Source: https://patents.google.com/patent/US8668651B2/en
Timestamp: 2019-04-20 09:11:47+00:00

Document:
A method for coupling an ECG monitor with an incompatible ECG lead set includes the steps of providing an ECG adapter including an adapter body having at least one monitor connector adapted for coupling to an input of an ECG monitor and at least one lead set receptacle adapted for coupling to a connector of an ECG lead set incompatible with the input of the ECG monitor, coupling the at least one monitor connector of the adapter body with the input of the ECG monitor and coupling the at least one lead set receptacle of the adapter body with the connector of the ECG lead set to thereby electrically couple the ECG lead set with the ECG monitor.
Electrocardiograph (ECG) monitors are widely used to obtain biopotential signals containing information indicative of the electrical activity associated with the heart and pulmonary system. To obtain biopotential signals ECG electrodes are applied to the skin of a patient in various locations and coupled to an ECG monitor. Placement of the electrodes is dependant on the information sought by the clinician.
The placement of the ECG electrodes on the patient has been established by medical protocols. The most common protocols require the placement of the electrodes in a 3-lead, a 5-lead or a 12-lead configuration. A 3-lead configuration requires the placement of three electrodes; one electrode adjacent each clavicle bone on the upper chest and a third electrode adjacent the patient's lower left abdomen. A 5-lead configuration requires the placement of the three electrodes in the 3-lead configuration with the addition of a fourth electrode adjacent the sternum and a fifth electrode on the patient's lower right abdomen. A 12-lead configuration requires the placement of 10 electrodes on the patient's body. Four electrodes, which represent the patient's limbs, include the left arm electrode (LA lead), the right arm electrode (RA lead), the left leg electrode (LL lead), and the right leg electrode (RL lead). Six chest electrodes (V1-V6 leads) are placed on the patient's chest at various locations near the heart. Three standard limb leads are constructed from measurements between the right arm and left arm (Lead I), the right arm and the left leg (Lead II) and the left arm to left leg (Lead III). The ten electrodes provide 12 measurement points consisting of Leads I, II, III, AVL, AVR, AVF, and V1-V6 with the right leg electrode typically used as a ground.
Electrodes, after placement on the patient, connect to an ECG monitor by an ECG lead set. One end of the ECG lead set, closest to the patient, connects to each electrode (alternatively, the electrodes may be integrated into the distal end of the ECG lead set) and receives biopotential signals from the body. The other end of the ECG lead set connects to the ECG input connector and supplies the biopotential signals received from the body to the ECG monitor.
ECG monitors and ECG lead sets are manufactured and sold by various companies. Although protocols have been established for the placement ECG electrodes, the various manufacturers typically use product specific connectors and wiring configurations.
Problems occur when an ECG lead set and an ECG monitor are electrically incompatible but have mechanically compatible connectors. While some problems may be automatically detected by the monitor, other problems, such as, for example, the incorrect order of V1-V6, may go undetected and the ECG monitor may provide the clinician with erroneous information.
Some ECG monitors are configured to connect to a specific type or family of ECG lead sets manufactured, distributed and sold by the same manufacturer of the ECG monitor. The ECG monitor, and specific type or family of ECG lead sets, may utilize, as a safety feature, a unique or specialized connector that is only compatible with the particular ECG monitor and incompatible with all other ECG lead sets.
While this safety feature may prevent a clinician from accidentally connecting an incompatible lead set to an ECG monitor, it also required each medical facility to supply a plurality of ECG lead sets for the various ECG monitor used within a medical facility.
The present application provides an ECG lead set, adapter system and methods for coupling a standard ECG lead set with any incompatible ECG monitor thus preventing the afore mentioned problems.
The present disclosure relates to medical equipment. In particular, the present disclosure relates to an ECG lead set, adapter system and methods for coupling an ECG lead set with an incompatible ECG monitor.
