Patent Grant
10945746
The present technology relates generally to sheathing tools and associated systems and methods. Some embodiments of the present technology relate to devices for loading an intravascular treatment device into a sheath.
Many medical procedures use medical device(s) to remove an obstruction (such as clot material) from a body lumen, vessel, or other organ. An inherent risk in such procedures is that mobilizing or otherwise disturbing the obstruction can potentially create further harm if the obstruction or a fragment thereof dislodges from the retrieval device. If all or a portion of the obstruction breaks free from the device and flows downstream, it is highly likely that the free material will become trapped in smaller and more tortuous anatomy. In many cases, the physician will no longer be able to use the same retrieval device to again remove the obstruction because the device may be too large and/or immobile to move the device to the site of the new obstruction.
Even in successful procedures, a physician must be cautious to prevent the walls of the vessel or body lumen from imparting undesired forces to shear or dislodge the obstruction as it passes through the vasculature during removal. These forces have the potential of fragmenting the obstruction. In some cases, the obstruction can simply break free from the retrieval device and can lodge in a new area causing more concern than the original blockage.
Procedures for treating ischemic stroke by restoring flow within the cerebral vasculature are subject to the above concerns. The brain relies on its arteries and veins to supply oxygenated blood from the heart and lungs and to remove carbon dioxide and cellular waste from brain tissue. Blockages that interfere with this blood supply eventually cause the brain tissue to stop functioning. If the disruption in blood occurs for a sufficient amount of time, the continued lack of nutrients and oxygen causes irreversible cell death (infarction). Accordingly, it is desirable to provide immediate medical treatment of an ischemic stroke. To access the cerebral vasculature, a physician typically advances a catheter from a remote part of the body (typically a leg) through the abdominal vasculature and into the cerebral region of the vasculature. Once within the cerebral vasculature, the physician deploys a device for retrieval of the obstruction causing the blockage. Concerns about dislodged obstructions or the migration of dislodged fragments increases the duration of the procedure at time when restoration of blood flow is paramount. Furthermore, a physician might be unaware of one or more fragments that dislodge from the initial obstruction and cause blockage of smaller more distal vessels.
Many physicians currently perform thrombectomies (i.e. clot removal) with stents to resolve ischemic stroke. Typically, the physician deploys a stent into the clot in an attempt to push the clot to the side of the vessel and re-establish blood flow. Tissue plasminogen activator (“tPA”) is often injected into the bloodstream through an intravenous line to break down a clot. However, it takes for the tPA to reach the clot because the tPA must travel through the vasculature and only begins to break up the clot once it reaches the clot material. tPA is also often administered to supplement the effectiveness of the stent. Yet, if attempts at clot dissolution are ineffective or incomplete, the physician can attempt to remove the stent while it is expanded against or enmeshed within the clot. In doing so, the physician must effectively drag the clot through the vasculature, in a proximal direction, into a guide catheter located within vessels in the patient's neck (typically the carotid artery). While this procedure has been shown to be effective in the clinic and easy for the physician to perform, there remain some distinct disadvantages using this approach.
For example, one disadvantage is that the stent may not sufficiently retain the clot as it pulls the clot to the catheter. In such a case, some or all of the clot might remain the vasculature. Another risk is that as the stent mobilizes the clot from the original blockage site, the clot might not adhere to the stent as the stent is withdrawn toward the catheter. This is a particular risk when passing through bifurcations and tortuous anatomy. Furthermore, blood flow can carry the clot (or fragments of the clot) into a branching vessel at a bifurcation. If the clot is successfully brought to the end of the guide catheter in the carotid artery, yet another risk is that the clot may be “stripped” or “sheared” from the stent as the stent enters the guide catheter. Regardless, simply dragging an expanded stent (either fully or partially expanded) can result in undesired trauma to the vessel. In most cases, since the stent is oversized compared to the vessel, dragging a fixed metallic (or other) structure can pull the arteries and/or strip the cellular lining from the vessel, causing further trauma such as a hemorrhagic stroke (leakage of blood from a cerebral vessel). Also, the stent can become lodged on plaque on the vessel walls resulting in further vascular damage.
In view of the above, there remains a need for improved devices and methods that can remove occlusions from body lumens and/or vessels.
At least some of the embodiments disclosed herein are devices, systems, and methods for facilitating a user in positioning an expandable, intravascular treatment device within a lumen of a catheter and/or sheath. For example, certain medical procedures may require multiple passes of the same treatment device in order to effectively treat the patient. Between passes, the treatment device is often completely removed from the catheter and/or patient and must be re-loaded into the catheter for the next pass. For instance, removing clot material from a blood vessel of a patient may include advancing a clot retrieving device to a treatment site within the blood vessel lumen, capturing at least a portion of the clot material with the clot retrieving device, removing the clot material and clot retrieving device from the patient, then repeating the foregoing process until a sufficient amount of clot material is removed.
