CN218305828U - Catheter assembly and ventricular assist device - Google Patents

Abstract

The utility model relates to a catheter subassembly and ventricular assist device. The catheter assembly includes: the guide pipe comprises a guide pipe wall, wherein the guide pipe wall is provided with a mounting groove formed by radially sinking from the outer peripheral surface of the guide pipe and a wire channel communicated with the mounting groove; a pump head assembly disposed at the distal end of the catheter, the pump head assembly including a pump housing having an inlet and an outlet, and an impeller disposed within the pump housing for causing, by rotation, blood to enter the pump housing from the inlet and to exit from the outlet; the driving shaft penetrates through the guide pipe and is used for transmitting power to the impeller; the sensor assembly comprises a sensor main body and a lead part, wherein the sensor main body is at least partially arranged in the mounting groove, and the lead part is connected with the sensor main body and penetrates through the lead channel. According to the utility model discloses a tubing assembly structural design is ingenious reasonable, and sensor assembly's installation is simple reliable, can prevent effectively that the sensor main part from being damaged, and is favorable to avoiding forming the thrombus in the installation department of sensor main part.

Description

Catheter assembly and ventricular assist device

Technical Field

The utility model relates to the field of medical equipment, especially, relate to a catheter subassembly and ventricular assist device.

Background

Heart failure is a health problem with a high mortality rate. In the case of cardiogenic shock, the ejection performance of the left ventricle of a patient is significantly diminished, and the diminished coronary blood supply may lead to irreversible cardiac deterioration. Thus, for this case, temporary interventional support (ventricular assist) will replace the left ventricular pumping function locally or mostly and improve the coronary blood supply.

Existing ventricular assist devices (also known as catheter pumps) are typically provided with sensors on the pump head assembly to detect some blood parameter (e.g., a pressure sensor is provided to detect blood pressure). Currently, in order to make the detection surface of the sensor sufficiently contact with blood to directly measure the corresponding parameter, it is generally necessary to provide the sensor on the outer surface of the corresponding component in the pump head assembly, which makes the sensor easily damaged and easily forms thrombus at the position where the sensor is provided. In addition, for some ventricular assist devices with collapsible pump head assemblies, the sensor disposed in the pump head assembly may adversely affect the collapsed outer diameter of the pump head assembly, so that the pump head assembly cannot obtain the desired outer diameter after being collapsed.

SUMMERY OF THE UTILITY MODEL

Based on the above-mentioned defect among the prior art, the utility model aims to provide a catheter subassembly, it can make the sensor of installing on the catheter subassembly be difficult for being destroyed, reduces the sensor and causes the possibility of thrombosis to reduce the sensor and fold up the adverse effect of the external diameter size of back to the pump head subassembly that can fold up.

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

The utility model provides a catheter assembly, catheter assembly includes:

a guide tube including a guide tube wall provided with a mounting groove formed by being depressed in a radial direction from an outer circumferential surface of the guide tube and a wire passage communicating with the mounting groove;

a pump head assembly disposed at a distal end of the catheter, the pump head assembly including a pump housing having an inlet and an outlet, and an impeller disposed within the pump housing for causing blood to enter the pump housing from the inlet and exit from the outlet by rotation;

a drive shaft inserted into the duct for transmitting power to the impeller;

the sensor assembly comprises a sensor main body and a lead part, wherein the sensor main body is at least partially arranged in the mounting groove, and the lead part is connected with the sensor main body and penetrates through the lead channel.

In at least one embodiment, the sensor body includes:

a mounting seat formed with a mounting recess;

and the induction body part is arranged in the mounting concave part and is not arranged to protrude from the top surface of the mounting seat.

In at least one embodiment, the top surface of the mount is disposed so as not to protrude from the outer circumferential surface of the pipe in the radial direction of the pipe.

In at least one embodiment, a proximal end side of the mounting recess is provided with an opening through which the wire portion passes.

In at least one embodiment, a wire protection tube is further included, the wire protection tube being connected to the wire channel and extending at least partially into the mounting groove.

In at least one embodiment, the sensor body is provided so as not to protrude from the outer peripheral surface of the catheter.

