The teachings relates to medical devices, and in particular, to defibrillation/monitor systems having a detachable pod with leads.
Each day thousands of Americans are victims of cardiac emergencies. Cardiac emergencies typically strike without warning, oftentimes striking people with no history of heart disease. The most common cardiac emergency is sudden cardiac arrest (“SCA”). It is estimated more than 1000 people per day are victims of SCA in the United States alone.
SCA occurs when the heart stops pumping blood. Usually SCA is due to abnormal electrical activity in the heart, resulting in an abnormal rhythm (arrhythmia). One such abnormal rhythm, ventricular fibrillation (VF), is caused by abnormal and very fast electrical activity in the heart. During VF the heart cannot pump blood effectively. Because blood may no longer be pumping effectively during VF, the chances of surviving decreases with time after the onset of the emergency. Brain damage can occur after the brain is deprived of oxygen for four to six minutes.
Applying an electric shock to the patient's heart through the use of a defibrillator treats VF. The shock clears the heart of the abnormal electrical activity (in a process called “defibrillation”) by depolarizing a critical mass of myocardial cells to allow spontaneous organized myocardial depolarization to resume.
Cardiac arrest is a life-threatening medical condition that may be treated with external defibrillation. External defibrillation includes applying electrodes to the patient's chest and delivering an electric shock to the patient to depolarize the patient's heart and restore normal sinus rhythm. The chance a patient's heart can be successfully defibrillated increases significantly if a defibrillation pulse is applied quickly.
In a scenario where a paramedic is responding to an emergency call with a non-specific patient condition, for example, there has been a car accident. The paramedic will typically carry his or her own defibrillator/monitor, a gurney, and drug box, and other supplies considered essential. If, perhaps, the car has driven off an embankment, the paramedic will have a long distance to run with all this equipment. This slows the response time to a call where someone may be bleeding to death. Smaller lighter equipment is always demanded by paramedics to save them time and effort, and allow them to get to the scene earlier. For just this reason, some paramedics will opt to carry only an AED (Automatic External Defibrillator) to the scene, and move the patient into the ambulance as quickly as possible, where other, more advanced monitoring equipment is available. In some countries, this approach has been incorporated into standard operating protocols, where the ambulance carries both ALS (advanced life support) equipment (which typically would include a multi-parameter monitor and defibrillator) and an AED. This approach, while effectively giving the user the choice of equipment to carry, forces the paramedic to learn two different defibrillators. The approach also forces the paramedics to possibly transfer the patient from one machine to the other once in the ambulance. It also adds costs to the ambulance service and potentially causes lost data between the two defibrillators for critical minutes, which may negatively impact the ability of EP Lab (Electro-Physiology Lab) doctors to determine the original cardiac condition.
Previous attempts to address the issue of product weight have done so by creating a manual defibrillator that separates from a patient monitor, or an AED, which separates from a single-channel patient monitor, or a manual defibrillator/pacemaker that separates from a 12-lead ECG monitor. These products suffer from limitations by the present standards, such as: limited capture of patient data, limited ability to monitor all necessary patient vital signs, and possible unreliability due to the nature of the electrical contacts between the two devices (e.g., dirt, mud, and damage to the case which could affect alignment of electrical contacts, thus preventing full functionality of the devices when mated).
In a scenario where a patient on a gurney is being transported through narrow doorways and down stairwells to an ambulance, or the situation where a patient is in an ambulance moving on a road at high speed with patient cables and IV (intravenous) lines running between the patient and other equipment within the ambulance. If the monitoring/therapeutic device is large or the route to the ambulance is particularly difficult, the paramedic might elect to carry the device separately from the gurney to prevent the device falling off the gurney or onto the patient. However, the paramedic is now restricted in his or her ability to detach the device from the gurney due to the number and length of patient cables between the device and the patient. Similar restrictions occur once the patient is loaded into a patient transport vehicle or when the patient is transferred from the ambulance to the emergency department. The number of cables and their similarity in color or dissimilarity in length can all contribute to delays in treating or transferring the patient and can restrict the paramedics mobility when treating the patient in a confined space. Additionally, delays may be created with cables having become tangled, or even cut, from their previous uses.
