorta. The cannula is then inserted over the filter wire to position in the aorta.
• the filter is adapted for temporary placement in a patient's artery or vein and can be replaced during a procedure without removing the cannula;
• the cannula may be adapted for attachment to a bypass-oxygenator;
• the inclusion of a separate filter lumen prevents occlusion of the perfusion lumen by the filter;
• the inclusion of a perforated wall between the perfusion and filter lumens reduces the pressure drop through the cannula;
• the cannula provides aortic cannulation during cardiopulmonary bypass in addition to providing protection from distal embolization; and (6) the devices minimize crowding of the surgical field during minimally invasive cardiovascular procedures.
• Fig. 1 depicts an embodiment of a cannula having a perforated filter lumen.
• Fig. 2 A depicts another embodiment of the cannula having an angled distal region.
• Fig. 2B depicts a cross-sectional view of the cannula of Fig. 2 A through section line B-B
• Fig. 2C depicts a cross-sectional view of the cannula of Fig. 2 A through section line C-C.
• Fig. 3 A depicts a cross-sectional view of another embodiment of the cannula having an oval-shaped filter lumen.
• Fig. 3B depicts a cross-sectional view of another embodiment of the cannula having a plurality of perforations between the blood lumen and filter lumen in a cross section.
• Fig. 3C depicts a cross-sectional view of another embodiment of the cannula having the filter lumen located in the center of the cannula.
• Fig. 4A depicts a blood filter inserted into an artery.
• Fig. 4B depicts the cannula of Fig. 2A inserted over the filter wire of Fig. 4A.
• Fig. 5 A depicts another embodiment of the cannula having a second perforated tubular member nested within the filter lumen.
• Fig. 5B depicts a cross-sectional view of the cannula in Fig. 5 A through section line B-B.
• Fig. 5C depicts clockwise rotation of the nested tubular member of Fig. 5B allowing partial alignment between apertures on the perforated wall and the nested tubular member.
• Fig. 5D depicts further clockwise rotation of the nested tubular member of Fig. 5C allowing misalignment between apertures on the perforated wall and the nested tubular member.
• Fig. 6 depicts the cannula and filter of Fig. 4B inserted in the ascending aorta during cardiopulmonary bypass.
• Fig. 1 depicts an embodiment of the cannula that comprises an elongate member having blood lumen 20 and filter lumen 25 extending to distal end 15.
• Lumen 20 adapted for infusion of oxygenated or deoxygenated blood, communicates with proximal end 12 which is adapted for attachment to a bypass-oxygenator.
• Lumen 25 is adapted for receiving a filter wire, and communicates proximally with proximal end 26 that optionally includes hemostatic valve 30, which may consist of a duckbill, o-ring, or other suitable seals or valve arrangements.
• Wall 35 which separates lumens 20 and 25, is perforated to allow communication of blood flow between the two lumens.
• the effective diameter of lumen 20 is therefore greater than the diameter of lumen 20 because it includes the area occupied by lumen 25.
• Fig. 2 A depicts another embodiment of the cannula having distal end 15 angled at approximately 90° relative to its proximal end. This configuration allows the cannula to be positioned witliin the region of interest to better fit the vessel geometry and thereby facilitate blood delivery and filter deployment in a vessel.
• the cannula includes flexible distal region 40 that allows the cannula to assume a linear configuration to facilitate insertion into a vessel. After insertion, the cannula returns to its preformed angled configuration within the vessel.
• Flange 44 mounted on a distal region of the cannula, allows placement of sutures to secure the cannula onto the vessel wall.
• FIG. 2B and 2C Cross-sectional views of wall 35 at different location on the cannula are depicted in Figs. 2B and 2C.
• Wall 35 includes apertures 33, which allow flow between lumens 20 and 25. In this embodiment, blood flows between the two lumens through aperture 33 in the cross-sectional view of the cannula depicted in Fig. 2C.
• wall 35 includes three apertures 33. The wall may include 2, 3, 4, 5, 6, 7, 8, or any other number of apertures suitable to allow blood flow between the two lumens.
• Fig. 3B depicts another embodiment of wall 35 separating lumens 20 and 25, such that the cross-sectional configuration of lumen 25 approximates an oval or elliptical shape.
• lumen 25 may also take on other suitable shapes, e.g., circular, square, or rectangular.
• lumen 25 is located in the center of lumen 20.
• lumen 25, shaped to receive a filter may be located anywhere within lumen 20.
• the filter in a collapsed state, is first inserted directly through an incision on a vessel and advanced to the region of interest.
• filter 50 is deployed downstream atheromatous lesion 101 to capture embolic debris as depicted in Fig. 4A.
