WO2023033488A1 - Apparatus for supporting outer wall of blood vessel - Google Patents
Apparatus for supporting outer wall of blood vessel Download PDFInfo
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- WO2023033488A1 WO2023033488A1 PCT/KR2022/012905 KR2022012905W WO2023033488A1 WO 2023033488 A1 WO2023033488 A1 WO 2023033488A1 KR 2022012905 W KR2022012905 W KR 2022012905W WO 2023033488 A1 WO2023033488 A1 WO 2023033488A1
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- Prior art keywords
- blood vessel
- vein
- support
- wall
- artificial blood
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Images
Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the present invention relates to a device for supporting the outer wall of a blood vessel, and more particularly, to a device for supporting the outer wall of a blood vessel for supporting the outer wall of an artificial blood vessel anastomosed with a vein and the outer wall of a vein when arteriovenous transplantation is performed using the artificial blood vessel.
- a complication that occurs frequently in patients undergoing dialysis by forming the dialysis line is blockage of the dialysis line due to blood vessel stenosis.
- abnormal blood flow disurbed flow
- vascular endothelial cell activation and functional abnormalities resulting in inflammatory response and neointimal formation ( Neo-intima formation process progresses, resulting in vascular stenosis and thrombosis.
- Autologous arteries and artificial vessels have physical differences in their physical properties, and there is a clear difference between the flow of arterial blood that flows in when an autologous artery is directly connected to a vein and the flow of arterial blood that enters and joins through an artificial vessel. Therefore, in order to create ideal blood flow in the AVG that connects artificial blood vessels and autologous veins, what angle should blood flow be spliced and what anatomical structure should the outer wall support of blood vessels be induced to maintain artificial blood vessels and autologous veins after surgery? Technology development is required.
- the outer wall support of a blood vessel also accepts pulsatile blood flow that repeats contraction and relaxation. Therefore, there is a demand for the development of a technology for minimizing deformation of blood vessels due to pulsatile blood flow in relation to the AVG blood vessel outer wall support.
- Patent Document 1 US 10849627 B2
- Patent Document 2 US 2015/0119908 A1
- the present invention is to solve the problems of the prior art described above, and an object of the present invention is to support the outer wall of the artificial blood vessel and the autologous vein after arteriovenous graft (AVG) connecting the artificial blood vessel and the autologous vein to provide an ideal blood flow. It is to provide a device for supporting the outer wall of a blood vessel that induces.
- AVG arteriovenous graft
- Another object of the present invention is to provide a device for supporting the outer wall of a blood vessel that minimizes deformation of blood vessels due to pulsatile blood flow that repeats contraction and relaxation after arteriovenous graft (AVG) connecting artificial blood vessels and autologous veins.
- AVG arteriovenous graft
- an artificial blood vessel support having a curved shape and arranged to surround an outer wall of an artificial blood vessel anastomosed with a vein and disposed to surround an outer wall of the vein, distal to the artificial blood vessel support
- An apparatus for supporting an outer wall of a blood vessel including a vein support unit connected to the artificial vessel support unit at an end thereof is provided.
- the artificial blood vessel support has an arc shape
- the vein support has a straight shape
- the artificial blood vessel support may intersect the vein support at the distal end.
- the artificial blood vessel support may come into contact with the vein support at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support.
- the artificial blood vessel support may have a length of 15 to 25 mm.
- a length from a connection portion with the artificial blood vessel support to a proximal end of the vein support may be 20 to 40 mm.
- At least one of the artificial blood vessel support part and the vein support part may include a plurality of annular segments spaced apart from each other in a longitudinal direction and disposed continuously in a wave shape along the circumferential direction, and a pair of adjacent annular segments. It may include a connecting member that is connected and disposed.
- the connecting member may include a bridge connecting a pair of adjacent troughs or a pair of ridges along the longitudinal direction.
- the connecting member connects the peaks located on both sides of the bridge in the circumferential direction and the valleys where the longitudinal ends of the bridge are in contact, or the valleys located on both sides of the bridge in the circumferential direction and the longitudinal ends of the bridge are in contact
- An auxiliary bridge connecting the mountain part may be further included.
- the artificial blood vessel support portion having a curved shape and surrounding the outer wall of the artificial blood vessel anastomosed with the vein is configured to be connected to the vein support portion at a predetermined angle.
- a plurality of annular segments that are continuously disposed apart from each other in a longitudinal direction and disposed in a wavy shape along the circumferential direction, and a connection that is disposed by connecting a pair of adjacent annular segments.
- FIG. 1 is a diagram showing the configuration of an apparatus for supporting the outer wall of a blood vessel according to an embodiment of the present invention.
- FIG. 2 is a view showing an anatomical structure in which blood vessel stenosis occurs frequently due to abnormal blood flow in an anastomotic portion between an artificial blood vessel and a vein.
- FIG. 3 is a view showing examples in which an artificial blood vessel having a straight shape is anastomosed with a vein.
- FIG. 4 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 3 .
- FIG. 5 is a view showing examples in which an artificial blood vessel having an arc shape is anastomosed with a vein.
- FIG. 6 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 5 .
- FIG. 7 is an upper perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- FIG. 8 is a lower perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- FIG. 9 is a rear view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- FIG. 10 is a view showing an annular segment and a connecting member of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- FIG. 11 is a graph showing the hemodynamic effect provided by the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- spatially relative terms such as “front”, “rear”, “upper” or “lower” may be used to describe the correlation with components shown in the drawings. These are relative terms based on what is shown in the drawings, and the positional relationship may be interpreted in the opposite way according to the orientation.
- 'proximal' means a position relatively close to the heart
- 'distal' means a position relatively far from the heart in the direction of blood flow. Therefore, it can be interpreted that arterial blood proceeds in a proximal to distal direction, and venous blood proceeds in a distal to proximal direction.
- that a component is “connected” to another component includes cases where they are not only directly connected to each other but also indirectly connected to each other unless there are special circumstances.
- FIG. 1 is a diagram showing the configuration of an apparatus for supporting the outer wall of a blood vessel according to an embodiment of the present invention.
- the device for supporting the outer wall of a blood vessel 100 is provided to surround and arrange an arteriovenous graft (AVG) artificial blood vessel and an autologous vein anastomosed with the artificial blood vessel.
- AVG arteriovenous graft
- the device for supporting the outer wall of blood vessels 100 minimizes the occurrence of abnormal blood flow in the arteriovenous graft and makes the blood flow smooth.
- an apparatus for supporting an outer wall of a blood vessel 100 includes an artificial blood vessel support unit 110 and a vein support unit 130 .
- the artificial blood vessel support 110 is disposed to surround the outer wall of the artificial blood vessel anastomosed with the vein.
- the artificial blood vessel refers to an arteriovenous transplanted blood vessel that is artificially created and connects an autologous artery to an autologous vein.
- the material of the artificial blood vessel may be polytetrafluoroethylene (ePTFE).
- the artificial blood vessel support 110 has a curved shape. More specifically, the artificial blood vessel support 110 may have an arc shape.
- the artificial blood vessel support 110 includes a tubular body 112 having a space inside the artificial blood vessel, an inlet 111 formed at a proximal end of the body 112, and a distal end of the body 112. It may be provided with an outlet 113 formed in.
- Vein support 130 is provided to be disposed while surrounding the outer wall of the vein.
- the vein refers to a vein joined to an artificial blood vessel at an arteriovenous transplant site.
- the vein support 130 is connected to the artificial blood vessel support 110 at the distal end of the artificial blood vessel support 110 . That is, the vein support 130 may communicate with the artificial blood vessel support 110 through the outlet 113 of the artificial blood vessel support 110 .
- Vein support 130 may have a straight shape.
- the vein support 130 includes a distal portion 131 disposed distal with respect to a connection portion with the artificial blood vessel support 110, an anastomosis portion 132 intersecting the outlet 113 of the artificial blood vessel support 110, A proximal portion 133 disposed proximal to the connection portion with the artificial blood vessel support 110 may be included.
- the artificial blood vessel support 110 has an arc shape
- the vein support 130 has a straight shape
- the artificial blood vessel support 110 intersects the vein support 130 at the distal end.
- the artificial blood vessel support 110 may come into contact with the vein support 130 at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support 130 .
- the angle between the artificial blood vessel support 110 and the vein support 130 is the tangential line TL of the artificial blood vessel support 110 at the intersection of the artificial blood vessel support 110 and the vein support 103. ) and an angle ( ⁇ ).
- the blood vessel support 110 has an arc shape and is connected to the vein support 130 at an angle of 15 degrees or more and less than 60 degrees
- computational fluid dynamics factor analysis for verifying the effect of improving blood flow at the vascular anastomosis site explain the results.
- FIG. 2 is a view showing an anatomical structure in which blood vessel stenosis occurs frequently due to abnormal blood flow in an anastomotic portion between an artificial blood vessel and a vein.
- the diameter of the artificial blood vessels and veins may be assumed to be 3 mm.
- the blood flow of arterial blood (A) flows into the inlet 111 at the highest speed in the range of 0.2 to 0.9 m/s, and is assumed to have a static pressure of 3700 to 5500 Pa at the outlet 113 , venous blood (V) can be assumed to have a constant velocity of 0.1 m/s.
- ANSYS Fluent 20.0 was used as a software for computational fluid dynamics, and to change the partial differential equation (PDE) representing the flow into the differential equation (FDE), which is an algebraic equation, continuous
- PDE partial differential equation
- FVM finite volume method
- FVM finite volume method
- the K- ⁇ SST turbulence model was additionally applied to simulate the turbulent flow of the fluid.
- the Carreau-Yasuda model was applied to the blood to apply the non-Newtonian model, and the density was set to 1060 kg/m 3 .
- the maximum shear stress WSSmax (Wall Shear Stress Max), time-average wall shear stress TAWSS (Time-Average Wall Shear Stress) and alternating shear index OSI (Oscillatory Shear Index) were measured in Table 1 below. ], and areas with OSI ⁇ 0.1, TAWSS ⁇ 2 Pa, and WSSmax ⁇ 70 Pa were classified as vulnerable to atherosclerosis.
