|Publication number||USRE43300 E1|
|Application number||US 10/126,295|
|Publication date||Apr 3, 2012|
|Filing date||Apr 18, 2002|
|Priority date||Dec 2, 1996|
|Publication number||10126295, 126295, US RE43300 E1, US RE43300E1, US-E1-RE43300, USRE43300 E1, USRE43300E1|
|Inventors||Vahid Saadat, John H. Ream|
|Original Assignee||Abbott Cardiovascular Systems Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (223), Non-Patent Citations (41), Referenced by (7), Classifications (46), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application is a continuation-in-part application of commonly assigned U.S. patent application Ser. No. 08/863,877, filed May 27, 1997, now U.S. Pat. No. 5,910,150 which claims the benefit of the filing date of U.S. provisional patent application Ser. No. 60/032,196, filed Dec. 2, 1996.
The present invention relates to apparatus and methods for performing surgery on an interior wall of a hollow-body organ such as the heart, or within the brain cavities and the like. More particularly, the present invention provides a device that enables a clinician to perform surgery on an interior wall of an organ or vessel using apparatus for stabilizing an end effector during the surgery.
A leading cause of death in the United States today is coronary artery disease, in which atherosclerotic plaque causes blockages in the coronary arteries, resulting in ischemia of the heart (i.e., inadequate blood flow to the myocardium). The disease manifests itself as chest pain or angina. In 1996, approximately 7 million people suffered from angina in the United States.
Coronary artery bypass grafting (CABG), in which the patient's chest is surgically opened and an obstructed artery replaced with a native artery harvested elsewhere, has been the conventional treatment for coronary artery disease for the last thirty years. Such surgery creates significant trauma to the patient, requires long recuperation times, and causes a great deal of morbidity and mortality. In addition, experience has shown that the graft becomes obstructed with time, requiring further surgery.
More recently, catheter-based therapies such as percutaneous transluminal coronary angioplasty (PTCA) and atherectomy have been developed. In PTCA, a mechanical dilatation device is disposed across an obstruction in the patient's artery and then dilated to compress the plaque lining the artery to restore patency to the vessel. Atherectomy involves using an end effector, such as a mechanical cutting device (or laser) to cut (or ablate) a passage through the blockage. Such methods have drawbacks, however, ranging from re-blockage of dilated vessels with angioplasty to catastrophic rupture or dissection of the vessel during atherectomy. Moreover, these methods may only be used for that fraction of the patient population where the blockages are few and are easily accessible. Neither technique is suitable for the treatment of diffuse atherosclerosis.
A more recent technique, which holds promise of treating a larger percentage of the patient population, including those patients suffering from diffuse atherosclerosis, is referred to as transmyocardial revascularization (TMR). In this method, a series of channels are formed in the left ventricular wall of the heart. Typically, between 15 and 30 channels about 1 mm in diameter and up to 3.0 cm deep are formed with a laser in the wall of the left ventricle to perfuse the heart muscle with blood coming directly from the inside of the left ventricle, rather than traveling through the coronary arteries. Apparatus and methods have been proposed to create those channels both percutaneously and intraoperatively (i.e., with the chest opened).
U.S. Pat. No. 5,389,096 to Aita et al. describes a catheter-based laser apparatus for percutaneously forming channels extending from the endocardium into the myocardium. U.S. Pat. No. 5,380,316 to Aita et al. describes an intraoperative laser-based system for performing TMR. U.S. Pat. No. 5,591,159 to Taheri describes a mechanical apparatus for performing TMR involving a catheter having an end effector formed from a plurality of spring-loaded needles.
Neither the Aita nor Taheri devices describe apparatus wherein the laser-tip or spring-loaded needles are stabilized during the channel-forming process. Because the end effector of such devices may shift position while in use, such previously known devices may not provide the ability to reliably determine the depth of the channels, nor the relative positions between channels if multiple channels are formed.
