US-20260123905-A1 - VASCULAR MONITORING SYSTEM, DEVICE AND METHOD

Abstract

A Doppler blood flow monitoring device includes a signal generation module, a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface. The signal generation module is configured to send a signal to a probe positioned in a probe receptacle on a vascular coupler positioned about a patient's vessel. The signal reception module is configured to receive a return signal from the probe. The signal filtration module is configured to filter the return signal. The signal conversion module is configured to convert the filtered signal into an audible indication and a visual indication corresponding to a characteristic of blood flow in the patient's vessel. The at least one speaker is configured to emit the first audible indication. Additionally, the user interface is configured to display the visual indication.

Inventors

• SHANNON WITKOWSKI
• MICHAEL SCHEIDNES
• Sung Kwon
• JAMES STUDER

Assignees

• BAXTER INTERNATIONAL INC.
• BAXTER HEALTHCARE SA

Dates

Publication Date

20260507

Application Date

20251230

Claims (20)

1. 1 . A Doppler blood flow monitoring device comprising: a signal generation module configured to send a signal to a probe positioned in a probe receptacle on a vascular coupler positioned about a patient's vessel; a signal reception module configured to receive a return signal from the probe; a signal filtration module configured to filter the return signal; a signal conversion module configured to convert the filtered signal into a visual indication corresponding to a characteristic of blood flow in the patient's vessel, wherein the visual indication includes a plurality of bars and each respective bar of the plurality of bars represents a blood velocity threshold; and a user interface configured to display the visual indication.
2. 2 . The device of claim 1 , wherein the signal sent by the signal generation module is at least one of (i) a pulsed ultrasonic signal or (ii) a pulse wave Doppler signal.
3. 3 . The device of claim 1 , wherein filtering the return signal includes at least one of (i) applying a low band-pass filter to the return signal, (ii) applying a high band-pass filter to the return signal, (iii) applying a fast Fourier transform to the return signal, or (iv) applying a frequency adjustment to the return signal, wherein the frequency adjustment is applied to the return signal prior to wave shaping the return signal.
4. 4 . The device of claim 3 , wherein the frequency adjustment is between 230 Hz and 240 Hz.
5. 5 . A Doppler blood flow monitoring system comprising: a vascular coupler positioned about a patient's vessel; a transducer attached to the vascular coupler; and a monitor configured to: generate a signal to send to the transducer, wherein the transducer is configured to emit an ultrasonic signal based on the signal generated by the monitor, and wherein the ultrasonic signal is transmitted through the patient's vessel, receive a return signal from the transducer, and convert the return signal into a first indication corresponding to a characteristic of blow flow in the patient's vessel, wherein the first indication is a visible indication including a plurality of bars, wherein each respective bar of the plurality of bars represents a blood velocity threshold.
6. 6 . The monitoring system of claim 5 , wherein the monitor is further configured to convert the return signal into a second indication, wherein the second indication is an audible indication.
7. 7 . The Doppler blood flow monitoring system of claim 5 , wherein the vascular coupler is a first vascular coupler and the transducer is a first transducer, and wherein the first vascular coupler and the first transducer are associated with a first channel of the monitor, and which further comprises: a second vascular coupler positioned about a different vessel of the patient; a second transducer, wherein the second vascular coupler and the second transducer are associated with a second channel of the monitor, wherein the first vascular coupler and the first transducer are connected to a first input connector port of the monitor via a first external lead, the first input connector port is associated with the first channel, the second vascular coupler and the second transducer are connected to a second input connector port of the monitor via a second external lead, the second input connector port is associated with the second channel; and the monitor is further configured to: generate another signal to send to the second transducer, receive a different return signal from the second transducer, and convert the different return signal into a primary indication and a secondary indication corresponding to a characteristic of blow flow in the different vessel of the patient.
8. 8 . The monitoring system of claim 7 , wherein the primary indication is an audible indication and the secondary indication is a visible indication.
9. 9 . The monitoring system of any of claim 5 , wherein the signal emitted from the transducer is at least one of a pulsed ultrasonic signal and a pulse wave Doppler signal, and wherein the signal generated by the monitor is at least one of a pulsed ultrasonic signal and a pulse wave Doppler signal.
10. 10 . The monitoring system of claim 5 , wherein the transducer is removably retained within the vascular coupler.
11. 11 . The monitoring system of claim 5 , wherein the vascular coupler is adapted to permit the transducer to be later removed from a receptacle of the vascular coupler.
12. 12 . The monitoring system of claim 5 , wherein the monitor is further configured to filter the return signal prior to converting the return signal into the first indication.
13. 13 . The monitoring system of claim 12 , wherein filtering the return signal includes applying a frequency adjustment to the signal, wherein the frequency adjustment is applied to the return signal prior to wave shaping the return signal, wherein the frequency adjustment is a frequency boost between 150 Hz and 300 Hz.
14. 14 . The monitoring system of claim 5 , wherein the transducer comprises a piezoelectric crystal.
15. 15 . A remote monitoring system comprising: a monitor configured to: generate a signal to send to a transducer positioned within a vascular coupler, wherein the vascular coupler is positioned about a patient's vessel, the transducer is configured to emit an ultrasonic signal based on the signal generated by the monitor, and the ultrasonic signal is transmitted through the patient's vessel, receive a return signal from the transducer, and convert the return signal into a first indication corresponding to a characteristic of blood flow in the patient's vessel, wherein the first indication is a visible indication including a plurality of bars, wherein each respective bar of the plurality of bars represents a blood velocity threshold; and a remote database configured to: receive one or more files associated with the first indication, and store the one or more files associated with the first indication, wherein the one or more files are remotely accessible via a user device.
