An apparatus for sealing a puncture hole

Abstract

The application relates to the technical field of medical equipment, and discloses a device for sealing a puncture hole, which comprises a conveying rod, a balloon catheter comprising a catheter and a balloon in communication with the catheter, the catheter being arranged in the conveying rod, the balloon being arranged at the distal end of the catheter and at least partially outside the end of the conveying rod, a push rod arranged in the gap between the conveying rod and the catheter, a plugging agent section arranged inside the conveying rod at the end close to the balloon, and an anti-failure section arranged between the plugging agent section and the push rod. The device for sealing a puncture hole is provided with the anti-failure section between the plugging agent section and the push rod, the anti-failure section can be not connected with the plugging agent section, so that the anti-failure section does not affect the plugging agent section whether or not clamped by the push rod gap, the anti-failure section can also be made of a material that does not deform along the axial direction of the device under extrusion, so that the anti-failure section cannot be clamped into the push rod and taken out due to the balloon being withdrawn, and the plugging agent section cannot be taken out of the device to cause arrangement failure.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a device for sealing a puncture hole. BACKGROUND

[0002] During surgery, it is sometimes necessary to perform a puncture procedure on a patient to extract tissue samples, inject drugs, drain pus or fluid, perform interventional surgery, etc. Common situations requiring puncture procedures include diagnostic puncture, therapeutic puncture, anesthesia, and blood tests, etc. Puncture procedures will form a puncture hole, and after the procedure, the closure of the puncture hole usually needs to be properly treated using various devices and biological solutions to prevent infection and promote healing, such as a plugging agent.

[0003] For example, patent number CN202211367668.0 discloses a plugging and hemostatic device, which comprises a shell, a pull tube movably connected to one end of the shell and extending towards the distal end of the shell, a catheter passing through the pull tube and capable of moving axially relative to the pull tube, and a sealing agent located between the pull tube and the catheter and arranged close to the distal end of the pull tube. After the first locking mechanism is unlocked, the push mechanism pushes the push tube to move distally, pushing the sealing agent exposed to the tissue to be tight and adhere to the puncture hole of the blood vessel and the tissue wall, extruding the sealing agent to make it fully adhere to the outer wall of the blood vessel and compact, effectively plugging and hemostasis.

[0004] The plugging agent is loaded in the delivery rod of the plugging and hemostatic device, and the working principle of the plugging agent is as follows: the delivery rod is inserted into the puncture hole, and when the backflow hole enters the blood, blood flow can be observed, indicating that the specified 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 clamp on the blood vessel to complete the positioning of the plugging and hemostatic device. At this time, the delivery rod is continuously pulled back and the push rod is pushed to release the plugging agent, and finally the fillers in the balloon are discharged through the catheter to make the balloon shrink, and then the balloon is extracted.

[0005] However, when the existing plugging device uses the plugging agent to seal the puncture hole, the plugging device needs to push out and extrude the plugging agent through the push tube in the device, and then the balloon is retracted into the push tube after shrinking. In this process, the plugging agent is affected by the forward compression of the push tube and the force of the balloon retraction, and at the same time, due to the softness and easy expansion of the plugging agent itself, the tail end of the plugging agent is easily partially clamped in the gap between the push tube and the balloon, causing the plugging agent to be taken out of the body with the device during the retraction of the device, ultimately resulting in the failure of the plugging of the puncture hole. SUMMARY

[0006] (I) Technical problems solved

[0007] In view of the defects of the prior art, the present application provides a device for sealing a puncture hole, which has the advantages of preventing the blocking agent from being taken out of the device when the device is withdrawn, thereby avoiding the problem of device failure caused by the blocking agent being taken out of the human body with the device when the device is withdrawn.

[0008] (II) Technical solutions

[0009] To achieve the above object, the present application provides the following technical solutions.

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

[0011] a delivery rod 1 for penetrating into the puncture hole;

[0012] a balloon catheter comprising a catheter 2 and a balloon 3 in communication with the catheter 2, the catheter 2 being arranged in the delivery rod 1 for inflating or deflating the balloon 3, the balloon 3 being arranged at the distal end of the catheter 2 and at least partially outside the end of the delivery rod 1, the balloon 3 being inflated for positioning the blood vessel wall 92;

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

[0014] a blocking agent section 5 arranged inside the delivery rod 1 at the end close to the balloon 3, the blocking agent section 5 being arranged in the gap between the catheter 2 and the delivery rod 1;

[0015] a failure prevention section 6 arranged in the gap between the delivery rod 1 and the catheter 2, the failure prevention section 6 being arranged between the blocking agent section 5 and the push rod 4 in the axial direction of the delivery rod 1, the failure prevention section 6 being arranged for preventing the blocking agent section 5 from being taken out of the device when the device is withdrawn.

