An inner diameter adjustable sheath

Abstract

The present application relates to a kind of sheath with adjustable inner diameter, comprising a tube body and a connecting assembly, the tube body includes an inner tube, an outer tube and a filling cavity formed between the inner and outer tubes and closed at the distal end, when the filling medium flows into the filling cavity, the inner tube can contract in the radial direction and the contraction increases with the increase of the filling medium flowing into the filling cavity, and when the filling medium flows out of the filling cavity, the inner tube can expand in the radial direction until it returns to the initial state. The present application makes the filling cavity fill by filling the filling medium into the filling cavity, so that the inner tube contracts or expands in the radial direction, the inner diameter of the tube body is adjustable, and then the sheath can match the instrument catheter of different outer diameter specifications. The design of the filling cavity also makes the connection of the instrument catheter and the tube body equivalent to a flexible connection, which is beneficial to the introduction of the instrument catheter and can reduce the risk of damage to the blood vessel by the outer wall of the distal end of the sheath when pushing the instrument catheter.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a sheath tube with adjustable inner diameter. BACKGROUND

[0002] Interventional therapy refers to a method of diagnosing and treating various diseases through "non-surgical operation" such as performing blood vessel angiography, collecting pathological, physiological, cytological and biochemical examination data, and performing drug perfusion, vascular embolization or expansion formation and body cavity drainage under the guidance of imaging methods.

[0003] Common equipment for interventional therapy includes a puncture needle, a catheter sheath, a guide wire (including a selection guide wire, an exchange guide wire, etc.), a catheter (including a selective catheter, an angiography catheter, a therapeutic catheter, etc.), a temporary or permanent implant (including a stent, a vena cava filter, a brain protection device, a plugging device, a spring plug, etc.), and other equipment (including a vascular closure device, a suturing device, a Y valve, a pressure pump, etc.).

[0004] In vascular interventional therapy, the first step is to establish and maintain a blood vessel access, which requires the use of equipment such as a puncture needle, a puncture sheath or a catheter sheath, a guide catheter and a Y valve. Among them, the catheter sheath is used to assist various interventional catheters to enter the blood vessel artery or vein and provide a stable surgical channel during percutaneous puncture catheterization.

[0005] The catheter sheath designed in the prior art is of a fixed inner diameter specification, 4F-12F (inner diameter range 1.5mm-4.2mm). The fixed specification catheter sheath is only suitable for introducing a medical instrument (various balloon catheters, stent delivery devices, etc.) of one outer diameter specification. In some clinical scenarios, different diagnostic or therapeutic instruments may require different diameter catheter sheaths. In this case, different specification puncture sheaths or catheter sheaths may need to be replaced, and repeated catheter interventional procedures are required, which increases the risk (blood vessel dissection, etc.) and time of the operation. In addition, since the medical instrument catheter inevitably contacts the catheter sheath when it is introduced into the catheter sheath, there is friction between the two, and the operator needs to manually push the medical instrument catheter several times during the entire vascular invasion process, which causes a certain degree of compression or scratching of the distal end of the catheter sheath to the blood vessel, increasing the risk of blood vessel injury. SUMMARY

[0006] The purpose of the present application is to provide a sheath tube with adjustable inner diameter.

[0007] To achieve the above purpose, the technical solution adopted by the present application is:

[0008] A sheath tube with adjustable inner diameter, comprising:

[0009] a tube body comprising an inner tube, an outer tube sleeved outside the inner tube, and a filling cavity formed between the inner tube and the outer tube for allowing the flow of a filling medium, the filling cavity being closed at a distal end and open at a proximal end;

[0010] a connecting assembly comprising a connecting seat connected to the proximal end of the tube body, and a hemostatic valve connected to the connecting seat, the connecting seat having a first cavity and a second cavity which are not in communication with each other, the first cavity being in communication with the inner tube and the hemostatic valve, and the second cavity being in communication with the filling cavity,

[0011] when the filling medium flows into the filling cavity through the second cavity, the inner tube is capable of shrinking in the radial direction and the shrinkage increases with the increase of the filling medium flowing into the filling cavity,

[0012] when the filling medium flows out of the filling cavity through the second cavity, the inner tube is capable of expanding in the radial direction until it returns to the initial state.