16. 16 . The remote monitoring system of claim 15 , wherein the monitor is further configured to filter the return signal prior to converting the return signal into the first indication.
17. 17 . The remote monitoring system of claim 16 , wherein filtering the return signal includes at least one of applying a low band-pass filter to the return signal, applying a high band-pass filter to the return signal, and applying a fast Fourier transform to the return signal.
18. 18 . The remote monitoring system of claim 15 , wherein filtering the return signal includes applying a frequency adjustment to the signal, wherein the frequency adjustment is applied to the return signal prior to wave shaping the return signal.
19. 19 . The remote monitoring system of claim 18 , wherein the frequency adjustment is a frequency boost between 150 Hz and 300 Hz.
20. 20 . The remote monitoring system of claim 15 , wherein the monitor is further configured to convert the return signal into a second indication, wherein the second indication is an audible indication, and wherein the remote database is configured to: receive one or more files associated with the second indication, and store the one or more files associated with the second indication, wherein the one or more files associated with the second indication are remotely accessible via a user device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/294,062, filed on May 14, 2021, which is the U.S. National Stage of International Application No. PCT/US2018/061191 filed on Nov. 15, 2018, entitled “VASCULAR MONITORING SYSTEM”. The entire disclosures of the foregoing applications are incorporated herein by reference in their entirety. BACKGROUND Plastic and reconstructive surgery regularly uses free flaps, for example in breast reconstruction. In free flap tissue surgery, a free flap (e.g., tissue and/or muscle and its associated artery and vein) is removed from one part of the body or donor site and is reattached to another part of the body or recipient site. The artery and vein of the transferred tissue and/or muscle are then anastomosed to a native artery and vein in order to achieve blood circulation in the transferred free flap (e.g., tissue and/or muscle). The anastomosis of the free flap tissue to the native tissue is typically done using microvascular techniques, including under microscopic visualization. In previous years, several surgical instruments and techniques have been developed to aid in anastomosis. One known system for creating an anastomosis is an anastomosis coupler, described in U.S. Pat. No. 7,192,400, the disclosure of which is incorporated herein by reference. This anastomotic coupler is a surgical instrument that allows a surgeon to more easily and effectively join together two blood vessel ends. The coupler involves the use of two fastener portions, in the shape of rings, upon which are secured respective sections of the vessel to be attached. Each fastener portion is also provided with a series of pins, and corresponding holes for receiving those pins, in order to close and connect the portions, and in turn the vessel, together (See FIGS. 7A, 7C and 7D). While free flap surgeries have a history of success, highly undesirable consequences of a flap failure still remain a possibility. One of the main causes of flap failure is a lack of blood being supplied to the flap tissue after the free flap is reattached at the recipient site. Things that commonly disturb circulation in a flap include vascular occlusion, hemorrhage, or infection. When not enough blood is supplied to the flap tissue, tissue necrosis results. However, if it can be recognized early enough that the flap is not receiving adequate circulation, it may be saved, or salvaged. The window of time for salvaging the flap after a lack of blood flow is recognized is very small. It is therefore critical that any lack of blood flow in a transferred flap be quickly recognized. Handheld Doppler probes, which are typically permanently positioned on the distal tip of a pen-like device instead of being placed or left within the body, are helpful in blood flow monitoring, but they suffer from several drawbacks. One drawback with handheld probes is their inability to be reliably positioned about a vessel. It is of great importance after microvascular surgery to monitor the region of the surgery in order to make sure that the blood flow is maintained at the desired level and that no problems, such as thromboses have occurred. Should thrombosis occur, the transferred tissue would die. Other indirect means of monitoring the functioning of blood flow through blood vessels, which have been subjected to microvascular surgery, are also often inadequate. For example, surface temperature measurements, transcutaneous PO2 monitoring, photo plethysmography and laser Doppler flow meters have been employed. However, these approaches generally require an accessible exposed portion of the flap. Additionally, buried free tissue transfers and intraoral flaps cannot be monitored effectively by these methods. SUMMARY The present disclosure provides improved vascular monitoring systems, devices and methods to improve the accessibility, detection and/or reliability of detecting blood flow to confirm vessel patency at an anastomotic site. In one example embodiment, a Doppler blood flow monitoring device includes a signal generation module, a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface. The signal generation module is configured to send a signal to a probe positioned in a probe receptacle on a vascular coupler positioned about a patient's vessel. The signal reception module is configured to receive a return signal from the probe. The signal filtration module is configured to filter the return signal. The signal conversion module is configured to convert the filtered signal into an audible indication and a visual indication corresponding to a characteristic of blood flow in the patient's vessel. The at least one speaker is configured to emit the first audible indication. Additionally, the user interface is configured to display the visual indication. In another example embodiment, a Doppler blood flow monitoring system incl