The prior art has tried to solve this problem by providing a wireless module that transmits data to a patient monitor, such as the MobiMed offered for Sale by Ortivus. However, this device does not include a defibrillator and does not have the capability to provide any therapeutic functions such as pacing, defibrillation or synchronous cardioversion without attaching another monitor/defibrillator to the patient, which further increases the complexity and ambulance provider cost. Additionally, the Ortivus patient module does not offer replaceable batteries so functionality is severely limited if a reliable source of battery charging is not available, or if the transport time is excessively long. Additionally, the Ortivus device does not offer a display to allow visual monitoring of the waveforms or vital signs if the other module is out of range or obscured.
A patient parameter monitoring pod in embodiments of the teachings may include one or more of the following features: (a) portable housing containing a power supply, (b) a patient parameter module connectable to a patient via lead cables to collect patient data, the patient data including at least one vital sign, (c) a transceiver adapted to wirelessly transmit the patient data to a defibrillator, (d) a data port adapted to supply the patient data via a direct electrical connection to the defibrillator, and (e) a carrying handle extending from the housing proximate a patient lead cable port that permits connection of the lead cables to the pod, the carrying handle positioned to protect the patient lead cable port and the patient lead cables attached to the port from direct impact.
A patient parameter monitoring pod in embodiments of the teachings may include one or more of the following features: (a) a housing holding a power supply, (b) patient lead cables attachable between a patient and the housing to collect patient data, the patient data including at least one vital sign, (c) a carrying handle extending from the housing proximate the patient lead cable port, the carrying handle positioned to protect the patient lead cable port and the patient lead cables attached to the port from direct impact, (d) a communications module adapted to send the patient data to a defibrillator, (e) a lead cable comb separator, the separator holding the lead cables apart from each other, and (f) a carrying strap connected to one of the pod and the bag.
A patient parameter monitoring pod in embodiments of the teachings may include one or more of the following features: (a) a portable patient monitoring pod and a component storage bag, the pod having an outer housing, a patient parameter module, and a data port, the patient parameter module connectable to a patient via lead cables to collect patient data, the patient data including at least one vital sign, the data port being exposed on the housing and adapted to supply the patient data via a direct electrical connection to a defibrillator, the component storage bag having pockets for holding the pod and components of the pod, the storage bag having openings exposing the data port and permitting passage therethrough of the patient lead cables, (b) a carrying handle extending from the housing proximate a patient lead cable port that permits connection of the lead cables to the pod, the carrying handle positioned to protect the patient lead cable port and the patient lead cables attached to the port from direct impact, and (c) a lead cable comb separator, the separator holding the lead cables apart from each other.
The following discussion is presented to enable a person skilled in the art to make and use the present teachings. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the generic principles herein may be applied to other embodiments and applications without departing from the present teachings. Thus, the present teachings are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the present teachings. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the present teachings.
With reference to
Pod 12 connects to a patient via several leads in order to measure the patient's vital signs. Pod 12 communicates the patient's vital signs either wirelessly or via an electrical connection to defibrillator monitor 14. The patient data or vital signs collected may include 3, 4, and 5 lead ECG readings, 12 lead ECG readings, non-invasive blood pressure (NIBP), pulse oximeter data, capnography data, invasive blood pressure, body temperature, CO2 levels, and additional patient monitoring functions. Additionally, pod 12 may include a small display 82 (
With reference to
With reference to
With reference to
With reference to
Generally base 14 and a pod communicate wirelessly to assist in preventing the tangling of cables, which can occur between a patient and base 14, particularly when transporting patients. Tethered cable 46 provides a system for use when the wireless link between pod 12 and base 14 fails for whatever reason or when precise signal synchronization demands a wired connection. Tethered cable 46 also provides the added advantage in that the user cannot lose cable 46 because it is tethered to base 14. Wireless links can impose a delay in communication between a pod and base 14 longer than may be experienced with a cable. When communications between base 14 and a pod require a faster response time (such as application of synchronous cardioversion or pacing where information from a pod must be transmitted to base 14), the user is advised of the need to plug cable 46 into the pod. The user is provided a user interface message to inform them of the need to attach cable 46.
