A tearable catheter sheath with hemostatic function

Abstract

This invention discloses a tearable catheter sheath with hemostatic function, relating to the field of medical device technology, which solves the problem of inconvenience for financial personnel in binding vouchers. It includes: a sheath assembly comprising two symmetrical tearable tube seats, with a tearable sheath tube commonly disposed on the inner edge surface of the bottom openings of the two tearable tube seats; tear lines are provided on the tearable sheath tube along the symmetrical axis of the two tearable tube seats to ensure that the tearable sheath tube can be torn simultaneously when the two tearable tube seats are torn outwards; and a limiting component disposed between the tearable tube seats and the tearable sheath tube; the limiting component includes a limiting ring disposed on the outer edge surface of the tearable sheath tube, which ensures that the opening position of the tearable sheath tube when peeled is above the puncture incision, preventing the tearable sheath tube from pulling the puncture incision to the sides and causing incision expansion when it is peeled off and withdrawn from the blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a tearable catheter sheath with hemostatic function. Background Technology

[0002] During cardiac pacing surgery, an electrode lead for the pacing pulse generator is inserted through a sheath into the heart. After positioning, the sheath is withdrawn, leaving the electrode lead inside the body. Because the proximal end of the electrode lead is connected to the pacing pulse generator, the sheath cannot detach from the lead; therefore, the sheath used in this procedure must be tearable. When withdrawing the sheath, it is symmetrically torn into two pieces, tearing as it is withdrawn, until the sheath is completely torn open and removed from the blood vessel, separating it from the lead.

[0003] Currently, after interventional treatment and catheter sheath fixation, a dilator needs to be inserted into the body through the lumen on the catheter sheath to prepare for subsequent interventional treatment. After the dilator is inserted, the catheter sheath needs to be peeled off. The existing method is to peel the catheter sheath to both sides through a tear-proof structure and separate the catheter sheath from the blood vessel and the dilator. However, when tearing the catheter sheath to both sides, the opening of the tear will expand to both sides, which will also cause the puncture incision to expand, enlarge the incision, and may cause bleeding, leading to safety hazards. Therefore, in order to solve this problem, a tear-proof catheter sheath with hemostasis function is proposed. Summary of the Invention

[0004] The purpose of this invention is to provide a solution to the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a tearable catheter sheath with hemostatic function, comprising;

[0006] The sheath assembly includes two mutually symmetrical tearable tube seats. The inner edge surfaces of the bottom openings of the two tearable tube seats are jointly provided with a tearable sheath tube. The tearable sheath tube is provided with tear lines along the symmetrical axis of the two tearable tube seats, so that the tearable sheath tube can be torn open synchronously when the two tearable tube seats are torn outward. It also includes a limiting component disposed between the tearable tube seats and the tearable sheath tube.

[0007] The limiting component includes a limiting ring disposed on the outer edge of the tearable sheath. The limiting ring is used to ensure that the opening position of the tearable sheath when it is peeled off is above the puncture incision, preventing the puncture incision from expanding outward. One end of the limiting ring is equipped with a pulling part through a winding part. The pulling part is used to pull the limiting ring to prevent compression of the puncture incision when the tearable tube seat is peeled off. The other end of the pulling part is connected to the tearable tube seat. The winding part allows the pulling part to extend as the tearable tube seat is torn.

[0008] Preferably, the winding part includes two mounting slots opened on the limiting ring and corresponding to the two tearable tube seats, and a winding wheel is connected in each of the two mounting slots. The pulling part is arranged on the two winding wheels.

[0009] The traction section includes a connector and a timing belt. One end of the timing belt is wrapped around the outer edge of the winding wheel, and the other end of the timing belt is set on the surface of the tearable tube seat through the connector. This allows the timing belt to pull the limiting ring to prevent pressure on the puncture incision when the tearable tube seat is peeled off. When the two tearable tube seats are torn outward, the two tearable tube seats pull the limiting ring through the timing belt and winding wheel via the connector. This prevents the peeled opening from pressing down on the limiting ring and contacting the puncture interface when the tearable sheath is torn open, reducing pressure on the incision and preventing bleeding. Furthermore, as the two tearable tube seats are gradually torn apart, the timing belt pulls the winding wheel to rotate, releasing the wound timing belt and causing it to stretch. This only lifts the limiting ring upward, without pulling it to the sides and tearing it open.

