CN114288528A - Balloon micro-catheter and preparation method thereof - Google Patents
Balloon micro-catheter and preparation method thereof Download PDFInfo
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- CN114288528A CN114288528A CN202111666659.7A CN202111666659A CN114288528A CN 114288528 A CN114288528 A CN 114288528A CN 202111666659 A CN202111666659 A CN 202111666659A CN 114288528 A CN114288528 A CN 114288528A
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Abstract
The application provides a balloon micro-catheter and a preparation method thereof, and relates to the technical field of medical instruments. The balloon microcatheter includes an inner tube assembly, a core wire, an outer tube assembly, and a compliant balloon. The inner lumen of the inner tube assembly forms a delivery channel for delivering the embolic agent and the device. The core wire is helically fixed to the outer wall of the inner tube assembly. The outer tube assembly is sleeved outside the inner tube assembly, the inner wall of the outer tube assembly abuts against the core wire, and a spiral channel for conveying the contrast medium is formed between the inner tube assembly and the outer tube assembly. Both ends of the compliance balloon are respectively attached to the distal end of the outer tube assembly and the distal end of the inner tube assembly, and a filling cavity is arranged in the compliance balloon and communicated with the spiral channel. The inner tube assembly and the outer tube assembly in the balloon microcatheter are linked together through the core wire, so that the inner tube assembly and the outer tube assembly can be kept relatively stable, and an ideal parallel coaxial structure is formed. And the spiral channel provides a special flow track for the contrast agent, so that the problems of poor image effect in the operation and the like caused by the fact that air bubbles are trapped in the balloon can be effectively prevented.
Description
Technical Field
The application relates to the field of medical instruments, in particular to a balloon micro-catheter and a preparation method thereof.
Background
Transcatheter hepatic artery chemoembolization (TACE) is a new tumor interventional therapy, which is to infuse a chemical embolization agent (common embolization agents include iodized oil, biological glue, microspheres and the like) to a target lesion area through a balloon microcatheter for blocking, so that tumor cells are starved due to lack of blood supply, and the treatment effect is achieved. Because of the better fluidity of the liquid embolic agent, the liquid embolic agent inevitably flows to a non-target lesion area during the infusion process, so that the normal capillary bed is occluded and swollen or ischemic injury (such as stroke, infarction, tissue necrosis and the like).
The balloon microcatheter is additionally provided with a compliant balloon at the distal end thereof and has a parallel and coaxial double-cavity structure for respectively infusing embolic agents and delivering contrast agents. As shown in fig. 1, after the balloon microcatheter is inserted into a blood vessel, before the embolization agent is infused, the contrast agent is infused into the balloon to expand the balloon and attach the balloon to the blood vessel wall, the assistance of the balloon creates the effect of local occlusion, so that the embolization agent is effectively concentrated in a target lesion area, the embolization agent is prevented from flowing to a non-target area, after the embolization agent is delivered, the balloon is retracted to the original state under the action of negative pressure, and then the balloon microcatheter is withdrawn from the blood vessel.
The balloon microcatheter which is currently on the market is formed by connecting and fixing the proximal end and the distal end of an inner tube assembly and an outer tube assembly with a catheter seat and a balloon respectively to form a parallel coaxial structure, namely, the linking point between the inner tube assembly and the outer tube assembly is the catheter seat and the balloon. In the process of pushing or rotating the balloon microcatheter, the inner tube assembly and the outer tube assembly are stressed asynchronously often to generate some common phenomena of uneven mechanical conduction, and the common phenomena that relative displacement occurs between the inner tube assembly and the outer tube assembly of the balloon microcatheter in an angiographic catheter or a tortuous blood vessel to cause easy blockage of pushing, even kinking deformation and the like are generally shown.
Disclosure of Invention
An object of the embodiments of the present application is to provide a balloon microcatheter, which can improve the technical problem that the inner tube assembly and the outer tube assembly of the balloon microcatheter are prone to cause uneven mechanical conduction in the pushing and rotating processes.
In a first aspect, embodiments of the present application provide a balloon microcatheter comprising: an inner tube assembly, a core wire, an outer tube assembly, and a compliant balloon.
The inner tube assembly has a lumen formed as a delivery channel for delivering embolic agents and instruments.
The core wire is helically fixed to the outer wall of the inner tube assembly.
The outer tube subassembly cover is established outside the inner tube subassembly, and outer tube subassembly and inner tube subassembly coaxial coupling, and the inner wall butt of outer tube subassembly is in the core silk, forms the spiral passage who is used for carrying the contrast medium between inner tube subassembly and the outer tube subassembly.
Both ends of the compliance balloon are respectively attached to the distal end of the outer tube assembly and the distal end of the inner tube assembly, and a filling cavity is arranged in the compliance balloon and communicated with the spiral channel.