In accordance with one embodiment, a method for coupling an ECG monitor with an incompatible ECG lead set, comprising the steps of providing an ECG adapter including an adapter body with at least one monitor connector and at least one lead set receptacle, coupling the monitor connector of the adapter body with the input of an ECG monitor and coupling the lead set receptacle of the adapter body with the connector of an ECG lead set to thereby electrically couple the ECG lead set with the ECG monitor. The at least one monitor connector may be adapted for coupling to an input of an ECG monitor. The at least one lead set receptacle is adapted for coupling to a connector of an ECG lead set incompatible with the input of the ECG monitor.
The step of coupling the at least one lead set receptacle may include connecting one of a six conductor Registered Jack (RJ25) style (or modular) connector and an eight conductor (RJ45) connector of the ECG lead set.
In a further embodiment of the present disclosure, the adapter body includes first and second lead set receptacles and the step of coupling the at least one lead set receptacle includes coupling the first and second ECG lead sets to the respective first and second lead set receptacles. The step of coupling the at least one lead set receptacle may include connecting an RJ25 connector of the first ECG lead set to the first lead set receptacle and connecting an RJ45 connector of the second ECG lead set to the second lead set receptacle.
In yet another embodiment of the present disclosure the ECG adapter system for coupling an ECG lead set with an incompatible ECG monitor includes at least one ECG adapter having at least one monitor connector and at least one lead set receptacle. The at least one monitor connector is adapted for coupling to an input of an ECG monitor. The at least one lead set receptacle is different from the at least one monitor connector and is adapted for coupling to a connector of an ECG lead set incompatible with the input of the ECG monitor. The at least one monitor connector may be a plug and the at least one connector may be a receptacle. Plug and/or receptacle may be one of an RJ25 connector and an RJ45 connector of the ECG lead set.
The adapter body may include a first and second lead set receptacles for coupling to connections of a respective first and second ECG lead sets. The first lead set receptacle is different from the second lead set receptacle to permit coupling to different ECG lead sets. The first lead set receptacle of the adapter body may be adapted for coupling to an RJ25 connector of the first ECG lead set and the second lead set receptacle of the adapter body may be adapted for coupling to an RJ45 connector of the second ECG lead set.
In a further embodiment, the ECG adapter system may include first and second ECG adapters. The at least one monitor connector of the adapter body of the first ECG adapter may be different than the at least one monitor connector of the adapter body of the second ECG adapter. The first and second ECG adapters may couple to the inputs of different ECG monitors.
At least a portion of the plurality of wires of the at least one lead set may form at least one ribbon cable. At least one of the plurality of wires forming the at least one ribbon cable may be separable from the at least one ribbon cable.
In yet another embodiment of the present disclosure, an ECG lead set system includes an ECG lead set including a plurality of lead wires for coupling to a plurality of electrodes, a plug connector coupled to one end of the ECG lead set and an adapter adapted for coupling the plug connector to an input of an ECG monitor. The adapter may include an adapter body having a lead set receptacle for coupling to the plug connector of the ECG lead set and a monitor plug different from the plug connector for coupling to the input of the ECG monitor.
The ECG lead set system may include an electrode connector coupled to the other end of the ECG lead set. The electrode connector may be selected from a group consisting of a snap connector, a wire dumbbell connector, a locking slot connector and a keyhole connector. The ECG lead set system may further include at least one ECG electrode connected to the electrode connector of the ECG lead set. Alternatively, at least one ECG electrode may be pre-wired to the other end of the ECG lead set.
The ECG lead set system may further include a sheath for housing at least a portion of the ECG lead set.
In a further embodiment of the present disclosure, at least a portion of the plurality of lead wires of the ECG lead set may form a ribbon cable. At least a portion of one of the plurality of lead wires, forming the ribbon cable, is separable from the ribbon cable.
FIG. 4B illustrates the ECG adapter system of FIG. 4A placed on a patient.
Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. As used herein and as is traditional, the term “distal” refers to the portion which is furthest from the user/clinician and the term “proximal” refers to the portion that is closest to the user/clinician. In addition, terms such as “above”, “below”, “forward”, “rearward”, etc. refer to the orientation of the figures or the direction of components and are simply used for convenience of description.
FIG. 1 shows an ECG monitoring system 10 incorporating an ECG adapter system 100 according to the present disclosure. The ECG monitoring system 10 includes an ECG monitor 20 and an ECG adapter system 100 that includes an adapter 110 and one or more ECG lead sets 120, 130.
