METHODS AND APPARATUS FOR TREATING EMBOLISM
A method and apparatus for treating a clot in the blood vessel of a patient, and particularly the treatment of a pulmonary embolism is disclosed. The treatment includes restoring flow through the clot followed by clot removal, either partially or substantially completely. The clot treatment device is expandable into the blood vessel and may contain radial extensions that assist in restoring flow as well as in removing clot material.
This application is a continuation of U.S. patent application Ser. No. 16/913,073, filed Jun. 26, 2020, and titled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” which is a is a continuation of U.S. patent application Ser. No. 15/949,350, filed Apr. 10, 2018, issued as U.S. Pat. No. 10,709,471, and titled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” which is a continuation of U.S. patent application Ser. No. 14/646,358, filed May 20, 2015, now issued as U.S. Pat. No. 10,004,531, and titled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” which is a § 371 U.S. national filing of PCT/US2013/071101, filed Nov. 20, 2013, and titled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” which is a continuation-in-part of U.S. patent application Ser. No. 13/843,742, filed Mar. 15, 2013, now issued as U.S. Pat. No. 8,784,434 and titled “METHODS AND APPARATUS FOR TREATING EMBOLISM,” which claims priority to U.S. Provisional Application No. 61/750,277, filed Jan. 8, 2013, and titled “DEVICES AND METHODS FOR TREATMENT OF VASCULAR OCCLUSION” and U.S. Provisional Application No. 61/728,775, filed Nov. 20, 2012, and titled “DEVICES AND METHODS FOR TREATMENT OF VASCULAR OCCLUSION,” each of which is incorporated by reference herein in its entirety.
TECHNICAL FIELDThis invention relates to the apparatus and methods of endovascular treatment of blood clots obstructing passageways in the circulatory system and particularly the endovascular treatment of pulmonary embolism.
BACKGROUNDThromboembolism is the formation in a blood vessel of a clot (thrombus) that breaks loose (embolizes) and is carried by the blood stream to another location in the circulatory system resulting in a clot or obstruction at that new location. For example, a clot may embolize and plug a vessel in the lungs (pulmonary embolism), the brain (stroke), the gastrointestinal tract, the kidneys, or the legs. Thromboembolism is a significant cause of morbidity (disease) and mortality (death), especially in adults. A thromboembolism can be sudden and massive or it may be small and multiple. A thromboembolism can be any size and a thromboembolic event can happen at any time.
When a thrombus forms in the venous circulation of the body it often embolizes to the lungs. Such a thrombus typically embolizes from the veins of the legs, pelvis, or inferior vena cava and travels to the right heart cavities and then into the pulmonary arteries thus resulting in a pulmonary embolism.
A pulmonary embolism results in right heart failure and decreased blood flow through the lungs with subsequent decreased oxygenation of the lungs, heart and the rest of the body. More specifically, when such a thrombus enters the pulmonary arteries, obstruction and spasm of the different arteries of the lung occurs which further decreases blood flow and gaseous exchange through the lung tissue resulting in pulmonary edema. All of these factors decrease the oxygen in the blood in the left heart. As a result, the oxygenated blood supplied by the coronary arteries to the musculature of both the left and right heart is insufficient for proper contractions of the muscle which further decreases the entire oxygenated blood flow to the rest of the body. This often leads to heart dysfunction and specifically right ventricle dysfunction.
This condition is relatively common and has many causes. Some of the more common causes are prolonged inactivity such as bed rest, extended sitting (e.g., lengthy aircraft travel), dehydration, extensive surgery or protracted disease. Almost all of these causes are characterized by the blood of the inferior peripheral major circulatory system coagulating to varying degrees and resulting in permanent drainage problems.
There exist a number of approaches to treating thromboembolism and particularly pulmonary embolism. Some of those approaches include the use of anticoagulants, thrombolytics and endovascular attempts at removal of the emboli from the pulmonary artery. The endovascular attempts often rely on catheterization of the affected vessels and application of chemical or mechanical agents or both to disintegrate the clot. Invasive surgical intervention in which the emboli is removed by accessing the chest cavity, opening the embolized pulmonary artery and/or its branches and removing the clot is also possible.
