Sheath tube body and guiding sheath tube for bronchoscope
By incorporating a composite layer design with spiral grooves and embedded springs within the sheath, the problems of high resistance and easy collapse when bending the bronchoscope guide sheath are solved, achieving excellent resistance to bending and collapse and good instrument passage.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHENZHEN INSIGHTERS MEDICAL TECH CO LTD
- Filing Date
- 2024-12-25
- Publication Date
- 2026-04-17
AI Technical Summary
The bronchoscope guide sheath has high bending resistance and is prone to bending and collapse, which affects the passage of other instruments.
A sheath tube body was designed, comprising a composite layer. The inner tube layer has a spiral groove, a spring is embedded in it, and it is covered by a covering layer. The spaces between the spiral grooves are straight sections to enhance elasticity and strength, disperse bending force, and reduce bending stress.
This improved the sheath's resistance to bending and collapse, ensuring the instrument's passability and inspection efficiency.
Smart Images
Figure CN224126402U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of guide tubes for bronchoscopy, specifically to a sheath tube body and a guide sheath for bronchoscopy. Background Technology
[0002] Bronchoscopy is an accurate diagnostic procedure. During bronchoscopy, due to the complex structure of the bronchi in the human lungs, and the tortuous and narrow distal bronchial passages, the insertion length of a conventional bronchoscope is limited, and its outer diameter is relatively large, limiting the lesion locations that can be reached. Therefore, a guiding sheath is used in bronchoscopy. The bronchial guiding sheath is a long, thin, hollow sheath used to deliver other instruments used in bronchoscopic diagnosis and treatment. Because of its long and thin structure, the guiding sheath can enter the bronchoscope's biopsy channel and reach lesions further and deeper into the bronchus, thus enabling the examination of distal lesions.
[0003] Because the proximal and distal ends of the bronchoscope are bent during surgery, the straight guide sheath faces greater resistance when used, and there is a risk of bending and collapse at the bends of the bronchoscope, which can affect the passage of other instruments. Utility Model Content
[0004] This invention provides a sheath body and a bronchial guide sheath to solve the technical problems of high bending resistance and easy bending and collapse of the bronchoscope guide sheath.
[0005] Firstly, this utility model provides a sheath tube body.
[0006] A sheath tube body, wherein the distal end of the sheath tube body is an insertion end for insertion into the human body, and the proximal end has a connector connection structure for connecting a sheath tube connector. The sheath tube body has a composite layer segment located between the distal end and the proximal end. The composite layer segment includes an inner tube layer on the radially inner side, a spring in the middle, and a covering layer on the outer side. The outer surface of the inner tube layer is provided with a spiral groove, and the spring is embedded in the spiral groove. The covering layer covers the inner tube layer and the outer side of the spring. There is a straight section between the spiral grooves, and the outer peripheral surface of the straight section is cylindrical.
[0007] In one technical solution, the ratio of the length of the straight section to the width of the spiral groove is not less than 1.5:1.
[0008] In one technical solution, the sheath tube body has a proximal tube section located on the side of the composite layer section near the proximal end. The proximal tube section is integrally formed with the inner tube layer of the composite layer section, and the proximal tube section and the inner tube layer are transitioned by a slope structure. The groove wall of the spiral groove is transitioned with the slope structure by a rounded corner structure.
[0009] In one technical solution, in the cross-section of the sheath body through the center line, the angle between the outline of the inclined structure and the center line of the sheath body is between 10° and 14°.
[0010] In one technical solution, the sheath body has at least two composite segments, one of which is a first composite segment and the other is a second composite segment. The first composite segment and the second composite segment are arranged at intervals, so that when the sheath body is in use, the first composite segment can be bent at the human bronchus and the second composite segment can be bent at the human larynx.
[0011] In one technical solution, the sheath tube body includes a imaging ring embedded at the distal end for imaging and positioning the distal end of the sheath tube body under X-ray, and the imaging ring is arranged at intervals with adjacent composite layer segments.
