EP3229710A1 - Devices, systems and methods for a piloting tip bushing for rotational atherectomy - Google Patents
Devices, systems and methods for a piloting tip bushing for rotational atherectomyInfo
- Publication number
- EP3229710A1 EP3229710A1 EP15868573.5A EP15868573A EP3229710A1 EP 3229710 A1 EP3229710 A1 EP 3229710A1 EP 15868573 A EP15868573 A EP 15868573A EP 3229710 A1 EP3229710 A1 EP 3229710A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- drive shaft
- distal section
- piloting
- guide wire
- profile
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
- A61B2017/320766—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven eccentric
Definitions
- the invention relates to devices and methods for removing tissue from body passageways, such as removal of atherosclerotic plaque from arteries, utilizing a high-speed rotational atherectomy device.
- Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (under the endothelium) of a patient's blood vessels. Very often over time, what initially is deposited as relatively soft, cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque. Such atheromas restrict the flow of blood, and therefore often are referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material. If left untreated, such stenoses can cause angina, hypertension, myocardial infarction, strokes and the like.
- Rotational atherectomy procedures have become a common technique for removing such stenotic material. Such procedures are used most frequently to initiate the opening of calcified lesions in coronary arteries. Most often the rotational atherectomy procedure is not used alone, but is followed by a balloon angioplasty procedure, which, in turn, is very frequently followed by placement of a stent to assist in maintaining patentcy of the opened artery. For non- calcified lesions, balloon angioplasty most often is used alone to open the artery, and stents often are placed to maintain patentcy of the opened artery.
- a burr covered with an abrasive abrading material such as diamond particles is carried at the distal end of a flexible drive shaft.
- the burr is rotated at high speeds (typically, e.g., in the range of about 150,000-190,000 rpm) while it is advanced across the stenosis.
- the bun- is removing stenotic tissue, however, it blocks blood flow.
- the burr Once the burr has been advanced across the stenosis, the artery will have been opened to a diameter equal to or only slightly larger than the maximum outer diameter of the burr. Frequently more than one size burr must be utilized to open an artery to the desired diameter.
- U.S. Pat. No. 5,314,438 discloses another atherectomy device having a drive shaft with a section of the drive shaft having an enlarged diameter, at least a segment of this enlarged surface being covered with an abrasive material to define an abrasive segment of the drive shaft.
- the abrasive segment When rotated at high speeds, the abrasive segment is capable of removing stenotic tissue from an artery.
- this atherectomy device possesses certain advantages over the Auth device due to its flexibility, it also is capable only of opening an artery to a diameter about equal to the diameter of the enlarged abrading surface of the drive shaft since the device is not eccentric in nature.
- U.S. Pat. No. 6,494,890 discloses a known atherectomy device having a drive shaft with an enlarged eccentric section, wherein at least a segment of this enlarged section is covered with an abrasive material. When rotated at high speeds, the abrasive segment is capable of removing stenotic tissue from an artery.
- the device is capable of opening an artery to a diameter that is larger than the resting diameter of the enlarged eccentric section due, in part, to the orbital rotational motion during high speed operation. Since the enlarged eccentric section comprises drive shaft wires that are not bound together, the enlarged eccentric section of the drive shaft may flex during placement within the stenosis or during high speed operation.
- U.S. Pat No. 5,681, 336 provides a known eccentric tissue removing burr with a coating of abrasive particles secured to a portion of its outer surface by a suitable binding material.
- This construction is limited, however because, as Clement explains at Col. 3, lines 53- 55, that the asymmetrical burr is rotated at "lower speeds than are used with high speed ablation devices, to compensate for heat or imbalance.” That is, given both the size and mass of the solid burr, it is infeasible to rotate the burr at the high speeds used during atherectomy procedures, i.e., 20,000-200,000 rpm. Essentially, the center of mass offset from the rotational axis of the drive shaft would result in development of significant centrifugal force, exerting too much pressure on the wall of the artery and creating too much heat and excessively large particles.
- the atherectomy device when the device is driven into the lesion, it can screw into the lesion.
- the atherectomy device may be limited to a certain size of lesion or stenosis for treatment because of the diameter of the burr.
- Prior art devices such as U.S. Patent No.
- the present invention overcomes these deficiencies and provides, inter alia, the above-referenced improvements.
- the present system is directed in various methods, devices and systems relating to rotational atherectomy. More specifically, a piloting element is mounted on a drive shaft, the piloting element comprising a shape and structure to facilitate opening pilot holes through difficult occlusions and/or stenosis.
- the high-speed rotational atherectomy device for opening a stenosis in an artery having a given diameter comprises a guide wire having a maximum diameter less than the diameter of the artery; a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a proximal end and a distal end; and a piloting element fixedly attached to the drive shaft proximate a distal end thereof.
- the piloting element has a concentric or eccentric profile.
