US20020165598A1 — Emboli Protection devices and related methods of …

Claim 1

Independent Claim 73 words

1 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; prior to advancing a device across a stenosis to be treated, stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; treating the stenosis while blood flow is stopped; and inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.

Claim 2

Dependent Claim 73 words

1 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; prior to advancing a device across a stenosis to be treated, stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; treating the stenosis while blood flow is stopped; and inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.

Claim 3

Dependent Claim 28 words

2 . The method of claim 1 , wherein advancing the evacuation sheath assembly includes advancing the evacuation sheath assembly from a distal end of a guide catheter.

Claim 4

Dependent Claim 30 words

3 . The method of claim 1 , wherein stopping blood flow includes creating a first seal between a distal portion of the evacuation sheath assembly and the blood vessel.

Claim 5

Dependent Claim 19 words

4 . The method of claim 3 , wherein creating a first seal includes inflating a distal sealing balloon.

Claim 6

Dependent Claim 27 words

5 . The method of claim 3 , wherein creating a first seal includes expanding an evacuation lumen of the evacuation sheath assembly within the blood vessel.

Claim 7

Dependent Claim 20 words

6 . The method of claim 5 , wherein expanding includes inflating a plurality of balloons surrounding the evacuation lumen.

Claim 8

Dependent Claim 24 words

7 . The method of claim 5 , wherein expanding includes pulling an actuation wire attached to a distal end of the evacuation lumen.

Claim 9

Dependent Claim 23 words

8 . The method of claim 5 , wherein expanding includes moving a delivery sheath holding the evacuation lumen in a compressed state.

Claim 10

Dependent Claim 31 words

9 . The method of claim 3 , wherein stopping blood flow further comprises creating a second seal between a guide catheter and a proximal portion of the evacuation sheath assembly.

Claim 11

Dependent Claim 19 words

10 . The method of claim 9 , wherein creating a second seal includes inflating a proximal sealing balloon.

Claim 12

Dependent Claim 22 words

11 . The method of claim 1 , wherein inducing retrograde blood flow includes applying a vacuum through the evacuation sheath assembly.

Claim 13

Dependent Claim 20 words

12 . The method of claim 1 , wherein treating the stenosis includes advancing an angioplasty catheter to the stenosis.

Claim 14

Dependent Claim 21 words

13 . The method of claim 1 , wherein treating the stenosis includes advancing a stent delivery system to the stenosis.

Claim 15

Dependent Claim 21 words

14 . The method of claim 1 , further comprising injecting contrast material into the blood vessel after stopping blood flow.

Claim 16

Dependent Claim 21 words

15 . The method of claim 1 , further comprising measuring pressure in the blood vessel prior to stopping blood flow.

Claim 17

Dependent Claim 21 words

16 . The method of claim 1 , further comprising measuring pressure in the blood vessel subsequent to stopping blood flow.

Claim 18

Dependent Claim 49 words

17 . The method of claim 1 , further comprising: measuring a first pressure in the blood vessel prior to stopping flow; measuring a second pressure in the blood vessel subsequent to stopping flow; and comparing the first and second pressures to confirm that blood flow has been stopped.

Claim 19

Dependent Claim 21 words

18 . The method of claim 1 , further comprising advancing a guidewire across the stenosis subsequent to stopping blood flow.

Claim 20

Dependent Claim 28 words

19 . The method of claim 18 , further comprising inducing retrograde blood flow within the blood vessel to remove embolic material dislodged by advancement of the guidewire.

Claim 21

Dependent Claim 32 words

20 . The method of claim 1 , wherein inducing retrograde flow includes venting pressure in a collection device in fluid communication with the blood vessel with normal antegrade blood flow stopped.

Claim 22

Dependent Claim 32 words

21 . The method of claim 19 , wherein inducing retrograde flow includes venting pressure in a collection device in fluid communication with the blood vessel with normal antegrade blood flow stopped.

Claim 23

Dependent Claim 20 words

22 . The method of claim 21 , wherein inducing retrograde flow further includes applying suction to the collection device.

Claim 24

Dependent Claim 28 words

23 . The method of claim 19 , further comprising stopping retrograde flow after embolic material dislodged by advancement of the guidewire is removed from the blood vessel.

