INTRAVASCULAR BLOOD FILTER

Abstract

Disclosed is a novel filter and delivery means. The device described within will not interfere with standard practice and tools used during standard surgical procedures and tools such as cannulas, clamps or dissection instruments including valve replacement sizing gages or other surgical procedures where the patient must be put on a heart-lung machine cross-clamping the aorta.

Claims

1. A filter system for preventing foreign material from traveling into carotid circulation, the system comprising: a guide catheter; a first filter; and a second filter; wherein the guide catheter is configured to deliver the first filter into a left common carotid artery and expand the first filter; wherein the guide catheter is configured to deliver the second filter into a right common carotid artery and expand the second filter.

2. The filter system of claim 1, wherein the guide catheter includes a first lumen configured to receive the first filter and a second lumen configured to receive the second filter.

3. The filter system of claim 2, wherein the first filter is mounted on a first guidewire and the second filter is mounted on a second guidewire.

4. The filter system of claim 3, wherein the guide catheter includes an active curving mechanism configured to steer the first filter into the left common carotid artery and to steer the second filter into the right common carotid artery.

5. The filter system of claim 4, wherein the active curving mechanism includes at least one deflection wire.

6. The filter system of claim 5, further comprising a handle on a proximal end of the guide catheter, the handle configured to provide an actuation force on the at least one deflection wire.

7. The filter system of claim 6, wherein the handle includes a rotational knob, wherein the handle is configured to translate a rotational movement of the rotational knob to a curving movement of a distal region of the at least one deflection wire.

8. The filter system of claim 7, wherein the guide catheter includes a screw mechanism configured to translate the rotational movement to the curving movement.

9. The filter system of claim 5, wherein the active curving mechanism is configured to bend at least the second lumen from a brachiocephalic artery into the right common carotid artery.

10. A method of preventing foreign material from traveling into carotid circulation, the method comprising: advancing a filter system through a right subclavian artery and into a brachiocephalic artery, the filter system including a guide catheter, a first filter, and a second filter; advancing the first filter into a left common carotid artery and expanding the first filter; and advancing the second filter into a right common carotid artery and expanding the second filter.

11. The method of claim 10, wherein the guide catheter includes a first lumen configured to receive the first filter and a second lumen configured to receive the second filter, wherein advancing the first filter includes advancing the first filter through the first lumen and advancing the second filter includes advancing the second filter through the second lumen.

12. The method of claim 11, wherein the guide catheter includes an active curving mechanism, wherein advancing the first filter includes steering the first filter into the left common carotid artery and advancing the second filter includes steering the second filter into the right common carotid artery.

13. The method of claim 12, wherein the active curving mechanism includes at least one deflection wire, wherein advancing the first filter includes moving the deflection wire to move the first filter from the brachiocephalic artery into the left common carotid artery, wherein advancing the second filter includes moving the deflection wire to move the second filter from the brachiocephalic artery into the right common carotid artery.

14. The method of claim 13, wherein advancing the second filter includes bending the second lumen into the right common carotid artery.

15. The method of claim 13, wherein the guide catheter includes a proximal handle with a rotational knob coupled to the deflection wire, wherein advancing the first and second filters includes rotating the rotational knob to move the deflection wire.

16. The method of claim 12, wherein advancing the second filter includes bending the second lumen from the brachiocephalic artery into the right common carotid artery.

17. A method of preventing foreign material from traveling into carotid circulation, the method comprising: advancing a filter system through a right subclavian artery and into a brachiocephalic artery, the filter system including a guide catheter having a first lumen and a second lumen, a first filter, a second filter, and at least one deflection wire configured to steer the first filter and the second filter; advancing and steering the first lumen and the first filter from the brachiocephalic artery into a left common carotid artery and expanding the first filter; and advancing and steering the second lumen and the second filter into a right common carotid artery and expanding the second filter.

18. The method of claim 17, wherein the first filter is mounted on a first guidewire and wherein advancing and steering the first filter includes steering the first guidewire into the left common carotid artery.

19. The method of claim 18, wherein the second filter is mounted on a second guidewire and wherein advancing and steering the second filter includes steering the second guidewire into the right common carotid artery.

20. The method of claim 17, wherein the guide catheter includes a proximal handle with a rotational knob coupled to the at least one deflection wire, wherein advancing the first and second filters includes rotating the rotational knob to move the at least one deflection wire.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 illustrates the vascular anatomy of the aorta and surrounding great vessels.

