Medical catheter with neck capsule medicine storage

Abstract

A neck-sac-type drug-reservoir medical catheter includes a catheter head, a catheter middle section, and a catheter tail. The catheter neck is located between the catheter head and the catheter middle section. The outer diameter of the catheter neck is smaller than that of the catheter head, forming a neck depression. At least one neck sac, which is embedded in or can be embedded in the neck depression, is circumferentially connected to the catheter neck. The neck sac consists of a neck sac connecting portion and a neck sac free portion. The neck sac connecting portion is sealed to the outer surface of the catheter. The gap between the inner surface of the neck sac and the outer surface of the catheter neck is the neck sac internal space. The neck sac internal space has an opening that communicates with the external fluid passage. An annular recess formed by the outer surface of the neck sac embedded in the catheter neck depression or by the catheter portion extending beyond the neck is the neck sac internal cavity, which can be used to contain drugs.

Description

Technical Field

[0001] This invention relates to a neck-shaped drug-carrying medical catheter, belonging to the field of medical device product technology. Background Technology

[0002] Medical catheters are thin tubes made of medical-grade materials and have a wide range of functions. They can be inserted into body cavities, blood vessels, the brain, or adipose tissue to assist in drainage, administration of liquid or solid drugs, and placement of surgical instruments. Special types of medical catheters can also be used in preclinical or clinical research to sample living biological components such as neurotransmitters, peptides and proteins, antibodies, nanoparticles and nanocarriers, enzymes, and vesicles.

[0003] When medical catheters are inserted into specific sites in a living organism, they can be used as gastric tubes, urinary catheters, suction catheters, biliary drainage tubes, ventricular drainage tubes, and vascular stenosis dilators. In all these cases, they must be inserted into the natural cavities, blood vessels, or pathological sinus tracts of the living organism. Medical catheters often encounter resistance when traveling through the natural channels of a living organism, including natural stenosis, pathological stenosis, and stenosis caused by reflexive contraction of smooth muscle. Usually, a lubricant is applied to the surface of the medical catheter before insertion, but the lubricant is usually completely lost when it reaches the stenosis. When the catheter tip is forced through the stenosis, it can cause severe shearing damage or even perforation of the body tissue. Even if the insertion is successful, the artificial damage to the local tissue can easily lead to secondary microbial infections, and it is impossible to accurately and continuously administer medication to the stenosis.

[0004] For stenosis caused by pathological reasons such as scarring, edema, or blood clotting, the best approach is to precisely release lubricant, corticosteroids, anesthetics, or anticoagulants through the catheter tip when the catheter reaches the stenosis. If severe stenosis is encountered during catheter travel and precise lubrication alone is ineffective, the catheter tip should be used to extend the stenotic stenosis tissue to facilitate passage. After the catheter tip has successfully passed through, the catheter neck stenosis should be precisely located to continuously expand the stenotic tissue and administer medication for targeted therapy.

[0005] This invention provides a neck-filled drug-carrying medical catheter. Narrowed tissue can be easily embedded into the neck depression of the catheter. After the neck sac expands, it can precisely widen the narrow area. The inner cavity of the neck sac can hold drugs. After the catheter encounters a narrow natural cavity or passes through smoothly, it can precisely release drugs for targeted treatment of lesions in the narrow area. Summary of the Invention

[0006] The objective of this invention is achieved as follows:

[0007] A neck-type drug-reservoir medical catheter includes a catheter head, a catheter middle section, and a catheter tail. A catheter neck is located between the catheter head and the catheter middle section. The outer diameter of the catheter neck is smaller than that of the catheter head, forming a neck recess. At least one neck sac, which can be embedded in or embedded in the neck recess, is circumferentially connected to the catheter neck. The neck sac consists of a neck sac connecting portion and a free neck sac portion. The neck sac connecting portion is sealed to the outer surface of the catheter. The gap between the inner surface of the neck sac and the outer surface of the catheter neck is called the neck sac internal space. The neck sac internal space has an opening that communicates with external fluid pathways. The annular recess formed by the outer surface of the concave neck sac or the portion of the catheter connected to the neck is the inner cavity of the neck sac. The inner cavity of the neck sac can be used to contain drugs. The outer edge opening of the inner cavity of the neck sac faces outward from the catheter. In use, when external fluid enters the fluid passage of the inner cavity of the neck sac, it enters the inner cavity of the neck sac through the opening of the inner cavity of the neck sac. The volume of the inner cavity of the neck sac increases. The external fluid compresses the inner surface of the neck sac, causing the volume of the inner cavity of the neck sac to decrease. The inner cavity of the neck sac may also disappear as the free part of the neck sac completely bulges out from the concave neck of the catheter. When the inner cavity of the neck sac contains drugs, the drugs contained in the inner cavity of the neck sac can be released.

[0008] The statement that the outer diameter of the catheter neck is smaller than the outer diameter of the catheter head means that the average outer diameter of the catheter neck is smaller than the average outer diameter of the catheter head.

[0009] The phrase "at least a portion of the free part of the neck sac is embedded in the neck recess of the catheter" means that the free part of the neck sac can be completely or partially embedded in the neck recess of the catheter; in the case of partial embedding, it means that the portion of the free part of the neck sac protruding outside the neck recess and the portion of the outer surface of the sac embedded in the neck recess together participate in forming the inner cavity of the neck sac of the catheter.

[0010] Depending on the degree of compression, the free part of the neck cyst may bulge completely out of the neck depression or only partially out of the neck depression, thus reducing or completely eliminating the internal cavity of the neck cyst.

