Patent Description:
The prior art relates to mechanical thrombectomy apparatuses, some apparatuses use maceration and some use aspiration. <CIT> and <CIT> are both directed to a rotational thrombectomy wire for breaking up thrombus or other obstructive material, both of which are incorporated herein by reference. <CIT> discloses a rotational thrombectomy wire for breaking up vascular thrombus or other obstructive material including a core having proximal region and a distal region and being rotatable by a motor. <CIT> discloses a tissue removing catheter which is advanced over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and a proximal end portion of the catheter outside of the body lumen. <CIT> discloses hemostasis valves and methods of use for sealing medical devices, particularly during intravascular access. <CIT> discloses an apparatus and method for clot aspiration and includes a vacuum system having a vacuum console and a blood/clot collection canister. Relevant prior art is also disclosed in <CIT> and <CIT>.

An embodiment of the disclosure meets the needs presented above by generally comprising a disposable thrombectomy maceration and aspiration apparatus and system for macerating and aspirating thrombus or other obstructive material in a lumen of a vascular graft or vessel.

The disclosure will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:.

With reference now to the drawings, and in particular to <FIG> thereof, a new thrombectomy system embodying the principles and concepts of an embodiment of the disclosure and generally designated by the reference numeral <NUM> will be described.

A disposable thrombectomy maceration and aspiration system <NUM> for macerating and aspirating thrombus or other obstructive material in a lumen of a vascular graft or vessel is best illustrated in <FIG>. The system <NUM> comprising three components: a disposable integrated aspiration pump and fluid collection device <NUM>, a disposable integrated thrombectomy and aspiration apparatus <NUM>, and a catheter <NUM>. As shown in <FIG> the catheter <NUM> and apparatus <NUM> couple together directly while the apparatus <NUM> and device <NUM> may be connected via a connection catheter <NUM>.

The disposable integrated aspiration pump and fluid collection device <NUM> has a base <NUM>, and the base <NUM> has a base compartment <NUM>. The base <NUM> may be made from any rigid material structurally capable of supporting the device <NUM>. Suitable rigid materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available.

A pump <NUM>, located in the base compartment <NUM>, has an intake port <NUM> and an exhaust port <NUM>. The pump <NUM> is designed to operate at a relatively low flow rate but to exert a large vacuum pressure. The pump flow rate in the present embodiment is configured to operate over <NUM> liters per minute (L/min) and to exert a vacuum pressure between <NUM> kPa (<NUM> inHg) and absolute vacuum, where absolute vacuum is <NUM> kPa (<NUM> inHg). As shown in <FIG>, the pump <NUM> in the present embodiment is attached to the base <NUM> by a pump mount <NUM>. The pump <NUM> may include additional features, such as a silencer <NUM>, to reduce the noise or provide additional benefits for the user. The pump <NUM> is designed to be disposable and compact to reduce the size needed for the base compartment <NUM> and to reduce the costs associated with long-use pumps of a similar nature that are commercially available. In the present embodiment, the pump utilizes diaphragm pumping technology to reduce the costs, while maintaining the high vacuum pressures.

As shown in <FIG>, a fluid collection compartment <NUM> is located above the base <NUM>. A column <NUM> extends within the fluid collection compartment <NUM> in substantially a vertical direction. The column <NUM> has a lower portion <NUM> and an upper portion <NUM> and forms a cavity <NUM> within the column <NUM>. The cavity <NUM> in the column <NUM> is in fluid communication with the base compartment <NUM> and is closed off at the upper portion <NUM>. The fluid collection compartment <NUM> will collect the macerated particulate, or other removed material, pulled into the fluid collection compartment <NUM> by the vacuum pressure the pump <NUM> creates.

A manifold <NUM> is located at the upper portion <NUM> of the column <NUM> and includes one or more inlets <NUM>. The manifold <NUM> has a generally disc shaped portion <NUM> and the disc shape portion <NUM> has a lower surface <NUM> which includes the inlets <NUM>, whereby the inlets <NUM> face in a downward direction as shown in <FIG>. The inlets <NUM> are configured to allow the vacuum pressure to be applied to the fluid collection compartment <NUM> while minimizing the chance of fluids entering the pump <NUM>.

A suction tube <NUM>, which has a first end <NUM> and a second end <NUM>, is found within the column <NUM>. The first end <NUM> of the suction tube <NUM> is in fluid communication with the intake port <NUM> of the pump <NUM>. The suction tube <NUM> then extends substantially vertically through the cavity <NUM> of the column <NUM> where the second end <NUM> of the suction tube <NUM> is in fluid communication with the inlets <NUM> on the manifold <NUM>. The suction tube <NUM> may be made of any suitable material which is rigid enough to not collapse under the vacuum pressure. Suitable materials may include plastics, metals, composites, or other natural and artificial materials commercially available. The suction tube <NUM> may be operably attached to the intake port <NUM> of the pump <NUM> by any mechanical means sufficient to prevent detachment while maintaining a seal needed to maintain the vacuum pressure in the fluid collection compartment <NUM>.