- a piloting element comprises a proximal section extending distally from a proximal end of the piloting element, the proximal section having a constant diameter; a distal section extending proximally from a distal end of the piloting element having a diameter at the distal end less than a diameter at the proximal end of the piloting element, the diameter increasing proximally from the distal end; and an intermediate section between the proximal section and the distal section, the intermediate section having a generally parabolic profile, wherein the diameter of the piloting element increases from the constant diameter of the proximal section to a maximum point and then decreases distally towards the distal section.
- the piloting element can be either concentric or eccentric.
- the piloting element has an inner lumen at least at the proximal section with a diameter greater than the diameter of the drive shaft. In at least one embodiment, the piloting element has a diameter less than a diameter of the drive shaft.
- a method for opening a stenosis in a blood vessel having a given diameter comprising: providing a guide wire having a maximum diameter less than the diameter of the artery; advancing the guide wire into a blood vessel to a position proximal to the stenosis; providing a flexible elongated, rotatable drive shaft advanceable over a guide wire, the drive shaft having a maximum diameter less than the diameter of the artery; the drive shaft having a rotational axis; the drive shaft having a piloting element fixedly attached to the drive shaft; advancing the piloting element into the artery to a position proximal to the stenosis; creating a piloting hole by rotating the drive shaft at a sufficient rotational speed.
- the piloting element has an orbital path such that the piloting hole has a diameter greater than a maximum diameter of the piloting element.
- FIG. 1 is a perspective view of a non-limiting exemplary embodiment of a rotational atherectomy device
- FIG. 2 is a perspective view of a non-limiting exemplary embodiment of a piloting element for a rotational atherectomy device
- FIG. 3 is a side view of the piloting element of FIG. 2;
- FIG. 4 is an end view of the piloting element of FIGS. 2-3 from a distal end thereof;
- FIG. 5 is an end view of the piloting element of FIGS. 2-4 from a proximal end thereof;
- FIG. 6 is a perspective view of another non-limiting exemplary embodiment of a piloting element for a rotational atherectomy device
- FIG. 7 is a side view of the piloting element of FIG. 6;
- FIG. 8 is an end view of the piloting element of FIGS. 6-7 from a distal end thereof;
- FIG. 9 is an end view of the piloting element of FIGS. 6-8 from a proximal end thereof;
- FIG. 10 is a perspective view of another non-limiting exemplary embodiment of a rotational atherectomy device
- FIG. 1 1 is a perspective view of yet another non-limiting exemplary embodiment of a rotational atherectomy device
- FIG. 12 is a perspective view of a non-limiting exemplary embodiment of a rotational atherectomy device
- FIG. 13 is a perspective view of the piloting element of FIG. 2 used with the rotational atherectomy device of FIGS. 11 and 12;
- FIG. 14 is a side view of the piloting element of FIG. 13;
- FIG. 15 is a perspective view of the piloting element of FIG. 6 used with the rotational atherectomy device of FIGS. 11 and 12;
- FIG. 16 is a side view of the piloting element of FIG. 15;
- FIG. 17 is a perspective view of the piloting element of FIG. 2 used with the rotational atherectomy device of FIGS. 1 1 and 12 having a flexible drive shaft extending into at least a portion of the piloting element;
- FIG. 18 is a side view of the piloting element of FIG. 17;
- FIG. 19 is a perspective view of the piloting element of FIG. 6 used with the rotational atherectomy device of FIGS. 11 and 12 having a flexible drive extending through the piloting element;
- FIG. 20 is a side view of the piloting element of FIG. 19.
- Various embodiments of the present invention comprise a rotational atherectomy system as described generally in US 6,494,890, entitled “ECCENTRIC ROTATIONAL
- 2010/0198239 entitled “MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”; U.S. Pat. Pub. No. 2010/0036402, entitled “ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”; U.S. Pat. Pub. No. 2009/0299391, entitled “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”; U.S. Pat. Pub. No.
- the device further comprises a proximal and/or a distal counterweight attached to the drive shaft, spaced from the abrasive section wherein each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section.
- each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section.
- a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with an abrasive section within a pre-curved section of the drive shaft.
- the device may further comprise a concentric or eccentric enlarged diameter section that is at least partially covered with abrasive material to comprise the abrasive section.
- the abrasive section may further comprise an abrasive crown or burr mounted to the drive shaft.
- the pre-curved drive shaft allows smaller diameter and/or massive abrasive regions to be used while sweeping larger diameters during high-speed rotation.
- the pre-curved region is substantially straightened for insertion into vasculature and placement adjacent stenosis by insertion of the guide wire. Removal of guide wire proximally from the pre-curved region allows the drive shaft to return to its pre-curved form for ablation. Reinsertion of the guide wire beyond the pre-curved region straightens the drive shaft for ease of removal.