• the distal end of the cannula is inserted over filter wire 55 through lumen 25 into the aorta as depicted in Fig. 4B.
• Sutures are placed on flange 44 to secure the cannula onto the aortic wall.
• the proximal end of the cannula is attached to a bypass-oxygenator.
• Oxygenated blood is then infused through lumen 20 of the cannula downstream the ascending aorta to maintain peripheral perfusion while filter 50 provides protection against distal embolization.
• cardiopulmonary bypass is discontinued, the cannula is removed from the aorta, and filter 50 is collapsed.
• the filter and the captured embolic material e.g., air, fluid, thrombi, calcium, atheromatous plaque, and/or tissue debris, generated during the procedure, are then removed from the aorta.
• the cannula and collapsed filter 50 are concomitantly removed from the aorta.
• an introducer (not shown) is first inserted through the aorta.
• the collapsed filter 50 is inserted through the lumen of the introducer to position in the ascending aorta. After expansion of the filter, the introducer is removed from the aorta, and the cannula is then introduced over filter wire 55 into the aorta as described above.
• the collapsed filter is first inserted in the lumen of an introducer. The filter/introducer is then inserted through an incision into the aorta. After deployment of the filter, the introducer is removed and the cannula is inserted over the filter wire into the aorta.
• Fig. 5 A depicts another embodiment of the cannula which includes a second perforated elongate tubular member 36 nested within filter lumen 25.
• Tubular member 36 also has a plurality of apertures 33 which are of the same shape and size as on wall 36.
• Tubular member 36 can be rotated clockwise or counterclockwise within lumen 25 such that apertures 33 on wall 35 and tubular member 36 overlap. This design allows regulation of blood flow between lumens 20 and 25.
• tubular member 36 is rotated such that apertures 33 on the tubular member align with apertures 33 on wall 35, thereby allowing maximal blood flow between the two lumens.
• the cannula includes apertures 33 on the entire length of wall 35 and tubular member 36. In other embodiments, only certain segment(s) of the cannula include apertures.
• the devices and methods described above can be used in open or minimally invasive cardiovascular surgeries.
• the cannula and filter 50 are deployed in ascending aorta 100 as depicted in Fig. 6.
• Filter wire 55 is insertable through lumen 25.
• the proximal end of lumen 25 includes hemostatic valve 30, which minimizes blood loss.
• Proximal end 12 of the cannula is attached to a bypass-oxygenator which receives deoxygenated blood from a vein, e.g., the inferior vena cava, oxygenates the blood, and returns the oxygenated blood to the aorta through lumen 20.
• the distal end of the cannula may include manometer 70, which measures blood pressure downstream of the cannula.
• the proximal end of the manometer is attached to pressure monitor 75 that displays blood pressure readings.
• blood flow between lumens 20 and 25 through the apertures in wall 35 and the nested tubular member can be regulated by rotation of the nested tubular member with respect to wall 35.
• the length of the cannula will generally be between 10 and 100 centimeters for aortic use, preferably approximately between 20 and 50 centimeters.
• the outer diameter of the cannula will generally be between 0.5 and 1.5 centimeters, preferably approximately between 0.8 and 1.2 centimeters.
• the inner diameter of the arterial lumen will generally be between 2 and 14 millimeters, preferably approximately between 4 and 7 millimeters.
• the inner diameter of the filter lumen will generally be between 1 and 7 millimeters, preferably approximately between 3 and 5 millimeters.
• the filter will be capable of expanding to an outer diameter of at least 0.2 centimeters, more preferably at least 0.5 centimeters, more preferably at least 1.0 centimeters, more preferably at least 1.5 centimeters, more preferably at least 2.0 centimeters, more preferably at least 2.5 centimeters, more preferably at least 3.0 centimeters, more preferably at least 3.5 centimeters, more preferably at least 4.0 centimeters, more preferably at least 4.5 centimeters, more preferably at least 5.0 centimeters.
• the filter will be capable of contracting to an outer diameter of between 0.05 and 2.0 millimeters, preferably approximately between 0.8 and 1.2 millimeters. These ranges cover suitable diameters for both pediatric and adult use.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• External Artificial Organs (AREA)

Abstract

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Cited By (64)

Citations (4)

• 2002
  • 2002-01-11 WO PCT/US2002/000700 patent/WO2002056955A1/en not_active Application Discontinuation

Patent Citations (4)

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