Patent Grant
10548478
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
A significant body of scientific and clinical evidence supports atherectomy as a viable primary or adjunctive therapy prior to stenting for the treatment of occlusive arterial disease.
Atherectomy offers a simple mechanical advantage over alternative therapies. By removing the majority of plaque mass (debulking), it creates a larger initial lumen and dramatically increases the compliance of the arterial wall. As a result, stent deployment is greatly enhanced.
Additionally, atherectomy provides several advantages related to the arterial healing response. When circumferential radial forces are applied to the vasculature, as in the case of angioplasty or stenting, the plaque mass is displaced, forcing the vessel wall to stretch dramatically. This stretch injury is a known stimulus for the cellular in-growth that leads to restenosis. By using atherectomy to remove the disease with minimal force applied to the vessel, large gains in lumen size can be created with decreased vessel wall injury and limited elastic recoiling. These effects have been shown to generate better acute results and lower restenosis rates.
Despite its advantages, atherectomy is not commonly performed due to the cost, complexity and limited applicability of available atherectomy devices. Many designs are unable to treat the wide range of disease states present in long complex lesions; luminal gain is often limited by the requirement of the physician to introduce multiple devices with increased crossing profiles; tissue collection is either unpredictable or considered unnecessary based on assumptions regarding small particle size and volumes; and optimal debulking is either not possible due to a lack of intravascular visualization or requires very long procedure times. Based on these limitations, current devices are likely to perform poorly in the coronary vasculature where safety and efficacy in de novo lesions, ostials, and bifurcations continue to pose great challenges.
In the past, atherectomy devices have focused on macerating or emulsifying the atherosclerotic plaque such that either it might be considered clinically insignificant enough to remain in the blood stream or that it can be aspirated proximally through small spaces in the catheter main body. When the plaque is not aspirated through the catheter to an external reservoir, the reliability of these devices to produce clinically insignificant embolization has been challenged. Aspiration necessitates that a vacuum be applied to a lumen or annular space within the catheter to remove emulsified tissue. In early clinical evaluations of aspiration, the presence of negative pressure at the distal working assembly caused the artery to collapse around the cutting element. This effect results in more aggressive treatment, dissections and/or perforations. In addition, options for post-procedural analysis of any removed disease are extremely limited or impossible using this methodology.
Other atherectomy devices include directional atherectomy devices, which use cup-shaped cutters that cut and “turn” the tissue distally into a storage reservoir in the distal tip of the device. This approach preserves the “as cut” nature of the plaque, but requires large distal collection elements. These large distal tip assemblies can limit the capability of the system to access small lesions and may cause additional trauma to the vessel.
Currently available atherectomy devices also do not include, and are poorly adapted for use with, real time image guidance. Although intravascular diagnostic devices have consistently shown lesions that are significantly eccentric, the typical practice of physicians is to treat target lesions as if they contain concentric disease. This circumferential treatment approach virtually ensures that potentially native arterial wall and healthy vessel will be cut from the vasculature.
Further, several design challenges are presented by a single use, disposable, and single-direction imaging catheter, such as an atherectomy catheter. For example, obtaining a clear image can be difficult, as nonuniform rotational distortion (“NURD”) can occur in the image as a result of the cutter vibrating or stalling as it encounters different types of tissue. Moreover, the imaging fiber, which runs from the static light source to the rotating distal tip, can become wound up as the catheter is in active (cutting) mode. Further, a motor can be required to drive the imaging assembly at the appropriate revolution rates for imaging, thereby significantly increasing the cost and complexity of the catheter.
Atherectomy catheter devices, systems and methods that may address some of these concerns are described and illustrated below.
SUMMARY OF THE DISCLOSURE
Described herein are atherectomy catheters with on-board imaging, systems including the atherectomy catheters, and methods of using the atherectomy catheters and systems.
In general, in one embodiment, an atherectomy catheter includes an elongate flexible catheter body, a cutter near the distal end of the catheter body, a drive shaft connected to the cutter and extending within the catheter body, an imaging element near the distal end of the catheter body and an imaging shaft connected to the imaging element and extending within the catheter body. The cutter and the imaging element are mechanically isolated, and the drive shaft is configured to be axially translated relative to the imaging shaft and the catheter body.
