An interventional guidewire device for measuring intravascular blood oxygen saturation

Abstract

This invention provides an interventional guidewire device for measuring intravascular oxygen saturation, belonging to the field of interventional surgical medical device technology. The guidewire device includes a guidewire body, a first oxygen measurement unit, and a second oxygen measurement unit. The guidewire body has a filamentous structure with a distal end and a proximal end. The first oxygen measurement unit is positioned at a predetermined distance from the distal end of the guidewire body and is used to measure oxygenation data at the distal end of the thrombus. The second oxygen measurement unit is positioned proximal to the first oxygen measurement unit and spaced at a predetermined distance from it, and is used to measure oxygenation data at the proximal end of the thrombus. During operation, the distal end of the guidewire body passes through the thrombus, with the first oxygen measurement unit positioned at the distal end of the thrombus and the second oxygen measurement unit positioned at the proximal end of the thrombus to measure oxygenation data at both ends of the thrombus. This invention primarily addresses the technical problem in existing technologies where it is impossible to assess oxygenation levels at the proximal and posterior ends of the thrombus before mechanical thrombectomy.

Description

Technical Field

[0001] This invention belongs to the field of interventional surgical medical device technology, specifically relating to an interventional guidewire device for measuring intravascular oxygen saturation. Background Technology

[0002] Stroke, also known as apoplexy, is a group of acute cerebrovascular diseases characterized by ischemic and hemorrhagic brain tissue damage. Due to its high incidence, high mortality, high disability rate, high recurrence rate, and high economic burden, it seriously endangers patients' lives, health, and quality of life.

[0003] Currently, the main clinical treatments for stroke include thrombolytic therapy and mechanical thrombectomy. Among these, thrombolytic therapy via arteries or veins is the standard method for treating acute ischemic stroke. However, this method has strict time requirements, demanding that patients arrive at the hospital within 3 to 4.5 hours of symptom onset for treatment. It also has many limitations regarding the medications used, and the recanalization rate is relatively low for acute ischemic strokes caused by the most severe large vessel occlusion.

[0004] Mechanical thrombectomy, a minimally invasive procedure, involves delivering a treatment device along the blood vessel to the target location to directly grasp or aspirate the thrombus. Due to its high recanalization rate, it has become an important treatment for stroke. While current mechanical thrombectomy techniques have improved recanalization rates to some extent, several unresolved issues remain, leading to poor prognoses for some patients after the procedure. For example, dissolved oxygen and carbon dioxide levels change between the proximal and distal ends of the thrombus after its formation. Accurately monitoring these indicators, especially dissolved oxygen, helps clinicians promptly identify whether a patient is suitable for mechanical thrombectomy or if they are at high risk of a poor prognosis, allowing for more personalized treatment plans. This is crucial for doctors to improve treatment methods and promote better patient outcomes. However, the current lack of relevant testing methods and instruments to accurately measure dissolved oxygen and carbon dioxide levels in the blood before and after thrombus formation results in poor prognoses for some patients after mechanical thrombectomy, impacting their quality of life. This not only subjects patients to surgery and its associated costs but also severely affects their quality of life and places a significant burden on their families.

[0005] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0006] The purpose of this invention is to provide an interventional guidewire device for measuring intravascular oxygen saturation, so as to solve the technical problem in the prior art that it is impossible to assess the blood oxygen index at the front and rear ends of the thrombus before mechanical thrombectomy.

[0007] To achieve the above objectives, the interventional guidewire device for measuring intravascular oxygen saturation of the present invention provides the following technical solution: An interventional guidewire device for measuring intravascular oxygen saturation includes: The guidewire body has a filamentous structure and has a distal and a proximal end; The first blood oxygen measurement unit is located at a predetermined distance from the distal end of the guidewire body and is used to measure blood oxygen data at the distal end of the thrombus. The second blood oxygen measuring unit is disposed at the proximal end of the first blood oxygen measuring unit and is spaced at a predetermined distance from the proximal end of the first blood oxygen measuring unit, and is used to measure blood oxygen data at the proximal end of the thrombus; During operation, the distal end of the guidewire body passes through the thrombus, and the first pulse oximetry unit is placed at the distal end of the thrombus, while the second pulse oximetry unit is placed at the proximal end of the thrombus, in order to measure the pulse oximetry data at both ends of the thrombus.

[0008] As a further optimized technical solution, it also includes: The signal transmission unit is connected to the first pulse oximetry unit and the second pulse oximetry unit respectively, and is arranged along the interior of the guidewire body, for transmitting the data measured by the first pulse oximetry unit and the second pulse oximetry unit to the outside; An external detection device is connected to a signal transmission unit and is used to receive data transmitted from the first blood oxygen measurement unit and the second blood oxygen measurement unit and calculate the blood oxygen saturation value.