[0012] In one technical solution, the inner tube layer of the composite segment is integrally formed with the other tube segments of the sheath tube body, and the material is a high molecular plastic with a hardness between 50D and 90D.
[0013] In one technical solution, the spring is made of at least one of stainless steel, nickel-titanium alloy, and spring steel.
[0014] In one technical solution, the Shore hardness of the coating layer is between 20A and 100A, and the material is at least one of silicone rubber, fluororubber, polyurethane adhesive, Pebax, TPU, acrylic adhesive, epoxy adhesive, and PE material.
[0015] Secondly, this utility model provides a guide sheath for a bronchoscope.
[0016] A bronchoscope guide sheath, comprising:
[0017] The sheath connector has a central channel, with one end for inserting external instruments and the other end for connecting to the sheath body.
[0018] The distal end of the sheath tube is an insertion end for insertion into the human body, and the proximal end has a connector structure for connecting the sheath tube connector. The sheath tube has a composite layer section located between the distal end and the proximal end. The composite layer section includes an inner tube layer on the radially inner side, a spring in the middle, and a covering layer on the outer side. The outer surface of the inner tube layer is provided with a spiral groove, and the spring is embedded in the spiral groove. The covering layer covers the inner tube layer and the outside of the spring. There is a straight section between the spiral grooves, and the outer peripheral surface of the straight section is cylindrical.
[0019] In one technical solution, the ratio of the length of the straight section to the width of the spiral groove is not less than 1.5:1.
[0020] In one technical solution, the sheath tube body has a proximal tube section located on the side of the composite layer section near the proximal end. The proximal tube section is integrally formed with the inner tube layer of the composite layer section, and the proximal tube section and the inner tube layer are transitioned by a slope structure. The groove wall of the spiral groove is transitioned with the slope structure by a rounded corner structure.
[0021] In one technical solution, in the cross-section of the sheath body through the center line, the angle between the outline of the inclined structure and the center line of the sheath body is between 10° and 14°.
[0022] In one technical solution, the sheath body has at least two composite segments, one of which is a first composite segment and the other is a second composite segment. The first composite segment and the second composite segment are arranged at intervals, so that when the sheath body is in use, the first composite segment can be bent at the human bronchus and the second composite segment can be bent at the human larynx.
[0023] In one technical solution, the sheath tube body includes a imaging ring embedded at the distal end for imaging and positioning the distal end of the sheath tube body under X-ray, and the imaging ring is arranged at intervals with adjacent composite layer segments.
[0024] In one technical solution, the inner tube layer of the composite segment is integrally formed with the other tube segments of the sheath tube body, and the material is a high molecular plastic with a hardness between 50D and 90D.
[0025] In one technical solution, the spring is made of at least one of stainless steel, nickel-titanium alloy, and spring steel.
[0026] In one technical solution, the Shore hardness of the coating layer is between 20A and 100A, and the material is at least one of silicone rubber, fluororubber, polyurethane adhesive, Pebax, TPU, acrylic adhesive, epoxy adhesive, and PE material.
[0027] The beneficial effects of this utility model are as follows:
[0028] This invention relates to a bronchoscope guide sheath with a composite section located between the distal and proximal ends. During use, the composite section can be positioned at the bends of the airway. Due to the annular groove on the inner tube of the composite section, it is easy to bend. Furthermore, the spring enhances the elasticity of the composite section and the strength of the lumen. Combined with the effect of the straight section in dispersing bending forces, it reduces the bending stress of the sheath, giving the composite section excellent resistance to bending and collapse, thus ensuring the passage of the instrument. Attached Figure Description
[0029] Figure 1This is a comparison diagram of the structure of the bronchoscope guide sheath in one embodiment of the present invention before and after deformation.
