Source: https://patents.google.com/patent/US10016217B2/en
Timestamp: 2019-01-17 14:16:21
Document Index: 780034026

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 2003240970', 'Application No. 2005800003261', 'Application No. 200780000590', 'Application No. 05', 'Application No. 09150973', 'Application No. 08158699', 'Application No. 17198059', 'Application No. 2004', 'Application No. 2004', 'Application No. 037563']

US10016217B2 - Apparatus and methods to install, support and/or monitor performance of intraosseous devices - Google Patents
US10016217B2
US10016217B2 US15262030 US201615262030A US10016217B2 US 10016217 B2 US10016217 B2 US 10016217B2 US 15262030 US15262030 US 15262030 US 201615262030 A US201615262030 A US 201615262030A US 10016217 B2 US10016217 B2 US 10016217B2
US15262030
US20160374722A1 (en )
Apparatus and methods may be provided to monitor performance of an intraosseous device, including a system comprising an intraosseous device, a sensor contained within a tip of the intraosseous device, a monitor configured to record a signal from the sensor, and an electrical conductor coupled to the sensor and configured to transmit the signal from the sensor to the monitor. The tip of the intraosseous device may be configured to penetrate bone and bone marrow such that the tip is disposed in the bone marrow. In certain embodiments, the tip may also include a side port for delivering fluids into the bone marrow.
This application is a continuation application of U.S. patent application Ser. No. 12/947,312, filed Nov. 16, 2010, which is a divisional application of U.S. patent application Ser. No. 11/461,885, filed Aug. 2, 2006, which is a continuation-in-part application of U.S. patent application Ser. No. 10/449,503, filed May 30, 2003, now U.S. Pat. No. 7,670,328, which claims the benefit of U.S. Provisional Patent Application No. 60/384,756, filed May 31, 2002. The contents of these applications are incorporated herein in their entirety by reference.
Another aspect of the present disclosure may include a system for monitoring performance of an intraosseous device, comprising an intraosseous device, a sensor, a monitor configured to record a signal from the sensor, and an electrical conductor coupled to the sensor and configured to transmit the signal from the sensor to the monitor. The intraosseous device may include a tip configured to penetrate bone and bone marrow such that the tip is disposed in the bone marrow, an end opposite from the tip configured to be disposed outside of the bone marrow, and a longitudinal bore extending from the tip to the end opposite from the tip. The sensor may be disposed in the tip of the intraosseous device. The sensor may be a pressure transducer configured to measure pressure.
The term “driver” may be used in this application to include any type of powered driver or manual driver satisfactory for inserting an intraosseous (IO) device such as a penetrator assembly or an IO needle into selected portions of a patient's vascular system.
Various techniques may be satisfactorily used to releasably engage or attach an IO device and/or penetrator assembly with manual drivers and powered drivers. For some applications a powered driver or a manual driver may be directly coupled with an IO device. For other applications various types of connectors may be used to couple a manual driver or a powered driver with an IO device. A wide variety of connectors and associated connector receptacles, fittings and/or other types of connections with various dimensions and configurations may be satisfactorily used to releasably engage an IO device with a powered driver or a manual driver.
Handle 206 may include a battery (not expressly shown) or other power source. Handle 206 may also include trigger assembly 208 for use in activating powered driver 200. Examples of powered drivers are shown in pending patent application Ser. No. 10/449,503 filed May 30, 2003 entitled “Apparatus and Method to Provide Emergency Access To Bone Marrow,” now U.S. Pat. No. 7,670,328; Ser. No. 10/449,476 filed May 30, 2003 entitled “Apparatus and Method to Access Bone Marrow,” now U.S. Pat. No. 7,699,850; and Ser. No. 11/042,912 filed Jan. 25, 2005 entitled “Manual Intraosseous Device,” now U.S. Pat. No. 8,641,715.