In view of the shortcomings of previously known TMR devices, it would be desirable to provide apparatus and methods for performing percutaneous surgery, such as TMR, that permit precise control of the end region of the device carrying the end effector.
It also would be desirable to control the location of the end region of the device within the ventricle both with respect to features of the ventricular walls and in relation to other channels formed by the device, and to stabilize the end region of the device within the organ, for example, to counteract reaction forces created by the actuation of the end effector during treatment.
A number of devices are known in the medical arts that provide certain aspects of the desired functionality. For example, U.S. Pat. Nos. 5,389,073 and 5,330,466 to Imran describe steerable catheters; U.S. Pat. No. 5,415,166 to Imran describes a device for endocardial mapping; U.S. Pat. No. 4,813,930 to Elliott describes a radially extendable member for stabilizing an angioplasty catheter within a vessel; U.S. Pat. No. 5,354,310 describes an expandable wire mesh and graft for stabilizing an aneurysm; and U.S. Pat. Nos. 5,358,472 and 5,358,485 to Vance et al. describe atherectomy cutters that provide for aspiration of severed material.
None of the foregoing references overcomes problems associated with locating an end region of a catheter against a position on the inside wall of a heart chamber. Moreover, the prior art is devoid of a comprehensive solution to the above-noted shortcomings of previously-known apparatus for percutaneously performing surgery, and especially for performing TMR.
In view of the foregoing, it is an object of this invention to provide apparatus and methods for performing surgery, such as TMR, that permit precise control of an end effector disposed in an end region of the apparatus.
It is another object of this invention to provide apparatus and methods, suitable for use in performing TMR and surgery of other hollow-body organs, that include the capability to stabilize within the organ an end region of the device carrying an end effector, for example, to counteract reaction forces created by the end effector during treatment.
These and other objects of the present invention are accomplished by providing apparatus having a directable end region carrying an end effector for performing surgery. Apparatus constructed in accordance with the present invention comprises a catheter having a longitudinal axis and an end region movable to a series of positions along the longitudinal axis. The end region may be selectively moved to a position at an angle relative to the longitudinal axis of the catheter, including a substantially orthogonal position. The catheter includes means for stabilizing a distal region of the apparatus within a hollow-body organ, and for counter-acting reaction forces developed during actuation of an end effector.
In a preferred embodiment of the apparatus of the invention, the catheter includes a catheter shaft and a guide member disposed for longitudinal sliding movement within a groove of the catheter shaft. The guide member includes an end region including an end effector maneuverable between a transit position wherein the end region lies parallel to a longitudinal axis of the catheter to a working position wherein the end region and end effector are oriented at an angle relative to the longitudinal axis, including a substantially orthogonal position. The catheter shaft preferably may include adjustable outwardly projecting stabilization members to provide a stable platform to counteract reaction forces generated when the end effector contacts the wall of the hollow-body organ.
Methods of using the apparatus of the present invention to perform surgery, such as transmyocardial revascularization, are also provided.
Further features of the invention, its nature and various advantages will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments, in which:
The present invention relates generally to apparatus and methods for percutaneously performing surgery within an organ or vessel. The apparatus of the present invention comprises a catheter including a stabilizing catheter shaft which percutaneously may be disposed within an organ. A guide member engaged with the catheter shaft includes an end region that may be selectively articulated to a position at an angle to a longitudinal axis of the catheter, including a position substantially orthogonal to the longitudinal axis. The end region carries an end effector (e.g., an ablative or mechanical cutting device) for treating tissue. Severed or ablated tissue may be aspirated through the catheter to its proximal end for disposal. The catheter shaft, either alone or in conjunction with stabilizing members, and the guide member, provides precise control over the location of the end region, and thus, the end effector.
