US20080045965A1 — Apparatus and Methods for Biopsy and Aspiration o…

Claim 1

Independent Claim 91 words

1 . Apparatus operable to insert an intraosseous device into a bone and associated bone marrow comprising: a powered driver having a housing with one end of a drive shaft extending therefrom; the intraosseous device having a first end operable to be inserted into the bone and associated bone marrow; a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device; and the coupler assembly having a second end operable to be releasably engaged with the one end of the drive shaft.

Claim 2

Dependent Claim 91 words

1 . Apparatus operable to insert an intraosseous device into a bone and associated bone marrow comprising: a powered driver having a housing with one end of a drive shaft extending therefrom; the intraosseous device having a first end operable to be inserted into the bone and associated bone marrow; a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device; and the coupler assembly having a second end operable to be releasably engaged with the one end of the drive shaft.

Claim 3

Dependent Claim 57 words

2 . The apparatus of claim 1 wherein the powered driver further comprises: a motor disposed within the housing and rotatably engaged with the drive shaft; a powered supply and electrical circuits operable to powered the motor; a switch connected to the electrical circuits; and the switch operable to activate the motor to rotate the drive shaft.

Claim 4

Dependent Claim 57 words

3 . The apparatus of claim 2 wherein the powered driver further comprises: a gear assembly disposed between the motor and the drive shaft; and the gear assembly operable to rotate the drive shaft at optimum revolutions per minute (RPM) for insertion of the first end of the intraosseous device into the bone and associated bone marrow.

Claim 5

Dependent Claim 56 words

4 . The apparatus of claim 2 wherein the powered driver further comprises: a gear assembly rotatably attached to the motor; a drive shaft extending from the gear assembly opposite from the motor; and the gear assembly operable to reduce rotation of the motor by a ratio between approximately sixty to one and eighty to one.

Claim 6

Dependent Claim 54 words

5 . The apparatus of claim 1 further comprising: the one end of the drive shaft extending from the housing having a generally hexagonal cross section; and the second end of the coupler assembly having a receptacle with a generally hexagonal cross section sized to receive the one end of the drive shaft therein.

Claim 7

Dependent Claim 155 words

6 . The apparatus of claim 1 further comprising: the first end of the coupler assembly including a first latch mechanism with at least one detent operable to releasably extend into and retract from an associated opening proximate the one end of the coupler assembly; the second end of the coupler assembly including a second latch mechanism with at least one detent operable to releasably extend into and retract from an associated opening proximate the second end of the coupler assembly; the second end of the intraosseous device having an annular groove sized to be releasably engaged with the at least one detent of the first latch mechanism disposed in the first end of the coupler assembly; and the one end of the drive shaft extending from the housing having an annular groove operable to be releasably engaged with the detent of the second latch mechanism disposed in the second end of the coupler assembly.

Claim 8

Dependent Claim 113 words

7 . The apparatus of claim 1 further comprising: a plurality of tapered surfaces disposed on exterior portions of the second end of the intraosseous device; the tapered surfaces having optimum dimensions and configurations for use in moving the detent mechanism from its first extended position to its second retracted position; and the one end of the drive shaft extending from the housing having a plurality of exterior tapered surfaces operable to move the detent mechanism in the second end of the coupler assembly from its first extended position to its second retracted position whereby the annular groove in the one end of the drive shaft may be aligned with the detent mechanism.

Claim 9

Dependent Claim 123 words

8 . The apparatus of claim 1 further comprising: a containment bag having a first opening and a second opening; the second end of the coupler assembly securely engaged with the first opening of the containment bag; a fluid barrier disposed between the first opening of the containment bag and adjacent portions of the coupler assembly; the second opening of the containment bag sized to allow inserting the powered driver therethrough to engage the one end of the drive shaft with the second end of the coupler assembly; and a closure mechanism operable to releasably close the second opening of the containment bag after the one end of the powered driver has been releasably engaged with the second end of the coupler assembly.

Claim 10

Dependent Claim 60 words

9 . The apparatus of claim 1 further comprising: the one end of the drive shaft extending from the housing having an annular recess disposed therein; and the second opening of the coupler assembly having a flexible detent disposed therein whereby the flexible detent may be releasably engaged with the annular recess of the one end of the drive shaft.

Claim 11

Dependent Claim 107 words

10 . The apparatus of claim 1 wherein the coupler assembly further comprises: an elongated core having a housing disposed on exterior portions of the elongated core; the housing including a first housing segment and a second housing segment operable to rotate independent of each other and relative to the elongated core; portions of the first housing segment slidably disposed within adjacent portions of the second housing segment; and a biasing mechanism disposed between adjacent portions of the first housing segment and the second housing segment to bias the first housing segment and second housing segment to move to a first, extended position relative to each other.

