VASCULAR MONITORING COLLAR

Abstract

A vascular monitoring system includes a collar designed to be placed around a patient's blood vessel and a transducer attached to the collar. The collar may consist of a strap that wraps around the patient's vessel and is held in a closed position. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's blood vessel.

Description

VASCULAR MONITORING COLLAR Related requests This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 959,587 filed on January 10, 2020, entitled VASCULAR MONITORING COLLAR and U.S. Provisional Patent Application No. 63 / 037,772 filed on June 11, 2020, entitled VASCULAR MONITORING COLLAR, which are incorporated herein by reference in their entirety. Background of the invention Plastic and reconstructive surgery commonly 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 taken from one part of the body or donor site and reattached to another part of the body or recipient site. The artery and vein of the transferred tissue and / or muscle are anastomosed to an artery and vein at the recipient site to establish blood circulation in the transferred free flap (e.g., tissue and / or muscle). The anastomosis of the free flap tissue to the recipient site tissue is usually performed using microvascular techniques, even under microscopic visualization. In previous years, several surgical instruments and techniques have been developed to assist in the anastomosis. One known system for creating an anastomosis is an anastomosis coupler, described in U.S. Patent Application No. 7,192,400, disclosure of which is incorporated herein by reference. This anastomosis coupler is a surgical instrument that enables the surgeon to more easily and effectively join the ends of two blood vessels. The coupler involves the use of two clamping portions, in the form of rings, onto which the respective sections of the vessel to be joined are fixed.Each closing portion is also provided with a series of pins and the corresponding holes to receive said pins, in order to close and connect the portions, and in turn the cup, to each other. Although free flap surgeries have a history of success, the highly undesirable consequences of flap failure remain a possibility. One of the main causes of flap failure is a lack of blood supply to the flap tissue after the free flap is reattached to the recipient site. Factors that commonly disrupt circulation in a flap include vascular occlusion, hemorrhage, or infection. When insufficient blood is supplied to the flap tissue, tissue necrosis occurs. However, if the flap is recognized early enough that it is not receiving adequate blood flow, it can be salvaged. The window of opportunity to save the flap after recognizing a lack of blood flow is very small. Therefore, it is critical to quickly recognize any lack of blood flow in a transferred flap. Handheld Doppler probes, which are typically permanently attached to the distal tip of a pen-like device rather than being placed or left inside the body, are useful for monitoring blood flow, but they have several drawbacks. One of the drawbacks of handheld Doppler probes is that they are not always easily accessible. Qbconn / zznz / B / YiAi manual probes are unable to reliably position themselves around a vessel. After microvascular surgery, it is crucial to monitor the surgical site to ensure that blood flow remains at the desired level and that no problems, such as thrombi, have developed. If thrombosis were to occur, the transferred tissue would die. Other indirect methods for monitoring blood flow through vessels that have undergone microvascular surgery are also often inadequate. For example, surface temperature measurements, transcutaneous POa monitoring, photoplethysmography, and laser Doppler flowmeters have been used. However, these approaches generally require an accessible, exposed portion of the flap. Furthermore, buried free tissue transfers and intraoral flaps cannot be effectively monitored using these methods. Brief description of the invention This disclosure provides improved vascular monitoring straps and collars, which can be used with vascular monitoring systems, devices, and methods to improve accessibility, detection, and / or reliability of blood flow detection to confirm vessel patency at an anastomotic site. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a first exemplary aspect of this disclosure, a vascular monitoring system includes a collar configured to be placed around a patient's vessel and a transducer attached to the collar. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of the above aspects, the collar includes at least one eyelet that is adapted to be sutured to adjacent tissue to securely position the collar around the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar includes a probe holder sized and shaped to receive the transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer attaches to the collar by means of a friction fit with the probe holder. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar is made of at least one of the following: implant-grade liquid silicone rubber (“LSR”) and high-consistency silicone rubber (“HCR”) with a durometer between 40 and 80. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar is configured to be placed around a patient vessel anastomosis site. According to another illustrative aspect of this disclosure, which can be used Qbconn / zznz / B / YiAi combined with one or more of any of the above aspects, the collar is configured to be placed in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is removably attached to the collar. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a second illustrative aspect of this disclosure, a vascular collar includes a cylindrical body portion with an opening. The opening has an inside diameter sized and shaped to be placed around a patient's vessel. The vascular collar also includes a probe holder and at least one mounting tab. The probe holder is configured to receive a transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the inside diameter is between 1.0 mm and 4.0 mm. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a third exemplary aspect of this disclosure, a vascular monitoring system includes a collar configured to be placed around a patient's vessel. The collar is configured to switch from an open to a closed configuration. The vascular monitoring system also includes a transducer attached to the collar. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar includes at least one closure structure configured to keep the collar in the closed configuration. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, at least one closure structure includes a first eyelet and a second eyelet. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, at least one closure structure is adapted to be sutured to adjacent tissue to securely position the collar around the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar includes a probe holder sized and shaped to receive the transducer. According to another illustrative aspect of this disclosure, which can be used Qbconn / zznz / B / YiAi combined with one or more of any of the above aspects, the transducer attaches to the collar by means of a friction fit with the probe holder. According to another exemplary aspect of the present disclosure, which may be used in combination with one or more of the above aspects, the neck is made of at least one of the implant-grade liquid silicone rubbers (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar is configured to be placed around a patient vessel anastomosis site. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the collar is configured to be placed in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is removably attached to the collar. