Catheter sheath assembly

Abstract

The invention provides a catheter sheath assembly which comprises a base, a connecting tube, a limiting tube and a sheath tube, and the base comprises a supporting tube; the supporting pipe is sleeved with the connecting pipe, and the connecting pipe is movably connected with the supporting pipe, so that the connecting pipe is fixed to the supporting pipe or can slide in the extending direction of the supporting pipe; the near end of the limiting tube is fixed to the far end of the connecting tube, and the far end of the limiting tube is configured to be used for being attached to a target object; the base, the connecting pipe and the limiting pipe are each provided with a through inner cavity in the axial direction. The near end of the sheathing canal is connected to the base and communicated with an inner cavity of the base, and the far end of the sheathing canal extends out of the far end of the limiting tube. The invention provides a catheter sheath assembly which can solve the problem that in the prior art, the effective length of a sheath tube cannot be accurately adjusted in an operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a catheter sheath assembly. Background Technology

[0002] In vascular interventional surgery, sheaths are frequently used for vascular puncture. The depth of sheath puncture varies from person to person, necessitating targeted adjustment. Current techniques typically employ snap-fit ​​or detachable designs, connecting the sheath to a fixation device using snap-fit ​​components. The length of the sheath inserted into the body is then adjusted preoperatively using these components. However, this adjustment method is generally only suitable for preoperative adjustments. Once the sheath is inserted, adjusting its length using traditional snap-fit ​​or detachable methods is difficult and prone to displacement, potentially causing vascular damage. Therefore, it is largely unsuitable for adjusting the length after the sheath has entered the blood vessel.

[0003] Furthermore, current catheter sheaths cannot accurately determine the depth of penetration during puncture, and are prone to dislodgement when withdrawing the catheter sheath during the procedure. For example, the depth of penetration of the catheter sheath currently used for percutaneous puncture cannot be determined under DSA (digital subtraction angiography). When the operator withdraws the catheter sheath, they cannot identify the relative distance between the puncture point and the tip of the sheath, which can easily lead to the catheter sheath being withdrawn from the puncture point and causing blood loss. Summary of the Invention

[0004] The purpose of this invention is to provide a catheter sheath assembly to solve the problem in the prior art that the effective length of the sheath cannot be precisely adjusted during surgery.

[0005] To address the aforementioned technical problems, this invention provides a catheter sheath assembly, comprising a base, a connecting tube, a limiting tube, and a sheath tube. The base includes a support tube. The connecting tube is sleeved on the support tube and is movably connected to the support tube, allowing the connecting tube to be fixed to the support tube or slidable along the extension direction of the support tube. The proximal end of the limiting tube is fixed to the distal end of the connecting tube, and the distal end of the limiting tube is configured to conform to a target object. The base, the connecting tube, and the limiting tube all have through cavities along the axial direction. The proximal end of the sheath tube is connected to the base and communicates with the cavity of the base, and the distal end of the sheath tube extends from the distal end of the limiting tube.

[0006] Furthermore, multiple limiting blocks are spaced apart along the axial direction on the outer wall of the support tube. The connecting tube includes a sliding part and a connecting part in sequence from the proximal end to the distal end. The wall of the sliding part is cut open along the axial direction to form an opening structure with a superior arc cross-section. The opening of the sliding part includes a first sidewall and a second sidewall opposite to each other. A fastening member matching the limiting block is connected to the first sidewall, and a gap is left between the fastening member and the second sidewall for the limiting block to move through along the axial direction. The connecting tube is rotatable relative to the support tube, so that one of the limiting blocks of the support tube cooperates with the fastening member to connect the connecting tube to the support tube, or the limiting block of the support tube is separated from the fastening member and located in the gap between the fastening member and the second sidewall, so that the connecting tube is slidable relative to the support tube.

[0007] Furthermore, the fastening element includes a first limiting member and a second limiting member spaced apart along the axial direction. One end of the first limiting member is fixed to the first sidewall, and one end of the second limiting member is fixed to the first sidewall. The other ends of both the first and second limiting members extend circumferentially along the connecting pipe, and each has a gap between itself and the second sidewall to allow the limiting block to move axially. There is a gap between the first and second limiting members that matches the limiting block. The connecting pipe is rotatable relative to the supporting pipe so that one of the limiting blocks of the supporting pipe is located between the first and second limiting members, thereby restricting the axial movement of the connecting pipe relative to the supporting pipe.

[0008] Furthermore, protrusions for preventing the limiting block from dislodging are formed on the surface of the first limiting member and / or the second limiting member.

[0009] Furthermore, a protruding handle is provided on the outer wall of the connecting part.

[0010] Furthermore, the catheter sheath assembly also includes a fixing tube, the inner wall of which is provided with internal threads; the proximal wall portion of the connecting tube has multiple through-wall grooves along its axial direction, the multiple grooves being spaced apart circumferentially along the connecting tube to divide the proximal portion of the connecting tube into multiple sheet-like segments; the outer walls of the multiple sheet-like segments are provided with external threads that match the internal threads of the fixing tube; the fixing tube is movably sleeved on the support tube, and the fixing tube is configured to be threadedly connected to or released from the proximal portion of the connecting tube to press the proximal portion of the connecting tube onto the support tube, or to release the connecting tube from the support tube.

