Extracardiac temporary pacemaker

Abstract

The present invention is related to an extracardiac temporary pacemaker designed for cardiac pacing, particularly for high-grade atrioventricular block and prolonged sinus pauses. The device integrates a pacemaker unit with battery within a transcutaneous patch, featuring thin, needle-like electrodes that penetrate the intercostal muscles to reach the epicardial surface of the heart. The design allows for rapid, significantly reducing the risk of complications associated with traditional intravascular pacemakers and providing a quick, safe, and more efficient solution for temporary cardiac pacing.

Description

[0001] DESCRIPTION

[0002] TITLE OF THE INVENTION : Extracardiac temporary pacemaker

[0003] FIELD OF THE INVENTION

[0004] The present invention generally relates to a medical device for cardiac pacing, and more specifically, to a transcutaneous temporary pacemaker designed for use in situations involving electrophysiological disorders such as cardiac conduction abnormalities, particularly slow heartbeat, high-grade atrioventricular block or prolonged sinus pauses.

[0005] BACKGROUND OF THE INVENTION

[0006] Cardiac pacing is a critical intervention in managing life-threatening situations such as high-grade atrioventricular block or long sinus pauses. These conditions can lead to dangerously slow ventricular escape rates or even a complete absence of ventricular activity, necessitating emergency temporary pacing. Traditionally, temporary pacemakers require intravascular access through one of the veins draining into the heart. This procedure ideally requires a catheterization laboratory (Cath lab) setting to ensure safety. However, in an emergency, bedside placement of temporary pacemakers is sometimes performed blindly or under echocardiographic guidance. These approaches are not without risks and can lead to serious complications, including local vascular hematoma, pericardial effusion, pericardial tamponade, and even death, with complication rates reaching up to 22%.

[0007] Conventionally, when placing a temporary pacemaker in a patient, the procedure typically involves either a vein-based, or surgical approach. The transvenous approach involves accessing the heart through a vein. Transvenous approach requires venous access through which a lead is placed inside the right ventricle under fluoroscopy or echo guidance and this lead is connected to external temporary pacemaker battery. This procedure typical requires 7-15 mins. The surgical approach involves an epicardial method, where a medical expert (cardiothoracic surgeon) uses a needle tip wires for temporary back-up pacing after major open heart surgeries (e.g. coronary arteries bypass graft, correction of congenital heart diseases, valve replacement etc). This needle tip wire is inserted into the epicardial surface of right or left ventricle which comes out of the xiphisternal region and connected to the temporary pacemaker battery. This procedure is typical performed by surgeons during open heart surgery and they leave temporary pacemaker as a backup for 24-48 hours post open-heart surgery.

[0008] US10369357B2 discloses a device and method for the treatment of bradyarrhythmia using a percutaneous temporary epicardial pacemaker device. The pacemaker device is attached subcutaneously with a distal portion inside the chest and the proximal portion outside, while the transcutaneous electrode patch is placed on the skin surface, typically on the left posterior chest beneath the scapula.

[0009] W02002000102A2 discloses a system and method for performing electrical therapy for a heart in pulseless electrical activity using an electrode placeable over the heart surface with the help of a blunted tipped device insertable via a thoracostomy. It discloses a patch that can be positioned on a patient's skin, the introduction of electrodes in the intercostal region for therapeutic purposes, and the placement of electrodes on the external surface of the heart for electrical therapy. It also discloses a system for performing defibrillation, cardioversion, anti-tachy cardial pacing, or pacing. There is a need for a temporary pacemaker patch that can be operated within minutes without any transvenous access in situations such as medical emergencies.

[0010] Given the risks and requirements, there is a clear need for a quick, safer, transcutaneous, non- traumatic, and more effective method of temporary cardiac pacing.

[0011] To overcome the drawbacks stated in the prior art, the applicant has developed an extracardiac, transcutaneous temporary pacemaker that can be used without the complications associated with traditional intravascular pacemakers.

[0012] OBJECT OF THE INVENTION

[0013] The principal object of the present invention is to provide a minimally invasive temporary pacemaker that can be safely and effectively used especially in emergencies.

[0014] Another object of the present invention is to provide a temporary pacemaker that alleviates the risks of complications such as vascular hematoma, pericardial effusion, and pericardial tamponade generally associated with the use of invasive pacemakers.