[0016] Preferably, the blocking agent section 5 and the failure prevention section 6 are not fixedly connected, the end surface of the blocking agent section 5 facing the failure prevention section 6 and the end surface of the failure prevention section 6 facing the blocking agent section 5 are not adhesive, and the contact surface between the blocking agent section 5 and the failure prevention section 6 is not adhesive when in contact.

[0017] Preferably, the failure prevention section 6 does not deform in the axial direction of the device under extrusion.

[0018] Preferably, the end surface of the blocking agent section 5 facing the failure prevention section 6 and the end surface of the failure prevention section 6 facing the blocking agent section 5 are flat, and the end surface of the blocking agent section 5 facing the failure prevention section 6 and the end surface of the failure prevention section 6 facing the blocking agent section 5 are parallel.

[0019] Preferably, the end surface of the blocking agent section 5 facing the failure prevention section 6 and the end surface of the failure prevention section 6 facing the blocking agent section 5 are both perpendicular to the central axis of the delivery rod 1.

[0020] Preferably, the failure prevention section 6 is arranged at one end of the plugging agent section 5 close to the push rod 4, and the end face of the plugging agent section 5 towards the failure prevention section 6 and the end face of the failure prevention section 6 towards the plugging agent section 5 abut each other; the material hardness of the failure prevention section 6 is the same as that of the plugging agent section 5, or the material hardness of the failure prevention section 6 is greater than that of the plugging agent section 5 and less than that of the push rod 4.

[0021] Preferably, the failure prevention section 6 and the plugging agent section 5 are both arranged outside the catheter 2 and have a ring or arc cross section, and the inner diameter and the outer diameter of the failure prevention section 6 are respectively equal to those of the plugging agent section 5.

[0022] Preferably, the inner diameter of the plugging agent section 5 and the failure prevention section 6 ranges from 0.6 mm to 1.2 mm, and the outer diameter of the plugging agent section 5 and the failure prevention section 6 ranges from 1.5 mm to 2.5 mm.

[0023] Preferably, the total axial length of the plugging agent section 5 and the failure prevention section 6 ranges from 15 mm to 20 mm, and the axial length of the failure prevention section accounts for 10% to 30%.

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

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

[0026] Preferably, the plugging agent section 5 is further provided with an additional agent section 501, and the additional agent section 501 is an agent 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] (Three) beneficial effects

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

[0029] 1. The device for sealing a puncture hole, by arranging a failure prevention section between the plugging agent section and the push rod, the failure prevention section can prevent the plugging agent section from being clamped when the balloon is withdrawn, thereby avoiding the plugging agent from being carried out and causing the plugging agent to fail to arrange.

[0030] 2. The device for sealing puncture hole, by setting the anti-failure section which is not fixedly connected with the plugging agent section at one end of the plugging agent section close to the push rod, the end surfaces of the plugging agent section and the anti-failure section are not adhesive, the anti-failure section is not fixedly connected with the plugging agent section, so that the anti-failure section does not affect the plugging agent section whether it is clamped by the push rod gap, and the plugging agent section can be ensured not to be taken out by the device to cause the plugging agent arrangement failure.

[0031] 3. The device for sealing puncture hole, by setting the anti-failure section at one end of the plugging agent section close to the push rod, the anti-failure section is made of a material which does not deform along the axial direction of the device when the balloon is withdrawn, when the device releases the plugging agent section and the anti-failure section into the human body, the anti-failure section does not deform along the axial direction of the device when the balloon is withdrawn, so that the anti-failure section will not be clamped into the push rod and taken out due to the balloon withdrawal, and the successful plugging agent arrangement is realized. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 It is the overall structure schematic diagram of the device for sealing puncture hole of the present application.

[0033] Figure 2 It is the structure schematic diagram of the A area of the device for sealing puncture hole of the present application.

[0034] Figure 3 It is the schematic diagram of the plugging agent section and the anti-failure section of the device for sealing puncture hole of the present application.

[0035] Figure 4 It is the cross-sectional view of the A area part of the device for sealing puncture hole of the present application.

[0036] Figure 5 It is the structure schematic diagram of the B area of the present application. Figure 4

[0037] Figure 6 It is the structure schematic diagram of the additional agent section added at the end of the plugging agent section in the seventh embodiment of the present application.

[0038] Figure 7 It is the cross-sectional view in the human body tissue when the present application is used.

