Catheter, system and manufacture of a catheter
Patent Information
- Application Number
- EP2022834885
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2022-12-07
- Publication Date
- 2025-10-15
AI Technical Summary
Catheters used in aspiration systems, such as thrombectomy or atherectomy, face challenges in maintaining a reliable and stable connection between the rotatable and stationary parts, which can lead to the rotatable part becoming loose and disengaging during procedures, potentially causing damage or safety issues.
The catheter design incorporates cylindrical sections with engagement features that allow for rotational movement of the rotatable part relative to the stationary part while preventing axial or longitudinal movement, ensuring a secure connection through features like snap fits, crimping, or grooves and protrusions, which are strategically located to enhance stability and reliability.
This design ensures a reliable and stable connection between the rotatable and stationary parts, reducing the likelihood of inadvertent disengagement and enhancing the catheter's stability and safety during procedures, thereby preventing loosening and longitudinal movement of the rotatable part.
Smart Images

Figure 1.1
Abstract
Description
[0001] Catheter, System and Manufacture of a Catheter
[0002] Technical Field
[0003] The present disclosure is directed to catheters , catheter systems , and methods of manufacture of a catheter .
[0004] Background
[0005] Catheters e . g . for aspiration systems , in particular for thrombectomy or atherectomy systems , may have a rotatable part and a stationary part , wherein the rotatable part rotates relative to the stationary part . The rotatable part may be configured to promote removal of clot and / or calci fications from a vessel wall during a procedure . To increase the patient ' s safety and to avoid damage to the catheter, it is desired to ensure reliable connection between the rotatable part and the stationary part . In particular, it shall be avoided that the rotatable part becomes loose and " escapes" from the stationary part and the remaining catheter during a treatment .
[0006] Summary
[0007] The present disclosure provides a catheter that may allow for reliable connection between the rotatable part and the stationary part . At the same time , the connection may support reliable and stable use of the catheter .
[0008] Embodiments are directed to a catheter, such as optionally for an aspiration system, further optionally for an atherectomy and / or thrombectomy system, wherein the catheter comprises a proximal end and a distal end and extends in a longitudinal direction . The catheter may extend in the longitudinal direction between the proximal end and the distal end . The catheter comprises a rotatable part at the catheter ' s distal end, i . e . the distal end of the catheter comprises the rotatable part . The rotatable part has a cylindrical section substantially extending in the longitudinal direction . The cylindrical section of the rotatable part may be regarded as a receiving section . The catheter further comprises a stationary part having a cylindrical section substantially extending in the longitudinal direction . The cylindrical section of the stationary part may be regarded as an insertion section for inserting into the receiving portion of the rotatable portion ( or vice versa ) . The rotatable part is rotatable relative to the stationary part around a longitudinal axis extending in the longitudinal direction . The cylindrical section of the stationary part is at least partially received within the cylindrical section of the rotatable part , such that the rotatable part at least partially overlaps the stationary part . Each of the stationary and rotatable parts comprises an engagement feature at the respective cylindrical section . The first and second engagement features are in engagement and are ( and the catheter is ) configured such that the engagement allows ( or allow) for rotation of the rotatable part relative to ( around) the stationary part while movement / translation / longitudinal movement of the rotatable part relative to the stationary part in the longitudinal direction is restricted / avoided . Optionally, at least movement in the distal direction (pointing distally in the longitudinal direction) is restricted / avoided . Optionally, movement in the longitudinal direction is not only restricted / avoided in the distal direction, but also in the proximal direction .
[0009] Engagement features of the disclosure allow for engagement of the stationary part and the rotatable part after assembly ( such as during use ) , so as to avoid inadvertent disengagement between the stationary part and the rotatable part in the longitudinal direction . At the same time , the engagement allows for rotation of the rotatable part relative to the stationary part .
[0010] By way of the engagement features , engagement between the stationary part and the rotatable part may be improved, to allow rotational movement of the rotatable part relative to the stationary part while preventing axial or longitudinal movement of the rotatable part in a distal direction .
[0011] Put di f ferently, due to engagement of the engagement features between the stationary part and the rotatable part , loosening and longitudinal / distal movement of the rotatable part away from the stationary part may be avoided . E . g . , in the longitudinal / distal direction, by way of a form fit between the first and second engagement features , loosening of the rotatable part from the stationary part may be avoided . In particular, the likelihood that the rotatable part disengages from the stationary part is reduced or prevented .
[0012] The engagement by way of the first and second engagement features may be ( i ) a flexible engagement ( such as a snap fit ) allowing for advertent ( dis ) engagement due to flexibility of at least one of the parts and / or ( ii ) an engagement obtained after assembly by way of a separate engaging step, such as by way of crimping, and / or ( iii ) an engagement ef fective during use ( at least most of the time , e . g . in most of the configurations assumed during use ) . Various realisations of the engagement are contemplated .
