CN115553854A

CN115553854A - Sheath pipe hemostasis module and sheath pipe

Info

Publication number: CN115553854A
Application number: CN202211338721.4A
Authority: CN
Inventors: 李洪灯; 李晓鹏; 陈晓宇
Original assignee: Shanghai Yixin Medical Devices Co ltd
Current assignee: Shanghai Yixin Medical Devices Co ltd
Priority date: 2022-10-28
Filing date: 2022-10-28
Publication date: 2023-01-03

Abstract

The application belongs to the technical field of interventional medical instruments, and provides a sheath hemostasis module which comprises a first hemostasis component and a second hemostasis component; the first hemostatic assembly comprises a first tube body, a first valve body and a second valve body, wherein the first valve body and the second valve body are assembled in the first tube body; the first valve body is a static sealing element, and the second valve body is a dynamic sealing element; the second hemostatic assembly comprises a second tube body, a third valve body and a fourth valve body which are assembled in the second tube body; the third valve body is a static sealing element, and the fourth valve body is a dynamic sealing element. This scheme sets up sheath pipe hemostasis module to the form of constituteing by a plurality of bodys to be provided with hemostasis subassembly in a plurality of bodys ingeniously, thereby make and to form multiple hemostasis subassembly when a plurality of bodys and possess multiple hemostasis function after the combination, so that ensure the normal clear of operation.

Description

Sheath pipe hemostasis module and sheath pipe

Technical Field

The utility model belongs to the technical field of intervene medical instrument, particularly, relate to a sheath pipe hemostasis module and sheath pipe.

Background

With the development of interventional therapy research on cardiovascular diseases and other body organ diseases, the mode of transcatheter interventional therapy is widely applied to various diseases. The transcatheter interventional therapy is a mode of introducing a specific instrument into a pathological change part of a human body through a catheter through a natural cavity or a tiny wound of the human body for treatment, and the treatment mode has the advantages of small wound, quick recovery, easy acceptance by patients and the like.

In transcatheter interventions, a puncture sheath plays an important role. When in use, a vascular access is required to be established in advance by using a catheter sheath, on one hand, a human vascular access is established, and instruments (such as a dilator, a delivery device, a guide wire and the like) can conveniently enter and exit a human body; on the other hand, the hemostatic effect is achieved, and blood loss of patients in operation is prevented.

When the instrument needs to be withdrawn from the catheter sheath, high pressure is usually formed between the catheter sheath and the head end of the instrument (especially a delivery device) to cause the catheter sheath to spray blood, which can cause blood loss of a patient and even influence the operation of a doctor, and increases the risk of the operation process.

Disclosure of Invention

The technical problem that this application will be solved lies in providing a sheath pipe hemostasis module and sheath pipe that improves hemostasis effect.

In order to solve the technical problems, the technical means adopted by the application is as follows:

a sheath hemostasis module is provided herein that includes a first hemostasis assembly and a second hemostasis assembly;

the first hemostatic assembly comprises a first tube body, a first valve body and a second valve body, wherein the first valve body and the second valve body are assembled in the first tube body; the first valve body is a static sealing element, and the second valve body is a dynamic sealing element;

the second hemostatic assembly comprises a second tube body, a third valve body and a fourth valve body which are assembled in the second tube body; the third valve body is a static sealing element, and the fourth valve body is a dynamic sealing element.

In the above-mentioned realization process, through being provided with sheath pipe hemostasis module to set up sheath pipe hemostasis module into the form of compriseing a plurality of bodys, and be provided with hemostasis subassembly in a plurality of bodys ingeniously, thereby make and can form multiple hemostasis subassembly when a plurality of bodys after the combination and possess multiple hemostasis function, so that ensure the normal clear of operation.

Further, the static seal comprises a static sealing portion and the dynamic seal comprises a dynamic sealing portion; the static seal of each hemostatic assembly is distal to the dynamic seal.

In the implementation process, the static sealing part and the dynamic sealing part are arranged, and the normal use of an interventional catheter and the like can not be influenced on the premise of ensuring the hemostasis effect of the hemostasis assembly by matching the static sealing part and the dynamic sealing part.

Further, the static sealing part is provided with a normally closed single seam, and the dynamic sealing part is provided with a via hole.

In the implementation process, the normally closed single slit can realize a relatively static sealing effect before the interventional catheter is stretched into and after the interventional catheter is pulled out, so that blood backflow and gushing are avoided; the through holes can realize the dynamic sealing function between the guiding pipe and the guiding pipe.