One example of an intraosseous device inserted into bone and associated bone marrow along with a supporting structure and attachment mechanism incorporating teachings of the present disclosure is shown in FIG. 5. For this example, the intraosseous device may be generally described as intraosseous (IO) needle 160 having a hollow, longitudinal bore extending therethrough (not expressly shown). First end or tip 161 of IO needle 160 may be designed to drill or cut through bone 152 and penetrate associated bone marrow 154. Tip 161 may be open to allow communication of fluids with bone marrow 154. Also, one or more side ports 163 may be formed in IO needle 160 to allow communication of fluids therethrough.
Supporting structure 180 may include relatively short, hollow cylinder 184 with a pair of flaps, tabs or wings 186 extending therefrom. Holes 181 and 182 may be formed in respective tabs 186. Tabs 186 may be formed from relatively flexible material which will conform with adjacent portions of a patient's skin, soft tissue and bone Hollow cylinder 184 may be formed from material with sufficient strength to prevent undesired movement of IO device 160. Interior dimensions of hollow cylinder 184 may correspond generally with exterior dimensions of IO needle 160 to provide a relatively snug fit therebetween.
FIG. 9A shows IO device 160 seated in bone 152 and associated bone marrow 154. Strap 170 may be placed around bone 152 and attached to supporting structure 180 as previously described. Sensor 178 may be attached to strap 170 for use in measuring various parameters associated with providing fluids and/or medications through IO device 160 to bone marrow 154. Such parameters may include, but are not limited to, pressure and/or changes in the size of a patient's limb, temperature and/or pulse rate. For example, sensor 178 may be a strain gauge operable to measure and detect increased stress placed on strap 170 by swelling, expansion or change size of a patient's limb. For some applications sensor 178 may be coupled with monitor and/or general purpose computer 190 via signal wire 196. When monitor 190 detects a preset value for one or more of these parameters, an alarm may be sounded. Monitor 190 may also include one or more programs operable to stop infusion of fluids and/or medication through IO device 160 in the event one or more parameters exceeds a preset limit.
As stated in U.S. Provisional Patent Application No. 60/384,756, in certain embodiments, a tip of a needle may contain a pressure transducer (e.g., the tip 161 of the IO device 160 a may contain the pressure transducer 192). The electrical wire from the transducer may exit the needle separate from a Luer lock port. The connector may be a standard Luer lock or any other conventional connector to allow monitoring of pressure directly from the fluid. Either of these models may be attached to a monitor or a computer to alert medical personnel of impending problems. Software may also be used as a servomechanism to automatically control pressure or other parameters. The probe may detect pressure, chemicals, temperature, oxygen stats, carbon dioxide levels, or lactic acid. The connector may be mechanical or electrical.
nutrition, electrolyte correction);
Drug overdose victims, often comatose, generally require immediate IV access to give antidotes and life saving medications such as Narcan. These patients usually have difficult venous access due to long term abuse of their veins IO access may give these patients an alternate route for delivery of medications and fluids while improving the safety of the healthcare workers.
Trauma victims and attempted suicide patients, often in shock due to blood loss, may also require swift replacement of fluids to save vital organs. Because of the shock condition (decreased blood pressure), veins collapse and are often impossible to find IO access may save precious minutes for paramedics and trauma surgeons responsible for their care.
1. A system for monitoring performance of an intraosseous device, comprising:
a tip configured to penetrate bone and bone marrow such that the tip is disposed in the bone marrow;
an end opposite from the tip configured to be disposed outside of the bone marrow; and
a longitudinal bore extending from the tip to the end opposite from the tip;
a sensor contained within the tip;
a monitor configured to record a signal from the sensor; and
an electrical conductor coupled to the sensor and configured to transmit the signal from the sensor to the monitor, the electrical conductor extending through the longitudinal bore of the intraosseous device.
2. The system of claim 1, wherein the sensor comprises a pressure transducer configured to measure pressure.
3. The system of claim 2, wherein the monitor is configured to detect when the pressure exceeds a preset value,
wherein monitor is further configured to sound an alert when the monitor detects that the pressure exceeds a preset value.
