Rotational atherectomy device with counterweighting
Abstract
This record has no abstract on file.
Term
Projected expiry 19 September 2028.
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- Filed
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6 claims: 3 independent, 3 dependent
- 1所与の直径を有する動脈における狭窄を開口するための高速回転式アテローム切除術用デバイスであって、 該動脈の直径よりも小さな最大直径を有するガイドワイヤと、 該ガイドワイヤ上で前進可能である、可撓性の細長い回転可能な駆動シャフトであって、回転軸および研磨部を有 し、該研磨部が、幾何学的に同心の輪郭を備え、そしてさらに密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、ならびに重心を含み、該重心が、該第1の材料の密度および該第2の材料の密度の結果として、長手方向平面において、該駆動シャフトの回転軸から該駆動シャフトの第2の側面に半径方向に離間してい る、駆動シャフトと、 該研磨部の近位側面上の 該駆動シャフト上の 近位 カウンタウェイト であって、幾何学的に同心の輪郭、密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、ならびに重心を含み、該重心が、該第1の材料の密度および該第2の材料の密度の結果として、該駆動シャフトの回転軸から該近位カウンタウェイトの第2の側面に半径方向に離間し、該近位カウンタウェイトの重心が、研磨要素の重心と同じ長手方向平面において、該駆動シャフトの回転軸から半径方向に離間している、近位カウンタウェイトと、 該研磨部の遠位側面上の該駆動シャフト上の遠位カウンタウェイトであって、幾何学的に同心の輪郭、密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、ならびに重心を含み、該重心が、該第1の材料の密度および該第2の材料の密度の結果として、該駆動シャフトの回転軸から該遠位カウンタウェイトの第2の側面に半径方向に離間し、該遠位カウンタウェイトの重心が、該研磨要素の重心と同じ長手方向平面において、該駆動シャフトの回転軸から半径方向に離間している、遠位カウンタウェイト と を備え 、 該近位カウンタウェイトの重心が、該遠位カウンタウェイトの重心から、180度の回転角で半径方向にオフセットされており、 該近位カウンタウェイトおよび該遠位カウンタウェイトの1つのみの重心が、該長手方向軸平面における該研磨要素の重心から180度の回転角で半径方向にオフセットされ ている、高速回転式アテローム切除術用デバイス。
- 2さらに、前記駆動シャフトの重心から回転軸までの第1の距離を備える前記近位カウンタウェイトの半径方向離間重心、および駆動シャフトの重心から回転軸までの第2の距離を備える該駆動シャフトの回転軸からの前記遠位カウンタウェイトの半径方向離間を備え、該第1の距離と該第2の距離が等価である、請求項1に記載の高速回転式アテローム切除術用デバイス。
- 3所与の直径を有する動脈における狭窄を開口するための高速回転式アテローム切除術用デバイスであって、 該動脈の直径よりも小さな最大直径を有するガイドワイヤと、 該ガイドワイヤ上で前進可能である、可撓性の細長い回転可能な駆動シャフトであって、回転軸および研磨部を有 し、該研磨部が、幾何学的に同心の輪郭を備え、そしてさらに密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、ならびに重心を含み、該重心が、該第1の材料の密度および該第2の材料の密度の結果として、長手方向平面において、該駆動シャフトの回転軸から該駆動シャフトの第2の側面に半径方向に離間してい る、駆動シャフトと、 該研磨部の近位側面上の 該駆動シャフト上の 近位 カウンタウェイト であって、幾何学的に偏心の輪郭、および該幾何学的に偏心の輪郭の結果として該駆動シャフトの回転軸から半径方向に離間した重心を含み、該近位カウンタウェイトの重心は、研磨要素の重心と同じ長手方向平面において該駆動シャフトの回転軸から半径方向に離間している、近位カウンタウェイトと、 該研磨部の遠位側面上の該駆動シャフト上の遠位カウンタウェイトであって、幾何学的に偏心の輪郭、および該幾何学的に偏心の輪郭の結果として、該駆動シャフトの回転軸から半径方向に離間した重心を含み、該遠位カウンタウェイトの重心は、該研磨要素の重心と同じ長手方向平面において該駆動シャフトの回転軸から半径方向に離間している、遠位カウンタウェイトと を備え、 該近位カウンタウェイトの重心が、該遠位カウンタウェイトの重心から、180度の回転角で半径方向にオフセットされており、 該近位カウンタウェイトおよび該遠位カウンタウェイトの1つのみの重心が、該長手方向軸平面における該研磨要素の重心から180度の回転角で半径方向にオフセットされ ている、高速回転式アテローム切除術用デバイス。
- 4さらに、前記駆動シャフトの重心から回転軸までの第1の距離を備える前記近位カウンタウェイトの半径方向離間重心、および該駆動シャフトの重心から回転軸までの第2の距離を備える該駆動シャフトの回転軸からの前記遠位カウンタウェイトの半径方向離間を備え、該第1の距離と該第2の距離が等価である、請求項3に記載の高速回転式アテローム切除術用デバイス。
- 5所与の直径を有する動脈における狭窄を開口するための高速回転式アテローム切除術用デバイスであって、 該動脈の直径よりも小さな最大直径を有するガイドワイヤと、 該ガイドワイヤ上で前進可能である、可撓性の細長い回転可能な駆動シャフトであって、回転軸および研磨部を有 し、該研磨部が、幾何学的に偏心の輪郭、および該幾何学的に偏心の輪郭の結果として長手方向平面において該駆動シャフトの回転軸から半径方向に離間した重心を備える、 駆動シャフトと、 該研磨部の近位側面上の 該駆動シャフト上の 近位 カウンタウェイト であって、幾何学的に同心の輪郭、密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、該第1の材料の密度および該第2の材料の密度の結果として、該重心が該駆動シャフトの回転軸から該近位カウンタウェイトの第1の側面に半径方向に離間し、該近位カウンタウェイトの重心が、研磨要素の重心と同じ長手方向平面において、該駆動シャフトの回転軸から半径方向に離間している、近位カウンタウェイトと、 該研磨部の遠位側面上の該駆動シャフト上の遠位カウンタウェイトであって、幾何学的に同心の輪郭、密度を有する第1の材料を含む第1の側面および該第1の材料の密度より大きい密度を有する第2の材料を含む第2の側面、ならびに重心を含み、該重心が、該第1の材料の密度および該第2の材料の密度の結果として、該駆動シャフトの回転軸から該遠位カウンタウェイトの第1の側面に半径方向に離間し、該遠位カウンタウェイトの重心が、該研磨要素の重心と同じ長手方向平面において、該駆動シャフトの回転軸から半径方向に離間している、遠位カウンタウェイト と を備え 、 該近位カウンタウェイトの重心が、該遠位カウンタウェイトの重心から、180度の回転角で半径方向にオフセットされており、 該近位カウンタウェイトおよび該遠位カウンタウェイトの1つのみの重心が、該長手方向軸平面における該研磨要素の重心から180度の回転角で半径方向にオフセットされ ている、高速回転式アテローム切除術用デバイス。
- 6さらに、前記駆動シャフトの重心から回転軸までの第1の距離を備える前記近位カウンタウェイトの半径方向離間重心、および該駆動シャフトの重心から回転軸までの第2の距離を備える該駆動シャフトの回転軸からの前記遠位カウンタウェイトの半径方向離間を備え、該第1の距離と該第2の距離が等価である、請求項5に記載の高速回転式アテローム切除術用デバイス。
Independent claims6
43 paragraphs, as filed
The present invention relates to devices and methods for removing tissue from a body passage, such as removal of arteriosclerotic plaque from an artery, utilizing a high-speed rotary atherectomy device.
