Vascular monitoring collar

Abstract

A vascular monitoring system includes a collar configured to be positioned around a patient's blood vessel and a transducer coupled to the collar. The collar may be formed from a bandage that wraps around the patient's blood vessel and maintains it in a closed configuration. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's blood vessel.

Description

[0001] Related applications

[0002] This application claims the benefit of and priority to 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 ARMONITORING COLLAR,” both of which are incorporated herein by reference in their entireties. Background Art

[0003] Free flaps are often used in plastic and reconstructive surgery, such as in breast reconstruction. In free flap tissue surgery, a free flap (e.g., tissue and / or muscle and its associated arteries and veins) is removed from one part of the body or donor site and reattached to another part of the body or recipient site. The arteries and veins of the transplanted tissue and / or muscle are then anastomosed with native arteries and veins to establish blood circulation in the transplanted free flap (e.g., tissue and / or muscle).

[0004] The anastomosis of free flap tissue to native tissue is typically performed using microvascular techniques, including observation under a microscope. Over the past few years, several surgical instruments and techniques have been developed to assist in performing the anastomosis. A known system for creating an anastomosis is the anastomotic coupler described in U.S. Patent No. 7,192,400, the disclosure of which is incorporated herein by reference. This anastomotic coupler is a surgical instrument that allows surgeons to more easily and effectively bring two blood vessel ends together. These couplers involve the use of two annular fastener parts to which the corresponding parts of the blood vessel to be attached are fixed. Each fastener part is also provided with a series of pins and corresponding holes for receiving these pins so that these parts, and thus the blood vessel, are closed and connected together.

[0005] While free flap surgery has a history of success, flap failure remains a highly undesirable outcome. One of the main causes of flap failure is a lack of blood supply to the flap tissue after the free flap has been reattached to the recipient site. Factors that commonly disrupt circulation in a flap include vascular occlusion, bleeding, or infection. When there is not enough blood supply to the flap tissue, tissue necrosis results. However, if it is recognized early that the flap is not receiving adequate circulation, the flap can be saved or salvaged. The window of time to salvage the flap after identifying insufficient blood flow is very small. Therefore, it is crucial to quickly identify any lack of blood flow in the transplanted flap.

[0006] Handheld Doppler probes, which are typically permanently located at the distal end of a pen-like device rather than placed or left inside the body, can aid in blood flow monitoring, but they have several disadvantages. One disadvantage of handheld probes is that they cannot be reliably positioned around blood vessels.

[0007] It is very important to monitor the surgical area after microvascular surgery to ensure that blood flow is maintained at the desired level and that problems such as thrombosis do not occur. If thrombosis occurs, the transplanted tissue will die. Other indirect means of monitoring blood flow function through blood vessels that have undergone microvascular surgery are also often insufficient. For example, surface temperature measurement, transcutaneous PO2 monitoring, photoplethysmography and laser Doppler flowmetry have been used. However, these methods usually require accessible exposed parts of the flap. In addition, these methods cannot effectively monitor buried free tissue transplants and intraoral flaps. Summary of the Invention

[0008] The present disclosure provides improved vascular monitoring bands and collars that can be used with vascular monitoring systems, devices, and methods to improve the accessibility, detection, and / or reliability of detecting blood flow to confirm vessel patency at anastomotic sites.

[0009] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a first exemplary aspect of the present disclosure, a vascular monitoring system includes: a collar configured to be positioned around a patient's blood vessel; and a transducer coupled to the collar. The transducer is configured to transmit an ultrasonic signal that is transmitted through the patient's blood vessel.

[0010] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar includes at least one eyelet adapted to be sutured to adjacent tissue to fixedly position the cuff around the patient's blood vessel.

[0011] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar includes a probe holder sized and shaped to receive the transducer.

[0012] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is coupled to the collar by a friction fit with the probe holder.

[0013] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the collar is made of at least one of implantable grade liquid silicone rubber ("LSR") and high consistency silicone rubber ("HCR") having a durometer between 40 and 80.

[0014] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar is configured to be positioned around an anastomotic site of a blood vessel of the patient.

[0015] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the collar is configured to be located at a location that is one of upstream of an anastomotic site of a blood vessel of the patient and downstream of the anastomotic site of the blood vessel of the patient.

[0016] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is removably coupled to the collar.

[0017] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a second exemplary aspect of the present disclosure, a vascular collar includes a cylindrical body portion having an opening having an inner diameter sized and shaped to be positioned around a patient's blood vessel. The vascular collar also includes a probe holder and at least one mounting boss. The probe holder is configured to receive a transducer.

[0018] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the inner diameter is between 1.0 mm and 4.0 mm.

[0019] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is configured to emit an ultrasound signal that is transmitted through a blood vessel of the patient.

[0020] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a third exemplary aspect of the present disclosure, a vascular monitoring system includes a collar configured to be positioned around a patient's blood vessel. The collar is configured to transition from an open configuration to a closed configuration. The vascular monitoring system also includes a transducer coupled to the collar. The transducer is configured to transmit an ultrasonic signal that is transmitted through the patient's blood vessel.

[0021] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar includes at least one closure structure configured to maintain the collar in the closed configuration.

[0022] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one closure structure includes a first eyelet and a second eyelet.