[0009] As a further optimized technical solution, both the first and second blood oxygen measurement units are optical sensors, and the signal transmission unit is an optical fiber.

[0010] As a further optimized technical solution, the external detection device is a blood oxygen analyzer.

[0011] As a further optimized technical solution, the guide wire body has an internal core wire and a guide layer coaxially sleeved on the outside of the core wire.

[0012] As a further optimized technical solution, the optical fiber is arranged between the core wire and the guide layer.

[0013] As a further optimized technical solution, the guide layer includes: A distal flexible segment is disposed at the distal end of the guide layer, and both the first blood oxygen measurement unit and the second blood oxygen measurement unit are embedded in the distal flexible segment. The proximal push segment is located at the proximal end of the guidewire body and is used to transmit driving force to the distal flexible segment.

[0014] As a further optimized technical solution, the distal flexible segment is composed of a spring structure, and the proximal pushing segment is composed of a submersible tube.

[0015] As a further optimized technical solution, the distance between the first blood oxygen measurement unit and the distal end of the guidewire body is 1-10cm; The axial distance between the second blood oxygen measuring unit and the first blood oxygen measuring unit is 2-8 cm.

[0016] As a further optimized technical solution, the signal transmission unit is connected to the external detection device through a connection unit. One end of the connection unit is provided with a first connector that mates with the proximal end of the guide wire body, and the other end is provided with a second connector that mates with the external detection device. A connection cable is arranged between the first connector and the second connector.

[0017] Beneficial effects: First, by setting a first and a second pulse oximetry measuring unit at a distance from the distal end of the guidewire body, this invention allows for the accurate and simultaneous measurement of the oxygen saturation and its difference between the distal and proximal ends of the thrombus during the initial stage of mechanical thrombectomy. This provides doctors with objective and quantitative data to assess thrombus metabolic activity and determine the severity of ischemia. Based on the measured difference in oxygen saturation at both ends of the thrombus, doctors can make precise decisions on whether to perform mechanical thrombectomy or choose other treatment options. In other words, it enables doctors to identify patients who are unsuitable for mechanical thrombectomy or have a high prognostic risk after mechanical thrombectomy in advance, and promptly change the treatment plan, thereby avoiding unnecessary surgical procedures, reducing patient suffering and economic burden, and significantly improving patient prognosis.

[0018] Secondly, this invention integrates the blood oxygen measurement function into the interventional guidewire, a commonly used guiding component in interventional devices. It can measure the blood oxygen saturation in the blood vessel. After the measurement is completed, if it is determined that mechanical thrombectomy can be performed normally, the guidewire body can guide other instruments to the target position in the conventional guidewire function without removing and repositioning the guidewire, thus making the surgical operation more convenient and efficient.

[0019] Furthermore, the guidewire body of the present invention adopts a double-layer structure of core wire and guide layer, wherein the distal flexible section is composed of a spring structure, which ensures that the distal end of the guidewire has good flexibility and passability, enabling the distal end of the guidewire body to safely reach the tortuous cerebrovascular lesion location; the proximal pushing section is composed of a hypotube, which has high axial thrust and anti-kink performance, thereby facilitating the doctor to accurately control the movement of the distal end of the guidewire. Attached Figure Description

[0020] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein: Figure 1 This is a schematic diagram of the guidewire body structure of an embodiment of the interventional guidewire device for measuring intravascular oxygen saturation according to the present invention. Figure 2 for Figure 1 Cross-sectional views of different parts of the structure, among which, Figure 2 (a) is a cross-sectional view along the AA direction. Figure 2 (b) is a cross-sectional view along the BB direction. Figure 2 (c) is a cross-sectional view along the CC direction. Figure 2 (d) is a cross-sectional view along the DD direction; Figure 3 This is a schematic diagram of the connection unit structure of an embodiment of the interventional guidewire device for measuring intravascular oxygen saturation of the present invention. Figure 4 This is a schematic diagram of one embodiment of the interventional guidewire device for measuring intravascular oxygen saturation according to the present invention.

[0021] In the figure: 100, guide wire body; 110, core wire; 120, guide layer; 121, distal flexible segment; 122, proximal pushing segment; 200, first blood oxygen measurement unit; 300, second blood oxygen measurement unit; 400, signal transmission unit; 500, connecting unit; 510, first connector; 520, second connector; 530, connecting cable. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0023] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances. Furthermore, the term "proximal end" uniformly refers to the end closer to the operator, while "distal end" refers to the end farther from the operator.