Furthermore, the first hemostatic assembly and the second hemostatic assembly are detachably mounted and connected; one end of the first pipe body, which is close to the second pipe body, is provided with a first installation cavity for accommodating the first hemostatic assembly; the outer shape of the first valve body is matched with the inner shape of the first installation cavity, and the first valve body is embedded in the first installation cavity.

In the implementation process, the external shape of the first valve body is skillfully set to be matched with the internal shape of the first installation cavity, so that the sealing performance of the first valve body between the first installation cavity and the first valve body after installation can be effectively improved, and the first valve body can be conveniently installed in the first installation cavity.

Furthermore, the first pipe body is provided with a first intervention channel and a flaring section located on the first intervention channel, and the flaring end of the flaring section is connected with the first installation cavity.

In the implementation process, the flaring section is ingeniously arranged, so that when the intervention pipeline and the like exit from the sheath tube, the influence caused by concentrated direct impact of backflow blood on the first valve body can be avoided, and the using effects of the first valve body and the sheath tube are ensured.

Furthermore, an accommodating cavity for accommodating the second valve body is arranged in the first valve body, the external shape of the second valve body is matched with the internal shape of the accommodating cavity, and the second valve body is embedded in the accommodating cavity.

In the implementation process, the second valve body is arranged, so that the entering of an interventional catheter and the like can be guided conveniently, and the backflow blocking of the first valve body can be strengthened when the interventional catheter and the like exit.

Furthermore, a second intervention channel is arranged in the second pipe body, and a second installation cavity is arranged at one end of the second intervention channel;

the outer shape of the third valve body is matched with the inner shape of the second mounting cavity, and the third valve body is embedded in the second mounting cavity.

In the implementation process, the external shape of the third valve body is skillfully set to be matched with the internal shape of the second mounting cavity, so that the sealing property between the third valve body and the second mounting cavity after mounting can be effectively improved, and the third valve body can be more conveniently mounted in the second mounting cavity.

Further, the other end of the second access channel is provided with a third installation cavity;

the outer shape of the fourth valve body is matched with the inner shape of the third installation cavity, and the fourth valve body is embedded in the third installation cavity.

In the implementation process, the external shape of the fourth valve body is skillfully set to be matched with the internal shape of the third installation cavity, so that the sealing performance of the fourth valve body between the installed fourth valve body and the third installation cavity can be effectively improved, and meanwhile, the fourth valve body can be installed in the third installation cavity more conveniently.

Furthermore, a transition section is arranged on the second intervening channel, and the third valve body and/or the fourth valve body partially extend into the transition section, so that the third valve body and the fourth valve body are mutually abutted and contacted.

In the implementation process, the fourth valve body is arranged, so that the entering of an interventional catheter and the like can be conveniently guided, and the backflow blocking of the third valve body can be enhanced when the interventional catheter and the like exit.

The guide insertion device further comprises a third pipe body, wherein a guide insertion channel is arranged on the third pipe body;

the third body with be detachable erection joint between the second body, first body, second body and connect in order between the third body.

In the implementation process, the arranged third tube body can play a role of an end cover, so that the protection of the hemostatic assembly arranged in the second tube body can be improved; simultaneously, set up the passageway is intervene in the direction can also be realized leading the entering of interveneeing pipe etc. to in the improvement operation experience.

Furthermore, threaded connection is adopted between the first pipe body and the second pipe body and between the second pipe body and the third pipe body, and an end face sealing structure is arranged between the first pipe body and the second pipe body and between the second pipe body and the third pipe body.

In the implementation process, the first pipe body, the second pipe body and the third pipe body are in threaded connection, so that the connection operation among the first pipe body, the second pipe body and the third pipe body can be more convenient and reliable; meanwhile, the end face sealing structure is arranged, so that the reliability of the catheter sheath in use can be further improved.

Still provide in this application a sheath pipe, it is provided with above a sheath pipe hemostasis module. Through using sheath pipe hemostasis module in the sheath for can form multiple hemostasis subassembly in the sheath, the hemostasis effect can obtain bigger promotion, thereby be convenient for ensure going on smoothly of operation, reduce the risk of executing the art.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments of the present application will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and that those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.

Fig. 1 is a schematic view illustrating the installation of the sheath hemostasis module according to the present application.

Fig. 2 is a schematic front view of the structure of fig. 1.

Fig. 3 is a schematic sectional structure view in the state of fig. 2.

Fig. 4 is a front view of a first tube according to the present application.

Fig. 5 is a schematic cross-sectional view of the first tubular body according to the present application.

Fig. 6 is a front view of a second tubular body according to the present application.

Fig. 7 is a schematic cross-sectional view of a second tubular body according to the present application.