[0030] Figure 2 This is a cross-sectional view of one embodiment of the bronchoscope guide sheath of this utility model;
[0031] Figure 3 This is a partial cross-sectional view of the sheath body in one embodiment of the bronchoscope guide sheath of this utility model;
[0032] Figure 4 A schematic diagram of the structure after omitting the spring and the covering layer in the sheath tube body;
[0033] Figure 5 for Figure 3 Enlarged view of a portion of point A in the middle;
[0034] Figure 6 for Figure 4 Enlarged view of a section at point B in the middle;
[0035] Figure 7 This is a schematic diagram of the bent state of a bronchoscope guide sheath of this utility model when used in a human bronchus.
[0036] Figure 8 This is a schematic diagram of the bent state of one embodiment of the bronchoscope guide sheath of this utility model when used in the human body;
[0037] Figure 9 This is a schematic diagram of the end connector of the bronchoscope guide sheath in one embodiment of the present invention.
[0038] Figure 10 This is a schematic diagram of the sheath connector in one embodiment of the bronchoscope guide sheath of this utility model.
[0039] 100. Sheath body; 101. Composite layer; 1011. Inner tube layer; 10111. Spiral groove; 10112. Threaded structure; 101121. Cylindrical surface; 1012. Spring; 1013. Covering layer; 102. Proximal tube segment; 103. Inclined structure; 104. Rounded corner structure; 105. Imaging ring; 106. Trumpet-shaped structure; 107. Lumen;
[0040] 200. Sheath connector; 201. Channel; 202. Connecting structure; 203. Connecting section; 2031. Annular groove; 2011. Large diameter section; 2012. Small diameter section; 2013. Transition section;
[0041] 300, Positioning Ring
[0042] 400. Human body; 401. Bronchi; 402. Pharynx;
[0043] 500. Bronchoscope. Detailed Implementation
[0044] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.
[0045] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments, and the operational steps involved in each embodiment can also be rearranged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the specification and drawings are only for clearly describing a particular embodiment and do not imply that they represent the necessary components and / or order.
[0046] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).
[0047] In this invention, the bronchoscope guide sheath has a composite section between its two ends. The inner tube of the composite section has a spiral groove, which makes the composite section easy to bend. At the same time, the spring improves the elasticity of the composite section and the strength of the lumen. The straight section can disperse the bending force when bending, so that the composite section has good resistance to bending and collapse.
[0048] One embodiment of the bronchoscopic guiding sheath in this utility model:
[0049] Please refer to Figure 1 and Figure 2 The bronchoscopic guiding sheath includes a sheath body 100, a sheath connector 200, and a positioning ring 300 fitted onto the sheath body 100. The sheath body 100 has a distal end for insertion into the human body and a proximal end closer to the operator. Between the distal and proximal ends of the sheath body 100 is a composite segment 101, which is easily bendable. Figure 1As shown in the dashed line, the composite layer 101 also has good anti-bending and anti-collapse performance.
[0050] For details regarding the structure of composite segment 101, please refer to [link / reference]. Figure 3 and Figure 4 The inner layer of the composite section 101 is an inner tube layer 1011. The outer diameter of the inner tube layer 1011 is smaller than the outer diameter of other sections of the sheath tube 100. The outer circumferential surface of the inner tube layer 1011 has a spiral groove 10111. The composite section 101 also has a spring 1012 wound in the spiral groove 10111. In order to ensure the smoothness of the outer circumferential surface of the sheath tube 100, the composite section 101 also includes a covering layer 1013 covering the inner tube layer 1011 and the spring 1012, which is used to fix the spring 1012 and the inner tube layer 1011 together and prevent the coil of the spring 1012 from coming out. The hardness of the covering layer is between 20A and 100A.
[0051] Since a spiral groove 10111 is formed on the outer circumferential surface of the inner tube layer 1011, a threaded structure 10112 is naturally formed on the outer circumferential surface of the inner tube layer 1011. Please refer to [reference needed]. Figure 5 and Figure 6 The spiral groove 10111 has a relatively large pitch, and the thread structure 10112 is a straight section with a cylindrical outer surface 101121 on the outer circumference. This gives the thread structure 10112 good bending force dispersion ability, preventing bending force from concentrating at one point and causing the sheath tube body 100 to easily bend and collapse when the composite layer section 101 bends. The spring 1012 enhances the elasticity of the composite layer section 101 and the strength of the lumen, further ensuring that the sheath tube body 100 is not easily bent and collapsed when bending at the composite layer section 101.