With reference again to
With reference to
With reference to
As stated before the pod is a detachable component of the defibrillator. It is generally stored within a receiving portion of the defibrillator but may be detached and carried to the emergency site, where it is used to monitor various medical parameters of the patient. The pod communicates information to the defibrillator either electrically or wirelessly. Typically, electrical communication is used when the pod is stored within the defibrillator and wireless communication is used when the pod is detached from the defibrillator. When communicating electrically, the defibrillator and pod are connected through electrical connections. In certain embodiments, the electrical connections comprise one or more leads connecting the defibrillator to the pod. In other embodiments, the electrical connections comprise direct electrical contact between the defibrillator and pod. For example, the pod may be stored within the defibrillator in such a way that each of their electrical components is in direct contact with each other. This direct electrical contact can be used for exchanging data or for recharging the pod battery.
When communicating wirelessly, the defibrillator and pod communicate via a wireless link. Typically, wireless communication is used when the pod is detached from the defibrillator. However, wireless communication can also be used when the pod is stored within the receiving portion.
The pod typically includes a display. The display can be used to display information that medical personnel may need while monitoring and/or delivering therapeutic functions to the patient at the emergency site. The display is primarily used for displaying patient information. For example, the display may be used to display current and historical patient data.
With reference to
With respect to
In many cases, it is desirable to protect the patient cables connecting the patient and the pod. The leads should remain connected to the patient at the emergency site and also while transporting the patient from the emergency site. Any accidental disconnection of the leads may cause a disruption in the monitoring and/or therapeutic processes.
With reference to
It is also desirable to ensure that the leads are connected to the patient and the pod in an organized manner. For example, anywhere between 1 to 12 or more leads may be connected to the patient and pod and it would be desirable to easily separate and/or untangle the leads. The present teachings also provides for a lead separator for organizing and separating the patient leads.
With reference to
It is often desirable to have a carrying bag 859 for easily transporting the pod to and from the emergency site. A pod-carrying bag 859 is also desirable for protecting the pod, its connectors, and other components from the outside environment. Thus, the present teachings also provides a carrying bag 859 for carrying the pod. Any suitable carrying bag may be used for carrying the pod.
With reference to
Component compartment 863 comprises an expandable portion 869 and a formed shell 871. Expandable portion 869 is connected to pod compartment 861 and comprises a plurality of accordion-like folds 873. The accordion-like folds 873 are hinged together at a common hinge 875. A formed shell 871 is connected to the expandable portion 869 at a point furthest from pod compartment 861. Formed shell 871 comprises a durable material and serves to protect the pod components.
With reference to
While an carrying bag has been described in
A typical pod carrying bag 859 will have means for carrying bag 859. For example, carrying bag 859 may be carried by use of a shoulder strap or by use of padded handgrips. In embodiments, a shoulder strap is used for carrying bag 859. A shoulder strap may also be attached directly to pod 879 itself, without the use of a carrying bag 859.
The shoulder straps may be attached to the carrying bag 859 in any suitable manner. For example, in some embodiments, as the embodiment shown in
In embodiments, as in the embodiment shown in
With the present teachings, it would also be desirable to provide a means for securing the pod to a patient gurney. It is desirable to secure the pod to a gurney for several reasons. For example, it is desirable to secure the pod to a gurney so that medical personnel have easy access to the module and corresponding equipment. In medical emergencies, time is of the essence and it is vitally important to have all necessary medical equipment and supplies, including the pod, readily on hand for use by paramedics, doctors and so on, while the patient is transported to and from an ambulance, emergency room, operating room or intensive care ward. Likewise, it is desirable to secure the pod to a gurney in order to prevent any movement of the pod relative to the patient, which may lead to disconnection of the leads connecting the pod to the patient.
As shown in
In some embodiments, the pod can be positioned alongside the patient on the gurney mattress. In other embodiments, the pod can be placed on the patient himself. For example,
When it is desired to position pod 905 on patient 907, two side flaps 909 are separated and folded downward over the body of patient 907 in a manner as displayed in
While it is perfectly suitable to place pod 905 on top of patient 907, it is often desirable (and sometimes necessary) to position pod 905 in proximity to patient 907 but not on top of or along with patient 907 on the gurney mattress, as mentioned above. For example, many ambulance gurneys are relatively compact so they may fit within an ambulance or transport helicopter and allow sufficient room for medical personnel to attend to patient 907 during transport. As a result, there is often not enough room for pod 905 to be placed on the gurney mattress.
