Atherectomy device including a sealed drive shaft

Abstract

A plaque resection device (100) for removing occlusive material from a subject's vasculature includes a sheath (116) and a drive shaft (216) disposed within the sheath. The drive shaft (216) is coupled with a cutting element (118). The drive shaft (216) is rotatable relative to the sheath (116) to rotate the cutting element (118). A material removal channel (218) for receiving occlusive material is defined between the drive shaft (216) and the sheath (116). The drive shaft (216) includes a coil (504) having an inner lumen (512). A sleeve (516) is disposed outside the coil (504) and inhibits occlusive material in the material removal channel (218) from passing through the coil and into the inner lumen (512).

Description

[0001] Cross-references to related applications

[0002] none. Technical Field

[0003] The devices and methods described herein generally relate to the treatment of occluded body cavities, such as removing occlusive material from blood vessels or other body parts. Background Technology

[0004] Peripheral and interventional cardiology is a medical specialty that involves the treatment of various forms of cardiovascular disease, including coronary artery disease and peripheral vascular disease. Coronary artery disease and peripheral vascular disease can result from narrowing of the arteries caused by atherosclerosis (also known as arteriosclerosis). Coronary artery disease generally affects the arteries of the heart—the arteries that carry blood to the heart muscle and surrounding tissues. Peripheral vascular disease refers to various diseases of the vascular system outside the heart and brain (for example, those that carry blood to the legs).

[0005] Atherosclerosis typically affects medium and large arteries and occurs when fat, cholesterol, and other substances accumulate on the arterial walls, forming fleshy or hard / calcified structures known as plaques / lesions. When plaques form within the arterial walls, the arteries may narrow and become less flexible, making it harder for blood to flow. In peripheral arteries, plaques are usually not localized but can extend up to 10 millimeters or more (and in some cases, 400 millimeters or more) along the axis of the artery.

[0006] Fragments of plaque can break off and travel through the affected artery to smaller vessels, potentially blocking them and causing tissue damage or death (embolism). In some cases, atherosclerotic plaques may be associated with weakening of the affected artery wall, which can lead to aneurysms. Minimally invasive surgery can be performed to remove plaque from arteries in an effort to alleviate or help prevent complications of atherosclerosis.

[0007] Several interventional procedures can be used to treat atherosclerosis. For example, in balloon angioplasty, a surgeon can advance a constricted intravascular balloon catheter into the narrowed artery and inflate the balloon to crush plaque and / or displace it against the vessel wall. Successful angioplasty can help reopen the artery and allow improved blood flow. Typically, balloon angioplasty is performed in conjunction with the placement of a stent or stent structure within the artery to help minimize restenosis. However, balloon angioplasty can stretch the artery and induce scar tissue formation, while stent placement can cut arterial tissue and also induce scar tissue formation. Scar tissue formation can lead to restenosis. In some cases, balloon angioplasty can also tear the vessel wall.

[0008] Plaque excision is another treatment for atherosclerosis and involves the mechanical removal (i.e., debulking) of plaque from the arterial wall using an endovascular device. Plaque excision devices allow plaque to be removed from the arterial wall, reducing the risk of stretching, cutting, or slicing the arterial wall and causing tissue damage that leads to restenosis. In some cases, plaque excision can be used to treat restenosis by removing scar tissue.

[0009] Unfortunately, some plaque resection devices are limited in structure and performance. For example, the rotary cutting element or assembly in some plaque resection devices can be driven by a coiled drive shaft. When such a shaft rotates in the bends of the vascular system, the coil slightly opens, allowing plaque and fluid to pass through the shaft and into the internal guidewire lumen. The plaque and fluid within the guidewire lumen increase friction between the shaft and the guidewire within the lumen, which can adversely affect the device's performance. Therefore, there is a need for improved plaque resection devices and methods. Summary of the Invention

[0010] This disclosure discloses a plaque resection device for removing occlusive material from a subject's vascular system. The plaque resection device includes a distal cutter assembly comprising 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 it into the housing. The device also includes a conduit coupled to the distal cutter assembly. The conduit 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 cause the cutting element to rotate relative to the housing. A material removal channel is defined between the drive shaft and the sheath for receiving the occlusive material from the housing. The drive shaft includes a coil having an inner lumen. A sleeve is disposed outside the coil, and the sleeve prevents the occlusive material in the material removal channel from passing through the coil and into the inner lumen.