[0011] To facilitate smoother passage of the catheter through narrow passages, the catheter tip is equipped with a head recess and a head sac. The head recess is formed by circumferentially distributed head sidewalls. The head sac consists of a head sac connecting part and a head sac free part. The head sac connecting part is sealed to the catheter tip, and at least a portion of the head sac free part is embedded in the catheter head recess. The gap between the inner surface of the head sac and the catheter head recess is called the lower head sac gap. The lower head sac gap has an opening that communicates with the external fluid passage. The pouch-like gap formed by the outer surface of the head sac embedded in the catheter head recess is the head sac inner cavity, which can be used to contain drugs. The opening of the head sac inner cavity faces outward from the head recess.

[0012] Another structural design for the catheter tip depression involves a circumferential ring that folds together to form a flap-like head sidewall. The head sidewall consists of at least two sidewall flaps, with the tops of the sidewall flaps being free and the bottoms connected. A gap is left between adjacent sidewall flaps. The tops of the free sidewall flaps can be located within the gap under the head capsule or outside the head capsule. This design allows the head capsule to bulge more easily when encountering a narrow passage, releasing the drug and expanding the capsule within the head capsule cavity. The gap between the sidewall flaps can also accommodate the drug.

[0013] The release of the drug contained in the cavity of the neck cyst and / or the cavity of the head cyst includes situations such as squeezing out, pushing out, and ejecting the drug; the drug can be selected from various dosage forms, such as solid drugs in the form of fine granules, spheres, or capsules, or gels, liquids, ointments, etc. with different physicochemical components; when the free part of the neck cyst bulges out of the neck depression and / or the free part of the head cyst bulges out of the head depression, the outer surface of the expanding neck cyst and / or the outer surface of the head cyst can continue to push the drug outward; the cyst can be made of non-compliant, partially compliant, or compliant materials; when the cyst is compliant, the expansion of the cyst after expansion is particularly sufficient for the expansion of narrow natural cavities and the application of the drug.

[0014] To enable continuous drug delivery and to distribute the drug evenly to the narrowed biological tissue during neck sac expansion, the system also includes a neck sac internal cavity fluid opening located within the neck sac internal cavity. The neck sac internal cavity fluid opening is connected to the outside of the catheter via a neck sac internal cavity fluid passage. When the neck sac retracts to the neck depression, the drug is continuously injected into the neck sac internal cavity through the neck sac internal cavity fluid opening, and the drug is evenly distributed on the target biological tissue when the neck sac expands again.

[0015] To facilitate the procedural expansion and compression of the narrowed biological tissue, the catheter neck is provided with two overlapping neck sacs. The outer neck sac is fitted over the inner neck sac, and the inter-sac cavity between the outer and inner neck sacs is connected to the inter-sac fluid passage through the inter-sac fluid opening.

[0016] To facilitate the expansion of the neck sac, a hollow elastic sac is also included, which is fitted onto the middle part of the catheter at or near the tail of the catheter. The internal space of the elastic sac is connected to the fluid passage in the interstitial space of the neck sac. Squeezing the elastic sac can inject the fluid inside the elastic sac into the interstitial space of the neck sac.

[0017] To facilitate flushing and lubrication of the natural cavities, the catheter tip is provided with at least one head fluid opening, which communicates with the inner lumen of the catheter or with the outside of the catheter through a head fluid passage in the catheter wall. When the catheter travels in the natural cavities, the head fluid opening can assist in drainage and flushing of the natural cavities, can continuously inject liquid drugs from the outside of the catheter through the head fluid opening, and can also be used to sample and study the biological living components in the natural cavities.

[0018] Another structure of the neck cyst is an eccentric structure with uneven wall thickness. The eccentric structure with uneven wall thickness of the neck cyst refers to the fact that the free part of the neck cyst can expand due to the continuous entry of external fluid into the interstitial space of the neck cyst to form an eccentric structure.

[0019] To facilitate fluid drainage, the catheter also includes an inner opening located below the neck of the catheter and an outer opening located at the tail of the catheter, both of which are in fluid communication with the inner lumen of the catheter.

[0020] The catheter's internal and external openings are in fluid communication with the catheter's internal lumen. This means that when the catheter's internal opening enters a natural cavity or other biological tissue, it can be used for purposes such as draining urine from the bladder to the outside (e.g., as a urinary catheter), aspirating sputum from the airway to the outside (e.g., as a suction catheter), aspirating gastric juice to the outside (e.g., as a gastrointestinal decompression tube), and injecting nutrient solution into the stomach (e.g., as a nasogastric feeding tube). The embedded structure of the catheter neck can release lubricants, anesthetics, acid-base regulators, receptor blockers or agonists, chemotherapy drugs, antibiotics, glucocorticoids, and other drugs through the balloon during catheter insertion. Furthermore, when the neck balloon is inflated, it can expand narrow passages such as natural cavities to facilitate catheter passage, such as through the nasopharynx, enlarged prostate, esophagus, or narrow airway.

[0021] To continuously expand the biological tissue at the narrow point of the natural cavity, a fixed cuff and / or an expansion cuff are also included below the neck of the catheter. When the expansion cuff travels to the narrow point of the natural cavity that has been pre-expanded by the cuff body at the neck of the catheter, fluid is injected into the fluid passage of the expansion cuff in the catheter body. The fluid enters the inner lumen of the expansion cuff and inflates it, thus expanding the corresponding biological tissue at the narrow point of the natural cavity.

