CN217854163U

CN217854163U - Catheter pump

Info

Publication number: CN217854163U
Application number: CN202221413341.8U
Authority: CN
Inventors: 刘刚; 张家良
Original assignee: Magassist Inc
Current assignee: Xinqing Medical Suzhou Co ltd
Priority date: 2022-03-15
Filing date: 2022-06-08
Publication date: 2022-11-22
Anticipated expiration: 2032-06-08
Also published as: CN219896782U; CN115227962A; CN115227962B; CN117771534A

Abstract

A catheter pump is disclosed that includes an introducer having a pre-collapsed passageway adapted to receive a pump head therein in an expanded state. When the introducer is in a first assembled state slidably received over the catheter, the pump head is collapsed over the distal end of the introducer by advancing the introducer and/or pulling the catheter backward. When the introducer is in a second, assembled state, separate from the catheter pump, the distal end of the pump head may be inserted into the proximal end of the introducer and the pump head collapsed via the proximal end of the introducer by pulling back on the introducer and/or pushing the catheter forward.

Description

Catheter pump

The present application claims priority from chinese patent application having application number 202220559625.1, filed on 3/15/2022, the entire contents of which are incorporated herein by reference.

Technical Field

The utility model relates to a catheter pump and a method for folding the pump head of the catheter pump, which belongs to the field of medical appliances.

Background

The catheter pump is adapted to be inserted into a desired location of the heart of a heart failure patient to assist the pumping function of the heart. From the viewpoint of alleviating the pain of the patient and reducing the complications of the puncture, it is desirable that the catheter pump be capable of being introduced into the human body in a small size.

The distal pump head of the catheter pump is a self-expanding and expandable structure, and in order to deliver the catheter pump into a human blood vessel with a small interventional size, the pump head needs to be folded outside the body. At present, the design method is to pre-install a tubular introducer at the proximal end of the catheter pump, and fold the pump head into the introducer tube by pushing the tubular introducer toward the pump head, but the introducer may be mistakenly operated during the operation process to cause the introducer to slip off from the distal end of the pump head, and some doctors may be more accustomed to folding the pump head from the distal end to the proximal end due to different operation habits of the doctors, so the folding method related at present cannot meet the requirements.

SUMMERY OF THE UTILITY MODEL

An object of the present invention is to provide a catheter pump and a method for folding a pump head of the catheter pump, which can fold up the pump head of the catheter pump from both the distal end and the proximal end.

In order to achieve the above purpose, the utility model provides a following technical scheme:

the utility model discloses catheter pump of first aspect includes the pipe, rotationally wears to establish drive shaft, folded cascade pump head and the introducer in the pipe. The collapsible pump head includes a pump housing connected to the distal end of the conduit, an impeller disposed within the pump housing. The impeller is connected to the distal end of the drive shaft, and the proximal end of the drive shaft may be connected to the motor to transmit the rotation of the motor to the impeller. The introducer comprises a pre-folding channel which is suitable for accommodating the pump head in the unfolding state into the introducer so as to switch the pump head to the folding state. The introducer has a first assembled state slidably disposed over the catheter and a second assembled state disposed separately from the catheter pump.

When the introducer is in the first assembled state, the pump head is collapsed into the pre-collapsed passage through the distal end of the introducer by advancing the introducer and/or pulling the catheter backward.

When the introducer is in the second assembled state, the distal end of the pump head may be inserted into the proximal end of the introducer, and the pump head may be collapsed into the pre-collapsed passage via the proximal end of the introducer by pulling the introducer backward and/or pushing the catheter forward;

the introducer can alternatively collapse the pump head into the pre-collapse channel in the first set-up state and the second set-up state.

A method of folding a pump head of a catheter pump as described above, comprising:

when the introducer is in a first assembled state, at least one of the introducer and the catheter is manipulated to move the introducer and the pump head toward each other, with the proximal end of the pump head inserted into the distal end of the introducer and eventually collapsed into the pre-collapsed passage.

When the introducer is in the second assembled state, at least one of the introducer and the pump head is manipulated to move the introducer and the pump head toward each other, with the distal end of the pump head inserted into the proximal end of the introducer and eventually collapsed into the pre-collapsed passage.

