Interventional drug delivery device for heart

Abstract

The invention provides an interventional drug delivery device for the heart. The interventional drug delivery device comprises an outer sleeve and an inner sleeve, and the inner sleeve is arranged in the outer sleeve in a sleeved mode; the spiral electrode is arranged at the far end of the outer sleeve; the ring electrode is arranged on the outer sleeve and is close to the near end of the outer sleeve; the electrode wire is connected with the spiral electrode and the ring electrode, and is positioned between the outer sleeve and the inner sleeve; and the injection needle is positioned at the far end of the outer sleeve and is communicated with the inner sleeve. The device has an intracavity icon measurement function and a local injection administration function, a heart conduction bundle and depth can be positioned through intracavity icon measurement of the spiral electrode, the device can be used for treatment of an injection needle on the conduction bundle or avoidance of the conduction bundle during treatment, and a target part can be accurately positioned for treatment; the defect that the deep part of the chamber wall cannot be ablated through radiofrequency ablation and the defect that conduction bundles are damaged in the outflow tract dredging operation of the cardiac surgery are overcome.

Description

Technical Field

[0001] This invention relates to the field of drug delivery device technology, and more particularly to an interventional drug delivery device for the heart. Background Technology

[0002] Radiofrequency ablation of the heart is a well-known treatment for arrhythmias. It involves inserting an ablation catheter into a specific area of ​​the heart via a vein or artery and releasing radiofrequency current to cause coagulative necrosis of the local endocardium and subendocardial myocardium, thereby terminating the arrhythmia. It has advantages such as minimal technical trauma, high success rate, and few complications. However, if the premature beat is located deep in the heart and the radiofrequency depth is limited, recurrence is likely after the procedure.

[0003] Radiofrequency ablation of the heart is also used in patients with hypertrophic obstructive cardiomyopathy to ablate the interventricular septum to reduce the outflow tract pressure gradient. Ablation is performed via an arterial approach on the left side of the endocardium of the interventricular septum. However, conduction bundles often run along the surface of the hypertrophic septum, which must be avoided during the procedure. This often results in insufficient ablation area, leading to a small reduction in pressure gradient and poor treatment outcomes. Left ventricular outflow tract recanalization surgery in cardiac surgery is often more effective, but postoperative complications may include complete left bundle branch block or even third-degree atrioventricular block, requiring pacing therapy.

[0004] Local drug delivery for repairing infarcted or diseased myocardial tissue is a current research focus, and some local drug delivery devices have emerged. Most of these devices are placed on the epicardial surface and are not minimally invasive. However, myocardial tissue in the subendocardium and myocardial wall (often the most severely ischemic areas or deep scars) usually cannot benefit, and their clinical value needs further verification. Summary of the Invention

[0005] To address the aforementioned problems, this invention provides an interventional drug delivery device for the heart, which has a mapping function and uses intracavitary mapping to locate and deliver drugs for chemical ablation or to promote the repair of specific tissues.

[0006] An interventional drug delivery device for the heart, comprising:

[0007] Outer tube;

[0008] Inner sleeve, which is fitted inside the outer sleeve;

[0009] A spiral electrode, wherein the spiral electrode is disposed at the distal end of the outer sleeve;

[0010] A ring electrode is disposed on the outer sleeve and near the proximal end of the outer sleeve;

[0011] An electrode wire, which connects the spiral electrode and the ring electrode, and is located between the outer sleeve and the inner sleeve;

[0012] An injection needle is located at the distal end of the outer cannula and is connected to the inner cannula.

[0013] As a preferred embodiment, it also includes:

[0014] An electrode holder is inserted into the distal end of the outer sleeve, the injection needle is inserted into the electrode holder, and the spiral electrode is welded to the electrode holder.

[0015] In a preferred embodiment, the electrode holder includes a plug body, a step body, and a sleeve body connected in sequence. The plug body is inserted into the outer sleeve and abuts against the inner sleeve. The step body abuts against the port at the far end of the outer sleeve. The sleeve body is exposed outside the outer sleeve, and the spiral electrode surrounds the outside of the sleeve body.

[0016] In a preferred embodiment, the electrode holder has a fixing through hole that extends through the electrode holder along its length and communicates with the inside of the inner sleeve. One end of the injection needle is inserted into the inner sleeve through the fixing through hole, while the other end of the injection needle is exposed outside the outer sleeve.

