Stent connection tube assembly for catheter pump and catheter pump

Abstract

A stent connection tube assembly for a catheter pump and a catheter pump. The catheter pump comprises a drive shaft, a catheter, and a pump head. A distal end of the catheter is connected to a proximal end of the stent connection tube assembly, and a distal end of the stent connection tube assembly is connected to a proximal end of the pump head. The stent connection tube assembly for the catheter pump comprises a stent connection tube and a stent proximal support member. An accommodating cavity having openings at both ends is provided within the stent connection tube, and the stent connection tube is provided with a first limiting structure. The stent proximal support member is sleeved within the accommodating cavity and is configured to support rotation of the drive shaft, and the drive shaft is configured to drive rotation of an impeller inside the pump head. The stent proximal support member is provided with a second limiting structure. The first limiting structure can cooperate with the second limiting structure to restrict axial movement and circumferential rotation of the stent proximal support member, thereby providing stable support for the drive shaft.

Description

Bracket connecting pipe assembly for catheter pump and catheter pump

[0001] This application requires:

[0002] Submitted to the China Patent Office on April 2, 2024, application number 202410393224.7, invention name “Standard connecting pipe assembly for catheter pump and catheter pump”;

[0003] Submitted to the China Patent Office on July 8, 2024, application number 202421593826.9, invention name “Ventricular Assist Device”;

[0004] Submitted to the China Patent Office on July 8, 2024, application number 202410905050.8, invention name “Pump head assembly and ventricular assist device”;

[0005] The entire contents of the priorities of the above three Chinese patent applications are incorporated into this application by reference. Technical Field

[0006] The present invention relates to the technical field of medical devices, and in particular to a bracket connecting tube assembly for a catheter pump and a catheter pump. Background Art

[0007] A catheter pump can be introduced into the patient's body through interventional means and assists in the transport of blood in the circulatory system. A catheter pump typically includes a pump head located inside the patient's body and a drive assembly located outside the patient's body. The drive assembly can be connected to the pump head via a slender drive shaft arranged in the catheter to provide power to the pump head. As an example, when the pump head is deployed in the left ventricle, the catheter pump can pump blood from the left ventricle of the heart into the aorta; when the pump head is deployed in the right ventricle, the catheter pump can pump blood from the inferior vena cava into the pulmonary artery.

[0008] To provide stable support for the drive shaft, catheter pumps are typically equipped with a proximal bearing, which is sleeved around the outer circumference of the drive shaft. In one prior art catheter pump, the proximal radial support member is the proximal bearing, and the axial shaft is the drive shaft. The proximal radial support member is mounted within a proximal support member housing.

[0009] However, in the prior art of the catheter pump, due to the lack of a limiting structure for the proximal radial support, after prolonged use, the proximal radial support may rotate relative to the proximal support housing, affecting the support function for the drive shaft. Summary of the Invention

[0010] The object of the present invention is to provide a support connecting tube assembly and a catheter pump for a catheter pump, so as to solve the technical problem in the prior art that the proximal radial support may rotate relative to the proximal support housing, thereby affecting the support for the drive shaft.

[0011] As conceived above, the technical solution adopted by the present invention is:

[0012] A support connecting tube assembly for a catheter pump, the catheter pump comprising a drive shaft, a catheter and a pump head, the distal end of the catheter being connected to the proximal end of the support connecting tube assembly, the distal end of the support connecting tube assembly being connected to the proximal end of the pump head, the support connecting tube assembly for the catheter pump comprising:

[0013] A bracket connecting tube, wherein a receiving cavity with openings at both ends is provided in the bracket connecting tube, and a first limiting structure is provided on the bracket connecting tube;

[0014] The proximal support member of the bracket is sleeved in the accommodating cavity, and the proximal support member of the bracket is used to support the rotation of the drive shaft, and the drive shaft is used to drive the impeller in the pump head to rotate. A second limiting structure is provided on the proximal support member of the bracket, and the first limiting structure can cooperate with the second limiting structure to limit the axial movement and circumferential rotation of the proximal support member of the bracket.

[0015] Catheter pump, comprising:

[0016] The aforementioned bracket connecting pipe assembly;

[0017] a catheter, wherein the distal end of the catheter is mounted on the proximal end of the stent connecting tube;

[0018] A pump head, wherein the distal end of the bracket connecting tube is connected to the proximal end of the pump head, the pump head comprises a bracket and an impeller, the proximal end of the bracket is connected to the distal end of the bracket connecting tube, and the impeller is disposed in the bracket;

[0019] A drive shaft is sleeved in the proximal support member of the bracket, and the drive shaft can drive the impeller to rotate.

[0020] Beneficial effects of the present invention:

[0021] When the stent connecting tube assembly for a catheter pump proposed in the present invention is applied to a catheter pump, the distal end of the catheter is connected to the proximal end of the stent connecting tube assembly, which is then connected to the proximal end of the pump head. The stent proximal end support member supports the rotation of the drive shaft. A first limiting structure is provided on the stent connecting tube, and a second limiting structure is provided on the stent proximal end support member. The first limiting structure cooperates with the second limiting structure to limit axial movement and circumferential rotation of the stent proximal end support member, thereby preventing axial movement and circumferential rotation of the stent proximal end support member during rotation of the drive shaft, thereby ensuring stable support of the drive shaft by the stent proximal end support member.

[0022] The catheter pump proposed in the present invention has restricted axial movement and circumferential rotation of the proximal support member of the bracket, so that the proximal support member of the bracket will not be driven to rotate by the drive shaft, and thus the proximal support member of the bracket will not move relative to the inner wall of the bracket connecting tube. On the one hand, it can stably support the rotational movement of the drive shaft to ensure the normal operation of the pump head; on the other hand, it can avoid wear on the inner wall of the bracket connecting tube, thereby ensuring the service life of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG1 is a schematic structural diagram of a catheter pump provided in an embodiment of the present invention;

[0024] FIG2 is a schematic cross-sectional view of a pump head according to an embodiment of the present invention;

[0025] FIG3 is a partial structural diagram of FIG2 ;

[0026] FIG4 is a schematic diagram of a catheter pump provided by an embodiment of the present invention when it is inserted into the heart;

[0027] FIG5 is a schematic diagram of a support connecting pipe assembly for a catheter pump provided by an embodiment of the present invention being installed on a catheter pump;

[0028] FIG6 is a partial structural diagram of FIG5;

[0029] 7 is a schematic structural diagram of a stent connecting tube according to an embodiment of the present invention;

[0030] FIG8 is a partial structural diagram of FIG7;

[0031] 9 is a schematic cross-sectional view of a stent connecting tube according to an embodiment of the present invention;

[0032] FIG10 is a schematic structural diagram of a proximal support member of a stent provided in an embodiment of the present invention.

[0033] FIG11 is a schematic axial cross-sectional view of some parts of a pump head in a catheter pump;

[0034] FIG12 is a schematic axial cross-sectional view of a pump head in another embodiment of the present invention;

[0035] FIG13 is an enlarged schematic diagram of point A in the structure shown in FIG12;

[0036] FIG14 is an enlarged schematic diagram of point B in the structure shown in FIG12;

[0037] FIG15 is a three-dimensional schematic diagram of the flexible support member in the structure shown in FIG12;

[0038] FIG16 is an axial cross-sectional view of the flexible support member shown in FIG15 ;

[0039] FIG17 is a schematic cross-sectional view of a point C in the structure shown in FIG16;

[0040] FIG18 is a schematic diagram of the structure shown in FIG12 with the resealable member in an uncompressed state;

[0041] FIG19 is a schematic diagram of the resealable member shown in FIG18 in a compressed state;

[0042] FIG20 is an axial cross-sectional view of the distal bearing in the structure shown in FIG12. DETAILED DESCRIPTION

[0043] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0044] Example 1

[0045] This embodiment provides a bracket connecting pipe assembly for a catheter pump.

[0046] Specifically, referring to Figures 1-4, the catheter pump usually needs to be at least partially inserted into the patient's body, for example, it can be deployed at a predetermined position in the left ventricle or right ventricle to pump blood to at least partially replace the heart's pumping function.

[0047] The catheter pump includes a catheter 10, a drive assembly 20, a drive shaft 30, and a pump head 40. The drive assembly 20 includes a drive shaft 30. The drive assembly 20 can be connected to the proximal end of the catheter 10 via a coupler and is configured as a power component to provide power. The distal end of the catheter 10 is connected to the pump head 40. The drive shaft 30 is provided inside the catheter 10, and one end of the drive shaft 30 is connected to the power output end of the drive assembly 20. The distal end of the catheter 10 is connected to the pump head 40.

[0048] The pump head 40 includes a pump casing and an impeller 403 installed in the pump casing, and the impeller 403 is connected to the other end of the drive shaft 30. Thus, when the drive shaft 30 rotates, the impeller 403 is driven to rotate together. The pump casing includes a bracket 401 in a metal lattice structure made of, for example, an alloy such as nickel and titanium. The metal lattice of the pump casing has a mesh design. The membrane 402 is installed on the pump casing and, together with the pump casing, defines an inlet area for pumping blood in and an outlet area for pumping blood out. In some embodiments, the membrane 402 covers the middle and rear end portion of the pump casing (i.e., the proximal portion close to the pump casing), whereby the membrane 402 can form an outlet area for blood at the proximal end, and the front end (i.e., the distal end) of the pump casing that is not covered by the membrane 402 can form an inlet area for blood, for example, the inlet area can be formed by the mesh of the pump casing. When the driving shaft 30 drives the impeller 403 to rotate, along with the rotation of the impeller 403, blood enters the fluid channel defined by the membrane 402 from the inlet area, passes through the membrane 402 and flows out from the outlet area.