[0039] Figure 8 It is the cross-sectional view in the human body tissue after the plugging agent is released of the present application.

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

[0041] ​With reference to the drawings of the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by a person of ordinary skill in the art without creative effort belong to the scope of protection of the present application.

[0042] In this document, the terms "proximal" and "distal" refer to the relative positional, directional, and orientation of elements or actions with respect to each other from the perspective of an operator using the medical device, although "proximal" and "distal" are not limiting, "proximal" generally refers to the end of the medical device that is closer to the operator during normal operation, and "distal" generally refers to the end that enters the patient's body first.

[0043] In this document, the left side of each view direction is distal, and the right side is proximal. The structures of the device will be described in detail below.

[0044] Embodiment one:

[0045] The present embodiment provides a device for sealing a puncture hole, wherein the occlusive agent section 5 and the failure prevention section 6 are non-fixedly connected, the failure prevention section can be taken out by the device or left in the human body when the device is withdrawn, the failure prevention section uses a biocompatible material that can be absorbed by the human body, and has the following technical features.

[0046] Please refer to Figures 1-7 A device for sealing a puncture hole, comprising: a delivery rod 1 for penetrating into the puncture hole; a balloon catheter comprising a catheter 2 and a balloon 3 in communication with the catheter 2, the catheter 2 is arranged in the delivery rod 1, the catheter 2 is used to add and extract the filling of the balloon 3 to make the balloon 3 inflate or shrink, the balloon 3 is arranged at the distal end of the catheter 2 and at least partially outside the end of the delivery rod 1, the balloon 3 is used to position the blood vessel 92 when inflated; a push rod 4 arranged in the gap between the delivery rod 1 and the catheter 2; an occlusive agent section 5 located inside the delivery rod 1 at the end close to the balloon 3, the occlusive agent section 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 in the gap between the balloon 3 and the push rod 4 in the axial direction; a failure prevention section 6 arranged in the gap between the delivery rod 1 and the catheter in the radial direction of the delivery rod 1, and located between the occlusive agent section 5 and the push rod 4 in the axial direction of the delivery rod 1, the failure prevention section 6 is used to prevent the occlusive agent section 5 from being taken out when the device is withdrawn.

[0047] Further, the plugging agent section 5 is not fixedly connected with the anti-failure section 6, the end face of the plugging agent section 5 facing the anti-failure section 6 is not adhered to the end face of the anti-failure section 6 facing the plugging agent section 5, and the contact surface between the plugging agent section 5 and the anti-failure section 6 is not adhered when in contact. In this way, when the balloon 3 is withdrawn and the anti-failure section 6 is clamped in the push rod 4, the anti-failure section 6 and the plugging agent section 5 do not adhere to each other, which ensures that the plugging agent section 5 and the anti-failure section 6 can be effectively separated, thereby avoiding that the plugging agent section 5 is taken out when the device is withdrawn, and avoiding that the plugging agent arrangement fails.

[0048] Further, the end face of the plugging agent section 5 facing the anti-failure section 6 is smooth and free of burrs, and the end face of the anti-failure section 6 facing the plugging agent section 5 is smooth and free of burrs. In this way, the embedded connection is less likely to occur when subjected to the extrusion force, which ensures that the plugging agent section 5 and the anti-failure section 6 can be effectively separated.

[0049] Further, the end face of the plugging agent section 5 facing the anti-failure section 6 is parallel to the end face of the anti-failure section 6 facing the plugging agent section 5, which avoids that the uneven force between the plugging agent section 5 and the anti-failure section 6 causes partial deformation of the plugging agent section and causes the plugging agent section to be clamped.

[0050] Further, in the present embodiment, the end face of the plugging agent section 5 facing the anti-failure section 6 is perpendicular to the central axis of the delivery rod 1, and the end face of the anti-failure section 6 facing the plugging agent section 5 is perpendicular to the central axis of the delivery rod 1. In this way, the force between the plugging agent section 5 and the anti-failure section 6 is parallel to the central axis of the delivery rod 1, and a relatively small force can be used for extrusion to push out and compact the plugging agent, which reduces the partial deformation of the plugging agent section 5 and the influence on the inner wall of the delivery rod 1 during the extrusion process, and also avoids that the uneven force during the withdrawal of the balloon 3 causes partial deformation of the plugging agent section 5 to form nested deformation and causes the plugging agent section to be clamped.

