Patent Application
20230037603
None.
The devices and methods described herein generally relate to treatment of occluded body lumens, such as the removal of occlusive material from a blood vessel or other body parts.
Peripheral and interventional cardiology is a medical specialty that relates to treatment of various forms of cardiovascular disease, including coronary artery disease and peripheral vascular disease. Coronary artery disease and peripheral vascular disease can arise due to the narrowing of the arteries by atherosclerosis (also called arteriosclerosis). Coronary artery disease generally affects arteries of the heart-arteries that carry blood to cardiac muscles and surrounding tissue. Peripheral vascular disease refers to various diseases of the vascular system outside the heart and brain, which carries blood, for example, to the legs.
Atherosclerosis commonly affects the medium and large arteries, and may occur when fat, cholesterol, and other substances build up on the walls of arteries and form fleshy or hard/calcified structures called plaques/lesions. As plaque forms within an arterial wall, the artery may narrow and become less flexible, which may make it more difficult for blood to flow therethrough. In the peripheral arteries, the plaque is typically not localized, but can extend in length along the axis of the artery for as much as 10 mm or more (in some instance up to 400 mm or more).
Pieces of plaque can break off and move through the affected artery to smaller blood vessels, which may in some instances block them and may result in tissue damage or tissue death (embolization). In some cases, the atherosclerotic plaque may be associated with a weakening of the wall of the affected artery, which can lead to an aneurysm. Minimally invasive surgeries may be performed to remove plaque from arteries in an effort to alleviate or help prevent the complications of atherosclerosis.
A number of interventional surgical methodologies may be used to treat atherosclerosis. In balloon angioplasty, for example, a physician may advance a collapsed, intravascular balloon catheter into a narrowed artery, and may inflate the balloon to macerate and/or displace plaque against the vessel wall. A successful angioplasty may help reopen the artery and allow for improved blood flow. Often, balloon angioplasty is performed in conjunction with the placement of a stent or scaffold structure within the artery to help minimize re-narrowing of the artery. Balloon angioplasty, however, can stretch the artery and induce scar tissue formation, while the placement of a stent can cut arterial tissue and also induce scar tissue formation. Scar tissue formation may lead to restenosis of the artery. In some instances, balloon angioplasty can also rip the vessel wall.
Atherectomy is another treatment methodology for atherosclerosis, and involves the use of an intravascular device to mechanically remove (that is, debulk) plaque from the wall of the artery. Atherectomy devices may allow for the removal of plaque from the wall of an artery, reducing the risk of stretching, cutter, or dissecting the arterial wall and causing tissue damage that leads to restenosis. In some instances, atherectomy may be used to treat restenosis by removing scar tissue.
Unfortunately, some atherectomy devices suffer from structural and performance limitations. For example, rotating cutting elements or assemblies of some atherectomy may be driven by coiled drive shafts. When such shafts are rotated in a curve of the vasculature, the coils open slightly and permit plaque and fluids to penetrate the shaft and enter an internal guide wire lumen. The plaque and fluids in the guide wire lumen increase friction between the shaft and a guide wire within the lumen, which can adversely impact device performance. Accordingly, it is desirable to provide improved atherectomy devices and methods.
The present disclosure presents an atherectomy device for removing occlusive material from the vasculature of a subject. The atherectomy device includes a distal cutter assembly, and the cutter assembly includes a housing and a cutting element carried by the housing. The cutting element includes at least one cutting blade. The cutting element is rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing. The device further includes a catheter coupled to the distal cutter assembly. The catheter includes a sheath and a drive shaft disposed within the sheath and coupled to the cutting element. The drive shaft is rotatable relative to the sheath to rotate the cutting element relative to the housing. The drive shaft and the sheath define therebetween a material removal passageway for receiving the occlusive material from the housing. The drive shaft includes a coil having an inner lumen. A jacket is disposed outwardly of the coil, and the jacket inhibits the occlusive material in the material removal passageway from passing through the coil and entering the inner lumen.
The atherectomy device according to the previous paragraph, wherein the jacket comprises a polymer.
The atherectomy device according to any of the previous paragraphs, wherein the polymer is a hydrophobic polymer.
The atherectomy device according to any of the previous paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).
The atherectomy device according to any of the previous paragraphs, wherein the coil is an inner coil, and further comprising an outer coil disposed outwardly from the inner coil, the outer coil being configured to proximally move the occlusive material in the material removal passageway upon rotation of the drive shaft relative to the sheath, and wherein the jacket is disposed between the inner coil and the outer coil.
The atherectomy device according to any of the previous paragraphs, further comprising an intermediate coil disposed between the inner coil and the jacket.
The present disclosure presents an atherectomy device for removing occlusive material from the vasculature of a subject. The atherectomy device includes a distal cutter assembly including a housing and a cutting element carried by the housing. The cutting element includes at least one cutting blade, and the cutting element is rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing. A catheter is coupled to the distal cutter assembly. The catheter includes a sheath that is configured to receive the occlusive material from the housing. The catheter further includes a drive shaft disposed within the sheath and coupled to the cutting element. The drive shaft is rotatable relative to the sheath to rotate the cutting element relative to the housing. The drive shaft includes an inner coil having an inner lumen and an outer coil disposed outwardly from the inner coil. The outer coil is configured to proximally move the occlusive material in a material removal passageway disposed between the drive shaft and the sheath upon rotation of the drive shaft relative to the sheath. A sealing layer is disposed between the inner coil and the outer coil. The sealing layer inhibits the occlusive material in the material removal passageway from passing through the inner coil and entering the inner lumen.
