Blood pumping device and blood pumping shell
By designing the arrangement of the accommodating space and flushing holes in the blood pumping device, the problem of insufficient arrangement of the central central pump sensor in the prior art is solved, a safer and more friendly intervention effect is achieved, and the risk of thrombosis is reduced.
Patent Information
- Application Number
- CN202420923542.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-30
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2034-04-30
AI Technical Summary
There are shortcomings in the arrangement of medical fiber pressure sensors for existing cardiac pumps, which affects the interventional effect and may lead to the formation of blood static zones and thrombosis.
A blood pumping device is designed, which includes a blood pumping housing and a sensor, the detector of the sensor is arranged in the receiving space and opens toward the space, the receiving space restricts the disengagement of the sensor by structural design or glue connection, and a flushing hole is provided in the housing passage to reduce the formation of a blood static zone.
This design not only provides physical protection to the sensor, reduces damage to blood vessels during intervention, but also reduces the formation of blood static zones through flushing holes and reduces the risk of thrombosis.
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Figure CN222605225U_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the field of medical devices, and in particular to a blood pumping device and a blood pumping housing. Background Art
[0002] During the insertion of the heart pump assembly through the blood vessels, the complex vascular environment (including tortuosity or calcification) may hinder the intervention of the heart pump or even damage the components of the heart pump. In particular, heart pumps are often used in surgeries that affect the patient's life, so it is important that the heart pump assembly can be accurately operated and delivered. To this end, it is important to accurately determine whether the heart pump is in the correct position during use. For example, by introducing a medical fiber optic pressure sensor, the blood pressure (for example, aortic pressure) in the operating environment of the heart pump is detected, and the blood pressure is used to assist in determining the position of the heart pump. However, there are deficiencies in the existing arrangement of medical fiber optic pressure sensors for heart pumps, which affect the intervention, and some even produce new blood stasis areas, which in turn lead to the formation of thrombi.
[0003] In some prior art, the blood pump assembly may include a shield that covers at least a portion of the sensor membrane to protect the sensor from damage when the blood pump assembly is inserted through an introducer and navigated through the patient's vascular system and / or when the blood pump assembly is inserted into the heart during surgery. One or more protective layers may be deposited on the sensor membrane to prevent the sensor membrane from being dissolved by interaction with the patient's blood. However, although the protective structure therein has an active protection mechanism and a passive protection mechanism that can protect the sensor from physical damage, the structure is complex and has poor assembly properties.
[0004] In addition, in some prior arts, a special external protective cover is provided to protect the sensitive elements of the sensor. However, when the catheter pump is inserted into the human body, although the structure of the protective cover can protect the sensor from physical damage, there is a risk of damaging the blood vessels.
[0005] In addition, in some existing technologies, the blood pump assembly arranges the sensor at the proximal end of the outflow window. There is an area with slow blood flow rate. The blood flowing out of the window cannot completely wash the sensor surface, so blood clots are easily formed. In addition, the sensor is arranged at the proximal end of the outflow window, which leads to inaccurate judgment of the catheter position.
[0006] Therefore, the prior art still needs to be improved and enhanced. Summary of the invention
[0007] In order to solve one or more of the above problems, the present application provides a blood pumping device. The blood pumping device can not only protect the sensor detection part from physical damage, but also intervene in the patient's body in a more friendly way. In addition, the one-piece molding processing method provided by the present disclosure can effectively utilize the variable diameter section structure of the blood pumping shell of the blood pumping device, and conveniently process a flushing hole at the bottom of the shell channel.
[0008] The above-mentioned purpose of the present application is achieved through the following technical solutions. In the first aspect of the present application, a blood pumping device is proposed, which includes a blood pumping shell and a sensor. The side wall of the blood pumping shell is provided with a accommodating space; the accommodating space is provided with a space opening, and the space opening is connected to the outer wall surface of the blood pumping shell. The detection part of the sensor is arranged in the accommodating space, and the detection part of the sensor is arranged to face the space opening.
[0009] Further, in some embodiments, the sensor is connected to the blood pump housing by glue, and a gap is provided between the detection portion of the sensor and the inner wall surface of the accommodating space; and / or
[0010] The accommodating space is provided with a flushing hole, and the flushing hole communicates with the inner wall surface of the blood pumping housing and the space opening.
[0011] Further, in some embodiments, the blood pump housing includes a distal housing section, a support leg housing section, and a blood pump housing section which are sequentially arranged from the distal end to the proximal end; the accommodating space is configured as a housing channel, and the space opening is configured as a channel distal opening; the housing channel is composed of a channel distal section and a channel blood pump housing section which are interconnected, the channel distal section includes a channel support leg section, the channel support leg section is arranged in the support leg housing section, and the channel blood pump housing section is arranged in the blood pump housing section; the channel distal section is provided with the channel distal opening.
[0012] Further, in some embodiments, the above-mentioned shell channel includes a proximal opening of the channel, and the above-mentioned proximal opening of the channel is arranged in the above-mentioned blood pump shell section, so that the above-mentioned sensor can enter the above-mentioned shell channel from the above-mentioned proximal opening of the channel, and the detection part of the above-mentioned sensor can be directed toward the above-mentioned distal opening of the channel; and / or the above-mentioned distal opening of the channel is constructed as a narrow opening, which limits the above-mentioned sensor from passing through the above-mentioned distal opening of the channel.
[0013] Further, in some embodiments, the shell channel is constructed as a groove structure, wherein the groove mouth is formed by the distal opening of the channel, and the groove wall is formed by the shell channel wall; the groove extends from the distal end of the distal segment of the channel to the proximal end of the distal segment of the channel.
[0014] Further, in some embodiments, the channel distal section also includes a channel distal shell section, which is arranged on the distal shell section, and the channel distal shell section is connected with the channel support leg section, and the channel distal shell section is provided with the channel distal opening; the blood pump housing also includes a heat shrink tube section, which is sleeved on the outer surface of the distal shell section, and the heat shrink tube section is arranged between the detection part of the sensor and the proximal end of the distal shell section.
[0015] Further, in some embodiments, the groove mouth is configured so that the detected liquid can enter the groove through the groove mouth and contact the end face of the detection part of the sensor arranged in the shell channel; and the groove mouth can limit the sensor from detaching from the blood pump shell.
[0016] Furthermore, in some embodiments, a flushing hole is provided at a distal end section of the shell channel, and the flushing hole passes through the shell channel and the inner wall surface of the blood pump shell; the flushing hole is at least partially directed toward an end face of a detection part of a sensor arranged in the shell channel, or the flushing hole is close to an end face of a detection part of a sensor arranged in the shell channel.
[0017] Furthermore, in some embodiments, the distal end section of the channel is composed of the channel support leg section, the support leg shell section is provided with a diameter-reducing section near the distal end shell section, and the flushing hole is provided in the diameter-reducing section.
[0018] In a second aspect of the present disclosure, a blood pumping housing is proposed, wherein a side wall of the blood pumping housing is provided with a accommodating space; the accommodating space is provided with a space opening, the space opening is connected to the outer wall surface of the blood pumping housing, the accommodating space is used to accommodate the detection part of the sensor, and the detection part of the sensor is arranged to face the space opening.
[0019] Therefore, various embodiments of the present disclosure provide the following beneficial effects:
[0020] (1) In some embodiments, the outer wall of the blood pump housing is provided with a storage space, which can accommodate the sensor, thereby preventing the exposed sensor from scratching the inner wall of the blood vessel during intervention; the storage space is provided with a space opening on the side of the outer surface of the blood pump housing, so that the detection part of the sensor is arranged inside the storage space, and the detection part of the sensor is arranged to be close to or facing the space opening, so that the sensor can be arranged implicitly to increase physical protection, and the detection data can be obtained from the opening. Furthermore, in some preferred embodiments, a gap is provided between the end face of the detection part of the sensor arranged in the housing channel and the groove wall (or the inner surface of the storage space or the inner surface of the housing channel) to accommodate the detected blood, so as to realize the sensor's blood detection data collection, and the gap between other parts of the sensor and the inner wall of the housing channel is filled with glue.
[0021] (2) In some embodiments, a shell channel is provided on the blood pump shell, and the shell channel is constructed inside the outer wall of the blood pump shell, and the shell channel is composed of a distal channel segment and a channel blood pump shell segment that are interconnected, so that the sensor can be hidden inside the shell channel, and a large area of the sensor is directly exposed to the outer surface environment of the blood pump shell to minimize physical damage (especially the detection part of the sensor, such as the head, which is particularly susceptible to damage); and the buried arrangement of the sensor can also avoid the protrusion of the sensor and its transmission line, which may cause damage to the inner wall of the blood vessel, for example, the blood vessel wall or other biological tissues are scratched by the protruding structure.