This and other embodiments can include one or more of the following features. The drive shaft and imaging shaft can be decoupled along the length of the catheter body. The drive shaft and imaging shaft can be coupled at a proximal end of the device. The atherectomy catheter can include a handle configured to transmit torque simultaneously to the proximal end of the drive shaft and the imaging shaft, and the drive shaft and imaging shaft can be coupled within the handle. The handle can include a translation mechanism configured to translate the drive shaft without translating the imaging shaft. The atherectomy catheter can include an inflatable element configured to urge the cutter against a vessel wall. The atherectomy catheter can include an elongate distal tip connected to the catheter body, and the elongate distal tip can include a cutting window therein, the cutting window sized and dimensioned so as to cause tissue to invaginate within the cutting window. The imaging element can include an optical fiber, and the optical fiber can be coupled to the imaging shaft only at a distal end of the imaging shaft. The imaging element can include an optical coherence tomography imaging element. The drive shaft and imaging shaft can be concentric, and the drive shaft can extend within the imaging shaft. The drive shaft and the imaging shaft both can extend substantially along a central axis of the catheter body. The imaging element can include an optical fiber, and the optical fiber can extend off-axis along the length of the catheter body. The optical fiber can be configured to rotate within the imaging shaft without wrapping around the drive shaft. The drive shaft and imaging shaft can be parallel. The imaging shaft can extend off-axis relative to the elongate body. The drive shaft can extend on-axis relative to the elongate body. The atherectomy catheter can include a handle configured to transmit torque simultaneously to the proximal end of the drive shaft and the imaging shaft. The handle further can include a rotation knob configured to allow rotation of the elongate body up to three rotations. The knob can include a rotation limiter, the rotation limiter can be configured to allow rotation of up to a set amount between one and three rotations while not lengthening the elongate body. The drive shaft and imaging shaft can be concentric, and the imaging shaft can extend within the drive shaft. A distal end of the drive shaft can include a clear annular portion connected to the cutter. The imaging element can be configured to be axially aligned with the clear annular portion for imaging. The clear annular portion can include sapphire, polycarbonate, glass, or acrylic.
In general, in one embodiment, an atherectomy catheter includes an elongate flexible catheter body. The atherectomy catheter includes a drive shaft extending within the catheter body, the drive shaft having a cutter attached thereto. The atherectomy catheter includes an elongate distal tip connected to the catheter body at a hinge point. The atherectomy catheter includes an inflatable body linked to the elongate flexible catheter body and to the elongate distal tip such that inflation of the inflatable body axially deflects the elongate distal tip away from the elongate flexible catheter body at the hinge point to expose the cutter. The inflatable body is linked to the elongated flexible catheter body and the elongated distal tip with a sling extending along an outer surface of the balloon and attached to the elongated flexible catheter body and the elongate distal tip.
This and other embodiments can include one or more of the following features. The atherectomy catheter can include a biasing mechanism configured to return the elongate distal tip to a position approximately axially aligned with the catheter body. The biasing mechanism can include a wedge activated by placing axial force on the drive shaft. The elongate distal tip can include a cutting window therein, and the cutting window can have an asymmetric shape configured to prevent the cutter from hitting a distal edge of the cutting window. The atherectomy catheter can include an imaging element attached to the cutter and configured to rotate therewith. The imaging element can be an optical coherence tomography imaging element. The imaging element can include an optical fiber, and the optical fiber can extend through the drive shaft substantially on-axis with the catheter body.
In general, in one embodiment, an atherectomy assembly includes an elongate flexible catheter body. The atherectomy assembly includes a drive shaft extending within the catheter body. The drive shaft has a rotatable cutter attached thereto and is axially movable with respect to the elongate flexible catheter body. The atherectomy assembly includes an optical fiber attached to the cutter and configured to rotate therewith. The atherectomy assembly includes a handle having a distal end attached to the elongate body and a proximal end configured to connect the optical fiber to a light source. The handle is configured such the optical fiber is axially movable with respect to the distal end and axially fixed with respect to the proximal end.
This and other embodiments can include one or more of the following features. The handle can include a tube within which the optical fiber can reside. The optical fiber can be configured to wind within the tube. The tube can be shaped as a ring, and the optical fiber can be configured to conform to an outer perimeter of the tube when in a compressed configuration and to conform to an inner perimeter of the tube when in an extended configuration. The optical fiber can be configured to transmit an optical coherence tomography signal.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
Described herein are atherectomy catheters. In general, the atherectomy catheters can include a rotatable cutter connected to a drive shaft. Further, the atherectomy catheters can include on-board imaging, such as optical coherence tomography (OCT) imaging. The atherectomy catheters can include a distal housing (nosecone) configured to hold excised tissue. The drive shaft can be moved distally to pack the excised tissue into the nosecone.