The ECG monitor 20 is configured to receive biopotential signals containing information indicative of the electrical activity associated with the heart and pulmonary system and to display the information on a user display 22. EGC monitor 20 includes at least one lead set input connector 24 configured to connect with at least one compatible ECG lead.
ECG adapter system 100 includes an adapter 110 and one or more ECG lead sets 120, 130. Each ECG lead set 120, 130 includes a plurality of lead wires 120 a-e, 130 a-e at least partially surrounded by a sheath 140. Sheath 140 may protect lead wires 120 a-e, 130 a-e from physical damage or may shield lead wires 120 a-e, 130 a-e from electrical interference. The sheath 140 of the ECG adapter system 100 may vary in length between about 2 to 10 feet.
At least a portion of lead wires 120 a-e, 130 a-e extends distally from sheath 140 a distance “d”, between about 2 to 40 inches. The distal end of lead wires 120 a-e may connect to one or more electrode connectors 121 a-e. Electrode connectors are configured to connect to an ECG electrode 122 shown separated from electrode connector 121 e. Alternatively, lead wires 130 a-e may be integrated into the electrodes 150 a-e. One or more electrodes 150 a-e may be coupled to the distal end of each individual lead wire 130 a-e or electrode may be formed from the and individual lead wire 130 a-e.
FIGS. 3A-3D illustrate various electrode connectors 221 a-d that may be attached to, or formed on, the distal end of a lead wire 220 a-b. Distal end of lead wire 220 a may attach to an electrode connector, such as, for example, a snap connector 221 a, a locking slot connector 221 e or a keyhole connector 221 d. Alternatively, distal end of lead wire 220 b may form the electrode connector, such as, for example, a dumbbell connector 221 b. Additionally, the standard snap or pinch clip connectors and others known in the field may terminate the distal end of the leadwire.
FIG. 3E is a schematic of an electrode 250 a attached to the distal end of lead wire 230 a. Alternatively, as illustrated in FIG. 3F, the distal end of the lead wire 230 b may form the conductive portion 250 c of the electrode 250 b.
Irrespective of the electrode configuration, (e.g., electrode connectors, pre-wired and/or integrated electrodes) in use the electrodes are connected to the ECG lead set 120, 130, disposed on a the patient and configured to received the biopotential signals.
Lead set connector 121, 131 is coupled to the proximal end of the ECG lead set 120, 130 and configured to couple with adapter 110. Adapter 110 includes at least one lead set receptacle 112 a, 112 b to electrically couple to the lead set connector 121, 131. Adapter 110 electrically couples the ECG lead sets 120, 130 of the ECG adapter system 100 with the ECG monitor 20.
Sheath 140 may be integrated into the lead set connector 121, 131 or may be formed from a suitable tubular member and coupled to the lead set connector 121, 131.
ECG lead set 120, 130 may be formed from a plurality of individual wires or from a suitable cable containing a plurality of wires, such as, for example, a multi-conductor shielded cable or ribbon cable. Sheath 140 may be the cable jacket or may be a separate tubular member at least partially surrounding a portion and/or length of the plurality of individual wires or cable.
Adapter 110 includes an adapter body 111 with an input receptacle 112 and a monitor plug 113. Input receptacle 112 includes at least one lead set receptacle 112 a, 112 b configured to couple to a lead set connectors 121, 131 of an ECG lead set 120, 130. Monitor plug 113 is configured for coupling to the lead set input connector 24 of the ECG monitor 20. Lead set connectors 121, 131 of the ECG lead sets 120, 130 are different than monitor plug 113 of the adapter 110 such that lead set connectors 121, 131 are not configured to connect to the lead set input connector 24 of the ECG monitor 20. The difference between the lead set connectors 121, 131 and the monitor plug 113 must be such that the lead set connectors 121, 131 are mechanically incompatible and/or physically incompatible with the lead set input connector 24 of the ECG monitor 20.