- one or more features, including configurations, placement, location, operational and functional characteristics, etc., of the various non-limiting exemplary embodiments of any and all abrading elements are equally or substantially equally applicable for the piloting elements of the instant disclosure.
- One or more such piloting elements may be provided individually and/or in combination with one or more abrading elements.
- FIG. 1 illustrates one embodiment of a rotational atherectomy device according to the present invention.
- the device includes a handle portion 10; an elongated, flexible drive shaft 20 having an eccentric abrading element 28 and a piloting element 29 comprising either a piloting tip or bushing mounted or otherwise disposed on the flexible drive shaft at a point distal to the abrading element 28; and an elongated catheter 13 extending distally from the handle portion 10.
- the drive shaft 20 is constructed from helically coiled wire as is known in the art and the abrading element 28 and the piloting element 29 are fixedly attached to the drive shaft 20.
- the drive shaft 20 has an outer surface 24 and an inner surface 22 defining an inner lumen, permitting the drive shaft 20 to be advanced and rotated over a guide wire 15.
- the catheter 13 has a lumen in which most of the length of the drive shaft 20 is disposed, except for the enlarged abrading element 28 and a section of the drive shaft 20 distal to the enlarged abrading element 28.
- a fluid supply line 17 may be provided for introducing a cooling and lubricating solution (typically saline or another biocompatible fluid) into the catheter 13.
- FIG. 10 illustrates another non-limiting exemplary embodiment of a rotational atherectomy device which does not include the abrading element 28.
- the device illustrated in FIG. 10 is substantially similar to that described with reference to FIG. 1.
- the handle 10 desirably contains a turbine (or similar rotational drive mechanism) for rotating the drive shaft 20 at high speeds.
- the handle 10 typically may be connected to a power source, such as compressed air delivered through a tube 16.
- a pair of fiber optic cables 25, alternatively a single fiber optic cable may be used, may also be provided for monitoring the speed of rotation of the turbine and drive shaft 20 (details regarding such handles and associated instrumentation are well known in the industry, and are described, e.g., in U.S. Pat. No.
- the handle 10 also desirably includes a control knob 11 for advancing and retracting the turbine and drive shaft 20 with respect to the catheter 13 and the body of the handle.
- the eccentric abrading element 28 comprises an eccentric enlarged section of the drive shaft, or an eccentric solid crown, or an eccentric burr attached to the drive shaft.
- the abrading element 28 has a center of mass spaced radially from the rotational axis of the drive shaft 20, facilitating the ability of the device to open the stenotic lesion to a diameter substantially larger than the outer diameter of the abrading element 28.
- the center of mass of the abrading element 28 may be radially spaced from the drive shaft's rotational axis by providing an abrading element 28 that comprises a differential combination of materials, wherein one side of at least one of the abrading element 28 comprises a more massive or denser material than the other side, which creates eccentricity as defined herein.
- the abrading element 28 may comprise a concentric profile or an eccentric profile.
- the abrading element 28 may achieve orbital motion, generated by a positioning of the center of mass of the abrading element 28 radially offset from the rotational axis of the drive shaft, either by using different densities of materials and/or geometrically moving the center of mass of the abrading element 28 radially away from the drive shaft's center of mass. This "eccentricity" may be achieved in either a concentric or an eccentric geometric profile.
- the abrading element 28 may be an enlarged section of the drive shaft, a burr, or a contoured abrading element and may comprise diamond coating. In other embodiments, the abrading element 28 may comprise a center of mass that is on the drive shaft's rotational axis.
- these known abrading elements 28 described above are limited to the minimum size lesions that can be treated because the abrasive features of the abrading element are of a diameter that is larger than the drive shaft diameter.
- the present device remedies that problem, among others. Further, if known abrading elements are forced or driven into a lesion, the abrading element 28 may grip and screw/auger into the lesion with a subsequent building and releasing of force that may undesirably affect the lesion or the blood vessel.
- the present invention addresses this problem by opening a pilot hole with a diameter equivalent to the diameter of the flexible drive shaft of the atherectomy system. This allows for the minimum required clearance between the abrading element 28 and the lesion to prevent gripping and screwing into the lesion.
- the piloting element 29 may be fixedly attached to the drive shaft 20, either by being mounted directly onto the outer surface of the drive shaft or mounted axially to the drive shaft at a distal end of the drive shaft. Since the piloting element 29 is fixedly attached to the drive shaft 20, where the abrading element 28 is also fixedly attached, the piloting element 29 will rotate in the same direction and at the same speed as the abrading element 28.
- the piloting element 29 coupled to the drive shaft 20 with or without the abrading element 28 may also comprise a concentric or eccentric profile. Irrespective of the presence or absence of the abrading element 28, the piloting element may also comprise a center of mass that is either collinear with the rotational axis of the drive shaft or that is offset radially from the drive shaft's rotational axis using the same techniques discussed above in connection with the abrading element 28. As such, in the absence of the abrading element 28, the piloting element 29 so configured will have operational and functional characteristics similar to those described for the abrading element 28.