[0049] In some embodiments, the pump head 40 can be foldable. This has advantages in the context of catheter pump interventions. The pump head 40 and the front end portion of the catheter 10 of the catheter pump are inserted into and retained within the patient's body, so the peripheral dimensions of the pump head 40 and the catheter 10 should be as small as possible. A smaller pump head 40 and catheter 10 means that they can enter the patient's body through a smaller puncture port, reducing the pain caused to the patient during the interventional procedure and minimizing complications caused by an oversized puncture port. In this embodiment, the pump head 40 can include a folded configuration and an unfolded configuration. In the folded configuration, the pump head 40 is folded, thereby occupying the smallest possible peripheral dimension. The folded configuration can correspond to the interventional procedure of the catheter pump. In the unfolded configuration, the pump head 40 returns from the folded configuration to the unfolded configuration. The unfolded configuration can correspond to the working state of the catheter pump, in which the blood pumping fluid channel of the pump head 40 is unobstructed and suitable for pumping blood.

[0050] In some embodiments, the pump housing of the pump head 40 can be made of an alloy material such as nickel-titanium. The pump head 40 can be implemented as a multi-mesh design, and at the same time, it can be unfolded by means of the memory properties of nickel-titanium alloy. The blades of the impeller 403 are made of a flexible material or a shape memory material and can be folded relative to the hub. When the pump head 40 includes a folding configuration, the blades of the impeller 403 are close to the hub to reduce the size occupied. After the external force constraining the blades of the impeller 403 is released, the stored energy of the blades is released, causing the blades to unfold and return to the unfolded state.

[0051] The catheter pump also includes a protective head 50 connected to the distal end of the pump head 40. When the catheter pump is inserted into a predetermined position in the human body, the protective head 50 can guide the insertion of the catheter pump. After the catheter pump is inserted into the predetermined position in the human body (i.e., after the catheter pump is deployed in place), during the operation of the catheter pump, the protective head 50 can maintain the posture of the pump head in the heart, preventing the pump head from adsorbing the inner wall of the heart or sucking the heart's chordae tendineae into the pump head, thereby causing danger. The protective head 50 is configured to be soft, so the protective head 50 is also called a flexible support member so as not to harm the patient's tissue. In some embodiments, the flexible end of the protective head 50 is supported on the inner wall of the ventricle in a non-invasive or non-destructive manner, separating the inlet of the pump head 40 from the inner wall of the ventricle. In one example, the protective head 50 is in a straight line shape. Of course, in other embodiments, the protective head 50 can be in any other appropriate shape.

[0052] Figure 4 shows a schematic diagram of a catheter pump according to this embodiment deployed in the left ventricle. Here, the portion of the membrane 402 extending proximally beyond the stent 401 is positioned across the heart valve. It should be understood that the illustrated embodiment is merely exemplary, and the catheter pump can also be placed as desired at other target locations in a patient, such as the right ventricle, within a blood vessel, or within another organ, through invasive surgery.

[0053] In this embodiment, the catheter pump is used to assist patients with heart failure. When the catheter pump head is placed in the left ventricle, it can assist in pumping blood from the heart to the aorta, partially fulfilling the heart's pumping function. In scenarios suitable for left ventricular assist, the catheter pump pumps blood from the left ventricle into the aorta, supporting blood circulation and reducing the workload of the subject's heart, or providing additional continuous pumping power when the heart's pumping capacity is insufficient.

[0054] Specifically, referring to FIG. 1 and FIG. 5 , the distal end of the catheter 10 is connected to the proximal end of the stent connecting tube assembly, and the distal end of the stent connecting tube assembly is connected to the proximal end of the pump head 40 .

[0055] When the catheter pump is in use, the drive assembly 20 is located outside the subject's body, and the end of all components close to the drive assembly 20 is the proximal end, and the other end away from the drive assembly 20 is the distal end.

[0056] Referring to FIG. 5 , in this embodiment, the stent connecting tube assembly for the catheter pump includes a stent connecting tube 1 and a stent proximal support 2 .

[0057] An accommodating cavity 11 with openings at both ends is provided in the bracket connecting tube 1 , and a first limiting structure is provided on the bracket connecting tube 1 .

[0058] The proximal support member 2 of the bracket is sleeved in the accommodating cavity 11. The proximal support member 2 of the bracket is used to support the rotation of the drive shaft 30. The drive shaft 30 is used to drive the impeller 403 in the pump head 40 to rotate. A second limiting structure is provided on the proximal support member 2 of the bracket. The first limiting structure can cooperate with the second limiting structure to limit the axial movement and circumferential rotation of the proximal support member 2 of the bracket.

[0059] Specifically, a drive shaft installation cavity with openings at both ends is provided in the proximal support member 2 of the stent. The drive shaft 30 passes through the drive shaft installation cavity and is supported by the proximal support member 2 of the stent to rotate.

[0060] When the stent connecting tube assembly for a catheter pump provided in this embodiment is applied to a catheter pump, the distal end of the catheter 10 is connected to the proximal end of the stent connecting tube assembly, which is then connected to the proximal end of the pump head 40, and the stent proximal end support 2 supports the rotation of the drive shaft 30. A first limiting structure is provided on the stent connecting tube 1, and a second limiting structure is provided on the stent proximal end support 2. The first limiting structure can cooperate with the second limiting structure to limit the axial movement and circumferential rotation of the stent proximal end support 2, thereby preventing the stent proximal end support 2 from axial movement and / or circumferential rotation during the rotation of the drive shaft 30, thereby ensuring that the stent proximal end support 2 stably supports the drive shaft 30.

[0061] Specifically, the proximal end of the stent connecting tube 1 is connected to the distal end of the catheter 10 , and the distal end of the stent connecting tube 1 is connected to the proximal end of the pump head 40 .

[0062] The axial movement and circumferential rotation of the proximal support 2 of the bracket are restricted, and the proximal support 2 of the bracket will not be driven to rotate by the drive shaft 30, and thus the proximal support 2 of the bracket will not move relative to the inner wall of the bracket connecting tube 1. On the one hand, it provides stable support for the rotational movement of the drive shaft 30 to ensure the normal operation of the pump head 40; on the other hand, it can avoid wear on the inner wall of the bracket connecting tube 1 and ensure the service life of the product.

[0063] Specifically, referring to Figures 7 and 10, in this embodiment, the first limiting structure includes two relatively arranged clips 121, and the second limiting structure includes two limiting grooves 211 arranged on the outer side surface of the proximal support member 2 of the stent. The clips 121 are clipped into the limiting grooves 211 in a one-to-one correspondence to limit the axial movement and circumferential rotation of the proximal support member 2 of the stent.

[0064] Specifically, when the proximal support member 2 of the stent is not assembled to the stent connecting tube 1, the clip 121 protrudes relative to the inner surface of the stent connecting tube 1; when the proximal support member 2 of the stent is sleeved into the accommodating cavity 11 of the stent connecting tube 1, the clip 121 clips into its corresponding limiting groove 211. Specifically, when the proximal support member 2 of the stent is assembled into the stent connecting tube 1 from the proximal end to the distal end, taking the orientation shown in Figures 8 and 10 as an example, the free end of the clip 121 is first lifted by the protrusion on the right side of the limiting groove 211; after the clip 121 passes over the protrusion on the right side of the limiting groove 211, the clip 121 returns to its original state and clips into the limiting groove 211.

[0065] In one example, the clamping member 121 is made of elastic material.

[0066] Further, referring to Figures 8 and 10, in this embodiment, in order to fully ensure the stability of the restriction on the axial movement and circumferential rotation of the proximal support member 2 of the stent, the first limiting structure includes a first abutment portion 122, and the first abutment portion 122 is arranged on the inner ring surface of the accommodating cavity 11, and the second limiting structure includes a second abutment portion 212 arranged on the outer side surface of the proximal support member 2 of the stent, and the first abutment portion 122 abuts against the second abutment portion 212 to limit the circumferential rotation of the proximal support member 2 of the stent and the movement of the proximal support member 2 of the stent toward the distal end of the stent connecting tube 1.

[0067] In one example, at least two first abutment portions 122 are spaced apart along the inner circumference of the accommodating cavity 11, and at least two second abutment portions 212 are provided on the outer side of the proximal support member 2 of the stent, and the first abutment portions 122 and the second abutment portions 212 are provided in one-to-one correspondence.

[0068] Specifically, in this embodiment, the axial movement and circumferential rotation of the proximal support member 2 of the bracket are restricted by a protruding structure provided at the distal end of the accommodating cavity 11, and the second abutting portion 212 is a recessed structure provided at the distal end of the proximal support member 2 of the bracket. The proximal support member 2 of the bracket is installed from the proximal end of the accommodating cavity 11 to the inside of the accommodating cavity 11. When the second abutting portion 212 moves to abut against the first abutting portion 122, it indicates that the proximal support member 2 of the bracket is installed in place. At this time, the clamping member 121 is also clamped into the corresponding limiting groove 211.

