US20140330286A1

Movatterモバイル変換

Info

Publication number: US20140330286A1
Application number: US14/212,987
Authority: US
Inventors: Michael P. Wallace
Original assignee: Individual
Current assignee: CardioProlific Inc
Priority date: 2013-04-25
Filing date: 2014-03-14
Publication date: 2014-11-06
Also published as: US20170027604A1; US10959750B2

Abstract

The present invention provides devices and methods for removal of obstructive matter from the patients that are located inside or outside of the patient's endovascular system using rotational energy. One or more therapeutic agents may be delivered to the treatment location to further facilitate the removal process

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is continuation-in-part of co-pending application Ser. No. 13/870,777 filled on Apr. 25, 2013.

FIELD OF THE INVENTION

The field of the present application pertains to medical devices. More specifically, the present application is related to systems and methods for intracerebral hemorrhage treatment and removal of obstructing matter from the other parts of human body.

DESCRIPTION OF RELATED ART

Spontaneous intracerebral hemorrhage (ICH) bleeding accounts for approximately 10-15% of all stroke cases, with reports of 37,000 to 52,400 cases annually in the U.S. alone. ICH has long been associated with high rates of morbidity and mortality. According to a ten-year study, 34% of patients with ICH die within 7 days, and 50% die within 30 days. For patients who survive up to a year, only an estimated 20% are expected to be functionally independent. In up to 45% of ICH cases, blood flows into the ventricles of the brain, resulting in Intraventricular Hemorrhage (IVH). This condition is associated with a much poorer prognosis and a death rate of up to 70%.

As blood spreads from the point of origin of an ICH through the brain, it can cause infections, high fever, headaches, vomiting, increased blood pressure, hyperglycemia (even in patients without diabetes), seizures, decreased consciousness, blood clots, and events related to blood clots. Prolongation of hospitalization, paralysis, morbidity, and mortality often result. In addition, expansion of the hematoma and resulting edema often cause brain damage. Hematomas also expand over time in many cases of ICH. For every 10% increase in hematoma growth, there is a 5% increase in mortality rate. Edema is characteristic of fluid collection within the vicinity of the hematoma. Products of edema can lead to neuronal death as it expands from the origins of the hematoma to the tissues beyond. Hematoma expansion, with or without edema, is a huge factor in a patient's outcome. Fatality rates are high in this patient population.

Treatment choices for ICH are limited, and the effectiveness of currently available treatment methods is also limited. Interventions in ultra-early hemostatic therapy are ideally useful in minimizing the continuing growth of the hematoma. The use of recombinant activated factor VII (rFVIIa), an approved drug for hemophiliac patients has been reported to reduce bleeding and hematoma growth when administered at the early stages of ICH (within 4 hours). There was a slight increase in thromboembolic events in the treatment group, however, compared to the placebo group. Also, patients given high doses were at an increased risk of IVH, especially in the higher dose groups. Though rFVIIa used within four hours of ICH minimizes the growth of hematoma, it is limited by its inability to remove hematoma once growth has stopped, and is not recommended at present for routine use.

For ICH, thrombolytics are not recommended to be used alone, and are currently being investigated for use in conjunction with aspiration and other surgical techniques. In patients with IVH, procedures traditionally included the use of a ventricular catheter to drain the blood. However, the use of a catheter alone is not recommended due to lack of catheter patency and slow removal of intraventricular blood. Thus, the administration of fibrinolytic agents as an adjunct to ventricular catheter use is being investigated.

For patients with hematomas resulting from ICH, the role of surgery in improving outcome is uncertain, as hematoma locations vary widely, and the damages from surgery may be greater than those from the hematoma. Patients with small hemorrhages are typically observed and medically managed. Those patients with cerebellar hemorrhage who have brainstem compression and rapidly deteriorating neurological status are recommended to undergo surgical evacuation of the hematoma as soon as possible. The use of craniotomy and surgical removal techniques in other cases are still uncertain.

The STICH trial compared early surgery with initial conservative treatments for patients with ICH. At 6 months, 26% of patients undergoing surgery had favorable outcomes compared to 24% of the initial conservative treatment. Mortality at 6 months was 36% for surgery compared with 37% for conservative treatment. None of these values reached significance, and no overall benefit was demonstrated for early surgery over conservative treatment. Although surgery for ICH is currently undergoing further study, these early data from STICH are not very promising.

Another ICH treatment option under investigation is the use of minimally invasive surgery (MIS) in hematoma evacuation. In theory, the use of MIS would reduce time of surgery, reduce tissue damage, and be performed with local anesthesia. There are several methods under the umbrella of MIS, including endoscopic and stereotactic techniques with or without thrombolysis. In a typical endoscopic surgery, the hematoma is accessed through a burr hole incision, in which a working channel is created into the center of the hematoma, and subsequent action is taken for hematoma removal through this channel. MIS stereotactic procedures involve the use of an image-guided system to precisely locate and visualize the hematoma which is then removed with a combination of aspiration and possibly a lytic drug. The disadvantage in the use of stereotactic techniques lies in the longer procedure times for the patients. Even so, studies have demonstrated a trend of increased clot removal and decreased mortality in subjects treated within 12-72 hours for both stereotactic and endoscopic options. However, functional improvement has not been consistently demonstrated, and clot resolution is highly dependent on where the catheter is positioned.

A number of inventions have been described in the general area of treating intracranial or intracerebral hemorrhage. Examples include U.S. Pat. No. 8,366,620, entitled Methods and apparatus for intracranial ultrasound delivery, and U.S. Patent Application Publication Nos.: 2012/0330196, entitled Methods and Apparatus for Removing Blood Clots and Tissue from the Patient's Head; 2012/0179073, entitled Ischemic Stroke Therapy; 2012/0078140, Method and Apparatus for Removing Blood Clots and Tissue from the Patient's Head; 2011/0319927, Methods and apparatus for removing blood clots from intracranial aneurysms; 2011/0313328, entitled Methods and apparatus for dissolving blockages in intracranial catheters; and 2011/0160621, entitled Methods and apparatus for dissolving intracranial blood clots.

