Vascular monitoring collar

Abstract

To provide an improved vascular monitoring strap and collar which may be used with a vascular monitoring system, device and method for improving access property, detection and / or reliability in detection of a blood flow for confirming a vascular patency in an anastomosis site.SOLUTION: A vascular monitoring system includes: a collar configured to be arranged around a vessel of a patient; and a transducer coupled to the collar. The collar may be formed of a strap wrapped around the vessel of the patient and maintained in a closed configuration. The transducer is configured to emit an ultrasonic signal transmitted through the vessel of the patient.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001]

[0001] Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 959,587, entitled "VASCULAR MONITORING COLLAR," filed on January 10, 2020, and U.S. Provisional Patent Application No. 63 / 037,772, entitled "VASCULAR MONITORING COLLAR," filed on June 11, 2020, both of which are hereby incorporated by reference in their entirety.

Background Art

[0002]

[0002] Plastic and reconstructive surgeries, such as in breast reconstruction, typically use free flaps. In free flap tissue surgery, a free flap (e.g., tissue and / or muscle, and the associated arteries and veins of that tissue and / or muscle) 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 to the native arteries and veins to achieve blood circulation within the transplanted free flap (e.g., tissue and / or muscle).

[0003]

[0003] Anastomosing a free flap tissue to its native tissue is typically performed using microvascular techniques, including 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 the anastomosis coupler described in U.S. Patent No. 7,192,400, the disclosure of which is incorporated herein by reference. This anastomosis coupler is a surgical instrument that enables a surgeon to more easily and effectively join two blood vessel ends together. The coupler involves the use of two clamp portions in the shape of rings, on which the cut ends of the vessels to be attached are secured. Each clamp portion is also provided with a series of pins and corresponding holes for receiving those pins to close and connect the portions, and thus the blood vessels, to each other.

[0004]

[0004] Free flap surgery has a history of success, but the very undesirable outcome of flap failure still remains a possibility. One of the main causes of flap failure is insufficient blood supply to the flap tissue after the free flap has been reattached to the recipient site. Generally, things that interfere with circulation within the flap include vascular occlusion, bleeding, or infection. When the flap tissue is not supplied with sufficient blood, tissue necrosis occurs. However, if it can be recognized early enough that the flap is not receiving sufficient circulation, the flap can be preserved or salvaged. The time frame for salvaging the flap after insufficient blood flow has been recognized is very small. Therefore, it is important to quickly recognize any insufficiency of blood flow in the transplanted flap.

[0005]

[0005] Handheld Doppler probes, which are typically permanently disposed at the distal tip of a pen-shaped device rather than being placed or retained within the body, are useful in blood flow monitoring, but those handheld Doppler probes are beset with several drawbacks. One drawback of handheld probes is that they cannot be reliably positioned around blood vessels.

[0006]

[0006] After microsurgery, it is very important to monitor the surgical site to confirm 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 the function of blood flow through the blood vessels that have undergone microsurgery are generally insufficient. For example, surface temperature measurement, transcutaneous PO2 monitoring, photoplethysmography, and laser Doppler flowmetry have been used. However, these techniques generally require an accessible exposed portion of the skin flap. In addition, buried free tissue transplantation and intraoral skin flaps cannot be effectively monitored by these methods.

Summary of the Invention

[0007]

[0007] The present disclosure provides an improved vascular monitoring strap and color 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 vascular patency at the anastomosis site.

[0008]

[0008] Aspects of the subject matter described herein may be useful alone or in combination with one or more of the other aspects described herein. In a first exemplary aspect of the present disclosure, a vascular monitoring system includes a color configured to be placed around a patient's blood vessel and a transducer coupled to the color. The transducer is configured to emit an ultrasonic signal transmitted through the patient's blood vessel.

[0009]

[0009] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the color includes at least one small hole adapted to be sutured to adjacent tissue to fixedly place the color around the patient's blood vessel.

[0010] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar includes a probe holder sized and shaped to receive a transducer.

[0011] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is coupled to the collar by a friction fit with the probe holder.

[0012] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is made of at least one of implant-grade liquid-silicon rubber ("LSR") and high-consistency silicone rubber ("HCR") having a durometer of 40 to 80.

[0013] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is configured to be disposed around the anastomosis site of the patient's blood vessel.

[0014] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is configured to be disposed at a position that is one of upstream and downstream of the anastomosis site of the patient's blood vessel.

[0015] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is removably coupled to the collar.

[0016] Aspects of the subject matter described herein may be useful, either alone or in combination with one or more other aspects described herein. In a second exemplary aspect of the present disclosure, the vascular collar is a cylindrical body portion having an opening, the opening having an inner diameter sized and shaped to be disposed around a patient's blood vessel, and includes the body portion. The vascular collar also includes a probe holder and at least one attachment tab. The probe holder is configured to receive a transducer.

[0017] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the inner diameter is from 1.0 mm to 4.0 mm.

[0018] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is configured to emit an ultrasonic signal transmitted through a patient's blood vessel.

[0019] Aspects of the subject matter described herein may be useful, either alone or in combination with one or more other aspects described herein. In a third exemplary aspect of the present disclosure, the vascular monitoring system includes a collar configured to be disposed 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 emit an ultrasonic signal transmitted through a patient's blood vessel.