Claim 25

Dependent Claim 23 words

24 . The method of claim 23 , further comprising injecting contrast material into the blood vessel after the retrograde flow is stopped.

Claim 26

Dependent Claim 30 words

25 . The method of claim 15 , wherein measuring the pressure in the blood LAW OFFICES vessel includes placing a pressure transducer in fluid communication with the blood vessel.

Claim 27

Dependent Claim 23 words

26 . The method of claim 25 , wherein the pressure transducer is in fluid communication with a lumen of a guide catheter.

Claim 28

Dependent Claim 24 words

27 . The method of claim 25 , wherein the pressure transducer is in fluid communication with a lumen of the evacuation sheath assembly.

Claim 29

Dependent Claim 16 words

28 . The method of claim 1 , wherein the blood vessel is a coronary artery.

Claim 30

Dependent Claim 17 words

29 . The method of claim 1 , wherein the blood vessel is a saphenous vein graft.

Claim 31

Dependent Claim 141 words

30 . A method for treating a diseased blood vessel, comprising: positioning a guide catheter proximate to the diseased blood vessel; positioning an evacuation sheath assembly within the diseased blood vessel; prior to advancing a device across a diseased area of the blood vessel, stopping normal antegrade blood flow in the blood vessel proximate to the diseased area; advancing a guidewire through the guide catheter and the evacuation sheath assembly across the diseased area of the blood vessel while the blood flow is stopped; causing retrograde flow of blood within the diseased blood vessel to remove embolic debris dislodged by advancement of the guidewire; advancing an interventional catheter into the blood vessel to treat the diseased area of the blood vessel; and causing retrograde flow of blood within the vessel to remove embolic debris dislodged by advancement of the interventional catheter.

Claim 32

Dependent Claim 141 words

30 . A method for treating a diseased blood vessel, comprising: positioning a guide catheter proximate to the diseased blood vessel; positioning an evacuation sheath assembly within the diseased blood vessel; prior to advancing a device across a diseased area of the blood vessel, stopping normal antegrade blood flow in the blood vessel proximate to the diseased area; advancing a guidewire through the guide catheter and the evacuation sheath assembly across the diseased area of the blood vessel while the blood flow is stopped; causing retrograde flow of blood within the diseased blood vessel to remove embolic debris dislodged by advancement of the guidewire; advancing an interventional catheter into the blood vessel to treat the diseased area of the blood vessel; and causing retrograde flow of blood within the vessel to remove embolic debris dislodged by advancement of the interventional catheter.

Claim 33

Dependent Claim 30 words

31 . The method of claim 30 , wherein causing retrograde flow of blood within the diseased blood vessel includes occluding normal antegrade blood flow within the diseased blood vessel.

Claim 34

Dependent Claim 28 words

32 . The method of claim 31 , wherein causing retrograde flow of blood further includes venting a collection device in fluid communication with the diseased blood vessel.

Claim 35

Dependent Claim 22 words

33 . The method of claim 31 , wherein causing retrograde flow of blood further includes applying suction to the blood vessel.

Claim 36

Dependent Claim 28 words

34 . The method of claim 30 , further comprising injecting a contrast dye into the blood vessel while blood flow is stopped prior to advancing the guidewire.

Claim 37

Dependent Claim 29 words

35 . The method of claim 30 , further comprising injecting a contrast dye into the blood vessel while blood flow is stopped prior to advancing the interventional catheter.

Claim 38

Dependent Claim 24 words

36 . The method of claim 30 , further comprising measuring pressure in the diseased blood vessel prior to stopping normal antegrade blood flow.

Claim 39

Dependent Claim 27 words

37 . The method of claim 36 , further comprising creating a seal within the diseased blood vessel subsequent to measuring the pressure in the blood vessel.

Claim 40

Dependent Claim 27 words

38 . The method of claim 37 , further comprising measuring pressure in the diseased blood vessel subsequent to creating the seal within the diseased blood vessel.

Claim 41

Dependent Claim 17 words

39 . The method of claim 30 , wherein the diseased blood vessel is a coronary artery.

Claim 42

Dependent Claim 18 words

40 . The method of claim 30 , wherein the diseased blood vessel is a saphenous vein graft.