In some embodiments, the atherectomy devices described herein can include an inflatable element configured to urge the cutter against the vessel wall. In some embodiments, the inflatable element can activate a hinge mechanism to hinge the nosecone off-axis with the catheter body, thereby exposing the cutter. In such embodiments, a biasing mechanism, such as a wedge, can optionally be used to realign the nosecone and the catheter body. In other embodiments, the inflatable element can urge the cutter against the vessel wall without a separate hinge mechanism. In such embodiments, the cutting window in the catheter can be sized so as to allow the tissue to invaginate within the cutting window and be excised by the rotatable cutter.
In some embodiments, the atherectomy devices described herein can be configured such that the imaging element and the cutter are driven by the same shaft. In other embodiments, there can be a separate imaging shaft and a separate drive shaft to separately control the distal rotation of the imaging element and the cutter, thereby advantageously reducing or eliminating nonuniform rotational distortion (NURD) in the resulting image. In such embodiments, the imaging and drive shafts can be driven by the same rotational mechanism at the proximal end. In such embodiments, the drive shaft and cutter can further advantageously be translated axially without requiring translation of the imaging shaft and imaging element.
Handles are also described herein for use with atherectomy devices. In some embodiments, the handle is configured to rotate an imaging shaft and a drive shaft concurrently while providing axial translation of only the drive shaft. In other embodiments, the handle is configured to provide axial movement of an optical fiber (with a drive shaft) at a distal end of the handle but not the proximal end of the handle.
In one embodiment, referring to
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The outer shaft 111 (or a housing connecting the outer shaft 111 to the nosecone 105) can include an imaging window 907 through which the imaging element 292 can be exposed. The imaging window 907 can extend 360 degrees around the circumference of the outer shaft 111, but can include structural struts 917 extending thereacross to both provide structural support and act as imaging markers. The imaging window 907 can further be used as a flush port to allow flush fluid to be delivered through the outer shaft 111 and to the area of imaging, thereby improving image quality. In some embodiments, flush fluid can extend through fluid ports 191 in the outer shaft 111.
The optical fiber 297 can run within the imaging shaft 922 to provide the imaging (e.g., OCT) signal. As shown in
As shown in
As shown in
The catheter 100 can further include a mechanism for packing tissue into the nosecone 105, such as by moving the drive shaft 113 and cutter 103 axially such that tissue can be urged by the distal surface of the cutter 103. Advantageously, the drive shaft 113 can be moved axially without movement of the imaging shaft 922, thereby allowing for packing of the tissue without disrupting the imaging.
Advantageously, by having an imaging shaft that is separate or decoupled from the drive shaft at their respective distal ends, the rotation of the cutter and the optical fiber can be mechanically isolated from one another (i.e., such that a mechanical action or reaction of one does not affect the other). For example, if the cutter stalls during rotation, such as when it hits a hard piece of tissue, the mechanically isolated imaging element can remain unaffected and continue rotating at the same constant speed. Such continuous rotation of the imaging element reduces or eliminates rotational distortion, such as nonuniform rotational distortion (NURD), thereby improving imaging quality.
Further, by having separate imaging and drive shafts, the drive shaft can advantageously be used to pack tissue while maintaining the imaging element in the same location, thereby ensuring that the imaging location is constant and well known. Moreover, by having separate imaging and drive shafts, the fluid flush can be delivered close to the imaging element even when the drive shaft is moved distally to pack tissue.
Further, by using the balloon 115 of catheter 100 to urge the cutter against the vessel wall and by having an optimally designed cutting window, tissue can be pressed into the cutting window and cut, thereby improving cutting quality without requiring an articulation mechanism in the catheter. Further, the balloon 115 can advantageously act as an occlusion element to restrict blood flow to the imaging element 292, thereby reducing the amount of saline flush required to obtain a clear image and improving image quality.