[0022] The fixed cuff and / or dilating cuff can be one or more; the dilating cuff can be used for dilation treatment of urethral scar stricture, benign prostatic hyperplasia, ureteral stricture, bile duct stricture, fallopian tube stricture, and local airway strictures of various levels, and can also be used for dilation of various surgical sinuses. The difference between this dilation and current technology is that when the catheter tip passes through the narrow passage, the embedded structure of the cuff in the tip minimizes shear damage. The subsequent dilation treatment with the dilating cuff is performed on the premise that the inner surface of the natural cavity is intact, resulting in minimal tissue damage.

[0023] To support the biological tissue corresponding to the narrowing, a stent expansion cuff is also included, which is placed below the neck of the catheter. When the stent expansion cuff travels to the narrowing part of the natural cavity that has been pre-expanded by the cuff body of the catheter neck, fluid is injected into the fluid passage of the stent expansion cuff in the catheter body. The fluid enters the inner cavity of the stent expansion cuff and inflates the stent expansion cuff. The stent that was pre-installed outside the stent expansion cuff is expanded, thereby supporting the biological tissue corresponding to the narrowing.

[0024] The stent expansion cuff is preferably made of a non-compliant material. The difference between the method of opening the stent and the current technology is that the current technology usually involves first inserting a dilator to expand the narrowed biological tissue, then removing the dilator and inserting a catheter with the stent attached, which is a cumbersome process. In contrast, the present invention allows the catheter to expand the narrowed biological tissue after the neck sac is filled when passing through the narrowed biological tissue, thus minimizing shear damage. Subsequently, the stent expansion cuff is filled, directly opening the stent attached to it. The two steps of first inserting the dilator and then inserting the stent-attached catheter in the current technology are completed in one step, reducing patient injury and improving medical efficiency.

[0025] To prevent possible adhesion between the inner surface of the neck bladder and the concave surface of the neck and / or between the inner surface of the head bladder and the concave surface of the head, an anti-adhesion structure and / or a filling medium are also included. The anti-adhesion structure may include a rib or groove. The filling medium may be pre-installed in the lower gap of the neck bladder and / or the lower gap of the head bladder to partially or completely block the contact between the inner surface of the bladder and the concave surface. The filling medium may be various types of lubricants, water, or even pre-filled gas.

[0026] The above orientation description is based on the catheter head facing the sky and the catheter tail facing the ground. That is, the catheter head is the top of the catheter and the catheter tail is the bottom of the catheter. The terms "upper part", "top", and "front part" in the text refer to the direction towards the top of the catheter, while "lower part", "bottom", and "rear part" refer to the direction towards the bottom of the catheter. Please refer to the attached diagram for specific details. In use, the catheter head, neck, and middle part are usually inserted into the living body's natural cavity, while the catheter tail is located outside the natural cavity.

[0027] The beneficial effects of this invention are:

[0028] 1. Tissue in the narrow part of the natural cavity is easy to embed into the neck depression of the catheter, and the neck sac can precisely press and expand the biological tissue in the narrow position.

[0029] 2. The neck capsule of the catheter can hold drug formulations, including liquid or gel-based therapeutic and lubricating drugs, and releases the drug precisely after the neck is recessed to reach the narrow position of the natural cavity.

[0030] 3. Once the neck depression reaches the narrow point of the natural cavity, the biological tissue at the narrow point is more easily embedded into the neck depression. The neck cyst expands and makes close contact with the biological tissue at the narrow point, which can fully spread the drug released from the inner cavity of the neck cyst while applying pressure to promote drug penetration into the biological tissue. Furthermore, when the neck cyst retracts back into the neck depression, lubricant and other drugs can be injected into the inner cavity of the neck cyst again through the fluid opening in the inner cavity of the neck cyst. When the neck cyst expands again, the drug can continue to be spread on the biological tissue. This operation can be repeated to ensure that the desired effect is achieved.

[0031] 4. Injecting lubricants or other medications into the fluid opening at the catheter tip helps the catheter tip pass smoothly through the most severe narrowing of the natural cavity; purified water or saline solution can also be injected through the fluid opening at the tip to flush the natural cavity; biological components within the natural cavity can also be extracted through the fluid opening at the tip for sampling and research.

[0032] 5. When a head depression and a head sac are set, the head depression can also accommodate different types of drugs, including lubricants and various therapeutic drugs; when the head sac expands biological tissue at the narrow point, releasing the expansion helps the catheter head pass through the narrow point smoothly.

[0033] 6. When setting up two overlapping neck sacs, the inner and outer sacs can be made of different materials, and the biological tissue at the narrowed area can be expanded by programmed pressure; for example, if a compliant material sac is used for expansion first, and then a semi-compliant or non-compliant material sac is used for expansion, the external pressure control system can have a pulsed pressure effect.

[0034] 7. During the advancement of the medical catheter, if resistance is encountered, the neck sac can be expanded radially to dilate the biological tissue. The dilation effect extends to the biological tissue near the catheter tip. The medical catheter is advanced when the cavity is temporarily widened after dilation. At this time, the catheter tip can pass through the newly dilated cavity more easily, avoiding shear damage caused by the forced advancement of the medical catheter tip and reducing the chance of secondary infection caused by shear damage, especially for medical catheters that need to be left in place for more than 24 hours. It also creates good natural cavity and vascular access conditions for the placement of various stents such as prostate stents and vascular stents that may be activated immediately after the medical catheter is inserted. Attached Figure Description

[0035] The following figures are not limited to the present invention:

[0036] Figure 1A Example 1: Three-dimensional schematic diagram of the neck cyst without expansion

[0037] Figure 1B Example 1: Three-dimensional schematic diagram of the neck cyst after expansion

[0038] Figure 1C Example 1: Cross-sectional view of the neck cyst without expansion

[0039] Figure 1D Schematic diagram of the catheter tip reaching the narrow part of the natural cavity.

