CN106806977B

CN106806977B - Transcatheter intramyocardial injection system

Info

Publication number: CN106806977B
Application number: CN201510868549.7A
Authority: CN
Inventors: 唐闽
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-11-28
Filing date: 2015-11-28
Publication date: 2024-04-19
Anticipated expiration: 2035-11-28
Also published as: CN106806977A

Abstract

The invention discloses a transcatheter intramyocardial injection system which comprises a catheter body, wherein an ablation part is fixed at the distal end of the catheter body, and a handle part is fixed at the proximal end of the catheter body. The ablation part comprises an elastic head end pipe, and an ablation electrode is arranged at the distal end of the elastic head end pipe and comprises at least one cavity; and an outlet needle hole is arranged on the ablation electrode. The puncture needle extends into the cavity of the ablation electrode through the elastic head end tube; the puncture needle extends to the outside of the catheter through the needle outlet hole; the distal end of the puncture needle comprises a bending section, and the inner diameter of the tube body of the puncture needle is 0.25-0.35 mm. When the system is used, the medicine can smoothly pass through the puncture needle tube body, and the puncture needle tube body can be ensured not to be folded in use.

Description

Transcatheter intramyocardial injection system

Technical Field

The invention relates to an injection system, in particular to a transcatheter intramyocardial injection system.

Background

The heart of the human body includes a left atrium, a right atrium, a left ventricle, and a right ventricle. Wherein the right atrium is connected with the superior vena cava and the inferior vena cava, and a septum is arranged between the left atrium and the right atrium. Coronary heart disease is currently the most common disease causing death, and heart failure or myocardial infarction occurs when coronary artery occlusion occurs to severely restrict blood flow to the heart muscle. Currently, 70% of heart failure patients are derived from myocardial infarction. Transient ischemia or occlusion can cause injury to the myocardium, which normally fails to regenerate.

Presently, less invasive interventional systems, such as catheter systems, are commonly used to administer drugs to the heart. Such as US20060095004 ("deflectable micro-implant delivery catheter"), US6059770 ("catheter providing endoluminal access"), and US6059969 ("system and method for locally delivering a medicament").

However, the existing injection catheter has still unsatisfactory effect, and a novel catheter is needed to find out the myocardial infarction area for drug injection treatment.

Disclosure of Invention

The invention provides a transcatheter intramyocardial injection system, which comprises a catheter body, wherein the catheter body is provided with a distal end, a proximal end and a central cavity, an ablation part is fixed at the distal end of the catheter body, and a handle part is fixed at the proximal end of the catheter body; the ablation part comprises an elastic head end pipe, the elastic head end pipe is provided with a distal end, a proximal end and at least one cavity, and an ablation electrode is arranged at the distal end of the elastic head end pipe; the ablation electrode comprises at least one cavity, and an outlet needle hole is formed in the ablation electrode; the central cavity of the catheter body also comprises a puncture needle and a wire, and the puncture needle and the wire extend into the cavity of the ablation electrode through the elastic head end tube; the puncture needle extends to the outside of the catheter through the needle outlet hole; the puncture needle is made of high-elasticity material, the distal end of the puncture needle comprises a bending section, and the inner diameter of the tube body of the puncture needle is 0.25-0.35 mm.

According to one embodiment of the invention, the ablation electrode comprises a through cavity, the distal end of the through cavity is provided with an outlet needle hole, the distal end of the puncture needle extends into the through cavity, and extends out of the catheter through the outlet needle hole.

The bending angle range of the puncture needle tube body is 30-90 degrees. The bending direction of the bending section is consistent with the bending control direction of the catheter.

The angle between the curved plane of the curved section of the distal end of the needle and the curved plane of the distal end of the catheter is less than 30 degrees. Preferably, the curved plane of the curved section of the distal end of the puncture needle is in the same plane as the curved plane of the distal end of the catheter.

The tip of the puncture needle tube body is a straight line section, and the length of the straight line section is 1-4mm. The needle point of the puncture needle tube body is of a microcosmic fillet structure.