The prior approaches to treatment, however, are lacking. For example, the use of agents such as anticoagulants and/or thrombolytics to reduce or remove a pulmonary embolism typically takes a prolonged period of time, e.g., hours and even days, before the treatment is effective. In some instances, such agents can cause hemorrhage in a patient. Moreover, the known mechanical devices for removing an embolism are typically highly complex, prone to cause undue trauma to the vessel, and can be difficult and expensive to manufacture.
Lastly, the known treatment methods do not emphasize sufficiently the goal of urgently restoring blood flow through the thrombus once the thrombus has been identified. In other words, the known methods focus primarily and firstly on overall clot reduction and removal instead of first focusing on relief of the acute blockage condition followed then by the goal of clot reduction and removal. Hence, known methods are not providing optimal patient care, particularly as such care relates to treatment of a pulmonary embolism.
SUMMARYIn view of the foregoing, several embodiments of the present technology to provide a method and system that initially restores an acceptable level of oxygenated blood to the patient's circulatory system followed by safe and effective removal of the thrombus.
Several embodiments of the present technology treat pulmonary embolism in a minimally invasive manner.
Several embodiments of the present technology can also provide a system that does not cause undue trauma to the vessel.
These and other objects, aspects, features and advantages of which the present technology is capable will be apparent from the following description of embodiments of the present technology, reference being made to the accompanying drawings, in which
Specific embodiments of the present technology will now be described with reference to the accompanying drawings. This present technology may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present technology to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the present technology. In the drawings, like numbers refer to like elements.
Referring to
It will be understood, however, that other access locations into the venous circulatory system of a patient are possible and which are consistent with the present technology. For example, the user can gain access through the jugular vein, the subclavian vein, the brachial vein or any other vein that connects or eventually leads to the superior vena cava. Use of other vessels that are closer to right atrium RA of the patient's heart may be attractive as this will reduce the length of the instruments needed to reach the pulmonary embolism.
Referring to
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In alternative embodiments, the clot treatment device 402 may be an “over the wire” device, in which case, the wire 401 is a tube or coil having a lumen, and the attachment member 403 and the tip 405 have a hollow central lumen for receiving a guide wire.
In yet a further embodiment, the distal end of the clot treatment device shall have a flexible, atraumatic extension from the device. In an alternative embodiment, the tip 405 is tapered to better penetrate the clot material in the vessel.
In preferred embodiments the clot treatment device 402 of the present technology has a generally cylindrical shape that, during use, creates a flow lumen through the clot material that restores significant blood flow across a clot. The treatment device 402 is not, however, limited to a generally cylindrical shape. For example, the shape can be generally conical, generally concave or generally convex along its axis such that the clot treatment device 402 creates a lumen for restoring the blood flow.
Referring again to
The clot treatment device 402 can self-expand from the undeployed state to the deployed state. For example, the clot treatment device 402 can be a shape-memory material, such as Nitinol, and may be formed as a braid or a stent that is set to have the expanded configuration of the deployed state shown in
Referring to
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The clot treatment device 402 accordingly restores blood flow through the clot 100 immediately or at least quickly after expanding to the deployed state as shown by arrows 407 in
The restoration of blood flow is anticipated to equate with restoration of a substantial portion of the normal blood flow rate for the patient. In less severe. e.g., “sub-massive,” pulmonary embolism patients, the clot treatment device 402 may increase blood flow rate by at least about 50 mllmin, at least about 150 mllmin or between about 100 to 250 mllmin. In severe, e.g., “massive,” pulmonary embolism patients, a larger amount of the pulmonary artery flow is compromised. Hence, in some embodiments, at least about 500 ml/min of blood flow rate may be restored. Moreover, at least a portion of the flow restoration is expected to occur prior to the removal of the clot 100, or any portion thereof.
The restoration of blood flow by the clot treatment device 402 can be achieved in a low pressure environment. For example, the pressure in the target vessel can be less than 60 mmHg and the blood can be venous blood, substantially non-oxygenated blood or low oxygenated blood.
In addition to restoring blood flow, the expansion of the clot treatment device 402 also deforms the clot material by pushing, penetrating and/or otherwise cutting into the clot material. This enhances the subsequent removal of the clot 100 since portions of the clot 100 may be captured and retained (1) between the radially extending portions 406; (2) through the pores of the mesh forming the radially extending portions 406; (3) along the longitudinal cylindrical sections 412 between the radially extending portions 406 of the removal device 402; and (4) within the clot treatment device 402 itself.