The present invention therefore offers a device having a directable end region and end effector for performing surgery that provides a degree of control heretofore unattainable. While the invention is described hereinafter as particularly useful in the emerging field of transmyocardial revascularization, apparatus constructed in accordance with the present invention may be advantageously used in performing surgery on other organs or vessels, such as the intestines, blood vessels or the brain cavities. In addition, while the present invention is described herein in the context of a mechanical cutting system, the control and stabilization apparatus of the present invention may be advantageously used with other types of cutting elements, such as lasers, cryogenic cutters or radio-frequency ablation devices.
End region 25 of guide member 22 may be positioned longitudinally with respect to catheter shaft 21 by imparting relative movement between guide member 22 and catheter shaft 21 using handle assembly 26. Catheter shaft 21 preferably includes a plurality of stabilizing members 27 to support and stabilize distal region 23 of the apparatus within the hollow-body organ.
Apparatus 20 is coupled via cable 28 to controller 29. In a preferred embodiment wherein the end effector comprises a rotating cutting head, controller 29 includes a motor and control logic for rotating the cutting head responsive to commands input at handle assembly 26 or a footpedal (not shown) and a vacuum source for aspirating severed tissue from the treatment site. Controller 29 optionally may further include RF circuitry (shown in dotted line) for energizing the cutting head to cauterize tissue as it is cut. Alternatively, controller 29 may include a laser source or radio frequency circuitry for causing laser or RF ablation, respectively, using a suitable end effector.
Referring now to
Guide member 22 includes end region 25 carrying an end effector and flanges 34 and 35 that slidingly engage grooves 31 and 32. End region 25 may be articulated in region 36 using control wires or a temperature actuated shape-memory alloy steering mechanism, such as described in the aforementioned patents to Imran. Guide member 22 may be constructed of a spring material (commonly called a Bowden) with spaces in-between the coils to allow it to bend when it is pulled by a control wire asymmetrically, as previously known in the art. Alternatively, guide member 22 may be constructed of a stiffer material such as polyimide coated over a braided steel tubular structure, such as employed in previously known neuro-navigational endoscope devices. In this case, slits are provided on the inside of the bend in region 36 so that the guide member bends in the direction of the slits. The slits allow a tight bend radius which may not otherwise be achievable.
Guide member 22 preferably includes a lumen, as described hereinafter, through which tissue may be evacuated from a treatment site by suction. Accordingly, guide member 22 may also be formed from a loosely wound spring reinforced with a soft elastomeric coating. The elastomeric coating advantageously serves the following functions: it provides sealing along the length of the guide member required to maintain adequate suction through the lumen; it prevents collapse of the lumen in the presence of applied suction; it resists kinking of the coils of the spring; and it also enables the guide member to be bent to relatively tight radii. Reinforced tubing suitable for use as guide member 22 is available from Adam Spence Corporation, Wall, N.J.
In the above-described embodiments, end region 25 of guide member 22 is movable from a transit position lying parallel to the longitudinal axis of catheter shaft 21 to a working position wherein end region 25 is articulated to a position substantially orthogonal to the longitudinal axis of the catheter shaft. In addition, end region 25 may be constructed to enable it to be locked in position at any angle a that may be desired for a given application.
With respect to
Accordingly, wires 27a-27d may be moved from a retracted position in which they are retracted against distal region 23 of catheter shaft 21 to an expanded position in which they engage a wall of the organ and urge end region 25 into engagement with an opposing wall of the organ, thereby stabilizing catheter shaft 21 against rotation.
Stabilization members 27 may be constructed of any suitable elastic material, including stainless steel, spring steel, nickel-titanium alloys, and a variety of plastics. A nickel-titanium alloy is preferred where wires 27a-27d comprise a continuous coil, as in
Where stabilization members 27 comprise a single coil, as in
The longitudinal position of end region 25 with respect to catheter shaft 21 may be adjusted by sliding guide member 22 in groove 30 of the catheter shaft. Handle assembly 26 preferably includes means, described hereinafter, for moving guide member with respect to catheter shaft 21 so that end region 25 may be positioned at a series of vertical locations. In addition, stabilization members 27 may be adjusted to provide some control over the lateral positioning of the catheter shaft and guide member with respect to the interior wall of the organ or vessel. Thus, apparatus 20 enables a matrix of treatment sites to be accessed without removing and repositioning the apparatus.