[0013] The cylindrical sections may provide guidance for the rotation of the rotatable part relative to the stationary part (which part may be regarded as a support for the rotatable part ) . At the same time , the cylindrical sections may help to align the engagement features relative to each other, as each engagement feature is provided at the respective cylindrical section, and, hence , to support reliable engagement between the engagement features . The respective engagement feature may be at one or both end ( s ) of the respective cylindrical section . The location of an engagement feature at an end of the cylindrical section ( a distal end or a proximal end of the cylindrical section) may help to improve the stability further .
[0014] Each of the cylindrical parts may comprise a window at the side . The respective engagement feature may be at one or both ends of the respective window .
[0015] As such, reliable connection between the stationary and rotatable parts may be achieved . At the same time , due to the engagement features at the respective cylindrical sections , an intuitive and reliable means for for connecting the stationary and rotatable part in a reliable way is provided .
[0016] The rotatable part and the stationary part may be regarded as forming a head of the catheter, e . g . , a distal rotor head .
[0017] The catheter ' s distal end may be the distal end of the rotatable part .
[0018] A part of the stationary part may be proximal to the rotatable part . A part of the rotatable part may be distal to the stationary part .
[0019] Optionally, the rotatable part and the stationary part are coaxial ; in particular the cylindrical section of the stationary part and the cylindrical section of the rotatable part may be coaxial / concentric relative to each other . This may improve the stability and guidance of the stationary part and the rotatable part relative to each other, and, hence , the engagement by way of the engagement features at the cylindrical parts . Optionally, the first engagement feature extends along the circumference of the cylindrical section of the stationary part . Alternatively or additionally, the second engagement feature may extend along the circumference of the cylindrical section of the rotatable part . By way of an extension of an engagement feature along the circumference of the respective part , the reliability and strength of the engagement may be improved .
[0020] The first engagement feature may optionally be provided at a distal end or a proximal end of the cylindrical section of the stationary part . Additionally or alternatively, the second engagement feature may be provided at a distal end or a proximal end of the cylindrical section of the rotatable part . The first and second engagement features may be provided at the same ends , i . e . both at proximal ends or both at distal ends .
[0021] The first or second engagement feature may be / comprise a groove / indentation . A groove / indentation in the stationary or the rotatable part may be formed so as to allow for engagement with the corresponding counterpart , i . e . the engagement feature of the other part . Optionally, the engagement feature of the other part is / comprises a tongue / protrusion . By way of a groove / indentation at one part and a protrusion / tongue at the other part , reliable and ef ficient engagement may be obtained .
[0022] Optionally, the first engagement feature is / comprises a groove / indentation at an outer side of the stationary part . The second engagement feature may be / comprise a tongue / protrusion extending inwardly of the rotatable part , optionally at least partially along the circumference of the cylindrical section of the rotatable part .
[0023] This may be preferable as to the reliability and strength of the catheter . For example , i f the rotatable part comprises a tongue or protrusion, the added material may strengthen and support the stability of the rotatable part . I f the stationary part has a groove / indentation, this may correspond to omission of material . This may result in the stationary part being "weakened" to some extent and becoming more flexible . It is contemplated that the rotatable part , which is on the outside of the catheter, is stable and strong . More flexibility may be acceptable for the stationary part , which is at least partially inside and, thus , "protected" by the rotatable part . Hence , selecting first and second engagement features accordingly may help to support the overall stability / strength .
[0024] Optionally, the first and / or second engagement feature is ring-shaped . In other words , the first and / or second engagement feature may extend around the circumference of the respective part .
[0025] The stationary part ( also called stator ) may, in one embodiment , have one or more slits extending from a distal end of the stationary part in the proximal direction . The provision of slits may support the flexibility of the stationary part . In particular, a slit may be compressible and, hence , the stationary art may be f lexible / compressible to some extent during assembly, so as to allow for the stationary part to be received within the rotatable part . The presence of a slit may mean that the stationary part is , in the slit , free of material . In particular, one or more slits may represent an opening or through-hole through the stationary part . The one or more slits defined above do not correspond to the groove / indentation as disclosed . Put di f ferently, the one or more slits are separate from the groove / indentation as described .
[0026] In particular, flexibility of the stationary part as conferred by the slit ( s ) may be desirable during assembly of the catheter, when the rotatable part is to be arranged at least in part around the stationary part. If the stationary part is flexible, the stationary part may snap in the rotatable part. Such snap-fit-connection may support that the rotatable part is not inadvertently disengaged.
[0027] Flexibility may allow for assembly of the parts already comprising the engagement features, i.e. to allow for positioning the stationary and rotatable parts, while avoiding that the first and second engagement features impede or hinder assembly.
[0028] Optionally, the one or more slits extend in the longitudinal direction. Further optionally, at least two slits are provided, optionally opposite to each other. These embodiments may be preferable as regards the stationary part's ability to be compressed and to radially expand (?) , i.e. in terms of flexibility.
