Equipment for sealing puncture hole

Abstract

The utility model relates to the technical field of medical equipment, and discloses equipment for sealing a puncture hole. The balloon catheter comprises a catheter body and a balloon communicated with the catheter body, the catheter body is arranged in the conveying rod in a penetrating mode, and the balloon is arranged at the far end of the catheter body and at least partially located on the outer side of the end of the conveying rod; the push rod is arranged in a gap between the conveying rod and the guide pipe; the blocking agent section is located in the end, close to the balloon, of the conveying rod; and the anti-failure section is arranged between the plugging agent section and the push rod. According to the equipment for sealing the puncture hole, the anti-failure section is arranged between the plugging agent section and the push rod, and the anti-failure section can be not connected with the plugging agent section, so that the plugging agent section cannot be influenced no matter whether the anti-failure section is clamped by a gap of the push rod or not; the anti-failure section can also be made of materials which do not deform in the axial direction of the device when being extruded, so that the anti-failure section cannot be clamped into the push rod to be taken out due to withdrawing of the balloon, and arrangement failure caused by the fact that the blocking agent section cannot be taken out by the device is avoided.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a device for sealing a puncture hole. Background Art

[0002] During surgery, it is sometimes necessary to perform punctures on patients to extract tissue samples, inject drugs, drain pus or fluid, perform interventional surgery, etc. Common situations that require punctures include diagnostic punctures, therapeutic punctures, anesthesia, and blood tests. Punctures will form puncture holes. After the operation, the closure of the puncture hole usually requires appropriate treatment using various devices and biological solutions to prevent infection and promote healing, such as occlusive agents.

[0003] For example, the patent number CN202211367668.0 discloses a blocking and hemostasis device, comprising: a housing; a pull tube, one end of which is movably connected to the housing, and the other end of which extends to the distal end of the housing; a catheter, which passes through the pull tube and can move axially relative to the pull tube; a sealant, which is located between the pull tube and the catheter and arranged near the distal end of the pull tube. After the first locking mechanism is unlocked, the pushing mechanism pushes the push tube to move toward the distal end, pushing the sealant exposed in the tissue tightly, fitting it to the puncture hole of the blood vessel and the tissue wall, squeezing the sealant to make it fully fit and compact with the outer wall of the blood vessel, and effectively blocking and stopping bleeding.

[0004] The occluding agent is loaded in the delivery rod of the occluding hemostatic device. The working principle of the occluding agent is as follows: the delivery rod is inserted into the puncture hole, and when the blood return hole enters the blood, blood outflow can be observed, which means that the designated position has been reached. Physiological saline or other fillers are filled into the balloon through the catheter to make the balloon swell, and then the delivery rod is pulled back to make the balloon stuck on the blood vessel to complete the positioning of the occluding hemostatic device. At this time, the delivery rod continues to be pulled back and the push rod is pushed to release the occluding agent. Finally, the filler in the balloon is discharged through the catheter to make the balloon shrink and then the balloon is withdrawn.

[0005] However, when the prior art blocking device uses the blocking agent to seal the puncture hole, the blocking device needs to push out and squeeze the blocking agent through the push tube in the device, and then shrink the balloon and withdraw it into the push tube. In this process, the blocking agent will be affected by the force of the push tube pressing forward and the balloon withdrawing. At the same time, because the blocking agent itself is soft and easy to expand, the tail end of the blocking agent is easily clamped in the gap between the push tube and the balloon, causing the blocking agent to be taken out of the human body when the device is withdrawn, and finally causing the failure of blocking the puncture hole. Utility Model Content

[0006] 1. Technical issues to be resolved

[0007] In view of the deficiencies in the prior art, the utility model provides a device for sealing puncture holes, which has the advantage of preventing the sealing agent from being carried out when the device is withdrawn, causing failure, and solves the problem of the sealing agent being carried out with the device when it is withdrawn from the human body, causing device failure.

[0008] (II) Technical solution

[0009] In order to achieve the above purpose, the utility model provides the following technical solutions:

[0010] A device for sealing a puncture hole, comprising:

[0011] A delivery rod 1, used to penetrate into the puncture hole;

[0012] A balloon catheter, comprising a catheter 2 and a balloon 3 connected to the catheter 2, wherein the catheter 2 is inserted into the delivery rod 1 and used to inflate or deflate the balloon 3, the balloon 3 is arranged at the distal end of the catheter 2 and at least partially located outside the end of the delivery rod 1, and the balloon 3 is used to locate the blood vessel wall 92 when inflated;

[0013] A push rod 4 is arranged in the gap between the delivery rod 1 and the catheter 2;

[0014] The plugging agent segment 5 is located inside the delivery rod 1 at one end close to the balloon 3, and the plugging agent segment 5 is located in the gap between the catheter 2 and the delivery rod 1;

[0015] The anti-failure segment 6 is arranged in the gap between the delivery rod 1 and the catheter 2, and is located between the plugging agent segment 5 and the push rod 4 in the axial direction of the delivery rod 1. The anti-failure segment 6 is used to prevent the plugging agent segment 5 from being carried out when the device is withdrawn.