In at least one embodiment, the sensor assembly has a plurality of the sensor bodies disposed at intervals in a circumferential direction of the catheter.

In at least one embodiment, a hermetic protective coating is at least partially formed on the sensor body.

In at least one embodiment, the sealing and protective coating comprises a silicone grease coating and a parylene coating, the parylene coating being disposed on an outer side of the silicone grease coating.

The utility model also provides a ventricular assist device, ventricular assist device includes:

the catheter assembly of any of the embodiments above;

and the power source is in transmission connection with the driving shaft to provide power.

Beneficial effects of the utility model

According to the utility model discloses a conduit subassembly forms wire passageway and mounting groove in the pipe with installation sensor assembly, through setting up the wire passageway, can reduce the wire when protecting to the wire and arrange the influence to conduit subassembly overall structure, through setting up the mounting groove, can let the response face and the blood of sensor main part fully contact when fixing the sensor main part steadily, can also prevent effectively in addition that the sensor main part from being damaged, and be favorable to avoiding forming the thrombus in the installation department of sensor main part. Structural design is ingenious reasonable on the whole, has utilized the current structure in the pipe subassembly effectively, does not occupy extra workspace for sensor assembly's installation is simple reliable. Further, for the pump head assembly capable of being folded, when the sensor main body is arranged inside the pump head assembly, the sensor main body is completely arranged in the installation groove of the guide pipe, and the adverse effect of the sensor main body on the size of the outer diameter of the folded pump head assembly can be reduced.

Drawings

Fig. 1 shows a schematic structural view of a ventricular assist device according to the present invention.

Fig. 2 shows a schematic structural view of a catheter assembly according to the present invention (sensor assembly not shown).

Fig. 3 showsbase:Sub>A cross-sectional viewbase:Sub>A-base:Sub>A of fig. 2.

Fig. 4 shows a schematic view of a portion of a catheter assembly provided with a sensor assembly according to the present invention.

Fig. 5 shows a cross-sectional view B-B of fig. 4 (only a partial structure is shown).

Fig. 6 shows a schematic structural view of a sensor assembly according to the present invention.

Fig. 7 shows a schematic structural view of a mounting seat according to the present invention.

Description of the reference numerals

1, a catheter; 11 a duct wall; 111 mounting grooves; 112 a wire channel; 12 a catheter lumen;

2 driving the shaft;

3 a pump head assembly; 31 a pump housing; 311 an inlet; 312 an outlet; 313, a bracket; 314, coating a film; 32 impellers;

4 a sensor body; 41 a mounting seat; 411 mounting recess; 412 an opening; a 42 sensing body portion;

5 a wire guide part; 6, protecting the wire; 7 power source.

Detailed Description

In order to make the technical solution and the advantages of the present invention more obvious and understandable, the following description is made in detail by way of exemplifying specific embodiments. Wherein the figures are not necessarily to scale, and certain features may be exaggerated or minimized to show details of the features more clearly; unless defined otherwise, technical and scientific terms used herein have the same meaning as technical and scientific terms used in the technical field to which this application belongs.

In the description of the present invention, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "height", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise" and the like indicate the orientation or positional relationship based on that shown in the drawings, and are only for convenience of simplifying the description of the present invention, and do not indicate that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, i.e., should not be construed as limiting the present invention.

In the present application, the terms "first", "second" are used for descriptive purposes only and are not to be construed as indicating the relative importance of the indicated features or the number of the indicated technical features. Thus, a feature defined as "first" or "second" may expressly include at least one such feature. In the description of the present invention, "a plurality" means at least two; "several" means at least one; unless explicitly defined otherwise.

In the present application, the terms "mounted," "connected," "secured," "disposed," and the like are to be construed broadly unless otherwise specifically limited. For example, "connected" may be a fixed connection, a removable connection, or an integral molding; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the interconnection of two elements or through the interaction of two elements. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.