[0011] Furthermore, the connecting pipe has a fixing hole on its wall that communicates with its inner cavity, and the inner wall of the fixing hole has a thread. The connecting pipe and the supporting pipe are movably connected by screws.

[0012] Furthermore, an asymmetrical slot is provided on the outer wall of the distal end of the connecting tube, and a locking block matching the slot is provided on the proximal end of the limiting tube. The proximal end of the limiting tube is sleeved on the distal end of the connecting tube, and the locking block engages in the slot.

[0013] Furthermore, the limiting tube includes a tube body and a limiting part. The proximal end of the tube body is fixed to the distal end of the connecting tube. The distal end of the tube body extends along an axis away from the limiting tube to form the limiting part. The end face of the limiting part is a bevel, which is inclined relative to the axis of the limiting tube. The end face of the limiting part is configured to fit the target object.

[0014] Furthermore, the tube body is made of an elastic material, and multiple grooves are formed circumferentially on the outer wall of the tube body.

[0015] Furthermore, the limiting tube is made of a radioactive material that can be detected by X-rays; the distal end of the sheath includes a radioactive ring.

[0016] Furthermore, the distal end of the sheath is bent to form a bend.

[0017] Furthermore, the sheath has multiple graduation lines arranged axially on its wall, and these graduation lines are configured to indicate the distance between the current graduation and the distal end of the sheath.

[0018] Furthermore, the base also includes a seat cover and a hemostatic valve. The seat cover has a through inner cavity, and the hemostatic valve is installed in the inner cavity of the seat cover. The seat cover is sleeved and connected to the proximal end of the support tube. The distal end of the sheath tube also passes through the seat cover and the hemostatic valve.

[0019] Furthermore, the seat cover includes an annular fixing ring and a support plate. The hemostatic valve is installed on the fixing ring, and the fixing ring is sleeved and connected to the proximal end of the support tube. One end of the support plate is connected to the outer wall of the fixing ring, and the other end of the support plate extends radially away from the fixing ring. A suture hole is provided on the support plate.

[0020] Furthermore, the catheter sheath assembly also includes a side branch tube and a three-way valve. The proximal end of the support tube is provided with a side branch interface that communicates with the inner lumen of the support tube. The proximal end of the side branch tube is connected to the side branch interface, and the three-way valve is located at the distal end of the side branch tube.

[0021] In summary, compared with the prior art, the catheter sheath assembly provided by the present invention has the following advantages:

[0022] In this design, the connecting tube is slidable relative to the supporting tube. Since the limiting tube is fixed to the connecting tube, the length of the sheath extending from the limiting tube can be adjusted by adjusting the relative position of the connecting tube and the supporting tube, thus achieving the purpose of adjusting the effective length of the sheath. Moreover, even after the sheath has been punctured into the blood vessel, the effective length of the sheath can be adjusted simply by adjusting the sliding of the connecting tube, without the need to disassemble the catheter sheath assembly for adjustment.

[0023] In addition, the limiting tube of the present invention is made of a soft, elastic material, which makes the tube body easy to deform during puncture, so as to conform to the actual puncture angle of the sheath in clinical practice, and make it easier for the end face of the limiting tube to fit the human skin. Furthermore, a groove is formed on the tube body of the limiting tube. When the end face of the limiting part is subjected to force, the tube body is squeezed. The existence of the groove can reserve space for the deformation and compression of the tube body.

[0024] When the catheter sheath assembly of this invention is used under DSA (digital subtraction angiography), the puncture site of the blood vessel can be located through the limiting tube and the sheath. Specifically, since the limiting tube is radiodetectable, and the distal end of the sheath includes a contrast ring, the length of the sheath inserted into the skin can be determined by the relative position between the contrast ring at the tip of the sheath and the limiting tube, thus identifying the puncture site. When it is necessary to withdraw the catheter sheath assembly, the limiting tube and the connecting tube can be separated first, and then the beveled end face of the limiting part of the limiting tube can be pressed against the puncture point. The other components of the catheter sheath can be slowly withdrawn. By observing the distance between the contrast ring at the tip of the limiting tube and the sheath under contrast imaging, the distance between the tip of the sheath and the puncture point can be accurately controlled, thus avoiding sheath dislodgement within the limited operating distance of the carotid artery.

[0025] In addition, the present invention has multiple graduation lines arranged axially on the wall of the sheath. The graduation line markings can be used to visually guide the surgeon to the length of the sheath entering the human body without radiation, which can prevent the sheath from dislodging. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the structure of a catheter sheath assembly according to Embodiment 1 of the present invention;

[0027] Figure 2 This is a cross-sectional schematic diagram of a catheter sheath assembly according to Embodiment 1 of the present invention;

[0028] Figure 3 This is a schematic diagram of the structure of the base cover in a catheter sheath assembly according to Embodiment 1 of the present invention;

[0029] Figure 4 This is a schematic diagram of the hemostatic valve in a catheter sheath assembly according to Embodiment 1 of the present invention;

[0030] Figure 5This is a schematic diagram of the support tube in a catheter sheath assembly according to Embodiment 1 of the present invention;

[0031] Figure 6 This is a schematic diagram of the connecting tube in a catheter sheath assembly according to Embodiment 1 of the present invention;

[0032] Figure 7 and Figure 8 This is a schematic diagram of the limiting tube in a catheter sheath assembly according to Embodiment 1 of the present invention;

[0033] Figures 9 to 14 This is a schematic diagram of the structure of a catheter sheath assembly with a groove formed on the outer wall of the limiting tube;

[0034] Figure 15 This is a schematic diagram illustrating the adjustment of the effective length of the catheter sheath assembly in Embodiment 1 of the present invention.