[0016] Preferably, the plugging agent segment 5 is not fixedly connected to the anti-failure segment 6, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 has no adhesion to the end surface of the anti-failure segment 6 facing the plugging agent segment 5, and the contact surface between the plugging agent segment 5 and the anti-failure segment 6 has no adhesion when in contact;

[0017] And / or, the failure prevention section 6 does not deform along the axial direction of the device when being squeezed.

[0018] Preferably, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 is flat with the end surface of the anti-failure segment 6 facing the plugging agent segment 5 , and the end surface of the plugging agent segment 5 facing the anti-failure segment 6 is parallel with the end surface of the anti-failure segment 6 facing the plugging agent segment 5 .

[0019] Preferably, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 are both perpendicular to the central axis of the delivery rod 1 .

[0020] Preferably, the anti-failure segment 6 is arranged at one end of the plugging agent segment 5 close to the push rod 4, and the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 abut against each other; the material hardness of the anti-failure segment 6 is the same as that of the plugging agent segment 5, or the material hardness of the anti-failure segment 6 is greater than that of the plugging agent segment 5 and less than that of the push rod 4.

[0021] Preferably, the anti-failure segment 6 and the plugging agent segment 5 are both sleeved on the outside of the catheter 2 and have an annular or arc-shaped cross section. The inner diameter and outer diameter of the anti-failure segment 6 are respectively kept equal to the inner diameter and outer diameter of the plugging agent segment 5 .

[0022] Preferably, the inner diameters of the plugging agent segment 5 and the anti-failure segment 6 range from 0.6 to 1.2 mm, and the outer diameters of the plugging agent segment 5 and the anti-failure segment 6 range from 1.5 to 2.5 mm.

[0023] Preferably, the total axial length of the plugging agent segment 5 and the anti-failure segment 6 is in the range of 15-20 mm, and the axial length proportion of the anti-failure segment is in the range of 10%-30%.

[0024] Preferably, the material of the failure prevention section 6 is a biomedical material that can be absorbed by the human body. The biomedical material in the failure prevention section 6 includes a polymer or a biomaterial. The polymer includes at least one or a combination of polyethylene glycol polymer and its derivatives, polyglycolic acid, polylactic acid, polyvinyl alcohol, polyglycolic acid-polylactic acid copolymer, polylactide copolymer, chitosan, collagen, cellulose, sodium alginate, sodium hyaluronate and gelatin. The biomaterial includes at least one or a combination of animal cells, tissues and other extracts.

[0025] Alternatively, the material of the failure-preventing section 6 is a biomedical material that cannot be absorbed by the human body.

[0026] Preferably, an additional preparation segment 501 is further provided on the blocking agent segment 5, and the additional preparation segment 501 is a preparation having at least one special effect of adhering to blood vessels, promoting blood coagulation, local analgesia, promoting tissue repair and growth, and reducing inflammation.

[0027] (III) Beneficial effects

[0028] Compared with the prior art, the utility model provides a device for sealing a puncture hole, which has the following beneficial effects:

[0029] 1. The device for sealing the puncture hole has an anti-failure section between the plugging agent section and the push rod. The anti-failure section can prevent the plugging agent section from being clamped when the balloon is withdrawn, thereby avoiding the plugging agent being brought out when the device is withdrawn, resulting in failure of the plugging agent arrangement.

[0030] 2. The device for sealing the puncture hole has an anti-failure segment that is not fixedly connected to the plugging agent segment at one end of the plugging agent segment close to the push rod. When the end faces of the plugging agent segment and the anti-failure segment are in contact, there is no adhesion, and the anti-failure segment and the plugging agent segment do not form a fixed connection, so that the anti-failure segment will not affect the plugging agent segment regardless of whether it is clamped by the push rod gap, thereby ensuring that the plugging agent segment will not be brought out by the equipment, resulting in failure of the plugging agent arrangement.

[0031] 2. The device for sealing the puncture hole is provided with an anti-failure segment at one end of the sealing agent segment close to the push rod. The anti-failure segment is made of a material that is squeezed when the balloon is withdrawn and does not deform along the axis of the device. When the device releases the sealing agent segment and the anti-failure segment to enter the human body, the anti-failure segment is squeezed when the balloon is withdrawn and does not deform along the axis of the device. Therefore, the anti-failure segment will not be clamped into the push rod and carried out due to the withdrawal of the balloon, thereby achieving successful deployment of the sealing agent. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 The utility model is a schematic diagram of the overall structure of the device for sealing the puncture hole.

[0033] Figure 2 This is a schematic structural diagram of region A of the device for sealing a puncture hole according to the present invention.

[0034] Figure 3 The utility model is a schematic diagram of the plugging agent section and the anti-failure section of the device for sealing the puncture hole.

[0035] Figure 4 It is a cross-sectional view of the A region of the device for sealing a puncture hole of the present invention.

[0036] Figure 5 For this utility model Figure 4 Schematic diagram of the structure of area B in the middle.

[0037] Figure 6 This is a structural schematic diagram of adding an additional agent segment at the end of the plugging agent segment in Example 7 of the utility model.

[0038] Figure 7 This is a cross-sectional view of the utility model when used in human tissue.