[0022] (3) Further, in some embodiments, the distal section of the channel further includes a distal housing section disposed in the blood pump housing, and the distal housing section of the channel is disposed at the distal end of the channel leg section and is connected to the channel leg section; on this basis, the blood pump housing further includes a heat shrinkable tube section, and the heat shrinkable tube section is sleeved on the outer surface of the distal housing section close to the leg housing section, that is, the heat shrinkable tube section is sleeved on the outer surface of the blood pump housing, and the heat shrinkable tube section sleeves the outer shell of the section through which the housing channel passes, that is, the heat shrinkable tube section is sleeved on the surface of the blood pump housing at the distal end of the housing channel, especially between the detection part of the sensor and the proximal end of the distal housing section, so that the blood pump housing is shrunk from the outer periphery to the axial direction thereof by heat shrinkage, and then the distal end of the sensor that may be exposed outside the blood pump housing is compressed and shrunk. Further, in some embodiments, the compression and shrinkage of the sensor by the heat shrinkable tube section can also partially strengthen the limiting effect of the housing channel on the sensor along the axial direction of the blood pump housing.
[0023] (4) In addition, in some other embodiments, the shell channel includes two openings, namely a proximal opening of the channel and a distal opening of the channel. The proximal opening of the channel is disposed at a blood pump shell section at a proximal end of the blood pump shell, so that a sensor arranged in the shell channel can enter the shell channel from the proximal opening of the channel and a detection portion of the sensor arranged in the shell channel can approach the distal opening of the channel.
[0024] (5) Furthermore, in some embodiments, the distal opening of the channel is constructed as a narrow opening. Such a narrow opening can enable the detection portion of the sensor arranged in the shell channel to abut against the distal opening of the channel in the shell channel, while also ensuring that the distal opening of the channel can prevent the sensor arranged in the shell channel from directly passing through the distal opening of the channel.
[0025] (6) Further, in some embodiments, the distal opening of the channel, the side wall of the shell channel and the bottom of the shell channel can together form a groove structure, whereby the groove mouth is formed by the distal opening of the channel, the groove wall is formed by the side wall of the shell channel, and the groove bottom is formed by the bottom of the shell channel. Furthermore, the groove extends from the distal end of the distal section of the channel to the proximal end of the distal section of the channel, thereby protecting the sensor end face from physical damage, while protecting the blood vessel wall or other biological tissue from being scratched by the protruding structure, and not increasing the maximum outer diameter of the non-bending length of the blood pump housing or the blood pump device (for example, a section of the blood pump housing or the blood pump device is regarded as a cylinder, for example, the blood pump section belongs to the non-bending length, and its maximum outer diameter is the maximum diameter of the cross-sectional circular surface of the cylinder). Alternatively, the opening spacing (opening size or opening width) of the groove mouth is smaller than the outer diameter of the sensor arranged in the shell channel (for example, considering a section of the sensor as a cylinder, the outer diameter of the sensor is the maximum diameter of the cross-sectional circular surface of the cylinder), and the opening spacing of the groove mouth enables the detected liquid to enter the groove through the groove mouth and contact the end face of the detection part of the sensor arranged in the shell channel, thereby realizing normal data acquisition operation of the sensor.
[0026] (7) Furthermore, in some embodiments, a flushing hole is provided at the distal end section of the channel of the shell channel, and the flushing hole can pass through the blood pump shell to ensure that the flushing hole is at least partially oriented toward the end face of the detection part of the sensor arranged in the shell channel. This design allows the blood on the inner surface of the blood pump shell to flow to the outer surface of the blood pump shell (towards the shell channel) through the flushing hole, and flush the detection part of the sensor (especially its end face), thereby reducing the formation of a blood stagnant area nearby, and then reducing the possibility of thrombosis; further, the opening of the flushing hole is at least partially oriented toward the end face of the detection part of the sensor arranged in the shell channel, so as to flush the surface of the detection part, thereby increasing the data accuracy and service life of the sensor.
[0027] (8) Furthermore, in some preferred embodiments, the distal section of the channel is composed only of the channel leg section, wherein the leg shell section is provided with a reducing section near the distal shell section. This is because the leg shell section forms a flow channel of the blood pump shell just in the gap between the legs, and at the distal root of the leg, due to the structure of the blood pump shell, a section where the inner diameter of the blood pump shell (from the proximal end to the distal end) gradually increases (in this section, the side wall of the blood pump shell gradually becomes thinner from the proximal end to the distal end), which is called the reducing section, and the flushing hole is provided in the reducing section, so that through an integrated molding processing method, the flushing hole can be directly cut and opened at the bottom of the reducing section at the distal end of the shell channel. This is because the shell channel of the original thickness, after entering the reducing section, is directly cut through the bottom of the section due to the thinning of the blood pump shell, and then the flushing hole is directly formed by the penetrated bottom, without the need for secondary through-processing to specially form the flushing hole. BRIEF DESCRIPTION OF THE DRAWINGS
[0028] The above and other features, advantages and aspects of the embodiments of the present disclosure will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings, in which:
[0029] Figure 1a A schematic diagram of a blood pumping device according to an embodiment of the present disclosure is shown;
[0030] Figure 1b Another schematic diagram of a blood pumping device according to an embodiment of the present disclosure is shown;
[0031] Figure 1c A partial diagram of a blood pumping device according to an embodiment of the present disclosure is shown;
[0032] Figure 1d Another partial view of a blood pumping device according to an embodiment of the present disclosure is shown;
[0033] Figure 2 Another schematic diagram of a blood pumping device according to an embodiment of the present disclosure is shown;
[0034] Figure 3 A schematic diagram showing a blood pumping device with a housing channel according to an embodiment of the present disclosure is shown;
[0035] Figure 4 A schematic cross-sectional view of a housing channel of a blood pumping device according to an embodiment of the present disclosure is shown;
[0036] Figure 5 A cross-sectional schematic diagram of a variable diameter section of a blood pumping device according to an embodiment of the present disclosure is shown;
[0037] Figure 6 A schematic cross-sectional view of a housing channel of a blood pump housing according to an embodiment of the present disclosure is shown;
[0038] Figure 7 Another schematic cross-sectional view of a housing channel of a blood pump housing according to an embodiment of the present disclosure is shown; and
[0039] In each of the accompanying drawings, the same or corresponding reference numerals represent the same or corresponding parts; the reference numerals are: blood pumping device 100, blood pumping housing 10, housing channel 20, groove mouth (channel distal opening) 20-1, groove wall 20-2, groove bottom 20-3, channel proximal opening 20-7, flushing hole 20-9, outflow channel 30, support leg 40, heat shrink tube sections 50, 50-1, sensor 60, reducing section 80. DETAILED DESCRIPTION
[0040] Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although certain embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be construed as being limited to the embodiments described herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present disclosure. It should be understood that the drawings and embodiments of the present disclosure are only for exemplary purposes and are not intended to limit the scope of protection of the present disclosure.
[0041] In the description of the embodiments of the present disclosure, the term "including" and similar terms should be understood as open inclusion, that is, "including but not limited to". The term "based on" should be understood as "based at least in part on". The term "one embodiment" or "the embodiment" should be understood as "at least one embodiment". The terms "first", "second", etc. may refer to different or the same objects. Other explicit and implicit definitions may also be included below.
[0042] In addition, it should be noted that, in the description of the embodiments of the present application, unless otherwise clearly defined, "in vivo" means inside the patient's tissues and organs, and "in vitro" means outside the patient's tissues and organs. At the same time, in the embodiments of the present application, "distal" refers to the direction away from the physician, and "proximal" refers to the direction close to the physician. Generally, a blood pumping device (also clinically called a ventricular assist device (VAD)) is used as a transitional support or permanent replacement therapy before heart transplantation, which can significantly improve the survival rate and quality of life of patients with end-stage heart failure. As a type of ventricular assist device, the blood pumping device has the function of assisting the delivery of oxygenated blood in the left ventricle into the aorta to complete the blood circulation.
[0043] In some of these application scenarios, the blood pumping device is inserted percutaneously and retrogradely enters the left ventricle through the femoral artery. There is a cage-shaped blood inlet at the front end of the blood pumping device, and a blood outlet is provided in the ascending aorta segment. There is a built-in micro axial flow pump between the blood inlet and the blood outlet. The micro axial flow pump is connected to an external controller through an in vivo wire, thereby drawing oxygenated blood from the left ventricle and pumping it directly into the ascending aorta through the micro axial flow pump, thereby establishing a left ventricle-ascending aorta drainage pathway.
[0044] In addition, for the convenience of description and understanding, before describing the technical solution of the present application, a brief introduction to the concepts appearing in the present application is first given. In the description of the embodiments of the present application, the general structural form of the blood pumping device is a long catheter-like structure, and a certain section may be a cylindrical structure (which may be referred to as a "blood pumping catheter" in some embodiments or usage scenarios); further, the blood pumping housing generally refers to the outer shell of the blood pumping device (or referred to as a "pump housing" in some scenarios), which is generally also a long catheter-like structure.