[0035] Figure 16 This is a schematic diagram of the structure of a catheter sheath assembly according to Embodiment 2 of the present invention;

[0036] Figure 17 This is a schematic diagram of the support tube in a catheter sheath assembly according to Embodiment 2 of the present invention;

[0037] Figures 18 to 20 This is a schematic diagram of the structure of the fixing tube in a catheter sheath assembly according to Embodiment 2 of the present invention;

[0038] Figure 21 and Figure 22 This is a schematic diagram of the connecting tube in a catheter sheath assembly according to Embodiment 2 of the present invention.

[0039] Figure 23 This is a schematic diagram illustrating the adjustment of the effective length of the catheter sheath assembly in Embodiment 2 of the present invention.

[0040] Figure 24 This is a schematic diagram of the structure of a catheter sheath assembly according to Embodiment 3 of the present invention;

[0041] Figure 25 This is a schematic diagram of the connecting tube in a catheter sheath assembly according to Embodiment 3 of the present invention;

[0042] Figure 26 This is a schematic diagram of the screw structure in a catheter sheath assembly according to Embodiment 3 of the present invention;

[0043] Figure 27 and Figure 28 This is a schematic diagram of the connection between the connecting tube and the support tube when the screw is tightened and loosened in a catheter sheath assembly according to Embodiment 2 of the present invention;

[0044] Figure 29This is a schematic diagram illustrating the adjustment of the effective length of the catheter sheath assembly in Embodiment 3 of the present invention.

[0045] The reference numerals in the attached figures are as follows:

[0046] 100-Base; 1-Seat cover; 2-Hemostatic valve; 3, 9-Support tube; 4, 11, 12-Connecting tube; 5-Limiting tube; 6-Sheath; 7-Side branch tube; 8-Three-way valve; 10-Fixing tube; 101-Fixing ring; 102-Support plate; 13-Screw; 121-Fixing hole; 31-Limiting block; 32-Side branch interface; 401-Sliding part; 402-Connecting part; 4011-First side wall; 4012-Second side wall; 41-Snap fastener; 411-First limiting part; 412-Second limiting part; 4111-Protrusion; 42-Handle; 43-Slot; 51-Limiting part; 52-Snap block; 53-Tube body; 54-Groove; 111-External thread; 112-Groove. Detailed Implementation

[0047] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a further detailed explanation of a catheter sheath assembly proposed in this invention. The advantages and features of the invention will become clearer from the following description.

[0048] It should be noted that the accompanying drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the purpose of the embodiments of the present invention. Please refer to the accompanying drawings to make the objectives, features, and advantages of the present invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only used to complement the content disclosed in the specification, for those skilled in the art to understand and read, and are not intended to limit the implementation conditions of the present invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to the size, without affecting the effects and objectives achieved by the present invention, should still fall within the scope of the technical content disclosed in the present invention.

[0049] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to 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.

[0050] In this document, 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 a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0051] In this application, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is closer to the physician during normal operation, while "distal" usually refers to the end that first enters the patient's body.

[0052] The inventors discovered in their research that during carotid artery puncture surgery, the precise control required for the effective length of the catheter insertion is far greater than that for femoral or radial artery punctures. This is mainly related to the following anatomical and procedural characteristics:

[0053] (1) High puncture point (located above the clavicle): The carotid artery puncture point is usually located above the clavicle, near the bifurcation of the carotid artery. If the sheath is inserted too deeply, it may directly enter the internal carotid artery (supplying blood flow to the brain), increasing the risk of cerebral embolism; if it is too shallow, it may dislodge or fail to stably support the catheter operation.

[0054] (2) Short carotid artery: The carotid artery is only about 6-8 cm long (with large individual differences), while the operable segments of the femoral artery and radial artery are longer (the femoral artery is about 15-20 cm and the radial artery is about 10-15 cm).

[0055] (3) Serious complications: Deviation of the sheath position during femoral / radial artery puncture usually leads to local hematoma, pseudoaneurysm, etc., most of which can be treated conservatively. However, slight deviation during carotid artery puncture may lead to carotid artery dissection (intimal stripping affects cerebral perfusion), cerebral embolism (disabling or fatal stroke), and hematoma compressing the airway (requiring emergency endotracheal intubation).

[0056] Therefore, during carotid artery puncture surgery, it is especially important to precisely adjust the effective length of the sheath to effectively protect important structures near the carotid artery puncture site and reduce the probability of complications.

[0057] Based on this, the present invention provides a catheter sheath assembly that can precisely adjust the effective length of the sheath, and can also adjust the effective length of the sheath during the operation.