[0051] Further, the anti-failure section 6 is arranged at one end of the plugging agent section 5 close to the push rod 4, and the end face of the plugging agent section 5 facing the anti-failure section 6 abuts against the end face of the anti-failure section 6 facing the plugging agent section 5. The abutment between the plugging agent section 5 and the anti-failure section 6 can maximize the prevention of the displacement difference in the radial direction between the two when the push rod 4 is extruded, which causes partial deformation of the plugging agent section 5 to form nested deformation and causes the plugging agent section to be clamped.

[0052] 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. Further, the hardness difference between the anti-failure section 6 and the plugging agent section 5 is within the range of 0-20 degrees. In this way, the nested deformation is avoided during the process of the push rod 4 pushing and compacting the plugging agent due to the too large hardness difference between the two.

[0053] In the embodiment, the delivery rod 1 has an inner cavity for accommodating the balloon catheter, the push rod 4, the occlusive agent section 5 and the anti-failure section 6. The push rod 4 is arranged in the delivery rod 1 and sleeved outside the catheter 2. The occlusive agent section 5 and the anti-failure section 6 are arranged in the delivery rod 1 and sleeved outside the catheter 2. The occlusive agent section 5 and the anti-failure section 6 are tubular structures. The cross section of the occlusive agent section 5 is circular ring-shaped. The cross section of the anti-failure section 6 is circular ring-shaped. In other embodiments, the push rod 4 can also be arranged in other shapes in the gap between the delivery rod 1 and the catheter 2 as long as it can achieve the function of pushing and compacting the occlusive agent. The occlusive agent section 5 and the anti-failure section 6 can also be arranged in other shapes in the gap between the delivery rod 1 and the catheter 2 as long as they can achieve the functions of plugging the puncture hole and preventing the occlusive agent from failing, such as two or more circular arc pieces.

[0054] Specifically, the anti-failure section 6 and the occlusive agent section 5 are sleeved outside the catheter 2 and have ring-shaped or arc-shaped cross sections. The inner diameter and the outer diameter of the anti-failure section 6 are equal to the inner diameter and the outer diameter of the occlusive agent section 5, respectively. The inner diameter and the outer diameter of the occlusive agent section 5 and the anti-failure section 6 are equal, so that the end face of the occlusive agent section 5 completely matches the end face of the anti-failure section 6. When an acting force is applied, the end face of the occlusive agent section 5 is completely stressed and each part is uniformly stressed.

[0055] In the embodiment, the sizes of the occlusive agent section 5 and the anti-failure section 6 are selected to have different inner and outer diameters when applied to different wounds. The size range of the inner diameter is 0.6-1.2mm, and the size range of the outer diameter is 1.5-2.5mm. When the inner and outer diameters of the occlusive agent section 5 and the anti-failure section 6 are within this range, the pressure is within a suitable range when an acting force is applied, avoiding deformation caused by excessive pressure.

[0056] The total length of the occlusive agent section 5 and the anti-failure section 6 ranges from 15mm to 20mm. The length of the anti-failure section 6 accounts for 10%-30%, and the length of the occlusive agent section 5 accounts for 70%-90%. In this way, the anti-failure section is within a suitable range, avoiding the situation that the anti-failure section is too short to prevent failure or the situation that the anti-failure section is too long to affect the plugging effect of the puncture hole. Specifically, for example, the total length of the occlusive agent section 5 and the anti-failure section 6 can be set to 15mm, 16mm, 17mm, 18mm, 19mm or 20mm. The length of the anti-failure section 6 can be set to 10%, 12%, 14%, 16%, 19%, 21%, 24%, 26%, 29% or 30%.

[0057] Specifically, in one embodiment, the length of the plugging agent section 5 is 13 mm, the inner diameter is 0.70 mm, and the outer diameter is 1.50 mm; the length of the failure prevention section 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 section 5 is 13 mm, the inner diameter is 0.7 mm, and the outer diameter is 1.8 mm; the length of the failure prevention section 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 section 5 is 13 mm; the inner diameter is 0.8 mm, and the outer diameter is 2.10 mm; the length of the failure prevention section 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 section 5 is 13 mm; the inner diameter is 0.8 mm, and the outer diameter is 2.43 mm; the length of the failure prevention section 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 section 6 that is not fixedly connected to the plugging agent section 5 is arranged on the side of the plugging agent section 5 close to the push rod 4, the failure prevention section 6 is located between the plugging agent section 5 and the push rod 4 in the axial direction of the delivery rod 1, the end face of the failure prevention section 6 connected to the plugging agent section 5 is non-adhesive, flat, parallel, and abuts against each other, the end face is perpendicular to the central axis of the device, the failure prevention section 6 and the plugging agent section 5 are tubular structures, have a circular ring-shaped cross section, have the same inner diameter and outer diameter, and are made of the same material, the material hardness of the failure prevention section 6 is equal to that of the plugging agent section 5, and both are made of a biocompatible medical material that can be absorbed by the human body.

