Medical Devices for Delivering Agents and / or Modalities to Organs

Abstract

The medical device has an outer tubular body and an inner tubular body. A tissue engaging member is attached to the distal end of the inner tubular body. The tissue engaging member and the inner tubular body are retractable within the outer tubular body. The tip of the tissue engaging member is configured to penetrate tissue of a patient and be secured to an organ. The movement of the tissue engaging member is limited to a predetermined angle and a predetermined distance. The medical device is configured to deliver multiple agents and / or modalities through the inner tubular body. The agents and / or modalities are supplied through a delivery mechanism disposed within the inner tubular body. A method of treating cardiac disease includes applying one or more agents and / or modalities to the same region of the heart, either simultaneously or sequentially.

Description

[Technical field]

[0001] The present disclosure is directed to medical devices, operating instructions for their use, and indications and methods for the treatment of human patients by delivering therapeutic agents and / or modalities directly to the patient's heart, or other organs. [Background technology]

[0002] Despite advances in medical technology, myocardial infarction remains the number one cause of death worldwide. When a myocardial infarction occurs, cardiac tissue is damaged and ultimately dies from ischemia caused by complete or incomplete obstruction of coronary blood flow. This obstruction initiates a cascade of events that leads to myocardial cell death, apoptosis, and necrosis. As the process of cell death continues, this condition can result in cardiac dysfunction, arrhythmias, and heart failure, the leading cause of morbidity in the elderly.

[0003] The heart is one of the organs with the poorest ability to regenerate. Once cardiac cells die, the chances of the lost cells being replenished with viable, functional cardiomyocytes are extremely low. This leads to high morbidity and mortality after ischemic cardiac injury, which are both important contributors to healthcare costs worldwide. Effective cardiac regenerative therapies are needed.

[0004] In order to develop methods for cardiac regenerative therapy, the delivery of various therapeutic agents and / or modalities to damaged or ischemic cardiac muscle has been explored. Multiple methods for delivering therapeutic agents to the heart have been tested, including intravenous injection, delivery by catheter, and direct injection from outside the heart.

[0005] Existing devices and methods developed for injecting drugs directly into the heart and pericardial cavity have carried the risk of serious complications, including unintentional heart wall perforation, bleeding, cardiac damage, and even patient death, so direct injection techniques are not currently widely used or otherwise standard of care for non-surgical cardiac patients. Summary of the Invention

[0006] A medical device is described that allows for accurate, timely, and safe direct delivery of agents and / or modalities into a patient's organ. The medical device can reduce the risk of unintentional puncture of the organ wall caused by the inability to precisely control the insertion depth of the delivery mechanism. The medical device also allows for simultaneous or sequential delivery of agents and / or modalities to the same region of the organ. [Problem to be solved by the invention]

[0007] The problem to be solved is illustrated in the context of the heart of a patient suffering from cardiac disease. However, similar precise insertion depth control of the delivery mechanism is also required for organs other than the heart. The disclosure should be easily adapted for use with organs other than the heart.

[0008] Previous direct delivery techniques to the heart carried the risk of unintentional puncture of the heart wall and penetration into the heart lumen. In particular, patients with ischemic heart disease often have a reduced thickness of the heart wall, making such patients at high risk of suffering from unintentional puncture of the heart wall. Such unintentional puncture can cause bleeding from the heart and cardiac tamponade, presenting a significant risk factor when performing direct delivery procedures. These needles lack a means to control the insertion depth, causing unintentional puncture. There was a need for a device and method that provides safe direct delivery of agents and / or modalities into the heart.

[0009] Furthermore, when simultaneous or sequential delivery of more than one agent and / or modality to the same region of the heart was desired, it was difficult to target the first target region with the second delivery device because the first delivery device had to be removed from the heart to use the second delivery device. What was desired were devices and methods that could assist in simultaneous or sequential delivery of more than one agent and / or modality to the same region of the heart without removing the first device. [Means for solving the problem]

[0010] The objective of the present disclosure can provide a solution to the above-mentioned problems. A device is disclosed that can assist in the delivery of drugs and / or modalities into the heart and can deliver multiple drugs and / or modalities into the same region of the heart with an insertion depth control mechanism. A method for treating cardiac disease by simultaneously or sequentially delivering drugs and / or modalities to the heart is also disclosed.

[0011] The embodiments disclosed in the present disclosure solve the above-mentioned problems and can relate to a medical device. The medical device has an outer tubular body and an inner tubular body that move relative to each other in a predetermined direction and distance. A tissue engaging member is attached to the distal end of the inner tubular body, and the tissue engaging member and the inner tubular body form a unit. The tissue engaging member has a helical shape. The unit of the helical tissue engaging member and the inner tubular body is retractable inside the outer tubular body. The advancement and retraction of the helical tissue engaging member and the inner tubular body is guided by a helical groove cut into the gear that guides the corkscrew-like movement of the inner tubular body. Rotation of the inner tubular body in one direction relative to the outer tubular body advances the inner tubular body and exposes a portion of the attached helical tissue engaging member from the distal end of the outer tubular body. Rotation of the inner tubular body in a second direction retracts the inner tubular body and the attached helical tissue engaging member into the outer tubular body. When the tissue engaging member is exposed outside the outer tubular body by the corkscrew-like movement, the tip of the tissue engaging member can penetrate the pericardium, and the tissue engaging member can be fixed inside the pericardium or within the myocardium by the corkscrew-like movement. The corkscrew-like movement of the tissue engaging member is limited to a predetermined angle, and therefore the advancement of the inner tubular body is limited to a predetermined distance. This configuration can reduce the risk of unintentional puncture of the heart wall. Since the tissue engaging member can fix the medical device on the heart and prevent movement of the medical device during application, multiple agents and / or modalities can be applied to a target region of the heart through the inner tubular body, either simultaneously or sequentially. The agents and / or modalities can be delivered through one or more delivery mechanisms located inside the outer tubular body. Effect of disclosure The medical device of the present disclosure can be used to deliver agents and / or modalities directly into the heart while reducing the risk of unintentional puncture of the heart wall. In addition, the medical device can allow for simultaneous or sequential application of agents and / or modalities to the same region of the heart. The medical device can be easily adapted to be used for direct delivery of agents and / or modalities to organs other than the heart.

[0012] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description. As will be understood, the present disclosure can be modified in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0013] A medical device for delivering agents and / or modalities to an organ is disclosed. The medical device has an outer tubular body having a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end. The inner tubular body has a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end. The inner tubular body is movable within the first lumen of the outer tubular body. The second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body, and the inner tubular body is movable from a first position to a second position along the first longitudinal axis of the outer tubular body. The helical tissue engaging member has a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end. The helical tissue engaging member is attached to the second distal end of the inner tubular body, and the third longitudinal axis of the helical tissue engaging member is substantially parallel to the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body. The helical tissue engaging member is located within the first lumen of the outer tubular body. The third distal end of the helical tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position, and the third distal end of the helical tissue engaging member extends outside the first distal end of the outer tubular body when the inner tubular body is in the second position.

[0014] A method for treating or monitoring a patient suffering from a cardiac disease is disclosed, the method comprising delivering one or more agents and / or modalities directly to the myocardium of a patient in need thereof.