A wide variety of techniques and devices have been developed for use in the removal or repair of tissues in arteries and similar body passages. The main purpose of such techniques and instruments is the removal of atherosclerotic plaques in the patient's arteries. Atherosclerosis is characterized by the accumulation of fatty deposits (atheroma) in the intima layer (under the endothelium) of the patient's blood vessels. Often, the first deposits of relatively soft, cholesterol-rich atherosclerotic substances harden over time to become calcified arteriosclerotic plaques. Such atheroma is often referred to as a stenotic lesion or stenosis because it restricts blood flow, and the closing substance is referred to as the stenotic substance. If left untreated, such stenosis can cause angina, hypertension, myocardial infarction, stroke, and the like.
Rotational atherectomy procedures are a common procedure for removing such stenotic material. Such procedures are most often used to initiate the opening of calcified lesions in the coronary arteries. Most often, the rotary atherectomy procedure is not used alone, but then a balloon angioplasty procedure is performed, as well as very often, a stent to assist in maintaining the patency of the open artery. Accompanied by detention. In non-calcified lesions, balloon angioplasty is most often used only for the opening of arteries, and stents are placed to maintain the patency of the opened arteries. However, studies have shown that a significant proportion of patients who have undergone balloon angioplasty and have a stent placed in an artery are most often the result of stent restenosis, i.e., excessive growth of scar tissue within the stent. Has been found to face long-term manifestation of stent closure. In such cases, the atherectomy procedure is a suitable procedure for removing excess scar tissue from the stent (balloon angioplasty is less effective within the stent), thereby patency of the artery. Gender is restored.
This type of rotary atherectomy device has been developed to attempt removal of stenotic material. In one type of device, as shown in Patent Document 1 (Auth), a concentric oval burr coated with an abrasive such as diamond particles is carried at the distal end of the flexible drive shaft. To. The burr rotates at high speed (typically, for example, in the range of about 150,000 to 190,000 rpm), but the burr advances across the stenosis. Bali removes stenotic tissue but closes blood flow. As the burr advances across the stenosis, the artery is opened to an outer diameter equal to or slightly larger than the maximum outer diameter of the burr. Since burrs have a fixed stationary diameter, burrs of multiple sizes must often be utilized to open the artery to the desired diameter. Other modifications by Auth devices that allow sweeping of variable diameters, or diameters larger than the burr's stationary diameter, during high speed rotation are not disclosed.
Patent Document 2 (Clement) provides an eccentric tissue removal burr having a coating of abrasive particles fixed to a portion of its outer surface by a suitable binding material. However, this structure, as Clement explains in column 3, lines 53-55, that asymmetric burrs rotate "at a slower rate than they can be used with high-speed cauterization devices to compensate for heat or imbalances." Is restricted. That is, given both the size and mass of the solid burrs, it is not feasible to rotate the burrs at the high speeds used in the atherectomy procedure, ie, at speeds in the range of about 20,000 to 200,000 rpm. .. In essence, the center of gravity offset from the axis of rotation of the drive shaft develops considerable and undesired centrifugal force, exerting excessive pressure on the arterial wall, producing excessive heat and excessively large particles. Similar to Auth, the burr size is fixed and may require the use of burrs of multiple sizes to open the target lumen to the desired diameter.
