Rotational Atherectomy Device with Distal Protection Capability and Method of Use

• US 20090069829A1
• Filed: 05/25/2006
• Published: 03/12/2009
• Est. Priority Date: 05/26/2005
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Lela Nadirashvili
• Inventors: Shturman, Leonid
• Granted Patent: US 8,109,954 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and die drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

Claims

1-116. -116. (canceled)

117. A rotational atherectomy device for removing a stenotic lesion from within a vessel of a patient, the device comprising a rotatable, flexible, hollow fluid impermeable drive shaft having an abrasive element located on the drive shaft proximal to its distal end and rotatable together with the drive shaft, the fluid impermeable drive shaft being insertable into the vessel to be treated to enable flushing fluid to be pumped into the fluid impermeable drive shaft through its proximal end portion in an antegrade direction, the flushing fluid flowing along the fluid impermeable drive shaft and entering the vessel to be treated through at least one luminal opening located distally to the abrasive element so that, the flushing fluid, upon entering the vessel, develops distal to the abrasive element such fluid pressure in the vessel which is sufficient to generate a retrograde flow of at least a portion of the flushing fluid around the abrasive element and the fluid impermeable drive shaft for removal from the treated vessel debris abraded by the rotating abrasive element during rotation of the drive shaft and entrained in the retrograde flowing flushing fluid.

118. A rotational atherectomy device according to claim 117, comprising a rotatable, flexible, hollow, fluid impermeable drive shaft which may be advanced into the vessel to be treated, the drive shaft having an abrasive element located on the drive shaft proximal to its distal end to abrade a stenotic lesion when the drive shaft rotates, wherein the flexible, hollow, fluid impermeable drive shaft has a fluid impermeable drive shaft lumen for pumping pressurised flushing fluid in an antegrade direction therealong into the vessel through at least one luminal opening located distal to the abrasive element so that at least a portion of said pressurised flushing fluid entering the vessel distal to the abrasive element through the or each luminal opening flows in a retrograde direction around the abrasive element and the fluid impermeable drive shaft to entrain debris abraded by the rotating abrasive element for removal of said debris from the treated vessel.

119. A rotational atherectomy device according to claim 117, wherein the abrasive element which is located on the fluid impermeable drive shaft proximal to its distal end is also spaced away from the distal end of the drive shaft.

120. A rotational atherectomy device according to claim 117, wherein pressurised flushing fluid is pumped along a lumen of the fluid impermeable drive shaft and into the vessel through the or each luminal opening located distal to the abrasive element at a fluid flow rate that generates a fluid pressure gradient between a region distal to the abrasive element and a region proximal to the abrasive element thereby causing at least a portion of the pressurised flushing fluid entering the vessel to flow in a retrograde direction around the abrasive element and the drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the treated vessel.

121. A rotational atherectomy device according to claim 117, wherein flushing fluid is pumped in an antegrade direction into a proximal end of a fluid impermeable drive shaft lumen, the flushing fluid entering the proximal end portion of the drive shaft along an axis which is coaxial with the longitudinal axis of the proximal end portion of the drive shaft.

122. A rotational atherectomy device according to claim 117, comprising a drive shaft sheath that extends over the fluid impermeable drive shaft and terminates proximal to the abrasive element, the sheath having an inner diameter larger than the outer diameter of the drive shaft so as to define an annular lumen around the fluid impermeable drive shaft so that the flushing fluid together with debris entrained in the flushing fluid, that has flowed in a retrograde direction around the abrasive element and the fluid impermeable drive shaft, flows into the annular lumen defined by the sheath for removal of said debris from the treated vessel.

123. A rotational atherectomy device according to claim 122, wherein the annular lumen between the fluid impermeable drive shaft and the sheath is in communication with a suction device operable to assist or cause retrograde flow of fluid and debris along the annular lumen for subsequent removal from the patient.

124. A rotational atherectomy device according to claim 122, wherein the annular lumen formed between the fluid impermeable drive shaft and the sheath is in communication with at least one fluid moving device, the or each fluid moving device being operable to move fluid along the annular lumen in at least one direction.

125. A rotational atherectomy device according to claim 122, comprising an inflatable element on the drive shaft sheath which reduces or prevents the antegrade flow of blood and retrograde flow of flushing fluid and debris around the inflatable element of the sheath, when the inflatable element is inflated within the vessel.

126. A rotational atherectomy device according to claim 125, comprising an inflation lumen which extends through the drive shaft sheath and communicates the inflatable element of the sheath to an inflation source.

127. A rotational atherectomy device according to claim 125, wherein the inflatable element is a balloon mounted adjacent to the distal end of the drive shaft sheath.

