An expandable functional sheath

Abstract

The utility model provides an expandable functional sheath tube, comprising a body, one end of which is connected to a functional sheath tube, and a flexible outer membrane layer, in which a support is arranged, and the two together constitute the functional sheath tube, and the flexible outer membrane layer is stretched by external force, so that the functional sheath tube expands under the external force and is in the most contracted state without external force. The expandable functional sheath tube, by providing an elastic silicone membrane as the flexible outer membrane layer, makes the functional sheath tube have the smallest diameter in the natural state without external force interference, and is in a contracted state spontaneously, and expands again when an instrument needs to be inserted for expansion, so as to ensure that the functional sheath tube maintains the contracted state for the longest time and the blood vessel expansion time is the shortest.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an expandable functional sheath tube. Background Art

[0002] At present, cardiovascular disease treatment technologies include drug therapy, surgical operations and interventional therapy. Among them, cardiovascular interventional therapy is widely used in clinical practice due to its advantages of less trauma, high safety and good therapeutic effect. Cardiovascular interventional therapy is a technology that uses vascular puncture to enter the heart cavity or blood vessels for diagnosis or treatment.

[0003] Functional sheaths are used to establish vascular access during cardiovascular interventional surgery to facilitate the introduction of interventional treatment / diagnostic devices into the patient's blood vessels.

[0004] Most of the existing functional sheaths are non-expandable and have a large diameter, which can easily cause vascular damage during insertion / removal and is not conducive to vascular suturing. In addition, the functional sheath is the first device to be inserted into the blood vessel and the last to be withdrawn. It stays in the blood vessel for a long time. If the blood vessel is expanded with a large diameter for a long time, it is easy to cause vascular spasm and increase the chance of surgical complications.

[0005] The Chinese patent with publication number CN220385602U discloses an expandable sheath, including a functional sheath and an auxiliary sheath. Among them, the wall of the functional sheath includes a support portion and a folding portion, and the support portion and the folding portion are alternately arranged to form the wall of the functional sheath together. Because the folding portion of the functional sheath has the characteristic of being foldable, the diameter of the functional sheath can be changed, that is, the functional sheath can be operated in a compressed state or an expanded state. In this regard, this patent also introduces an auxiliary sheath. By sleeve-mounting the auxiliary sheath on the outside of the functional sheath, the functional sheath can be in a compressed state for a long time. In this way, the functional sheath can enter and exit the blood vessel with a smaller diameter, reducing damage to the blood vessel and the patient's discomfort. Relatively speaking, when the auxiliary sheath is no longer sleeved on the outside of the functional sheath, the diameter of the functional sheath will return to the diameter in the natural state, that is, it will be in an expanded state to allow instruments with larger diameters to pass through.

[0006] The specification of the expandable sheath disclosed above states in paragraph

[0075] that “If the auxiliary sheath is to be removed, the connection between the first docking portion and the hemostatic valve must be released first, and then the auxiliary sheath is pulled out from the proximal end of the functional sheath. After the auxiliary sheath is removed, the first docking portion and the hemostatic valve are fixedly connected again. Conversely, if the auxiliary sheath is to be re-sheathed on the outside of the functional sheath, the connection between the first docking portion and the hemostatic valve must be released again, and after the auxiliary sheath is re-sheathed on the functional sheath, the first docking portion and the hemostatic valve are fixedly connected again.”

[0007] The above disclosed expandable functional sheath tube, as shown in the attached Figure 1 and Figure 2As shown, the expandable functional sheath tube is provided with an auxiliary sheath tube outside the functional sheath tube, and the folded portion is compressed to make the functional sheath tube in a compressed state, thereby changing the tube diameter. However, the above device has the following problems:

[0008] First, during use, the disassembly and assembly of the auxiliary sheath increases the operation process and time. Especially in the process of inserting the auxiliary sheath into the blood vessel, the operation is inconvenient and it is easy to cause air to enter and form embolism, increasing the risk of damaging the patient's blood vessels.

[0009] Second, after the auxiliary sheath is released, the folded portion of the functional sheath is always in an expanded state. At this time, the expanded state of the functional sheath cannot adjust its own expanded size as the external dimensions of the interventional treatment / diagnostic device change. The coordination between the functional sheath and various interventional treatment / diagnostic devices needs to be further improved.