Patent Document 3 (Shturman) and Patent Document 4 (Shturman) specifically disclose an atherectomy device having a drive shaft with an enlarged eccentric portion, in which at least a portion of the enlarged portion is coated with an abrasive. When rotated at high speed, the abrasive can remove the stenotic tissue from the artery. The device is capable of opening an artery to a diameter larger than the stationary diameter of the magnifying eccentric part, which is partly due to the orbital rotational motion during high speed operation. The orbital rotational motion is mainly due to the center of gravity of the enlarged eccentric portion offset from the rotation axis of the drive shaft. Since the extended eccentric portion may include an uncoupled drive shaft wire, the extended eccentric portion of the drive shaft may bend during placement within the constriction or during high speed operation. This flexion allows for larger diameter openings during high speed operation, but may result in less control over the diameter of the artery being actually polished. The disclosures of Patent Documents 3 and 4 are incorporated herein by reference in their entirety.
<p num="0007"><patcit num="1"><text>U.S. Pat. No. 4,990,134</text></patcit><patcit num="2"><text>U.S. Pat. No. 5,681,336</text></patcit><patcit num="3"><text>U.S. Pat. No. 6,132,444</text></patcit><patcit num="4"><text>U.S. Pat. No. 6,494,890</text></patcit></p>
<p num="0008"> The present invention provides a rotary atherectomy device with a flexible, elongated, rotatable drive shaft with a polished portion, which can be attached to a drive shaft with an enlarged diameter portion of the drive shaft, or as an alternative. Equipped with the highest polishing part. The device further comprises proximal and / or distal counterweights that are attached to the drive shaft and separated from the grind, where each counterweight is the length of the drive shaft to stimulate orbital motion by the grind. It has its center of gravity offset from the axis of direction. When placed in the artery with respect to the stenotic tissue and rotated at sufficiently high speed (eg, within the range of about 20,000 rpm to about 200,000 rpm), due to the orbital nature of the polished part, it is more than the static outer diameter of the polished part. Also rotates to open a stenotic lesion to a substantially larger diameter.</p><p num="0009"> An object of the present invention is to provide a device for high-speed rotary atherectomy having a polishing portion having a high-speed rotating diameter that exceeds its stationary diameter.</p><p num="0010"> An object of the present invention is to provide a device for high-speed rotary atherectomy having a concentric polishing portion having a high-speed rotary diameter that exceeds its stationary diameter.</p><p num="0011"> Another object of the present invention is to provide a device for high-speed rotary atherectomy having an eccentric polishing portion having a high-speed rotary diameter that exceeds its stationary diameter.</p><p num="0012"> Another object of the present invention is to provide a device for high speed rotary atherectomy in which the drive shaft has two counterweights, one located proximal to the abrasive and one located distally. To do.</p><p num="0013"> Another object of the present invention is to provide a high speed rotary atherectomy device having at least one counterweight on the drive shaft, the at least one counterweight located proximal to or distal to the grind. There is.</p><p num="0014"> The following drawings and embodiments for carrying out the invention more specifically illustrate these and other embodiments of the invention.</p><p num="0015"> A more complete understanding of the present invention can be made in light of the embodiments for carrying out the following inventions relating to the various embodiments of the present invention relating to the following accompanying drawings.<u style="single"> For example, the present invention provides:</u><u style="single">(Item 1)</u><u style="single"> A high-speed rotary atherectomy device for opening a stenosis in an artery having a given diameter.</u><u style="single"> A guide wire with a maximum diameter smaller than the diameter of the artery,</u><u style="single"> A flexible, elongated, rotatable drive shaft that is rotatable on the guide wire and has a rotating shaft and a polished portion.</u><u style="single"> With at least one counterweight on the drive shaft above</u><u style="single"> A device for high-speed rotary atherectomy.</u><u style="single">(Item 2)</u><u style="single"> At least one of the above counterweights</u><u style="single"> Proximal counterweights separated from the polished part at a distance proximal to</u><u style="single"> With a distal counterweight separated at a distance distal to the polished part</u><u style="single"> The device for high-speed rotary atherectomy according to item 1, further equipped with.</u><u style="single">(Item 3)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the polished portion is eccentric.</u><u style="single">(Item 4)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein at least one of the counterweights is eccentric.</u><u style="single">(Item 5)</u><u style="single"> The high-speed rotary atherectomy device according to item 2, wherein at least one of the proximal and distal counterweights is eccentric.</u><u style="single">(Item 6)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the polished parts are concentric.</u><u style="single">(Item 7)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein at least one counterweight is concentric.</u><u style="single">(Item 8)</u><u style="single"> The high-speed rotary atherectomy device according to item 2, wherein at least one of the proximal and distal counterweights is concentric.</u><u style="single">(Item 9)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the at least one counterweight is solid and is fixedly attached to the drive shaft.</u><u style="single">(Item 10)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the polished portion is solid and is fixedly attached to the drive shaft.</u><u style="single">(Item 11)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the polishing portion includes an enlarged portion of the drive shaft.</u><u style="single">(Item 12)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the at least one counterweight comprises an enlarged portion of the drive shaft.</u><u style="single">(Item 13)</u><u style="single"> The device for high-speed rotary atherectomy according to item 1, wherein the polished portion is partially hollow.</u><u style="single">(Item 14)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, wherein the at least one counterweight is partially hollow.</u><u style="single">(Item 15)</u><u style="single"> The high-speed rotary atherectomy device according to item 1, further comprising the eccentric polishing part and at least one counterweight which is solid.</u><u style="single">(Item 16)</u><u style="single"> Further, the distance proximally separated between the proximal counterweight and the polished portion is substantially equivalent to the distal distance between the distal counterweight and the polished portion. There is a device for high-speed rotary atherosctomy according to item 2.