[0039] Figure 8 This is a cross-sectional view of the utility model in human tissue after the blocking agent is released.

[0040] In the figure: 1, delivery rod; 2, catheter; 3, balloon; 4, push rod; 5, plugging agent segment; 6, anti-failure segment; 101, blood return hole; 401, cavity; 501, additional preparation segment; 91, human tissue; 92, blood vessel wall; 93, blood. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0042] In this document, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of an operator using the medical device. Although "proximal" and "distal" are not restrictive, the "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, and the "distal" usually refers to the end that first enters the patient's body.

[0043] In this article, the left side of each view direction is the far end, and the right side is the near end. The following is a detailed description of each structure of the device.

[0044] Embodiment 1:

[0045] This embodiment provides a device for sealing a puncture hole, wherein the sealing agent segment 5 and the anti-failure segment 6 are not fixedly connected, and the anti-failure segment can be taken out of the device or left in the human body when the device is withdrawn. The anti-failure segment is made of biomedical materials that can be absorbed by the human body and has the following technical features.

[0046] See also Figure 1-7 , a device for sealing a puncture hole, comprising: a delivery rod 1, which is used to penetrate into the puncture hole; a balloon catheter, comprising a catheter 2 and a balloon 3 connected to the catheter 2, the catheter 2 is inserted into the delivery rod 1, the catheter 2 is used to add and extract fillers to the balloon 3 to make the balloon 3 swell or shrink, the balloon 3 is arranged at the distal end of the catheter 2 and at least partially located outside the end of the delivery rod 1, and the balloon 3 is used to locate the blood vessel 92 when it is swollen; a push rod 4, which is arranged in the gap between the delivery rod 1 and the catheter 2; a plugging agent segment 5, which is located inside the delivery rod 1 at one end close to the balloon 3, the plugging agent segment 5 is located in the gap between the delivery rod 1 and the catheter 2 in the radial direction of the delivery rod 1, and is located in the gap between the balloon 3 and the push rod 4 in the axial direction; an anti-failure segment 6, which is arranged in the gap between the delivery rod 1 and the catheter in the radial direction of the delivery rod 1, and is located between the plugging agent segment 5 and the push rod 4 in the axial direction of the delivery rod 1, and the anti-failure segment 6 is used to prevent the plugging agent segment 5 from being taken out when the device is withdrawn.

[0047] It is further provided that the plugging agent segment 5 is not fixedly connected to the anti-failure segment 6, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 have no adhesion, and the contact surface between the plugging agent segment 5 and the anti-failure segment 6 has no adhesion when in contact. In this way, when the balloon 3 is withdrawn and the anti-failure segment 6 is clamped in the push rod 4, the anti-failure segment 6 and the plugging agent segment 5 do not adhere to each other, ensuring that the plugging agent segment 5 and the anti-failure segment 6 can be effectively separated, thereby avoiding the plugging agent segment 5 being taken out when the device is withdrawn, and avoiding the failure of the plugging agent arrangement.

[0048] It is further provided that the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 are smooth and free of burrs, so that embedded connection is further less likely to occur when subjected to extrusion force, ensuring that the plugging agent segment 5 and the anti-failure segment 6 can be effectively separated.

[0049] Furthermore, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 is parallel to the end surface of the anti-failure segment 6 facing the plugging agent segment 5, thereby avoiding partial deformation of the plugging agent segment due to uneven force between the plugging agent segment 5 and the anti-failure segment 6, resulting in the plugging agent segment being clamped.

[0050] Further, in this embodiment, the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 are both perpendicular to the central axis of the delivery rod 1. In this way, the force between the plugging agent segment 5 and the anti-failure segment 6 is parallel to the central axis of the delivery rod 1, and the plugging agent can be pushed out and compacted by squeezing with a relatively small force, which reduces the partial deformation of the plugging agent segment 5 caused by the squeezing process and the impact on the inner wall of the delivery rod 1, and also avoids the partial deformation of the plugging agent segment 5 caused by uneven force when the balloon 3 is withdrawn, forming a nested deformation and causing the plugging agent segment to be clamped.

[0051] Further, the anti-failure segment 6 is arranged at one end of the plugging agent segment 5 close to the push rod 4, and the end surface of the plugging agent segment 5 facing the anti-failure segment 6 abuts against the end surface of the anti-failure segment 6 facing the plugging agent segment 5. The plugging agent segment 5 abuts against the anti-failure segment 6, which can maximally prevent the radial displacement difference between the two when the push rod 4 is squeezed, causing the plugging agent segment 5 to be partially stressed and partially unstressed, resulting in partial deformation of the plugging agent segment 5 to form nested deformation, resulting in the plugging agent segment being clamped.

[0052] The material hardness of the anti-failure segment 6 is the same as that of the plugging agent segment 5, or the material hardness of the anti-failure segment 6 is greater than that of the plugging agent segment 5 and less than that of the push rod 4. Furthermore, the hardness difference between the anti-failure segment 6 and the plugging agent segment 5 is between 0 and 20 degrees. In this way, the hardness difference between the two is too large during the process of the push rod 4 pushing and compacting the plugging agent, thereby preventing nesting deformation.