In summary, ICH is a very common cause of death and disability with no ideally effective treatment currently available. Thus, there is a significant need for improved methods and systems for treating ICH. Ideally, such methods and systems would provide effective reduction of morbidity and mortality rates associated with ICH. Also ideally, such methods and systems would be relatively easy to use and inexpensive to manufacture, so that they could be made readily available in emergency medicine settings. At least some of these objectives will be met by the embodiments described below.

There are many clinical approaches for removing obstructing material, unwanted matter from human body, many of which are performed surgically when the treatment site is accessed directly through a surgical incision. However, in recent years a variety of catheter devices have been developed for endovascular and outside endovascular removal of obstructive matter, such as blood clots, thrombus, atheroma, plaque and the like. For example, a catheter device is inserted into a blood vessel at an access site, and is then advanced through the vessel lumen until the treatment site is reached. These techniques may employ various devices to fragment the unwanted clot or tissue from blood vessels such as rotating baskets or impellers as described in U.S. Pat. Nos. 5,766,191 and 5,569,275, cutters as described in U.S. Pat. No. 5,501,694 and high pressure fluid infusion to create a Venturi effect as described in U.S. Pat. No. 5,795,322. Other devices rely on the principles of the Archimedes type screw, such as a one-piece solid machined screw to break up and/or remove clot. The U.S. Pat. No. 5,556,408 describes an atherectomy cutter employing a vacuum source for removal of loose stenotic material and other debris from a vessel. Removal of thrombus by a rotating core wire on a drive shaft is described in the U.S. Pat. No. 5,695,507. Fragmentation and removal of tissue using high pressure liquid is described in the U.S. Pat. No. 5,795,322. The U.S. Pat. No. 4,923,462 describes a coiled wire coated with Teflon and used as a drive shaft to rotate a catheter. Furthermore, the U.S. Pat. No. 5,334,211 describes a coiled guidewire used to stabilize an atherectomy device. Atherectomy catheters with rotating helical pumping elements are described in the U.S. Pat. Nos. 4,732,154; 4,886,490; 4,883,458; 4,979,939; 5,041,082; 5,135,531; 5,334,211; 5,443,443; and 5,653,696. A rotary thrombectomy catheter having an inner helical blade is commercially available under the trade name Straub Rotarex® from Straub Medical AG, as described in a brochure with a copyright of August 1999. Use and construction of the Straub Rotarex® also appears to be described in Schmitt et al. (1999) Cardiovascular Interventional Radiology 22:504-509 and in U.S. Pat. Nos. 5,876,414 and 5,873,882. Other patents of interest include U.S. Pat. Nos. 4,737,153; 4,966,604; 5,047,040; 5,180,376; 5,226,909; 5,462,529; 5,501,694; 5,569,275; 5,630,806; 5,766,191, 5,843,031; 5,911,734; 5,947,940; 5,972,019; 5,376,100; 5,569,275; 7,037,316; 7,179,269; 7,235,088; 7,666,161; 7,763,010; 7,842,006; 7,842,055; 7,938,820; 7,942,852; 8,062,317; 8,414,543; 8,414,543; 8,535,290 and 8,545,447, as well as published PCT applications WO 99/56801, WO 99/56638, and WO 98/38929. Motor drive units for catheters and other devices are described in U.S. Pat. Nos. 4,771,774 and 5,485,042.

In many instances, the luminal treatment techniques include infusing the vessel or treatment site with fluid (saline, thrombolytic agent or therapeutic drug) to assist in breaking up the clot or tissue into a particle size that can then be aspirated through a lumen of the treatment device or using a secondary catheter hooked up to a source of vacuum/suction. Depending on the method of fragmentation and the consistency of the clot or tissue, the particle size can vary. If the material is not thoroughly fragmented, the larger particles can build up in the catheter and block the aspiration lumen.

While these catheters and techniques have been well known and are fairly successful, there is a need for improved devices for more efficiently disrupting and evacuating fragmented material from the vessel or body lumen in order to overcome the difficulties of continued fluid infusion and material build up that blocks the aspiration lumen. Furthermore, it would be desirable to have devices that allow faster aspiration and removal of larger particles of fragmented material, thereby reducing procedure time. Preferably, such improved devices will have a low profile to enable percutaneous, minimally invasive and surgical use, and will be flexible and torqueable to enable their use in areas difficult to access. Furthermore, such devices can be designed to be placed over a guidewire and will be structured to mechanically translate and transport the fragmented material by directly aspirating it through the device shaft. Optionally, the devices should include mechanisms for infusing liquids to further facilitate disruption of the occlusive materials.

BRIEF SUMMARY

Example embodiments described herein have several features, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features of some embodiments will now be summarized.

In one aspect, a method for removing a blood clot from a cranium of a patient may involve: forming an opening in the patient's cranium; advancing an elongate blood clot removal device through the opening into the cranium; positioning a distal end of the clot removal device at or near the clot; rotating a rotating member of the clot removal device at or near the distal end of the clot removal device to at least partially break up the clot; and removing the at least partially broken up clot from the cranium through the clot removal device. In some embodiments, the rotating member may be rotated at a speed of between about 10 revolutions per minute and about 500,000 revolutions per minute. In some embodiments, the blood clot may be located underneath dura mater of the patient's brain, and the elongate clot removal device is advanced through the dura mater.

In some embodiments, the blood clot resides in an epidural or subdural space of the patient's cranium. In some embodiments, the blood clot is a result of an intracerebral hemorrhage. In some embodiments, the method may include, before the advancing step, placing an introducer device in the opening in the cranium, where the clot removal device is advanced into the cranium through the introducer device. Some embodiments may include, before the advancing step, placing a trocar in the opening in the cranium, where the clot removal device is advanced into the cranium through the trocar. Any embodiments may also optionally include monitoring the placement of blood clots removal device and/or trocar using a monitoring device such as but not limited to an image guided navigation system, a computed tomography scan, ultrasound and endoscopes.

The clots removal device advancement to the treatment location may be monitored by any suitable visualization apparatus including but not limited to CT (Computed Tomography), MRI (Magnetic Resonance Imaging), radiographic technologies or Optical Coherence Tomography (OCT). The clot removal device may be used with endoscope systems. Some endoscopes also include working channel where the blood clot removal device can be advanced to the treatment area. Also, a mini camera for a distal visualization may be provided as an integral part of the blood clots removal device. In recent years, neuro guided-navigational systems are gaining a lot of popularity in neurosurgery and are frequently used to navigate, position and immobilize neurosurgery devices and tools inside the skull. Such access device can be a part of a stereotaxis frame or it can be frameless and therefore directly secured to the skull. The device's relative location can be also tracked in the skull based on previously obtained MRI, CT or ultrasound images by using reflective elements mounted on the proximal end of the clot removal device system and IR light sources that can locate the specific position and orientation of the cranium.