Claim 12

Dependent Claim 255 words

11 . A coupler assembly operable to releasably engage one end of a drive shaft extending from a powered driver with an intraosseous (IO) device having a first end operable to penetrate a bone and associated bone marrow, the coupler assembly comprising: an elongate core having a first end operable to be releasably engaged with a second end of the IO device; the elongate core having a second end operable to be releasably engaged with the one end of the drive shaft extending from the powered driver; a housing assembly having a first end and a second end with respective openings formed in the first end and the second end of the housing assembly; the dimensions and configurations of the first end and the second end of the housing assembly selected to be compatible with slidably disposing exterior portions of the elongated core therein; a biasing mechanism disposed between an interior shoulder of the housing assembly and an exterior shoulder of the elongated core to bias the housing assembly to a first position defined in part by the first end and the second end of the elongated core generally aligned with and disposed proximate to the first end and the second end of the housing assembly; a first receptacle disposed in the first end of the elongated core at a location corresponding with the first end of the coupler assembly; and a second receptacle disposed in the second end of the elongated core at a location corresponding with the second end of the coupler assembly.

Claim 13

Dependent Claim 255 words

11 . A coupler assembly operable to releasably engage one end of a drive shaft extending from a powered driver with an intraosseous (IO) device having a first end operable to penetrate a bone and associated bone marrow, the coupler assembly comprising: an elongate core having a first end operable to be releasably engaged with a second end of the IO device; the elongate core having a second end operable to be releasably engaged with the one end of the drive shaft extending from the powered driver; a housing assembly having a first end and a second end with respective openings formed in the first end and the second end of the housing assembly; the dimensions and configurations of the first end and the second end of the housing assembly selected to be compatible with slidably disposing exterior portions of the elongated core therein; a biasing mechanism disposed between an interior shoulder of the housing assembly and an exterior shoulder of the elongated core to bias the housing assembly to a first position defined in part by the first end and the second end of the elongated core generally aligned with and disposed proximate to the first end and the second end of the housing assembly; a first receptacle disposed in the first end of the elongated core at a location corresponding with the first end of the coupler assembly; and a second receptacle disposed in the second end of the elongated core at a location corresponding with the second end of the coupler assembly.

Claim 14

Dependent Claim 89 words

12 . The coupler assembly of claim 11 wherein the housing assembly further comprises: a first housing segment and a second housing segment; a latch mechanism operable to hold the first housing segment in an extended position relative to the second housing segment; and the latch mechanism operable to allow the first housing segment and the second housing segment to slide longitudinally relative to the elongated core in response to inserting the one end of the drive shaft extending from the powered driver into engagement with the first receptacle.

Claim 15

Dependent Claim 68 words

13 . The coupler assembly of claim 11 further comprising: the elongated core operable to rotate in response to rotation of the one end of the drive shaft by the powered driver; and exterior portions of the elongated core and interior portions of the housing assembly operable to allow the housing assembly to rotate with the elongated core or to not rotate with the elongated core as appropriate.

Claim 16

Dependent Claim 83 words

14 . The coupler assembly of claim 11 further comprising: a first latch mechanism disposed proximate the first end of the housing and a second latch mechanism disposed proximate the second end of the housing; the first latch mechanism operable to be releasably engaged with the second end of the intraosseous device disposed in the first receptacle; and the second latch mechanism operable to be releasably engaged with one end of a drive shaft disposed in the second receptacle of the elongated core.

Claim 17

Dependent Claim 46 words

15 . The coupler assembly of claim 14 further comprising: first latch mechanism having a generally omega shape with a portion of the elongated core extending therethrough; and the second latch mechanism having a generally omega shape with another portion of the elongated core extending therethrough.

Claim 18

Dependent Claim 40 words

16 . The coupler assembly of claim 11 further comprising an arrow disposed on exterior portions of the housing assembly with the arrow pointing from the second end of the coupler assembly towards the first end of the coupler assembly.

Claim 19

Dependent Claim 119 words

17 . Apparatus operable to insert an intraosseous device into a bone and associated bone marrow comprising: a powered driver having a housing with one end of a drive shaft extending therefrom; the intraosseous device having a first end operable to be inserted into the bone and associated bone marrow; a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device; the coupler assembly having a second end operable to be releasably engaged with the one end of the drive shaft; a containment bag having a first opening and a second opening; and the second end of the coupler assembly securely engaged with the first opening in the containment bag.

Claim 20

Dependent Claim 119 words

17 . Apparatus operable to insert an intraosseous device into a bone and associated bone marrow comprising: a powered driver having a housing with one end of a drive shaft extending therefrom; the intraosseous device having a first end operable to be inserted into the bone and associated bone marrow; a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device; the coupler assembly having a second end operable to be releasably engaged with the one end of the drive shaft; a containment bag having a first opening and a second opening; and the second end of the coupler assembly securely engaged with the first opening in the containment bag.

Claim 21

Dependent Claim 32 words

18 . The apparatus of claim 17 further comprising the second opening of the containment bag having a configuration and dimensions sized to allow placing the powered driver within the containment bag.

