CN117137411A

CN117137411A - Medical device and method for producing medical device

Info

Publication number: CN117137411A
Application number: CN202311131743.8A
Authority: CN
Inventors: 陈东; 张克文; 方建新; 于永建
Original assignee: Xinguangwei Medical Technology Suzhou Co ltd
Current assignee: Xinguangwei Medical Technology Suzhou Co ltd
Priority date: 2023-09-04
Filing date: 2023-09-04
Publication date: 2023-12-01

Abstract

The present disclosure provides a medical device comprising a handle portion and an insertion portion, further comprising a traction assembly comprising: the device comprises a fixed ring and at least two traction wires, wherein one end of each traction wire is fixed on the fixed ring; the other end of the traction wire penetrates through the insertion part to extend into the handle part and is connected with the adjusting structure of the handle part; the adjustment structure is capable of pulling or releasing the pull wire to cause bending of the insertion portion. The disclosure also provides a method of making a medical device.

Description

Medical device and method for producing medical device

Technical Field

The disclosure relates to a medical instrument and a preparation method of the medical instrument, and belongs to the technical field of medical instruments.

Background

Transoral choledochoscope is often used in digestive surgery and can treat diseases of the biliary and pancreatic ducts.

Because of the complexity of the human body structure, the curvature of the transoral choledochoscope needs to be curved in four directions to smoothly reach the operation target position.

In the prior art, bending of a multi-lumen tube is generally achieved by arranging four pull wires in the multi-lumen tube. One end of the four traction wires is fixed at four positions of the head end of the multi-cavity tube, and the four traction wires are controlled in four directions through a control rotating wheel of a handle of an operation part. Based on this, when the traction wires are installed, the four traction wires are respectively provided independently and respectively penetrated into the four holes of the multi-lumen tube. The installation method is complex in process and long in time consumption, and the problem of wire leakage and threading easily occurs when workers assemble a plurality of multi-cavity tubes.

Disclosure of Invention

In order to solve one of the above technical problems, the present disclosure provides a medical device and a method for manufacturing the medical device.

According to one aspect of the present disclosure, there is provided a medical device comprising a handle portion and an insertion portion, further comprising a traction assembly comprising:

a fixing ring, and

at least two traction wires, one end of each traction wire is fixed on the fixing ring; the other end of the traction wire penetrates through the insertion part to extend into the handle part and is connected with the adjusting structure of the handle part; the adjustment structure is capable of pulling or releasing the pull wire to cause bending of the insertion portion.

The medical device according to at least one embodiment of the present disclosure, the insertion portion includes a multi-lumen tube having a plurality of lumens formed along an axial direction thereof, and the fixing ring has a through hole formed therein corresponding to the plurality of lumens.

In accordance with at least one embodiment of the present disclosure, the plurality of lumens include a plurality of pulling wire holes therein in a number consistent with the number of the pulling wires, the through holes of the fixing ring include mounting holes in one-to-one correspondence with the pulling wire holes, and the pulling wires pass through the mounting holes and the pulling wire holes so that the fixing ring of the pulling assembly is in contact with one end of the multi-lumen tube.

In accordance with at least one embodiment of the present disclosure, the pulling wire holes are uniformly arranged along the circumference of the multi-lumen tube.

According to at least one embodiment of the present disclosure, one end of the traction wire is provided with a plug, the size of the plug is larger than the size of the mounting hole of the fixing ring, the plug is located at one side of the fixing ring, and the other end of the traction wire is located at the other side of the fixing ring.

In accordance with at least one embodiment of the present disclosure, one end of the traction wire is fixed to the fixing ring by a spot welding process.

In accordance with a medical device of at least one embodiment of the present disclosure, the central axis of the mounting hole of the securing ring coincides with the central axis of the pulling wire hole of the multi-lumen tube when the pulling assembly is mounted to the multi-lumen tube.

According to another aspect of the present disclosure, there is provided a method for manufacturing a medical device as described above, the method comprising:

preparing a traction assembly, and

penetrating the other end of the traction wire of the traction assembly into a traction wire hole from one end of a multi-cavity tube of the medical instrument and exposing the other end of the multi-cavity tube; and bringing the securing ring into contact with one end of the multilumen tubing.

A method of making a medical device according to at least one embodiment of the present disclosure, the method of making a traction assembly comprising:

preparing a fixing ring, wherein the fixing ring at least comprises a through hole corresponding to a cavity channel of the multi-cavity tube; and

one end of the traction wire is fixed on the fixed ring, and the other end of the traction wire penetrates through the mounting hole in the through hole and the traction wire hole of the multi-cavity tube.

A method of making a medical device according to at least one embodiment of the present disclosure, wherein at least a portion of the pull wire is positioned within the mounting hole.