[0023] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one closure structure is adapted to be sutured to adjacent tissue to fixedly position the cuff around a blood vessel of the patient.

[0024] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar includes a probe holder sized and shaped to receive the transducer.

[0025] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is coupled to the collar by a friction fit with the probe holder.

[0026] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the collar is made of at least one of implantable grade liquid silicone rubber ("LSR") and high consistency silicone rubber ("HCR") having a durometer between 40 and 80.

[0027] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the collar is configured to be positioned around an anastomotic site of a blood vessel of the patient.

[0028] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the collar is configured to be located at a location that is one of upstream of an anastomotic site of a blood vessel of the patient and downstream of the anastomotic site of the blood vessel of the patient.

[0029] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is removably coupled to the collar.

[0030] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a fourth exemplary aspect of the present disclosure, a vascular collar includes a body portion configured to transition from an open configuration to a closed configuration. The body portion has an opening in the closed configuration, and the opening has an inner diameter sized and shaped to be positioned around a patient's blood vessel. The vascular collar also includes a probe holder and at least one mounting boss. The probe holder is configured to receive a transducer.

[0031] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the mounting projection includes a closure feature adapted to retain the collar in the closed configuration after the collar is transitioned from the open configuration to the closed configuration.

[0032] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the body portion is made of a flexible / ductile material that allows the body portion to transition from the open configuration to the closed configuration when a closing force is applied to the collar.

[0033] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a fifth exemplary aspect of the present disclosure, a vascular monitoring system includes: a bandage configured to be positioned around a patient's blood vessel; a buckle configured to maintain the bandage in a closed configuration around the patient's blood vessel; and a transducer coupled to the bandage. The transducer is configured to transmit an ultrasonic signal that is transmitted through the patient's blood vessel.

[0034] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the bandage includes at least one eyelet adapted to be sutured to adjacent tissue to fixedly position the bandage about the patient's blood vessel.

[0035] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the strap includes a probe holder sized and shaped to receive the transducer.

[0036] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is coupled to the strap by a friction fit with the probe holder.

[0037] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the band is made of at least one of implantable grade liquid silicone rubber ("LSR"), high consistency silicone rubber ("HCR"), high density polyethylene ("HDPE"), Nusil 4750, Nusil 4840, and thermoplastics.

[0038] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the bandage, in its closed configuration, is configured to be positioned around an anastomotic site of a blood vessel of the patient.

[0039] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the bandage is configured, in its closed configuration, to be positioned at a location that is one of upstream of an anastomotic site of a blood vessel of the patient and downstream of the anastomotic site of the blood vessel of the patient.

[0040] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is removably coupled to the collar.

[0041] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a sixth exemplary aspect of the present disclosure, a vascular bandage includes: an elongated bandage body having a first end and a second end; a plurality of sized holes positioned along the bandage body beginning near the first end; and a closure pin positioned adjacent to the second end of the bandage body. The closure pin is sized and shaped to be press-fit through one of the plurality of sized holes and is configured to maintain the vascular bandage in a closed configuration when press-fit through the sized hole. The closed configuration forms a cylindrical shape having an inner diameter sized and shaped to be positioned about a patient's blood vessel. Additionally, the vascular bandage includes a probe holder and at least one mounting protrusion. The probe holder is configured to receive a transducer.

[0042] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the inner diameter is between 1.0 mm and 4.0 mm.

[0043] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is configured to emit an ultrasound signal that is transmitted through a blood vessel of the patient.

[0044] Aspects of the subject matter described herein can be used alone or in combination with one or more other aspects described herein. In a seventh exemplary aspect of the present disclosure, a vascular monitoring system includes a bandage configured to transition from an open configuration to a closed configuration. The bandage, when positioned in the closed configuration, forms a loop configured to be positioned around a patient's blood vessel. The vascular monitoring system also includes a transducer coupled to the loop. Furthermore, the transducer is configured to transmit an ultrasonic signal that is transmitted through the patient's blood vessel.

[0045] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the strap includes at least one closure structure configured to maintain the strap in the closed configuration.

[0046] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one closure structure includes a clip, a buckle, and a strap.

[0047] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one closure structure includes a prong and a sized hole.

[0048] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the strap includes a probe holder sized and shaped to receive the transducer.

[0049] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is coupled to the strap by a friction fit with the probe holder.

[0050] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the band is made of at least one of implantable grade liquid silicone rubber ("LSR"), high consistency silicone rubber ("HCR"), high density polyethylene ("HDPE"), Nusil 4750, Nusil 4840, and thermoplastics.

[0051] Aspects of the subject matter described herein may be used alone or in combination with one or more other aspects described herein. In an eighth exemplary aspect of the present disclosure, a vascular binder includes a base and a saddle portion extending from the base portion. The saddle portion has a proximal end and two corresponding distal ends. The vascular binder also includes two corresponding strap portions extending from respective distal ends of the saddle portion. The saddle portion and the two corresponding strap portions are sized and shaped to be positioned around a patient's blood vessel. In addition, the vascular binder includes a probe holder formed within the base portion, the probe holder being configured to receive a transducer.

[0052] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transducer is configured to emit an ultrasound signal that is transmitted through a blood vessel of the patient.

[0053] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the vascular band includes at least one eyelet adapted to be sutured to adjacent tissue to fixedly position the bandage about the patient's blood vessel.