[0010] Preferably, the two tearable tube seats and the tearable sheath are formed with cavities through in-mold injection molding. The cavities are used for the insertion of the dilator after the catheter sheath is positioned. After the tearable tube seats and the tearable sheath are inserted into the puncture incision and positioned, the dilator can be inserted into the cavity to facilitate subsequent interventional treatment.

[0011] Preferably, the limiting ring is provided with a positioning component. When the tearable sheath is peeled off by the tearable tube seat, the positioning component is used to position the expansion tube. The positioning component includes two mounting columns set on the limiting ring, and the outer edges of the two mounting columns, which are far apart from each other, are respectively rotatably provided with rotating shafts. Both rotating shafts are provided with slots. Limiting blocks are fixedly installed on the outer edges of the two mounting columns, and the two limiting blocks abut against the slot surfaces on the two rotating shafts respectively. Mounting rotating plates are fixedly installed on the two rotating shafts. The limiting blocks are used to control the rotation angle of the mounting rotating plates on the rotating shafts. After the two tearable tube seats are separated, a part of the expansion tube is exposed. At this time, by rotating the rotating shafts, the two mounting rotating plates are rotated to a position where they are in the same straight line as the expansion tube.

[0012] Preferably, each of the two mounting plates is rotatably mounted with a rotating rod, and each rotating rod is provided with a magnetic positioning piece. After the two magnetic positioning pieces attract each other, a cavity is formed inside for positioning the expansion tube. After the two rotating plates and the expansion tube are aligned in a straight line, the two magnetic positioning pieces are pinched to complete the assembly of the magnetic positioning pieces and clamp the outer wall of the expansion tube. This prevents the problem of a part of the expansion tube being pulled out from the puncture incision when the tearable sheath is torn open and peeled off through the tearable tube seat, due to friction between the inner wall of the tearable sheath and the surface of the expansion tube. This reduces the harm to the patient caused by puncture interventional treatment and has better practicality.

[0013] Preferably, two end caps are provided within the cavity formed by the two tearable tube seats, and a halved sealing plug is installed between the two end caps. The sealing plug is used to achieve a seal, control the air pressure inside the cavity, and inhibit blood outflow. A snap-fit ​​cap is attached to the outer edge of each end cap via a snap fastener, and foam is embedded in the center of the snap-fit ​​cap. The foam is coated with medical-grade silicone oil to ensure lubrication during insertion of the expansion tube. The sealing plug is molded from liquid silicone and has high resilience. Before installation into the tube seat, the plug is cut in half using a tool, and the two end caps press together to ensure a tight seal, stabilize the internal air pressure, and inhibit blood outflow.

[0014] Preferably, one of the tearable tube seats has an extension tube connection port integrally formed on it. The extension tube connection port is used to draw out the air in the tearable sheath, which facilitates medical staff to perform interventional treatment.

[0015] Preferably, both the tearable sheath and the limiting ring are made of injection-molded high-density polyethylene to improve their tearability. Both the tearable sheath and the limiting ring are provided with tear lines of a thickness of 0 mm to facilitate peeling. 30% barium sulfate is added to the tearable sheath to ensure that the outline of the tearable sheath can be clearly seen under X-ray during clinical use.

[0016] Compared with the prior art, the beneficial effects of the present invention are:

[0017] 1. When the tearable sheath is torn open and peeled off, the limiting ring on the limiting component can limit the position of the torn fork in the tearable sheath, so that the position of the torn fork is not at the puncture incision position, but above the limiting ring. This prevents the tearable sheath from pulling the puncture incision to both sides and causing the incision to expand when it is peeled off to both sides and withdrawn from the blood vessel. This reduces bleeding in such cases and has good practicality.

[0018] 2. When the two tearable tube seat is torn outward, the two tearable tube seat pulls the limiting ring through the connector, synchronous belt and winding wheel to prevent the peeled opening from pressing down on the limiting ring and contacting the puncture interface when the tearable sheath is torn, thereby reducing pressure on the incision and further preventing bleeding.

[0019] 3. After the tearable sheath is completely peeled off, the length of the timing belt reaches its limit. At this point, pulling the tearable tube seat to both sides will directly tear the limiting ring through the tear line on the timing belt and the limiting ring. The entire peeling operation is completed in one step, without the need for subsequent peeling of the limiting ring, which improves the convenience in actual use.