[0015] The figures are not drawn to scale and are for illustrative purposes only: dimensions such as relative sizes and thicknesses may be adjusted to suit a particular application. Like numbers refer to like parts throughout. [Brief description of the drawings]

[0016] [Figure 1A]FIG. 1 illustrates a side proximal isometric view of a medical device according to one embodiment. [Figure 1B] FIG. 13 is a side proximal isometric view of a medical device according to another embodiment. [Figure 2A-1] 2A-1 shows a side view of a medical device according to one embodiment, with portions of the outer and inner tubular bodies removed. FIG. 2A-2 shows the proximal half of the medical device. [Figure 2A-2] 2A-1 is a side view of a medical device according to one embodiment, with portions of the outer and inner tubular bodies removed. FIG. 2A-2 shows the distal half of the medical device. [Figure 2A-3] 2A-1 shows a cross-section of a medical device at the location shown in FIG. 2A-1. [Figure 2B] 2A-2 shows a cross-section of the medical device at the location shown in FIG. 2A-2, but only the outer tubular body is shown. [Figure 2C] 2A-2 shows a cross-section of the medical device at the location shown in FIG. 2A-2, but only the outer tubular body is shown. [Figure 2D] 2A-2 shows a cross-section of the medical device at the location shown in FIG. 2A-2, but only the outer tubular body is shown. [Figure 2E] 2A-1 shows a cross-section of the medical device at the location shown in FIG. 2A-1, but only the outer tubular body is shown. [Figure 2F] 2A-1 shows a cross-section of the medical device at the location shown in FIG. 2A-1, but only the outer tubular body is shown. [Figure 2G-1] 1 is a side view of a medical device according to another embodiment, with portions of the outer and inner tubular bodies removed. [Figure 2G-2] 1 is a side view of a medical device according to another embodiment, with portions of the outer and inner tubular bodies removed. [Figure 3A] FIG. 1 is a cross-sectional view along the long axis of a medical device according to one embodiment. [Figure 3B] FIG. 1 is a cross-sectional view along the long axis of a medical device according to one embodiment. [Figure 3C]1 is a cross-sectional view along a longitudinal axis of a medical device according to another embodiment. [Figure 3D] 1 is a cross-sectional view along a longitudinal axis of a medical device according to another embodiment. [Figure 4A] FIG. 1 is an enlarged cross-sectional side distal isometric view of a distal end of a medical device according to one embodiment having two needles. [Figure 4B] FIG. 2 is a close-up side proximal isometric view of a proximal end of a medical device according to one embodiment. [Figure 5A] FIG. 1 is an enlarged cross-sectional side distal isometric view of a distal end of a medical device according to one embodiment having two needles. [Figure 5B] FIG. 2 is a close-up side proximal isometric view of a proximal end of a medical device according to one embodiment. [Figure 6] FIG. 1 illustrates a medical device inserted into a patient to treat the heart, according to one embodiment. [Figure 7A] FIG. 1 illustrates a distal end of a medical device inserted into a body cavity and in contact with the pericardium, according to one embodiment. [Figure 7B] 13 is a view according to another embodiment showing a distal end of a medical device inserted into a body cavity and in contact with the pericardium. [Figure 8A] FIG. 2 shows a distal end of a medical device inserted into a body cavity, according to one embodiment. [Figure 8B] 13A-13C are views showing a distal end of a medical device inserted into a body cavity according to another embodiment. [Figure 9A] 1 illustrates a distal end of a medical device inserted into a body cavity, with the tissue engaging member not shown, according to one embodiment. [Figure 9B] 13 is a view of another embodiment showing the distal end of a medical device inserted into a body cavity, the helical tissue engaging member not shown. [Figure 10] FIG. 1 is a side proximal isometric view of a medical device according to one embodiment attached to a holder. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] "Heart" generally refers to all parts of the heart, including the pericardium, myocardium, pericardial cavity, ventricles, atria, septum, coronary arteries, and atria. "Heart muscle" generally refers to the myocardium.

[0018] "Same region" of the heart refers to substantially overlapping regions in which the applied agents and / or modalities can exert their effect, but is not limited to the same region. "Delivering" to the heart includes injection or topical application of agents and / or modalities to the heart. Application of a modality includes application of a current or voltage via electrodes and measurement of a current or voltage via electrodes.

[0019] Forming a "tight seal" means that when two items are connected, there is no or negligible leakage of air or liquid into or out of the connection when medically relevant pressures are applied.

[0020] "Puncture / piercing," "unintentional puncture / piercing," "penetration / penetration," and "unintentional penetration / piercing," with respect to the heart, mean the complete penetration of the heart wall by an object, which may cause leakage of blood from the heart.

[0021] The present disclosure generally relates to medical devices and methods for treating patients, and methods for operating medical devices. More specifically, the present disclosure relates to devices and methods for delivering agents and / or modalities directly to a patient's organ while reducing the risk of unintentional puncture of the organ wall. The following embodiments are described using the patient's heart as an example. However, the medical device can also be applied to the direct delivery of agents and / or modalities into organs other than the heart. Embodiment 1A and 1B are side proximal isometric views of a medical device according to some embodiments. The medical device (1) has an outer tubular body (10) and a thumb button (60). The outer tubular body (10) has a first proximal end (11) and a first distal end (12). A first longitudinal axis (13) extends in a direction from the first proximal end (11) to the first distal end (12). On a side of the outer tubular body (10) close to the first proximal end (11), side port 1 (70) and side port 2 (75) are movably disposed via slit 1 (71) and slit 2 (76), respectively. Side port 1 (70) and side port 2 (75) are offset at an angle around the peripheral contour of the sidewall of the outer tubular body (10). The angle at which side port 1 (70) and side port 2 (75) are disposed may be between 0 and 180 degrees. The thumb push button (60) may have a ring (83) for controlling a valve (not shown) that is movable independently of the thumb push button (60) and rotates about the first longitudinal axis (13). The thumb push button (60) may have a central luer lock (81) at the proximal end (463) of the medical device (1). The central luer lock (81) may optionally be fitted with a cap (501). The operation of side port 1 (70), side port 2 (75), thumb push button (60), the ring (83) for controlling a valve, and the central luer lock (81) will be described in more detail later in this specification. An inner tubular body is disposed inside the outer tubular body (10), which is not shown in this figure and will be described later in this specification.

[0022] 2A-1 and 2A-2 are side views of a medical device (1) according to one embodiment. An example having two needles is shown. FIG. 2A-1 is the proximal portion of the medical device (1) and FIG. 2A-2 is the distal portion of the medical device (1). Portions of the outer tubular body (10) and the inner tubular body (20) have been removed to show the interior. FIG. 2A-3 and FIG. 2B-2F are cross-sectional views at the positions shown in FIG. 2A-1 and FIG. 2A-2. Only the outer tubular body (10) is shown in FIG. 2B-2F.

[0023] The medical device (1) has an inner tubular body (20) and a helical tissue engaging member (30) within an outer tubular body (10). The outer tubular body (10) has a first inner surface (14) and a first lumen (15) extending along a first longitudinal axis (13).

[0024] The outer tubular body (10) of the medical device (1) can be made of stainless steel or any surgically suitable material. The outer surface of the outer tubular body (10) can be tapered such that the outer diameter of the outer tubular body (10) increases from the first distal end (12) to the first proximal end (11). The first distal end (12) of the outer tubular body (10) can be chamfered and can have a cutting edge (16) to aid in penetrating the body wall (101) (see Figures 7A and 7B) of the subject (100) (see Figure 6). The outer tubular body (10) can be shaped to facilitate insertion into the patient and to prevent bending of the medical device (1) due to pressure from the body. For example, the cross-sectional shape of the outer tubular body (10) can be circular near the proximal and distal ends and gradually change to a rounded square-like shape and a rounded trapezoid shape in the middle section. Although a series of cross sections of one embodiment are shown in Figures 2B-2F, the outer tubular body (10) can be configured in any shape and order that facilitates insertion into a patient and prevents bending due to pressure from the body.