- FIG. 3 is a view showing examples in which an artificial blood vessel having a straight shape is anastomosed with a vein.
- the examples shown in FIG. 3 are those in which the artificial graft has a straight shape and is connected to the vein, and the artificial graft has an angle of 15 degrees and 30 degrees, respectively, to the vein. straight 30°), 45° (straight 45°), and 60° (straight 60°) angles.
- FIG. 4 shows the result of analyzing the abnormal blood flow area in the examples of FIG. Specifically, FIG. 4 shows the area of the area of OSI ⁇ 0.1, the area of TAWSS ⁇ 2Pa, and the area of WSSmax ⁇ 70Pa in the toe area T.
- the examples of FIG. 3 all have areas where errors occur in OSI, TAWSS, and WSSmax.
- the artificial graft has a straight shape and forms a straight 15° with the vein, the region with OSI ⁇ 0.1 and the region with TAWSS ⁇ 2Pa are eliminated, showing relatively good blood flow, but still A region in which shear stress was high was observed with WSSmax ⁇ 70Pa.
- FIG. 5 is a view showing examples in which an artificial blood vessel having an arc shape is anastomosed with a vein.
- the examples shown in FIG. 5 are those in which the artificial graft has an arc shape and is connected to the vein. Round 30°), 45° (Round 45°) and 60° (Round 60°) are meeting.
- FIG. 6 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 5 . Specifically, FIG. 6 shows the area of the area of OSI ⁇ 0.1, the area of TAWSS ⁇ 2Pa, and the area of WSSmax ⁇ 70 Pa in the toe area (T).
- the region with WSSmax ⁇ 70 Pa where a high shear force of 70 Pa or more is applied is lost regardless of the angle, and the region with OSI ⁇ 0.1 and TAWSS ⁇ 2 Pa is artificial blood vessel (Graft) vein. (Vein) has been confirmed to appear only when it forms an angle of 60 degrees. However, when the tangential angle exceeded 60 degrees, a tendency for abnormal blood flow to increase was observed.
- Graft blood vessel
- the artificial graft has an arc shape and is connected to the vein at an angle of 15 degrees or more and less than 60 degrees. Accordingly, the apparatus 100 for supporting the outer wall of the blood vessel according to an embodiment of the present invention needs to support the artificial blood vessel (graft) and the vein (vein) to maintain these shapes, and for this purpose, the artificial blood vessel support unit 110 In shape, the vein support 130 has a straight shape, but the artificial blood vessel support 110 is in contact with the vein support 130 at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support 130. desirable.
- the artificial blood vessel support 110 having an arc shape forms an angle of 30 degrees with the vein support 130, and the diameter d1 of the artificial blood vessel support 110 and the diameter of the vein support 130
- (d2) is 3 mm
- the radius of curvature R is 20 mm
- the distance from the center of curvature O of the artificial blood vessel support 110 to the outermost radial side of the artificial blood vessel support 110 ( R+d1) becomes 23 mm.
- the innermost length L1 of the artificial blood vessel support 110 in the radial direction is 25.8 mm
- the outermost length L3 of the artificial blood vessel support 110 in the radial direction is 16.4 mm
- the length of the artificial blood vessel support 110 is 16.4 mm. (L2) becomes 20 mm.
- the crossing length L4 of the artificial blood vessel support 110 and the vein support 130 is 10.954 mm
- the intersection area of the artificial blood vessel support 110 and the vein support 130 is 39.47 mm 2 .
- the length L2 of the artificial blood vessel support 110 is preferably 15 to 25 mm for the anatomical structure of blood vessels and the convenience of the operator.
- the length L2 of the artificial blood vessel support 110 may be 20 mm.
- the length from the connection portion with the artificial blood vessel support 110 of the vein support 130 to the proximal end in other words, the length L5 of the proximal portion 133 is 20 to 40 mm.
- the arc-shaped artificial vessel support 110 forms an angle of 30 degrees with the vein support 130, and the diameter d1 of the artificial vessel support 110 and the diameter d2 of the vein support 130 When each of these is 3 mm, it has been confirmed that no turbulent flow occurs in the vein even when the proximal portion 133 has a length of 20 mm.
- FIG. 7 is an upper perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention
- FIG. 8 is a perspective view of the lower side of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention
- FIG. It is a rear view of the device for supporting the outer wall of a blood vessel according to the embodiment.
- FIG. 10 is a view showing an annular segment and a connecting member of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
- an apparatus 200 for supporting an outer wall of a blood vessel includes an artificial blood vessel support 210 and a vein support 230 .
- the shape of the artificial blood vessel support part 210 and the vein support part 230, the angle formed with each other, the length of the artificial blood vessel support part 210, and the artificial blood vessel support part 210 among the vein support parts 230 The length from the connection site to the proximal end (length of the proximal portion) is the same as described in relation to one embodiment of the present invention. Therefore, detailed descriptions of overlapping contents will be omitted, and only non-overlapping contents will be described.
- the vein support 230 has a slot 230a formed along the longitudinal direction. During the operation of the outer wall support device 200 for the blood vessel, the patient's vein can be easily inserted into the vein support 230 through the slot 230a and placed therein.
- the vein support 230 may be made of a material that memorizes its shape depending on temperature.
- the vein support 230 has a shape in which the slot 230a is open during surgery, but has a shape in which the slot 230a is closed so as to entirely cover the vein at a predetermined temperature (eg, body temperature). can be transformed into
- a predetermined temperature eg, body temperature
- the slot 230a of the vein support 230 is opened to facilitate insertion of the vein, but after surgery, the slot 230a is closed inside the patient's body, and the vein support 230 is The outer wall can be supported as a whole. Meanwhile, once the slot 230a is deformed into a closed shape, the shape may be maintained regardless of temperature.
- vein support 230 may be made of a material that does not remember its shape, and the slot 230a may be artificially closed by a surgeon after inserting the vein.
- both the artificial blood vessel support 210 and the vein support 230 are spaced apart in the longitudinal direction and are continuously disposed. It includes a plurality of annular segments 300 arranged in a wavy shape along the circumferential direction, and a connecting member 400 connected to a pair of adjacent annular segments 300 and disposed.
- deformation of a blood vessel due to repeated pulsatile blood flow in an arteriovenous transplant unit can be minimized through the plurality of annular segments 300 and the connection member 400 .
- a plurality of annular segments 300 are spaced apart in the longitudinal direction and continuously arranged, and are arranged in a wavy shape along the circumferential direction, respectively.
- the plurality of annular segments 300 may form the artificial blood vessel support 210 and the vein support 230 .
- the plurality of annular segments 300 may integrally form the artificial blood vessel support 210 and the vein support 230 .
- the connecting member 400 connects a pair of adjacent annular segments 300 and is disposed.
- the connection member 400 may include a bridge 410 connecting a pair of valleys or a pair of peaks adjacent to each other along the longitudinal direction.
- the connecting member 400 connects the peaks located on both sides of the bridge 410 in the circumferential direction and the valley where one end of the bridge 410 in the longitudinal direction is in contact, or connects the bridge in the circumferential direction (
- An auxiliary bridge 420 may be further included to connect valleys located on both sides of 410 and hills where one end of the bridge 410 in the longitudinal direction is in contact.
- the bridge 410 and the auxiliary bridge 420 of the connection member 400 minimize deformation of blood vessels due to repeated pulsatile blood flow in the arteriovenous transplant. More specifically, it improves the distribution of stress applied to the inside of the apparatus 200 for supporting the outer wall of blood vessels, thereby reducing maximum stress and alleviating stress concentration. Through this, it is possible to reduce fatigue and prevent breakage of the device for supporting the outer wall of the blood vessel 200 .
- FIG. 11 is a graph showing the hemodynamic effect provided by the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention. Specifically, FIG. 11 shows that the thickness of the annular segment 300 is 0.4 mm, the diameter (r) of the valley or peak is 0.3 mm, the amplitude (A) of the valley or peak is 1.27 mm, and the length (l) of the valley or peak is 0.3 mm. 0.65 mm, the distance (S) between a pair of adjacent valleys or ridges along the longitudinal direction is designed to be 2.4 mm, and the diameter of the blood vessel is assumed to be 3 mm. The results of the analysis of hemodynamic factors are shown.
- the connecting member 400 includes only the bridge 410 and supports the outer wall of the blood vessel without the auxiliary bridge 420.
- a vein (Model B) disposed inside the device 200 and a vein (Model B) disposed inside the vessel outer wall supporting device 200 having both the bridge 410 and the auxiliary bridge 420 in the connecting member 400 C) decreased hemodynamic stability, such as a decrease in the WSS area of the diastolic phase (see FIG. 11(a)), low TAWSS (see FIG. 11(b)), and a decrease in OSI (see FIG. 11(c)) you can check what you see.
- the vein (Model C) in which the connection member 400 is disposed inside the vessel outer wall support device 200 having both the bridge 410 and the auxiliary bridge 420 shows the most stable hemodynamic factor. Therefore, hemodynamic stability can be maximized when the connection member 400 includes both the bridge 410 and the auxiliary bridge 420 .
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Abstract
Disclosed is an apparatus for supporting an outer wall of a blood vessel. An apparatus for supporting an outer wall of a blood vessel according to an embodiment of the present invention comprises: an artificial blood vessel support part which has a curved shape and is provided so as to surround an outer wall of an artificial blood vessel anastomosed with a vein; and a vein support part which is provided so as to surround an outer wall of the vein, and is connected to the artificial blood vessel support part at a distal end of the artificial blood vessel support part.
Description
본 발명은 혈관 외벽 지지 장치에 관한 것으로, 더욱 상세하게는 인조 혈관을 이용하여 동정맥 이식을 한 경우에 정맥과 문합된 인조 혈관의 외벽과 정맥의 외벽을 지지하기 위한 혈관 외벽 지지 장치에 관한 것이다.The present invention relates to a device for supporting the outer wall of a blood vessel, and more particularly, to a device for supporting the outer wall of a blood vessel for supporting the outer wall of an artificial blood vessel anastomosed with a vein and the outer wall of a vein when arteriovenous transplantation is performed using the artificial blood vessel.