[0058] Example 1

[0059] like Figure 1 and Figure 2 As shown, the present invention provides a catheter sheath assembly, including a base 100, a connecting tube 4, a limiting tube 5, and a sheath 6. The base 100 includes a support tube 3; the connecting tube 4 is sleeved on the support tube 3, and the connecting tube 4 is movably connected to the support tube 3 so that the connecting tube 4 is fixed on the support tube 3 or slidable along the extension direction of the support tube 3; the proximal end of the limiting tube 5 is fixed to the distal end of the connecting tube 4, and the distal end of the limiting tube 5 is configured to conform to a target object; the base 100, the connecting tube 4, and the limiting tube 5 all have through cavities in the axial direction; the proximal end of the sheath 6 is connected to the base 100 and communicates with the cavity of the base 100, and the distal end of the sheath 6 extends from the distal end of the limiting tube 5.

[0060] In this design, the connecting tube 4 is slidable relative to the supporting tube 3. Since the limiting tube 5 is fixed to the connecting tube 4, the length of the sheath 6 extending from the limiting tube 5 can be adjusted by adjusting the relative position of the connecting tube 4 and the supporting tube 3, thus achieving the purpose of adjusting the effective length of the sheath 6 (the length of the sheath extending from the limiting tube 4). Moreover, even after the sheath 6 has been punctured into the blood vessel, the effective length of the sheath 6 can be adjusted simply by adjusting the sliding of the connecting tube 4, without the need to disassemble the catheter sheath assembly for adjustment.

[0061] As one implementation of the present invention, such as Figure 5 and Figure 6 As shown, multiple limiting blocks 31 are spaced apart along the axial direction on the outer wall of the support tube 3. The connecting tube 4 includes a sliding part 401 and a connecting part 402 sequentially from the proximal end to the distal end. The tube wall of the sliding part 401 is axially cut to form an opening structure with a superior arc cross-section. The opening of the sliding part 401 includes opposing first sidewalls 4011 and second sidewalls 4012. The first sidewall 4011 and the second sidewall 4012 are elongated strip surfaces extending along the axial direction of the sliding part 401, and their width is the same as the tube wall thickness of the sliding part 401. The first sidewall 4011 has... A fastener 41 is connected to the limiting block 31, and a gap is left between the fastener 41 and the second side wall 4012 for the limiting block 31 to move axially through. The connecting pipe 4 is rotatable relative to the supporting pipe 3, so that one of the limiting blocks 31 of the supporting pipe 3 cooperates with the fastener 41 to connect the connecting pipe 4 to the supporting pipe 3, or so that the limiting block 31 of the supporting pipe 3 is separated from the fastener 41, so that the limiting block 31 is located in the gap between the fastener 31 and the second side wall 4012, and the connecting pipe 4 is slidable relative to the supporting pipe 3.

[0062] The connection or free sliding between the connecting pipe 4 and the support pipe 3 is achieved by setting the limiting block 31 and the fastener 41. Specifically, as follows: Figure 15 As shown, by rotating the connecting tube 4 to a suitable position, all the limiting blocks 31 on the outer wall of the support tube 3 can freely pass through the gap between the fastener 41 and the second side wall 4012. This allows the connecting tube 4 to slide freely on the support tube 3, thereby adjusting the effective length of the sheath 6 as needed. Once the effective length of the sheath 6 is adjusted to the correct position, rotating the connecting tube 4 again causes a corresponding limiting block 31 on the outer wall of the support tube 3 to engage and fix with the fastener 41. This restricts the sliding of the connecting tube 4 on the support tube 3, achieving the purpose of fixing the effective length of the sheath 6. Through the above-described method, the effective length of the sheath 6 can be effectively adjusted. Even after the sheath 6 has been punctured into the blood vessel, when further adjustment of its effective length is needed, the position of the base 100 can remain unchanged, and adjustment can be made solely by rotating the connecting tube 4. This avoids rotation of the distal end of the sheath 6 within the blood vessel, preventing damage to the inner wall of the blood vessel.

[0063] In the above scheme, the structure of the fastener 41 may include a first limiting member 411 and a second limiting member 412 distributed axially at intervals. One end of the first limiting member 411 is fixed to the first side wall 4011, and one end of the second limiting member 412 is fixed to the first side wall 4011. The other ends of the first limiting member 411 and the second limiting member 412 extend circumferentially along the connecting pipe 4, and a gap is left between them and the second side wall 4012 for the limiting block 31 to move axially. There is a gap between the first limiting member 411 and the second limiting member 412 that matches the limiting block 31. The connecting pipe 4 is rotatable relative to the supporting pipe 3, so that one of the limiting blocks 31 of the supporting pipe 3 is located in the gap between the first limiting member 411 and the second limiting member 412, thereby restricting the axial movement of the connecting pipe 4 relative to the supporting pipe 3. Preferably, a protrusion 4111 for preventing the limiting block from dislodging can also be formed on the surface of the first limiting member 411 and / or the second limiting member 412. For example, the protrusion 4111 can be provided on the surface opposite to the first limiting member 411 and the second limiting member 412. The protrusion 4111 can be an elastic structure. When the connecting tube 4 is rotated, the limiting block 31 can squeeze the protrusion 4111 into the gap between the first limiting member 411 and the second limiting member 412. After being assembled in place, the protrusion 4111 restores its deformation and becomes a barrier to prevent the limiting block 31 from accidentally dislodging. When the limiting block 31 needs to be dislodged, the connecting tube 4 can be rotated in the opposite direction with a little force to continue squeezing the protrusion 4111, so that the limiting block 31 can be dislodged from the gap without affecting the sliding of the connecting tube 4. When the connecting tube 4 is rotated so that the limiting block 31 enters the space between the upper and lower limiting members, the connecting tube 4 can no longer slide on the support tube 3 due to the obstruction of the upper and lower limiting members. However, when the connecting tube 4 is rotated in the opposite direction so that the limiting block 31 is dislodged from the space between the two limiting members, the limiting block 31 can freely pass through the gap between the limiting member and the second side wall 4012, and the connecting tube 4 can slide freely relative to the support tube 3, adjusting the effective length of the sheath 6. To facilitate the application of force to rotate the connecting tube 4, a protruding handle 42 can be provided on the outer wall of the connecting part 402. The handle 42 can serve as a force application point for the operator to grip and rotate the connecting tube 4. More preferably, there can be two handles 42, symmetrically distributed on the outer wall of the connecting part 402.