[0020] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar includes at least one closure structure configured to maintain the collar in the closed configuration.

[0021] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the at least one closure structure includes a first aperture and a second aperture.

[0022]

[0022] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, at least one closed structure is adapted to be sutured to adjacent tissue to fixedly dispose the collar around the patient's blood vessel.

[0023]

[0023] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar includes a probe holder sized and shaped to receive a transducer.

[0024]

[0024] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is coupled to the collar by a friction fit with the probe holder.

[0025]

[0025] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is made of at least one of implant-grade liquid-silicon rubber ("LSR") and high-consistency silicone rubber ("HCR") with a durometer of 40 to 80.

[0026]

[0026] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is configured to be disposed around the anastomosis site of the patient's blood vessel.

[0027]

[0027] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the collar is configured to be disposed at a position that is one of upstream and downstream of the anastomosis site of the patient's blood vessel.

[0028] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is removably coupled to the collar.

[0029] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. In a fourth exemplary aspect of the present disclosure, the 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 disposed around a patient's blood vessel. The vascular collar also includes a probe holder and at least one attachment tab. The probe holder is configured to receive a transducer.

[0030] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the attachment tab includes a closure feature adapted to hold the collar in the closed configuration after transitioning from the open configuration to the closed configuration.

[0031] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the body portion is made of a flexible 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.

[0032] Aspects of the subject matter described herein may be useful 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 strap configured to be disposed around a patient's blood vessel, a fastener configured to maintain the strap in a closed configuration around the patient's blood vessel, and a transducer coupled to the strap. The transducer is configured to emit an ultrasonic signal transmitted through the patient's blood vessel.

[0033] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap includes at least one small hole adapted to be sutured to adjacent tissue to fixedly dispose the strap around a patient's blood vessel.

[0034] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap includes a probe holder sized and shaped to receive a transducer.

[0035] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is coupled to the strap by a friction fit with the probe holder.

[0036] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap is made of at least one of implant-grade liquid silicone rubber ("LSR"), high consistency silicone rubber ("HCR"), high density polyethylene ("HDPE"), Nusil 4750, Nusil 4840, and thermoplastic materials.

[0037] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap is configured to be disposed around the anastomosis site of a patient's blood vessel in its closed form.

[0038] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap is configured to be disposed at a position that is either upstream or downstream of the anastomosis site of a patient's blood vessel in its closed form.

[0039] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is removably coupled to the color.

[0040] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. In a sixth exemplary aspect of the present disclosure, the vascular strap includes an elongate strap body having a first end and a second end, a plurality of sizing holes beginning near the first end and disposed along the strap body, and a closure protrusion disposed adjacent to the second end of the strap body. The closure protrusion is sized and shaped to be press-fitted through a sizing hole of the plurality of sizing holes, and the closure protrusion is configured to maintain the vascular strap in a closed configuration when press-fitted through the sizing hole. The closed configuration forms a cylindrical shape having an inner diameter sized and shaped to be disposed around a patient's blood vessel. Further, the vascular strap includes a probe holder and at least one attachment tab. The probe holder is configured to receive the transducer.

[0041] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the inner diameter is from 1.0 mm to 4.0 mm.

[0042] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is configured to emit an ultrasonic signal transmitted through a patient's blood vessel.

[0043] Aspects of the subject matter described herein can be useful, either alone or in combination with one or more of the other aspects described herein. In a seventh exemplary aspect of the present disclosure, a vascular monitoring system includes a strap configured to transition from an open configuration to a closed configuration. The strap forms a collar when in the closed configuration, and the collar is configured to be disposed around a patient's blood vessel. The vascular monitoring system also includes a transducer coupled to the collar. Additionally, the transducer is configured to emit an ultrasonic signal transmitted through the patient's blood vessel.

[0044] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap includes at least one closure structure configured to maintain the strap in the closed configuration.

[0045]

[0046] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, at least one closure structure includes a fastener, a retainer, and a band.

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

[0048]

[0049] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap includes a probe holder sized and shaped to receive the transducer. According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is coupled to the strap by a friction fit with the probe holder.According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap is made of at least one of implant-grade liquid silicone rubber ("LSR"), high consistency silicone rubber ("HCR"), high density polyethylene ("HDPE"), Nusil 4750, Nusil 4840, and thermoplastic materials.

[0050]

[0050] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. In an eighth exemplary aspect of the present disclosure, the vascular strap includes a base portion and a saddle portion extending from the base portion. The saddle portion has a proximal end and two distal ends each. The vascular strap also includes two band portions each extending from each distal end of the saddle portion. The saddle portion and the two band portions are sized and shaped to be disposed around a patient's blood vessel. Further, the vascular strap includes a probe holder formed within the base portion, the probe holder being configured to receive a transducer.

[0051]

[0051] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the transducer is configured to emit an ultrasonic signal transmitted through a patient's blood vessel.

[0052]

[0052] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the vascular strap includes at least one small hole adapted to be sutured to adjacent tissue to fixedly dispose the strap around a patient's blood vessel.