[0053] In this embodiment, the delivery rod 1 has an inner cavity for accommodating the balloon catheter, the push rod 4, the plugging agent segment 5 and the anti-failure segment 6. The push rod 4 is inserted into the delivery rod 1 and sleeved outside the catheter 2. The plugging agent segment 5 and the anti-failure segment 6 are arranged in the delivery rod 1 and sleeved outside the catheter 2. The plugging agent segment 5 and the anti-failure segment 6 are tubular structures. The cross section of the plugging agent segment 5 is annular, and the cross section of the anti-failure segment 6 is annular. In other embodiments, the push rod 4 can also be set to other shapes located in the gap between the delivery rod 1 and the catheter 2, as long as the function of pushing and compacting the plugging agent can be achieved; the plugging agent segment 5 and the anti-failure segment 6 can also be set to other shapes located in the gap between the delivery rod 1 and the catheter 2, as long as the function of blocking the puncture hole and preventing the plugging agent from failing can be achieved, such as two or more arc pieces.

[0054] Specifically, the anti-failure segment 6 and the plugging agent segment 5 are both sleeved on the outside of the catheter 2, and the cross section is annular or arc-shaped, and the inner diameter and outer diameter of the anti-failure segment 6 are respectively kept equal to the inner diameter and outer diameter of the plugging agent segment 5. The inner and outer diameters of the plugging agent segment 5 and the anti-failure segment 6 are kept equal, so that the end face of the plugging agent segment 5 is completely fitted with the end face of the anti-failure segment 6, and when receiving the applied force, the end face of the plugging agent segment 5 is completely stressed and each part is evenly stressed.

[0055] In this embodiment, different inner and outer diameters are selected for the plugging agent segment 5 and the anti-failure segment 6 when applied to different wounds, with the inner diameter ranging from 0.6 to 1.2 mm and the outer diameter ranging from 1.5 to 2.5 mm. When the inner and outer diameters of the plugging agent segment 5 and the anti-failure segment 6 are subjected to force within this range, the pressure is within a suitable range to avoid deformation caused by excessive pressure.

[0056] The total length of the plugging agent segment 5 and the anti-failure segment 6 is in the range of 15-20 mm, of which the length of the anti-failure segment 6 accounts for 10%-30%, and the length of the plugging agent segment 5 accounts for 70%-90%. In this way, the anti-failure segment is within a suitable range to avoid the anti-failure segment being too short, resulting in no anti-failure effect, and the anti-failure segment being too long, resulting in insufficient plugging agent segment, which affects the plugging effect of the puncture hole. Specifically, for example, the total length of the plugging agent segment 5 and the anti-failure segment 6 can be set to 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, and the length of the anti-failure segment 6 can be set to 10%, 12%, 14%, 16%, 19%, 21%, 24%, 26%, 29%, 30%.

[0057] Specifically, in one embodiment, the length of the plugging agent segment 5 is 13 mm, the inner diameter is 0.70 mm, and the outer diameter is 1.50 mm, and the length of the anti-failure segment 6 is 3 mm, the inner diameter is 0.70 mm, and the outer diameter is 1.50 mm; in another embodiment, the length of the plugging agent segment 5 is 13 mm, the inner diameter is 0.7 mm, and the outer diameter is 1.8 mm, and the length of the anti-failure segment 6 is 3 mm, the inner diameter is 0.7 mm, and the outer diameter is 1.8 mm; in another embodiment, the length of the plugging agent segment 5 is 13 mm, the inner diameter is 0.8 mm, and the outer diameter is 2.10 mm, and the length of the anti-failure segment 6 is 3 mm, the inner diameter is 0.8 mm, and the outer diameter is 2.10 mm; in another embodiment, the length of the plugging agent segment 5 is 13 mm, the inner diameter is 0.8 mm, and the outer diameter is 2.43 mm, and the length of the anti-failure segment 6 is 3 mm, the inner diameter is 0.8 mm, and the outer diameter is 2.43 mm.

[0058] In this embodiment, specifically, a failure prevention segment 6 non-fixedly connected to the plugging agent segment 5 is provided on one side of the plugging agent segment 5 close to the push rod 4, and the failure prevention segment 6 is located between the plugging agent segment 5 and the push rod 4 in the axial direction of the conveying rod 1. The end faces of the anti-failure segment 6 connected to the plugging agent segment 5 are non-adhesive, flat, parallel, and abut against each other, and the end faces are perpendicular to the central axis of the equipment. The anti-failure segment 6 and the plugging agent segment 5 are tubular structures with circular cross-sections, the same inner diameter and outer diameter, and the same material. The material hardness of the anti-failure segment 6 is equal to that of the plugging agent segment 5, and both use biomedical materials that can be absorbed by the human body.

[0059] There are actually two possible situations for the anti-failure segment 6 during the use of the device. Both situations can prevent the layout failure of the plugging agent segment 5, thereby improving the success rate of the device application. In the first situation, when the balloon 3 shrinks and withdraws, if a clamping problem occurs, the anti-failure segment 6 will be clamped and taken out when the device is withdrawn, and the plugging agent segment 5 will be separated from the anti-failure segment 6, and the plugging agent segment 5 will still remain in the affected area to play a plugging and hemostatic role; in the second situation, when the balloon 3 shrinks and withdraws, if no clamping problem occurs, the plugging agent segment 5 and the anti-failure segment 6 will remain in the affected area after the device is withdrawn to play a plugging and hemostatic role. In the above two situations, the plugging agent segment 5 can remain in the human body and be absorbed in the human body, which can cope with the different situations of the puncture positions of different patients, improve the fault tolerance rate, and ensure the success rate of the device application.

