Electrical connector and cover for simultaneously connecting an epicardial wire, a bedside monitor, and a temporary pacemaker

Abstract

An interface unit for epicardial pacing and telemetry monitoring connects a pacemaker and a bedside monitor for simultaneous pacing during electrogram visualization using epicardial pacing leads. The interface unit includes an electrically insulating housing with a one-handed manual attachment portion for the epicardial lead and a retractable protective shroud extending over the epicardial lead. The interface unit further includes electrical connectors for selective attachment to the pacemaker and the bedside monitor.

Description

Technical Field

[0001] The present technology relates to an interface unit for epicardial pacing and telemetry monitoring, and more particularly to an electrical connector for a pacemaker and a bedside monitor that performs simultaneous pacing during electrogram visualization using an epicardial pacing lead.

Background Art

[0002] With telemetry monitoring, medical professionals can monitor the electrical activity of the heart in real time and over an extended period. Telemetry monitoring is often used following cardiac surgery when the patient's risk of arrhythmia is highest. Conventional surface electrocardiogram (ECG) electrodes are placed on the patient's skin to detect and monitor the heart rhythm.

[0003] Due to the risk of postoperative arrhythmia, temporary pacing wires are placed on the outside of the cardiac epicardium to allow pacing of the heart by a temporary external pacemaker for many patients.

[0004] Conventionally, the heart rhythm is obtained from surface ECG electrodes placed on the patient's chest and viewed on a bedside monitor. However, it is not easy to visualize atrial signals using surface ECG electrodes. Therefore, when a medical professional detects irregularities, the conventional solution is for an ECG technician to connect the epicardial pacing wire to an ECG monitor so that the medical professional can interpret the ECG signal with high accuracy. In other words, the epicardial pacing wire is placed closer to the atrial impulse than the surface ECG electrodes, and therefore, high-quality information about the atrial waveform is obtained. When an arrhythmia is detected and the medical professional requests pacing of the heart, the epicardial pacing wire must be removed from the ECG monitor and reconnected to a temporary pacemaker for pacing.

[0005] The process of connecting and disconnecting epicardial pacing wires takes time and may need to be repeated for continuous visualization and pacing. This also involves the risk of connection errors for the three sets of connectors from the ECG monitor, pacemaker, and epicardial connection. Summary of the Invention Problems to be Solved by the Invention

[0006] The present invention has been made to solve the above conventional problems. Means for Solving the Problems

[0007] The present invention provides an interface unit for epicardial pace adjustment and telemetry monitoring that simultaneously connects a pacemaker and a bedside monitor for simultaneous pacing during electrocardiogram visualization using an epicardial pacing lead. The interface unit includes an electrically insulated housing for one-handed manual attachment of the epicardial lead and a retractable protective shroud extending over the epicardial lead. The interface unit further includes electrical connectors for selective attachment to the pacemaker and bedside monitor.

[0008] In one aspect, the present invention provides an interface unit for epicardial pacing and telemetry monitoring, including: an electrical insulating housing; first and second electrical terminals adapted to be accessible from corresponding openings of the housing and removably accommodate first and second epicardial lead wires parallel to an insertion axis inside the housing; a first electrical connector mounted on the insulating housing to removably accommodate a pacemaker connector with third and fourth electrical terminals; a second electrical connector mounted on the insulating housing to accommodate a telemetry monitor connection part with a fifth terminal; a circuit disposed in the housing for providing electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal; first and second openings for accommodating the first and second epicardial wires before the first and second epicardial wires are movably mounted to the housing so as to move between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, and an electrical insulating shroud serving as an insulating cover for the first and second epicardial wires extending outward from the first and second terminals.

[0009] Therefore, it is a feature of at least one embodiment of the present invention to provide an interface unit for protecting epicardial leads from the environment and to enable a user to easily connect epicardial leads to the terminals of the unit by placing the terminals proximal to the insertion opening.

[0010] The shroud may be movable relative to the housing along the insertion axis.

[0011] Therefore, it is a feature of at least one embodiment of the present invention to enable insertion of epicardial wires into the unit and movement of the protective shroud without interfering with the wires.

[0012] The housing has front and rear side surfaces, and the openings of the first and second terminals are on the front surface and the first electrical connector is on the opposite rear surface such that the first and second epicardial wires and the first connector from the pacemaker connector extend parallel to each other on a common axis.

[0013] Thus, providing a more intuitive connection of the lead / connector to the interface unit with less wire bending is a feature of at least one embodiment of the present invention.

[0014] The housing further comprises upper and lower surfaces on both sides, and the second electrical connector is on the upper surface.

[0015] Thus, visually isolating each electrical connector of the unit and making the ECG monitor connector accessible when the unit is supported on the patient's chest is a feature of at least one embodiment of the present invention.

[0016] Buttons can be used to restrain the first and second epicardial lead wires.

[0017] Thus, the connector hole is of a sufficiently large size so that the force required for wire insertion is zero and the clamping force on the wire is applied by a spring-biased button, which is a feature of at least one embodiment of the present invention. The connector hole also accommodates epicardial wires of various sizes and diameters.

[0018] The buttons can be provided on both the left and right side surfaces of the housing.

[0019] Thus, spatially removing the epicardial wire from other connectors and enabling attachment without pressing the patient downward is a feature of at least one embodiment of the present invention. This feature also enables quick release of the epicardial wire by gripping both buttons simultaneously.

[0020] The buttons can be spring-biased to restrain the first and second epicardial lead wires. The buttons can be the first and second buttons on both sides that are biased away from each other by a common spring.

[0021] Therefore, enabling the restraint and release of the epicardial wire with one hand is a feature of at least one embodiment of the present invention. Also, due to the spring force, the wire can be removed with a force greater than the force to remove the wire from the heart.

[0022] The operating axis may be orthogonal to the insertion axis.

[0023] Therefore, using a natural grip angle for the operation of the side button is a feature of at least one embodiment of the present invention. Also, due to this feature, the wire will not become detached due to an unexpected movement of the housing caused by button pressing.

[0024] A block arm that extends to the housing and is disposed between the first and second electrical terminals and the first and second openings in the first position and provides a path between the first and second terminals and the first and second openings in the second position may be provided on the button. The block arm may include a window portion that is aligned with the insertion axis when the button is in the second position.

[0025] Therefore, preventing environmental exposure of the terminals when the wire is not attached is a feature of at least one embodiment of the present invention.

[0026] The circuit may have a resistance of at least 50 kiloohms.

[0027] Therefore, enabling the unit to function with various telemetry monitors that perform different levels of electrical protection (e.g., CF (Cardiac Floating) type classification) is a feature of at least one embodiment of the present invention.

[0028] The tether cover may cover at least one of the first and second connectors.

[0029] Therefore, preventing accidental short circuits when the pacemaker is not in use is a feature of at least one embodiment of the present invention.