[0010] Thirdly, the functional sheath has the function of changing the tube diameter through the staggered design of the telescopic part and the folding part. When the functional sheath is used, if it is subjected to the pressure of the blood vessel wall, the folding part collapses, which is easy to form an angular shape, causing embolism and increasing the risk of damaging the patient's blood vessels. Therefore, an expandable functional sheath is proposed to solve the above problems. Utility Model Content

[0011] In view of the deficiencies of the prior art, the utility model provides an expandable functional sheath tube, which has the advantages of automatically adjusting its own expansion state as the outer diameter of the interventional treatment / diagnosis instrument changes, and is easy to use.

[0012] To achieve the above-mentioned purpose, the utility model provides the following technical solutions: an expandable functional sheath, comprising a functional sheath, comprising a flexible outer membrane layer, a support member fixed on the inner side of the flexible outer membrane layer, a plurality of support members arranged at intervals around the circumference, and the plurality of support members and the flexible outer membrane layer together constitute the functional sheath.

[0013] Furthermore, the support member is a plastic member, which is a sheet-like strip with an arc-shaped cross section. In a natural state, the sides of multiple plastic members are close to each other to form the inner wall of the functional sheath.

[0014] Furthermore, the support member is a support steel wire, and a plurality of support steel wires evenly distributed around the circumference are arranged in the flexible outer membrane layer.

[0015] Furthermore, the number of the supporting steel wires is twenty-four.

[0016] Furthermore, the flexible outer membrane layer has an inner and outer double-layer structure, and the supporting steel wire is arranged between the inner and outer double-layer flexible outer membrane layers.

[0017] Furthermore, the cross section of the supporting steel wire is flat.

[0018] Furthermore, the flexible outer film layer is a silicone film or a PE film.

[0019] Compared with the prior art, the technical solution of this application has the following beneficial effects:

[0020] 1. The expandable functional sheath is provided with an elastic silicone membrane as a flexible outer membrane layer, so that when the device is in a natural state without external interference, the diameter of the functional sheath is the smallest and it is spontaneously in a contracted state. When it is necessary to insert an instrument for expansion, it will expand again, ensuring that the functional sheath maintains a contracted state for the longest time and the blood vessel expansion time is the shortest.

[0021] 2. The expandable functional sheath has a supporting steel wire arranged on the inner side of the tube wall, which can prevent the tube wall from collapsing to form sharp edges and scratching the blood vessels when the sheath is withdrawn, and can also prevent the flexible outer membrane layer from axially flipping and folding due to pressure when the sheath is withdrawn and scratching the blood vessels. When the device is used to intervene in the blood vessel, the device can be directly inserted, and the operation is simple and safe. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a reference diagram of the external structure of the prior art;

[0023] Figure 2 Reference diagram of the internal structure of the prior art

[0024] Figure 3 This is a schematic diagram of the external structure of the utility model;

[0025] Figure 4 for Figure 3 Enlarged view of point A in the middle;

[0026] Figure 5 This is an exploded view of the utility model;

[0027] Figure 6 It is a structural cross-sectional view of the first embodiment of the functional sheath tube;

[0028] Figure 7 is a cross-sectional view of the functional sheath in the expanded state in the first implementation;

[0029] Figure 8 It is a stereoscopic diagram of the functional sheath in the expanded state in the first implementation;

[0030] Fig. 9 is a structural cross-sectional view of a second embodiment of a functional sheath tube;

[0031] Fig.10 A three-dimensional diagram of a functional sheath in the second embodiment;

[0032] Fig.11 This is a reference diagram of the state of withdrawing the functional sheath tube in the second embodiment;

[0033] Fig.12 A three-dimensional diagram of a functional sheath tube in the second embodiment;

[0034] Fig.13 This is a cross-sectional view of a functional sheath tube of the third embodiment;

[0035] Fig.14 This is a reference diagram of the state when the functional sheath is withdrawn in the third embodiment.