[0040] Figure 1E : A diagram illustrating the narrowing of the natural cavity caused by the neck indentation

[0041] Figure 1F Schematic diagram of the tissue at the site of neck cyst dilation and narrowing.

[0042] Figure 2A : Three-dimensional schematic diagram of Example 2

[0043] Figure 2B : A diagram illustrating the indentation of the head reaching the narrow part of the natural cavity.

[0044] Figure 2C Schematic diagram of the tissue at the site of stenosis and dilation of the head cyst.

[0045] Figure 2D Schematic diagram of the tissue at the site of further expansion of the neck cyst.

[0046] Figure 3A : Three-dimensional schematic diagram of Example 3

[0047] Figure 3B Cross-sectional schematic diagram of Example 3

[0048] Figure 4A Example 4: Cross-sectional view of the neck cyst without expansion

[0049] Figure 4B Example 4: Cross-sectional view of the neck cyst after expansion

[0050] Figure 5A Example 5: Cross-sectional view of the neck cyst without expansion.

[0051] Figure 5B Example 5: Cross-sectional view of the neck cyst after expansion

[0052] Figure 6A Example 6: Schematic diagram of the narrowed area of ​​the dilating cuff.

[0053] Figure 6B : Three-dimensional schematic diagram of Example 6

[0054] Figure 7A Example 7: 3D schematic diagram of the support frame not fully extended.

[0055] Figure 7B Example 7: 3D schematic diagram of the support after it is opened Detailed Implementation

[0056] The embodiments of the present invention are not limited to the following:

[0057] Example 1:

[0058] like Figure 1A-1F As shown, a neck-type drug-reservoir medical catheter 1 includes a catheter head 11, a catheter middle portion 12, and a catheter tail 13. A catheter neck 14 is further provided between the catheter head 11 and the catheter middle portion 12. The outer diameter of the catheter neck 14 is smaller than that of the catheter head 11, thus forming a neck recess N. At least one neck sac 7 is circumferentially connected to the catheter neck 14, which is embedded in or can be embedded in the neck recess N. The neck sac 7 is preferably made of flexible materials such as silicone rubber or latex, and the wall thickness is preferably less than 0.5 mm. In this embodiment, the medical catheter 1 also includes... The catheter has an inner opening 101 located below the neck 14 and an outer opening 102 located at the tail 13. Both the inner and outer openings are in fluid communication with the inner lumen 10. The head 11 and neck 14 are connected to the catheter body 12 by a separate head and neck member H made of a preferred elastic material. The bottom section H111 of the head and neck member is inserted into the inner lumen 10. The bottom section H111 is provided with a conformal plug B to prevent the head and neck member from transitioning to the channel H1. 131 communicates with the inner lumen 10 of the catheter; the neck sac 7 is composed of a neck sac connecting part 71 and a neck sac free part 72. The neck sac connecting part 71 is sealed to the outer surface 15 of the catheter, which can be welded or bonded. In this example, the outer surface 15 of the catheter that is sealed to the neck sac connecting part 71 is the outer surface of the head and neck component H; the relative position of the neck sac connecting part 71 is fixed, while the neck sac free part 72 is not bonded to the outer surface 15 of the catheter and is prone to deformation under force; the inner surface 73 of the neck sac is connected to the neck of the catheter. The gap between the outer surfaces 154 of the neck capsule is the inner gap 70 of the neck capsule. The inner gap 70 of the neck capsule has an opening 700 that is in fluid communication with the outside. In this embodiment, the fluid passage 701 of the inner gap of the neck capsule is located inside the sidewall 16 of the catheter. The annular recess formed by the outer surface 74 of the neck capsule, which is embedded in the neck recess N of the catheter 1, or the catheter portion connected to the neck, is the inner cavity 75 of the neck capsule. The inner cavity 75 of the neck capsule can be used to contain the drug D. The outer edge opening of the inner cavity 75 of the neck capsule faces the outside of the catheter. Figure 1A-1CAs shown, in this embodiment, a hollow elastic bladder 3 is fitted on the catheter tail 13 or the middle part 12 of the catheter near the catheter tail 13. The internal space 30 of the elastic bladder is connected to the fluid passage 701 in the gap inside the neck bladder. Squeezing the elastic bladder 3 can inject the fluid in the internal space 30 of the elastic bladder into the gap 70 inside the neck bladder.