[0030] Proximal to the first and second openings, reference labels of plus and minus signs may be respectively arranged.

[0031] Therefore, providing an intuitive connection of the positive and negative wires of the epicardial lead to prevent confusion is a feature of at least one embodiment of the present invention.

[0032] A detent may be arranged between the housing and the shroud at at least one of the first and second positions.

[0033] Therefore, maintaining the shroud in the extended protection position when the epicardial lead wire is attached to the unit is a feature of at least one embodiment of the present invention.

[0034] The second electrical connector is a stud connector defined by a metal boss that extends outward from the housing and is electrically coupled to the circuit assembly, and the stud connector is disposed on the outer surface of the housing.

[0035] Therefore, making connections with various standard ECG monitor connectors is a feature of at least one embodiment of the present invention.

[0036] In another aspect, the present invention provides a pacemaker configured to provide an electrical pulse for performing electrical pacing of the heart through an epicardial pacing lead connected to the patient's heart, a telemetry monitor configured to receive an electrocardiogram signal from the epicardial pacing lead and provide a display of the electrocardiogram signal, an electrical insulation housing, first and second electrical terminals accessible from corresponding openings of the housing and adapted to removably accommodate first and second epicardial lead wires into the interior of the housing parallel to the insertion axis, a first electrical connector attached to the insulating housing and adapted to removably accommodate a pacemaker connector with third and fourth electrical terminals, a second electrical connector attached to the insulating housing and adapted to accommodate a telemetry monitor connection portion with a fifth terminal, a circuit disposed within the housing and configured to perform electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal, and first and second epicardial wires are accommodated in the first and second electrical terminals and are movably attached to the housing so as to move between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, and an electrical insulation shroud serving as an insulating cover for the first and second epicardial wires extending outwardly from the first and second terminals.

[0037] Accordingly, it is a feature of at least one embodiment of the present invention that the pacemaker is optionally connectable to the interface unit during potential map visualization.

[0038] The first opening and the first terminal are aligned on a first insertion axis, the second opening and the second terminal are aligned on a second insertion axis, and the first and second insertion axes are spaced apart in parallel.

[0039] Accordingly, it is a feature of at least one embodiment of the present invention that each of the positive and negative openings and terminals is insulated to prevent short circuits and connection errors.

[0040] In another aspect, the present invention provides a connector including a housing having an opening and a circuit assembly disposed within the housing. The circuit assembly includes a circuit board having terminals. The connector further includes a shroud movable relative to the housing between a first position and a second position. The housing is at least partially disposed within the shroud. The connector further includes a button including a block arm disposed between the terminal and the opening. The button is movable on an operating axis between a blocked position and an unblocked position. The connector further includes a biasing member biasing the button toward the blocked position.

[0041] In another aspect, the present invention provides a connector including a housing having a first opening and a second opening and a circuit assembly disposed within the housing. The circuit assembly includes a circuit board having a first terminal and a second terminal. The connector further includes a shroud at least partially surrounding the housing, the shroud including a first external opening and a second external opening. The first opening, the first terminal, and the first external opening are aligned on a first insertion axis, and the second opening, the second terminal, and the second external opening are aligned on a second insertion axis. The housing is at least partially disposed within the shroud.

[0042] In another aspect, the present invention provides a connector including a housing having an opening and a circuit assembly disposed within the housing. The circuit assembly includes a circuit board having terminals defining an insertion axis. The connector further includes a button coupled to the housing. The button defines a block portion and a window portion, and the button is movable on an operating axis between a blocked position and an unblocked position. The operating axis is orthogonal to the insertion axis. The connector further includes a biasing member biasing the button toward the blocked position. When the button is in the blocked position, the block portion of the button is disposed between the opening and the terminal, and when the button is in the unblocked position, the window portion of the button is disposed between the opening and the terminal.

[0043] These specific objectives and advantages apply only to some embodiments included in the claims and thus do not define the scope of the present invention.

[0044] Other features and aspects of the present invention will become apparent from the following detailed description and consideration of the accompanying drawings.

Brief Description of the Drawings

[0045]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8A

Figure 8B

Figure 8C

Figure 8D

Figure 9

Figure 10

Embodiments for Carrying Out the Invention

[0046] Before the embodiments of the present invention are described in detail, it should be understood that the present invention is not limited to the details of the assembly and mechanism of the components listed in the following description or shown in the following drawings. The present invention can be practiced or implemented in other embodiments and in various ways. Also, it should be understood that the phrases and terms used herein are for the purpose of explanation and should not be regarded as limiting. Referring to FIG. 1, a medical system 10 for the care of patient 14 includes an electrocardiogram (ECG) monitor 18, a pacemaker 24, a plurality of pacing wires 28, and a connector 100. The connector 100 (i.e., an adapter, coupling, etc.) is configured to be interfaced and connected to a number of medical instruments of the medical system 10. For example, the connector 100 can be configured to interface and connect (i.e., provide a connection, interconnect, etc.) with the plurality of pacing wires 28, the pacemaker 24, and the ECG monitor 18. More specifically, the pacemaker 24 is electrically coupled to the connector 100 by a pacemaker code 32 (shown in FIG. 9), the ECG monitor 18 is electrically coupled to the connector 100 by an ECG lead wire 36, and as will be described in more detail below, the patient 14 is electrically coupled to the connector 100 by the plurality of pacing wires 28. Aspects of such an integrated medical system are disclosed in U.S. Patent Application Publication No. 15 / 229,371, the entire content of which is incorporated herein by reference.

[0047] Referring to FIGS. 2 through 4, the connector 100 includes an outer shroud 104, an inner housing 108 that is at least partially slidably disposed within the shroud 104, and first and second buttons 112 and 116 that extend outwardly from the outer shroud 104 and the inner housing 108. In the illustrated embodiment, the shroud 104 is a generally rectangular housing formed by joining upper and bottom members 104A, 104B, for example, by adhesion or welding, and the inner housing 108 is a generally rectangular box similarly formed by joining upper and bottom members 108A, 108B (FIG. 3), for example, by adhesion or welding. The outer shroud 104 and the inner housing 108 can be made of biocompatible and gamma-compatible materials. In one embodiment, the outer shroud 104 is an electrical insulating plastic such as polycarbonate-ABS (PC-ABS), and the inner housing can be an electrical insulating plastic such as polybutylene terephthalate (PBT). The outer shroud 104 and the inner housing 108 are colored in a color other than white so as to specify a connector for atrial pacing rather than for ventricular pacing. For example, the outer shroud 104 can be blue and the inner housing 108 can be gray. It is understood that other compatible materials and colors can be used.