[0025] The inner tubular body (20) has a second proximal end (21, see FIG. 3A), a second distal end (22), a second longitudinal axis (23) extending between the second proximal end (21) and the second distal end (22), and a second lumen (25) extending in the direction of the second longitudinal axis (23). The inner tubular body is connected to the gear (50) and may have a widened portion (120) on its proximal side.

[0026] The inner tubular body (20) is movably disposed within the first lumen (15) of the outer tubular body (10). The inner tubular body (20) is operably coupled to the first proximal end (11) of the outer tubular body (10) and to the thumb push button (60). The inner tubular body (20) is displaceable from a first position to a second position along the first longitudinal axis (13) of the outer tubular body (10). The movement of the inner tubular body (20) is corkscrew-like, and it can rotate about the second longitudinal axis (23) when moving between the first and second positions.

[0027] A gear (50) attached to the outer tubular body (10) has a helical groove (52) configured to engage a protrusion (18) formed on the inner tubular body (20). The helical groove (52) and the protrusion (18) are configured to guide the corkscrew-like movement of the inner tubular body (20). The helical groove (52) is configured such that the rotation of the inner tubular body (20) is limited to a predetermined angle.

[0028] Rotation of the inner tubular body (20) can be guided by gears (50) such that when the inner tubular body (20) is rotated in a first direction about the second longitudinal axis (23), the inner tubular body (20) and the helical tissue engaging member (30) move toward the first distal end (12) of the outer tubular body (10), and when the inner tubular body (20) is rotated in a second direction about the second longitudinal axis (23), the inner tubular body (20) and the helical tissue engaging member (30) move toward the first proximal end (11) of the outer tubular body (10).

[0029] The thumb push button (60) is configured to trigger movement of the inner tubular body (20). The mechanism for rotating the inner tubular body (20) is not particularly limited and can be any one of suitable rotation control mechanisms including manual rotation, a spring (55) actuated mechanism, a torsion hub, and an electromechanical control device.

[0030] The medical device (1) can be configured such that the range of rotation of the inner tubular body (20) relative to the outer tubular body (10) is limited to a first predetermined angle, and each operation of the thumb push button (60) allows rotation of the inner tubular body (20) relative to the outer tubular body (10) through a second predetermined angle.

[0031] The helical tissue engaging member (30) has a third proximal end (31), a third distal end (32), and a third longitudinal axis (33) extending from the third proximal end (31) to the third distal end (32). The third proximal end (31) of the helical tissue engaging member (30) is attached to the second distal end (22) of the inner tubular body (20) and extends further in a distal direction of the inner tubular body (20). The first longitudinal axis (13) of the outer tubular body (10), the second longitudinal axis (23) of the inner tubular body (20), and the third longitudinal axis (33) of the helical tissue engaging member (30) are substantially parallel to or substantially overlap one another.

[0032] The helical tissue engaging member (30) moves with the inner tubular body (20) as a unit. In operation, the third distal end (32) of the helical tissue engaging member (30) is recessed relative to the first distal end (12) of the outer tubular body (10) when the inner tubular body (20) is in the first position, and the third distal end (32) of the helical tissue engaging member (30) extends outside the first distal end (12) of the outer tubular body (10) when the inner tubular body (20) is in the second position.

[0033] The tissue engaging member (30) can have a tip (34) at the third, distal end (32). In actuation, when the inner tubular body (20) is moved from the first position to the second position, the tip (34) can make an incision in or penetrate the pericardium (91) (see Figures 7A-8B, this feature is described in more detail later in this specification). The corkscrew-like movement can allow the tissue engaging member (30) to engage the pericardium (91) or myocardium (93) (see Figures 7A-8B). The free end of the tip (34) can be blunt so as not to cause unintended damage to the subject's heart (90) (see Figure 6).

[0034] The medical device (1) may further include at least one delivery mechanism. The delivery mechanism is located within the first lumen (15) of the outer tubular body (10) and is operably coupled to the outer tubular body (10). In Fig. 2A-1 and Fig. 2A-2, an embodiment is shown having two needles, needle 1 (44) and needle 2 (45). Needle 1 (44) is connected to side port 1 (70) and needle 2 (45) is connected to side port 2 (75). The movement of the needles is guided by needle guide (500). The at least one delivery mechanism is further described below.

[0035] 2G-1 and 2G-2 show a medical device (1) in another embodiment. In this embodiment, a gear (50) attached to the inner tubular body (20) has a helical groove (51) configured to engage with a protrusion (17) formed on the first inner surface (14) of the outer tubular body (10) toward the first lumen (15) of the outer tubular body (10). The helical groove (51) and the protrusion (17) are configured to guide the corkscrew-like movement of the inner tubular body (20). The helical groove (51) is formed such that the rotation of the gear (50) and the inner tubular body (20) is limited to a predetermined angle.

[0036] Figures 3A and 3B are cross-sectional views along the longitudinal axis of a medical device (1) according to one embodiment. Figure 3A shows the proximal portion of the medical device (1) and Figure 3B shows the distal portion of the medical device (1). An example having two needles is shown. The tissue engaging member is not shown.

[0037] The medical device (1) may include at least one delivery mechanism. The delivery mechanism is located within a first lumen (15) of the outer tubular body (10) and is operably coupled to the outer tubular body (10). The delivery mechanism is displaceable along a first longitudinal axis (13) of the outer tubular body (10) from a third position (retracted position) to a fourth position (exposed position). During actuation, a distal end of the delivery mechanism is recessed relative to the first distal end (12) of the outer tubular body (10) when the delivery mechanism is in the third position and extends out of the second distal end (12) of the outer tubular body (10) when the delivery mechanism is in the fourth position.

[0038] In Figures 3A and 3B, the delivery mechanism is described using one example having two needles. However, the delivery mechanism is not limited to these examples and can be replaced with other embodiments, such as catheters, guidewires, electrodes, leads, and cameras. The delivery mechanisms can be configured to be used exclusively or simultaneously.

[0039] In the embodiment shown in Figures 3A and 3B, the lumen of Needle 1 (49) is continuous with Side Port 1 (70) and opens at the bottom of Side Port 1 (70). The lumen of Needle 2 is continuous with Side Port 2 (not shown) and opens at the bottom of Side Port 2 (not shown).

[0040] The inner tubular body (20) is disposed within a first lumen of the outer tubular body (15). The proximal end of the inner tubular body (21) opens towards the proximal end (463) of the medical device (1). A central luer lock (81) may be disposed at the proximal end of the medical device (463). The central luer lock (81) may be configured to receive tubing, a stopcock, another medical device, or the like, and to form a tight seal. The central luer lock (81) may be configured to receive a cap (501). The cap may be of any shape or material that prevents contamination of the central luer lock (81) when the central luer lock (81) is not in use.