128. A rotational atherectomy device according to claim 125, wherein the inflatable element comprises a flexible sleeve extending around the outside of the drive shaft sheath which forms a potentially inflatable annular space around it, the sleeve having distal and proximal ends, the distal end of the sleeve being bonded to an outer surface of the drive shaft sheath near its distal end while the potentially inflatable annular space being in communication with an inflation device so that said space between the drive shaft sheath and the sleeve is inflatable to restrict or block the flow of fluids around the sleeve.

129. A rotational atherectomy device according to claim 125, wherein the inflation medium to inflate the inflatable element of the sheath is helium or other gas which is soluble in blood and which will not cause the formation of an embolism if it leaks into the vessel.

130. A rotational atherectomy device according to claim 117, wherein at least a portion of the drive shaft which is located proximal to the abrasive element is fluid impermeable, thereby preventing flushing fluid pumped along a lumen of the fluid impermeable drive shaft from being transmitted through a wall of the drive shaft into a portion of the vessel which is located proximal to the abrasive element.

131. A rotational atherectomy device according to claim 117, wherein the fluid impermeable drive shaft comprises a substantially fluid impervious membrane to prevent transmission of fluid out from a lumen of the fluid impermeable drive shaft through a wall of the drive shaft.

132. A rotational atherectomy device according to claim 117, wherein the drive shaft is formed from at least one helically coiled wire and a fluid impermeable membrane which prevents flow of fluid out from a lumen of the drive shaft between adjacent turns of said helically coiled wire.

133. A rotational atherectomy device according to claim 132, wherein the fluid impervious membrane terminates distal to the abrasive element but proximal to the distal end of the drive shaft to allow flow of fluid between adjacent turns of said helically coiled wire out from the drive shaft lumen into a portion of the vessel which is located distal to the abrasive element, the luminal openings in the drive shaft being formed by a space or spaces between the adjacent turns of the coiled wire or wires through which fluid passes from the drive shaft lumen into said portion of the vessel which is located distal to the abrasive element.

134. A rotational atherectomy device according to claim 117, wherein at least a distal portion of the fluid impermeable drive shaft which is expected to enter the diseased vessel or section thereof is made only from the fluid impermeable membrane, thereby allowing this section of the drive shaft to be made very thin walled and of very small outer diameter.

135. A rotational atherectomy device according to claim 132, wherein the hollow drive shaft which is wound from at least one helically coiled wire is covered by a fluid impermeable membrane and is rotatable in such direction of rotation that the coil windings of the drive shaft at least partially generate or assist in the generation of antegrade flow of flushing fluid along a lumen of the fluid impermeable drive shaft.

136. A rotational atherectomy device according to claim 117, wherein the fluid impermeable drive shaft of the present invention has two generally round support elements located on either side and spaced away from the abrasive element, both the abrasive element and support elements having their centres of mass collinear with the longitudinal axis of the drive shaft, at least one of the support elements preventing the abrasive element from being turned into a wall of the vessel and the support elements located on either side of the abrasive element allowing the abrasive element only to slide or, only to rotate and slide, along the wall of the vessel.

137. A rotational atherectomy device according to claim 136, wherein one of the support elements is positioned at the distal end of the drive shaft and the other proximal to the abrasive element.

138. A rotational atherectomy device according to claim 137, wherein each support element is positioned at or about the same distance from the abrasive element.

139. A rotational atherectomy device according to claim 117, wherein the abrasive element has its centre of mass offset from a longitudinal axis of the drive shaft and the drive shaft has a rounded element at the distal end of the drive shaft, the rounded element being a counterweight which has its centre of mass offset from the longitudinal axis of the drive shaft in a direction diametrically opposite to the direction in which the centre of mass of the abrasive element is offset from the longitudinal axis of the drive shaft.

140. A rotational atherectomy device according to claim 139, wherein a second counterweight is located on the drive shaft proximal to such eccentric abrasive element and has its centre of mass also offset from the longitudinal axis of the drive shaft in a direction diametrically opposite to the direction in which the centre of mass of the eccentric abrasive element is offset from the longitudinal axis of the drive shaft.

141. A rotational atherectomy device according to claim 140, wherein both counterweights are of a similar mass and each of them is positioned at the same or about the same distance from the abrasive element.

142. A rotational atherectomy device according to claim 141, wherein each of the two counterweights has a mass which is equal to one-half of a mass of the eccentric abrasive element.

143. A rotational atherectomy device according to claim 141, wherein a body of the eccentric abrasive element and bodies of the counterweights are made from materials having different density.

144. A rotational atherectomy device according to claim 117, comprising a bearing support housing to which the drive shaft is rotatably coupled so that the drive shaft can be rotated with respect to the bearing support housing and flushing fluid can be pumped into a lumen of the fluid impermeable drive shaft.