[0053]

[0053] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the probe holder includes a receptacle sized and shaped such that the transducer is coupled to the strap by friction fitting with the receptacle of the probe holder.

[0054]

[0054] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the color is made of at least one of implant-grade liquid-silicon rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer of 40 to 80.

[0055]

[0055] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the saddle portion and each of the two band portions are sized such that the inner diameter of the color is 1.0 mm to 4.0 mm when the vascular strap is closed to form a color around the blood vessel.

[0056]

[0056] According to another exemplary aspect of the present disclosure, which can be used in combination with any one or more of the foregoing aspects, the strap includes at least one closure structure configured to maintain the strap in a closed configuration.

[0057]

[0057] Therefore, an advantage of the present disclosure is to improve the accessibility of blood flow data.

[0058]

[0058] Another advantage of the present disclosure is to improve the detection of blood flow for confirming vascular patency.

[0059]

[0059] Another advantage of the present disclosure is to enable remote monitoring of blood flow at the anastomosis site.

[0060]

[0060] Moreover, a further advantage of the present disclosure is to reduce the occurrence of free flap insufficiency and serious adverse events resulting from insufficient blood flow in the free flap.

[0061]

[0061] Yet another advantage of the present disclosure is to provide a system, device, and / or method for early detection of insufficient blood flow or circulation within a free flap.

[0062]

[0062] Additional features and advantages of the disclosed vascular monitoring color are described in and will be apparent from the following detailed description and figures. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those of ordinary skill in the art upon consideration of the figures and description. Also, any particular embodiment need not have all of the advantages listed herein. Further, it should be noted that the words used herein are primarily selected for readability and teaching purposes and not to limit the scope of the inventive subject matter.

Brief Description of the Drawings

[0063]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 5C

Figure 6

Figure 7A

Figure 7B

Figure 7C

Figure 8A

Figure 8B

Figure 9A

Figure 9B

DETAILED DESCRIPTION OF THE INVENTION

[0064]

[0075] As described above, the vascular monitoring color is provided to improve accessibility, detection, and / or reliability for detecting blood flow to confirm vascular viability at the anastomosis site. Free flap surgery has a history of success, but the very undesirable outcome of flap failure still remains a possibility. One of the main causes of flap failure is insufficient blood supply to the flap tissue after the free flap has been reattached to the recipient site. Generally, things that interfere with circulation within the flap include vascular occlusion, bleeding, or infection. When sufficient blood is not supplied to the flap tissue, tissue necrosis occurs. However, preferably, the vascular monitoring color disclosed herein enables early detection of insufficient blood flow or circulation within the free flap so that the free flap can be preserved or salvaged before tissue necrosis occurs.

[0065]

[0076] Using the vascular monitoring color described above, blood flow can be monitored at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site to confirm the vascular viability of surgical procedures such as free flap transplantation microvascular reconstruction. The color can be used with a monitoring system in various environments such as a hospital operating room or a post-anesthesia care unit to detect blood flow and confirm vascular viability (either on-site or remotely) both during and after surgery. Free flap transplantation can be used to reconstruct body parts from cancer surgery and injuries using the patient's own tissue. Examples include breast reconstruction, tongue reconstruction, jaw and cheek reconstruction, hand and foot reconstruction after traumatic injury, etc. Typically, microvascular anastomosis is a critical point of the surgery that determines the success of the flap. By providing a blood flow monitoring function at the anastomosis site, the vascular monitoring color disclosed herein enables early detection of low blood flow or insufficient blood flow within the flap tissue, thereby enabling a physician (e.g., a surgeon) to take corrective measures before necrosis occurs and the free flap becomes unusable.

[0066]

[0077] The vascular monitoring collar can be used with a flow monitoring system that includes a multi-component probe system, such as that described in International Application No. US2018 / 061191, "Vascular Monitoring System, Device and Method," the disclosure of which is incorporated herein by reference.

[0067]

[0078] As shown in FIG. 1, the probe assembly 100 can include a probe connector 110 that can be connected to a probe monitoring system. The probe assembly 100 can also include a suture sleeve 120 configured for attachment (e.g., via sutures) to a patient's body or clothing. The suture sleeve 120 can be constructed of a medical grade material suitable for contact with human skin, such as a USP grade V or VI material. The probe assembly 100 can be attached to or guided onto the skin using various alternative approaches, including for example the use of patches and adhesive pads. The suture sleeve 120, adhesive pad, or alternative approach can be attached to the skin such that the force required to remove the pad or alternative approach from the skin is not greater than the force required to remove the probe.

[0068]

[0079] Extending from the probe connector 110 is a probe wire 130. At the end of the probe wire 130 is a "probe end" component 140, such as a collar (see FIGS. 2 through 8B) and / or a Doppler probe or transducer coupled (e.g., press fit) within the collar. In one example, the "probe end" component 140 can include a transducer removably coupled to a separate collar. In another example, the "probe end" component 140 can be a collar and transducer assembly (see FIGS. 2 through 8B).