[0059] The failure prevention section 6 can exist in two possible situations during the use of the device, both of which can prevent the arrangement failure of the plugging agent section 5 and improve the success rate of the device application. In the first situation, when the balloon 3 is retracted, if clamping problems occur, the failure prevention section 6 will be clamped out when the device is retracted, and the plugging agent section 5 will be separated from the failure prevention section 6, and the plugging agent section 5 will still remain in the affected area to play a plugging and hemostatic role; in the second situation, when the balloon 3 is retracted, if no clamping problems occur, both the plugging agent section 5 and the failure prevention section 6 remain in the affected area to play a plugging and hemostatic role after the device is retracted. In the above two situations, the plugging agent section 5 can remain in the human body and be absorbed in the human body, can cope with different situations of different patient puncture positions, can improve the fault tolerance, and can ensure the success rate of the device application.

[0060] For the failure prevention section 6, the same biocompatible medical material as the plugging agent section 5 can be used, or a different biocompatible medical material from the plugging agent section 5 can be used.

[0061] In the present embodiment, the occlusive segment 5 and the failure prevention segment 6 are both prepared by freeze-drying cross-linked polymers to form porous materials, which have the characteristics of absorbing blood to swell, being soft, and having a smooth surface. Specifically, monomers containing ester groups and amine groups, respectively, are used for cross-linking reactions, and freeze-dried hydrogels are obtained by freeze-drying, and then the freeze-dried hydrogels are further processed to obtain the occlusive segment 5 and the failure prevention segment 6. The monomers can be polyethylene glycol and derivatives thereof, and / or chitosan and derivatives thereof.

[0062] The polyethylene glycol and derivatives thereof can include polyethylene glycol derivatives having at least two end groups and having at least one end group capable of cross-linking, or the first functional group of the polyethylene glycol can be chemically reacted in situ with the second functional group to form a covalent bond, thereby forming a cross-linkable gel.

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

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

[0065] In other embodiments, the failure prevention segment 6 can also use a different biomaterial than the occlusive segment 5, such as sodium hyaluronate, sodium alginate, collagen, and mixtures thereof.

[0066] Embodiment Two:

[0067] The present embodiment provides a device for sealing a puncture hole, which is different from Embodiment One in that the failure prevention segment 6 uses a biomaterial that cannot be absorbed by the human body, and has the following technical features.

[0068] The difference from Embodiment One is that the failure prevention segment 6 uses a biomaterial that cannot be absorbed by the human body, such as medical rubber, medical silicone, etc. In the process of using the device, the failure prevention segment 6 is taken out of the device when clamping problems occur, and is left in the human body when no clamping problems occur.

[0069] Specifically, in the embodiment, for the anti-failure section 6, a pipe with the same inner diameter and outer diameter as the plugging agent section 5 can be used, the end surface of the pipe is polished smooth, the end surface in contact with the plugging agent section 5 is kept flat, non-adhesive, parallel to each other, and perpendicular to the central axis of the conveying rod 1, and the anti-failure section 6 is not fixedly connected with the plugging agent section 5. The material of the anti-failure section 6 is different from that of the plugging agent section 5, the hardness of the anti-failure section 6 is greater than or equal to the hardness of the plugging agent section 5 and less than or equal to the hardness of the push rod 4, and the hardness difference between the anti-failure section 6 and the plugging agent section 5 is within the range of 0-20 degrees. When the balloon 3 is retracted, there can be two possible situations:

[0070] First, when the balloon 3 is retracted, if clamping occurs, the anti-failure section 6 will be clamped out when the device is retracted, and the plugging agent section 5 will be separated from the anti-failure section 6 and left in the affected area to play a plugging and hemostatic role;

[0071] Second, when the balloon 3 is retracted, if clamping does not occur, the plugging agent section 5 and the anti-failure section 6 are left in the affected area, and the plugging agent section 5 is left in the affected area to play a plugging and hemostatic role.

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

[0073] Embodiment three:

[0074] The 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 arranged to be taken out by the device when or after the balloon 3 is retracted.

[0076] In this embodiment, the anti-failure section 6 is fixedly connected with the device, such as being fixedly connected with the distal end of the push rod 4 or being connected through a connecting line, and the anti-failure section 6 is taken out of the human body at the same time or after the device is retracted.