- the abrading element 28 will act as a counterweight, causing orbital motion of the piloting element 29 and thereby creating an increased rotational diameter for the abrading element 28.
- the abrading element 28 and the piloting element 29 are both eccentric and in still other embodiments, the abrading element 28 and the piloting element 29 are both concentric.
- the eccentricity and/or the positioning of the center of mass of the piloting element 29 may also increase its rotational working diameter.
- the piloting element 29 may be spaced apart from the abrading element 28 along the drive shaft 20. In other embodiments, a proximal end of the piloting element 29 abuts a distal end of the abrading element 28. Piloting element 29 in at least some embodiments comprises a distalmost tip that is of the same diameter as the drive shaft to facilitate opening of stenosis in preparation for the abrading element's rotational entry therein.
- FIGS. 2-9 illustrate some non-limiting exemplary profiles of the piloting element 29.
- the piloting element 29 has a proximal end 42, a distal end 44, an outer surface 46, and an inner surface 48 that defines a lumen.
- the inner surface 48 of the piloting element 29 mates or is engaged with the outer surface 24 of the drive shaft 20.
- the piloting element 29 may be fixedly attached to a distal end of the drive shaft 20, and the lumen defined by the inner surface 48 allows the piloting element 29 to be advanced and rotated over a guide wire 15.
- the piloting element 29 is fixedly disposed to the outer surface of the drive shaft or fixedly attached to a distal end of the drive shaft 20 such that it rotates simultaneously with the abrading element, rather than separately or selectively rotated.
- the piloting element 29 may have a shape with a distal end having a diameter smaller than the proximal end. In some embodiments, the piloting element 29 increases in diameter from the distal end 44 to the proximal end 42. In some embodiments, the piloting element 29 has a bulbous profile. In some embodiments, such as the embodiments shown in FIGS.
- the outer diameter of the piloting element 29 has a constant diameter in a proximal section extending distally of the proximal end 42; in an intermediate section, the diameter of the piloting element 29 increases to a maximum point at a distal end of the intermediate section; and in a distal section, the diameter of the piloting element 29 tapers at a constant slope to a diameter at the distal end 44 less than the constant diameter at the proximal end.
- the outer diameter of the piloting element 29 has a constant diameter in a proximal section extending distally of the proximal end 42; in an intermediate section, the diameter of the piloting element 29 increases to a maximum point at a distal end of the intermediate section; and in a distal section, the outer diameter of the piloting element 29 decreases to a diameter at the distal end 44 less than the constant diameter at the proximal end. In some embodiments, the outer diameter of the piloting element 29 may decrease to a diameter less than the outer diameter of the drive shaft. In the embodiments shown in FIGS. 2-9, the piloting element 29 is symmetrical about a central axis. In other embodiments, the piloting element 29 is asymmetrical about the central axis, such that the piloting element 29 has an orbital path, which may or may not be different than the orbital path of the abrading element 28.
- the piloting element 29 may have an abrasive coating disposed on some or all of the outer surface 46 of the piloting element 29.
- the abrasive coating may be disposed in discrete areas in a desired pattern.
- the piloting element 29 has a cutting feature on the outer surface 46.
- the piloting element 29 has an impact feature on the outer surface 46.
- the piloting element 29 has a thread-like cutting feature disposed about the outer surface 46.
- the piloting element 29 is shaped like an auger drill bit with a helical screw blade.
- the piloting element 29 can also be used for creating a piloting lumen through the stenosis or for creating a cavity extending distally from the piloting hole into the stenosis. For instance, in a non-limiting exemplary embodiment, this can be accomplished by continuing to advance the piloting element 29 distally through the stenosis after the piloting hole is drilled. The piloting lumen can be thus created by the atherectomy device with or without the abrading element 28.
- the piloting lumen can be created by spacing the abrading element 28 and the piloting element 29 apart by a distance approximately equal to a length of the stenosis.
- a diameter of the piloting lumen can be made greater than the maximum outer diameter of the piloting element 29 by using a piloting tip or bushing having a center of mass offset radially from a rotational axis, using an eccentric piloting element 29, affixing an element having a mass proximal and/or distal of the piloting element 29 so as to induce an eccentric rotational path.
- the abrading element 28 can be used, as described elsewhere, for creating the diameter of the piloting lumen greater than the maximum outer diameter of the piloting element 29. Additional embodiments for configuring and/or using the piloting element 29 for creating a piloting hole in and/or a piloting lumen through a stenosis, as described herein, will become apparent to a person having ordinary skill in the art. All such embodiments are considered as being within the metes and bounds of the instant disclosure as claimed.