The atherectomy device according to the previous paragraph, wherein the sealing layer comprises a polymer.
The atherectomy device according to any of the previous paragraphs, wherein the polymer is a hydrophobic polymer.
The atherectomy device according to any of the previous paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).
The atherectomy device according to any of the previous paragraphs, further comprising an intermediate coil disposed between the inner coil and the sealing layer.
The present disclosure presents an atherectomy device for removing occlusive material from the vasculature of a subject. The atherectomy device includes a distal cutter assembly including a housing and a cutting element carried by the housing. The cutting element has at least one cutting blade. The cutting element is rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing. The atherectomy device further includes a catheter coupled to the distal cutter assembly. The catheter includes a sheath that is configured to receive the occlusive material from the housing. A drive shaft is disposed within the sheath and coupled to the cutting element. The drive shaft is rotatable relative to the sheath to rotate the cutting element relative to the housing. The drive shaft includes an inner coil having an inner lumen. An outer conveyor is disposed outwardly from the inner coil. The outer conveyor is configured to proximally move the occlusive material in a material removal passageway disposed between the drive shaft and the sheath upon rotation of the drive shaft relative to the sheath. A sealing layer is disposed between the inner coil and the outer conveyor. The sealing layer inhibits the occlusive material in the material removal passageway from passing through the inner coil and entering the inner lumen.
The atherectomy device according to the previous paragraphs, wherein the sealing layer comprises a polymer.
The atherectomy device according to any of the previous paragraphs, wherein the polymer is a hydrophobic polymer.
The atherectomy device according to any of the previous paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).
The atherectomy device according to any of the previous paragraphs, further comprising an intermediate coil disposed between the inner coil and the sealing layer.
The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as X1-Xn, Y1-Ym, and Z1-Z0, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (for example, X1 and X2) as well as a combination of elements selected from two or more classes (for example, Y1 and Z0).
The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” may be used interchangeably.
The term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. Section 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary, brief description of the drawings, detailed description, abstract, and claims themselves.
It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation as an alternative, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation as an alternative, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.
The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure may be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.
It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the disclosure or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the disclosure is not necessarily limited to the particular embodiments illustrated herein.
Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
The present disclosure relates generally to devices, systems, and methods for mechanical atherectomy. Referring to
With continued reference to
Still referring to
The second cutting element 206 is generally disposed within the housing 202 and, in some embodiments and as illustrated, may be completely disposed within the housing 202. The second cutting element 206 is also generally disposed proximally from the first cutting element 204, although the second cutting element 206 includes a shaft or stem 212 that is received in the central opening 210. The stem 212 may couple to the first cutting element 204 in various manners. For example, the stem 212 may couple to the first cutting element 204 via welding. In some embodiments and as illustrated, the stem 212 extends distally relative to the first cutting element 204. The stem 212 includes an inner lumen 214 for receiving a guide wire 104 (shown elsewhere).
Referring specifically to
Referring to
Referring now to
With continued reference to
The coiled section 504 further includes a jacket 516, also referred to as an intermediate jacket and a sealing layer, disposed radially outwardly from the intermediate coil 514. The jacket 516 may extend over the majority of the length of the coiled section 504, more specifically, from the distal solder joint 506 to the proximal solder joint 508. The jacket 516 provides a seal for the intermediate coil 514 and the inner coil 510 or, stated another way, the jacket 516 inhibits the occlusive material in the material removal passageway 218 (shown elsewhere) from passing through the intermediate coil 514, through the inner coil 510, and entering the inner lumen 512. The jacket 516 may be formed of, for example, one or more polymers, more specifically a hydrophobic polymer, such as PTFE or fluorinate ethylene propylene (FEP). The jacket 516 may be formed over the intermediate coil 514, for example, in a heat-shrinking process, an extrusion process, or the like.
In some embodiments, the jacket 516 provides one or more advantages. For example, by inhibiting occlusive material from penetrating the drive shaft 216, the jacket 516 causes rotational friction between the drive shaft 216 and the guide wire 104 to remain relatively low and/or constant during use of the atherectomy device 102. In some embodiments, an atherectomy device 102 including the jacket 516 may be subjected to rotational friction between the drive shaft 216 and the guide wire 104 during use of the atherectomy device 102 that is reduced by about 96 percent compared to a similar atherectomy device lacking the jacket 516. As another example, the jacket 516 provides damping and reduces vibration of the drive shaft 216. As yet another example, the jacket 516 permits the inner lumen 512 of the drive shaft 216 to be used as a delivery lumen for providing, for example, a fluid to the subject, such as a therapeutic agent, nitroglycerin, saline solution, contrast solution, or the like.
Still referring to
The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Summary for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
Moreover, though the description has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, for example, as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/085404 | 12/10/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62951000 | Dec 2019 | US |