Referring now to
Orientation of end region 25 of guide member 22 is accomplished by control wire 46, which is slidingly disposed in lumen 47 of guide member 22. As described hereinabove, guide member 22 preferably comprises a spring material with spaces in-between the coils to allow it to bend when control wire 46 is retracted in a proximal direction. Alternatively, guide member 22 may be constructed of polyimide coated over a braided steel tube and includes slits on the inside of bend region 36 so that end region 25 bends in the direction of the slits when control wire 46 is retracted in a proximal direction.
Cutting head 41 is connected to the motor of controller 29 via drive rod 45. Drive rod 45 may be formed of a flexible tube such as a bowden or a covered coil or may be formed of a plastic having both high torquability and flexibility. Drive rod 45 is disposed in lumen 44 for a limited range of reciprocation, e.g., up to 3.0 cm, to permit extension of cutting head 41 beyond the end of guide member 22. When end region 25 is in its transit position, cutting head 41 is disposed just below distal endface 48 of guide member 22. Drive rod 45 is hollow and preferably includes a covering of a soft plastic or elastomeric material to allow the application of a negative pressure to aspirate the severed tissue.
Applicant expects that high speed rotation of cutting head 41 will generate frictional heating of the tissue surrounding the cutting head, thereby causing coagulation of the tissue with minimal thermal damage to the surrounding tissue. Alternatively, tubular member 42 of cutting head 41 may comprise an electrically conductive material and be electrically coupled to the optional radio-frequency generator circuitry in controller 29 to provide coagulation of the edges of a channel formed in the tissue by cutting head 41. In this embodiment, tubular element 42 serves as the electrode in a monopolar coagulation arrangement. In addition, a second electrode (not shown) may be formed on the working end spaced apart from the cutting head 41, so that tubular member 42 serves as one electrode of a bipolar coagulation arrangement. Applicant expects that the sealing action produced by RF coagulation, if provided, will simulate the lesions produced by a laser.
With respect to
Upper portion 52 includes indicator 57a that may be selectively aligned with indicators 57b, so that the channels formed by end effector 40 are positioned at a series of spaced-apart locations. Cable 28 extends from upper portion 52 and connects the working end of apparatus 20 to controller 29. Upper portion 52 also includes button 58 which may be moved in slot 59 to control the articulation of end region 25 of guide member 22, and depth control lever 60 disposed in slot 61. Depth control lever 60 is moved within slot 61 to control reciprocation of cutting head 41 from end region 25. Slot 61 has a length so that when button 60 is moved to fully extend cutting head 41 from guide member 22, a proximal portion of tubular member 42 remains within guide member 22. In addition, or alternatively, a user-adjustable limit bar (not shown) may be provided in slot 61 to select the maximum extension of cutting head 41 desired for a particular application.
RF button 62 also may be provided to control activation of the optional RF circuitry of controller 29 to coagulate tissue surrounding the channel formed by micromorcellator 40. RF button also could take the form of a microswitch located within slot 61 of handle assembly 50, so as to provide automatic activation of the RF coagulation feature for a short period of time when depth control lever 60 is advanced to contact the user-adjustable limit bar.
It will therefore be seen that handle assembly 50 provides for longitudinal movement of end region 25 with respect to catheter shaft 21 via relative movement between upper portion 52 and lower portion 51 (using knob 53); provides selective deployment of stabilization members 27 via button 55; selective orientation of end region 25 via button 58; control over the depth of the channels formed by end effector 40 via depth control lever 60; and, optionally, activation of an RF coagulation feature via button 62.