[0045] The so-called axial direction of the blood pump shell generally refers to the axis formed by the centers of the upper and lower bottom surfaces of the cylinder when the blood pump shell presents a cylindrical structure. The so-called circumferential direction of the blood pump shell refers to the direction of circular motion along the circle where a specific point on the outer surface of the blood pump shell is located. The so-called radial direction of the blood pump shell refers to the direction from the center of the circle to a certain point on the outer circumference of the circle where a certain point on the axis of the blood pump shell is located, that is, the direction away from the axis or pointing to the axis. The so-called outer diameter of the blood pump shell generally refers to the diameter of the circle where a certain point on the outer surface of a section presents a cylindrical structure is located. The so-called inner diameter of the blood pump shell generally refers to the diameter of the circle where a certain point on the inner surface of a section presents a cylindrical structure is located.
[0046] In addition, the so-called parallel to the axis means maintaining parallelism within a certain range, rather than being a strictly parallel straight line from beginning to end. Deviations within a certain range are also within the protection scope of this application, and this application does not make specific restrictions on this. Similarly, perpendicular to the axis also means maintaining perpendicularity within a certain range, rather than being a strictly perpendicular straight line from beginning to end. Deviations within a certain range are also within the protection scope of this application, and this application does not make specific restrictions on this.
[0047] In addition, the sensor arranged in the shell channel or the sensor arranged on the blood pumping shell of the blood pumping device is generally a long strip structure, which can be a cylindrical structure in a certain section. The so-called outer diameter of the sensor generally refers to the diameter of the circle at a certain point on the outer surface of the sensor section presenting a cylindrical structure. The so-called opening spacing of the groove mouth refers to the width of the opening at the opening of the groove mouth. The so-called opening distance of the groove mouth is smaller than the outer diameter of the sensor means that the opening size of the groove mouth is smaller than the diameter of the circle at a certain point on the outer surface of the sensor, that is, the size of the groove mouth can prevent (for example, block) the sensor from passing through the opening of the groove mouth. In some embodiments, the so-called top of the shell channel can refer to the side of the shell channel close to the outer surface of the blood pumping shell; the so-called bottom of the shell channel can refer to the side of the shell channel close to the inner surface of the blood pumping shell (that is, close to the inner side covered by the blood pumping shell); the so-called side wall of the shell channel can refer to the side of the channel connecting the top of the shell channel and the bottom of the shell channel.
[0048] It should be noted that the "housing channel" opened on the outer wall of the blood pump housing is similar to opening a tunnel inside the outer wall of the blood pump housing. In addition to the openings at both ends, the middle section of the tunnel is not connected to the outer surface or inner surface of the blood pump housing, so that the sensor can enter through the proximal opening of the housing channel, extend to the distal end in the housing channel, and finally reach the vicinity of the opening at the distal end of the housing channel. It should be noted that in some embodiments, the "inner wall surface" can be the "inner surface" and vice versa; similarly, the "outer wall surface" can be the "outer surface" and vice versa.
[0049] Generally, a blood pumping device can detect the blood pressure at the blood inlet and / or blood outlet through a sensor, the outside of which is covered and protected by a blood pumping shell, and the inside of which is a driving unit, such as a driving motor. Generally, the sensor is installed on the outer surface of the blood pumping shell of the blood pumping device (also called a driving device). After the blood pumping device is inserted into the human body, the sensor using this installation method is easily damaged by the all-round impact of blood, thereby reducing the detection accuracy of the sensor; further, directly arranging the sensor on the outer surface of the blood pumping shell relatively increases the outer diameter of the blood pumping shell, and even due to the protrusion of the sensor and its transmission line, it may cause damage to the inner wall of the blood vessel, that is, the increased intervention is more unfriendly (for example, the blood vessel wall or other biological tissues are scratched by the protruding structure).
[0050] In addition, the installation method of directly installing the sensor inside the blood pumping housing of the blood pumping device will also have corresponding disadvantages: for example, this method of directly installing the sensor inside the blood pumping housing of the blood pumping device requires additional arrangement or construction of a structure for sensor installation on the inner wall of the blood pumping housing, which will make the internal structure of the blood pumping device complicated, thereby increasing the difficulty of installing the blood pumping device as a whole component. After all, the motor, sensor and transmission line inside the blood pumping housing need to be encapsulated, which leads to the need to determine the sensor and its transmission line before encapsulating the blood pumping housing, resulting in a high degree of binding between the sensor and the blood pumping device, reducing the medical workers' choice of sensor type or brand; furthermore, the blood pumping housing of the blood pumping device is usually provided with a cleaning liquid flow channel, and the sensor is easily exposed to the cleaning liquid in the cleaning liquid flow channel, resulting in the sensor being easily damaged and reducing the detection accuracy. The hydraulic pressure of the cleaning liquid will also interfere with the sensor's detection results of blood pressure, etc. In addition, a blood stasis area is easily formed between the sensor and the housing channel, and a blood stasis area is also easily formed on the detection end face of the sensor, and blood thrombus is most likely to be generated in the blood stasis area.
[0051] In order to solve at least one of the above problems, as well as one or more of the other potential problems, an exemplary embodiment of the present disclosure proposes a blood pumping device. The blood pumping device includes a blood pumping housing and a sensor, the side wall of the blood pumping housing is provided with a receiving space; the receiving space is provided with a space opening, the space opening is connected to the outer wall surface of the blood pumping housing, the detection part of the sensor is arranged in the receiving space, and the detection part of the sensor is arranged to face the space opening. In the working state, the detection part of the sensor is located in the receiving space, and the blood around the blood pumping device can contact the detection part of the sensor through the space opening.
[0052] The accommodation space can limit the sensor from being separated from the blood pump housing. In some implementations, the accommodation space limits the sensor from being separated from the blood pump housing through structural design. In another alternative implementation, the accommodation space is connected to the sensor (for example, the two are connected by glue) to limit the sensor from being separated from the blood pump housing.
[0053] It can be understood that in some embodiments of the present application, the sensor includes a sensor head (which includes the detection part of the sensor and other related key components) and a sensor transmission line connected to the sensor head for transmitting the sensor collected data. For example, the sensor can be an optical fiber sensor. In some other embodiments of the present application, the sensor includes a sensor head (which includes the detection part of the sensor and other related key components). For example, the sensor can be a pressure-sensitive sensor that transmits data information wirelessly. The present application does not specifically limit the type of sensor.
[0054] In some embodiments of the present application, the distribution position, distribution size, and distribution form of the accommodating space on the blood pump housing are not specifically limited in this application. The distribution position of the space opening on the blood pump housing is also not specifically limited in this application. For example, the space opening can be located in the area of the blood pump housing close to the blood inlet, that is, the sensor is used to obtain environmental parameters near the blood inlet; for another example, the space opening can also be located in the area of the blood pump housing close to the blood outlet, that is, the sensor is used to obtain environmental parameters near the blood outlet; for another example, the space opening can also be located in the middle area of the blood pump housing, that is, the sensor is used to obtain environmental parameters in the middle area of the blood pump housing. The position of the space opening can be adaptively adjusted according to actual needs.
[0055] It should be noted that in some embodiments of the present disclosure, in order to more clearly show the housing channel, which is shown as exposed on the surface of the blood pump housing in the drawings, the housing channel is buried inside the housing layer of the blood pump housing between the distal opening of the channel and the proximal opening of the channel and cannot be simply seen from the outer surface; of course, in some embodiments, the distal opening of the channel can cover the outer surface of a certain section of the blood pump housing, that is, the opening can be relatively large in some embodiments.
[0056] In some application scenarios, the sensor is used to measure relevant parameters at the blood outlet, that is, the spatial opening on the accommodating space is opened in the area near the blood outlet in the blood pump housing, and the sensor is a fiber optic sensor. It can be understood that this scenario is only part of the applicable scenario of the technical solution of this application, and it is not the only scenario. For the convenience of description and understanding, the technical solution of this application will be described in detail below using this application scenario as an example.
[0057] Figure 1a FIG. 1 shows a schematic diagram of a blood pumping device according to an embodiment of the present disclosure. Figure 1a As shown, the blood pumping device 100 includes a blood pumping housing 10 and a sensor 60. A flow channel (not shown in full) is formed in the blood pumping housing 10, and an inflow channel (not shown) and an outflow channel 30 communicating with the flow channel are provided on the blood pumping housing 10. In the working state, the inflow channel is located in the left ventricle, and the outflow channel 30 is located in the aorta. Under the action of the blood pumping device 100, blood enters the flow channel from the inflow channel and flows out from the outflow channel 30.