[0041] A valve (82) and a ring (83) for controlling the valve can be disposed on the thumb push button (60). The opening of the valve (82) can be varied from fully closed to fully open, and the ring (83) for controlling the valve is configured to control the opening size of the valve (82). A central luer lock (81) or a structure performing a similar function can be disposed on the distal or proximal side of the valve (82). The central luer lock (81) or a structure performing a similar function can be enclosed inside the thumb push button (60) or can be exposed as shown in Figures 1A-2A-1, 2G-1, 3A, 3C, 4B, and 5B. The shape of the thumb push button (60) is not limited to the shapes shown in Figures 1A-6, but can be any ergonomically suitable shape, for example, as shown in the embodiment of Figure 10 (see thumb push button (160) and ring (183) for controlling the valve). The mechanism for controlling the valve (82) can take many forms, including a ring, lever, or button.

[0042] In operation, valve (82) provides control of the flow of material provided through inner tubular body (20). Alternatively, an external tube can be inserted through an opening in valve (82) and connected to inner tubular body (20) distal to valve (82). In the latter case, valve (82) provides a barrier to maintain sterility of the connection.

[0043] Another embodiment is shown in Figures 3C and 3D as a cross-sectional view along the long axis of the medical device (1). Figure 3C shows the proximal portion of the medical device (1) and Figure 3D shows the distal portion of the medical device (1). An example is shown having two optional needles (44 and 45) and an optional central tubular body (46) as a delivery mechanism. The tissue engagement member is not shown. The central tubular body (46) is disposed within the second lumen (25) of the inner tubular body (20). The central tubular body (46) has a proximal end (461) and a distal end (462) and has a hollow structure. The proximal end (461) of the central tubular body can be continuous with the central tube material (80). The lumen of the central tubular body (47) is continuous with the lumen of the central tube material (48) and opens towards the proximal end (463) of the medical device (1).

[0044] FIG. 4A is an enlarged cross-sectional view of a side distal isometric view of the distal end of a medical device (1) according to one embodiment, and FIG. 4B is an enlarged side proximal isometric view of the proximal end of the medical device (1). Two needles (needle 1 (44) and needle 2 (45)) and inner tubular body (20) are shown. Portions of the outer tubular body (10) and inner tubular body (20) have been removed to show the interior. The tissue engaging members are not shown. The needles are in a third (retracted) position and are recessed relative to the first distal end of the outer tubular body (12). The second distal end (22) of the inner tubular body (20) may be blunt or beveled.

[0045] The delivery mechanism can be configured to move between a third position (retracted position) and a fourth position (exposed position) by moving the side port. In one embodiment shown in Figures 4A and 4B where the delivery mechanism is a needle, Needle 1 (44) is connected to Side Port 1 (70) and Needle 2 (45) is connected to Side Port 2 (75). Needle 1 (44) and Needle 2 (45) are independently movable by manipulating Side Port 1 (70) and Side Port 2 (75), respectively. The travel distances (74) and (79) of Needle 1 (44) and Needle 2 (45) are limited by Slit 1 (71) and Slit 2 (76), respectively, formed in the side of the outer tubular body (10). When side port 1 (70) is at the proximal end (72) of slit 1, needle 1 (44) is in the third position (retracted position), and when side port 1 (70) is at the distal end (73) of slit 1, needle 1 (44) is in the fourth position (exposed position). Similarly, when side port 2 (75) is at the proximal end (77) of slit 2, needle 2 (45) is in the third position (retracted position), and when side port 2 (75) is at the distal end (78) of slit 2, needle 2 (45) is in the fourth position (exposed position).

[0046] During operation, therapeutic agents and / or modalities are supplied through side port 1 (70) and side port 2 (75) into the proximal end (441) of needle 1 (44) and the proximal end (451) of needle 2 (45) and can be delivered from the distal end (442) of needle 1 (44) and the distal end (452) of needle 2 (45), respectively.

[0047] Side port 1 (70) and side port 2 (75) can be configured to connect with tubing, stopcocks, syringes, or other medical devices. The stopcocks prevent air or fluid leakage and can be configured to fluidly connect a syringe, tubing, or other medical device to the medical device (1).

[0048] Figure 5A is an enlarged cross-sectional view of a side distal isometric view of the distal end of a medical device (1) according to another embodiment, and Figure 5B is an enlarged side proximal isometric view of the proximal end. Two optional needles (Needle 1 (44) and Needle 2 (45)) and central tubular body (46) are shown. Portions of outer tubular body (10) and inner tubular body (20) have been removed to show the interior. The tissue engaging members are not shown.

[0049] The medical device (1) may optionally include a central tubular body (46). The central tubular body (46) is another embodiment of a delivery mechanism and has a lumen (47). The second distal end (22) of the inner tubular body may be blunt or beveled. The distal end (462) of the central tubular body may also be blunt or beveled. The lumen of the central tubular body (47) is continuous with a central tube (80) at the proximal end of the central tubular body, which opens into a proximal end (463) of the medical device (1). The proximal end (461) of the central tubular body (46) is operably connected to the thumb push button (60) such that the central tubular body (46) moves with the inner tubular body (20) when the thumb push button (60) is operated.

[0050] The central tubular body (46) can be wider than needle 1 (44) and needle 2 (45), allowing fluid to pass in both directions through the central tubular body (46). In operation, for example, the central tubular body (46) can aspirate fluids or substances present in the tissue. Alternatively, the central tubular body (46) can "wash" the tissue, for example, by first delivering saline to the tissue and then removing the injected saline. Additionally, the central tubular body (46) can deliver materials having a higher viscosity, such as gels.

[0051] In operation, agents and / or modalities delivered using the medical device (1) include medicines, growth factors, cells, electrical currents, voltages, and electrical signals. 6 is a diagram showing a medical device (1) inserted into a patient to treat a heart (90), according to one embodiment. During insertion of the medical device (1) into the subject (100), the inner tubular body (not shown) is held in a first position, and the tissue engaging member (not shown) and the delivery mechanism (not shown) are retracted within the medical device (1).

[0052] Figure 7A is a diagram according to one embodiment showing the distal end (12) of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). Figure 7B is a diagram according to another embodiment showing the distal end (12) of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). The inner tubular body (20) is shown in a first position, with the tissue engaging member (30) retracted within the medical device (1). The medical device is not inserted into the pericardium (91), pericardial cavity (92), and myocardium (93) in these views. The delivery mechanism is shown in a third position, with the delivery mechanism retracted within the medical device (1).

[0053] FIG. 8A is a diagram according to one embodiment showing the distal end of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). FIG. 8B is a diagram according to another embodiment showing the distal end of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). The helical tissue engaging member (30) is engaged with the pericardium (91) in these views. The helical tissue engaging member (30) can reach the pericardial cavity (92) and the myocardium (93). The inner tubular body (20) is shown in a second position. The delivery mechanism is shown in a third position, retracted within the interior of the medical device (1).

[0054] FIG. 9A is a diagram according to one embodiment showing the distal end (12) of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). The inner tubular body (20) and the two needles (44 and 45) are in a fourth position, with the tip (22) of the inner tubular body and the tips (442 and 452) of the two needles inserted into the pericardial cavity (92) and the myocardium (93). FIG. 9B is a diagram according to another embodiment showing the distal end (12) of the medical device (1) inserted through the body wall (101) and in contact with the pericardium (91). The central tubular body (46) and the two needles (44 and 45) are in a fourth position, with the tip (462) of the central tubular body and the tips (442 and 452) of the two needles inserted into the pericardial cavity (92) and the myocardium (93). The tissue engaging members are not shown in these figures.