[0013] The present application realizes the adjustment of the inner diameter of the tube body by arranging the filling cavity between the inner tube and the outer tube, filling the filling cavity with the filling medium, and thus shrinking or expanding the inner tube in the radial direction, so that the sheath tube can match the instrument catheter of different outer diameter specifications. The design of the filling cavity also makes the connection of the instrument catheter and the inner tube equivalent to a flexible connection, which is beneficial to the introduction of the instrument catheter and can reduce the risk of damage to the blood vessel by the outer wall of the distal end of the sheath tube when pushing the instrument catheter.

[0014] Preferably, a plurality of grooves are arranged on the inner side wall of the outer tube or the outer side wall of the inner tube along the extension direction of the tube body. The arrangement of the grooves can ensure a certain gap between the outer tube and the inner tube, thereby preventing the outer tube and the inner tube from being attached together in the initial state and being difficult to fill.

[0015] Further preferably, the plurality of grooves are arranged at equal intervals in sequence.

[0016] More preferably, the grooves are located on the inner side wall of the outer tube.

[0017] In some embodiments, the plurality of grooves are connected end to end in a spiral shape. The arrangement of the spiral grooves can reduce the flowability of the filling medium, to a certain extent, can reduce the relative movement of the inner tube and the outer tube, and can improve the flexibility and passability of the tube body.

[0018] In some embodiments, along the extension direction of the tube body, the depth of the grooves first increases and then decreases. By making the depth of the grooves fluctuate, the flowability of the filling medium can be further reduced.

[0019] Further, the groove is semi-elliptical in cross section along the extension direction of the tube body.

[0020] Preferably, the maximum depth of the groove is not greater than 0.5 mm and the maximum width is not greater than 2 mm.

[0021] Preferably, the inner diameter of the outer tube is greater than or equal to the outer diameter of the inner tube.

[0022] Preferably, the inner tube has elastic deformation capacity.

[0023] Preferably, the outer tube does not or slightly deforms elastically when the filling cavity is filled.

[0024] Preferably, the filling medium is a liquid, including but not limited to physiological saline.

[0025] Preferably, the connecting seat comprises a connecting seat body having the first cavity and the second cavity, the first cavity being located in the middle region of the connecting seat body, the second cavity being located outside the first cavity, the inner tube proximal end being connected to the inner or outer sidewall of the distal end portion of the first cavity, the outer tube proximal end being sleeved on the distal end portion of the connecting seat body, and the connecting member being arranged outside the outer tube proximal end and tightly adhering the outer tube to the connecting seat body.

[0026] Further preferably, the outer diameter of the distal end portion of the connecting seat body gradually decreases from the proximal end to the distal end, and the outer tube proximal end has a variable diameter section matching the distal end portion of the connecting seat body.

[0027] Preferably, a three-way valve is mounted on the second cavity.

[0028] Preferably, the sheath further comprises a catheter detachably arranged in the inner tube, the catheter having different outer diameter specifications, and when the catheter is replaced from one outer diameter specification to another, the inner tube is controlled to contract or expand so as to tightly adhere the inner sidewall of the inner tube to the outer sidewall of the catheter.

[0029] Preferably, the hemostatic valve comprises a hemostatic valve seat, a hemostatic valve cover and a hemostatic gasket, one end of the hemostatic valve seat is connected to the connecting seat and its main passage is in communication with the first cavity, the other end is connected to the hemostatic valve cover, the hemostatic gasket is located between the hemostatic valve cover and the hemostatic valve seat, and the distal end face and the proximal end face of the hemostatic gasket are respectively provided with a cutout, and the cutouts on the distal end face and the proximal end face of the hemostatic gasket do not cut through to the other face.