The catheter pump of the second aspect of the present invention comprises a catheter, a driving shaft rotatably disposed in the catheter, a foldable pump head, an introducer, and an intervention sheath. The collapsible pump head includes a pump housing connected to the distal end of the conduit, an impeller disposed within the pump housing. The impeller is connected to the distal end of the drive shaft, and the proximal end of the drive shaft may be connected to the motor to transmit rotation of the motor to the impeller. The access sheath includes an access channel that receives the pump head. The introducer is operably interfaced with the access sheath and includes a pre-collapsed passage adapted to receive the pump head therein in an expanded state.

Wherein, the introducer is arranged separately from the catheter pump, the distal end of the pump head can be butted with the proximal end of the introducer, and the pump head is folded into the pre-folding channel through the proximal end of the introducer by pulling the introducer backwards and/or pushing the catheter forwards.

The distal end of the introducer is butted with the proximal end of the intervention sheath, and the pump head is transferred into the intervention channel from the pre-folding channel by pushing the catheter forwards.

at least one of the introducer and the pump head is manipulated to move the introducer and the pump head toward each other, with the distal end of the pump head inserted into the proximal end of the introducer and eventually collapsed into the pre-collapsed passage.

The distal end of the introducer is butted with the proximal end of the intervention sheath, and the catheter is pushed forward, so that the pump head in a folded state is transferred into the intervention sheath from the pre-folding channel.

The introducer can fold the pump head from the proximal end and the distal end, and a doctor can fold the pump head from the proximal end or the distal end according to the operation habit. In addition, when the pump head is folded from the distal end of the introducer, if the introducer slips off from the distal end of the pump head due to misoperation, the pump head can be continuously folded from the proximal end of the introducer, and the operation is simple.

Drawings

Fig. 1 is a schematic perspective view of a catheter pump according to the present invention.

Fig. 2 is another perspective view of the catheter pump provided by the present invention.

Fig. 3 is a schematic perspective view of the introducer in a first assembled state in which the introducer is slidably disposed over the catheter.

Fig. 4 is a perspective view of the introducer provided by the present invention in a second, assembled state, separated from the catheter pump.

Fig. 5 is a sectional view of a part of the structure of the catheter pump provided by the present invention.

Fig. 6 is a partially enlarged view of fig. 5.

Fig. 7 is a perspective view of a catheter pump according to another embodiment of the present invention.

Fig. 8 is another perspective view of a catheter pump according to another embodiment of the present invention.

Fig. 9 is a partial perspective view of a catheter pump according to another embodiment of the present invention.

Detailed Description

The terms "proximal", "rear" and "distal", "front", as used herein, refer to the physician operating the catheter pump. The terms "proximal", "posterior" refer to the portion that is relatively close to the clinician, and the terms "distal", "anterior" refer to the portion that is relatively far from the clinician. For example, the motor is at the proximal and rear ends and the guard head is at the distal and front ends.

The catheter pump of the present invention defines "axial" or "axial extension" with respect to the direction of extension of the drive shaft, and the term "inner" is relative to the axially extending centerline, with the direction relatively closer to the centerline being "inner" and the direction relatively further from the centerline being "outer".

It is to be understood that the terms "proximal," "distal," "rear," "front," "inner," "outer," and these terms are defined for convenience of description. However, catheter pumps can be used in many orientations and positions, and thus these terms of expressing relative positional relationships are not intended to be limiting and absolute. For example, the above definitions of the directions are only for convenience of illustration of the technical solution of the present invention, and do not limit the directions of the catheter pump of the present invention in other situations, including but not limited to product testing, transportation, manufacturing, etc., which may cause the catheter pump to be inverted or to change its position. In the present invention, the above definitions shall, if there are other explicit provisions and limitations, comply with the explicit provisions and limitations.

Referring to fig. 1 and 2, a catheter pump 100 according to an embodiment of the present invention may be at least partially inserted into a subject to assist the blood pumping function of the heart and reduce the burden on the heart. The catheter pump 100 may act as a left ventricular assist, pumping blood in the left ventricle into the ascending aorta. And can also be used as right ventricle assistant to pump the blood in the vein to the right ventricle.

The following will be described primarily with the catheter pump 100 as the left ventricular assist as the primary scenario. However, as can be seen from the above description, the scope of the embodiments of the present invention is not limited thereto.