말기신부전(end-stage renal disease)의 유병률이 지속적으로 상승하면서 혈액투석로 확보(hemodialysis vascular access)를 위한 동정맥루(Arteriovenous Fistula, AVF) 수술을 받는 환자들이 지속적으로 증가하고 있다. 투석로 형성은 말기 신부전으로 요독증이 발생하거나, 폐부종, 전해질 불균형이 발생하였을 때 혈액투석을 하는 환자들에게 필요하며, 중심정맥관 시술을 통하여 투석을 시작하면서 동정맥루 수술을 받고, 적절한 성숙을 이룬 후에 투석을 지속하게 된다. 이때, 자가 혈관의 상태 및 임상적 소견에 따라 자가 정맥과 동맥을 접합시키기도 하며, 인조 혈관을 이용하여 투석로를 형성하기도 한다.As the prevalence of end-stage renal disease continues to rise, the number of patients undergoing arteriovenous fistula (AVF) surgery for hemodialysis vascular access continues to increase. Dialysis line formation is necessary for patients undergoing hemodialysis when uremia occurs due to end-stage renal failure, pulmonary edema, or electrolyte imbalance occurs. will continue At this time, depending on the state of the autologous blood vessel and clinical findings, the autologous vein and artery may be joined, or a dialysis path may be formed using an artificial blood vessel.
이렇게 투석로를 형성하여 투석 받는 환자들에서 많은 빈도로 발생하는 합병증이 바로 혈관 협착으로 인한 투석로 막힘 현상이다. 이러한 혈관 협착의 기전을 살펴보면, 혈관 접합부 주변에서 혈관 구조 및 정맥으로 동맥혈이 유입되면서 발생하는 이상 혈류(disturbed flow)로 인하여 혈관내피세포 활성화 및 기능 이상이 생기고, 이로 인하여 염증 반응 및 신생내막 형성(Neo-intima formation) 과정이 진행되어 혈관 협착 및 혈전증(thrombosis)이 발생하게 된다.A complication that occurs frequently in patients undergoing dialysis by forming the dialysis line is blockage of the dialysis line due to blood vessel stenosis. Looking at the mechanism of such vascular stenosis, abnormal blood flow (disturbed flow) caused by the inflow of arterial blood into the vascular structure and veins around the vascular junction causes vascular endothelial cell activation and functional abnormalities, resulting in inflammatory response and neointimal formation ( Neo-intima formation process progresses, resulting in vascular stenosis and thrombosis.
이와 같은 혈관 협착이 발생하는 근본적인 원인인 이상 혈류를 막고, 이상 혈류로 인하여 불규칙한 모양으로 재구조화(remodeling)되는 정맥의 변화를 막기 위하여, 동정맥루 수술 시 혈관 외벽을 지지해주는 구조체를 삽입함으로서 이상 혈류의 층류화(laminar flow)를 유도하는 기술이 제시되어 왔다.In order to prevent abnormal blood flow, which is the fundamental cause of vascular stenosis, and to prevent changes in veins that are remodeled into irregular shapes due to abnormal blood flow, a structure supporting the outer wall of the blood vessel is inserted during arteriovenous fistula surgery to prevent abnormal blood flow. Techniques for inducing laminar flow have been proposed.
관련된 선행 기술들을 검토하면, US 10849627 B2 및 US 2015/0119908 A1 등이 자가 동맥 및 자가 정맥을 연결하는 동정맥루(Arteriovenous Fistula, AVF) 모델의 외·내벽 지지체 대한 디자인을 제안하고 있다. 그러나 자가 동맥이 아닌 인조 혈관(graft)과 자가 정맥을 연결하는 동정맥 이식(Arteriovenous Graft, AVG)에 대한 혈류 역학적 연구 및 혈관 외벽 지지체의 대한 제안은 거의 찾아보기 어려운 실정이다.When reviewing related prior art, US 10849627 B2 and US 2015/0119908 A1 suggest designs for external and internal wall supports of an Arteriovenous Fistula (AVF) model connecting autologous arteries and autologous veins. However, hemodynamic studies on arteriovenous graft (AVG) that connects an artificial non-autologous artery (graft) with an autologous vein and proposals for a support for the outer wall of a blood vessel are hardly found.
자가 동맥과 인조 혈관은 그 자체의 물성에 물리적 차이가 있으며, 자가 동맥을 정맥에 직접 연결했을 때 들어오는 동맥혈과 인조 혈관을 타고 들어와 합류되는 동맥혈의 흐름에는 분명한 차이가 존재한다. 따라서 인조 혈관과 자가 정맥을 연결하는 AVG에서 이상적인 혈류를 만들기 위하여 어떠한 각도로 혈류를 접합시켜야 하는지, 혈관 외벽 지지체는 수술 후 인조 혈관과 자가 정맥이 어떤 해부학적 구조를 유지하도록 유도해야하는지에 대한 연구 및 기술의 개발이 요구되고 있다.Autologous arteries and artificial vessels have physical differences in their physical properties, and there is a clear difference between the flow of arterial blood that flows in when an autologous artery is directly connected to a vein and the flow of arterial blood that enters and joins through an artificial vessel. Therefore, in order to create ideal blood flow in the AVG that connects artificial blood vessels and autologous veins, what angle should blood flow be spliced and what anatomical structure should the outer wall support of blood vessels be induced to maintain artificial blood vessels and autologous veins after surgery? Technology development is required.
한편, 동맥경화로 인한 협심증 및 심근경색에서 사용되는 스텐트와 마찬가지로 혈관 외벽 지지체 역시, 수축과 이완을 반복하는 박동성(Pulsatile) 혈류를 수용하게 된다. 따라서 AVG 혈관 외벽 지지체와 관련하여서 박동성 혈류에 따른 혈관의 변형을 최소화하기 위한 기술의 개발도 함께 요구되고 있는 실정이다.Meanwhile, like a stent used in angina pectoris and myocardial infarction due to arteriosclerosis, the outer wall support of a blood vessel also accepts pulsatile blood flow that repeats contraction and relaxation. Therefore, there is a demand for the development of a technology for minimizing deformation of blood vessels due to pulsatile blood flow in relation to the AVG blood vessel outer wall support.
(특허문헌 1) US 10849627 B2 (Patent Document 1) US 10849627 B2
(특허문헌 2) US 2015/0119908 A1(Patent Document 2) US 2015/0119908 A1
본 발명은 전술한 종래기술의 문제점을 해결하기 위한 것으로, 본 발명의 목적은 인조 혈관과 자가 정맥을 연결하는 동정맥 이식(Arteriovenous Graft, AVG) 후 인조 혈관 및 자가 정맥의 외벽을 지지하여 이상적인 혈류 흐름을 유도하는 혈관 외벽 지지 장치를 제공하는 것이다.The present invention is to solve the problems of the prior art described above, and an object of the present invention is to support the outer wall of the artificial blood vessel and the autologous vein after arteriovenous graft (AVG) connecting the artificial blood vessel and the autologous vein to provide an ideal blood flow. It is to provide a device for supporting the outer wall of a blood vessel that induces.
본 발명의 다른 목적은 인조 혈관과 자가 정맥을 연결하는 동정맥 이식(Arteriovenous Graft, AVG) 후 수축과 이완을 반복하는 박동성 혈류에 따른 혈관의 변형을 최소화시켜주는 혈관 외벽 지지 장치를 제공하는 것이다.Another object of the present invention is to provide a device for supporting the outer wall of a blood vessel that minimizes deformation of blood vessels due to pulsatile blood flow that repeats contraction and relaxation after arteriovenous graft (AVG) connecting artificial blood vessels and autologous veins.
본 발명에서 해결하고자 하는 기술적 과제는 여기에 제한되지 않으며, 언급되지 않은 다른 기술적 과제는 아래의 기재로부터 통상의 기술자에게 명확하게 이해될 수 있을 것이다.The technical problem to be solved in the present invention is not limited thereto, and other technical problems not mentioned will be clearly understood by those skilled in the art from the following description.
본 발명의 일 측면에 따르면, 정맥과 문합된 인조 혈관의 외벽을 둘러싸며 배치되도록 구비되고, 곡선 형상을 가지는 인조 혈관 지지부 및 상기 정맥의 외벽을 둘러싸며 배치되도록 구비되고, 상기 인조 혈관 지지부의 원위 단부에서 상기 인조 혈관 지지부와 연결되는 정맥 지지부를 포함하는 혈관 외벽 지지 장치가 제공된다.According to one aspect of the present invention, an artificial blood vessel support having a curved shape and arranged to surround an outer wall of an artificial blood vessel anastomosed with a vein and disposed to surround an outer wall of the vein, distal to the artificial blood vessel support An apparatus for supporting an outer wall of a blood vessel including a vein support unit connected to the artificial vessel support unit at an end thereof is provided.
이때, 상기 인조 혈관 지지부는 호 형상을 가지고, 상기 정맥 지지부는 직선 형상을 가지며, 상기 인조 혈관 지지부는 상기 원위 단부에서 상기 정맥 지지부와 교차할 수 있다.In this case, the artificial blood vessel support has an arc shape, the vein support has a straight shape, and the artificial blood vessel support may intersect the vein support at the distal end.
또한, 상기 인조 혈관 지지부는 상기 정맥 지지부와의 교차 지점에서 상기 정맥 지지부와 15도 이상 60도 미만의 각도를 이루며 접할 수 있다.In addition, the artificial blood vessel support may come into contact with the vein support at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support.
또한, 상기 인조 혈관 지지부는 15~25㎜의 길이를 가질 수 있다.In addition, the artificial blood vessel support may have a length of 15 to 25 mm.
또한, 상기 정맥 지지부 중 상기 인조 혈관 지지부와의 연결 부위에서 근위 단부까지의 길이는 20~40㎜일 수 있다.In addition, a length from a connection portion with the artificial blood vessel support to a proximal end of the vein support may be 20 to 40 mm.