[0036] In the figure: 1. puncture member; 11. gripper; 12. puncture sheath; 13. support wire; 2. body; 21. hemostatic valve; 22. first docking part; 23. second docking part; 3. functional sheath; 31. plastic part; 32. flexible outer membrane layer; 33. thick end; 4. injection assembly. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0038] See also Figure 3-14 The expandable functional sheath in the present application comprises a functional sheath 3 and a hemostatic valve 21. The proximal end of the functional sheath 3 is provided with a first docking portion 22 for docking with the hemostatic valve 21. The first docking portion 22 is sleeved on the second docking portion 23 on the hemostatic valve 21. The first docking portion 22 and the second docking portion 23 are sealed with glue or hot-pressed to complete the sleeve connection.

[0039] The hemostatic valve 21 adopts the existing technology, because the hemostatic flap on the hemostatic valve 21 is a one-way opening structure and is made of flexible material.

[0040] It can be understood that because the first docking portion 22 is used to dock with the hemostatic valve 21, when the functional sheath 3 is in a contracted state, the first docking portion 22 still maintains the tubular structure in the expanded state; and because the proximal end of the functional sheath 3 is connected to the second docking portion 23, the proximal end of the functional sheath 3 will be in a structural shape in the expanded state under the action of the second docking portion 23.

[0041] Specifically, the second docking portion 23 is a plastic or ceramic joint, and the first docking portion 22 of the functional sheath 3 is made of a flexible material, so as to be elastically and tightly sleeved on the second docking portion 23 .

[0042] The device further comprises a puncture member 1 and a puncture sheath 12 which penetrates the functional sheath tube 3. The puncture member 1 is movably inserted into the puncture sheath 12. The puncture member 1 is hollow to allow for instrument intervention.

[0043] The device is provided with an expansion sheath 3 that is in the most contracted state in its natural state, so that the device will expand only when an instrument is needed to be inserted for expansion, thereby ensuring that the expansion sheath 3 maintains the contracted state for the longest time and the blood vessel is dilated for the shortest time, thereby maximizing the protection of the blood vessel;

[0044] Specifically, during clinical use, the functional sheath 3 is in a released state to form a passage. At this time, the puncture sheath 12 is inserted into the functional sheath 3 through the hemostatic valve 21, and the puncture sheath 12 will push open the leaflets of the hemostatic valve on the hemostatic valve 21 to form a vascular passage. The puncture member 1 can enter and exit the patient's body through the passage formed by the hemostatic valve 21, the vascular passage and the functional sheath 3. After the operation, it is removed from the patient's body together with the puncture sheath 12, and the hemostatic valve on the hemostatic valve 21 prevents blood from flowing out. The device, by providing the puncture sheath 12, not only plays the role of preliminarily expanding the functional sheath 3, but also can open the hemostatic valve in the functional sheath 3, which is convenient for the instrument to enter and exit. At the same time, the expansion and contraction of the functional sheath can be completed by plugging and unplugging the puncture sheath 12, which simplifies the operation steps and achieves the purpose of convenient use, safety and efficiency of the device.

[0045] The innovative technical content of the present application is to improve the functional sheath tube so as to achieve the purpose of enabling the functional sheath tube 3 to automatically adjust its own expansion state as the outer diameter of the interventional treatment / diagnosis device changes.

[0046] In the present application, the functional sheath tube 3 includes a flexible outer membrane layer 32 and a support member, which together constitute the functional sheath tube 3 .

[0047] The support member is in the shape of a long strip, and a plurality of support members are distributed in the circumferential direction. The support member has sufficient anti-bending ability, and the function of the support member is to be inserted into the blood vessel together with the functional sheath tube 3.

[0048] The flexible outer membrane layer 32 is made of a flexible material and has a certain expansion and deformation capability. The flexible outer membrane layer 32 is used to hold a plurality of support members and deform and expand after the support members are compressed to adapt to the change in the outer diameter of the puncture sheath 12 inserted into the functional sheath 3.

[0049] In the present application, the diameter expansion range of the flexible outer membrane layer 32 is within 0.5 mm. When the outer diameter of the puncture sheath 12 is smaller than the minimum inner diameter of the functional sheath tube 3, the functional sheath tube 3 does not need to be deformed; when the outer diameter of the puncture sheath 12 is larger than the minimum inner diameter of the functional sheath tube 3, the puncture sheath 12 expands the inner diameter of the functional sheath tube 3 outward, and the functional sheath tube 3 is deformed to a state of adaptation with the puncture sheath 12.