A controller <NUM> is also located in the base compartment <NUM> of the base <NUM>. The controller <NUM> is electronically coupled to a fluid level sensor <NUM> and an audible alarm <NUM>. The fluid level sensor <NUM> is located at a designated sensor elevation <NUM> within the fluid collection compartment <NUM>. The fluid level sensor <NUM> detects the presence of fluid at the designated sensor elevation <NUM> and communicates that status to the controller <NUM>. The controller <NUM> includes a means to activate the audible alarm <NUM> for a preset amount of time when the fluid level sensor <NUM> detects fluid at the designated sensor elevation <NUM>, and at the end of the preset amount of time, the controller mechanism shuts off the pump <NUM>. This shut-off on the controller <NUM> allows for the device <NUM> to automatically shut off the pump <NUM> while notifying the user of both the status of the fluid collection compartment <NUM> and the impending loss of vacuum. This feature allows the user to focus on the procedure and to continue to operate once the audible alarm <NUM> is heard to get to the safest position possible for the patient before the pump <NUM> is shut off and the vacuum is lost. While the fluid collection compartment <NUM> may be visible during use, the fluid level sensor <NUM> reduces the need to visually check on the fluid level to prevent overfilling. If a procedure would require continued use, the full device <NUM> can be removed and a second disposable integrated aspiration pump and fluid collection device <NUM> could be coupled to continue with the procedure without having to remove the catheter <NUM> from the patient. <FIG> illustrates how the controller <NUM> may be a part of a larger Printed Circuit Board (PCB) <NUM> wherein the audible alarm <NUM> and other components are coupled to the controller <NUM> via the PCB <NUM>. <FIG> is an illustrative diagram of the components electronically coupled to the controller <NUM>.

The fluid level sensor <NUM> in the present embodiment includes a non-contact capacitance sensor. The fluid level sensor <NUM> is located on an inner surface <NUM> of the column <NUM>. The column <NUM> also has an outer surface <NUM>. The fluid level sensor <NUM> includes a strip of copper <NUM> with a first <NUM> end and a second <NUM> end and is located on the inner surface <NUM> of the column <NUM> extending around a portion of the circumference of the inner surface <NUM> of the column <NUM>, as illustrated in <FIG>. The strip of copper <NUM> forms a gap between the first <NUM> and second <NUM> ends of the strip of cooper <NUM>. <FIG> illustrates where a hydrophobic film <NUM> is located on at least a portion of the outer surface <NUM> of the column <NUM>. The hydrophobic film <NUM> repels the macerated fluids to reduce the chance of the fluid level sensor <NUM> picking up temporary increases in the fluid level. Scenarios where this may occur is if the device <NUM> is bumped or the aspirated particulate splashes to the designated sensor elevation <NUM>.

A sensor wire <NUM> couples the strip of copper <NUM> to the controller <NUM>. A portion of the suction tube <NUM> extends within the cavity <NUM> of the column <NUM> and is covered by a shielding material <NUM>. A shielding wire <NUM> with a first end <NUM> and a second end <NUM> with the first end <NUM> of the shielding wire <NUM> being coupled to ground on the controller <NUM> and the second end <NUM> of the shielding wire <NUM> being coupled to the shielding material <NUM>. The shielding wire <NUM> helps focus the fluid level sensor <NUM> on sensing outside the column <NUM>. The fluid level sensor <NUM> as shown in the present embodiment is only one method for sensing fluid levels through an adjacent wall. Other commercially available methods, such as an inductive field, could also be implemented to provide the same benefit.

The base compartment <NUM> also has a battery compartment <NUM> and battery contacts <NUM> for receiving one or more batteries <NUM>. The battery contacts <NUM> couple the batteries <NUM> to the controller <NUM> to provide power. The base <NUM> also has a battery door <NUM> for removing and disposing of the batteries <NUM> separate from the device <NUM> and a vent <NUM> in fluid communication with the base compartment <NUM> and ambient air. The batteries <NUM> may be rechargeable or disposable. Suitable batteries <NUM> may include dry cell, lithium-ion, nickel metal hydride or other commercially available batteries capable of powering the device <NUM>. In the present embodiment, lithium CR2 batteries <NUM> are shown.

Illustrated in <FIG>, a fluid filter <NUM> located within the fluid collection compartment <NUM> may also be included in the device <NUM>. The fluid filter <NUM> has a fluid permeable ledge <NUM> to allow a portion of the macerated thrombus to remain on the fluid filter <NUM> for observation while the liquid portions of the aspirated materials will pass through to the fluid collection compartment <NUM>. This observation aids the user in evaluating the type of materials being aspirated and allows for additional visibility when the aspirated fluids may otherwise obscure the macerated materials. <FIG> illustrates how the fluid filter <NUM> also reduces access of tools or equipment into the fluid collection compartment <NUM> to prevent attempts at re-sterilization and reuse. The fluid filter <NUM> may be made of a structurally rigid material capable of withstanding the necessary forces. Examples of suitable rigid materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available.

A float shut-off mechanism <NUM> is configured to mechanically seal the suction tube <NUM> off from the fluid collection compartment <NUM> should the fluid collection compartment <NUM> fill up and the fluid level sensor <NUM> fail to shut off the pump <NUM>. The float shut-off mechanism <NUM> includes a float <NUM> located below the inlets <NUM> of the manifold <NUM>, whereby when the level of fluid rises and raises the float <NUM> to a designated maximum fluid elevation <NUM>, the float <NUM> will engage the inlets <NUM> and close off the fluid communication between the inlets <NUM> and the fluid collection compartment <NUM>. An embodiment may further include a seal layer <NUM> fixed to the float <NUM> to provide improved engagement to close off the fluid communication between the inlets <NUM> and the fluid collection compartment <NUM>. <FIG> illustrates the location of the seal layer <NUM> adjacent to the manifold <NUM> when the float <NUM> is in a shut-off level position <NUM> at the designated maximum fluid elevation <NUM>. The need for a mechanical backup to the electronic fluid level sensor <NUM> shut-off is another safety measure to protect the patient from over-aspiration. From a product design standpoint the float shut-off mechanism <NUM> also prevents the pump <NUM> from pulling aspirated materials into the pump <NUM> itself through the suction tube <NUM>.