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

[0078] Embodiment four:

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

[0080] The difference between this embodiment and the first embodiment is that the failure prevention section 6 does not deform in the axial direction of the device when it is squeezed during the withdrawal of the balloon 3, so that the failure prevention section 6 will not be clamped into the gap between the push rod and the catheter during the withdrawal of the balloon 3, thus ensuring that the occlusive section remains in the body during the withdrawal of the device, and achieving successful placement of the occlusive agent. After the withdrawal of the device, the occlusive section 5 and the failure prevention section 6 both remain in the body, or the failure prevention section 6 is withdrawn after the withdrawal of the balloon 3, or the failure prevention section 6 is withdrawn after the withdrawal of the device.

[0081] For this embodiment, the failure prevention section 6 and the occlusive section 5 are not fixedly connected. In this way, the failure prevention section can be selected to remain in the body or be withdrawn according to actual needs.

[0082] For this embodiment, the failure prevention section 6 that remains in the body is made of implantable biomedical materials, such as high polymer materials. The hardness of the material is the same as that of the occlusive section 5, or is greater than or equal to the hardness of the occlusive section 5 and less than or equal to the hardness of the push rod 4. The difference in hardness between the failure prevention section 6 and the occlusive section 5 is within the range of 0-20 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, has the following technical features.

[0085] The difference between this embodiment and the fourth embodiment is that the failure prevention section 6 does not deform in the axial direction of the device when it is squeezed during the withdrawal of the balloon 3, the occlusive section 5 and the failure prevention section 6 are fixedly connected, and the occlusive section 5 and the failure prevention section 6 both remain in the body after the withdrawal of the balloon 3 and the device. In this way, the fixed connection between the failure prevention section 6 and the occlusive section 5 is more evenly stressed when it is squeezed, and the failure prevention section 6 and the occlusive section 5 are less likely to deform and be clamped.

[0086] Embodiment Six:

[0087] This embodiment provides a device for sealing a puncture hole, which, in addition to the technical solutions of the above embodiments, has the following technical features.

[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, has the following technical features.

[0090] The embodiment provides a specific arrangement of the plugging agent section 5, as shown in the figure. Figure 6 As shown in the figure, the plugging agent section 5 is additionally provided with an additional agent section 501, and the additional agent section 501 is an agent having at least one special effect of adhering to a blood vessel, promoting blood coagulation, local analgesia, promoting tissue repair and growth, and reducing inflammation.

[0091] Specifically, the additional agent section 501 is arranged at the distal end of the plugging agent section 5, and the plugging agent section 5 can be formed by using a mixture of non-cross-linked polymer precursors at the distal end of the plugging agent section 5 to form a head end, or the distal end with the additional agent can be formed by adding the additional agent in the distal end part of the plugging agent section 5.

[0092] Further, the plugging agent section 5 can be formed by using a mixture of non-cross-linked polymer precursors at the distal end of the plugging agent section 5 to form a head end, and in the human body, in-situ cross-linking reaction occurs when the mixture contacts blood, the mixture adheres to the surface of the blood vessel, and the plugging and hemostasis effect is enhanced; or the distal end with the additional agent can be formed by adding the additional agent in the distal end part of the plugging agent section 5, including but not limited to chitosan, blood coagulation factors, etc., and in the human body, the additional agent promotes the blood near the wound to coagulate quickly, reduces the amount of bleeding, and enhances the hemostasis effect. The distal end additional agent can have analgesic function, including but not limited to lidocaine, tetracaine, etc., and is released at the wound to achieve local analgesic effect.

[0093] In other embodiments, the additional agent section 501 can be arranged at the proximal end or any one section or all of the plugging agent section 5, and the plugging agent section 5 can be connected to the plugging agent section 5 by using a mixture of non-cross-linked polymer precursors, or the additional agent can be added in part or all of the plugging agent section 5.

[0094] Embodiment eight:

[0095] The embodiment provides a device for sealing a puncture hole, and provides a specific implementation of the failure prevention section 6 using a biocompatible material that can be absorbed by the human body, and has the following technical features.

[0096] The material of the failure prevention section 6 is a biocompatible material that can be absorbed by the human body, so that when the failure prevention section 6 remains in the human body, the plugging and hemostasis effect is enhanced, and when the failure prevention section 6 is taken out of the human body, the failure prevention section 6 prevents the arrangement of the plugging agent section 5 from failing.