[0048] Referring in more detail to FIGS. 3 and 4, the shroud 104 includes an upper wall portion 120 that extends in a plane parallel to the plane of the patient 14's chest and is generally spaced apart from the patient 14's chest, a bottom wall portion 124 that extends in a plane parallel to the plane of the patient 14's chest and is generally in contact with the patient 14's chest, and a front wall portion 128 that extends perpendicular to the plane of the patient 14's chest and is generally disposed below the patient 14. In addition, the shroud 104 includes side wall portions 140 that join the upper wall portion 122 and the bottom wall portion 124 at the respective left and right edges, and rectangular openings are provided in the side wall portions 140 that define tracks 144 for receiving the corresponding buttons 112, 116, which will be considered in more detail below.

[0049] The front wall portion 128 includes a first external opening 132 and a second external opening 136, which are spaced apart and are round holes for accommodating the proximal end portion 48 of the pacing wire 28. The holes have a diameter of at least 0.9 mm and at least 1 mm, and are approximately 1.5 mm. The holes may have a diameter generally larger than the maximum diameter of the end rod 52 of the pacing wire 28 so as to accommodate the insertion of different wire sizes.

[0050] In the illustrated embodiment, the rear end portion 138 of the shroud 104 is generally open (i.e., not surrounded) so that the housing 108 is slidably received in the rear end portion 138 of the shroud 104. However, in an alternative embodiment, the inner housing 108 may be completely surrounded by the shroud 104. As will be described in more detail below, the shroud 104 is movable relative to the housing 108 between a first storage position (FIG. 8A) and a second extended position (FIG. 8D) to block the proximal end portion 48 of the pacing wire 28.

[0051] The housing 108 includes a top wall portion 145 that extends parallel to the plane 121 of the patient 14's chest and is generally spaced apart from the patient 14's chest, a bottom wall portion 146 that extends parallel to the plane 121 of the patient 14's chest and is generally in contact with the patient 14's chest, a front wall portion 147 that extends perpendicular to the plane 121 of the patient 14's chest and is generally disposed below the patient 14, and a rear wall portion 149 that extends perpendicular to the plane 121 of the patient's chest and is generally disposed above the patient 14. In addition, the housing 108 includes side wall portions 150 that join the top wall portion 145 and the bottom wall portion 146 at the left and right edges, respectively.

[0052] The front wall portion 147 includes a first opening 184 and a second opening 188, and the first opening 184 and the second opening 188 are spaced apart and are round holes for accommodating the proximal end portion 48 of the pacing wire 28. The holes can have a diameter of at least 0.9 mm and at least 1 mm and can be approximately 1.5 mm. To accommodate the insertion of different wire sizes, the holes can have a diameter generally larger than the maximum diameter of the end rod 52 of the pacing wire 28. The first opening 184 and the second opening 188 can have a diameter larger than that of the first external opening 132 and the second external opening 136.

[0053] The first opening 184 and the second opening 188 correspond to the arrangement of the first external opening 132 and the second external opening 136 of the shroud 104 and are configured to accommodate the proximal end portion 48 of the pacing wire 28. The first opening 184 and the first external opening 132 are aligned on the first insertion axis 192. Similarly, the second opening 188 and the second external opening 136 are aligned on the second insertion axis 196. In other words, the first opening 184 is coaxially aligned with the first terminal 156, and the first external opening 132 is coaxially aligned with the first opening 184. Similarly, the second opening 188 is coaxially aligned with the second terminal 160, and the second external opening 136 is coaxially aligned with the second opening 188. Therefore, the first insertion axis 192 is defined independently and collectively by each of the first terminal 156, the first opening 184, and the first external opening 132. Similarly, the second insertion axis 196 is defined independently and collectively by each of the second terminal 160, the second opening 188, and the second external opening 136. The first and second insertion axes 192, 196 extend substantially parallel to the plane 121 of the patient's chest.

[0054] In the illustrated embodiment, the first insertion axis 192 is preferably spaced from and parallel to the second insertion axis 196. In one embodiment, the first insertion axis 192 is spaced from the second insertion axis 196 by at least 20 mm or at least 25 mm or at least 30 mm. In one embodiment, when the shroud 104 is in the second position (FIG. 8D), the first insertion axis 192 is spaced from the second insertion axis 196 by a distance that is at least three times to six times the distance between the front wall portion 128 of the shroud 104 and the terminals 156, 160. In an alternative embodiment, the first insertion axis 192 and the second insertion axis 196 intersect, but no contact of the pacing wire 28 is seen.

[0055] Referring to FIGS. 8A - 8D and as described in more detail below, the user can selectively position the shroud 104 by moving it to a first storage position (FIG. 8A), a second extended position (FIG. 8D), or any intermediate position therebetween. In other words, the shroud 104 is movable (e.g., slidable) relative to the housing 108 along the first insertion axis 192 and the second insertion axis 196. When the shroud 104 is in the second position (FIG. 8D), the front wall portion 128 and the first and second external openings 132, 136 held by the front wall portion 128 are positioned farther from the terminals 156, 160 than when the shroud 104 is in the first position (FIG. 8A). In one embodiment, when the shroud 104 is in the second position (FIG. 8D), the front wall portion 128 is positioned at least 4 mm or at least 5 mm or at least 6 mm away from the terminals 156, 160.

[0056] Referring also to FIGS. 4 and 7, the inner surface of the bottom wall portion 124 of the shroud 104 includes a detent 200 that is received in a first recess 204 (i.e., a first track) formed in the outer surface of the bottom wall portion 146 of the housing 108 when the shroud 104 is in the first storage position (FIG. 8A), and is received in a second recess 208 (i.e., a second track) formed in the housing 108 when the shroud 104 is in the second extended position (FIG. 8D). In an alternative embodiment, the detent 200 is formed in the housing 108 and the corresponding recesses 204, 208 are formed in the shroud 104.

[0057] In the illustrated embodiment, the detent 200 is a cantilever spring arm 212 formed on the shroud 104 and having an inwardly biasing protrusion 216 formed at the tip of the cantilever spring arm 212 (FIG. 4). The first recess 204 is disposed adjacent to the second recess 208 on the outer surface of the bottom wall portion 146 of the housing 108, and the second recess 208 is disposed closer to the openings 184, 188 than the first recess 204. A plurality of cam surfaces 220 are formed in the housing 108 and disposed between the first recess 204 and the second recess 208. In the illustrated embodiment, three cam surfaces 220 are disposed between the first recess 204 and the second recess 208. The first cam surface 220a extends between the first recess 204 and the second recess 208, the second cam surface 220b extends upwardly from the first recess 204 to the first cam surface 220a, and the third cam surface 220c extends downwardly from the first cam surface 220a to the second recess 208.