[0055] 10 is a side proximal isometric view of a medical device attached to a holder, according to one embodiment. A medical device (1) can be attached to the holder (84) for ergonomic use. The holder (84) has a device receiver (85), a handle (88), and a trigger (89). The device receiver (85) has the same profile as the outer surface of the outer tubular body (10) and a protrusion (87) that engages with a preformed thread (86) on the side of the outer tubular body (10). The medical device (1) can be snapped into the device receiver (85) of the holder (84) and released by pulling the trigger (89).

[0056] A method for treating or monitoring a patient suffering from a cardiac condition includes delivering one or more agents and / or modalities directly to the subject's heart, including the myocardium and pericardial cavity. Such agents and / or modalities include, but are not limited to, pharmaceuticals, growth factors, cells, electrical currents, voltages, and electrical signals. When more than one agent and / or modality is delivered, a first agent or modality and one or more additional agents and / or modalities can be delivered simultaneously or sequentially to the same region of the patient's heart. A medical device (1) can be used for such direct delivery to the patient's heart (90).

[0057] A method of treating or monitoring a patient suffering from a cardiac condition using a medical device (1) is disclosed. The method includes inserting a first distal end (12) of the medical device (1) with the inner tubular body (20) in a first position into a body cavity of the patient, as shown in FIG. 6. The method also includes manipulating the medical device (1) such that the first distal end (12) of the medical device (1) contacts the pericardium (91) of the patient, as shown in FIG. 7A and 7B. The method also includes penetrating the pericardium (91) using a tip (34) of the helical tissue engaging member (30), as shown in FIG. 8A and 8B. The method also includes rotating the inner tubular body (20) in a first direction such that the helical tissue engaging member (30) enters the pericardial cavity (92) and the myocardium (93). The method also includes positioning the inner tubular body (20) in a second position. The method also includes moving a delivery mechanism, such as needle 1 (44) or needle 2 (45), from a third position (retracted position) to a fourth position (exposed position), as shown in Figures 9A and 9B. The method also includes sequentially or simultaneously delivering one or more agents and / or modalities to the myocardium (93). The method also includes releasing the medical device (1) from the patient by rotating the helical shaped tissue engaging member (30) in a second direction. The method also includes removing the medical device (1) from the patient.

[0058] When medical device (1) is used to deliver two or more agents and / or modalities sequentially to the heart, medical device (1) can remain attached to the myocardium via the helical-shaped tissue engaging member (30) during delivery of a first agent or modality and during delivery of one or more additional agents and / or modalities, and medical device (1) can remain connected to the heart (90) between the delivery of the first agent or modality and the delivery of the one or more additional agents and / or modalities.

[0059] Alternatively, when the medical device (1) is used to deliver two or more agents and / or modalities simultaneously to the heart (90), more than one delivery mechanism can be advanced to a fourth position (exposed position) while the medical device (1) is attached to the pericardium (91) or myocardium (93) via the helical tissue engaging member (30). Working Example Below, a further detailed description of the medical device and method of treating a patient according to several different embodiments is provided, however, it should be understood that the present disclosure is not limited to the embodiments shown below.

[0060] In operation, the materials of the medical device (1) can be any suitable material for medical use. In one embodiment, the outer tubular body (10) and the inner tubular body (20) are made of Type 316 stainless steel hypodermic tubing (H316). In one embodiment, the helical tissue engaging member (30) is made of AISI 304 alloy. In one embodiment, the spring (55) configured to control the movement of the inner tubular body (20) is made of MP35N or a similar alloy. In one embodiment, the spring is made of a biocompatible material with a spacing between each helical ring of about 0.8 mm to about 1.1 mm. In one embodiment, the central tubular body (46) is made of AISI 316 or a similar alloy. The above-mentioned materials can be substituted with other surgically compatible materials used for similar purposes.

[0061] In operation, the first distal end (12) of the outer tubular body (10) can have a cutting edge (16) and can be beveled such that the cutting edge has an angle of between about 10° and about 70° relative to the first longitudinal axis (13) of the outer tubular body.

[0062] In one embodiment, the second distal end (22) of the inner tubular body (20) is configured to form a seal when the tissue engagement member (30) engages the heart (90). A port can be disposed at the second distal end (22) of the inner tubular body (20) that allows for the passage of a delivery mechanism without breaking the seal formed between the heart (90). The port can be made of a resilient material and is configured to allow for the passage of a delivery mechanism without breaking the seal formed between the second distal end (22) of the inner tubular body (20) and the heart (90).

[0063] In operation, the tissue engaging member (30) can be a spring and the short tip (34) can have a blunt end configured to be capable of penetrating the pericardium but not unintentionally penetrating the myocardium (93). The tissue engaging member (30) is corkscrew shaped and when rotated in a first direction, it advances into the heart (90) and when rotated in a second direction, it moves out of the heart. This movement of the tissue engaging member (30) helps secure the medical device (1) onto the heart (90) and form a seal between the inner tubular body (20) and the heart (90).

[0064] In operation, the gear (50) is configured to control the movement of the inner tubular body (20), and the mechanism can be of any design configured to provide a similar rotational movement to the inner tubular body (20). In the embodiment shown in Figure 3A, a protrusion (18) formed on the outer surface of the inner tubular body (20) engages with a helical groove (52) formed on the inner surface of the gear (50) to guide its rotational movement. In the embodiment shown in Figure 3C, a protrusion (17) formed on the inner surface (14) of the outer tubular body (10) engages with a helical groove (51) formed around the circumference of the gear (50) to guide the rotational movement of the inner tubular body (20).

[0065] In operation, rotating the gear (50) in a first direction advances the combined inner tubular body (20) and tissue engaging member (30) unit, exposing the tissue engaging member (30) from the distal end (12) of the outer tubular body (10). Rotating the gear (50) in a second direction retracts the combined inner tubular body (20) and tissue engaging member (30) unit into the outer tubular body (10). The helical grooves (51 and 52) are configured to limit the rotation of the inner tubular body (20) to a predetermined angle, e.g., about 1080°, and thus limit the distance the tissue engaging member (30) can advance to a predetermined length. This can reduce the risk of unintended or accidental over-rotation, which can cause unintended puncture of the heart (90). In operation, the rotation angle range can be adjusted according to the target tissue.

[0066] In operation, rotation and advancement of the inner tubular body (20) can be actuated by a thumb push button (60). The thumb push button (60) can be configured to interface with a spring (55), and actuation of the thumb push button can be configured to allow rotation of the inner tubular body (20) in a first direction through a predetermined angle. For example, a single press of the thumb push button (60) can trigger a rotation of the inner tubular body (20) in a first direction through approximately 90° and advance the tissue engagement member (30) a predetermined distance. The total number of advances allowed can be limited, for example, to approximately 12, thus limiting the rotation of the combined inner tubular body (20) and tissue engagement member (30) unit to approximately 1080°. This mechanism can allow the operator to precisely control the depth to which the tissue engagement member (30) is inserted, reducing the risk of unintentional puncture of the heart (90). The tissue engaging member (30) can be released from the tissue by rotating the tissue engaging member (30) in a second direction.

[0067] During actuation, various mechanical designs can be used to induce rotational movement of the inner tubular body (20). In one embodiment, a torsion hub (not shown) can be disposed on the medical device (1). The torsion hub can be manually rotated by a user to advance and retract the tissue engaging member (30). The rotation of the torsion hub can be limited to a predetermined number of turns or to a predetermined angle by molded stops formed on the gear (50).