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a fourth illustrative aspect of this disclosure, a vascular collar includes a body portion configured to transition from an open to a closed configuration. The body portion has an opening in the closed configuration, and the opening has an inside diameter sized and shaped to fit around a patient's vessel. The vascular collar also includes a probe holder and at least one mounting tab. The probe holder is configured to receive a transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the mounting tab includes a locking feature that is adapted to retain the collar in the closed configuration after moving from the open configuration to the closed configuration. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the body portion is made of a flexible / malleable material that allows the body portion to go from the open configuration to the closed configuration when a closing force is applied to the collar. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a fifth illustrative aspect of this disclosure, a vascular monitoring system includes a strap configured to be placed around a patient's vessel, a closure configured to maintain the strap in a closed configuration around the patient's vessel, and a transducer attached to the strap. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. According to another illustrative aspect of this disclosure, which can be used Qbconn / zznz / B / YiAi combined with one or more of any of the above aspects, the strap includes at least one eyelet that is adapted to be sutured to adjacent tissue to securely position the strap around the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the strap includes a probe holder sized and shaped to receive the transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is attached to the strap by means of a friction fit with the probe holder. According to another exemplary aspect of this disclosure, which may be used in combination with one or more of the above aspects, the strap is made of at least one of the following: implant-grade liquid silicone rubber (LSR), high-consistency silicone rubber (HCR), high-density polyethylene (HDPE), Nusil 4750, Nusil 4840, and a thermoplastic. According to another illustrative aspect of the present disclosure, which may be used in combination with one or more of any of the above aspects, the strap, in its closed configuration, is configured to be placed around a patient vessel anastomosis site. According to another exemplary aspect of the present disclosure, which may be used in combination with one or more of the above aspects, the strap, in its closed configuration, is configured to be placed in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is removably attached to the collar. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In a sixth exemplary aspect of this disclosure, a vascular strap includes an elongated strap body having a first end and a second end, a plurality of adjustment holes positioned along the strap body beginning near the first end, and a locking tab positioned adjacent to the second end of the strap body. The locking tab is sized and shaped to snap through one of the adjustment holes, and the locking tab is configured to maintain the vascular strap in a closed configuration when snapped through the adjustment hole. The closed configuration has a cylindrical shape with an inside diameter sized and shaped to be placed around the patient's vessel.In addition, the vascular strap includes a probe holder and at least one mounting tab. The probe holder is configured to receive a transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the inside diameter is between 1.0 mm and 4.0 mm. According to another illustrative aspect of this disclosure, which can be used Qbconn / zznz / B / YiAi combined with one or more of any of the above aspects, the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. The aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. In a seventh illustrative aspect of this disclosure, a vascular monitoring system includes a strap configured to transition from an open to a closed configuration. The strap, which forms a collar when placed in the closed configuration, is configured to be placed around a patient's vessel. The vascular monitoring system also includes a transducer attached to the collar. Furthermore, the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the strap includes at least one closure structure configured to keep the strap in the closed configuration. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, at least one closure structure includes a clamp, a snap, and a band. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the at least one closure structure includes a tab and an adjustment hole. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the strap includes a probe holder sized and shaped to receive the transducer. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the transducer is attached to the strap by means of a friction fit with the probe holder. According to another exemplary aspect of the present disclosure, which may be used in combination with one or more of the above aspects, the strap is made of at least one of the following: implant-grade liquid silicone rubbers (LSR), high-consistency silicone rubber (HCR), high-density polyethylene (HDPE), Nusil 4750, Nusil 4840, and a thermoplastic. The aspects of the subject matter described herein may be useful alone or in combination with one or more aspects described herein. In an eighth illustrative aspect of this disclosure, a vascular strap includes a base portion and a saddle portion extending from the base portion. The saddle portion has a proximal end and two respective distal ends. The vascular strap also includes two respective band portions extending from the respective distal ends of the saddle portion. The saddle portion and the two respective band portions are sized and shaped to be placed around the patient's vessel. In addition, the vascular strap includes a probe holder formed within the base portion, the probe holder configured to receive a transducer. According to another illustrative aspect of this disclosure, which can be used Qbconn / zznz / B / YiAi combined with one or more of any of the above aspects, the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the vascular strap includes at least one eyelet that is adapted to be sutured to adjacent tissue to securely position the strap around the patient's vessel. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the probe holder includes a receptacle sized and shaped for the transducer to attach to the strap through a friction fit with the probe holder receptacle. According to another exemplary aspect of the present disclosure, which may be used in combination with one or more of the above aspects, the neck is made of at least one of the implant-grade liquid silicone rubbers (LSR'j) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80. According to another illustrative aspect of the present disclosure, which may be used in combination with one or more of any of the above aspects, the mounting portion and the two respective band portions are sized so that when the vascular strap is closed to form a neck around a vessel, the inside diameter of the neck is between 1.0 mm and 4.0 mm. According to another illustrative aspect of this disclosure, which may be used in combination with one or more of any of the above aspects, the strap includes at least one closure structure configured to keep the strap in the closed configuration. Therefore, one advantage of this disclosure is to improve the accessibility of blood flow data. Another advantage of this disclosure is to improve the detection of