[0060] The failure prevention segment 6 may be made of the same biomedical material as the plugging agent segment 5 , or may be made of a biomedical material different from that of the plugging agent segment 5 .

[0061] In this embodiment, the plugging agent segment 5 and the anti-failure segment 6 are both prepared by freeze drying using cross-linked polymers to form a porous material with the characteristics of swelling upon absorption of blood, softness, and smooth surface. Specifically, monomers containing ester groups and amine groups are used for cross-linking reaction, freeze-dried to obtain freeze-dried hydrogel, which is then further processed to obtain the plugging agent segment 5 and the anti-failure segment 6. The monomers may be polyethylene glycol and its derivatives, and / or chitosan and its derivatives.

[0062] Polyethylene glycol and its derivatives may include polyethylene glycol derivatives with at least two terminal groups and at least one terminal group capable of crosslinking, or the first functional group of polyethylene glycol may react in situ with the second functional group to form a covalent bond, thereby forming a crosslinkable gel.

[0063] In some embodiments, the first functional group or the second functional group can include a strong electrophilic agent. For example, the first functional group and the second functional group can be one or more of epoxide, succinimide, N-hydroxysuccinimide, acrylate, methacrylate, maleimide and N-hydroxysulfosuccinimide.

[0064] Alternatively, in some embodiments, the first functional group and / or the second functional group may be an amine group, a thiol group, a carboxyl group, and / or a hydroxyl group.

[0065] In other embodiments, the failure-preventing segment 6 may also be made of a biomedical material different from that of the plugging agent segment 5 , such as sodium hyaluronate, sodium alginate, collagen, and a mixture thereof.

[0066] Embodiment 2:

[0067] This embodiment provides a device for sealing a puncture hole, which is different from the first embodiment in that the anti-failure section 6 is made of a biomedical material that cannot be absorbed by the human body and has the following technical features.

[0068] The difference from the first embodiment is that the anti-failure section 6 is made of biomedical materials that cannot be absorbed by the human body, such as medical rubber, medical silica gel, etc. During the use of the device, the anti-failure section 6 is taken out by the device when a clamping problem occurs, and remains in the human body when no clamping problem occurs.

[0069] Specifically, in this embodiment, for the anti-failure segment 6, a tube with the same inner diameter and outer diameter as the plugging agent segment 5 can be used, and the outer surface of the tube end face is polished smooth, and the end face in contact with the plugging agent segment 5 is kept flat, non-adhesive, parallel to each other, and perpendicular to the central axis of the delivery rod 1, and is non-fixedly connected to the plugging agent segment 5. The material of the anti-failure segment 6 is different from that of the plugging agent segment 5. The hardness of the anti-failure segment 6 is greater than or equal to the hardness of the plugging agent segment 5 and less than or equal to the hardness of the push rod 4. The hardness difference between the anti-failure segment 6 and the plugging agent segment 5 is between 0 and 20 degrees. When the balloon 3 shrinks and withdraws, there may be two possible situations:

[0070] First, when the balloon 3 is contracted and withdrawn, if a clamping problem occurs, the anti-failure segment 6 will be clamped and taken out when the device is withdrawn, and the plugging agent segment 5 will be separated from the anti-failure segment 6 and remain in the affected area to play a blocking and hemostatic role;

[0071] Second, when the balloon 3 contracts and withdraws, if there is no clamping problem, the device is withdrawn and the blocking agent segment 5 and the anti-failure segment 6 remain in the affected area, and the blocking agent segment 5 remains in the affected area to play a blocking and hemostatic role.

[0072] The above two situations do not affect the absorption of the plugging agent segment 5 in the human body and its successful arrangement in the human body, and can cope with different situations of puncture positions of different patients, improve the fault tolerance rate, and ensure the success rate of the device application.

[0073] Embodiment three:

[0074] This embodiment provides a device for sealing a puncture hole, which has the following technical features.

[0075] The difference from the first embodiment is that the anti-failure section is configured to be brought out by the device when or after the balloon 3 is withdrawn.

[0076] In this embodiment, the anti-failure section 6 is fixedly connected to the device, such as fixedly connected to the distal end of the push rod 4, or connected by a connecting line, and the anti-failure section 6 is withdrawn from the human body while or after withdrawing the device.

[0077] Further, the anti-failure section 6 is made of a material with a certain strength and not easy to break, so that it can be stably taken out by the device. When the device is withdrawn, the anti-failure section 6 is separated from the plugging agent and withdrawn together with the device.

[0078] Embodiment 4:

[0079] This embodiment provides a device for sealing a puncture hole, which has the following technical features.