Fig. 8 is a front view of a third tube according to the present application.

Fig. 9 is a schematic cross-sectional view of a third tubular body according to the present application.

Fig. 10 is a front view of the first valve body according to the present application.

Fig. 11 is a schematic cross-sectional structural view of a first valve body according to the present application.

Fig. 12 is a front view of a second valve body according to the present application.

Fig. 13 is a schematic cross-sectional view of a second valve body according to the present application.

Fig. 14 is a front view of a third valve body according to the present application.

Fig. 15 is a schematic cross-sectional view of a third valve body according to the present application.

Fig. 16 is a front view schematically illustrating a fourth valve body according to the present invention.

Fig. 17 is a schematic sectional view of a fourth valve body according to the present application.

Fig. 18 is a schematic structural view of a sheath according to the present application in a use state.

Description of the labeling:

1-a first pipe body, 10-a first intervention channel, 101-a first installation cavity, 1011-an annular bulge, 102-a flaring section, 103-a pressure relief channel, 11-a first hemostatic component, 111-a first valve body, 1111-a normally closed single slit, 1112-an annular groove, 1113-an accommodating cavity, 1114-an inward flanging, 112-a second valve body and 1121-a via hole;

2-a second tube body, 20-a second intervention channel, 201-a second installation cavity, 202-a third installation cavity, 203-a transition section, 21-a second hemostasis component, 211-a third valve body, 212-a fourth valve body, 213-a spherical structure;

3-a third tube, 30-a guide intervention channel;

4-a sheath catheter; 5-an interventional catheter.

Detailed Description

So that the manner in which the above recited objects, features and advantages of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to the embodiments thereof which are illustrated in the appended drawings. In addition, the embodiments and features of the embodiments of the present application may be combined with each other without conflict. In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention, and the described embodiments are merely a subset of the embodiments of the present invention, rather than a complete embodiment. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments of the present invention, belong to the protection scope of the present invention.

It should be noted that: unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures. Meanwhile, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not to be construed as indicating or implying relative importance. "distal" and "proximal" are general terms in the art, with distal referring to the end of the sheath that is closer to the patient's heart or away from the operator; proximal, as opposed to distal, refers to the end closer to the operator or the end further from the patient's heart.

As shown in fig. 1 to 18, in this embodiment, a sheath hemostasis module is provided, which includes a first hemostasis component 11 and a second hemostasis component 21, and the first hemostasis component 11 and the second hemostasis component 21 are detachably mounted and connected, so that after being assembled, the first hemostasis component 11 and the second hemostasis component 21 can have multiple hemostasis functions.

The first hemostatic assembly 11 includes a first tube 1, and a first valve body 111 and a second valve body 112 assembled in the first tube 1. In this embodiment, the first valve body 111 is a static seal, and the second valve body 112 is a dynamic seal.

The second hemostatic member 21 includes a second tube 2, a third valve body 211 and a fourth valve body 212 assembled in the second tube 2. In this embodiment, the third valve body 211 is a static seal, and the fourth valve body 212 is a dynamic seal.

The static seal referred to in this embodiment, i.e., the structure that seals the pathway-like instruments in a static state during the neutral period before they enter the body during surgery and after they are withdrawn from the body after surgery. The pointed sealing element, namely the passage instrument, has corresponding in and out movement in the operation process of a doctor, and the sealing element realizes sealing under the dynamic state of the instrument.

Further, in the present embodiment, a static sealing portion is disposed on the static sealing member, and a dynamic sealing portion is disposed on the dynamic sealing member; and the static seal on each hemostatic assembly is distal to the dynamic seal. The arrangement is such that the static seal on each hemostatic assembly is closer to the patient's blood vessel than the dynamic seal; when the delivery system is withdrawn, the delivery system is firstly withdrawn to pass through the static sealing part and then is withdrawn to pass through the dynamic sealing part, when the static sealing part is withdrawn, the static sealing part performs a sealing function, and even if the sealing effect of the dynamic sealing part at the near end is not ideal, the bleeding risk can be reduced. And the dynamic sealing part is positioned at the near end of the static sealing part, so that the conveying system can conveniently enter.

In this embodiment, the static seal portion is preferably provided as the normally closed single slit 1111, and the dynamic seal portion is preferably provided as the through hole 1121.

As one of the application examples, the third pipe body 3 is further provided in the present scheme. In this embodiment, a case where the first pipe 1, the second pipe 2, and the third pipe 3 are all provided as one will be mainly described as an example. In other application examples, at least two second tubes 2 may be provided, for example, after a plurality of second tubes 2 are connected in sequence, the first tube 1 and the third tube 3 are respectively connected to two ends of the connected second tubes 2, thereby forming a sheath tube as a whole.