And a sealing ring is also arranged in the needle outlet hole of the ablation electrode.

The far-end tube body of the puncture needle is provided with a plurality of small holes. Preferably, the hole interval between the small holes is 1.5-2 mm, and the phase of each hole is 120 degrees.

The handle part comprises a needle outlet handle and a catheter bending control handle, wherein the catheter bending control handle is arranged at the far end of the needle outlet handle and is connected with the needle outlet handle through a tail end connecting pipe. Preferably, the distal end of the needle outlet handle is provided with a sliding core, and the sliding core is provided with scales, and the precision of the scales is 1mm.

In a preferred embodiment of the present invention, in the transcatheter myocardial injection system, the inner diameter of the tube body of the puncture needle 18 is 0.25-0.35 mm, and the wall thickness is 0.05-0.4 mm, and the design can ensure that the injection liquid, such as stem cells, smoothly passes through the needle tube, and can ensure that the needle tube does not cause dead fold in use.

Drawings

FIG. 1 is a schematic diagram of the architecture of a transcatheter intramyocardial injection system according to the present invention;

FIG. 2 shows a cross-sectional view of catheter body 14 in accordance with a preferred embodiment of the present invention;

FIG. 3 is a cross-sectional view taken along line A-A shown in FIG. 2;

FIG. 4 is a cross-sectional view taken along line C-C of FIG. 3;

FIG. 5 is a cross-sectional view taken along line B-B of FIG. 3;

FIG. 6 is an enlarged view of FIG. 3 at I;

FIG. 7 is an enlarged view at II in FIG. 3;

Fig. 8 shows the needle-out view of the puncture needle.

Detailed Description

The technical scheme of the present invention will be described in further detail below by way of examples with reference to the accompanying drawings, but the present invention is not limited to the following examples.

Fig. 1 shows a schematic structural view of a preferred transcatheter myocardial injection system 10 of the present invention, comprising a catheter body 14 having a distal end and a proximal end, an ablation portion 15 being provided at the distal end of the catheter body 14, and a handle portion 13 being provided at the proximal end of the catheter body 14.

The handle portion 13 comprises a needle outlet handle 31 and a catheter bend control handle 32, wherein the proximal end of the needle outlet handle 31 is provided with a syringe connection holder, and the distal end thereof is provided with a sliding core 35. The sliding core 35 is provided with scales, the precision of which is 1mm, and when the needle is withdrawn, the numerical value of the scales is the length of the withdrawn needle. The syringe connecting seat is connected with the luer connector. The catheter bend control handle 32 is disposed at the distal end of the needle exit handle and is connected to the needle exit handle 31 by a tail end connecting tube 36. The proximal end of the catheter bend handle 32 is also provided with a lead and lead attachment plug 37.

Fig. 2 is a cross-sectional view of the catheter body 14 according to the preferred embodiment of the present invention, and fig. 3 is a cross-sectional view taken along line A-A shown in fig. 2. FIG. 4 is a cross-sectional view taken along line C-C of FIG. 3; fig. 5 is a sectional view taken along line B-B in fig. 3.

The catheter body 14 includes a stiffening tube and a main tube surrounding the stiffening tube, and the main tube may be made of a biocompatible polymeric material such as a polyether block amide, polyurethane or nylon material. The inner wall of the main body tube may further comprise at least one wire braid (not shown), which may be a stainless steel braid, and the wire braid may be one, two or more. The stiffening tube comprises a single central chamber 41 which may be made of any suitable polymeric material such as polyether block amide, polyurethane or nylon material integrally extruded. The catheter body 14 may be elongate, flexible, but incompressible along its length, with the central lumen 41 extending axially of the catheter body 14. A wire 43, a traction wire 42, extends within the central chamber 41.