[0030] Further preferably, the hemostatic valve seat has a branch passage in communication with the main passage, and a three-way valve is connected to the branch passage.

[0031] Preferably, the hemostatic pad is an elastomer. The elastomer has the effect of preventing blood from flowing out when the instrument passes through or when there is no instrument.

[0032] Preferably, the cutout is in the shape of a cross.

[0033] Thanks to the above technical solution, the present application has the following advantages compared with the prior art:

[0034] The tube body of the sheath includes an inner tube, an outer tube, and a filling cavity formed between the inner tube and the outer tube. The filling cavity is filled by filling medium, so that the inner tube is contracted or expanded in the radial direction, the inner diameter of the tube body is adjustable, and the sheath can match instrument catheters of different outer diameters.

[0035] The design of the filling cavity also makes the connection of the instrument catheter and the tube body equivalent to a flexible connection, which is beneficial to the introduction of the instrument catheter and can reduce the risk of damage to the blood vessel by the outer wall of the distal end of the sheath when pushing the instrument catheter. BRIEF DESCRIPTION OF DRAWINGS

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0037] Figure 1 Structure diagram of the sheath of embodiment 1;

[0038] Figure 2 Structure diagram of the sheath of embodiment 1; Figure 1 Exploded diagram of the sheath;

[0039] Figure 3 Structure diagram of the sheath of embodiment 1; Figure 1 Sectional view of the sheath;

[0040] Figure 4 Structure diagram of the sheath of embodiment 1; Figure 3 Enlarged diagram of part A of the sheath;

[0041] Figure 5 Enlarged diagram of part B of the sheath; Figure 3 Enlarged diagram of part B of the sheath;

[0042] Figure 6 Structure diagram of the sheath catheter of embodiment 1;

[0043] Figure 7 Structure diagram of the sheath catheter of embodiment 1; Figure 6 Exploded diagram of the sheath of embodiment 1;

[0044] Figure 8Structure diagram of the sheath for introducing another catheter in Example 1;

[0045] Figure 9 Structure diagram of the sheath for introducing another catheter in Example 1; Figure 8 Structure diagram of the sheath for introducing another catheter in Example 1;

[0046] 1, tube body; 11, outer tube; 111, groove; 112, outer tube reducing section; 12, inner tube; 121, inner tube reducing section; 122, inner tube distal end; 13, filling lumen;

[0047] 2, connecting seat; 21, connecting seat body; 211, first lumen; 212, second lumen; 22, connecting piece; 23, first three-way valve;

[0048] 3, hemostatic valve; 31, hemostatic valve seat; 32, hemostatic valve cover; 33, hemostatic pad; 331, hemostatic pad proximal end face cutout; 332, hemostatic pad distal end face cutout; 34, second three-way valve;

[0049] 4, dilator; 41, dilator handle;

[0050] 5, inner sleeve;

[0051] L, maximum width of the groove; D, maximum depth of the groove. DETAILED DESCRIPTION

[0052] In the following, only certain exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope of the embodiments of the present application. Therefore, the drawings and the description are considered to be exemplary in nature rather than limiting.

[0053] In the description of the embodiments of the present application, it needs to be understood that the terms "distal", "proximal" and the like indicate the orientation or positional relationship defined with the orientation of the sheath in use, wherein the side close to the operator is the proximal end and the side away from the operator is the distal end. It is only for the convenience of describing the embodiments of the present application and simplifying the description, and is not intended to indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the embodiments of the present application.

[0054] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the embodiments of the present application, the meaning of "multiple" is two or more, unless otherwise explicitly and specifically limited.

[0055] In the embodiments of the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0056] The disclosure below provides many different embodiments or examples for implementing different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the components and configurations of specific examples are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. In addition, the embodiments of the present invention may repeat reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or configurations discussed.