[0017] In a preferred embodiment, the spiral electrode surrounds the injection needle.

[0018] In a preferred embodiment, the electrode wires are accommodated between the inner sleeve and the outer sleeve, and between the connector and the outer sleeve, and the electrode wires are welded to the electrode holder and the ring electrode, respectively.

[0019] In a preferred embodiment, the outer sleeve includes a connector, a proximal tube body, and a distal tube body, which are connected in sequence. The proximal tube body, the ring electrode, and the distal tube body are sleeved outside the inner sleeve.

[0020] In a preferred embodiment, the diameter of the distal tube is 1.2 mm to 1.5 mm, and the diameters of the proximal tube and the distal tube are equal.

[0021] In a preferred embodiment, the length of the interventional drug delivery device for the heart is 45mm to 52mm, and the length of the spiral electrode is 1.8mm to 3.0mm.

[0022] In a preferred embodiment, the outer sleeve is an outer sleeve made of insulating material, and the inner sleeve is an inner sleeve made of insulating material.

[0023] Compared with existing technologies, this technical solution has the following advantages:

[0024] Combining intracardiac mapping and local injection drug delivery capabilities, intracardiac mapping using a helical electrode can locate the cardiac conduction bundle and its depth, allowing for injection of treatments targeting the conduction bundle or avoiding it during treatment. Impedance monitoring helps avoid larger blood vessels during localization. Pacing mapping determines the distance between the helical electrode and the conduction bundle, overcoming the limitations of current radiofrequency ablation techniques (too small range) and cardiac surgery volume reduction procedures that damage the conduction bundle. Simultaneously, mapping enables precise drug delivery, filling a gap in current clinical treatment. It can accurately locate the target site for treatment, overcoming the limitations of radiofrequency ablation in ablating deep ventricular walls and the inadequacy of cardiac surgery outflow tract recanalization procedures that damage the conduction bundle; making minimally invasive and precise repair of deep ventricular myocardial tissue possible.

[0025] The present invention will be further described below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the interventional drug delivery device for the heart according to the present invention;

[0027] Figure 2 This is an internal cross-sectional view of the interventional drug delivery device for the heart according to the present invention;

[0028] Figure 3 This is a cross-sectional view of the proximal end of the interventional drug delivery device for the heart described in this invention.

[0029] In the diagram: 100 outer sleeve, 110 connector, 120 proximal tube body, 130 distal tube body, 200 inner sleeve, 300 spiral electrode, 400 ring electrode, 500 electrode lead, 600 injection needle, 700 electrode holder, 7000 fixing through hole, 710 plug body, 720 stepped body, 730 socket body. Detailed Implementation

[0030] The following description is intended to disclose the present invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the invention.

[0031] like Figure 1 and Figure 2 As shown, the interventional drug delivery device for the heart includes:

[0032] Outer tube 100;

[0033] Inner sleeve 200, the inner sleeve 200 is sleeved inside the outer sleeve 100;

[0034] A spiral electrode 300 is disposed at the distal end of the outer sleeve 100;

[0035] A ring electrode 400 is disposed on the outer sleeve 100 and close to the proximal end of the outer sleeve 100;

[0036] Electrode wire 500 connects the spiral electrode 300 and the ring electrode 400, and is located between the outer sleeve 100 and the inner sleeve 200;

[0037] An injection needle 600 is located at the distal end of the outer sheath 100 and is connected to the inner sheath 200.

[0038] After the spiral electrode 300 reaches the endocardium of the target heart, the distal end of the outer cannula of the device can be directly held and rotated to allow the spiral electrode 300 to enter the myocardial tissue. Multiple rotations can achieve deep implantation into the myocardium. Furthermore, a multi-channel electrocardiogram recorder can be connected to the ring electrode 400 to record the intracavitary potential of the tissue near the spiral electrode 300. Based on this potential, it can be determined whether the epicardium or the endocardium on the opposite side of the interventricular septum has been reached. In other words, intracavitary mapping using the spiral electrode 300 can locate the cardiac conduction bundle and its depth. Specific drugs can be injected as needed at the location of the spiral electrode 300 using the injection needle 600, achieving drug delivery after mapping and localization, completing chemical ablation or promoting the repair of specific tissues.