In the realization process, the micro balloon catheter of the application is a spiral core wire by winding on the surface of the inner tube assembly, and the inner wall of the outer tube assembly is abutted to the core wire, so that the inner tube assembly and the outer tube assembly are effectively linked together, and the inner tube assembly and the outer tube assembly can be kept relatively stable in the process of pushing and rotating the micro balloon catheter, thereby forming an ideal parallel coaxial structure, avoiding the problem that the mechanical conduction is not uniform, causing the relative displacement between the inner tube assembly and the outer tube assembly in the contrast catheter or tortuous blood vessels, causing the pushing to be easily blocked, and even causing the kinking deformation and other problems.
In one possible embodiment, the helical curve equation is: x is P Cos (t (n) 360), Y is P Sin (t (n) 360), and Z is Kt.
Wherein, P is the internal diameter of the outer pipe assembly, the parameter t is more than 0 and less than or equal to 1, the extreme value K of the range is the length of the outer pipe assembly, and n is the number of turns.
In one possible embodiment, the thickness value T of the core filament is (P-W)/2.
Wherein P is the inner diameter of the outer tube assembly and W is the outer diameter of the inner tube assembly.
Optionally, the shape of the cross-section of the core wire is quadrilateral, circular or triangular.
Optionally, the shape of the cross-section of the core wire is quadrilateral.
Optionally, the core wire is made of stainless steel, nitinol, or tungsten.
Optionally, the core wire is made of stainless steel.
In one possible embodiment, the junction of the inner tube assembly and the compliant balloon forms a vent hole that allows only gas to pass through but not contrast media, the vent hole communicating with the inflation lumen.
The pitch of the core wire is less than or equal to 15 mm.
In the implementation process, the vent holes only allow gas to pass through but not allow contrast medium to pass through, so that the contrast medium is prevented from leaking outwards, due to the unique structure of the core wire, the core wire can enable the cavity between the inner tube assembly and the outer tube assembly to form a unique spiral channel, the contrast medium can enter the filling cavity of the compliance balloon along the spiral channel, the spiral channel with the pitch less than or equal to 15mm can enable the contrast medium to flow in the spiral channel and gradually extrude the gas in the spiral channel and the filling cavity through the vent holes, the contrast medium reaches the vent holes and is closed, the problem that the vent holes are blocked by the contrast medium before the gas is incompletely discharged is effectively prevented, bubbles exist in the inflated balloon, and the balloon imaging effect in the hepatic artery chemical embolization through the catheter is poor.
In a possible embodiment, the inner pipe assembly comprises a lining, a reinforcing layer and a plastic layer which are sequentially arranged from inside to outside, wherein the lining is made of polytetrafluoroethylene, the reinforcing layer is formed by weaving or encircling metal wires, and the plastic layer is made of nylon, polyurethane, polyimide, polyether ether ketone or polyamide.
In one possible embodiment, the hardness of the plastic layer increases or decreases along the length of the inner tube assembly, and the hardness of the plastic layer near one end of the compliant balloon is the lowest.
Optionally, the inner tube assembly comprises a plurality of sections sequentially arranged along the length direction, the hardness of the plastic layer of the first section far away from the compliant balloon is 63-85D, the hardness of each section of plastic layer decreases gradually by 5-20D section by section, and the hardness of the plastic layer of the last section is 25-35D.
In one possible embodiment, the pitch of the core wire secured to the outer wall of the inner tube assembly increases or decreases in sequence along the length of the inner tube assembly, with the pitch of the core wire being the smallest near the end of the compliant balloon.
In the implementation process, the pitch of the core wire close to one end of the compliant balloon is minimum, and the pitch of the core wire far from one end of the compliant balloon is maximum, namely, the flow of the contrast agent in the partial section far from the compliant balloon is ensured to be larger, and the flow of the contrast agent in the partial section near the compliant balloon is ensured to be smaller, so that the flow of the contrast agent in each section is controlled, the compliant balloon is prevented from being burst due to sharp filling, and the preparation time before operation is saved.
In a possible embodiment, the balloon microcatheter further comprises a catheter hub, one end of the catheter hub is connected to the proximal end where the outer tube assembly and the inner tube assembly are sleeved, the catheter hub has a first port and a second port, and the first port and the second port are respectively communicated with the conveying channel and the spiral channel.
In one possible embodiment, the balloon microcatheter further comprises a first visualization ring and a second visualization ring, both embedded in the inner tube assembly, with the first visualization ring disposed in the compliant balloon and the second visualization ring disposed at a distal end of the inner tube assembly.
In the above implementation, a first visualization ring is used to image the location of the compliant balloon, i.e., the occlusion location, and a second visualization ring is used to image the distal end of the inner tube assembly, i.e., the embolization location.