According to the method for manufacturing the medical device of at least one embodiment of the present disclosure, one end of the traction wire is fixed to the fixing ring through a spot welding process.

Drawings

The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

Fig. 1 is a schematic structural view of a medical device according to one embodiment of the present disclosure.

Fig. 2 is a schematic structural view of a part of the structure of a medical device according to one embodiment of the present disclosure.

Fig. 3 is an exploded structural schematic view of a partial structure of a medical device according to one embodiment of the present disclosure.

Fig. 4 is a schematic structural view of a traction assembly according to one embodiment of the present disclosure.

Fig. 5 is a flow chart of a method of manufacturing a medical device according to one embodiment of the present disclosure.

The reference numerals in the drawings specifically are:

10 handle portion

20 insert part

100 fixing ring

200 traction wire

210 plug

300 multicavity pipe

310 traction wire hole

320 device holes.

Detailed Description

The present disclosure is described in further detail below with reference to the drawings and the embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant content and not limiting of the present disclosure. It should be further noted that, for convenience of description, only a portion relevant to the present disclosure is shown in the drawings.

In addition, embodiments of the present disclosure and features of the embodiments may be combined with each other without conflict. The technical aspects of the present disclosure will be described in detail below with reference to the accompanying drawings in conjunction with embodiments.

Unless otherwise indicated, the exemplary implementations/embodiments shown are to be understood as providing exemplary features of various details of some ways in which the technical concepts of the present disclosure may be practiced. Thus, unless otherwise indicated, features of the various implementations/embodiments may be additionally combined, separated, interchanged, and/or rearranged without departing from the technical concepts of the present disclosure.

The use of cross-hatching and/or shading in the drawings is typically used to clarify the boundaries between adjacent components. As such, the presence or absence of cross-hatching or shading does not convey or represent any preference or requirement for a particular material, material property, dimension, proportion, commonality between illustrated components, and/or any other characteristic, attribute, property, etc. of a component, unless indicated. In addition, in the drawings, the size and relative sizes of elements may be exaggerated for clarity and/or descriptive purposes. While the exemplary embodiments may be variously implemented, the specific process sequences may be performed in a different order than that described. For example, two consecutively described processes may be performed substantially simultaneously or in reverse order from that described. Moreover, like reference numerals designate like parts.

When an element is referred to as being "on" or "over", "connected to" or "coupled to" another element, it can be directly on, connected or coupled to the other element or intervening elements may be present. However, when an element is referred to as being "directly on," "directly connected to," or "directly coupled to" another element, there are no intervening elements present. For this reason, the term "connected" may refer to physical connections, electrical connections, and the like, with or without intermediate components.

For descriptive purposes, the present disclosure may use spatially relative terms such as "under … …," under … …, "" under … …, "" lower, "" above … …, "" upper, "" above … …, "" higher "and" side (e.g., as in "sidewall"), etc., to describe one component's relationship to another (other) component as illustrated in the figures. In addition to the orientations depicted in the drawings, the spatially relative terms are intended to encompass different orientations of the device in use, operation, and/or manufacture. For example, if the device in the figures is turned over, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "below" … … can encompass both an orientation of "above" and "below". Furthermore, the device may be otherwise positioned (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, when the terms "comprises" and/or "comprising," and variations thereof, are used in the present specification, the presence of stated features, integers, steps, operations, elements, components, and/or groups thereof is described, but the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof is not precluded. It is also noted that, as used herein, the terms "substantially," "about," and other similar terms are used as approximation terms and not as degree terms, and as such, are used to explain the inherent deviations of measured, calculated, and/or provided values that would be recognized by one of ordinary skill in the art.

Fig. 1 is a schematic structural view of a medical device according to one embodiment of the present disclosure. Fig. 2 is a schematic structural view of a part of the structure of a medical device according to one embodiment of the present disclosure. Fig. 3 is an exploded structural schematic view of a partial structure of a medical device according to one embodiment of the present disclosure. Fig. 4 is a schematic structural view of a traction assembly according to one embodiment of the present disclosure.

As shown in fig. 1 to 4, the present disclosure provides a medical device including a handle portion 10 and an insertion portion 20 provided to the handle portion 10, the handle portion 10 being provided in a shape that is convenient for a medical staff to hold, wherein the handle portion 10 includes a front end and a rear end, the medical staff can hold the handle portion 10 during a procedure on a patient by the medical staff, and the front end of the handle portion 10 is directed toward the patient, and accordingly, the rear end of the handle portion 10 is directed away from the patient, i.e., toward the medical staff. Accordingly, the rear end of the insertion portion 20 is mounted to the handle portion 10, and at least part of the rear end of the insertion portion 20 is located within the handle portion 10.

The medical device also includes a traction assembly, which may include a fixation ring 100, a traction wire 200, and the like.