[0058] Continue to refer Figure 1a, a accommodating space is provided on the side wall of the blood pump housing 10 (the illustrated embodiment is the housing channel 20), and a space opening is provided on the accommodating space (the illustrated embodiment is the channel distal opening 20-1), and the space opening is connected to the outer wall surface of the blood pump housing 10. At least the detection part of the sensor 60 is located in the accommodating space and faces the space opening. The accommodating space can limit the sensor from detaching from the blood pump housing, and the detection part of the sensor 60 can contact the surrounding environment of the blood pump device through the space opening, and then measure the relevant parameters of the surrounding environment. The accommodating space can accommodate the sensor, thereby preventing the exposed arrangement of the sensor from scratching the inner wall of the blood vessel during intervention; the accommodating space is provided with a space opening on one side of the outer surface of the blood pump housing, so that the detection part of the sensor is arranged inside the accommodating space, and the detection part of the sensor is arranged to be close to or facing the space opening, so that the sensor can be implicitly arranged to increase physical protection, and the detection data of the surrounding environment can be obtained through the opening. In this exemplary embodiment, the blood pumping device 100 also includes a blood pumping motor (which is blocked by the blood pump housing section of the blood pumping housing 10 and is therefore not fully shown), wherein the blood pumping motor is located in the blood pumping housing 10 and is in the proximal region of the blood pumping housing 10. It can be understood that the blood pumping motor in this embodiment can be a structure of a conventional motor with the outer shell removed. The blood pumping housing 10 includes a distal housing section, a support leg housing section, and a blood pump housing section, which are sequentially arranged from the distal end to the proximal end. The outflow channel 30 is arranged on the blood pumping housing 10, and in particular, the outflow channel 30 is a channel for blood outflow formed by the cooperation between the support leg 40 of the support leg housing section and the blood pump housing section corresponding to the blood pumping motor. The housing channel 20 is arranged in the side wall of the blood pumping housing 10. It should be noted that the housing channel 20 can be a type of accommodating space.
[0059] In addition, in the illustrated example embodiment of the blood pumping device 100, the blood pumping motor is located at the proximal end of the blood pumping device 100, and the outer shell or shell section corresponding to the blood pumping motor can be divided into the blood pump shell section of the blood pumping shell 10; and in the blood pumping shell, the shell section with the support foot 40 near the distal end of the blood pumping motor can be divided into the support foot shell section of the blood pumping shell 10. It should be understood that the support foot shell section is the section from the proximal end where the support foot contacts the blood pumping shell 10 to the distal end (the root of the support foot); it should be understood that the distal end of the support foot shell section is connected to the distal shell section of the blood pumping shell 10, and then the section can be divided into the distal shell section of the blood pumping shell 10.
[0060] In some other embodiments, a blood pumping device without a blood pumping motor is provided. In the working state, the blood pumping motor is located outside the body. Figure 1a The specific structure of the corresponding embodiment will not be described repeatedly here.
[0061] Furthermore, in this exemplary embodiment, the blood pumping device 100 also includes a shell channel 20, which is arranged inside the side wall of the blood pumping shell 10 (similar to opening a tunnel inside the outer wall), and the shell channel 20 is composed of a channel distal section and a channel blood pump shell section that are interconnected, and the channel distal section includes a channel support foot section, and the channel support foot section is arranged in the support foot shell section of the blood pumping shell 10, and the channel blood pump shell is arranged in the blood pump shell section of the blood pumping shell 10; a channel distal opening is arranged on one side of the channel distal section of the shell channel close to the outer surface of the blood pumping shell, and the channel distal opening is constructed to pass through the shell channel and the outer surface of the blood pumping shell.
[0062] In order to further strengthen the position limitation of the sensor arranged in the housing channel 20, the following is explained in conjunction with the accompanying drawings and some embodiments. In some embodiments, the blood pumping device further includes a heat shrinkable tube section. The heat shrinkable tube section is used to strengthen the position limitation of the sensor on the housing channel 20.
[0063] Figure 1b Another schematic diagram of a blood pumping device according to an embodiment of the present disclosure is shown. In this exemplary embodiment, the heat shrinkable tube segment 50 is more clearly shown, and the heat shrinkable tube segment 50 can further tighten and limit the sensor 60 arranged in the housing channel 20 along the radial direction of the blood pumping housing 10 (that is, from the outer periphery of the blood pumping housing to its axial direction). It should be noted that in some embodiments, the heat shrinkable tube segment 50 is a coating section (it should be understood that it is similar to an additional sleeve tube segment) disposed on the outer surface of the blood pumping housing 10, and can be limited by one or more annular grooves. Figure 1c A partial view of a blood pumping device according to an embodiment of the present disclosure is shown, which includes an embodiment of a heat shrink tubing segment 50. In addition, Figure 1d Another partial view of the blood pumping device according to an embodiment of the present disclosure is shown. In this illustrated embodiment, the heat shrinkable tube section 50-1 is in the form of a plurality of annular groove structures for position limiting. Further, the surface of the blood pumping housing 10 within the range of the coating section can be roughened by sandblasting or the like to increase the coating strength of the heat shrinkable tube section 50.
[0064] Further, the heat shrinkable tube section 50 may be made of PET\PTFE\PE\FEP, and the heat shrinking temperature is within the heat-resistant temperature range of the optical fiber (for example, less than 200°C). Preferably, the heat shrinkable tube section 50 is made of PET. Further, the single-side wall thickness of the heat shrinkable tube section 50 may range from 0.01mm to 0.08mm.
[0065] In some embodiments, the shell channel 20 is configured to pass through a heat shrink tube segment 50; the heat shrink tube segment 50 can strengthen the radial limiting effect of the shell channel 20 along the blood pump housing 10. In particular, when the heat shrink tube segment 50 shrinks, the sensor 60 embedded in the shell channel 20 is limited in the radial direction of the blood pump housing 10, so as to better limit the sensor 60 in the shell channel 20 (and then tighten the portion of the distal end of the sensor that may be exposed outside the blood pump housing).
[0066] Further, in some embodiments, in order to fully arrange the heat shrinkable tube section 50, based on the design that the housing channel 20 is arranged to pass through the heat shrinkable tube section 50, the housing channel 20 is arranged from the proximal end of the blood pump housing 10 to the distal non-window section of the outflow channel 30 of the blood pump housing 10 (i.e., the distal end of the support leg housing section, i.e., the root of the support leg; if arranged in the window section, the heat shrinkable tube section will block the window section, resulting in poor blood flow), and the distal non-window section is close to the distal end of the outflow channel 30 of the blood pump housing 10. Such an arrangement is conducive to limiting the position of the sensor 60 in the housing channel 20 along the axial direction of the blood pump housing 10, arranging the housing channel 20 in the distal non-window section of the outflow channel 30 is also conducive to grooving the blood pump housing 10, and the sensor detection area is arranged near the outflow channel 30 of the blood pump housing 10, resulting in more accurate detection data.
[0067] In some other embodiments, the housing channel 20 further includes a housing segment at the distal end of the housing of the blood pump, and the housing segment is disposed at the distal end of the channel leg segment, and the housing segment is interconnected with the channel leg segment; on this basis, as shown in the figure, the blood pump housing 10 further includes a heat shrinkable tube segment 50, and the heat shrinkable tube segment 50 is disposed on the outer surface of the housing segment at the distal end near the leg segment, and the housing channel 20 is configured to pass through the heat shrinkable tube segment 50. Preferably, in one embodiment, the distal end of the heat shrinkable tube segment 50 does not exceed the detection portion of the sensor (i.e., close to the detection portion of the sensor but not covering the detection portion of the sensor), and the proximal end of the heat shrinkable tube segment 50 does not cover the window section of the outflow channel 30 (the so-called window section is the window area between the legs). In this way, the heat shrink tube section 50 can be fully arranged, and when the heat shrink tube section 50 shrinks, the partial section of the sensor in the shell channel 20 that may be exposed on the outer surface of the blood pump shell is restricted (compressed) in the radial direction of the blood pump shell, and then indirectly, the sensor 60 arranged in the shell channel 20 is also limited in the axial direction of the blood pump shell 10, so as to better limit the sensor 60 in the shell channel 20.
[0068] Obviously, in other embodiments, the heat shrink tubing section is not necessarily required. Figure 2Another schematic diagram of a blood pumping device according to an embodiment of the present disclosure is shown. In this illustrated embodiment, the distal end of the housing channel 20 may end near the root of the leg 40 (i.e., near the distal end of the leg housing section of the blood pumping housing or near the proximal end of the distal housing section of the blood pumping housing), and then the sensor 60, especially its detection portion, may be arranged near the distal end position of the housing channel 20.
[0069] However, when using the limiting arrangement of the housing channel, it is also necessary to consider that the gap between the sensor and the housing channel will produce a blood stasis area, and then produce a thrombus, which is explained in detail below with reference to the accompanying drawings.
[0070] Figure 3 A schematic diagram of a blood pumping device with a housing channel according to an embodiment of the present disclosure is shown. In the illustrated embodiment, a channel distal opening 20-1 is provided at the distal end of the housing channel 20 (generally, in some embodiments, the channel distal section of the housing channel is close to the outer surface of the blood pumping housing), in which the detection part of the sensor can be arranged, and a flushing hole 20-9 can be provided at the bottom of the housing channel 20 (on the side of the housing channel 20 close to the inner surface of the blood pumping housing) through the channel distal opening 20-1. The flushing hole 20-9 can penetrate the blood pumping housing 10, so that the blood on the inner surface of the blood pumping housing 10 can flow to the housing channel 20 through the flushing hole 20-9, and the housing channel 20 is provided with a channel distal opening 20-1, and the channel distal opening 20-1 is connected with the flushing hole 20-, or the channel distal opening 20-1 is connected with the flushing hole 20- through the housing channel 20, so that the blood finally flows to the outer surface of the blood pumping housing 10 through the channel distal opening 20-1. This arrangement allows blood to flow out from the flushing hole 20-9 and flush the detection part of the sensor (especially the end face of the detection part of the sensor), thereby reducing the formation of a blood stagnant area between the end face of the sensor and the shell channel 20 (especially the gap between the sensor and the inner wall of the shell channel 20), thereby reducing the possibility of thrombosis.