또한, 상기 인조 혈관 지지부 및 상기 정맥 지지부 중 어느 하나 이상은, 길이 방향으로 이격되어 연속적으로 배치되며, 각각 둘레 방향을 따라 물결 형상을 가지고 배치되는 복수개의 환형 세그먼트와, 인접한 한 쌍의 환형 세그먼트를 연결하며 배치되는 연결부재를 포함할 수 있다.In addition, at least one of the artificial blood vessel support part and the vein support part may include a plurality of annular segments spaced apart from each other in a longitudinal direction and disposed continuously in a wave shape along the circumferential direction, and a pair of adjacent annular segments. It may include a connecting member that is connected and disposed.
또한, 상기 연결부재는 길이 방향을 따라 인접한 한쌍의 골부 또는 한쌍의 산부를 연결하는 브리지를 포함할 수 있다.In addition, the connecting member may include a bridge connecting a pair of adjacent troughs or a pair of ridges along the longitudinal direction.
또한, 상기 연결부재는 둘레 방향에서 상기 브리지의 양측에 위치한 산부와 상기 브리지의 길이 방향 일단이 접하고 있는 골부를 연결하거나 둘레 방향에서 상기 브리지의 양측에 위치한 골부와 상기 브리지의 길이 방향 일단이 접하고 있는 산부를 연결하는 보조 브리지를 더 포함할 수 있다.In addition, the connecting member connects the peaks located on both sides of the bridge in the circumferential direction and the valleys where the longitudinal ends of the bridge are in contact, or the valleys located on both sides of the bridge in the circumferential direction and the longitudinal ends of the bridge are in contact An auxiliary bridge connecting the mountain part may be further included.
상기한 구성을 갖는 본 발명의 혈관 외벽 지지 장치에 따르면, 정맥과 문합된 인조 혈관의 외벽을 둘러싸며 배치되도록 구비되며 곡선 형상을 가지는 인조 혈관 지지부가 소정의 각도를 형성하며 정맥 지지부에 연결되도록 구성됨으로써 동정맥 이식부에서의 이상 혈류의 발생을 최소화하고 혈류의 흐름을 원활하게 할 수 있다.According to the device for supporting the outer wall of the blood vessel of the present invention having the above configuration, the artificial blood vessel support portion having a curved shape and surrounding the outer wall of the artificial blood vessel anastomosed with the vein is configured to be connected to the vein support portion at a predetermined angle. As a result, the occurrence of abnormal blood flow in the arteriovenous graft can be minimized and the flow of blood can be smoothed.
또한, 본 발명의 혈관 외벽 지지 장치에 따르면, 길이 방향으로 이격되어 연속적으로 배치되며 각각 둘레 방향을 따라 물결 형상을 가지고 배치되는 복수개의 환형 세그먼트와, 인접한 한 쌍의 환형 세그먼트를 연결하며 배치되는 연결부재를 통해 동정맥 이식부에서 반복하는 박동성 혈류에 따른 혈관의 변형을 최소화할 수 있다.In addition, according to the device for supporting the outer wall of a blood vessel of the present invention, a plurality of annular segments that are continuously disposed apart from each other in a longitudinal direction and disposed in a wavy shape along the circumferential direction, and a connection that is disposed by connecting a pair of adjacent annular segments. Through this member, deformation of blood vessels due to repeated pulsatile blood flow at the arteriovenous transplant site can be minimized.
본 발명의 효과는 상기한 효과로 한정되는 것은 아니며, 본 발명의 상세한 설명 또는 청구범위에 기재된 발명의 구성으로부터 추론 가능한 모든 효과를 포함하는 것으로 이해되어야 한다.The effects of the present invention are not limited to the above effects, and should be understood to include all effects that can be inferred from the detailed description of the present invention or the configuration of the invention described in the claims.
도 1은 본 발명의 일 실시예에 따른 혈관 외벽 지지 장치의 구성을 나타낸 도면이다.1 is a diagram showing the configuration of an apparatus for supporting the outer wall of a blood vessel according to an embodiment of the present invention.
도 2는 인조 혈관과 정맥의 문합부에서 혈류 이상으로 혈관 협착이 빈발하는 해부학적 구조를 나타낸 도면이다.2 is a view showing an anatomical structure in which blood vessel stenosis occurs frequently due to abnormal blood flow in an anastomotic portion between an artificial blood vessel and a vein.
도 3은 직선 형상을 가지는 인조 혈관이 정맥과 문합되는 예들을 나타낸 도면이다.3 is a view showing examples in which an artificial blood vessel having a straight shape is anastomosed with a vein.
도 4는 도 3의 예들에서 이상 혈류 영역을 분석한 결과를 나타낸 것이다.FIG. 4 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 3 .
도 5는 호 형상을 가지는 인조 혈관이 정맥과 문합되는 예들을 나타낸 도면이다.5 is a view showing examples in which an artificial blood vessel having an arc shape is anastomosed with a vein.
도 6은 도 5의 예들에서 이상 혈류 영역을 분석한 결과를 나타낸 것이다.FIG. 6 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 5 .
도 7은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 상측 사시도이다.7 is an upper perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
도 8은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 하측 사시도이다.8 is a lower perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
도 9는 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 후면도이다.9 is a rear view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
도 10은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 환형 세그먼트 및 연결부재를 나타낸 도면이다.10 is a view showing an annular segment and a connecting member of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
도 11은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치가 제공하는 혈류학적 효과를 나타낸 그래프이다.11 is a graph showing the hemodynamic effect provided by the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
이하, 첨부한 도면을 참고로 하여 본 발명의 실시예에 대하여 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있도록 상세히 설명한다. 본 발명은 여러 가지 상이한 형태로 구현될 수 있으며 여기에서 설명하는 실시예에 한정되지 않는다. 본 발명을 명확하게 설명하기 위해서 도면에서 설명과 관계없는 부분은 생략하였으며, 명세서 전체를 통하여 동일 또는 유사한 구성요소에 대해서는 동일한 참조부호를 붙였다.Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those skilled in the art can easily carry out the present invention. This invention may be embodied in many different forms and is not limited to the embodiments set forth herein. In order to clearly describe the present invention, parts irrelevant to the description are omitted in the drawings, and the same reference numerals are assigned to the same or similar components throughout the specification.
본 명세서에서, "포함하다" 또는 "가지다" 등의 용어는 명세서상에 기재된 특징, 숫자, 단계, 동작, 구성 요소, 부품 또는 이들을 조합한 것이 존재함을 설명하려는 것이지, 하나 또는 그 이상의 다른 특징들이나 숫자, 단계, 동작, 구성 요소, 부품 또는 이들을 조합한 것들의 존재 또는 부가 가능성을 미리 배제하지 않는 것으로 이해되어야 한다.In this specification, terms such as "include" or "have" are intended to describe the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but one or more other features It should be understood that the presence or addition of numbers, steps, operations, components, parts, or combinations thereof is not precluded.
본 명세서에서, 도면에 도시된 구성 요소들과의 상관 관계를 설명하기 위해 공간적으로 상대적인 용어인 "전방", "후방", "상부" 또는 "하부" 등이 사용될 수 있다. 이들은 도면 상 도시된 것을 기준으로 정하여진 상대적인 용어들로서 배향에 따라 위치 관계는 반대로 해석될 수도 있다. 또한, 본 명세서에서, 혈액의 진행 방향에 있어서 '근위'는 심장과 상대적으로 가까운 위치, '원위'는 심장과 상대적으로 먼 위치를 의미한다. 그러므로 동맥혈은 근위에서 원위 방향으로 진행하고, 정맥혈은 원위에서 근위 방향으로 진행하는 것으로 해석될 수 있다. 한편, 어떤 구성 요소가 다른 구성 요소와 "연결"되어 있다는 것은 특별한 사정이 없는 한 서로 직접 연결되는 것뿐만 아니라 간접적으로 서로 연결되는 경우도 포함한다.In this specification, spatially relative terms such as "front", "rear", "upper" or "lower" may be used to describe the correlation with components shown in the drawings. These are relative terms based on what is shown in the drawings, and the positional relationship may be interpreted in the opposite way according to the orientation. In addition, in the present specification, 'proximal' means a position relatively close to the heart, and 'distal' means a position relatively far from the heart in the direction of blood flow. Therefore, it can be interpreted that arterial blood proceeds in a proximal to distal direction, and venous blood proceeds in a distal to proximal direction. On the other hand, that a component is “connected” to another component includes cases where they are not only directly connected to each other but also indirectly connected to each other unless there are special circumstances.
도 1은 본 발명의 일 실시예에 따른 혈관 외벽 지지 장치의 구성을 나타낸 도면이다.1 is a diagram showing the configuration of an apparatus for supporting the outer wall of a blood vessel according to an embodiment of the present invention.
본 발명의 일 실시예에 따른 혈관 외벽 지지 장치(100)는 동정맥 이식(Arteriovenous Graft, AVG)된 인조 혈관과, 인조 혈관과 문합된 자가 정맥을 둘러싸며 배치되도록 구비된다. 혈관 외벽 지지 장치(100)는 동정맥 이식부에서의 이상 혈류의 발생을 최소화하고 혈류의 흐름을 원활하게 만들어 준다.The device for supporting the outer wall of a blood vessel 100 according to an embodiment of the present invention is provided to surround and arrange an arteriovenous graft (AVG) artificial blood vessel and an autologous vein anastomosed with the artificial blood vessel. The device for supporting the outer wall of blood vessels 100 minimizes the occurrence of abnormal blood flow in the arteriovenous graft and makes the blood flow smooth.
도 1을 참조하면, 본 발명의 일 실시예에 따른 혈관 외벽 지지 장치(100)는 인조 혈관 지지부(110) 및 정맥 지지부(130)를 포함한다.Referring to FIG. 1 , an apparatus for supporting an outer wall of a blood vessel 100 according to an embodiment of the present invention includes an artificial blood vessel support unit 110 and a vein support unit 130 .