[0054] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the probe holder includes a receptacle sized and shaped such that the transducer is coupled to the strap by a friction fit with the receptacle of the probe holder.

[0055] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the collar is made of at least one of implantable grade liquid silicone rubber ("LSR") and high consistency silicone rubber ("HCR") having a durometer between 40 and 80.

[0056] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the prior aspects, the saddle portion and the two corresponding band portions are sized such that, when the vascular band is closed to form a loop around a blood vessel, the loop has an inner diameter between 1.0 mm and 4.0 mm.

[0057] According to another exemplary aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the strap includes at least one closure structure configured to maintain the strap in the closed configuration.

[0058] Thus, one advantage of the present disclosure is improved accessibility of blood flow data.

[0059] Another advantage of the present disclosure is improved detection of blood flow to confirm the patency of blood vessels.

[0060] Another advantage of the present disclosure is that it provides remote monitoring of blood flow at the anastomotic site.

[0061] Yet another advantage of the present disclosure is to reduce the occurrence of free flap failure and serious adverse events due to insufficient blood flow in the free flap.

[0062] Another advantage of the present disclosure is to provide a system, device, and / or method for early detection of insufficient blood flow or circulation in a free flap.

[0063] Additional features and advantages of the disclosed vascular monitoring collar are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings and description. Moreover, it is not necessary for any particular embodiment to have all of the advantages listed herein. Furthermore, it should be noted that the language used in the specification has been selected primarily for readability and instructional purposes, and not to limit the scope of the inventive subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 is a schematic diagram of a probe lead system according to an example embodiment of the present disclosure.

[0065] Figure 2 is a perspective view of a vascular collar with a transducer coupled to the collar according to an example embodiment of the present disclosure.

[0066] Figure 3A 、 Figure 3B and Figure 3C A vascular collar and transducer are shown positioned about a patient's blood vessel according to an example embodiment of the present disclosure.

[0067] Figure 4A is a perspective view of another example vascular collar in an open configuration with a transducer coupled to the collar according to an example embodiment of the present disclosure.

[0068] Figure 4B is in a closed configuration according to an example embodiment of the present disclosure Figure 4A Perspective view of a vascular collar.

[0069] Figure 5A 、 Figure 5B and Figure 5C A vascular collar and transducer are shown positioned about a patient's blood vessel according to an example embodiment of the present disclosure.

[0070] Figure 6 is a perspective view of a vascular ligature forming a vascular cuff according to an example embodiment of the present disclosure.

[0071] Figure 7A is a perspective view of a vascular ligature forming a vascular cuff according to an example embodiment of the present disclosure.

[0072] Figure 7B is a front view of a vascular ligature forming a vascular cuff according to an example embodiment of the present disclosure.

[0073] Figure 7C According to an exemplary embodiment of the present disclosure Figure 7B Cross-sectional view of the vascular band along line 7C-7C.

[0074] Figure 8A and Figure 8B A vascular band and transducer are shown positioned about a patient's blood vessel to form a vascular loop, according to an example embodiment of the present disclosure.

[0075] Figure 9A and Figure 9B A vascular band and transducer are shown positioned about a patient's blood vessel to form a vascular loop, according to an example embodiment of the present disclosure. DETAILED DESCRIPTION

[0076] As described above, a vascular monitoring collar is provided to improve the accessibility, detection and / or reliability of detecting blood flow to confirm vascular patency at the anastomosis site. Although free flap surgery has a history of success, the highly adverse consequences of flap failure still exist. One of the main causes of flap failure is the lack of blood supply to the flap tissue after the free flap is reattached at the recipient site. Factors that commonly disrupt circulation in the flap include vascular occlusion, bleeding, or infection. When there is not enough blood supply to the flap tissue, tissue necrosis can result. However, the vascular monitoring collar disclosed herein advantageously enables early detection of insufficient blood flow or circulation in a free flap, so that the free flap can be preserved or saved before tissue necrosis occurs.

[0077] The above-mentioned vascular monitoring collar can be used to monitor blood flow at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site to confirm the vascular patency of surgical procedures such as free flap transplantation microvascular reconstruction. The collar can be used in conjunction with monitoring systems in various environments (e.g., hospital operating rooms or post-anesthesia care units) to detect blood flow and confirm vascular patency (on-site or remotely) during and after surgery. Free flap transplantation can be used to use the patient's own tissue to recreate body parts in surgery due to cancer and injury. Examples include chest reconstruction after trauma, tongue reconstruction, mandibular and cheek reconstruction, hand and foot reconstruction, etc. Typically, microvascular anastomosis is the key point of surgery that determines the success of the flap. By providing the ability to monitor blood flow at the anastomosis site, the vascular monitoring collar disclosed herein allows for early detection of low blood flow or insufficient blood flow within the flap tissue, thereby enabling medical practitioners (e.g., surgeons) to take corrective measures before necrosis occurs and the free flap becomes unusable.

[0078] The vascular monitoring collar can be used in conjunction with a flow monitoring system including a multi-component probe system, such as those described in PCT / US2018 / 061191 (“Vascular Monitoring Systems, Apparatus, and Methods”), the disclosure of which is incorporated herein by reference.