[0039] like Figure 1 and Figure 2 As shown, the outer sleeve 100 includes a connector 110, a proximal tube body 120, and a distal tube body 130. The connector 110, the proximal tube body 120, the ring electrode 400, and the distal tube body 130 are connected in sequence. The proximal tube body 120, the ring electrode 400, and the distal tube body 130 are sleeved outside the inner sleeve 200.

[0040] The connector 110 is a standard Luer connector, a standardized micro-dose-free connector that connects to a syringe to administer medication into the injection needle 600 connected to the inner cannula 200. (Reference) Figure 1 The connector 110 is generally conical, and the proximal tube 120, the ring electrode 400, and the distal tube 130 are all tubular structures, forming an overall elongated structure. The diameters of the proximal tube 120, the ring electrode 400, and the distal tube 130 are approximately equal, ranging from 1.2 mm to 1.5 mm, preferably 1.44 mm. It is evident that the overall outer diameter of the proximal tube 120, the ring electrode 400, and the distal tube 130 is very small, providing sufficient torque. Therefore, after multiple rotations, the spiral electrode 300 can achieve deep myocardial implantation.

[0041] To ensure that no air enters the inner sleeve 200, flush with heparinized saline or the drug to be injected before using this device, and seal the connector 110 with the connector with the control valve.

[0042] like Figure 2 and Figure 3 As shown, the interventional drug delivery device for the heart further includes:

[0043] An electrode holder 700 is inserted into the distal end of the outer sleeve 100. An injection needle 600 is inserted into the electrode holder 700, and a spiral electrode 300 is welded to the electrode holder 700. The electrode holder 700, in addition to fixing the spiral electrode 300, also seals the distal ends of the outer sleeve 100 and the inner sleeve 200, and fixes the injection needle 600.

[0044] Specifically, the electrode holder 700 includes a plug body 710, a step body 720, and a sleeve body 730 connected in sequence. The plug body 710 is inserted into the outer sleeve 100 and abuts against the inner sleeve 200. The plug body 710 can be welded to the distal end of the outer sleeve 100. The step body 720 abuts against the port at the distal end of the outer sleeve 100. The sleeve body 730 is exposed outside the outer sleeve 100. The spiral electrode 300 is spiral in shape and surrounds the outside of the sleeve body 730.

[0045] More specifically, the electrode holder 700 has a fixing through hole 7000, which extends through the electrode holder 700 along its length and communicates with the interior of the inner sleeve 200. One end of the injection needle 600 is inserted into the inner sleeve 200 through the fixing through hole 7000, and the other end of the injection needle 600 is exposed outside the outer sleeve 100.

[0046] refer to Figure 3 The spiral electrode 300 surrounds the injection needle 600 so that the injection needle 600 remains centered on the spiral electrode 300. Furthermore, one end of the injection needle 600 is exposed within the outer sheath 100 but does not extend beyond the spiral electrode 300, thus ensuring that the injection needle 600 is enclosed by the spiral electrode 300, improving the accuracy of drug delivery.

[0047] As can be seen from the above, the electrode holder 700, the outer sleeve 100 and the inner sleeve 200 are all hollow structures. The injection needle 600 can also be a hollow structure. The international standard 25G, corresponding to the domestic No. 5 injection needle, can be selected. The outer diameter of this specification injection needle is 0.51mm and the inner diameter is 0.25mm.

[0048] refer to Figure 1 The length of the spiral electrode 300 is 1.8 mm to 3.0 mm, and the overall length of the interventional drug delivery device for the heart is 45 mm to 52 mm.

[0049] like Figure 2 As shown, the electrode wire 500 is accommodated between the inner sleeve 200 and the outer sleeve 100, and between the connector 710 and the outer sleeve 100. The electrode wire 500 is welded and fixed to the electrode holder 700 and the ring electrode 400, respectively, thus enabling the ring electrode 400 and the rotating electrode 300 to conduct electricity. The inner sleeve 200 and the outer sleeve 100 can be made of insulating material, such as medical polyurethane, to insulate and isolate the electrode wire 500 from the outside.