A pressure transducer <NUM> and a pressure display <NUM> are located in the base compartment <NUM> and coupled to the controller <NUM>. The pressure transducer <NUM> is in fluid communication with the suction tube <NUM>. The controller <NUM> includes a means of determining the pressure measured at the pressure transducer <NUM> and displaying the measured pressure on the pressure display <NUM>. To maximize the pressure, the controller <NUM> includes means for operating the pump <NUM> to regulate the pressure wherein the controller <NUM> regulates the pressure to a preset maximum vacuum and accordingly displays the preset maximum vacuum pressure on the pressure display <NUM>. The pressure display <NUM> may consist of a segment bar display.

The function of the pressure transducer <NUM> and pressure display <NUM> allows the user a means of verifying the pressure being applied by the pump <NUM>. The pressure display <NUM> may use any commercially available means of conveying these conditions. Examples include LEDs, LCDs, digital readouts, and other visible means of communication. In the present embodiment, the pressure display <NUM> uses the segment bar display method wherein an initial bar indicates the device <NUM> has been activated and sequential bars are illuminated to indicate the relative pressure sensed by the pressure transducer <NUM> with the final bar in the sequence indicating maximum pressure being sensed.

A lid <NUM> closing off the top of the fluid collection compartment <NUM> may be included in the device <NUM>. The lid <NUM> is removable to expose the interior of the fluid collection compartment <NUM>. A suction port <NUM> in fluid communication with the fluid collection compartment <NUM> is attached to the lid <NUM>. <FIG> illustrates how the suction port <NUM> has a catheter fitting <NUM> for coupling to catheters, whereby the catheter may be connected to another medical device. In the present embodiment, the catheter is the connection catheter <NUM>, which is used to couple the device <NUM> to the apparatus <NUM>. However, the catheter may also be a traditional catheter used to aspirate within the patient. Additionally, the catheter may simply be a connecting tube used to couple the device <NUM> to a medical device that requires aspiration.

The catheter fitting <NUM> extends from the lid <NUM> in a horizontal direction to provide a low profile, and optionally includes the connection catheter <NUM> with a first end <NUM> and a second end <NUM>. The first end <NUM> of the connection catheter <NUM> is secured to the catheter fitting <NUM> and the second end <NUM> of the connection catheter <NUM> has an aspiration coupling <NUM>. <FIG> illustrates how the lid <NUM> and connection catheter <NUM> project horizontally and an additional option wherein the connection catheter <NUM> may coil up to save space during packaging and transportation. The connection catheter <NUM> may be any suitable connection tube of medical grade, examples including catheters and other commercially available tubes used in medical devices. The aspiration coupling <NUM> in the present embodiment is used to removably couple the device <NUM> to the disposable integrated thrombectomy and aspiration apparatus <NUM>. A manually operated pressure equilibration valve <NUM> may be secured to the fluid collection compartment <NUM> wherein when operated it will equalize the pressure in the fluid collection compartment <NUM> to ambient pressure. The pressure equilibration valve <NUM> allows for easier removal of the lid <NUM> from the device <NUM> by removing the vacuum from within the fluid collection compartment <NUM>.

In the present embodiment, the base <NUM> includes a base sidewall <NUM> and a base top wall <NUM>, and base bottom wall <NUM> which define the base compartment <NUM>. The column <NUM> extends vertically from the base top wall <NUM>. The base top wall <NUM> includes an upper surface <NUM> surrounding the column <NUM> and includes a first ribbed pattern <NUM> which rises above the upper surface <NUM> of the base top wall <NUM>. The first ribbed pattern <NUM> is configured to dissuade attempts at reusing the device <NUM> by confirming re-sterilization is problematic. The first ribbed pattern <NUM> may be any pattern or feature capable of accomplishing this goal, including a hexagon pattern, a honeycomb pattern, a wavey pattern, a crosshatch pattern, or other conceivable pattern wherein re-sterilization is made more difficult when compared to a smooth flat surface. As shown in <FIG>, the first ribbed pattern <NUM> is a hexagon pattern in the present embodiment.

In the present embodiment shown in <FIG>, the column <NUM> is generally cylindrical and includes the lower portion <NUM> and the upper portion <NUM>. The lower portion <NUM> of the column <NUM> has a tapered profile in the vertical direction. The lower portion <NUM> of the column <NUM> and the upper portion <NUM> of the column <NUM> are separated by a stepped portion <NUM>. In the present embodiment the fluid filter <NUM> is located on the column <NUM> at the stepped portion <NUM>. The upper portion <NUM> includes a tapered profile in the vertical direction with the manifold <NUM> secured to the upper portion <NUM> of the column <NUM>.

The device <NUM> may further include a canister housing <NUM> made of a transparent material to aid in visibility of the macerated particulate. The canister housing <NUM> has a main cylindrical portion <NUM> with an open top end <NUM> and an open bottom end <NUM> as best illustrated in <FIG>. The open bottom end <NUM> of the canister housing <NUM> is closed by the base <NUM>. The removable lid <NUM> seals the open top end <NUM>. The lid <NUM> includes an upper surface <NUM> and a lower surface <NUM>. The lower surface <NUM> of the lid <NUM> includes a second ribbed pattern <NUM> which extends below the lower surface <NUM> of the lid <NUM>. The main cylindrical portion <NUM> of the canister housing <NUM>, the lid <NUM>, the upper surface <NUM> of the base top wall <NUM>, and the column <NUM> of the base <NUM> define the fluid collection compartment <NUM>. The second ribbed pattern <NUM> is configured to dissuade attempts at reusing the device <NUM> by confirming re-sterilization is problematic. The second ribbed pattern <NUM> may be any pattern or feature including a hexagon pattern, a honeycomb pattern, a wavey pattern, a crosshatch pattern, or other conceivable pattern wherein re-sterilization is made more difficult when compared to a smooth flat surface. <FIG> illustrates that the second ribbed pattern <NUM> is a hexagon pattern in the present embodiment.