The present invention also relates to medical apparatus and methods and more particularly to devices and methods for removal of unwanted tissue such as thrombus, atheroma, fluid, polyps, cysts or other obstructive matter from endovascular system including arteries, veins, previously implanted stents, grafts, shunts, fistulas and the like, as well as, body organs, ureters, bile ducts, fallopian tubes or localized tumors.

In some embodiments, the method may further involve delivering at least one pharmacologic agent to the blood clot using the clot removal device. For example, the agent may include, but is not limited to, tissue plasminogen activator, tPA, BB-10153, rTPA, Urokinease, Streptokinase, Alteplase, Desmoteplase, other blood clot reducing agents, aspirin, Clopidorgel, Ticclopidine, other antiplatelet agents, Abciximab, Tirofiban, Eptifibatide, and/or other GIIb/IIIa inhibitors. In some embodiments, the method may further involve delivering a sterile solution of sodium chloride into the cranium through the clot removal device.

In some embodiments, removing the clot involves applying suction to the clot via the clot removal device. In an alternative embodiment, removing the clot may involve allowing the clot to gravitationally drain via the clot removal device.

In another aspect, a method for removing a blood clot from a cranium of a patient may involve advancing an elongate blood clot removal device through an opening into the cranium, positioning a distal end of the clot removal device at or near the clot, rotating a rotating member of the clot removal device at a speed of between about 10 revolutions per minute and about 500,000 revolutions per minute to at least partially break up the clot, and applying suction to the clot via the clot removal device to remove the clot from the cranium.

In various embodiments, positioning the distal end of the clot removal device may involve positioning the distal end near the clot, immediately adjacent the clot, contacting the clot and within the clot.

Some embodiments of the method may further involve cooling brain tissue during the rotating step. For example, cooling brain tissue may involve cooling the patient's neck, cooling the patient's head and/or cooling the patient's body.

In another aspect, a system for removing a blood clot from a cranium of a patient may include: an elongate clot removal member having an inner lumen and an outer diameter along at least a distal portion of the clot removal member of between about 0.5 millimeter and about 5 millimeters; a rotating member housed within the lumen of the clot removal member and configured to rotated within the clot removal member at a rate of between about 10 revolutions per minute and about 500,000 revolutions per minute; and a vacuum source coupled with the clot removal member to generate a vacuum within the lumen.

In some embodiments, the elongate clot removal device may include a rigid distal shaft portion, a flexible proximal shaft portion, and a handle disposed between the distal shaft portion and the proximal shaft and including an aperture in fluid communication with the lumen and configured to be covered with a finger of a user to regulate application of the vacuum. Optionally, the system may further include an introducer device for placing in a burr hole in the cranium to facilitate advancing the clot removal member into the cranium. Also optionally, the system may further include a trocar for advancing through the introducer device into the cranium, where the clot removal member is advanced into the cranium through the trocar.

According to the present invention, improved devices and methods are provided for transporting material between a target site in the body of a patient and a location external to the patient. In some cases, the materials will be transported by methods which will generally be referred to as aspiration. In other cases, the material may be transported from the external location to the target site within the body lumen, which methods will generally referred to as infusion or irrigation. In all cases, the material transport will be enhanced by rotation of a rotational member disposed in a lumen of a device. The rotational member will usually comprise a tubular or solid rotational member having an end extending at least partially within a device and the distal end of the rotational member located inside the device or partially extending beyond the distal end of the device. Thus, rotation of the rotational member will break the material that is aspirated through the device and outside the patient.

For example, the obstructing material removal device of the present invention may be used to infuse thrombolytic and other therapeutic agents and/or aspirate fragmented clot, thrombus, and other occlusive materials in conjunction with angioplasty, atherectomy, laser ablation, embolectomy, atherectomy and other known intravascular interventions.

In one embodiment, a device for removing obstructing matter from a patient include an elongated rotational member having a distal end, and a proximal end connectable to a rotation generating device that is configured to rotate the rotational member along its longitudinal axis. An internal irrigation catheter is at least partially surrounding the rotational member. An aspiration catheter is positioned around the internal irrigation catheter and the rotational member and adjacent to the distal portion of the rotational member. The aspiration catheter may have a guidewire lumen for a better navigation to the treatment location. The rotating rotational member breaks up obstructing matter and facilitates its aspiration through the aspiration catheter outside the patient. The rotational member may rotate clockwise, counter clock wise or both and can be made of a single rotating member, multimember rotating members or both. In addition, the rotational member can be configured to translate proximally and distally within the device to aid in breaking up the clot and preventing the device from clogging during aspiration.

In various embodiments, the device for removal obstructive material can operate in rotational continuous mode, pulse mode and a combination of both. In some other embodiment rotations can be modulated. Modulation of rotations may include speed modulation through electronic adjustment of voltage, current, as well as, pulse parameters (ON/OFF time) or any combination of all.

In another embodiment, a device for removing obstructing matter from a patient includes a rotational member rotating around its primary axis, which also creates angular motion on the distal end of the rotating member Angular motion includes rotational motion of the rotational member which is off-set from the primary longitudinal axis of the rotational device.

In another embodiment, a device for removing obstructing matter from a patient includes a rotational member having a bend that changes longitudinal axial motion of the rotational member to angular motion. Such bend may be located along the length of the rotational member. If such bend or deformation is located on the distal end of the rotational member, it will rotate the distal end of the rotational member in angular motion while the proximal portion of the rotational member will mostly rotate along its primary longitudinal axis.

In yet another embodiment, a device for removing obstructing matter from a patient include a cam, an irregularly shaped projection located on a rotating shaft of the motor or on the rotational member that changes rotary motion into a reciprocating back and forth motion of the rotational member along its longitudinal axis.