blood flow to confirm vessel patency. Another advantage of this disclosure is that it provides remote monitoring of blood flow at an anastomotic site. Yet another advantage of this disclosure is to reduce the occurrence of free flap failures and serious adverse events due to insufficient blood flow in a free flap. Yet another advantage of this disclosure is to provide a system, device and / or method for the early detection of insufficient blood flow or circulation in a free flap. Other features and advantages of the disclosed vascular monitoring collar are described in the following detailed description and figures, and will be apparent from them. The features and advantages described herein are not exhaustive, and in particular, many additional features and advantages will be apparent to a person skilled in the art from the figures and description. Furthermore, any particular modality does not necessarily have all the advantages listed herein. It should also be noted that the language used in the descriptive specification has been selected primarily for readability and instruction, and not to limit the scope of the inventive subject matter. Qbconn / zznz / B / YiAi Brief description of the figures Figure 1 is a schematic view of a probe cable system according to an example embodiment of this disclosure. Figure 2 is a perspective view of a vascular collar with a transducer attached to the collar according to an exemplary modality of the present disclosure. Figures 3A, 3B, and 3C illustrate a vascular collar and transducer placed around a patient's vessel according to an exemplary modality of this disclosure. Figure 4A is a perspective view of another example of a vascular collar in an open configuration with a transducer attached to the collar according to an exemplary modality of the present disclosure. Figure 4B is a perspective view of the vascular collar of Figure 4A in the closed configuration according to an exemplary modality of the present disclosure. Figures 5A, 5B, and 5C illustrate a vascular collar and transducer that are placed around a patient's vessel according to an exemplary modality of this disclosure. Figure 6 is a perspective view of a vascular strap forming a vascular neck according to an exemplary modality of the present disclosure. Figure 7A is a perspective view of a vascular strap forming a vascular neck according to an exemplary modality of the present disclosure. Figure 7B is a front view of a vascular strap forming a vascular neck according to an exemplary modality of the present disclosure. Figure 7C is a cross-sectional view of the vascular belt of Figure 7B along line 7C-7C according to an exemplary modality of the present disclosure. Figures 8A and 8B illustrate a vascular strap and transducer that are placed around a patient's vessel to form a vascular collar according to an exemplary modality of this disclosure. Figures 9A and 9B illustrate a vascular strap and transducer that are placed around a patient's vessel to form a vascular collar according to an exemplary modality of this disclosure. Detailed description of the example modalities As discussed previously, a vascular monitoring collar is provided to improve the accessibility, detection, and / or reliability of blood flow detection to confirm vessel patency at an anastomotic site. Although free flap surgeries have a history of success, the highly undesirable consequences of flap failure remain a possibility. One of the main causes of flap failure is insufficient blood supply to the flap tissue after the free flap is reattached to the recipient site. Factors that commonly disrupt circulation in a flap include vascular occlusion, hemorrhage, or infection. When insufficient blood is supplied to the flap tissue, tissue necrosis results. Qbconn / zznz / B / YiAi However, the vascular monitoring collar disclosed herein advantageously allows for the early detection of insufficient blood flow or circulation in a free flap, so that it can be saved or rescued before tissue necrosis. The vascular monitoring collar described above can be used to monitor blood flow at, upstream of, or downstream of the anastomosis site to confirm vessel patency during a surgical procedure, such as free flap transfer microvascular reconstruction. The collar can be used in conjunction with a monitoring system in various settings, such as a hospital operating room or post-anesthesia care unit, to detect blood flow and confirm vessel patency (in situ or remotely) both intraoperatively and postoperatively. Free flap transfer can be used to reconstruct body parts operated on for cancer and injuries using the patient's own tissue.Examples include breast reconstruction, tongue reconstruction, jaw and cheek reconstruction, and hand and foot reconstruction following traumatic injuries. Typically, the microvascular anastomosis is the critical point of the surgery, determining the flap's success. By providing blood flow monitoring capabilities at the anastomosis site, the vascular monitoring collar disclosed here enables the early detection of low or no blood flow within the flap tissue. This allows a physician (e.g., a surgeon) to take corrective action before necrosis develops and the free flap becomes unusable. The vascular monitoring collar can be used in conjunction with a flow monitoring system that includes multi-component probe systems, such as that described in document PCT / US2018 / 061191 (“Vascular Monitoring System, Device and Method”), the disclosure of which is incorporated herein by reference. As illustrated in Figure 1, a probe assembly 100 may include a probe connector 110 that can be connected to a probe monitoring system. The probe assembly 100 may also include a suture handle 120 configured for fixation (e.g., by sutures) to a patient's body or clothing. The suture handle 120 may be made of medical-grade material suitable for contact with human skin, e.g., USP Grade V or VI material. Several alternative methods, such as adhesive patches and pads, may be used to fix the probe assembly 100 or the cable to the skin. The suture handle 120, adhesive pad, or alternative approaches may be fixed to the skin such that the force required to remove the pad or alternative approaches from the skin is greater than the force required to remove the probe. A probe cable 130 extends from probe connector 110. At the end of probe cable 130 is a probe end component 140, such as a collar (see Figures 2 to 8B) and / or the Doppler probe or transducer that attaches (e.g., by pressing) into the collar. In one example, the probe end component 140 may include a transducer that attaches removably to a separate collar. In another example, the probe end component 140 may be an assembly of QbCQnn / zznz / B / viAi collar and transducer (see figures 2 to 8B). Figure 2 illustrates an example of a “probe end” component 140a. As illustrated in Figure 2, a collar 200 may include eyelets 210a and 210b that provide a gripping surface for a clinician and also allow the collar 200 to anchor to adjacent tissue, as illustrated later in Figures 3B and 3C. The collar 200 also includes a probe holder 220 configured to receive a Doppler probe or transducer 230. In one example, the Doppler probe or transducer 230 can be press-fitted into the probe holder 220. The probe holder 220 may include a receptacle configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and angle from a longitudinal axis of the collar 200. The receptacle of the probe holder 220 may have an octagonal or hexagonal profile.For example, the octagonal or hexagonal profile can provide multiple surfaces for friction coupling with the Doppler probe or transducer 230. In one example, the angle of the Doppler probe or transducer may be approximately 30 degrees from a flat end face of