Monitor plug 113 of adapter 110 is configured to connect to a specific ECG monitor 20 and may include any safety feature or unique/specialized aspect required to allow monitor plug 113 to connect with the lead set input connector 24 of the ECG monitor 20. A separate, and possibly unique, adapter 110 may be required for each ECG monitor 20. The lead set receptacles 112 a, 112 b of the various adapters 110, irrespective of the ECG monitor 20 that it connects to, may be configured to accept the lead set connectors 121, 131 of the ECG lead set 120, 130. Lead set receptacles 112 a, 112 b are electrically coupled to the monitor plug 113 such that the ECG lead set 120, 130, which is otherwise incompatible with the ECG monitor 20, connects to ECG monitor 20. The adapter 110 couples an ECG lead set 120, 130 with an ECG monitor 20, wherein the lead set input connector 24 of the ECG monitor 20 and the lead set connector 121, 131 of the ECG lead set 120, 130 are otherwise incompatible.
Lead set connector 121, 131 and the respective mating lead set receptacle 112 a, 112 b may be formed of standard connectors. Lead set connectors 121, 131 and lead set receptacles are formed with connectors not presently associated or used with current ECG monitors, such as, for example, but not limited to, RJ45 and RJ25 telephone connectors commonly used in the telecommunications industry but not presently associated with ECG monitors. Alternatively, lead set connectors 121, 131 and lead set receptacles 112 a, 112 b may be designed and/or constructed specifically for this application.
In use, the lead set connector 121, 131 couples to the respective lead set receptacle 112 a, 112 b. For example, lead set connector 121 may be an RJ25 connector and may connect to an RJ25 lead set receptacle 112 a of the adapter receptacle 112. Similarly, lead set connector 131 may be an RJ45 connector and may connect to an RJ45 lead set receptacle 112 b of the adapter receptacle 112. Monitor plug 113 couples to the lead set input connector 24 of the ECG monitor 20 thereby electrically connecting electrode connectors 121 a-e and/or electrodes 150 a-e to the ECG monitor 20. As a further alternative, RJ11, RJ14 and RJ50 lead set connectors and corresponding receptacles are also envisioned.
Variations of the adapter 110 from FIG. 1 are illustrated in FIGS. 2A-2C. In FIG. 2A, the adapter 210 a include a monitoring plug 213 a configured to connects to input connector 224 a of ECG monitor 220 a. The input connector 224 a on ECG monitor 220 a may be configured to receive a lead set connector that may connect one or more types of lead sets to the ECG monitor 220 a, e.g., configured to connect to a 3-lead lead set, a 5-lead lead set and/or a 12-lead lead set. Lead set receptacle 212 a on adapter 210 a may also be configured to connect to a single type of lead set connector that may connect to a 3-lead lead set, a 5-lead lead set and/or a 12-lead lead set, or other types of ECG lead sets, and configured as an ECG lead sets described herein. Lugs 214 on adapter 210 a may connect to terminals 225 a on ECG monitor 220 a.
In FIG. 2B, adapter 210 b includes two monitoring plugs 213 b, 213 c that connect to a first input connector 224 b and a second input connector 224 c of ECG monitor 220 b. First input connector 224 b of the ECG monitor 220 b may be configured to receive a first type of ECG Lead set, such as, for example, a 3-lead EGC lead set, and second connector 224 c of the ECG monitor 220 b may be configured to receive a different type of ECG lead set, such as, for example, a 5-lead ECG lead set or a 12-lead ECG lead set. Adapter 210 b may include a first lead set receptacle 212 b and a second lead set receptacle 212 c configured to connect to an ECG lead set of the present disclosure as described herein.
In FIG. 2C, adapter 210 c includes an adapter body 211 and one or more remote adapter bodies 211 a, 211 b having one or more monitor plugs 213 d, 213 e. Monitor plugs 213 d, 213 e are configured to connect with first and second input connectors 224 d, 224 e, respectively, of the ECG monitor 220 c. First and second adapter bodies 211 a, 211 b are connected to the adapter body 211 through cable 215 a, 215 b or other suitable means of forming an electrical and/or mechanical connection.
Other suitable variations of a monitor plug required to connect an adapter of the present disclosure to various other ECG monitors are contemplated and within the scope of this disclosure.