145. A rotational atherectomy device according to claim 144, wherein the bearing support housing includes at least one bearing disposed therein which rotatably supports a rigid hollow bearing supported shaft.

146. A rotational atherectomy device according to claim 145, wherein the proximal end portion of the flexible, hollow, fluid impermeable drive shaft is coupled to a distal end portion of the rigid hollow bearing supported shaft so that the drive shaft rotates when the rigid hollow bearing supported shaft is rotated.

147. A rotational atherectomy device according to claim 117, comprising a flushing fluid supply tube which is releasably and operatively coupled to the proximal end portion of the fluid impermeable drive shaft thereby allowing flushing fluid to be pumped in a straight forward direction from the flushing fluid supply tube into a fluid impermeable lumen of the flexible drive shaft.

148. A rotational atherectomy device according to claim 147, wherein, after operatively coupling the flushing fluid supply tube to the drive shaft, the longitudinal axis of the flushing fluid supply tube and the drive shaft are disposed in a coaxial relationship to each other so that flushing fluid can flow straight out of the distal end of the flushing fluid supply tube and into a proximal end of the drive shaft lumen.

149. A rotational atherectomy device according to claim 146, wherein the hollow bearing supported shaft slideably receives, through its distal end, a flushing fluid supply tube therein to enable flushing fluid to be supplied from a flushing fluid source through the fluid supply tube and the rigid hollow bearing supported shaft into the flexible fluid impermeable drive shaft.

150. A rotational atherectomy device according to claim 149, wherein the hollow bearing supported shaft can freely rotate around a stationary fluid supply tube coaxially received within it through its proximal end, thereby forming a rotatable fluid supply coupling between these two elements to facilitate the straight forward flow of flushing fluid from a distal end of the stationary fluid supply tube into the rotatable hollow bearing supported shaft.

151. A rotational atherectomy device according to claim 146, wherein at least one gas turbine is mounted on the hollow bearing supported shaft and serves as a prime mover for rotating the flexible, hollow, fluid impermeable drive shaft.

152. A rotational atherectomy device according to claim 147, wherein a flexible fluid supply hose connects a proximal end of the flushing fluid supply tube to a remotely located source of flushing fluid.

153. A rotational atherectomy device according to claim 117, wherein flushing fluid is supplied into a fluid impermeable lumen of the flexible drive shaft from a flushing fluid supply tube, a distal end portion of the fluid supply tube being coaxial with the proximal end portion of the flexible drive shaft, thereby enabling flushing fluid to flow in a straight forward direction from the flushing fluid supply tube into the fluid impermeable lumen of the flexible drive shaft.

154. A rotational atherectomy device according to claim 146, wherein the device includes an optical sensing mechanism for detecting the speed of rotation of the flexible, fluid impermeable drive shaft, the sensing mechanism comprising a light emitting fibre, a light receiving optical fibre and, an actuator mounted on the rigid hollow bearing supported shaft for rotation together with the bearing supported shaft and located between the light emitting and light receiving optical fibres, the actuator being configured to intermittently block light emitted by the light emitting optical fibre from being received by the light receiving optical fibre when the drive shaft is rotated.

155. A rotational atherectomy device according to claim 154, wherein the actuator comprises an opaque disc mounted on the rigid bearing support shaft and has one or more translucent or transparent regions therein to allow light to pass through said regions from the light emitting to the light receiving optical fibre.

162. A rotational atherectomy device according to claim 136, wherein the distal support element is fluid inflatable and the proximal support element is solid.

163. A rotational atherectomy device according to claim 139, wherein the counterweight at the distal end of the drive shaft is fluid inflatable.

164. A rotational atherectomy device according to claim 163, wherein the counterweight at the distal end of the drive shaft is fluid inflatable and another solid counterweight is located proximal to the abrasive element.

156. A rotational atherectomy device comprising a prime mover for rotating a hollow flexible drive shaft and a fluid supply line for providing an antegrade flow of fluid along a lumen of said hollow flexible drive shaft, the fluid supply line comprising a straight, stationary fluid supply tube at its distal end and a flexible fluid supply tube at its proximal end, at least the distal end portion of the straight, stationary fluid supply tube being located inside a hollow shaft of the prime mover, the hollow prime mover shaft and the straight, stationary hollow supply tube being coaxial relative to each other thereby permitting rotation of the hollow prime mover shaft around said straight stationary fluid supply tube.

157. A rotational atherectomy device according to claim 156, wherein an abrasive element is mounted on the rotatable, flexible, hollow drive shaft.

158. A rotational atherectomy device according to claim 157, wherein the abrasive element is mounted proximal to the distal end of the drive shaft.