In yet another embodiment, a device for removing obstructing matter from a patient includes a rotational member that is connected to a motion converter that changes its longitudinal motion in to a reciprocal and angular motion. Such converter can be located on the rotational shaft of the motor or on the rotational member. In such embodiment, the rotational member rotates in angular motion, while simultaneously; the rotational member is reciprocating back and forth.

In another embodiment of the present invention, the distal end of device for obstructive material removal has a change in cross sectional area, narrowing or distal taper to increase fluid aspiration velocity into the device. In addition, a bend or deflection is implemented on the very distal end of the device to cover a larger treatment area and create more angular motion.

Some embodiments of the present invention include advancing a device for obstruction material removal to the treatment site in conjunction with appropriate positioning of the device at the treatment site. Advancing the device may be accomplished by conventional approaches either using additional positioning catheter such as guiding catheter or sheath and/or with a guidewire. Guidewire-assisted methods may include any approach, such as over-the-wire or monorail deployment.

As noted above, some embodiments may include repeated applications, or multiple applications at the same site, or at another portion of a treatment site. Thus, for example, embodiments of the devices and methods may include repositioning the device for removal of obstructive material and repeating the step of activating the device. Positioning the device for obstructive matter removal at the target site may include positioning the device nearby the target site, or it may include contacting a healthy tissue at the treatment site.

Another aspect of the present invention may include plaque reduction to increase the patency of the afflicted vessel as a stand-alone intervention directed toward increasing vessel patency, or such treatments may be done in conjunction with other interventional approaches.

In various other embodiments of the present invention, removing obstructive material further include performing therapeutic, diagnostic, supporting or drug delivery procedure before, during or after obstructive material removal from the patient.

As used herein, “rotational member” and “rotating member” of the device for removal of obstructive material from the patient refer to same component.

As used herein, “obstructive matter” and “obstructive material” refer to same subject.

These and other aspects and embodiments will be described in further detail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF DRAWINGS

Certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description below having reference to the figures that follow.

FIG. 1 is a perspective view of an intracerebral hemorrhage treatment system, according to one embodiment;

FIG. 2 is a side, cross-sectional view of a blood clot removal device that is part of the system ofFIG. 1, according to one embodiment;

FIGS. 3A-3F are side views of six alternative embodiments of distal end configurations of rotating members of the blood clot removal device ofFIGS. 1 and 2, according to various alternative embodiments;

FIGS. 4A-4D are side, partial cross-sectional views illustrating a method for removing one or more clots from a cranium, according to one embodiment;

FIG. 5 is a side, cross-sectional view of an obstructing matter removal device that is attached to a separate rotational device as shown inFIG. 1 with addition of an inner catheter for irrigation delivery;

FIG. 6 shows a rotating member made of solid material having a continual cross sectional area;

FIG. 7 shows a rotating member a distal tapered configuration;

FIG. 8A-D show a rotating member with several different configurations;

FIG. 9 shows a rotating member having a bend on the distal portion;

FIG. 10A-B show a rotational member having a primary bend on the distal very end, and an adjacent secondary bend;

FIG. 11A-B show a converter that transforms circular rotations of the motor shaft into angular rotations and reciprocating motion of the rotational member;

FIG. 12A-D show several configurations and structures of the rotational member; and

FIG. 13A-C show several configurations of the distal end of the device for obstructive material removal having decreased cross sectional area on the distal end.

DETAILED DESCRIPTION

Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments. However, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

In the following description, embodiments will sometimes be described for use in treating intracerebral hemorrhage (ICH), which is one type of intracranial hemorrhage. This description related to ICH should not be interpreted as limiting any particular embodiment or this application as a whole to ICH treatment. In fact, many embodiments of the systems and methods described herein may be applied to either ICH or to other forms of intracranial hemorrhage. Therefore, unless an embodiment or feature is described specifically as applying only to ICH, any embodiment or feature may be used in treating ICH and/or other types of intracranial hemorrhage.

Referring now toFIG. 1, one embodiment of an ICH treatment system100 (or “ICH removal system”) may include ahardware box110, a blood clot removal device120 (or “catheter”), and a bloodclot collection bag130. Thehardware box110 may be placed on anIV pole140, for example, or may be attached to any other suitable support device in alternative embodiments. In various alternative embodiments, theICH system100 may include fewer components or additional components. For example, in one embodiment, thesystem100 may not include thecollection bag130, and some other type of collection device may be used, such as any suitable, currently available device for collecting blood or blood clots. In other embodiments, at least one introducer device may be included with thesystem100. For example, an introducer and/or a trocar may be included in thesystem100 in some embodiments. Therefore, the embodiment of thesystem100 illustrated inFIG. 1 is provided for exemplary purposes only and should not be interpreted as limiting the scope of the system.

Thehardware box110 may house an electrical motor and one or more vacuum pumps, neither of which are pictured inFIG. 1, since they are housed within thebox110. The front panel of theICH hardware box110 may include an ON/OFF switch111 for activating the vacuum pump and electrical motor, avacuum level indicator112 for indicating the vacuum level applied to the bloodclot removal device120, arotational inlet113 for attaching the bloodclot removal device120 to thehardware box110, and anaspiration inlet114 for attaching aspiration tubing206 (FIG. 2) of the bloodclot removal device120 to the hardware box110 (vacuum pump inside the hardware box110). In general, thebox110 contains a source of vacuum force and a motor for moving a rotating member220 (FIG. 2) in the bloodclot removal device120. Thebox110 may either contain or be attachable to a power source. For example, in some embodiments, thebox110 may be attached to an electrical cable (not shown) for plugging into a wall outlet. In other embodiment, thebox110 may include one or more disposable or rechargeable batteries.

Attachment of the bloodclot removal device120 to thehardware box110 connects aproximal end222 of the rotational member220 (FIG. 2) located inside theconnector208 of the blood clot removal device120 (FIG. 2) to aslot115 located on the motor shaft inside theinlet113. Theslot115 rotates when the motor is activated and thus rotates the proximalrotational member222. In various alternative embodiments, theinlet113 and/or theslot115 may have different configurations. For example, although this description focuses on aclot removal device120 having a proximal rotatingmember222, in alternative embodiments any suitable alternative form of moveable member may be substituted. For example, in some embodiments a member that translates, oscillates, vibrates and/or the like may be substituted for the proximal rotatingmember222. Thus, neither the bloodclot removal device120 nor the hardware box is limited to rotational movement. Generally, a blood clot, blood and/or other tissue that may be removed from the head or other part of the body, in various embodiments, is aspirated by the vacuum pump (not shown) located inside thehardware box110 through the blood clot removal device120 (FIG. 2) and acollection tube129 to thecollection bag130. Thecollection bag130 may be attached, for example, to ahook141 located on thepole140.

