CN108852449B - Blood vessel closing device and hemostasis system - Google Patents
Blood vessel closing device and hemostasis system Download PDFInfo
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- CN108852449B CN108852449B CN201810747066.5A CN201810747066A CN108852449B CN 108852449 B CN108852449 B CN 108852449B CN 201810747066 A CN201810747066 A CN 201810747066A CN 108852449 B CN108852449 B CN 108852449B
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
Abstract
The invention provides a vascular closure device, which comprises a support frame and a sealing membrane, wherein the support frame comprises a body and a stable structure, the edge of the body is convexly provided with a plurality of oppositely-arranged stable structures, the central position of the body is provided with an intermediate structure, and the sealing membrane is laid on the outer surface of the support frame; the body comprises a plurality of pull rings and a plurality of pull wires, the pull rings are arranged at the edge of the body, and one pull wire is connected with two oppositely arranged pull rings; the invention also provides a hemostatic system; the vascular closure device provided by the invention can effectively achieve the purpose of hemostasis in an interventional operation, reduce the operation time and improve the difficulty and complexity of hemostasis in the operation.
Description
Technical Field
The invention belongs to the field of medical instruments, and relates to a vascular closure device and a hemostasis system, in particular to a percutaneous large-diameter vascular closure device and a hemostasis system.
Background
In recent years, with the advancement of interventional treatment techniques, such as transcatheter heart valve replacement or repair, thoracic aortic aneurysm repair, or cardiac ablation, etc., it has become necessary to insert a catheter through an incision in the patient's skin and underlying tissue to access an artery or vein for surgery. After the operation is completed, the catheter needs to be removed from the blood vessel, and the incision of the blood vessel into which the catheter is inserted must be closed. Due to the high blood pressure in the artery, conventional methods such as pressing, suturing, adhesives, etc. take a long time to stop bleeding, are prone to cause unnecessary deformation of the blood vessel, and are difficult to achieve a good sealing effect.
CN104394776A discloses a vascular closure device, comprising: a deployable support frame deployable within a vessel; a sealing membrane at least partially supported by the support frame; and a cross-member support extending across at least a portion of the sealing membrane; wherein, upon expanding the support frame, the device is configured to intraluminally place the sealing membrane against a puncture site existing in the vessel wall; and wherein the cross-member support comprises a flexible wire attached to the sealing membrane at an intermediate portion thereof and configured to maintain the sealing membrane against the puncture site, the present invention provides a vascular closure device that lacks a structure that provides overall stability, and has a small sealing membrane contact area that is detrimental to achieving greater stability and better hemostasis.
CN105307575A discloses a vascular closure device and a method of positioning a vascular closure device, comprising a sheath 10 having a distal end and at least one proximal end, wherein the sheath 10 comprises a tubular body 100, at least one distal balloon member 11 is fixedly arranged at the distal end of the tubular body 100 of the sheath 10, and at least one expandable anchor member 12 is fixedly arranged on the tubular body of the sheath 10 proximal to the distal balloon member 11, wherein at least the distal side of the distal balloon member 11 is a pressure area for applying pressure to the outside of the vessel wall. The vascular closure device disclosed by the method is complex, low in overall stability and poor in blood coagulation effect.
CN108135594A discloses a vascular closure device comprising: an elongated housing having a proximal end and a distal end, the distal end adapted to be proximate to the tissue; first and second engagement members releasably arranged to the elongate housing; a deployment member arranged to the elongated housing and adapted to deploy the first and second engagement members into engaging contact with the tissue at a distance from each other and out of engagement with a wall portion of the blood vessel; and a retraction member arranged to the elongate housing and adapted to reduce the distance between the first and second engagement members to close the passageway. The vascular closure device provided by the method has a complex structure and is complex to apply, and hemostasis is not facilitated in an emergency.
Aiming at the problems existing in the postoperative hemostasis of the existing interventional therapy technology, a novel vascular closure device needs to be developed so as to achieve the effects of rapid hemostasis, high stability and degradability.
Disclosure of Invention
The invention aims to provide a vascular closure device and a hemostasis system, which solve the problems of long hemostasis time of a vascular incision, easy vascular deformation and the like in the hemostasis process after the existing interventional operation.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present invention provides a vascular closure device, comprising a support frame and a sealing membrane, wherein the support frame comprises a body and a stabilizing structure, the edge of the body is provided with a plurality of oppositely arranged stabilizing structures in a protruding manner, the center of the body is provided with an intermediate structure, and the sealing membrane is laid on the outer surface of the support frame.