As noted above, in some embodiments, the drive shaft 113 and imaging shaft 922 can be unconnected at the distal end of the catheter to allow for separate imaging and cutting but connected at the proximal end of the catheter so that they can be rotated from the same source, such as the same drive system. Although the shafts can be connected at the proximal end of the cutter, rotational distortion can still be avoided because the rotating motor can be strong enough to spin at the same speed regardless of the resistance to rotation placed on the cutter at the distal end. Accordingly, even if the drive shaft slows down due to stalling, the imaging shaft can continue to rotate at the same constant input speed.
Referring to
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As shown in
Handle 200 advantageously provides for rotation of the concentric imaging and drive shafts while allowing for axial movement of the drive shaft and not the imaging shaft or imaging fiber. The handle 200 can further advantageously be configured such that the optical fiber does not have to undergo any steep bends therein, thereby making the fiber more robust.
In some embodiments, rotation of the drive shaft and imaging shaft can be decoupled by, for example, using magnets in the handle to couple the input rotation with the drive shaft rotation. In such a configuration, the internal drive shaft can be rotated at a speed different than the imaging shaft without interrupting the rotation of the optical fiber. Rotating the imaging shaft at a different speed, or without, the drive shaft can advantageously allow for imaging with cutting and/or rotating at different speeds that are individually optimized for imaging and cutting.
Although described as being used with catheter 100, it is to be understood that the handle 200 and/or elements of the handle could be used with a variety of different catheters while still providing separate rotation of concentric imaging and drive shafts and/or axial movement of one or more shafts without axial movement of another.
Referring to
Referring still to
As noted above, the drive shaft 1313 can include a clear annular portion 1395 at the distal end thereof. The clear annular portion 1395 can advantageously keep blood away from the exit path of the OCT light beam while providing a window for the light beam to travel through. The clear annular portion 1395 can include an optically transparent material, such as sapphire, polycarbonate, glass, or acrylic. In some embodiments, material used for the clear annular portion 1395 can be substantially free of micro-defects that can cause light therein to scatter, as such scattering of light can reduce the amount of light transmitted to and from the tissue and reduce image quality. In some embodiments, the materials used for the clear annular portion 1395 can have a flat response between 1260 nm and 1380 nm, i.e., the optical transmission can be relative constant between the used wavelength. Having a flat response advantageously ensures that there is no interference with OCT signals, improving image quality.
In some embodiments, the refractive index of the clear annular portion 1395 can be similar to the refractive index of the glue in which the distal end of the optical fiber is embedded. For example, the refractive index of polycarbonate is low, such as between 1.584 and 1.586, which in some embodiments can be comparable to the refractive index of the glue attached to the fiber, such as Masterbond EP42HT-2, EpoTek OG127-4 or OG116, produced by Epoxy Technology and UV curable photonics adhesive OP-4-20658. Using a clear annular portion 1395 having a refractive index that is similar to the glue in which the distal end of the optical fiber is embedded advantageously reduces the back-reflection at the glue/annular portion interface, thereby increasing image quality. As another example, the refractive index of sapphire is high, such as about 1.78, which can result in a higher back-reflection of a glue with a low refractive index (such as those described above) is used (a higher mismatch between the refractive indices results in higher back-reflection). Accordingly, a glue with a higher mismatch can be used, such as NOA 1625 from Norland Optical adhesives.
In other embodiments, rather than matching the refractive indices of the glue and the clear annular portion 1395, the housing geometry could be modified such that the light beam hits the clear annular portion 1395 at an angle so that very little or none of the reflective light can be coupled back into the fiber. In other words, the mirror, glue, fiber, the clear optical portion can be configured such that the angle of incidence of light to the interface medium between the glue and the clear annular portion is close to the polarization angle (also called the Brewster's angle) wherein all of the light is transmitted with minimal reflection.
When the clear annular portion 1395 is used, the focal length of the OCT light beam can be extended to compensate for the additional material through which the light has to travel. To do so, the beam diameter at the waste can be increased or a fiber or GRIN fiber with a larger diameter can be used.
A cutter 1303, such as an annular cutter, can be attached to the clear annular portion 1395 of the drive shaft 1313. In some embodiments, the cutter can be carved out of the clear annular portion 1395. For example, if the material for the clear annular portion 1395 is strong, such as sapphire, then the cutter 1303 and clear annular portion 1395 can be made of the same piece. Having the cutter 1303 and clear annular portion 1395 be made of the same piece can advantageously allow the images to be generated from a location very close to the cutter 1303, helping to achieve more precise cutting.