The ablation portion 15 includes a flexible head tube 54, which may be made of a biocompatible material, including a distal end, a proximal end, and at least one lumen. According to an embodiment of the present invention, the elastic head-end tube 54 includes a first chamber 51, a second chamber 52, and a third chamber 53. The first chamber 51, the second chamber 52 and the third chamber 53 may be eccentric chambers, or may be a central chamber and two eccentric chambers. The inner wall of the flexible head tube 54 may further include at least one wire braid (not shown), which may be a stainless steel braid, and one, two or more layers of wire braid; there may be no braid.

The proximal end of the flexible head tube 54 is a ground end having an outer diameter that matches the inner diameter of the catheter body 14, as shown in fig. 3, and is inserted into the catheter body 14, which may be secured by bonding, welding or other suitable means, such as by ultraviolet curing glue, to the catheter body 14.

FIG. 6 is an enlarged view of FIG. 3 at I; FIG. 7 is an enlarged view at II in FIG. 3; fig. 8 shows the needle-out view of the puncture needle.

As shown in fig. 3, 4, 5 and 6, an ablation electrode 16 is provided at the distal end of the flexible head tube 54. The number of ring electrodes 17 along the length of the flexible head tube 54 may be varied according to actual needs, and may be one, two, three, four or more. The ablation electrode 16 includes at least one through chamber. According to a specific embodiment of the present invention, the ablation electrode 16 may be comprised of three chambers 61, 62, 63. The three chambers 61, 62, 63 may be all eccentric chambers, or may be one central chamber and two eccentric chambers. One of the chambers is a through chamber, and the distal end thereof is open at the ablation electrode 16 as an exit needle 64. The axis of the through chamber 61 may be parallel to the axis of the catheter body 14 or may form an angle with the axis of the catheter body 14.

The ablation electrode 16 may also include at least one cavity, with the housing of the ablation electrode 16 having an exit needle 64. According to an embodiment of the present invention, an adapter is provided between the ablation electrode 16 and the flexible head tube, the adapter comprising three holes communicating with the first chamber 51, the second chamber 52 and the third chamber 53 of the flexible head tube, respectively. Hollow tubes may be sealingly secured within the three bores of the adapter, respectively. One of the hollow tubes extends into the outlet needle hole. The hollow tube may be sealingly secured within the bore by welding, bonding or other suitable means.

The needle 18, which may be made of any suitable highly elastic material, such as a nickel titanium alloy material. The distal end of the needle 18 may extend through the central lumen 41 of the catheter body 14 into the first lumen 51 of the flexible head tube and then into one of the through lumens 61 of the ablation electrode 16. The distal end of the needle 18 may extend out of the through chamber 61 through the exit orifice 64.

The puncture needle 18 can resist the bending of a smaller curvature radius, such as R is more than or equal to 1.5mm, which is active or passive, and the inner diameter is unchanged and can be restored to be straight. The inner diameter of the tube body of the puncture needle 18 is 0.25-0.35 mm, and the wall thickness is 0.05-0.4 mm, so that the puncture needle can be ensured not to be dead-folded during bending. If the outer diameter is larger than 0.4mm, the hardness is too high, and the bending control function cannot be realized. The design can ensure that perfusion liquid, such as stem cells, smoothly passes through the puncture needle tube body and can ensure that the puncture needle tube body is not subjected to dead folding in use.

The distal end of the needle cannula of the needle 18 includes a curved section 81. The needle 18 is straightened within the catheter and the distal end of the needle 18 returns to a curved state when the needle is extended outside the catheter. The presence of the curved section 81 deflects the forward direction of the needle tip as it extends out of the catheter tip, and the tube of the needle 18 is curved at an angle in the range of 30-90 degrees. The structure is suitable for being pricked into ventricular musculature, and is not easy to be penetrated. The bending direction of the bending section 81 is consistent with the bending control direction of the catheter, and the included angle between the bending plane of the bending section 81 and the bending plane of the distal end of the catheter is smaller than 30 degrees, preferably in the same plane. This structure is favorable to needle point puncture atress, and is favorable to making the puncture direction parallel to endocardium. The tip of the puncture needle tube body is a straight line section, and the length of the straight line section is 1-4mm. This configuration is advantageous in ensuring that the needle tip is turned according to the curve after passing through the endocardium.