the collar 200 and therefore 120 degrees from the longitudinal axis of the collar 200. In another example, the angle may be between 30 and 60 degrees from the flat end face of the collar 200 and therefore between 120 and 150 degrees from the longitudinal axis of the collar 200. As illustrated in Figure 2, the collar 200 has an inner diameter (D) 240 and a collar width (Width) 250. The collar 200 can be sized and shaped (e.g., ring-shaped) to fit a vessel of similar size (e.g., an artery or vein). For example, the collar 200 can have an inner diameter (D) 240 between 1.0 mm and 4.0 mm. The collar width (Width) 250 can be between 2.5 mm and 5.0 mm to provide stability to the vessel. The collar 200 can be made of silicone, such as liquid silicone rubber (LSR) or high-consistency silicone rubber (HCR). The silicone can have a durometer between 40 and 80 (e.g., Shore A) and a tear strength between 240 and 350 ppi. The silicone described above allows the collar 200 to conform to the vessel surface. In other examples, the collar 200 can be made of high-density polyethylene (HDPE). Alternatively, the collar 200 can be made of Nusil 4750, Nusil 4840, a thermoplastic, or similar material. The collar 200 can also be made of other flexible or malleable materials. In one example, the collar 200 is permanently implanted in the patient. Furthermore, the collar can also be bioabsorbable. As illustrated in Figures 3A, 3B, and 3C, the size and shape of the 200 collar (e.g., ring-shaped) are adapted so that it fits a vessel of similar size (e.g., artery or vein). As discussed previously, the collar can have an internal diameter (De) 240 between 1.0 mm and 4.0 mm. In one example, the internal diameter (De) 240 of the 200 collar can be provided in 0.5 mm increments. It should be appreciated that the 200 collar can be sized and shaped to accommodate vessels (e.g., veins and arteries) typically encountered in microsurgical and vascular reconstruction procedures and is adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. For example, Figures 3A and 3B illustrate the necklace 200 placed over a glass 300 and its advance along it before Qbconn / zznz / B / YiAi of an anastomosis. The collar 200 can be positioned near the anastomosis site, either at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. Once the collar 200 is in its intended location along the vessel 300, it can be anchored to the adjacent tissue by suturing loops 210a and 210b to the adjacent tissue. Suturing loops 210a and 210b to the adjacent tissue can advantageously provide tension relief for the removal of the Doppler probe 230, as illustrated in Figure 3C. Figures 3B and 3C illustrate the use of sutures 305 to fix the collar 200, and more specifically the eyelets 210a and 210b, to the adjacent tissue. It should be noted that other fixation methods, such as staples, clips, etc., may be used. Figures 4A and 4B illustrate another example of the “probe end” component 140 and an example of collar 200. Figure 4A illustrates collar 200 in an open configuration, while Figure 4B illustrates collar 200 in a closed configuration. Similar to collar 200 illustrated in Figure 2, the collar 200 illustrated in Figures 4A and 4B may include eyelets 210a and 210b that provide a gripping surface for a clinician and also allow the collar 200 to be anchored to adjacent tissue. For example, the clinician can grasp eyelets 210a and / or 210b with forceps, clamps, or another medical tool while placing collar 200. Once collar 200 is in place, the clinician can squeeze eyelets 210a and 210b to close the collar and suture the two eyelets 210a and 210b to maintain the collar in the closed configuration (see Figure 5B). Once collar 200 is closed around the vessel, the clinician can suture eyelets 210a and / or 210b to the surrounding tissue.The collar 200 also includes a probe holder 220 configured to receive a Doppler probe or transducer 230. In one example, the Doppler probe or transducer 230 can be press-fitted into the probe holder 220. The probe holder 220 may include a receptacle configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and angle from a longitudinal axis of the collar 200 when the collar 200 is in the closed configuration. In one example, the angle of the Doppler probe or transducer 230 may be approximately 30 degrees from a flat end face of the collar 200 and therefore 150 degrees from the longitudinal axis of the collar 200 when the collar 200 is in the closed configuration.In another example, the angle can be between 30 degrees and 60 degrees from the flat end face of collar 200 and therefore between 120 and 150 degrees from the longitudinal axis of collar 200. The collar 200 can be made of flexible or malleable materials that allow it to transition between open and closed configurations. In one example, the collar 200 is permanently implanted in the patient. Furthermore, the collar 200 can also be bioabsorbable. For example, the collar 200 illustrated in Figures 4A, 4B, 5A, 5B, and 5C can have the same material properties as the collar 200 illustrated in Figures 2, 3A, 3B, and 3C. As illustrated in Figure 4A, the Collar 200 starts in an open configuration and can be placed along a vessel even if the vessel has not been sectioned or cut for an anastomosis. For example, the Collar 200 can be placed along an uncut vessel to monitor blood flow through that vessel. The collar illustrated in Figures 4A and 4B can also be pushed along a vessel before or after an anastomosis has been completed, which Qbconn / zznz / B / YiAi advantageously provides flexibility during a surgical operation. Similar to the collar 200 illustrated in Figures 2, 3A, 3B, and 3C, the collar 200 in Figures 4A and 4B can be positioned near the anastomosis site, either at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. Figures 5A, 5B, and 5C illustrate the placement of collar 200 on vessel 300. Collar 200 can be sized and shaped (e.g., clamp-shaped) so that it fits a vessel 300 of similar size (e.g., an artery or vein). For example, collar 200 can have an inside diameter (De) 240 similar to that of collar 200 in Figure 2, when in the closed configuration, between 1.0 mm and 4.0 mm. In one example, the inside diameter (De) 240 of collar 200 in the closed position can be provided in 0.5 mm increments. It should be appreciated that the 200 collar can be sized and shaped to accommodate vessels (e.g., veins and arteries) typically encountered in microsurgical and vascular reconstruction procedures and is adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system.Once the collar 200 has been positioned in its intended location along the vessel 300, the collar 200 can be closed by suturing loops 210a and 210b so that the collar 200 remains in the closed configuration. The collar 200 can also be anchored to the adjacent tissue by suturing loops 210a and / or 210b to the adjacent tissue. Suturing loops 210a and 210b to the adjacent tissue can advantageously provide tension relief for the removal of the Doppler probe 230, as illustrated in Figure 5C. Figures 5B and 5C illustrate sutures 305 as a means of maintaining the collar 200 in the closed configuration. It should be appreciated that other means of fixation, such as staples, clips, etc., can be used to maintain the collar 200 in the closed configuration. Figure 6 illustrates another form of a 600a collar or leash. For example, as illustrated in Figure 6, the 600a leash may include one or more 610 eyelets that provide a gripping surface for a clinician and also allow the 600a collar or leash to be anchored to adjacent tissue. The collar or strap 400 also includes a probe holder 220 configured to receive a Doppler probe or transducer 230. Similar to the modalities described in Figures 2 to 5C, the Doppler probe