</u><u style="single">(Item 17)</u><u style="single"> The polished portion, the proximal counterweight, and the distal counterweight each have a center of gravity, and the center of gravity of the polished portion and the proximal and distal counterweights are aligned in substantially the same longitudinal plane. The device for rotary atherosctomy described in item 2.</u><u style="single">(Item 18)</u><u style="single"> The rotary atherome according to item 17, wherein the centers of gravity of the proximal counterweight and the distal counterweight are each separated from the center of gravity of the polished portion by an angle of 180 degrees around the rotation axis of the drive shaft. Device for excision.</u><u style="single">(Item 19)</u><u style="single"> The rotary atherectomy device of item 18, further comprising said masses of said proximal and said distal counterweights, each of which is about 1/2 the mass of the polished portion.</u><u style="single">(Item 20)</u><u style="single"> A high-speed rotary atherectomy device for opening a stenosis in an artery having a given diameter.</u><u style="single"> With a guide wire having a maximum diameter smaller than the diameter of the artery,</u><u style="single"> A flexible, elongated, rotatable drive shaft that is rotatable on the guide wire and has a rotating shaft and an eccentric grind.</u><u style="single"> An eccentric proximal counterweight separated at a distance proximal to the polished part,</u><u style="single"> An eccentric distal counterweight separated from the polished part at a distance,</u><u style="single"> A device for high-speed rotary atherectomy.</u><u style="single">(Item 21)</u><u style="single"> The rotary atherectomy device according to item 20, wherein the eccentric polishing section, proximal and distal counterweights are enlarged sections of the drive shaft.</u><u style="single">(Item 22)</u><u style="single"> The rotary atherectomy device according to item 20, wherein the eccentric grind, proximal and distal counterweights are solid.</u><u style="single">(Item 23)</u><u style="single"> The rotary atherectomy device according to item 20, wherein the eccentric polishing portion is at least partially hollow.</u><u style="single">(Item 24)</u><u style="single"> A method for generating a rotating diameter in a lumen provided with a polished portion of a flexible drive shaft, wherein the rotating diameter is larger than the stationary diameter of the polished portion.</u><u style="single"> To provide a guide wire having a diameter smaller than the diameter of the lumen,</u><u style="single"> To provide a flexible, elongated, rotatable drive shaft that is rotatable on the guide wire, the drive shaft has a rotating shaft and an eccentric grind.</u><u style="single"> To provide an eccentric proximal counterweight at a distance proximal to the polished portion.</u><u style="single"> To provide an eccentric distal counterweight at a distance distal to the polished portion.</u><u style="single"> To rotate the drive shaft at high speed</u><u style="single"> Including methods.</u><u style="single">(Item 25)</u><u style="single"> A method for removing obstacles from the lumen,</u><u style="single"> To provide a guide wire having a maximum diameter smaller than the diameter of the lumen,</u><u style="single"> To provide a flexible, elongated, rotatable drive shaft that is rotatable on the guide wire, the drive shaft has a rotating shaft and an eccentric grind.</u><u style="single"> To provide at least one counterweight on the drive shaft,</u><u style="single"> To rotate the drive shaft at high speed</u><u style="single"> Including methods.</u></p>
<figref num="1">It is a perspective view of one Embodiment of the inflexible eccentric cutting head of the device for rotary atherectomy of this invention.</figref><figref num="2">It is a perspective fracture view of the flexible eccentric enlargement part of the prior art of a drive shaft.</figref><figref num="3">It is sectional drawing in the breaking longitudinal direction of the eccentric enlargement part of the drive shaft of the prior art.</figref><figref num="4">FIG. 5 is a cross-sectional view in the longitudinal direction of fracture showing the flexibility of a solid eccentric expansion burr of the prior art attached to a drive shaft.</figref><figref num="5">FIG. 5A is a perspective view of a prior art eccentric polishing head or top mounted on a drive shaft. FIG. 5B is a bottom view of a prior art eccentric polishing head or top mounted on a drive shaft. FIG. 5C is a longitudinal sectional view of a prior art eccentric polishing head or top mounted on a drive shaft.</figref><figref num="6">It is sectional drawing in the longitudinal direction of one Embodiment of this invention.</figref><figref num="7">FIG. 7A is a cross-sectional view of an embodiment of the present invention. FIG. 7B is a cross-sectional view of an embodiment of the present invention. FIG. 7C is a cross-sectional view of an embodiment of the present invention.</figref><figref num="8">It is a cross-sectional view which shows three different positions of the rapid rotary polishing part of the device for eccentric rotary atherectomy of this invention.</figref><figref num="9">It is a schematic diagram corresponding to three positions of the rapid rotation type polishing part shown in FIG.</figref>
The present invention can accommodate a variety of modifications and alternative forms, the details of which are illustrated in the drawings by way of example and are described in detail herein. However, it should be understood that it is not intended to limit the invention to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention.
FIG. 1 shows a typical rotary atherectomy device of the present invention. The device includes a handle portion 10, an elongated flexible drive shaft 20 having a polishing portion 28 with an eccentric enlarged diameter portion 28A, and an elongated catheter 13 extending distally from the handle portion 10. The drive shaft 20 and its eccentric expansion diameter portion 28 are composed of spirally wound wires. Catheter 13 has a lumen in which most of the length of the drive shaft 20 except for the enlarged diameter portion 28A and the short section distal to the enlarged diameter portion 28 is placed. The drive shaft 20 also includes an inner lumen, which allows the drive shaft 20 to advance and rotate on the guide wire 15. The fluid supply line 17 may be provided to introduce a cooling solution and a lubricating solution (typically saline or another biocompatible fluid) into the catheter 13.
The handle 10 preferably includes a turbine (or similar rotational drive mechanism) to rotate the drive shaft 20 at high speed. The handle 10 may be connected to a power source such as compressed air delivered via the tube 16. Also, a pair of fiber optic cables 23 may be provided to monitor the rotational speed of the turbine and drive shaft 20 (details regarding such handles and related appliances are well known in the art, eg, Auth. (Explained in US Pat. No. 5,314,407) issued in. The handle 10 also preferably includes a control knob 11 for retracting the turbine and drive shaft 20 with respect to the catheter 13 and the handle body.