[0050] The electrode wire 500 is made of 3 to 4 strands of MP35N alloy steel wire wound together. MP35N is a nickel-cobalt alloy that can be age-hardened and has a unique combination of properties, including ultra-high strength, toughness, ductility and excellent corrosion resistance.

[0051] The interventional drug delivery device for the heart also includes a recorder connected to the loop electrode 400. The recorder can be a multi-lead electrophysiological recorder or a pacing testing instrument. After the spiral electrode 300 reaches the vicinity of the expected position, it can be connected to the multi-lead electrophysiological recorder via a bridging cable to record the intracavitary potential of the injection needle 600 and the vicinity of the spiral electrode 300. The depolarization potential is used to map the His-Purkinje system, and the repolarization potential is used to determine whether the epicardium or the endocardium on the opposite side of the interventricular septum has been reached. Simultaneously, impedance monitoring can be used to avoid larger blood vessels, and pacing mapping can be used to determine the conduction bundle distance. Drug delivery is then administered after the target site is determined.

[0052] The method of using the interventional drug delivery device for the heart is as follows:

[0053] The patient lies supine on the catheterization lab operating table. The subclavian vein, femoral vein, radial artery, and femoral artery are selected as puncture sites. After routine disinfection and draping, and satisfactory local anesthesia with 1% lidocaine, the vein / artery is punctured. A guidewire is inserted into the right or left ventricle, and a suitable sheath is advanced along the guidewire. Once the distal end of the sheath reaches the endocardial side of the target site, the device is inserted. When the helical electrode 300 reaches the endocardium of the target site, the outer sheath 100 of the device can be directly held and rotated to allow the helical electrode 300 to enter the myocardial tissue. Due to the very small outer diameter of the device and its ability to provide sufficient torque, multiple rotations can achieve deep myocardial implantation. After the helical electrode 300 reaches the desired position, a multi-channel electrophysiological recorder can be connected via a bridging wire to record the intracavitary potential near the helical electrode 300. The depolarization potential is used to map the His-Purkinje system, and the repolarization potential is used to determine whether the epicardium or the endocardium on the opposite side of the interventricular septum has been reached. Simultaneously, impedance monitoring avoids larger blood vessels, and pacing mapping determines the conduction bundle distance. After determining the target site, medication is administered.

[0054] After the spiral electrode 300 reaches the desired position, it can be connected to a pacing testing instrument. One end is connected to the proximal loop electrode 400, and the other end is connected to the subcutaneous muscle tissue or the electrode of other pacing leads in the heart chamber. This enables unipolar measurement of pacing threshold, impedance, and ECG signals. Since the spiral electrode 300 serves as the input end of the ECG signal, the infusion site of the injection needle 600 can be considered as the desired target location.

[0055] This device is compatible with clinical delivery sheaths of 5F or higher. If increased push force is required, the electrode can be implanted together with the delivery sheath via wire shaping. Since the diameter of the distal injection needle 600 is smaller than that of the wire used in the device, there is no need to worry about the wire penetrating and damaging myocardial tissue. Because the spiral electrode 300 is non-retractable, it is not recommended to implant the pacing electrode using the wire insertion method alone.

[0056] In summary, this invention combines intracardiac mapping and local injection drug delivery. Intracardiac mapping using the helical electrode 300 can locate the cardiac conduction bundle and its depth, which can be used for treatment of the conduction bundle by the injection needle 600 or to avoid the conduction bundle during treatment. Impedance monitoring can avoid large blood vessels during localization. Pacing mapping can determine the distance between the helical electrode and the conduction bundle, overcoming the limitations of current radiofrequency ablation techniques (too small range) and cardiac surgery volume reduction procedures that damage the conduction bundle. Simultaneously, mapping enables precise drug delivery, filling a gap in current clinical treatment. It allows for precise target location and treatment, overcoming the limitations of radiofrequency ablation in ablating deep ventricular walls and the inadequacy of cardiac surgery outflow tract recanalization procedures that damage the conduction bundle; making minimally invasive and precise repair of deep ventricular myocardial tissue possible.