인조 혈관 지지부(110)는 정맥과 문합된 인조 혈관의 외벽을 둘러싸며 배치되도록 구비된다. 여기서, 인조 혈관은 인공적으로 만들어져 자가 동맥이 자가 정맥과 연결될 수 있도록 동정맥 이식된 혈관을 의미한다. 예를 들면, 인조 혈관의 재질은 폴리테트라플루오르 에틸렌(ePTFE)이 될 수 있다.The artificial blood vessel support 110 is disposed to surround the outer wall of the artificial blood vessel anastomosed with the vein. Here, the artificial blood vessel refers to an arteriovenous transplanted blood vessel that is artificially created and connects an autologous artery to an autologous vein. For example, the material of the artificial blood vessel may be polytetrafluoroethylene (ePTFE).
인조 혈관 지지부(110)는 곡선 형상을 가진다. 더욱 상세하게, 인조 혈관 지지부(110)는 호 형상을 가질 수 있다. 인조 혈관 지지부(110)는 내부에 인조 혈관이 배치될 수 있도록 공간을 구비하는 관형의 몸체(112)와, 몸체(112)의 근위 단부에 형성된 유입구(111)와, 몸체(112)의 원위 단부에 형성된 유출구(113)를 구비할 수 있다.The artificial blood vessel support 110 has a curved shape. More specifically, the artificial blood vessel support 110 may have an arc shape. The artificial blood vessel support 110 includes a tubular body 112 having a space inside the artificial blood vessel, an inlet 111 formed at a proximal end of the body 112, and a distal end of the body 112. It may be provided with an outlet 113 formed in.
정맥 지지부(130)는 정맥의 외벽을 둘러싸며 배치되도록 구비된다. 여기서, 정맥은 동정맥 이식 부위에서 인조 혈관과 접합된 정맥을 의미한다. Vein support 130 is provided to be disposed while surrounding the outer wall of the vein. Here, the vein refers to a vein joined to an artificial blood vessel at an arteriovenous transplant site.
정맥 지지부(130)는 인조 혈관 지지부(110)의 원위 단부에서 인조 혈관 지지부(110)와 연결된다. 즉, 정맥 지지부(130)는 인조 혈관 지지부(110)의 유출구(113)를 통해 인조 혈관 지지부(110)와 연통될 수 있다.The vein support 130 is connected to the artificial blood vessel support 110 at the distal end of the artificial blood vessel support 110 . That is, the vein support 130 may communicate with the artificial blood vessel support 110 through the outlet 113 of the artificial blood vessel support 110 .
정맥 지지부(130)는 직선 형상을 가질 수 있다. 정맥 지지부(130)는 인조 혈관 지지부(110)와의 연결 부위를 기준으로 원위에 배치된 원위 부분(131)과, 인조 혈관 지지부(110)의 유출구(113)와 교차하는 문합부(132)와, 인조 혈관 지지부(110)와의 연결 부위를 기준으로 근위에 배치된 근위 부분(133)을 포함할 수 있다. Vein support 130 may have a straight shape. The vein support 130 includes a distal portion 131 disposed distal with respect to a connection portion with the artificial blood vessel support 110, an anastomosis portion 132 intersecting the outlet 113 of the artificial blood vessel support 110, A proximal portion 133 disposed proximal to the connection portion with the artificial blood vessel support 110 may be included.
본 발명의 일 실시예에서, 인조 혈관 지지부(110)는 호 형상을 가지고, 정맥 지지부(130)는 직선 형상을 가지되, 인조 혈관 지지부(110)는 원위 단부에서 정맥 지지부(130)와 교차할 수 있다.In one embodiment of the present invention, the artificial blood vessel support 110 has an arc shape, the vein support 130 has a straight shape, and the artificial blood vessel support 110 intersects the vein support 130 at the distal end. can
더욱 상세하게, 인조 혈관 지지부(110)는 정맥 지지부(130)와의 교차 지점에서 정맥 지지부(130)와 15도 이상 60도 미만의 각도를 이루며 접할 수 있다. 이때, 인조 혈관 지지부(110)가 정맥 지지부(130)와 이루는 각도는 인조 혈관 지지부(110)와 정맥 지지부(103)의 교차 지점에서 인조 혈관 지지부(110)의 접선(TL)이 정맥 지지부(130)와 이루는 각도(θ)로 정의될 수 있다.More specifically, the artificial blood vessel support 110 may come into contact with the vein support 130 at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support 130 . At this time, the angle between the artificial blood vessel support 110 and the vein support 130 is the tangential line TL of the artificial blood vessel support 110 at the intersection of the artificial blood vessel support 110 and the vein support 103. ) and an angle (θ).
이하에서는 혈관 지지부(110)가 호 형상을 가지고, 정맥 지지부(130)와 15도 이상 60도 미만의 각도를 이루며 연결될 때 혈관 문합부위에서의 혈류의 개선 효과를 검증하기 위한 전산유체역학 인자 분석의 결과를 설명한다.Hereinafter, when the blood vessel support 110 has an arc shape and is connected to the vein support 130 at an angle of 15 degrees or more and less than 60 degrees, computational fluid dynamics factor analysis for verifying the effect of improving blood flow at the vascular anastomosis site explain the results.
도 2는 인조 혈관과 정맥의 문합부에서 혈류 이상으로 혈관 협착이 빈발하는 해부학적 구조를 나타낸 도면이다.2 is a view showing an anatomical structure in which blood vessel stenosis occurs frequently due to abnormal blood flow in an anastomotic portion between an artificial blood vessel and a vein.
도 2를 참조하면, 정맥혈(V)이 흐르는 자가 정맥과 문합된 인조 혈관을 통하여 동맥혈(A)이 자가 정맥으로 유입될 때, 이상 혈류가 발생하는 부위는 사람의 발 모양을 모사하여 발가락 부위(T), 뒤꿈치 부위(H), 바닥 부위(F)로 나타낼 수 있으며, 전산유체역학 인자 분석 시 이들 부위들을 관심 영역으로 해석할 수 있다.Referring to FIG. 2, when arterial blood (A) is introduced into an autologous vein through an artificial blood vessel anastomosed with an autologous vein through which venous blood (V) flows, the site where abnormal blood flow occurs is the toe (toes) by replicating the shape of a human foot. T), heel region (H), and bottom region (F), and these regions can be interpreted as regions of interest when analyzing computational fluid dynamics factors.
이때, 인조 혈관과 정맥의 직경은 3mm로 가정될 수 있다. 또한, 동맥혈(A)의 혈류는 0.2~0.9m/s의 범위에서 변환하는 최고 속도로 유입구(111)로 유입되고, 유출구(113)에서 3700~5500Pa의 정압(Static pressure)을 가지는 것으로 가정되고, 정맥혈(V)은 0.1m/s의 일정한 속도를 가지는 것으로 가정될 수 있다.At this time, the diameter of the artificial blood vessels and veins may be assumed to be 3 mm. In addition, the blood flow of arterial blood (A) flows into the inlet 111 at the highest speed in the range of 0.2 to 0.9 m/s, and is assumed to have a static pressure of 3700 to 5500 Pa at the outlet 113 , venous blood (V) can be assumed to have a constant velocity of 0.1 m/s.
한편, 전산유체역학의 소프트웨어로서 ANSYS Fluent 20.0이 사용되었고, 유동을 표현하는 편미분 방정식(Partial Differential Equation, PDE)을 대수 방정식(Algebraric equation)인 차분 방정식(Finite Differential Equation, FDE)으로 바꾸어주기 위하여 연속적인 물리공간을 격자(mesh)를 이용하여, 특히 유한체적법(Finite Volume Method, FVM)을 유한하게 이산화한 다음, 지배 방정식으로서 연속방정식(Continuity equation), 운동량 방정식(Momentum equation), 에너지 방정식(Energy equation)을 설정한 뒤, 유체의 난류 움직임을 모사하기 위하여 추가적으로 K-ω SST 난류 모델을 적용하였다.On the other hand, ANSYS Fluent 20.0 was used as a software for computational fluid dynamics, and to change the partial differential equation (PDE) representing the flow into the differential equation (FDE), which is an algebraic equation, continuous After the finite volume method (FVM) is finitely discretized using a mesh, the continuity equation, the momentum equation, and the energy equation ( After setting the energy equation), the K-ω SST turbulence model was additionally applied to simulate the turbulent flow of the fluid.
또한, 혈액은 비뉴턴성 모델을 적용하기 위하여 Carreau-Yasuda model을 적용하였으며, 밀도(density)는 1060㎏/㎥으로 설정되었다.In addition, the Carreau-Yasuda model was applied to the blood to apply the non-Newtonian model, and the density was set to 1060 kg/m 3 .
또한, 혈류 역학적 이상을 확인하기 위하여 최대 전단 응력 WSSmax(Wall Shear Stress Max), 시간 평균 내벽 전단 응력 TAWSS(Time-Average Wall Shear Stress) 및 교번 전단 지수 OSI(Oscillatory Shear Index)를 아래의 [표 1]과 같이 정의하고, OSI ≥ 0.1, TAWSS ≤ 2 Pa, WSSmax ≥ 70 Pa인 부분을 동맥경화에 취약한 부위로 분류하였다.In addition, in order to confirm the hemodynamic abnormality, the maximum shear stress WSSmax (Wall Shear Stress Max), time-average wall shear stress TAWSS (Time-Average Wall Shear Stress) and alternating shear index OSI (Oscillatory Shear Index) were measured in Table 1 below. ], and areas with OSI ≥ 0.1, TAWSS ≤ 2 Pa, and WSSmax ≥ 70 Pa were classified as vulnerable to atherosclerosis.