[0057] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0058] Example 1

[0059] like Figures 1 to 3 As shown, a sheath tube includes a tube body 1 with an adjustable inner diameter and a connecting assembly connected to the tube body 1.

[0060] The tubular body 1 comprises an inner tube 12 and an outer tube 11 sleeved outside the inner tube 12. A filling lumen 13 is formed between the inner and outer tubes 12, allowing the flow of a filling medium. The distal end of the filling lumen 13 is closed, while the proximal end is open. Specifically, the distal end of the filling lumen 13 is sealed by folding the distal end 122 of the inner tube outwardly and connecting it to the outer wall of the outer tube 11. The inner tube 12 has a certain elastic deformation capacity. When the filling medium is introduced into the filling lumen 13 and the filling lumen 13 is completely filled, the filling medium in the filling lumen 13 exerts a compressive force on the inner tube 12, causing the inner tube 12 to contract radially. This contraction increases as more filling medium flows into the filling lumen 13. When the filling medium flows out of the filling lumen 13, the inner tube 12 can expand radially until it returns to its original state. That is, when a larger inner diameter of the tube body 1 is required, less filling medium is introduced; when a smaller inner diameter of the tube body 1 is required, more filling medium is introduced. Preferably, the filling medium is a liquid, including but not limited to physiological saline.

[0061] The present application can control the contraction degree of the inner layer tube 12 in the radial direction by controlling the amount of the filling medium entering the filling cavity 13, so as to realize the adjustable inner diameter of the tube body 1, and further enable the sheath tube to match the instrument catheter of different outer diameter specifications, which is very convenient to operate, and avoids repeated catheter interventions for matching the instrument catheter of different outer diameter specifications, thereby reducing the risk of surgery. In addition, the design of the filling cavity 13 also enables the connection of the instrument catheter and the tube body 1 to be equivalent to a flexible connection, which is beneficial to the introduction of the instrument catheter and can reduce the risk of damage to the blood vessel at the distal end of the sheath tube when pushing the instrument catheter.

[0062] Further, the inner diameter of the outer layer tube 11 is greater than or equal to the outer diameter of the inner layer tube 12. In the embodiment, the inner diameter of the outer layer tube 11 is slightly larger than the outer diameter of the inner layer tube 12, and the outer layer tube 11 does not elastically deform or slightly elastically deforms when the filling cavity 13 is filled. A plurality of grooves 111 are arranged on the inner side wall of the outer layer tube 11, so as to have a certain gap between the outer layer tube 11 and the inner layer tube 12, thereby preventing the outer layer tube 11 and the inner layer tube 12 from being bonded together in the initial state and being difficult to fill. Specifically, as shown in Figure 4 and Figure 5 , the plurality of grooves 111 are arranged in equal intervals along the extension direction of the outer layer tube 11 and connected in a spiral shape. The spiral grooves 111 can reduce the flowability of the filling medium, and to a certain extent, can reduce the relative movement of the inner layer tube 12 and the outer layer tube 11, and improve the flexibility and passability of the tube body 1. Taking one of the grooves 111 as an example, the depth of the groove 111 first increases and then decreases, that is, the depth of the groove 111 fluctuates. In this way, the flowability of the filling medium can be further reduced. In the embodiment, the cross section of the groove 111 along the extension direction of the outer layer tube 11 is a semi-elliptical shape, and the maximum depth D is not greater than 0.5 mm and the maximum width L is not greater than 2 mm. The proximal end portion of the outer layer tube 11 is an outer layer tube variable diameter section 112, and the diameter of the outer layer tube variable diameter section 112 gradually increases from the distal end to the proximal end.

[0063] As shown in Figure 2 , Figure 3 and Figure 4 , the connecting assembly includes a connecting seat 2 connected to the proximal end of the tube body 1, and a hemostatic valve 3 connected to the connecting seat 2.