[0079] like Figure 1 As shown, probe assembly 100 can include probe connector 110, and this probe connector 110 can be connected to probe monitoring system.This probe assembly 100 can also include suturing sleeve 120, and this suturing sleeve 120 is configured to be used for attachment (for example, via suture) to patient's body or clothes.This suturing sleeve 120 can be made of medical grade material, for example USPV level or VI level material suitable for contacting with human skin.Can use various alternative devices probe assembly 100 or lead to be attached to skin, for example, include and use patch and adhesive pad.Suturing sleeve 120, adhesive pad or alternative device can be attached to skin, so that the force required for removing pad or alternative device from skin must be greater than the force required for removing probe.

[0080] The probe wire 130 extends from the probe connector 110. At one end of the probe wire 130 is an "end-of-probe" component 140, such as a ferrule (see Figures 2 to 8B ) and / or a Doppler probe or transducer coupled (e.g., press fit) into the collar. In one example, the "probe end" component 140 may include a transducer that is removably coupled to a separate collar. In another example, the "probe end" component 140 may be a collar and transducer assembly (see Figures 2 to 8B ).

[0081] Figure 2An example "probe tip" component 140a is shown. Figure 2 As shown, the loop 200 may include eyelets 210a and 210b that provide a gripping surface for the clinician and also allow the loop 200 to be anchored to adjacent tissue, such as Figure 3B and Figure 3C As further shown, 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-fit into the probe holder 220. The probe holder 220 can include a receptacle configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and angle relative to the longitudinal axis of the collar 200. The receptacle of the probe holder 220 can have an octagonal or hexagonal profile. For example, the octagonal or hexagonal profile can provide multiple surfaces for frictionally engaging the Doppler probe or transducer 230. In one example, the Doppler probe or transducer can be angled approximately 30 degrees from the flat end surface of the collar 200, and thus 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 surface of the collar 200 , and thus between 120 and 150 degrees from the longitudinal axis of the collar 200 .

[0082] like Figure 2 As shown, the collar 200 has an inner diameter (D C )240 and collar width (W C ) 250. The size and shape (e.g., annular) of the collar 200 can be designed so that the collar fits over a similarly sized blood vessel (e.g., an artery or vein). For example, the collar 200 can have an inner diameter (D) between 1.0 mm and 4.0 mm. C )240. Ring width (W C )250 can be between 2.5mm and 5.0mm to provide stability on the vessel.

[0083] The loop 200 can be made of silicone, such as implantable grade liquid silicone rubber ("LSR") or high consistency silicone rubber ("HCR"). The silicone can have: a hardness (e.g., Shore A) between 40 and 80; and a tear strength between 240 ppi and 350 ppi. The above silicone allows the loop 200 to conform to the surface of the blood vessel. In other examples, the loop 200 can be made of high-density polyethylene ("HDPE"). Alternatively, the loop 200 can be made of Nusil 4750, Nusil 4840, thermoplastics, etc. The loop 200 can be made of other flexible or tough materials. In one example, the loop 200 is permanently implanted in the patient's body. In addition, the loop can also be bioresorbable.

[0084] like Figure 3A 、 Figure 3B and Figure 3C As shown, the size and shape (e.g., annular) of the collar 200 is adapted so that the collar 200 fits over a similarly sized blood vessel (e.g., an artery or vein). As described above, the collar may have an inner diameter (D) between 1.0 mm and 4.0 mm. C ) 240. In one example, the inner diameter (D C ) 240 can be provided in 0.5 mm size increments. It should be understood that the size and shape of the collar 200 can be designed to accommodate blood vessels (e.g., veins and arteries) commonly encountered in microsurgery and revascularization procedures and to be suitable for end-to-end anastomosis of these veins and arteries in the peripheral vasculature. For example, Figure 3A and Figure 3B The loop 200 is shown positioned over and along the vessel 300 prior to anastomosis. The loop 200 can be positioned adjacent the anastomosis site such that the loop 200 is at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. After the loop 200 is positioned at its desired location along the vessel 300, the loop 200 can be anchored to the adjacent tissue by suturing the eyelets 210a and 210b to the adjacent tissue. Suturing the eyelets 210a and 210b to the adjacent tissue can advantageously provide strain relief for removal of the Doppler probe 230, as shown. Figure 3C shown. Figure 3B and Figure 3C Suture 305 is shown as a means of attaching the loop 200, and more specifically the eyelets 210a and 210b, to adjacent tissue. It should be understood that other attachment means, such as staples, clips, etc., may be used.

[0085] Figure 4A and Figure 4B Another example "probe tip" component 140a and an example collar 200 are shown. Figure 4A The collar 200 is shown in an open configuration, while Figure 4B The collar 200 is shown in a closed configuration. Figure 2 The collar 200 shown is similar, Figure 4A and Figure 4B The illustrated collar 200 may include eyelets 210a and 210b that provide a gripping surface for the clinician and also allow the collar 200 to be anchored to adjacent tissue. For example, the clinician may grasp the eyelets 210a and / or 210b using forceps, pliers, or other medical tools while positioning the collar 200. After the collar 200 is in place, the clinician may squeeze the eyelets 210a, 210b together to close the collar 200 and suture the two eyelets 210a, 210b together to maintain the collar 200 in a closed configuration (see FIG. Figure 5B After the loop 200 is closed around the blood vessel, the clinician can suture the eyelets 210a and / or 210b to nearby tissue. The loop 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-fit into the probe holder 220. The probe holder 220 can include a receptacle configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and a predetermined angle relative to the longitudinal axis of the loop 200 when the loop 200 is in the closed configuration. In one example, when the loop 200 is in the closed configuration, the Doppler probe or transducer 230 can be angled approximately 30 degrees from the flat end face of the loop 200 and thus 150 degrees from the longitudinal axis of the loop 200. In another example, the angle may be between 30 and 60 degrees from the flat end surface of the collar 200 , and thus between 120 and 150 degrees from the longitudinal axis of the collar 200 .