<FIG> shows an embodiment wherein, the base sidewall <NUM> may be cylindrical and include a base width <NUM> and a base sidewall height <NUM>. Also, the main cylindrical portion <NUM> of the canister housing <NUM> has a main cylindrical portion width <NUM> and height <NUM>. The base width <NUM> is wider than the main cylindrical portion width <NUM>. The base sidewall height <NUM> is less than the main cylindrical portion height <NUM>.

An embodiment as shown in <FIG> may include the base sidewall <NUM>, base top wall <NUM> and the column <NUM> as a unitary molded component <NUM>. An outer perimeter portion <NUM> of the base top wall <NUM> is generally flat and void of the first ribbed pattern <NUM>. The canister housing <NUM> may include an annular shelf <NUM> extending radially outward from the open bottom end <NUM> of the main cylindrical portion <NUM>. An area of the annular shelf <NUM> is located above the outer perimeter portion <NUM> of the base top wall <NUM>, and a skirt <NUM> extends downward from the annular shelf <NUM> of the canister housing <NUM>. The skirt <NUM> is in an opposed facing relationship with the base sidewall <NUM>. The base sidewall <NUM> includes at least one opening <NUM> for access to a power switch <NUM> and viewing of the pressure display <NUM>, the power switch <NUM> and the display are located in the base compartment <NUM> with the skirt <NUM> having an aperture <NUM> to be generally aligned with the power switch <NUM>.

In an embodiment, the base bottom wall <NUM> is a separate component from the base <NUM>, and includes the battery door <NUM> for gaining access to the battery compartment <NUM>. The base bottom wall <NUM> supports the pump <NUM>, the controller <NUM>, the printed circuit board, the pressure transducer <NUM>, the audible alarm <NUM>, the power switch <NUM> and the pressure display <NUM> (specifically a segment light bar). The vent <NUM> in fluid communication with the base compartment <NUM> may also be a part of the base bottom wall <NUM>. As illustrated in <FIG>, a lower surface <NUM> of the base bottom wall <NUM> has low profile legs <NUM> to raise the lower surface <NUM> of the base bottom wall <NUM> and provide unobstructed flow for the vent <NUM>. The printed circuit board <NUM> (PCB) aids in reducing the space needed to couple the controller <NUM> to the associated elements controlled by the controller <NUM>. This allows the device <NUM> to remain compact, while also reducing the need for various connecting wires to the individual elements.

The low profile legs <NUM> are configured to elevate the device <NUM> above the environment surface during operation. The height of the low profile legs <NUM> may be between <NUM> (. <NUM>") to <NUM> (. <NUM>") so as to maintain a low center of gravity to improve stability. This elevation may improve the traction and stability of the device <NUM> when resting on the environment surface and also to allow improved venting of the positive pressure created by the pump <NUM> by increasing the volume of air being expressed through the vent. The base bottom wall <NUM> and low profile legs <NUM> may be made from any rigid material structurally capable of supporting the device <NUM>. Suitable rigid materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available. The low profile legs <NUM> may have an additional coating or be made from a material providing increased friction to reduce movement during operation. The low profile legs <NUM> may additionally be an integral portion of the base bottom wall <NUM> or base <NUM> to reduce the need for additional components.

In an embodiment, the manifold <NUM> includes the generally disc shaped portion <NUM> which has the lower surface <NUM> which contains the inlets <NUM> facing in a downward direction. The manifold <NUM> includes a manifold tube portion <NUM> extending downward into the column <NUM> being in fluid communication with the second end of the suction tube. The first end <NUM> of the suction tube <NUM> is in fluid communication with a mid-section <NUM> which has a tap <NUM> configured to attach to a pump intake tube <NUM> and a mid-section tube <NUM>. <FIG> illustrates the present embodiment's layout for the pump intake tube <NUM>, mid-section <NUM>, tap <NUM> and mid-section tube <NUM>. The pump intake tube <NUM> is coupled to the intake port <NUM> of the pump <NUM>. The mid-section tube <NUM> is coupled to the pressure transducer <NUM>. Additionally, the float <NUM> is generally disc shaped and has a cylindrical bore <NUM> and an upper surface <NUM>, wherein the column <NUM> extends through the cylindrical bore <NUM>. The float <NUM> has a low fluid level position <NUM> and the shut-off level position <NUM>, wherein in the shut-off level position <NUM>, the upper surface <NUM> of the float <NUM> engages the inlets <NUM> and closes off the fluid communication between the inlets <NUM> and the fluid collection compartment <NUM>. The float <NUM> moves between the low fluid level position <NUM>, illustrated in <FIG>, and the shut-off level position <NUM>, illustrated in <FIG>.

The disposable integrated thrombectomy and aspiration apparatus <NUM> for breaking up and aspirating thrombus or other obstructive material in a lumen of a vascular graft or vessel is removably coupled to the disposable integrated aspiration pump and fluid collection device <NUM>. The apparatus <NUM> includes the following major components: a maceration wire <NUM>, a motor <NUM> operatively connected to the maceration wire <NUM>, and an aspiration pathway <NUM>.