[0069]

[0080] Figure 2 shows an exemplary "probe tip" component 140a. As shown in Figure 2, the collar 200 can include small holes 210a and 210b, which provide a gripping surface for the clinician and also allow the collar 200 to be fixed to the adjacent tissue, as further shown 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 may be press-fitted within the probe holder 220. The probe holder 220 can include a receptacle configured to removably hold the Doppler probe or transducer 230 at a predetermined distance and a predetermined angle with respect to the longitudinal axis of the collar 200. The receptacle of the probe holder 220 may have an octagonal or hexagonal contour. For example, the octagonal or hexagonal contour can provide multiple surfaces for frictional engagement with the Doppler probe or transducer 230. In one example, the angle of the Doppler probe or transducer may be approximately 30 degrees from the flat end face of the collar 200 and thus 120 degrees from the longitudinal axis of the collar 200. In another example, the angle may be from 30 degrees to 60 degrees from the flat end face of the collar 200 and thus from 120 to 150 degrees from the longitudinal axis of the collar 200.

[0070]

[0081] As shown in Figure 2, the collar 200 has an inner diameter (D C ) 240 and a collar width (W C ) 250. The collar 200 may be sized and shaped (e.g., ring-shaped) such that the collar 200 fits over a blood vessel of a similar size (e.g., artery or vein). For example, the collar 200 may have an inner diameter (D C ) 240 of 1.0 mm to 4.0 mm. The collar width (W C ) 250 may be 2.5 mm to 5.0 mm to provide stability on the blood vessel.

[0071]

[0082] Color 200 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 of 40 to 80 (e.g., Shore A) and a tear strength of 240 to 350 ppi. The silicone described above enables Color 200 to conform to the surface of the blood vessel. In other examples, Color 200 may be made of high-density polyethylene ("HDPE"). Alternatively, Color 200 may be made of Nusil 4750, Nusil 4840, a thermoplastic, or the like. Color 200 may be made of other flexible or pliable materials. In one example, Color 200 is permanently implanted within the patient. Additionally, the color may also be bioabsorbable.

[0072]

[0083] As shown in FIGS. 3A, 3B, and 3C, the size and shape of Color 200 (e.g., ring-shaped) are adapted to fit Color 200 over a blood vessel of a similar size (e.g., artery or vein). As described above, the color may have an inner diameter (D C ) of 240 from 1.0 mm to 4.0 mm. In one example, the inner diameter (D C)240 may be provided in 0.5 mm increments. Color 200 may be sized and shaped to correspond to blood vessels (e.g., veins and arteries) commonly encountered in microsurgical and vascular reconstruction procedures and may be adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. For example, FIGS. 3A and 3B show Color 200 disposed over and advanced along blood vessel 300 prior to anastomosis. Color 200 may be disposed near the anastomosis site such that Color 200 is positioned at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. After Color 200 has been positioned along blood vessel 300 in its intended position, Color 200 may be secured to adjacent tissue by suturing holes 210a and 210b to the adjacent tissue. Suturing holes 210a and 210b to the adjacent tissue may effectively provide strain relief for removal of Doppler probe 230 as shown in FIG. 3C. FIGS. 3B and 3C show suture 305 as a means of attaching Color 200, and more particularly holes 210a and 210b, to adjacent tissue. It should be understood that other attachment means such as staples, clips, etc. may be used.

[0073]

[0084] Figures 4A and 4B show another exemplary "probe tip" component 140a and an exemplary color 200. FIG. 4A shows the color 200 in an open configuration, while FIG. 4B shows the color 200 in a closed configuration. Similar to the color 200 shown in FIG. 2, the color 200 shown in FIGS. 4A and 4B can include small holes 210a and 210b, which provide a gripping surface for the clinician and also enable the color 200 to be fixed to adjacent tissue. For example, when placing the color 200, the clinician can grip the small holes 210a and / or 210b with forceps, pliers, or other medical instruments. After the color 200 is in place, the clinician can close the color 200 by squeezing the small holes 210a, b together and stitch the two small holes 210a, b together to maintain the color 200 in a closed configuration (see FIG. 5B). After the color 200 is closed around a blood vessel, the clinician can stitch the small holes 210a and / or 210b to nearby tissue. The color 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 may be press-fitted within the probe holder 220. The probe holder 220 can include a receptacle configured to removably hold the Doppler probe or transducer 230 at a predetermined distance and a predetermined angle with respect to the longitudinal axis of the color 200 when the color 200 is in the closed configuration. In one example, the angle of the Doppler probe or transducer 230 may be approximately 30 degrees from the flat end face of the color 200, and thus 150 degrees from the longitudinal axis of the color 200, when the color 200 is in the closed configuration. In another example, the angle may be from 30 to 60 degrees from the flat end face of the color 200, and thus 120 - 150 degrees from the longitudinal axis of the color 200.

[0074]

[0085] The collar 200 may be made of a flexible or pliable material that allows the collar 200 to transition between an open configuration and a closed configuration. In one example, the collar 200 is permanently implanted within a patient. Additionally, the collar 200 may also be bioabsorbable. For example, the collar 200 shown in FIGS. 4A, 4B, 5A, 5B, and 5C may have the same material properties as the collar 200 shown in FIGS. 2, 3A, 3B, and 3C.