In one embodiment, a back panel of thehardware box110 may include an IV pole mounting clamp116, anaspiration outlet117, and anelectrical inlet118. Theaspiration outlet117 is used for coupling thecollection tube129 with thebox110. Theelectrical inlet118 is used for connecting an electrical cord for attachment to a wall outlet or other electrical power source. In various embodiments the rotatingproximal member222 can be directly affixed to an electrical motor, and in such configuration the electrical motor within an enclosure would become an integral part of the device120 (not shown). In one embodiment the electrical motor can be directly connected via electrical cable to the power source either in thebox110 or to the electrical outlet on the wall. In another embodiment, energy source such as batteries may be included with the motor in the enclosure. Irrigation inlet and aspiration outlet may also be attached to thebox110, or independently to any suitable irrigation pump and aspiration pump available.

With reference now toFIG. 2, the ICH bloodclot removal device120 may generally include three main portions—a rigiddistal tube201, ahandle assembly210, and aproximal shaft203. One continuousinner lumen212 may extend through most or all of the length of all three portions. Some embodiments may include two or more lumens. In various embodiments, the rigiddistal tube201 may have a length of about 10-45 cm, and more preferably about 15-30 cm, and an outer diameter of about 0.5-5 mm, and more preferably about 1-3 mm. The rigiddistal tube201 is rigid relative to theproximal shaft203 and has an open distal end202 (or a distal end with one or more openings) for aspirating blood clots, blood, etc. into thelumen212. The rigiddistal tube201 may also be referred to as a “wand,” and it will be sufficiently rigid to allow a physician user to push it to a desired location in the brain, but it will also have an atraumaticdistal end202 configured to minimize damage if it contacts a vital structure. The rigid distal tube may be made of any suitable, relatively rigid material, such as but not limited to a metal, metal alloys including superelastic Nitinol or polymer. Also, in some instances the rigid distal tube can be made of flexible materials as seen in vascular catheter devices.

Extending through thelumen212 is a rotatingmember220, which rotates rapidly at or near withdistal end202 to help break up blood clots as they enter thelumen212. The rotatingmember220 may include a shapedproximal end222, configured to couple with a driver/motor for rotating the rotatingmember220. The rotatingmember220 will be described further below.

Thehandle assembly210 provides a holding place for a user to hold thedevice120 and manipulate thedistal tube201. Thehandle assembly210 also provides a way for the user to regulate the vacuum level applied to thedistal end202 of thetube201. Thehandle assembly210 may include anaperture211 that is in fluid communication with aninner lumen212. If theaperture211 is open, as shown, vacuum applied to thecatheter120 from thehardware box110 brings in air from outside of thehandle210 through theaperture211. Thus, vacuum applied at thedistal end202 of thecatheter tube201 is minimal or significantly reduced when theaperture211 is open. If theaperture211 is closed, such as by covering it with a finger, during removal of a blood clot from inside a cranium, a maximum vacuum will be applied to thedistal end202 of thetube201. Thehandle210 can be made of metal, metal alloy including superelastic Nitinol, polymer, rubber or a combination thereof.

Theproximal shaft203 may be attached to thehandle210 or may be a proximal extension of thehandle210. Theproximal shaft203 is a typically a single lumen polymer tube. A sealedinsert204 connects theproximal shaft203 with aconnector208. The sealedinsert204 may include anoutlet205 for connecting to avacuum tube206 and a sealingmember207 for preventing air from entering theproximal shaft203 from the proximal end of thedevice120. Thus, the sealed insert helps ensure maximum aspiration pressure on thedistal end202 of thetube201 by preventing air leakage. Thevacuum tube206 may be connected to theaspiration inlet114 located on the front panel of the box110 (FIG. 1).

Theproximal connector208 is configured to enable attachment of the bloodclot removal device120 to theinlet113 inside thehardware box110. The rotatingmember220 extends longitudinally through the bloodclot removal device120 from theproximal connector208 to thedistal end202. The rotatingmember220 has adistal end221 located within thetube201 at or near the tube'sdistal end202. Theproximal end222 of the rotatingmember220 extends out of the proximal connector, in this embodiment. Theproximal insert222 is configured for easy connection with theslot115 located on the motor shaft inside therotational inlet113 of the box110 (FIG. 1). Thedistal end221 of the rotational member is configured to macerate blood clots when rotated and during aspiration of blood clots into thedistal end202 of thetube201. Such chopping up of blood clots under vacuum allows for an effective and continuous removal of blood clots.

Referring now toFIGS. 3A-3F, six alternative embodiments ofdistal ends221 of the rotatingmember220 are illustrated. These embodiments are by no means the only configurations that may be employed, but are merely provided for exemplary purposes. The embodiments of the distal end shown in these figures are a ball shaped distal end301 (FIG. 3A), a flat/circular distal end311 (FIG. 3B), a bent distal end321 (FIG. 3C), a coiled distal end of any pitch331 (FIG. 3D), a flat, proximal deformation341 (proximal to the extreme distal end of the rotatingmember220—FIG. 3E), a basket351 (FIG. 3F) and sinusoidal shape (not shown). Any configuration of therotational member220 that crushes, macerates, disintegrates or otherwise at least partially breaks up a blood clot at thedistal end202 of thetube220 or facilitates mashing blood clots along the entire length of theICH removal catheter120 is suitable for this application.

FIGS. 4A-4D illustrate a method for removing a blood clot from a cranium, according to one embodiment.FIG. 4A shows a cross-sectional view of thehuman head400, including the cranium401 (or “skull”), a few mainintracerebral vessels402 and a blood clot403 (or collection of multiple blood clots). For purposes of this description, no distinction is made between removing one blood clot and removing multiple blood clots from the brain. In various embodiments, the systems and methods described herein may be used for removing one clot, multiple clots in one location or multiple clots in different locations.