According to the vascular closure device provided by the invention, the stable structure is arranged around the support frame, so that the device has higher stability, the intermediate structure is arranged at the central position of the body, so that the contact area of the sealing membrane is larger, the stability and the hemostatic effect are further improved, and the intermediate shape of the sealing membrane after degradation can provide a foundation for the next operation. Because the function of the sealing membrane can form thrombus and prevent blood from flowing out, the aim of quickly stopping bleeding is achieved, the operation time is reduced, and the difficulty and complexity of operation hemostasis are improved.
In the invention, the contact area between the central part of the stabilizing structure and the sealing membrane is more, the connecting force between the bracket and the sealing membrane bracket is stronger, the stabilizing structure can be more stable in a high-pressure arterial blood vessel, the stabilizing structure has a structure similar to an auricle when being unfolded in a plane, and the middle of the stabilizing structure is hollowed and is connected with the body.
Preferably, the body comprises a plurality of pull rings and a plurality of pull wires, the pull rings are arranged at the edge of the body, and one pull wire is connected to two oppositely arranged pull rings.
Preferably, the vascular closure device is heat treated to form a curved surface structure.
In the invention, the blood vessel closing device is processed into the required size by high-temperature heat setting at 510 ℃, and is further processed by the processes of borax, acid cleaning, polishing and the like to form an arc surface structure.
In the present invention, the diameter of the molded support frame of the heat-treated vascular closure device is the diameter of the arc formed by bending the heat-treated support frame, and is also the diameter of the mold for molding the arc, and is generally 7 to 20mm, preferably 10mm or 12 mm.
Preferably, the support frame consists of a number of rods.
In the present invention, the support frame is composed of several rods of selected corresponding materials, forming a planar structure or a cambered surface structure after heat treatment.
Preferably, the rod width is 0.3-0.7mm, and may be, for example, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.6mm, 0.65 mm, 0.7mm, or the like, preferably 0.5 mm.
Preferably, the rod thickness is 0.05-0.12mm, and may be, for example, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, 0.1mm, 0.11mm, 0.12mm, or the like, preferably 0.1 mm.
Preferably, the material of the support body frame is nickel titanium alloy.
In the present invention, nitinol has a shape memory effect and high elasticity.
Preferably, the length of the stabilizing structure is 18-25mm, for example 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm or 25mm, etc., preferably 21 mm.
In the present invention, if the length of the stabilizing structure is too small, stable sealing of blood is not easy; too long a length is not conducive to accessing the delivery system or blood vessel, 21mm being the optimal size.
In the present invention, the length of the stabilizing structure refers to the length in the axial direction along the diameter (or major axis) of the body.
Preferably, the body is circular or elliptical in shape, preferably circular.
In the invention, when the body is in a circular or oval shape, the body can be better applied according to a conveying system.
Preferably, when the body is circular in shape, the diameter is 16-25mm in length, for example 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm or 25mm, and the like, preferably 20 mm.
Preferably, when the body is oval in shape, the length of the major axis is 16-25mm, and may be, for example, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, etc., preferably 20 mm.
Preferably, the intermediate structure is circular or elliptical in shape, preferably circular.
In the invention, when the body is in a circular or oval shape, a larger contact area can be formed between the body and the sealing film, which is beneficial to improving the stability and the hemostatic effect.
Preferably, the material of the sealing membrane is a biodegradable material.
Preferably, the biodegradable material comprises any one of or a combination of at least two of poly-L-lactide (PLLA), poly (lactic-co-glycolic acid) (PLGA), Polyglycolide (PGA), and polylactic caprolactone (PLCL), preferably polylactic caprolactone.
In the present invention, the vascular closure device is made biodegradable over time by using biodegradable materials.
Preferably, the method of applying the sealing membrane to the outer surface of the support frame comprises any one or a combination of methods of solvent bonding, thermal welding, laser welding, ultrasonic welding, mechanical joining, layer joining, preferably solvent bonding.
Preferably, the pull line is connected to the pull ring by any one of sewing, sticking or hooking, and preferably by sewing.
Preferably, the material of the pull string comprises any one of sheep intestine, poly-L-lactide (PLLA), poly (lactic-co-glycolic acid) (PLGA), Polyglycolide (PGA), and polylactic caprolactone (PLCL), preferably polyglycolide.