[0059] In this embodiment, the catheter head 11 is provided with at least one head fluid opening 1108. The head fluid opening 1108 communicates with the outside of the catheter 1 through a head fluid passage 1109 inside the catheter wall. A head and neck transition channel H1131 is provided on the independent head and neck component H and is sealed to the head fluid passage 1109. In use, such as Figure 1D As shown, when the medical catheter 1 is advanced within the natural cavity C of a living organism, upon reaching the narrow point C1, it is compressed by the inner surface C2 of the natural cavity. When advancement is obstructed, lubricant is injected into the head fluid opening 1108 through the head fluid passage 1109, allowing the catheter head 11 to easily pass through the narrow point C1. The head fluid opening 1108 can also be used to flush the natural cavity C or to sample and study the biological tissue within the natural cavity. As the medical catheter 1 gradually advances within the natural cavity C; Figure 1E As shown, the catheter neck indentation N reaches the narrow point C1. The external opening 31 of the elastic balloon is blocked with a finger while the elastic balloon 3 (not shown in the figure) is squeezed. Air in the elastic balloon cavity 30 enters the fluid passage 701 of the neck balloon internal space through the elastic balloon internal opening 1107, and then enters the neck balloon internal space 70 through the neck balloon internal space opening 700; as... Figure 1F As shown, the increased volume and pressure of the interstitial space 70 within the neck sac compress the inner surface 73 of the neck sac, causing the volume of the inner cavity 75 of the neck sac to decrease. The inner cavity 75 of the neck sac may also disappear as the free portion 72 of the neck sac completely bulges out of the neck recess N of the catheter 1. The liquid drug D contained in the inner cavity 75 of the neck sac flows out from the opening at the outer edge of the inner cavity 75 of the neck sac, eventually releasing the liquid drug D contained in the inner cavity 75 of the neck sac completely. At this time, the enlarged free portion 72 of the neck sac can expand and compress the inner surface C2 of the natural cavity, causing the narrow section C1 of the natural cavity to be opened. After the open state is maintained for several seconds or longer, the elastic sac 3 is released. At this time, the opened natural cavity C has not yet recovered. The medical catheter 1 is then advanced to allow it to pass through the originally narrow section. This operation can also be repeated to fully expand and treat the biological tissue at the narrow section.

[0060] This embodiment can be applied to various medical catheters such as gastric tubes, urinary catheters, suction catheters, biliary drainage tubes, and ventricular drainage tubes. Typically, gastric juice and urine flow into the inner lumen 10 of the catheter through the inner opening 101 and then exit through the outer opening 102. Liquids can also be infused in reverse. Using the technology of this invention, when the above-mentioned medical catheters encounter resistance while traveling in biological natural cavities or other sinus tracts, the neck sac 7 of the medical catheter can be expanded radially to expand the biological tissue. The medical catheter can be advanced when the natural cavity C is temporarily widened after expansion, reducing the probability of secondary infection caused by shearing damage, especially for medical catheters that need to be left in place for more than 24 hours. It also creates favorable cavity conditions for the placement of airway stents, biliary stents, esophageal stents, vascular stents, prostate stents, ureteral stents, etc., which may be activated immediately after the medical catheter 1 is inserted.

[0061] When the neck sac structure is used for a urinary catheter, it can be used as a conventional Foley balloon after being inflated in the bladder.

[0062] After the neck indentation N of the medical catheter 1 reaches the target location on the living organism, the drug is released, achieving precise drug delivery. After the drug D is released, it can closely contact the biological tissue through the free part 72 of the expanded neck sac, and the drug D released from the inner cavity 75 of the neck sac is fully coated on the tissue, and the penetration is promoted by pressure. When the inner cavity 75 of the neck sac contains lubricant, the release and coating at the narrow part of the natural cavity C, etc., combined with the expansion of the sac, makes it easier for the medical catheter to pass through the narrow part. The neck sac 7 can be made of non-compliant, partially compliant, or compliant materials. When the neck sac 7 is made of compliant materials, such as silicone, latex, thermoplastic elastomer, etc., the expansion of the neck sac 7 at the narrow part of the natural cavity is particularly sufficient and safe.

[0063] Example 2:

[0064] like Figures 2A-2DAs shown, unlike the above embodiment, the catheter head 11 also has a head recess H110 and a head capsule 2. The head recess H110 is surrounded by circumferentially distributed head sidewalls H112. The bag-shaped head capsule 2 is preferably made of flexible materials such as silicone rubber or latex, and the wall thickness is preferably less than 0.5 mm. The head capsule 2 is composed of a head capsule connecting part 21 and a head capsule free part 22. The head capsule connecting part 21 is circumferentially sealed to the outer surface area of ​​the catheter head 11, and can be welded or bonded. The relative position of the head capsule connecting part 21 is fixed, while the head capsule free part 22 is not bonded to the catheter head 11 and is easily deformed under force. At least a part of the head capsule free part 22 is embedded in the head recess H110 of the catheter 1. The gap between the inner surface 23 of the head capsule and the head recess H110 is the head capsule lower gap 1102. The gap 1102 is provided with a head capsule lower gap opening 1104 that is in fluid communication with the outside. It is connected to the head capsule lower gap fluid passage 1105 through the head and neck component transition channel H1131 in the head and neck component H. In this embodiment, the head capsule lower gap fluid passage 1105 is located in the catheter sidewall 16. The bag-shaped gap formed by the outer surface 24 of the head capsule embedded in the head recess H110 of the catheter 1 is the head capsule inner cavity 1103, which can be used to contain the drug D. In this embodiment, the neck capsule 7 is pleated and embedded in the neck recess N. It also includes a neck capsule inner cavity fluid opening 751 provided in the neck capsule inner cavity 75. The neck capsule inner cavity fluid opening 751 is connected to the outside of the catheter 1 through the neck capsule inner cavity fluid passage 752. When the medical catheter travels in the natural cavity, lubricant and other drugs can be continuously injected through the neck capsule inner cavity fluid passage 752. Figure 2B-2C The diagram shows a liquid drug D contained within a head capsule, with the head capsule cavity opening 1106 located at the tip of the catheter head 11, facing outwards from the head indentation H110. Figure 2A A hollow second elastic bladder 8 is shown, which is fitted onto the tail 13 of the catheter or the middle part 12 of the catheter near the tail 13. The internal space 80 of the second elastic bladder is connected to the fluid passage 1105 of the lower gap of the head bladder through the internal opening 801 of the second elastic bladder. The wall of the second elastic bladder 8 is provided with a second external opening 81. Squeezing the second elastic bladder 8 can inject the fluid in the internal space 80 of the second elastic bladder, usually the air contained therein, into the lower gap 1102 of the head bladder.