or transducer 230 can be snapped into the probe holder 220. As mentioned above, the probe holder 220 may include a receptacle 620 configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and angle from a longitudinal axis of the collar or strap 600a when the strap 600a is closed around a vessel.The receptacle 620 of the probe holder 220 may be similar in size and shape to the probe holder illustrated in Figures 2 to 5C. For example, the probe holder 220 may have an octagonal or hexagonal profile that provides multiple surfaces for friction coupling with the Doppler probe or transducer 230. In one example, the angle of the Doppler probe or transducer 230 may be approximately 30 degrees to 60 degrees from a flat end face of the collar or strap 600a and therefore 120 degrees to 150 degrees from the longitudinal axis of the collar formed by the strap 600a when the strap 600a is closed around the vessel. The 600a collar or leash may be made of high-density polyethylene (“HDPE”). In a For example, the 600a strap may be made of silicone, such as implant-grade liquid silicone rubber (“LSR”) or high-consistency silicone rubber (“HCR”). The silicone may have a durometer between 40 and 80 (e.g., Shore A) and a tear strength between 240 and 350 ppi. The silicone described above allows the collar or strap to conform to the vessel surface while providing a robust material that can withstand the stresses associated with closing the 600a strap around a vessel. In other examples, the 600a strap may be made of Nusil 4750, Nusil 4840, a thermoplastic, or similar material. The 600 strap may be made of other flexible or malleable materials so that the 600a strap is adapted to wrap around a patient's vessel. In one example, the 600a strap is permanently implanted in the patient and can be bioabsorbable. Once the 600a strap is wrapped around the patient's vessel and held in its closed position, it resembles a closed collar. The 600a strap has a strap width (Anche) 650 and a strap length (Longc) 660. The strap width (Anche) can be between 2.5 mm and 5.0 mm to provide stability to a vessel. The strap length (Longc) 660 can be long enough to allow the 600a strap to wrap around a vessel and also long enough for closure (see Figures 8A and 8B). For example, the 600a strap can be sized and shaped so that when closed, it forms a collar that fits a vessel of similar size (e.g., an artery or vein). For example, the collar formed by the closed 600a strap can have an inside diameter of between 1.0 mm and 4.0 mm. In one example, the 600a belt can be supplied in increments of approximately 1.5 mm to accommodate different vessel sizes (e.g., vessel sizes that differ in increments of approximately 0.5 mm). It should be appreciated that the 600a strap can be sized and shaped to accommodate vessels (e.g., veins and arteries) typically encountered in microsurgical and vascular reconstruction procedures and is adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. Figures 7A, 7B, and 7C illustrate another exemplary form of a 600b strap. The 600b strap may include a base portion 710, a mounting portion 720, and a band portion 730. The probe holder 220 may be formed as part of the base portion 710, which provides stability to the 600b strap and also offers a gripping surface for a clinician when manipulating and positioning the 600b strap. The mounting portion 720 has a proximal end 722 and two respective distal ends 724a, b. The mounting portion 720 may extend from the base portion 710 at the proximal end of the mounting portion 722. A respective band portion 730 extends from each end of the mounting portion 720. For example, each respective band portion 730 can be extended from the respective distal end 724a,b of the saddle portion 720. The saddle portion 720 and the respective band portions 730 can be found at a junction 725 (e.g., the respective distal ends 724a,b of saddle portion 720). When strap 600b is extended in a more open configuration, a first end of strap 600b would be a band portion 730, followed by a first part of saddle portion 720 and base portion 710, then strap 600b would continue to a second part of saddle portion 730 and another respective band portion 730. In one example, the saddle portion 720 extends outward from the base portion 710 and forms a contact surface 740 for a portion of a vessel. The contact surface 740 may be shaped like an inverted or upside-down saddle, creating a bowl-like surface. For example, the saddle portion 720 may be flexible while maintaining sufficient rigidity to create a preformed contact surface 740. Alternatively, the saddle portion 720 and the band portion 730 may be flexible and elastic enough to allow the band 600b to lie flat on a horizontal surface when the contact surface 740 is adjacent to that surface. As illustrated in Figures 7B and 7C, the base portion 710 has a height (AIbase) 750 and a width (AnchBASE) 760. The height (AHbase) 750 can be approximately 2.25 mm and the width (AnchBASE) 760 can be between 2.5 mm and 5.0 mm. Wider base portions 710 can be implemented to give the vessel additional stability. Furthermore, the mounting portion 720 has a height (Alte) 752, which can be approximately 2.65 mm. The distance 764 between each end of the mounting portion 720 (for example, at the junction 725) can be approximately 4.0 mm. The band portion 730 has a height (Aíband) 754, which can be approximately 6.0 mm. When the belt 600b is in a relaxed position (as illustrated in Figure 7B), especially with a mounting portion 720 that retains its shape, the distance 766 between each end of the band portions 730 can be approximately 5.0 mm. The belt portion can have a wall thickness (Espbanda) 770 between approximately 0.1 mm and approximately 0.3 mm. The wall thickness (Espbanda) 770 can be selected and configured based on a closure mechanism for the 600b belt. For example, different closure clamps may be compatible with different wall thicknesses. Furthermore, the wall thickness (Espbanda) 770 can be selected to increase or decrease the flexibility, stiffness, and / or durability of the 600b belt. The 600b belt can have a width (AncheoRREA) 762 at the end of the 730 belt portion of approximately 2.5 mm to 5.0 mm. Like the wall thickness (Espbanda) 770, the width (AncheoRREA) 762 can be selected to increase or decrease the flexibility, stiffness, and / or durability of the 600b belt. Additionally, the width (AncheoRREA) 762 can be selected and configured based on a 600b strap locking mechanism.For example, different closure clamps may be compatible with different strap widths. The dimensions of the 720 mounting portion and the 730 band portions can be adjusted to accommodate different vessel sizes. For example, the band portion can be tall enough to provide an adequate sealing surface after the 600b strap is closed around a vessel with a diameter between 1.0 mm and 4.0 mm. It should be appreciated that the 600ab strap can be sized and shaped to accommodate vessels (e.g., veins and arteries) typically encountered in microsurgical and vascular reconstruction procedures and is adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. QfrCQnn / zznz / E / YiAi As illustrated in Figure 7C, which is a cross-sectional view around line 7C7C in Figure B, the probe holder 220 receptacle 620 may have a tapered profile with a cylindrical transition region 780. The diameter of the cylindrical transition region 780 may be between 0.015 in. and 0.030 in. (e.g., 0.38 mm and 0.76 mm). Cylindrical transition regions 780 with smaller diameters may provide a tighter grip or clamping force on a corresponding Doppler probe or transducer 230. The probe holder 220 may be oriented at an angle 782 between 120 and 150 degrees with respect to the longitudinal axis of the collar formed by