Referring now to
Insertion of apparatus 20 into the left ventricle is with guide member 22 in its distal-most position with stabilization members 27 fully retracted and end region 25 in its transit position. As barbs 33 of catheter shaft 21 engage apex 205 of the left ventricle, catheter shaft 21 (and guide member 22) preferentially bends in regions 65 and 66 to form a “dog-leg”, in which distal region 23 becomes urged against a lateral wall of the ventricle. Regions 65 and 66 where the bends take place may be made flexurally weaker than the remainder of the catheter shaft to aid in the bending of the catheter at these locations.
The motor and vacuum source of controller 29 are then actuated to cause cutting head 41 to rotate and to induce negative pressure in lumen 44 of micromorcellator 40. The clinician then pushes depth control lever 60 distally in slot 61, causing cutting head 41 to be advanced beyond distal endface 48 of guide member 22 and engage the endocardium. When micromorcellator 40 engages the endocardium, a reaction force is generated in catheter shaft 21 that tends both to push end region 25 away from the tissue and to cause the catheter shaft to want to rotate. The relatively flat configuration of catheter shaft 21, in conjunction with barbs 33, is expected to adequately counteract the torque induced by operation of the micromorcellator. In addition, stabilization members 27 function to counteract both these outward reaction and torque effects.
As micromorcellator 40 is advanced to form channel 207 in the left ventricular wall, tissue severed by cutting head 41 is suctioned into lumen 44 and aspirated to the proximal end of apparatus 20 via the vacuum source of controller 29. The depth of channel 207, which is proportional to the movement of depth control lever 60 in slot 61, may be predetermined using conventional ultrasound techniques, MRI scanning, or other suitable methods. As channel 207 is formed, tissue severed from the ventricular wall is aspirated through lumen 44 of guide member 22, thereby reducing the risk of embolization of the severed material. In addition, applicant expects that the use of suction through lumen 44 will assist in stabilizing the micromorcellator, and tend to draw tissue into the cutting head.
Once micromorcellator 40 has achieved its maximum predetermined depth, cutting head 41 is withdrawn from channel 207 by retracting depth control lever 60 to its proximal-most position, thereby returning cutting head 41 to a position just below distal endface 48 of end region 25 of guide member 22. It is expected that rotation of cutting head 41 will generate sufficient frictional heat in the tissue contacting the exterior of cutting head 41 to coagulate the tissue defining the channel.
Optionally, RF button 62 may be depressed on handle assembly 50 to apply a burst of RF energy to the edges of channel 207 as micromorcellator 40 achieves its maximum predetermined depth, and while cutting head 41 is stationary, rotating or being withdrawn from the channel. If provided, this burst of RF energy is expected to further coagulate the tissue defining the walls of channel 207 and modify the surface properties of the tissue.
As shown in
The foregoing methods enable a matrix of channels to be formed illustratively in the left ventricular wall. It will of course be understood that the same steps may be performed in mirror image to stabilize the apparatus against the left ventricular wall while actuating the end effector to produce a series of channels in the septal region. In accordance with presently accepted theory, the formation of such channels in the endocardium or septal region enables oxygenated blood in the left ventricle to flow directly into the myocardium and thus nourish and oxygenate the muscle. It is believed that these channels may be drilled anywhere on the walls of the heart chamber, including the septum, apex and left ventricular wall, and the above-described apparatus provides this capability.
Referring now to
Dual-rail embodiment 70 may be used without stabilization members, or alternatively catheter shaft 73 may include the stabilization members of
Wires 71 and 72, in cooperation with a distally-directed axial force exerted on the handle assembly by the clinician, serve to anchor the catheter against a lateral wall of the left ventricle, while catheter shaft 74 and guide member 79 are advanced along the dual-rail. Like apparatus 20, apparatus 70 may include flexurally weaker locations along its length to aid in positioning distal region 74 within the left ventricle.