In a second aspect, embodiments of the present application provide a method for preparing a balloon microcatheter, which includes: and winding the core wire outside the inner pipe assembly in a spiral shape, sleeving a heat-shrinkable tube outside the core wire for rheoforming, taking down the heat-shrinkable tube, and sleeving the outer pipe assembly outside the inner pipe assembly.
In the implementation process, the preparation method is simple and convenient, and the prepared balloon micro-catheter is stable in structure.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.
FIG. 1 is a schematic diagram of the operation of a balloon microcatheter;
fig. 2 is a schematic structural view of a conventional balloon microcatheter filled with a contrast medium;
fig. 3 is a schematic structural view of a conventional balloon microcatheter filled with a contrast agent;
FIG. 4 is a schematic structural view of a balloon microcatheter according to an embodiment of the present application;
fig. 5 is a cross-sectional view from a first perspective of a balloon microcatheter according to embodiments of the present application;
fig. 6 is a cross-sectional view from a second perspective of a balloon microcatheter of an embodiment of the present application;
FIG. 7 is a schematic structural view of an inner tube assembly with a core wire wrapped around the inner tube assembly in accordance with an embodiment of the present application;
FIG. 8 is a cross-sectional view of a tubular body according to an embodiment of the present application;
FIG. 9 is a cross-sectional view of an inner tube assembly according to an embodiment of the present application;
fig. 10 is a schematic structural view of a balloon microcatheter according to an embodiment of the present application after being filled with a contrast agent;
fig. 11 is a photomicrograph of a compliant balloon of example 1 of the present application;
fig. 12 is a photomicrograph of the compliant balloon of comparative example 1 of the present application.
Icon: 10-balloon microcatheter; 100-a catheter hub; 101-a first cavity; 102-a second cavity; 103-a first interface; 104-a second interface; 200-a tube body; 201-a transport channel; 202-a helical channel; 203-bubbles; 210-an inner tube assembly; 211-inner liner; 212-a reinforcement layer; 213-a plastic layer; 214-vent hole; 220-an outer tube assembly; 230-core filament; 300-a compliant balloon; 301-filling the cavity; 400-stress protection sleeve; 510-a first developer ring; 520-a second developer ring; 600-contrast agent.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present application, it should be noted that the terms "upper", "lower", "inner", "outer", and the like indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships conventionally found in use of products of the application, and are used only for convenience in describing the present application and for simplification of description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
In the description of the present application, it is further noted that, unless expressly stated or limited otherwise, the terms "disposed," "mounted," and "connected" are to be construed broadly, e.g., as meaning fixedly connected, detachably connected, or integrally connected; either mechanically or electrically. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
At present, the near end and the far end of an inner tube assembly and an outer tube assembly of a saccule microcatheter are respectively connected and fixed with a catheter seat and a saccule to form a parallel coaxial structure, and the saccule microcatheter is generally punctured through femoral artery or radial artery and then reaches a target lesion area under the navigation effect of a micro guide wire to infuse an embolism reagent. The effective length of the balloon microcatheter is generally 110cm, 130cm and 150cm, the balloon microcatheter is fixedly connected through two points, and often in the process of pushing or rotating the balloon microcatheter, the inner tube assembly and the outer tube assembly are stressed asynchronously to generate some common phenomena of uneven mechanical conduction, which is shown in the way that relative displacement occurs between the inner tube assembly and the outer tube assembly in an angiographic catheter or a tortuous blood vessel, so that pushing is easily blocked, even kinking deformation and the like are caused.
Referring also to fig. 2, in preparation for transcatheter hepatic artery chemoembolization, contrast medium 600 is delivered to expel the gas from the filling channel and filling lumen 301 through vent 214. The filling channel of the existing balloon microcatheter is an annular channel, when the contrast medium 600 is infused, if the contrast medium 600 is intermittently pushed, the contrast medium 600 flows along one side of the filling channel, and when the contrast medium 600 is continuously pushed, the contrast medium 600 continues to move forward, and the air bubbles 203 are generated. When the contrast agent 600 flowing at the front end reaches the vent hole 214 and closes, the bubble 203 cannot be discharged. Referring to fig. 3, as the balloon is continuously inflated with the continuous infusion of the contrast medium 600, the original air bubbles 203 enter the inflated balloon, so that the air bubbles 203 exist in the inflation cavity 301 of the balloon, which results in poor imaging effect in transcatheter hepatic artery chemoembolization.
Referring to fig. 4 and 5, the present application provides a balloon microcatheter 10 comprising: catheter hub 100, catheter body 200, compliant balloon 300, and a visualization ring. One end of the tube 200 is connected to the catheter hub 100 and the other end is provided with a compliant balloon 300 and a visualization ring.