[0011] According to the plaque removal device described in the preceding paragraph, the cannula comprises a polymer.

[0012] The plaque removal device according to any of the preceding paragraphs, wherein the polymer is a hydrophobic polymer.

[0013] The plaque removal device according to any of the preceding paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

[0014] The plaque removal device according to any of the preceding paragraphs, wherein the coil is an inner coil, and the plaque removal device further includes an outer coil disposed outward from the inner coil, the outer coil being configured to move occluded material in the material removal channel proximally when the drive shaft rotates relative to the sheath, and a sheath being disposed between the inner coil and the outer coil.

[0015] The plaque removal device according to any of the preceding paragraphs further includes an intermediate coil disposed between the inner coil and the sleeve.

[0016] This disclosure discloses a plaque resection device for removing occlusive material from a subject's vascular system. The plaque resection device includes a distal cutter assembly comprising a housing and a cutting element carried by the housing. The cutting element includes at least one cutting blade and is rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move it into the housing. A catheter is coupled to the distal cutter assembly. The catheter includes a sheath configured to receive the occlusive material from the housing. The catheter also includes a drive shaft disposed within the sheath and coupled to the cutting element. The drive shaft is rotatable relative to the sheath to cause the cutting element to rotate 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 cause the occlusive material to move proximally in a material removal channel disposed between the drive shaft and the sheath as the drive shaft rotates relative to the sheath. A sealing layer is disposed between the inner and outer coils. This sealing layer prevents the occlusive material in the material removal channel from passing through the inner coil and entering the inner lumen.

[0017] According to the plaque removal device described in the preceding paragraph, the sealing layer comprises a polymer.

[0018] The plaque removal device according to any of the preceding paragraphs, wherein the polymer is a hydrophobic polymer.

[0019] The plaque removal device according to any of the preceding paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

[0020] The plaque removal device according to any of the preceding paragraphs further includes an intermediate coil disposed between the inner coil and the sealing layer.

[0021] This disclosure discloses a plaque resection device for removing occlusive material from a subject's vascular system. The plaque resection device includes a distal cutter assembly comprising 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 it into the housing. The plaque resection device also includes a conduit coupled to the distal cutter assembly. The conduit includes a sheath 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 cause the cutting element to rotate relative to the housing. The drive shaft includes an inner coil having an inner lumen. An outer delivery device is disposed outwardly from the inner coil. The outer delivery device is configured to move the occlusive material proximally in a material removal channel disposed between the drive shaft and the sheath as the drive shaft rotates relative to the sheath. A sealing layer is disposed between the inner coil and the outer delivery device. This sealing layer prevents the occlusive material in the material removal channel from passing through the inner coil and into the inner lumen.

[0022] According to the plaque removal device described in the preceding paragraph, the sealing layer comprises a polymer.

[0023] The plaque removal device according to any of the preceding paragraphs, wherein the polymer is a hydrophobic polymer.

[0024] The plaque removal device according to any of the preceding paragraphs, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

[0025] The plaque removal device according to any of the preceding paragraphs further includes an intermediate coil disposed between the inner coil and the sealing layer.

[0026] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both combined and separate in use. 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” refers to a single A, a single B, a single C, A and B together, A and C together, B and C together, and A, B, and C together. When each of A, B, and C in the above expressions refers to an element (e.g., X, Y, and Z) or a class of elements (e.g., X1-X), the meaning is different. n Y1-Y m and Z1-Z o When used, this phrase is intended to refer to a single element selected from X, Y, and Z, or a combination of elements selected from the same category (e.g., X1 and X2), or a combination of elements selected from two or more categories (e.g., Y1 and Z). o ).

[0027] The term "a" or "an" entity refers to one or more of the same entity. Therefore, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0028] The term “means” as used herein shall be given the broadest possible interpretation in accordance with Section 112(f) of 35 U.S.SC. Therefore, claims containing the term “means” shall cover all structures, materials, or actions set forth herein, and all their equivalents. Furthermore, structures, materials, or actions, and their equivalents, shall include all that is described in the summary, description of the drawings, detailed description, abstract, and claims.