[0058] When the shroud 104 is in the storage position (FIG. 8A), the protrusion 216 of the detent 200 is received in the first recess 204 formed in the housing 108. When a predetermined amount of force is applied to the shroud 104 on the insertion axes 192, 196, the protrusion 216 is moved upwardly along the cam 220b out of the first recess 204. Due to the momentum of the force, the protrusion moves to the extended position (FIG. 8D). During insertion of the end rod 52 of the pacer wire 28 into the shroud 104, the shroud 104 remains in the storage position (FIG. 8A) until a predetermined amount of force is applied, preventing an unexpected movement of the shroud 104 during installation.

[0059] When the shroud 104 moves to the extended position (FIG. 8D) on the insertion axes 192, 196, the shroud 104 moves away from the housing 108, and the spring arm 212 flexes away from the housing 108 as the protrusion 216 performs a cam operation along the inclined cam surfaces 220b, 220a, 220c respectively, and finally is received in the second recess 208 along the downwardly extending cam surface 220c from the cam surface 220a. The second recess 208 is sized to closely receive the inwardly biasing protrusion 216. The wall of the second recess 208 opposite the cam surface 220c is substantially perpendicular to the bottom surface of the second recess 208 and restricts further movement of the protrusion 216 on the insertion axes 192, 196. Therefore, the protrusion 216 is selectively fixed in the second recess 208 to hold the shroud 104 in the extended position (FIG. 8D).

[0060] The shroud 104 is held in the extended position (FIG. 8D) until the user applies a force at the threshold level to the shroud 104. In particular, when the user applies a force at the threshold level on the insertion axes 192, 196, the housing 108 and the shroud 104 are pressed against each other to move the shroud 104 back to the retracted position (FIG. 8A). More specifically, when a force at the threshold level is applied to the shroud 104, the spring arm 212 is flexed to cause the protrusion 216 to perform a sliding cam operation beyond the cam surface 220 and into the first recess 204.

[0061] In one embodiment, the threshold level of force required to flex the spring arm and cause the protrusion 216 to perform a sliding cam operation beyond the cam surface 220 and into the first recess 204 is greater than the threshold level of force required to flex the spring arm 212 away from the housing 108 when the protrusion 216 performs a cam operation along the cam surface 220 and is received in the second recess 208. In other words, the level of force required to move the shroud 104 to the extended position (FIG. 8D) is less than the level of force required to move the shroud 104 back to the retracted position (FIG. 8A).

[0062] Referring to FIGS. 3 and 4, the connector 100 further includes a biasing member 224 (e.g., a coil spring) disposed within the housing 108 and positioned between the opposing first button 112 and second button 116. The first button 112 and the second button 116 are partially received within the housing 108 and held within a rectangular cavity 226 within the housing 108. The first button 112 and the second button 116 extend from the housing 108 and are disposed within tracks 114 of the shroud 104 so as to slide when the shroud 104 is moved between the extended position (FIG. 8D) and the retracted position (FIG. 8A). In the illustrated embodiment, the first button 112 is functionally identical to the second button 116 but is a reverse mirror image of the second button 116, and thus the description of the first button 112 is equally applicable to the second button 115 except for having a mirror image geometry. However, in alternative embodiments, there may be variations between the first button 112 and the second button 116.

[0063] Referring to FIG. 5, the first button 112 is shown alone for clarity. The button 112 includes a user operation portion 228, a stem 232, a block arm 236, and a sheet 240 (i.e., a spring sheet). Referring to FIG. 3, the block arm 236 and the sheet 240 are coupled to and disposed within the housing 108, the stem 232 extends from the housing 108, and the user operation portion 228 is disposed outside the housing 108 and outside the shroud 104. In particular, the stem 232 extends into a slot 244 formed in the housing 108, and the user operation portion 228 is received within a track 144 formed in the shroud 104. In the illustrated embodiment, the user operation portion 228 is rounded and is configured to be operated on an operation axis 248 by a user (i.e., by depressing the user operation portion 228). The stem 232 connects the user operation portion 228 to the sheet 240 and the block arm 236. The sheet 240 is configured to accommodate or support the biasing member 224. In the illustrated embodiment, the sheet 240 is formed as a recess. In an alternative embodiment, the sheet 240 can be, for example, a cylinder into which the biasing member 224 is fitted.

[0064] As will be described in more detail below, in response to an operation of the user operation portion 228, the button 112 moves on the operation axis 248 between a blocked position (FIG. 8A) and an unblocked position (FIG. 8B). In other words, in response to a user operation, i.e., a pressing of the button 112, the button 112 further moves on the operation axis 248 into the housing 108. Since the biasing member 224 biases the button 112 to the blocked position (FIG. 8A), when the user releases the user operation portion 228, the button 112 automatically moves back to the blocked position (FIG. 8A). In the illustrated embodiment, the operation axis 248 is orthogonal to the first insertion axis 192 and the second insertion axis 196. In an alternative embodiment, the operation axis 248 is not orthogonal to the first insertion axis 192 and / or the second insertion axis 196.

[0065] Referring to FIGS. 6 and 8A - 8C, the biasing member 224 (e.g., a coil spring) is disposed between the first button 112 and the second button 116 to bias both the first button 112 and the second button 116 to the blocked position (FIG. 8A). In particular, the first end portion 252 of the biasing member 224 is received within the seat 240 of the first button 112, and the second opposite end portion 256 of the biasing member 224 is received within the seat 240 of the second button 116. The coil spring may have ground ends that stabilize the biasing member 224 between the seat 240 on both sides of the first button 112 and the second button 116 and prevent rotation of the coil spring.

[0066] Similar to the first button 112, the second button 116 is movable on the operating axis 248 between a blocked position (FIG. 8A) and an unblocked position (FIG. 8B). In the illustrated embodiment, the first button 112 is movable relative to the housing 108 independently of the second button 116. In other words, the first button 112 can move on the operating axis 248 without necessarily moving the second button 116, and vice versa. As will be described in more detail below, the buttons 112, 116 are also movable to an intermediate position between the blocked position (FIG. 8A) and the unblocked position (FIG. 8B). As an example of an intermediate position, the buttons 112, 116 are also movable to a constrained position (FIG. 8C). As will be described in more detail below, when the buttons 112, 116 are in the constrained position (FIG. 8C), the buttons 112, 116 fix the end rod 52 of the pacing wire 26 into the connector 100.

[0067] Continuing to refer to FIG. 5, the block arm 236 of the button 112 is spaced apart from the seat 240 of the button 112, extends along the front wall portion 147 of the housing 108, and includes a block portion 260 and a window portion 264. The window portion 264 includes an opening 268 formed in the block arm 236 and a plurality of inclined surfaces 272 adjacent to the opening 268. The space 266 formed between the seat 240 of the button 112 and the block arm 236 supports the circuit assembly 148 as further described below.