[0065] When using, such as Figure 2BAs shown, when the medical catheter 1 is advanced into the natural cavity C of a living organism, upon reaching the narrow point C1, it is compressed by the inner surface C2 of the natural cavity. When the advancement is obstructed, the second elastic capsule 8 (not shown in the figure) is simultaneously compressed by blocking the second external opening 81 of the second elastic capsule 8. Air from the internal space 80 of the second elastic capsule enters the fluid passage 1105 of the subcapsular space 1105 through the inner opening 801 of the second elastic capsule, and then enters the subcapsular space 1102 of the head capsule through the opening 1104 of the subcapsular space 1104. Figure 2C As shown, the increased volume and pressure of the space 1102 under the head capsule cause the inner surface of the head capsule to deform under pressure. The liquid drug D contained in the inner cavity 1103 of the head capsule flows out from the opening 1106 of the inner cavity of the head capsule (not shown in the figure). At the same time, the expanded free part 22 of the head capsule can expand and compress the inner surface C2 of the natural cavity, causing the narrow part C1 of the natural cavity to be opened. At this time, the narrow part C1 of the natural cavity has not yet recovered. Then, the medical catheter 1 can be advanced to pass through the originally narrow part; such as Figure 2D As shown, after the medical catheter 1 is advanced, when the neck sac 7 reaches the narrow point C1, the elastic sac 3 is squeezed using the above method to inject air from the internal space 30 of the elastic sac into the interstitial space 70 of the neck sac (not shown in the figure). The neck sac 7 deforms and expands under pressure, and the liquid drug D contained in the inner cavity 75 of the neck sac flows out. At the same time, the expanded free part 72 of the neck sac can expand again to compress the inner surface C2 of the natural cavity. During the retraction period after the neck sac 7 deforms and expands, lubricant and other drugs can be injected into the fluid opening 751 of the inner cavity of the neck sac through the fluid passage 752 of the inner cavity of the neck sac. The drug is applied to the narrow point C1 by the re-expansion of the neck sac 7. This operation can be repeated so as to perform multiple expansion treatments on the biological tissue at the narrow point C1.

[0066] Example 3:

[0067] like Figure 3A , 3BAs shown, unlike Embodiment 1, the catheter neck 14 is provided with two overlapping neck sacs 7, with the outer neck sac 7b covering the inner neck sac 7a. The inter-sac cavity 770 between the outer neck sac 7b and the inner neck sac 7a is connected to the inter-sac fluid passage 772 through the inter-sac fluid opening 771. It also includes two vertically arranged hollow elastic sacs 3 fitted onto the catheter tail 13 or the middle portion 12 near the catheter tail 13. The lower elastic sac 3a's lower elastic sac internal space 30a is connected to the inter-sac fluid passage 70 of the neck sac. 1. The lower elastic sac 3a is connected to the upper elastic sac 3b. Squeezing the lower elastic sac 3a can inject fluid from the lower elastic sac's internal space 30a into the neck sac's internal space 70, thereby causing the inner neck sac 7a to deform and expand. The upper elastic sac 3b's internal space 30b is connected to the fluid passage 772 between the neck sacs. Squeezing the upper elastic sac 3b can inject fluid from the upper elastic sac's internal space 30b into the neck sac's internal space 770, thereby causing the outer neck sac 7b to deform and expand. The different degrees and times of expansion of the two overlapping neck sacs 7 can achieve the programmed compression and expansion treatment effect on the narrowed tissue. Figure 3A The neck sac 7, with its inner and outer layers overlapping, is shown in an uninflated state. Figure 3B The image shows the inflated state of the folded neck cyst 7.

[0068] Example 4:

[0069] like Figure 4A , 4B As shown, unlike Example 1, considering the irregular shape and contour of human tissues including natural cavities and individual differences among patients, the neck sac 7 is an eccentric structure with significantly uneven wall thickness. In this example, the right side of the neck sac 7 is thicker than the left side. The free portion 72 of the neck sac can expand to form an eccentric structure due to the continuous entry of external fluid into the interstitial space 70 of the neck sac. External fluid can be injected into the interstitial space 70 of the neck sac through the fluid passage 701, causing the neck sac 7 to deform and expand, expanding and pressing the narrowed tissue. Due to the uneven wall thickness of the left and right sides of the neck sac, the eccentric expansion after the sac is filled is prone to rotational displacement, resulting in irregular... The compression of narrow tissues allows the thin-walled cysts to expand more easily and make more thorough contact with irregular biological tissues. Different filling degrees and speeds of the neck cysts can also achieve different expansion effects. Drugs can also be injected into natural cavities through the head fluid passage 1109 within the tube wall via the head fluid opening 1108, or the natural cavities can be flushed through the head fluid opening 1108, or tissues in the natural cavities can be extracted for sampling and research through the head fluid opening 1108. Alternatively, lubricants and other drugs can be injected into the neck cyst cavity 75 through the neck cyst cavity fluid passage 752 via the neck cyst cavity fluid opening 751, and then applied to the biological tissues of the natural cavities as the neck cysts expand. Figure 4A The neck cyst 7 is shown in its uninflated state. Figure 4B The state of the neck cyst 7 after it has expanded is shown.