[0024] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0025] The shapes and sizes of the components in the accompanying drawings do not reflect the actual proportions of the product; they are only intended to illustrate the content of the invention.

[0026] like Figure 1-4 As shown in the specific embodiment of the present invention, the present invention provides an interventional guidewire device for measuring intravascular blood oxygen saturation. The device includes a guidewire body 100 with a filamentous structure, the guidewire body 100 having a distal end and a proximal end, a total length of 1.5-3.5 m, and a diameter of 0.01-0.035 inch; a first blood oxygen measuring part 200 and a second blood oxygen measuring part 300 are disposed on the guidewire body 100, the diameters of the first blood oxygen measuring part 200 and the second blood oxygen measuring part 300 being 0.01-0.1 mm; the first blood oxygen measuring part 200 being 1-10 cm from the distal end of the guidewire body 100, and used to measure blood oxygen data at the distal end of the thrombus; the second blood oxygen measuring part 300 being disposed at the proximal end of the first blood oxygen measuring part 200 and spaced 2-8 cm from it, and used to measure blood oxygen data at the proximal end of the thrombus. During operation, the distal end of the guidewire body 100 passes through the thrombus. The first pulse oximetry unit 200 is placed at the distal end of the thrombus, and the second pulse oximetry unit 300 is placed at the proximal end of the thrombus to measure the pulse oximetry data at both ends of the thrombus. This invention integrates pulse oximetry measurement function onto the interventional guidewire, enabling accurate measurement of blood oxygen saturation and its difference before and after the thrombus in a single measurement. This provides objective evidence for doctors to assess the thrombus status and develop personalized treatment plans. Simultaneously, it can identify patients unsuitable for mechanical thrombectomy, avoiding unnecessary surgery and improving patient prognosis.

[0027] Example 1 like Figure 1As shown, the interventional guidewire device for measuring intravascular oxygen saturation includes a guidewire body 100, a first oxygen measurement unit 200, and a second oxygen measurement unit 300.

[0028] The guidewire body 100 is a long, thin filament with a total length of 2.5 m and an outer diameter of 0.014 inch, having a distal end (the end furthest from the operator) and a proximal end (the end closest to the operator). The guidewire body 100 includes an internal core wire 110 and a guide layer 120 coaxially sleeved on the outside of the core wire 110. The core wire 110 is made of nickel-titanium alloy and extends through at least a portion of the guidewire body 100 to provide axial support and anti-kink properties.

[0029] The guide layer 120 comprises a distal flexible segment 121 and a proximal pushing segment 122, which are integrally fixedly connected to the distal flexible segment 121. The distal flexible segment 121 is approximately 30 cm long and consists of a stainless steel spring coil to ensure good compliance and passability of the distal guidewire, allowing it to safely traverse tortuous vascular pathways. The pitch of the spring structure gradually increases from the proximal to the distal end to further ensure distal compliance. The proximal pushing segment 122 is approximately 220 cm long and is constructed using a hysteresis tube. The hysteresis tube is made of stainless steel or nickel-titanium tubing and possesses high axial thrust and anti-kink properties. It is used to transmit driving force to the distal flexible segment 121, facilitating precise control of the distal guidewire's direction and position by the operator.

[0030] Both the first pulse oximetry unit 200 and the second pulse oximetry unit 300 are embedded and fixed on the distal flexible segment 121 of the guide layer 120. Specifically, the first pulse oximetry unit 200 is positioned at a predetermined distance from the distal end of the guidewire body 100; in this embodiment, this predetermined distance is 5 cm. The second pulse oximetry unit 300 is positioned proximal to the first pulse oximetry unit 200 and spaced apart from it by a predetermined distance; in this embodiment, this predetermined distance is 5 cm. The first pulse oximetry unit 200 is positioned distal to the thrombus, and the second pulse oximetry unit 300 is positioned proximal to the thrombus to measure pulse oximetry data at both ends of the thrombus.

[0031] In this embodiment, both the first pulse oxygen measurement unit 200 and the second pulse oxygen measurement unit 300 are optical sensors, preferably fiber optic sensors with a diameter of 0.05 mm, used to transmit and / or receive optical signals for measuring pulse oxygen saturation. The first pulse oxygen measurement unit 200 and the second pulse oxygen measurement unit 300 transmit the optical signals to an external detection device (not shown in the figure) through the signal transmission unit 400, which will be described in detail below.