Claim 43

Dependent Claim 75 words

41 . A method of performing a procedure on a blood vessel, comprising; positioning a guide catheter proximate to the blood vessel; positioning an evacuation sheath assembly within the guide catheter; measuring pressure in the blood vessel to obtain a first pressure measurement; creating a seal between the evacuation sheath assembly and the blood vessel; measuring pressure in the blood vessel to obtain a second pressure measurement; and comparing the first and second pressure measurements.

Claim 44

Dependent Claim 75 words

41 . A method of performing a procedure on a blood vessel, comprising; positioning a guide catheter proximate to the blood vessel; positioning an evacuation sheath assembly within the guide catheter; measuring pressure in the blood vessel to obtain a first pressure measurement; creating a seal between the evacuation sheath assembly and the blood vessel; measuring pressure in the blood vessel to obtain a second pressure measurement; and comparing the first and second pressure measurements.

Claim 45

Dependent Claim 35 words

42 . The method of claim 41 , wherein measuring pressure in the blood vessel to obtain the first and second pressure measurements includes placing a pressure transducer in fluid communication with the blood vessel.

Claim 46

Dependent Claim 23 words

43 . The method of claim 42 , wherein the pressure transducer is in fluid communication with a lumen of the guide catheter.

Claim 47

Dependent Claim 24 words

44 . The method of claim 42 , wherein the pressure transducer is in fluid communication with a lumen of the evacuation sheath assembly.

Claim 48

Dependent Claim 30 words

45 . The method of claim 41 , further comprising forming a second seal between the evacuation sheath assembly and the guide catheter prior to obtaining the second pressure measurement.

Claim 49

Dependent Claim 32 words

46 . The method of claim 41 , further comprising releasing the seal and forming a new seal if the first pressure measurement is substantially the same as the second pressure measurement.

Claim 50

Dependent Claim 29 words

47 . The method of claim 41 , further comprising commencing an interventional operation within the blood vessel if the first pressure is substantially greater than the second pressure.

Claim 51

Dependent Claim 18 words

48 . The method of claim 41 , further comprising inducing retrograde blood flow in the blood vessel.

Claim 52

Dependent Claim 25 words

49 . The method of claim 48 , wherein inducing retrograde blood flow includes venting a collection device in fluid communication with the blood vessel.

Claim 53

Dependent Claim 21 words

50 . The method of claim 49 , wherein inducing retrograde blood flow further includes applying suction to the collection device.

Claim 54

Dependent Claim 22 words

51 . The method of claim 41 , wherein creating the seal includes expanding a sealing surface of the evacuation sheath assembly.

Claim 55

Dependent Claim 22 words

52 . The method of claim 51 , wherein creating the seal includes expanding an evacuation lumen of the evacuation sheath assembly.

Claim 56

Dependent Claim 20 words

53 . The method of claim 52 , wherein expanding includes inflating a plurality of balloons surrounding the evacuation lumen.

Claim 57

Dependent Claim 24 words

54 . The method of claim 52 , wherein expanding includes pulling an actuation wire attached to a distal end of the evacuation lumen.

Claim 58

Dependent Claim 23 words

55 . The method of claim 52 , wherein expanding includes moving a delivery sheath holding the evacuation lumen in a compressed state.

Claim 59

Dependent Claim 22 words

56 . The method of claim 51 , wherein the sealing surface is on a distal portion of the evacuation sheath assembly.

Claim 60

Dependent Claim 16 words

57 . The method of claim 56 , wherein the sealing surface is an inflatable balloon.

Claim 61

Dependent Claim 23 words

58 . The method of claim 45 , wherein forming the second seal includes expanding a sealing surface of the evacuation sheath assembly.

Claim 62

Dependent Claim 22 words

59 . The method of claim 58 , wherein the sealing surface is on a proximal portion of the evacuation sheath assembly.

Claim 63

Dependent Claim 16 words

60 . The method of claim 59 , wherein the sealing surface is an inflatable balloon.

Claim 64

Dependent Claim 40 words

61 . The method of claim 45 , wherein creating the seal includes expanding a first sealing surface of the evacuation sheath assembly and wherein forming the second seal includes expanding a second sealing surface of the evacuation sheath assembly.

Claim 65

Dependent Claim 38 words

62 . The method of claim 61 , wherein the first sealing surface is on a distal portion of the evacuation sheath assembly and the second sealing surface is on a proximal portion of the evacuation sheath assembly.