[0029] In one embodiment, the second engagement feature may comprise at least one crimp, optionally at the proximal end of the cylindrical part of the rotatable part. The crimp may be an inwardly protruding crimp, meaning that the material of the rotatable part was shifted radially inwardly, i.e. toward the inside of the catheter. By way of the crimp, an inward protrusion (e.g. as described above) may be formed. Also more than one crimp, such as multiple crimps, optionally on opposite sides, are contemplated.
[0030] If the second engagement feature comprises at least one crimp, the first engagement feature may comprise at least one groove, optionally an annular groove. The crimped material may protrude into the groove so as to establish engagement with the annular groove. Optionally, an annular groove is provided at the proximal end of the cylindrical part of the stationary part. A crimp represents one way to build a protrusion after assembly of the catheter, so that , during assembly, no protrusion may be an obstacle . More speci fically, the stationary part and the rotatable part may be combined and be crimped together, e . g . by using a crimping tool and squeezing force . Other possibilities are contemplated .
[0031] Also the alternative or inverted embodiment is contemplated, namely that the first engagement feature comprises at least one crimp . Since the stationary part is at least partially inside the rotatable part , the crimp may be an outward crimp . The corresponding counterpart , i . e . the second engagement feature , may comprise at least one annular groove . Optionally two crimps and / or on opposite sides may be provided .
[0032] In one embodiment , the second engagement feature may comprise at least one inward protrusion at the proximal end of the cylindrical part of the rotatable part , and the stationary part may comprise at least one slot extending from the distal end to the proximal end of the stationary part for receiving the inward protrusion of the rotatable part during assembly . The stationary part may further comprise at least one annular groove / indentation at the proximal end of the cylindrical part of the stationary part for receiving the inward protrusion . In this case , a slot is provided so as to allow for movement of the protrusion within the slot during assembly . In this case , no slit conferring flexibility to the stationary part may be needed . The slot does not correspond to a slit or a groove / indentation as described . However, the slot may be in the form of a groove , namely by way of omission of material from the cylindrical part .
[0033] Also an alternative or inverted embodiment is contemplated, namely that the first engagement feature comprises at least one outward protrusion at the distal end of the cylindrical part of the rotatable part . The rotatable part may comprise at least one slot extending from the distal end of the rotatable part for receiving the outward protrusion of the stationary part during assembly . The rotatable part may further comprise at least one annular groove / indentation at the distal end of the cylindrical part of the rotatable part for receiving the outward protrusion .
[0034] The slot may extend straight in the longitudinal direction and / or along a non-straight , i . e . tortuous path overall extending in the longitudinal direction . While a straight path of the slot may be beneficial when it comes to the assembly, a tortuous path may be advantageous so as to avoid inadvertent loosening of the rotary part from the stationary part by way of inadvertent movement of the protrusion within the slot .
[0035] Optionally, the protrusion may comprise a pin or a crimp . The pin may be welded to the rotatable part , for example . Alternatively, the pin may be formed during molding of the respective part or in 3D printing .
[0036] The second engagement feature which includes the protrusion may comprise at least two individual protrusions , namely two individual engagement features . The individual engagement features (protrusions ) may be distanced equally around the circumference of the rotatable part relative to each other . Put di f ferently, the second engagement feature may have an equal angular distribution . This may support stability and reliability .
[0037] Optionally, the catheter may comprise a rotatable helix . The helix may be connected to the rotatable part , so that rotation of the helix imparts rotation to the rotatable part .
[0038] The disclosure is also directed to a catheter, e . g . for an aspiration system, optionally a thrombectomy or an atherectomy system, wherein the catheter comprises a proximal end and a distal end and extends in a longitudinal direction . The ( distal end of the ) catheter comprises a rotatable part at the catheter ' s distal end and a stationary part , wherein the rotatable part is rotatable relative to ( around) the stationary part around a longitudinal axis extending in the longitudinal direction . The stationary part has a first engagement feature extending around the circumference of the stationary part , and the rotatable part has a second engagement feature having at least one crimp engaging with the first engagement feature . The remaining disclosure in this regard equally applies to this embodiment . Speci fically, the remaining claims may define this embodiment further .
[0039] The disclosure is also directed to a catheter, e . g . for an aspiration system, optionally a thrombectomy or an atherectomy system, wherein the catheter comprises a proximal end and a distal end and extends in a longitudinal direction . The ( distal end of the ) catheter comprises a rotatable part at the catheter ' s distal end, and a stationary part , wherein the rotatable part is rotatable relative to the stationary part around a longitudinal axis extending in the longitudinal direction . The stationary part has a first engagement feature extending around the circumference of the stationary part and a ( longitudinal ) slot generally extending along the longitudinal direction and at the outer surface of the stationary part . The rotatable part has a second engagement feature having at least one pin protruding inwardly from the inner surface of the rotatable part . The catheter is configured such that the pin is receivable within the slot of the stationary part during assembly of the catheter ( i . e . the pin can move along and inside the slot ) , and the pin is engageable with the first engagement feature during use of the catheter, i . e . after assembly . This in particular applies for engagement during rotation of the rotatable part relative to the stationary part .