[0086] The collar 200 can be made of a flexible or tough material that allows the collar 200 to be transformed between an open configuration and a closed configuration. In one example, the collar 200 is permanently implanted in the patient. Alternatively, the collar 200 can be bioresorbable. For example, Figure 4A 、 Figure 4B 、 Figure 5A 、 Figure 5B and Figure 5C The collar 200 shown may have Figure 2 、 Figure 3A 、 Figure 3B and Figure 3C The collar 200 shown has the same material properties.

[0087] like Figure 4A As shown, the collar 200 is in an open configuration at the beginning and can be positioned along a blood vessel even if the vessel has not been cut or opened for anastomosis. For example, the collar 200 can be positioned along an unopened blood vessel to monitor blood flow through the vessel. Figure 4A and Figure 4B The illustrated loop 200 can also be advanced along the vessel before or after the anastomosis is completed, which advantageously provides flexibility during the surgical procedure. Figure 2 、 Figure 3A 、 Figure 3B and Figure 3C The collar 200 shown in FIG. Figure 4A and Figure 4B The collar 200 may be positioned adjacent to the anastomotic site such that the collar is located at the anastomotic site, upstream of the anastomotic site, or downstream of the anastomotic site.

[0088] Figure 5A 、 Figure 5B and Figure 5C The loop 200 is shown positioned on a blood vessel 300. The size and shape (e.g., clip-shaped) of the loop 200 can be designed so that the loop 200 fits over a similarly sized blood vessel 300 (e.g., an artery or vein). For example, when in the closed configuration, the loop 200 can have a shape similar to that of the blood vessel 300. Figure 2 The inner diameter of the collar 200 is similar to the inner diameter (D C ) 240, the inner diameter is between 1.0 mm and 4.0 mm. In one example, the inner diameter (D C ) 240 is in a closed position and can be provided in 0.5 mm size increments. It should be understood that the size and shape of the loop 200 can be designed to accommodate blood vessels (e.g., veins and arteries) commonly encountered in microsurgery and revascularization procedures, and is suitable for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. After the loop 200 is positioned at its desired position along the blood vessel 300, the loop 200 can be closed by suturing the eyelets 210a, 210b together so that the loop 200 remains in the closed configuration. The loop 200 can also be anchored to adjacent tissue by suturing the eyelets 210a and / or 210b to the adjacent tissue. Suturing the eyelets 210a and 210b to the adjacent tissue can advantageously provide strain relief for removal of the Doppler probe 230, as Figure 5C shown. Figure 5B and Figure 5C Sutures 305 are shown as a means of maintaining the loop 200 in a closed configuration. It should be understood that other attachment means, such as staples, clips, etc., may be used to maintain the loop 200 in a closed configuration.

[0089] Figure 6 Another embodiment of a loop or strap 600a is shown. Figure 6 As shown, the band 600a may include eyelets 610 that provide a gripping surface for the clinician and also allow the loop or band 600a to be anchored to adjacent tissue. The loop or band 400 also includes a probe holder 220 that is configured to receive a Doppler probe or transducer 230. Similar to Figures 2 to 5C In the embodiment described in the foregoing, the Doppler probe or transducer 230 can be press-fit into the probe holder 220. As described above, the probe holder 220 can include a receptacle 620 configured to removably retain the Doppler probe or transducer 230 at a predetermined distance and a predetermined angle relative to the longitudinal axis of the loop or band 600a when the band 600a is closed around the blood vessel. The size and shape of the receptacle 620 of the probe holder 220 can be similar to that of the foregoing. Figures 2 to 5CFor example, probe holder 220 may have an octagonal or hexagonal profile that provides multiple surfaces for frictionally engaging Doppler probe or transducer 230. In one example, when bandage 600a is closed around a blood vessel, Doppler probe or transducer 230 may be angled at approximately 30 to 60 degrees relative to the flat end surface of the loop or bandage 600a, and thus at an angle of 120 to 150 degrees relative to the longitudinal axis of the loop formed by bandage 600a.

[0090] The loop or band 600a can be made of high-density polyethylene ("HDPE"). In one example, the band 600a can be made of silicone, such as implantable liquid silicone rubber ("LSR") or high-consistency silicone rubber ("HCR"). The silicone can have: a hardness (e.g., Shore A) between 40 and 80; and a tear strength between 240 ppi and 350 ppi. The above-mentioned silicone allows the loop or band to conform to the surface of the blood vessel while providing a strong material that can withstand the stress associated with closing the band 600a around the blood vessel. In other examples, the band 600a can be made of Nusil 4750, Nusil 4840, thermoplastics, etc. The band 600a can be made of other flexible or tough materials so that the band 600a is suitable for wrapping around a patient's blood vessel. In one example, the band 600a is permanently implanted in the patient's body and can be bioresorbable.