the closed strap 600b. Figures 8A and 8B illustrate an example of the placement of a belt, such as belt 600a or belt 600b, around a 300 vessel. Belts 600a and 600b may be generally referred to as belt 600 hereafter. The belt 600 illustrated in Figures 8A and 8B may include each of the features of belt 600a described in Figure 6, each of the features of belt 600b, or a combination thereof. As illustrated in Figure 8B, a strap assembly 800 may include a clamp 810, a snap, a band, or other locking mechanism that holds the strap 600 in a closed configuration around a cup 300 so that the strap 600 forms a collar around the cup 300. For example, Figures 8A and 8B illustrate the strap 600 wrapped around a cup 300 to form a collar.The collar formed by the 600 strap can be positioned near the anastomosis site, either at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. After the 600 strap is wrapped around the 300 vessel and held in its closed orientation (e.g., forming a collar) and positioned along the 300 vessel, the collar can be anchored to the adjacent tissue by suturing one or more loops (see Figure 6) to the adjacent tissue. Similar to the methods described in Figures 3C and 5C, suturing the loops to the adjacent tissue can advantageously provide tension relief for Doppler probe withdrawal. Figures 9A and 9B illustrate another exemplary embodiment of a 600c strap with a closure mechanism different from the clip, snap, or band illustrated in Figure 8B. For example, the 600c strap may include multiple adjustment holes 910 that are spaced along the length of the 600c strap and are adapted to maintain the 600c strap in a closed configuration when adjusted over a closure tab 920. For example, the adjustment holes 910 may be sized and shaped so that they can be pressed onto a closure tab 920. The adjustment holes 910 may be spaced along the 600c strap with a gap of approximately 1.5 mm between each hole to accommodate different cup sizes (for example, container sizes that differ in increments of approximately 0.5 mm). The spacing between each 910 adjustment hole can be 1.0 mm or some other interval to accommodate different ranges of cup sizes. As discussed above, the 600a, 600b, and 600c belts described herein can be sized and shaped to suit specific cup sizes, such that one belt is configured for cups between 1.0 and 2.0 mm, another belt is configured for cups between 2.0 and 3.0 mm, and a different belt is configured for cups between 3.0 and 4.0 mm. In the case when QbCQnn / zznz / B / viAi Different strap sizes or lengths are available to accommodate different vessel sizes. The 910 adjustment holes can be positioned closer together so that the strap can be adjusted to encircle a vessel between 1.0 and 2.0 mm in diameter in 0.2 mm increments (e.g., the 910 sized holes can be configured so that the strap can be adjusted to form a collar having an inside diameter of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, and 2.0 mm). It should be appreciated that the 600c strap can be sized and shaped, and the 910 adjustment holes can be positioned to accommodate vessels (e.g., veins and arteries) typically encountered in microsurgical and vascular reconstruction procedures and are adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. The 920 tab may include a flange or lip configured to hold the 600c belt in the closed configuration. For example, a 910 adjustment hole may be positioned over the 920 tab and press-fitted so that the 920 tab is driven through the 910 adjustment hole. The belt material may allow the adjustment hole to expand and flex to fit the flange or lip of the 920 tab before returning to its original shape. After the 920 tab is pushed through the 910 adjustment hole, the flange or lip is designed to prevent the 600c belt from unwinding to an open position. For example, the flange or lip may be sized and shaped so that the forces associated with the tendency of the strap to relax back to its open position are insufficient to cause the adjustment hole 910 to expand and flex to fit back over the flange or lip of the tab 920.The material of the 600c strap and the geometry of the 910 adjustment hole and tab are configured so that a physician can manipulate the 600c strap between an open configuration and a closed configuration, while preventing the 600c strap from opening without the physician's intervention. Like the strap illustrated in Figures 8A and 8B, the strap illustrated in Figures 9A and 9B may include each of the features of the strap described in Figure 6 or Figures 7A-7C. In addition, the straps illustrated in Figures 6, 7A-7C, 8A, 8B, 9A, and 9B may be configured and arranged so that, when in a closed configuration, the straps form a collar that is oriented similarly to the collars illustrated in Figures 2, 3A, 3B, 3C, 4B, 5B, and 5C.For example, the probe holder may include a receptacle configured to removably retain the Doppler probe or transducer at a predetermined distance and angle relative to a longitudinal axis of the collar formed by the strap when the strap is in the closed configuration (e.g., the angle of the Doppler probe or transducer may be approximately 30 degrees from a flat end face of the collar and therefore 120 degrees from the longitudinal axis of the collar formed by the strap when the strap is in the closed configuration). In another example, the angle may be between 30 degrees and 60 degrees from the flat end face of the 600 strap and therefore between 120 and 150 degrees from the longitudinal axis of the collar formed by the closed 600 strap. Detection devices, such as the Doppler probe or the transducer inserted in the collar, allow a doctor (e.g., a surgeon) to monitor and analyze blood flow and / or blood speed to determine the success of the surgery and / or confirm vessel patency. Qbconn / zznz / B / YiAi Any transducer suitable for ultrasonic Doppler monitoring can be used with the collar. In one example, the Doppler probe or transducer is made of an approved implantable material, such as HDPE or silicone. In another example, the transducer 230 comprises a piezoelectric crystal. The transducer 230 can be any size that fits the dimensions of a corresponding probe holder used in the collar. For example, a circular transducer 230 is suitable for a receptacle having a circular inner surface. In another example, the receptacle 620 formed by the probe holder can be octagonal or hexagonal (see Figure 3A) to provide a tighter friction fit with the Doppler probe or transducer tip. The transducer 230 can be a circular piezoelectric crystal with a size of approximately 0.5 mm to 1 mm.In one example, the Doppler probe or 230 transducer includes a tip with a circular piezoelectric crystal of approximately 0.5 mm to 1 mm, a coaxial cable coated with Teflon, and a metal connector. The Doppler probes attached to the collars or straps disclosed herein can be adapted to detect blood flow at the anastomosis site and confirm vessel patency intraoperatively and postoperatively. For example, blood flow can be detected postoperatively for up to approximately 14 days. The many features and advantages of this disclosure are evident from the written description, and therefore the appended claims are intended to cover all such features and advantages. Furthermore, since those skilled in the art may readily make numerous modifications and changes, this disclosure is not limited to the exact construction and operation illustrated and described. Therefore, the described embodiments should be considered illustrative and not restrictive, and the disclosure should not be limited to the details provided herein, but should be defined by the following claims and their full scope of equivalents, whether foreseeable or unforeseeable now or in the future.