[0069] Furthermore, the pump head 40 includes a bracket 401, the proximal end of the bracket 401 is connected to the distal end of the bracket connecting tube 1, and the proximal end of the bracket 401 is a plurality of bracket connecting legs 4011. In order to realize the connection of the bracket connecting legs 4011 at the distal end of the bracket connecting tube 1, in this embodiment, the outer surface of the bracket connecting tube 1 is provided with a bracket mounting groove 13, and the bracket connecting legs 4011 are installed in the bracket mounting groove 13.

[0070] In one example, a plurality of bracket installation grooves 13 are provided at intervals on the outer surface of the bracket connecting tube 1 along the outer circumference of the bracket connecting tube 1 , and the bracket connecting legs 4011 correspond to the bracket installation grooves 13 one by one.

[0071] Furthermore, in order to prevent the bracket connecting leg 4011 from detaching from the bracket mounting groove 13 during use, referring to Figure 5, the bracket connecting pipe assembly also includes a fixing sleeve 5, which is fixedly arranged on the outer side surface of the bracket connecting pipe 1, and a clamping cavity is formed between the inner wall of the fixing sleeve 5 and the outer side surface of the bracket connecting pipe 1, and the bracket connecting leg 4011 is clamped in the clamping cavity, and the clamping cavity includes the bracket mounting groove 13.

[0072] In one example, in this embodiment, the fixing sleeve 5 is made of metal.

[0073] In order to limit the installation position of the fixing sleeve 5 , more specifically, referring to FIG. 8 , a plurality of groups of limiting protrusion assemblies 14 are provided at intervals on the outer side surface of the bracket connecting tube 1 .

[0074] The limiting protrusion assembly 14 can limit the distal end of the fixing sleeve 5. Specifically, when installing the fixing sleeve 5, the fixing sleeve 5 is sleeved from the proximal end of the stent connecting tube 1 to the outer circumference of the stent connecting tube 1, and then the fixing sleeve 5 is moved axially along the outer circumference of the stent connecting tube 1 until the distal end surface of the fixing sleeve 5 abuts the limiting protrusion 141 of the limiting protrusion assembly 14, indicating that the fixing sleeve 5 is installed in place.

[0075] Each set of limiting protrusion assemblies 14 includes two limiting protrusions 141 spaced apart along the circumference of the stent connecting tube 1. A membrane accommodating cavity 142 is formed between two adjacent sets of limiting protrusion assemblies 14. The membrane accommodating cavity 142 is used to accommodate the membrane 402 of the pump head 40. It should be noted that the membrane accommodating cavity 142 is formed between two adjacent sets of limiting protrusion assemblies 14. That is, the portion of the outer side of the stent connecting tube 1 where the limiting protrusion assemblies 14 are not provided constitutes the membrane accommodating cavity 142.

[0076] Specifically, in this embodiment, a group of limiting protrusion assemblies 14 are arranged on opposite sides of the outer surface of the farthest end of the bracket connecting tube 1; the two circumferentially arranged limiting protrusion assemblies 14 can ensure the stability of the limiting of the fixing sleeve 5; at the same time, the circumferential space of the bracket connecting tube 1 where the limiting protrusion assembly 14 is not arranged can be used as an accommodating space for the coating 402 when the pump head 40 is folded.

[0077] A first limiting structure is provided between the two limiting protrusions 141 of the same limiting protrusion assembly 14. Two groups of limiting protrusion assemblies 14 are provided at intervals on the outer side surface of the bracket connecting tube 1 along the outer circumference of the bracket connecting tube 1.

[0078] Specifically, a clamping member 121 is provided between the two limiting protrusions 141 of the same limiting protrusion assembly 14 .

[0079] A U-shaped through-slot 18 is provided on the side wall of the main body of the support connecting tube 1 between the two limiting protrusions 141 of the same limiting protrusion assembly 14. After the U-shaped through-slot 18 is provided, a clip 121 is formed on the side wall of the main body of the support connecting tube 1. The provision of the U-shaped through-slot 18 reduces the circumferential dimension of each limiting protrusion 141, thereby reducing the surface area of ​​the limiting protrusion 141 protruding from the outer surface of the support connecting tube 1. With this arrangement, when the pump head 40 is folded, the coating 402 is tightly attached to the outer surface of the pump head 40. The limiting protrusions 141 on the outer surface of the support connecting tube 1 will preferentially contact the coating 402. In this way, the limiting protrusions 141 with smaller surface areas can play a role in sorting out the stacked coatings 402, separating the stacked coatings 402 from each other and accommodating them respectively into the two spaces separated by the two groups of limiting protrusion assemblies 14.

[0080] After the stent proximal support member 2 is installed in place, the clip 121 is also clipped into the corresponding limiting groove 211. Specifically, referring to Figures 7-9, in this embodiment, along the circumference of the stent connecting tube 1, the outer peripheral surface of the distal end of the stent connecting tube 1 is provided with a plurality of protruding ribs 17 at intervals. A stent mounting groove 13 is formed between two adjacent protruding ribs 17. The two limiting protrusions 141 of each limiting protrusion assembly 14 are protruded from the distal ends of two adjacent protruding ribs 17.

[0081] In this embodiment, each limiting protrusion 141 is protruding from the distal end of the protruding rib 17 .

[0082] In one example, in this embodiment, the distal end of the raised rib 17 is narrower and the proximal end is wider. With this arrangement, the surface area of ​​the limiting protrusion 141 arranged at the distal end of the raised rib 17 is also smaller; with this arrangement, during the folding process of the pump head 40, the soft and larger diameter coating 402 gradually adheres to the outer surface of the bracket connecting tube 1, and tends to move toward the proximal or distal end relative to the limiting protrusion 141. In this way, the limiting protrusion 141 with a smaller surface area can play a role in combing the stacked coatings 402, so that the stacked coatings 402 are separated from each other and accommodated in the space between the two adjacent groups of limiting protrusion components 14 on both sides.

[0083] Furthermore, the distal end of the limiting protrusion 141 is provided with a first inclined surface 1411, and the distal end of the stent connecting tube 1 is provided with a first curved surface 15. The first inclined surface 1411 smoothly connects with the first curved surface 15. Furthermore, when assembled, as shown in FIG6 , the distal end surface of the stent connecting tube 1 and the distal end surface of the stent proximal support member 2 form a smooth surface. This arrangement can reduce the risk of hemolysis when blood flows through this area.

[0084] Specifically, referring to Figures 5 and 9, in this embodiment, along the installation direction of the proximal support member 2 of the stent in the accommodating chamber 11, an introduction chamber 111, a transition chamber 112, and an installation chamber 113 are sequentially provided in the accommodating chamber 11. The inner diameter of the introduction chamber 111 is larger than the inner diameter of the installation chamber 113, and the inner diameter of any cross-section of the transition chamber 112 is smaller than the inner diameter of the introduction chamber 111 and larger than the inner diameter of the installation chamber 113. This arrangement facilitates the rapid installation of the proximal support member 2 of the stent in the accommodating chamber 11 and ensures the stable installation of the proximal support member 2 of the stent in the installation chamber 113. Specifically, in this embodiment, the introduction chamber 111 and the installation chamber 113 are both cylindrical chambers, and the transition chamber 112 is a truncated cone-shaped cavity.

[0085] 5 and 6 , the bracket connecting pipe assembly further includes a retaining ring 3 , which is installed in the introduction cavity 111 and abuts against the inner wall of the transition cavity 112 .

[0086] Specifically, the retaining ring 3 is installed at the distal end of the introduction cavity 111 and abuts against the inner side wall of the proximal end of the transition cavity 112 .

[0087] In one example, the inner diameter of the transition cavity 112 gradually decreases from the inner diameter of the introduction cavity 111 to the inner diameter of the installation cavity 113 .

[0088] In one example, the outer diameter of the retaining ring 3 is larger than the proximal inner diameter of the transition cavity 112, so that the retaining ring 3 can be limited to slide toward the distal end; or the outer diameter of the retaining ring 3 is smaller than the proximal inner diameter of the transition cavity 112, but larger than the distal inner diameter of the transition cavity 112, so that the retaining ring 3 can also be limited to slide toward the distal end.

[0089] 5 and 6 , further, the catheter 10 is fixedly installed in the accommodating cavity 11 , and the retaining ring 3 abuts against the distal end surface of the catheter 10 .

[0090] In one example, the retaining ring 3 is fixed to the distal end face of the catheter 10. Specifically, in a catheter pump, the catheter 10 is made of a relatively soft material, and a stopper 301 is provided on the drive shaft 30. The stopper 301 is fixed to the drive shaft 30 and can rotate and move axially with the drive shaft 30. When the drive shaft 30 moves proximally along its own axis, the stopper 301 moves to abut the retaining ring 3. The retaining ring 3 is much harder than the catheter 10. The provision of the retaining ring 3 prevents the stopper 301 from directly contacting the distal end of the catheter 10 and thereby wearing the catheter 10.

[0091] Specifically, referring to FIG9 , the introduction cavity 111 , the transition cavity 112 and the installation cavity 113 are coaxially arranged in sequence from the proximal end to the distal end.

[0092] Furthermore, a seal 4 is provided on the outer side of the proximal support member 2 of the stent. The proximal support member 2 is mounted in the mounting cavity 113, and the seal 4 is sandwiched between the inner sidewall of the mounting cavity 113 and the outer side of the proximal support member 2. The seal 4 is used to seal the gap between the outer surface of the proximal support member 2 and the inner wall of the stent connecting tube 1. On the one hand, it prevents perfusion fluid from leaking from this gap, resulting in insufficient perfusion fluid in the space between the inner surface of the proximal support member 2 and the outer surface of the drive shaft 30, i.e., an inability to lubricate the proximal support member 2 and the drive shaft 30; on the other hand, it prevents blood in the environment from flowing into this gap and causing blood clotting.