In the present invention, the material of the pull string may also be pure natural collagen or the like.
In the invention, the accurate position of the vascular closure device can be reached by controlling the pull wire, thereby achieving the purpose of effectively and rapidly stopping bleeding.
In the present invention, the tab has a bar width of 0.2 to 0.5mm, for example, 0.2mm, 0.3mm, 0.4mm, or 0.5mm, and preferably 0.3 mm.
Preferably, the number of tabs is 2-8, for example 2, 3, 4, 5, 6, 7 or 8, preferably 4.
In the invention, the number of the pull rings is at least 2, so that the pull wire can be normally connected. The number of the pull wires is preferably 4, the pull wires are arranged on the edge of the body structure and are symmetrically distributed, so that the stress of the vascular closing device is favorably applied to achieve the purpose of tightly adhering to the blood vessel in the tensioning process of the pull wires.
In a second aspect, the present invention provides a hemostatic system that includes a vascular closure device and a delivery system, the vascular closure device being placed inside the delivery system.
In the invention, the arc diameter of the vascular closure device is designed to be generally larger than the diameter of the blood vessel, when the device is released in the blood vessel, the device has certain tension on the blood vessel, then the device can be tightly attached to the blood vessel wall under the tensioning of the pull wire, blood forms thrombus on the sealing membrane, the blood can be endothelialized after a long time, then the blood gradually grows together with the blood vessel, the incision of the blood vessel is blocked, and the sealing membrane and the pull wire can be degraded after a long time.
In the invention, the operation process of the hemostasis system is that the vascular closing device is curled and placed in the lumen of the conveying system, the vascular closing device is released at the vascular incision during hemostasis, the pull wire is tensioned to enable the closing device to be tightly attached to the blood vessel, thrombus can be formed under the action of the sealing membrane to prevent blood from flowing out, so that the purpose of rapid hemostasis is achieved, and the sealing membrane and the pull wire can be biodegraded after operation along with the time lapse.
The hemostasis system provided by the invention is simple and convenient to operate, can accurately position the target part, can quickly seal the blood vessel after the operation, achieves the effect of quickly stopping bleeding, and avoids the problem of blood vessel deformation.
Compared with the prior art, the invention has the following beneficial effects:
according to the vascular closure device provided by the invention, the stable structure is arranged around the support frame, so that the device has higher stability, the intermediate structure is arranged at the central position of the body, so that the contact area of the sealing membrane is larger, the stability and the hemostatic effect are further improved, and the intermediate shape of the sealing membrane after degradation can provide a foundation for the next operation. Because the function of the sealing membrane can form thrombus and prevent blood from flowing out, the hemostatic aim can be effectively achieved in the interventional operation, the operation time is reduced, and the hemostatic difficulty and complexity of the operation are improved.
Drawings
FIG. 1 is a schematic representation of a vascular closure device of example 1 of the present invention after heat treatment, wherein 1-the support frame, 2-the sealing membrane, 3-the pull wire, 4-the pull ring, 5-the stabilization construct, 6-the circular body, 7-the circular intermediate construct.
Fig. 2 is a schematic plan view of a vascular closure device according to example 2 of the present invention, in which 1-support frame, 2-sealing membrane, 3-pull wire, 4-pull ring, 5-stabilizing structure, 6-round body, 7-round intermediate structure, without heat treatment.
Fig. 3 is a schematic plan view of a vascular closure device of example 3 of the present invention, without heat treatment, in which the 1-support frame, the 2-sealing membrane, the 3-pull wire, the 4-pull ring, the 5-stabilizing structure, the 6-circular body, and the 7-elliptical intermediate structure.
Fig. 4 is a schematic view of the application of the vascular closure device in the hemostatic system according to example 4 of the present invention.
FIG. 5 is a schematic plan view showing the structure of the vascular closure device of comparative example 1 of the present invention, in which 1-the support frame, 2-the sealing membrane, 4-the pull ring, 5-the stabilizing structure, 6-the circular body.
Detailed Description
The technical solution of the present invention is further explained by the following embodiments. It should be understood by those skilled in the art that the examples are only for the understanding of the present invention and should not be construed as the specific limitations of the present invention.