- a method for opening a stenosis in a blood vessel having a given diameter comprising: providing a guide wire having a maximum diameter less than the diameter of the artery; advancing the guide wire into a blood vessel to a position proximal to the stenosis;
- a flexible elongated, rotatable drive shaft advanceable over a guide wire the guide wire having a maximum diameter less than the diameter of the artery;
- the drive shaft having a rotational axis;
- the drive shaft having at least one eccentric abrading element 28 and a piloting element 29 fixedly attached to the drive shaft; advancing the piloting element 29 into the artery to a position proximal to the stenosis; creating a piloting hole by rotating the drive shaft at a sufficient rotational speed; advancing the abrading element 28 through the piloting hole, rotating the drive shaft at the rotational speed, and moving the across the stenotic lesion, thereby opening the stenotic lesion to a diameter larger than the nominal diameter of the eccentric enlarged diameter section.
- FIGS. 11 and 12 respectively, illustrate non-limiting exemplary embodiments of rotational atherectomy devices 100 and 150 with the guide wire 15 retracted.
- Devices 100 and 150 are substantially similar to the non-limiting exemplary rotational atherectomy devices described elsewhere with reference to FIGS. 1 and 10.
- One difference between devices 100 and 150, and the devices of FIGS. 1 and 10 is the draft shaft.
- the drive shaft 20 in the devices of FIGS. 1 and 10 is substantially straight throughout its longitudinal extent
- devices 100 and 150 respectively, include drive shafts 102 and 152 having a pre-curved or pre-bent distal section 104.
- the piloting element 29 is fixedly attached to the pre-bent distal section 104 in the manner described elsewhere with reference to FIGS.
- device 100 includes the abrading element 28 fixedly attached to the substantially straight section of the drive shaft 102 proximal of the pre-bent distal section 104 in the manner described elsewhere with reference to FIGS. 1-10.
- device 150 does not include the abrading element 28.
- device 100 is configured such that the guide wire 15 can be used for straightening the pre-bent distal section 104, or for permitting the distal section 104 to bend to its pre-bent profile.
- the distal section 104 can be straightened when the guide wire 15 traverses or extends through the distal section 104.
- the distal section 104 returns to its pre-bent profile when the guide wire 15 is retracted proximally such that no portion of the guide wire 15 traverses or extends through the distal section 104.
- the piloting element 29, which is fixedly attached to the distal section 104 will also straighten and bend with the distal section 104.
- device 100 may be configured with the distal section 104 (and the piloting element 29) having two distinct or discrete positions, viz., a substantially straight position and a maximally bent position such as illustrated in FIGS. 13-16.
- the distal section 104 may remain substantially straight while any portion of the guide wire 15 traverses or extends therethrough. Then, when a distal end of the guide wire 15 is retracted proximally out of the distal section 104, the distal section 104 becomes fully bent when no portion of the guide wire 15 traverses or extends through the distal section 104 as illustrated in FIGS. 13-16.
- the entire distal section 104 becomes substantially straight as illustrated in FIGS. 2, 3, 6 and 7.
- the guide wire 15 does not have to extend or traverse the entire distal section 104 for straightening it.
- device 100 may be configured with the distal section 104 having a continuously varying bent profile dictated by the extent or length of the guide wire 15 within the distal section 104.
- the distal section 104 having a continuously varying bent profile dictated by the extent or length of the guide wire 15 within the distal section 104.
- the distal section 104 may remain substantially straight while the guide wire 15 traverses or extends through the entirety of the distal section 104. Then, as the distal end of the guide wire 15 is retracted proximally through the distal section 104, at least that portion of the distal section 104 distal of the distal end of the guide wire 15 starts bending and reaches its maximum pre-bent profile when no portion of the guide wire 15 traverses or extends through the distal section 104 as illustrated in FIGS. 13-16.
- the proximal portion of the distal section 104 traversed by the guide wire 15 proximal of the guide wire's distal end will become substantially straight while the distal portion of the distal section 104 distal of the distal end of the guide wire 15 will be bent.
- the entire distal section 104 will become substantially straight, as in the exemplary embodiments illustrated in FIGS. 2, 3, 6 and 7, when the guide wire 15 traverses or extends through the entire distal section 104.
- the drive shaft 102/152 extends within the lumen of the catheter 13 and is delivered over the guide wire 15 to the location of the stenosis. Furthermore, the drive shaft 102/152 is configured for rotating about the guide wire 15 extending therethrough. Accordingly, a rotational axis 1 10 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 will be substantially coincident with each other. With comparative reference to FIGS. 2, 3, 6 and 7 and FIGS. 13-16, it is seen that when a distal end 1 12 of the guide wire 15 is retracted
- the distal section 104 is maximally bent to its default pre- bent profile as illustrated in FIGS. 13-16.
- the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 will remain substantially coincident with each other.
- the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 remain substantially coincident with each other.
- the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 remain substantially coincident with each other irrespective of whether or not the guide wire 15, or any portion thereof, traverses or extends through the distal section 104 and irrespective of the profile of the distal section 104.