The maceration wire <NUM> extends in an axial direction and is configured to macerate the thrombus when rotated about a linear axis <NUM>. The maceration wire <NUM> has a first arcuate region <NUM> extending in a first direction transverse to the axial direction and a second arcuate region <NUM> spaced in the axial direction from the first arcuate region <NUM> and extending in a second direction transverse to the axial direction. The first <NUM> and second <NUM> arcuate regions are positioned near a terminating end <NUM> of the maceration wire <NUM>. The maceration wire <NUM> may comprise a variety of layers and segments with these layers and segments being used to provide the flexibility and shape required for the above features.

In the present embodiment, the maceration wire <NUM> includes a tip <NUM> at the terminating end <NUM> of the maceration wire <NUM> as illustrated in <FIG>. The tip <NUM> is configured to blunt the terminating end <NUM> to reduce trauma to the patient. The maceration wire <NUM> includes a coil core <NUM>, a coil casing <NUM>, and a terminating end cover <NUM> all designed to allow the maceration wire <NUM> to be flexible enough to have the first <NUM> and second <NUM> arcuate regions when deployed with the terminating end cover <NUM> providing a layer of protection between the coil casing <NUM> and the lumen of the patient.

The motor <NUM> is operatively connected to the maceration wire <NUM> opposite the terminating end <NUM> so as to rotate the macerating wire about the linear axis <NUM> such that the first arcuate region <NUM> and the second arcuate region <NUM> break up the thrombus or other obstructive material in the lumen. The motor <NUM> may be any commercially available motor suitable to the task of rotating the maceration wire <NUM> during operation. The motor <NUM> may be attached to the maceration wire <NUM> by any means capable of permanently securing the maceration wire <NUM> in place and maintaining that connection during operation whereby the wire will rotate when the motor <NUM> is actuated. Commercially available means may include one or more mechanical clamping, fusing, fastening, compressing sheaths or other suitable connection means. In the present embodiment a microtube <NUM> is permanently crimped to the maceration wire <NUM> opposite the terminating end <NUM> and attached to a drive shaft <NUM> of the motor <NUM> via a flexible coupler <NUM> which fixes the maceration wire <NUM> to rotate along with the drive shaft <NUM>.

The aspiration pathway <NUM> extends in the axial direction between a catheter connection port <NUM> and an aspiration pump connection port <NUM> and has an interior surface <NUM>. The catheter connection port <NUM> is configured to removably couple the catheter <NUM> to the apparatus <NUM> and the aspiration pump connection port <NUM> is configured to removably couple the apparatus <NUM> to the device <NUM> described above. Figure A-A illustrates how at least a portion of the aspiration pathway <NUM> includes an annular portion <NUM> defined as the boundary between the interior surface <NUM> of the aspiration pathway <NUM> and the maceration wire <NUM> whereby the macerated particulate may be aspirated from the patient. At least a portion of the interior surface <NUM> is slidable in relation to the maceration wire <NUM> when that portion is moved between a deployed position <NUM> and a retracted position <NUM>. <FIG> Illustrates the apparatus <NUM> in the deployed position <NUM>, and <FIG> illustrates the apparatus <NUM> in the retracted position <NUM>. The maceration wire <NUM> extends through the catheter connection port <NUM> and into the catheter <NUM> when the catheter <NUM> is coupled to the apparatus <NUM>.

The aspiration pathway <NUM> has an extraction portion <NUM> whereby the macerated particulate may be diverted from the annular portion <NUM> at a diversion point <NUM> positioned between the aspiration pump connection port <NUM> and the catheter connection port <NUM>. The aspiration pathway <NUM> is further defined in part by an internal surface <NUM> of the extraction portion <NUM>.

A variable flow control valve <NUM> may be located in the aspiration pathway <NUM> and configured to operate between a fully open condition <NUM> and a fully closed condition <NUM> whereby the user controls the amount of vacuum pressure passing through the aspiration pathway <NUM> by adjusting the variably flow control valve to the fully open condition <NUM>, to the fully closed condition <NUM>, or to position between the fully open <NUM> and the fully closed <NUM> conditions. In the present embodiment the aspiration valve is positioned in the extraction portion <NUM> nearer the aspiration pump connection port <NUM> than the diversion point <NUM>.

The variable flow control valve <NUM> in the present embodiment comprises a plunger <NUM> which is biased <NUM> upwardly in the fully closed condition <NUM> with an aspiration shaft <NUM> extending from the plunger <NUM> configured to allow the user to manually press the plunger <NUM> downwardly and out of the aspiration pathway <NUM> to engage the fully open condition <NUM>. The variable flow control valve <NUM> may comprise any method capable of controlling aspiration through the aspiration pathway <NUM>, this includes all types of mechanical valves capable of opening and closing access through the aspiration pathway <NUM>. The benefit to the present embodiment is that the user can manually control the aspiration between the fully open <NUM> and fully closed <NUM> conditions as desired for the specific procedure. This variable flow control valve <NUM> further improves user operability by not requiring the user to use the aspiration pump device <NUM> as the sole means of starting and stopping aspiration during the procedure. When not required, the variable flow control valve <NUM> can be placed in the fully closed position while the aspiration pump device <NUM> is operating. The variable flow control valve <NUM> saves time and improves vacuum pressure control by allowing control on the apparatus <NUM>.