[0064] Furthermore, an asymmetrical groove 43 may be provided on the distal outer wall of the connecting pipe 4, and a locking block 52 matching the groove 43 may be provided on the proximal end of the limiting pipe 5, such as... Figure 8As shown, the proximal end of the limiting tube 5 is fitted onto the distal end of the connecting tube 4, and the locking block 52 engages with the locking groove 43. This invention does not limit the connection method between the proximal end of the limiting tube 5 and the distal end of the connecting tube 4; it can be a snap-fit ​​connection, a threaded connection, an adhesive connection, or other fixing methods. Since the limiting tube 5 is used to conform to the human skin and abut against the puncture point, and the distal end face of the limiting tube 5 is generally not a regular symmetrical structure, if the limiting tube 5 is not properly installed on the connecting tube 4, it may not effectively abut against the puncture point. Therefore, this solution uses an asymmetrical locking groove 43 and a matching locking block 52 to achieve a foolproof assembly design, fixing the assembly angle between the limiting tube 5 and the connecting tube 4. Only after they are properly engaged can they achieve a fixed connection. This limits the direction of the distal end face of the limiting tube 5, ensuring that the beveled end face of the limiting tube 5 abuts against the puncture point.

[0065] Preferred, such as Figure 7 and Figure 8 As shown, the limiting tube 5 includes a tube body 53 and a limiting part 51. The proximal end of the tube body 53 is fixed to the distal end of the connecting tube 4. The distal end of the tube body 53 extends along an axis away from the limiting tube 5 to form the limiting part 51. The end face of the limiting part 51 is inclined and is set at an angle relative to the axis of the limiting tube 5. The end face of the limiting part 51 is configured to conform to the target object. After the area of ​​the limiting part 51 is extended and enlarged, the end face can effectively abut against the puncture point. On the other hand, its inclined design can indicate the puncture angle of the sheath 6.

[0066] Preferred, such as Figure 9 As shown, the tube body 53 is made of an elastic material, and multiple grooves 54 are formed circumferentially on the outer wall of the tube body 53. These grooves 54 may or may not penetrate the tube body 53. The tube body 53 is made of a soft, elastic material, making it easily deformable during puncture, conforming to the actual puncture angle of the sheath in clinical practice, and facilitating the fit of the limiting part 51 to the human skin. Furthermore, the grooves 54 on the tube body 53 allow for deformation and compression of the tube body when the end face of the limiting part 51 is subjected to force. The shape of the grooves 54 is not limited in this invention. Figures 9 to 14 As shown, the grooves can be rectangular grooves arranged in a linear array, triangular grooves arranged in a linear array, or rectangular grooves arranged in a spiral, etc.

[0067] Furthermore, the limiting tube 5 is made of a radiopaque material, meaning it is radiopaque. Correspondingly, the distal end of the sheath 6 includes a radiopaque ring. Under DSA (digital subtraction angiography), the puncture site of the blood vessel can be located using the limiting tube 5. Specifically, because the limiting tube 5 is radiopaque and the distal end of the sheath 6 includes a radiopaque ring, the length of the sheath 6 inserted into the skin can be determined by the relative position between the radiopaque ring at the tip of the sheath 6 and the limiting tube 5, thus identifying the puncture site. When it is necessary to withdraw the catheter sheath assembly, the limiting tube 5 can be separated from the connecting tube 4 first. Then, the beveled end face of the limiting portion 51 of the limiting tube 5 is pressed against the puncture point, and the other components of the catheter sheath are slowly withdrawn. By observing the distance between the radiopaque ring at the tip of the limiting tube 5 and the sheath 6 under contrast imaging, the distance between the tip of the sheath 6 and the puncture point can be accurately controlled, thus preventing the sheath 6 from dislodging within the limited carotid artery manipulation distance.