Claim 66

Dependent Claim 18 words

63 . The method of claim 62 , wherein the first and second sealing surfaces are inflatable balloons.

Claim 67

Dependent Claim 16 words

64 . The method of claim 41 , wherein the blood vessel is a coronary artery.

Claim 68

Dependent Claim 17 words

65 . The method of claim 41 , wherein the blood vessel is a saphenous vein graft.

Claim 69

Dependent Claim 89 words

66 . A method of isolating fluid communication between a catheter and a blood vessel to facilitate visualization of the blood vessel, comprising: advancing a catheter proximate to the blood vessel; advancing an evacuation sheath assembly including a sealing surface through the catheter and partially into the blood vessel; expanding the sealing surface to create a seal between the blood vessel and the evacuation sheath assembly thereby stopping normal blood flow in the vessel; and injecting contrast dye into the blood vessel while the normal blood flow is stopped.

Claim 70

Dependent Claim 89 words

66 . A method of isolating fluid communication between a catheter and a blood vessel to facilitate visualization of the blood vessel, comprising: advancing a catheter proximate to the blood vessel; advancing an evacuation sheath assembly including a sealing surface through the catheter and partially into the blood vessel; expanding the sealing surface to create a seal between the blood vessel and the evacuation sheath assembly thereby stopping normal blood flow in the vessel; and injecting contrast dye into the blood vessel while the normal blood flow is stopped.

Claim 71

Dependent Claim 33 words

67 . The method of claim 66 , further comprising expanding a second sealing surface of the evacuation sheath assembly to create a second seal between the catheter and the evacuation sheath assembly.

Claim 72

Dependent Claim 15 words

68 . The method of claim 66 , wherein the catheter is a guide catheter.

Claim 73

Dependent Claim 23 words

69 . The method of claim 66 , wherein expanding the sealing surface includes expanding an evacuation lumen of the evacuation sheath assembly.

Claim 74

Dependent Claim 20 words

70 . The method of claim 69 , wherein expanding includes inflating a plurality of balloons surrounding the evacuation lumen.

Claim 75

Dependent Claim 24 words

71 . The method of claim 69 , wherein expanding includes pulling an actuation wire attached to a distal end of the evacuation lumen.

Claim 76

Dependent Claim 22 words

72 . The method of claim 69 , wherein expanding includes moving a sheath holding the evacuation lumen in a compressed state.

Claim 77

Dependent Claim 27 words

73 . The method of claim 66 , wherein expanding the sealing surface includes expanding a sealing surface on a distal portion of the evacuation sheath assembly.

Claim 78

Dependent Claim 17 words

74 . The method of claim 69 , wherein expanding the sealing surface includes inflating a balloon.

Claim 79

Dependent Claim 79 words

75 . An evacuation sheath assembly comprising: a tube having first and second lumens and first and second sealing surfaces, wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing surfaces; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.

Claim 80

Dependent Claim 79 words

75 . An evacuation sheath assembly comprising: a tube having first and second lumens and first and second sealing surfaces, wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing surfaces; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.

Claim 81

Dependent Claim 17 words

76 . The assembly of claim 75 , wherein the first and second sealing surfaces are balloons.

Claim 82

Dependent Claim 17 words

77 . The assembly of claim 75 , wherein the first and second sealing surfaces are elastomeric.

Claim 83

Dependent Claim 36 words

78 . The assembly of claim 75 , wherein the first sealing surface is located on a proximal portion of the tube and the second sealing surface is located on a distal portion of the tube.

Claim 84

Dependent Claim 24 words

79 . The assembly of claim 78 , wherein the second sealing surface is expandable to a greater diameter than the first sealing surface.

Claim 85

Dependent Claim 24 words

80 . The assembly of claim 75 , wherein the evacuation lumen is configured to expand from a delivery configuration to an evacuation configuration.

Claim 86

Dependent Claim 19 words

81 . The assembly of claim 75 , wherein the tube includes an inner layer and an outer layer.

Claim 87

Dependent Claim 16 words

82 . The assembly of claim 81 , wherein the outer layer forms the sealing surfaces.

Claim 88

Dependent Claim 16 words

83 . The assembly of claim 81 , wherein the inner layer forms the evacuation lumen.

Claim 89

Dependent Claim 25 words

84 . The assembly of claim 81 , wherein the inner layer comprises a first material and the outer layer comprises a second, different material.