[0064] The connector 2 includes a connector body 21 and a connector 22. The connector body 21 has a first lumen 211 and a second lumen 212, which are not interconnected. The first lumen 211 is located in the middle region of the connector body 21 and communicates with the inner tube 12 and the hemostatic valve 3. Specifically, the proximal portion of the inner tube 12 is an inner tube reducing section 121, which connects to the inner or outer wall of the distal portion of the first lumen 211, connecting the first lumen 211 with the inner tube 12. The second lumen 212 is located outside the first lumen 211 and is mounted with a first three-way valve 23. The second lumen 212 communicates with the filling lumen 13, allowing the filling medium to flow into the filling lumen 13 through the second lumen 212. Specifically, the outer diameter of the distal part of the connecting seat body 21 gradually decreases from its proximal end to the distal end and matches the outer tube reducing section 112. The outer tube reducing section 112 is sleeved on the distal part of the connecting seat body 21. The connecting piece 22 is arranged on the outside of the outer tube reducing section 112 and makes the outer tube 11 fit tightly with the connecting seat body 21, so that the filling medium can flow from the second cavity 212 into the filling cavity 13.

[0065] The hemostatic valve 3 includes a hemostatic valve seat 31, a hemostatic valve cover 32 and a hemostatic gasket 33. One end of the hemostatic valve seat 31 is connected to the connecting seat body 21 and its main channel is connected to the first cavity 211. The other end is connected to the hemostatic valve cover 32. The hemostatic gasket 33 is located between the hemostatic valve cover 32 and the hemostatic valve seat 31. The distal and proximal surfaces of the hemostatic gasket 33 are respectively provided with incisions. The incisions (331 / 332) on the distal and proximal surfaces of the hemostatic gasket 33 do not cut through to the other side. Preferably, the hemostatic gasket 33 is an elastomer. When there is an instrument passing through or without an instrument, the elastomer has the function of preventing blood from flowing out. Furthermore, the incision 332 on the distal surface of the hemostatic gasket and the incision 331 on the proximal surface of the hemostatic gasket are cross-shaped. The hemostatic valve seat 31 has a branch channel connected to the main channel, and the branch channel is connected to the second three-way valve 34. Of course, the hemostatic valve 3 may also be a hemostatic valve 3 with other structures in the art, and the present invention does not impose any specific limitation thereto.

[0066] In some embodiments, the sheath tube further comprises a catheter detachably disposed within the inner tube 12, wherein the catheter has different outer diameters. When the catheter is changed from one outer diameter to another, the inner tube 12 is controlled to contract or expand so that the inner wall of the inner tube 12 fits in with the outer wall of the catheter. Specifically, the catheter includes but is not limited to inner sleeves 5 ( Figure 6 、 Figure 7 As shown), expansion tube 4 ( Figure 8 、 Figure 9 As shown), when it is an expansion tube 4, the distal end of the expansion tube 4 has an expander handle 41.

[0067] The steps for using the sheath tube of the present invention are as follows:

[0068] (1) Insert the expansion tube 4 into the inner tube 12 through the hemostatic valve 3 and the connecting seat 2, and introduce the filling medium into the filling cavity 13 through the second channel to fill the filling cavity 13. The inner tube 12 shrinks radially to fit the outer wall of the expansion tube 4, and the guide wire invades the blood vessel. After reaching the blood vessel, the expansion tube 4 is pulled out.

[0069] (2) According to the outer diameter specification of the inner cannula 5, a portion of the filling medium is discharged through the second channel to appropriately relieve the pressure of the filling cavity 13, and the inner cannula 5 is inserted into the inner tube 12 through the hemostatic valve 3 and the connecting seat 2. After reaching the target position, the filling medium is introduced into the filling medium through the second channel until the inner wall of the inner tube 12 fits with the outer wall of the inner cannula 5. At this time, the instrument enters through the inner cannula 5.