[0075]

[0086] As shown in FIG. 4A, the collar 200 begins in the open configuration and can be positioned along a blood vessel even if the blood vessel has not been cut or severed for anastomosis. For example, the collar 200 can be positioned along an uncut blood vessel to monitor blood flow through that vessel. The collar 200 shown in FIGS. 4A and 4B can also be advanced along the blood vessel before anastomosis or after anastomosis is complete, which preferably provides flexibility during surgery. Similar to the collar 200 shown in FIGS. 2, 3A, 3B, and 3C, the collar 200 in FIGS. 4A and 4B can be positioned near the anastomosis site such that the collar 200 is located at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site.

[0076]

[0087] FIGS. 5A, 5B, and 5C show the collar 200 being placed on a blood vessel 300. The collar 200 may be sized and shaped (e.g., clip-shaped) such that the collar 200 fits over a blood vessel 300 of a similar size (e.g., artery or vein). For example, when in the closed configuration, the collar 200 may have an inner diameter (D C )240 similar to the inner diameter of the collar 200 in FIG. 2, of 1.0 mm to 4.0 mm. In one example, the inner diameter (D C)240 may be provided in 0.5 mm increments. Color 200 may be sized and shaped to correspond to blood vessels (e.g., veins and arteries) commonly encountered in microsurgical and vascular reconstruction procedures and should be understood to be adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system. After Color 200 is placed at its intended location along blood vessel 300, Color 200 may be closed by suturing holes 210a, b together such that Color 200 remains in its closed configuration. Color 200 may also be secured to adjacent tissue by suturing holes 210a and / or 210b to the adjacent tissue. Suturing holes 210a, b to the adjacent tissue may be effective in providing strain relief for removal of Doppler probe 230, as shown in FIG. 5C. FIGS. 5B and 5C show suture 305 as a means of maintaining Color 200 in its closed configuration. It should be understood that other attachment means such as staples, clips, etc. may be used to maintain Color 200 in its closed configuration.

[0077]

[0088] FIG. 6 shows another embodiment 600a of the collar or strap. For example, as shown in FIG. 6, the strap 600a can include small holes 610, which provide a gripping surface for the clinician and also allow the collar or strap 600a to be fixed 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 embodiments described in FIGS. 2 through 5C, the Doppler probe or transducer 230 may be press-fitted within the probe holder 220. As described above, the probe holder 220 can include a receptacle 620 configured to removably hold the Doppler probe or transducer 230 at a predetermined distance and a predetermined angle relative to the longitudinal axis of the collar or strap 600a when the strap 600a is closed around a blood vessel. The receptacle 620 of the probe holder 220 may be sized and shaped similar to the probe holders shown in FIGS. 2 through 5C. For example, the probe holder 220 may have an octagonal or hexagonal profile that provides a plurality of surfaces for frictional engagement 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 the flat end face of the collar or strap 600a, and thus 120 degrees to 150 degrees from the longitudinal axis of the collar formed by the strap 600a, when the strap 600a is closed around a blood vessel.

[0078]

[0089] The color or strap 600a may be made of high density polyethylene ("HDPE"). In one example, the strap 600a 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 (e.g., Shore A) of 40 - 80 and a tear strength of 240 - 350 ppi. The silicone described above provides a robust material that can withstand the stresses associated with closing the strap 600a around a blood vessel while allowing the color or strap to conform to the blood vessel surface. In other examples, the strap 600a may be made from Nusil 4750, Nusil 4840, a thermoplastic, etc. The strap 600a may be made from other flexible or pliable materials such that the strap 600a is adapted to wrap around the patient's blood vessel. In one example, the strap 600a is permanently implanted within the patient and may be bioabsorbable.

[0079]

[0090] When the strap 600a wraps around the patient's blood vessel and is maintained at its closed position, the strap 600a may resemble a closed collar. The strap 600a has a strap width (W S ) 650 and a strap length (L S ) 660. The strap width (W S ) may be 2.5 mm to 5.0 mm to provide stability on the blood vessel. The strap length (L S ) 660 may be long enough such that the strap 600a can wrap around the blood vessel, and the strap length (L S)660 may also have a length sufficient for closure (see FIGS. 8A and 8B). For example, the strap 600a may be sized and shaped such that when closed, the strap 600a forms a collar that fits over a blood vessel (e.g., artery or vein) of a similar size. For example, the collar formed by the closed strap 600a may have an inner diameter of 1.0 mm to 4.0 mm. In one example, the strap 600a may be provided in increments of about 1.5 mm to accommodate different blood vessel sizes (e.g., different blood vessel sizes in increments of about 0.5 mm). The strap 600a may be sized and shaped to accommodate blood vessels (e.g., veins and arteries) commonly encountered in microsurgical and vascular reconstruction procedures and is understood to be adapted for end-to-end anastomosis of such veins and arteries in the peripheral vasculature.

[0080]

[0091] FIGS. 7A, 7B, and 7C show another exemplary embodiment 600b of a strap. The strap 600b can include a base portion 710, a saddle 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 strap 600b and also provides a gripping surface for the clinician when manipulating and positioning the strap 600b. The saddle portion 720 has a proximal end 722 and two distal ends 724a, b, respectively. The saddle portion 720 may extend from the base portion 710 at the proximal end 722 of the saddle portion. Extending from the saddle portion 720 at each end is each band portion 730. For example, each corresponding band portion 730 may extend from each of the distal ends 724a, b of the saddle portion 720.