Referring to fig. 6 to 8, the tube 200 has a proximal end close to the catheter hub 100 and a distal end close to the compliant balloon 300, the tube 200 includes an inner tube assembly 210, a core wire 230 and an outer tube assembly 220, a delivery channel 201 for delivering the embolic agent or the device is formed in an inner cavity of the inner tube assembly 210, the core wire 230 is spirally fixed on an outer wall of the inner tube assembly 210, the outer tube assembly 220 is sleeved outside the inner tube assembly 210, the outer tube assembly 220 and the inner tube assembly 210 are coaxially connected, an inner wall of the outer tube assembly 220 abuts against the core wire 230, and a spiral channel 202 for delivering the contrast agent is formed between the inner tube assembly 210 and the outer tube assembly 220.
Optionally, core wire 230 extends from the proximal end of inner tube assembly 210 to the proximal end of compliant balloon 300.
Referring to fig. 9, the inner pipe assembly 210 includes an inner liner 211, a reinforcing layer 212, and a plastic layer 213 arranged in sequence from the inside to the outside.
The lining 211 is made of high-lubricity Polytetrafluoroethylene (PTFE), the reinforcing layer 212 is formed by weaving or encircling metal wires, and the plastic layer 213 is made of nylon (PA), polyurethane (TPU), Polyimide (PI), polyether ether ketone (PEEK) or polyamide (Pebax).
The metal wire comprises a stainless steel wire, a nickel-titanium wire or a tungsten wire, the outer diameter of the metal wire is 2/10000-20/10000 inch, and the section of the metal wire is quadrilateral, circular or triangular.
Optionally, the metal wire is a stainless steel wire.
Optionally, the cross-section of the wire is quadrilateral.
The inner tube assembly 210 has an effective length of 100 to 200cm, an inner diameter of 0.40 to 0.70mm, and an outer diameter of 0.55 to 0.85 mm.
Optionally, the inner tube assembly 210 has an effective length of 120-180 cm, an inner diameter of 0.40-0.60 mm, and an outer diameter of 0.55-0.75 mm.
Alternatively, the inner tube assembly 210 has an effective length of 150cm, an inner diameter of 0.50mm, and an outer diameter of 0.65 mm.
In order to provide the catheter body 200 with a rigid proximal end and a flexible distal end, the hardness of the plastic layer 213 increases or decreases along the length of the inner tube assembly 210, and the hardness of the plastic layer 213 near the end of the compliant balloon 300 is the lowest.
For example, the inner tube assembly 210 may be divided into a plurality of sections, each section of the inner tube assembly 210 has a plastic layer 213 made of nylon with different hardness, and the hardness of the plastic layer 213 increases or decreases along the length direction of the inner tube assembly 210.
Assuming that the length of each segment is L in sequence along the length direction1、L2、L3……LnWherein n is more than or equal to 3 and less than or equal to 7. Wherein the length is L1Is adjacent to catheter hub 100 and has a length LnIs adjacent to the compliant balloon 300.
L is less than or equal to 20cmn-1+Ln≤70cm；
100cm≤L1+L2+......+Ln-1+Ln≤200cm；
Alternatively, 120cm ≦ L1+L2+......+Ln-1+Ln≤180cm；
Alternatively, L1+L2+......+Ln-1+Ln＝150cm。
Assuming that the hardness of each segment is H along the length direction1、H2、H3……HnWherein n is more than or equal to 3 and less than or equal to 7. Wherein the hardness is H1Is close to catheter hub 100 and has a hardness of HnIs adjacent to the compliant balloon 300.
H is less than or equal to 5Di-1-Hi≤20D,(1＜i≤n)；
The hardness of the first section of the plastic layer 213 away from the compliant balloon 300 is 63-85D, and the hardness of the last section of the plastic layer 213 is 25-35D.
In an embodiment of the present application, the inner tube assembly 210 includes a first section, a second section, a third section and a fourth section sequentially arranged from a proximal end to a distal end along a length direction, the first section has a length of 620mm, the second section has a length of 440mm, the third section has a length of 220mm, the fourth section has a length of 220mm, the first section is made of Pebax72D, the second section is made of Pebax55D, the third section is made of Pebax35D, and the fourth section is made of Pebax 25D. In other embodiments of the present application, the inner tube assembly 210 includes a first section, a second section, a third section, a fourth section, a fifth section and a sixth section sequentially arranged from a proximal end to a distal end along a length direction, a material of the plastic layer 213 of the first section is nylon 25, a material of the plastic layer 213 of the second section is Pebax72D, a material of the plastic layer 213 of the third section is Pebax55D, a material of the plastic layer 213 of the fourth section is Pebax40D, a material of the plastic layer 213 of the fifth section is Pebax35D, and a material of the plastic layer 213 of the sixth section is Pebax 25D.