[0097] The biocompatible material includes a high molecular polymer or a biological tissue, and the high molecular polymer includes 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.; and the biological material includes 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 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. Non-limiting examples of branched polyethylene glycol derivatives include, but are not limited to, Y-form PEG NHS esters, Y-form PEG maleimide, Y-form PEG acetaldehyde, and Y-form PEG propionaldehyde. Non-limiting examples of heterofunctional polyethylene glycol derivatives include, but are not limited to, hydroxy PEG carboxyl groups, hydroxy PEG amines, HCl salts, amine PEG carboxyl groups, HCl salts, acrylate PEG NHS esters, maleimide PEG amines, TFA salts, maleimide PEG NHS esters, 4-arm PEG succinimide succinate pentaerythritol, 4-arm PEG carboxymethyl-hydroxybutyrate-N-hydroxysuccinimide ester, 4-arm PEG succinimide glutarate, 4-arm PEG amine, 8-arm PEG amine, and 8-arm PEG amine salts. Non-limiting examples of linear monofunctional polyethylene glycol derivatives include, but are not limited to, methoxyPEG succinimide carboxymethyl ester, methoxyPEG maleimide, methoxyPEG vinyl sulfone, methoxyPEG mercapto, methoxyPEG propionaldehyde, methoxyPEG amine, and HCl salts. The molecular weight of the polyethylene glycol derivatives can be between approximately 2500 and 50000 Da.

[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, with deacetylation ranging from 50% to 99%.

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

[0102] For example, cellulose can 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 cellulose can be between 500 and 20,000 Da.

[0103] For example, sodium alginate can be its derivatives, such as acetylated sodium alginate, phosphorylated sodium alginate, sulfated sodium alginate, and oxidized sodium alginate.

[0104] Working principle: such as Figure 7 As shown, the device head, that is Figure 1When the middle A region of the device reaches the blood 93 through the puncture hole on the human tissue 91 and the blood vessel wall 92, and the blood hole 101 on the push rod 1 reaches the blood 93, the blood flows from the blood hole 101 into the cavity 401 behind the push rod 4, and the cavity 401 is connected to the part of the device outside the human tissue 91. It is observed that the blood flows out, indicating that it has reached the blood 93; at this time, physiological saline or other fillers are filled into the balloon 3 through the catheter 2, so that the balloon 3 is inflated; at this time, the device is pulled back outward, so that the inflated balloon 3 is pressed against the blood vessel wall 92, completing the positioning of the blood vessel wall 92, so that the occlusive agent section 5 can be released at the end of the puncture hole; at this time, after positioning, the fillers in the balloon 3 are discharged through the catheter 2, so that the balloon 3 is deflated, and then the balloon 3 is withdrawn, so that the occlusive agent section 5 remains in the puncture hole. In the prior art, the occlusive agent section 5 is easily clamped into the push rod 4 and taken out together, so an end face non-adhesion failure prevention section 6 is arranged at the end of the occlusive agent section 5. When the failure prevention section 6 is not fixedly connected with the occlusive agent section 5, it can be clamped and taken out by the push rod 4 or remain in the puncture hole; the failure prevention section 6 can also be made of a material that does not deform along the axial direction of the device when the balloon 3 is withdrawn, so that the failure prevention section 6 does not deform when the balloon 3 is withdrawn and thus is not clamped into the push rod 4; both the above two ways can avoid the occlusive agent section 5 being clamped and taken out by the device, resulting in failure of the occlusive agent arrangement; as shown in FIG. 6, it is a schematic view of the occlusive agent expanding in the puncture hole after the occlusive agent section 5 and the failure prevention section 6 are released. Figure 8

[0105] In summary, the device for sealing the puncture hole, by arranging the failure prevention section between the occlusive agent section and the push rod, the failure prevention section can prevent the occlusive agent section from being clamped into the push rod when the balloon is withdrawn, thereby avoiding the occlusive agent section being taken out by the device when the device is withdrawn, resulting in failure of the occlusive agent arrangement.

[0106] The device for sealing the puncture hole, by arranging the failure prevention section 6 at the end of the occlusive agent section 5 close to the push rod 4, the end faces of the occlusive agent section 5 and the failure prevention section 6 are non-adhesion when they are in contact, the failure prevention section 6 is not fixedly connected with the occlusive agent section 5, so that whether the failure prevention section 6 is clamped by the gap of the push rod 4 or not does not affect the occlusive agent section 5, ensuring that the occlusive agent section 5 can not be taken out by the device, resulting in failure of the arrangement.

[0107] The device for sealing the puncture hole, by arranging the failure prevention section 6 at the end of the occlusive agent section 5 close to the push rod 4, the failure prevention section 6 is made of a material that does not deform along the axial direction of the device when the balloon 3 is withdrawn, so that the failure prevention section 6 does not deform when the device releases the occlusive agent section 5 and the failure prevention section 6 into the human body, thereby the failure prevention section 6 is not clamped into the push rod 4 and taken out due to the balloon 3 being withdrawn, realizing successful arrangement of the occlusive agent.