[표 1][Table 1]
도 3은 직선 형상을 가지는 인조 혈관이 정맥과 문합되는 예들을 나타낸 도면이다. 도 3에 나타난 예들은 인조 혈관(Graft)이 직선 형상을 가지고, 정맥(Vein)과 연결되는 것들로서, 인조 혈관(Graft)이 정맥(Vein)과 각각 15도(straight 15°), 30도(straight 30°), 45도(straight 45°) 및 60도(straight 60°)의 각도를 이루며 만나고 있다.도 4는 도 3의 예들에서 이상 혈류 영역을 분석한 결과를 나타낸 것이다. 구체적으로 도 4는 발가락 부위(T)에서 OSI≥0.1인 영역의 면적, TAWSS≤2Pa인 영역의 면적, WSSmax≥70Pa인 영역의 면적을 보여주고 있다.3 is a view showing examples in which an artificial blood vessel having a straight shape is anastomosed with a vein. The examples shown in FIG. 3 are those in which the artificial graft has a straight shape and is connected to the vein, and the artificial graft has an angle of 15 degrees and 30 degrees, respectively, to the vein. straight 30°), 45° (straight 45°), and 60° (straight 60°) angles. FIG. 4 shows the result of analyzing the abnormal blood flow area in the examples of FIG. Specifically, FIG. 4 shows the area of the area of OSI≥0.1, the area of TAWSS≤2Pa, and the area of WSSmax≥70Pa in the toe area T.
도 4를 참조하면, 도 3의 예들은 모두 OSI, TAWSS 및 WSSmax에 이상이 발생한 영역을 가지고 있음을 확인할 수 있다. 한편, 인조 혈관(Graft)이 직선 형상을 가지고, 정맥(Vein)과 15도(straight 15°)를 이룰 경우 OSI≥0.1인 영역과 TAWSS≤2Pa인 영역이 없어지며 상대적으로 좋은 혈류를 보였으나 여전히 WSSmax≥70Pa으로 전단 응력이 높게 관찰되는 영역이 나타났다.Referring to FIG. 4 , it can be confirmed that the examples of FIG. 3 all have areas where errors occur in OSI, TAWSS, and WSSmax. On the other hand, when the artificial graft has a straight shape and forms a straight 15° with the vein, the region with OSI≥0.1 and the region with TAWSS≤2Pa are eliminated, showing relatively good blood flow, but still A region in which shear stress was high was observed with WSSmax≥70Pa.
도 5는 호 형상을 가지는 인조 혈관이 정맥과 문합되는 예들을 나타낸 도면이다. 도 5에 나타난 예들은 인조 혈관(Graft)이 호 형상을 가지고, 정맥(Vein)과 연결되는 것들로서, 인조 혈관(Graft)이 정맥(Vein)과 각각 15도(Round 15°), 30도(Round 30°), 45도(Round 45°) 및 60도(Round 60°)의 각도를 이루며 만나고 있다.5 is a view showing examples in which an artificial blood vessel having an arc shape is anastomosed with a vein. The examples shown in FIG. 5 are those in which the artificial graft has an arc shape and is connected to the vein. Round 30°), 45° (Round 45°) and 60° (Round 60°) are meeting.
도 6은 도 5의 예들에서 이상 혈류 영역을 분석한 결과를 나타낸 것이다. 구체적으로 도 6은 발가락 부위(T)에서 OSI≥0.1인 영역의 면적, TAWSS≤2Pa인 영역의 면적, WSSmax≥70 Pa인 영역의 면적을 보여주고 있다.FIG. 6 shows a result of analyzing abnormal blood flow regions in the examples of FIG. 5 . Specifically, FIG. 6 shows the area of the area of OSI≥0.1, the area of TAWSS≤2Pa, and the area of WSSmax≥70 Pa in the toe area (T).
도 6을 참조하면, 도 5의 예들은 모두 70Pa 이상의 높은 전단력이 가해지는 WSSmax≥70 Pa인 영역이 각도와 상관없이 소실되었으며, OSI≥0.1, TAWSS≤2Pa인 영역이 인조 혈관(Graft)이 정맥(Vein)이 60도의 각도를 이루는 경우에만 나타나는 것으로 확인되었다. 다만, 접선의 각도가 60도가 넘어갈 경우 이상 혈류가 증가하는 경향이 관찰되었다.Referring to FIG. 6, in all the examples of FIG. 5, the region with WSSmax ≥ 70 Pa where a high shear force of 70 Pa or more is applied is lost regardless of the angle, and the region with OSI ≥ 0.1 and TAWSS ≤ 2 Pa is artificial blood vessel (Graft) vein. (Vein) has been confirmed to appear only when it forms an angle of 60 degrees. However, when the tangential angle exceeded 60 degrees, a tendency for abnormal blood flow to increase was observed.
이러한 결과를 고려할 때, 인조 혈관(Graft)은 호 형상을 가지고 정맥(Vein)과 15도 이상 60도 미만의 각도를 이루며 연결되는 것이 바람직하다. 이에 따라 본 발명의 일 실시예에 따른 혈관 외벽 지지 장치(100)는 인조 혈관(Graft)과 정맥(Vein)이 이러한 형상을 유지하도록 지지하는 것이 필요하며, 이를 위하여 인조 혈관 지지부(110)는 호 형상을 가지고, 정맥 지지부(130)는 직선 형상을 가지되, 인조 혈관 지지부(110)는 정맥 지지부(130)와의 교차 지점에서 정맥 지지부(130)와 15도 이상 60도 미만의 각도를 이루며 접하는 것이 바람직하다.Considering these results, it is preferable that the artificial graft has an arc shape and is connected to the vein at an angle of 15 degrees or more and less than 60 degrees. Accordingly, the apparatus 100 for supporting the outer wall of the blood vessel according to an embodiment of the present invention needs to support the artificial blood vessel (graft) and the vein (vein) to maintain these shapes, and for this purpose, the artificial blood vessel support unit 110 In shape, the vein support 130 has a straight shape, but the artificial blood vessel support 110 is in contact with the vein support 130 at an angle of 15 degrees or more and less than 60 degrees at an intersection with the vein support 130. desirable.
본 발명의 일 실시예에서, 호 형상을 가지는 인조 혈관 지지부(110)가 정맥 지지부(130)와 30도의 각도를 이루고, 인조 혈관 지지부(110)의 직경(d1)과 정맥 지지부(130)의 직경(d2)이 각각 3㎜라고 할 때, 곡률 반지름(R)은 20㎜가 되고, 인조 혈관 지지부(110)의 곡률 중심(O)에서 인조 혈관 지지부(110)의 반경 방향 최외측까지의 거리(R+d1)는 23㎜가 된다.In one embodiment of the present invention, the artificial blood vessel support 110 having an arc shape forms an angle of 30 degrees with the vein support 130, and the diameter d1 of the artificial blood vessel support 110 and the diameter of the vein support 130 When (d2) is 3 mm, the radius of curvature R is 20 mm, and the distance from the center of curvature O of the artificial blood vessel support 110 to the outermost radial side of the artificial blood vessel support 110 ( R+d1) becomes 23 mm.
이때, 인조 혈관 지지부(110)의 반경 방향 최내측의 길이(L1)는 25.8㎜, 인조 혈관 지지부(110)의 반경 방향 최외측의 길이(L3)는 16.4㎜, 인조 혈관 지지부(110)의 길이(L2)는 20㎜가 된다. 또한, 인조 혈관 지지부(110)와 정맥 지지부(130)의 교차 길이(L4)는 10.954㎜, 인조 혈관 지지부(110)와 정맥 지지부(130)의 교차 면적은 39.47㎟으로 나타난다.At this time, the innermost length L1 of the artificial blood vessel support 110 in the radial direction is 25.8 mm, the outermost length L3 of the artificial blood vessel support 110 in the radial direction is 16.4 mm, and the length of the artificial blood vessel support 110 is 16.4 mm. (L2) becomes 20 mm. In addition, the crossing length L4 of the artificial blood vessel support 110 and the vein support 130 is 10.954 mm, and the intersection area of the artificial blood vessel support 110 and the vein support 130 is 39.47 mm 2 .
이러한 측정치를 고려할 때, 본 발명의 일 실시예에서, 혈관의 해부학적인 구조 및 수술자의 편의상 인조 혈관 지지부(110)의 길이(L2)는 15~25㎜인 것이 바람직하다. 예를 들면, 인조 혈관 지지부(110)의 길이(L2)는 20㎜가 될 수 있다.Considering these measurements, in one embodiment of the present invention, the length L2 of the artificial blood vessel support 110 is preferably 15 to 25 mm for the anatomical structure of blood vessels and the convenience of the operator. For example, the length L2 of the artificial blood vessel support 110 may be 20 mm.
또한, 본 발명의 일 실시예에서, 정맥 지지부(130) 중 인조 혈관 지지부(110)와의 연결 부위에서 근위 단부까지의 길이 다시 말하면, 근위 부분(133)의 길이(L5)는 20~40㎜일 수 있다. 혈류역학적 인자 분석 결과 호 형상을 가지는 인조 혈관 지지부(110)가 정맥 지지부(130)와 30도의 각도를 이루고, 인조 혈관 지지부(110)의 직경(d1)과 정맥 지지부(130)의 직경(d2)이 각각 3㎜라고 할 때, 근위 부분(133)이 20㎜의 길이를 가질 경우에도 정맥에서 난류(tuebulent flow)가 발생하지 않는 것으로 확인되었다.In addition, in one embodiment of the present invention, the length from the connection portion with the artificial blood vessel support 110 of the vein support 130 to the proximal end, in other words, the length L5 of the proximal portion 133 is 20 to 40 mm. can As a result of hemodynamic factor analysis, the arc-shaped artificial vessel support 110 forms an angle of 30 degrees with the vein support 130, and the diameter d1 of the artificial vessel support 110 and the diameter d2 of the vein support 130 When each of these is 3 mm, it has been confirmed that no turbulent flow occurs in the vein even when the proximal portion 133 has a length of 20 mm.
도 7은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 상측 사시도이고, 도 8은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 하측 사시도이며, 도 9는 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 후면도이다. 또한, 도 10은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치의 환형 세그먼트 및 연결부재를 나타낸 도면이다.7 is an upper perspective view of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention, FIG. 8 is a perspective view of the lower side of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention, and FIG. It is a rear view of the device for supporting the outer wall of a blood vessel according to the embodiment. Also, FIG. 10 is a view showing an annular segment and a connecting member of the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention.