Optionally, the inner tube assembly 210 further includes an outermost high lubricity hydrophilic coating, and the high lubricity hydrophilic coating is prepared by a dip coating and UV curing process.
Referring to fig. 6 to 8, the outer tube assembly 220 is made of polyurethane, polyimide, polyetheretherketone or polyamide. The outer tube assembly 220 has an effective length of 100 to 200cm, an inner diameter of 0.55 to 0.85mm, and an outer diameter of 0.85 to 1.15 mm.
Optionally, the outer tube assembly 220 has an effective length of 120-180 cm, an inner diameter of 0.65-0.85 mm, and an outer diameter of 0.85-1.05 mm.
Alternatively, outer tube assembly 220 has an effective length of 148.5cm, an inner diameter of 0.75mm, and an outer diameter of 0.95 mm.
Optionally, the outer tube assembly 220 further includes a high lubricity hydrophilic coating on the outermost layer, and the high lubricity hydrophilic coating is prepared by a dip coating and UV curing process.
The core wire 230 is made of stainless steel, nitinol, or tungsten. The outer diameter of the core wire 230 is 10/10000-80/10000 inch. The cross-section of core wire 230 is quadrilateral, circular or triangular in shape.
Optionally, the core wire 230 is made of stainless steel.
Alternatively, the cross-section of the core wire 230 is quadrilateral in shape.
The pitch of the core wire 230 is less than or equal to 15 mm.
The curvilinear equation for the helix exhibited by core wire 230 is: x is P Cos (t (n) 360), Y is P Sin (t (n) 360), and Z is Kt.
Wherein, P is the inner diameter of the outer tube assembly 220, the parameter t is more than 0 and less than or equal to 1, the extreme value K of the range is the length of the outer tube assembly 220, and n is the number of turns.
It should be noted that the core wire 230 secured to the inner tubing assembly 210 may have an equal pitch throughout the length of the inner tubing assembly 210 or may have a different pitch for each section.
Pitch Si＝Li/mi，(1≤i≤n)，m1+m2+......+mi+......+mnN; wherein L isiLength of assembly, m, corresponding to section i of inner tube assembly 210iFor which the core wire 230 is wound around the outer surface of the segment.
The pitch of the core wire 230 secured to the outer wall of the inner tube assembly 210 increases or decreases along the length of the inner tube assembly 210, and the pitch of the core wire 230 near the end of the compliant balloon 300 is minimized.
Namely L1/m1＞L2/m2＞.......＞Ln/mn，(3≤n≤7)；
Meanwhile, L is more than or equal to 3mmi/mi≤15mm，(1≤i≤n)；
When the inner tube assembly 210 includes the first, second, third and fourth segments arranged in sequence from the proximal end to the distal end in the length direction, the pitch of the core wire 230 fixed to the outer wall of the first segment > the pitch of the core wire 230 fixed to the outer wall of the second segment > the pitch of the core wire 230 fixed to the outer wall of the third segment > the pitch of the core wire 230 fixed to the outer wall of the fourth segment.
The first section of the inner tube assembly 210 is far away from the compliant balloon 300, and the fourth section is close to the compliant balloon 300, so that the flow rate of the contrast agent in the section far away from the compliant balloon 300 is ensured to be larger, and the flow rate of the contrast agent in the section close to the compliant balloon 300 is smaller, thereby controlling the flow rate of the contrast agent in each section and preventing the compliant balloon 300 from being burst due to sharp filling.
Optionally, the first, second, third and fourth segments correspond to m values of 60, 50, 40 and 70.
To ensure that a stable helical channel 202 can be formed between inner tube assembly 210 and outer tube assembly 220, the inner diameter P of outer tube assembly 220, the outer diameter W of inner tube assembly 210, and the thickness value T of core wire 230 satisfy the following relationship:
(P-W)/2＝T。
referring to fig. 4 and 5, the catheter hub 100 has a cylindrical first cavity 101 and a cylindrical second cavity 102 extending from the first cavity 101 and coaxial with the first cavity 101, and the first cavity 101 is far away from the compliant balloon 300 than the second cavity 102. And the catheter hub 100 further has a first interface 103 and a second interface 104, and the first interface 103 and the second interface 104 are respectively communicated with the first cavity 101 and the second cavity 102.
At the portion of body 200 within catheter hub 100, outer tube assembly 220 and inner tube assembly 210 first extend into second lumen 102 to form a clearance fit, and then inner tube assembly 210 extends further through outer tube assembly 220 into first lumen 101 to form a clearance fit. Because the inner diameter of first cavity 101 is slightly larger than the outer diameter of inner tube assembly 210, and the inner diameter of second cavity 102 is slightly larger than the outer diameter of outer tube assembly 220, it can be ensured that outer tube assembly 220 and second cavity 102 are well matched, and inner tube assembly 210 and first cavity 101 are well matched. While the first port 103 can communicate with the feed channel 201 in the inner tube assembly 210 through the first lumen 101, the second port 104 can also communicate with the helical channel 202 between the inner tube assembly 210 and the outer tube assembly 220 through the second lumen 102.