Further, similar to the catheter 100, the catheter 1300 can include a nosecone 1305 extending from the distal end of the catheter body around the cutter 1303 to store tissue removed by the cutter 1303. The nosecone 1305 includes a cutting window 1307 therein configured to expose a portion of the cutter 1303. Similar to catheter 100, the catheter 1300 can further includes an inflatable element, such as a balloon, configured to urge the cutter 1303 against the side of a vessel (and can include a corresponding optimized cutting window 1307 for cutting tissue as described with respect to catheter 100).
The rotation of the imaging shaft 1322 and the drive shaft 1313 can be decoupled from one another at the distal end of the device, thereby providing for separate rotation of the cutter 1303 and the imaging element 1392. As described below, in some embodiments, the rotation of the imaging shaft 1322 and the drive shaft 1313 can be coupled at the proximal end (such as in the handle so as to be driven by the same motor) while remaining decoupled along the length of the catheter. In some embodiments, a separating layer 1384, such as a polyimide layer, can be placed between the drive shaft 1313 and the imaging shaft 1322. The separating layer 1374 can advantageously be used to prevent the transfer of energy between the drive shaft 1313 and the imaging shaft 1322 (for example, such that if the drive shaft 1313 gets bogged down while cutting, the chances of it affecting the imaging shaft 1322 will be reduced).
The catheter 1300 can include a mechanism for packing tissue into the nosecone 1305, such as by moving the drive shaft 1313 and cutter 1303 distally as shown in
Similar to catheter 100, by having an imaging shaft that is separate or decoupled from the drive shaft at their respective distal ends, the rotation of the cutter and the optical fiber can be mechanically isolated from one another, imaging quality can be improved due to reduced NURD.
Further, by having separate imaging and drive shafts, the drive shaft can advantageously be used to pack tissue while maintaining the imaging element in the same location, thereby ensuring that the imaging location is constant and well known.
By placing the imaging element within the center of the catheter, the catheter can advantageously be reduced in size (for example, relative to a device where there is an annular space between an inner drive shaft and an outer imaging shaft). The catheter 1300 can thus be, for example, less than 8 French, such as 6-8 French, which can advantageously make the catheter 1300 useable in small diameter vessels, such as coronary vessels. Further, by placing the drive shaft around the imaging shaft, as in catheter 1300, the drive shaft can advantageously be larger and more robust, such as 0.05″ to 0.06.″ In some embodiments, the drive shaft can include a multi-layer coil, which can also advantageously increase the robustness of the drive shaft, thereby providing a cutting system that is more resistant to stalling.
In some embodiments, the drive shaft 1313 and imaging shaft 1322 can be unconnected at the distal end of the catheter to allow for separate imaging and cutting but connected at the proximal end of the catheter so that they can be rotated from the same source, such as the same drive system. Although the shafts can be connected at the proximal end of the cutter, rotational distortion can still be avoided because the rotating motor can be strong enough to spin at the same speed regardless of the torque placed on the cutter at the distal end. Accordingly, even if the drive shaft slows down due to stalling, the imaging shaft can continue to rotate at the same constant speed.
Referring to
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Referring still to
The rotation of the imaging shaft 822 and the drive shaft 313 can be decoupled at the distal end of the device, thereby providing for mechanically isolated rotation of the cutter 303 and the imaging element 492. As described below, in some embodiments, the rotation of the imaging shaft 822 and the drive shaft 313 can be coupled at the proximal end (such as in the handle so as to be driven by the same motor) while remaining decoupled along the length of the catheter. Optionally, as shown in
The outer shaft 311 can include an imaging window 807 through which the imaging element 492 can be exposed. The imaging window 807 can have a width of less than 1 mm while still enabling OCT imaging therethrough. The imaging window 807 can extend 360 degrees around the circumference of the outer shaft 311, but can include structural struts 317 extending thereacross to both provide structural support and act as imaging markers. In some embodiments, the struts 317 can be offset to account for the off-center imaging tip 308, enabling accurate OCT image orientation.
The imaging window 807 can further be used as a flush port to allow flush fluid to be delivered through the imaging shaft 822 and to the area of imaging, thereby improving image quality. Advantageously, by having the fluid pumped directly through the imaging shaft, the dimensions of the imaging window 807 do not need to be extended to enable this type of flushing.