[0068] In another embodiment, a spring-loaded button (not shown) with a gear mechanism (not shown) can be used. For example, the button can be configured to cause rotation of the inner tubular body (20) a predetermined angle, e.g., about 90°, each time the button is actuated, and the degree of rotation can be controlled by the number of times the button is pressed, e.g., up to about 12 times.

[0069] In yet another embodiment, a preloaded torsion spring (not shown) can be used to rotate the combined inner tubular body (20) and tissue engaging member (30) unit. In this embodiment, actuation of the thumb push button (60) triggers rotation of the inner tubular body (20) by the torsion spring until rotation is stopped by the ends of the helical grooves (51 and 52), for example after approximately 1080 degrees of rotation. This design allows for "manual reloading" of the torsion spring by rotating the attached torsion hub relative to the device body.

[0070] Further different mechanisms for controlling the rotation are possible, for example by electromechanical means configured to drive the gears to rotate at a desired angle during operation. In operation, tip (34) of tissue engaging member (30) can be designed such that fully depressing spring-loaded thumb push button (60) results in tip (34) being fully extended into pericardial space (92). Releasing thumb push button (60) eliminates the extra clearance required for rotation and causes engagement of gears (50), thereby causing tip (34) to retract slightly from the full extension seen when thumb push button (60) is fully depressed.

[0071] In the embodiment shown in Figures 4B and 5B, needle 1 (44) is coupled to a side port (70). In operation, the side port (70) is used as an entry site for agents and / or modalities and as a knob for moving needle 1 (44). Slit 1 (71) formed in the outer tubular body (10) limits the movement of side port (70) to a position between the proximal end (72) of slit 1 (71) and the distal end (73) of slit 1 (71). The side port (70) at the proximal end (72) of slit 1 (71) corresponds to a third position of the delivery mechanism, and the side port (70) at the distal end (73) of slit 1 (71) corresponds to a fourth position of the delivery mechanism. The medical device (1) can accommodate more than one delivery mechanism within the inner tubular body (20), and more than one delivery mechanism can be used simultaneously or sequentially.

[0072] In operation, the delivery mechanism can be one or more selected from needles, catheters, guidewires, mapping electrodes, leads, and cameras, including tip-based catheter cameras. The delivery mechanism is configured to perform procedures including injection of agents and / or modalities into the heart, electrical stimulation of the heart, monitoring of voltages and currents within the heart, and direct imaging of the heart. When delivery of multiple agents and / or modalities is desired, the tissue engaging member (30) can secure the medical device (1) in place while multiple agents and / or modalities can be delivered simultaneously or sequentially.

[0073] In operation, the delivery mechanism and inner tubular body (20) can be connected to an external plunger device or an external pump, which can have programming capabilities. Treatment methods The following describes a method for treating or monitoring a patient suffering from a cardiac condition.

[0074] When agents and / or modalities are delivered directly to the heart of a patient suffering from a cardiac disease, the agents and / or modalities have an immediate effect and are beneficial to the patient. For example, in cardiac diseases requiring immediate intervention, such as cardiac arrest or cardiac ischemia, direct delivery methods have significant advantages over other methods, since the agents and / or modalities immediately reach the target tissue and the delivery method does not require the agents and / or modalities to be delivered to the heart by the bloodstream. Similarly, in regenerative therapy of damaged myocardium, direct delivery methods are advantageous because the agents and / or modalities can be targeted to the infarcted region and their delivery does not depend on blood flow, which is often lost or reduced when the myocardium is damaged. Such agents and / or modalities include medicines, growth factors, cells, currents, voltages, or electrical signals.

[0075] During operation, it may be beneficial to apply multiple agents and / or modalities to the same region of the heart. For example, a target region can be primed by injecting a drug, and the same region can be injecting a second drug or cells. In yet another embodiment, a drug can be applied and later monitored or stimulated by electrodes. In another embodiment, cardiac activity can be monitored first and later another agent and / or modality can be inject. The combination and order in which these agents and / or modalities are applied are not limited to these embodiments and can be in any combination and order.

[0076] In operation, application of a drug and / or modality can be performed using the medical device (1). The drug and / or modality can be delivered through the delivery mechanism. The flow of the drug and / or modality can be either from the medical device (1) to the heart or from the heart to the medical device (1), and the flow of the drug and / or modality is reversible. The drug and / or modality can be delivered simultaneously or sequentially. That is, for example, a drug can be delivered through the delivery mechanism while a saline solution can be delivered through the inner tubular body (20). In one embodiment, when an affected area requires cleaning before delivery of a drug, the medical device (1) can first be secured to the heart (90) using the tissue engaging member (30), then the affected area can be cleaned with several changes of saline solution passed through the inner tubular body (20), and then the drug can be delivered to the cleaned area through the delivery mechanism. During the above-mentioned cleaning and delivery process, the medical device (1) can remain attached to the heart via the tissue engaging member (30), ensuring that the same affected area is treated.

[0077] Although the present disclosure has been described with reference to preferred embodiments, those skilled in the art will recognize that various changes in form and detail can be made therein without departing from the spirit and scope of the present disclosure. Those skilled in the art will also recognize that the medical device can be used for direct delivery into organs other than the heart. Aspects The medical device of the present application has the following aspects and obvious variations thereof. Please note that any one of the following aspects 1 to 17, 24, and 25 can be combined with any one of the following aspects 18 to 23.

[0078] [Aspect 1] A medical device for delivering agents and / or modalities to an organ, comprising: an outer tubular body having a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end; an inner tubular body having a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end; the inner tubular body is movably disposed within the first lumen of the outer tubular body; the second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body; an inner tubular body displaceable from a first position to a second position along a first longitudinal axis of the outer tubular body; a tissue engaging member comprising a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end, a tissue engaging member is attached to the second distal end of the inner tubular body, a third longitudinal axis of the tissue engaging member being substantially parallel to or overlapping the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body; the tissue engaging member is within the first lumen of the outer tubular body; the third distal end of the tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position; A medical device comprising: a tissue engaging member, the third distal end of the tissue engaging member extending out of the first distal end of the outer tubular body when the inner tubular body is in the second position.

[0079] [Embodiment 2] The device further comprises at least one delivery mechanism having a fourth proximal end and a fourth distal end; the at least one delivery mechanism is located within the first lumen of the outer tubular body; at least one delivery mechanism is operably coupled to the outer tubular body; the at least one delivery mechanism is displaceable from a third position to a fourth position along the first longitudinal axis of the outer tubular body; a fourth distal end of the at least one delivery mechanism is recessed relative to the first distal end of the outer tubular body when the at least one delivery mechanism is in the third position; The medical device of embodiment 1, wherein the fourth distal end of the at least one delivery mechanism extends outside the first distal end of the outer tubular body when the at least one delivery mechanism is in the fourth position.

[0080] [Embodiment 3] The outer tubular body is made of stainless steel, an outer diameter of the outer tubular body increases from the first distal end to the first proximal end; 3. The medical device of embodiment 1 or 2, wherein the first distal end of the outer tubular body is beveled.

[0081] [Embodiment 4] Further comprising a central port, a central port attached to the second distal end of the inner tubular body; The medical device of any one of aspects 1 to 3, wherein the central port has an opening.

[0082] [Embodiment 5] Further comprising a tip attached to the third distal end of the tissue engaging member; The medical device according to any one of aspects 1 to 4, wherein the free end of the tip portion is blunt. [Aspect 6] Further comprising a gear, Aspect 6. The medical device of any one of aspects 1-5, wherein the gear is configured to control the movement of the inner tubular body.