[0071] In particular, in some embodiments, the relative position of the end face of the detection part at the distal end of the sensor and the flushing hole 20-9 along the axial direction of the housing channel 20 (i.e., the distal and proximal directions) requires that the end face of the detection part at the distal end of the sensor does not block the flushing hole 20-9, and the minimum distance between the end face of the detection part at the distal end of the sensor and the flushing hole 20-9 does not exceed the first preset distance. In some of the implementations, the first preset distance can be any one of 0mm, 0.5mm, 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 4mm and 5mm. It can be understood that the above-mentioned first preset distance is only a partial example, and other first preset distances that can avoid the sensor from blocking the flushing hole 20-9 and ensure the flushing effect of blood on the end face of the sensor detection part through the flushing hole 20-9 are all within the protection scope of this application, and this application does not make specific limitations on this. The minimum distance between the end face of the detection part at the far end of the sensor and the flushing hole 20-9 can be: the minimum distance between the projection of the end face of the detection part in the first plane and the projection of the flushing hole 20-9 in the first plane, wherein the first plane can be any plane passing through the axis. In some application scenarios, the minimum distance can be the minimum axial distance. Preferably, the end face of the detection part of the sensor is at the proximal edge of the flushing hole 20-9 but does not block the flushing hole 20-9.
[0072] In particular, in some embodiments, the cross section of the flushing hole 20-9 can be set to be: a water drop shape, a round hole shape, a semicircular shape, a crescent shape; preferably, the flushing hole 20-9 can be set to be smooth and without edges and corners; the cross section is perpendicular to the radial direction. In particular, in some embodiments with a heat shrink tube section, the end face of the detection part of the sensor is at the proximal end of the flushing hole and the end face of the detection part of the sensor is also at the distal end of the heat shrink tube.
[0073] In some embodiments, the housing channel 20 includes a proximal channel opening 20-7 and a distal channel opening 20-1, and the proximal channel opening 20-7 is disposed in the blood pump housing section of the blood pump housing, so that the sensor arranged in the housing channel 20 can enter the housing channel 20 from the proximal channel opening 20-7, and the detection portion of the sensor arranged in the housing channel 20 can approach the distal channel opening 20-1. The housing channel includes two openings, the proximal channel opening 20-7 and the distal channel opening 20-1, and the proximal channel opening 20-7 is disposed in the blood pump housing section at the proximal end of the blood pump housing, so that the sensor arranged in the housing channel 20 can enter the housing channel 20 from the proximal channel opening 20-7, and the detection portion (especially the end face thereof) of the sensor arranged in the housing channel 20 can approach the distal channel opening 20-1. In some alternative embodiments, the shell channel may include two openings, a proximal opening of the channel and a distal opening of the channel. The proximal opening of the channel is arranged at the support shell section of the blood pump housing, so that a sensor arranged in the shell channel can enter the shell channel from the proximal opening of the channel, and so that the detection portion (especially the end face thereof) of the sensor arranged in the shell channel can be close to the distal opening of the channel.
[0074] Furthermore, the channel distal opening 20-1 is configured as a narrow opening so that the detection portion (especially near the end surface) of the sensor arranged in the housing channel 20 can abut against the channel distal opening 20-1 in the housing channel 20, and the channel distal opening 20-1 can prevent the sensor arranged in the housing channel 20 from directly passing through the channel distal opening 20-1. Further, in some embodiments, the opening of the flushing hole is at least partially oriented toward the end surface of the detection portion of the sensor arranged in the housing channel, so as to flush the surface of the detection portion, thereby increasing the data accuracy and service life of the sensor.
[0075] It should be understood that in some alternative embodiments, the shell channel 20 has only two openings, namely the proximal channel opening and the distal channel opening. The area between the proximal channel opening and the distal channel opening of the shell channel 20 is a hollow chamber, and the wall of the hollow chamber is formed by the blood pump shell.
[0076] In order to better explain the structure of the housing channel near the distal opening of the channel, further description is given below in conjunction with the accompanying drawings.
[0077] Figure 4A schematic cross-sectional view of a housing channel of a blood pumping device according to an embodiment of the present disclosure is shown. In the illustrated embodiment, the housing channel 20 is a groove structure in the illustrated section. The channel distal opening 20-1, the side wall of the housing channel and the bottom of the housing channel together constitute a groove structure, wherein the groove opening is constituted by the channel distal opening 20-1 (or the groove opening is the channel distal opening 20-1), the groove wall is constituted by the side wall of the housing channel, and the groove bottom is constituted by the bottom of the housing channel 20. Generally, the groove may include a groove mouth 20-1, a groove wall 20-2 and a groove bottom 20-3. The groove mouth 20-1 is configured as a narrow opening so that at least part of the sensor is arranged in the groove. Since the groove mouth 20-1 is a narrow opening, it blocks the sensor arranged in the groove from directly passing through the groove mouth 20-1 (obviously, if the sensor is in the area between the openings of the shell channel, the inner wall of the shell channel will obviously limit the sensor). Then, the sensor can be limited in the circumferential direction of the blood pump housing 10 by the groove walls 20-2 on the left and right sides of the groove, and the sensor can be limited in the radial direction (direction pointing to or away from the axis of the blood pump housing) by the groove mouth 20-1 above the groove and the groove bottom 20-3 below the groove. However, in the above-mentioned embodiments, only the circumferential limitation of the sensor in the groove (i.e. the so-called left-right direction) of the blood pump housing is considered, and the radial limitation of the sensor in the groove (i.e. the direction away from or close to the blood pump housing (i.e. the so-called up-down direction)) is also considered, but the limitation of the sensor in the groove along the axial direction of the blood pump housing (i.e. the so-called front-to-back direction, or in the distal and proximal directions) is not considered.
[0078] To this end, in some embodiments, the narrow opening of the groove 20-1 allows the groove to extend from the distal end of the channel distal segment to the proximal end of the channel distal segment, while still protecting the sensor end face from physical damage, while protecting the blood vessel wall or other biological tissue from being scratched by the protruding structure, and does not increase the maximum outer diameter of the non-bendable length of the blood pump housing or the blood pump device (for example, a section of the blood pump housing or the blood pump device is regarded as a cylinder, for example, the blood pump section belongs to the non-bendable length, and its maximum outer diameter is the maximum diameter of the cross-sectional circular surface of the cylinder). Further, the opening spacing (opening size or opening width) of the groove 20-1 is smaller than the outer diameter of the sensor arranged in the housing channel (for example, a section of the sensor is regarded as a cylinder, and the outer diameter of the sensor is the maximum diameter of the cross-sectional circular surface of the cylinder), and the opening spacing of the groove 20-1 allows the detected liquid to enter the groove through the groove 20-1 and contact the end face of the detection part of the sensor arranged in the housing channel, thereby realizing normal data acquisition of the sensor. In some other embodiments, the opening spacing (opening size or opening width) between the groove opening 20-1 and the corresponding part of the sensor detection part is smaller than the outer diameter of the sensor arranged in the housing channel (for example, if a section of the sensor is regarded as a cylinder, the outer diameter of the sensor is the maximum diameter of the cross-sectional circular surface of the cylinder), and the opening spacing of the corresponding parts enables the detected liquid to enter the groove through the groove opening 20-1 and contact the end face of the detection part of the sensor arranged in the housing channel, thereby realizing the normal data collection work of the sensor. The opening spacing of the remaining parts of the groove opening 20-1 may not be specifically limited.
[0079] In addition, it should be understood that there is obviously a gap between the detection part of the sensor arranged in the groove and the groove wall 20-2. In particular, the gap between the groove and the non-detection section of the sensor can be filled with corresponding glue, which can strengthen the position of the sensor in the groove and prevent the occurrence of blood stasis due to the above-mentioned gap, and then the formation of thrombus. Obviously, the gap between the shell channel 20 and the non-detection section of the sensor can be filled with corresponding glue, which can strengthen the position of the sensor in the shell channel 20 and prevent the occurrence of blood stasis due to the above-mentioned gap, and then the formation of thrombus. Accordingly, a gap is set between the end face of the detection part of the sensor arranged in the groove and the groove wall 20-2 (especially the end of the groove or the shell channel at the farthest end), so that the groove mouth 20-1 can expose the detection part of the sensor (especially the end face), and then the sensor can perform effective detection work, and at the same time the gap can accommodate the detected blood, so that the sensor can collect the detection data of the blood.
[0080] Further, in the illustrated embodiment, the groove is arranged to extend along the axial direction of the blood pump housing (which may be the distal and proximal directions as shown in the figure), and the groove is arranged to pass through the foot of the outflow channel; this is conducive to the arrangement of the sensor and the sensor transmission line along the outer surface of the blood pump housing, and through the foot of the outflow channel, it is also conducive to the continuous arrangement of the groove along the outer surface of the blood pump housing. In the illustrated embodiment, the sensor passes through the outer surface of the blood pump housing (blood pump housing section) outside the blood pump motor, penetrates from the proximal surface of the groove of the outflow channel, and is fixed to the foot of the outflow channel by glue (for example, glue that can directly contact blood).