4. The system of claim 1, wherein the sensor is configured to measure a plurality of parameters, the plurality of parameters comprising two or more of pressure, temperature, oxygen levels, carbon dioxide levels, and lactic acid concentrations.
5. The system of claim 4, wherein the monitor is configured to detect when one or more parameters of the plurality of parameters fall outside of a desirable range.
6. The system of claim 1, wherein the intraosseous device comprises a side port proximate to the tip, the side port configured to deliver a fluid into the bone marrow.
7. The system of claim 6, further comprising a connector receptacle disposed proximate to the end opposite from the tip of the intraosseous device.
8. The system of claim 7, wherein the connector receptacle comprises a Luer lock connection, the Luer lock connector configured to attach to a source of the fluid.
9. The system of claim 7, wherein the connector receptacle has an outer diameter that is greater than an outer diameter of the intraosseous device.
10. The system of claim 1, further comprising a supporting structure configured to prevent movement of the intraosseous device, the supporting structure comprising:
a body defining a longitudinal bore configured to receive the intraosseous device, the longitudinal bore having inner dimensions that correspond to exterior dimensions of the intraosseous device; and
at least one tab extending from the body.
11. The system of claim 10, further comprising an attachment mechanism,
wherein the attachment mechanism is configured to engage the supporting structure,
wherein the attachment mechanism is configured to secure the supporting structure to a limb of a patient when the attachment mechanism is engaged with the support structure.
12. The system of claim 11, wherein the at least one tab comprises a structure that is configured to engage with a corresponding structure formed on the attachment mechanism.
13. The system of claim 11, wherein the attachment mechanism is sized to engage with a surface of the limb of the patient.
14. The system of claim 1, wherein the tip comprises a tapered surface.
15. The system of claim 1, wherein the intraosseous device comprises a tapered surface extending from the tip towards the end opposite from the tip, the tapered surface configured to form a fluid seal with the bone penetrated by the intraosseous device.
16. A system for monitoring performance of an intraosseous device, comprising:
an end opposite from the tip configured to be disposed outside of the bone marrow;
a longitudinal bore extending from the tip to the end opposite from the tip; and
a side port proximate to the tip and in fluid communication with the longitudinal bore;
a pressure transducer contained within the tip, the pressure transducer configured to measure pressure;
a monitor configured to record the pressure measured by the pressure transducer; and
an electrical conductor coupled to the pressure transducer and configured to transmit the pressure measured by the pressure transducer from the pressure transducer to the monitor, the electrical conductor extending through the longitudinal bore of the intraosseous device.
17. The system of claim 16, wherein the intraosseous device is configured to deliver a fluid into the bone marrow.
18. The system of claim 17, wherein the pressure transducer is configured to measure the pressure in an area of the bone marrow when the intraosseous device is delivering the fluid into the bone marrow.
19. The system of claim 17, wherein the intraosseous device comprises a tapered surface extending from the tip towards the end opposite from the tip, the tapered surface configured to form a fluid seal with the bone penetrated by the intraosseous device.
20. The system of claim 17, further comprising a seal assembly configured to isolate the electrical conductor from the fluid when the intraosseous device is delivering the fluid into the bone marrow.
US15262030 2002-05-31 2016-09-12 Apparatus and methods to install, support and/or monitor performance of intraosseous devices Active US10016217B2 (en)
US15262030 US10016217B2 (en) 2002-05-31 2016-09-12 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
US16030333 US20180317963A1 (en) 2002-05-31 2018-07-09 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
US12947312 Continuation US9439667B2 (en) 2002-05-31 2010-11-16 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
US16030333 Division US20180317963A1 (en) 2002-05-31 2018-07-09 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
US20160374722A1 true US20160374722A1 (en) 2016-12-29
US10016217B2 true US10016217B2 (en) 2018-07-10
US15262030 Active US10016217B2 (en) 2002-05-31 2016-09-12 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
US16030333 Pending US20180317963A1 (en) 2002-05-31 2018-07-09 Apparatus and methods to install, support and/or monitor performance of intraosseous devices
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