[0029] It should be understood that each maximum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every lower numerical limit, as if such lower numerical limits were expressly stated herein. Each minimum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every larger numerical limit, as if such larger numerical limits were expressly stated herein. Each numerical range given in this disclosure is considered to include, as if falling within that wider numerical range, every and every narrower numerical range, as if such narrower numerical ranges were all expressly stated herein.

[0030] The foregoing is a simplified summary of this disclosure, intended to provide an understanding of some aspects of the disclosure. This summary is neither extensive nor exhaustive; it is not intended to identify key or essential elements of the disclosure, nor to depict its scope, but rather to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description given below. As will be understood, other aspects, embodiments, and configurations of the disclosure may utilize one or more features described above or in detail below, individually or in combination. Attached Figure Description

[0031] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings simply illustrate preferred and alternative examples of how this disclosure can be made and used, and should not be construed as limiting this disclosure to the examples shown and described. Other features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated in the accompanying drawings with reference to them.

[0032] Figure 1This is a side view of a plaque excision system according to an embodiment of the present disclosure.

[0033] Figure 2A yes Figure 1 Detailed side view of the distal portion of the plaque excision system.

[0034] Figure 2B yes Figure 1 Detailed perspective view of the distal portion of the plaque excision system.

[0035] Figure 2C yes Figure 2A Detailed transverse cross-sectional view of the distal portion of the plaque excision system.

[0036] Figure 3A yes Figure 1 A perspective view of the distal cutting element of the plaque resection system.

[0037] Figure 3B yes Figure 3A Side view of the distal cut element.

[0038] Figure 4A yes Figure 1 A perspective view of the proximal cutting element of the plaque resection system.

[0039] Figure 4B yes Figure 4A A front view of the proximal cut element.

[0040] Figure 5 yes Figure 1 A transverse cross-sectional view of the drive shaft of the plaque removal system.

[0041] It should be understood that the accompanying drawings are not necessarily drawn to scale. In some cases, details that are not necessary for understanding this disclosure or that make other details difficult to understand may be omitted. Of course, it should be understood that this disclosure is not limited to the specific embodiments shown herein. Detailed Implementation

[0042] Before explaining any embodiments of this disclosure in detail, it should be understood that the application of this disclosure is not limited to the details of the construction and component arrangement set forth in the following description or shown in the following drawings. This disclosure can have other embodiments and can be practiced or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The terms “comprising,” “including,” or “having,” and variations thereof, as used herein, are intended to cover the items listed thereafter and their equivalents, as well as additional items.

[0043] This disclosure generally relates to devices, systems, and methods for mechanical plaque resection. (Reference) Figure 1This illustration shows an exemplary embodiment of the plaque resection system described herein. The plaque resection system 100 includes an intravascular plaque resection device 102 and a guidewire 104, the plaque resection device 102 being disposed on the guidewire. In some embodiments, the guidewire 104 is silicon-coated or uncoated (bare), or otherwise does not contain a polytetrafluoroethylene (PTFE) coating. Some embodiments of the plaque resection system according to this disclosure include a guidewire 104 comprising a PTFE coating, or some embodiments of the plaque resection system according to this disclosure lack a guidewire 104.

[0044] Continue to refer to Figure 1 The plaque resection device 102 generally includes a handle 106 and a catheter 108. The handle 106 is configured to be gripped and manipulated by a user (e.g., a medical professional) during plaque resection procedures. The catheter 108 is coupled to the handle 106 and extends distally relative to the handle 106. The catheter 108 is configured to be positioned within a blood vessel of a subject (e.g., a patient) during plaque resection procedures to facilitate the removal of occlusive material (e.g., plaque). In some embodiments, and as shown, the distal portion 110 of the catheter 108 has an arcuate shape or configuration. In some embodiments, the distal portion 110 of the catheter 108 normally has an arcuate configuration (“normally” is understood to mean that the catheter 108 is not subjected to any external contact forces, such as contact with the vessel wall), and is deflectable to other configurations. In other embodiments, the distal portion 110 of the catheter 108 normally has a straight shape or configuration and is deflectable to other configurations. In some embodiments, the catheter 108 is selectively rotatable about a catheter rotation axis 112 relative to the handle 106 to facilitate proper positioning and / or “sweeping” of the distal portion 110 of the catheter 108 during plaque resection procedures. In some embodiments, and as shown, the handle 106 carries a rotatable knob or dial 114 for selectively rotating the catheter 108 relative to the handle 106. The catheter 108 includes an outer sheath 116 coupled to a cutter assembly 118 extending distally from the outer sheath 116. The cutter assembly 118 will be described in further detail below.