- the terms “rotational axis 110 of the drive shaft 102/152" and “longitudinal axis of the guide wire 15" may be used interchangeably, and are both referenced by the numeral 110.
- the distal section 104 is maximally bent to its default pre-bent profile, i.e., when no portion of the guide wire 15 traverses or extends through the distal section 104, a distance 106 at the distal end 44 of the piloting element 29 between a longitudinal axis 108 of the distal section 104 and the rotational axis 110 of the drive shaft 102/152 will be a maximum.
- piloting element 29, and its distal end 44 in particular, be maximally offset or spaced away from the rotational axis 110 of the drive shaft and the substantially coincident longitudinal axis of the guide wire 15.
- the piloting element 29 when the drive shaft 102/152 rotates about its rotational axis 1 10, the piloting element 29, being spaced away from the rotational axis 110, will have an orbital path which will also be offset or spaced away from the rotational axis 1 10 of the drive shaft 102/152.
- the diameter of the orbital path i.e., the distance between the orbital path and the rotational axis 110, will be approximately the same as or slightly larger than the distance 106.
- the "slightly larger" diameter may be approximately equal to the sum of the distance 106 and the maximum distance between the outer surface 46 and the longitudinal axis 108 of the distal section 104.
- the diameter of the orbital path i.e., the distance between the orbital path and the rotational axis 1 10
- the eccentricity of the piloting element 29 will be a function of the eccentricity of the piloting element 29 and/or the location of the center of mass and/or the geometrical center.
- the distance 106 will depend on the default pre-bent profile of the distal section 104. In another non-limiting exemplary embodiment, the distance 106 can be customized and/or changed prior to using the device 100. For instance, the device 100 may be manufactured and supplied with a substantially straight distal section 104 or with the distal section 104 having a default pre-set bent profile, and the distal section 104 can be bent to a default pre-bent profile as desired by the user. In a non-limiting exemplary
- a shape-memory material may be used at least in that section or location of the drive shaft 102/152 where the bend will be made.
- the distal section 104 will be substantially straight and substantially aligned with the drive shaft 102/152 proximal of the distal section 104.
- the longitudinal axis 108 of the distal section 104 and the rotational axis 110 of the drive shaft 102/152 will be substantially coincident with each other, and the distance 106 will be negligibly small.
- the orbital path and/or the diameter of the orbital path of the piloting element 29 will be a function of one or more factors pertaining to the piloting element 29, including the eccentricity or concentricity of the piloting element 29, the location of the center of mass and/or the geometrical center of the piloting element 28, the shape of the piloting element 29, the presence or absence of the abrading element 28, etc.
- the orbital path and/or the diameter of the orbital path of the piloting element will also be a function of one or more factors pertaining to the abrading element 28, including the eccentricity or concentricity of the abrading element 28, the location of the center of mass and/or the geometrical center of the abrading element 28, the shape of the abrading element 28, etc.
- the fully bent, partially bent or straight profile of the distal section 104 may be affected by retracting or extracting the distal section 104 into or out of the catheter 13. For instance, if no portion of the guide wire 15 traverses or extends through the distal section 104 and/or if the guide wire 15 extending through or at least into a portion of the distal section 104 is sufficiently flexible, then the catheter 13 may be used for fully or partially straightening the pre-bent distal section 104 by retracting the entire or a portion of the distal section 104 proximally into the lumen of the catheter 13 through which the drive shaft 102/152 extends.
- FIGS. 17 and 18, respectively, are a perspective view and a side view of the distal section 104, i.e., the piloting element, illustrated with the flexible drive shaft 15 extending into at least a portion thereof; and FIGS. 19 and 20, respectively, are a perspective view and a side view of the distal section 104, i.e., the piloting element, illustrated with the flexible drive shaft 15 extending therethrough.
- the catheter 13 may be used for affecting the profile (i.e., bent, straight, and/or partially bent/straight) while the guide wire 15 traverses or extends through the entire distal section 104 or through at least a portion of the distal section 104.
- such embodiments do not require the guide wire 15 to be completely retracted out of the distal section 104 before retracting or extracting the distal section 104 into or out of the catheter 13.
- the guide wire 15 must be completely retracted out of the distal section 104 before retracting or extracting the distal section 104 into or out of the catheter 13.
- the guide wire 15 must be completely extracted out of the distal section 104 before the catheter 13 may be used for affecting the profile (i.e., bent, straight, and/or partially
- the guide wire 15 may be highly flexible. In certain embodiments, the guide wire 15 may be sufficiently stiff such that it bends or straightens out with the distal section 104 while at the same time being sufficiently flexible for traversing the vasculature.
- the distance 106 will increase or decrease as determined by the extent of the guide wire 15 traversing or extending through the distal section 104. For instance, the distance 106 will increase as the distal end of the guide wire 15 is retracted proximally through the distal section 104, and the distance 106 will decrease as the distal end of the guide wire 15 is extended distally through the distal section 104.