[0015] Yet another object of the invention is to provide a temporary pacemaker that can be easily and quickly applied especially in emergency scenarios.

[0016] SUMMARY OF THE INVENTION The present invention relates to a device for extracardiac minimally invasive temporary pacing of the heart. Said device comprises a transcutaneous patch (100) with a pacemaker unit (120) incorporated within. Said pacemaker unit (120) comprises a battery (121), and leads (122) with very thin insulin needle-sized wires (123) with electrodes (124) at the tips.

[0017] The extracardiac temporary pacemaker (100) of the present invention provides a quick, safe and efficient temporary pacing solution, significantly reducing the risk of complications associated with conventional intravascular temporary pacemakers.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0020] Figure 1(a) and Figure 1(b) illustrate anteroposterior views of the extracardiac temporary patch pacemaker (100) positioned on the chest in accordance with the embodiments of the present invention;

[0021] Figure 2 illustrates a lateral view of the extracardiac temporary patch pacemaker (100) placed in the fifth intercostal space in the left parasternal region;

[0022] Figure 3(a) illustrates the prototype of a single-lead extracardiac temporary patch pacemaker (100) of the present invention; Figure 3(b) illustrates the prototype of a dual-lead extracardiac temporary patch pacemaker (100) of the present invention; and

[0023] Figure 4 illustrates the prototype of a transcutaneous patch with an extracardiac pacemaker (100) of the present invention.

[0024] DETAILED DESCRIPTION OF THE INVENTION

[0025] The summary of the present invention, as well as the detailed description, is better understood when read in conjunction with the accompanying drawings that illustrate one or more possible embodiments of the present invention.

[0026] The present invention is related to a device intended for electrical stimulation to the external surface of the heart. The term “patch pacemaker” in the present disclosure is meant for the interpretation of a device for cardiac pacing on the epicardial surface of the heart. In particular and as described in detail below, the described patch pacemaker may be used for treating slow heartbeat, high-grade atrioventricular block or prolonged sinus pauses without the risk of serious complications such as vascular hematoma, pericardial effusion, pericardial tamponade, and even death.

[0027] The present invention relates to an extracardiac minimally invasive temporary patch pacemaker (100) designed for quick pacing of the heart. Said pacemaker unit (120) is incorporated within a transcutaneous patch (110), and comprises a battery (121), leads (122) with very thin insulin needle-sized wires (123) with electrodes (124) at the tips, and a switch (125) for operating said pacemaker (100). Said wires (123) have the ability to penetrate the skeletal intercostal muscles and pericardial space, and reach the epicardial surface of the heart, enabling effective pacing without causing damage due to their small size.

[0028] According to an embodiment of the present invention, a single lead (122) as shown in Figure 3(a) is used for pacing. According to an alternate embodiment, two leads (122) as shown in Figure 3(b) are used for pacing, wherein said leads (122) behave as cathodes thereby enhancing the chances of capture. According to the embodiments of the present invention, said leads (122) of the patch pacemaker unit (120) act as a cathode and are connected to the battery (121) present within the patch (110), and the body of the pacemaker unit (120) acts as anode which is integrated with the battery (121) of said pacemaker unit (120) inside the patch (110).

[0029] The patch pacemaker (100) of the present invention is positioned in the fifth intercostal space in the left parasternal region, and pacing of the heart initiates as soon as the electrodes (124) come into contact with the epicardial surface of the heart. This can be confirmed through real time ECG monitoring.

[0030] The various embodiments of the present invention can be better understood with reference to, but not limited to, a dual-lead pacemaker (100) described herein as an example.

[0031] In accordance with the embodiments of the present invention, said patch pacemaker (100) as illustrated in the accompanying figures may be of any shape including but not limited to rectangular, cylindrical, circular, and elliptical. Said patch pacemaker (100) as shown in Figure 3, comprises leads (122) that are connected inside the body of the pacemaker unit (120) and act as the cathode, and the body of the pacemaker unit (120) that acts as the anode. The length of said leads (122) can range from 2 cm - 4 cm depending on the patient's thoracic muscle and subcutaneous thickness. Said patch pacemaker (100) comprises a lead tip with fine dimensions to ensure minimal invasiveness and reduce the risk of tissue damage.