As a preferable scheme, in this embodiment, the first pipe 1 and the second pipe 2, and the second pipe 2 and the third pipe 3 are connected by threads. Set up to threaded connection's mode, can realize first body 1 with second body 2, second body 2 with the relative position locking after connecting between the third body 3 also can have better sealing performance simultaneously.

Further, in this embodiment, an end face sealing structure is further provided between the first pipe 1 and the second pipe 2, and between the second pipe 2 and the third pipe 3. As an example of application, the end face sealing structure includes an annular sealing ring (not shown in the figure), and the annular sealing ring is interposed between connection contact surfaces of the first pipe 1 and the second pipe 2, and between connection contact surfaces of the second pipe 2 and the third pipe 3, so as to further improve the sealing reliability of the assembled sheath.

In addition, as shown in fig. 5, in the present embodiment, a first insertion channel 10 is disposed in the first tube 1, and a first installation cavity 101 for installing the first hemostatic assembly 11 is disposed at an end of the first insertion channel 10 close to the second tube 2.

Preferably, a flared section 102 is disposed on the first access channel 10 near the first installation cavity 101, and a flared end of the flared section 102 is connected to the first installation cavity 101.

Preferably, a pressure relief channel 103 is further provided corresponding to the first access channel 10.

In this embodiment, the outer shape of the first valve body 111 is configured to be matched with the inner shape of the first mounting cavity 101, and if the first valve body 111 is configured to be circular truncated cone, the inner portion of the first mounting cavity 101 is also circular truncated cone, so that when the first valve body 111 is mounted in the first mounting cavity 101, the outer peripheral surface of the first valve body 111 is attached to the inner wall surface of the first mounting cavity 101, and the sealing performance between the first valve body 111 and the first mounting cavity 101 after being mounted can be effectively improved.

As a preferable scheme, in this embodiment, an annular protrusion 1011 is disposed in the first mounting cavity 101, an annular groove 1112 is disposed on an outer peripheral surface of the first valve body 111, the first valve body 111 is embedded in the first mounting cavity 101, and the annular protrusion 1011 is in clamping connection with the annular groove 1112.

Further, a receiving chamber 1113 for the second valve body 112 is disposed in the first valve body 111. In this embodiment, the outer shape of the second valve body 112 is configured to be matched with the inner shape of the accommodating chamber 1113, for example, the second valve body 112 is configured to be circular truncated cone. Therefore, when the second valve body 112 is installed in the accommodating cavity 1113, the outer peripheral surface of the second valve body 112 is attached to the inner wall surface of the accommodating cavity 1113, and the sealing performance between the second valve body 112 and the accommodating cavity 1113 after installation can be effectively improved.

As a preferable scheme, in this embodiment, an inner flange 1114 arranged in a ring shape is disposed in the accommodating cavity 1113, the second valve body 112 is embedded in the accommodating cavity 1113, and the bottom of the second valve body 112 abuts against the inner side of the inner flange 1114.

In addition, as shown in fig. 7, a second access passage 20 is provided in the second pipe body 2, a second installation cavity 201 and a third installation cavity 202 are respectively provided at two ends of the second access passage 20, and a transition section 203 is provided between the second installation cavity 201 and the third installation cavity 202.

Preferably, the outer shape of the third valve body 211 is adapted to the inner shape of the second mounting cavity 201, for example, the outer peripheral surface of the third valve body 211 is circular truncated cone. Meanwhile, the third valve body 211 is embedded in the second installation cavity 201, and the third valve body 211 and the second installation cavity 201 can be installed and fixed by arranging an annular protrusion 1011 and an annular groove 1112.

Further, the outer shape of the fourth valve body 212 is configured to be matched with the inner shape of the third mounting cavity 202, for example, the outer peripheral surface of the fourth valve body 212 is configured to be a circular truncated cone. The fourth valve body 212 is embedded in the third installation cavity 202, and an annular protrusion 1011 and an annular groove 1112 are also arranged between the fourth valve body 212 and the third installation cavity 202 to realize installation and fixation.

Preferably, in this embodiment, a spherical structure 213 is disposed on each of the third valve body 211 and the fourth valve body 212, and the third valve body 211 and/or the fourth valve body 212 is disposed in the transition section 203 by extending through the spherical structure 213, so that the third valve body 211 and the fourth valve body 212 are in abutting contact with each other.