Claim 90

Dependent Claim 16 words

85 . The assembly of claim 84 , wherein the second material is an expandable material.

Claim 91

Dependent Claim 18 words

86 . The assembly of claim 75 , wherein the evacuation lumen is shorter than the inflation lumen.

Claim 92

Dependent Claim 52 words

87 . An evacuation sheath assembly comprising: an elongated tube defining an expandable evacuation lumen having a compressed delivery configuration and an expanded operational configuration, and a first sealing surface configured to form a seal within a catheter and a second sealing surface configured to form a seal with a blood vessel.

Claim 93

Dependent Claim 52 words

87 . An evacuation sheath assembly comprising: an elongated tube defining an expandable evacuation lumen having a compressed delivery configuration and an expanded operational configuration, and a first sealing surface configured to form a seal within a catheter and a second sealing surface configured to form a seal with a blood vessel.

Claim 94

Dependent Claim 22 words

88 . The evacuation sheath assembly of claim 87 , wherein the evacuation lumen is expandable by inflation of the sealing surfaces.

Claim 95

Dependent Claim 30 words

89 . The evacuation sheath assembly of claim 87 , wherein the evacuation lumen is expandable by actuation of a wire connected to a distal end of the evacuation lumen.

Claim 96

Dependent Claim 25 words

90 . The evacuation sheath assembly of claim 87 , wherein the evacuation lumen is maintained in the compressed delivery configuration by a delivery sheath.

Claim 97

Dependent Claim 42 words

91 . The evacuation sheath assembly of claim 87 , wherein the second sealing surface is located on a distal portion of the evacuation sheath assembly and the first sealing surface is located on a proximal portion of the evacuation sheath assembly.

Claim 98

Dependent Claim 19 words

92 . The evacuation sheath assembly of claim 87 , wherein the second sealing surface includes an inflatable balloon.

Claim 99

Dependent Claim 23 words

93 . The evacuation sheath assembly of claim 87 , wherein the second sealing surface includes an outer surface of the evacuation lumen.

Claim 100

Dependent Claim 20 words

94 . The evacuation sheath assembly of claim 91 , wherein the first and second sealing surfaces are inflatable balloons.

Claim 101

Dependent Claim 26 words

95 . The evacuation sheath assembly of claim 94 , wherein the second sealing surface is expandable to a greater diameter than the first sealing surface.

Claim 102

Dependent Claim 22 words

96 . The evacuation sheath assembly of claim 87 , further comprising a radiopaque marker on a surface of the evacuation lumen.

Claim 103

Dependent Claim 46 words

97 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing surfaces.

Claim 104

Dependent Claim 46 words

97 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing surfaces.

Claim 105

Dependent Claim 26 words

98 . The combination of claim 97 , wherein the evacuation lumen is configured to isolate fluid communication between the blood vessel and the catheter lumen.

Claim 106

Dependent Claim 31 words

99 . The combination of claim 97 , wherein the first sealing surface includes a proximal portion of the evacuation sheath assembly configured to seal against the lumen of the catheter.

Claim 107

Dependent Claim 24 words

100 . The combination of claim 97 , wherein the second sealing surface is located on a distal portion of the evacuation sheath assembly.

Claim 108

Dependent Claim 18 words

101 . The combination of claim 97 , wherein the first and second sealing surfaces include expandable surfaces.

Claim 109

Dependent Claim 18 words

102 . The combination of claim 97 , wherein the first and second sealing surfaces include inflatable balloons.

Claim 110

Dependent Claim 28 words

103 . The combination of claim 97 , wherein the second sealing surface is configured to create a seal between the evacuation sheath assembly and the blood vessel.

Claim 111

Dependent Claim 44 words

104 . The combination of claim 97 , wherein the second sealing surface includes an inflatable balloon on a distal portion of the evacuation sheath assembly and the first sealing surface includes an inflatable balloon on a proximal portion of the evacuation sheath assembly.

Claim 112

Dependent Claim 70 words

105 . The combination of claim 97 , wherein the first sealing surface is located on a proximal portion of the evacuation sheath assembly and is configured to form a seal with the lumen of the catheter, and wherein the second sealing surface is located on a distal portion of the evacuation sheath assembly and is configured to form a seal between the evacuation sheath assembly and the blood vessel.