[0068] Referring to FIG. 8A, the circuit assembly 148 is disposed between the block arm 236 and the housing 108. More specifically, the block arm 236 of the first button 112 is disposed between the first terminal 156 and the first opening 184. Similarly, the block arm 236 of the second button 116 is disposed between the second terminal 160 and the second opening 188. When the button 112 is in the blocked position (FIG. 8A), the blocking portion 260 of the block arm 236 is disposed between and aligned with the first opening 184 and the first terminal 156. Similarly, when the button 112 is in the unblocked position (FIG. 8B), the window portion 265 of the block arm 236 is disposed between and aligned with the first opening 184 and the first terminal 156.

[0069] The circuit assembly 148 is disposed within the housing 108 and held within the space 266 of the first button 112 and the second button 116. The circuit assembly 148 includes a rectangular circuit board 152 that extends parallel to the front wall portion 128 and holds the first terminal 156 and the second terminal 160. The substrate of the rectangular circuit board 152 has a thickness of approximately 3 mm to 4 mm, which is about twice the average thickness of a typical circuit board, thus adding strength and insertion contact depth. The substrate of the rectangular circuit board 152 can be a glass fiber reinforced epoxy resin including copper foil bonds on one or both sides. The substrate of the rectangular circuit board 152 can also include a 30-layer glass fiber reinforced epoxy resin including copper foil bonds on one or both sides adhered with two or more layers, such as prepregs (adhesive sheets).

[0070] Referring to FIGS. 4 and 10, circuit assembly 148 may include a protection signal adjustment circuit. In the illustrated embodiment, circuit assembly 148 includes a register 164 that passively adjusts an electrical signal passing through circuit assembly 148. In other words, register 164 prevents an undesirable large amount of current from flowing to connector 100. More specifically, register 164 prevents a large amount of current from flowing through connector 100 to ECG monitor 18. In the illustrated embodiment, circuit assembly 148 does not include software or an active decision circuit configuration, which simplifies the overall design and reduces the total cost. The printed circuit may be copper plated or etched on the surface of the substrate. The copper circuit may be coated with a layer of tin-lead to prevent oxidation. The contact fingers may be plated with tin-lead, nickel, and gold for conductivity.

[0071] Referring to FIG. 10 in detail, the positive wire 350 and the negative wire 352 of the pacemaker code 32 connecting the pacemaker 24 can be received in a pacemaker connector 172 having female sockets 313 that are exposed from the housing 108 and respectively connected to connection points 354, 356 of a circuit assembly 148 held within the housing 108. The same connection points 354, 356 can also be connected to epicardial terminals 156, 160 that are exposed from the housing 108 and communicate with the positive wire 358 and the negative wire 360 of the epicardial pacing wire 28. The connection points 354, 356 can be connected to a resistor 362 sized between 1 kiloohm and 50 kiloohms or higher than 50 kiloohms to prevent overloading of the pacemaker signal by the circuit assembly 148. The resistor 362 can be a potentiometer comprising an adjustable voltage divider that varies the resistance. Following the resistor 362, a signal output 364 comprises a lead 366 accessible to the ECG monitor 18 through a stud connector 168. Specifically, the lead 366 is connected to the (V) terminal of the ECG monitor 18. A set of ECG connectors 368, for example four cables, can be placed on the chest of the patient 14 and further attached to corresponding body surface electrodes 370 that are electrically coupled to the ECG monitor 18 at the opposite ends. The output signals of the ECG connectors 368 can be combined (e.g., averaged) to synthesize a reference point (virtual ground) for the signal output 364 of the lead 366.

[0072] Referring to FIG. 4, the first terminal 156 and the second terminal 160 are conductive through-hole electrical connections formed in the circuit board 152, and the holes extend parallel to the first external opening 132 and the second external opening 136 and perpendicular to the circuit board 152. The through-hole electrical connector can be an eyelet having sharp inner edges that bite into the first terminal 156 and the second terminal 162 at the end rods 52 for good electrical contact with the pacing wire 28. In one embodiment, the eyelet can be a brass eyelet plated with tin to prevent oxidation or corrosion.

[0073] In some embodiments, a low-voltage overmold (not shown) potted within the housing 108 and around the circuit assembly 148 may hold the circuit assembly 148 in place. The overmold provides, among other things, electrical insulation, protection against ingress of dirt and debris, and additional structural support.

[0074] During surgery, the distal end 40 of the pacing wire 28 is placed on the outer layer (i.e., epicardium) of the patient's heart 44, while the proximal end 48 of the pacing wire 28 is accessible outside the patient 14. The exposed proximal end 48 of the pacing wire 28 enables both the technique of detecting and monitoring the heart rhythm (i.e., via the ECG monitor 18) and the technique of sending an electrical signal to pace the heart (i.e., by the external pacemaker 24).

[0075] Referring more particularly to FIG. 8C, the proximal end 48 of the pacing wire 28 includes an exposed rigid end rod 52 that is electrically coupled to the distal end 40 of the pacing wire 28 by an insulating wire portion 56 extending therebetween. It is understood that the end rod 52 may have various diameters and lengths. For example, the diameter of the end rod 52 may vary between 0.8 mm and 2.2 mm, while the length of the end rod 52 may vary between 15 mm and 25 mm and may be approximately 23 mm.

[0076] As will be described in more detail below, the first terminal 156 and the second terminal 160 are configured to receive the exposed proximal end 48 of the pacing wire 28. More particularly, the terminals 156, 160 are configured to receive and make electrical connection with the end rod 52 of the pacing wire 28.

[0077] Continuing with reference to FIG. 4, the connector 100 further includes a stud connector 168 and a pacemaker connector 172 disposed on the outer surface of the housing 108. The stud connector 168 is electrically coupled to the circuit assembly 148 by at least one wire 176, and the pacemaker connector 172 is electrically coupled to the circuit assembly 148 by a wire 180.

[0078] More specifically, the upper wall portion 145 of the housing 108 can support a stud connector 168 that is a metal boss extending outwardly from the housing 108 and configured to be connected to an ECG lead wire 36 that can utilize either a "snap" type or a "clip" type connection. The ECG lead wire 36 is electrically coupled to the stud connector 168 for monitoring and displaying the heart rhythm detected by the epicardial pacing wire 28. The ECG monitor 18 is electrically coupled to the connector 100 by an ECG lead wire 36 that provides an electrical connection between the stud connector 168 and the circuit assembly 148.

[0079] The rear wall portion 149 of the housing 108 can support a pacemaker connector 172 that can be a Hypertronic series connector (D series) by Smiths Interconnect having compatibility with, for example, a pacemaker code 32 associated with a Medtronic Pacemaker. In other words, the pacemaker connector 172 interfaces the epicardial pacing wire 28 with an external pacemaker 24.

[0080] A D-shaped socket may be included in the pacemaker connector 172 and includes an internal cavity 312 for housing a connector of the pacemaker code 32 on a third insertion axis 314 that extends generally parallel to the planar 121 of the patient's chest and generally parallel to the first insertion axis 192 and the second insertion axis 196 of the first opening 184 and the second opening 188, respectively. The internal cavity 312 may include two female terminals 313 that are arranged in a side-by-side configuration and configured to house the male contacts 315 of the pacemaker code 32. The third insertion axis 314 may be provided generally in the same plane as the first and second axes 192, 196.