[0025] FIG. 2 illustrates the common technique in carotid filter 8 insertion for carotid stenting 10 as delivered via femoral artery over a guidewire 9.

[0026] FIG. 3 illustrates the aortic vasculature where sheaths could be placed by the interventional cardiologist. The right femoral 11 being the most common access as the cardiologist works from the right side of the patient which is presented to the physician while on the table. The right radial artery 12 has been used but due to the small diameter of the vessel is not a common insertion point for the cardiologist.

[0027] FIG. 4 illustrates a brachial entry with common introducer 13 and guidewire 8 techniques.

[0028] FIG. 5 illustrates the guide catheter 14 being inserted to the introducer 13 over the guidewire 8 in a brachial artery entry where the guide catheter 14 has a preshaped distal section to access the left common carotid 3.

[0029] FIG. 6 illustrates a closer view of the guide catheter 14 and guidewire 8 accessing the left carotid artery where the first filter would be placed.

[0030] FIG. 7 illustrates the deployment of the first filter 9 through the guide catheter 14 over a guidewire 8 where the filter 9 is fully opposed to the left carotid artery.

[0031] FIG. 8 illustrates both filters 9 deployed and protecting the carotid arteries utilizing a common guidewire 8 and common guide catheter 14.

[0032] FIG. 9 illustrates a dual lumen catheter 29 where each filter 9 has a single guidewire 8. Both filters 9 are in a conventional orientation where the flow is in the distal direction or toward the distal tip of the guidewire 8. Independent recovery of the filters 9 could occur or a common recovery sheath may be used to load both into one sheath.

[0033] FIG. 10 illustrates both filters 9 being delivered via subclavian where the left filter is delivered via left subclavian artery with an entry point in the radial artery. Each delivery would include a guidewire 8 and a guide catheter 14 where a pre-shaped curve would allow access into the respective carotid artery.

[0034] FIG. 11 illustrates a single organization catheter 15 to retain two filter 9 guidewires 8 controlling the potential for entanglement with each wire or other catheters introduced to the body. These catheters would include pigtail catheters used for contrast injections, balloon catheters for dilation or other catheters for delivery of therapeutic agents or implantable devices such as stents or prosthetic heart valves where the catheters are generally larger (18-26 French) in diameter. The catheter would have two distal exit ports to allow each filter to exit at the respective ostia. A distal section would extend beyond the brachiocephalic trunk allowing for a smooth shape to the catheter and ensure it is close to the outer radius of the arch.

[0035] FIG. 12 illustrates a dual lumen catheter 16 with an active curving mechanism to steer each lumen to the respected carotid artery. The deflection will allow for active steering of each distal section to account for any differences in anatomy from patient to patient. Similar to electrophysiology catheters a deflection wire 18 could be tensioned to provide a bias or curve to tip. The delivery of each filter would be in a conventional orientation where the blood flow would be in the distal direction and toward the tip of the guidewire. External to the body would be a handle mechanism 17 providing an actuation force to the distal portion of the catheter. This actuation could be a rotational knob 19 translating a rotation movement to a screw mechanism providing a tension to a wire connected to the catheter tip. Other methods could include an electrical signal to drive a motion or hydraulic actuation to translate a force.

[0036] FIG. 13 illustrates a filter 9 delivered over the guidewire 8 from the carotid artery in a retrograde approach just short of the aortic arch. Once the procedure is completed the filter can be snared with a conventional snare 20 to remove it from the body. This will allow for a very small (0.03 inch) entry port in the neck to introduce the device and a larger recovery sheath 21 in the groin where other devices are introduced.

[0037] FIG. 14 illustrates a set of filters in the carotid arteries delivered and ready for additional procedures to occur under filtered protection. During a percutaneous heart valve delivery there may be multiple catheters in the aortic arch consuming much of the available area. Shown here is a pigtail catheter 22 and a delivery catheter 24 for a percutaneous heart valve 23 all within the aortic arch. The filters 9 are clear of the aortic space and will not interfere with delivery or withdrawal of these catheters.

[0038] FIG. 15 illustrates another delivery pathway for the placement in the carotid or brachiocephalic trunk. Delivery includes a guidewire 8 introduced via carotid artery or subclavian artery just short of the aortic arch leaving the arch free from interference while delivering other catheters to the heart. These filters 9 can be retrieved either through the groin or recovered back through the entry point in the carotid or subclavian artery.