Some embodiments of the present technology include a device for sheathing (and/or re-sheathing) a treatment device, such as a clot retrieving device. In some embodiments, the device includes a first channel and a second channel, each of which are configured to receive the treatment device in a constrained state therethrough. In some embodiments, the first channel may extend to a first opening and the second channel may extend to a second opening that is surrounded by a sidewall. The second opening may be spaced apart from the first opening by a gap, and the length of the gap may be great enough to allow a first portion of the treatment device to self-expand over the sidewall while a second portion of the treatment device generally maintains its diameter in the constrained state while crossing the gap.
The subject technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause, e.g., clause (1, 16, 20, 23, etc.). The other clauses can be presented in a similar manner.
Additional features and advantages of the subject technology are described below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
The present technology provides devices, systems, and methods for sheathing and/or re-sheathing an intravascularly deliverable treatment device. Although many of the embodiments are described below with respect to devices, systems, and methods for removing clot material/treating embolism (such as a cerebral embolism), the sheathing tools of the present technology may be used to re-sheath any intravascularly deliverable, expandable treatment device. Other applications and other embodiments in addition to those described herein are within the scope of the technology. For example, the sheathing tools of the present technology may be used with devices for removing emboli from body lumens other than blood vessels (e.g., the digestive tract, etc.) and/or may be used to remove emboli from blood vessels outside of the brain (e.g., pulmonary blood vessels, blood vessels within the legs, etc.). In addition, the sheathing tools of the present technology may be used with devices for removing luminal obstructions other than clot material (e.g., plaque, resected tissue, etc.).
The sheath 19 may be configured to be detachably coupled to the catheter 100, the sheathing tool 200, and/or the support 300 and is configured to slidably receive the treatment device 10 in a low-profile, constrained state (not shown) therethrough. In some embodiments, such as the embodiment shown in
As shown in
In some embodiments, the treatment device 10 includes an elongated member 12 and a treatment assembly 14 coupled to a distal region of the elongated member 12. The treatment assembly 14 may be configured to be intravascularly positioned at or adjacent clot material within a blood vessel lumen and includes a first element 17 and a second element 15. In some embodiments, the first element 17 may be a self-expanding stent 17 (e.g., a laser-cut stent) and the second element 15 may be a self-expanding mesh (e.g., a braid, a weave, a lattice structure, a fabric, etc.). In some embodiments, the first and second elements 17, 15 may have other suitable configurations.
The first element 17 may have a proximal portion 17a coupled to the elongated member 12 and a distal portion 17b, and the second element 15 may have a free end portion 15b and a fixed end portion 15a coupled to the elongated member 12. The second element 15 may be flexible such that it is movable between a first position (
Examples of suitable treatment devices 10 for use with the system 1 can be found in U.S. patent application Ser. No. 15/594,410, filed May 12, 2017, which is incorporated by reference herein in its entirety. Although the sheathing tools discussed below are described with reference to the treatment device 10 shown in
When the sheathing tool 200 is in a first position, the first and second openings 214, 224 are spaced apart by a gap g having a first length, and when the sheathing tool 200 is in a second position, the first and second openings 214, 224 are spaced apart by a gap g having a second length less than the first length. The second length may be great enough to allow the second element 15 to self-expand such that the second element 15 is positioned over the sidewall while the first element 17 generally maintains its diameter in the constrained state while crossing the gap g. In other words, because the first element 17 does not have enough space between the first and second openings 214, 224 to expand, the first element 17 crosses the gap g in a constrained state which allows the first element 17 to enter through the second opening 224. If the gap g is too long, the distal ends of the first element 17 may begin to expand/splay outwardly and prevent the first element 17 from entering the second channel 226. Likewise, if the gap g is too short, the second element 15 may not have enough room for the distal portion 15b to flare radially outwardly to an extent that allows the second element 15 to extend over the second protrusion 222 and/or receive the second protrusion 222 within the lumen 27 (
As shown in
This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown and/or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, in alternative embodiments the steps may have another suitable order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. Accordingly, this disclosure and associated technology can encompass other embodiments not expressly shown and/or described herein.
Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Similarly, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the terms “comprising” and the like are used throughout this disclosure to mean including at least the recited feature(s) such that any greater number of the same feature(s) and/or one or more additional types of features are not precluded. Directional terms, such as “upper,” “lower,” “front,” “back,” “vertical,” and “horizontal,” may be used herein to express and clarify the relationship between various elements. It should be understood that such terms do not denote absolute orientation. Reference herein to “one embodiment,” “an embodiment,” or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.
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