[0040] The disclosure is also directed to an aspiration system comprising a catheter as described . The disclosure is also directed to the manufacture of a catheter, optionally of a catheter of the disclosure , wherein the catheter comprises a proximal end and a distal end and extends in a longitudinal direction . Common manufacturing methods include molding, 3D printing and / or welding . According to the disclosure , manufacture may comprise providing a rotatable part at the catheter ' s distal end, and a stationary part , wherein the rotatable part is rotatable relative to the stationary part around a longitudinal axis extending in the longitudinal direction . Further, a second engagement feature of the rotatable part is crimped with a first engagement feature of the stationary part . The first engagement feature extends around the circumference of the stationary part and the second engagement feature at least partially engages along the circumference with the first engagement feature .
[0041] Also the inverted embodiment is contemplated, wherein the first engagement feature is crimped ( outwardly) and is in engagement with the second engagement feature of the rotatable part . In this embodiment , the second engagement feature may extend around the inner circumference of the rotatable part , i . e . the lumen defined by the cylindrical section . In this embodiment , the engagement feature which is not crimped may be a groove , in particular an annular groove .
[0042] Directions correspond to the usual nomenclature in medical applications . In particular, the distal direction is the ( longitudinal ) direction pointing away from the medical practitioner / surgeon towards the patient and away from the end of the medical device , while the proximal direction is the opposite direction, i . e . the direction extending from the patient to the medical practitioner / surgeon .
[0043] Further embodiments and details of the disclosure will become apparent in connection with the detailed description and the drawings . For each of the four embodiments shown in the drawings , the description in connection with the other embodiments applies , except for mutual exclusions .
[0044] Brief Description of the Drawings
[0045] Figures la to Id schematically depict a first embodiment of the disclosure , wherein Fig . la depicts a crosssection of the catheter, and Figs , lb and 1c depict a stationary part , and Fig . Id depicts a crosssection of a rotatable part .
[0046] Figures 2a to 2c schematically depict a second embodiment of the disclosure , wherein Fig . 2a depicts a cutout catheter, Fig . 2b depicts an enlarged view of Fig . 2a, and Fig . 2c depicts a stationary part .
[0047] Figures 3a and 3b schematically depict a third embodiment of the disclosure , wherein Fig . 3a depicts assembled rotatable and stationary parts , and Fig . 3b additionally depicts a helix .
[0048] Figures 4a and 4b schematically depict a fourth embodiment of the disclosure , wherein Fig . 4a depicts a rotatable part and Fig . 4b depicts a stationary part .
[0049] Figure 5 schematically depicts a distal end of a catheter of the disclosure .
[0050] Figure 6 schematically depicts an aspiration system of the disclosure .
[0051] Detailed Description
[0052] Figure la shows a catheter 1 having a distal end lb and a proximal end la . The catheter 1 extends in the longitudinal direction L . The distal end lb of the catheter 1 points in the distal direction D . The catheter 1 comprises a stationary part / stator 3 , and a rotatable part / rotor 4 at its distal end lb . The rotatable part 4 is at the catheter ' s distal end lb and may form the catheter ' s distal tip . The rotatable part 4 has a cylindrical section 4b extending substantially in the longitudinal direction L . The stationary part 3 has a cylindrical section 3b substantially extending in the longitudinal direction L . The catheter 1 may further include a catheter tube 1c proximal to the proximal end of the stationary part 3 . The catheter tube 1c extends towards the proximal end la of the catheter 1 .
[0053] The rotatable part 4 is rotatable relative to the stationary part 3 around a longitudinal axis A extending in the longitudinal direction L . The rotatable part 4 is rotatable also relative to the catheter tube 1c . The stationary part 3 is stationary with respect to the catheter tube 1c .
[0054] The stationary part 3 is at least partially received within the rotatable part 4 . In particular, the cylindrical section 3b of the stationary part 3 is at least partially accommodated by the cylindrical section 4b of the rotatable part 4 , such that the rotatable part 4 at least partially overlaps the stationary part 3 .
[0055] Each of the stationary and rotatable parts 3 , 4 comprise at least one engagement feature 3a, 4a at the respective cylindrical section 3b, 4b . Speci fically, the stationary part 3 comprises a first engagement feature 3a at the cylindrical section 3b . The rotatable part 4 comprises a second engagement feature 4a at the cylindrical section 4b . The first 3a and second 4a engagement features are in engagement . These features are configured such that engagement allows for rotation of the rotatable part 4 relative to the stationary part 3 . At the same time , longitudinal movement of the rotatable part 4 relative to the stationary part 3 is restricted / avoided due to the engagement . In the embodiment shown in Fig . la, the rotatable part 4 may be biased / pressed against the stationary part 3 (by way of the helix 5 shown in Fig . 2a, for example ) in the proximal direction opposite to the distal direction D . ( The engagement as described may in particular be helpful i f the helix 5 e . g . breaks apart and may no longer be able to push the rotatable part in the proximal direction . ) The rotatable part 4 cannot move in the proximal direction, as it abuts the stationary part 3 in the proximal direction . However, in other embodiments (not shown) , it is conceivable that it is the engagement features 3a, 4a which are configured such that movement of the rotatable part 4 relative to the stationary part 3 is restricted / avoided ( also ) in the proximal direction due to the engagement features .