[0093] In one example, an annular seal installation groove 22 that cooperates with the seal 4 is provided on the outer side surface of the proximal support 2 of the stent.

[0094] In one example, the inner diameter of the introduction cavity 111 is not less than the outer diameter of the seal 4 in a natural state; the inner diameter of the installation cavity 113 is less than the outer diameter of the seal 4 in a natural state.

[0095] It can be understood that the sealing member 4 is made of elastic material.

[0096] Specifically, in this embodiment, the sealing member 4 is first installed on the stent proximal support member 2 , and then the stent proximal support member 2 is installed on the stent connecting tube 1 .

[0097] During the process of installing the proximal support member 2 of the stent, since the inner diameter of the introduction cavity 111 is not less than the outer diameter of the seal 4 in its natural state, the proximal support member 2 of the stent can smoothly pass through the introduction cavity 111, and the outer peripheral surface of the seal 4 will not come into contact with the inner wall of the introduction cavity 111, thus avoiding the wear of the outer peripheral surface of the seal 4 and affecting the final sealing effect; then the proximal support member 2 of the stent carries the seal 4 into the transition cavity 112 at the same time. Since the inner wall of the transition cavity 112 is a gradually inclined surface, the seal 4 is gradually compressed during the process of the proximal support member 2 of the stent passing through the transition cavity 112. Finally, the proximal support member 2 of the stent carries the seal 4 into the installation cavity 113 and is installed in place. The inner diameter of the installation cavity 113 is less than the outer diameter of the seal 4 in its natural state. Therefore, in the installation cavity 113, the seal 4 is in a compressed state to ensure the sealing performance.

[0098] Further, referring to Figures 7 and 9, in this embodiment, an opening 16 communicating with the introduction cavity 111 is provided on the outer wall of the stent connecting tube 1 opposite to the introduction cavity 111; the distal end of the catheter 10 is installed in the introduction cavity 111, and the opening 16 is located on the outer surface of the catheter 10.

[0099] Specifically, when connecting the catheter pump's catheter 10 to the stent connecting tube 1, a heat shrink tubing is placed over the stent connecting tube 1. The heat shrink tubing is heated, and the catheter 10 is subsequently heated. The heat shrink tubing melts and enters the opening 16, connecting the catheter 10 and the stent connecting tube 1. Furthermore, because the material of the catheter 10 deforms when heated, some of the catheter material also enters the opening 16, strengthening the connection between the catheter 10 and the stent connecting tube 1.

[0100] Example 2

[0101] 1 to 4 , this embodiment provides a catheter pump.

[0102] Specifically, referring to FIG. 1 to FIG. 4 , FIG. 5 and FIG. 6 , the catheter pump includes the bracket connecting pipe assembly for the catheter pump of the first embodiment, a catheter 10 , a pump head 40 and a drive shaft 30 .

[0103] The distal end of the catheter 10 is installed on the proximal end of the stent connecting tube 1 .

[0104] The distal end of the bracket connecting tube 1 is connected to the proximal end of the pump head 40 . The pump head 40 includes a bracket 401 and an impeller 403 . The proximal end of the bracket 401 is connected to the distal end of the bracket connecting tube 1 . The impeller 403 is disposed in the bracket 401 .

[0105] The drive shaft 30 is sleeved in the proximal support member 2 of the stent, and the drive shaft 30 can drive the impeller 403 to rotate.

[0106] During operation of the catheter pump provided in this embodiment, the distal end of the catheter 10 is connected to the proximal end of the stent connecting tube assembly, which is in turn connected to the proximal end of the pump head 40. The stent proximal support member 2 supports the rotation of the drive shaft 30. A first limiting structure is provided on the stent connecting tube 1, and a second limiting structure is provided on the stent proximal support member 2. The first limiting structure can cooperate with the second limiting structure to limit the axial movement and circumferential rotation of the stent proximal support member 2, thereby preventing the stent proximal support member 2 from axial movement and / or circumferential rotation during the rotation of the drive shaft 30, thereby ensuring that the stent proximal support member 2 stably supports the drive shaft 30.

[0107] The axial movement and circumferential rotation of the proximal support 2 of the bracket are restricted, and the proximal support 2 of the bracket will not be driven to rotate by the drive shaft 30, and thus the proximal support 2 of the bracket will not move relative to the inner wall of the bracket connecting tube 1. On the one hand, it provides stable support for the rotational movement of the drive shaft 30 to ensure the normal operation of the pump head 40; on the other hand, it can avoid wear on the inner wall of the bracket connecting tube 1 and ensure the service life of the product.

[0108] Specifically, the stent 401 is used to support the unfolding of the membrane 402. The stent 401 can be located inside the membrane 402 or outside the membrane 402 to support the membrane 402. When the pump head 40 is in the radially unfolded state, the stent 401 contacts the inner wall of the membrane 402 and expands radially to support the unfolding of the membrane 402.

[0109] The support 401 is a grid structure, and the multiple meshes, especially the diamond meshes, are designed to facilitate the folding and unfolding of the support 401. The impeller 403 is housed in the support 401 and is located in the covering film 402.

[0110] Further, referring to Figure 1, in this embodiment, the catheter pump also includes a drive assembly 20, the proximal end of the catheter 10 is connected to the drive assembly 20, and the drive assembly 20 includes a drive shaft 30; the drive shaft 30 extends in the catheter 10, the bracket 401 is a foldable bracket, and the impeller 403 is a foldable impeller; the middle area of ​​the bracket 401 covered by the film 402 forms a fluid channel, the area of ​​the distal end of the bracket 401 not covered by the film 402 forms a blood inlet, that is, the inlet area mentioned above, and the area of ​​the proximal end of the bracket 401 not covered by the film 402 forms a blood outlet.

[0111] The coating also includes an extension section, which can extend proximally from the fluid channel to the aorta. After the blood flows out of the blood outlet, it will flow proximally along the extension section of the coating 402 until it flows out from the outlet area mentioned above.

[0112] Specifically, when the catheter pump is working, the stent 401 is located in the left ventricle, the extension section spans the aortic valve, and the blood entering from the inlet area of ​​the pump head 40 is transported to the aorta through the extension section; the membrane 402 is flexible, and during the operation of the catheter pump, the extension section acts as a one-way valve.

[0113] Furthermore, the drive shaft 30 includes a drive soft shaft and a hard shaft. The proximal end of the drive soft shaft is fixedly connected to the output shaft of the drive motor of the drive assembly 20, and the distal end of the drive soft shaft is fixedly connected to the hard shaft. The hard shaft is rotatably supported in the proximal support member 2 of the bracket, and the impeller 403 is fixedly supported on the hard shaft, and the hard shaft can drive the impeller 403 to rotate.

[0114] During the use of the catheter pump, the drive assembly 20 is located outside the body, and the proximal end of the drive flexible shaft is fixedly connected to the output shaft of the drive motor of the drive assembly 20. The proximal end support member 2 of the stent supports the hard shaft of the drive shaft 30.

[0115] In one example, the catheter pump further includes a delivery sheath, which can place the stent 401 and the impeller 403 in a folded state, so that the catheter pump can be inserted into a human blood vessel in this state.

[0116] Specifically, during operation, the catheter pump pushes the catheter 10 forward, causing the pump head 40 to move out of the delivery sheath. At this time, the bracket 401 and the impeller 403 return to the expanded state and continue to push the catheter 10 until the pump head 40 enters the left ventricle; the drive assembly 20 works, causing the impeller 403 to rotate and pump blood, and the blood enters the fluid channel from the inlet area of ​​the pump head 40, and then flows out from the outlet area of ​​the pump head 40.

[0117] Currently, when a catheter pump is operating, the impeller rotates at high speed relative to the distal bearing. To prevent excessive temperatures between the impeller and the distal bearing, the drive shaft is typically hollow, allowing external perfusion fluid to flow between the two, flushing the distal bearing. Currently, perfusion fluid is primarily directed to the distal bearing through the following structure: a distal bearing chamber is provided at the distal end of the pump housing, the distal bearing is at least partially fitted within the inner bore of the distal bearing chamber, and the inner bore of the distal bearing chamber is provided with an annular stop that abuts the distal end face of the distal bearing. A flexible support member is secured to the distal side of the distal bearing chamber. A hemostatic valve is also provided between the annular stop and the flexible support member to prevent perfusion fluid flowing out of the hollow drive shaft from entering the interior of the flexible support member. Blocked by the hemostatic valve, perfusion fluid flowing out of the hollow drive shaft flows back and flushes the distal bearing.

[0118] However, since the annular limit table and the distal bearing are both made of hard materials, once the abutment surfaces of the two cannot fit completely, some of the perfusion fluid will flow out from between the abutment surfaces, resulting in the inability to ensure lubrication of the gap between the drive shaft and the distal bearing, causing the local temperature between the drive shaft and the distal bearing to rise, which may seriously threaten the health of the user.

[0119] Based on the above research findings, the inventors of the present application conducted further exploration and proposed a technical solution that can effectively prevent the leakage of the perfusion fluid and achieve reliable lubrication between the distal bearing and the drive shaft.