As can be understood from the above description and figures, the deployment of the clot treatment device 402 results in an outwardly expanding generally cylindrical force being urged against an inner surface of the clot 100 because the flow restoration portions 412 expand to the first cross-sectional dimension D1 greater than the diameter DL of the delivery catheter lumen 607. This force pushes the clot material outwardly and creates a lumen through which blood flow is restored. As can also be appreciated, the presence of the radially extending capture portions 406 on the clot treatment device 402 causes the outwardly expanding generally cylindrical force to vary in magnitude along the axis of the clot treatment device 402. The force on the clot material may be greater at the locations of the radially extending capture portions 406.
In braided embodiments of the clot treatment device 402, deployment/expansion of the device leads the filaments of the braid to change their angular orientation with respect to the axis of the device. This angular change may improve or enhance adherence of clot material to the clot treatment device 402.
After the clot treatment device 402 has been expanded and blood flow restored, the user then retracts the clot treatment device 402 in a proximal direction as shown in
As further shown in
It will be appreciated that variations in the above-described method are contemplated. For example, in certain circumstances a guide catheter 604 may not be necessary or desirable and the user may choose to use only the delivery catheter 606 for placing and manipulation of the clot treatment device 402. As a further example, the clot may be of such a nature that the user may desire repeat the above-described process, or at least portions of it, in order to more fully remove the clot 100 or clot material.
Referring next to
In certain circumstances, it may be advisable to remove the clot 100 without capturing it in the guide catheter 606 or the collection catheter 612 (if used) and remove the clot 100 by withdrawing the entire system, e.g., guide catheter 605, delivery catheter 604, clot treatment device 402 and collection catheter 612 (if used) simultaneously.
In several embodiments, the expandable portion 614 of the collection catheter 612 is a conical funnel or other tapered member constructed from a mesh, braid or stent structure. Such structure assists in retrieving and containing the clot material in the withdrawal process. In yet further preferred embodiments, the collection catheter 612 contains structural features to assist in the expansion of the expandable portion 614 and to hold the expandable portion 614 open towards the wall of the blood vessel. Such features (not shown) include interwoven support struts, self expanding material (e.g., Nitinol), longitudinal wire supports, stent supports, polymeric webbing, etc.
In another embodiment of the present invention, a vacuum apparatus may be used to aid in the removal of the clot material. Referring to
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The elongated inner member 1020 can be a tube or coil having inner lumen configured to receive the guidewire 602 for over-the-wire or rapid exchange delivery of the expandable member 1010 to the clot. The outer elongated member 1022 can be a tube or coil having a lumen configured to receive the inner elongated member 1020 such that the inner elongated member 1020 and/or the outer elongated member 1022 can move relative to each other along the longitudinal dimension of the clot treatment device 402.
In the operation of the clot treatment device 402 shown in
In the foregoing embodiments, the radially extending capture portions 406 provide more surface area along the device than a device that is uniformly cylindrical. Moreover, the radially extending capture portions 406 extend transversely to the longitudinal dimension of the device to more effectively transfer the axial force as the device is moved axially along the vessel after deployment. Such increased surface area facilitates the treatment and/or retrieval of a much larger portion of the clot 100 than is generally feasible with a uniformly cylindrical device. For example, in a preferred embodiment of the clot treatment device 402, the device will have an external surface area between 1.5× and 6× the surface area of a uniformly cylindrical device of the same general diameter of the cylindrical sections 412. In other preferred embodiments the ratio will be 2× to 4×.
This is advantageous particularly during retraction of the clot treatment device 402 through the clot 100. As shown in
The clot treatment device 402 is intended for use in large vessels, i.e., vessels with a diameter greater than 8 mm. For example, the diameter of the pulmonary arteries typically range from 15 to 30 mm whereas the first branches of the pulmonary arteries typically range from 10 to 15 mm and the secondary and tertiary branches typically range from 5 to 10 mm. At the same time, however, it is important to minimize the size of catheter providing access to the clot 100. Accordingly, the clot treatment device 402 has a large expansion ratio. In a preferred embodiment the expansion ratio from the diameter of the cylindrical sections 412 in the collapsed state to the expanded state will be between 4 and 8. In another preferred embodiment the ratio will be between 5 and 7. The large expansion ratio also enables the formation of a flow channel in the clot 100 that is large, e.g., on the order of 4-8 mm.