[0050] In the present application, the wall thickness of the flexible outer membrane layer 32 is 0.1-0.2 mm. The small thickness can reduce the pressure effect of the insertion of the puncture sheath 12 on the inner wall of the blood vessel.

[0051] Preferably, the flexible outer film layer 32 is a silicone film. The flexible outer film layer 32 is expanded and stretched by external force, so that the multiple support members are radially separated from each other under the external force, and the multiple support members are in a closed state with the center close to each other under the action of the flexible outer film layer 32 itself to recover the deformation force inward without external force.

[0052] The flexible outer membrane layer 32 is stretched by the external force, so that the functional sheath tube 3 expands under the external force and is in the most contracted state without the external force.

[0053] The device is configured to have a functional sheath 3 that is in the most contracted state in its natural state, so that the device will expand only when an instrument needs to be inserted for expansion, thereby ensuring that the functional sheath 3 maintains the contracted state for the longest time and the blood vessel is expanded for the shortest time, thereby maximizing the protection of the blood vessel.

[0054] In actual operation, since the device is already provided with an expandable functional sheath 3, and there is no need to reduce the diameter of the functional sheath 3, there is actually no need to set up additional components to change the diameter of the functional sheath 3. When in use, the instrument can be directly inserted to support the functional sheath 3 through the instrument, so that the diameter of the functional sheath 3 can be directly changed with the instrument. However, since the instrument is of an irregular shape, when it contacts the flexible outer membrane layer 32, the shape of the flexible outer membrane layer 32 changes with it. When inserted into a blood vessel, it is easy to scratch the blood vessel. The device maintains the basic shape of the functional sheath 3 by setting a support member, so that when the diameter is expanded, the functional sheath 3 maintains an arc-shaped expansion, has a high degree of fit with the blood vessel, and avoids scratching the blood vessel.

[0055] In the present application, the supporting member for maintaining the basic arc shape of the functional sheath tube 3 can adopt various embodiments, and the present application provides three preferred embodiments:

[0056] Embodiment 1

[0057] See also Figure 6-8 The supporting member is a plastic member 31, which is a sheet-like strip with an arc-shaped cross section. In a natural state, the sides of the plurality of plastic members 31 are close to each other to form the inner wall of the functional sheath 3.

[0058] The device is achieved by configuring the support member to be a medical plastic member, with the outer side being connected to the flexible outer film layer 32 by hot pressing and laminating, and the inner side being a smooth arc surface. The three support members are spaced apart from each other, so that when the functional sheath 3 is supported, the flexible outer film layer 32 can be stretched under force, thereby achieving the expansion of the functional sheath 3. The circumference of the hard plastic member 31 is much larger than the flexible outer film layer 32, so that the basic shape of the functional sheath 3 is maintained during expansion, and the fit to the blood vessel is high to avoid scratching the blood vessel.

[0059] Furthermore, when the functional sheath tube 3 is in an expanded state, the flexible outer membrane layer 32 becomes thinner due to stretching and forms a bulge between the flexible outer membrane layer 32 and the plastic member 31 , and the bulge is located on the inner side of the tube wall.

[0060] The functional sheath 3 needs to be as smooth as possible. When expanding, the flexible outer membrane layer 32 is stretched, so that the thickness becomes thinner, while the thickness of the rigid plastic part 31 remains unchanged. A bulge will be generated at the connection between the flexible outer membrane layer 32 and the plastic part 31. Figure 2The protrusions on the outside of the functional sheath may scratch the blood vessels. However, the present application changes the structure by setting the protrusions at the connection on the inside of the tube wall, so that the contour of the outer side of the tube wall is smooth, without corners or protrusions, and can fit the inner wall of the blood vessel well to avoid scratching the blood vessel.

[0061] Embodiment 2

[0062] See also Figure 9-12 The support member is a support steel wire 13. A plurality of support steel wires 13 evenly distributed around the circumference are arranged inside the flexible outer membrane layer 32, so that the functional sheath tube 3 maintains an arc shape when it expands, and when the functional sheath tube 3 collapses, each support steel wire 13 abuts against each other, so that the outer periphery of the functional sheath tube 3 presents an arc-shaped structure. Preferably, the number of support steel wires 13 is twenty-four.