Example 1
The blood vessel closing device after heat treatment (as shown in fig. 1) provided by this embodiment comprises a support frame 1 and a sealing membrane 2, wherein the support frame 1 comprises a circular body 6 and a stable structure 5, the stable structure 5 is convexly arranged at the edge of the circular body 6, a circular intermediate structure 7 is arranged at the central position of the circular body 6, the sealing membrane 2 is laid on the whole outer surface of the support frame 1 in a solvent bonding manner, the circular body 6 comprises four pull rings 4 and two pull wires 3, the pull rings 4 are arranged at the edge of the circular body 6, and the pull wires 3 are connected between the two pull rings 4 which are oppositely arranged in a sewing manner.
Wherein, the material of the support body frame 1 is nickel-titanium alloy, the material of the sealing film 2 is polylactic acid caprolactone, and the material of the stay wire 3 is polyglycolide; the width of the rod of the support frame 1 is 0.5mm, and the thickness is 0.1 mm; the diameter of the circular body 6 is 20 mm; the rod width of the pull ring is 0.3 mm; the length of the stabilizing structure 5 is 21 mm.
Example 2
The non-heat-treated vascular closure device (as shown in fig. 2) provided by the embodiment comprises a support frame 1 and a sealing membrane 2, wherein the support frame 1 comprises a circular body 6 and a stabilizing structure 5, the stabilizing structure 5 is arranged at the edge of the circular body 6 in a protruding manner, a circular intermediate structure 7 is arranged at the central position of the circular body 6, the sealing membrane 2 is laid on the whole outer surface of the support frame 1 in an ultrasonic welding manner, the circular body 6 comprises four pull rings 4 and two pull wires 3, the pull rings 4 are arranged at the edge of the circular body 6, and the pull wires 3 are connected between the two pull rings 4 which are arranged oppositely in a hooking manner.
Wherein the support body frame 1 is made of nickel-titanium alloy, the sealing film 2 is made of polyglycolic acid-lactic acid copolymer, and the pull wire 3 is made of polylactic acid caprolactone; the width of the rod of the support frame 1 is 0.3mm, and the thickness is 0.12 mm; the diameter of the circular body 6 is 25 mm; the rod width of the pull ring is 0.2 mm; the length of the stabilizing structure 5 is 25 mm.
Example 3
The non-heat-treated vascular closure device (as shown in fig. 3) provided by the present embodiment comprises a support frame 1 and a sealing membrane 2, wherein the support frame 1 comprises a circular body 6 and a stabilizing structure 5, the stabilizing structure 5 is disposed at the edge of the circular body 6 in a protruding manner, an elliptical intermediate structure 7 is disposed at the center of the circular body 6, the sealing membrane 2 is laid on the outer surface of the support frame 1 in a mechanical connection manner, the circular body 6 comprises four pull rings 4 and two pull wires 3, the pull rings 4 are disposed at the edge of the circular body 6, and the pull wires 3 are connected between the two pull rings 4 disposed in an adhering manner.
Wherein the support body frame 1 is made of nickel-titanium alloy, the sealing membrane 2 is made of poly-L-lactide, and the stay wire 3 is made of sheep intestine; the width of the rod of the support frame 1 is 0.7mm, and the thickness is 0.05 mm; the diameter of the circular body 6 is 16 mm; the rod width of the pull ring is 0.5 mm; the length of the stabilizing structure 5 is 18 mm.
Example 4
The present embodiments provide for the use of a vascular closure device in a hemostatic system
The blood vessel closing device is placed in a lumen of a conveying system in a curling mode (as shown in figure 4), the blood vessel closing device is released at a blood vessel incision during hemostasis, the pull wire is tensioned to enable the closing device to be tightly attached to the blood vessel, thrombus can be formed due to the effect of the sealing membrane, blood is prevented from flowing out, the purpose of rapid hemostasis is achieved, and the sealing membrane and the pull wire can be biodegraded after operation along with the lapse of time.
Comparative example 1
The present comparative example provides a vascular closure device (as shown in fig. 5) comprising a support frame 1, a sealing membrane 2, a pull ring 4, a stabilizing structure 5, a circular body 6. As can be seen from the figure, the vascular closure device provided in this comparative example has no intermediate stabilizing structure, and the stabilizing structure 5 is provided only on one side.
Practical applications have found that such vascular closure devices are less stable due to the lack of a stabilizing device on one side; and the loss of the intermediate structure causes that the sealing membrane is not easy to cling to the vessel wall, the hemostatic effect is reduced, and the hemostasis is not facilitated.