[0039] FIG. 16 illustrates a conventional entry to the carotid artery where the sheath is placed in a retrograde manner. A sheath 13 is placed into the carotid artery where access may be gained to the vasculature either anti grade or retrograde depending upon the desired placement of the device.

[0040] FIG. 17 illustrates an example of a common filter design where the guidewire 8 passes through the central portion of the filter 27. A memory material such as Nitinol is used to expand the filter material to the vessel wall.

[0041] FIGS. 18A-B illustrate other examples of filters where a loop style 25 has the guidewire passing along the side of the device and functions like a wind-sox when deployed in the vessel. The other example is a framed filter where when expanded the filter material is opposed to the vessel wall and the guidewire 8 passes through the central portion of the device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0042] Before standard intervention would occur by a cardiologist a filter would be placed into the carotid arteries to protect the circulation to the brain where emboli could induce a stroke and leave the patient debilitated. Placement of these filters to the patient's carotid circulation would be most convenient if it occurred without obstruction of the aorta where other catheters would be passed and preferably on the patient's right side as it is common practice for the doctor to steer the catheters from this side of the table. Standard practice is to gain access in the right femoral artery where a sheath would be placed to introduce catheters, guidewires and other device delivery means. This would leave the left femoral artery open but often it too is used for other diagnostic catheters and it is less convenient to work across the patient's body. Other access sites would include carotid entry but the neck area is often again inconvenient to operate from and generally too far from the other wires and catheters. The final entry point would be an arm entry where a sheath would be placed into the brachial or radial artery for access to the subclavian artery and more distally the aorta and the carotid arteries. This approach would allow the doctor to access the patient's right arm placing a sheath into the radial artery and delivering catheters, guidewires and sheaths to the carotid arteries. After a 5 French sheath placement a guide catheter would be placed into the radial artery and advanced to the brachiocephalic trunk where the right carotid artery meets the subclavian. From here a curve in the guide catheter would allow a 180 turn to occur accessing from the brachiocephalic trunk into the aortic arch and back up the left carotid artery which is commonly found one centimeter down the aortic arch. Once the guide catheter is place a filter may be advanced into the left carotid artery and deployed leaving this vessel protected from emboli. The guide catheter could be moved proximally to leave this vasculature and back into the brachiocephalic trunk artery where a coaxial filter could now be placed protecting this carotid artery. The connection between the two filters is a common axial link where the distal or left carotid filter would be attached to a 0.014 inch guidewire as normally constructed and the more proximal filter would utilize a tubular member such as a polymer or Nitinol hypo tube. The distal filter may need to be gently engaged to the vessel wall to allow the connection guidewire to be tensioned removing any slack or loop within the aortic arch. This may be possible with engagement barbs restricting proximal motion of the device in the vessel when deployed. Other means may be a stronger force in the memory metal loop to keep the device opposed to the wall. Now the circulation to the brain is protected and the aortic arch is clear from obstruction the normal procedure can occur. Examples of these procedures include but are not limited to: [0042] Coronary stenting [0043] Aortic valve replacement via catheterization [0044] Aortic or mitral valve replacement via transapical [0045] Aortic balloon valvuloplasty [0046] Mitral valvuloplasty [0047] Mitral valve replacement via catheterization [0048]

[0043] Diagnostic catheterization [0049] Surgical valve replacement (aortic or mitral) [0050] Surgical valve repair (aortic or mitral) [0051] Annuloplasty ring placement [0052] Atrial fibrillation catheterization [0053] PFO closure (surgical or catheter based) [0054] Left atrial appendage closure (catheter or surgical)

[0044] Once the procedure has been completed the filters may be removed immediately or left in place if an antitrombotic coating is added or the patient remains on blood thinning agents to limit clot from forming on the filters. It may be advantageous to leave the filters in for a period of twenty four hours as the patient begins to recover. When removal is necessary the goal is to not dislodge any trapped emboli within the filter. Conventionally this is accomplished by pulling the filter into a larger recovery sheath to first close the open end of the filter and draw the remaining portion safely back into the recovery catheter. With the filters being opposed in direction it may be advantageous to move the distal filter into the proximal filter and recover them both together in a nested orientation.