[0091] Once the band 600a is wrapped around the patient's blood vessel and maintained in its closed position, the band 600a can resemble a closed loop. The band 600a has a band width (W S )650 and strap length (L S )660. Band width (W S ) can be between 2.5mm and 5.0mm to provide stability on the vessel. Bandage length (L S ) 660 can be long enough so that the band 600a can be wrapped around the vessel and still have sufficient length for closure (see Figure 8A and Figure 8B). For example, the size and shape of the bandage 600a can be designed so that when closed, the bandage 600a forms a loop that fits over a similarly sized blood vessel (e.g., an artery or vein). For example, the loop formed by the closed bandage 600a can have an inner diameter between 1.0 mm and 4.0 mm. In one example, the bandage 600a can be provided in increments of approximately 1.5 mm to accommodate different blood vessel sizes (e.g., blood vessel sizes that are differentiated in increments of approximately 0.5 mm). It should be understood that the size and shape of the bandage 600a can be designed to accommodate blood vessels (e.g., veins and arteries) commonly encountered in microsurgery and revascularization procedures, and is suitable for end-to-end anastomosis of these veins and arteries in the peripheral vascular system.

[0092] Figure 7A 、 Figure 7B and Figure 7C Another example embodiment of a strap 600b is shown. The strap 600b may include a base 710, a saddle 720, and a strap 730. The probe holder 220 may be formed as part of the base 710, which provides stability to the strap 600b and also provides a gripping surface for the clinician when manipulating and positioning the strap 600b. The saddle 720 has a proximal end 722 and two corresponding distal ends 724a, 724b. The saddle 720 may extend from the base 710 at the proximal end 722 of the saddle. A corresponding strap 730 may extend from the saddle 720 at each end. For example, each corresponding strap 730 may extend from a corresponding distal end 724a, 724b of the saddle 720.

[0093] Saddle portion 720 and corresponding strap portion 730 may meet at a joint 725 (e.g., respective distal ends 724a, 724b of saddle portion 720). When strap 600b is expanded to its most open configuration, the first end of strap 600b will be strap portion 730, followed by the first portion of saddle portion 720 and base portion 710, and then strap 600b will continue to the second portion of saddle portion 720 and another corresponding strap portion 730.

[0094] In one example, saddle portion 720 extends outward from base portion 710 and forms a contact surface 740 for a portion of a blood vessel. Contact surface 740 can be shaped like an inverted or upside-down saddle that creates a bowl-like or basin-like surface. For example, saddle portion 720 can be flexible while maintaining sufficient rigidity to create a pre-formed contact surface 740. Alternatively, saddle portion 720 and strap portion 730 can be sufficiently flexible and resilient that, when contact surface 740 is adjacent to a horizontal surface, strap 600b will lie flat on the horizontal surface.

[0095] like Figure 7B and Figure 7C As shown, the base 710 has a height (H BASE)750 and width (W BASE )760. Height (H BASE )750 may be approximately 2.25 mm, and the width (W BASE ) 760 can be between 2.5 mm and 5.0 mm. A wider base 710 can be implemented to provide additional stability on the blood vessel.

[0096] In addition, the saddle 720 has a height (H S ) 752, which may be approximately 2.65 mm. The distance 764 between each end of the saddle 720 (eg, at the joint 725) may be approximately 4.0 mm. The band 730 has a height (H BAND ) 754, the height may be approximately 6.0 mm. When the strap 600b is in a relaxed position (e.g. Figure 7B ), particularly where the saddle 720 maintains its shape, the distance 766 between the ends of the strap 730 may be approximately 5.0 mm.

[0097] The band portion may have a wall thickness (T BAND )770. Wall thickness (T BAND ) 770 can be selected and configured based on the closure mechanism of the strap 600b. For example, different closure clips can be compatible with different wall thicknesses. In addition, the wall thickness (T BAND ) 770 to increase or decrease the flexibility, rigidity and / or durability of the strap 600b. The strap 600b may have a width (W) of approximately 2.5 mm to 5.0 mm at the end of the strap portion 730. STRAP )762. Similar to wall thickness (T BAND )770, you can choose the width (W STRAP )762 to increase or decrease the flexibility, rigidity and / or durability of the strap 600b. In addition, the width (W STRAP ) 762 can be selected and configured based on the closure mechanism of the strap 600b. For example, different closure clips can be compatible with different strap widths.

[0098] The dimensions of the saddle portion 720 and the band portion 730 can be adjusted for different vessel sizes. For example, the band portion can have a sufficient height to provide an adequate closure surface after the band 600b is closed around a vessel having a vessel diameter between 1.0 mm and 4.0 mm. It should be understood that the size and shape of the band 600ab can be designed to accommodate vessels (e.g., veins and arteries) commonly encountered in microsurgery and revascularization procedures and to be suitable for end-to-end anastomosis of these veins and arteries in the peripheral vascular system.