The outer circumferential surface of the fixing ring 100 may be formed as a cylindrical surface, whereby the fixing ring 100 can have a central axis, and correspondingly, also an axial direction and a circumferential direction. The fixing ring 100 may be provided with a through hole, at least a portion of which corresponds to the drawing wire hole and is formed as a mounting hole, the mounting hole being capable of being used for the drawing wire 200 to pass therethrough, and a portion of which is capable of being used for the device to pass therethrough and is formed as a device through hole.

In the present disclosure, the pulling wire 200 may be a steel wire and may have a central axis. Preferably, the number of the traction wires 200 may be more than two, so that the multi-lumen tube 300 can be bent in more than two directions, whereby a medical staff can conveniently handle the traction wires 200 and bend the multi-lumen tube 300 and reach a surgical target site of a human body.

In a specific embodiment, the number of the traction wires 200 may be four, and the central axes of the four traction wires 200 are disposed parallel to each other, and accordingly, the number of the mounting holes of the fixing ring 100 is also four, and at least part of the traction wires 200 are located in the mounting holes.

Of course, the number of the traction wires 200 is not limited thereto, and the number of the traction wires 200 may be set to more than four, for example, in order to achieve bending of the multi-lumen tube 300 in more directions.

Accordingly, one end of each traction wire 200 is fixed to the fixing ring 100, and the other end of the traction wire 200 can pass through the insertion portion 20, extend into the handle portion 10, and be connected with the adjusting structure of the handle portion 10; wherein the adjustment structure is capable of pulling or releasing the pull wire 200 to cause bending of the insertion portion 20. At this time, four traction wires 200 are provided at different positions in the circumferential direction of the fixing ring 100.

That is, when the traction wires 200 are disposed in the same radial direction of the fixing ring 100, the traction wires 200 are operated only to bend the multi-lumen tube 300 in the same direction, and in order to avoid this, there are no two or more traction wires 200 disposed in the same radial direction of the fixing ring 100 among the traction wires 200.

More preferably, the central axes of the traction wires 200 can be located on the outer surface of a certain cylinder and can be formed as generatrix of the cylinder, and accordingly, the central axis of the cylinder can coincide with the central axis of the fixing ring 100. That is, the distance between the central axes of the traction wires 200 and the central axis of the fixing ring 100 is the same.

In a preferred embodiment, the plane in which the central axes of two oppositely disposed traction wires 200 lie passes through the central axis of the fixing ring 100, so that when the traction wires 200 are disposed in four, the four traction wires 200 may be formed as four ridges of a certain rectangular parallelepiped, and the central axis of the rectangular parallelepiped is disposed coincident with the central axis of the fixing ring 100.

In the present disclosure, four traction wires 200 are uniformly arranged along the circumferential direction of the fixing ring 100, whereby a medical staff can precisely control the bending direction of the multi-lumen tube 300 to facilitate the multi-lumen tube 300 to rapidly reach a target position.

The insertion portion 20 includes a multi-lumen tube 300, a plurality of lumens are formed in the multi-lumen tube 300 along the axial direction thereof, and the fixing ring 100 is formed with through holes corresponding to the plurality of lumens.

More specifically, the plurality of lumens include the drawing wire holes 310 in the number consistent with the number of the drawing wires 200, the through holes of the fixing ring 100 include mounting holes in one-to-one correspondence with the drawing wire holes 310, and the drawing wires 200 pass through the drawing wire holes 310 so that the fixing ring 100 of the drawing assembly is in contact with one end of the multi-lumen tube 300.

In this disclosure, the plurality of lumens may further include a device aperture 320 for device penetration, and in one particular embodiment, the device aperture 320 may include an instrument aperture for consumable instrument penetration and a guidewire aperture for guidewire penetration. Correspondingly, the through hole also includes a device through hole corresponding to the device hole 320. More preferably, the size of the device passageway in the securing ring 100 is greater than or equal to the size of the device aperture 320 of the multi-lumen tube 300, whereby the securing ring 100 does not interfere with the passage of consumable instruments, guidewires, etc. through the securing ring 100.

When the pulling assembly is mounted to the multi-lumen tube 300, the central axis of the mounting hole of the fixing ring 100 coincides with the central axis of the pulling wire hole 310 of the multi-lumen tube 300, thereby enabling the pulling wire 200 to move more smoothly along the pulling wire hole 310.

In one embodiment, one end of the traction wire 200 is provided with a plug 210, the size of the plug 210 is larger than the size of the fixing ring 100, for example, the maximum diameter of the plug 210 is larger than the diameter of the mounting hole of the fixing ring 100, so that the plug 210 cannot pass through the mounting hole; more specifically, the plug 210 may be a knot of the traction wire 200 or a member separately fixed to one end of the traction wire 200.