Optionally, the first hub 103 and the second hub 104 are both luer hubs.
Optionally, catheter hub 100, inner tube assembly 210 and outer tube assembly 220 are bonded by UV glue.
The catheter hub 100 is made of nylon.
The balloon microcatheter 10 further comprises a stress protection sleeve 400, wherein the stress protection sleeve 400 is sleeved at the joint of the catheter hub 100 and the catheter body 200.
The stress protection sleeve 400 is made of a nylon elastomer.
Alternatively, the length of inner tube assembly 210 within catheter hub 100 and stress relief sheath 400 is 55mm and the length of outer tube assembly 220 within catheter hub 100 and stress relief sheath 400 is 35 mm.
Referring to fig. 4, 5 and 10, both ends of the compliant balloon 300 are attached to the distal end of the outer tube assembly 220 and the distal end of the inner tube assembly 210, respectively, and the compliant balloon 300 has an inflation lumen 301 therein, the inflation lumen 301 being in communication with the helical channel 202.
The compliant balloon 300 assumes a deflated/folded state prior to inflation, and the compliant balloon 300 inflates upon low pressure infusion of contrast agent 600 such that its appearance contour is adapted to the vascular pathological structure of the target lesion.
The compliant balloon 300 is made of polyurethane (TPU), thermoplastic elastomer (TPE), polyvinyl chloride thermoplastic elastomer or silicone elastomer.
Optionally, the ends of the compliant balloon 300 are joined to the distal ends of the outer tube assembly 220 and the inner tube assembly 210 by welding, laser welding, or adhesive bonding.
The length of the compliant balloon 300 is 5-25 mm, and the diameter is 2-8 mm.
Optionally, the compliant balloon 300 is 12mm in length and 6mm in diameter.
The compliant balloon 300 has a nominal diameter as its diameter and a length equal to the nominal diameter.
The junction of the distal end of the inner tube assembly 210 and the compliant balloon 300 forms a vent hole 214 that allows only gas to pass through but not contrast agent 600. The contrast medium 600 flows in the spiral channel 202 and gradually extrudes the gas in the spiral channel 202 and the filling cavity 301 and is discharged through the vent holes 214, and the contrast medium 600 fills the spiral channel 202 and the filling cavity 301, and then the contrast medium 600 reaches the vent holes 214 and closes the vent holes 214 without leaving air bubbles in the spiral channel 202 and the filling cavity 301.
The balloon microcatheter 10 includes a first visualization ring 510 and a second visualization ring 520, both of the first visualization ring 510 and the second visualization ring 520 embedded in the inner tube assembly 210, with the first visualization ring 510 disposed in the compliant balloon 300 and the second visualization ring 520 disposed at the distal end of the inner tube assembly 210 near the compliant balloon 300.
The first visualization ring 510 is used for marking the position of the compliant balloon 300 under the action of an image, namely, a blocking position; the second visualization ring 520 is used to image the distal end of the inner tubing assembly 210, i.e., the location of the emboli.
Optionally, a developer ring is disposed between the reinforcement layer 212 and the plastic layer 213.
The developing ring is made of platinum-iridium alloy (Pt-lr).
The present application also provides a method of making a balloon microcatheter, comprising:
s1, forming the inner pipe assembly 210
The inner tube assembly 210 is formed by first winding or braiding a reinforcing layer 212 on an inner liner 211, then coating a plastic tube outside the reinforcing layer 212, and placing the plastic tube in a heat shrinkable tube to be melted in a rheometer.
S2, winding core wire 230
Straightening the inner pipe assembly 210, spirally winding the core wire 230 outside the inner pipe assembly 210, performing spot welding in the winding process to enable the core wire 230 to be stably attached to the outer wall of the inner pipe assembly 210, and sleeving a heat shrink pipe outside the core wire 230 after winding is completed to perform rheoforming, so that part of the core wire 230 is embedded into the inner pipe assembly 210.
Optionally, the temperature of the rheoforming is 250-260 ℃.
Optionally, the time for the rheoforming is 10-15 min.
S3, preparing the pipe body 200
The heat-shrinkable tube is removed, and the outer tube assembly 220 is sleeved outside the inner tube assembly 210 to obtain the tube body 200.
S4, post-processing
The catheter hub 100 and the compliant balloon 300 are respectively installed at both ends of the catheter body 200 to manufacture the balloon microcatheter 10.