[0081] In some embodiments, the pacemaker connector 172 may be held in place by a low-pressure overmold (not shown) potted in the housing 108. The overmold provides, among other things, electrical insulation, protection against ingress of dust and debris, and additional structural support.

[0082] Referring to FIG. 9, in one embodiment, a simple cut connector 330 is provided that includes a "D" shaped flange 332 that engages a corresponding "D" shaped socket of a corresponding pacemaker connector 172 and supports first and second protrusions 334, i.e., positive and negative protrusions, that are arranged in a side-by-side configuration and received in the corresponding female terminals 313 of the pacemaker connector. The "D" shaped flange 332 facilitates engagement of the engagement orientation of the simple cut connector 330 of the pacemaker code 32 with the pacemaker connector 172. The simple cut connector 330 may further include a push button 336 associated with a slidable detent that engages and disengages with a corresponding hole or recess of the pacemaker connector 172.

[0083] A Y-connector 338 includes a first cable 340 that branches into two cables 342, 344 having wire connector ends 346 at their distal ends that are coupled to a simple cut-off connector 330 and are coupled to and compatible with an external pacemaker 24. The simple cut-off connector 330 is further coupled to the Y-connector 338. A strain relief bushing (not shown) in the form of a series of ridges where the simple cut-off connector 330 and the wire connector ends 346 meet the cables 340, 342, 344 is further included in the simple cut-off connector 330 and the wire connector ends 346. Accordingly, an extracorporeal pacemaker 24 is electrically coupled to the connector 100 by a pacemaker cord 32 that provides an electrical connection between a pacemaker connector 172 and a circuit assembly 148.

[0084] Referring to FIGS. 2 and 4, the connector 100 further includes a retention cover 276 configured to cover or protect one or more of the electrical connections of the stud connector 168 and / or the pacemaker connector 172. The cover 276 includes a mount 280 (FIG. 4), a first end 284 coupled to the mount 280 by a first flexible arm portion 288, and a second end 292 coupled to the mount 280 by a second flexible arm portion 296. In other words, the cover 276 is a both-end cover having a second end 292 opposite the first end 284. The mount 280 is fitted into a groove 300 formed in the housing 108, and the mount 280 includes an opening 304 (FIG. 4) in which a portion of the stud connector 168 is received. In other words, the stud connector 168 fixed to the housing 108 fixes the cover 276 to the groove 300 of the housing 108.

[0085] The first end 284 of the cover 276 includes a protruding boss 308 configured to be received within the pacemaker connector 172 (i.e., female connector). More specifically, the protruding boss 308 is received within an internal cavity 312 defined by the pacemaker connector 172. The second end 292 of the cover 276 includes a plug 316 in which an opening 320 is formed. The plug 316 is configured to cover the stud connector 168 (i.e., male connector). More specifically, the stud connector 168 is partially received within the opening 320 formed in the plug 316. In the illustrated embodiment, the cover 276 is made of a flexible material (e.g., an elastomeric material) that moves (i.e., flexes) the first flexible arm portion 288 and the second flexible arm portion 296 relative to the mount 280. Accordingly, the first end 284 and the second end 292 are movable relative to the mount 280.

[0086] Referring to FIGS. 2 and 3, the connector 100 further includes a mounting portion 222 formed in the housing 108. In the illustrated embodiment, the mounting portion 22 is curved (i.e., arcuate in shape). For example, a user may attach a clip (e.g., an ID badge clip) or other suitable fixture to the mounting portion 222 such that the connector 100 can be secured to a patient's gown, bedsheet, or other material on the patient side. In other words, the connector 100 need not be placed directly on the skin of the patient 14. In one embodiment, the pacemaker connector 172 is oriented at the rear end of the connector to face the patient's head, whereas the pacing wire 28 is received by the connector 100 opposite the pacemaker connector 172 to face the patient's feet at the front end of the connector 100. The stud connector 168 is disposed on an upper wall portion parallel to the patient's chest, which is a natural plane for an ECG lead placed on the patient's chest. The buttons 112, 116 on both sides are oriented on the left and right sides of the connector 100 on both side surfaces of the housing 108 and are easily gripped by the user's hand between the thumb, index finger, and middle finger.

[0087] During operation, the connector 100 is interconnected to various medical devices 18, 24, 28 of the medical system 10. Specifically, the connector 100 allows for simultaneous and continuous interconnection of the pacing wire 28, the pacemaker 24, and the ECG monitor 18. In particular, the ECG lead wire 36 is coupled to the stud connector 168, and the pacemaker code 32 is electrically coupled to the pace generator connector 170. In addition to the connection of the ECG monitor 18 and the pacemaker 24 to the connector 100, as described below, the user can electrically couple the epicardial pacing wire 26 to the connector 100.

[0088] First, the connector 100 is in the neutral state shown in FIG. 8A. In the neutral state, the shroud 104 is in the first storage position, and the biasing member 224 biases the first and second buttons 112, 116 to their respective blocking positions. When the buttons 112, 116 are in the blocking positions, the blocking portion 260 of the blocking arm 236 is disposed between the terminals 156, 160 and the openings 184, 188. While in the blocking position, the blocking portion 260 prevents the pacing wire 26 from being inserted into and electrically coupled to the circuit assembly 148. Thus, the blocking portions 160 of the buttons 112, 116 protect the terminals 156, 160. Also, when the shroud 104 is in the storage position, the overall size of the connector 100 is reduced.

[0089] Referring to FIG. 8B, to electrically couple the pacing wire 28 to the connector 100, the first button 112 and / or the second button 116 can be operated. In the illustrated embodiment, the first button 112 can be operated independently of the second button 116. Specifically, when the user's force 324, for example, the index finger and the middle finger hold the right side wall 140 and the thumb presses the button 112, the first button 112 is pressed on the operation axis 248. Also, when the user's force 328, for example, the index finger and the middle finger hold the left side wall 140 and the thumb presses the button 116, the second button 116 is pressed on the operation axis 248. When the first and second buttons 112, 116 are fully pressed, the buttons 112, 116 are in the non-blocking position. In the non-blocking position, the window 264 formed in the block portion 260 is aligned with the corresponding openings 184, 188 of the housing 108 and the outer openings 132, 136 of the shroud 104. In other words, when the buttons 112, 116 are in the non-blocking position, the connector 100 is configured to receive the end rod 52 of the pacing wire 28 in one of the terminals 156, 160.