[0099] like Figure 7C As shown in Figure 7C In a cross-sectional view taken about line 7C-7C of FIG. B , the receptacle 620 of the probe holder 220 can have a conical profile with a cylindrical transition region 780. The diameter of the cylindrical transition region 780 can be between 0.015 inches and 0.030 inches (e.g., 0.38 mm and 0.76 mm). The cylindrical transition region 780 having a smaller diameter can provide a tighter grip or squeeze on the corresponding Doppler probe or transducer 230. The probe holder 220 can be oriented at an angle 782 between 120 degrees and 150 degrees to the longitudinal axis of the loop formed by the closure band 600 b.

[0100] Figure 8A and Figure 8B An example of positioning a band, such as band 600a or band 600b, around blood vessel 300 is shown. Band 600a and band 600b may be collectively referred to as band 600 hereinafter. Figure 8A and 8B The strap 600 shown in FIG. 1 may include Figure 6 Each feature of strap 600a, each feature of strap 600b, or any combination thereof. Figure 8B As shown, ligature assembly 800 may include a clamp 810, buckle, strap, or other closure mechanism that maintains ligature 600 in a closed configuration around blood vessel 300 such that ligature 600 forms a loop around blood vessel 300. For example, Figure 8A and Figure 8B The ligature 600 is shown wrapped around the vessel 300 to form a loop. The loop formed by the ligature 600 can be positioned adjacent to the anastomosis site, such that the loop is located at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. After the ligature 600 is wrapped around the vessel 300 and maintained in its closed orientation (e.g., such that the ligature 600 forms a loop) and is positioned at its desired location along the vessel 300, the loop formed by the ligature 600 can be closed by inserting the eyelets (see FIG. Figure 6 ) is sutured to adjacent tissues and anchored to adjacent tissues. Figure 3C and Figure 5C Similar to the embodiments described in , suturing the eyelet to the adjacent tissue can advantageously provide strain relief for removal of the Doppler probe.

[0101] Figure 9A and Figure 9B Another example embodiment of a strap 600c is shown having a Figure 8BThe closure mechanism may be a different one than the clamp, buckle, or strap shown. For example, the bandage 600c may include a plurality of sizing holes 910 spaced along the bandage 600c and adapted to maintain the bandage in a closed configuration when fitted over the closure pins 920. For example, the sizing holes 910 may be sized and shaped such that they can be press-fitted over the closure pins 920. The sizing holes 910 may be spaced along the bandage 600c with each hole spaced approximately 1.5 mm apart to accommodate different vessel sizes (e.g., vessel sizes separated by approximately 0.5 mm increments). The spacing between each sizing hole 910 may be altered to 1.0 mm or some other spacing to accommodate different intervals in vessel size.

[0102] As described above, the sizes and shapes of the bandages 600a, 600b, and 600c described herein can be designed for specific vessel sizes, such that one bandage is configured for vessels between 1.0 mm and 2.0 mm, another bandage is configured for vessels between 2.0 mm and 3.0 mm, and a different bandage is configured for vessels between 3.0 mm and 4.0 mm. Where there are different bandage sizes or lengths for different vessel sizes, sizing holes 910 can be positioned more closely together so that the bandage can be adjusted in 0.2 mm increments to accommodate vessels between 1.0 mm and 2.0 mm in diameter (e.g., sizing holes 910 can be configured so that the bandage can be adjusted to form loops having inner diameters of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, and 2.0 mm). It should be understood that the size and shape of the band 600c can be designed and the sized holes 910 can be positioned to accommodate blood vessels (e.g., veins and arteries) commonly encountered in microsurgery and revascularization procedures and are suitable for end-to-end anastomosis of such veins and arteries in the peripheral vasculature.

[0103] Pin 920 can include a flange or lip configured to maintain strap 600c in a closed configuration. For example, sizing hole 910 can be located above pin 920 and press-fitted over pin 920 so that pin 920 is pushed through sizing hole 910. The material of the strap can allow the sizing hole to expand and flex to fit over the flange or lip of pin 920 before relaxing back to its original shape. After pin 920 is pushed through sizing hole 910, the flange or lip is adapted to prevent strap 600c from unwinding to an open position. For example, the flange or lip can be sized and shaped so that the force associated with the strap's tendency to relax back to its open position is insufficient to cause sizing hole 910 to expand and flex to refit over the flange or lip of pin 920. The material of strap 600c and the geometry of sized holes 910 and prongs are configured to allow a clinician to manipulate strap 600c between an open configuration and a closed configuration, while also preventing strap 600c from opening without the clinician's intervention.

[0104] Similar to Figure 8A and Figure 8B The straps shown in Figure 9A and Figure 9B The straps shown in Figure 6 or Figures 7A-7C Each of the features of the strap described in. In addition, Figure 6 、 Figures 7A-7C 、 Figure 8A 、 Figure 8B 、 Figure 9A and Figure 9B The straps shown in FIG. 1 may be constructed and arranged so that when in the closed configuration, the straps form a Figure 2 、 Figure 3A 、 Figure 3B 、 Figure 3C 、 Figure 4B 、 Figure 5B and Figure 5C For example, the probe holder may include a receptacle configured to removably retain the Doppler probe or transducer at a predetermined distance and at a predetermined angle relative to the longitudinal axis of the loop formed by the strap when the strap is in the closed configuration (e.g., the Doppler probe or transducer may be angled approximately 30 degrees from the flat end face of the loop, and thus 120 degrees from the longitudinal axis of the loop formed by the strap when the strap is in the closed configuration). In another example, the angle may be between 30 and 60 degrees from the flat end face of strap 600, and thus between 120 and 150 degrees from the longitudinal axis of the loop formed by closing strap 600.