[0020] 4. By rotating the shaft, the groove on the shaft rotates until it contacts the limiting block. At this time, the two mounting plates rotate to a position close to the expansion tube. The rotation angle of the mounting plates can be controlled by the limiting block, so that the position closest to the expansion tube is when the plate rotates to its limit, improving the convenience in actual use. At this time, pinch the two magnetic positioning pieces so that they attract each other. The cavity formed inside clamps the expansion tube, preventing the expansion tube from being pulled out of the blood vessel and causing bleeding when the tearable sheath is torn open due to the upward friction generated when the inner wall of the tearable sheath separates to both sides. This also reduces harm to the patient and further prevents bleeding during puncture and interventional treatment, with a better effect in inhibiting bleeding.

[0021] 5. The sealing plug is made of liquid silicone, which has high resilience. Before installation into the tube seat, it is cut in half using a tool and squeezed by two end caps to ensure a good seal, stabilize the internal air pressure, and inhibit blood leakage.

[0022] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0023] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0024] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0025] Figure 2 This is a schematic diagram of the overall front view of the present invention;

[0026] Figure 3 This is a structural schematic diagram of the entire invention from another angle;

[0027] Figure 4 This is a schematic diagram of the structure of the sheath assembly of the present invention;

[0028] Figure 5 This is a schematic diagram of the structure of the limiting component of the present invention;

[0029] Figure 6 This is a schematic diagram of the structure of the limiting component and the positioning component of the present invention;

[0030] Figure 7 For the present invention Figure 3 Enlarged structural diagram at point A;

[0031] Figure 8 For the present invention Figure 3 Enlarged structural diagram at point B.

[0032] In the diagram: 1. Sheath assembly; 101. Tearable sheath tube; 102. Extension tube connector; 103. Tearable tube base; 104. Fastening cap; 105. Buckle; 106. Foam; 107. Sealing plug; 108. End cap; 2. Limiting assembly; 201. Connector; 202. Limiting ring; 203. Synchronous belt; 204. Mounting slot; 205. Winding wheel; 3. Positioning assembly; 301. Rotating shaft; 302. Mounting column; 303. Limiting block; 304. Mounting rotating plate; 3101. Rotating rod; 3102. Magnetic positioning plate. Detailed Implementation

[0033] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0034] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0035] In the description of this invention, "several" means one or more, "more than" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0036] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0037] Example

[0038] Please see Figures 1 to 8 The illustrated tearable catheter sheath with hemostatic function includes:

[0039] The sheath assembly 1 includes two symmetrically symmetrical tearable tube seats 103. A tearable sheath 101 is commonly disposed on the inner edge surface of the bottom openings of the two tearable tube seats 103. A tear line is formed on the tearable sheath 101 along the symmetrical axis of the two tearable tube seats 103, allowing the tearable sheath 101 to be torn simultaneously when the two tearable tube seats 103 are torn outwards. During interventional treatment, the tearable sheath 101 is inserted into the puncture incision. A cavity is formed within the two tearable tube seats 103 and the tearable sheath 101 through in-mold injection molding. This cavity is used after the catheter sheath is positioned. After inserting the dilator into the patient's body through the cavity between the tearable tube seat 103 and the tearable sheath 101, the tearable tube seat 103 is pulled to both sides to separate the two tearable tube seats 103. Since the tearable sheath 101 and the limiting ring 202 are both made of injection-molded high-density polyethylene, and the tearable sheath 101 and the limiting ring 202 are both provided with tear lines with a thickness of 0.15mm, the tearable sheath 101 can be peeled off through the two tearable tube seats 103 and withdrawn from the blood vessel, separating it from the dilator.

[0040] When the tearable sheath 101 is torn open and peeled off, the limiting ring 202 on the limiting component 2 can limit the position of the torn fork in the tearable sheath 101, so that the position of the torn fork is not at the puncture incision position, but above the limiting ring 202. This prevents the tearable sheath 101 from pulling the puncture incision to both sides and causing the incision to expand when it is peeled off to both sides and withdrawn from the blood vessel, thus reducing bleeding in such cases. It has good practicality. In addition, one end of the limiting ring 202 is equipped with a traction part through the winding part. The traction part is used to pull the limiting ring 202 to prevent compression of the puncture incision when the tearable tube seat 103 is peeled off. The other end of the traction part is connected to the tearable tube seat 10. The three-phase connection allows the winding part to extend as the tearable tube seat 103 is torn open. The winding part includes two mounting slots 204 opened on the limiting ring 202 and corresponding to the two tearable tube seats 103. Each of the two mounting slots 204 is connected to a winding wheel 205. The pulling part is set on the two winding wheels 205. The pulling part includes a connector 201 and a timing belt 203. One end of the timing belt 203 is wrapped around the outer edge of the winding wheel 205, and the other end of the timing belt 203 is set on the surface of the tearable tube seat 103 through the connector 201. This allows the timing belt 203 to pull the limiting ring 202 to prevent pressure on the puncture incision when the tearable tube seat 103 is peeled off.