In the present disclosure, unless expressly defined otherwise, a first feature is "on," "above," "over," and "above," "below," "under," "beneath," or "below" a second feature, and the first and second features are in direct contact, or in indirect contact via intermediate media. Also, a first feature "on," "above," and "over" a second feature may be that the first feature is directly on or obliquely above the second feature, or simply means that the first feature has a higher level than the second feature. A first feature "under," "below," and "beneath" a second feature may be directly or obliquely under the first feature or may simply mean that the first feature is at a level less than the second feature.

An embodiment of a ventricular assist device and catheter assembly incorporating the same according to the present invention is described in detail below with reference to fig. 1-7.

In the present embodiment, as shown in fig. 1 to 7, there is provided a ventricular assist device including a catheter assembly, a power source 7, and a control host (not shown). Wherein the power source 7 may be a motor for powering the drive shaft 2. The control host comprises a data processing unit which is in communication connection with the sensor assembly through a wire part 5. The control host is also electrically connected with the motor and used for controlling the starting, the stopping and the rotating speed of the motor.

The catheter assembly of the present invention comprises a catheter 1, a drive shaft 2, a pump head assembly 3 and a sensor assembly. Wherein the drive shaft 2 is inserted in the catheter 1, the pump head assembly 3 is arranged at the distal end of the catheter 1, and the sensor assembly is arranged on the catheter 1 for detecting blood parameters at the catheter, which parameters may specifically include blood pressure, blood flow or other blood chemical performance parameters (e.g. glucose content, bilirubin values, hemoglobin values, etc.). It is further described that the sensor assembly may directly detect the blood parameter, or may calculate and analyze other parameters such as the rotation speed of the motor according to the detection result to finally obtain the target parameter.

As shown in fig. 1 to 5, the catheter 1 comprises a catheter wall 11, the catheter wall 11 forming a catheter lumen 12, and the drive shaft 2 is inserted in the catheter lumen 12 for transmitting power to the pump head assembly 3.

The pump head assembly 3 comprises a pump housing 31 and an impeller 32. The pump casing 31 is formed with an inlet 311 and an outlet 312, the impeller 32 is disposed inside the pump casing 31, the power source 7 provides power to the driving shaft 2, the driving shaft 2 transmits the power to the impeller 32, so that the impeller 32 rotates at a preset speed, and the rotation of the impeller causes blood to enter the pump casing 31 from the inlet 311 and to be discharged from the outlet 312, so as to pump the blood.

Further, the pump housing 31 includes a holder 313 made of nickel or titanium alloy in a metal lattice, and a coating 314 covering the holder 313. The metal lattice of the stent 313 has a mesh design, with the cover 314 covering the part of the stent 313, the mesh of the distal part of the stent 313 not covered by the cover 314 forming the above-mentioned inlet 311, the proximal end of the cover 314 covering the outside of the distal end of the catheter 1, and the proximal end of the cover 314 forming the above-mentioned outlet 312. The impeller 32 may comprise a hub connected to the distal end of the drive shaft 2 and blades supported on the outer wall of the hub, the blades being helical in this embodiment, and the number of the blades may be one, two, three or more, although the blades may be other shapes as known in the art.

In this embodiment, the pump head assembly 3 may be collapsible. In the art, the size and hydrodynamic performance of the pump head assembly 3 are two conflicting parameters. In short, the pump head assembly 3 is desirably small in size from the viewpoint of alleviating pain of the subject and ease of intervention. Whereas a large flow rate of the pump head assembly 3 is desirable for providing a strong auxiliary function to the subject, a large flow rate generally requires a large size of the pump head assembly 3.

By making the pump head assembly 3 collapsible, the pump head assembly 3 can have a smaller collapsed size and a larger expanded size, thereby meeting the requirements of alleviating pain of the subject during the intervention/transportation process, facilitating the intervention, and providing a large flow rate.