[0052] In one embodiment, please refer to Figure 6 The ratio of the length L1 of the straight section to the width L2 of the spiral groove 10111 is 1.6. In other embodiments, the ratio of the length L1 of the straight section to the width L2 of the spiral groove 10111 can be less than 1.6, such as 1.5, or greater than 1.6, such as 1.7, 1.8, etc., as long as the technical performance index of the composite layer section 101 is easy to bend but not easy to bend and collapse is met.
[0053] Please refer to Figure 6The section of the sheath tube 100 located on the side of the composite layer 101 near the proximal end is called the proximal tube section 102. The proximal tube section 102 is integrally formed with the inner tube layer 1011, and the transition between the two is a sloped structure 103. The sloped structure 103 and the groove wall of the spiral groove 10111 are transitioned by a rounded corner structure 104. In this way, the end of the covering layer 1013 has the largest possible amount of adhesion between the inner tube layer 1011 and the proximal tube section 102, thereby improving the adhesion strength between the covering layer 1013 and the inner tube layer 1011 and the proximal tube section 102 and preventing the end of the covering layer 1013 from lifting.
[0054] In one embodiment, please refer to Figure 6 For the cross section of the sheath body 100 passing through the centerline, the angle R between the outline of the inclined structure 103 and the centerline of the sheath body 100 is 12°. In other embodiments, it can be less than 12°, such as 11°, 10°, etc., or greater than 12°, such as 13°, 14°, etc.
[0055] Please refer to Figure 1 and Figure 2 The sheath body 100 has two spaced-apart composite segments 101. One composite segment, located closer to the distal end, is the first composite segment, with a length between 100 and 300 mm. The other composite segment, located closer to the proximal end, is the second composite segment, with a length between 50 and 200 mm. Please refer to [reference needed]. Figure 7 and Figure 8 When in use, the first composite layer is inserted into the bronchus 401 of the human body 400 and forced to bend, and the second composite layer is inserted into the pharynx 402 and forced to bend.
[0056] The additional designations of "first" and "second" for the two composite segments 101 are intended to distinguish them from those at different locations, and do not indicate a difference in their structures. Alternatively, the composite segment closer to the distal end can be designated as the "first composite segment," and the composite segment closer to the proximal end as the "second composite segment." In other embodiments, the sheath body may include three or more composite segments; alternatively, it may have only one composite segment, which corresponds to the human pharynx.
[0057] To facilitate identification of the insertion position of the distal end of the sheath body 100 within the human body, the sheath body 100 also includes a radiopaque ring 105 located at the distal end. The radiopaque ring 105 and the adjacent composite layer segment 101 are arranged at intervals along the length of the sheath body 100. The material can be platinum-iridium alloy or tungsten steel. During use, the distal end of the sheath body 100 can be located by radiopaque imaging under X-ray. Regarding the installation method of the radiopaque ring 105 within the sheath body 100, it can be bonded to the inner wall of the sheath body 100 or pressed and fixed to the inner wall of the sheath body 100. Those skilled in the art will understand that the lumen 107 of the sheath body 100 can be used to deliver other diagnostic, therapeutic, or other external instruments. The inner diameter of the sheath body 100 can be between 1.0 and 5.0 mm, and the outer diameter can be between 1.2 and 6.0 mm.
[0058] In one embodiment, the tube segments of the sheath body 100 located on both sides of the composite layer segment 101 are integrally formed with the inner tube layer 1011 of the composite layer segment 101, ensuring the smoothness of the inner wall of the lumen 107. The material can be made of PTFE, ePTFE, FEP, PA, Pebax, PE, or other polymer plastics with a hardness between 50D and 90D. It can be a single material or a mixture of multiple materials. The spring 1012 is made of at least one of stainless steel, nickel-titanium alloy, and spring steel. The coating layer 1013 can be formed by rheological coating of one or more of the following materials: silicone rubber, fluororubber, polyurethane adhesive, Pebax, TPU, hard acrylic adhesive, epoxy adhesive, and PE. In terms of shape, the formed coating layer 1013 has a tubular structure.