[0063] The support steel wire 13 may also be a flat steel wire in cross section. The flat support steel wire 13 facilitates hot pressing and laminating of the inner and outer side surfaces of the support steel wire 13 with the flexible outer film layer 32 .

[0064] This embodiment provides a number of evenly distributed support wires 13, so that when the instrument is inserted into the functional sheath tube 3, the irregular instrument simultaneously supports each support wire 13, so that the functional sheath tube 3 can maintain an arc shape when expanding;

[0065] In addition, due to the pressure difference between the inside and outside, when the functional sheath tube 3 is pulled out of the human body, the functional sheath tube 3 is compressed. Due to the expanded structure, if there is no special design, as in the prior art, the flexible outer membrane layer 32 may collapse, and the overlap of the plastic part 31 may be triangular or irregular with edges and corners due to the collapse of the flexible outer membrane layer 32. In this way, the functional sheath tube 3 forms edges and corners as a whole, which increases the possibility of damaging blood vessels. When pulled out, due to the pressure difference between the inside and outside, the flexible outer membrane layer 32 may not only collapse, but also axially flip and bend. In this way, embolism is easily formed when blood flows through. In the present application, by setting the support wire 13, firstly, when collapsed, each support wire 13 abuts against each other, so that the periphery of the functional sheath tube 3 is an arc-shaped structure without forming sharp corners, thereby reducing the possibility of damaging the blood vessel. Secondly, the support wire 13 is flexible, has a certain rigidity and deformability, and the support wire 13 can resist the pressure difference. The whole support wire 13 will not axially flip or bend, thereby ensuring that the flexible outer membrane layer 32 will not axially bend, thereby blocking blood circulation and avoiding embolism.

[0066] Embodiment 3

[0067] See also Figure 13-14 The flexible outer membrane layer 32 has an inner and outer double-layer structure, and the supporting steel wire 13 is arranged between the inner and outer double-layer flexible outer membrane layers 32. In the embodiment of the present application, the supporting steel wire 13 can also be used to set the flexible outer membrane layer 32 as two layers, and the supporting steel wire 13 is placed between the two layers of flexible outer membrane layers 32. This design makes the resistance force more uniform when the instrument supports the supporting steel wire 13.

[0068] Furthermore, one end of the functional sheath tube 3 close to the body 2 is set as a thick end 33, and the diameter of the thick end 33 is larger than the diameter of the functional sheath tube 3 below. For example, the diameter of the thick end is 2.1 mm, and the diameter of the rest of the functional sheath tube 3 is 1.7 mm.

[0069] The fixing process of the support member and the outer film layer 32 in the present application is an existing mature process in the art, including but not limited to the technologies disclosed in Chinese patents No. CN200410023450, CN202120661164, CN201910293717, CN200720190162, and CN201710531071.

[0070] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An expandable functional sheath, comprising a functional sheath (3), characterized in that: It comprises a flexible outer membrane layer (32) which is in a contracted state when no external force is applied, a support member being fixed on the inner side of the flexible outer membrane layer (32), a plurality of support members being arranged at intervals around the circumference, and the plurality of support members and the flexible outer membrane layer (32) together forming the functional sheath tube (3).

2. The expandable functional sheath according to claim 1, characterized in that: The support member is a plastic member (31), and the plastic member (31) is a sheet-like strip with an arc-shaped cross section. In a natural state, the sides of a plurality of plastic members (31) are close together to form the inner wall of the functional sheath tube (3).

3. The expandable functional sheath according to claim 1, characterized in that: The support member is a support steel wire (13), and a plurality of support steel wires (13) evenly distributed around the circumference are arranged in the flexible outer membrane layer (32).

4. The expandable functional sheath according to claim 3, characterized in that: The number of the supporting steel wires (13) is twenty-four.

5. An expandable functional sheath according to claim 3 or 4, characterized in that: The flexible outer membrane layer (32) has an inner and outer double-layer structure, and the supporting steel wire (13) is arranged between the inner and outer double-layer flexible outer membrane layers (32).

6. The expandable functional sheath according to claim 5, characterized in that: The supporting steel wire (13) has a flat cross section.

7. The expandable functional sheath according to claim 1, characterized in that: The flexible outer film layer (32) is a silicone film or a PE film.

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