FIG. 4A is yet another embodiment of an ECG adapter system 300 including an adapter 310 and an ECG lead set 330 having a separable or tearable ribbon cable 360. A lead set connector 321 is coupled to the proximal end of the ribbon cable 360 and a plurality of electrodes 321 a-e, or plurality of electrode connectors (not shown), are coupled the distal end of the individual lead wires 320 a-320 e. One or more adhesive backed sliders 361 may be slidably disposed on a portion of the ribbon cable 360.
Adapter 310 includes an adapter body 311, an input receptacle 312 and a monitoring plug 313. Input receptacle 312 includes at least one lead set receptacle 312 a. Lead set receptacle 312 a may be configured to receive an RJ25 connector or any other suitable receptacle or connector may be used. Monitoring plug 313 is configured to connect to an input connector 324 of an ECG monitor 320.
In use, as illustrated in FIG. 4B, the distal portion of one or more individual lead wires 320 a-320 e may separated from, or may be pulled away from, one or more of the remaining lead wires forming the ribbon cable 360 in order to increase the distal portion of an individual lead wires 320 a-320 e separated from the ribbon cable 360 or from the other individual lead wires 320 a-320 e. For example, distal end of lead wires 320 e and 320 d may be further separated from the ribbon cable 360 such that the respective electrodes 321 d, 321 e may be disposed on the lower abdomen “la” of patient “p”. Similarly, distal end of lead wires 320 b and 320 c are further separated from each other such that the respective electrodes 321 b, 321 c may be disposed on the patient “p” adjacent the left and right side of the upper chest “uc”. Adhesive backed sliders 361 may be positioned on the ribbon cable 360 and disposed on the patient “p” to secure ECG adapter system 300 on the patient “p” and/or to prevent further separation of the ribbon cable 360.
In a further embodiment of the present disclosure, ribbon cable 360 of the ECG adapter system 300 may include a plurality of layers to electrically shield the wires of the ribbon cable 360 from electrical interference or noise. Alternatively, lead wires 320 a-320 e that form the ribbon cable 360 may be individually shielded.
coupling the ECG adapter to each of the lead set connectors to thereby electrically couple the ECG lead sets with the ECG monitor.
2. The method of claim 1, wherein coupling the ECG adapter to the ECG monitor and coupling the ECG adapter to each of the lead set connectors comprises coupling first and second ECG lead sets to a single input of the ECG monitor.
3. The method of claim 1, wherein coupling the ECG adapter to the ECG monitor and coupling the ECG adapter to each of the lead set connectors includes coupling a single ECG lead set to first and second inputs of the ECG monitor.
4. The method of claim 1, further comprising obtaining biopotential signals with each ECG lead set for reception by the ECG monitor.
5. The method of claim 1 wherein coupling the ECG adapter to each of the lead set connectors comprises coupling the ECG adapter to at least one of a six conductor Registered Jack (RJ) connector or an eight conductor RJ connector.
6. The method of claim 1 wherein coupling the ECG adapter to each of the lead set connectors comprises coupling the ECG adapter to at least one of an RJ25 connector or an RJ45 connector.
wherein coupling the ECG adapter to each of the lead set connectors comprises mechanically engaging each of the ECG lead sets to the respective first and second lead set receptacles.
8. The method of claim 7 wherein mechanically engaging each of the ECG lead sets to the respective first and second lead set receptacles comprises connecting an RJ25 connector of a first ECG lead set to the first lead set receptacle and connecting an RJ45 connector of a second ECG lead set to the second lead set receptacle.
9. The method of claim 1 wherein coupling the ECG adapter to the ECG monitor comprises mechanically engaging at least one monitor connector of the adapter with an input of the ECG monitor.
10. The method of claim 1 wherein coupling the ECG adapter to each of the lead set connectors comprises mechanically engaging at least one lead set receptacle of the adapter with a connector of an ECG lead set.
11. The method of claim 1 wherein selecting an ECG adapter from a plurality of ECG adapters according to the number of the at least one input, the configuration of each input, and the number of the at least one ECG lead set further comprises selecting an ECG adapter from a plurality of ECG adapters according to the number of the at least one input, the configuration of each input, the number of the at least one ECG lead set and the configuration of a lead set connector of each ECG lead set.
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