[0081] In some embodiments, the sensor (especially its detection part) is arranged near the blood outflow outlet (i.e., the outflow channel, i.e., the outflow window between the legs). When the sensor is arranged on the blood pump housing near the blood outflow outlet, the specific position of the end face of the sensor detection part needs to be reasonably set to ensure other functions of the blood pump device.
[0082] In some embodiments, the distal end of the blood pumping housing is set to a stepped structure, the proximal end of the spring tube is placed on the stepped surface, and the proximal end face of the spring tube is aligned with the distal end of the outer peripheral surface of the blood pumping housing. Among them, the overlapping method of the spring tube and the blood pumping housing can be adhesive bonding. The present application realizes the stable connection between the sensor and the blood pumping housing, and the stable connection between the blood pumping housing and the spring tube by reasonably setting the relative position of the end face of the detection part of the sensor and the distal end of the outer peripheral surface of the blood pumping housing. The axial distance between the end face of the detection part of the sensor and the distal end of the outer peripheral surface of the blood pumping housing is not less than the second preset distance. In some of the implementations, the second preset distance can be any one of 0mm, 0.5mm, 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 4mm and 5mm. It can be understood that the above second preset distance is only a partial example, and other second preset distances that can not only realize the stable connection between the sensor and the blood pumping housing, but also ensure the stable connection between the blood pumping housing and the spring tube are all within the protection scope of the present application, and the present application does not make specific limitations on this.
[0083] In addition, the present application determines the connection mode between the sensor and the blood pump housing by reasonably setting the relative position between the end face of the detection part of the sensor and the nearest end of the support leg housing segment. In some embodiments of the present application, the sensor (e.g., the detection part of the sensor) is at least partially arranged on the support leg housing segment and / or the distal housing segment. That is, the axial distance between the end face of the detection part of the sensor and the proximal end of the support leg housing segment is not less than the third preset distance. In some of the implementations, the third preset distance can be any one of 0mm, 0.5mm, 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 4mm and 5mm. It can be understood that the above-mentioned third preset distance is only a partial example, and other third preset distances that can ensure the performance of the blood pump motor are within the protection scope of the present application, and the present application does not make specific limitations on this.
[0084] The above assembly range can accurately determine whether the catheter is inserted too deeply, without causing additional damage to the patient, and protecting the patient's ventricular health. Further, in some embodiments, the distance between the distal end of the sensor and the end surface of the corresponding groove is 0.5-2 mm, preferably 0.5 mm.
[0085] Further, in some embodiments, the groove extends from the distal end of the distal end section of the channel to the proximal end of the distal end section of the channel. In order to better embed the sensor into the groove, in some embodiments, the opening spacing of the groove opening 20-1 of the groove is smaller than the outer diameter of the sensor arranged in the groove, and the opening spacing of the groove opening 20-1 allows the liquid to be detected (i.e., blood) to enter the groove through the groove opening 20-1 and contact the distal end surface of the detection portion of the sensor arranged in the groove. In short, the opening spacing of the groove opening 20-1 of the groove should be small enough to prevent the sensor arranged in the groove from coming out of the opening, and should also be large enough to allow the liquid to be detected (e.g., blood) to enter the groove and contact the detection portion of the sensor.
[0086] In a preferred embodiment, if the groove on the blood pump housing is cut in a plane perpendicular to the axis of the blood pump housing, a cross-sectional structure diagram of the groove can be obtained, and the cross-sectional structure of the groove can be circular or square. Preferably, in an embodiment where the cross-sectional diagram of the groove is circular, the distance between the center of the groove and the center of the outflow channel section is less than the outer diameter of the outflow channel section, and the inner diameter range of the groove is: the outer diameter of the sensor + 0.02mm to the outer diameter of the sensor + 0.05mm, thereby ensuring that the sensor can be smoothly loaded on the outflow channel axially. Further, the groove mouth width of the groove is the chord length of the outermost diameter of the circle, and the chord length occupies the circumference angle of 1 to 5° of the circumference of the circle where the outflow channel section is located. If the circumferential angle is too large, the radial fixing sensor function cannot be realized; if the circumferential angle is too small, for example, close to 0°, it is easy to form a blood dead space and a thrombus, which affects the function and life of the sensor. For example, if it is 0°, the detection part of the sensor cannot directly contact the environment to be measured, and the function of measuring the aortic pressure cannot be realized. In another embodiment, the cross section of the groove is trapezoidal or rounded, the distance between the bottom edge of the groove and the center of the outflow channel section is the inner diameter of the outflow channel section, and the bottom edge length ranges from 0.5 mm to 0.7 mm, and the trapezoidal bilateral angle is from 35° to 70°. It should be noted that based on the implementation of the above groove pattern, the above heat shrink tube section can be assembled in the following manner: first, the sensor is arranged in the housing channel, generally, the sensor is bonded to the housing channel by glue (preferably, the glue fills the gap between the sensor and the side wall of the housing channel), so that the sensor is fixed, and then for the sensor that has been bonded by glue in the groove, a heat shrink tube (heat shrink tube section) is set to strengthen (shrink) and fix the part of the sensor that may be exposed on the outer surface of the blood pump housing (by pressing the sensor to strengthen the fixation).
[0087] It should be noted that in the above or following embodiments, the sensor is not necessarily a necessary component of the blood pumping device. Describing the sensor as "a sensor embedded in a groove" or "a sensor arranged in a shell channel" is actually to illustrate that the sensor can be accommodated and limited in the groove (or in the shell channel), rather than that the sensor is a necessary component of the blood pumping device.
[0088] Generally, although the orientation of the opening of the flushing hole 20-9 toward the detection part of the sensor arranged in the housing channel can be set by constructing a complex structure of the groove bottom 20-3, this will introduce a more complicated design and a more difficult machining process. Therefore, it is necessary to explain the specific opening position of the flushing hole 20-9 in conjunction with the drawings.
[0089] Figure 5A cross-sectional schematic diagram of a variable diameter section of a blood pumping device according to an embodiment of the present disclosure is shown. In the illustrated embodiment, the distal section of the channel is only composed of the channel leg section, that is, the distal section of the channel does not include the distal housing section of the channel, and the leg housing section is provided with a variable diameter section near the distal housing section (this is because the blood pumping device constructs an outflow channel through the leg 40, resulting in the inner section diameter of the blood pumping housing near the distal end of the leg (that is, near the root section of the leg) gradually decreasing from the proximal end to the distal end, and such a blood pumping housing section is referred to as a variable diameter section 80 in the present disclosure), and the flushing hole can be provided in the variable diameter section 80.
[0090] In some embodiments, the housing channel is configured to be the end section from the proximal end of the blood pump housing section of the blood pump housing to the diameter reducing section 80 of the leg housing section of the blood pump housing. In some embodiments, the flushing hole 20-9 can be disposed in the diameter reducing section 80 of the leg housing section of the blood pump housing, and the diameter reducing section is also generally close to the outflow channel 30. The flushing hole 20-9 is disposed at the distal end of the leg 40 of the outflow channel 30, and the distal end of the leg 40 is exactly the diameter reducing section of the blood pump housing 10 at the distal end. In particular, the bottom of the groove presents an inclined bottom surface, and the flushing hole 20-9 is provided on the inclined bottom surface. At this time, the opening of the flushing hole 20-9 is at least partially oriented toward the proximal direction of the groove. Since the groove is generally arranged along the axial direction of the blood pump housing 10, the opening of the flushing hole 20-9 is oriented toward the proximal direction of the groove, so that the blood flushing has an impact force component oriented toward the proximal direction of the groove, which can then be more conducive to the blood flowing out of the flushing hole 20-9 flushing the end surface of the detection part of the sensor 60. Further, in some embodiments, the opening of the flushing hole 20-9 is at least partially oriented toward the end surface of the detection portion of the sensor 60 arranged in the housing channel to flush the surface of the detection portion. In some preferred embodiments, the opening of the flushing hole 20-9 is oriented toward the proximal end of the housing channel as much as possible (this is because the sensor 60 is generally arranged along the housing channel, and the housing channel generally extends along the axial direction of the blood pump housing 10). For another example, most preferably, in some embodiments, the center of the end face of the detection part of the sensor 60 is directed toward the center of the end face, so that the blood entering through the flushing hole 20-9 has the same axial (in this case, the distal to proximal direction) liquid impact force as the blood flowing through the outside of the blood pumping device or the blood pumping housing 10, and the reduction of the liquid impact force in the direction away from the axis of the blood pumping housing 10 (and this impact force in the non-vascular blood flow direction) will not only not contribute to the flushing of the end face of the sensor 60, but will also disturb the flow of the original blood in the blood vessel, and even interfere with the original flow of the blood in the blood vessel (for example, generating reverse flow, or convection vortex), which is likely to form a similar blood stasis area or blood slow movement area in the original blood vessel (blood stasis or slow movement caused by mutual impact between blood flowing in opposite directions or vertically) and generate thrombus. Therefore, arranging the flushing hole 20-9 in such a way that the opening is at least partially directed toward the detection part of the sensor 60 arranged in the housing channel can avoid the aforementioned situation of thrombus generation as much as possible.