[0057] This invention utilizes minimally invasive techniques to puncture a vein, reaching the right side of the interventricular septum via a specially designed sheath. A distal spiral is then used to reach the myocardium, where a mapping system locates the site for drug delivery. Local drug delivery for repairing infarcted or diseased myocardial tissue is a current research focus, and several local drug delivery devices have emerged. However, most of these devices are placed on the epicardial surface and are not minimally invasive. Subendocardial and intramural myocardial tissue (often the most severely ischemic areas or deep scars) typically do not benefit. This device overcomes these shortcomings by using mapping to locate the site, achieving multi-point and deep drug delivery. It can be used for chemical ablation of arrhythmias or hypertrophic myocardium, as well as for specific site drug delivery after electrophysiological mapping for tissue repair.

[0058] The embodiments described above are only used to illustrate the technical ideas and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. The scope of patent application of the present invention should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in the present invention still fall within the patent scope of the present invention.

Claims

1. An interventional drug delivery device for the heart, characterized in that, The utility model relates to a kind of electrode fixing seat and electrode, which is suitable for electrophysiological examination and treatment. It includes: Outer sleeve (100); Inner sleeve (200), the inner sleeve (200) is sleeved in the outer sleeve (100) inside; Spiral electrode (300), the spiral electrode (300) is arranged at the distal end of the outer sleeve (100); Ring electrode (400), the ring electrode (400) is arranged on the outer sleeve (100), and is close to the proximal end of the outer sleeve (100); Electrode lead (500), the electrode lead (500) is connected the spiral electrode (300) and the ring electrode (400), and is located between the outer sleeve (100) and the inner sleeve (200); 2. The device for the intervention administration to the heart according to claim 1, characterized in that, Injection needle (600), the injection needle (600) is located at the distal end of the outer sleeve (100), and is communicated with the inner sleeve (200). It also includes:

3. The device for the intervention administration to the heart according to claim 2, characterized in that Electrode fixing seat (700), the electrode fixing seat (700) is inserted in the distal end of the outer sleeve (100), the injection needle (600) is inserted in the electrode fixing seat (700), and the spiral electrode (300) is welded on the electrode fixing seat (700).

4. The device for the intervention administration to the heart according to claim 2, wherein The electrode fixing seat (700) includes plug-in body (710), step body (720) and sleeve body (730) connected in sequence, the plug-in body (710) is inserted in the outer sleeve (100), and is abutted with the inner sleeve (200), the step body (720) is abutted on the port at the distal end of the outer sleeve (100), the sleeve body (730) is exposed outside the outer sleeve (100), and the spiral electrode (300) is surrounded outside the sleeve body (730).

5. The device for the intervention administration to the heart according to claim 1, characterized in that, The electrode fixing seat (700) is provided with fixed through hole (7000), the fixed through hole (7000) penetrates the electrode fixing seat (700) along the length direction of the electrode fixing seat (700), the fixed through hole (7000) is communicated with the inside of the inner sleeve (200), one end of the injection needle (600) is inserted into the inner sleeve (200) through the fixed through hole (7000), and the other end of the injection needle (600) is exposed outside the outer sleeve (100).

6. The device for the intervention administration to the heart according to claim 3, characterized in that, The spiral electrode (300) is surrounded around the injection needle (600).

7. The device for the intervention administration to the heart according to claim 1, characterized in that, The electrode lead (500) is accommodated between the inner sleeve (200) and the outer sleeve (100), and between the plug-in body (710) and the outer sleeve (100), and the electrode lead (500) is welded with the electrode fixing seat (700) and the ring electrode (400) respectively. The outer sleeve (100) includes joint (110), proximal tube body (120) and distal tube body (130), the joint (110), the proximal tube body (120), the ring electrode (400) and the distal tube body (130) are connected in sequence, and the proximal tube body (120), the ring electrode (400) and the distal tube body (130) are sleeved outside the inner sleeve (200).

8. The device for the intervention administration to the heart according to claim 7, characterized in that, The diameter of the distal tube body (130) is 1.2mm-1.5mm, and the diameter of the proximal tube body (120) and the distal tube body (130) is equal.

9. The device for the intervention administration to the heart according to claim 1, characterized in that, The length of the interventional administration device for heart is 45mm-52mm, and the length of the spiral electrode (300) is 1.8mm-3.0mm.

10. The device for the intervention administration to the heart according to claim 1, characterized in that The outer sleeve (100) is an outer sleeve made of insulating material, and the inner sleeve (200) is an inner sleeve made of insulating material.

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