The optical fiber 497 can run through the imaging shaft 822 to provide the imaging (e.g., OCT) signal. The optical fiber 497 can be attached at its distal end to the imaging tip 308. The optical fiber 497 can otherwise be free to float within the imaging shaft 822. As shown in
As shown in
The catheter 300 can further include a mechanism for packing tissue into the nosecone 305. Thus, for example, the cutter 303 can be moved distally by extending the drive shaft 313 distally. Advantageously, the drive shaft 313 can be translated proximally and distally while keeping the imaging shaft 822 (and thus the imaging sensor 492) in place.
Similar to catheters 100 and 1300, by having an imaging shaft that is separate from the drive shaft at least at the proximal ends in catheter 300, rotational distortion, such as NURD, can reduced or eliminated, thereby improving imaging quality. Further, by having separate imaging and drive shafts, the drive shaft can advantageously be used to pack tissue while maintaining the imaging element in the same location, thereby ensuring that the imaging location is constant and well known. Moreover, by having separate imaging and drive shafts, the fluid flush can be delivered close to the imaging element even when the drive shaft is moved distally to pack tissue.
Further, by using the balloon of catheter 300 to urge the cutter against the vessel wall and by having an optimally designed cutting window, tissue can be pulled into the cutting window and cut, thereby improving cutting quality without requiring a hinge mechanism in the catheter. Further, the balloon can advantageously act as an occlusion element to at least partially block blood flow to the imaging element, thereby reducing the amount of saline flush required to obtain a clear image and improving image quality.
In some embodiments, the drive shaft 313 and imaging shaft 822 can be unconnected at the distal end of the catheter to allow for separate imaging and cutting but connected at the proximal end of the catheter so that they can be rotated from the same source, such as the same drive system. Although the shafts can be connected at the proximal end of the cutter, rotational distortion can still be avoided because the rotating motor can be strong enough to spin at the same speed regardless of the torque placed on the catheter at the distal end. Accordingly, even if the drive shaft slows down due to stalling, the imaging shaft will continue to rotate at the same speed.
An exemplary handle 400 for use with catheter 300 is shown in
The handle 400 can be configured such that the drive shaft 313 and the imaging shaft 822 can be rotated separately at the distal end of the catheter but rotated with the same source at the proximal end of the catheter. The handle 400 can further include a mechanism that allows for axial translation of the drive shaft 313 (e.g., to pack tissue with the cutter), but not the imaging shaft 822.
Referring to
As shown in
The handle 400 can further include a handle ring or slide 447 configured to slide along the handle 400 to translate the drive shaft 313 axially, such as to pack tissue by the cutter 303. As shown in
The outer rotation knob 463 can be configured to rotate relative to the rest of the handle 400 to allow the user to torque the outer shaft 311 to orient the distal tip of the catheter 300 in the desired position. The knob 463 can rotate the outer shaft 311 independently of the imaging shaft 822, drive shaft 313, and inflation tube 319. Accordingly, the rotation of the knob can be limited to reduce wrapping or unwanted extension of the shafts/tube. For example, the rotation can be limited to less than 3 full rotations, such as less than 2 full rotations, such as less than 1.5 full rotations in either direction.
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In some embodiments, the handle 400 can include one or more luer ports such that the user can deliver imaging flush and balloon inflation to the distal tip.
Handle 400 advantageously provides for rotation of the parallel imaging and drive shafts while allowing for axial movement of the drive shaft and not the imaging shaft or imaging fiber. Moreover, the handle provides for connection to a drive system at high rotation speeds (such as up to 10,000 rpm), it provides a fluidic seal to enable flushing from the handle to the distal tip, it provides for balloon inflation via air or solution, it allows for independent rotation of the outer shaft, and it allows the balloon lumen to be moved from the outer diameter of the torque shaft to the interior annular space of the torque shaft to increase usability of the device.
Although described as being used with catheter 300, it is to be understood that the handle 400 and/or elements of the handle could be used with a variety of different catheters while still providing separate rotating of concentric imaging and drive shafts and/or axial movement of one or more shafts without axial movement of another.