In some embodiments, a first step of a method for treating ICH may include forming an opening in the cranium. The opening is typically aburr hole405, which is a standard and commonly performed access opening through a skull. However, it can also be any other aperture often used for mini-craniotomy. In some embodiments, theburr hole405 or some other opening may have already been formed before the method is begun, for example by some other physician for another purpose. In either case, the next step in some embodiments may be to position anintroducer404 through theburr hole405 or other aperture in theskull401. A distal end of theintroducer404 may be positioned near to or inside the blood clot(s)403. Positioning of theintroducer404 can be achieved with the use of any suitable devices or currently available technology for helping position a device, including but not limited to ultrasound and neuro-navigational systems.

Referring toFIG. 4B, a next step of the method may involve advancing atrocar500 through theintroducer404. When adistal end501 of thetrocar500 is positioned at, within or near theclots403, the introducer distal end may be slightly retracted proximally away from theblood clots403 to allow trocar distal end501 a better view of theclots403. Thetrocar500 may be any suitable, currently available or yet to be invented trocar. Typically, the trocar will include visualization and working channels, and many different trocars are currently available for use in neurosurgical procedures. Examples of companies providing trocars include, but are not limited to, Storz (Hopkins 6° Telescope w/ Angled Eyepiece), Aesculap (Minop Intraventricular Neuroendoscopic System) and Adeor (Haematoscope).

In some embodiments, thetrocar500 may be advanced into thecranium401 and positioned at or nearblood clots403 without use of anintroducer404. In other words, the introducer step described in reference toFIG. 4A may be skipped in some embodiments.

Referring now toFIG. 4C, the next step in one embodiment may involve advancing the bloodclot removal device120 into thecranium401. In this embodiment, the bloodclot removal device120 is advanced through thetrocar500, which is advanced through theintroducer404. Thedistal tube201 is positioned through the working channel of thetrocar500. Thetrocar500 has a visualization feature (small camera) located at or near its distal end (not shown) that allows the physician to observe thedistal end202 of thetube201 in relation toblood clots403. When thedistal end202 of the tube is in a desired location near to, at or within the clot(s), the physician may activate theICH removal system100 by turning switch111 (FIG. 1) to the ON position. Whensystem100 is activated, aspiration and rotation of the rotating member220 (FIG. 2) begin. However, the system will be unable to removeblood clots403 until theaperture211 on thehandle assembly210 is covered by the physician's finger. When theaperture211 is closed,blood clots403 will be suctioned toward the aperture in thetube201, thus causing the rotatingmember220 to macerate theblood clots403. The maceratedclots403 continue to be suctioned proximally through theclot removal device120 and eventually exit thedevice120 and proceed through thevacuum tube206 into thecollection bag130.

FIG. 4D illustrates the same human head as that shown inFIGS. 4A-4C, after removingblood clots403 and removing the trocar and the catheter. It is common to such procedures thatresidual blood clots403 are left in the treatment area. Some of these blood clots maybe left due to inability to locate and remove them. Other blood clots maybe left to prevent further bleeding and creation of more blood clots. If vessels in the treatment area are bleeding after blood clots removal, one or more conventional tools may be used to cauterize these vessels.

FIG. 5 shows a device for obstructive material removal that utilizes a conventional irrigant, a sterile solution of sodium chloride (NaCl) to facilitate blood clot removal. This device is similar to one shown inFIG. 2 with addition ofinner irrigation catheter502, having anirrigation inlet503 and a divertingmember504 located inside the sealedinsert204. Theirrigation diverting member504 is constructed such way that irrigant is delivered intoirrigation inlet503, through thediverter504 and into theirrigation catheter502 without leaking into theaspiration outlet205. Theirrigation catheter502 is positioned around therotational member220. Theirrigation inlet503 is connected to an irrigation pump which maybe a part of thehardware system110 inFIG. 1 (not shown) or any other irrigation pumps available. It also can be connected to irrigation pressure bag commonly used in operational rooms. Thedistal end505 of theirrigation catheter502 may be terminated at any location along the rotatingmember220, preferable within its distal part. During the activation of the system the rotatingmember220 rotates axially while irrigation is delivered from theirrigation tube503 through the divertingmember504 to thedistal end505 of theirrigation catheter502, and along therotation member220. Irrigation liquid vacuumed by the inner aspiration forces inside theaspiration catheter203 ones it reaches thedistal end505 of theirrigation catheter502. The rotatingdistal end221 of therotational member220 changes compliance of material to be removed that is sucked into thedistal end202 by braking material, inducing cracks, creating channels, splitting, tearing, gashing, liquefying or other means such that the modified structure of the material to be removed is further dragged into theaspiration lumen212 of thedevice120, around theirrigation catheter502 and outside the body. Delivery of irrigant to thedistal end505 of theirrigation catheter502 provides a liquid flush to further facilitate obstruction material removal and transport under vacuum throughaspiration lumen212 of theprobe201 and thecatheter203. Delivery of irrigation to the distal portion of thedevice120 can also be accomplished using a space between outside surface of theirrigation catheter502 and inside channel of the aspiration lumen212 (not shown). In such case the inside lumen of thecatheter502 would serve as the aspiration lumen.

In addition to providing irrigation that facilitates obstructive material removal, flow of irrigant around therotational member220 may serve as a coolant. While rotating, therotational member220 may generate heat, especially around the divertingmember504 and sealinsert204. A continuous flow of irrigant around therotational member220 within the diverting member and the seal insert areas will reduce generated heat and increase device reliability and efficacy.

For a better visualization or location of thedevice120, a radiopaque marker orelectromagnetic sensor506 maybe located on the distal end of theirrigation catheter probe201. Also to assure a desirable positioning of the rotatingdistal end221 of therotational member220, a radiopaque marker orelectromagnetic sensor507 may be located on the distal end of therotational member220. In some embodiments theirrigation catheter203 structure can extend until thedistal end202 replacing theprobe201.

Thedistal end221 of therotational member220 can be positioned inside thedevice212, outside of thedevice212, or its location maybe adjusted by the operator as desirable during use. For a better navigation of thedevice120 to the treatment location, aguidewire lumen508 is implemented with thedistal end510 terminated on thedistal end202 of thecatheter probe201 orcatheter body203. Theproximal end509 of theguidewire lumen508 maybe terminated proximally along thecatheter probe201 orcatheter body203. Thedevice120 longitudinal configurations may include a flexible structure, rigid structure or combination of both, and maybe made of polymer, metal, metal alloys including Nitinol and combination of all.