159. A rotational atherectomy device for removing a stenotic lesion from within a vessel of a patient, the device comprising a rotatable, flexible, hollow drive shaft having a longitudinal axis of rotation and an abrasive element mounted on a region of the drive shaft proximal to its distal end, wherein said region of the drive shaft which receives the abrasive element has a non-circular cross section when viewed at right angles to the longitudinal axis of rotation of the drive shaft, thereby preventing rotation of the abrasive element relative to the drive shaft.

160. A rotational atherectomy device according to claim 159, wherein the drive shaft is fluid impermeable.

161. A rotational atherectomy device according to claim 159, wherein said region comprises a seat formed in the drive shaft to receive the abrasive element.

165. A rotational atherectomy device for removing a stenotic lesion from within a vessel of a patient, the device comprising a rotatable, flexible, hollow fluid impermeable drive shaft having a longitudinal axis of rotation and a symmetric abrasive element mounted on a region of the drive shaft proximal to and spaced away from its distal end, wherein the drive shaft also includes two fluid inflatable support elements, a distal fluid inflatable support element located at a distal end of the drive shaft and spaced away from the abrasive element and, a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element.

166. A rotational atherectomy device according to claim 165 wherein the distal and proximal fluid inflatable support elements are equally spaced from the abrasive element.

167. A rotational atherectomy device according to claim 165 wherein the distal fluid inflatable support element includes at least one inflow opening communicating a lumen of the fluid impermeable drive shaft with an interior space of the distal fluid inflatable support element, said space at least partially defined by a fluid impermeable membrane.

168. A rotational atherectomy device according to claim 167 wherein the distal fluid inflatable support element includes at least one outflow opening communicating the interior space of the distal fluid inflatable support element with a vascular space within the vessel of the patient.

169. A rotational atherectomy device according to claim 168 wherein the at least one outflow opening is located in a portion of the fluid impermeable membrane which tapers inwards and faces rearwards towards the abrasive element when the distal fluid inflatable support element is inflated.

170. A rotational atherectomy device according to claim 168 wherein the distal fluid inflatable support element is configured to convert a flow of fluid in an antegrade direction along the fluid impermeable drive shaft to a retrograde flow of fluid around the fluid impermeable drive shaft and its abrasive element.

171. A rotational atherectomy device according to claim 166 wherein the proximal inflatable support element includes at least one inflow opening communicating a lumen of the fluid impermeable drive shaft with an interior space of the proximal fluid inflatable support element, said space at least partially defined by a fluid impermeable membrane.

172. A rotational atherectomy device for removing a stenotic lesion from within a vessel of a patient, the device comprising a rotatable, flexible, hollow fluid impermeable drive shaft having a longitudinal axis of rotation and an eccentric abrasive element mounted on a region of the drive shaft proximal to and spaced away from its distal end, wherein the drive shaft also includes two fluid inflatable counterweights, a distal fluid inflatable counterweight located at a distal end of the drive shaft and spaced away from the abrasive element and, a proximal fluid inflatable counterweight located proximal to and spaced away from the abrasive element.

173. A rotational atherectomy device according to claim 172 wherein the distal and proximal fluid inflatable counterweights are equally spaced from the abrasive element.

174. A rotational atherectomy device according to claim 172 wherein the distal fluid inflatable counterweight includes at least one inflow opening communicating a lumen of the fluid impermeable drive shaft with an interior space of the distal fluid inflatable counterweight, said space at least partially defined by a fluid impermeable membrane.

175. A rotational atherectomy device according to claim 174 wherein the distal fluid inflatable counterweight includes at least one outflow opening communicating the interior space of the distal fluid inflatable counterweight with a vascular space within the vessel of the patient.

176. A rotational atherectomy device according to claim 175 wherein the at least one outflow opening is located in a portion of the fluid impermeable membrane which tapers inwards and faces rearwards towards the abrasive element when the distal fluid inflatable counterweight is inflated.

177. A rotational atherectomy device according to claim 175 wherein the distal fluid inflatable counterweight is configured to convert a flow of fluid in an antegrade direction along the fluid impermeable drive shaft to a retrograde flow of fluid around the fluid impermeable drive shaft and its abrasive element.

178. A rotational atherectomy device according to claim 172 wherein the proximal fluid inflatable counterweight includes at least one inflow opening communicating a lumen of the fluid impermeable drive shaft with an interior space of the proximal inflatable counterweight, said space at least partially defined by a fluid impermeable membrane.

179. A rotational atherectomy device according to claim 172 wherein a centre of mass of each of the inflated distal and proximal fluid inflatable counterweights is located in the same plane as a centre of mass of the eccentric abrasive element, but diametrically opposite with respect to the rotational axis of the fluid impermeable drive shaft.