[0080] The difference from the first embodiment is that the anti-failure segment 6 does not deform along the axial direction of the device when it is squeezed when the balloon 3 is withdrawn, so that the anti-failure segment 6 will not be clamped in the gap between the push rod and the catheter during the withdrawal of the balloon 3, thereby ensuring that the plugging agent segment remains in the body during the withdrawal of the device, and achieving successful deployment of the plugging agent. After the device is withdrawn, the plugging agent segment 5 and the anti-failure segment 6 both remain in the human body, or the anti-failure segment 6 is withdrawn after the balloon 3 is withdrawn, or the anti-failure segment 6 is withdrawn after the device is withdrawn.

[0081] In this embodiment, the anti-failure segment 6 and the plugging agent segment 5 are non-fixedly connected. In this way, the anti-failure segment can be left in the body or withdrawn according to actual needs.

[0082] In this embodiment, the anti-failure segment 6 left in the human body is made of implantable biomedical materials, such as polymer materials, etc. The hardness of the material is the same as that of the plugging agent segment 5, or greater than or equal to the hardness of the plugging agent segment 5 and less than or equal to the hardness of the push rod 4, and the hardness difference between the anti-failure segment 6 and the plugging agent segment 5 is between 0 and 20 degrees.

[0083] Embodiment five:

[0084] This embodiment provides a device for sealing a puncture hole, which, in addition to the technical solutions of the above embodiments, also has the following technical features.

[0085] The difference from the fourth embodiment is that the anti-failure segment 6 does not deform along the axial direction of the device when it is squeezed when the balloon 3 is withdrawn, and the plugging agent segment 5 and the anti-failure segment 6 are fixedly connected, and the plugging agent segment 5 and the anti-failure segment 6 remain in the human body after the balloon 3 and the device are withdrawn. In this way, the anti-failure segment 6 and the plugging agent segment 5 are fixedly connected and the force is more uniform when they are squeezed, and the anti-failure segment 6 and the plugging agent segment 5 are not easily deformed and clamped.

[0086] Embodiment six:

[0087] This embodiment provides a device for sealing a puncture hole, which is different from the first embodiment in that the end surface of the plugging agent segment 5 facing the anti-failure segment 6 and the end surface of the anti-failure segment 6 facing the plugging agent segment 5 are both non-adhesive, the contact surfaces between the plugging agent segment 5 and the anti-failure segment 6 are non-adhesive, and the anti-failure segment 6 does not deform along the axial direction of the device when it is squeezed when the balloon is withdrawn. This can double guarantee the successful placement of the plugging agent and further improve the success rate of the device.

[0088] Embodiment seven:

[0089] This embodiment provides a device for sealing a puncture hole, which, in addition to the technical solutions of the above embodiments, also has the following technical features.

[0090] This embodiment provides a specific configuration of the plugging agent segment 5, such as Figure 6 As shown, an additional preparation segment 501 is also provided on the blocking agent segment 5. The additional preparation segment 501 is a preparation having at least one special effect of adhering to blood vessels, promoting blood coagulation, local analgesia, promoting tissue repair and growth, and reducing inflammation.

[0091] Specifically, the additional agent segment 501 is disposed at the distal end of the plugging agent segment 5 . The plugging agent segment 5 can be formed into a head end at the distal end of the plugging agent segment 5 by using a mixture of non-cross-linked polymer precursors, or can be formed into a distal end with an additional agent by adding an additional agent to the distal end of the plugging agent segment 5 .

[0092] Furthermore, the plugging agent segment 5 can be formed into a head end at the distal end of the plugging agent segment 5 by using a mixture of non-crosslinked polymer precursors. When in contact with blood in the human body, an in-situ crosslinking reaction will occur, adhere to the surface of the blood vessel, and enhance the hemostatic effect of plugging; or an additional preparation can be added to the distal part of the plugging agent segment 5 to form a distal end with an additional preparation, including but not limited to chitosan, coagulation factors, etc., which will promote the accelerated coagulation of blood near the wound when in contact with blood in the human body, reduce the amount of bleeding, and enhance the hemostatic effect. The distal additional preparation can have analgesic function, including but not limited to lidocaine, tetracaine, etc., which are released at the wound to achieve a local analgesic effect.

[0093] In other embodiments, the additional agent segment 501 may be disposed at the proximal end or any segment or all of the plugging agent segment 5 , and the plugging agent segment 5 may be connected to the plugging agent segment 5 by using a mixture of non-cross-linked polymer precursors, or the additional agent may be added partially or completely to the plugging agent segment 5 .

[0094] Embodiment eight:

[0095] This embodiment provides a device for sealing a puncture hole, provides a specific implementation method in which the failure prevention section 6 is made of a biomedical material that can be absorbed by the human body, and has the following technical features.

[0096] The material of the anti-failure segment 6 is a biomedical material that can be absorbed by the human body. The anti-failure segment 6 can enhance the hemostatic effect when it remains in the human body, and can prevent the failure of the blocking agent segment 5 when it is taken out of the human body.

[0097] The biomedical material comprises a macromolecular polymer or biological tissue, wherein the macromolecular polymer comprises but is not limited to: polyethylene glycol polymer and its derivatives, polyglycolic acid, polylactic acid, polyvinyl alcohol, polyglycolic acid-polylactic acid copolymer, polylactide copolymer, chitosan, collagen, cellulose, sodium alginate, sodium hyaluronate, gelatin, etc.; the biological material comprises but is not limited to: animal cells, tissues or other extracts.