FIGS. 2 to 3 show details of the polishing portion 28 including the eccentric enlarged diameter portion 28A. The drive shaft 20 comprises one or more spiral wound wires 18, which define a guide wire cavity 19 and a hollow cavity 25 within the enlarged diameter portion 28A. Except for the guide wire 15 traversing the hollow cavity 25, the hollow cavity 25 is substantially empty. The polishing portion 28, designated as the eccentric enlarged diameter portion 28A, comprises a proximal 30, intermediate 35 and distal 40 portion having a tissue removal surface 37 on it. The wire rotation 31 of the proximal portion 30 of the eccentric enlarged diameter portion 28A preferably has a diameter that gradually increases distally at a substantially constant rate, thereby forming a substantially conical shape. The wire rotation 41 of the distal portion 40 preferably has a diameter that gradually decreases distally at a substantially constant rate, thereby forming a substantially conical shape. The wire rotation 36 of the intermediate portion 35 is provided with a diameter that varies stepwise to provide a substantially convex outer surface, and the proximal and distal conical portions of the enlarged diameter portion 28A of the drive shaft 20. It has a shape that provides a smooth transition between and.
At least a portion of the polished portion 28, designated as the eccentric enlarged diameter portion 28A (preferably the intermediate portion 35), comprises an outer surface 37 capable of tissue removal. Preferably, the tissue removal surface comprises a coating film 37 of the polishing material 24 so as to define the tissue removal category of the drive shaft 20. The abrasive can be any public material such as diamond powder, fused quartz, titanium nitride, tungsten carbide, aluminum oxide, boron carbide, or other ceramic materials. Preferably, the abrasive is composed of diamond chips (or diamond dust particles) that are attached directly to the wire rotation of the drive shaft 20 by a suitable binder 26, such attachment by conventional electroplating or fusion techniques. It can be achieved using well-known techniques such as (see, eg, US Pat. No. 4,018,576). Alternatively, the external tissue removal surface may simply be a section of wire rotation roughened to provide a suitable polished surface. In yet another variant, the outer surface may be etched or cut (eg, by a laser) to provide a small but effective polished surface. Other similar techniques may also be utilized to provide a suitable tissue removal surface.
FIG. 4 shows another type of known polishing section 28, shown as an eccentric solid, or at least partially hollow burr 28B. The solid, or at least partially hollow, abrasive burr 28B comprises a coating of abrasive 24 attached to the drive shaft 20 by means well known to those skilled in the art and secured to the surface by a suitable binder 26.
Figures 5A, 5B, and 5C are eccentric polishing heads or top 28C, as described in Thatcher et al., US Application No. 11 / 761,128, which disclosure is incorporated herein by reference in its entirety. Another known polished surface 28 comprising. The lumen 23 may be provided with a hollow compartment 25 to interfere with attachment to the drive shaft 20 and to help move the center of gravity away from or closer to the axis of rotation of the drive shaft 20. The polished portion 28C comprises a proximal 30, intermediate 35 and distal 40 portion, the proximal 30 and distal 40 portions tilting from the intermediate portion 35, which is represented to have a cylindrical shape.
Therefore, one embodiment according to the present invention may also include an eccentric enlargement portion 28A of the drive shaft, or an eccentric solid maximum or polishing head 28C, or an eccentric burr 28B attached to the drive shaft. The grind 28 has a center of gravity radially separated from the axis of rotation of the drive shaft 20, which allows the device to open the stenotic lesion to a diameter substantially larger than the outer diameter of the grind 28. Promote the ability to do. This is the geometric center of the polishing section 28, that is, the eccentric enlarged diameter portion of the drive shaft 20, or the eccentric solid polishing head or the highest portion 28C, or the burr 28B attached to the drive shaft 20 of the drive shaft 20. This can be achieved by separating it from the axis of rotation. Alternatively, the center of gravity of the grind 28 may be radially separated from the axis of rotation of the drive shaft by providing the grind 28 containing different combinations of materials, with at least one aspect of the grind 28 , Containing more or denser material than the other side, which forms the eccentricity defined herein. As will be appreciated by those skilled in the art, the formation of an eccentricity, eg, a center of gravity offset from the axis of rotation of the drive shaft, due to the use of different materials within the structure of the abrasive 28 is concentric, eccentric, solid burr, partially. It is applicable to any embodiment of the polishing section 28 described herein, regardless of whether it is a hollow top or polishing head, or an enlarged section of a drive shaft, or equivalent.
Further, this particular embodiment of the present invention may comprise at least one counterweight located on, and fixedly attached to, a drive shaft to stimulate the orbital motion of the eccentric grinded portion. One such at least one counterweight may be located proximal to the grind, while another at least one counterweight may be located distal to the grind.
In one embodiment shown in FIG. 6, the polished portion 28 is represented as an eccentric enlarged diameter portion 28A of the drive shaft 20. The distal counterweight 100 is located distal to the polishing section 28 and the proximal counterweight 102 is located proximal to the polishing section. An alternative embodiment may include only the distal counterweight 100 operably combined with the grind 28, or only the proximal counterweight 102 operably combined with the grind 28.
Although many alternative embodiments are contemplated by the present invention, counterweights 100, 102 are solid and eccentric burrs, as shown in FIG.