[0059] In one embodiment, the groove wall of the spiral groove 10111 and the tooth crest of the thread structure 10112 are rounded to further increase the amount of adhesion between the covering layer 1013 and the inner tube layer 1011, thereby improving the adhesion strength.
[0060] For connection with the sheath connector 200, the proximal end of the sheath body 100 has a connector connection structure. In one embodiment, please refer to... Figure 9 The connector connection structure is a flared structure 106 at the proximal end of the sheath tube body 100.
[0061] The sheath connector 200 can be made of plastic or metal. For the structure of the sheath connector 200, please refer to [reference needed]. Figure 10The sheath connector 200 has a central channel 201. One end of the channel 201 is for inserting an external instrument, and the other end is for connecting to the lumen 107 of the sheath body 100. In terms of external structure, the outer circumferential surface of the end of the sheath connector 200 for inserting the external instrument has a connecting structure 202 for connecting to the external instrument, and the other end has a connecting section 203 for connecting to the sheath body 100. The connecting section 203 has a frustum-shaped structure, and the outer circumferential surface of the small-diameter end of the frustum-shaped structure has an annular groove 2031. The depth of the annular groove 2031 is the same as the wall thickness of the sheath body 100. During assembly, the trumpet-shaped structure 106 of the sheath body 100 is inserted into the annular groove 2031, so that the outer wall of the connecting section 203 is flush with the outer wall of the trumpet-shaped structure 106 of the sheath body 100.
[0062] In other embodiments, the connector connection structure of the sheath tube body 100 can also be other structural forms, such as forming a threaded structure on the inner wall surface of the proximal end of the sheath tube body. Correspondingly, the end of the sheath tube connector connected to the sheath tube body is a threaded tube section with external threads. During assembly, the sheath tube body and the sheath tube connector are screwed together.
[0063] For the structure of channel 201 of sheath connector 200, please refer to Figure 10 The channel 201 has a large-diameter section 2011 at one end for inserting external instruments, and a small-diameter section 2012 at the other end for connecting to the lumen 107 of the sheath body 100. The diameter of the small-diameter section 2012 is equal to the diameter of the lumen 107 of the sheath body 100. The end of the channel 201 between the large-diameter section 2011 and the small-diameter section 2012 is a transition section 2013 with a gradually changing diameter. Thus, when inserting external instruments into the bronchoscope guide sheath, the external instruments first enter the large-diameter section 2011. Then it is fed inward. During the feeding process, the transition section 2013 can guide the end of the external instrument to smoothly enter the small diameter section 2012. Since the small diameter section 2012 and the lumen 107 of the sheath body 100 have the same diameter, the external instrument can smoothly enter the lumen 107 of the sheath body 100 after entering the small diameter section 2012. This avoids the external instrument from generating a pushing force on the sheath body 100 when it enters the sheath body 100 from the sheath connector 200, thus ensuring the reliability of the connection between the sheath body 100 and the sheath connector.
[0064] In one embodiment, please refer to Figure 10The length of the small-diameter section 2012 extending along the centerline of the sheath connector 200 is the same as the dimension of the annular groove 2031 extending along the centerline of the sheath connector 200. This results in a thicker wall for the sheath connector forming the transition section 2013. A thicker wall naturally results in higher strength, improving the ability of the transition section 2013 to resist impacts from external instruments when guiding them. In other embodiments, the length of the small-diameter section extending along the centerline of the sheath connector 200 can be greater than the dimension of the annular groove 2031 extending along the centerline of the sheath connector 200, thus resulting in an even thicker wall for the transition section.