[0098] Depending on the embodiment, polyethylene glycol, chitosan, collagen, cellulose, sodium alginate, etc. can all be of different types.

[0099] For example, polyethylene glycol can be a modified derivative, and the non-limiting examples of polyethylene glycol derivatives that can be used include but are not limited to branched polyethylene glycol derivatives, heterofunctional polyethylene glycol derivatives, linear monofunctional polyethylene glycol derivatives, and even combinations thereof. The non-limiting examples of branched polyethylene glycol derivatives include but are not limited to Y-shaped PEG NHS esters, Y-shaped PEG maleimides, Y-shaped PEG acetaldehyde, and Y-shaped PEG propionaldehyde. The non-limiting examples of heterofunctional polyethylene glycol derivatives include but are not limited to hydroxy PEG carboxyl, hydroxy PEG amine, HCl salt, amine PEG carboxyl, HCl salt, acrylate PEG NHS ester, maleimide PEG amine, TFA salt, maleimide PEG NHS ester, 4-arm PEG succinimidyl succinate pentaerythritol, 4-arm PEG carboxylmethyl-hydroxybutyrate-N-hydroxysuccinimidyl ester, 4-arm PEG succinimidyl glutarate, 4-arm PEG amine, 8-arm PEG amine, 8-arm PEG amine salt. Non-limiting examples of linear monofunctional polyethylene glycol derivatives include, but are not limited to, methoxy PEG succinimidyl carboxymethyl ester, methoxy PEG maleimide, methoxy PEG vinyl sulfone, methoxy PEG thiol, methoxy PEG propionaldehyde, methoxy PEG amine, HCl salt. The molecular weight of the polyethylene glycol derivative can be between about 2500-50000Da.

[0100] For example, chitosan can be free chitosan, chlorinated chitosan, chitosan glutamate, chitosan acetate, chitosan dicarboxylate, chitosan adipate, chitosan succinate or chitosan fumarate, and even combinations thereof.Chitosan can be at least partially deacetylated, and the deacetylation range can be between 50%-99%.

[0101] For example, the collagen can be type I, type II, type III, type V, and type XI, as well as combinations thereof.

[0102] For example, the cellulose may be methylcellulose, carboxymethylcellulose, ethylcellulose, hydroxyethylcellulose, cyanoethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, cellulose nitrate, cellulose acetate, cellulose acetate butyrate and cellulose xanthate, and even combinations thereof. The molecular weight of the cellulose may be between 500-20000 Da.

[0103] For example, sodium alginate can be a derivative thereof, such as acetylated sodium alginate, phosphated sodium alginate, sulfated sodium alginate, or oxidized sodium alginate.

[0104] Working principle: Figure 7 As shown, the device head is Figure 1The portion of the middle A area passes through the puncture hole on the human tissue 91 and the blood vessel wall 92 to reach the blood 93. When the blood return hole 101 on the delivery rod 1 reaches the blood 93, the blood flows from the blood return hole 101 into the cavity 401 behind the push rod 4. The cavity 401 is connected to the portion of the device located outside the human tissue 91. The blood outflow is observed to indicate that the blood has reached the blood 93. At this time, physiological saline or other fillers are filled into the balloon 3 through the catheter 2 to make the balloon 3 swell. At this time, the device is pulled back outward so that the swollen balloon 3 presses against the blood vessel wall 92, completing the positioning of the blood vessel wall 92, so that the blocking agent segment 5 can be released at the end of the puncture hole. At this time, after the positioning is completed, the balloon 3 is pushed into the blood vessel wall 92 through the catheter 2. The filling in the balloon 3 is discharged, causing the balloon 3 to shrink, and then the balloon 3 is pulled out, leaving the plugging agent segment 5 in the puncture hole. In the prior art, the plugging agent segment 5 is easily clamped into the push rod 4 and taken out together, so an anti-failure segment 6 with a non-adhesive end face is provided at the end of the plugging agent segment 5. When the anti-failure segment 6 is not fixedly connected to the plugging agent segment 5, it can be clamped and taken out by the push rod 4 or remain in the puncture hole; the anti-failure segment 6 can also be made of a material that is squeezed when the balloon 3 is withdrawn and does not deform along the axis of the device. The anti-failure segment 6 does not deform when the balloon 3 is withdrawn and thus will not be clamped into the push rod 4; the above two methods can prevent the plugging agent segment 5 from being clamped and taken out by the equipment, resulting in failure of the plugging agent arrangement; Figure 8 , which is a schematic diagram of the expansion of the plugging agent in the puncture hole after the plugging agent segment 5 and the anti-failure segment 6 are released.

[0105] In summary, the device for sealing the puncture hole, by setting an anti-failure section between the plugging agent section and the push rod, can prevent the plugging agent section from being clamped in the push rod when the balloon is withdrawn, thereby avoiding the plugging agent section being brought out when the device is withdrawn, resulting in failure of the plugging agent arrangement.