The radially extending portions 406, in their fully expanded position are intended to have a size that matches the diameter of the target blood vessel. However, the diameters may be slightly larger than the vessel diameter so to apply greater radial force against the blood vessel (without causing trauma) in those circumstances when it is desirable to improve clot collection. Similarly, in those circumstances where there is a concern of creating trauma on delicate blood vessels, the radially extending portions 406 may have a diameter that is smaller than the vessel diameter. It is contemplated that different sizes of the device 402 will be available for selection by the user for a particular presentation of the patient.
As for the length of the clot treatment device 402, it is known that a typical pulmonary embolism will have a length within the range between about 2 em and 10 em and sometimes between about 1 em and 20 em. Accordingly, in a preferred embodiment, the clot treatment device 402 will have a length that exceeds the length of the embolism so that a portion of the clot treatment device is positioned distal of the clot 100 during expansion.
With regard to the delivery catheter 606, in a preferred embodiment for use with a pulmonary embolism, the size will be around 1F-6F. Smaller diameters will pass through the clot 100 more easily. In addition, the delivery catheter 606 may have stiffness characteristics to assist in making sure the delivery catheter 606 passes through the clot in a smooth manner. Such stiffness characteristics include self expanding Nitinol wire braids or stent structures that are contained within the structure of the delivery catheter 606. The delivery catheter 606 also has sufficient flexibility so that it may carry the clot treatment device 402 and still pass through a tortuous vessel path as described above starting with insertion of the delivery catheter 606 in the femoral vein FV.
In some preferred embodiments, the method and device in accordance with the present invention may reduce the Mean Resting Pulmonary Artery Pressure (MRPAP). Upon at least partial relief from the clot 100, MRPAP may be reduced by about 20-50 mmHg to a normal range of 8-20 mmHg. In some embodiments, the reduction in MRPAP may be about 25-50%. In some embodiments, the reduction in MRPAP may be about 15% to 40% and in other embodiments between about 30% and 75%.
Such a reduction in MRPAP can occur in two steps. A first step is when the clot treatment device 402 is first deployed and blood flow is at least partially restored. A second step may be when the clot treatment device 402 is retracted and at least some of the clot 100 is removed from the vessel. A third step may be after the clot treatment device 402 has been removed and the effect of the body's own processes and/or thrombolytic drugs that may have been used before, during or after the procedure take effect upon clot that has been disrupted by the clot treatment device.
The radially expanding guide member 1510 may also be formed by conventional machining, laser cutting, electrical discharge machining (EDM) or other means known in the art to make a fenestrated, mesh or porous structure that can be affixed near the distal end of the shaft 1502. In some embodiments the radially expanding guide member 1510 may self-expand, but in other embodiments it may be actuated by an operator using, for example, electrical or electromechanical means. By having a porous radially expanding guide member 1510, the guide catheter 1500 may be substantially centered within a vessel without blocking a large portion of the flow around the catheter. In some embodiments, the radially expanding guide member 1510 may block less than about 50% of the flow about the catheter and in other embodiments less than about 25% of the flow. When the guide member 1510 is made with a braid of filaments (e.g. wires), it may be formed from a tubular braid. In some embodiments, the tubular braid may be formed with approximately 12 to approximately 144 filaments, or in other embodiments from about 36 to about 96 filaments. The pores as measured by the largest circle that can be inscribed within an opening of the mesh may be between about 0.5 mm and 5 mm.
The concept of a non-permeable material can also be applied to the guide catheter 1500 shown above in
The CE members 1952 can be disposed about an exterior surface of the device 402. For example, as shown in
As shown in
The CE members can have a single radius of curvature or have regions with different radii or have a complex or changing radius of curvature. For example, as shown in
As shown in
Referring to
Several examples of the present technology are as follows:
1. A device for treating a pulmonary embolism, comprising:
-
- an expandable flow restoration portion; and
- a plurality of capture elements including at least a first capture element and a second capture element, wherein the flow restoration portion is between the first and second capture elements, and wherein the flow restoration portion and the capture elements are configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state in which the flow restoration portion has a first cross-sectional dimension greater than that of the low-profile state such that the flow restoration portion forms a flow channel through the device and the capture elements project outwardly from the flow restoration portion.
2. The device of example 1 wherein the flow restoration portion and the capture elements comprise an expandable braided material that is heat set to have the deployed state.