도 7 내지 도 10을 참조하면, 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치(200)는 인조 혈관 지지부(210) 및 정맥 지지부(230)를 포함한다. 본 발명의 다른 일 실시예에서, 인조 혈관 지지부(210) 및 정맥 지지부(230)의 형상과, 서로 이루는 각도, 인조 혈관 지지부(210)의 길이 및 정맥 지지부(230) 중 인조 혈관 지지부(210)와의 연결 부위에서 근위 단부까지의 길이(근위부의 길이)는 본 발명의 일 실시예와 관련하여 설명한 바와 같다. 그러므로 중복된 내용에 대해서는 상세한 설명을 생략하고, 중복되지 않는 내용에 대해서만 설명한다.Referring to FIGS. 7 to 10 , an apparatus 200 for supporting an outer wall of a blood vessel according to another embodiment of the present invention includes an artificial blood vessel support 210 and a vein support 230 . In another embodiment of the present invention, the shape of the artificial blood vessel support part 210 and the vein support part 230, the angle formed with each other, the length of the artificial blood vessel support part 210, and the artificial blood vessel support part 210 among the vein support parts 230 The length from the connection site to the proximal end (length of the proximal portion) is the same as described in relation to one embodiment of the present invention. Therefore, detailed descriptions of overlapping contents will be omitted, and only non-overlapping contents will be described.
본 발명의 다른 일 실시예에서, 정맥 지지부(230)는 길이 방향을 따라 슬롯(230a)이 형성되어 있다. 혈관 외벽 지지 장치(200)의 시술 시 슬롯(230a)을 통해 정맥 지지부(230)의 내부로 환자의 정맥이 용이하게 삽입되어 배치될 수 있다.In another embodiment of the present invention, the vein support 230 has a slot 230a formed along the longitudinal direction. During the operation of the outer wall support device 200 for the blood vessel, the patient's vein can be easily inserted into the vein support 230 through the slot 230a and placed therein.
정맥 지지부(230)는 온도에 의존적으로 형상을 기억하는 재질로 만들어질 수 있다. 예를 들면, 정맥 지지부(230)는 수술 시에는 슬롯(230a)이 개방되는 형상을 가지되 소정의 온도(예를 들면, 체온)에서 정맥을 전체적으로 감싸도록 슬롯(230a)이 폐쇄된 형상을 가지도록 변형될 수 있다. 이 경우 수술 과정에서는 정맥 지지부(230)의 슬롯(230a)이 개방되어 정맥의 삽입이 용이하게 이루어지되, 수술 후 환자의 신체 내부에서는 슬롯(230a)이 폐쇄되며, 정맥 지지부(230)가 정맥의 외벽을 전체적으로 지지할 수 있다. 한편, 일단 슬롯(230a)이 폐쇄된 형상으로 변형된 후에는 온도와 관계 없이 그 형상이 유지될 수 있다.The vein support 230 may be made of a material that memorizes its shape depending on temperature. For example, the vein support 230 has a shape in which the slot 230a is open during surgery, but has a shape in which the slot 230a is closed so as to entirely cover the vein at a predetermined temperature (eg, body temperature). can be transformed into In this case, in the course of surgery, the slot 230a of the vein support 230 is opened to facilitate insertion of the vein, but after surgery, the slot 230a is closed inside the patient's body, and the vein support 230 is The outer wall can be supported as a whole. Meanwhile, once the slot 230a is deformed into a closed shape, the shape may be maintained regardless of temperature.
물론, 정맥 지지부(230)는 형상을 기억하지 않는 재질로 만들어질 수도 있으며, 슬롯(230a)은 정맥의 삽입 후 수술을 수행하는 의사에 의해 인위적으로 폐쇄되는 것도 가능하다.Of course, the vein support 230 may be made of a material that does not remember its shape, and the slot 230a may be artificially closed by a surgeon after inserting the vein.
한편, 도 10에 도시된 바와 같이, 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치(200)에서 인조 혈관 지지부(210) 및 정맥 지지부(230)는 모두 길이 방향으로 이격되어 연속적으로 배치되며 각각 둘레 방향을 따라 물결 형상을 가지고 배치되는 복수개의 환형 세그먼트(300)와, 인접한 한 쌍의 환형 세그먼트(300)를 연결하며 배치되는 연결부재(400)를 포함하고 있다.Meanwhile, as shown in FIG. 10, in the device for supporting the outer wall of a blood vessel 200 according to another embodiment of the present invention, both the artificial blood vessel support 210 and the vein support 230 are spaced apart in the longitudinal direction and are continuously disposed. It includes a plurality of annular segments 300 arranged in a wavy shape along the circumferential direction, and a connecting member 400 connected to a pair of adjacent annular segments 300 and disposed.
본 발명의 다른 일 실시예에 의할 경우 복수개의 환형 세그먼트(300)와 연결부재(400)를 통해 동정맥 이식부에서 반복하는 박동성 혈류에 따른 혈관의 변형을 최소화할 수 있다.According to another embodiment of the present invention, deformation of a blood vessel due to repeated pulsatile blood flow in an arteriovenous transplant unit can be minimized through the plurality of annular segments 300 and the connection member 400 .
복수개의 환형 세그먼트(300)는 길이 방향으로 이격되어 연속적으로 배치되며, 각각 둘레 방향을 따라 물결 형상을 가지고 배치된다. 복수개의 환형 세그먼트(300)는 인조 혈관 지지부(210)와 정맥 지지부(230)를 형성할 수 있다. 이때, 복수개의 환형 세그먼트(300)는 인조 혈관 지지부(210)와 정맥 지지부(230)를 일체로 형성할 수도 있다.A plurality of annular segments 300 are spaced apart in the longitudinal direction and continuously arranged, and are arranged in a wavy shape along the circumferential direction, respectively. The plurality of annular segments 300 may form the artificial blood vessel support 210 and the vein support 230 . In this case, the plurality of annular segments 300 may integrally form the artificial blood vessel support 210 and the vein support 230 .
연결부재(400)는 인접한 한 쌍의 환형 세그먼트(300)를 연결하며 배치된다. 연결부재(400)는 길이 방향을 따라 인접한 한쌍의 골부 또는 한쌍의 산부를 연결하는 브리지(410)를 포함할 수 있다.The connecting member 400 connects a pair of adjacent annular segments 300 and is disposed. The connection member 400 may include a bridge 410 connecting a pair of valleys or a pair of peaks adjacent to each other along the longitudinal direction.
또한, 본 발명의 다른 일 실시예에서, 연결부재(400)는 둘레 방향에서 브리지(410)의 양측에 위치한 산부와 브리지(410)의 길이 방향 일단이 접하고 있는 골부를 연결하거나 둘레 방향에서 브리지(410)의 양측에 위치한 골부와 브리지(410)의 길이 방향 일단이 접하고 있는 산부를 연결하는 보조 브리지(420)를 더 포함할 수 있다.In addition, in another embodiment of the present invention, the connecting member 400 connects the peaks located on both sides of the bridge 410 in the circumferential direction and the valley where one end of the bridge 410 in the longitudinal direction is in contact, or connects the bridge in the circumferential direction ( An auxiliary bridge 420 may be further included to connect valleys located on both sides of 410 and hills where one end of the bridge 410 in the longitudinal direction is in contact.
본 발명의 다른 일 실시예에서, 연결부재(400)의 브리지(410) 및 보조 브리지(420)는 동정맥 이식부에서 반복하는 박동성 혈류에 따른 혈관의 변형을 최소화시켜준다. 더욱 상세하게, 혈관 외벽 지지 장치(200)의 내부에 가해지는 응력(stress)의 분포를 개선시켜주는데, 최대 응력을 감소시키고, 응력 집중 현상을 완화시켜줄 수 있다. 이를 통해 혈관 외벽 지지 장치(200)의 피로 현상의 완화 및 파단 방지를 달성할 수 있다.In another embodiment of the present invention, the bridge 410 and the auxiliary bridge 420 of the connection member 400 minimize deformation of blood vessels due to repeated pulsatile blood flow in the arteriovenous transplant. More specifically, it improves the distribution of stress applied to the inside of the apparatus 200 for supporting the outer wall of blood vessels, thereby reducing maximum stress and alleviating stress concentration. Through this, it is possible to reduce fatigue and prevent breakage of the device for supporting the outer wall of the blood vessel 200 .
도 11은 본 발명의 다른 일 실시예에 따른 혈관 외벽 지지 장치가 제공하는 혈류학적 효과를 나타낸 그래프이다. 구체적으로, 도 11은 환형 세그먼트(300)의 두께를 0.4㎜, 골부 또는 산부의 직경(r)을 0.3㎜, 골부 또는 산부의 진폭(A)을 1.27㎜, 골부 또는 산부의 길이(l)를 0.65㎜, 길이 방향을 따라 인접한 한쌍의 골부 또는 한쌍의 산부 사이의 거리(S)를 2.4㎜로 설계하고, 혈관의 직경을 3㎜로 가정하여 혈관 외벽 지지 장치(200)에 의해 지지되는 정맥의 혈역학적 인자에 대한 분석을 수행한 결과를 보여준다. 11 is a graph showing the hemodynamic effect provided by the device for supporting the outer wall of a blood vessel according to another embodiment of the present invention. Specifically, FIG. 11 shows that the thickness of the annular segment 300 is 0.4 mm, the diameter (r) of the valley or peak is 0.3 mm, the amplitude (A) of the valley or peak is 1.27 mm, and the length (l) of the valley or peak is 0.3 mm. 0.65 mm, the distance (S) between a pair of adjacent valleys or ridges along the longitudinal direction is designed to be 2.4 mm, and the diameter of the blood vessel is assumed to be 3 mm. The results of the analysis of hemodynamic factors are shown.