For example, one or both of the proximal and distal counterweights 100, 102 may include an enlarged diameter portion of the drive shaft, also formed as an enlarged eccentric diameter abrasive portion 28A. In this embodiment, the counterweights 100, 102 are substantially hollow extended wire rotations of the drive shaft 20 formed by the use of a mandrel during the wire rotation winding process. If only one of the proximal 102 or distal 100 counterweights is the magnified eccentric diameter polishing part of the drive shaft 20, the remaining counterweights are concentric, i.e. collinear to the axis of rotation of the drive shaft. It may have a center of gravity and an enlarged diameter portion of the drive shaft, a solid top or at least a partially hollow top, or is eccentric and has a solid burr or at least a partially hollow top or polishing. May have a head.
Alternatively, one or both of the proximal and distal counterweights 100, 102 are solid as shown in FIG. 6 and can be attached to the wire rotation of the drive shaft 20 by means well known to those of skill in the art. As an alternative, the proximal and distal counterweights 100, 102 may be at least partially hollow.
Still further, as an alternative, one or both of the counterweights 100, 102 may contain a combination of different materials, and at least one aspect of the counterweights 100, 102 may be larger or higher than the other aspect. It contains a density material, which forms the eccentricity as defined herein. As those skilled in the art will recognize, the formation of eccentricity by the use of different materials within counterweights 100, 102, eg, the center of gravity offset from the axis of rotation of the drive shaft, is concentric, eccentric solid burr, partially hollow. It is applicable to any of the embodiments of counterweights 100, 102, regardless of the highest portion or the polishing head, the enlarged portion of the drive shaft, or the equivalent.
In one embodiment, the proximal and distal counterweights 100, 102 are substantially equivalent in overall mass as shown in FIG. 6, and each counterweight 100, 102 is the overall of the polished portion 28. Proximal and distal counterweights 100, 102 are equidistant from the polishing section 28, and proximal and distal counterweights 100, 102 are from the axis of rotation of the drive shaft 20. Proximal and distal counterweights 100, 102 include a center of gravity that is equidistant, and the proximal and distal counterweights 100, 102 have a center of gravity that is equidistant from the center of gravity of the eccentric polishing section 28. Alternative and equivalent mass distributions between the polishing section 28 and the counter weights (including multiple) for use in manipulating the orbital rotation diameter of the polishing section 28 during high speed rotation are easy for those skilled in the art. Yes, it is within the scope of the present invention.
In addition, one or both of the counterweights (proximal and / or distal) 100, 102 may be concentric, i.e. spherical or elliptical profiles, or other concentric shapes, and counterweights (near). One or both of (position and / or distal) 100, 102 have a center of gravity that is substantially on the axis of rotation of the drive shaft 20, ie, collinear.
Alternatively, one or both of the counterweights (proximal and / or distal) 100, 102 can be eccentric, i.e., one embodiment is radially separated from the axis of rotation of the drive shaft 20. It comprises counterweights (proximal and / or distal) 100, 102 having a center of gravity and aligned in the same longitudinal plane as the center of gravity of the eccentric polishing section 28 illustrated in FIG. The radial separation of the center of gravity of the counterweights can be achieved by separating the geometric center of each of the counterweights 100, 102 from the axis of rotation of the drive shaft 20, proximal counterweight 102 and distal counterweight 100. Each has a center of gravity separated from the center of gravity of the eccentric polishing portion 28 by a rotation angle of 180 degrees, as shown in FIG. The centers of gravity of the proximal 102 and distal 100 counterweights may be offset by 180 degrees. This counterweight arrangement stimulates orbital motion by the grind 28, which is capable of sweeping and opening stenotic lesions to a diameter substantially larger than the outer diameter of the static eccentric dilated diameter 28. To promote.
An alternative embodiment may include at least one of counterweights 100, 102 having a center of gravity that may or may not be separated from the center of gravity of the polishing section 28 by a rotation angle of 180 degrees. In one embodiment of the present invention, the orbital rotation diameter of the polishing portion 28 during high-speed rotation is suppressed by arranging the centers of gravity of at least one counterweights 100 and 102 at a rotation angle of zero degrees from the center of gravity of the polishing portion 28. Can be done. This embodiment can be applied regardless of whether the polishing portions 28 are eccentric or concentric. For example, by attaching at least one eccentric counterweight 100, 102, suppression can be achieved in an embodiment comprising an eccentric grind 28, the center of gravity of the eccentric grind 28 and at least one eccentric counterweight 100, 102. Is a substantially collinear, i.e., substantially zero degree rotation separation angle. Alternatively, if the polishing section 28 is provided as a concentric embodiment in which its center of gravity is on the axis of rotation of the drive shaft 20, at least one counterweight 100, 102 is also concentric with its center of gravity on the axis of rotation of the drive shaft 20. It may be provided in an embodiment. As a further alternative, if the grind 28 is provided as an eccentric embodiment in which its center of gravity is offset from the axis of rotation of the drive shaft 20, at least one counterweight has a rotation angle of 180 degrees from the center of gravity of the grind 28. Can be provided with a center of gravity located at. In this embodiment, the drive shaft 28 may be provided with at least one counterweight with or without a distance between at least one counterweight and the polishing section 28.
Those skilled in the art will appreciate that the respective arrangements of the counterweight (s) and the polishing section 28, as well as their center of gravity, disclosed herein and above, stimulate the orbital motion of the polishing section 28. In all forms, profiles and types of grinds 28 and counterweights (s) described herein, i.e. to increase or suppress the rotational diameter, i.e. to decrease the rotational diameter. You will easily recognize that it can be applied.
Significantly, the present invention provides a cavity with a swept diameter equivalent to that of the larger diameter grinder 28 of the prior art, without the counterweights 100, 102 described herein. , Proximal and distal counterweights 100, 102 and smaller diameter grinds 28 may be allowed in combination.