[0041] When the two-tearable tube seat 103 is torn outwards, the two-tearable tube seat 103, through the connector 201, pulls the limiting ring 202 via the timing belt 203 and the winding wheel 205. This prevents the peeled opening of the tearable sheath 101 from pressing downwards and contacting the limiting ring 202 with the puncture interface, reducing pressure on the incision and preventing bleeding. Furthermore, as the two-tearable tube seat 103 is gradually torn open, the timing belt 203 pulls the winding wheel 205 to rotate, releasing the wound timing belt 203, thereby allowing the timing belt 202 to be released. 3. The elongation will only lift the limiting ring 202 upwards, without pulling the limiting ring 202 to both sides and tearing it open. After the tearable sheath 101 is completely peeled off, the length of the timing belt 203 reaches its limit. At this time, pulling the tearable tube seat 103 to both sides will directly tear the limiting ring 202 through the tear line on the timing belt 203 and the limiting ring 202. The entire peeling operation is completed in one step, without the need for subsequent peeling of the limiting ring 202, which improves the convenience in actual use.

[0042] When the tearable sheath 101 is peeled off through the tearable tube seat 103 and the internal dilator tube is just exposed, the positioning component 3 can limit the dilator tube to prevent it from being pulled out of the blood vessel during peeling. The positioning component 3 includes two mounting posts 302 set on the limiting ring 202, and rotating shafts 301 are rotatably mounted on the outer edges of the two mounting posts 302, which are far apart from each other. Both rotating shafts 301 have slots. Limiting blocks 303 are fixedly mounted on the outer edges of the two mounting posts 302, and the two limiting blocks 303 abut against the slot surfaces of the two rotating shafts 301. Mounting plates 304 are fixedly mounted on the two rotating shafts 301. The limiting blocks 303 are used to control the rotation angle of the mounting plates 304 on the rotating shafts 301. Rotating rods 3101 are rotatably mounted on the two mounting plates 304, and both rotating rods 3101 are provided with magnets. The magnetic positioning pieces 3102, when attracted together, form a cavity inside for positioning the expansion tube. By rotating the rotating shaft 301, the slot on the rotating shaft 301 rotates to contact the limiting block 303. At this time, the two mounting plates 304 rotate to a position close to the expansion tube. The rotation angle of the mounting plates 304 can be controlled by the limiting block 303, so that when it rotates to the limit, it is the position closest to the expansion tube, improving the convenience in actual use. At this time, pinching the two magnetic positioning pieces 3102 makes them attract each other, and the cavity inside forms a clamping effect on the expansion tube, preventing the expansion tube from being pulled out of the blood vessel and causing bleeding when the inner wall of the tearable sheath 101 is torn open due to the upward friction generated when the inner wall of the tearable sheath 101 separates to both sides. This also reduces harm to the patient and further prevents bleeding during puncture interventional treatment, with a better effect of inhibiting bleeding.

[0043] Two end caps 108 are installed within the cavities formed by the two tearable tube seats 103. A halved sealing plug 107 is installed between the two end caps 108. The sealing plug 107 is used to achieve a seal and control the air pressure inside the cavity. The sealing plug 107 is made of liquid silicone and has high resilience. Before the tube seat is installed, it is cut in half by a tool and the two sealing plugs 107 are squeezed by the two end caps 108 to ensure the sealing effect, stabilize the internal air pressure, and inhibit blood outflow. The outer surface of the end cap 108 is provided with a snap-fit ​​cap 104 by a snap-fit ​​105. A foam 106 is embedded in the center of the snap-fit ​​cap 104. The foam 106 is coated with medical-grade silicone oil to ensure lubrication when the expansion tube is inserted. One of the tearable tube seats 103 has an extension tube connection port 102 integrally formed on it. The extension tube connection port 102 is used to suck out the air in the tearable sheath tube 101, which facilitates interventional treatment by medical staff.