[0068] Preferably, the radiation detectability of the limiting tube 5 can be achieved by the following operations: for example, during the injection molding process of the limiting tube 5, a developer (such as barium sulfate, bismuth compounds, tungsten powder, zirconium dioxide, etc.) can be added to the injection molded part to form a limiting tube 5 with radiation detectability. Of course, radiation detectability can also be achieved by coating the surface of the limiting tube 5 with developing ink or developing coating. A developing metal (platinum-iridium, platinum-tungsten, etc.) sheet / wire can also be embedded at the distal end of the limiting tube 5.

[0069] Furthermore, the sheath 6 of the present invention, used as a channel for other interventional devices to enter the blood vessel, can be composed of an inner layer, a middle layer (reinforcing layer), and an outer layer, with a radiopaque marker, such as a contrast ring, at its distal end. The distal end of the sheath 6 can be bent to form a bend, for example, the distal end of the sheath 6 has a pre-shaped tip at an angle of 5-45° to the main body, preferably 15°. This bend can conform to the angle between the sheath 6 and the carotid artery, avoiding damage to the inner wall of the blood vessel during puncture, making it easier for the sheath 6 to enter the blood vessel, and can also cooperate with the beveled end face of the limiting part 51 of the limiting tube 5 to achieve monitoring of the puncture angle.

[0070] Furthermore, multiple graduation lines can be provided axially on the wall of the sheath 6, and these graduation lines are configured to indicate the distance between the current graduation and the distal end of the sheath. These graduation lines can be used for radiation-free visual cues to the surgeon indicating the length of the sheath 6 inserted into the body, thus preventing the sheath 6 from dislodging.

[0071] Furthermore, such as Figure 2 , Figure 3 and Figure 4As shown, the base 100 of the present invention further includes a cover 1 and a hemostatic valve 2. The cover 1 has a through inner cavity, and the hemostatic valve 2 is installed in the inner cavity of the cover 1. The cover 2 is sleeved and connected to the proximal end of the support tube 3. The distal end of the sheath 6 also passes through the cover 1 and the hemostatic valve 2. The main function of the cover 1 is to fix the hemostatic valve 2 and the support tube 3. The hemostatic valve 2 can effectively prevent blood backflow and air intake, ensuring the sealing and safety during the operation.

[0072] The connection between the sheath 6 and the base 100 can be varied. For example, the proximal end of the sheath 6 can be connected to the cover 1 of the base 100, and the inner cavities of the two can be connected. The distal end of the sheath 6 can pass through the inner cavities of the support tube 3, the connecting tube 4, and the limiting tube 5, and extend out of the limiting tube 5. Alternatively, the outer wall of the sheath 6 can be connected and fixed to the inner wall of the support tube 3, and the distal end of the sheath 6 can pass through the inner cavities of the support tube 3, the connecting tube 4, and the limiting tube 5, and extend out of the limiting tube 5. For example, the prepared sheath 6 can be placed in the mold for preparing the support tube 3, and the support tube 3 can be formed by a rubber-coating injection molding process. In this case, the sheath 6 and the support tube 3 can be integrally formed so that the outer wall of the sheath 6 and the inner wall of the support tube 3 are tightly fitted and connected.

[0073] Preferably, the cover 1 includes an annular fixing ring 101 and a support plate 102. The hemostatic valve 2 is mounted on the fixing ring 101, which is sleeved onto the proximal end of the support tube 3. One end of the support plate 102 is connected to the outer wall of the fixing ring 101, and the other end of the support plate 102 extends radially away from the fixing ring 101. A suture hole is provided on the support plate 102. Sutures can pass through the suture hole to fix the sheath assembly to the skin, preventing unexpected displacement or dislodgement of the sheath 6 during surgery.

[0074] Furthermore, such as Figure 1 As shown, the sheath assembly of the present invention further includes a side branch tube 7 and a three-way valve 8. A side branch interface 32 communicating with the inner cavity of the support tube 3 is provided at the proximal end of the support tube 3. The proximal end of the side branch tube 3 is connected to the side branch interface 32. The three-way valve 8 is located at the distal end of the side branch tube 7. Physiological saline or heparinized saline can be injected into the sheath assembly through the side branch tube 7 for flushing, irrigation, air venting, or drainage. The three-way valve 8 allows for selective switching or parallel operation of the fluid pathway while maintaining a closed system.

[0075] Example 2

[0076] In this embodiment 2, the connection method between the connecting pipe and the support pipe has been changed. The remaining structural components are basically the same as in embodiment 1, and will not be described again here.

[0077] In addition to using the buckle and limit block method mentioned in Embodiment 1 to achieve segmented adjustment of the effective length of the sheath tube 6, Embodiment 2 of the present invention also provides another implementation scheme for continuously adjusting the effective length of the sheath tube 6.