The catheter pump 100 comprises a motor 1, a catheter 2, a collapsible pump head 3 deliverable through the catheter 2 to a desired location of the subject's heart, such as the left ventricle, for pumping blood, and a coupler 4 connected to the proximal end of the catheter 2 for detachable mating with the motor 1. The collapsible pump head 3 comprises a pump housing 31 connected to the distal end of the conduit 2 and having an inlet end 311 and an outlet end 312, and an impeller (not shown) disposed within the pump housing 31.

The pump housing 31 includes a holder 313 made of nickel or titanium alloy in a metal lattice, and a coating 314 covering the holder 313. The membrane 314 defines a blood flow channel and may be an elastic membrane. The metal lattice of the stent 313 has a mesh design, the cover 314 covers the middle and rear end portions of the stent 313, and the mesh of the portion of the stent 313 not covered by the cover 314 at the front end forms the inlet end 311. The rear end of the coating 314 covers the distal end of the catheter 2, and the outlet end 312 is an opening formed at the rear end of the coating 314.

The impeller comprises a hub and blades supported on the outer wall of the hub. The impeller can be driven to rotate to draw blood into the pump housing 31 from the inlet end 311 and expel the blood from the outlet end 312.

The catheter pump 100 further comprises a drive shaft (not shown) rotatably disposed through the catheter 2, the drive shaft being connected proximally to the motor 1 and distally to the impeller to transmit rotation of the motor 1 to the impeller for pumping blood.

The drive shaft includes flexible axle and is connected to the hard axle of flexible axle distal end, and the flexible axle is worn to establish in pipe 2, and the hard axle is worn to establish in wheel hub.

The proximal and distal ends of the support 313 are connected to proximal and distal bearing chambers (not shown) and 32, respectively, and proximal and distal bearings (not shown) are disposed in the proximal and distal bearing chambers 32, respectively. The near end and the far end of the hard shaft are respectively arranged in the near end bearing and the far end bearing in a penetrating way. Thus, the rigid shaft is supported at both ends by the two bearings, and the rigid shaft has a high rigidity, so that the impeller is preferably held in the pump housing 31.

The motor 1 has a motor shaft and a socket formed at the front end of the motor housing for mating with the coupler 4. The hub includes an active magnet connected to the motor shaft. The coupler 4 includes a passive magnet attached to the proximal end of the drive shaft. The motor 1 and the conduit 2 are detached by detaching the hub and the coupler 4.

The pump head 3 and the front end portion of the catheter 2 are fed into and held in the subject, and it is desirable that the size of the pump head 3 and the catheter 2 is as small as possible. The smaller size of the pump head 3 and the catheter 2 can enter the body of the subject through the smaller puncture opening size, so that the pain of the subject caused by the interventional procedure can be reduced, and the complications caused by the oversize puncture opening can be reduced.

In the art, the size and hydrodynamic performance of the pump head 3 are two conflicting parameters. The pump head 3 is desirably small in size from the viewpoint of alleviating pain of the subject and ease of intervention. However, a large flow rate is desired for the pump head 3 to provide a strong auxiliary function to the subject, and a large flow rate generally requires a large size of the pump head 3.

Therefore, in order to reduce the size of the puncture opening and ensure a large flow rate of the pump head 3, the pump head 3 is a collapsible pump having a collapsed state and an expanded state. In particular, in the pump head 3 corresponding to the access configuration, the pump housing and the impeller are in a collapsed state, and the pump head 3 is accessed and/or transported in the subject's vasculature with a first, smaller outer diameter dimension. In the corresponding operating configuration of the pump head 3, the pump housing and impeller are in an expanded state so that the pump head 3 pumps blood at a desired location with a second radial dimension that is greater than the first radial dimension.

By providing the collapsible pump head 3, the pump head 3 has a smaller collapsed size and a larger expanded size, so as to satisfy the requirements of alleviating pain of a subject during an intervention/transportation process, facilitating the intervention, and providing a large flow rate.

By the design of the multiple meshes, especially the diamond meshes, of the pump shell 31, folding can be achieved well, and unfolding can be achieved by means of the memory property of the nickel-titanium alloy. The blades of the impeller are made of flexible materials or shape memory materials, can be bent relative to the hub and have a folding configuration and an unfolding configuration. The tip of the blade in the folded configuration is close to the hub and the tip of the blade in the unfolded configuration is far from the hub. The blades can store energy when being folded, and the energy storage of the blades is released after the external constraint is removed, so that the blades can be unfolded.