Claims

1. A vascular monitoring system comprising: a collar configured to be placed around the patient's vessel; and a transducer attached to the collar, the transducer being configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

2. The monitoring system according to claim 1, wherein the collar includes at least one eyelet that is adapted to be sutured to the adjacent tissue to securely position the collar around the patient's vessel.

3. The monitoring system according to any of claims 1 or 2, wherein the collar includes a probe holder of the size and shape to receive the transducer.

4. The monitoring system according to claim 3, wherein the transducer is coupled to the collar by friction fit with the probe support.

5. The monitoring system according to any of claims 1 to 4, wherein the collar is made of at least one of implant-grade liquid silicone rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80.

6. The monitoring system according to any of claims 1 to 5, wherein the collar is configured to be placed around an anastomosis site of the patient's vessel.

7. The monitoring system according to any of claims 1 to 5, wherein the collar is configured to be placed in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site.

8. The monitoring system according to any of claims 1 to 7, wherein the transducer is removably coupled to the collar.

9. A vascular collar comprising: a cylindrical body portion with an opening, the opening having an inside diameter shaped and sized to fit around a patient's vessel; a probe holder configured to receive a transducer; and at least one mounting tab.

10. The vascular collar according to claim 9, wherein the internal diameter is between 1.0 mm and 4.0 mm.

11. The vascular collar according to any of claims 9 and 10, wherein the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

12. A vascular monitoring system comprising: a collar configured to be placed around a patient's vessel, the collar being configured to switch from an open configuration to a closed configuration; and a transducer coupled to the collar, the transducer being configured to emit an ultrasonic signal Qbconn / zznz / B / YiAi that is transmitted through the patient's vessel.

13. The system according to claim 12, wherein the collar includes at least one locking structure configured to maintain the collar in the closed configuration.

14. The system according to claim 13, wherein at least one closure structure includes a first eyelet and a second eyelet.

15. The system according to any of claims 13 and 14, wherein at least one closure structure is adapted to be sutured to adjacent tissue to securely position the collar around the patient's vessel.

16. The monitoring system according to any of claims 12 to 15, wherein the collar includes a probe holder of the size and shape to receive the transducer.