Claim 113

Dependent Claim 25 words

106 . The combination of claim 97 , wherein the evacuation sheath assembly further comprises an inflation lumen in fluid communication with the sealing surfaces.

Claim 114

Dependent Claim 21 words

107 . The combination of claim 97 , further comprising a marker on a proximal portion of the evacuation sheath assembly.

Claim 115

Dependent Claim 23 words

108 . The combination of claim 97 , further comprising a marker adjacent at least one of the first and second sealing surfaces.

Claim 116

Dependent Claim 25 words

109 . The combination of claim 97 , further comprising a soft flexible tip on a LAW OFFICES distal end of the evacuation sheath assembly.

Claim 117

Dependent Claim 21 words

110 . The combination of claim 97 , wherein a distal end of the evacuation lumen is formed at an angle.

Claim 118

Dependent Claim 21 words

111 . The combination of claim 97 , wherein proximal and distal ends of the evacuation lumen are formed at angles.

Claim 119

Dependent Claim 23 words

112 . The combination of claim 97 , further comprising a flexible, steerable tip on a distal end of the evacuation sheath assembly.

Claim 120

Dependent Claim 52 words

113 . An evacuation sheath assembly comprising: an elongated tube defining an evacuation lumen having proximal and distal ends; a proximal sealing surface at a proximal end of the tube configured to form a seal with a catheter; and a distal sealing surface configured to form a seal with a blood vessel.

Claim 121

Dependent Claim 52 words

113 . An evacuation sheath assembly comprising: an elongated tube defining an evacuation lumen having proximal and distal ends; a proximal sealing surface at a proximal end of the tube configured to form a seal with a catheter; and a distal sealing surface configured to form a seal with a blood vessel.

Claim 122

Dependent Claim 20 words

114 . The evacuation sheath assembly of claim 113 , wherein the ends of the lumen are formed at angles.

Claim 123

Dependent Claim 19 words

115 . The evacuation sheath assembly of claim 113 , wherein the proximal sealing surface includes an inflatable balloon.

Claim 124

Dependent Claim 19 words

116 . The evacuation sheath assembly of claim 113 , wherein the distal sealing surface includes an inflatable balloon.

Claim 125

Dependent Claim 31 words

117 . The evacuation sheath assembly of claim 113 , wherein the proximal and distal sealing surfaces include inflatable balloons, and wherein the distal balloon is larger than the proximal balloon.

Claim 126

Dependent Claim 30 words

118 . The evacuation sheath assembly of claim 113 , wherein the evacuation lumen includes a proximal portion of a first diameter and a distal portion of a second diameter.

Claim 127

Dependent Claim 20 words

119 . The evacuation sheath assembly of claim 118 , wherein the first diameter is smaller than the second diameter.

Claim 128

Dependent Claim 24 words

120 . The evacuation sheath assembly of claim 113 , wherein the evacuation lumen is expandable from a delivery configuration to an operational configuration.

Claim 129

Dependent Claim 28 words

121 . The evacuation sheath assembly of claim 120 , wherein the evacuation lumen is compressible by a delivery sheath to maintain the lumen in the delivery configuration.

Claim 130

Dependent Claim 19 words

122 . The evacuation sheath assembly of claim 120 , wherein the evacuation lumen includes inner and outer layers.

Claim 131

Dependent Claim 29 words

123 . The evacuation sheath assembly of claim 122 , wherein the evacuation lumen is expanded from the delivery configuration to the operational configuration by expanding the outer layer.

Claim 132

Dependent Claim 16 words

124 . The evacuation sheath assembly of claim 123 , wherein the outer layer is inflatable.

Claim 133

Dependent Claim 20 words

125 . The evacuation sheath assembly of claim 120 , wherein the evacuation lumen is an expandable coated, braided sheath.

Claim 134

Dependent Claim 17 words

126 . The evacuation sheath assembly of claim 125 , wherein the braided sheath comprises a metal.

Claim 135

Dependent Claim 17 words

127 . The evacuation sheath assembly of claim 125 , wherein the braided sheath comprises a polymer.

Claim 136

Dependent Claim 22 words

128 . The evacuation sheath assembly of claim 113 , further comprising a pressure transducer in fluid communication with the evacuation lumen.