3. The device of any of examples 1 and 2 wherein the flow restoration portion and the capture elements are integrally formed from a common braided material.
4. The device of any of examples 1-3, further comprising a plurality of flow restoration portions and the capture elements comprise a series of radially extending capture portions, and wherein the radially extending capture portions are separated from each other by individual flow restoration portions.
5. The device of example 4 wherein the flow restoration portions comprise expandable cylindrical sections and the capture elements comprise radially expandable disk-like capture portions of the braided material.
6. The device of example 1 wherein the flow restoration portion comprises a radially expandable cylindrical braided material and the capture elements comprise protuberances projecting from the flow restoration portion.
7. The device of any of examples 1-6 wherein the flow restoration portion has an expansion ratio from the undeployed state to the deployed state of approximately 1:4 to 1:8.
8. The device of any of examples 1-6 wherein the flow restoration portion has an expansion ratio from the undeployed state to the deployed state of approximately 1:5 to 1:7.
9. The device of any of examples 1-8 wherein the flow restoration portion has a diameter of approximately 4-8 mm in the deployed state to restore blood flow through a pulmonary embolism.
10. The device of any of examples 1-9 wherein the flow restoration portions and the capture elements comprises a self-expanding braided material, and the capture elements comprise capture portions that have a second diameter greater than the first cross-sectional dimension of the flow restoration portions in the deployed state.
11. The device of any of examples 1-3 and 6-9 wherein the flow restoration portion comprises a single expandable braided tube, and the capture elements comprise clot engagement members configured to project from the flow restoration portion in the deployed state.
12. The device of example 11 wherein the clot engagement members comprise arcuate members that form hook-like elements projecting from the flow restoration portion.
13. The device of example 11 wherein the clot engagement members are formed from wires of the expandable braided tube that defines the flow restoration portion.
14. The device of example 11 wherein the clot engagement members are formed from separate wires that project through interstices of the expandable braided tube that defines the flow restoration portion.
15. A pulmonary embolism treatment device, comprising:
-
- an outer elongated member having a distal end;
- an inner elongated member within the outer elongated member, wherein the inner elongated member and/or the outer elongated member slides relative to the other, and wherein the inner elongated member has a distal end; and
- an expandable member having a proximal portion attached to the distal end of the outer elongated member and a distal portion attached to the distal end of the inner elongated member, the expandable member having a flow restoration portion and a plurality of capture elements arranged along the flow restoration portion, wherein the flow restoration portion and the capture elements are configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state in which the flow restoration portion has a first cross-sectional dimension greater than that of the low-profile state that defines a flow channel through the device and the capture elements project outwardly from the flow restoration portion.
16. The pulmonary embolism treatment device of example 15 wherein the expandable member comprises a braided material.
17. The pulmonary embolism treatment device of example 15 wherein the device has a plurality of flow restoration portions and the capture elements are separated by individual flow restoration portions, and wherein (a) the capture elements comprise capture portions formed from a continuous shape-memory braided material heat-set to the deployed state and (b) the capture portions project from the flow restoration portions to a second cross-sectional dimension in the deployed state.
18. The pulmonary embolism treatment device of example 17 wherein the flow restoration portions comprise cylindrical portions and the first cross-sectional dimension comprises a first diameter in the deployed state, and the capture portions comprise disk-like projections having a second diameter greater than the first diameter in the deployed state.
19. The pulmonary embolism treatment device of any of examples 11-18 wherein the flow restoration portion(s) have an expansion ratio from the undeployed state to the deployed state from 1:4 to 1:8.
20. The pulmonary embolism treatment device of any of examples 11-18 wherein the flow restoration portion(s) have an expansion ratio from the undeployed state to the deployed state from 1:5 to 1:7.
21. The pulmonary embolism treatment device of any of examples 11-20 wherein the first elongated member comprises an outer tube and the second elongated member comprises an inner tube within the outer tube.
22. The pulmonary embolism treatment device of any of examples 11-20 wherein the first elongated member comprises an outer tube and the second elongated member comprises a coil within the outer tube.
23. The pulmonary embolism device of any of examples 11-20 wherein the first elongated member comprises an outer coil and the second elongated member comprises an inner coil.
24. The pulmonary embolism treatment device of any of examples 11-23 wherein the flow restoration portion(s) and the capture elements comprise a self-expanding braided material.