In the pump head 3 corresponding to the intervention configuration, the blades are in a folded configuration, wrapped on the outer wall of the hub and at least partially in contact with the inner wall of the pump housing 31. When the pump head 3 is in the corresponding operating configuration, the vanes extend radially outwardly from the hub and are spaced from the inner wall of the pump head 3 when in the extended configuration.

The pump head 3 is folded by means of external constraint, and the pump head 3 is self-unfolded after the constraint is removed. In the present embodiment, the "collapsed state" refers to a state in which the pump head 3 is radially constrained, that is, a state in which the pump head 3 is radially compressed and folded into a minimum radial dimension by an external pressure. The "expanded state" refers to a state in which the pump head 3 is not radially constrained, that is, a state in which the bracket 313 and the radially outer side of the impeller are expanded to the maximum radial dimension.

Referring to fig. 3 to 5, the catheter pump 100 further includes an introducer 5, and the pump head 3 can be switched between the expanded state and the collapsed state by the introducer 5. The introducer 5 includes a pre-folding passage 51 adapted to accommodate the pump head 3 in the unfolded state therein, so that the pump head 3 is switched to the folded state.

It is clear that the inner diameter dimension of the pre-collapse channel 51 defines the outer diameter dimension of the pump head 3 in the collapsed state, i.e. the inner diameter dimension of the pre-collapse channel 51 is equal to the outer diameter dimension of the pump head 3 in the collapsed state.

The introducer 5 has a first assembled state slidably fitted over the catheter 2 and a second assembled state disposed separately from the catheter pump 100. That is, the introducer 5 may be slidably disposed outside the catheter 2 as part of the catheter pump 100, or the introducer 5 may be separately present as an accessory that does not fit with any portion of the catheter pump 100.

The introducer 5 is configured to alternatively collapse the pump head 3 into the pre-collapse channel 51 in the first set-up state and the second set-up state. The pump head 3 can be collapsed into the pre-collapsed channel 51 of the introducer 5 in either of two assembled states. The appropriate set-up state may be selected for a particular operation in a desired folding manner for better handling, rather than being limited to taking both set-up states at the same time.

When the introducer 5 is in the first assembled state, the pump head 3 is collapsed into the pre-collapsed passage 51 via the distal end of the introducer 5 by either pulling the catheter 2 back while advancing the introducer 5 or pulling the catheter 2 back while advancing the introducer 5.

When the introducer 5 is in the second assembled state, the distal end of the pump head 3 may be inserted into the proximal end of the introducer 5 and the pump head 3 collapsed into the pre-collapsed passage 51 via the proximal end of the introducer 5 by pulling back the introducer 5, or pushing forward the catheter 2, or both pulling back the introducer 5 and pushing forward the catheter 2.

External restraint applied to the pump head 3 may be accomplished by an introducer 5. When the introducer 5 is in the first assembling state and the introducer 5 moves towards the far end, the pump head 3 can be integrally contained in the introducer, so that the pump head 3 can be forcibly folded; then, as the introducer 5 is moved proximally, the radial constraint on the pump head 3 is removed and the pump head 3 switches to the deployed state. When the introducer 5 is in the second assembling state and the introducer 5 moves towards the proximal end, the pump head 3 can be integrally contained in the introducer, so that the pump head 3 can be forcibly folded; when the introducer 5 is then moved distally, the radial constraint on the pump head 3 is removed and the pump head 3 switches to the deployed state.

The pump head 3 is folded by a radial restraining force applied by the introducer 5, and the impeller enclosed by the pump head 3 is housed in the pump housing 31. Thus, in essence, the collapsing process of the pump head 3 is: the introducer 5 applies a radial constraining force to the pump casing 31, and when the pump casing 31 is radially compressed, a radial constraining force is applied to the impeller.

That is, the pump casing 31 is folded directly by the introducer 5, while the impeller is folded directly by the pump casing 31. As described above, the impeller has elasticity. Therefore, although in the folded state, the impeller is folded and stored energy to always have a tendency of radial expansion, and then the impeller contacts the inner wall of the pump shell 31 and exerts a reaction force on the pump shell 31.

After the restraint of the introducer 5 is removed, the pump housing 31 supports the elastic covering membrane 314 to be unfolded under the action of the self memory characteristic, and the impeller is automatically unfolded under the action of the released energy storage.