[0070] Example 5:

[0071] like Figure 5A , 5B As shown, unlike Example 1, the catheter neck 14 is provided with two neck sacs 7 around its circumference, namely the upper neck sac 7c and the lower neck sac 7d. External fluid enters the upper neck sac inner space 70c through the fluid passage 701c in the inner space of the upper neck sac and then through the opening 700c in the inner space of the upper neck sac. The volume of the upper neck sac inner space 70c increases, compressing the upper neck sac 7c and causing it to deform and expand. External fluid can also enter the lower neck sac inner space 70d through the fluid passage 701d in the inner space of the lower neck sac and then through the opening 700d in the inner space of the lower neck sac. The volume of the lower neck sac inner space 70d increases, compressing the lower neck sac 7d and causing it to deform and expand. Figure 5A The image shows the uninflated state of the cysts 7 in the upper and lower neck. Figure 5B The diagram shows the state of the upper and lower neck cysts 7 after expansion; this series of double-neck cysts can expand alternately to achieve a peristaltic forward movement effect, and the two cysts can also expand to different degrees at the same time to expand different parts of the biological channel.

[0072] Example 6:

[0073] Unlike Example 1, as Figure 6A As shown, it also includes an expansion cuff 4 fitted below the neck 14 of the catheter. When the traveling catheter head 11 encounters urethral stricture caused by conditions such as benign prostatic hyperplasia (BPH), it smoothly passes through the stricture through the expansion of the neck cuff 7. When the expansion cuff 4 reaches the narrowed part of the natural cavity that has been pre-expanded by the neck cuff 7 of the catheter 1, fluid is injected into the expansion cuff fluid passage 40 within the main body of the catheter 1. The fluid enters the inner cavity 41 of the expansion cuff 4, inflating it and expanding the corresponding biological tissue at the narrowed natural cavity. Figure 6B As shown, a fixed cuff F can be added to this embodiment. After the fixed cuff F enters the bladder cavity G, it inflates and remains at the bladder opening to prevent the catheter tip 11 from detaching from the bladder cavity G. The dilating cuff 4, located below the fixed cuff F, is situated in the prostatic urethra. After inflating, the dilating cuff 4 can stably and continuously dilate the prostate PG. The dilating cuff 4 can be made of either a compliant or non-compliant material. When used to treat benign prostatic hyperplasia and the dilating cuff 4 is made of a non-compliant material, the maximum diameter that the dilating cuff 4 can expand to is preferably the same as the maximum diameter of the existing urinary catheter, minimizing the damage to the urethra that may be caused by dilation.

[0074] The dilation cuff 4, based on the innovative structure of this invention, can be used for dilation treatment of urethral scar stricture, benign prostatic hyperplasia, ureteral stricture, bile duct stricture, fallopian tube stricture, and local airway strictures of various levels. It can also be used for dilation of various surgical sinuses. The difference between this dilation and current technology is that when the catheter passes through the stricture, the embedded structure of the neck cuff 7 minimizes the shearing damage to the tissue. The subsequent dilation treatment of the dilation cuff 4 is performed on the premise that the inner surface of the natural cavity is intact, resulting in minimal tissue damage.

[0075] Example 7:

[0076] like Figure 7A , 7B As shown, unlike Embodiment 1, it also includes a stent expansion sleeve 5 fitted below the neck 14 of the catheter. The stent expansion sleeve 5 is preferably made of a non-compliant material. When the stent expansion sleeve 5 travels to the narrow part of the natural cavity that has been pre-expanded by the neck sac 7 of the catheter 1, fluid is injected into the fluid passage 50 of the stent expansion sleeve in the body of the catheter 1. The fluid enters the inner cavity 51 of the stent expansion sleeve and inflates the stent expansion sleeve 5. The stent 6 is stretched open, thereby supporting the biological tissue corresponding to the narrow part. Figure 7A This shows the state where the stent expansion sleeve 5 is not expanded and the stent 6 is not displaced. Figure 7B This shows the state of the stent 6 being stretched open when the stent expansion sleeve 5 expands.

[0077] This method of opening the stent 6 has a significant advantage over current technologies. Current technologies typically involve first inserting a dilator to expand the narrowed biological tissue, then removing the dilator and inserting a catheter with the stent 6 attached. This process is cumbersome and can cause secondary damage to natural cavities or the vascular endothelium. In contrast, the present invention allows the neck sac 7 to expand the narrowed biological tissue after it is filled, minimizing shear damage. Subsequently, the stent expansion sac 5 directly opens the stent 6 attached to it. This method combines the two steps of inserting a dilator and then inserting the stent-attached catheter in the current technology into a single step, reducing tissue damage and improving medical efficiency.