Claim 22

Dependent Claim 58 words

19 . The apparatus of claim 17 wherein the containment bag further comprises: a closure mechanism operable to seal the second opening of the containment bag after the powered driver has been releasably engaged with the second end of the coupler assembly; and the closure mechanism operable to prevent the non-sterile powered driver from contaminating the intraosseous device.

Claim 23

Dependent Claim 42 words

20 . The apparatus of claim 17 further comprising the containment bag formed from a flexible, clear polymeric material operable to be sterilized and operable to allow use of the powered driver to insert the intraosseous device into a selected target area.

Claim 24

Dependent Claim 44 words

21 . The apparatus of claim 17 wherein the containment bag further comprises: a flexible stay attached to portions of the second opening; and the flexible stay operable to hold the second opening in an open position to accommodate placing a powered driver therein.

Claim 25

Dependent Claim 232 words

22 . A hub assembly operable to releasably engage a first intraosseous device with a second intraosseous device comprising: each intraosseous device having a respective first end operable to penetrate a bone and associated bone marrow; a first hub having a first end and a second end with a longitudinal bore extending between the first end and the second end of the first hub; a second end of the first intraosseous device disposed within the first end of the first hub and the first intraosseous device extending from the first end of the first hub; the longitudinal bore of the first hub communicating with a lumen in the first intraosseous device; the second end of the first hub having a respective threaded connection to dispose thereon; a second hub having a first end and a second end with a second end of the second intraosseous device disposed within the first end of the second hub and the second intraosseous device extending from the first end of the second hub; the first end of the second hub having a respective threaded connection operable to be releasably engaged with the threaded connection disposed on the second end of the first hub; and an annular recess formed in exterior portions of the hub assembly whereby a detent mechanism may be inserted into the annular recess to releasably engaging the hub assembly with the detent mechanism.

Claim 26

Dependent Claim 232 words

22 . A hub assembly operable to releasably engage a first intraosseous device with a second intraosseous device comprising: each intraosseous device having a respective first end operable to penetrate a bone and associated bone marrow; a first hub having a first end and a second end with a longitudinal bore extending between the first end and the second end of the first hub; a second end of the first intraosseous device disposed within the first end of the first hub and the first intraosseous device extending from the first end of the first hub; the longitudinal bore of the first hub communicating with a lumen in the first intraosseous device; the second end of the first hub having a respective threaded connection to dispose thereon; a second hub having a first end and a second end with a second end of the second intraosseous device disposed within the first end of the second hub and the second intraosseous device extending from the first end of the second hub; the first end of the second hub having a respective threaded connection operable to be releasably engaged with the threaded connection disposed on the second end of the first hub; and an annular recess formed in exterior portions of the hub assembly whereby a detent mechanism may be inserted into the annular recess to releasably engaging the hub assembly with the detent mechanism.

Claim 27

Dependent Claim 178 words

23 . A sterile sleeve operable to releasably engage a non-sterile powered driver with a sterile intraosseous device having a first end operable to penetrate a bone and associated bone marrow, the sterile sleeve comprising: a first opening and a second opening; the first opening of the sterile sleeve operable to form a fluid barrier with adjacent portions of a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device and a second end of the coupler assembly operable to be releasably engaged with one end of a drive shaft extending from the powered driver; the second opening of the sterile sleeve sized to allow inserting a powered driver therethrough to engage the one end of the drive shaft extending from the powered driver with the second end of the coupler assembly; and a closure mechanism operable to close the second opening of the sterile sleeve after the one end of the drive shaft of the powered driver has been engaged with the second end of the coupler assembly.

Claim 28

Dependent Claim 178 words

23 . A sterile sleeve operable to releasably engage a non-sterile powered driver with a sterile intraosseous device having a first end operable to penetrate a bone and associated bone marrow, the sterile sleeve comprising: a first opening and a second opening; the first opening of the sterile sleeve operable to form a fluid barrier with adjacent portions of a coupler assembly having a first end operable to be releasably engaged with a second end of the intraosseous device and a second end of the coupler assembly operable to be releasably engaged with one end of a drive shaft extending from the powered driver; the second opening of the sterile sleeve sized to allow inserting a powered driver therethrough to engage the one end of the drive shaft extending from the powered driver with the second end of the coupler assembly; and a closure mechanism operable to close the second opening of the sterile sleeve after the one end of the drive shaft of the powered driver has been engaged with the second end of the coupler assembly.

Claim 29

Dependent Claim 52 words

24 . The sterile sleeve of claim 23 further comprising: a flexible strip of material attached to portions of the second opening; and the flexible strip operable to hold the second opening in a first, open position prior to placing the powered driver through the second opening and into the sterile sleeve.

Claim 30

Dependent Claim 86 words

25 . The sterile sleeve of claim 23 wherein the closure mechanism further comprises: a flap having a first position extending from the second opening to allow access to interior portions of the containment bag; the flap operable to be folded over the second opening to a second position blocking access to interior portions of the containment bag; and one edge of the flap operable to form a seal with adjacent portions of the containment bag after the flap has been moved to the second position.

Apparatus and Methods for Biopsy and Aspiration of Bone Marrow

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