An injection port <NUM> may also be included as a part of the aspiration pathway <NUM>, whereby the injection port <NUM> allows injectable solutions to enter the aspiration pathway <NUM>. By allowing access to the aspiration pathway <NUM> the user can introduce the injectable solutions into the lumen without removing the present invention from the patient's body to save time and reduce trauma to the patient. Examples of injectable solutions include contrast medium to improve visibility of the affected area and treating chemicals which may aid in the maceration of the obstruction. The injection port <NUM> may be any commercially available one-way port or valve which allows for a sterile introduction without compromising the seal required by the aspiration pathway <NUM>. During introduction, the variable flow control valve <NUM> needs to be in the fully closed condition <NUM> to prevent the injectable solution from being aspirated into the aspiration pump device <NUM>.

The aspiration pathway <NUM> further includes an interface <NUM> which has a variable length and is fluidly operable with the aspiration pathway <NUM> when the aspiration pathway <NUM> is in the retracted position <NUM>. At least a portion <NUM> of the interface <NUM> may be fluidly bypassed when the aspiration pathway <NUM> is in the deployed position <NUM> as shown in <FIG>. One or more seals <NUM> in the aspiration pathway <NUM> maintain the vacuum pressure while the aspiration pathway <NUM> is moved between the deployed position <NUM> and the retracted position <NUM>. The interior surface <NUM> and the catheter connection port <NUM> are slidable in relation to the maceration wire <NUM> along the axial direction when the aspiration pathway <NUM> moves between the deployed position <NUM> and the retracted position <NUM>. The interface <NUM> allows the aspiration pathway <NUM> to extend while maintaining fluid operability. <FIG> illustrates that when in the deployed position <NUM> the terminating end <NUM> of the maceration wire <NUM> is extending beyond the catheter <NUM> and in the sinuous shape needed to macerate the walls of the lumen when rotated. When in the retracted position <NUM>, the terminating end <NUM> of the maceration wire <NUM> is retracted into the catheter <NUM> and in a generally linear orientation to ease the maneuverability and reduce the risk of trauma while the catheter <NUM> and apparatus <NUM> are maneuvered into the desired location of the procedure.

<FIG> illustrates how in the present embodiment, the interface <NUM> comprises a first section <NUM> and a second section <NUM> which are telescopically coupled to and extending away from the first section <NUM>. The first section <NUM>, which includes the aspiration pump connection port <NUM>, variable flow control valve <NUM>, and injection port <NUM>, is fixed in relation to the maceration wire <NUM>. The second section <NUM>, which includes the annular portion <NUM> and the catheter connection port <NUM> whereby the aspiration pathway <NUM> is extended when the second section <NUM> is in the retracted position <NUM>, is slidably engaged with the maceration wire <NUM>. The first <NUM> and second <NUM> sections are fluidly connected and sealed to maintain the vacuum pressure during operation. The sealing may be accomplished by any of a variety of commercially available means, including O-rings and valves which restrict access beyond a specific point. In the present embodiment, the first <NUM> and second <NUM> sections have an O-ring attached as the seal <NUM> to maintain contact between the telescopically coupled sections to prevent the pressure or macerated particulate from escaping the aspiration pathway <NUM> during movement between the deployed <NUM> and retracted <NUM> positions. Also, the second section <NUM> of the aspiration pathway <NUM> has a valve <NUM> which is in contact with a sheath <NUM> surrounding the maceration wire <NUM> adjacent to where the maceration wire <NUM> is attached to the motor <NUM> wherein the valve <NUM> and sheath are configured to seal the location where the maceration wire <NUM> passes through the annular portion <NUM> of the aspiration pathway <NUM> and to the motor <NUM>. The maceration wire <NUM> is rotatably operable to maintain the function needed to macerate the obstruction, while the valve <NUM> and sheath <NUM> maintain the necessary seal.

A deployment control <NUM> is attached to the interface <NUM> and configured to move the aspiration pathway <NUM> between the deployed position <NUM> and the retracted position <NUM>. The interface <NUM>, a portion of the interior surface <NUM> of the aspiration pathway <NUM>, and the catheter connection port <NUM> move with the deployment control <NUM>. The deployment control <NUM> in the present embodiment is a handle, but a knob, a button, or any other graspable objects are intended to be alternative embodiments. The deployment control <NUM> may be made from any rigid material, for example, structurally capable of withstanding multiple movements between the retracted <NUM> and deployed <NUM> positions as well as the stresses of the procedure. Suitable rigid materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available.

A housing <NUM> containing at least a portion of the maceration wire <NUM>, the motor <NUM>, the aspiration pathway <NUM>, one or more deployment tracks <NUM>, a power source <NUM> and the above-mentioned features comprised in these individual parts may be included in the apparatus <NUM>. The housing <NUM> provides the user a physical means to operate and manipulate the apparatus <NUM>. The deployment tracks <NUM> define the pathway along which the deployment control <NUM> will move between the deployed position <NUM> and the retracted position <NUM>. The deployment tracks <NUM> include a plurality of mechanical restraints <NUM> configured to removably secure the deployment control <NUM> in either the deployed position <NUM> or the retracted position <NUM>. In the present embodiment of the invention the mechanical restraints <NUM> are flexible detents which deflect and removably secure to the deployment control <NUM> such that the user must apply a higher pressure to move the deployment control <NUM> and connected elements out of the deployed <NUM> or retracted <NUM> position.

The housing <NUM> shown in the present embodiment is constructed to be compact, disposable and with a unitary construction where possible to improve mobility, allow for sterilized pre-packaging and to reduce unnecessary assembly prior to use. The housing <NUM> may be a hand-grip size and shape whereby the user can actuate a maceration control <NUM> and manipulate the housing <NUM> with one hand. An example of such a hand-grip shape would be a pistol style grip found in similar apparatus. Disassembly of the housing <NUM> may be hampered by adhesives used in construction to reduce the temptation to re-sterilize and reuse the apparatus <NUM> in a subsequent procedure. The housing <NUM> may be made of any suitably rigid materials capable of withstanding the forces applied and sterility requirements of the procedure. Suitable materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available.