It should be noted that, when the plastic layer 213 of the inner tube assembly 210 is made of a plurality of nylon materials, the nylon materials with different hardness are welded to form a whole plastic tube in a form that the hardness is gradually increased or decreased along the length direction of the inner tube assembly 210, and then the plastic tube is sleeved on the reinforcement layer 212 and placed in the heat shrink tube to be rheologically melted in the rheometer.
The following is a detailed description of a balloon microcatheter 10 of the embodiments of the present application:
example 1
The present embodiment provides a balloon microcatheter 10, which includes: catheter hub 100, catheter body 200, compliant balloon 300, stress shield 400, first visualization ring 510, and second visualization ring 520.
The catheter body 200 comprises an inner catheter assembly 210, a core wire 230 and an outer catheter assembly 220, wherein the inner catheter assembly 210 is internally provided with a delivery channel 201 for delivering the embolic agent or the instrument, the core wire 230 is fixedly wound on the outer wall of the inner catheter assembly 210 in a spiral shape, the outer catheter assembly 220 is sleeved outside the inner catheter assembly 210, the core wire 230 abuts against the inner wall of the outer catheter assembly 220, and a spiral channel 202 for delivering the contrast agent is formed among the core wire 230, the inner catheter assembly 210 and the outer catheter assembly 220.
The inner tube assembly 210 has an effective length of 150cm, an inner diameter of 0.50mm and an outer diameter of 0.65 mm.
The inner pipe assembly 210 includes an inner liner 211, a reinforcing layer 212, and a plastic layer 213, which are sequentially arranged from the inside to the outside. The lining 211 is made of high-lubricity polytetrafluoroethylene, the reinforcing layer 212 is formed by weaving stainless steel wires with the diameter of 10/10000inch and a quadrangular cross section, and the plastic layer 213 is provided with a Pebax72D tube with the length of 620mm, a Pebax55D tube with the length of 440mm, a Pebax35D tube with the length of 220mm and a Pebax25D tube with the length of 220mm in sequence from the near end to the far end.
The outer tube assembly 220 has an effective length of 148.5cm, an inner diameter of 0.75mm and an outer diameter of 0.95 mm.
The core wire 230 is a stainless steel wire with a quadrangular cross section, the thickness is 0.05mm, and the spiral curve equation of the core wire 230 is as follows: x is 0.75 Cos (t (n) 360)), Y is 0.75 Sin (t (n) 360)), and Z is Kt.
The number m of the core wire 230 corresponding to the Pebax72D tube is 60, the number m of the core wire 230 corresponding to the Pebax55D tube is 50, the number m of the core wire 230 corresponding to the Pebax35D tube is 40, and the number m of the core wire 230 corresponding to the Pebax25D tube is 70.
The junction of the inner tube assembly 210 and the compliant balloon 300 forms a vent hole 214 that allows only gas to pass through but not contrast media. The ends of the compliant balloon 300 are attached to the distal ends of the outer and inner tube assemblies 220, 210 by welding.
The compliant balloon 300 is 12mm in length and 6mm in diameter.
Comparative example 1
The comparative example of the present application provides a balloon microcatheter 10 which does not have the core wire 230 structure of example 1, and the other structure is the same as example 1.
Test examples
The balloon microcatheter 10 of example 1 and comparative example 1 of the present application was taken, the contrast agent 600 was infused, the gas was vented through vent holes 214, and after the contrast agent reached vent holes 214 and was allowed to close, the contrast agent 600 was continuously infused, causing inflation of the inflation lumen 301, and the condition of the compliant balloon 300 was observed under a microscope, as shown in fig. 11 and 12.
It can be seen that the balloon microcatheter 10 of example 1 was filled with the contrast agent 600 without air bubbles in the compliant balloon 300; whereas the balloon microcatheter 10 of comparative example 1 had significant air bubbles 203 in the compliant balloon 300 after filling with the contrast agent 600.