[0083] [Embodiment 7] When the inner tubular body is rotated in a first direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first distal end of the outer tubular body; A medical device described in any one of aspects 1 to 6, wherein when the inner tubular body is rotated in a second direction about the second longitudinal axis, the inner tubular body and the tissue engagement member move toward the first proximal end of the outer tubular body.

[0084] [Aspect 8] A spring, a thumb push button; the spring is configured to control the movement of the inner tubular body; A medical device according to any one of aspects 1-7, wherein the thumb push button is configured to control the movement of the spring.

[0085] [Aspect 9] The range of rotation of the inner tubular body relative to the outer tubular body is limited to a first predetermined angle, A medical device according to any one of aspects 1-8, wherein actuation of the thumb push button enables rotation of the inner tubular body relative to the outer tubular body through a second predetermined angle.

[0086] [Aspect 10] A medical device described in any one of aspects 1 to 9, wherein at least one delivery mechanism includes a needle, catheter, tube, guidewire, mapping electrode, lead, and camera.

[0087] [Aspect 11] A medical device described in any one of Aspects 1 to 10, wherein the at least one delivery mechanism includes at least two delivery mechanisms. [Aspect 12] A medical device described in any one of Aspects 1 to 11, wherein at least two delivery mechanisms are used exclusively.

[0088] [Aspect 13] A medical device described in any one of Aspects 1 to 11, wherein at least two delivery mechanisms are used simultaneously. [Embodiment 14] The present invention further includes a side port operably coupled to the outer tubular body, the at least one delivery mechanism is configured to be moved between the third and fourth positions by operation of a side port or a thumb push button; A medical device described in any one of aspects 1-13, wherein the side port is configured to be a conduit for delivering an agent and / or modality that is fed through the side port and dispensed from the fourth distal end of the at least one delivery mechanism.

[0089] [Embodiment 15] Further comprising a stopcock attached to the side port, The stopcock is configured to prevent air leakage; 15. The medical device of any one of aspects 1-14, wherein the stopcock is configured to connect a syringe.

[0090] [Aspect 16] A medical device described in any one of aspects 1 to 15, further comprising a plunger configured to control injection of a drug and / or modality. [Aspect 17] A medical device described in any one of aspects 1 to 16, wherein the agent and / or modality comprises a medicine, a gel, a growth factor, a cell, an electric current, a voltage, or an electrical signal.

[0091] [Aspect 18] A method for treating or monitoring a patient suffering from cardiac disease, comprising: A method comprising delivering one or more agents and / or modalities directly to the myocardium of a patient in need thereof.

[0092] [Embodiment 19] The one or more agents and / or modalities include a first agent or modality and one or more additional agents and / or modalities; the first agent or modality and the one or more additional agents and / or modalities are delivered simultaneously or sequentially; The method of embodiment 18, wherein the region receiving the first agent or modality and the region receiving the one or more additional agents and / or modalities substantially overlap.

[0093] [Aspect 20] The method of any one of aspects 18 or 19, wherein the first agent or modality and the one or more additional agents and / or modalities comprise a pharmaceutical agent, a gel, a growth factor, a cell, an electric current, a voltage, or an electrical signal.

[0094] [Aspect 21] The method described in any one of aspects 18 to 20, wherein delivering one or more agents and / or modalities directly to the myocardium of a patient in need thereof comprises delivering one or more agents and / or modalities using a medical device described in any one of aspects 1 to 17.

[0095] [Aspect 22] A method of inserting a first distal end of a medical device with an inner tubular body in a first position into a body cavity of a patient, comprising: manipulating the medical device such that a first distal end of the medical device contacts the pericardium of the patient; penetrating the pericardium using a distal end of the tissue engaging member; rotating the inner tubular body in a first direction to engage the tissue engaging member with the patient's heart; Positioning the inner tubular body in a second position; delivering one or more agents and / or modalities to the myocardium; Releasing the medical device from the patient by rotating the tissue engaging member in a second direction; 22. The method of embodiment 21, further comprising removing the medical device from the patient.

[0096] [Embodiment 23] The medical device is attached to the myocardium via a tissue engaging member during delivery of the first agent or modality and during delivery of one or more additional agents and / or modalities; 23. The method of any one of aspects 21 and 22, wherein the medical device is not released from the myocardium between the delivery of the first agent or modality and the delivery of the one or more additional agents and / or modalities.

[0097] [Aspect 24] A medical device described in any one of aspects 1 to 17, wherein the first longitudinal axis of the outer tubular body, the second longitudinal axis of the inner tubular body, and the third longitudinal axis of the tissue engagement member are substantially parallel.

[0098] [Aspect 25] A medical device described in any one of aspects 1 to 17 and 24, wherein the first longitudinal axis of the outer tubular body, the second longitudinal axis of the inner tubular body, and the third longitudinal axis of the tissue engagement member overlap.

[0099] The terms used herein are intended to describe particular embodiments and are not intended to be limiting. The terms "a", "an" and "the" include the plural unless expressly indicated otherwise. The terms "comprises" and / or "comprising", as used herein, indicate the presence of stated features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements and / or components.

[0100] With respect to the foregoing description, it will be understood that changes may be made in details, particularly in matters relating to the materials of construction employed and the shape, size, and configuration of parts, without departing from the scope of the present disclosure. As used herein, the term "embodiment" may, but does not necessarily, refer to the same embodiment. The embodiments herein and described are merely examples. Other and further embodiments may be devised without departing from the basic scope thereof, with the true scope and spirit of the disclosure being indicated by the following claims. [Explanation of symbols]

[0101] 1...medical device, 10...outer tubular body, 11...first proximal end of outer tubular body, 12...first distal end of outer tubular body, 13...first longitudinal axis of outer tubular body, 14...first inner surface of outer tubular body, 15...first lumen of outer tubular body, 16...cutting edge, 17...projection formed on outer tubular body, 18...projection formed on inner tubular body, 20...inner tubular body, 21...second proximal end of inner tubular body, 22...second distal end of inner tubular body, 23...second longitudinal axis of inner tubular body Shaft, 24...second inner surface of inner tubular body, 25...second lumen of inner tubular body, 30...tissue engaging member, 31...third proximal end of tissue engaging member, 32...third distal end of tissue engaging member, 33...third longitudinal axis of tissue engaging member, 34...tip, 44...needle 1, 45...needle 2, 46...central tubular body, 47...lumen of central tubular body, 50...gear, 51...spiral groove, 52...spiral groove, 60...thumb push button, 160...thumb push button, 70...side port 1, 71...slit 1, 72...proximal end of slit 1, 73...distal end of slit 1, 74...travel distance of side port 2, 75...side port 2, 76...slit 2, 77...proximal end of slit 2, 78...distal end of slit 2, 79...travel distance of side port 2, 80...central tubing, 81...central luer lock, 82...valve, 83...ring for controlling valve, 183...ring for controlling valve, 84...holder, 85...device receiving portion of holder, 8 6...thread, 87...protrusion, 88...handle, 89...trigger, 90...heart, 91...pericardium, 92...pericardial cavity, 93...myocardium, 100...subject, 101...body wall, 120...widened portion of inner tubular body, 441...proximal end of needle 1, 442...distal end of needle 1, 451...proximal end of needle 2, 452...distal end of needle 2, 461...proximal end of central tubular body, 462...distal end of central tubular body, 463...proximal end of medical device, 500...needle guide, 501...lid.