[0032] Furthermore, the signal transmission unit 400 is an optical fiber. In this embodiment, two optical fibers are arranged independently. One fiber is used to connect the first pulse oximetry unit 200, and the other is used to connect the second pulse oximetry unit 300. The two optical fibers are arranged inside the guide wire body 100 between the core wire 110 and the guide layer 120, and are used to transmit the optical signals measured by the first pulse oximetry unit 200 and the second pulse oximetry unit 300 to the external detection device at the near end, specifically as follows: Figure 2 As shown, Figure 2 The cross-sectional structure of different parts of the guidewire body 100 is shown, and the arrangement of the optical fibers is clearly demonstrated.

[0033] In this embodiment, the external detection device is a pulse oximeter, used to receive data transmitted from the first pulse oximeter 200 and the second pulse oximeter 300 and calculate the blood oxygen saturation value. The fiber optic sensor is configured to emit and / or receive near-infrared light with wavelengths including 660 nm and 805 nm. Since oxyhemoglobin and deoxyhemoglobin have different absorption rates for these two types of light, the pulse oximeter receives the spectral changes reflected from red blood cells through the first pulse oximeter 200 and the second pulse oximeter 300, measuring the difference in light absorption between oxyhemoglobin and deoxyhemoglobin in the blood, thereby accurately calculating the blood oxygen saturation (SaO2).

[0034] Furthermore, the signal transmission unit 400 is connected to an external detection device via a connection unit 500. For example... Figure 3 As shown, one end of the connecting unit 500 is provided with a first connector 510 that mates with the proximal end of the guide wire body 100, and the other end is provided with a second connector 520 that mates with external testing equipment. A connecting cable 530 is arranged between the first connector 510 and the second connector 520. The length of the connecting cable 530 can be set to any value within the range of 1 to 5m, depending on the production model.

[0035] like Figure 4 As shown, the working process of the interventional guidewire device in this embodiment is as follows: Preoperative preparation: First, connect the guidewire body 100 and the connecting unit 500 to the external testing equipment to complete the self-test.

[0036] Following standard interventional surgical procedures, vascular access is first established using conventional guidewires, guiding catheters, and distal access catheters.

[0037] Under DSA image guidance, the interventional guidewire device of the present invention is delivered along the pathway to the thrombus location in the target blood vessel. The distal end of the guidewire body 100 passes through the thrombus, and the operator carefully places the first pulse oxygenation measuring unit 200 at the distal end of the thrombus and the second pulse oxygenation measuring unit 300 at the proximal end of the thrombus according to the preset sensor spacing.

[0038] The guidewire body 100 is connected to an external detection device via the connection unit 500. The external detection device receives optical signals from the first pulse oximetry unit 200 and the second pulse oximetry unit 300, and uses near-infrared spectroscopy to measure the difference in light absorption between oxyhemoglobin and deoxyhemoglobin in the blood. Taking into account the influence of factors such as blood temperature, pH value, and hemoglobin concentration, it accurately calculates the pulse oximetry values ​​and their difference at the distal and proximal ends of the thrombus.

[0039] Based on the displayed blood oxygen saturation values ​​before and after the thrombus and the difference between the two, the doctor determines the metabolic activity of the thrombus and the severity of ischemia, and whether mechanical thrombectomy is appropriate. If it is determined that mechanical thrombectomy can be performed, the guidewire body 100 for blood sample measurement can be used as a regular guidewire to guide microcatheters and other instruments into the body.

[0040] Example 2 This embodiment has the same basic structure as Embodiment 1, with the difference being in some dimensional parameters. In this embodiment, the guidewire body 100 has a total length of 3.0 m and an outer diameter of 0.035 inch. The distance between the first pulse oximetry unit 200 and the farthest end of the guidewire body 100 is 2 cm, and the distance between the second pulse oximetry unit 300 and the first pulse oximetry unit 200 is 3 cm. The connecting cable 530 has a length of 1.5 m. The interventional guidewire device of this embodiment is suitable for pulse oximetry measurement of peripheral blood vessels (such as lower limb arteries). The longer proximal push segment 122 provides better thrust transmission efficiency and is suitable for peripheral interventional procedures requiring a longer delivery path.

[0041] Example 3 This embodiment has the same basic structure as Embodiment 1, differing only in some dimensional parameters. In this embodiment, the guidewire body 100 has a total length of 1.8m and an outer diameter of 0.018 inches. The distance between the first pulse oximetry unit 200 and the farthest end of the guidewire body 100 is 8cm, and the distance between the second pulse oximetry unit 300 and the first pulse oximetry unit 200 is 7cm. The connecting cable 530 has a length of 4m. This embodiment is suitable for pulse oximetry measurement in medium-sized blood vessels.