[0056] The cylindrical sections 3b and 4b each have a tubular wall 3c, 4c . In particular, the tubular walls 3c, 4c define a tubular lumen of the cylindrical section 3b, 4b of the respective part 3 , 4 . The cylindrical section 3c of the stationary part 3 is at least partially received inside the lumen of the rotatable part 4 . Hence , the rotatable part 4 is at least partially outside the stationary part 3 and rotates around the stationary part 3 . The lumens of the rotatable part 4 and of the stationary part 3 are each configured to receive a rotatable helix 5 and material removed from the vasculature (not shown) .
[0057] As shown in Figure la, the rotatable part 4 comprises at least one window 7 , and the stationary part 3 comprise at least one window 6 , in the respective cylindrical section 3b, 4b . Upon rotation of the rotatable part 4 around the stationary part 3 , the windows 6 and 7 may overlap to the ef fect that the windows 6 and 7 may be congruent and, hence , form a through hole / opening . By opening and closing such opening by way of rotation of the window 7 in the rotatable part 4 around the window 6 in the stationary part 3 , removal of material from the vasculature through the windows 6 and 7 and along the catheter tube 1c is facilitated . The windows 6 and 7 allow for entry of material removed from the vasculature into the catheter 1 .
[0058] In the embodiment shown in Figure la, which is a first embodiment , a flexible engagement between the first engagement feature 3a and the second engagement feature 4a takes place . This may be regarded as a snap- fit-engagement . Speci fically, in Figure la, the first engagement feature is a tongue 3a, i . e . a protrusion, on the stationary part 3 and protrudes towards the outside , i . e . radially outwards . The second engagement feature 4a at the rotatable part 4 is an inner groove , i . e . a groove pointing radially inwards . The protrusion / tongue 3a protrudes into the groove / indentation 4a and, accordingly, establishes engagement between the engagement features 3a and 4a, and thus , between the stationary part 3 and the rotatable part 4 .
[0059] Figure lb shows the stationary part 3 without the rotatable part 4 and shows the protrusion / tongue 3a of the stationary part 3 in detail . The tongue 3a extends around the circumference of the distal end of the stationary part 3 and may be " interrupted" by the slit 3d . Figure lb also shows a slit 3d, wherein the slit 3d is provided between the distal end of the stationary part 3 and the window 6 , and connects the distal end of the stationary part 3 and the window 6 . As such, the window 6 is open towards the distal end of the stationary part 3 . Alternatively or additionally, a slit 3d may be provided as shown in Figure 1c, namely at a part of the cylindrical section 3c of the stationary part 3 within material forming the cylindrical section 3b . In the slit 3d shown in Figure 1c, the slit 3d is provided between the openings 6 and is not connected to the openings 6 . A single slit 3d, as shown in Figure 1c, or two slits 3d, optionally at two opposite sides , as shown in Figure lb may be provided . The slit 3d may allow for compression of the distal end of the stationary part 3 during assembly with the rotatable part 4 and, hence , may allow the stationary part 3 to snap into engagement with the rotatable part 4 during assembly .
[0060] The slits Id as shown in Figures lb and 1c extend in the longitudinal direction L, in particular the distal direction D . The slits 3d may have a straight configuration and extension in the longitudinal direction L ( from the distal end of the stationary part 3 in the proximal direction opposite the distal direction D) , such as depicted . Alternatively, but not shown, the slits 3 may be curved .
[0061] Figure Id shows a cross section of the rotatable part 4 . The window 7 is formed in the cylindrical section 4b of the rotatable part 4 . The rotatable part 4 has , at the distal end of the cylindrical part 4b, the groove or indentation 4a .
[0062] Generally, the engagement features 3a, 4a may extend along the circumference the cylindrical section 3b, 4b of the respective part 3 , 4 . Figure 1c shows the annular protrusion 3a at the distal end of the stator 3 , and Figure Id shows the annular groove 4a at the distal end of the cylindrical section of the rotatable part 4 .
[0063] In the depicted embodiment (but not limited to this embodiment ) , the first and second engagement features 3a, 4a are provided at the distal end of the cylindrical sections 3b, 4b, respectively . As such, the first engagement feature 3a is provided at the distal end of the stationary part 3 , while the second engagement feature 4a is provided proximal to the distal end of the rotatable part 4 , at the distal end of the window 7 . Generally, an engagement feature 3a, 4a may be at the proximal end and / or distal end of the corresponding window 6 , 7 of the stationary part 3 / the rotatable part 4 . Figures 2a to 2c show a second embodiment , which is the inversion of the embodiment 1 , wherein the stationary part 3 comprises a groove / indentation 3a ' and the rotatable part 4 comprises a protrusion / tongue 4a ' . The first and second embodiments di f fer as to whether the groove / indentation is the first or second engagement feature . Correspondingly, the tongue / protrusion is the second or first engagement feature , acting as a counterpart .