[0065] The positioning ring 300 is a hollow ring structure made of silicone or rubber, which has elastic deformation capability. The positioning ring 300 is elastically clamped to the outer wall of the sheath body 100. When in use, the position of the positioning ring 300 on the sheath body 100 can be adjusted in advance to determine the depth to which the sheath body 100 is inserted into the human body 400.
[0066] Please refer to the following when using it. Figure 7 and Figure 8 When the bronchoscope 500 is used routinely, due to the structural characteristics of the human body 400, it is inserted into the bronchus through the mouth. It will bend at approximately 90° in the pharynx 402 and also needs to be bent when entering the bronchus. The bronchoscope guide sheath is inserted into the biopsy channel of the bronchoscope 500. The distal end of the sheath body 100 exits from the distal end of the bronchoscope 500. Based on the structural design of the sheath body 100 with two composite segments 101, the sheath body 100 bends but does not collapse when it is in the pharynx 402 and when it enters the bronchus 401. When used with the bronchoscope 500, the passageway can be maintained without being affected by the bend. This helps biopsy forceps or other instruments to accurately and quickly reach the lesion location and improve examination efficiency.
[0067] In this utility model, the sheath body has the same structure as the bronchial guide sheath in the above embodiments, and will not be described again here.
[0068] The above-described specific examples are for illustrative purposes only and are not intended to limit the scope of this invention. Those skilled in the art to which this invention pertains can make various simple deductions, modifications, or substitutions based on the concept of this invention.
Claims
1. A sheath tube, characterized by, The distal end of the sheath tube is an insertion end for insertion into the human body, and the proximal end has a connector structure for connecting the sheath tube connector. The sheath tube has a composite layer section located between the distal end and the proximal end. The composite layer section includes an inner tube layer on the radially inner side, a spring in the middle, and a covering layer on the outer side. The outer surface of the inner tube layer is provided with a spiral groove, and the spring is embedded in the spiral groove. The covering layer covers the inner tube layer and the outside of the spring. There is a straight section between the spiral grooves, and the outer peripheral surface of the straight section is cylindrical.
2. The sheath tube of claim 1, wherein, The ratio of the length of the straight section to the width of the spiral groove is not less than 1.5:
1.
3. The sheath tube of claim 1 or 2, wherein The sheath tube has a proximal tube section located on the side of the composite layer section near the proximal end. The proximal tube section is integrally formed with the inner tube layer of the composite layer section, and the proximal tube section and the inner tube layer are transitioned by a slope structure. The groove wall of the spiral groove is transitioned by a rounded corner structure.
4. The sheath tube of claim 3, wherein, In the cross-section of the sheath body through the center line, the angle between the outline of the inclined structure and the center line of the sheath body is between 10° and 14°.
5. The sheath tube of claim 1 or 2, wherein The sheath has at least two composite segments, one of which is a first composite segment and the other is a second composite segment. The first composite segment and the second composite segment are arranged at intervals, so that when the sheath is in use, the first composite segment can be bent at the bronchus and the second composite segment can be bent at the larynx.
6. The sheath tube of claims 1 or 2, wherein, The sheath tube includes a developing ring embedded at the distal end for developing and positioning the distal end of the sheath tube under X-ray. The developing ring is arranged at intervals with adjacent composite layer segments.
7. The sheath tube of claims 1 or 2, wherein The inner tube layer of the composite section is made of a high-molecular plastic with a hardness between 50D and 90D.
8. The sheath tube of claims 1 or 2, wherein, The spring is made of any one of stainless steel, nickel-titanium alloy, or spring steel.
9. The sheath tube of claims 1 or 2, wherein, The Shore hardness of the coating layer is between 20A and 100A, and the material is any one of silicone rubber, fluororubber, polyurethane adhesive, Pebax, TPU, acrylic adhesive, epoxy adhesive, and PE material.
10. A guide sheath for bronchoscopy, characterized by, include: The sheath connector has a central channel, with one end for inserting external instruments and the other end for connecting to the sheath body. The sheath body is the sheath body as described in any one of claims 1-9.