Apparatus and methods for intravascular embolic protection
The present invention provides intravascular embolic protection apparatus including a blood filter element having an accommodating passageway adapted to permit passage of a procedure device therethrough and to substantially seal against passage of particles between the embolic protection apparatus and the procedure device by accommodating to a size and shape of the procedure device. Furthermore, the present invention provides a method of performing an endovascular procedure on a patient including the steps of delivering an embolic protection apparatus to a location within a vascular lumen of the patient; passing a procedure device through an accommodating passageway of the apparatus, the accommodating passageway accommodating to a size and shape of the procedure device; performing the endovascular procedure; and removing the procedure device from the patient.
1 . An intravascular embolic protection apparatus comprising:
a blood filter element adapted to capture particles and to allow blood to flow therethrough;
an opening adapted to face blood flow;
a closed portion adapted to retain captured particles; and
an accommodating passageway adapted to permit passage of a procedure device therethrough from a position proximal to the closed portion to a position distal to the opening and to substantially seal against passage of particles between the embolic protection apparatus and the procedure device by accommodating to a size and shape of the procedure device.
2 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is sealable to substantially prevent passage of particles through the passageway when a procedure device is not disposed in the passageway.
3 . The intravascular embolic protection apparatus of claim 2 , wherein the passageway is self-sealing.
4 . The intravascular embolic protection apparatus of claim 3 , wherein the passageway is biased toward a sealed position.
5 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway has a tapered opening for catheter guidance.
6 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is expandable to permit devices of different sizes to pass through the passageway.
7 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is a lumen in the apparatus.
8 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is a fold in the apparatus.
9 . The intravascular embolic protection apparatus of claim 1 , wherein the apparatus is self-expanding from a delivery configuration to a deployed configuration.
10 . The intravascular embolic protection apparatus of claim 9 , wherein the passageway is expandable independent of the rest of the apparatus.
11 . The intravascular embolic protection apparatus of claim 1 , wherein the apparatus is radially symmetrical.
12 . The intravascular embolic protection apparatus of claim 1 , wherein the apparatus is bilaterally symmetrical.
13 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is located in a center of the apparatus.
14 . The intravascular embolic protection apparatus of claim 1 , wherein the passageway is located off-center of the apparatus.
15 . The intravascular embolic protection apparatus of claim 1 , wherein the closed portion defines a plurality of pockets adapted to trap and retain particles.
16 . The intravascular embolic protection apparatus of claim 1 , wherein the closed portion is tapered to facilitate recapture of the apparatus.
17 . The intravascular embolic protection apparatus of claim 1 , wherein the blood filter element defines the opening and the closed portion.
18 . The intravascular embolic protection apparatus of claim 17 , wherein the blood filter element defines the passageway.
19 . The intravascular embolic protection apparatus of claim 18 , wherein the opening surrounds the passageway.
20 . The intravascular embolic protection apparatus of claim 18 , wherein the closed portion surrounds the passageway.
21 . The intravascular embolic protection apparatus of claim 18 , wherein the blood filter element provides a bias force to substantially seal the passageway, and wherein the bias force may be overcome to permit passage of the procedure device through the passageway.
22 . The intravascular embolic protection apparatus of claim 1 , wherein the blood filter element comprises a mesh material.
23 . The intravascular embolic protection apparatus of claim 22 , wherein the mesh material is formed from a single wire.
24 . The intravascular embolic protection apparatus of claim 22 , wherein the mesh-material is formed from multiple wires.
25 . The intravascular embolic protection apparatus of claim 22 , wherein the mesh material is formed from multiple meshes.
26 . The intravascular embolic protection apparatus of claim 22 , wherein the mesh material is covered at least in part by filter material.
27 . The intravascular embolic protection apparatus of claim 22 , wherein the mesh material defines the passageway.
28 . The intravascular embolic protection apparatus of claim 27 , wherein the mesh material provides a bias force to substantially seal the passageway, and wherein the bias force may be overcome to permit passage of the procedure device through the passageway.
29 . The intravascular embolic protection apparatus of claim 1 , wherein the apparatus is adapted to be delivered via a catheter.