[0108] ​It has to be noted that, in the present document, the terms "first", "second", etc. merely serve to identify different entities or actions and do not necessarily require or imply any actual relationship or order between these entities or actions. Moreover, the terms "comprises", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without further constraints, exclude the presence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0109] While embodiments of the application have been shown and described, it is to be understood that the application is not limited to these embodiments. Rather, it is the intention to cover any variation falling within the spirit and scope of the application, which is defined by the appended claims and their equivalents.

Claims

1. An apparatus for sealing a puncture hole, characterized by, The invention relates to a device for sealing a puncture hole in a blood vessel wall (92), comprising: a delivery rod (1) for penetrating into the puncture hole; a balloon catheter comprising a catheter (2) and a balloon (3) in communication with the catheter (2), the catheter (2) being arranged in the delivery rod (1) for inflating or deflating the balloon (3), the balloon (3) being arranged at the distal end of the catheter (2) and at least partially outside the end of the delivery rod (1), the balloon (3) being inflated for positioning the blood vessel wall (92) when inflated; a push rod (4) arranged in the gap between the delivery rod (1) and the catheter (2); a sealing agent section (5) arranged inside the delivery rod (1) at the end close to the balloon (3), the sealing agent section (5) being arranged in the gap between the catheter (2) and the delivery rod (1); a failure prevention section (6) arranged in the gap between the delivery rod (1) and the catheter (2), the failure prevention section (6) being arranged between the sealing agent section (5) and the push rod (4) in the axial direction of the delivery rod (1), the failure prevention section (6) being arranged for preventing the sealing agent section (5) from being taken out when the device is withdrawn; the sealing agent section (5) and the failure prevention section (6) are not fixedly connected, the end face of the sealing agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the sealing agent section (5) are not adhered to each other, and the contact surface between the sealing agent section (5) and the failure prevention section (6) is not adhered when in contact; and / or, the failure prevention section (6) does not deform in the axial direction of the device under extrusion.

2. A device for sealing a puncture according to claim 1, wherein, the end face of the sealing agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the sealing agent section (5) are flat, and the end face of the sealing agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the sealing agent section (5) are parallel.

3. A device for sealing a puncture hole according to claim 2, wherein the end face of the sealing agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the sealing agent section (5) are both perpendicular to the central axis of the delivery rod (1).

4. An apparatus for sealing a puncture hole according to claim 3, wherein the failure prevention section (6) is arranged at the end of the sealing agent section (5) close to the push rod (4), the end face of the sealing agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the sealing agent section (5) abut each other; the material hardness of the failure prevention section (6) is the same as that of the sealing agent section (5), or the material hardness of the failure prevention section (6) is greater than that of the sealing agent section (5) and less than that of the push rod (4).

5. The apparatus for sealing a puncture hole according to claim 1, wherein the failure prevention section (6) and the sealing agent section (5) are both arranged outside the catheter (2) and have a cross-section in the shape of a ring or an arc, and the inner diameter and the outer diameter of the failure prevention section (6) are the same as those of the sealing agent section (5).

6. An apparatus for sealing a puncture hole according to claim 5, wherein the size range of the inner diameter of the sealing agent section (5) and the failure prevention section (6) is 0.6-1.2mm, and the size range of the outer diameter of the sealing agent section (5) and the failure prevention section (6) is 1.5-2.5mm.

7. An apparatus for sealing a puncture hole according to claim 6, wherein the total axial length of the sealing agent section (5) and the failure prevention section (6) ranges from 15mm to 20mm, and the axial length of the failure prevention section accounts for 10%-30%.

8. The apparatus for sealing a puncture hole according to claim 1, wherein The material of the failure prevention section (6) is a bio-compatible material that can be absorbed by the human body. The bio-compatible material in the failure prevention section (6) comprises a polymer or a biological material. The polymer comprises at least one of 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 biological material comprises at least one of or a combination of cells, tissues, and other extracts of animals. Alternatively, the material of the failure prevention section (6) is a bio-compatible material that cannot be absorbed by the human body.

9. The apparatus for sealing a puncture hole according to claim 1, wherein The occlusive agent section (5) is further provided with an additional agent section (501). The additional agent section (501) is an agent having at least one of the special effects of adhering to blood vessels, promoting blood coagulation, local analgesia, promoting tissue repair and growth, and reducing inflammation.

Images