The introducer 5 is switchable between a first assembled state and a second assembled state. The introducer 5 can be switched from the first assembled state to the second assembled state, or the introducer 5 can be switched from the second assembled state to the first assembled state. That is, the introducer 5 is in the first assembled state, the pump head 3 is collapsed into the introducer 5 by pulling back the catheter 2, and when the catheter 2 is continued to be pulled back, the introducer 5 is caused to slip off the distal end of the pump head 3, and the introducer 5 is in the second assembled state. The pump head 3 is folded into the introducer 5 by pushing the pump head 3 forward, and when the pump head 3 is pushed forward continuously, the introducer 5 is sleeved outside the catheter 2, and the introducer 5 is in a first assembling state.

Therefore, the introducer 5 can fold the pump head 3 from the proximal end and the distal end, so that the operation of a doctor is facilitated, and the doctor can select to fold the pump head 3 from the proximal end or the distal end according to the operation habit of the doctor. And when the pump head 3 is folded in the first assembling state, if the introducer 5 slips off the distal end of the pump head 3 due to misoperation, the pump head 3 can be continuously folded in the second assembling state, so that the operation is simple.

The introducer 5 includes an introducer catheter 52 defining a pre-collapsed passage 51, and an introducer sheath 54 disposed at the proximal end of the introducer catheter 52, the introducer sheath 54 defining a guide lumen 53 communicating with the pre-collapsed passage 51. The inner diameter dimension of the introducer catheter 52 defines the outer diameter dimension of the pump head 3 in the collapsed state, such that collapsing of the pump head 3 can be achieved by driving that pump head 3 into the introducer catheter 52.

Referring to fig. 6, the guide lumen 53 includes at least an enlarged section 531 at the proximal end, and the inner diameter of the enlarged section 531 is at least not smaller than the diameter of the pump head 3 in the expanded state. Thereby facilitating the folding of the pump head 3 from the proximal end of the introducer 5 and the expandable section 531 functions as a guide to guide the pump head 3 to the pre-collapsed passage 51. The problem that the folding of the pump head 3 is blocked, unsmooth and laborious due to the overlarge difference between the inner diameter of the pre-folding channel 51 and the diameter of the pump head 3 in the unfolding state is avoided.

The guide lumen 53 further includes a necked-down segment 532 at a distal end, the necked-down segment 532 having an inner diameter that is less than the inner diameter of the enlarged segment 531 and at least no greater than the inner diameter of the pre-collapse passage 51. The necked-down section 532 allows for a smooth transition of the pump head 3 in the collapsed state from the necked-down section 532 to the pre-collapsed channel 51.

The guiding lumen 53 further includes a transition segment 533 connecting the expanding segment 531 and the necking segment 532, wherein the inner wall of the transition segment 533 gradually tapers from the proximal end to the distal end. When the pump head 3 moves from the expanding section 531 and passes through the transition section 533, the transition section 533 gradually reduces, and the inner diameter gradually reduces, so that the pump head 3 is slowly and gradually folded, the folding force is reduced, and the smoothness of the pump head 3 entering the introducer 5 is improved.

Referring to fig. 5 and 6, the introducer seat 54 is configured as an operating handle 54, and the guide chamber 53 is formed on the operating handle 54. The operating handle 54 is provided at the proximal end of the introducer catheter 52, facilitating the surgeon's ability to move forward or backward by grasping the operating handle 54, improving its maneuverability.

The introducer catheter 52 is made of PTFE. The PTFE material with low friction coefficient can effectively reduce the conveying force when the pump head 3 moves relatively in the introducer catheter 52 and improve the conveying compliance. In other embodiments, the introducer catheter 52 can be made of other materials having a low coefficient of friction, not specifically listed herein.

The catheter pump 100 includes a protection head 6 connected to the distal end of the pump head 3, and in order for the introducer 5 to smoothly fold the pump head 3 from the distal end, the protection head 6 extends along the axis of the pump head 3, that is, the protection head 6 is linear, so that the introducer 5 can smoothly enter from the distal end. In addition, the protection head 6 is configured to be soft so as not to damage the tissue of the subject, and the protection head 6 may be made of any material that macroscopically exhibits flexibility, and the flexible end portion supports on the inner wall of the heart chamber in a non-invasive or non-invasive manner, and separates the suction port of the pump head 3 from the inner wall of the heart chamber, so as to prevent the suction port of the pump head 3 from adhering to the inner wall of the heart chamber due to the reaction force of the fluid (blood) during the operation of the pump head 3, and thus, ensure the effective pumping area.