[0045] Figure 2A-2C The distal portion 110 of catheter 108 is shown, which, among other components, includes an outer sheath 116 and a cutter assembly 118. The cutter assembly 118 includes a collar 200 coupled to and extending distally from the outer sheath 116. The cutter assembly 118 also includes a housing 202 coupled to and extending distally from the collar 200. The housing 202 rotatably carries the cutting element. See details. Figure 2B-2CThe housing 202 rotatably carries a first or distal cutting element 204 and a second or proximal cutting element 206. The rotation of the first cutting element 204 and the second cutting element 206 relative to the housing 202 along the rotation direction 209 about the rotation axis 208 causes the cutting elements 204, 206 to cut the obstructing material and deliver the obstructing material into the housing 202 (also known as the "debulking" process).

[0046] Still referencing Figure 2B-2C The first cutting element 204 extends generally distally from the second cutting element 206 and the housing 202. The first cutting element 204 includes a central opening 210 (see...). Figure 2C A guide wire 104 is used for connection with a second cutting element 206. The second cutting element 206 is generally disposed within the housing 202, and in some embodiments, as shown, may be completely disposed within the housing 202. The second cutting element 206 is also generally disposed near the first cutting element 204, although the second cutting element 206 includes a shaft or rod 212 received in a central opening 210. The rod 212 can be connected to the first cutting element 204 in various ways. For example, the rod 212 can be connected to the first cutting element 204 by welding. In some embodiments, as shown, the rod 212 extends distally relative to the first cutting element 204. The rod 212 includes an inner lumen 214 for receiving a guide wire 104 (shown elsewhere).

[0047] For details, please refer to the following: Figure 2C The plaque removal device 102 also includes a rotatable drive shaft 216 that connects the first cutting element 204 and the second cutting element 206 to a prime mover (e.g., a motor carried by the handle 106 – not shown). That is, the prime mover rotates the drive shaft 216, which in turn rotates the first cutting element 204 and the second cutting element 206 to facilitate cutting the occlusive material and delivering it into the housing 202. In some embodiments, the cutter assembly 118 captures the cut occlusive material from the blood without using vacuum suction. In other embodiments, vacuum suction can help capture the cut occlusive material. In either case, the housing 202 delivers the cut occlusive material to a material removal channel 218 formed between the outer sheath 116 and the drive shaft 216. Due to the characteristics of the drive shaft 216 (described further below) and / or vacuum suction, the occlusive material moves proximally through the material removal channel 218, and the occlusive material is thus removed from the subject's vascular system.

[0048] refer to Figures 3A-3BThe first cutting element 204 includes one or more first or distal cutting grooves or blades 300 that extend distally relative to the housing 202 (shown elsewhere). In some embodiments and as shown, the first cutting element 204 includes two cutting blades 300. In some embodiments and as shown, one or more of the first cutting blades 300 extend helically relative to the axis of rotation 208.

[0049] Now for reference Figures 4A-4B The second cutting element 206 includes one or more second or proximal cutting grooves or blades 400. In some embodiments, the number of blades 400 in the second cutting element 206 is twice that of the first cutting element 204 (shown elsewhere). In some embodiments, and as shown, the second cutting element 206 includes four cutting blades 400. In some embodiments, and as shown, one or more of the second cutting blades 400 extend helically relative to the axis of rotation 208.