[0105] A sensing device, such as a Doppler probe or transducer, inserted into the collar enables a medical practitioner (eg, a surgeon) to monitor and analyze blood flow and / or blood flow velocity to determine surgical success and / or confirm vessel patency.

[0106] Any transducer suitable for ultrasonic Doppler monitoring can be used with the collar. In one example embodiment, 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 of any size to accommodate the size of the corresponding probe holder used on the collar. For example, a circular transducer 230 is adapted to be received by a receptacle whose inner surface is circular in shape. 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 tip of the Doppler probe or transducer. The transducer 230 can be a round piezoelectric crystal with a size between about 0.5 mm and about 1 mm. In one example, the Doppler probe or transducer 230 includes: a tip having a round piezoelectric crystal with a size between about 0.5 mm and about 1 mm; a coaxial line coated with Teflon; and a metal connector.

[0107] The Doppler probe coupled to the ring or band disclosed herein can be adapted to detect blood flow at the anastomotic site and confirm vascular patency at the anastomotic site during and after surgery. For example, blood flow can be detected up to approximately 14 days after surgery.

[0108] Many features and advantages of the present disclosure are apparent from the written description, and therefore, the appended claims are intended to cover all such features and advantages of the present disclosure. Furthermore, since many modifications and variations will readily occur to those skilled in the art, the present disclosure is not limited to the exact construction and operation shown and described. Therefore, the described embodiments are to be considered illustrative rather than restrictive, and the present disclosure is not to be limited to the details given herein, but is to be defined by the full scope of the following claims and their equivalents, whether presently or in the future, foreseeable or unforeseeable.

Claims

1. A vascular monitoring system comprising: a binder having a base portion and a saddle portion, wherein the saddle portion is configured to be positioned about a patient's blood vessel, wherein the saddle portion includes a contact surface configured to contact a portion of the patient's blood vessel; a first strap portion and a second strap portion, wherein the first strap portion and the second strap portion extend from respective distal ends of the saddle portion; a buckle configured to engage the first strap portion and the second strap portion, wherein a distance between the first strap portion and the second strap portion decreases as the first strap portion and the second strap portion extend through the buckle; a transducer coupled to the strap, the transducer configured to transmit an ultrasonic wave signal that is transmitted through a blood vessel of the patient; and A probe holder, the probe holder comprising: a receptacle having a conical profile, wherein the receptacle is configured to receive the transducer and removably retain the transducer, and wherein the transducer is coupled to the receptacle by a friction fit; and Cylindrical transition area.

2. The monitoring system of claim 1 , wherein the bandage includes at least one eyelet adapted to be sutured to adjacent tissue to fixedly position the bandage about the patient's blood vessel.

3. The monitoring system of any one of claims 1 and 2, wherein the diameter of the cylindrical transition region is between 0.015 inches and 0.030 inches.

4. The monitoring system of claim 1 , wherein the strap is made of at least one of implantable grade liquid silicone rubber (LSR), high consistency silicone rubber (HCR), HDPE, Nusil 4750, Nusil 4840, and thermoplastic.

5. The monitoring system of claim 1 , wherein the transducer is removably coupled to the strap.

6. A vascular bandage comprising: base; a saddle extending from the base, the saddle having a proximal end, a first distal end, and a second distal end; a first strap portion and a second strap portion, the first strap portion extending from the first distal end of the saddle portion and the second strap portion extending from the second distal end of the saddle portion, wherein the saddle portion and the first and second strap portions are sized and shaped to be positioned about a patient's blood vessel, wherein the saddle portion includes a contact surface configured to contact a portion of the patient's blood vessel, and wherein the first and second strap portions are configured to extend through a buckle in a closed configuration; the buckle configured to engage the first strap portion and the second strap portion, wherein a distance between the first strap portion and the second strap portion decreases as the first strap portion and the second strap portion extend through the buckle; and a probe holder formed in the base, the probe holder comprising: a receptacle having a conical profile, wherein the receptacle is configured to receive a transducer and removably retain the transducer, and wherein the transducer is coupled to the receptacle by a friction fit, and wherein the transducer is configured to transmit an ultrasound signal that is transmitted through a blood vessel of the patient; and Cylindrical transition area.

7. The vascular ligature of claim 6, wherein the vascular ligature comprises at least one eyelet adapted to be sutured to adjacent tissue to fixedly position the ligature about the patient's blood vessel.

8. The vascular ligature of claim 6, wherein the diameter of the cylindrical transition region is between 0.015 inches and 0.030 inches.

9. The vascular band of claim 6, wherein the vascular band is made of at least one of implant grade liquid silicone rubber (LSR) and high consistency silicone rubber (HCR) having a durometer between 40 and 80.

10. The vascular band of claim 6, wherein the saddle portion and the first and second strap portions are sized such that when the vascular band is closed to form a loop around a blood vessel, the loop has an inner diameter between 1.0 mm and 4.0 mm.

11. The vascular ligature of claim 6, wherein the buckle is configured to maintain the vascular ligature in the closed configuration.

Images