[0070] (3) When an inner sleeve 5 with another outer diameter is required, repeat step (2) until the inner diameter of the tube body 1 matches the inner sleeve 5.

[0071] The inner diameter of the sheath tube of the present invention is adjustable and can match instrument catheters with different outer diameters, thereby avoiding damage to the vascular wound caused by multiple replacement of the sheath tube (which contacts the vascular puncture port), and greatly reducing surgical risks.

[0072] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. An inner diameter adjustable sheath, characterized by, The sheath comprises: a tube body comprising an inner tube, an outer tube sleeved outside the inner tube, a filling cavity formed between the inner tube and the outer tube for allowing the flow of filling medium, the distal end of the filling cavity being closed and the proximal end being open, a plurality of grooves being arranged on the inner side wall of the outer tube or the outer side wall of the inner tube along the extension direction of the tube body, the grooves being connected end to end in a spiral shape and the depth of the grooves first increasing and then decreasing; a connecting assembly comprising a connecting seat connected to the proximal end of the tube body and a hemostasis valve connected to the connecting seat, the connecting seat having a first cavity and a second cavity which are not in communication with each other, the first cavity being in communication with the inner tube and the hemostasis valve, and the second cavity being in communication with the filling cavity, when the filling medium flows into the filling cavity through the second cavity, the inner tube can contract in the radial direction and the contraction increases with the increase of the filling medium flowing into the filling cavity, when the filling medium flows out of the filling cavity through the second cavity, the inner tube can expand in the radial direction until it returns to the initial state.

2. The adjustable internal diameter sheath of claim 1, wherein, the cross section of the groove in the extension direction of the tube body is semicircular; and / or the maximum depth of the groove is not greater than 0.5 mm and the maximum width is not greater than 2 mm.

3. The adjustable internal diameter sheath of claim 1, wherein, the inner diameter of the outer tube is greater than or equal to the outer diameter of the inner tube.

4. The adjustable inside diameter sheath of claim 1, wherein, the connecting seat comprises a connecting seat body having the first cavity and the second cavity, the first cavity being located in the middle region of the connecting seat body and the second cavity being located outside the first cavity, the proximal end of the inner tube being connected to the inner side wall or the outer side wall of the distal end portion of the first cavity, the proximal end of the outer tube being sleeved on the distal end portion of the connecting seat body, and the connecting member being arranged outside the proximal end of the outer tube and tightly fitting the outer tube and the connecting seat body.

5. The adjustable internal diameter sheath of claim 4, wherein, the outer diameter of the distal end portion of the connecting seat body gradually decreases from the proximal end to the distal end, and the proximal end of the outer tube has a variable diameter section matching the distal end portion of the connecting seat body.

6. The adjustable inside diameter sheath of claim 1, wherein, a three-way valve is mounted on the second cavity.

7. The adjustable inside diameter sheath of claim 1, wherein, the sheath further comprises a catheter detachably arranged in the inner tube, the catheter having different outer diameter specifications, and when the catheter is replaced from one outer diameter specification to another, the inner tube is controlled to contract or expand so that the inner side wall of the inner tube is tightly fitted with the outer side wall of the catheter.

8. The adjustable inside diameter sheath of claim 1, wherein, the hemostasis valve comprises a hemostasis valve seat, a hemostasis valve cover and a hemostasis pad, one end of the hemostasis valve seat being connected to the connecting seat and the main passage thereof being in communication with the first cavity, the other end being connected to the hemostasis valve cover, the hemostasis pad being located between the hemostasis valve cover and the hemostasis valve seat, the distal end face and the proximal end face of the hemostasis pad being respectively provided with a cutout, and the cutouts on the distal end face and the proximal end face of the hemostasis pad not cutting through to the other face.

9. The adjustable internal diameter sheath of claim 8, wherein, the hemostasis valve seat has a branch passage in communication with the main passage, and a three-way valve is connected to the branch passage.

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