[0081]

[0092] The saddle portion 720 and each band portion 730 may contact at a joint 725 (for example, each of the distal ends 724a, b of the saddle portion 720). When the strap 600b is spread out in its most open configuration, the first end of the strap 600b is the band portion 730, followed by the first portion of the saddle portion 720, and the base portion 710, and then the strap 600b continues with the second portion of the saddle portion 730 and each other band portion 730.

[0082]

[0093] In one example, the saddle portion 720 extends outward from the base portion 710 to form a contact surface 740 with a portion of the blood vessel. The contact surface 740 may be shaped like an inverted or upside-down saddle that creates a bowl-shaped or trough-shaped surface. For example, the saddle portion 720 may be flexible while maintaining sufficient rigidity to create the pre-formed contact surface 740. Alternatively, the saddle portion 720 and the band portion 730 may be sufficiently flexible and elastic such that the strap 600b lies flat on the horizontal plane when the contact surface 740 is adjacent to the horizontal plane.

[0083]

[0094] As shown in FIGS. 7B and 7C, the base portion 710 has a height (H BASE ) 750 and a width (W BASE ) 760. The height (H BASE ) 750 may be about 2.25 mm, and the width (W BASE ) 760 may be between 2.5 mm and 5.0 mm. A wider base portion 710 may be implemented to provide additional stability on the blood vessel.

[0084]

[0095] Furthermore, the saddle portion 720 may have a height (H S ) 752 that can be about 2.65 mm. The distance 764 between each end of the saddle portion 720 (for example, at the joint 725) may be about 4.0 mm. The band portion 730 may have a height (H BAND)It has 754. When the strap 600b is in the relaxed position, especially when the saddle portion 720 retains its shape, the distance 766 between the ends of the band portion 730 may be about 5.0 mm (as shown in FIG. 7B).

[0085]

[0096] The band portion may have a wall thickness (T BAND )770. The wall thickness (T BAND )770 may be selected and configured based on the closure mechanism for the strap 600b. For example, different closure fasteners may be compatible with different wall thicknesses. Further, the wall thickness (T BAND )770 can be selected to increase or decrease the flexibility, rigidity, and / or durability of the strap 600b. The strap 600b may have a width (W STRAP )762 of the ends of the band portion of about 2.5 mm to 5.0 mm. Similar to the wall thickness (T BAND )770, the width (W STRAP )762 can be selected to increase or decrease the flexibility, rigidity, and / or durability of the strap 600b. Further, the width (W STRAP )762 may be selected and configured based on the closure mechanism for the strap 600b. For example, different closure fasteners may be compatible with different strap widths.

[0086]

[0097] The dimensions of the saddle portion 720 and the band portion 730 can be adjusted for different vessel sizes. For example, the band portion may have a height sufficient to provide an appropriate closure surface after the strap 600b is closed around a vessel having a vessel diameter of 1.0 mm to 4.0 mm. It should be understood that the strap 600ab may be sized and shaped to accommodate vessels (e.g., veins and arteries) commonly 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.

[0087]

[0098] As shown in FIG. 7C, which is a cross-sectional view taken along line 7C-7C of FIG. B, the receiving port 620 of the probe holder 220 may have a conical profile with a cylindrical transition region 780. The diameter of the cylindrical transition region 780 may be from 0.015 inches to 0.030 inches (e.g., 0.38 mm to 0.76 mm). A cylindrical transition region 780 having a smaller diameter may achieve a tighter grip or clamping on the corresponding Doppler probe or transducer 230. The probe holder 220 may be oriented at an angle 782 of 120 to 150 degrees from the longitudinal axis of the collar formed by the closed strap 600b.

[0088]

[0099] Figures 8A and 8B show examples of placing a strap, such as strap 600a or strap 600b, around blood vessel 300. Straps 600a and 600b may generally be referred to as strap 600 hereinafter. The strap 600 shown in Figures 8A and 8B can include each of the features of strap 600a described in Figure 6, each of the features of strap 600b, or a combination thereof. As shown in Figure 8B, the strap assembly 800 can include a fastener 810, a fixture, a band, or other closing mechanism that maintains the strap 600 in a closed configuration around the blood vessel 300 such that the strap 600 forms a collar around the blood vessel 300. For example, Figures 8A and 8B show the strap 600 wrapping around the blood vessel 300 to form a collar. The collar formed by the strap 600 may be disposed near the anastomosis site such that the collar is positioned at the anastomosis site, upstream of the anastomosis site, or downstream of the anastomosis site. After the strap 600 wraps around the blood vessel 300 (e.g., such that the strap 600 forms a collar) and is maintained in the closing orientation of the strap 600 and disposed at the intended position of the strap 600 along the blood vessel 300, the collar formed by the strap 600 may be secured to the adjacent tissue by suturing the small holes (see Figure 6) to the adjacent tissue. Similar to the embodiments described in Figures 3C and 5C, suturing the small holes to the adjacent tissue can be effective in providing strain relief for removal of the Doppler probe.