The power source <NUM> may be rechargeable or disposable. Suitable power sources <NUM> may include dry cell, lithium-ion, nickel metal hydride or other commercially available batteries capable of powering the apparatus <NUM>. In the present embodiment, lithium CR2 batteries are shown. The housing <NUM> may include a power source door <NUM> for removing and disposing of the power source <NUM> separate from the apparatus <NUM>. By allowing the power source <NUM> to be removable the user can dispose of the components in the most efficient and safe manner available.

The maceration control <NUM> configured to actuate the motor <NUM> to rotate the maceration wire <NUM> is electronically coupled to the motor <NUM>. The maceration control <NUM> is positioned on the housing <NUM> at a trigger finger position to allow the user to actuate the maceration control <NUM> without repositioning the user's hand during operation or positioning. The position of the maceration control <NUM> should be ergonomically located at an index finger position for the hand holding the apparatus <NUM>. In an embodiment, the maceration control <NUM> is positioned on a bottom edge <NUM> of the housing <NUM> such that the user can operate the maceration control <NUM> and variable flow control valve <NUM> while holding the apparatus <NUM> in a single hand. The maceration control <NUM> may be actuated by any commercially available means wherein the user can press or touch the maceration control <NUM> to actuate the motor <NUM>.

The catheter <NUM> is removably coupled to the catheter connection port <NUM> via a catheter coupler <NUM> and covers a portion of the maceration wire <NUM>. The catheter <NUM> is configured to insert into the body of the patient and maneuver to the procedure location, and to extend the aspiration pathway <NUM> to the location site such that aspiration is possible around the maceration wire <NUM>. <FIG> illustrates that the catheter <NUM> further includes a flexible sheath <NUM> extending distally in the axial direction away from the catheter coupler <NUM>. The flexible sheath <NUM> has an inside surface <NUM> and a distal opening <NUM> positioned opposite of the catheter coupler <NUM>. The inside surface <NUM> and the maceration wire <NUM> define a catheter annular portion <NUM> of the aspiration pathway <NUM> whereby the inside surface <NUM> is of sufficient size to allow the macerated particulate to be aspirated from the distal opening <NUM> toward the aspiration pump connection port <NUM> of the apparatus <NUM>. The catheter <NUM> is slideably engaged with the maceration wire <NUM> and fixed to move in direct connection to the deployment control <NUM>.

The flexible sheath <NUM> is relatively movable in the axial direction such that the terminating end <NUM> of the maceration wire <NUM> is near the distal opening <NUM> of the flexible sheath <NUM> wherein the maceration wire <NUM> has a first configuration <NUM> when the flexible sheath <NUM> is in the retracted position <NUM> and a second configuration <NUM> when the flexible sheath <NUM> is in the deployed position <NUM>. In the first configuration <NUM>, the wire is relatively linear when contained within the flexible sheath <NUM> and in the second configuration <NUM> the wire has a generally sinuous shape with the first <NUM> and second <NUM> arcuate regions extending away from the linear axis <NUM>. The flexible sheath <NUM> may be made from any rigid material structurally capable of withstanding the pressure of the vacuum without collapsing to maintain the aspiration pathway <NUM> during operation. The material must also be flexible enough to navigate through the patient's body during the procedure. Suitable rigid materials may include plastics, metals, composites, or other natural and artificial materials which are commercially available. Since these materials are inserted into the patient's body, sterilization is essential, and the catheter <NUM> is intended to arrive sterile to the procedure area. There may be a variety of flexible sheath <NUM> sizes, shapes, materials, or other configurations which are specific to the procedure and patient's needs.

An auxiliary injection port <NUM> may be fluidly coupled to the catheter <NUM>, whereby the auxiliary injection port <NUM> allows injectable solutions to enter the catheter annular portion <NUM> of the aspiration pathway <NUM>. Similar to the injection port <NUM> described above, the variable flow control valve <NUM> should be in the fully closed position during introduction of the injectable solution. Examples of injectable solutions include contrast medium to improve visibility of the affected area and treating chemicals which may aid in the maceration of the obstruction. The auxiliary injection port <NUM> may be any commercially available one-way port or valve which allows for a sterile introduction without compromising the necessary seal required by the aspiration pathway <NUM>.

The inside surface <NUM> of the flexible sheath <NUM> has a diameter between <NUM> and <NUM> (5F and 20F or <NUM>" and <NUM>") whereby the catheter annular portion <NUM> allows the maceration wire <NUM> to pass through the flexible sheath <NUM> and to rotate within the flexible sheath <NUM> while not obstructing the aspiration pathway <NUM>.

Medical devices are intended to save lives and improve the health and wellbeing of the patient, and to ensure this it is essential to reduce the risk of infection or contamination when operating equipment which will enter the patient's body. To this end it is a well-established practice to provide sterile equipment to the operation site and to make equipment disposable when feasible to reduce the chance of contamination from reuse. The disposable thrombectomy maceration and aspiration system <NUM> as presently embodied has several unique features and construction methods which reduce the cost of replacement and aid in safely disposing of the device <NUM>, apparatus <NUM>, and catheter <NUM>.

Both the batteries <NUM> and power sources <NUM>, for the apparatus <NUM> and the aspiration pump device <NUM>, are removable to allow for disposal in the safest manner for the environment. Batteries <NUM> and power sources <NUM> often require unique disposal techniques to prevent environmental contamination or other dangerous conditions.