[0120] Please refer to Figures 11 to 20. The catheter pump 100 in this embodiment also includes a drive assembly, a catheter, a pump head and a drive shaft. The functions of each component are the same as those of the catheter pump 100 in the embodiment shown in Figure 1. As mentioned above, the catheter pump 100 can be used to assist the heart in pumping blood to reduce the burden on the heart. The pump head 40 can assist the left ventricle in working and pump the blood in the left ventricle into the aorta. Of course, the pump head 40 can also be inserted into other target positions of the subject as desired through interventional surgery. For example, the pump head 1 is inserted into the right ventricle, and the catheter pump 100 is used to assist the right ventricle in working and pump the blood in the vein into the right ventricle. Furthermore, the pump head 40 can also be inserted into the blood vessels or other organs. The catheter pump 100 is also called a heart assist device or a ventricular assist device.

[0121] In the embodiment of the present application, the drive assembly 20 can be a motor, and of course it can also be other power components. This article continues to introduce the technical solution by taking the drive assembly 20 as an example of a motor. The transmission mode of the motor and the drive shaft 30 can adopt a magnetic coupling mode. The motor is connected to the proximal end of the catheter 10 and the drive shaft 30 through a coupler 04 and is configured to provide power as a power component. Of course, the transmission mode of the motor and the drive shaft 30 can also adopt other modes. The distal end of the catheter 10 is connected to the pump head 40. The interior of the catheter 10 is provided with a drive shaft 30, and one end of the drive shaft 30 is connected to the power output end of the motor.

[0122] 11 , the pump head 40 includes a pump housing 4 - 1 having a blood inlet 13 a and a blood outlet 13 b , wherein the pump housing 4 - 1 may include a support 401 and a covering membrane 402 , and the specific structure of the pump housing 4 - 1 may refer to the above description.

[0123] In the embodiment of the present application, the coating 402 further includes an extension segment, which can extend proximally from the fluid channel into the aorta; the extension segment and the fluid channel constitute an extended fluid channel.

[0124] Please refer to Figure 11 again to understand that in the embodiment of the present application, the drive shaft 30 can be rotatably supported at both ends of the pump housing 4-1. Specifically, the drive shaft 30 includes a soft shaft 311 and a hard shaft 312. The proximal end of the soft shaft 311 is fixedly connected to the power output shaft of the drive assembly 20, and the distal end of the soft shaft 311 is fixedly connected to the hard shaft 312. The soft shaft 311 is usually inserted into the interior of the catheter 10 to prevent the drive shaft 30 from contacting the outside world. On the one hand, it ensures the normal operation of the drive shaft 30, and on the other hand, it prevents the drive shaft 30 from directly contacting the subject during operation and causing harm to the subject. The two ends of the hard shaft 312 are rotatably supported at both ends of the pump housing 4-1. The two ends of the pump housing 4-1 are connected to the proximal bearing chamber and the distal bearing chamber 016. The proximal bearing 015 is installed inside the proximal bearing chamber, and the distal bearing 017 is installed inside the distal bearing chamber 016. The hard shaft 312 is supported by the proximal bearing 015 and the distal bearing 017. Both the proximal bearing 015 and the distal bearing 017 are made of hard materials, such as ceramics.

[0125] The distal bearing chamber 016 in the present application is a sleeve having an axially penetrating hollow inner cavity, and the sleeve is fixed at the distal end of the pump casing 4 - 1 .

[0126] The pump head 40 also includes an impeller 403, which is located inside the pump housing 4-1 and fixedly connected to the hard shaft 312 of the drive shaft 30. When the drive shaft 30 rotates, the drive shaft 30 can drive the impeller 403 to rotate together, thereby pumping blood from the blood inlet 13a of the pump housing 4-1 into the interior of the pump housing 4-1 and pumping the blood flowing into the pump housing 4-1 out of the blood outlet. When the membrane also includes an extension section, the blood pumped out of the blood outlet will continue to flow proximally along the extension section. The extended fluid channel formed by the extension section and the flow channel introduces blood into the aorta.

[0127] In this embodiment of the present application, the catheter pump further includes a delivery sheath (not shown), which allows the pump head 40 and impeller 403 to be placed in a collapsed state, allowing the pump head 40 to be inserted into a human blood vessel in this state. When the pump head 40 and impeller 403 are removed from the distal end of the delivery sheath, the pump head 40 and impeller 403 return to the expanded state.

[0128] [Corrected 28.04.2025 according to Rule 91] Please refer to Figure 12 to understand that in the embodiment of the present application, the catheter pump also includes a protective head 50. The following technical solution will be described by taking the protective head 50 as an example of a flexible support member. Flexible support member The flexible support member is installed or fixed to the distal end of the pump housing 4-1. The function of the flexible support member can be described above. The distal end 515 of the flexible support member can be in the shape of an arc, as shown in Figure 12; or the distal end of the flexible support member can also be a coiled flexible protrusion, as shown in Figure 1. Those skilled in the art should understand that the illustrated shape is only exemplary, and the flexible support member can be in any other appropriate shape as long as the above-mentioned purpose can be achieved.

[0129] [Corrected 28.04.2025 in accordance with Rule 91] Referring to Figure 13, in this embodiment of the present application, both the drive shaft 30 and the flexible support member have hollow lumens, which are connected to form a guidewire channel. The hollow lumen 11a of the flexible support member extends axially through the flexible support member. During operation of the catheter pump, the guidewire channel also serves as a perfusion channel for the perfusion fluid.

[0130] Typically, the coupler 04 is provided with an irrigation liquid interface 41, and the irrigation liquid is injected into the catheter 10 through the interface 41. The flexible shaft 311 passing through the catheter 10 is a liquid-permeable woven structure. Therefore, when the irrigation liquid flows forward in the catheter 10, it will enter the hollow structure of the flexible shaft 311 by penetration.

[0131] The perfusate flowing through the catheter 10, after reaching the distal end, flushes and lubricates the proximal bearing 015 on the pump head 40. The perfusate flowing through the flexible shaft 311 continues to flow forward into the rigid shaft 312 and out of the distal end of the rigid shaft 312. Intercepted by the resealable member 19 disposed between the distal end of the rigid shaft 312 and the flexible support member, the perfusate flows back, flushing and lubricating the distal bearing 017.

[0132] It should be noted that the perfusion fluid flowing out of the catheter 10 can also lubricate the drive shaft 30 , especially the flexible shaft 311 .

[0133] Before use, the connector of the motor is separated from the coupler 04. When in use, the guide wire that plays a guiding role is first inserted into the vascular system of the subject. Subsequently, the user (generally a medical staff) holds the distal end of the catheter pump (the distal end of the flexible support member) and inserts the proximal end of the guide wire into the distal end of the guide wire channel until the guide wire passes through the entire flexible support member and the drive shaft 30 and is passed out from the proximal end face of the coupler 04. Subsequently, the catheter 10 is pushed so that the pump head 40 is transported to the desired position (e.g., the left ventricle) along the guide path established by the guide wire in the vascular system of the subject. After the pump head 40 is delivered to the desired position, the guide wire is withdrawn to complete the intervention operation of the pump head 40. The connector of the motor is then connected to the coupler 04, and the motor is activated to work.

[0134] Please understand from Figures 12, 13, and 14 that in order to allow the perfusate flowing out of the distal end of the rigid shaft 312 to flow back and lubricate the distal bearing 017, a resealable member 19 is provided in the guidewire channel. Resealable member 19 is secured to a sleeve secured to the distal end of the pump housing 4-1. The sleeve has an axially extending hollow inner cavity. In this application, the sleeve and the distal bearing chamber are the same component. Of course, in other embodiments, the sleeve and the distal bearing chamber may be separate components. That is, resealable member 19 is secured within the distal bearing chamber 016, located between the distal end of the drive shaft 30 and the proximal end of the flexible support member. Resealable member 19 serves to block the path of the perfusate from continuing forward and out of the distal end of the flexible support member, allowing the perfusate to flow back and flush the distal bearing 017.

[0135] As can be seen from the above description, the catheter pump has a guidewire channel for the guidewire to pass through, so the structure of the resealable component 19 should be able to allow the guidewire to pass through. Several specific structures of the resealable component 19 for the guidewire to pass through will be described in detail later.

[0136] In the embodiment of the present application, the distal bearing 017 is usually made of a hard material, and the resealable member 19 is usually an elastic flexible member, and its material can be silicone, rubber, polyurethane or other biocompatible materials. In the embodiment of the present application, the proximal end of the resealable member 19 can be limited by a limiter in the sleeve (distal bearing chamber 016) to determine the proximal installation position of the resealable member 19 and improve the speed of installation. The limiter can be the distal bearing 017 fixed in the sleeve, and the proximal end face of the resealable member 19 and the distal end face of the distal bearing 017 are axially elastically abutted to seal the gap between the proximal end face of the resealable member 19 and the distal end face of the distal bearing 017. Of course, the limiter can also be a structure such as a step surface or a retaining ring provided in the distal bearing chamber 17.

[0137] In the embodiment of the present application, the proximal end face of the resealable member 19 elastically abuts against the distal end face of the distal bearing 017 axially to seal the gap between the proximal end face of the resealable member 19 and the distal end face of the distal bearing 017 .