As shown in fig. 9, a guide passage 30 is provided in the third pipe body 3. Preferably, the guiding access channel 30, the first access channel 10 and the second access channel 20 are coaxially arranged. The third tube 3 can function as an end cap, so that the protection of the sealing element arranged in the second tube 2 can be improved; meanwhile, the guide intervention channel 30 is arranged to guide the entering of instruments and the like, so that the operation experience is improved.

In this embodiment, a sheath is further provided, as shown in fig. 18, which includes the above-mentioned sheath hemostasis module and a sheath catheter 4 connected to the distal end of the sheath hemostasis module. When in use, after the first tube body 1, the second tube body 2 and the third tube body 3 are assembled, the sheath catheter 4 is inserted into the first insertion channel 10 of the first tube body 1, so as to facilitate the first-stage puncture operation; after the sheath catheter 4 is punctured in place, for example, it is inserted into a blood vessel of a patient, at this time, an intervention operation of the delivery system is performed, and the intervention catheter 5 is inserted from the guiding intervention channel 30 of the third tube 3 and is inserted into the sheath catheter 4.

At this time, the through holes 1121 of the second valve body 112 and the fourth valve body 212 and the interventional catheter 5 are in a dynamic sealing state, that is, the access instrument has corresponding in and out movement during the operation of the doctor, and the sealing state is realized under the dynamic state of the instrument. The first valve body 111 and the third valve body 211 are in an open state under the influence of the interventional catheter 5; when the instruments and the interventional catheter 5 are withdrawn, the first valve body 111 and the third valve body 211 are restored to a static sealing state, namely, the normally closed single slit 1111 is completely closed in a neutral period before the passage type instruments enter the body in the operation process and after the instruments are withdrawn after the operation, and the sealing state is realized in a static state.

This scheme sets up sheath pipe hemostasis module to the form of constituteing by a plurality of bodys to be provided with hemostasis subassembly in a plurality of bodys ingeniously, thereby make when a plurality of bodys after the combination, can form multiple hemostasis subassembly in the sheath intraductal and possess multiple hemostasis function, improved the use reliability of sheath pipe effectively, so that ensure the normal clear of operation.

The above description is only a specific embodiment of the present application, and is not intended to limit the scope of the present application, and it is obvious to those skilled in the art that various modifications and variations can be made in the present application. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application. Any person skilled in the art can easily think of the changes or substitutions in the technical scope of the present disclosure, and shall also cover the protection scope of the present disclosure. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising a … …" does not exclude the presence of another identical element in a process, method, article, or apparatus that comprises the element.

Claims

1. A sheath hemostasis module, comprising a first hemostasis assembly and a second hemostasis assembly;

2. The sheath hemostasis module of claim 1, wherein the static seal comprises a static seal portion and the dynamic seal comprises a dynamic seal portion; the static seal of each hemostatic assembly is distal to the dynamic seal.

3. The sheath hemostasis module of claim 2, wherein the static seal is provided with a normally closed single slit and the dynamic seal is provided with a via.

4. The sheath hemostasis module of any one of claims 1-3, wherein the first hemostasis component is removably attachable to the second hemostasis component;

one end of the first pipe body, which is close to the second pipe body, is provided with a first installation cavity for accommodating the first hemostatic assembly;

the outer shape of the first valve body is matched with the inner shape of the first installation cavity, and the first valve body is embedded in the first installation cavity.

5. The sheath hemostasis module of claim 4, wherein the first tube defines a first access channel and a flared section disposed on the first access channel, the flared section having a flared end connected to the first mounting cavity.

6. The sheath hemostasis module of claim 4, wherein the first valve body has a cavity therein for receiving the second valve body, the second valve body has an outer shape that is adapted to an inner shape of the cavity, and the second valve body is embedded in the cavity.

7. The sheath hemostasis module of claim 1 or 6, wherein a second access channel is disposed in the second tube, and a second installation cavity is disposed at one end of the second access channel;

8. The sheath hemostasis module of claim 7, wherein the other end of the second access channel is provided with a third mounting lumen;

9. The sheath hemostasis module of claim 8, wherein the second access channel is provided with a transition section, and the third valve body and/or the fourth valve body partially extend into the transition section and bring the third valve body and the fourth valve body into abutting contact with each other.

10. The sheath hemostasis module of claims 1 or 9, further comprising a third tube having a guide access channel disposed thereon;

11. The sheath hemostasis module of claim 10, wherein the first tube and the second tube and the third tube are threaded, and wherein an end face seal is disposed between the first tube and the second tube and the third tube.

12. A sheath comprising a sheath hemostatic module of any one of claims 1-11.