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As described above, the atherectomy catheter 1100 can include a hinge point 1109 to provide a rotational axis during opening of the nosecone 1105. For example, the hinge point 1109 can be a living hinge or a pin that attaches to either the proximal or distal housings. As shown in
The balloon 1115 can be attached to an inflation tube 1119. As shown in
In use, the balloon 1115 can be inflated, through the inflation tube 1119, with a gas or liquid. As the balloon 1115 inflates, it can apply force to the center of the sling element 1117. The force on the center of the sling element 1117 can push the center away from the central axis 1110 of the catheter body 1101 and cause the attached edges of the sling element 1117 to pull on the distal end of the catheter body 101 and the proximal end of the nosecone 105. The simultaneous pulling on both the catheter body 1101 and the nosecone 1105 can force the catheter 1100 to bend at the hinge point 1109, thereby exposing the cutter 1103 out of the window 1107. In some embodiments, the cutter 1103 can have a diameter that is smaller than the window 107 to allow it to extend out of the window 1107.
Advantageously, by using the balloon 1115 to open the nosecone 1105, less force is placed on the drive shaft 1113 (relative to designs where tension or compression must be placed on the drive shaft to open the nosecone), thereby improving image quality. Further, the balloon 1115 can advantageously act as an occlusion element to at least partially block blood flow to the imaging element 1292, thereby reducing the amount of saline flush required to obtain a clear image and improving image quality. Further, use of the balloon 1115 to activate deflection can advantageously provide user-adjustable force for engaging the cutter 1103 with a vessel wall, as the balloon 1115 can be adjusted to provide variable urge force. Moreover, in some embodiments, the sling mechanism 1117 can act as a smooth sliding surface against the inside of a vessel, allowing it to maintain contact with the tissue without having an abrupt change in diameter. The sling mechanism 117 can also advantageously protect the balloon 1115 to avoid popping of the balloon 1115 or peeling of the balloon 1115 away from the catheter body 1101 due to friction.
In order to close the nosecone 1105 and store the cutter 1103, the balloon 1115 is deflated. As the balloon 1115 is deflated, the sling element 1117 becomes less taut, releasing the nosecone 1105 deflection force. In order to fully close the nosecone 1105, a biasing mechanism can be used. Referring to
In some embodiments, rather than (or in addition to) closing the nosecone through movement of the drive shaft (as described with respect to
The nosecone 1105 can open using the balloon 1115 and sling 1117 while it can close by either moving the drive shaft 1113 and forcing the nosecone 105 closed over the nosecone wedge 1557 or by use of a living hinge. By allowing the balloon 1115 to open the nosecone 1105, forces are advantageously minimized at the imaging element 1292 during atherectomy. This is less of an issue when closing the nosecone 1105 after cutting, as the closing and packing of the cutter 1103 is carried out after therapy is complete. Further, using either movement of the shaft and the nosecone wedge 1557 or a living hinge to close the nosecone advantageously brings the nosecone 1105 fully on-axis with the catheter body 1101 before the cutter 1103 moves into the nosecone 1105 (as described further below), preventing the cutter 1103 from hitting the nosecone 1105 housing and thus preventing the cutter 1103 from dulling over time.
Further, the catheter 1100 can include a mechanism for packing tissue into the nosecone 1105, such as by moving the drive shaft 1113 axially. In one embodiment, as described above, movement of the drive shaft distally closes the nosecone 1105. Moving the drive shaft 1113 further distally will move the cutter 1103 into the nosecone 1105, thus packing tissue with a distal face of the cutter.
In some embodiments, the cutting window 1107 can be designed so as to further prevent the cutting window 1107 from interfering with the movement of the drive shaft 1113 and cutter 1103 distally. For example, as shown in
Although the balloon/hinge embodiments have been described herein with respect to a catheter having a single drive and imaging shaft, it is to be understood that the same mechanisms could be used with any of the catheters described herein, including the catheters with separate imaging and drive shafts.
Referring to
In one embodiment, shown in
When the flexible drive shaft is in the normal or compressed configuration, as shown in
The handle 1800 can allow for a set range of translation that is established by several factors, including the overall length of the distal portion 1804 of the flexible drive shaft, the length of the rigid tube 1802, the radius of curvature of the proximal portion 1804 of the flexible drive shaft which correlates to its ability to collapse, and the inner diameter of the rigid tube 1802 which correlates to its capacity to manage and contain the collapsed distal portion 1804. For example, the amount of translation of the flexible drive shaft can be approximately 1 inch.
In another embodiment of a handle configured to provide all of the axial movement of a drive shaft, referring to
The rest of the flexible drive shaft can be otherwise unattached to the rigid tube 1902. The distal portion 1904 of the flexible drive shaft can form a loop 1907 within the loop 1903 of the rigid tube 1902. The rigid tube 1902 can be configured such that, as shown in
The handle 1900 can allow for a set range of translation that is established by the relative difference in length between the outer and inner perimeters of the loop 1903 of the rigid tube 1902. For example, the loop 1907 of the flexible drive shaft can expand from 2 inches to 2.6 inches, allowing for up to 1.8 inches of translation by the flexible drive shaft at the distal end.