- the distance 106 will be a maximum when the distal section 104 is devoid of any portion of the guide wire 15, i.e., when the distal end of the guide wire 15 has been retracted proximal of the distal section 104.
- the entire drive shaft 102/152 including the pre-bent distal section 104 having the piloting element 29, will be substantially straight, and the rotational axis 1 10 of the drive shaft 102/152, including the pre-bent distal section 104 having the piloting element 29, and the longitudinal axis of the guide wire 15 will be substantially coincident with each other.
- the entirety of the substantially straight drive shaft 102/152 will rotate about the longitudinal axis of the guide wire 15, and the piloting element 29 will have an orbital path as described elsewhere with reference to FIGS. 1 and 10.
- the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 will be substantially coincident with each other.
- the piloting element 29 affixed on the bent distal section 104 will be radially offset or spaced apart from the substantially coincident rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15.
- the piloting element 29 when the drive shaft 102/152 rotates about its rotational axis 110, i.e., about the longitudinal axis of the guide wire 15, the piloting element 29 will have an orbital path that is radially spaced away or offset from the rotational axis 1 10 of the drive shaft 102/152, and the diameter of the orbital path traversed by the piloting element 29 on the bent distal section 104 will be larger than the diameter of the orbital path traversed by the piloting element 29 on a substantially straight, i.e., unbent, distal section 104. In a non-limiting exemplary embodiment, the diameter of the orbital path will be substantially the same as the distance 106.
- the diameters of the orbital paths of the abrading element 28 and the piloting element 29 are substantially the same. In certain embodiments, the orbital paths of the abrading element 28 and the piloting element 29 have different diameters. In some embodiments, the center of mass and/or the geometrical center of the abrading element 28 and of the piloting element 29 are substantially co-linear or not co- linear or substantially co-planar or not co-planar with each other. In certain embodiments, the center of mass and/or the geometrical center of the abrading element 28 and of the piloting element 29 are angularly offset from each other. For instance, the angular offset of the centers may range from 0° to 360° relative to one another.
- the rotational atherectomy device(s) includes a proximal and/or distal counter-weight for either one or both of the abrading element 28 and the piloting element 29.
- a proximal and/or distal counter-weight for either one or both of the abrading element 28 and the piloting element 29 includes a proximal and/or distal counter-weight for either one or both of the abrading element 28 and the piloting element 29.
- Non-limiting exemplary embodiments of one or more counterweights are disclosed in co-owned US Patent No. 8,348,965, which is incorporated herein by reference in its entirety. While only counter- weights for or associated or coupled with an abrading element are illustrated and described in US Patent No. 8,348,965, similar or different counter-weights for or associated or coupled with a piloting element are contemplated and are therefore considered as being within the metes and bounds of the instant disclosure.
- one or more counter-weights are included as distinct or discrete components or elements separate from their respective or corresponding abrading element 28 and/or piloting element 29. As such, the one or more counter-weights may be fixedly attached to or otherwise disposed on the drive shaft either proximate to or spaced away from the abrading element 28 and/or the piloting element 29. In some embodiments, one or more counter-weights are integral with or otherwise disposed on their respective or corresponding abrading element 28 and/or piloting element 29. In certain embodiments, any two or more counter-weights may be substantially co-linear or not co-linear or substantially co-planar or not co-planar with each other.
- any two-or more counter- weights may be angularly offset from each other at angle(s) ranging between 0° and 360° relative to one another.
- piloting elements may be affixed to or otherwise disposed on a pre-bent or a straight, i.e., not pre-bent, distal section or distal tip or end of the drive shaft. All such embodiments, including modifications thereof, are considered as being within the metes and bounds of the instant disclosure.
- ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT disclose a variety of techniques for fixedly forming or adapting the pre-bent distal section 104.
- a unique heat setting method is used with conventional metal such as stainless steel.
- the method for forming the pre-curved distal section 104 starts with using a coil winder to wind the drive shaft, and then heating the entire length of the wound drive shaft at a pre-determined temperature for a pre-determined duration of time for relaxing and stabilizing the coil dimensions.
- a mandrel shaped in the desired curved drive shaft form is inserted into the lumen at the distal end of the straight (and pre-relaxed) drive shaft.
- the distal section of the drive shaft is forced to take on the shape of the mandrel.
- a local heat treatment at a pre-determined temperature for a pre-determined duration of time is performed on the curved portion of the drive shaft.
- the mandrel is removed and the curved shape is retained by the drive shaft thus forming the pre-bent or pre-curved distal section 104.
- Other mechanisms and methods for forming the pre-curved distal section 104 may include using shape memory alloy materials.