[0106] The device for sealing the puncture hole has an anti-failure segment 6 which is non-fixedly connected to the plugging agent segment 5, arranged at one end of the plugging agent segment 5 close to the push rod 4. When the end faces of the plugging agent segment 5 and the anti-failure segment 6 are in contact, there is no adhesion, and the anti-failure segment 6 and the plugging agent segment 5 do not form a fixed connection, so that the anti-failure segment 6 will not affect the plugging agent segment 5 regardless of whether it is clamped by the gap of the push rod 4, thereby ensuring that the plugging agent segment 5 will not be carried out by the device and cause the arrangement to fail.

[0107] The device for sealing the puncture hole is provided with an anti-failure segment 6 at one end of the sealing agent segment 5 close to the push rod 4. The anti-failure segment 6 is made of a material that is squeezed when the balloon 3 is withdrawn and does not deform along the axis of the device. When the device releases the sealing agent segment 5 and the anti-failure segment 6 to enter the human body, the anti-failure segment 6 will not be squeezed and deformed, so that the anti-failure segment 6 will not be clamped into the push rod 4 and taken out due to the withdrawal of the balloon 3, thereby achieving successful deployment of the sealing agent.

[0108] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0109] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, combinations and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A device for sealing a puncture hole, characterized in that: include: A delivery rod (1), used for penetrating into the puncture hole; A balloon catheter, comprising a catheter (2) and a balloon (3) connected to the catheter (2), wherein the catheter (2) is inserted into the delivery rod (1) and is used to inflate or contract the balloon (3), wherein the balloon (3) is arranged at the distal end of the catheter (2) and is at least partially located outside the end of the delivery rod (1), and when inflated, the balloon (3) is used to locate the blood vessel wall (92); A push rod (4) is arranged in the gap between the delivery rod (1) and the catheter (2); A plugging agent segment (5) is located inside the delivery rod (1) at one end close to the balloon (3), and the plugging agent segment (5) is located in the gap between the catheter (2) and the delivery rod (1); The anti-failure section (6) is arranged in the gap between the delivery rod (1) and the catheter (2), and is located between the plugging agent section (5) and the push rod (4) in the axial direction of the delivery rod (1). The anti-failure section (6) is used to prevent the plugging agent section (5) from being carried out when the device is withdrawn.

2. A device for sealing a puncture hole according to claim 1, characterized in that: The plugging agent segment (5) is not fixedly connected to the anti-failure segment (6); the end surface of the plugging agent segment (5) facing the anti-failure segment (6) and the end surface of the anti-failure segment (6) facing the plugging agent segment (5) are not adhesive; and the contact surfaces between the plugging agent segment (5) and the anti-failure segment (6) are not adhesive when in contact; And / or, the failure prevention section (6) does not deform along the axial direction of the device when it is squeezed.

3. A device for sealing a puncture hole according to claim 2, characterized in that: The end surface of the plugging agent segment (5) facing the anti-failure segment (6) is flat with the end surface of the anti-failure segment (6) facing the plugging agent segment (5), and the end surface of the plugging agent segment (5) facing the anti-failure segment (6) is parallel with the end surface of the anti-failure segment (6) facing the plugging agent segment (5).

4. A device for sealing a puncture hole according to claim 3, characterized in that: The end surface of the plugging agent segment (5) facing the anti-failure segment (6) and the end surface of the anti-failure segment (6) facing the plugging agent segment (5) are both perpendicular to the central axis of the delivery rod (1).

5. A device for sealing a puncture hole according to claim 4, characterized in that: The anti-failure section (6) is arranged at one end of the plugging agent section (5) close to the push rod (4); the end surface of the plugging agent section (5) facing the anti-failure section (6) and the end surface of the anti-failure section (6) facing the plugging agent section (5) abut against each other; the material hardness of the anti-failure section (6) is the same as that of the plugging agent section (5), or the material hardness of the anti-failure section (6) is greater than that of the plugging agent section (5) and less than that of the push rod (4).

6. A device for sealing a puncture hole according to claim 2, characterized in that: The anti-failure section (6) and the plugging agent section (5) are both sleeved on the outside of the catheter (2) and have a ring-shaped or arc-shaped cross section. The inner diameter and outer diameter of the anti-failure section (6) are respectively kept equal to the inner diameter and outer diameter of the plugging agent section (5).

7. A device for sealing a puncture hole according to claim 6, characterized in that: The inner diameters of the plugging agent segment (5) and the anti-failure segment (6) are in the range of 0.6-1.2 mm, and the outer diameters of the plugging agent segment (5) and the anti-failure segment (6) are in the range of 1.5-2.5 mm.

8. A device for sealing a puncture hole according to claim 7, characterized in that: The total axial length of the plugging agent segment (5) and the anti-failure segment (6) is in the range of 15-20 mm, and the axial length proportion of the anti-failure segment is in the range of 10%-30%.

9. A device for sealing a puncture hole according to claim 2, characterized in that: The plugging agent segment (5) is also provided with an additional preparation segment (501), and the additional preparation segment (501) is a preparation having at least one special effect of adhering to blood vessels, promoting blood coagulation, local analgesia, promoting tissue repair and growth, and reducing inflammation.

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