도 11에 나타난 혈역학적 분석은 검증을 위해 혈관 외벽 지지 장치(200)가 적용되지 않은 정맥(Model A), 연결부재(400)가 브리지(410)만 구비하고 보조 브리지(420)를 구비하지 않은 혈관 외벽 지지 장치(200)의 내부에 배치된 정맥(Model B), 연결부재(400)가 브리지(410)와 보조 브리지(420)를 모두 구비한 혈관 외벽 지지 장치(200)의 내부에 배치된 정맥(Model C)에 대해 수행되었다.In the hemodynamic analysis shown in FIG. 11, for verification, the vein (Model A) to which the outer wall support device 200 is not applied, and the connecting member 400 is provided with only the bridge 410 and no auxiliary bridge 420. A vein (Model B) disposed inside the vessel outer wall supporting device 200 and a connecting member 400 disposed inside the vessel outer wall supporting device 200 having both the bridge 410 and the auxiliary bridge 420 It was performed on a vein (Model C).
도 11을 참조하면, 혈관 외벽 지지 장치(200)가 적용되지 않은 정맥(Model A)에 비하여, 연결부재(400)가 브리지(410)만 구비하고 보조 브리지(420)를 구비하지 않은 혈관 외벽 지지 장치(200)의 내부에 배치된 정맥(Model B) 및 연결부재(400)가 브리지(410)와 보조 브리지(420)를 모두 구비한 혈관 외벽 지지 장치(200)의 내부에 배치된 정맥(Model C)이 이완기(diastolic phase)의 WSS 영역 감소(도 11의 (a) 참조), 낮은 TAWSS(도 11의 (b) 참조), OSI 감소(도 11의 (c) 참조) 등 혈역학적 안정성을 보이는 것을 확인할 수 있다.Referring to FIG. 11 , compared to the vein (Model A) to which the device 200 for supporting the outer wall of the blood vessel is not applied, the connecting member 400 includes only the bridge 410 and supports the outer wall of the blood vessel without the auxiliary bridge 420. A vein (Model B) disposed inside the device 200 and a vein (Model B) disposed inside the vessel outer wall supporting device 200 having both the bridge 410 and the auxiliary bridge 420 in the connecting member 400 C) decreased hemodynamic stability, such as a decrease in the WSS area of the diastolic phase (see FIG. 11(a)), low TAWSS (see FIG. 11(b)), and a decrease in OSI (see FIG. 11(c)) you can check what you see.
특히, 연결부재(400)가 브리지(410)와 보조 브리지(420)를 모두 구비한 혈관 외벽 지지 장치(200)의 내부에 배치된 정맥(Model C)이 가장 안정적인 혈역학적 인자를 보여주고 있다. 따라서 연결부재(400)가 브리지(410)와 보조 브리지(420)를 모두 구비할 때 혈역학적 안정성이 극대화될 수 있다.In particular, the vein (Model C) in which the connection member 400 is disposed inside the vessel outer wall support device 200 having both the bridge 410 and the auxiliary bridge 420 shows the most stable hemodynamic factor. Therefore, hemodynamic stability can be maximized when the connection member 400 includes both the bridge 410 and the auxiliary bridge 420 .
본 발명의 일 실시예들에 대하여 설명하였으나, 본 발명의 사상은 본 명세서에 제시되는 실시예들에 의해 제한되지 아니하며, 본 발명의 사상을 이해하는 당업자는 동일한 사상의 범위 내에서, 구성요소의 부가, 변경, 삭제, 추가 등에 의해서 다른 실시예를 용이하게 제안할 수 있을 것이다. 그러나 이 또한 본 발명의 사상범위 내에 든다고 할 것이다.Although one embodiment of the present invention has been described, the spirit of the present invention is not limited by the embodiments presented herein, and those skilled in the art who understand the spirit of the present invention, within the scope of the same spirit, the components Other embodiments may be easily proposed by adding, changing, deleting, adding, or the like. However, it will be said that this is also within the scope of the present invention.
Claims (8)
- 정맥과 문합된 인조 혈관의 외벽을 둘러싸며 배치되도록 구비되고, 곡선 형상을 가지는 인조 혈관 지지부 및An artificial blood vessel support having a curved shape and disposed surrounding the outer wall of the artificial blood vessel anastomosed with the vein; and상기 정맥의 외벽을 둘러싸며 배치되도록 구비되고, 상기 인조 혈관 지지부의 원위 단부에서 상기 인조 혈관 지지부와 연결되는 정맥 지지부를 포함하는 혈관 외벽 지지 장치.An apparatus for supporting an outer wall of a blood vessel, comprising a vein support portion disposed surrounding an outer wall of the vein and connected to the artificial blood vessel support portion at a distal end of the artificial blood vessel support portion.
- 제 1 항에 있어서,According to claim 1,상기 인조 혈관 지지부는 호 형상을 가지고,The artificial blood vessel support has an arc shape,상기 정맥 지지부는 직선 형상을 가지며,The vein support has a straight shape,상기 인조 혈관 지지부는 상기 원위 단부에서 상기 정맥 지지부와 교차하는 혈관 외벽 지지 장치.The artificial blood vessel support portion intersects the vein support portion at the distal end of the blood vessel outer wall support device.
- 제 2 항에 있어서,According to claim 2,상기 인조 혈관 지지부는 상기 정맥 지지부와의 교차 지점에서 상기 정맥 지지부와 15도 이상 60도 미만의 각도를 이루며 접하는 혈관 외벽 지지 장치.The artificial blood vessel support unit is in contact with the vein support unit at an intersection with the vein support unit at an angle of 15 degrees or more and less than 60 degrees.
- 제 3 항에 있어서,According to claim 3,상기 인조 혈관 지지부는 15~25㎜의 길이를 가지는 혈관 외벽 지지 장치.The artificial blood vessel support unit has a length of 15 to 25 mm.
- 제 3 항에 있어서,According to claim 3,상기 정맥 지지부 중 상기 인조 혈관 지지부와의 연결 부위에서 근위 단부까지의 길이는 20~40㎜인 혈관 외벽 지지 장치.The vessel outer wall support device having a length of 20 to 40 mm from a connection portion with the artificial blood vessel support part to a proximal end of the vein support part.
- 제 1 항에 있어서,According to claim 1,상기 인조 혈관 지지부 및 상기 정맥 지지부 중 어느 하나 이상은,At least one of the artificial blood vessel support and the vein support,길이 방향으로 이격되어 연속적으로 배치되며, 각각 둘레 방향을 따라 물결 형상을 가지고 배치되는 복수개의 환형 세그먼트와,A plurality of annular segments spaced apart from each other in the longitudinal direction and continuously disposed, each having a wavy shape along the circumferential direction;인접한 한 쌍의 환형 세그먼트를 연결하며 배치되는 연결부재를 포함하는 혈관 외벽 지지 장치.An apparatus for supporting an outer wall of a blood vessel comprising a connection member disposed to connect a pair of adjacent annular segments.
- 제 6 항에 있어서,According to claim 6,상기 연결부재는 길이 방향을 따라 인접한 한쌍의 골부 또는 한쌍의 산부를 연결하는 브리지를 포함하는 혈관 외벽 지지 장치.The connecting member includes a bridge connecting a pair of valleys or a pair of hills adjacent to each other in a longitudinal direction.
- 제 7 항에 있어서,According to claim 7,상기 연결부재는 둘레 방향에서 상기 브리지의 양측에 위치한 산부와 상기 브리지의 길이 방향 일단이 접하고 있는 골부를 연결하거나 둘레 방향에서 상기 브리지의 양측에 위치한 골부와 상기 브리지의 길이 방향 일단이 접하고 있는 산부를 연결하는 보조 브리지를 더 포함하는 혈관 외벽 지지 장치.The connection member connects peaks located on both sides of the bridge in the circumferential direction and valleys at which one end of the bridge is in contact with the peaks, or connects peaks located at both sides of the bridge and one end in the longitudinal direction of the bridge in contact with the peaks in the circumferential direction. A device for supporting the outer wall of a blood vessel further comprising an auxiliary bridge connected thereto.
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6743243B1 (en) * | 1998-03-20 | 2004-06-01 | Sumit Roy | Support device for endoscopic suturless anastomosis |
US20060195175A1 (en) * | 2005-02-25 | 2006-08-31 | Abbott Laboratories Vascular Enterprises Limited | Modular vascular prosthesis having axially variable properties and improved flexibility and methods of use |
JP2009502226A (en) * | 2005-07-22 | 2009-01-29 | アーク・セラピューティックス・リミテッド | Stent |
US8361092B1 (en) * | 2007-06-18 | 2013-01-29 | Wilson T. Asfora | Vascular anastomosis device and method |
JP2018126556A (en) * | 2011-08-01 | 2018-08-16 | ラミネート・メディカル・テクノロジーズ・リミテッド | External vascular support |
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US5925061A (en) * | 1997-01-13 | 1999-07-20 | Gore Enterprise Holdings, Inc. | Low profile vascular stent |
US20150119908A1 (en) | 2013-10-25 | 2015-04-30 | Abbott Cardiovascular Systems Inc. | Extravascular devices supporting an arteriovenous fistula |
EP3257482B1 (en) * | 2015-02-13 | 2019-07-10 | Piolax Medical Devices, Inc. | Stent |
US10849627B2 (en) | 2015-08-28 | 2020-12-01 | University Of Cincinnati | Arteriovenous fistula implant effective for inducing laminar blood flow |
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Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6743243B1 (en) * | 1998-03-20 | 2004-06-01 | Sumit Roy | Support device for endoscopic suturless anastomosis |
US20060195175A1 (en) * | 2005-02-25 | 2006-08-31 | Abbott Laboratories Vascular Enterprises Limited | Modular vascular prosthesis having axially variable properties and improved flexibility and methods of use |
JP2009502226A (en) * | 2005-07-22 | 2009-01-29 | アーク・セラピューティックス・リミテッド | Stent |
US8361092B1 (en) * | 2007-06-18 | 2013-01-29 | Wilson T. Asfora | Vascular anastomosis device and method |
JP2018126556A (en) * | 2011-08-01 | 2018-08-16 | ラミネート・メディカル・テクノロジーズ・リミテッド | External vascular support |
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