The dual-rail design of apparatus 70 also may be advantageously employed to determine the location of end region 75 and end effector 81 with respect to the interior of the hollow-body organ or vessel. In this embodiment, wires 71 and 72 are electrically connected within cushion 77 and have a uniform resistance per unit length. Electrodes 80 are positioned in distal end 82 of catheter shaft 73 to measure the resistance of wires 71 and 72 between the electrodes.
The resistance between electrodes 80 may be measured, for example, by ohmmeter circuitry, to determine the distance between the distal end 82 of the catheter shaft and the apex of the left ventricle. In conjunction with the displacement between the upper and lower portions of the handle assembly (see
Referring now to FIGS. 8 and 9A-9C, a first alternative embodiment of the stabilization members of the present invention are described. In
Accordingly, wires 91a-91d of the embodiment of
As illustrated in
Referring now to
As described hereinabove, guide member 102 moves relative to catheter shaft 101 to enable the clinician to form a series of vertically aligned channels in the myocardium. Once a line of channels has been formed, the catheter must be moved laterally to a new location and the procedure repeated until the desired number of channels has been achieved. One expedient for doing so, for example, applicable to the apparatus of
Specifically, when inflated, stabilization members 103 provide a degree of hoop strength that ensures proper contact of the distal face of end region 106 with the wall of the hollow-body organ or vessel at all times. Once a vertical row of channels has been formed, stabilization members 103 are deflated by the clinician and end region 106 is moved to a new lateral position. The stabilization members are fully re-inflated and another vertical row of channels is formed, as discussed hereinabove.
With respect to FIGS. 11 and 12A-12C, another embodiment of the apparatus of the present invention is described in which the stabilization members comprise longitudinally-oriented balloons. Apparatus 110 is otherwise similar to the apparatus of
Referring now to
End region 125 of guide member 122 may be positioned longitudinally with respect to catheter shaft 121 by imparting relative movement between guide member 122 and catheter shaft 121 using handle assembly 126. Catheter shaft 121 includes stabilizing assembly 127 to support and stabilize distal region 123 of the apparatus within an organ or vessel.
Apparatus 120 is coupled via cable 128 to controller 129. In a preferred embodiment, wherein the end effector comprises a flexible wire having a sharpened tip, controller 129 includes a hydraulic or pneumatic piston, valve assembly and control logic for extending and retracting the end effector beyond the distal endface of end region 125 responsive to commands input at handle assembly 126 or a footpedal (not shown). Controller 129 optionally may further contain RF generator circuitry for energizing electrodes disposed on the end effector to cause a controlled degree of necrosis at the treatment site.
Referring now to
End region 125 of guide member 122 is movable from a transit position lying parallel to longitudinal axis 124 of catheter shaft 121 to a working position wherein end region 125 is articulated to a position substantially orthogonal to the longitudinal axis of the catheter shaft. In addition, end region 125 may be constructed to enable it to be locked in position at any angle a that may be desired for a given application.
Stabilization assembly 127 comprises flat band 137 of resilient material, such as stainless steel, that projects outwardly from catheter shaft 121 in distal region 123. Illustratively, stabilization assembly 127 comprises multiple loops 127a-127c of band 137. Band 137 has its distal end affixed to the distal end of catheter shaft 121, and its proximal end connected to handle assembly 126. Band 137 passes through an interior lumen of catheter shaft 121 (see
In the position shown in
The longitudinal position of end region 125 with respect to catheter shaft 121 may be adjusted by sliding guide member 122 in track 130 of the catheter shaft. Handle assembly 126 preferably includes means, described hereinafter, for moving guide member 122 with respect to catheter shaft 121 so that end region 125 may be positioned at a series of longitudinal locations In addition, stabilization assembly 127 may be adjusted to provide some control over the lateral positioning of the catheter shaft and guide member with respect to the interior wall of the organ or vessel. Thus, apparatus 120 enables a matrix of treatment sites to be accessed without removing and repositioning the apparatus.