- shape memory alloy materials such as Nitinol, which exhibits super-elastic properties and increased flexibility is used. Additional non-limiting examples of super-elastic metal alloys that are usable for forming the pre-bent or pre-curved distal section 104 are described in detail in U.S. Pat. No. 4,665,906. The disclosure of U.S. Pat. No.
- 4,665,906 is herein expressly incorporated by reference insofar as it describes the compositions, properties, chemistries, and behavior of specific metal alloys which are superelastic within the temperature range at which the pre-curved distal section 104 of the drive shaft 102/152 operates. Any and all such superelastic metal alloys may be used to form the pre-curved section 104 of the drive shaft 102/152.
- drive shafts 102/152 having the pre-curved distal section 104 Prior to insertion into the vasculature, drive shafts 102/152 having the pre-curved distal section 104 are provided in the pre-curved configuration.
- the pre-curved distal section 104 is then mechanically "deformed” to a generally linear and/or straight configuration and profile by inserting a substantially linear guide wire 15 into the drive shaft lumen and through the distal section 104.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/567,360 US20150094749A1 (en) | 2013-03-14 | 2014-12-11 | Devices, systems and methods for a piloting tip bushing for rotational atherectomy |
PCT/US2015/064462 WO2016094386A1 (en) | 2014-12-11 | 2015-12-08 | Devices, systems and methods for a piloting tip bushing for rotational atherectomy |
Publications (2)
Publication Number | Publication Date |
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EP3229710A1 true EP3229710A1 (en) | 2017-10-18 |
EP3229710A4 EP3229710A4 (en) | 2018-08-08 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP15868573.5A Withdrawn EP3229710A4 (en) | 2014-12-11 | 2015-12-08 | Devices, systems and methods for a piloting tip bushing for rotational atherectomy |
Country Status (6)
Country | Link |
---|---|
EP (1) | EP3229710A4 (en) |
JP (1) | JP2017536944A (en) |
CN (1) | CN106999194A (en) |
AU (1) | AU2015360745A1 (en) |
CA (1) | CA2969876A1 (en) |
WO (1) | WO2016094386A1 (en) |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030216761A1 (en) * | 1990-03-27 | 2003-11-20 | Samuel Shiber | Guidewire system |
US5843103A (en) * | 1997-03-06 | 1998-12-01 | Scimed Life Systems, Inc. | Shaped wire rotational atherectomy device |
US6001112A (en) * | 1998-04-10 | 1999-12-14 | Endicor Medical, Inc. | Rotational atherectomy device |
WO2003043685A2 (en) * | 2001-11-19 | 2003-05-30 | Cardiovascular Systems, Inc | High torque, low profile intravascular guidewire system |
GB2426456B (en) * | 2005-05-26 | 2010-10-27 | Leonid Shturman | Rotational device with eccentric abrasive element and method of use |
US8628549B2 (en) * | 2006-06-30 | 2014-01-14 | Atheromed, Inc. | Atherectomy devices, systems, and methods |
US8551128B2 (en) * | 2007-12-06 | 2013-10-08 | Cardiovascular Systems, Inc. | Rotational atherectomy device with pre-curved drive shaft |
US8177801B2 (en) * | 2008-04-18 | 2012-05-15 | Cardiovascular Systems, Inc. | Method and apparatus for increasing rotational amplitude of abrasive element on high-speed rotational atherectomy device |
US9101387B2 (en) * | 2008-06-05 | 2015-08-11 | Cardiovascular Systems, Inc. | Directional rotational atherectomy device with offset spinning abrasive element |
EP2744424B1 (en) * | 2011-08-17 | 2017-11-08 | Samuel Shiber | Adaptive rotary catheter for opening obstructed bodily vessels |
US9289230B2 (en) * | 2012-09-17 | 2016-03-22 | Cardiovascular Systems, Inc. | Rotational atherectomy device with a system of eccentric abrading heads |
US20140316447A1 (en) * | 2013-03-14 | 2014-10-23 | Cardiovascular Systems, Inc. | Devices, systems and methods for a piloting tip bushing for rotational atherectomy |
-
2015
- 2015-12-08 CA CA2969876A patent/CA2969876A1/en not_active Abandoned
- 2015-12-08 WO PCT/US2015/064462 patent/WO2016094386A1/en active Application Filing
- 2015-12-08 JP JP2017531272A patent/JP2017536944A/en active Pending
- 2015-12-08 CN CN201580067778.7A patent/CN106999194A/en active Pending
- 2015-12-08 AU AU2015360745A patent/AU2015360745A1/en not_active Abandoned
- 2015-12-08 EP EP15868573.5A patent/EP3229710A4/en not_active Withdrawn
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WO2016094386A1 (en) | 2016-06-16 |
JP2017536944A (en) | 2017-12-14 |
AU2015360745A1 (en) | 2017-06-15 |
CA2969876A1 (en) | 2016-06-16 |
EP3229710A4 (en) | 2018-08-08 |
CN106999194A (en) | 2017-08-01 |
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