Claim 137

Dependent Claim 20 words

129 . The evacuation sheath assembly of claim 120 , wherein the proximal and distal sealing surfaces are inflatable balloons.

Claim 138

Dependent Claim 20 words

130 . The evacuation sheath assembly of claim 129 , wherein the distal balloon is larger than the proximal balloon.

Claim 139

Dependent Claim 27 words

131 . The evacuation sheath assembly of claim 120 , wherein the proximal and distal sealing surfaces include portions of an outer surface of the evacuation lumen.

Claim 140

Dependent Claim 25 words

132 . The evacuation sheath assembly of claim 113 , further comprising a proximal shaft portion attached to a proximal end of the elongate tube.

Claim 141

Dependent Claim 32 words

133 . The evacuation sheath assembly of claim 132 , wherein the evacuation lumen is expandable and wherein an actuation wire for expanding the evacuation lumen passes through the proximal shaft portion.

Claim 142

Dependent Claim 22 words

134 . The evacuation sheath assembly of claim 132 , further comprising at least one radiopaque marker on the proximal shaft portion.

Claim 143

Dependent Claim 22 words

135 . The evacuation sheath assembly of claim 113 , further comprising a flexible tip on a distal end of the assembly.

Claim 144

Dependent Claim 23 words

136 . The evacuation sheath assembly of claim 113 , wherein a distal end of the evacuation lumen is formed at an angle.

Claim 145

Dependent Claim 27 words

137 . The evacuation sheath assembly of claim 113 , further comprising at least one marker adjacent at least one of said proximal and distal sealing surfaces.

Claim 146

Dependent Claim 107 words

138 . An evacuation sheath assembly comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and a first sealing region on a proximal portion of the evacuation lumen and a second sealing region on a distal portion of the evacuation lumen, wherein at least one of the first and second sealing regions is in fluid communication with the inflation lumen, and wherein the first sealing region is expandable to a first diameter and the second sealing region is expandable to a second diameter different than the first diameter.

Claim 147

Dependent Claim 107 words

138 . An evacuation sheath assembly comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and a first sealing region on a proximal portion of the evacuation lumen and a second sealing region on a distal portion of the evacuation lumen, wherein at least one of the first and second sealing regions is in fluid communication with the inflation lumen, and wherein the first sealing region is expandable to a first diameter and the second sealing region is expandable to a second diameter different than the first diameter.

Claim 148

Dependent Claim 83 words

139 . An evacuation sheath assembly comprising: an elongated tube defining an inflation lumen and an expandable evacuation lumen having a compressed configuration and an expanded configuration; and a plurality of expandable surfaces along a length of the tube, wherein a most proximal expandable surface forms a proximal sealing surface and wherein a most distal expandable surface forms a distal sealing surface, and wherein expansion of the plurality of expandable surfaces expands the evacuation lumen from the compressed configuration to the expanded configuration.

Claim 149

Dependent Claim 83 words

139 . An evacuation sheath assembly comprising: an elongated tube defining an inflation lumen and an expandable evacuation lumen having a compressed configuration and an expanded configuration; and a plurality of expandable surfaces along a length of the tube, wherein a most proximal expandable surface forms a proximal sealing surface and wherein a most distal expandable surface forms a distal sealing surface, and wherein expansion of the plurality of expandable surfaces expands the evacuation lumen from the compressed configuration to the expanded configuration.

Claim 150

Dependent Claim 77 words

140 . An evacuation sheath assembly comprising: an elongated sheath defining an evacuation lumen having open proximal and distal ends, wherein the sheath is expandable from a delivery configuration to an operational configuration; a proximal hollow shaft connected to a proximal end of the sheath; and an actuation wire connected to a distal end of the sheath, the actuation wire being movable within said shaft from a distal position to a proximal position to expand said sheath.

Claim 151

Dependent Claim 77 words

140 . An evacuation sheath assembly comprising: an elongated sheath defining an evacuation lumen having open proximal and distal ends, wherein the sheath is expandable from a delivery configuration to an operational configuration; a proximal hollow shaft connected to a proximal end of the sheath; and an actuation wire connected to a distal end of the sheath, the actuation wire being movable within said shaft from a distal position to a proximal position to expand said sheath.