[0138] During installation, the resealable member 19 is axially compressed between the flexible support member and the limit member (distal bearing 017). An axial preload can be applied axially between the distal bearing 017 and the resealable member 19, so that the resealable member 19 has a certain amount of elastic deformation in both the axial and circumferential directions. The axial elastic deformation of the resealable member 19 can improve the sealing between the abutting end faces of the distal bearing 017 and the resealable member 19, thereby preventing the perfusion fluid flowing out from the distal end of the drive shaft 30 from overflowing from the abutting surface between the distal bearing 017 and the resealable member 19, allowing the perfusion fluid to completely flow back to flush the distal bearing 017. The circumferential deformation can make the resealable member 19 circumferentially abut the inner wall of the distal bearing chamber 016, and can also improve the circumferential sealing between the resealable member 19 and the distal bearing chamber 016, thereby improving the sealing between the two and thereby improving the working performance of the catheter pump.

[0139] The larger the abutment surface between the distal bearing 017 and the resealable member 19, the better the sealing performance. To maximize the sealing performance between the two, the pump head 40 in the embodiment of the present application further includes a pre-pressed member 018, which is fixed within the distal bearing 017 and can be press-fitted into the inner hole of the distal bearing 017 by interference fit. The material of the pre-pressed member 018 can be the same as that of the distal bearing 017, for example, both can be ceramic. Of course, the material of the pre-pressed member 018 can also be different from that of the distal bearing 017, for example, the pre-pressed member 018 can be made of a material with a slightly lower hardness than that of the distal bearing 017. The distal end face of the pre-pressed member 018 elastically abuts against the proximal end face of the resealable member 19 to seal the gap between the distal end face of the pre-pressed member 018 and the proximal end face of the resealable member 19. In this way, the distal end surface of the distal bearing 017 and the distal end surface of the pre-pressing member 018 can be abutted and sealed with the resealable member 19, the abutting area is relatively large, and the sealing reliability is relatively high.

[0140] In addition, under certain operating conditions, such as when the pump head 40 is transitioning between the folded and unfolded states, or when the pump head is being positioned at a target location, the drive shaft 30 is capable of moving relative to the distal bearing chamber 016. The proximal end surface of the pre-loaded component 018 can serve as a limit structure for the distal movement of the drive shaft 30. When the drive shaft 30 is within the distal bearing chamber 016 and moves toward the pre-loaded component 018, the distal end of the drive shaft 30 can abut against the proximal end surface of the pre-loaded component 018, thereby limiting the distal movement of the drive shaft 30.

[0141] Furthermore, a pre-loaded part 018 is installed inside the distal bearing chamber 016. The hollow inner cavity of the pre-loaded part 018 includes a cylindrical inner cavity located at the proximal end and a conical inner cavity connected to the distal end of the cylindrical inner cavity. The diameter of the conical inner cavity gradually increases from the proximal end to the distal end; the pre-loaded part 018 can be provided with a conical inner cavity on the end face close to the resealable part 19, so that when a guide wire is passed through the distal side of the flexible support part, the conical inner cavity of the pre-loaded part 018 can guide the guide wire to a certain extent, so that the guide wire quickly enters the conical inner cavity, and the cylindrical inner cavity connected to the conical inner cavity can further guide the guide wire so that the guide wire can smoothly enter the inner hole of the drive shaft 30, thereby improving the wire threading efficiency.

[0142] The distal end surface of the distal bearing 017 and the distal end surface of the pre-pressing member 018 may be located on the same axial cross section, that is, the proximal end surface of the resealable member 19 may be a plane, as shown in FIG. 14 .

[0143] In the embodiment of the present application, the distal end surface of the pre-pressing member 018 is axially aligned with the distal end surface of the distal bearing chamber 016. Of course, it is not excluded that the distal end surface of the distal bearing 017 and the distal end surface of the pre-pressing member 018 are axially staggered, and accordingly, the proximal end surface of the resealable member 19 is a stepped surface to abut against the distal end surfaces of the distal bearing 017 and the distal end surface of the pre-pressing member 018, respectively.

[0144] In a preferred embodiment, the hardness of pre-compression member 018 is less than that of distal bearing 017, and greater than that of resealable member 19. The hardness of the material of pre-compression member 018 is between that of distal bearing 017 and resealable member 19. This ensures that the pre-compression member 018 can avoid scratching the guidewire while still meeting the required working strength.

[0145] Of course, the pre-pressed member 018 and the distal bearing 017 can also be hard parts, such as ceramics. The pre-pressed member 018 and the distal bearing 017 can be designed as an integral body, or as separate bodies. The resealable member 19 is an elastic member.

[0146] Before being installed in the distal bearing chamber 016, the diameter of the resealable member 19 can be slightly larger than the inner diameter of the distal bearing chamber 016 at the corresponding position. Due to the flexibility of the resealable member 19, it can be forcibly compressed and installed in the distal bearing chamber 016, thereby forming a contact force with the distal bearing 017 and the pre-compression member 018. Of course, the contact force can be further improved by the following method.

[0147] In the embodiment of the present application, the seal between the proximal end face 191 of the resealable member and the distal end face 171 of the distal bearing, and the seal between the proximal end face 191 of the resealable member and the distal end face of the pre-pressed member 018 can be achieved by applying an axial extrusion force to the distal end face of the resealable member 19. That is, during installation, after the resealable member 19 is placed in the distal bearing chamber 016, an axial extrusion force is applied to the distal end face of the resealable member 19, so that the proximal end face of the resealable member 19 and the distal end face of the distal bearing 017 are sealed against each other, and the proximal end face of the resealable member 19 and the distal end face of the pre-pressed member 018 are sealed against each other.

[0148] In one specific embodiment, a flexible support member can be used to apply an axial compressive force to the distal end surface of the resealable member 19. Specifically, after the pump head 40 is assembled, the resealable member 19 is elastically compressed between the proximal end of the flexible support member and the distal end of the distal bearing 017. This embodiment utilizes the flexible support member to apply an axial compressive force to the resealable member 19, eliminating the need for additional structures within the distal bearing chamber 016. The distal bearing chamber 016 has a simple structure, resulting in a relatively light pump head 40.

[0149] In the embodiment of the present application, an axial compressive force is applied to the distal end surface of the resealable member 19, so that the axial length of the resealable member 19 in the assembled state is shorter than the axial length of the resealable member 19 in the uncompressed state. In this way, under the action of the axial restoring force of the resealable member 19, the resealable member 19 can be sealed against the distal bearing 017.

[0150] For the elastic-flexible part, when an axial extrusion force is applied to the distal end face of the resealable part 19, while it is axially shortened, the diameter of the resealable part 19 tends to increase because the volume of the resealable part 19 remains unchanged, so as to achieve sealing between the outer wall of the resealable part 19 and the inner wall of the distal bearing chamber 016.

[0151] Theoretically, the greater the axial extrusion force, the greater the axial resilience of the resealable element 19. Accordingly, the greater the abutment force between the resealable element 19 and the distal end surface of the distal bearing 017, and the better the sealing performance. Similarly, the circumferential diameter of the resealable element 19 tends to increase, allowing the outer circumferential wall 194 to form a seal with the inner wall of the distal bearing chamber 016. However, this also increases the difficulty of passing the guidewire through the resealable element 19. Therefore, it should be noted that the axial extrusion force applied to the resealable element 19 should not affect the smooth passage of the guidewire.

[0152] In a specific embodiment, the distal bearing chamber 016 is fixed to the distal end of the pump housing 4-1 by a flexible support member. A proximal end of the flexible support member is provided with a convex portion 511, which extends from the distal end of the distal bearing chamber 016 (sleeve) into the interior of the distal bearing chamber 016, and the distal end face of the resealable member 19 elastically abuts against the proximal end face of the convex portion 511 to apply axial extrusion force. The boss 512 is sealed to the inner wall of the distal bearing chamber 016 in the circumferential direction of at least part of the axial section. The flexible support member can be injection molded, and the flexible support member is connected to the distal bearing chamber 016 at the same time as the injection molding. This connection method is simple. Of course, the connection between the flexible support member and the distal bearing chamber 016 is not limited to the above-mentioned injection molding method. For example, in some other embodiments, the flexible support member can be separately molded and then fixedly connected to the distal bearing chamber 016 by bonding, heat shrink tubing, interference fit, etc.

[0153] In this embodiment, the protrusion 511 of the flexible support member is inserted into the interior of the distal bearing chamber 016, and the two are fixedly connected and located inside the distal bearing chamber 016. The distal bearing chamber 016 can be connected to the pump housing 4-1 through the flexible support member. There is no need to set a connecting structure between the distal bearing chamber 016 and the pump housing 4-1. To a certain extent, the length of the distal bearing chamber 016 can be reduced, and the length of the rigid section of the pump head can be further reduced.

[0154] In an embodiment of the present application, the guidewire channel includes at least the hollow inner cavity 11a of the flexible support member, the guidewire hole of the resealable member 19 (not shown in the figure), the hollow inner cavity 18a of the pre-loaded member 018 and the hollow inner cavity 30A of the drive shaft 30. In a feasible embodiment, after the guidewire is removed from the guidewire channel, the guidewire hole on the resealable member 19 can be closed, thereby ensuring the sealing of the resealable member 19, and the perfusion fluid can be completely intercepted, refluxed and flushed the distal bearing 017.

[0155] Of course, after the guidewire is removed, the guidewire hole on the resealable component 19 may not be completely closed, as long as it can cut off the flow and allow the perfusion fluid to flow back.