The utility model discloses still provide a method of folding (folding up) the pump head of catheter pump as shown above, it includes:

when the introducer is in a first assembled state, operating at least one of the introducer and the catheter to cause the introducer and the pump head to move toward each other, inserting the proximal end of the pump head into the distal end of the introducer and finally collapsing into the pre-collapsed passage;

when the introducer is in the second assembled state, at least one of the introducer and the pump head is manipulated to move the introducer and the pump head toward each other, with the distal end of the pump head inserted into the proximal end of the introducer and ultimately collapsed into the pre-collapsed passage.

The pump head is folded (collapsed) to facilitate subsequent delivery to the vasculature of the subject.

Wherein, when the introducer is in the first assembled state, at least one of the introducer and the pump head is operated to move the introducer and the pump head toward each other by: the pump head is collapsed into the pre-collapsed channel via the distal end of the introducer by either pulling the catheter forward or pulling the catheter backward while pushing the introducer forward, so that the pump head is switched to the collapsed state.

The method of manipulating at least one of the introducer and the pump head to move the introducer and the pump head toward each other when the introducer is in the second assembled state comprises: the distal end of the pump head may be abutted with the proximal end of the introducer and the pump head may be switched to the collapsed state by pulling back the introducer, or pushing forward the catheter, or both, thereby collapsing the pump head into the pre-collapsed passage via the proximal end of the introducer.

Referring to fig. 7 to 9, a catheter pump 200 according to another embodiment of the present invention is substantially the same as the catheter pump 100 according to the previous embodiment, except that the catheter pump 200 according to this embodiment further includes an interventional sheath 7, and the interventional sheath 7 includes an interventional channel for receiving the pump head 3. The introducer 5 is operably interfaced with the access sheath 7 to place the access and pre-plication channels in communication.

Wherein, the introducer 5 is arranged separately from the catheter pump 200, the distal end of the pump head 3 can be butted with the proximal end of the introducer 5, and the pump head 3 is folded into the pre-folding channel through the proximal end of the introducer 5 by pulling the introducer 5 backwards, or pushing the catheter 2 forwards by a colleague pulling the introducer 5 backwards. The introducer 5 and the collapsible pump head 3 are described above and will not be described in detail.

The distal end of the introducer 5 interfaces with the proximal end of the access sheath 7, and the pump head 3 is transferred from the pre-collapsed channel into the access channel by pushing the catheter 2 forward.

Wherein the introducer 5 is operably interfaced with the access sheath 7 in such a manner that the introducer 5 is at least partially operable to penetrate the access sheath 7 to provide communication between the pre-plication channel and the access channel, as shown in particular in fig. 9.

Another way in which the introducer 5 may be operably interfaced with the access sheath 7 is to end-interface the distal end of the introducer 5 with the proximal end of the access sheath 7 to provide communication between the pre-collapsed passage and the access passage, as shown in particular in fig. 7 and 8.

The pump head 3 is delivered in a collapsed state through the access sheath 7 to the vascular system, enabling the pump head 3 to enter the subject with a smaller access size.

The access sheath 7 has an inner diameter smaller than the outer diameter of the coupler 4 and is partially accessible to the vasculature of the subject through the puncture. The access sheath 7 is advanced through the puncture into the vascular system at its forward end and is left at its rear end outside the body for forming or establishing a passage for the device into the vascular system.

The introducer 5 has an inner diameter larger than the outer diameter of the catheter 2 and the outer diameter of the pump head 3 in the collapsed state, in order to fit over the pump head 3 and catheter 2.

To achieve docking of the introducer 5 and the insertion sheath 7, the inner diameter of the introducer 5 is less than or equal to the inner diameter of the insertion sheath 7. In an embodiment, the outer diameter of the introducer 5 may be less than or equal to the inner diameter of the access sheath 7 to enable at least partial operable penetration of the introducer 5 into the access sheath 7.

When the catheter pump 100 is inserted into the subject to assist in pumping blood, the catheter pump 100 is kept inserted into the subject, and the insertion sheath 7 is kept in the puncture.

