APPARATUS AND METHODS TO INSTALL, SUPPORT AND/OR MONITOR PERFORMANCE OF INTRAOSSEOUS DEVICES

• US 20110098604A1
• Filed: 11/16/2010
• Published: 04/28/2011
• Est. Priority Date: 05/31/2002
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences II LLC
• Original Assignee: Teleflex Medical Devices, Sarl (Teleflex Incorporated)
• Inventors: Miller, Larry J.
• Granted Patent: US 9,439,667 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/08 Limbs
• CPC Class Codes: A61M 2210/086 Legs
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16836 : by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

Various types of supporting structures, supporting devices, attachment mechanisms and attachment techniques may be provided to support and/or stabilize an intraosseous device installed at a target site in a patient. Various methods and procedures may also be provided to releasably engage a supporting structure or supporting device proximate a target site. Apparatus and methods may be provided to monitor performance of an intraosseous device during communication of drugs, medications and/or fluids with an intraosseous space.

Claims

1-13. -13. (canceled)

14. A system operable to monitor the performance of an intraosseous device disposed in bone marrow comprising:

the intraosseous device having the first end operable to be inserted into the bone marrow;

the intraosseous device having a second end extending from the bone marrow;

the intraosseous device a wire extending through the longitudinal bore of the intraosseous device and engaged with the pressure sensor; and

the wire coupled with a pressure monitor to record intraosseous pressure of the bone marrow.

15. The system of claim 14 further comprising:

a supporting structure having an opening formed therein;

the opening having a configuration and interior dimensions compatible with exterior dimensions of the intraosseous device; and

an attachment mechanism operable to releasably engage these supporting structure to the patient.

16. A system for monitoring performance of an intraosseous device disposed in bone marrow in a patient'"'"'s limb comprising:

the intraosseous device having a first end operable to the be disposed within the bone marrow and a second end operable to be connected with tubing;

the tubing operable to communicate fluid between a fluid source and the bone marrow;

a pressure sensor operable to monitor pressure in a compartment of the patient'"'"'s limb adjacent to the bone marrow; and

the pressure sensor operable to detect any increase in pressure within the compartment of the patient'"'"'s limb.

17. The system of claim 16 further comprising:

the fluid source having a control valve; and

the pressure sensor operable to close the control valve when pressure in the compartment sees a preset level.

18. The system of claim 16 wherein the pressure sensor further comprises:

a hollow needle insert into the compartment;

a hollow tube connecting the hollow needle with a pressure gauge; and

the pressure gauge connected to a pressure monitor.

19. A method of providing vascular access in a patient'"'"'s limb comprising:

inserting an intraosseous device into bone marrow at a target site in patient'"'"'s limb;

releasably attaching a supporting structure with the intraosseous device; and

releasably attaching the supporting structure with the patient proximate the injection site.

20. The method of claim 19 further comprising monitoring intraosseous pressure within the bone marrow.

21. The method of claim 19 further comprising:

monitoring tissue pressure in a compartment of the patient'"'"'s limb approximate the bone marrow; and

alerting medical personnel if the tissue pressure exceeds a preset limit.

22. The method of claim 19 further comprising:

monitoring intraosseous pressure within the bone marrow;

alerting medical personnel when the intraosseous pressure exceeds a preset limit.

23. The method of claim 19 further comprising:

attaching the support structure to the patient with a strap having a strain gage operable to detect increases in the size of the patient'"'"'s limb; and

alerting medical personnel if the increase in the size of the patient'"'"'s leg exceeds a preset limit.

24. An apparatus for penetrating a bone and associated bone marrow comprising:

a penetrator assembly operable to penetrate the bone and associated bone marrow;

the penetrator assembly including an outer penetrator having a first end and a second end;

the first end of the outer penetrator operable to be inserted in the bone and associated bone marrow;

the outer penetrator having a generally tapered exterior configuration extending between the first end to the second end; and

the exterior configuration of the outer penetrator selected to provide an optimum seal with adjacent portions of the bone.

25. The apparatus of claim 24 wherein the penetrator assembly further comprises:

an inner penetrator slidably disposed within the outer penetrator; and

the inner penetrator releasably engaged with the outer penetrator.

26. The apparatus of claim 24 further comprising:

a connector receptacle disposed proximate the second end of the outer penetrator; and

the connector receptacle operable to releasably engage the apparatus with a driver.

27. The apparatus of claim 24 further comprising the penetrator assembly operable to be releasably engaged with a powered driver.

28. The apparatus of claim 24 further comprising the penetrator assembly operable to be releasably engaged with a manual driver.

29. An intraosseous device operable to harvest bone marrow comprising:

a first end and a second end;

the first end of the intraosseous device operable to penetrate bone and bone marrow;

a longitudinal bore extending between the first end and the second end;

exterior portions of the intraosseous device having a tapered configuration extending from the first end towards the second end;

a layer of sealant disposed on exterior portions of the intraosseous device extending from the first end towards the second end; and

the tapered configuration and the layer of sealant cooperating with each other to substantially reduce or eliminate leakage of any fluid between the exterior of the intraosseous device and adjacent portions of the bone.

30. The intraosseous device of claim 29 further comprising the layer of sealant selected from the group consisting of silicone and methyl methacrylate.

31. An intraosseous device operable to harvest bone marrow comprising:

an outer penetrator having a first end and a second end;

the first end of the outer penetrator operable to penetrate bone and bone marrow;

a longitudinal bore extending between the first end and the second end;

exterior portions of the outer penetrator having a generally tapered configuration extending from the first end towards the second end; and

the generally tapered configuration of exterior portions of the outer penetrator operable to form a fluid barrier with adjacent portions of the bone and to substantially reduce or eliminate leakage of fluid between the exterior of the outer penetrator and the adjacent portions of the bone.

32. An intraosseous device operable to harvest bone marrow comprising:

a first end and a second end;

the first end of the intraosseous device operable to penetrate bone and bone marrow;

a longitudinal bore extending between the first end and the second end; and

exterior portions of the outer penetrator having a layer of sealant disposed thereon to substantially reduce or eliminate leakage of any fluid between the exterior portions of the outer penetrator and adjacent portions of the bone.

33. The intraosseous device of claim 32 further comprising the sealant selected from the group consisting of silicone and methyl methacrylate.