FIG. 6 shows a close view of therotational member220 undergoing rotations around theaxis602 that is at its mass center. Thedistal end221 of therotational member220 develops a kinetic energy directly related to its mass moment of inertia. As thedistal end221 of therotational member220 rotates, its kinetic energy converts to potential energy. Therotational member220 represents a cantilever beam, a one side supported beam. Theproximal insert222 is configured for connection with theslot115 located insideapertures113 of thebox110 as shown inFIG. 1. Therotational member220 is connected through thedistal insert222 into theslot115. This juncture serves as one site support beam. Thus, therotating shaft220 uniformly distributes load (per unit length) causing a deflection on the distal end221 (unsupported end). When therotational member220 is rotated by theshaft600 of themotor601 located inside the box110 (FIG. 1), thedistal end221 will create transverse motions or displacement X fromlocation603 tolocation604. Forces of the potential energy and transverse motion at thedistal end221 of therotational member220 may be utilized to break or liquefy obstructing material to be removed.

FIG. 7 shows therotational member220 having a tapereddistal configuration700. Such tapering will increase deflection of thedistal end221 of therotational member220, and further increase its transverse motion XX frompoint701 topoint702. Transverse motion frequency parameters will also increase with increase of the taper ratio.

FIG. 9 shows another aspect of the present invention that includes therotational member220 having a primary bend ordeformation900 implemented on the distal portion of therotational member220. Such bend ordeformation900 will cause that the distal portion of the rotational member will undergo angular rotation around theradius901 in addition to transverse motions (not shown). The distal portion of therotational member220 will undertake angular motion along the length Y from thebend900 todistal end221 of therotational member220. In practical use, forces will be applied to the obstructing material by thedistal end221 of therotational member220, as well as, thebend900 which undergoes angular movement itself will further break, agitate, smash or liquefy material to be removed. Several bends maybe incorporated along the distal portion of therotational member220 to further increase device efficacy (not shown).

FIGS. 10A-B show similar configuration of therotational member220 as inFIG. 9 with exception that the verydistal end221 of therotational member220 comprises a primaryinward bend1000. Thus, thebend900 becomes a secondary bend.FIG. 10B comprises a primaryoutward bend1020 that is located on thedistal end221 of therotational member220, while having the samesecondary bend900. Suchinside bend1000 andoutside bend1020 in addition to thesecondary bend900 will add efficacy to break, liquefy and remove obstructive material. Several additional bends maybe incorporated along the distal portion of therotational member220 to further increase device efficacy (not shown).

FIG. 11A-B show another embodiment of the present invention comprising therotational member220 reciprocal motion in addition to angular motion.FIG. 11A show an apparatus comprising therotational member220 connected to a cam orconverter1100 that changes rotational motion of themotor shaft1101 shown byarrow1102 to a reciprocal motion shown byarrow1103 and longitudinal displacement X, Theconvertor1100 also produces angular motion of therotational member220 as shown byarrow1104. Such converter can be located on therotational motor shaft1101, on therotational member220 or it can be an integral part of either one. Theconverter1100 consists of a flat washer or a thincircular dish1105 that is attached to the distal end of the motor shaft1001 at angle α. Therotational member220 is attached off center to thecircular dish1105 atlocation1106. When themotor shaft1101 rotates along its longitudinal axis as shown by thearrow1102, the angularly attacheddish1105 undergoes circular rotation under the angle α. In addition, off center attachedrotational member220 undergoes angular motion as show byarrow1104. However, due tocircular dish1105 angulations at angle α, therotational member220 undertakes a linear back and forth motion at displacement or stroke X shown byarrow1103. A combination of angular motion and reciprocal motion of therotational member220 may further increase efficacy in removing obstructive material. Embodiments including a converter to angular and reciprocal motion may have a separate motor with appropriate attachment located inside thebox110 as shown inFIG. 1 or such motor can be affixed within the structure of the device (not shown).

FIG. 11B shows another apparatus of the present invention comprising a bend ordeflection1121 located on the distal end of themotor shaft1120. Themotor1122 and themotor shaft1121 are position at angle α in respect to therotational member220. While theshaft1120 of themotor1122 rotates in circular motion as shown by thearrow1123, thedistal end221 of therotational member220 attached to thebend1121 on the shaft of1120 at the attachment point1124 undergoes angular motion as shown byarrow1125 and also keeps on reciprocal motion X.

In yet another embodiment of the present invention an additional element may be attached at an angle to the distal end of therotational member220 to produce the same effect as the bend ordeflection1121 shown inFIGS. 10A and 10B. Such element can be made of metal, metal alloy including superelastic Nitinol, polymer, ceramic, rubber or combination of all and attached to the distal end of therotational member220 by bonding, fusing, melting, soldering, welding and other attachment methods known in the art. Also, a similar element may be attached at the distal portion of therotational member220 instead ofbend900 shown inFIGS. 10A and 10B. Both such elements maybe attached to therotational member220 creating a similar

primary bend

1000 and1020, as well as a similarsecondary bend900 as shown inFIGS. 10A and 10B. While addition of such elements is not show on any of figures of the present invention, addition of such embodiments would be obvious for any person familiar with the art.

The method of action described and shown inFIG. 11A-B may be used with embodiments described inFIGS. 5-10 as desired. Therotational member220 may reciprocate at frequencies anywhere between 1 Hz-20000 Hz and stroke range can be between 0.1 mm-10 mm. Such reciprocating apparatus as show inFIG. 11A-B may comprise means for adjusting the force with which therotational member220 is accelerated. To this end therotational member220 may be spring loaded and the spring force may be varied.