To sum up, the balloon microcatheter 10 of the present application is through being spiral core wire 230 in the outer wall winding of inner tube assembly 210 to make the inner wall butt of outer tube assembly 220 in core wire 230, thereby make at the in-process of propelling movement and rotatory balloon microcatheter 10, inner tube assembly 210 and outer tube assembly 220 can keep relatively stable, form an ideal parallel coaxial structure, avoid because of mechanics conduction is inhomogeneous, cause inner tube assembly 210 and outer tube assembly 220 to take place relative displacement in radiography pipe or tortuous blood vessel, cause the propelling movement easily to be obstructed, kink warp scheduling problem even. Meanwhile, due to the unique structure of the core wire 230, the core wire 230 can enable the cavity between the inner tube assembly 210 and the outer tube assembly 220 to form the unique spiral channel 202, the contrast agent 600 can enter the filling cavity 301 of the compliant balloon 300 along the unique spiral channel 202, and the spiral channel 202 with the thread pitch less than or equal to 15mm can enable the contrast agent 600 to gradually extrude the gas in the spiral channel 202 and the filling cavity 301 when flowing in the spiral channel 202, so that the phenomenon that the air vent 214 is blocked by the contrast agent 600 before the gas is not completely discharged, so that the bubble exists in the filling cavity 301, and the balloon imaging effect in the transcatheter hepatic artery chemical embolization is poor. In addition, the balloon microcatheter 10 of the present application can control the flow rate of the contrast agent 600 by controlling the pitch of the core wire 230 in each segment of the tube body 200, thereby preventing the balloon from being burst due to abrupt filling.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (10)
1. A balloon microcatheter, comprising:
an inner tube assembly having a lumen formed as a delivery channel for delivering embolic agents and instruments;
a core wire helically fixed to an outer wall of the inner tube assembly;
the outer tube assembly is sleeved outside the inner tube assembly and is coaxially connected with the inner tube assembly, the inner wall of the outer tube assembly abuts against the core wire, and a spiral channel for conveying a contrast medium is formed between the inner tube assembly and the outer tube assembly;
a compliant balloon having two ends attached to the distal ends of the outer and inner tube assemblies, respectively, the compliant balloon having a filling lumen therein, the filling lumen being in communication with the helical channel.
2. The balloon microcatheter of claim 1, wherein the curvilinear equation of the spiral is: x ═ P × Cos (t ═ n × 360)), Y ═ P × Sin (t ═ n × 360)), Z ═ Kt;
wherein P is the inner diameter of the outer pipe assembly, the parameter t is more than 0 and less than or equal to 1, the extreme value K of the range is the length of the outer pipe assembly, and n is the number of turns.
3. The balloon microcatheter according to claim 1, wherein the thickness value T ═ P-W)/2 of the core wire;
wherein P is the inner diameter of the outer tube assembly and W is the outer diameter of the inner tube assembly;
optionally, the shape of the cross section of the core wire is quadrilateral, circular or triangular;
optionally, the shape of the cross section of the core wire is quadrilateral;
optionally, the core wire is made of stainless steel, nickel-titanium alloy or tungsten;
optionally, the core wire is made of stainless steel.
4. The balloon microcatheter of claim 1, wherein the junction of the inner tube assembly and the compliant balloon forms a vent hole that allows only gas to pass through but not the contrast agent, the vent hole communicating with the inflation lumen;
the thread pitch of the core wire is less than or equal to 15 mm.
5. The balloon microcatheter according to claim 1, wherein the inner tube assembly comprises a lining, a reinforcing layer and a plastic layer, which are sequentially arranged from inside to outside, wherein the lining is made of polytetrafluoroethylene, the reinforcing layer is formed by weaving or encircling metal wires, and the plastic layer is made of nylon, polyurethane, polyimide, polyether ether ketone or polyamide.
6. The balloon microcatheter of claim 5, wherein the hardness of the plastic layer increases or decreases sequentially along the length of the inner tube assembly, and the plastic layer near one end of the compliant balloon has the lowest hardness;
optionally, the inner tube assembly comprises a plurality of sections which are sequentially arranged along the length direction, the hardness of the plastic layer far away from the first section of the compliant balloon is 63-85D, the hardness of each section of the plastic layer is gradually reduced by 5-20D section by section, and the hardness of the plastic layer at the last section is 25-35D.
7. The balloon microcatheter of claim 6, wherein the pitch of the core wire fixed to the outer wall of the inner tube assembly is sequentially increased or decreased along the length of the inner tube assembly, and the pitch of the core wire near one end of the compliant balloon is minimized.
8. The balloon microcatheter according to any one of claims 1-7, further comprising a catheter hub, wherein one end of the catheter hub is connected to a proximal end where the outer tube assembly and the inner tube assembly are sleeved, the catheter hub has a first port and a second port, and the first port and the second port are respectively communicated with the delivery channel and the spiral channel.
9. The balloon microcatheter of any of claims 1-7, further comprising a first visualization ring and a second visualization ring, both embedded in the inner tube assembly, the first visualization ring disposed in the compliant balloon, the second visualization ring disposed at a distal end of the inner tube assembly.
10. A method for manufacturing a balloon microcatheter according to any of claims 1 to 9, wherein the method for manufacturing the balloon microcatheter comprises: and spirally winding the core wire outside the inner pipe assembly, sleeving a heat-shrinkable tube outside the core wire for rheoforming, taking down the heat-shrinkable tube, and sleeving the outer pipe assembly outside the inner pipe assembly.
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| CN202111666659.7A CN114288528A (en) | 2021-12-31 | 2021-12-31 | Balloon micro-catheter and preparation method thereof |
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