[0089]

[0100] Figures 9A and 9B show another exemplary embodiment 600c of a strap having a closure mechanism different from the fastener, retainer, or band shown in Figure 8B. For example, the strap 600c can include a plurality of sizing holes 910, which are spaced along the strap 600c and are adapted to maintain the strap 600c in a closed configuration when fitted over the closure projection 920. For example, the sizing holes 910 may be sized and shaped such that the sizing holes 910 can be press-fitted over the closure projection 920. The sizing holes 910 may be spaced along the strap 600c at intervals of about 1.5 mm between each hole to accommodate different vessel sizes (e.g., different vessel sizes in increments of about 0.5 mm). The interval between each sizing hole 910 may alternatively be 1.0 mm or some other interval to accommodate different intervals of vessel sizes.

[0090]

[0101] As described above, the straps 600a, 600b, and 600c described in this specification may be sized and shaped for specific blood vessel sizes such that one strap is configured for blood vessels 1.0 to 2.0 mm, another strap is configured for blood vessels 2.0 to 3.0 mm, and different straps are configured for blood vessels 3.0 to 4.0 mm. If there are different strap sizes or lengths adapted for different blood vessel sizes, the sizing holes 910 may be arranged at closer intervals so that the strap can be adjusted to fit around blood vessels with a diameter of 1.0 to 2.0 mm in 0.2 mm increments (e.g., the sizing holes 910 may be configured so that the strap can be adjusted to form collars having inner diameters of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, and 2.0 mm). The strap 600c may be sized and shaped to correspond to blood vessels (e.g., veins and arteries) commonly encountered in microsurgical and vascular reconstruction procedures and adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system, and it should be understood that the sizing holes 910 may be arranged to correspond to blood vessels (e.g., veins and arteries) commonly encountered in microsurgical and vascular reconstruction procedures and adapted for end-to-end anastomosis of such veins and arteries in the peripheral vascular system.

[0091]

[0102] The protrusion 920 can include a flange or lip configured to maintain the strap 600c in a closed configuration. For example, the sizing hole 910 may be disposed on and press fit onto the protrusion 920 such that the protrusion 920 is pushed through the sizing hole 910. The material of the strap may allow the sizing hole to expand and bend to fit over the flange or lip of the protrusion 920 before relaxing back to its original shape of the sizing hole. After the protrusion 920 is pushed through the sizing hole 910, the flange or lip is adapted to prevent the strap 600c from loosening to the open position. For example, the flange or lip may be sized and shaped such that the force associated with the tendency of the strap to relax back to its open position is insufficient to cause the sizing hole 910 to expand and bend to fit back over the flange or lip of the protrusion 920. The material of the strap 600c and the geometric shapes of both the sizing hole 910 and the protrusion are configured such that a clinician can manipulate the strap 600c between the open and closed configurations while preventing the strap 600c from being opened without the clinician's intervention.

[0092]

[0103] Similar to the straps shown in FIGS. 8A and 8B, the straps shown in FIGS. 9A and 9B can each include the features of the straps described in FIG. 6 or FIGS. 7A-7C. Further, the straps shown in FIGS. 6, 7A-7C, 8A, 8B, 9A, and 9B can be configured and arranged such that when in a closed configuration, the straps form a color oriented similarly to the colors shown in FIGS. 2, 3A, 3B, 3C, 4B, 5B, and 5C. For example, the probe holder can include a receptacle configured to removably hold a Doppler probe or transducer at a predetermined distance and a predetermined angle with respect to the longitudinal axis of the color formed by the strap when the strap is in a closed configuration (e.g., the angle of the Doppler probe or transducer can be approximately 30 degrees from the flat end face of the color and thus 120 degrees from the longitudinal axis of the color formed by the strap when the strap is in a closed configuration). In another example, the angle can be from 30 degrees to 60 degrees from the flat end face of the strap 600 and thus 120 to 150 degrees from the longitudinal axis of the color formed by the closed strap 600.

[0093]

[0104] Sensing devices, such as a Doppler probe or transducer inserted into the color, enable a physician (e.g., a surgeon) to monitor and analyze blood flow and / or blood flow velocity to determine the success of a surgery and / or confirm vascular patency.

[0094]

[0105] Any transducer suitable for ultrasonic Doppler monitoring can be used with color. In an exemplary 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 that fits the dimensions of the corresponding probe holder used on color. For example, the circular transducer 230 is suitable for being received by a receptacle having an inner surface that is circular in shape. In another example, the receptacle 620 formed by the probe holder may be octagonal or hexagonal (see FIG. 3A) to achieve a more secure friction fit with the Doppler probe or transducer tip. The transducer 230 may be a circular piezoelectric crystal having a size of about 0.5 mm to about 1 mm. In one example, the Doppler probe or transducer 230 includes a tip having a circular piezoelectric crystal with a size of about 0.5 mm to about 1 mm, a Teflon®-coated coaxial wire, and a metal connector.