Claims

1. A neck-shaped drug-reservoir type medical catheter (1), comprising a catheter head (11), a catheter middle portion (12), and a catheter tail portion (13); characterized in that, A catheter neck (14) is provided between the catheter head (11) and the middle part of the catheter (12). The outer diameter of the catheter neck (14) is smaller than that of the catheter head (11), thus forming a neck recess (N). At least one neck sac (7) is connected around the catheter neck (14) and can be embedded in or can be embedded in the neck recess (N). The neck sac (7) is composed of a neck sac connecting part (71) and a neck sac free part (72). The neck sac connecting part (71) is sealed to the outer surface (15) of the catheter. The gap between the inner surface (73) of the neck sac and the outer surface (154) of the catheter neck is the neck sac inner gap (70). The neck sac inner gap (70) is provided with a neck sac that communicates with the external fluid. The internal space opening (700) communicates with the internal space fluid passage (701) of the neck sac; the annular recess formed by the outer surface (74) of the neck sac in the neck depression (N) of the catheter (1) or the catheter portion attached to the neck is the internal cavity (75) of the neck sac, which can be used to contain the drug (D). The outer edge opening of the internal cavity (75) of the neck sac faces the outside of the catheter. In use, when the external fluid enters the internal space fluid passage (701) of the neck sac, it enters the internal space (70) of the neck sac through the internal space opening (700). The volume of the internal space (70) of the neck sac increases, and the external fluid is compressed by the internal surface (73) of the neck sac. The volume of the inner cavity (75) of the neck sac is reduced, and the inner cavity (75) of the neck sac can also disappear as the free part (72) of the neck sac completely bulges out from the neck recess (N) of the catheter (1). When the inner cavity (75) of the neck sac contains the drug (D), the drug (D) contained in the inner cavity (75) of the neck sac can be released. The catheter head (11) is also provided with a head recess (H110) and a head sac (2). The head recess (H110) is surrounded by circumferentially distributed head sidewalls (H112). The head sac (2) is composed of a head sac connecting part (21) and a head sac free part (22). The head sac connecting part (21) is sealed to the catheter head (11). At least a portion of the free part (22) is embedded in the head recess (H110) of the catheter (1). The gap between the inner surface (23) of the head capsule and the head recess (H110) is the head capsule lower gap (1102). The head capsule lower gap (1102) is provided with a head capsule lower gap opening (1104) that communicates with the external fluid and is connected to the head capsule lower gap fluid passage (1105). The bag-shaped gap formed by the outer surface (24) of the head capsule embedded in the head recess (H110) of the catheter (1) is the head capsule inner cavity (1103), which can be used to contain the drug (D). The head capsule inner cavity opening (1106) faces outward from the head recess (H110).

2. The neck-shaped drug-reservoir medical catheter according to claim 1, characterized in that, It also includes a neck capsule cavity fluid opening (751) disposed in the neck capsule cavity (75), the neck capsule cavity fluid opening (751) being connected to the outside of the catheter (1) through the neck capsule cavity fluid passage (752).

3. The neck-shaped drug-reservoir medical catheter according to claim 1, characterized in that, The neck of the catheter (14) is provided with two overlapping neck sacs (7), with the outer neck sac (7b) covering the inner neck sac (7a). The inter-sac cavity (770) between the outer neck sac (7b) and the inner neck sac (7a) is connected to the inter-sac fluid passage (772) through the inter-sac fluid opening (771).

4. A neck-shaped drug-reservoir medical catheter according to claim 1, characterized in that, It also includes a hollow elastic bladder (3) fitted on the end of the catheter (13) or the middle part (12) of the catheter near the end of the catheter (13). The internal space (30) of the elastic bladder is connected to the fluid passage (701) in the gap of the neck bladder. Squeezing the elastic bladder (3) can inject the fluid in the internal space (30) of the elastic bladder into the gap (70) of the neck bladder.

5. A neck-shaped drug-reservoir medical catheter according to claim 1, characterized in that, The catheter head (11) is provided with at least one head fluid opening (1108), which is connected to the inner lumen (10) of the catheter or connected to the outside of the catheter (1) through a head fluid passage (1109) in the catheter wall.

6. A neck-shaped drug-reservoir medical catheter according to claim 1, characterized in that, The neck cyst (7) is an eccentric structure with uneven wall thickness.

7. A neck-shaped drug-reservoir medical catheter according to any one of claims 1-6, characterized in that, It also includes an inner opening (101) of the catheter lumen located below the neck (14) of the catheter and an outer opening (102) of the catheter lumen located at the tail (13) of the catheter, the inner opening (101) and the outer opening (102) of the catheter lumen being in fluid communication with the inner lumen (10) of the catheter.

8. A neck-shaped drug-reservoir medical catheter according to any one of claims 1-6, characterized in that, It also includes a fixed cuff (F) and / or an expansion cuff (4) fitted below the neck (14) of the catheter. When the expansion cuff (4) travels to the narrow part of the natural cavity that has been pre-expanded by the neck cuff (7) of the catheter (1), fluid is injected into the expansion cuff fluid passage (40) in the body of the catheter (1). The fluid enters the inner cavity (41) of the expansion cuff and inflates the expansion cuff (4), expanding the biological tissue corresponding to the narrow part of the natural cavity.

9. A neck-shaped drug-reservoir medical catheter according to any one of claims 1-6, characterized in that, It also includes a stent expansion cuff (5) fitted below the neck (14) of the catheter. When the stent expansion cuff (5) travels to the narrow part of the natural cavity that has been pre-expanded by the neck cuff (7) of the catheter (1), fluid is injected into the fluid passage (50) of the stent expansion cuff inside the body of the catheter (1). The fluid enters the inner cavity (51) of the stent expansion cuff and inflates the stent expansion cuff (5). The stent (6) pre-fitted outside the stent expansion cuff (5) is opened, thereby supporting the biological tissue corresponding to the narrow part.

Images