[0032] According to an embodiment of the present invention, said leads (122) are uniform throughout the length and have a pointed tip. According to an alternate embodiment, said leads (122) are uniform till 50% of their length and taper therefrom towards the tip.

[0033] Figure 4 illustrates the design of the transcutaneous patch (110) with the pacemaker unit (120) placed within. The pacemaker unit (120) comprises two protruding leads (122) the tips of which act as cathode. The patch pacemaker (100) is equipped with a backing layer (111) and an adhesive to securely attach said patch (110) to the skin, and provide reliable contact and stability, which is essential for effective monitoring and pacing. Said patch pacemaker (100) is easy to place on the patient's chest due to the simplicity of the design.

[0034] The lead (122) of the patch pacemaker (100) of the present invention may be made of a biocompatible material, such as platinum or a platinum-iridium alloy, stainless steel, iridium, tantalum, titanium, gold, silver, and ruthenium to ensure durability and conductivity while minimizing the risk of adverse reactions.

[0035] According to an example, the distal portion of said leads (122) is made of but not limited to platinum-iridium, and the proximal portion of said leads (122) is made of but not limited to stainless steel which is coated with silicone for insulation. The tip of said electrode (124) is needle shaped. Said leads (122) are made up of but not limited to stainless steel for conducting current, and the distal portion behaves as cathode.

[0036] Said leads (122) of the patch pacemaker (100) of the present invention are designed to penetrate the skeletal intercostal muscles and pericardial space, and reach the epicardial surface of the heart. Said leads (122) are designed to touch the epicardial surface to achieve effective pacing without causing significant trauma. Said leads (122) have a diameter of 0.3 mm to 0.5 mm, and a length of 2 cm to 4 cm.

[0037] The patch (110) housing the pacemaker unit (120) comprises a backing layer (111) with adhesive for adhesion of said device to the patient’s body. The patch (110) housing the pacemaker unit (120) is made of a pliable waterproof material which allows it to conform to the contours of the patient's body and maintain its position during use. Said patch (110) may be of any shape. Said patch (110) and backing layer (111) may be made of a material selected from but not limited to high medicalgrade silicone, polyurethane, polydimethylsiloxane (PDMS), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), thermoplastic elastomers (TPE), hydrogels, and medical-grade polycarbonate. Said patch (110) has a length of 7 cm to 8 cm and a width of 2.5 cm to 3 cm. Said pacemaker unit (120) has a length of 2.5 cm to 3 cm, width of 1.5 cm to 2 cm, and a height of 1 cm to 1.5 cm.

[0038] Said adhesive used in the patch (110) is hypoallergenic and designed to maintain strong adhesion even in the presence of sweat or body fluids, ensuring that the patch (110) remains securely in place during the pacing period. Said adhesive material may be selected from acrylic adhesive, silicone adhesive, hydrocolloid adhesive, polyurethane adhesive, medical-grade pressure-sensitive adhesive (PSAS), hot-melt adhesive, and rubber-based adhesive.

[0039] The battery (121) used in the patch pacemaker (100) of the present invention is compact in size and has reliable power output. Said battery (121) may be made of a material selected from but not limited to lithium, lithium carbon monofluoride, lithium polycarbon fluoride, lithium iodide, silver-oxide, zinc air, lithium polymer, nickel-metal hydride (NiMH), and nickel-cadmium. Said battery (121) is designed to last for 1 week to 1 month to ensure sufficient pacing time.

[0040] Said patch pacemaker (100) has the capacity to pace from 0.5 volts to 40 volts with a pulse width ranging from 0.2 ms to 40 ms. The pulse width can be variable. It has sensing capacity along with pacing, wherein said sensing capacity is 0.3 mV to 20 mV. Said sensing capacity is intrinsic cardiac activity. The pacing rate of said device ranges from 30 bpm to 250 bpm (beats per minute).

[0041] The patch pacemaker (100) of the present invention is disposable, thereby alleviating the risk of cross-contamination and need for sterilization. Each unit is intended for single-patient use, ensuring maximum safety and hygiene.