In particular, the pump head assembly 3 may have a compressed state and an expanded state. The pump head assembly 3 is in a compressed state to form an access configuration in which the pump housing 31 and impeller 32 are in a compressed state, and the pump head assembly 3 can be accessed into the vasculature of a human or delivered within the vasculature of a subject in a first, smaller outer diameter dimension. The pump head assembly 3 is in an expanded configuration, in which the pump housing 31 and impeller 32 are in an expanded configuration, and the pump head assembly 3 is capable of pumping blood within the heart chamber with a second radial dimension that is greater than the first radial dimension. It should be added that the present invention is not limited to the pump housing 31 and the impeller 32 being foldable, and the pump housing 31 may be only foldable to a certain extent (i.e. the support 313 may be foldable), and the impeller 32 may not be foldable, so that the pump head assembly 3 may have a smaller foldable size and a larger unfolded size, which may satisfy the requirements of easy intervention and providing a large flow rate to a certain extent. Of course, the present invention is not limited thereto, and the pump head assembly 3 may be non-collapsible.

In the present embodiment, the sensor assembly is provided on the catheter wall 11 of the catheter 1, specifically, as shown in fig. 5, the catheter wall 11 includes a mounting groove 111, the mounting groove 111 is formed by being recessed in the radial direction from the outer peripheral surface of the catheter 1, and the mounting groove 111 is provided without communicating with the catheter lumen 12 described above.

The sensor assembly includes a sensor body 4, and the sensor body 4 is disposed in the mounting groove 111 without protruding from the outer circumferential surface of the catheter 1. In this way, it is advantageous to prevent the sensor body from being damaged, while it is advantageous to avoid thrombus formation at the installation site of the sensor body. Wherein the sensor body 4 can be arranged in the mounting groove 111 adhesively with the duct wall 11 by means of glue.

In the present embodiment, as shown in fig. 5 to 6, the sensor main body 4 includes a mount 41 and a sensing body portion 42. Wherein, the mounting seat 41 is disposed in the mounting groove 111 and disposed without protruding from the outer circumferential surface of the catheter 1, the mounting seat 41 is formed with a mounting concave portion 411, and the sensing body portion 42 is disposed in the mounting concave portion 411 and disposed without protruding from the top surface of the mounting concave portion 411. Thus, the damage of the induction body part is more favorably avoided.

As shown in fig. 5 to 6, the sensor assembly further includes a wire portion 5, the conduit wall 11 includes a wire passage 112 communicating with the mounting groove 111, one end of the wire portion 5 is connected to the sensor body 4, and the other end of the wire portion 5 passes through the wire passage 112 to be connected to the data processing unit. The wire portion 5 has two data transmission lines, a power line and a ground line, one end of each of the two data transmission lines and the power line is connected to the sensing body portion 42, the other end extends to the proximal end of the catheter assembly, and the ground line is disposed inside the sensing body portion 42. Further, an opening 412 is provided on the proximal end side of the fitting recess 411, and the wire guide portion 5 passes through the opening 412 and enters the wire guide passage 112. Thus, the bending of the lead portion 5 during the layout can be reduced, which is advantageous for improving the service life and reliability of the lead portion.

In this embodiment, the control host further includes a display interface, the display interface may display various blood parameters detected by the sensor body, the display mode may be in a graphic or digital form, and the display interface may also be used to display other operating parameters of the ventricular assist device, such as a real-time rotation speed of the motor. When the blood parameter or the operating parameter of the ventricular assist device detected by the sensor main body exceeds the threshold value or is abnormal, the control host machine can further send out a prompt, for example, a voice prompt can be sent out, a prompt can also be sent out through the change of a light signal (for example, the light changes on or off or the color changes), and further, when the abnormality occurs, the control host machine can automatically control the rotating speed of the motor or directly close the motor.

In the present invention, the wire passage 112 is not limited to be provided completely inside the conduit wall 11 as shown in fig. 5, and may be configured as a wire groove formed by recessing radially from the outer peripheral surface of the conduit wall 11. It is further noted that the cross-section of the wire passage 112 may be circular, polygonal or other shapes, and the cross-section of the wire groove may be curved, U-shaped or other shapes.

In the present embodiment, it is preferable that a wire protection tube 6 is disposed in the wire passage 112 for further protecting the wire part 5, and one end of the wire protection tube 6 extends into the mounting groove 111. It should be added that the wire protection tube 6 may not be disposed in the wire passage 112, and may be configured to extend from the side wall of the mounting groove 111 in the axial direction of the catheter 1, and the length of the wire protection tube 6 may be set such that the wire protection tube 6 just covers the portion of the wire part 5 exposed outside the wire passage 112 when the sensor body 4 is in the mounting position.