[0044] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0045] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A tearable catheter sheath with hemostatic function, comprising: A sheath assembly (1) includes two mutually symmetrical tearable tube seats (103). A tearable sheath tube (101) is provided on the inner edge surface of the bottom openings of the two tearable tube seats (103). The tearable sheath tube (101) has tear lines along the symmetrical axis of the two tearable tube seats (103) to ensure that the tearable sheath tube (101) is torn simultaneously when the two tearable tube seats (103) are torn outwards. Its characteristic is that... It also includes a limiting component (2) disposed between the tearable tube seat (103) and the tearable sheath (101); The limiting component (2) includes a limiting ring (202) disposed on the outer edge of the tearable sheath (101). The limiting ring (202) is used to ensure that the opening position of the tearable sheath (101) when it is peeled off is above the puncture incision, preventing the puncture incision from expanding outward. One end of the limiting ring (202) is equipped with a pulling part through a winding part. The pulling part is used to pull the limiting ring (202) to prevent compression of the puncture incision when the tearable tube seat (103) is peeled off. The other end of the pulling part is connected to the tearable tube seat (103). The winding part can extend the pulling part as the tearable tube seat (103) is torn open. The winding part includes two mounting slots (204) opened on the limiting ring (202) and corresponding to the two tearable tube seats (103), and winding wheels (205) are connected in both mounting slots (204). The pulling part is arranged on the two winding wheels (205). The pulling part includes a connector (201) and a timing belt (203). One end of the timing belt (203) is wrapped around the outer edge of the winding wheel (205), and the other end of the timing belt (203) is set on the surface of the tearable tube seat (103) through the connector (201). This allows the timing belt (203) to pull the limiting ring (202) to prevent pressure on the puncture incision when the tearable tube seat (103) is peeled off. The two tearable tube seats (103) and the tearable sheath (101) have cavities formed inside them by in-mold injection molding. The cavities are used for the insertion of the expansion tube after the catheter sheath is positioned. The limiting ring (202) is provided with a positioning component (3). When the tearable sheath (101) is peeled off by the tearable tube seat (103), the positioning component (3) is used to position the expansion tube. The positioning component (3) includes two mounting columns (302), and the outer edges of the two mounting columns (302) are respectively rotatably provided with rotating shafts (301). Both rotating shafts (301) are provided with slots. The outer edges of the two mounting columns (302) are fixedly installed with limiting blocks (303), and the two limiting blocks (303) respectively abut against the slot surfaces on the two rotating shafts (301). Both rotating shafts (301) are fixedly provided with mounting plates (304). The limiting blocks (303) are used to control the rotation angle of the mounting plates (304) on the rotating shafts (301).

2. The tearable catheter sheath with hemostatic function according to claim 1, characterized in that: Rotating rods (3101) are rotatably mounted on both mounting plates (304), and magnetic positioning pieces (3102) are provided on both rotating rods (3101). After the two magnetic positioning pieces (3102) attract each other, a cavity is formed inside for positioning the expansion tube.

3. The tearable catheter sheath with hemostatic function according to claim 2, characterized in that: Two end caps (108) are provided in the cavity formed by the two tearable tube seats (103). A half-cut sealing plug (107) is installed between the two end caps (108). The sealing plug (107) is used to achieve sealing, control the air pressure in the cavity, and inhibit blood outflow. The outer surface of the end cap (108) is provided with a snap cap (104) by a buckle (105). Foam (106) is embedded in the center of the snap cap (104). The foam (106) is coated with medical grade silicone oil to ensure the lubrication performance when the expansion tube is inserted.

4. The tearable catheter sheath with hemostatic function according to claim 3, characterized in that: One of the tearable tube seats (103) has an extension tube connection port (102) integrally formed on it. The extension tube connection port (102) is used to suck out the air in the tearable sheath (101) to facilitate medical staff to perform interventional treatment.

5. A tearable catheter sheath with hemostatic function according to claim 3, characterized in that: The tearable sheath (101) and the limiting ring (202) are both made of injection-molded high-density polyethylene to improve their tearability. Both the tearable sheath (101) and the limiting ring (202) have tear lines with a thickness of 0.15 mm to facilitate peeling. Thirty percent barium sulfate is added to the tearable sheath (101) to make the outline of the tearable sheath (101) visible under X-ray during clinical use.

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