The micro fillet design exists at the needle point of the puncture needle tube body, so that the tip position is not located at the outer wall of the puncture needle tube body but located at the inner wall of the needle tube. The round angle direction of the needle point faces the bending direction, so that the tilting direction of the needle point is consistent with the bending direction. This configuration is advantageous for sharper needle tips and for deflecting the needle tip penetration direction in a curved direction during needle ejection.

A sealing ring may be further disposed in the needle outlet hole 64 of the ablation electrode 16, and may be made of a polymer material such as silica gel, PTFE or TPU. On the one hand, the air in the needle tube shape-moving channel can be prevented from entering blood, and meanwhile, the blood can be prevented from flowing back into the needle tube shape-moving channel. When the needle tip is retracted to the limit position in the ablation electrode, the tip of the needle tip does not contact the sealing ring, and the sealing ring can be prevented from being scratched by the needle tip.

The distal tube of the needle 18 may be free of holes and may be irrigated only near the distal orifice. The distal tube of the needle 18 may also be provided with a plurality of small holes, which may be according to the actual needs. The hole spacing between the small holes can be 1.5-2 mm, and the phase of each hole is 120-degree equal. The total cross section of the outlet of the pipe body of the puncture needle 18 is smaller than the cross section area of the narrowest part of the pipe body, so that the pressure of the water discharged from each hole is ensured to be equal.

The proximal end of the needle 18 extends through the central lumen 41 of the catheter body 14 into the needle exit handle 31 by any suitable means known to those skilled in the art.

The infusion fluid, which may be any suitable drug, such as stem cells, etc., enters the body of the needle 18 through the proximal end of the needle exit handle 31. When the tube of the needle 18 extends outside the through chamber 61 of the ablation electrode 16, irrigation liquid flows out to the corresponding irrigation site through the tube of the needle 18.

Also included within the central chamber 41 is at least one thermal sensor 45 extending therein, which may be a thermocouple or thermistor; the number of thermal sensors may also be two, three, four or more, as shown in fig. 3,4, 5 and 6, with the distal end of the thermal sensor 45 extending through the central lumen 41 of the catheter body 14 into the second lumen 52 of the flexible head tube and then into one of the lumens 62 of the ablation electrode 16. The thermal sensor 45 may be secured to the electrode housing of the ablation electrode 16 by welding, adhesive or other suitable means, such as by welding. The proximal end of the thermal sensor 45 extends through the central lumen 41 into the catheter bend control handle 13 and extends from the catheter bend control handle 13 to connect with a temperature monitoring device (not shown).

The pull wire 42, which may be stainless steel or nitinol material, extends distally through the central lumen 41 into the second lumen 52 of the flexible headend tube as shown in fig. 3,4, 5 and 6. A length of pull wire 42 extending within the central lumen of the catheter body 14 may also be externally sleeved with a spring tube. The spring tube may be a tight structure with tightening force, and is externally sleeved with a protective sleeve (not shown). The second protective sleeve may be made of any suitable material, such as a polyamide material, for the spring tube to extend therein. The distal and proximal ends of the second protective sleeve may be secured to the spring tube by bonding, welding or other suitable means, such as by ultraviolet-curable glue. As shown in fig. 3, a length of traction wire 42 extending within the flexible head end tube may also be externally sleeved with a protective sleeve made of any suitable material, such as polytetrafluoroethylene material.

The distal end of the pull wire 42 extends into one of the chambers 62 of the ablation electrode 16 and is secured at its end within the ablation electrode 16 by welding, adhesive or other suitable means, such as by welding. The proximal end of the pull wire 21 is secured to the catheter bend handle 13 by any suitable means known to those skilled in the art.

The distal end of the lead wire 43, as shown in fig. 3, 4, 5 and 6, extends through the central lumen 41 into the third lumen 53 of the flexible head tube and is electrically connected to the ablation electrode 16 and the ring electrode 17, respectively, by welding or other suitable means, such as by welding. A protective tube may be provided outside the wire 43.