[0078] Specifically, such as Figures 16 to 23 As shown, the catheter sheath assembly in this embodiment also includes a fixing tube 10, the inner wall of which is provided with internal threads; in this embodiment 2, the proximal wall portion of the connecting tube 11 has multiple through-wall grooves 112 along its axial direction, the multiple grooves 112 are distributed at intervals along the circumference of the connecting tube to divide the proximal portion of the connecting tube 11 into multiple sheet-like segments, for example, cross-shaped grooves, to evenly divide the connecting tube 11 into 4 segments; the outer walls of the multiple sheet-like segments are provided with external threads 111 that match the internal threads of the fixing tube 10; the fixing tube 10 is movably sleeved on the support tube 9, and the fixing tube 10 is configured to be threadedly connected to or loosened with the proximal portion of the connecting tube 11 to press the proximal portion of the connecting tube 11 onto the support tube 9, or to loosen the connecting tube 11 from the support tube 9. Specifically, when the fixing tube 10 and the connecting tube 11 are threaded together, multiple sheet-like segments near the proximal end of the connecting tube 11 are compressed and brought together in the axial direction, thus pressing them against the support tube 9 and fixing the connecting tube 11 to the support tube 9. When the fixing tube 10 and the connecting tube 11 are loosened, the connecting tube 11 can slide freely relative to the support tube 9, thereby adjusting the effective length of the sheath tube 6.

[0079] Preferably, the fixing tube 10 is a tapered tube with a small port at the proximal end and a large port at the distal end. Correspondingly, the proximal part of the connecting tube 11 is also tapered. The tapered tube design allows the clamping force between the connecting tube 11 and the supporting tube 9 to become stronger during the thread tightening process of the fixing tube 10, making the connection between the two tighter and preventing the effective length of the sheath tube 6 from changing, which would cause the sheath tube 6 to come out.

[0080] Example 3

[0081] In this embodiment 3, the connection method between the connecting pipe and the support pipe is changed in another way, while the other structural components are basically the same as in embodiment 1.

[0082] In embodiment 3 of the present invention, as Figures 24 to 29 As shown, the connecting pipe 12 has a fixing hole 121 on its wall that communicates with its inner cavity. The inner wall of the fixing hole 121 has a thread. The connecting pipe 12 and the support pipe 9 are movably connected by a screw 13.

[0083] Specifically, when screw 13 is tightened in fixing hole 121, the end of screw 13 passes through fixing hole 121, contacts and presses against support tube 9. At this time, connecting tube 12 cannot slide along support tube 9, thus fixing connecting tube 12 to support tube 9. When screw 13 is loosened radially outward along support tube 9, the end of screw 13 does not contact support tube 9. At this time, connecting tube 12 can slide freely relative to support tube 9, thereby adjusting the effective length of sheath tube 6.

[0084] In summary, compared with the prior art, the catheter sheath assembly provided by the present invention has the following advantages:

[0085] In this design, the connecting tube is slidable relative to the supporting tube. Since the limiting tube is fixed to the connecting tube, the length of the sheath extending from the limiting tube can be adjusted by adjusting the relative position of the connecting tube and the supporting tube, thus achieving the purpose of adjusting the effective length of the sheath. Moreover, even after the sheath has been punctured into the blood vessel, the effective length of the sheath can be adjusted simply by adjusting the sliding of the connecting tube, without the need to disassemble the catheter sheath assembly for adjustment.

[0086] In addition, the limiting tube of the present invention is made of a soft, elastic material, which makes the tube body easy to deform during puncture, so as to conform to the actual puncture angle of the sheath in clinical practice, and make it easier for the end face of the limiting tube to fit the human skin. Furthermore, a groove is formed on the tube body of the limiting tube. When the end face of the limiting part is subjected to force, the tube body is squeezed. The existence of the groove can reserve space for the deformation and compression of the tube body.

[0087] When the catheter sheath assembly of this invention is used under DSA (digital subtraction angiography), the puncture site of the blood vessel can be located through the limiting tube and the sheath. Specifically, since the limiting tube is radiodetectable, and the distal end of the sheath includes a contrast ring, the length of the sheath inserted into the skin can be determined by the relative position between the contrast ring at the tip of the sheath and the limiting tube, thus identifying the puncture site. When it is necessary to withdraw the catheter sheath assembly, the limiting tube and the connecting tube can be separated first, and then the beveled end face of the limiting part of the limiting tube can be pressed against the puncture point. The other components of the catheter sheath can be slowly withdrawn. By observing the distance between the contrast ring at the tip of the limiting tube and the sheath under contrast imaging, the distance between the tip of the sheath and the puncture point can be accurately controlled, thus avoiding sheath dislodgement within the limited operating distance of the carotid artery.

[0088] In addition, the present invention has multiple graduation lines arranged axially on the wall of the sheath. The graduation line markings can be used to visually guide the surgeon to the length of the sheath entering the human body without radiation, which can prevent the sheath from dislodging.

[0089] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the scope of the claims. Obviously, those skilled in the art can make various modifications and variations to the invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations of the invention fall within the scope of the claims and their equivalents, the invention also intends to include these modifications and variations.

Claims

1. A catheter sheath assembly, characterized in that, Includes a base, connecting tube, limiting tube, and sheath. The base includes a support tube; The connecting tube is sleeved on the supporting tube, and the connecting tube and the supporting tube are movably connected so that the connecting tube is fixed on the supporting tube or can slide along the extension direction of the supporting tube. The proximal end of the limiting tube is fixed to the distal end of the connecting tube, and the distal end of the limiting tube is configured to conform to the target object. The base, the connecting pipe, and the limiting pipe all have through cavities along the axial direction. The proximal end of the sheath is connected to the base and communicates with the inner cavity of the base, while the distal end of the sheath extends from the distal end of the limiting tube.