Similarly, medical waste requires specific procedural steps be taken to properly dispose of safely. The lid <NUM> for the aspiration pump device <NUM> is removable which allows the interior of the fluid collection compartment <NUM> to be accessible for collecting samples for testing or diagnosis or to empty the medical waste into a proper disposal container separate from the aspiration pump device <NUM>. By allowing the waste to be removable, the aspiration pump device <NUM> can be disposed of in the most environmentally and economically available method.

Re-sterilization and reuse of the aspiration pump device <NUM> is discouraged by adding difficult to clean ribbed patterns <NUM> and <NUM> to the bottom of the fluid collection compartment <NUM> and lid <NUM>. Additionally, inclusion of the fluid filter <NUM> will obstruct access for larger cleaning instruments into the fluid collection compartment <NUM> to reduce the chance of reuse. Permanent construction methods may also be used in the construction of the aspiration pump device <NUM> and apparatus <NUM> to not allow for separation of the pieces for replacement or re-sterilization. The housing <NUM> of the apparatus <NUM> may use adhesives or filling materials to fill any voids around the motor <NUM> or power supply to permanently attach the individual parts and prevent access to the motor <NUM> for replacement or to the aspiration pathway <NUM> for attempts at cleaning. The aspiration pathway's <NUM> configuration with the telescopically coupled interface <NUM> does not adequately allow for re-sterilization due to the lack of accessibility and interlocking construction. Reuse of the catheter <NUM> would be highly irresponsible due to the amount of contact the catheter <NUM> has with the patient, so disposability is nearly a requirement. The maceration wire <NUM> is also in direct contact with the patient and is permanently attached to the motor <NUM> which makes replacement impractical without permanently damaging the housing <NUM> of the apparatus <NUM>.

Additionally, disposability allows for the components used to be chosen with performance taking priority over durability. By choosing the pump <NUM> and motor <NUM> that are highly effective but not designed for extended use or reuse, the equipment can reduce the costs often associated with large capital investment equipment which locks the buyer into larger costs and longer cost recuperation windows. Reusable equipment is also subject to repair costs and re-sterilization costs which may be difficult to estimate at the time of purchase.

The present invention is designed to be disposable, modular, sterile, and economical, by implementing a compact and unitary design along with permanent assembly methods to ensure the user and patient receive the best available operational capabilities while reducing economical costs.

In use, the individual components of the invention arrive to the procedure site in individually packaged and sterile units. Once opened and assembled the deployment control <NUM> of the apparatus <NUM> should be placed in the retracted position <NUM> which will put the maceration wire <NUM> in the first configuration <NUM> during positioning. The distal opening <NUM> of the flexible sheath <NUM> can be inserted into the patent and maneuvered to the site of the obstruction. The distal opening <NUM> is then moved through the obstruction and the deployment control <NUM> moved into the deployed position <NUM> which places the maceration wire <NUM> into the second configuration <NUM>. The aspiration pump device <NUM> can be actuated when desired and the desired vacuum pressure can be obtained. The maceration control <NUM> may then be actuated to rotate the maceration wire <NUM> while the maceration wire <NUM> and apparatus <NUM> are moved backward through the obstruction to macerate the obstruction. Aspiration can be applied during the maceration whereby the macerated materials will then pass through the aspiration pathway <NUM> throughout the catheter <NUM> and apparatus <NUM> before depositing in the fluid collection compartment <NUM> of the device <NUM>. The aspiration can continue with or without maceration until the macerated particulate has been removed or the aspiration pump device <NUM> has been filled.

Claim 1:
A disposable integrated thrombectomy and aspiration apparatus (<NUM>) for breaking up and aspirating thrombus or other obstructive material in a lumen of a vascular graft or vessel, said apparatus comprising
a maceration wire (<NUM>) extending in an axial direction;
a motor (<NUM>) operatively connected to said maceration wire (<NUM>); and
an aspiration pathway (<NUM>) extending between a catheter connection port (<NUM>) and an aspiration pump connection port (<NUM>) and including an interior surface (<NUM>), at least a portion of said aspiration pathway (<NUM>) including an annular portion (<NUM>) defined as the boundary between said interior surface (<NUM>) of said aspiration pathway (<NUM>) and said maceration wire whereby the macerated particulate may be aspirated from the patient,
characterized in that at least a portion of said annular portion (<NUM>) is slidable in relation to said maceration wire (<NUM>) when said portion of said annular portion (<NUM>) is moved between a deployed position and a retracted position, said maceration wire (<NUM>) extending through said catheter connection port (<NUM>), wherein said aspiration pathway (<NUM>) further includes an interface (<NUM>) having a variable length and being fluidly operable with said aspiration pathway (<NUM>) when said aspiration pathway (<NUM>) is in a retracted position (<NUM>), at least a portion of said interface (<NUM>) being fluidly bypassable when said aspiration pathway (<NUM>) is in a deployed position (<NUM>), said interface (<NUM>) comprises a first section (<NUM>) and a second section (<NUM>) being telescopically coupled to and extending away from said first section (<NUM>), said first section (<NUM>) including said aspiration pump connection port and being fixed in relation to said maceration wire (<NUM>), said second section (<NUM>) including said annular portion (<NUM>) and said catheter connection port (<NUM>) whereby said aspiration pathway (<NUM>) is extended when said second section (<NUM>) is in said retracted position, said second section (<NUM>) being slidably engaged with said maceration wire (<NUM>), said first and second sections (<NUM>, <NUM>) being fluidly connected and sealed to maintain the vacuum pressure during operation.