FIGS. 12A-D show several configurations of therotational member220.FIG. 12A shows therotational member220 comprising a continual solid configuration,FIG. 12B shows therotational member220 made of a tubular configuration; both with the same dimensions and same cross sectional area along its length. The tubular rotational member shown inFIG. 12B could be configured to deliver the irrigation fluid, thereby eliminating the need for aseparate irrigation catheter502 as shown inFIG. 5. The tubular rotational member shown inFIG. 12B could also be configured to have a closed distal end and openings at other distal locations to control where the irrigation fluid would exit from the tubular distal member (not shown). The tubular rotational member inFIG. 12 B could be made out our superelastic materials such as Nitinol.FIG. 12C shows a dual configuration of therotational member220 that is a combination of a continual solid member and continual tube connected together.FIG. 12D shows an example of a bundle that consists of three solid components connected to a tube component.

Rotational member

220 embodiments described and showed inFIGS. 12A-D may be made of but not limited to metal, metal alloy including Nitinol, ceramics, polymer or combination of all and have configurations comprising of but not limited to solid, hollow, multimember or combination of all. Furthermore,rotational member220 may have cross sectional configurations made of but not limited to circular, oval, square, rectangular or any combination of all.

Although the invention has been described above with respect to certain embodiments, it will be appreciated that various changes, modifications, deletions and alterations may be made to above-described embodiments without departing from the spirit and scope of the invention. Accordingly, it is intended that all such changes, modifications, additions and deletions will be incorporated into the scope of the following claims. More specifically, description and examples have been provided that relate to treatment and removal of obstructive material from areas appropriate for treating such sites. However, the scope of the invention includes other application related to obstructive material removal from treatment sites including endovascular location, outside of endovascular locations, as well as, cancerous tissue removal, tumor or other particular target site.

Various alternative embodiments may involve use of such rotational medical devices to remove blood clots or other tissue located in other parts of a patient's body, either inside or outside of the patient's endovascular system. Locations inside the endovascular system may include, but are not limited to, the arterial system, the venous system, fistulas, vascular grafts and/or combinations thereof. Locations outside the endovascular system may include, but are not limited to, internal organs and the head. In some embodiments, one or more minor device modifications may be made to the embodiment of the system described above, to accommodate a different anatomical usage within the body. For example, in one embodiment, the blood clot removal device may have a flexible, rather than a stiff, distal portion to facilitate accessing clots in a different part of the body.

Elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. The invention is susceptible to various modifications and alternative forms and should not be limited to the particular forms or methods disclosed. To the contrary, the invention is to cover all modifications, equivalents and alternatives thereof.

Some scientific and theoretical considerations have been provided as to the mechanism by which the devices and therapeutic methods are effective; these considerations have been provided only for the purpose of conveying an understanding of the invention, and have no relevance to or bearing on claims made to this invention.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims

What is claimed is:

1. A device for removing obstructive material from a patient, the device comprising:

an elongate rotational member having a distal end and a proximal end;

an internal irrigation catheter at least partially surrounding the rotational member; and

an aspiration catheter at least partially surrounding the rotational member and the irrigation catheter,

wherein the distal portion of the rotational member is configured to change compliance of the obstructive material and facilitate obstructive material aspiration outside the patient.

2. The device ofclaim 1, wherein the rotational member is configured to move in at least one way selected from the group consisting of rotational motion along its longitudinal axis, angular motion, reciprocal motion and combinations thereof.

3. The device ofclaim 1, wherein the rotational member has a shape selected from the group consisting of continuous diameter along its length, tapered along its entire length, tapered along a distal portion in a distal direction and tapered along a distal portion in a proximal direction.

4. The device ofclaim 1, wherein the rotational member comprises at least one longitudinal member selected from the group consisting of a single solid rod, multiple solid rods, a tube and combinations thereof.

5. The method ofclaim 4, wherein the rotational member has a shape selected from the group consisting of circular, oval, square and rectangular.

6. The device ofclaim 1, wherein the rotational member comprises a material selected from the group consisting of metals, polymers, metal alloys and combinations thereof.

7. The device ofclaim 1, further comprising a handle disposed on the aspiration catheter including an aperture in fluid communication with the lumen and configured to be covered with a finger of a user to regulate application of the vacuum.

8. The device ofclaim 1, further comprising a radiopaque marker positioned on at least one of a distal end of the aspiration catheter or the distal end of the rotational member.

9. The device ofclaim 1, further comprising a guidewire lumen.

10. The device ofclaim 1, wherein the distal end of the rotational member has a shape selected from the group consisting of a ball shape, a flat circular end, a bent distal end, a coiled distal end, a flat deformation, a basket, and a sinusoidal shape.

11. The device ofclaim 1, wherein a distal portion of the rotational member includes at least one bend.

12. The device ofclaim 1, wherein the distal end of the rotational member is housed in a location selected from the group consisting of inside the device, outside of the device, and moveable between inside and outside the device.

13. A device for removing obstructive material from a human body, the device comprising:

a rotational member having a proximal portion and a distal portion that tapers in a direction from proximal to distal and configured to rotate angularly in a distal direction;

an aspiration catheter disposed over the rotational member; and

means to deliver irrigation inside the aspiration catheter.

14. The device ofclaim 13, wherein the distal portion of the rotational member further includes at least one bend.

15. The device ofclaim 13, wherein the proximal portion of the rotational member is configured to rotate axially.

16. A device for removing obstructing matter from a human body, the device comprising:

a rotational member having a proximal portion and a distal portion that includes at least a primary bend at or near a distal end of the rotational member, wherein the rotational member is configured to rotate angularly in a distal direction; and

an aspiration catheter disposed over the rotational member.

17. The device ofclaim 16, wherein the primary bend comprises an inwardly directed bend.

18. The device ofclaim 16, wherein the primary bend comprises an outwardly directed bend.

19. The device ofclaim 16, further comprising at least one secondary bend on the distal portion of the rotational member.

20. A device for removing obstructing matter from a human body, the device comprising:

a rotational member connected to a converter that changes axial rotary motion into angular and reciprocating motion; and

an aspiration catheter;

wherein the rotational member changes compliance of the obstructive material to facilitate removal of the obstructive material outside the body.

21. A device for removing obstructing matter from a human body, the device comprising:

a rotational member;

an aspiration catheter; and

irrigation catheter,

wherein a distal end of the device has a smaller cross sectional dimension than an adjacent proximal portion part of the device.

22. The device ofclaim 21, wherein a configuration of the device toward its distal end is selected from the group consisting of at least one step cross sectional area reduction and a continuous taper.

23. The device ofclaim 22, further including a bend on the distal end of the device.