25. The pulmonary embolism treatment device of any of examples 11-24 wherein the outer elongated member is configured to slide distally with respect to the inner elongated member to move the expansion member from the undeployed state to the deployed state.
26. The pulmonary embolism treatment device of any of examples 11-25, further comprising a guide catheter having a shaft with a distal end and an expandable guide member at the distal end of the shaft, wherein the shaft has a lumen configured to receive the expandable member in the undeployed state.
27. The pulmonary embolism treatment device of example 26 wherein the expandable guide member comprises radially expandable mesh.
28. The pulmonary embolism treatment device of example 27 wherein the radially expandable mesh comprises a braided material.
29. The pulmonary embolism treatment device of any of examples 26-28 wherein the expandable guide member has a funnel shape.
30. The pulmonary embolism treatment device of any of examples 26-29 wherein at least a portion of the expandable guide member is permeable to allow blood to flow through the expandable guide member when the expandable guide member is expanded.
31. The pulmonary embolism treatment device of any of examples 26-29 wherein the expandable guide member has a non-permeable portion at the distal end of the shaft and a permeable portion extending distally from the non-permeable portion.
32. A pulmonary embolism treatment device, comprising:
-
- an elongated member having a distal end;
- an expansion portion having a proximal end attached to the distal end of the elongated member, and the expansion portion having a distal end; and
- an expandable member having a proximal portion attached to the distal end of the elongated member and a distal portion attached to the distal end of the expansion portion, the expandable member having at least one of flow restoration portion and a plurality of capture elements arranged such that the capture elements are separated by individual flow restoration portion, wherein the flow restoration portion and the capture elements are configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state in which (a) the flow restoration portion has a first cross-sectional dimension greater than that of the low-profile state that defines a flow channel through the device and (b) the capture elements project outwardly from the flow restoration portion, and wherein the expansion portion is stretched from a normal state when the expandable member is in the undeployed state such that the expansion portion is configured to axially contract the expandable member from the undeployed state to the deployed state.
33. A method of treating a pulmonary embolism, comprising:
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- delivering an embolectomy device through the heart to a pulmonary embolism that at least partially restricts blood flow through a pulmonary vessel, wherein the embolectomy device has a plurality of capture elements separated by an expandable cylindrical section;
- deploying the embolectomy device within the pulmonary embolism by expanding the cylindrical section into the pulmonary embolism so that the cylindrical section forms an expanded flow channel through the pulmonary embolism and thereby restores blood flow through the pulmonary embolism and by expanding the capture elements to a greater extent than the cylindrical section so that at least a portion of the pulmonary embolism is captured the capture elements;
- moving the embolectomy device and at least a portion of the pulmonary embolism along the pulmonary vessel; and
- withdrawing the embolectomy device and at least a portion of the pulmonary embolism from the pulmonary vessel.
34. The method of example 33 wherein deploying the embolectomy device comprises expanding a plurality of radial extendable capture elements of the embolectomy device.
35. The method of example 34, wherein at least one of the plurality of radial extendable capture elements is expanded distal relative to the pulmonary embolism.
36. The method of example 33, further comprising applying vacuum while withdrawing the embolectomy device.
37. The method of example 36, wherein withdrawing the embolectomy device includes urging the portion of the pulmonary embolism into a funnel catheter.
38. The method of example 37, wherein deploying the embolectomy device comprises expanding the device such that a surface area of the embolectomy device expands within a range of at least 200% to 400% of the surface area of a uniformly cylindrical device.
39. The method of example 33 wherein deploying the embolectomy device comprises expanding the generally cylindrical section by 400% to 800% of its diameter in the undeployed state.