2. The catheter sheath assembly according to claim 1, characterized in that, Multiple limiting blocks are spaced apart along the axial direction on the outer wall of the support tube. The connecting tube includes a sliding part and a connecting part in sequence from the proximal end to the distal end; The wall of the sliding part is cut open along the axial direction to form an opening structure with a superior arc cross-section. The opening of the sliding part includes opposing first and second sidewalls; A buckle matching the limiting block is connected to the first sidewall, and a gap is left between the buckle and the second sidewall for the limiting block to move through axially. The connecting pipe is rotatable relative to the supporting pipe, so that one of the limiting blocks of the supporting pipe cooperates with the fastener to connect the connecting pipe and the supporting pipe, or so that the limiting block of the supporting pipe is separated from the fastener and located in the gap between the fastener and the second side wall, so that the connecting pipe is slidable relative to the supporting pipe.

3. A catheter sheath assembly according to claim 2, characterized in that, The fastener includes a first limiting member and a second limiting member distributed axially at intervals. One end of the first limiting member is fixed to the first side wall, and one end of the second limiting member is fixed to the first side wall. The other ends of the first limiting member and the second limiting member extend circumferentially along the connecting pipe, and a gap is left between them and the second side wall for the limiting block to move through axially. There is a gap between the first limiting member and the second limiting member that matches the limiting block. The connecting pipe is rotatable relative to the supporting pipe, such that one of the limiting blocks of the supporting pipe is located between the first limiting member and the second limiting member, thereby restricting the axial movement of the connecting pipe relative to the supporting pipe.

4. A catheter sheath assembly according to claim 3, characterized in that, The first limiting member and / or the second limiting member have protrusions formed on their surfaces to prevent the limiting block from dislodging.

5. A catheter sheath assembly according to claim 2, characterized in that, A protruding handle is also provided on the outer wall of the connecting part.

6. A catheter sheath assembly according to claim 1, characterized in that, It also includes a fixing tube, the inner wall of which is provided with internal threads; The proximal end of the connecting tube has multiple through-wall grooves along its axial direction. These grooves are spaced apart circumferentially along the connecting tube to divide the proximal end of the connecting tube into multiple sheet-like segments. The outer walls of the plurality of the sheet-like tubes are provided with external threads that match the internal threads of the fixed tube; The fixing tube is movably sleeved on the support tube. The fixing tube is configured to be threadedly connected to or detached from the proximal portion of the connecting tube, so as to press the proximal portion of the connecting tube onto the support tube, or to detach the connecting tube from the support tube.

7. A catheter sheath assembly according to claim 1, characterized in that, The connecting pipe has a fixing hole on its inner wall that communicates with its inner cavity. The inner wall of the fixing hole has a thread. The connecting pipe and the supporting pipe are movably connected by screws.

8. A catheter sheath assembly according to claim 1, characterized in that, The distal outer wall of the connecting tube is provided with an asymmetrical slot, and the proximal end of the limiting tube is provided with a locking block that matches the slot. The proximal end of the limiting tube is sleeved on the distal end of the connecting tube, and the locking block is engaged in the slot.

9. A catheter sheath assembly according to claim 1, characterized in that, The limiting tube includes a tube body and a limiting part. The proximal end of the tube body is fixed to the distal end of the connecting tube. The distal end of the tube body extends along an axis away from the limiting tube to form the limiting part. The end face of the limiting part is a bevel, which is inclined relative to the axis of the limiting tube. The end face of the limiting part is configured to fit the target object.

10. A catheter sheath assembly according to claim 9, characterized in that, The tube body is made of elastic material, and multiple grooves are formed on the outer wall of the tube body along the circumference.

11. A catheter sheath assembly according to claim 1, characterized in that, The limiting tube is made of a radioactive material that can be detected by radiation; the distal end of the sheath includes a radioactive ring.

12. A catheter sheath assembly according to claim 1, characterized in that, The distal end of the sheath is bent to form a bend, and the angle between the bend and the main body of the sheath is 5-45°.

13. A catheter sheath assembly according to claim 1, characterized in that, The sheath has multiple graduation lines arranged axially on its wall, and these graduation lines are configured to indicate the distance between the current graduation and the distal end of the sheath.

14. A catheter sheath assembly according to claim 1, characterized in that, The base also includes a seat cover and a hemostatic valve. The seat cover has a through inner cavity, and the hemostatic valve is installed in the inner cavity of the seat cover; the seat cover is sleeved and connected to the proximal end of the support tube; The distal end of the sheath also passes through the seat cap and the hemostatic valve.

15. A catheter sheath assembly according to claim 1, characterized in that, The seat cover includes an annular retaining ring and a support plate. The hemostatic valve is installed on the fixing ring, and the fixing ring is sleeved and connected to the proximal end of the support tube; One end of the support plate is connected to the outer wall of the fixing ring, and the other end of the support plate extends radially away from the fixing ring. The support plate has stitching holes.

16. A catheter sheath assembly according to claim 1, characterized in that, It also includes a side branch pipe and a three-way valve. The proximal end of the support pipe is provided with a side branch interface that communicates with the inner cavity of the support pipe. The proximal end of the side branch pipe is connected to the side branch interface. The three-way valve is located at the distal end of the side branch pipe.

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