[0050] Figure 5 A cross-sectional view of drive shaft 216 is shown. Drive shaft 216 generally includes a distal coupling 500 coupled to cutter assembly 118 (shown elsewhere), a proximal coupling 502 coupled to prime mover (not shown), and a coiled portion 504 extending and coupled between the distal coupling 500 and the proximal coupling 502. The distal coupling 500 is a generally cylindrical component that receives a portion of the coiled portion 504. The distal coupling 500 can be soldered to and coupled to the coiled portion 504 via a distal solder joint 506. The distal coupling 500 may be formed of metal, such as stainless steel, more specifically 304 stainless steel. Similarly, the proximal coupling 502 is a generally cylindrical component that receives a portion of the coiled portion 504. The proximal coupling 502 can be soldered to and coupled to the coiled portion 504 via a proximal solder joint 508. The proximal connector 502 may be made of metal, such as stainless steel, more specifically 304 stainless steel.

[0051] Continue to refer to Figure 5The coiled portion 504 includes several components that provide flexibility to the drive shaft 216 and inhibit the penetration of occlusive material. More specifically, the coiled portion 504 includes an inner coil 510, which, together with a distal connector 500 and a proximal connector 502, defines an inner lumen 512 configured to receive a guide wire 104 (shown elsewhere). The inner coil 510 may have approximately 10 wires, each with a diameter of approximately 0.004 inches. The inner coil 510 may be right-handed. The inner coil 510 may be formed of a metal, such as stainless steel, more specifically 304 stainless steel. The coiled portion 504 also includes an intermediate coil 514 disposed radially outward from the inner coil 510. The intermediate coil 514 may have approximately 10 wires, each with a diameter of approximately 0.004 inches. The intermediate coil 514 may be left-handed. The intermediate coil 514 may be formed of a metal, such as stainless steel, more specifically 304 stainless steel.

[0052] The coiled portion 504 also includes a sleeve 516, also referred to as an intermediate sleeve and sealing layer, disposed radially outward from the intermediate coil 514. The sleeve 516 may extend over a large portion of the length of the coiled portion 504, more specifically, from the distal brazing point 506 to the proximal brazing point 508. The sleeve 516 provides a seal for the intermediate coil 514 and the inner coil 510, or in other words, the sleeve 516 inhibits occlusion material in the material removal channel 218 (shown elsewhere) from passing through the intermediate coil 514, through the inner coil 510, and into the inner lumen 512. The sleeve 516 may be formed of, for example, one or more polymers, more specifically, hydrophobic polymers such as PTFE or fluorinated ethylene propylene (FEP). The sleeve 516 may be formed on the intermediate coil 514, for example, in a heat-shrinking process, an extrusion process, or a similar process.

[0053] In some embodiments, the cannula 516 provides one or more advantages. For example, by inhibiting occlusive material from passing through the drive shaft 216, the cannula 516 results in relatively low and / or constant rotational friction between the drive shaft 216 and the guidewire 104 during use of the plaque resection device 102. In some embodiments, during use of the plaque resection device 102, the plaque resection device 102 including the cannula 516 can withstand approximately 96% less rotational friction between the drive shaft 216 and the guidewire 104 compared to a similar plaque resection device lacking the cannula 516. As another example, the cannula 516 provides damping and reduces vibration of the drive shaft 216. As yet another example, the cannula 516 allows the inner lumen 512 of the drive shaft 216 to be used as a delivery chamber for administering, for example, fluids such as therapeutic agents, nitroglycerin, saline, contrast agent solutions, or the like to a subject.

[0054] Still referencing Figure 5The drive shaft 216 also includes an outer coil 518, also referred to as an outer conveyor or helical pump, arranged radially outward from the sleeve 516. As the drive shaft 216 rotates relative to the sleeve, the outer coil 518 causes occluded material in the material removal channel 218 to be conveyed proximally. The outer coil 518 may have a single wire with a diameter of approximately 0.006 inches (i.e., 0.006 inches ± 0.001 inches). The outer coil 518 may have a pitch of approximately 0.030 inches. The outer coil 518 may be right-handed. The outer coil 518 may be formed of a metal, such as stainless steel, more specifically 304 stainless steel.

[0055] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. For example, in the preceding summary of the invention, various features of this disclosure have been combined in one or more aspects, embodiments, and / or configurations for the purpose of simplification. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations different from those discussed above. This approach to disclosure should not be construed as reflecting an intention that the claims require more features than expressly recited in each claim. Rather, as reflected in the following claims, the inventive aspect lies in fewer than all features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are incorporated herein by reference, and each claim stands independently as a separate preferred embodiment of this disclosure.