[0042] In summary, the principle of this invention for measuring intravascular oxygen saturation in proximal and distal thrombi is as follows: After a thrombus occurs, because the thrombus blocks or partially blocks the blood vessel, the oxygen saturation in the blood near the thrombus inevitably changes. The guidewire device of this invention features two optical sensors spaced at a predetermined distance at the distal end of the guidewire. In clinical use, these optical sensors are placed at the proximal and distal ends of the thrombus, respectively. The signals transmitted by the optical sensors are directly converted into oxygen saturation values ​​by an external detection device. Doctors determine the state of the thrombus based on the difference in oxygen saturation before and after the thrombus formation, thereby providing appropriate treatment plans or identifying patients with a poor prognosis who do not require mechanical thrombectomy. Targeted treatment plans can improve surgical success rates and patient prognosis; if mechanical thrombectomy is deemed less beneficial, surgery can be avoided, reducing patient suffering and financial burden.

[0043] It is understood that the above description is merely exemplary and the embodiments of this application do not limit the scope of the application.

[0044] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention are within the protection scope of the present invention.

Claims

1. An interventional guidewire device for measuring intravascular blood oxygen saturation, characterized by, include: The guidewire body (100) has a filamentous structure and has a distal end and a proximal end; The first blood oxygen measurement unit (200) is located at a predetermined distance from the distal end of the guidewire body (100) and is used to measure blood oxygen data at the distal end of the thrombus. The second blood oxygen measuring unit (300) is disposed at the proximal end of the first blood oxygen measuring unit (200) and is spaced at a set distance from the proximal end of the first blood oxygen measuring unit (200) for measuring blood oxygen data at the proximal end of the thrombus. During operation, the distal end of the guidewire body (100) passes through the thrombus, and the first blood oxygen measurement unit (200) is placed at the distal end of the thrombus, while the second blood oxygen measurement unit (300) is placed at the proximal end of the thrombus to measure blood oxygen data at both ends of the thrombus.

2. The interventional guidewire device for measuring blood oxygen saturation in blood vessels of claim 1, wherein, Also includes: A signal transmission unit (400) is connected to a first blood oxygen measurement unit (200) and a second blood oxygen measurement unit (300) respectively, and is arranged along the interior of the guidewire body (100) to transmit the data measured by the first blood oxygen measurement unit (200) and the second blood oxygen measurement unit (300) to the outside. An external detection device is connected to a signal transmission unit (400) and is used to receive data transmitted by a first blood oxygen measurement unit (200) and a second blood oxygen measurement unit (300) and to calculate the blood oxygen saturation value.

3. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 2, characterized in that, Both the first blood oxygen measurement unit (200) and the second blood oxygen measurement unit (300) are optical sensors, and the signal transmission unit (400) is an optical fiber.

4. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 3, characterized in that, The external detection device is a blood oxygen analyzer.

5. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 3, characterized in that, The guide wire body (100) has an inner core wire (110) and a guide layer (120) coaxially sleeved on the outside of the core wire (110).

6. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 5, characterized in that, The optical fiber is arranged between the core wire (110) and the guide layer (120).

7. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 5, characterized in that, The guide layer (120) includes: The distal flexible segment (121) is disposed at the distal end of the guide layer (120), and the first blood oxygen measurement unit (200) and the second blood oxygen measurement unit (300) are both embedded in the distal flexible segment (121). The proximal push segment (122) is disposed at the proximal end of the guidewire body (100) and is used to transmit driving force to the distal flexible segment (121).

8. The interventional guidewire device for measuring intravascular oxygen saturation according to claim 7, characterized in that, The distal flexible segment (121) is composed of a spring structure, and the proximal push segment (122) is composed of a hysteresis tube.

9. The interventional guidewire device for measuring intravascular oxygen saturation according to any one of claims 1-8, characterized in that, The distance between the first blood oxygen measurement unit (200) and the distal end of the guidewire body (100) is 1-10 cm; The distance between the second blood oxygen measuring unit (300) and the first blood oxygen measuring unit (200) along the axial direction is 2-8 cm.

10. The interventional guidewire device for measuring intravascular oxygen saturation according to any one of claims 2-8, characterized in that, The signal transmission unit (400) is connected to the external detection device through a connection unit (500). One end of the connection unit (500) is provided with a first connector (510) that mates with the proximal end of the guide wire body (100), and the other end is provided with a second connector (520) that mates with the external detection device. A connecting cable (530) is arranged between the first connector (510) and the second connector (520).

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