Guidewire for crossing occlusions or stenoses

• US 20050228418A1
• Filed: 06/06/2005
• Published: 10/13/2005
• Est. Priority Date: 04/06/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Norborn Medical, Inc. (Boston Scientific Corporation), Revascular Therapeutics Inc. (Boston Scientific Corporation)
• Inventors: Sudaria, Rudolfo, Chechelski, Victor, Noriega, Gerardo V.
• Granted Patent: US 8,043,312 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320004 abrasive

Abstract

Systems and methods for crossing stenosis, partial occlusions, or complete occlusions within a body lumen. The systems generally include an elongate member such as a hollow guidewire that houses a rotatable and translatable drive shaft. The drive shaft typically has a distal portion that is advanced to create a path in the occlusive material that is large enough to allow the hollow guidewire to cross the occlusive material.

Claims

1-79. -79. (canceled)

80. A guidewire device for creating or enlarging a passageway in occlusive material in a body lumen, comprising:

a flexible guidewire body comprising a proximal end, a distal end, and an axial passage; and

a shaft extending through the axial passage of the guidewire body, wherein activation of a distal tip of the shaft creates the passageway or enlarges the passageway through the occlusive material in the body lumen.

81. The device of claim 80, further comprising a housing coupled to the proximal end of the guidewire body.

82. The device of claim 81, wherein the housing is fixedly coupled to the guidewire body.

83. The device of claim 80, wherein the distal end of the guidewire body is deflectable.

84. The device of claim 83, comprising a pull wire extending from the proximal end of the guidewire body and coupled to the steerable distal end.

85. The device of claim 84, wherein the guidewire body comprises a separating element positioned between the shaft and the pull wire.

86. The device of claim 85, wherein the separating element comprises a tube disposed coaxially to the guidewire body.

87. The device of claim 80, wherein the guidewire body comprises varying degrees of stiffness along its length.

88. The device of claim 87, wherein a distal portion of the guidewire body is more flexible than a proximal portion of the guidewire body.

89. The device of claim 80, wherein the shaft and distal tip are rotatable and wherein the distal tip comprises a plurality of cutting edges.

90. The device of claim 80, wherein the distal tip comprises a plurality of connected filaments.

91. The device of claim 80, wherein the distal tip comprises a rounded end.

92. The device of claim 80, wherein the proximal end of the guidewire body is coupled to a vacuum source or a fluid source such that the target site can be aspirated or infused through the axial passage.

93. The device of claim 80, wherein the movement of the tip comprises rotation, translation, reciprocation, and/or vibration.

94. The device of claim 80, wherein the guidewire body comprises a first tubular member coupled to a second tubular member.

95. The device of claim 94, wherein the first tubular member is a solid-walled tubular member and the second tubular member is a coil.

96. The device of claim 80, wherein the guidewire body has an outer diameter between approximately 0.0015 inches and approximately 0.0040 inches.

97. The device of claim 80, wherein the guidewire body has a torqueability ratio between the proximal end and distal end of approximately 1:

1.

98. The device of claim 80, further comprising a radiographic marker at the distal end of the guidewire body.

99. A guidewire device for creating or enlarging a passageway in occlusive material in a body lumen, comprising:

a flexible guidewire body comprising a proximal end, a distal end, and an axial passage, wherein a distal portion of the guidewire body is more flexible than a proximal portion of the guidewire body; and

a drive shaft extending through the axial passage of the guidewire body, wherein a distal tip of the shaft is activatable to create the passageway or enlarge the passageway in the occlusive material in the body lumen.

100. The device of claim 99, further comprising a housing coupled to the proximal end of the guidewire body.

101. The device of claim 109, wherein the housing is fixedly coupled to the guidewire body.

102. The device of claim 99, wherein the distal end of the guidewire body is deflectable.

103. The device of claim 102, comprising a pull wire extending from the proximal end of the guidewire body and coupled to the steerable distal end.

104. The device of claim 103, wherein the guidewire body comprises a separating element positioned between the shaft and the pull wire.

105. The device of claim 104, wherein the separating element comprises a tube disposed coaxially to the guidewire body.

106. The device of claim 99, wherein the shaft and distal tip are rotatable, wherein the distal tip comprises a plurality of cutting edges.

107. The device of claim 99, wherein the distal tip comprises a plurality of connected filaments.

108. The device of claim 99, wherein the distal tip comprises a rounded end.

109. The device of claim 99, wherein the proximal end of the guidewire body is coupled to a vacuum source or a fluid source such that the target site can be aspirated or infused through the axial passage.

110. The device of claim 99, wherein the movement of the distal tip comprises rotation, translation, reciprocation, and/or vibration.

111. The device of claim 99, wherein the guidewire body comprises a first tubular member coupled to a second tubular member.

112. The device of claim 111, wherein the first tubular member is a solid-walled tubular member and the second tubular member is a coil.

113. The device of claim 99, wherein the guidewire body has an outer diameter between approximately 0.0015 inches and approximately 0.0040 inches.

114. The device of claim 99, wherein the guidewire body has a torqueability ratio between the proximal end and distal end of approximately 1:

1.

115. The device of claim 99, further comprising a radiographic marker at the distal end of the guidewire body.

116. A flexible guidewire device for creating or enlarging a passageway in occlusive material in a body lumen, the device having a torqueability ratio from a proximal end to a distal end of approximately 1:

1, comprising;

a flexible guidewire body comprising a proximal end, a distal end, and an axial passage, the flexible guidewire body having an outer diameter between about 0.014 inches and about 0.040 inches; and

a rotatable drive shaft extending through the axial passage of the guidewire body, wherein a distal tip of the shaft comprises a rounded end or a plurality of connected filaments.

117. The guidewire device of claim 116, wherein the distal tip comprises a plurality of cutting edges.

118. The device of claim 116, further comprising a housing coupled to the proximal end of the guidewire body.

119. The device of claim 118, wherein the housing is fixedly coupled to the guidewire body.

120. The device of claim 116, wherein the distal end of the guidewire body is steerable.

121. The device of claim 120, comprising a pull wire extending from the proximal end of the guidewire body and coupled to the steerable distal end.

122. The device of claim 121, wherein the guidewire body comprises a separating element positioned between the shaft and the pull wire.

123. The device of claim 122, wherein the separating element comprises a tube disposed coaxially to the guidewire body.

124. The device of claim 116, wherein the guidewire body comprises varying degrees of stiffness along its length.

125. The device of claim 116, wherein a distal portion of the guidewire body is more flexible than a proximal portion of the guidewire body.

126. The device of claim 116, wherein the proximal end of the guidewire body is coupled to a vacuum source or a fluid source such that the target site can be aspirated or infused through the axial passage.

127. The device of claim 116, wherein the guidewire body comprises a first tubular member coupled to a second tubular member.

128. The device of claim 127, wherein the first tubular member is a solid-walled tubular member and the second tubular member is a coil.

129. The device of claim 116, further comprising a radiographic marker at the distal end of the guidewire body.