In the present embodiment, the sensor unit may include a plurality of sensor bodies 4 and corresponding lead portions 5, and the plurality of sensor bodies 4 may be provided at intervals in the circumferential direction of the catheter 1 in order to avoid wire collision of the lead portions 5 corresponding to different sensor bodies 4. Wherein, the angle of spacing between two adjacent sensor bodies 4 in the circumferential direction of the catheter 1 may be set to be at least larger than a preset spacing angle, preferably, the preset spacing angle may be 30 degrees, that is, the angle of spacing between two adjacent sensor bodies 4 in the circumferential direction of the catheter 1 is at least larger than 30 degrees, preferably, two adjacent sensor bodies 4 are set at an interval of 180 degrees, 135 degrees, 90 degrees, 45 degrees or other angles in the circumferential direction of the catheter 1.

The utility model discloses in, form wire passageway and mounting groove in order to install the sensor unit in the pipe wall, through setting up the wire passageway, can reduce the wire when protecting to the wire and arrange the influence to pipe subassembly overall structure, through setting up the mounting groove, can let the response face and the blood of sensor unit fully contact when fixing the sensor unit steadily, can also prevent effectively in addition that the sensor unit from being damaged, and be favorable to avoiding forming the thrombus in the installation department of sensor unit. Structural design is ingenious reasonable on the whole, has utilized the current structure in the pipe subassembly effectively, does not occupy extra workspace for sensor assembly's installation is simple reliable. Further, for the pump head assembly that can fold, when setting up the sensor main part in pump head assembly inside, the sensor main part is installed in the mounting groove of pipe wall completely, can also reduce the sensor main part to the outside diameter size after the pump head assembly folds up the harmful effects that produces.

In this embodiment, sensor body 4 can set up sealed protective coating, and sealed protective coating can not influence sensor body to the measuring of blood parameter, is favorable to preventing that sensor body long-time direct contact blood from taking place to become invalid simultaneously. Wherein the sealing protection coating can be one of a silicone grease coating and a parylene (parylene) coating. When the silicone coating is provided alone, water in blood may diffuse into the silicone coating and cause it to expand to generate tension, which may cause a detection error of the sensor body, and thus, preferably, the sealing protective coating may include a two-layer structure of the silicone coating and a parylene (parylene) coating, and the parylene coating is provided on the outer side of the silicone coating. Through further coating parylene coating outside the silicone grease coating, can effectively avoid sensor main part to detect the mistake, can guarantee the leakproofness of sensor body better.

In the present embodiment, preferably, the coating application and installation of the sensor body 4 is achieved by the following sequence: the sensor body 4 is formed by installing the sensing body part 42 in the installation seat 41, then the sealing protective coating is coated on the sensor body 4, namely the silicone grease coating and the parylene coating are sequentially coated, and after the coating is finished, the sensor body 4 is adhered in the installation groove 111 in an adhesive mode. In other embodiments, the sensor body 4 may be adhered to the mounting groove 111 by gluing after the silicone grease coating is applied, and then the parylene coating may be applied; it is further preferred that the seal protection coating applied on the sensor body 4 is arranged to remain flat with the outer peripheral surface of the catheter wall 11 when the sensor body 4 completes the coating step and is installed in the installation groove 111, to further reduce the probability of thrombus formation. The lead portion 5 is preferably inserted into the lead passage 112 before the sensor body 4 is mounted in the mounting groove 111.

In the present embodiment, the sensor body 4 may be a pressure sensor for detecting blood pressure, but may be another type of sensor.

In this embodiment, the ventricular assist device can be used for left ventricular assist as well as right ventricular assist.