[0156] [Corrected 28.04.2025 according to Rule 91] Please refer to Figures 15 to 17 again. In the embodiment of the present application, the proximal end of the flexible support member includes an inner cavity 513, and the protrusion 511 is arranged in the inner cavity 513. The proximal end surface of the protrusion 511 protrudes from the proximal end surface of the inner cavity 513. An annular space is formed between the inner wall of the inner cavity 513 and the outer wall of the protrusion 511. The distal end of the distal bearing chamber 016 is fixed in the annular space, and the distal end of the pump head 40 is fixed to the outer surface of the inner cavity. To be precise, the pump housing 4-1 is fixed to the outer surface 110 of the inner cavity.

[0157] In the above embodiment, the flexible support member, distal bearing chamber 016, and pump housing 4-1 are securely connected in a relatively reliable manner. For example, the three can be securely connected during the injection molding process of the flexible support member. The pump head 40 secured by the above structure is also relatively short, which helps meet the requirements of a miniaturized design of the pump head 40.

[0158] [Corrected 28.04.2025 according to Rule 91] Referring to Figures 19 and 18 , in the embodiment of the present application, the distal end of the resealable member 19 further includes a groove 193. During assembly, the protrusion 511 squeezes the groove 193, causing the groove 193 to deform, thereby sealing the gap between the outer wall of the resealable member 19 and the inner wall of the distal bearing chamber (sleeve) 16. Because the protrusion 511 is inserted into the groove 193, it can exert a radially outward force on the inner wall of the groove 193. Thus, when the resealable member 19 is axially compressed, it can also deform radially outward to abut and seal against the inner circumferential wall of the distal bearing chamber 16, thereby improving the sealing performance and reducing the risk of perfusion fluid leakage.

[0159] In one embodiment, the proximal end surface of the protrusion 511 includes a boss 512. When the resealable element 19 is in an uncompressed state, the axial depth of the groove 193 is greater than the axial height of the boss 512. When the resealable element 19 is assembled, the groove 193 is squeezed and deformed until it aligns with the outer surface of the boss 512. In this embodiment, when the resealable element 19 is compressed, the distal shaft section of the resealable element 19 including the groove 193 is more easily deformed under the axial compressive force. Furthermore, the boss 512 is at least partially inserted into the groove 193, exerting a radially outward force on the inner wall of the groove 193. This causes the resealable element 19 to deform radially outward when axially compressed, thereby abutting and sealing against the inner wall of the distal bearing 017, thereby improving sealing performance. Furthermore, the groove at the distal end of the resealable element 19 reduces the travel distance of the guidewire through the resealable element 19, making it easier to insert the guidewire.

[0160] In addition, after the resealable member 19 is compressed, the outer surface of the boss 512 fits against the inner wall of the groove, which can also limit the proximal end of the flexible support member to be installed in place.

[0161] [Corrected 28.04.2025 in accordance with Rule 91] Please refer to Figures 16 to 19 to understand that in this embodiment of the present application, the distal end surface of the resealable member 19 includes an annular surface 192 located around the groove, and the proximal end surface of the protrusion 511 includes an annular surface 514 located around the boss 512. When the resealable member 19 is assembled, the annular surface 192 and the annular surface 514 are in contact, thereby limiting the proximal installation of the flexible support member. Furthermore, when the resealable member 19 is axially compressed, the annular surface 514 and the annular surface 192 contact each other, ensuring a sufficient axial force-bearing area, thereby facilitating the axial shortening of the resealable member 19.

[0162] In the embodiment of the present application, the groove 193 can have various forms, such as a tapered groove, a rectangular groove, a trapezoidal groove or other forms of grooves. The following takes the tapered groove 193 as an example to specifically describe the specific structure of the groove 193 and the boss 512.

[0163] In the embodiment of the present application, the groove 193 can be a tapered groove, with the radial dimension of the tapered groove gradually increasing from the proximal end to the distal end of the resealable member 19. The boss 512 of the flexible support member is a tapered boss, with the radial dimension of the boss gradually increasing from the proximal end to the distal end of the elastic member. When the resealable member 19 is in a non-compressed state, the axial length L2 of the tapered groove is greater than the axial length L4 of the boss, and the taper angle a of the boss is greater than the taper angle b of the tapered groove. In some examples, the taper angle a of the boss is 2 to 3 times the taper angle b of the tapered groove. In this way, the tapered surface of the boss more easily exerts a force that causes deformation in both directions on the tapered surface of the tapered groove.

[0164] In some examples, the diameter of the tapered groove at its small end is preferably 1.1 to 1.3 times the diameter of the tapered platform at its small end. That is, the ratio of the two diameters can be any value between 1.1 and 1.3 (inclusive), such as 1.1, 1.15, 1.2, 1.25, 1.3, etc. In this embodiment, the diameter of the tapered groove at its small end is relatively larger than that of the tapered platform. This provides space for the resealable member 19 to deform radially inward when squeezed.

[0165] In this embodiment, when the resealable member 19 is assembled, the inner circumferential wall of the tapered groove fits against the outer circumferential wall of the tapered platform. The tapered groove is more easily deformed under pressure, and the tapered platform matches the tapered groove. When the tapered groove deforms, the tapered outer surface of the tapered platform more easily exerts a force on the inner wall of the tapered groove, causing the deformation to occur in both directions.

[0166] In this embodiment of the present application, when the resealable member 19 is in an uncompressed state, the axial depth of the groove 193 is greater than the axial height of the boss 512. When the resealable member is in an assembled state, the groove 193 is squeezed and deformed until it conforms to the outer surface of the boss 512. After assembly, the groove 193 is compressed axially and shortened, and also deforms radially to conform to the outer surface of the boss 512 and the inner surface of the sleeve, thereby achieving a seal.

[0167] In the embodiment of the present application, the axial length L3 of the tapered groove when the resealable component 19 is fully assembled is 1 / 3 to 1 / 2 of the axial length L2 of the tapered groove when the resealable component 19 is in a non-compressed state; in this way, the change in the axial length of the resealable component 19 basically occurs in the axial section where the tapered groove is located, and the change in the depth of the tapered groove ensures the compression amount of the resealable component 19, thereby ensuring the sealing performance of the resealable component 19.

[0168] In the embodiment of the present application, the axial shortening (L-L1) of the resealable component 19 from the non-compressed state to the assembled state is 20% to 30% of the axial length L of the resealable component 19 in the non-compressed state; this can not only meet the axial abutment force requirements of the resealable component 19 and the distal bearing 017, as well as the radial deformation of the resealable component 19 and the circumferential sealing requirements of the distal bearing chamber 016, but also avoid excessive extrusion of the resealable component 19, thereby improving the performance of the resealable component 19.

[0169] In an embodiment of the present application, the resealable member 19 is in a non-compressed state, and the axial length of the conical groove is 40% to 55% of the axial length of the resealable member 19, preferably 43% to 52%, and further preferably 45% to 50%, for example, 40%, 42%, 43%, 45%, 48%, 50%, 52% or 55%.

[0170] When the axial length of the tapered groove of the resealable member 19 varies within the above-mentioned numerical range, the sealing requirement can be met while the resealable member 19 can be prevented from being crushed.

[0171] In order to ensure that the perfusion fluid continuously flushes the gap between the drive shaft 30 and the distal bearing 017 , there needs to be sufficient pressure drop between the distal end of the drive shaft 30 and the proximal end of the distal bearing 017 .

[0172] [Corrected 28.04.2025 according to Rule 91] Referring to FIG. 20 , in the embodiment of the present application, along the proximal-to-distal direction, the inner bore 172 of the distal bearing 017 includes a first bore section 1721, a second bore section 1722, and a third bore section 1723 connected in sequence. Please understand in conjunction with FIG. 13 that the drive shaft 30 is supported and engaged with the first bore section 1721. Specifically, the hard shaft 312 of the drive shaft 30 is supported by the first bore section 1721, and the outer diameter of the hard shaft 312 is substantially equal to the inner diameter of the first bore section 1721. The diameter of the second bore section 1722 is greater than the outer diameter of the drive shaft 30, that is, the diameter of the second bore section 1722 is greater than the outer diameter of the hard shaft 312. The diameter of the third hole section 1723 is larger than that of the second hole section 1722. A step surface 1724 is formed between the second and third hole sections 1722, 1723. The proximal end surface of the pre-loaded element 018 abuts against the step surface 1724, thereby axially positioning the pre-loaded element 018. During the forward and backward movement of the drive shaft 30, the distal end of the drive shaft 30 remains within the second hole section 1722. That is, whether the pump head 40 is in the collapsed or expanded state, the distal end of the drive shaft 30 remains within the second hole section 1722 and does not come into contact with the pre-loaded element 018.

[0173] [Corrected 28.04.2025 in accordance with Rule 91] During operation, the perfusate flowing out of the drive shaft 30 flows along the first gap between the inner wall of the second bore section 1722 and the drive shaft 30, then flows into the second gap between the inner wall of the first bore section 1721 and the drive shaft 30, and then flows through the second gap. Referring to Figure 13, the pressure drop P of the perfusate from position E to position F is related to the minimum gap size in the flow path, the mating length, and the flow rate. As shown in the figure, pressure drop P = P2 - P1. The minimum gap in this flow path is at the first bore section 1721. Because the diameter and length of the first bore section 1721 are constant and the preset flow rate is constant, the factor affecting the pressure drop is the mating length between the rigid shaft 312 and the distal bearing 017.

[0174] In the embodiment of the present application, the diameter of the second hole section 1722 is larger than the outer diameter of the drive shaft 30, and the fitting length between the drive shaft 30 and the distal bearing 017 is always equal to the length of the first hole section 1721. This ensures that the perfusion fluid pressure drop remains unchanged and ensures that the refluxed perfusion fluid flows between the hard shaft 312 and the inner surface of the distal bearing 017.