[0064] Figure 2a shows a helix 5 . The helix 5 was omitted from the Figures la to Id, but may equally be present in the first embodiment and any other embodiment . The helix 5 is connected to the rotatable part 4 , in particular at the distal end of the rotatable part 4 . The helix 5 conveys material removed from the vasculature from the distal end of the catheter 1 towards the proximal end of the catheter 1 . Rotation of the helix 5 imparts rotation to the rotatable part 4 .
[0065] Figure 2b shows an enlargement of the part of the catheter 1 shown in Figure 2a and in particular shows the engagement of the groove 3a ' in the stationary part with the protrusion 4a ' of the rotatable part 4 .
[0066] Figure 2c shows that , also in this embodiment , the stationary part 3 has a groove 3a ' and may have a slit 3d, as shown in connection with the first embodiment .
[0067] Generally, the rotatable part 4 and / or the stationary part may comprise metal .
[0068] Figures 3a and b show a third embodiment , wherein the stationary part 3 and the rotatable part 4 are engaged after assembly, e . g . by way of crimping . Figure 3a shows a moment during the assembly of the stationary part 3 and the rotatable part 4 . The stationary part 3 comprises a groove or indentation 3a' ' at the outer side of the stationary part 3, namely an annular groove 3a' ' . Figure 3b shows the assembled catheter 1, wherein the catheter tube 1c has been omitted. The rotatable part 4 has at least one crimp 4a' ' representing a second engagement feature. The crimp 4a' ' points inwardly, i.e. inside the groove 3a' ' . Accordingly, crimped material which protrudes from the remaining rotatable part 4 inwardly engages with the annular groove 3a' ' .
[0069] Since the crimp 4a' ' forms a protrusion and can rotate within the annular groove 3a' ', rotation of the rotatable part 4 relative to the stationary part 3 is possible. However, movement of the rotatable part 4 in the longitudinal direction D is prohibited, since the crimped material 4a' ' is captured within the groove 4a' ' in the longitudinal direction .
[0070] The annular groove 3a' ' and the inward crimp 4a' ' are provided at the proximal end of the respective cylindrical section 3b, 4b. However, an alternative position at the respective distal end is also contemplated.
[0071] Figures 4a and 4b show a fourth embodiment. In this embodiment, the stationary part 3 does not need to have a slit 3d in the stationary part 3 (as shown for the first and second embodiments, which may allow for flexibility and, hence, deformation and compression of the stationary part 3 for assembly) . Rather, for assembly of the stationary part 3 and the rotatable part 4 of the fourth embodiment, the stationary part 3 comprises a slot 3e. The slot 3e represents a reduction of the thickness of the material of the stationary part 3, wherein the slot 3e does not extend through the entire material, but the slot 3e comprises remaining material. However, alternatively, the slot 3e may also be free of material and represent a through-hole.
[0072] The rotatable part 4 comprises a pin 4a' ' ', which is received within the slot 3e during assembly. The slot 3e allows for the rotatable part 4 to receive the stationary part 3, i.e. to be put on the stationary part 3. After assembly, once the pin 4a' ' ' has reached the final (proximal) position in the longitudinal direction L, the pin 4a' ' ' is received within an annular groove / indentation 3a' ' ' . The annular groove 3a' ' ' may be connected to, i.e. be continuous with the slot 3e. As shown in Figure 4b, the slot 3e may extend straight in the longitudinal direction L, and the annular groove 3a' ' ' may extend along the outer circumference of the stationary part 3. Hence, the slot 3e and the annular groove 3a' ' ' may be perpendicular to each other. In embodiments, the slot 3e and the annular groove 3a' ' ' are both formed on the outside of the stationary part 3.
[0073] Figure 4a shows the inward protrusion or inward pin 4a' ' ' at the proximal end of the cylindrical part 4b of the rotatable part 4. Figure 4b shows the stationary part 3 the having the slot 3e extending from the distal end of the stationary part
[0074] 3 so as to receive the inward pin 4a' ' ' of the rotatable part
[0075] 4 during assembly. In this embodiment, the rotatable 4 can only escape in the longitudinal direction L from the stationary part 3 if the angular position of the pin 4a' ' ' corresponds to the slot 3e. Only upon such alignment, the engagement between the pin 4a' ' ' and the annular groove 3a' ' ' could be undone, i.e. ( in) advertently disengaged. At all other positions, the pin 4a' ' ' is captured in the annular groove 3a' ' ', which restricts disengagement in the longitudinal direction, but allows for rotation of the rotatable part 4 around the stationary part 3.