Through adopting above-mentioned technical scheme, according to the utility model discloses a catheter subassembly has following advantage at least:

(1) The utility model discloses an among the duct assembly, form wire passageway and mounting groove in the pipe wall with the installation sensor subassembly, through setting up the wire passageway, can reduce the wire when protecting the wire and arrange the influence to duct assembly overall structure, through setting up the mounting groove, can let the response face and the blood of sensor main part fully contact when fixing the sensor main part steadily, can also prevent effectively in addition that the sensor main part from being damaged, and be favorable to avoiding forming the thrombus in the installation department of sensor main part. Structural design is ingenious reasonable on the whole, has utilized the current structure in the pipe subassembly effectively, does not occupy extra workspace for sensor assembly's installation is simple reliable. Further, for the pump head assembly that can fold, when setting up the sensor main part in pump head assembly inside, the sensor main part is installed in the mounting groove of pipe wall completely, can also reduce the sensor main part and produce harmful effects to the external diameter size after the pump head assembly folds up.

(2) The utility model discloses an among the duct assembly, the top surface of the installation seat is not outstanding to the response somatic part of sensor main part, and the top surface of installation seat does not stick out in the outer peripheral face of pipe, more is favorable to preventing that the sensor main part from being damaged, avoids forming the thrombus in the installation department of sensor main part to the at utmost.

(3) In the catheter component of the utility model, the sealing protective coating is arranged on the sensor main body, which can not affect the detection of the sensor main body on blood parameters and is beneficial to preventing the sensor main body from losing efficacy due to long-time direct contact with blood; and sealed protective coating includes that the silicone congeals fat coating and two-layer structure of parylene coating, and the parylene coating sets up in the outside of silicone congeals fat coating, can effectively avoid sensor main part to detect the mistake, can guarantee the leakproofness of sensor main part better.

It will be appreciated that ventricular assist devices incorporating the catheter assemblies described above also have the same benefits.

It should be understood that the above embodiments are exemplary and are not intended to encompass all possible embodiments encompassed by the claims. Various modifications and changes may be made on the basis of the above embodiments without departing from the scope of the present invention. Likewise, various features of the above embodiments may be combined in any combination to form additional embodiments of the invention that may not be explicitly described. Therefore, the above embodiments only represent some embodiments of the present invention, and do not limit the scope of the present invention.

Claims (10)

1. A catheter assembly, characterized in that the catheter assembly comprises:

a guide tube including a guide tube wall provided with a mounting groove formed by being depressed in a radial direction from an outer circumferential surface of the guide tube and a wire passage communicating with the mounting groove;

a pump head assembly disposed at a distal end of the catheter, the pump head assembly including a pump housing having an inlet and an outlet, and an impeller disposed within the pump housing for causing blood to enter the pump housing from the inlet and exit from the outlet by rotation;

a driving shaft inserted into the duct for transmitting power to the impeller;

the sensor assembly comprises a sensor main body and a lead part, wherein the sensor main body is at least partially arranged in the mounting groove, and the lead part is connected with the sensor main body and penetrates through the lead channel.

2. The catheter assembly of claim 1, wherein the sensor body comprises:

a mounting seat formed with a mounting recess;

and the induction body part is arranged in the mounting concave part and is not arranged to protrude out of the top surface of the mounting seat.

3. The catheter assembly of claim 2, wherein a top surface of the mount is provided so as not to protrude from an outer peripheral surface of the catheter in a radial direction of the catheter.

4. The catheter assembly of claim 2, wherein a proximal end side of the mounting recess is provided with an opening through which the wire portion passes.

5. The catheter assembly of claim 1, further comprising a wire protection tube connected with the wire channel and extending at least partially into the mounting groove.

6. The catheter assembly of claim 1, wherein the sensor body is disposed without protruding from an outer peripheral surface of the catheter.

7. The catheter assembly of claim 1, wherein the sensor assembly has a plurality of the sensor bodies, the plurality of the sensor bodies being disposed at intervals in a circumferential direction of the catheter.

8. The catheter assembly of claim 1, wherein the sensor body has a seal protection coating formed at least partially thereon.

9. The catheter assembly of claim 8, wherein the seal protection coating comprises a silicone grease coating and a parylene coating disposed on an outer side of the silicone grease coating.

10. A ventricular assist device, comprising:

the catheter assembly of any one of claims 1-9;

and the power source is in transmission connection with the driving shaft to provide power.

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