In some embodiments, the flexible drive shafts described herein can include a flexible outer tube surrounding an inner coil. The inner coil can spin within the outer tube while the outer tube provides support for the coil to maintain its shape while manipulated.
Both of the handles 1800 and 1900 can include a mechanism on the handle to control the extension of the distal wire. For example, as shown in
The handles 1800 and 1900 can further include a coupling, such as the coupling 1912 configured to couple the respective handle with a drive mechanism. The distal portion of the drive shaft can be placed in-line with the drive system, enabling translation of the flexible drive shaft without requiring complex exterior slide mechanisms to accommodate the fixed length optical fiber.
Using a handle, such as the handles 1800 and 1900 shown in
In one embodiment, the atherectomy catheters described herein include a flush port close to the cutter. The flush port can be used to deliver flushing fluid to the area of imaging, thereby improving image quality. Referring to
Referring to
As shown in
Any of the catheters described herein can further include a guidewire lumen, such as a monorail guidewire lumen. In some embodiments, the monorail guidewire lumen can run parallel to one or more of the struts or markers in the imaging window, thereby not hindering the imaging of the vessel. In other embodiments, the guidewire lumen can be used an imaging marker to identify the orientation of the device.
Any of the shafts described herein (such as the imaging shaft, drive shaft, or outer shafts) can be made of a multi-layer coil. The shafts can include, for example, stainless steel. In one exemplary embodiments, the shaft can be made of 8 adjacent filars wound in one direction with another layer of 8 filars wound in the opposite direction on top of the first layer. The number of filars on each layer may vary as might the diameter of the filars. The drive cable may also comprise 3 layers of filars, adjacent layers being wound in opposite directions.
The catheters described herein can be driven with a reusable drive system, which can provide the torque for the drive shaft and/or optical fiber as well as the optical connection from a light source. Exemplary drive shafts are described in U.S. patent application Ser. No. 13/654,357, titled “ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATION MECHANISM FOR CATHETERS,” filed Oct. 17, 2012 and International Patent Application titled “ATHERECTOMY CATHETER DRIVE ASSEMBLIES,” filed herewith, all of which are incorporated by reference in their entireties.
Further, as described above, the catheters described herein can be used with optical coherence tomography imaging. Exemplary optical coherence tomography systems are described in copending patent applications: U.S. patent application Ser. No. 12/790,703, titled “OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICAL IMAGING,” filed May 28, 2010, Publication No. US-2010-0305452-A1; U.S. patent application Ser. No. 12/829,267, titled “CATHETER- BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHY IMAGING SYSTEM,” filed Jul. 1, 2010, Publication No. US-2011-0021926-A1; and International Patent Application titled “OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,” filed herewith, all of which are incorporated by reference in their entireties. In some embodiments, side-firing optical fibers can be used in place of the reflective elements to direct the OCT signal into the tissue.
Additional details pertinent to the present invention, including materials and manufacturing techniques, may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Further, it is to be understood that although specific embodiments are described above, elements of one or more of each of the embodiments can be combined or added while still falling within the scope of this disclosure. Thus, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there is a plurality of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements, these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
This patent application is a 371 of International Application No. PCT/US13/32494, filed Mar. 15, 2013, titled “BALLOON ATHERECTOMY CATHETERS WITH IMAGING”, which claims priority to U.S. Patent Application No. 61/697,743, titled “BALLOON ATHERECTOMY CATHETERS WITH IMAGING,” filed on Sep. 6, 2012, which is incorporated by reference herein. This application is also a continuation-in-part of U.S. patent application Ser. No. 13/175,232, filed Jul. 1, 2011, now U.S. Pat. No. 9,345,510, titled “ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS”, which claims priority to Provisional Application No. 61/492,693, filed Jun. 2, 2011, titled “ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS”, Provisional Application No. 61/468,396, filed Mar. 28, 2011, titled “OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES”, and Provisional Application No. 61/360,886, filed Jul. 1, 2010, titled “ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS”.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2013/032494 | 3/15/2013 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2014/039099 | 3/13/2014 | WO | A |
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