[0095]

[0106] The Doppler probe coupled to the color or strap disclosed herein can be adapted to detect blood flow at the anastomosis site and to confirm vascular patency during and after surgery at the anastomosis site. For example, blood flow can be detected up to about 14 days after surgery.

[0096]

[0107] Many features and advantages of the present disclosure are apparent from the described description, and accordingly, the appended claims are intended to cover all such features and advantages of the present disclosure. Further, since numerous modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to the exact construction and operation as illustrated and described. Accordingly, the described embodiments should be considered exemplary and not restrictive, and the present disclosure should not be limited to the details given herein, but should be defined by the full scope of the following claims and equivalents of those claims, whether foreseeable or unforeseeable at present or in the future.

Claims

1. A vascular monitoring system comprising: a collar configured to be disposed around a patient's blood vessel; a transducer coupled to the collar and configured to emit ultrasonic signals transmitted through the patient's blood vessel; a probe holder having a receptacle configured to receive and removably hold the transducer, wherein the transducer is frictionally fitted to the receptacle; A vascular monitoring system comprising the above components.

2. The vascular monitoring system according to claim 1, wherein the collar includes at least one aperture adapted to be sutured to adjacent tissue to fixedly position the collar around the patient's blood vessel.

3. The vascular monitoring system according to claim 1 or 2, wherein the collar is made of at least one of implant-grade liquid silicone rubber (LSR) and high consistency silicone rubber (HCR) having a durometer of 40 to 80.

4. The vascular monitoring system according to any one of claims 1 to 3, wherein the collar is configured to be disposed around an anastomosis site of the patient's blood vessel.

5. The vascular monitoring system according to any one of claims 1 to 3, wherein the collar is configured to be disposed at a position that is either upstream or downstream of the anastomosis site of the patient's blood vessel.

6. A vascular collar comprising: a cylindrical body portion having an opening with an inner diameter sized and shaped to be disposed around a patient's blood vessel; a probe holder configured to receive a transducer; at least one attachment tab; A vascular collar comprising the above components.

7. The vascular collar according to claim 6, wherein the inner diameter is 1.0 mm to 4.0 mm.

8. The vascular collar according to claim 6 or 7, wherein the transducer is configured to emit ultrasonic signals transmitted through the patient's blood vessel.

9. A vascular monitoring system comprising: a collar configured to be disposed around a patient's blood vessel and configured to transition from an open configuration to a closed configuration; a transducer coupled to the collar and configured to emit ultrasonic signals transmitted through the patient's blood vessel; A probe holder having a receptacle configured to receive and removably hold the transducer, wherein the transducer is coupled to the receptacle by friction fitting, the probe holder; A vascular monitoring system comprising.

10. The vascular monitoring system according to claim 9, wherein the collar includes at least one closing structure configured to maintain the collar in the closed configuration.

11. The vascular monitoring system according to claim 10, wherein the at least one closing structure includes a first small hole and a second small hole.

12. The vascular monitoring system according to claim 10 or 11, wherein the at least one closing structure is adapted to be sutured to adjacent tissue to fixedly position the collar around the patient's blood vessel.

13. The vascular monitoring system according to any one of claims 9 to 12, 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 of 40 to 80.

14. The vascular monitoring system according to any one of claims 9 to 13, wherein the collar is configured to be disposed around an anastomosis site of the patient's blood vessel.

15. The vascular monitoring system according to any one of claims 9 to 13, wherein the collar is configured to be disposed at a position that is one of upstream of the anastomosis site of the patient's blood vessel and downstream of the anastomosis site of the patient's blood vessel.

16. A vascular collar, A body portion configured to transition from an open configuration to a closed configuration, having an opening in the closed configuration, and having an inner diameter sized and shaped to be disposed around a patient's blood vessel, the body portion; A probe holder having a receptacle configured to receive and removably hold the transducer, wherein the transducer is coupled to the receptacle by friction fitting, the probe holder; At least one attachment tab; A vascular collar comprising.

17. The vascular collar according to claim 16, wherein the attachment tab includes a closing feature adapted to hold the collar in the closed configuration after transitioning from the open configuration to the closed configuration.

18. The vascular collar according to claim 16 or 17, wherein the body portion is made of a flexible / flexible material that enables the body portion to transition from the open configuration to the closed configuration when a closing force is applied to the collar.

19. A vascular strap, comprising: An elongated strap body having a first end and a second end; A plurality of sizing holes starting near the first end and disposed along the strap body; A closing projection disposed adjacent to the second end of the strap body, The closing projection being sized and shaped such that it is press-fitted through a sizing hole of the plurality of sizing holes; The closing projection being configured to maintain the vascular strap in a closed configuration when press-fitted through the sizing hole; The closing projection forming a cylindrical shape having an inner diameter sized and shaped to be disposed around a patient's blood vessel in the closed configuration; A probe holder having a receptacle configured to receive and removably hold a transducer, the transducer being coupled to the receptacle by friction fit; At least one mounting tab; A vascular strap.

20. The vascular strap according to claim 19, wherein the inner diameter is from 1.0 mm to 4.0 mm.

21. The vascular strap according to claim 19 or 20, wherein the transducer is configured to emit an ultrasonic signal transmitted through the patient's blood vessel.

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