[0056] Furthermore, although the description has included descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure, for example, to the skill and knowledge of those skilled in the art upon understanding this disclosure. It is intended to obtain rights to alternative aspects, embodiments, and / or configurations included within the permitted scope, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps to the claimed structure, function, scope, or steps, whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to publicly offer any patentable subject matter.

Claims

1. A plaque resection device for removing occlusive material from a subject, the plaque resection device comprising: The distal cutter assembly includes: case; A cutting element, carried by the housing and including at least one cutting blade, the cutting element being 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 coupled to the distal cutter assembly, the catheter comprising: jacket; A drive shaft disposed within the sheath and coupled to the cutting element, the drive shaft being rotatable relative to the sheath to cause the cutting element to rotate relative to the housing, and defining a material removal channel between the drive shaft and the sheath for receiving the occlusive material from the housing, the drive shaft comprising: Including the coil within the inner cavity; and A sleeve positioned outside the coil prevents the occlusive material in the material removal channel from passing through the coil and entering the inner lumen.

2. The plaque removal device according to claim 1, wherein, The sleeve comprises a polymer.

3. The plaque removal device according to claim 2, wherein, The polymer is a hydrophobic polymer.

4. The plaque removal device according to claim 3, wherein, The hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

5. The plaque removal device according to claim 1, wherein, The coil is an inner coil, and the plaque removal device also includes an outer coil disposed outward from the inner coil, the outer coil being configured to move the occlusive material in the material removal channel proximally when the drive shaft rotates relative to the sheath, and the sheath being disposed between the inner coil and the outer coil.

6. The plaque removal device according to claim 5, wherein, The plaque removal device also includes an intermediate coil disposed between the inner coil and the sleeve.

7. A plaque resection device for removing occlusive material from a subject, the plaque resection device comprising: The distal cutter assembly includes: case; A cutting element, carried by the housing and including at least one cutting blade, the cutting element being 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 coupled to the distal cutter assembly, the catheter comprising: A sheath configured to receive the occlusive material from the housing; A drive shaft disposed within the sheath and connected to the cutting element, the drive shaft being rotatable relative to the sheath to cause the cutting element to rotate relative to the housing, the drive shaft comprising: Including the inner coil of the inner cavity; An outer coil is disposed outward from the inner coil, the outer coil being configured to move the occlusive material proximally in a material removal channel disposed between the drive shaft and the sheath when the drive shaft rotates relative to the sheath; and A sealing layer disposed between the inner coil and the outer coil prevents the occlusive material in the material removal channel from passing through the inner coil and entering the inner lumen.

8. The plaque removal device according to claim 7, wherein, The sealing layer comprises a polymer.

9. The plaque removal device according to claim 8, wherein, The polymer is a hydrophobic polymer.

10. The plaque removal device according to claim 9, wherein, The hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

11. The plaque removal device according to claim 7, wherein, The plaque removal device also includes an intermediate coil disposed between the inner coil and the sealing layer.

12. A plaque resection device for removing occlusive material from a subject, the plaque resection device comprising: The distal cutter assembly includes: case; A cutting element, carried by the housing and including at least one cutting blade, the cutting element being 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 coupled to the distal cutter assembly, the catheter comprising: A sheath configured to receive the occlusive material from the housing; A drive shaft disposed within the sheath and connected to the cutting element, the drive shaft being rotatable relative to the sheath to cause the cutting element to rotate relative to the housing, the drive shaft comprising: Including the inner coil of the inner cavity; An outer conveyor disposed outward from the inner coil, the outer conveyor being configured to move the occlusion material proximally in a material removal channel disposed between the drive shaft and the sheath as the drive shaft rotates relative to the sheath; and A sealing layer disposed between the inner coil and the outer conveyor prevents the obstructing material in the material removal channel from passing through the inner coil and entering the inner lumen.

13. The plaque removal device according to claim 12, wherein, The sealing layer comprises a polymer.

14. The plaque removal device according to claim 13, wherein, The polymer is a hydrophobic polymer.

15. The plaque removal device according to claim 14, wherein, The hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP).

16. The plaque removal device according to claim 12, wherein, The plaque removal device also includes an intermediate coil disposed between the inner coil and the sealing layer.

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