[0090] Referring to FIG. 8C, when the end rod 52 of the pacing wire 26 is inserted into the terminals 156, 160, the buttons 112, 116 can be released by the user. After releasing the buttons 112, 116, the biasing member 224 also biases the buttons 112, 116 to the blocking position of FIG. 8A. However, when the end rod 52 is inserted into the terminals 156, 160, the buttons 112, 116 are prevented from returning completely to the blocking position. Instead, the end rod 52 of the pacing wire 28 is clamped (i.e., fixed) between the circuit assembly 148, the window 264 of the buttons 112, 116, and the openings 184, 188 of the housing 108, and the buttons 112, 116 are biased to the restraining position. In other words, the biasing member 224 biases the buttons 112, 116 to the restraining position where the end rod 52 is fixed in the connector 100. Therefore, after the user releases the buttons 112, 116, the pacing wire 28 is automatically fixed within the connector 100. In the blocking position, the end rod 52 makes a reliable electrical connection with the first terminal 156 and the second terminal 160.

[0091] Referring to FIG. 8D, the shroud 104 can be moved to the extended position while or after the pacing wire 28 is fixed to the connector 100. In the illustrated embodiment, when the shroud 104 is in the extended position, the shroud 104 completely surrounds the end rod 52 that extends outwardly from the housing 108. In one embodiment, at least a portion of the insulated wire portion 56 of the pacing wire 28 is received within the shroud 104 when the shroud 104 is in the extended position. The epicardial pacing wire 28 is fragile, and it is not desirable to expose the pacing wire 28 (especially the end rod 52) to the surrounding environment. For example, the pacing wire 28 can be damaged or otherwise physically damaged when exposed to the environment surrounding the patient 14. Further, when the end rod 52 of the pacing wire 28 is exposed, the end rod 52 can receive an electrostatic shock that affects proper pacing of the heart and accurate monitoring of the heart rhythm.

[0092] To disconnect the pacing wire 28 from the connector 100, the corresponding buttons 112, 116 are depressed to move the buttons 112, 116 to the unblocked position (FIG. 8B) as well. While the buttons 112, 116 are in the unblocked position, the end rod 52 of the pacing wire 28 is freely removable from the terminals 156, 160 and the connector 100. The pacing wire 28 can be removed from the connector 100 together with the shroud 104 in the extended position, the retracted position, or a position therebetween.

[0093] For example, it is understood that if the pacing wire 28 is pulled out of the connector 100 by the patient, the proximal end 48 of the pacing wire 28 can be removed from the connector 100 by a threshold level of force without the corresponding buttons 112, 116 also moving to the unblocked position (FIG. 8B) in an emergency situation. The threshold level of force is less than the threshold level of force required to pull the distal end 40 of the pacing wire 28 away from the patient's heart 44.

[0094] Reference labels indicating proper connection of the positive and negative pacing wires 28 are affixed to the shroud 104. For example, it is understood that labels of plus (+) and minus (-) signs may be attached to the openings for the epicardial terminals 156, 160 to indicate where the positive wire 358 or the negative wire 360 of the epicardial pacing wire 28 is to be inserted. The shroud 104 may be pulled or pushed relative to the inner housing 108 in a direction to lock or unlock the shroud 104 between the first storage position (FIG. 8A) and the second extended position (FIG. 8D), i.e., along the first and second insertion axes 192, 196, and other markings such as arrows may be shown. Arrows may also be used to indicate the locations of the buttons 112, 116 on the side walls of the connector 100 that are operated to insert the pacing wire 28.

[0095] The connector 100 avoids the time-consuming operation of switching the connection to the epicardial pacing wire 28 and reduces the risk of connection errors.

[0096] Certain terms are used herein for reference purposes only and are not intended to be limiting. For example, "upper", "lower", "above", and "below" refer to directions on the drawings being referred to. Terms such as "front", "back", "rear", "bottom", and "side" describe the orientation of component parts in any consistent reference system that is clear by referring to the text in which the component being considered is described and the associated drawings. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning. Similarly, words such as "first", "second", and other words representing numbers used to refer to structures do not imply a sequence or order unless clearly indicated by the context. When an element is described as being electrically connected, this connection may be direct or through intervening conductive elements.

[0097] When introducing elements or features of the present disclosure and exemplary embodiments, the articles "a", "an", "the", and "said" are intended to mean that there is one or more of such elements or features. "Comprising", "including", and "having" are intended to be inclusive and mean that there may be additional elements or features other than those specifically recited. It should be further understood that method steps, processes, and operations described herein are not to be construed as necessarily requiring implementation in the particular order discussed or illustrated unless the order of implementation is specifically defined. It is also understood that additional or alternative steps may be employed.

[0098] It is clearly intended that the claims be understood to cover modifications of these embodiments including those that are not limited to the embodiments and illustrations contained herein but include portions of the embodiments within the scope of the following claims and combinations of elements from different embodiments. All publications described herein, including patent and non-patent publications, are hereby incorporated by reference in their entirety.

Description of Reference Numerals

[0099] 10 Medical system 14 Patient 18 Electrocardiograph (ECG) monitor 24 Pacemaker 28 Pacing wire 32 Pacemaker code 36 ECG lead wire 40 Distal end of the pacing wire 44 Heart 48 Proximal end of the pacing wire 52 End rod 100 Connector 104 Outer shroud 104A Upper member 104B Bottom member 108 Inner housing 108A Upper member 108B Bottom material 112 First button 116 Second button 120 Upper wall part 121 Plane of the patient's chest 124 Bottom wall part 128 Front wall part 132 First external opening 136 Second external opening 138 Rear end part 140 Side wall part 144 Track 145 Upper wall part 146 Bottom wall part 147 Front wall part 148 Circuit assembly 149 Rear wall part 150 Side wall part 152 Circuit board 156 First terminal 160 Second terminal 164 Register 168 Stud connector 172 Pacemaker connector 176 Wire 180 Wire 184 First opening 188 Second opening 192 First insertion axis 196 Second insertion axis 200 Retainer 204 First recess 208 Second recess 212 Spring arm 216 Protrusion 220 Cam surface 220A First cam surface 220B Second cam surface 220C Third cam surface 222 Mounting part 224 Biasing member 226 Rectangular cavity 228 User operation part 232 Stem 236 Block arm 240 Seat 244 slots 248 operating axis 252 first end of the biasing member 256 second end of the biasing member 260 block portion 264 window portion 266 space 268 opening 272 inclined surface 276 retaining cover 280 mount 284 first end 288 first flexible arm portion 292 second end 296 second flexible arm portion 300 groove portion 304 opening 308 protruding boss 312 internal cavity 313 female terminal 314 third insertion axis 315 male contact 316 plug 320 opening 324 user force 328 user force 330 simple cut connector 332 flange 334 first and second protrusions 336 push button 338 Y connector 340 first cable 342, 344 cables 346 connector end 350 positive wire 352 negative wire 354, 356 connection points 358 positive wire 360 negative wire 362 register 364 signal output 366 lead 368 ECG connector 370 body surface electrode

Claims

1. An interface unit for epicardial pacing and telemetry monitoring, an electrically insulating housing, first and second electrical terminals accessible from corresponding openings of the housing and adapted to removably receive first and second epicardial lead wires into the housing parallel to an insertion axis, a first electrical connector mounted to the insulating housing to removably receive a pacemaker connector at third and fourth terminals, a second electrical connector mounted to the insulating housing to receive a telemetry connector connection at a fifth terminal, a circuit disposed within the housing providing electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal, first and second openings for receiving the first and second epicardial wires before the first and second epicardial wires are movably mounted to the housing such that the first and second epicardial wires are received by the first and second electrical terminals and move between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, and an electrical insulating shroud serving as an insulating cover for the first and second epicardial wires extending outwardly from the first and second terminals, The interface unit, wherein the shroud is movable relative to the housing along the insertion axis.