Those skilled in the art will also recognize a number of combinations and replacements of these parameters for a given rotational speed of the drive shaft 20. Those skilled in the art will recognize that modifications of any of these parameters increase or decrease / suppress the diameter of the orbital path taken by the grind. Therefore, the diameter of the orbital path may be customized for individual cavities.
Another embodiment of the invention is described in US Pat. No. 5,314,438 of Shturman, the disclosure of which is incorporated herein by reference in its entirety, with a concentric magnifying grind of the drive shaft 28. Can be equipped. Alternatively, the polishing section 28 of this embodiment may include concentric solid burrs attached to drive shafts, as is known in the art, see, for example, US Pat. No. 4,990,134 of Auth. Concentric in this sense means that the polished portion 28 formed by wire rotation or solid or semi-solid, i.e., hollow burrs, includes profiles that are spherical or elliptical, or other concentric shapes and are concentric. The polished portion 28 means having a center of gravity that is substantially collinear, that is, on the axis of rotation of the drive shaft 20.
Further, this particular embodiment of the present invention comprises two counterweights 100, 102 that are attached to or mounted on the drive shaft 20 to stimulate the orbital motion of the concentric grind 28. .. Preferably, the distal counterweight 100 is located distal to the concentric grind 28 and the proximal counterweight 102 is located proximal to the concentric grind 28.
One or both of the proximal and / or distal counterweights 100, 102 may comprise an enlarged diameter portion of the drive shaft formed similar to the enlarged eccentric diameter abrasive portion 28A shown in FIG. In this embodiment, the counterweights 100, 102 may be a substantially solid extended wire rotation of the drive shaft formed by using a mandrel during the wire rotation winding process. If only one of the proximal 102 or distal 102 counterweights is the magnified eccentric diameter polishing part of the drive shaft 20, the remaining counterweights are concentric, i.e. collinear to the axis of rotation of the drive shaft. It may have a center of gravity and an enlarged diameter portion of the drive shaft 20, a solid burr or at least a partially hollow polishing head, or an eccentric and solid burr or at least a partially hollow polishing head. obtain.
Alternatively, one or both of the proximal and distal counterweights 100, 102 may be solid and attached to the wire rotation of the drive shaft 20 by means well known to those of skill in the art. Further, as an alternative, the proximal and distal counterweights 100, 102 may be at least partially hollow.
In one embodiment in which the polishing portions 28 are concentric, the proximal and distal counter weights 100, 102 are substantially equivalent in overall mass, and each counter weight 100, 102 is the entire concentric polishing portion 28. Proximal 102 and distal 100 counterweights are equidistant from the concentric polishing section 100, and the proximal and distal center of gravity are equidistant from the axis of rotation of the drive shaft 20. Yes, the proximal and distal centers of gravity are equidistant from the center of gravity of the concentric polishing section 28.
The counterweights 100, 102 may be concentric, i.e. spherical or elliptical profiles, or other concentric shapes, and the counterweights 100, 102 substantially have a center of gravity on the axis of rotation of the drive shaft 20.
Preferably, in the present embodiment comprising the concentric polishing section 28, the counter weights 100, 102 are eccentric, i.e., one embodiment has a center of gravity radially separated from the rotation axis of the drive shaft 20. And distal 100 counterweights may be provided, each having a center of gravity offset in the same longitudinal plane and in the same longitudinal plane as the center of gravity of the concentric polishing section 28 collinear to the axis of rotation. Further, the centers of gravity of the proximal 102 and distal 100 counterweights may both be above or below the axis of rotation of the drive shaft 20, but both centers of gravity are of the same length. Aligned in the directional plane, it forms an "offset" between the center of gravity of the polished portion 28 and the center of gravity of the proximal 102 and distal 100 counterweights. The centers of gravity of the proximal 102 and distal 100 counterweights are offset 180 degrees from each other around the axis of rotation of the drive shaft 20 or other angular offsets, as will be readily recognized by those skilled in the art. Good.
Similar to the eccentric grind embodiment, the concentric grind embodiment is proximal 102 and distal by separating the geometric centers of the counterweights 100, 102 away from the axis of rotation of the drive shaft 20. Eccentricity of 100 Counterweights A radial separation of the centroids of the embodiment can be achieved, with the proximal counterweight 102 and the distal counterweight 100 each separated from the center of gravity of the concentric polishing section and in the same longitudinal plane. Has a center of gravity. This counterweight embodiment stimulates orbital motion by the grind 28, facilitating the ability of the grind 28 to sweep and open stenotic lesions to a diameter substantially larger than the outer diameter of the stationary concentric grind 28. To do. As mentioned above, the present invention provides smaller diameter grinds 28, proximal 102 and distal, while opening a cavity with a swept diameter equivalent to the larger diameter concentric grinds 28 of the prior art. It may be possible to use with 100 counterweights.
7A-7C show the eccentric polishing head illustrated in FIGS. 5A, 5B and 5C during high speed rotation with the eccentric counterweights 100, 102 mounted on the drive shaft 20, as described herein. The position of the center of gravity 29 of the three cross-sectional sections (shown as a cross section) of the eccentric polishing part 28 shown as 28C is shown. The eccentric polishing section 28 can be divided into many such thin sections, each section having its own center of gravity. FIG. 7B is taken at the position where the polishing section 28 has its maximum cross-sectional diameter (in this case, the maximum diameter of the intermediate portion 35 of the eccentric polishing section 28), and FIGS. 7A and 7C are eccentric polishing. It was taken at the distal 40 and proximal 30 parts of part 28, respectively. In each of these cross-sectional sections, the center of gravity 29 is separated from the axis of rotation of the drive shaft, and the axis of rotation of the drive shaft 20 coincides with the center of the guide wire 15. The center of gravity 29 of each cross-section section also closely coincides with the geometric center of such a cross-section section. FIG. 7B illustrates the section with the largest cross-sectional diameter. In this section, both the center of gravity 29 and the geometric center are located farthest (ie, maximally separated) from the axis of rotation of the drive shaft 20. Naturally, the center of gravity of the entire polishing section 28 is a composite of the individual centers of gravity of the multiple sections of the enlarged diameter section, and therefore the overall center of gravity is the rotation of the drive shaft 20 more than the center of gravity of the sections shown in FIG. 7B. Get closer to the axis.