When the introducer 5 is a long sheath, due to its length and the inner diameter of the long sheath being smaller than the outer diameter of the coupler 4, the coupler 4 cannot penetrate into the long sheath, which may cause the long sheath to interfere with the coupler 4 to restrict movement of the pump head 3 within the subject's vasculature. To this end, the long sheath is a tearable sheath that is operatively peeled off after the pump head 3 has entered the vascular system, and the access sheath 7 is disposed through the puncture, thereby avoiding interference of the tearable sheath with the coupler 4.

The method for the tearing sheath to be peeled off is as follows: the tearable sheath is torn while moving proximally.

Because the inner diameter of the tearable sheath is smaller than the outer diameter of the coupler 4, the two parts of the proximal end formed by the tearable sheath in the process of being peeled do not interfere with the coupler 4, so that the tearable sheath can be smoothly withdrawn from the puncture.

In order to achieve easy peeling of the tearable sheath without being affected by the coupler 4, the tearable sheath may have a lateral opening (not shown) at the proximal end along which the tearable sheath can be peeled open, which is labor-saving and convenient to operate.

The lateral openings may be provided in two, with the two lateral openings being disposed opposite each other on opposite sides of the proximal end of the tearable sheath.

In another embodiment, the tearable sheath may be connected with a pre-press tear seam on each side of the symmetrical position. When the tearable sheath is peeled off, the tearable sheath may be torn in half along the pre-press tear line while withdrawing the proximal end.

The tearable sheath can be made of polytetrafluoroethylene materials, the two symmetrical and completely consistent tearable sheath tubes are manufactured through stamping technology and integrated, the two symmetrical and completely consistent tearable sheath tubes are butted through a hot melting technology, and a pre-pressing tearable seam is formed at the butt joint.

Referring to fig. 7 and 8, the proximal end of the insertion sheath 7 is provided with a first lock catch 71, the distal end of the introducer 5 is provided with a second lock catch 55, and the first lock catch 71 and the second lock catch 22 are detachably locked.

When the distal end of the introducer 5 is docked with the access sheath 7, the pump head 3 is transferred from the pre-collapsed access into the access by pushing the catheter 2 forward. At this time, the first latch 71 and the second latch 22 are locked, and the introducer 5 and the insertion sheath 7 cannot be separated from each other. Therefore, when the catheter 2 is pushed forwards, the reaction force of the pump head 3 prevents the process that the introducer 5 moves backwards and is separated from the intervention sheath 7 to cause the transfer of the pump head 3 from the pre-folding channel to the intervention channel from being blocked, and the phenomenon that the intervention sheath 7 moves at the puncture port under the action of external force to damage the puncture port in the transfer process of the pump head 3 is also avoided. The size of the puncture opening is ensured, the puncture opening can be healed conveniently, the probability of puncture opening complications is reduced, and meanwhile, the pain of a testee can be relieved.

The structure of the first lock catch 71 and the second lock catch 22 is not particularly limited, and may be detachably locked.

The utility model discloses still provide a method of folding as above-mentioned catheter pump's pump head, include:

operating at least one of the introducer and the pump head to cause the introducer and the pump head to move toward each other, and inserting the distal end of the pump head into the proximal end of the introducer and finally folding into the pre-folding channel;

the distal end of the introducer is butted with the proximal end of the interventional sheath, and the catheter is pushed forward, so that the pump head in a folded state is transferred into the interventional sheath from the pre-folding channel.

The pump head is collapsed into the pre-collapse channel as described above, and will not be described herein.

In the process that the pump head is transferred into the intervention channel from the pre-folding channel, the introducer and the intervention sheath are axially kept fixed, and specifically, locking of the first lock catch and the second lock catch is realized.

Wherein the access sheath is partially accessed to the vasculature of the subject through the puncture, and after the pump head is transferred into the access sheath, the method further comprises: and continuously pushing the catheter forwards to enable the pump head to move out of the distal end of the intervention sheath, enter the vascular system of the subject in a deployed state, intervene to the target position, and realize the blood pumping working state of the catheter pump by matching and connecting the motor and the catheter.

It should be noted that the access sheath is always partially inserted into the puncture to facilitate the subsequent removal of the pump head from the subject.