[0175] In the embodiments of the present application, please refer to the prior art for other structures of the catheter pump, which will not be described in detail herein.

[0176] Note that the above are only preferred embodiments of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments, and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments and may include many other equivalent embodiments without departing from the concept of the present invention. The scope of the present invention is determined by the scope of the appended claims.

Claims

1. A support connecting tube assembly for a catheter pump, the catheter pump comprising a drive shaft (30), a catheter (10) and a pump head (40), the distal end of the catheter (10) being connected to the proximal end of the support connecting tube assembly, the distal end of the support connecting tube assembly being connected to the proximal end of the pump head (40), wherein: The support connecting pipe assembly for the catheter pump includes: A support connecting tube (1), wherein a receiving cavity (11) with openings at both ends is provided in the support connecting tube (1), and a first limiting structure is provided on the support connecting tube (1); The proximal end support member (2) of the bracket is sleeved in the accommodating cavity (11), and the proximal end support member (2) of the bracket is used to support the rotation of the drive shaft (30), and the drive shaft (30) is used to drive the impeller (403) in the pump head (40) to rotate. A second limiting structure is provided on the proximal end support member (2) of the bracket, and the first limiting structure can cooperate with the second limiting structure to limit the axial movement and circumferential rotation of the proximal end support member (2) of the bracket.

2. The bracket connecting pipe assembly for a catheter pump according to claim 1, wherein: The first limiting structure includes two clamping members (121) arranged opposite to each other, and the second limiting structure includes two limiting grooves (211) arranged on the outer side surface of the proximal support member (2) of the stent, and the clamping members (121) are clamped with the limiting grooves (211) in a one-to-one correspondence to limit the axial movement and circumferential rotation of the proximal support member (2) of the stent.

3. The bracket connecting pipe assembly for a catheter pump according to claim 1, wherein: The first limiting structure includes a first abutment portion (122), which is arranged on the inner ring surface of the accommodating cavity (11); the second limiting structure includes a second abutment portion (212) which is arranged on the outer side surface of the proximal end support member (2) of the stent; the first abutment portion (122) abuts against the second abutment portion (212) to limit the circumferential rotation of the proximal end support member (2) of the stent and the movement of the proximal end support member (2) of the stent toward the distal end of the stent connecting tube (1).

4. The bracket connecting pipe assembly for a catheter pump according to claim 1, wherein: The outer surface of the bracket connecting tube (1) is provided with a bracket mounting groove (13); the pump head (40) comprises a bracket (401), the proximal end of the bracket (401) is connected to the distal end of the bracket connecting tube (1), and the proximal end of the bracket (401) is a plurality of bracket connecting legs (4011), and the bracket connecting legs (4011) are installed in the bracket mounting groove (13).

5. The bracket connecting pipe assembly for a catheter pump according to claim 4, wherein: The outer surface of the distal end of the bracket connecting tube (1) is provided with a plurality of raised ridges (17) at intervals, and a bracket mounting groove (13) is formed between two adjacent raised ridges (17).

6. The bracket connecting pipe assembly for a catheter pump according to claim 4, wherein: The bracket connecting tube assembly further comprises a fixing sleeve (5), the fixing sleeve (5) being fixedly mounted on the outer side surface of the bracket connecting tube (1), and a clamping cavity being formed between the inner wall of the fixing sleeve (5) and the outer side surface of the bracket connecting tube (1), and the bracket connecting leg (4011) being clamped in the clamping cavity.

7. The bracket connecting pipe assembly for a catheter pump according to claim 6, wherein: The outer side surface of the support connecting tube (1) is provided with a plurality of groups of limiting protrusion assemblies (14) at intervals, the limiting protrusion assemblies (14) comprising two limiting protrusions (141) arranged at intervals along the circumference of the support connecting tube (1), and a coating accommodating cavity (142) is formed between two adjacent groups of the limiting protrusion assemblies (14); The limiting protrusion assembly (14) is capable of limiting the distal end of the fixing sleeve (5); The first limiting structure is provided between the two limiting protrusions (141) of the same limiting protrusion assembly (14).

8. The bracket connecting pipe assembly for a catheter pump according to claim 7, wherein: A "U"-shaped through groove (18) is provided on the side wall of the main body of the bracket connecting tube (1) between the two limiting protrusions (141) of the same limiting protrusion assembly (14); after the "U"-shaped through groove (18) is provided, a first limiting structure is formed on the side wall of the main body of the bracket connecting tube (1).

9. The bracket connecting pipe assembly for a catheter pump according to claim 7, wherein: The distal end of the limiting protrusion (141) is provided with a first inclined surface (1411), and the distal end of the support connecting tube (1) is provided with a first curved surface (15), and the first inclined surface (1411) and the first curved surface (15) are smoothly connected; the distal end surface of the support connecting tube (1) and the distal end surface of the support proximal support member (2) are spliced ​​to form a smooth surface.

10. The bracket connecting pipe assembly for a catheter pump according to any one of claims 1 to 9, wherein: Along the installation direction of the proximal support member (2) of the stent in the accommodating cavity (11), an introduction cavity (111), a transition cavity (112) and an installation cavity (113) are sequentially arranged in the accommodating cavity (11), the inner diameter of the introduction cavity (111) is larger than the inner diameter of the installation cavity (113), the inner diameter of any cross section of the transition cavity (112) is smaller than the inner diameter of the introduction cavity (111) and larger than the inner diameter of the installation cavity (113), and the stent connecting pipe assembly further includes a retaining ring (3), which is installed in the introduction cavity (111) and abuts against the inner wall of the transition cavity (112).

11. The bracket connecting pipe assembly for a catheter pump according to claim 10, wherein: The inner diameter of the transition cavity (112) gradually decreases from the inner diameter of the introduction cavity (111) to the inner diameter of the installation cavity (113).

12. The bracket connecting pipe assembly for a catheter pump according to claim 10, wherein: The catheter (10) is fixedly installed in the accommodating cavity (11), and the retaining ring (3) abuts against the distal end surface of the catheter (10).

13. The bracket connecting pipe assembly for a catheter pump according to claim 12, wherein: The introduction cavity (111), the transition cavity (112) and the installation cavity (113) are coaxially arranged in sequence from the proximal end to the distal end; Alternatively or alternatively, the retaining ring (3) is fixed to the distal end surface of the catheter (10).

14. The bracket connecting pipe assembly for a catheter pump according to claim 10, wherein: The outer side surface of the proximal end support member (2) of the stent is sleeved with a sealing member (4), the proximal end support member (2) of the stent is installed in the installation cavity (113), and the sealing member (4) is sandwiched between the inner side wall of the installation cavity (113) and the outer side surface of the proximal end support member (2) of the stent.

15. The bracket connecting tube assembly for a catheter pump according to claim 14, wherein: The inner diameter of the introduction cavity (111) is not less than the outer diameter of the sealing member (4) in a natural state; and the inner diameter of the installation cavity (113) is less than the outer diameter of the sealing member (4) in a natural state.

16. The bracket connecting tube assembly for a catheter pump according to claim 10, wherein: An opening (16) communicating with the introduction cavity (111) is provided on the side wall of the support connecting tube (1) opposite to the introduction cavity (111); the distal end of the catheter (10) is installed in the introduction cavity (111), and the opening (16) is located on the outer surface of the catheter (10).

17. A catheter pump, wherein include: The bracket connecting pipe assembly for a catheter pump according to any one of claims 1 to 16; a catheter (10), wherein the distal end of the catheter (10) is mounted on the proximal end of the stent connecting tube (1); A pump head (40), wherein the distal end of the support connecting tube (1) is connected to the proximal end of the pump head (40), the pump head (40) comprises a support (401) and an impeller (403), the proximal end of the support (401) is connected to the distal end of the support connecting tube (1), and the impeller (403) is arranged in the support (401); A drive shaft (30), wherein the drive shaft (30) is sleeved in the proximal support member (2) of the stent, and the drive shaft (30) is capable of driving the impeller (403) to rotate.

18. The catheter pump according to claim 17, wherein The catheter pump also includes a drive assembly (20), the proximal end of the catheter (10) is connected to the drive assembly (20), and the drive assembly (20) includes the drive shaft (30); the drive shaft (30) extends in the catheter (10), the bracket (401) is a foldable bracket, and the impeller (403) is a foldable impeller; the middle area of ​​the bracket (401) covered by the membrane (402) forms a fluid channel, the distal area of ​​the bracket (401) not covered by the membrane (402) forms a blood inlet, and the proximal area of ​​the bracket (401) not covered by the membrane (402) forms a blood outlet; the membrane (402) also includes an extension section, and the extension section can extend from the fluid channel to the proximal end into the aorta.

19. The catheter pump according to claim 17, wherein The drive shaft (30) includes a soft drive shaft and a hard shaft, the proximal end of the soft drive shaft is fixedly connected to the output shaft of the drive motor of the drive assembly (20), and the distal end of the soft drive shaft is fixedly connected to the hard shaft, the hard shaft is rotatably supported in the proximal support member (2) of the stent, the impeller (403) is fixedly supported on the hard shaft, and the hard shaft can drive the impeller (403) to rotate; the catheter pump also includes a delivery sheath, which can put the stent (401) and the impeller (403) in a folded state, so that the catheter pump can be inserted into a human blood vessel in this state.

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