[0042] According to the embodiments of the present invention, the patch pacemaker (100) is a minimally invasive extracardiac temporary patch pacemaker (100) that comprises a transcutaneous patch (110) holding a pacemaker unit (120) comprising very thin electrodes (124) that act as a cathode, and a battery (121) that acts as the anode, wherein said patch (110) further comprises a backing layer (111) and an adhesive for secure attachment to the skin of the patient, and said electrodes (124) trigger pacing of the heart as soon as they come in contact with the epicardial surface, and a switch (125) for operating said pacemaker (100).

[0043] The aforementioned described features help alleviate the problems associated with prior art technologies. It will be appreciated by those skilled in the art that various modifications and alternatives to those details could be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are meant to be illustrative only and not limiting as to the scope of the invention which is to be given the full breadth of the appended claims and any and all equivalents thereof.

[0044] It is to be understood, however, that the present invention would not be limited by any means to the components, arrangements and materials that are not specifically described, and any change to the materials, variations, and modifications can be made without departing from the scope described in the present invention.

Claims

We / 1 Claim:

1. A minimally invasive extracardiac temporary patch pacemaker (100), characterized in that said extracardiac temporary patch pacemaker (100) comprises of: a transcutaneous patch (110); a pacemaker unit (120) housed within said transcutaneous patch (110), said pacemaker unit (120) comprising of: a battery (121) positioned within said pacemaker unit (120); at least one lead (122) comprising a very thin needle-sized wire (123) with electrode (124) at its distal tip; and a switch (125) for operating said pacemaker (100); and an adhesive backing layer (111) integrated with said transcutaneous patch (110) to securely attach the patch (110) to a patient's skin; wherein, said at least one lead (122) is configured to act as a cathode and is electrically connected to said battery (121), and the body of said pacemaker unit (120) is configured to act as an anode which is integrated with said battery (121) inside said patch (110); said lead (122) has a diameter of 0.3 mm to 0.5 mm, and a length of 2 cm to 4 cm, dimensioned to penetrate skeletal intercostal muscles and pericardial space to reach an epicardial surface of the heart; and said patch pacemaker (100) is positionable at a region corresponding to the fifth skeletal intercostal muscles in the left parasternal region, and is configured, to trigger pacing as soon as the electrode (124) makes contact with the epicardial surface of the heart.

2. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim1, wherein said transcutaneous patch (110) has a length of 7 cm to 8 cm, and a width of 2.5 cm to 3 cm.

3. The minimally invasive extracardiac temporary patch pacemaker ( 100) as claimed in claim 1, wherein said pacemaker (100) has a length of 2.5 cm to 3 cm, width of 1.5 cm to 2 cm, and height of 1 cm to 1.5 cm.

4. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein said pacemaker (100) is a single-lead pacemaker or a dual-lead pacemaker.

5. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein said lead (122) is uniform along the length, and has a pointed tip at the distal end.

6. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein said lead (122) is uniform for a length of 50% at the proximal end, and taper therefrom towards the tip at the distal end.

7. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein the distal portion of said lead (122) is made of a biocompatible material selected from platinum, platinum-iridium alloy, stainless steel, iridium, tantalum, titanium, gold, silver, and ruthenium, and the proximal portion of said lead (122) is made of stainless steel coated with silicone.

8. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1 , wherein said patch (110) and and backing layer (111) are made of a waterproof and pliable material selected from high medical-grade silicone, polyurethane, polydimethylsiloxane (PDMS), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), thermoplastic elastomers (TPE), hydrogels, and medical-grade polycarbonate.

9. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein said battery (121) is made of a material selected from lithium, lithium carbon monofluoride, lithium iodide, silver oxide, zinc air, lithium polymer, nickel-metal hydride (NiMH), and nickel-cadmium.

10. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein the adhesive material used in said backing layer (111) is made of a hypoallergenic material selected from acrylic adhesive, silicone adhesive, hydrocolloid adhesive, polyurethane adhesive, medical-grade pressure-sensitive adhesive (PSAS), hot- melt adhesive, and rubber-based adhesive.

11. The minimally invasive extracardiac temporary patch pacemaker (100) as claimed in claim 1, wherein said pacemaker (100) is capable of pacing the heart with 0.5 volts to 40 volts, and a pulse width of 0.2 ms to 40 ms, and a sensing capacity of intrinsic cardiac activity is0.3 mV to 20 mV.

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