[0091] Additionally, based on the above-mentioned embodiments, a method for integrally forming a shell channel of a blood pumping device may be provided below, the method comprising: milling the outer wall of the blood pumping shell from the proximal end to the distal end with a milling cutter to form a shell channel sequentially passing through the blood pump shell section, the support shell section, and the distal shell section; at the variable diameter section, the bottom of the shell channel is directly cut from the proximal end to the distal end by the milling cutter to form a flushing hole. It should be understood that at the variable diameter section, the inner diameter of the blood pumping shell gradually increases from the proximal end to the distal end, which in turn causes the side wall of the blood pumping shell to gradually become thinner from the proximal end to the distal end. When cutting from the thicker blood pumping shell section to the thinner blood pumping shell section, it is easy to cut through the bottom (close to the inner surface of the blood pumping shell) in the section from thick to thin, and then only one processing can be used to open the shell channel inside the blood pumping shell, and after entering the variable diameter section, a flushing hole can be directly opened in the shell channel close to the inner surface of the blood pumping shell.
[0092] Thus, in some embodiments, the flushing hole can be directly cut at the far end of the housing channel and at the bottom of the variable diameter section by an integrated molding processing method; in particular, if the housing channel is processed in an integrated molding method, the flushing hole can be directly cut from the proximal end to the distal end by a milling cutter at the variable diameter section and at the bottom of the housing channel through the process steps; and the opening of the obtained flushing hole can be at least partially oriented toward the proximal end of the groove. In particular, in some embodiments, the flushing hole can be oriented toward the center of the end face of the detection part of the sensor. Thus, it is convenient for the blood flowing out of the flushing hole to flush the end face of the sensor, and it is not easy to cause problems such as blood backflow and blood convection. Through the above processing technology, in addition to eliminating the risk of radial displacement and falling off of the sensor; the groove structure in the blood pump housing can be realized through traditional precision machining processes, or drill or milling or laser, because the leg section of the blood pump housing is a variable diameter section structure, the strength of the blood pump housing can be improved; the variable diameter section structure can directly obtain the flushing hole by controlling the axial machining depth, that is, the variable diameter section is tilted at this place due to the bottom of the groove. In addition, the cross-sectional view of the housing channel formed by the one-piece molding method can be as follows: Figure 6-7 As shown. Figure 6 In an exemplary embodiment, the bottom wall thickness of the housing channel is greater than 0.05 mm. For example, the cross-section of the housing channel is circular,,,, and the center of the circle is on the support foot. Figure 7In the exemplary embodiment, the cross section of the shell channel presents a notched circle, but the shell channel can still ensure that the sensor can be accommodated. Furthermore, the cross section of the shell channel presents a notched circle, that is, a groove structure is formed, and its length should not exceed the length of the leg shell section; thereby protecting the sensor from radial (the direction in which the central axis of the blood pumping shell points to the outer surface of the blood pumping shell) shedding, and ensuring that the sensor is physically protected in the axial direction (the direction of the central axis of the blood pumping device) during the intervention process with the blood pumping device. It should be noted that the above-mentioned flushing hole cannot be blocked by the sensor. Therefore, in some preferred embodiments, a sensor detection part is arranged near the proximal edge of the flushing hole, so that the flushing hole will not be blocked by the sensor, but can also drive blood to the sensor for detection, and can also flush the sensor detection part, and the setting of the flushing hole can also prevent the gap area between the shell channel and the sensor or other areas in the shell channel from generating blood stagnation areas, thereby causing the formation of thrombus.
[0093] In some embodiments, a blood pumping shell for a blood pumping device is provided, comprising: a distal shell section, a support leg shell section, and a blood pump shell section arranged in sequence from the distal end to the proximal end, wherein the blood pumping shell is provided with a shell channel, the shell channel is constructed inside the outer side wall of the blood pumping shell, the shell channel is composed of a channel distal section and a channel blood pump shell section that are interconnected, the channel distal section includes a channel support leg section, the channel support leg section is arranged in the support leg shell section, and the channel blood pump shell is arranged in the blood pump shell section; the channel distal section of the shell channel is provided with a channel distal opening on the side close to the outer surface of the blood pumping shell, and the channel distal opening is constructed to pass through the shell channel and the outer surface of the blood pumping shell.
[0094] In some embodiments, a processing method for a blood pump housing is provided, wherein the blood pump housing includes a variable diameter section, and since the wall thickness of the variable diameter section gradually increases from the distal end to the proximal end, the following one-piece molding processing method is produced by utilizing this structural feature, specifically including: forming a housing channel on the side wall of the blood pump housing, wherein the housing channel is connected to the inner wall surface of the variable diameter section. It should be noted that the so-called side wall of the blood pump housing refers to the blood pump housing seen from the distal end to the proximal end or from the proximal end to the distal end, along the axial direction of the blood pump housing. Obviously, the blood pump housing has a certain thickness, so a side wall is formed.
[0095] It is understandable that the blood pumping housing can be any blood pumping housing of the aforementioned blood pumping device.
[0096] Further, in some embodiments, the shell channel also includes a channel distal shell section, which is arranged at the distal shell section of the blood pumping shell, and the channel distal shell section is arranged at the distal end of the channel support leg section and is connected to the channel support leg section; the blood pumping shell also includes a heat shrinkable tube section, which is sleeved on the outer surface of the distal shell section close to the support leg section, and the heat shrinkable tube section can tighten the surface of the blood pumping shell in this section when heated, and the shell channel is arranged to pass through the heat shrinkable tube section, and the detection part of the sensor is at the distal end of the heat shrinkable tube section and is not covered by the heat shrinkable tube section.
[0097] Further, in some embodiments, the above-mentioned shell channel includes a proximal channel opening and a distal channel opening, and the above-mentioned proximal channel opening is arranged in the blood pump shell section of the above-mentioned blood pump shell, so that the sensor arranged in the above-mentioned shell channel can enter the above-mentioned shell channel from the above-mentioned proximal channel opening, and the detection part of the sensor arranged in the above-mentioned shell channel can be close to the above-mentioned distal channel opening.
[0098] Further, in some embodiments, the distal opening of the channel is configured as a narrow opening so that the detection portion of the sensor arranged in the shell channel can abut against the distal opening of the channel in the shell channel, and the distal opening of the channel can block the sensor arranged in the shell channel from directly passing through the distal opening of the channel.
[0099] Further, in some embodiments, the distal opening of the channel, the side walls of the shell channel and the bottom of the shell channel together constitute a groove structure, wherein the groove mouth is constituted by the distal opening of the channel, the groove walls are constituted by the side walls of the shell channel, and the groove bottom is constituted by the bottom of the shell channel.
[0100] Furthermore, in some embodiments, the groove extends from the distal end of the distal section of the channel to the proximal end of the distal section of the channel.
[0101] Further, in some embodiments, the opening spacing of the above-mentioned groove mouth is smaller than the outer diameter of the sensor arranged in the above-mentioned shell channel, and the opening spacing of the above-mentioned groove mouth enables the detected liquid to enter the above-mentioned groove through the above-mentioned groove mouth and contact the end face of the detection part of the sensor arranged in the above-mentioned shell channel.
[0102] Further, in some embodiments, a distal end section of the housing channel is provided with a flushing hole, the flushing hole passes through the blood pump housing, and the flushing hole at least partially faces an end face of a detection portion of a sensor arranged in the housing channel.
[0103] Furthermore, in some embodiments, the distal end section of the channel is composed of the channel support leg section, the support leg shell section is provided with a diameter-reducing section near the distal end shell section, and the flushing hole is provided in the diameter-reducing section.
[0104] In some embodiments, a method for integrally molding the shell channel of the above-mentioned blood pump shell is also proposed, which includes: milling the outer wall of the above-mentioned blood pump shell from the proximal end to the distal end with a milling cutter to form a shell channel that passes through the above-mentioned blood pump shell section, the above-mentioned support leg shell section, and the above-mentioned distal shell section in sequence; at the above-mentioned variable diameter section, the bottom of the above-mentioned shell channel is directly cut by the above-mentioned milling cutter from the proximal end to the distal end to form the above-mentioned flushing hole.
[0105] In some embodiments, a blood pump housing is proposed, which includes: a distal housing section, a support leg housing section, and a blood pump housing section arranged in sequence from the distal end to the proximal end; the blood pump housing is provided with a housing channel, the housing channel is constructed inside the outer side wall of the blood pump housing, the housing channel is composed of a channel distal section and a channel blood pump housing section that are interconnected, the channel distal section includes a channel support leg section, the channel support leg section is arranged in the support leg housing section, and the channel blood pump housing is arranged in the blood pump housing section; the channel distal section of the housing channel is provided with a channel distal opening on one side close to the outer surface of the blood pump housing.