[0076] Also the inverted embodiment is conceivable, namely that the rotatable part 4 comprises an (inner) slot (not shown) and an (inner) annular groove (not shown) , wherein the stationary part 3 comprises an (outer) pin (not shown) .
[0077] In Figure 4b, the slot 3e is straight and extends in the longitudinal direction L. Alternatively, the slot 3e may have a tortuous path with the overall extension in the longitudinal direction . This could help to avoid inadvertent movement of the rotatable part 4 in the distal direction D . The protrusion 4a ' ' ' may be a pin or a crimp . For example , a pin may be welded to the rotatable part 4 .
[0078] Figure 4a a shows a single pin 4a ' ' ' . More than one pin 4a' ' ' may be present , including correspondingly more than one slits 3e at the stationary part 3 .
[0079] Generally, an engagement feature 3a, 4a may comprise at least two individual sub-engagement features . Optionally, the subengagement features may be equally distant and distributed around the circumference and relative to each other . This in particular applies to the protrusions / tongues , crimps and pins , as described .
[0080] Figure 5 shows an aspiration system 2 of the disclosure . The aspiration system 2 comprises the catheter 1 . The catheter tube 1c, the stationary part 3 as well as the rotatable part 4 are shown in Figure 5 .
[0081] Figure 5 also shows a guidewire 9 . The guidewire 9 passes through the opening 8 at the distal end of the catheter 1 , formed by the distal tip of the rotatable part 4 . Figure 5 also shows the windows 6 and 7 in their overlapping orientation, so that an opening through the rotatable part 4 and stationary part 3 is formed . Through this opening, the helix 5 is visible .
[0082] Figure 6 shows an aspiration system 2 . The aspiration system 2 comprises , in addition to the catheter 1 , a handle 10 including a housing 11 and a motor 12 . The motor 12 serves for rotation of the helix 5 and, hence , of the rotatable part 4 . The aspiration system 2 further comprises a control unit 13 for controlling rotation of the rotatable helix 5 , and an optional foot switch 14 . The system 2 also comprises a collection bag 15 for collecting material removed from the vasculature .
[0083] Reference Signs
[0084] 1 Catheter la Proximal end of catheter lb Distal end of catheter
[0085] 1c Catheter tube
[0086] 2 Aspiration system
[0087] 3 Stationary part ( Stator )
[0088] 3a, 3a' , 3a' ' , 3a' ' ' First engagement feature ( of stationary part )
[0089] 3b Cylindrical section of stationary part
[0090] 3c Tubular wall of cylindrical section of stationary part 3d Slit
[0091] 3e Slot
[0092] 4 Rotatable part (Rotor )
[0093] 4a, 4a' , 4a' ' , 4a' ' ' Second engagement feature ( of rotatable part )
[0094] 4b Cylindrical section of rotatable part
[0095] 4c Tubular wall of cylindrical section of rotatable part
[0096] 5 Helix
[0097] 6 Window in stationary part
[0098] 7 Window in rotatable part
[0099] 8 Opening
[0100] 9 Guidewire
[0101] 10 Handle
[0102] 11 Housing
[0103] 12 Motor
[0104] 13 Control unit
[0105] 14 Foot switch
[0106] 15 Collection bag
[0107] L Longitudinal direction
[0108] A Longitudinal axis
[0109] D Distal direction
Claims
Claims1. A Catheter (1) comprising proximal end (la) and a distal end (lb) and extends in a longitudinal direction (L) , a rotatable part (4) at the catheter's distal end (lb) , having a cylindrical section (4b) substantially extending in the longitudinal direction (L) , a stationary part (3) having a cylindrical section (3b) substantially extending in the longitudinal direction (L) , wherein the rotatable part (4) is rotatable relative to the stationary part (3) around a longitudinal axis (A) extending in the longitudinal direction (L) , the cylindrical section (3b) of the stationary part is at least partially received within the cylindrical section (4b) of the rotatable part, such that the rotatable part (4) at least partially overlaps the stationary part (3) , the stationary part (3) comprises a first engagement feature (3a) at the cylindrical section (3b) of the stationary part, and the rotatable part (4) comprises a second engagement feature (4a) at the cylindrical section (4b) of the rotatable part, wherein the first (3a) and second (4a) engagement features are in engagement and configured to allow for rotation of the rotatable part (4) relative to the stationary part (3) while avoiding movement of the rotatable part (4) relative to the stationary part (3) in the longitudinal direction, at least in a distal direction.
2. The Catheter of claim 1, wherein the first engagement feature (3a) extends along the circumference of the cylindrical section (3b) of the stationary part (3) and / or wherein the second engagement feature (4a) extends along the circumference of the cylindrical section (4b) of the rotatable part (4) .
3. The Catheter of any of the preceding claims, wherein the first engagement feature (3a) is provided at a distal end and / or a proximal end of the cylindrical section (3b) of the stationary part (3) , and / or the second engagement feature (4a) is provided at a distal end and / or a proximal end of the cylindrical section (4b) of the rotatable part (4) .