As used herein, the term "eccentricity" is used herein to refer to the eccentric enlarged diameter portion 28A of the drive shaft 20, or the eccentric solid burr 28B, or the highest portion of the eccentric at least partially hollow. Difference in position between the geometric center of the polishing head 28C or the polishing portion 28 with the eccentric counterweight (including multiple) and the rotation axis of the drive shaft, or the eccentric expansion diameter portion 28A, eccentric solid burr 28B , And the difference in position between the center of gravity of the eccentric and at least partially hollow top or polishing head 28C, or the eccentric polishing section 28 with eccentric counterweights 100, 102, and the rotation axis of the drive shaft 20. Please understand that it is defined as a thing. Any of these differences at proper rotational speeds allow the grind 28 to open the stenosis to a diameter substantially larger than the nominal diameter of the grind 28. Furthermore, in the eccentric polishing section 28, which has a shape that is not a regular geometric shape, the concept of "geometric center" is drawn through the axis of rotation of the drive shaft, and its perimeter of the eccentric enlarged diameter section is its. It can be approximated by placing the midpoint of the longest chord connecting the two points around the cross section at the position with the maximum length. Moreover, those skilled in the art will appreciate that the defined eccentricity has a substantially concentric profile, but one aspect of the profile is greater than the other, for example by hollowing out a portion of one side of the polishing section 28. You will recognize that it can be designed on the polishing section 28.
Further, the concentricity as defined herein is on the axis of rotation of the drive shaft 20, i.e., a center of gravity that is collinear and a profile that is substantially symmetrical with respect to the polished portion 28 and / or counterweight. It should also be understood that it is defined as meaning 100, 102.
8 and 9 show substantially spiral orbital paths taken by various embodiments of the eccentric polishing head 28 of the present invention, the polishing head 28 being shown with respect to a guide wire 15 in which the polishing head 28 is advanced. The pitch of the spiral paths in FIGS. 8 and 9 has been exaggerated for illustration purposes, and in fact each spiral path of the eccentric magnifying polishing head 28 has a very thin layer of tissue through the tissue removal surface 37. Only removal, many such spiral passages are made by the eccentric magnifying polishing head 28 as the device repeatedly moves back and forth across the stenosis to completely open the stenosis. FIG. 9 schematically shows three different rotational positions of the eccentric magnifying polishing head 28 of the rotary atherectomy device of the present invention. At each position, the polished surface of the eccentric magnifying polishing head 28 contacts the plaque "P" to be removed, and the three positions are identified by three different points of contact with the plaque "P", which are these points. , B1, B2, and B3 are shown in the drawing. Note that at each point, the most radial radius of the drive shaft is approximately the same portion of the polished surface of the eccentric magnifying polishing head 28 that contacts a portion of the tissue, the tissue-removed surface 37. I want to be.
The present invention should not be considered to be limited to the particular embodiments described above, but rather should be understood to cover all aspects of the invention. Various modifications, equivalent processes, and numerous structures to which the present invention may be applicable will be readily apparent to those skilled in the art of the present invention by considering this specification.
Every citation, both ways
| Document | Relation | Office |
|---|---|---|
| WO2006126176A1 | Cites | World Intellectual Property Organization (WIPO) |
| WO2006126076A1 | Cites | World Intellectual Property Organization (WIPO) |
| JP08509390A | Cites | Japan |
| JP2002506668A | Cites | Japan |
| US06494890B1 | Cites | United States of America |
14 members in 8 offices
Priority claims7
| Document | Office | Kind | Date |
|---|---|---|---|
| 11876891 | United States of America | – | |
| 87689107 | United States of America | A | |
| 2008077023 | United States of America | W | |
| 2007876891 | – | – | – |
| 2008077023 | – | – | – |
| US20070876891 | – | – | – |
| WO2008US77023 | – | – | – |
Members14
| Document | Office | Kind | |
|---|---|---|---|
| US2009105736A1 | United States of America | A1 | |
| AU2008317176A1 | Australia | A1 | |
| CA2701159A1 | Canada | A1 | |
| WO2009055172A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP2203121A1 | European Patent Office (EPO) | A1 | |
| CN101835432A | China | A | |
| JP2011500271A | Japan | A | |
| HK1144544A | Hong Kong, China | A | |
| EP2203121A4 | European Patent Office (EPO) | A4 | |
| US8348965B2 | United States of America | B2 | |
| CN101835432B | China | B | |
| JP5301552B2This record | Japan | B2 | |
| AU2008317176B2 | Australia | B2 | |
| CA2701159C | Canada | C |
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Numbers
- Publication
- 5301552
- Publication, DOCDB
- 5301552
- Publication, EPODOC
- JP5301552B
- Application
- 2010531103
- Application, DOCDB
- 2010531103
- Application, EPODOC
- JP20100531103
Titles2
- Japanese
- カウンタウェイトを有する回転式アテローム切除術用デバイス
- English
- Rotating atherectomy device with counterweight
Classification
- CPC, 5
- A61B17/320758
- A61B17/3207
- A61B2017/22038
- A61B2017/320004
- A61B2017/320766
- IPC, 2
- A61B17 00
- A61B17 22