2. The interface unit of claim 1, wherein the housing has front and rear side surfaces, and the openings of the first and second terminals are in the front surface and the first electrical connector is in the opposite rear surface such that the first and second epicardial wires and the first electrical connector from the pacemaker connector can extend parallel to a common axis.

3. The interface unit of claim 1, wherein the housing further has upper and lower side surfaces, and the second electrical connector is in the upper surface.

4. An interface unit for epicardial pacing and telemetry monitoring, An electrical insulation housing, and First and second electrical terminals that are accessible from a corresponding opening of the housing and are adapted to removably receive first and second epicardial lead wires into the housing parallel to an insertion axis; A first electrical connector mounted to the insulating housing so as to removably receive a pacemaker connector at third and fourth terminals; A second electrical connector mounted to the insulating housing so as to receive a telemetry connector connection at a fifth terminal; A circuit disposed within the housing that provides electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal; Before the first and second epicardial wires are movably mounted to the housing so that the first and second epicardial wires are received by the first and second electrical terminals and move between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, an electrical insulation shroud that serves as an insulation cover for the first and second epicardial wires extending outwardly from the first and second terminals, and having first and second openings for receiving the first and second epicardial wires; Buttons for restraining the first and second epicardial lead wires; An interface unit in which the buttons are on left and right side surfaces of the housing.

5. An interface unit for epicardial pace adjustment and telemetry monitoring, An electrical insulation housing, and First and second electrical terminals that are accessible from a corresponding opening of the housing and are adapted to removably receive first and second epicardial lead wires into the housing parallel to an insertion axis; A first electrical connector mounted to the insulating housing so as to removably receive a pacemaker connector at third and fourth terminals; A second electrical connector mounted to the insulating housing so as to receive a telemetry connector connection at a fifth terminal; A circuit disposed within the housing, the circuit providing electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal. Before the first and second epicardial wires are movably mounted to the housing so as to be movable between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, the first and second epicardial wires are received by the first and second electrical terminals, and the housing is provided with first and second openings for receiving the first and second epicardial wires, and an electrical insulation shroud that serves as an insulating cover for the first and second epicardial wires extending outwardly from the first and second terminals. A button for restraining the first and second epicardial lead wires. The button is on both the left and right side surfaces of the housing. The button is biased on the operating axis by a spring so as to restrain the first and second epicardial lead wires. The button is the first and second buttons on both sides biased in opposite directions on the operating axis by a common spring, an interface unit.

6. The interface unit according to claim 5, wherein the operating axis is orthogonal to the insertion axis.

7. The interface unit according to claim 4 or 5, wherein the button includes a block arm that extends to the housing and is disposed between the first and second electrical terminals and the first and second openings in the first position, and provides a path between the first and second electrical terminals and the first and second openings in the second position.

8. The interface unit according to claim 7, wherein the block arm includes a window portion that is aligned on the insertion axis when the button is in the second position.

9. The interface unit according to any one of claims 1, 4, or 5, wherein the circuit has a resistance of at least 1 kiloohm.

10. The interface unit according to any one of claims 1, 4, or 5, further comprising a tethering cover that covers at least one of the first and second connectors.

11. The interface unit according to any one of claims 1, 4, or 5, further comprising reference labels of minus and plus signs respectively disposed proximal to the first and second openings.

12. The interface unit according to any one of claims 1, 4, or 5, wherein the second electrical connector is a stud connector defined by a metal boss extending outward from the housing and electrically coupled to the circuit assembly, and the stud connector is disposed on an outer surface of the housing.

13. An interface unit for epicardial pacing adjustment and telemetry monitoring, an electrically insulating housing, first and second electrical terminals accessible from corresponding openings of the housing and adapted to removably receive first and second epicardial lead wires into the housing parallel to an insertion axis, a first electrical connector mounted to the insulating housing so as to removably receive a pacemaker connector with third and fourth terminals, a second electrical connector mounted to the insulating housing so as to receive a telemetry connector connection part with a fifth terminal, a circuit disposed in the housing, the circuit providing electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal, first and second openings for receiving the first and second epicardial wires before the first and second epicardial wires are movably mounted to the housing so as to move between a first position proximal to the first and second electrical terminals and a second position removed from the first and second terminals, and an electrical insulating shroud serving as an insulating cover for the first and second epicardial wires extending outward from the first and second terminals, The interface unit further including a detent disposed between the housing and the shroud at at least one of the first and second positions.

14. A connector assembly for epicardial pacing and telemetry monitoring, a pacemaker configured to provide an electrical impulse for performing electrical pacing on the heart through an epicardial pacing lead connected to the patient's heart; a telemetry monitor configured to receive an electrical heart signal from the epicardial pacing lead and provide a display of the electrical heart signal; an interface unit, an electrical insulation housing, first and second electrical terminals accessible from corresponding openings of the housing and adapted to removably receive first and second epicardial lead wires into the interior of the housing parallel to the insertion axis; a first electrical connector mounted to the insulating housing to removably receive a pacemaker connector with third and fourth electrical terminals; a second electrical connector mounted to the insulating housing to receive a telemetry monitor connection part with a fifth terminal; a circuit disposed within the housing, the circuit providing electrical communication between the second and third electrical terminals and between the first, fourth terminals and the fifth terminal; first and second openings for receiving the first and second epicardial wires before the first and second epicardial wires are received in the first and second electrical terminals and are movably mounted to the housing between a first position proximal to the first and second terminals and a second position removed from the first and second terminals, and an electrical insulation shroud serving as an insulation cover for the first and second epicardial wires extending outward from the first and second terminals; an interface unit comprising, the connector assembly, wherein the shroud is movable on the insertion axis relative to the housing.

15. The assembly of claim 14, wherein the first opening and the first terminal are aligned on a first insertion axis, the second opening and the second terminal are aligned on a second insertion axis, and the first and second insertion axes are spaced apart in parallel. The assembly of claim 14, further comprising a button for restraining the first and second epicardial lead wires.

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