4. The Catheter of any of the preceding claims, wherein the first (3a' ) or second (4a) engagement feature comprises a groove and / or an indentation.
5. The Catheter of any of the preceding claims, wherein the second (4a' ) or first (3a) engagement feature comprises a tongue and / or protrusion.
6. The Catheter of claims 4 and 5, wherein the first engagement feature (3a, f) comprises a groove and / or indentation at an outer side of the stationary part (3) , and the second engagement feature (4a, f) comprises a tongue and / or protrusion extending inwardly from the rotatable part (4) , and optionally at least partially along the circumference of the cylindrical section (4b) of the rotatable part.
7. The Catheter of any of the preceding claims 4 to 6, wherein the first and / or second engagement feature is ring- shaped .
8. The Catheter of any of the preceding claims, wherein the stationary part (3) has one or more slits (3d) extending from a distal end of the stationary part (3) .
9. The Catheter of claim 8, wherein the one or more slits(3d) extend in the longitudinal direction (L) .
10. The Catheter of claim 8 or 9, wherein at least two slits (3d) are provided, optionally opposite to each other.
11. The Catheter of any of the preceding claims, wherein the second engagement feature (4a) comprises at least one crimp (4a, f) , optionally at the proximal end of the cylindrical part of the rotatable part.
12. The Catheter of claim 11, wherein the first engagement feature (3a, f) comprises at least one annular groove, optionally at the proximal end of the cylindrical part of the stationary part.
13. The Catheter of any of the preceding claims, wherein the second engagement feature (4a) comprises at least one inward protrusion (4a' ' ' ) at the proximal end of the cylindrical part of the rotatable part, and the stationary part (3) comprises at least one slot (3e) extending from the distal end of the stationary part (3) for receiving the inward protrusion (4a' ' ' ) of the rotatable part during assembly, and further comprises at least one annular groove and / or indentation (3a' ' ' ) at the proximal end of the cylindrical part of the stationary part for receiving the inward protrusion (4a' ' ' ) .
14. The Catheter of claim 13, wherein the slot (3e) extends straight in the longitudinal direction (L) and / or along a tortuous path along the longitudinal direction (L) .
15. The Catheter of claim 13 or 14, wherein the protrusion (4a' ' ' ) comprises a pin, optionally welded to the rotatable part, or a crimp.
16. The Catheter of any of the preceding claims, wherein the second engagement feature (4a, 4a' , 4a' ' , 4a' ' ' ) comprises at least two individual engagement features, the individualengagement features equally distanced around the circumference of the rotatable part relative to each other.
17. A Catheter extending in a longitudinal direction (L) between a proximal end (la) and a distal end (lb) , the catheter comprising: a rotatable part (4) at the distal end (lb) , and a stationary part (3) , wherein the rotatable part (4) is rotatable relative to the stationary part (3) around a longitudinal axis (A) extending in the longitudinal direction (L) , wherein the stationary part has a first engagement feature (3a' ' ) extending around the circumference of the stationary part, and the rotatable part has second engagement feature (4a' ' ) having at least one crimp engaging with the first engagement feature (3a' ' ) .
18. A Catheter comprising a proximal end (la) and a distal end (lb) and extends in a longitudinal direction (L) , a rotatable part (4) at the catheter's distal end (lb) , and a stationary part (3) , wherein the rotatable part (4) is rotatable relative to the stationary part (3) around a longitudinal axis (A) extending in the longitudinal direction (L) , wherein the stationary part (3) has a first engagement feature (3a' ' ' ) extending around the circumference of the stationary part and a slot (3e) extending along the longitudinal direction (L) and the surface of the stationary part; and the rotatable part (4) has second engagement feature (4a' ' ' ) having at least one pin protruding inwardly from the surface of the rotatable part, and the pin (4a' ' ' ) is receivable within the slot (3e) of the stationary part during assembly of the catheter, and the pin (4a' ' ' ) is engageable with the first engagement feature (3a' ' ' ) during use of the catheter.
19. An Aspiration system comprising a catheter according to any of the preceding claims, optionally further comprising a rotatable helix comprised in the catheter.
20. Manufacture of a catheter, optionally a catheter of any of the preceding claims 1 to 18, wherein the catheter (1) comprises a proximal end (la) and a distal end (lb) and extends in a longitudinal direction (L) , the manufacture comprising :- Providing a rotatable part (4) at the catheter's distal end (lb) , and a stationary part (3) , wherein the rotatable part (4) is rotatable relative to the stationary part (3) around a longitudinal axis (A) extending in the longitudinal direction (L) ,- Crimping a second engagement feature (4a' ' ) of the rotatable part (4) with a first engagement feature (3a' ' ) of the stationary part (3) , the first engagement feature (3a' ' ) extending around the circumference of the stationary part (3) and the second engagement feature (4a' ' ) at least partially along the circumference engaging with the first engagement feature .