The proximal end of the wire 43 is secured to the catheter bend handle 13 by any suitable means known to those skilled in the art, such as by welding to the wire connection plug 37.

When the transcatheter myocardial injection system 10 is in use, the femoral vein or femoral artery is punctured by a common puncture needle, and the puncture is completed and then the puncture needle is placed into a vascular sheath. The injection system 10 is placed into a blood vessel through a vascular sheath and into the right atrium, right ventricle, or left atrium through the inferior vena cava or aorta. The electrode mapping function is utilized to find the target position, the X image or the developing position of the head electrode is utilized to determine the puncture position, the needle tip of the puncture needle 18 is punctured into the cardiac muscle, and the medicine is injected into the cavity through the luer connector.

The embodiments of the present invention are not limited to the examples described above, and those skilled in the art can make various changes and modifications in form and detail without departing from the spirit and scope of the present invention, which are considered to fall within the scope of the present invention.

Claims

1. A transcatheter intramyocardial injection system comprising a catheter body having a distal end, a proximal end, and a central lumen, the distal end of the catheter body having an ablation portion secured thereto, the proximal end of the catheter body having a handle portion secured thereto;

the ablation part comprises an elastic head end pipe, the elastic head end pipe is provided with a distal end, a proximal end and at least one cavity, and an ablation electrode is arranged at the distal end of the elastic head end pipe; the ablation electrode comprises at least one cavity, and an outlet needle hole is formed in the ablation electrode;

The central cavity of the catheter body also comprises a puncture needle and a wire, and the puncture needle and the wire extend into the cavity of the ablation electrode through the elastic head end tube; the puncture needle extends to the outside of the catheter through the needle outlet hole, the ablation electrode comprises a through cavity, the distal end of the through cavity is the needle outlet hole, the distal end of the puncture needle extends into the through cavity, and extends out of the catheter through the needle outlet hole;

The puncture needle is made of a high-elasticity material, the distal end of the puncture needle comprises a bending section, the inner diameter of a tube body of the puncture needle is 0.25-0.35 mm, the puncture needle is in a straightened state when inside a catheter, when the puncture needle extends to the outside of the catheter, the bending section of the puncture needle is restored to a bending state, the tip of the puncture needle tube body is a straight line section, and the length of the straight line section is 1-4mm;

the handle part comprises a needle outlet handle and a catheter bending control handle, wherein the catheter bending control handle is arranged at the far end of the needle outlet handle and is connected with the needle outlet handle through a tail end connecting pipe.

2. The transcatheter myocardial internal injection system of claim 1, wherein the thickness of the tube wall of the needle is 0.05mm to 0.4mm.

3. A transcatheter myocardial internal injection system as claimed in claim 1 or claim 2, wherein the angle of curvature of the needle cannula body is in the range 30-90 degrees.

4. A transcatheter myocardial injection system according to claim 1 or 2, wherein the bending direction of the bending section coincides with the controlled bending direction of the catheter.

5. The transcatheter myocardial injection system of claim 4, wherein the angle between the curved plane of the curved section of the distal end of the needle and the curved plane of the distal end of the catheter is less than 30 degrees; the curved plane of the curved section of the distal end of the puncture needle is in the same plane as the curved plane of the distal end of the catheter.

6. The transcatheter myocardial injection system of claim 1, wherein the needle tip of the needle cannula body is of a micro rounded configuration.

7. The transcatheter myocardial injection system of claim 1, wherein a seal ring is further disposed within the exit needle aperture of the ablation electrode.

8. The transcatheter myocardial internal injection system as defined in claim 1, wherein said needle has a plurality of small holes in the distal tube thereof; the hole interval between the small holes is 1.5-2 mm, and the phase of each hole is 120-degree equal.

9. The transcatheter myocardial injection system of claim 1, wherein the distal end of the needle exit handle is provided with a sliding core having graduations thereon with an accuracy of 1mm.