Accordingly, the plug 210 is located at one side of the fixing ring 100, and the other end of the traction wire 200 is located at the other side of the fixing ring 100, that is, when the traction assembly is manufactured, the other end of the traction wire 200 (i.e., the end where the traction wire 200 is suspended) can pass through the mounting hole, and the plug 210 is in contact with one surface of the fixing ring 100, and then the plug 210 and/or one end of the traction wire 200 can be fixed to the fixing ring 100 through a spot welding process, thereby fixing the traction wire 200 to the fixing ring 100.

As shown in fig. 5, the present disclosure provides a method of manufacturing a medical device, which is capable of manufacturing the medical device described above.

More specifically, the preparation method of the medical device comprises the following steps: preparing a pulling assembly, and threading the other end (depending end) of all of the pulling wires 200 of the pulling assembly from one end of the multi-lumen tube 300 of the medical device into the pulling wire aperture 310 and out of the other end of the multi-lumen tube 300; and the fixing ring 100 is brought into contact with one end of the multi-lumen tube 300.

Further, the pulling wire 200 can be coupled to the adjusting structure after being passed out of the multi-lumen tube 300, and the pulling wire 200 can be pulled or released by the adjusting structure, thereby enabling the distal end of the multi-lumen tube 300 (i.e., the end provided with the fixing ring 100) to be bent.

In a preferred embodiment, the preparing a traction assembly includes: preparing a fixing ring 100, wherein the fixing ring 100 at least comprises through holes corresponding to a plurality of channels of the multi-cavity tube 300; and fixing one end of the drawing wire 200 to the fixing ring 100 and the other end passing through the drawing wire hole 310 of the multi-lumen tube 300.

The through hole of the fixing ring 100 includes a mounting hole therein, and at least a portion of the traction wire 200 is positioned in the mounting hole. More specifically, one end of the traction wire 200 is provided with a plug 210, and the size of the plug 210 is larger than that of the fixing ring 100, for example, the maximum diameter of the plug 210 is larger than that of the mounting hole of the fixing ring 100, so that the plug 210 cannot pass through the mounting hole; more specifically, the plug 210 may be a knot of the traction wire 200 or a member separately fixed to one end of the traction wire 200.

In the description of the present specification, reference to the terms "one embodiment/manner," "some embodiments/manner," "example," "a particular example," "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment/manner or example is included in at least one embodiment/manner or example of the application. In this specification, the schematic representations of the above terms are not necessarily for the same embodiment/manner or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments/modes or examples. Furthermore, the various embodiments/modes or examples described in this specification and the features of the various embodiments/modes or examples can be combined and combined by persons skilled in the art without contradiction.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

It will be appreciated by those skilled in the art that the above-described embodiments are merely for clarity of illustration of the disclosure, and are not intended to limit the scope of the disclosure. Other variations or modifications will be apparent to persons skilled in the art from the foregoing disclosure, and such variations or modifications are intended to be within the scope of the present disclosure.

Claims

1. A medical device comprising a handle portion and an insertion portion, further comprising a traction assembly, the traction assembly comprising:

a fixing ring, and

2. The medical device according to claim 1, wherein the insertion portion includes a multi-lumen tube having a plurality of lumens formed along an axial direction thereof, and the fixing ring has through holes formed therein corresponding to the plurality of lumens.

3. The medical device of claim 2, wherein the plurality of lumens include a plurality of draw wire holes therein in a number corresponding to the number of draw wires, wherein the through holes of the securing ring include mounting holes therein in a one-to-one correspondence with the draw wire holes, and wherein the draw wires pass through the mounting holes and draw wire holes such that the securing ring of the draw assembly contacts an end of the multi-lumen tube.

4. A medical device according to claim 3, wherein the pulling wire holes are evenly arranged along the circumference of the multi-lumen tube.

5. A medical device according to claim 3, wherein one end of the traction wire is provided with a plug, the plug being larger in size than the mounting hole of the fixing ring, and the plug being located on one side of the fixing ring, and the other end of the traction wire being located on the other side of the fixing ring.

6. The medical device of claim 1, wherein one end of the pull wire is secured to the securing ring by a spot welding process.

7. A medical device according to claim 3, wherein the central axis of the mounting hole of the securing ring coincides with the central axis of the pulling wire hole of the multi-lumen tube when the pulling assembly is mounted to the multi-lumen tube.

8. A method of manufacturing a medical device according to any one of claims 1 to 7, comprising:

preparing a traction assembly, and

9. The method of preparing a medical device according to claim 8, wherein preparing a traction assembly comprises:

10. The method of making a medical device according to claim 9, wherein at least a portion of the pull wire is positioned within the mounting hole; and/or one end of the traction wire is fixed on the fixing ring through a spot welding process.