The applicant states that the present invention is illustrated by the above embodiments of the vascular closure device and the hemostatic system of the present invention, but the present invention is not limited to the above process steps, i.e. it does not mean that the present invention must rely on the above process steps to be carried out. It will be apparent to those skilled in the art that any modification of the present invention, equivalent substitutions of selected materials and additions of auxiliary components, selection of specific modes and the like, which are within the scope and disclosure of the present invention, are contemplated by the present invention.
Claims (22)
1. The vascular closure device is characterized by comprising a support frame and a sealing membrane, wherein the support frame comprises a body and a stabilizing structure, the stabilizing structure is convexly arranged on the upper side and the lower side of the edge of the body, an intermediate structure is arranged at the central position of the body, and the sealing membrane is laid on the outer surface of the support frame;
the body comprises a plurality of pull rings and a plurality of pull wires, the pull rings are arranged at the edge of the body, and one pull wire is connected with two oppositely arranged pull rings;
the sealing film is made of polylactic acid caprolactone, and the stay wire is made of polyglycolide;
the length of the stabilizing structure is 18-25 mm;
the support body frame is made of nickel-titanium alloy;
the body is circular or elliptical in shape;
the shape of the intermediate structure is circular or elliptical;
two transverse short rods are respectively arranged on the left side and the right side of the middle part of the support body frame;
the middle body structure is connected to the round frame structure of the body through the transverse short rods, and the middle of the middle body structure is hollow;
the middle shape of the degraded sealing film can provide a foundation for the next operation;
the operation process of the hemostatic system is as follows: the blood vessel closing device is placed in a lumen of a conveying system in a curling mode, the blood vessel closing device is placed at a blood vessel incision during hemostasis, the pull wire is tensioned to enable the blood vessel closing device to be tightly attached to a blood vessel, thrombus can be formed under the action of the sealing membrane, and the sealing membrane and the pull wire can be biodegraded after operation along with the lapse of time.
2. The vascular closure device according to claim 1, wherein the vascular closure device is heat treated to form a curved surface.
3. The vascular closure device according to claim 1, wherein the support frame consists of a number of rods.
4. The vascular closure device according to claim 3, wherein the rod width is 0.3-0.7 mm.
5. The vascular closure device according to claim 4, wherein the rod width is 0.5 mm.
6. The vascular closure device according to claim 3, wherein the rod thickness is 0.05-0.12 mm.
7. The vascular closure device according to claim 6, wherein the stem thickness is 0.1 mm.
8. The vasculature closure device of claim 1 wherein the stabilizing structure is 21mm in length.
9. The vasculature closure device of claim 1 wherein the body is circular in shape.
10. The vasculature closure device of claim 1 wherein the diameter is 16-25mm in length when the body is circular in shape.
11. The vasculature closure device of claim 10 wherein the diameter is 20mm in length when the body is circular in shape.
12. The vasculature closure device of claim 1 wherein the length of the major axis is 16-25mm when the body is oval in shape.
13. The vasculature closure device of claim 12 wherein the length of the major axis is 20mm when the body is oval in shape.
14. The vasculature closure device of claim 1 wherein the intermediate structure is circular in shape.
15. The vasculature closure device of claim 1 wherein the sealing membrane is applied to the outer surface of the support frame by any one or a combination of solvent bonding, heat welding, laser welding, ultrasonic welding, mechanical bonding, and layer bonding.
16. The vasculature closure device of claim 1 wherein the pull wire is attached to the pull ring by any one of suturing, gluing, or hooking.
17. The vasculature closure device of claim 16 wherein the pull wire is attached to the pull ring by a sutured attachment.
18. The vascular closure device according to claim 1, wherein the pull ring has a stem width of 0.2-0.5 mm.
19. The vascular closure device according to claim 18, wherein the pull ring has a stem width of 0.3 mm.
20. The vascular closure device according to claim 1, wherein the number of pull tabs is 2-8.
21. The vascular closure device according to claim 20, wherein the number of pull tabs is 4.
22. A haemostatic system, wherein the system comprises a vascular closure device as claimed in any of claims 1-21 and a delivery system, the vascular closure device being placed inside the delivery system.
Priority Applications (1)
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| WO2015009634A2 (en) * | 2013-07-15 | 2015-01-22 | E-Pacing, Inc. | Vasculature closure devices and methods |
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| WO2015009634A2 (en) * | 2013-07-15 | 2015-01-22 | E-Pacing, Inc. | Vasculature closure devices and methods |
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