[0106] In some embodiments, a blood pumping device is provided, which includes: a blood pumping shell and a sensor, wherein the outer wall of the blood pumping shell is provided with a accommodating space; the accommodating space is provided with a space opening on one side close to the outer surface of the blood pumping shell; the detection part of the sensor is arranged inside the accommodating space, and the detection part of the sensor is arranged to be close to or toward the space opening.
[0107] Furthermore, in some embodiments, the gap between the sensor and the inner wall of the accommodation space is filled with glue, and a gap is provided between the end surface of the detection portion of the sensor and the inner wall of the accommodation space.
[0108] Further, in some embodiments, the blood pump housing includes: a distal housing section, a support leg housing section, and a blood pump housing section which are sequentially arranged from the distal end to the proximal end; the accommodating space is constructed as a housing channel, and the space opening is constructed as a channel distal opening; the housing channel is constructed inside the outer side wall of the blood pump housing, and the housing channel is composed of a channel distal section and a channel blood pump housing section which are interconnected, and the channel distal section includes a channel support leg section, and the channel support leg section is arranged in the support leg housing section, and the channel blood pump housing is arranged in the blood pump housing section; the channel distal section of the shell channel is provided with the channel distal opening on one side close to the outer surface of the blood pump housing, so that the channel distal opening is constructed to pass through the shell channel and the outer surface of the blood pump housing.
[0109] Furthermore, in some embodiments, the detection portion of the sensor is close to or toward the distal opening of the channel.
[0110] Furthermore, in some embodiments, the shell channel further includes a channel distal shell segment, which is disposed at the distal shell segment of the blood pumping shell, and is disposed at the distal end of the channel support leg segment and is connected to the channel support leg segment; the blood pumping shell further includes a heat shrinkable tube segment, which is sleeved on the outer surface of the distal shell segment close to the support leg segment, and the shell channel is configured to pass through the heat shrinkable tube segment.
[0111] Further, in some embodiments, the above-mentioned shell channel includes a proximal channel opening and a distal channel opening, and the above-mentioned proximal channel opening is arranged in the blood pump shell section of the above-mentioned blood pump shell, so that the sensor arranged in the above-mentioned shell channel can enter the above-mentioned shell channel from the above-mentioned proximal channel opening, and the detection part of the sensor arranged in the above-mentioned shell channel can be close to the above-mentioned distal channel opening; the above-mentioned distal channel opening is constructed as a narrow opening so that the detection part of the sensor arranged in the above-mentioned shell channel can abut against the above-mentioned distal channel opening in the above-mentioned shell channel, and the above-mentioned distal channel opening can block the sensor arranged in the above-mentioned shell channel from directly passing through the above-mentioned distal channel opening.
[0112] Further, in some embodiments, the distal opening of the channel, the side walls of the shell channel and the bottom of the shell channel together constitute a groove structure, wherein the groove mouth is constituted by the distal opening of the channel, the groove walls are constituted by the side walls of the shell channel, and the groove bottom is constituted by the bottom of the shell channel; the groove extends from the distal end of the distal segment of the channel to the proximal end of the distal segment of the channel.
[0113] Further, in some embodiments, the opening spacing of the above-mentioned groove mouth is smaller than the outer diameter of the sensor arranged in the above-mentioned shell channel, and the opening spacing of the above-mentioned groove mouth enables the detected liquid to enter the above-mentioned groove through the above-mentioned groove mouth and contact the end face of the detection part of the sensor arranged in the above-mentioned shell channel.
[0114] Furthermore, in some embodiments, a flushing hole is provided on one side of the inner surface of the accommodating space close to the blood pumping housing.
[0115] Furthermore, in some embodiments, a flushing hole is provided at a distal end section of the shell channel, and the flushing hole passes through the shell channel and the inner surface of the blood pump shell; the flushing hole is at least partially directed toward an end face of a detection portion of a sensor arranged in the shell channel, or the flushing hole is close to an end face of a detection portion of a sensor arranged in the shell channel.
[0116] Furthermore, in some embodiments, the distal end section of the channel is composed of the channel support leg section, the support leg shell section is provided with a diameter-reducing section near the distal end shell section, and the flushing hole is provided in the diameter-reducing section.
[0117] In some embodiments, a method for integrally molding the shell channel of the above-mentioned blood pumping device is also provided, which includes: milling the outer wall of the above-mentioned blood pumping shell from the proximal end to the distal end with a milling cutter to form a shell channel that passes through the above-mentioned blood pump shell section, the above-mentioned support leg shell section, and the above-mentioned distal shell section in sequence; at the above-mentioned variable diameter section, the bottom of the above-mentioned shell channel is directly cut by the above-mentioned milling cutter from the proximal end to the distal end to form the above-mentioned flushing hole.
[0118] In some embodiments, a blood pump housing is further provided, which includes: a distal housing section, a support leg housing section, and a blood pump housing section arranged in sequence from the distal end to the proximal end; the blood pump housing is provided with a housing channel, the housing channel is constructed inside the outer side wall of the blood pump housing, the housing channel is composed of a channel distal section and a channel blood pump housing section that are interconnected, the channel distal section includes a channel support leg section, the channel support leg section is arranged in the support leg housing section, and the channel blood pump housing is arranged in the blood pump housing section; the channel distal section of the housing channel is provided with a channel distal opening on one side close to the outer surface of the blood pump housing.
[0119] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same or similar parts between the various embodiments can be referenced to each other. The selection of terms used in this article is intended to best explain the principles, practical applications or technical improvements of each embodiment in the market, or to enable other ordinary technicians in this technical field to understand the various embodiments disclosed in this article.
[0120] The above description is only an optional embodiment of the present disclosure and is not intended to limit the present disclosure. For those skilled in the art, the present disclosure may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present disclosure shall be included in the protection scope of the present disclosure.
Claims
1. A blood pump housing, characterized in that: The side wall of the blood pump housing is provided with a receiving space; The accommodating space is provided with a space opening, the space opening is communicated with the outer wall surface of the blood pump housing, the accommodating space is used to accommodate the detection part of the sensor, and the detection part of the sensor is arranged to face the space opening.
2. A blood pumping device, characterized in that: comprising a blood pump housing and a sensor as claimed in claim 1, The detection portion of the sensor is arranged in the accommodation space.
3. The blood pumping device according to claim 2, characterized in that: The sensor is connected to the blood pump housing by glue, and a gap is provided between the detection portion of the sensor and the inner wall surface of the accommodating space; and / or The accommodating space is provided with a flushing hole, and the flushing hole communicates with the inner wall surface of the blood pump housing and the space opening.
4. The blood pumping device according to claim 2, characterized in that: The blood pump housing comprises a distal housing section, a support housing section, and a blood pump housing section which are arranged in sequence from the distal end to the proximal end; The accommodating space is configured as a shell channel, and the space opening is configured as a channel distal opening; the shell channel is composed of a channel distal section and a channel blood pump shell section which are interconnected, the channel distal section includes a channel support foot section, the channel support foot section is arranged on the support foot shell section, and the channel blood pump shell section is arranged on the blood pump shell section; the channel distal section is provided with the channel distal opening.
5. The blood pumping device according to claim 4, characterized in that: The housing channel comprises a channel proximal opening, and the channel proximal opening is arranged in the blood pump housing section, so that the sensor can enter the housing channel from the channel proximal opening, and the detection part of the sensor can face the channel distal opening; and / or The distal opening of the channel is configured as a narrow opening, which limits the sensor from passing through the distal opening of the channel.
6. The blood pumping device according to claim 4, characterized in that: The shell channel is constructed as a groove structure, wherein the groove mouth of the groove structure is formed by the distal opening of the channel, and the groove wall of the groove structure is formed by the shell channel wall; the groove extends from the distal end of the distal segment of the channel to the proximal end of the distal segment of the channel.
7. The blood pumping device according to claim 6, characterized in that: The channel distal section also includes a channel distal shell section, which is arranged in the distal shell section, and the channel distal shell section is connected with the channel support leg section, and the channel distal shell section is provided with the channel distal opening; the blood pump housing also includes a heat shrink tube section, which is sleeved on the outer surface of the distal shell section, and the heat shrink tube section is arranged between the detection part of the sensor and the proximal end of the distal shell section.
8. The blood pumping device according to claim 6, characterized in that: The groove opening is configured to allow the detected liquid to enter the groove through the groove opening and contact the end surface of the detection portion of the sensor arranged in the housing channel; and the groove opening can limit the sensor from being separated from the blood pump housing.
9. The blood pumping device according to claim 4, characterized in that: The distal end section of the housing channel is provided with a flushing hole, and the flushing hole penetrates the housing channel and the inner wall surface of the blood pump housing; The flushing hole at least partially faces an end surface of a detection part of the sensor arranged in the housing passage, or the flushing hole is close to an end surface of the detection part of the sensor arranged in the housing passage.
10. The blood pumping device according to claim 9, characterized in that The distal end section of the channel is composed of the channel support foot section, the support foot housing section is provided with a diameter reducing section close to the distal end housing section, and the flushing hole is provided in the diameter reducing section.