Claim 152

Dependent Claim 135 words

141 . A method of treatment of a blood vessel, comprising: advancing a guide catheter proximate to the blood vessel; advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter; creating a first seal between the proximal portion of the evacuation sheath assembly and the guide catheter; creating a second seal between a distal portion of the evacuation sheath assembly and the blood vessel; stopping normal antegrade blood flow within the blood vessel; treating a stenosis within the blood vessel; causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly; and re-establishing normal antegrade blood flow within the blood vessel.

Claim 153

Dependent Claim 135 words

141 . A method of treatment of a blood vessel, comprising: advancing a guide catheter proximate to the blood vessel; advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter; creating a first seal between the proximal portion of the evacuation sheath assembly and the guide catheter; creating a second seal between a distal portion of the evacuation sheath assembly and the blood vessel; stopping normal antegrade blood flow within the blood vessel; treating a stenosis within the blood vessel; causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly; and re-establishing normal antegrade blood flow within the blood vessel.

Claim 154

Dependent Claim 77 words

142 . An evacuation sheath assembly, comprising: an elongated tube defining an expandable evacuation lumen having first a first delivery configuration and a second operational configuration; and a sealing surface on a distal portion of the evacuation lumen, the sealing surface having a non-sealing configuration that corresponds to the first delivery configuration and a sealing configuration that corresponds to the second operational configuration, wherein the sealing configuration is configured to create a seal with a blood vessel.

Claim 155

Dependent Claim 77 words

142 . An evacuation sheath assembly, comprising: an elongated tube defining an expandable evacuation lumen having first a first delivery configuration and a second operational configuration; and a sealing surface on a distal portion of the evacuation lumen, the sealing surface having a non-sealing configuration that corresponds to the first delivery configuration and a sealing configuration that corresponds to the second operational configuration, wherein the sealing configuration is configured to create a seal with a blood vessel.

Claim 156

Dependent Claim 60 words

143 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; at least one inflatable sealing surface in fluid communication with the inflation lumen; and a soft steerable tip on a distal end of the elongated tube.

Claim 157

Dependent Claim 60 words

143 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; at least one inflatable sealing surface in fluid communication with the inflation lumen; and a soft steerable tip on a distal end of the elongated tube.

Claim 158

Dependent Claim 59 words

144 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the open distal end of the evacuation lumen is angled.

Claim 159

Dependent Claim 59 words

144 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the open distal end of the evacuation lumen is angled.

Claim 160

Dependent Claim 54 words

145 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and first and second sealing surfaces on the tube; wherein the open proximal end of the evacuation lumen is angled.

Claim 161

Dependent Claim 54 words

145 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and first and second sealing surfaces on the tube; wherein the open proximal end of the evacuation lumen is angled.

Claim 162

Dependent Claim 58 words

146 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the evacuation lumen is shorter than the inflation lumen.

Claim 163

Dependent Claim 58 words

146 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the evacuation lumen is shorter than the inflation lumen.

Claim 164

Dependent Claim 77 words

147 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein a proximal portion of the evacuation lumen has a first diameter and a distal portion of the evacuation lumen has a second diameter larger than the first diameter.

Claim 165

Dependent Claim 77 words

147 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein a proximal portion of the evacuation lumen has a first diameter and a distal portion of the evacuation lumen has a second diameter larger than the first diameter.

Claim 166

Dependent Claim 92 words

148 . A method for treating a diseased blood vessel, comprising: positioning a guide catheter within the ostium of a target vessel; advancing an evacuation sheath assembly through the guide catheter and beyond a major side branch of the target vessel; forming a first seal between the target vessel and a distal portion of the evacuation sheath assembly; forming a second seal between the catheter and a proximal portion of the evacuation sheath assembly; and advancing an interventional device through a lumen of the evacuation sheath assembly to treat the target vessel.

Claim 167

Dependent Claim 92 words

148 . A method for treating a diseased blood vessel, comprising: positioning a guide catheter within the ostium of a target vessel; advancing an evacuation sheath assembly through the guide catheter and beyond a major side branch of the target vessel; forming a first seal between the target vessel and a distal portion of the evacuation sheath assembly; forming a second seal between the catheter and a proximal portion of the evacuation sheath assembly; and advancing an interventional device through a lumen of the evacuation sheath assembly to treat the target vessel.

Emboli Protection devices and related methods of use

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