In addition to mounting the pod onto the supporting surface 893 of the gurney as described above, the pod may also be positioned about one of the rails of the gurney. In certain embodiments, as in
In
In
In some embodiments, the holding tray is detachably secured to a gurney so a paramedic may attach tray 923 to a gurney when needed. In other embodiments, the tray is permanently secured to a gurney so no attachment/detachment of the tray is needed. Holding tray 923 can also include support straps for firmly gripping pod 925 and/or pod carrying bag within tray 923. Tray 923 may also be provided with one or more bumper pads around its edges to protect the patient and medical staff from injury if the tray is accidentally bumped into.
One skilled in the art will appreciate that the present teachings can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present teachings is limited only by the claims that follow.
Number | Date | Country | Kind |
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PCT/US2004/012421 | Apr 2004 | WO | international |
This application claims priority to International PCT Application No. PCT/US2004/012421 titled “Defibrillator/Monitor System Having a Pod with Leads Capable of Wirelessly Communicating” filed on Apr. 22, 2004, and to U.S. Provisional Application Ser. No. 60/530,151 titled “Defibrillator/Monitor System Having a Pod with Leads Capable of Wirelessly Communicating” filed on Dec. 17, 2003, which are both hereby incorporated by reference in their entirety. This disclosure is related to the following co-pending PCT applications entitled “AN EXTERNAL DEFIBRILLATOR WITH POWER AND BATTERY SHARING CAPABILITIES WITH A POD” PCT/US04/42376 filed Dec. 17, 2004, and “DEFIBRILLATOR/MONITOR SYSTEM HAVING A POD WITH LEADS CAPABLE OF WIRELESSLY COMMUNICATING” PCT/US/04/42377 filed Dec. 17, 2004, which are herein incorporated by reference in their entirety and not admitted as prior art with respect to the present disclosure by its mention in this section.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US2004/042792 | 12/17/2004 | WO | 00 | 3/5/2008 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2005/058413 | 6/30/2005 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3724455 | Unger | Apr 1973 | A |
3865101 | Saper et al. | Feb 1975 | A |
4096856 | Smith et al. | Jun 1978 | A |
5105821 | Reyes | Apr 1992 | A |
5311449 | Adams | May 1994 | A |
5470343 | Fincke et al. | Nov 1995 | A |
5593426 | Morgan et al. | Jan 1997 | A |
5685314 | Geheb et al. | Nov 1997 | A |
5724985 | Snell et al. | Mar 1998 | A |
6134468 | Morgan et al. | Oct 2000 | A |
6141584 | Rockwell et al. | Oct 2000 | A |
6183417 | Geheb et al. | Feb 2001 | B1 |
6223077 | Schweizer et al. | Apr 2001 | B1 |
6402691 | Peddicord et al. | Jun 2002 | B1 |
6441747 | Khair et al. | Aug 2002 | B1 |
6771172 | Robinson et al. | Aug 2004 | B1 |
6957102 | Silver et al. | Oct 2005 | B2 |
6978181 | Snell | Dec 2005 | B1 |
7570994 | Tamura et al. | Aug 2009 | B2 |
20020116028 | Greatbatch et al. | Aug 2002 | A1 |
20020116029 | Miller et al. | Aug 2002 | A1 |
20020116033 | Greatbatch et al. | Aug 2002 | A1 |
20020116034 | Miller et al. | Aug 2002 | A1 |
20020128689 | Connelly et al. | Sep 2002 | A1 |
20020128691 | Connelly | Sep 2002 | A1 |
20020133086 | Connelly et al. | Sep 2002 | A1 |
20020133199 | MacDonald et al. | Sep 2002 | A1 |
20020133200 | Weiner et al. | Sep 2002 | A1 |
20020133201 | Connelly et al. | Sep 2002 | A1 |
20020133202 | Connelly et al. | Sep 2002 | A1 |
20020133208 | Connelly | Sep 2002 | A1 |
20020133211 | Weiner et al. | Sep 2002 | A1 |