17. The monitoring system according to claim 16, wherein the transducer is coupled to the collar via a friction fit with the probe support.

18. The monitoring system according to any of claims 12 to 17, wherein the collar is made of at least one of the following: implant-grade liquid silicone rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80.

19. The monitoring system according to any of claims 12 to 18, wherein the collar is configured to be placed around an anastomosis site of the patient's vessel.

20. The monitoring system according to any of claims 12 to 18, wherein the collar is configured to be placed in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site.

21. The monitoring system according to any of claims 12 to 20, wherein the transducer is removably coupled to the collar.

22. A vascular collar comprising: a body portion configured to transition from an open configuration to a closed configuration, wherein the body portion has an opening in the closed configuration, the opening having an inside diameter of the size and shape to be placed around a patient's vessel; a probe holder configured to receive a transducer; and at least one mounting tab.

23. The vascular collar according to claim 22, wherein the mounting tab includes a locking feature that is adapted to retain the collar in the closed configuration after the transition from the open configuration to the closed configuration.

24. The vascular collar according to any of claims 22 and 23, wherein the body portion is made of a flexible / malleable material that allows the body portion to pass from the open configuration to the closed configuration when a closing force is applied to the collar.

25. A vascular monitoring system comprising: a strap configured to be placed around the patient's vessel; a clasp configured to keep the strap in a closed configuration around the patient's vessel; and a transducer attached to the strap, the transducer being configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

26. The monitoring system according to claim 25, wherein the strap includes at least one eyelet that is adapted to be sutured to adjacent tissue to securely position the strap around the patient's vessel.

27. The monitoring system according to any of claims 25 and 26, wherein the strap includes a probe holder of size and shape to receive the transducer.

28. The monitoring system according to claim 27, wherein the transducer is coupled to the belt by means of a friction fit with the probe support.

29. The monitoring system according to any of claims 25 to 28, wherein the strap is made of at least one of the following: implant-grade liquid silicone rubber (LSR), high-consistency silicone rubber (HCR), HDPE, Nusil 4750, Nusil 4840, and a thermoplastic.

30. The monitoring system according to any of claims 25 to 29, wherein the strap, in its closed configuration, is configured to be placed around an anastomosis site of the patient's vessel.

31. The monitoring system according to any of claims 25 to 29, wherein the strap, in its closed configuration, is configured to be positioned in a location that is one of the following: upstream of a patient vessel anastomosis site and downstream of the patient vessel anastomosis site.

32. The monitoring system according to any of claims 25 to 31, wherein the transducer is removably coupled to the collar.

33. A vascular strap comprising: an elongated strap body having a first end and a second end; a plurality of adjustment holes positioned along the strap body starting near the first end; a locking tab located adjacent to the second end of the strap body, wherein the locking tab is sized and shaped for press-fitting through one of the adjustment holes, the locking tab is configured to retain the vascular strap in a closed configuration when press-fitted through the adjustment hole, and the closed configuration has a cylindrical shape having an inside diameter sized and shaped to fit around the patient's vessel; a probe holder configured to receive a transducer; and at least one mounting tab.

34. The vascular belt according to claim 33, wherein the inner diameter is between 1.0 mm and 4.0 mm. Qbconn / zznz / B / YiAi 35. The vascular strap according to any of claims 33 and 34, wherein the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

36. A vascular monitoring system comprising: a strap configured to transition from an open configuration to a closed configuration, the strap forming a collar when placed in the closed configuration, the collar being configured to be placed around a patient's vessel; and a transducer coupled to the collar, the transducer being configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

37. The monitoring system according to claim 36, wherein the strap includes at least one locking structure configured to keep the strap in the closed configuration.

38. The system according to claim 37, wherein at least one closure structure includes a clamp, a clasp, and a band.

39. The system according to claim 37, wherein the at least one closing structure includes a tab and an adjustment hole.

40. The monitoring system according to any of claims 36 to 39, wherein the strap includes a probe holder of the size and shape to receive the transducer.

41. The monitoring system according to claim 40, wherein the transducer is coupled to the belt through a friction fit with the probe support.

42. The monitoring system according to any of claims 36 to 41, wherein the strap is made of at least one of the following: implant-grade liquid silicone rubber (LSR) and high-consistency silicone rubber (HCR) HDPE, Nusil 4750, Nusil 4840, and a thermoplastic.

43. A vascular strap comprising: a base portion; a saddle portion extending from the base portion, the saddle portion having a proximal end and two respective distal ends; and two respective band portions extending from the respective distal ends of the saddle portion, wherein the saddle portion and the two respective band portions are sized and shaped to be placed around a patient's vessel; and a probe holder formed within the base portion, which is configured to receive a transducer.

44. The vascular strap according to claim 43, wherein the transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel.

45. The vascular strap according to any of claims 43 and 44, wherein the vascular strap includes at least one eyelet that is adapted to be sutured to the adjacent tissue to securely position the strap over the patient's vessel.

46. ​​The vascular strap according to any of claims 43 to 45, wherein the probe holder includes a receptacle of size and shape for the transducer to be coupled to the Qbconn / zznz / B / YiAi strap via a friction fit with the receptacle of the probe holder.

47. The vascular strap according to any of claims 43 to 46, wherein the collar is made of at least one of the following: implant-grade liquid silicone rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80.

48. The vascular strap according to any of claims 43 to 47 wherein the mounting portion and the two respective band portions are of such size that when the vascular strap is closed to form a neck around a vessel, the inside diameter of the neck is between 1.0 mm and 4.0 mm.

49. The vascular strap according to any of claims 43 to 48, wherein the strap includes at least one closure structure configured to maintain the strap in the closed configuration.

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