When the catheter pump-assisted blood pumping is complete, removing the catheter pump from the subject is: pulling the catheter towards the proximal end to accommodate the pump in the unfolded state into the access sheath, so that the pump head is switched to the folded state; continued proximal pulling of the catheter causes the pump head to move out of the access sheath. And finally, pulling the intervention sheath to the proximal end to remove the intervention sheath from the body.

The utility model discloses a leading-in device slidable ground cover is established outside the pipe, perhaps sets up with catheter pump separation. The pump head may be collapsed from the distal end of the introducer when the introducer is slidably disposed over the catheter. When the introducer and catheter pump are separately disposed, the pump head can be collapsed from the proximal end of the introducer. The introducer can fold the pump head from the near end and the far end, so that the operation of a doctor is facilitated, and the doctor can select to fold the pump head from the near end or the far end according to the operation habit of the doctor. And when the pump head is folded from the distal end of the introducer, if the introducer slips off from the distal end of the pump head due to misoperation, the pump head can be continuously folded from the proximal end of the introducer, and the operation is simple.

The above embodiments only represent several embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. A catheter pump, characterized by: the method comprises the following steps:

a conduit;

a drive shaft rotatably disposed through the conduit;

foldable pump head includes: a pump housing connected to a distal end of the catheter, an impeller disposed within the pump housing; the impeller is connected to a distal end of the drive shaft, a proximal end of the drive shaft being connectable to a motor to transmit rotation of the motor to the impeller;

an introducer which comprises a pre-folding channel which is suitable for accommodating the pump head in an unfolding state into the introducer so as to switch the pump head to a folding state; the introducer is provided with a first assembling state which is sleeved outside the catheter in a sliding way and a second assembling state which is arranged separately from the catheter pump;

collapsing the pump head into the pre-collapsed passage through the distal end of the introducer by pushing the introducer forward and/or pulling the catheter backward while the introducer is in the first assembled state;

when the introducer is in the second assembled state, the distal end of the pump head is insertable into the proximal end of the introducer and the pump head is collapsed into the pre-collapsed passage via the proximal end of the introducer by pulling back on the introducer and/or pushing forward on the catheter;

the introducer can alternatively collapse the pump head into the pre-collapse channel in the first set state and the second set state.

2. Catheter pump according to claim 1, wherein the introducer is switchable from the first assembled state to the second assembled state or vice versa.

3. The catheter pump of claim 1, wherein the introducer comprises an introducer catheter defining the pre-collapsed passage, an inner diameter of the introducer catheter defining a diameter of the pump head in a collapsed state.

4. The catheter pump of claim 3, wherein the introducer further comprises an introducer hub disposed at the proximal end of the introducer catheter, the introducer hub defining an introducer lumen in communication with the pre-collapsed passage, the introducer lumen including at least an enlarged section at the proximal end, the enlarged section having an inner diameter at least no smaller than a diameter of the pump head in the deployed state.

5. The catheter pump of claim 4, wherein the introducer lumen further comprises a necked-down section at the distal end, the necked-down section having an inner diameter that is less than the inner diameter of the enlarged section and at least no greater than the inner diameter of the introducer catheter.

6. The catheter pump of claim 5, wherein the guide lumen further comprises a transition section connecting the enlarged section and the necked section, the transition section having an inner wall that tapers gradually from the proximal end to the distal end.

7. The catheter pump of claim 4, wherein the introducer is a tearaway sheath and the introducer hub is configured as an operating handle.

8. A catheter pump, characterized by: the method comprises the following steps:

a conduit;

a drive shaft rotatably disposed through the conduit;

an access sheath including an access channel receivable of the pump head;

an introducer operably interfacing with the access sheath, including a pre-collapsed channel adapted to receive the pump head therein in an expanded state;

wherein the introducer is provided separately from the catheter pump, the distal end of the pump head is capable of abutting the proximal end of the introducer, and the pump head is collapsed into the pre-collapsed passage via the proximal end of the introducer by pulling back the introducer and/or pushing forward the catheter;

the distal end of the introducer is docked with the proximal end of the access sheath, and the pump head is displaced from the pre-collapsed passage into the access passage by pushing the catheter forward.

9. The catheter pump of claim 8, wherein the introducer has an inner diameter less than or equal to an inner diameter of the interventional sheath.

10. The catheter pump of claim 8, wherein the proximal end of the access sheath is provided with a first latch and the distal end of the introducer is provided with a second latch, the first and second latches releasably latching.