Claims

1. A medical device for delivering agents and / or modalities to an organ, comprising: an outer tubular body including a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end; an inner tubular body comprising a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end; the inner tubular body is movably disposed within the first lumen of the outer tubular body; the second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body; an inner tubular body displaceable from a first position to a second position along the first longitudinal axis of the outer tubular body; a tissue engaging member comprising a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end, the tissue engaging member is attached to the second distal end of the inner tubular body; the tissue engaging member is helically shaped and configured to move in a corkscrew-like motion when the inner tubular body is rotated about the second longitudinal axis; the tissue engaging member is configured to penetrate and secure the medical device to a target tissue by the corkscrew-like movement when the tissue engaging member is rotated about the second longitudinal axis; the tissue engaging member is within the first lumen of the outer tubular body, the third distal end of the tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position, and the third distal end of the tissue engaging member extends outside the first distal end of the outer tubular body when the inner tubular body is in the second position; a tissue engaging member, the third longitudinal axis of the tissue engaging member being substantially parallel to the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body when the inner tubular body is in the first position, the second position, and positions between the first and second positions; at least one delivery mechanism having a fourth proximal end and a fourth distal end, the at least one delivery mechanism is located within the first lumen of the outer tubular body and outside the second lumen of the inner tubular body; the at least one delivery mechanism is operably coupled to the outer tubular body; the at least one delivery mechanism is displaceable from a third position to a fourth position along the first longitudinal axis of the outer tubular body; the fourth distal end of the at least one delivery mechanism is recessed relative to the first distal end of the outer tubular body when the at least one delivery mechanism is in the third position; at least one delivery mechanism, wherein the fourth distal end of the at least one delivery mechanism is configured to extend out of the first distal end of the outer tubular body when the at least one delivery mechanism is in the fourth position.

2. the outer tubular body is made of stainless steel; an outer diameter of the outer tubular body increases from the first distal end to the first proximal end; The medical device of claim 1 , wherein the first distal end of the outer tubular body is beveled.

3. a tip attached to the third distal end of the tissue engaging member; The medical device of claim 1 , wherein the free end of the tip is blunt.

4. Further comprising gears; the gear is configured to control the movement of the inner tubular body; The medical device of claim 1 , wherein the range of rotation of the gear relative to the outer tubular body is limited to a first predetermined angle.

5. when the inner tubular body is rotated in a first direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first distal end of the outer tubular body; 5. The medical device of claim 4, wherein when the inner tubular body is rotated in a second direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first proximal end of the outer tubular body.

6. A spring, a thumb push button; the spring is configured to control movement of the inner tubular body; The medical device of claim 5 , wherein the thumb button is configured to control the movement of the spring.

7. a range of rotation of the inner tubular body relative to the outer tubular body is limited to a first predetermined angle; The medical device of claim 6 , wherein operation of the thumb push button incrementally enables rotation of the inner tubular body relative to the outer tubular body.

8. The medical device of claim 1 , wherein the at least one delivery mechanism comprises at least one selected from the group consisting of a needle, a catheter, a tube, a guidewire, a mapping electrode, a lead, and a camera.

9. a side port operably coupled to the outer tubular body; the at least one delivery mechanism is configured to move between the third position and the fourth position by operating the side port or the thumb button; 7. The medical device of claim 6, wherein the side port is configured to be a conduit for delivery of the agent and / or the modality fed through the side port and dispensed from the fourth distal end of the at least one delivery mechanism.

10. a stopcock attached to the side port; The stopcock is configured to prevent air leakage; The medical device of claim 9 , wherein the stopcock is configured to connect a syringe.

11. The medical device of claim 1 , wherein the agent and / or modality comprises a medicine, a gel, a growth factor, a cell, an electrical current, a voltage, or an electrical signal.

12. A medical device for delivering agents and / or modalities to an organ, comprising: an outer tubular body comprising a first proximal end, a first distal end, a first lumen extending between the first proximal end and the first distal end, and a first longitudinal axis extending from the first proximal end to the first distal end; an outer diameter of the outer tubular body increases from the first distal end to the first proximal end; an outer tubular body, the first distal end of the outer tubular body being chamfered; an inner tubular body comprising a second proximal end, a second distal end, a second lumen extending between the second proximal end and the second distal end, and a second longitudinal axis extending from the second proximal end to the second distal end; the inner tubular body is movably disposed within the first lumen of the outer tubular body; the second proximal end of the inner tubular body is operably coupled to the first proximal end of the outer tubular body; an inner tubular body displaceable from a first position to a second position along the first longitudinal axis of the outer tubular body; a tissue engaging member comprising a third proximal end, a third distal end, and a third longitudinal axis extending from the third proximal end to the third distal end, the tissue engaging member is attached to the second distal end of the inner tubular body; the tissue engaging member is helically shaped and configured to move in a corkscrew-like motion when the inner tubular body is rotated about the second longitudinal axis; the tissue engaging member is configured to penetrate and secure the medical device to a target tissue by the corkscrew-like movement when the tissue engaging member is rotated about the second longitudinal axis; the tissue engaging member is within the first lumen of the outer tubular body, the third distal end of the tissue engaging member is recessed relative to the first distal end of the outer tubular body when the inner tubular body is in the first position, and the third distal end of the tissue engaging member extends outside the first distal end of the outer tubular body when the inner tubular body is in the second position; a tissue engaging member, the third longitudinal axis of the tissue engaging member being substantially parallel to the first longitudinal axis of the outer tubular body and the second longitudinal axis of the inner tubular body when the inner tubular body is in the first position, the second position, and positions between the first and second positions; A gear, the gear is configured to control movement of the inner tubular body; a rotatable range of the gear relative to the outer tubular body is limited to a first predetermined angle; when the inner tubular body is rotated in a first direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first distal end of the outer tubular body; when the inner tubular body is rotated in a second direction about the second longitudinal axis, the inner tubular body and the tissue engaging member move toward the first proximal end of the outer tubular body; a gear, the range of rotation of the inner tubular body relative to the outer tubular body being limited to a first predetermined angle; A spring, a spring configured to control movement of the inner tubular body; and A thumb push button, the thumb push button is configured to control the movement of the spring; a thumb push button, operation of which incrementally enables rotation of the inner tubular body relative to the outer tubular body; at least one delivery mechanism having a fourth proximal end and a fourth distal end, the at least one delivery mechanism is located within the first lumen of the outer tubular body and outside the second lumen of the inner tubular body; the at least one delivery mechanism is operably coupled to the outer tubular body; the at least one delivery mechanism is displaceable from a third position to a fourth position along the first longitudinal axis of the outer tubular body; the fourth distal end of the at least one delivery mechanism is recessed relative to the first distal end of the outer tubular body when the at least one delivery mechanism is in the third position; at least one delivery mechanism, wherein the fourth distal end of the at least one delivery mechanism is configured to extend out of the first distal end of the outer tubular body when the at least one delivery mechanism is in the fourth position.

13. It also has a central luer lock. a lumen of the central luer lock is continuous with the second lumen of the inner tubular body or with a lumen of the at least one delivery mechanism; the central luer lock is configured to be a conduit for delivery of the agent and / or the modality fed through the central luer lock and dispensed from the second distal end of the inner tubular body or the fourth distal end of the at least one delivery mechanism; The medical device of claim 12 , wherein the central luer lock is configured to receive a stopcock.

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