20020133216 | Connelly et al. | Sep 2002 | A1 |
20020138102 | Weiner et al. | Sep 2002 | A1 |
20020138107 | Weiner et al. | Sep 2002 | A1 |
20020138108 | Weiner et al. | Sep 2002 | A1 |
20020138110 | Connelly et al. | Sep 2002 | A1 |
20020138112 | Connelly et al. | Sep 2002 | A1 |
20020138113 | Connelly et al. | Sep 2002 | A1 |
20020138124 | Helfer et al. | Sep 2002 | A1 |
20020143258 | Weiner et al. | Oct 2002 | A1 |
20020147470 | Weiner et al. | Oct 2002 | A1 |
20020183796 | Connelly | Dec 2002 | A1 |
20020198569 | Foster et al. | Dec 2002 | A1 |
20030028219 | Powers et al. | Feb 2003 | A1 |
20030050538 | Naghavi et al. | Mar 2003 | A1 |
20030088275 | Palmer et al. | May 2003 | A1 |
20030212311 | Nova et al. | Nov 2003 | A1 |
20040049233 | Edwards | Mar 2004 | A1 |
20040162586 | Covey et al. | Aug 2004 | A1 |
20050124866 | Elaz et al. | Jun 2005 | A1 |
20060142808 | Pearce et al. | Jun 2006 | A1 |
20080077185 | Pearce et al. | Mar 2008 | A1 |
20080183229 | Neumiller et al. | Jul 2008 | A1 |
Number | Date | Country |
---|---|---|
1228782 | Aug 2002 | EP |
1250944 | Oct 2002 | EP |
0166182 | Sep 2001 | WO |
03009895 | Feb 2003 | WO |
Entry |
---|
Office Action for U.S. Appl. No. 10/583,209 dated Oct. 19, 2010, (9 pp). |
Response to Office Action for U.S. Appl. No. 10/583,209 dated Dec. 20, 2010 (8 pp). |
Office Action from U.S. Appl. No. 10/583,175, mailed Oct. 2, 2009, 14 pp. |
Response to Office Action mailed Oct. 2, 2009, from U.S. Appl. No. 10/583,175, filed Jan. 4, 2010, 14 pp. |
Restriction Requirement from U.S. Appl. No. 11/256,275, mailed Feb. 5, 2008, 7 pp. |
Response to Restriction Requirement mailed Feb. 5, 2008, from U.S. Appl. No. 11/256,275, filed May 14, 2008, 1 pg. |
Office Action from U.S. Appl. No. 11/256,275, mailed Jun. 9, 2008, 6 pp. |
Response to Office Action mailed Jun. 9, 2008, from U.S. Appl. No. 11/256,275, filed Oct. 8, 2008, 9 pp. |
Office Action from U.S. Appl. No. 11/256,275, mailed Jan. 6, 2009, 8 pp. |
Response to Office Action mailed Jan. 6, 2009, from U.S. Appl. No. 11/256,275, filed Apr. 3, 2009, 7 pp. |
Office Action from U.S. Appl. No. 11/256,275, mailed Jun. 9, 2009, 11 pp. |
Response to Office Action mailed Jun. 9, 2009, from U.S. Appl. No. 11/256,275, filed Sep. 9, 2009, 9 pp. |
International Search Report and Written Opinion from international application No. PCT/US2004/042376, mailed Mar. 24, 2005, 7 pp. |
International Preliminary Report on Patentability from international application No. PCT/US2004/042376, issued Jun. 20, 2006, 6 pp. |
International Search Report and Written Opinion from international application No. PCT/US2004/012421, mailed Sep. 13, 2004, 7 pp. |
International Preliminary Report on Patentability from international application No. PCT/US2004/012421, issued Oct. 28, 2005, 6 pp. |
Non Final Office Action for corresponding U.S. Appl. No. 11/256,275, dated Feb. 3, 2010, (14 pgs.). |
Response to Non Final Office Action for corresponding U.S. Appl. No. 11/256,275 dated Apr. 20, 2010 (pgs.). |
Office Action from U.S. Appl. No. 11/256,275 dated Feb. 3, 2011 (10 pp). |
Office Action from U.S. Appl. No. 10/583,209, mailed Mar. 16, 2010, 10 pp. |
Response to Office Action dated Mar. 16, 2010, from U.S. Appl. No. 10/583,209, filed Jun. 16, 2010, 17 pp. |
Office Action from U.S. Appl. No. 10/583,175, dated Apr. 29, 2010, 25 pp. |
Response to Office Action dated Apr. 29, 2010, from U.S. Appl. No. 10/583,175, filed Jul. 29, 2010, 13 pp. |
Number | Date | Country | |
---|---|---|---|
20080221397 A1 | Sep 2008 | US |
Number | Date | Country | |
---|---|---|---|
60530151 | Dec 2003 | US |