40. The method according to and of examples 33-39 wherein deploying the embolectomy device comprises expanding a braided material into a preset shape having a plurality of radially extending disk-like capture portions that define the capture elements.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the exampled invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
Claims
1. A system for treating a thrombus within a blood vessel of a patient, comprising:
- a guide catheter configured to be positioned within the blood vessel proximal to the thrombus;
- a thrombus treatment device configured to be advanced through the guide catheter, wherein the thrombus treatment device comprises— an elongated member; and a thrombus disruption element positioned over the elongated member, wherein the thrombus disruption element has a proximal portion, a distal portion, and a central portion extending between the proximal portion and the distal portion, wherein the thrombus disruption element has an outer surface that tapers (a) radially outward away from the elongated member in a distal direction at least partially between the proximal portion and the central portion and (b) radially inward toward the elongated member in the distal direction at least partially between the central portion and the distal portion, and wherein the thrombus disruption element is configured to be (a) advanced into the thrombus distally from the guide catheter via distal movement of the elongated member and (b) retracted proximally through the thrombus via proximal movement of the elongated member; and
- a vacuum pump fluidly connected to the guide catheter, wherein the vacuum pump is configured to generate a vacuum and automatically apply the vacuum to the guide catheter to at least partially aspirate the thrombus into the guide catheter.
2. The system of claim 1 wherein the elongated member is a wire.
3. The system of claim 1 wherein the proximal portion of the thrombus disruption element is fixed to the elongated member.
4. The system of claim 1 wherein the proximal portion and the distal portion of the thrombus disruption element are fixed to the elongated member.
5. The system of claim 1 wherein the elongated member extends distally past the distal portion of the elongated member.
6. The system of claim 5 wherein the proximal portion and the distal portion of the thrombus disruption element are fixed to the elongated member.
7. The system of claim 1 wherein the thrombus disruption element comprises an expandable mesh.
8. The system of claim 1 wherein the blood vessel is a peripheral blood vessel.
9. The system of claim 1 wherein the thrombus is a pulmonary embolism.
10. A system for treating a thrombus within a blood vessel of a patient, comprising:
- a guide catheter configured to be positioned within the blood vessel proximal to the thrombus;
- a thrombus treatment device configured to be advanced through the guide catheter, wherein the thrombus treatment device comprises— a wire; and a thrombus disruption element positioned over the wire, wherein the thrombus disruption element has a proximal portion and a distal portion, wherein the proximal portion tapers radially outward away from the wire in a distal direction, wherein the distal portion tapers radially inward toward the wire in the distal direction, and wherein the thrombus disruption element is configured to be (a) pushed distally from the guide catheter into the thrombus via pushing of the wire and (b) pulled proximally through the thrombus via pulling of the wire; and
- a vacuum pump fluidly connected to the guide catheter, wherein the vacuum pump is configured to generate a vacuum and automatically apply the vacuum to the guide catheter to at least partially aspirate the thrombus into the guide catheter.
11. The system of claim 10 wherein the proximal portion and the distal portion of the thrombus disruption element are fixed to the wire.
12. The system of claim 10 wherein the elongated member wire extends distally past the distal portion of the elongated member.
13. The system of claim 10 wherein the blood vessel is a peripheral blood vessel.
14. The system of claim 10 wherein the thrombus is a pulmonary embolism.
15. A system for treating a thrombus within a blood vessel of a patient, comprising:
- a guide catheter;
- a thrombus treatment device configured to be advanced through the guide catheter, wherein the thrombus treatment device comprises— a wire; and a thrombus disruption element positioned over the wire, wherein the thrombus disruption element has a proximal portion and a distal portion, wherein the proximal portion tapers radially outward away from the wire in a distal direction, and wherein the distal portion tapers radially inward toward the wire in the distal direction, and wherein the thrombus disruption element is configured to be (a) pushed distally relative to the guide catheter via pushing of the wire and (b) pulled proximally relative to the guide catheter via pulling of the wire; and
- a vacuum pump fluidly connected to the guide catheter, wherein the vacuum pump is configured to generate a vacuum and automatically apply the vacuum to the guide catheter.
16. The system of claim 15 wherein the proximal portion and the distal portion of the thrombus disruption element are fixed to the wire.
17. The system of claim 15 wherein the elongated member wire extends distally past the distal portion of the elongated member.
18. The system of claim 15 wherein the vacuum pump is fluidly connected to a proximal end portion of the guide catheter.
19. The system of claim 15 wherein the thrombus disruption element has a maximum diameter of about 4 millimeters or greater.
20. The system of claim 15 wherein the thrombus disruption element is configured to self-expand.
Type: Application
Filed: Mar 28, 2023
Publication Date: Aug 3, 2023
Inventors: Robert F. Rosenbluth (Laguna Niguel, CA), Brian J. Cox (Laguna Niguel, CA), Paul Lubock (Monarch Beach, CA), Richard Quick (Mission Viejo, CA)
Application Number: 18/191,728