30 . The intravascular embolic protection apparatus of claim 29 , wherein the apparatus is further adapted to be delivered over a guidewire.
31 . The intravascular embolic protection apparatus of claim 30 further comprising a guidewire tube.
32 . The intravascular embolic protection apparatus of claim 29 , wherein the apparatus further comprises an anchor element.
33 . The intravascular embolic protection apparatus of claim 29 , wherein the apparatus further comprises multiple attachment wires.
34 . The intravascular embolic protection apparatus of claim 33 , wherein the multiple attachment wires can be independently controlled.
35 . The intravascular embolic protection apparatus of claim 29 , wherein the apparatus is configured for delivery against blood flow.
36 . The intravascular embolic protection apparatus of claim 1 , wherein the apparatus is further adapted to be recaptured into a catheter.
37 . The intravascular embolic protection apparatus of claim 36 , wherein the blood filter element is further adapted to retain captured particles during recapture of the apparatus into the catheter.
38 . The intravascular embolic protection apparatus of claim 36 further comprising a recapture guide element attached to the blood filter element.
39 . The intravascular embolic protection apparatus of claim 38 , wherein the recapture guide element comprises longitudinal recapture wires.
40 . The intravascular embolic protection apparatus of claim 38 , wherein the recapture guide element comprises spiral recapture wires.
41 . The intravascular embolic protection apparatus of claim 36 further comprising a lasso for recapturing the apparatus within the catheter.
42 . A method of performing an endovascular procedure on a patient with a procedure device, the method comprising:
delivering an embolic protection apparatus to a location within a vascular lumen of the patient, the embolic protection apparatus comprising an accommodating passageway;
passing the procedure device through the accommodating passageway from a point proximal to the embolic protection apparatus to a point distal to the embolic protection apparatus after the delivering step, the accommodating passageway accommodating to a size and shape of the procedure device;
performing the endovascular procedure; and
removing the procedure device from the patient.
43 . The method of claim 42 , wherein the embolic protection device comprises a filter, the method further comprising filtering blood flowing in the vascular lumen.
44 . The method of claim 42 , wherein delivering the embolic protection apparatus further comprises delivering the embolic protection device in a direction against the vascular lumen's blood flow direction.
45 . The method of claim 42 further comprising removing the embolic protection apparatus from the patient.
46 . The method of claim 45 further comprising retaining captured particles in the apparatus during the removing step.
47 . The method of claim 45 , wherein removing the embolic protection apparatus further comprises capturing the embolic protection apparatus in a catheter.
48 . The method of claim 47 , wherein capturing the embolic protection apparatus further comprises capturing the embolic protection apparatus with a capture tool.
49 . The method of claim 42 , wherein delivering the embolic protection apparatus further comprises permitting the embolic protection apparatus to self-expand.
51 . The method of claim 42 , wherein delivering the embolic protection apparatus further comprises delivering the embolic protection apparatus over a guidewire.
52 . The method of claim 51 , wherein the embolic protection apparatus further comprises a guidewire tube, the method further comprising removing the guidewire tube prior to the passing step.
53 . The method of claim 42 further comprising anchoring the embolic protection apparatus with. an anchor element.
54 . The method of claim 42 , wherein passing the procedure device through the accommodating passageway further comprises opening the passageway.
55 . The method of claim 54 , wherein opening the passageway further comprises causing the passageway to self-seal against the procedure device.
56 . The method of claim 54 , wherein opening the passageway further comprises overcoming the passageway's sealing bias.
57 . The method of claim 42 , wherein the passageway comprises a lumen in the embolic protection apparatus, and wherein passing the procedure device through the accommodating passageway further comprises passing the procedure device through the lumen.
58 . The method of claim 57 , wherein passing the procedure device through the accommodating passageway further comprises using the passageway to guide the procedure device.
59 . The method of claim 58 , wherein the lumen of the accommodating passageway of the embolic protection apparatus is off-center.
59 . The method of claim 42 , wherein the passageway comprises a fold in the embolic protection apparatus, and wherein passing the procedure device through the accommodating passageway further comprises passing the procedure device through the fold.
60 . The method of claim 42 further comprising substantially sealing the accommodating passageway after the removing step.