With respect to
Threaded post 145 is coupled to the proximal end of band 137, and slides in a slot (not visible in
Upper portion 141 includes indicator 147a that may be selectively aligned with indicators 147b, so that the treatment sites are positioned at a series of spaced-apart locations. Cable 128 extends from upper portion 141 and connects the end effector of apparatus 120 to controller 129. Button 148 disposed on the top surface of upper portion 141 may be depressed to command the control logic of controller 129 to reciprocate the end effector from end region 125, and optionally, cause necrosis at the treatment site. Button 149, disposed in a slot in the upper surface of the proximal end of guide tube 122 (not visible in
Handle assembly 126 therefore provides for longitudinal movement of end region 125 with respect to catheter shaft 121 via relative movement between upper portion 141 and lower portion 140 (using knob 142); provides selective deployment of stabilization assembly 127 (using post 145 and thumbwheel 146); selective orientation of end region 125 (using button 149); and control over operation of the end effector (using button 148).
Referring now to
With respect to
Apparatus 170 includes distal region 173 within which guide member 172 has end region 175 that is selectively movable between a transit position parallel to longitudinal axis 174 of catheter shaft 171 and a working position (as shown), substantially orthogonal to longitudinal axis 174. Distal region 173 preferably includes an end effector, as described in detail hereinabove. End region 175 of guide member 172 may be positioned longitudinally with respect to catheter shaft 171 by imparting relative movement between guide member 172 and catheter shaft 171 using handle assembly 176. Catheter shaft 121 includes stabilizing element 177 to support and stabilize distal region 173 of the apparatus within an organ or vessel.
Distal region 173 of apparatus 170 is described in greater detail with respect to
Stabilization element 177 comprises wire or band 186 of resilient material, such as stainless steel, that exits catheter shaft 171 through skive 187, and is fixed to catheter shaft 171 near distal end 188. When deployed within a hollow organ, such as a chamber of the heart, as depicted in
While preferred illustrative embodiments of the invention are described, it will be apparent to one skilled in the art that various changes and modifications may be made without departing from the invention, and the appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.
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|US8784355||Jul 13, 2010||Jul 22, 2014||Silk Road Medical, Inc.||Methods and systems for establishing retrograde carotid arterial blood flow|
|US8858490||Jul 12, 2010||Oct 14, 2014||Silk Road Medical, Inc.||Systems and methods for treating a carotid artery|
|US8961551||Dec 22, 2006||Feb 24, 2015||The Spectranetics Corporation||Retractable separating systems and methods|
|US9011364||Mar 17, 2011||Apr 21, 2015||Silk Road Medical, Inc.||Methods and systems for establishing retrograde carotid arterial blood flow|
|US9028520||Dec 22, 2006||May 12, 2015||The Spectranetics Corporation||Tissue separating systems and methods|
|US9126018||Dec 18, 2014||Sep 8, 2015||Silk Road Medical, Inc.||Methods and devices for transcarotid access|
|U.S. Classification||606/159, 606/170, 607/122, 606/15, 606/7|
|Cooperative Classification||A61B2018/00916, A61B18/1492, A61B2017/003, A61B2018/00208, A61B2019/304, A61B2017/3488, A61B17/3207, A61B2018/1861, A61B2018/00738, A61B2018/00392, A61B2018/1437, A61B2017/00685, A61B2019/4857, A61B2017/306, A61B2017/00398, A61B2018/00839, A61B2019/5278, A61B2018/00291, A61B17/320758, A61B2017/00247, A61B2018/00196, A61B19/5244, A61B18/00, A61B2217/005, A61B2018/00761, A61B2017/22077, A61B2018/1435, A61B2218/002, A61B2017/00039, A61M25/0084, A61B2018/00279, A61B2218/007, A61B2018/00267, A61B2017/00026, A61B19/5225, A61B2017/00022|
|European Classification||A61B18/14V, A61B18/00, A61B17/3207, A61B17/3207R|