U.S. patent application number 14/281168 was filed with the patent office on 2014-09-11 for bone marrow aspiration needle.
This patent application is currently assigned to Biomet Biologics, LLC. The applicant listed for this patent is Biomet Biologics, LLC. Invention is credited to Matthew D. Landrigan, James M. McKale.
Application Number | 20140257133 14/281168 |
Document ID | / |
Family ID | 45556643 |
Filed Date | 2014-09-11 |
United States Patent
Application |
20140257133 |
Kind Code |
A1 |
Landrigan; Matthew D. ; et
al. |
September 11, 2014 |
Bone Marrow Aspiration Needle
Abstract
A bone marrow aspiration assembly including a cannulated
introducer needle and an aspiration needle. The cannulated
introducer needle is curved to approximate a natural curvature of
an iliac crest. The aspiration needle includes apertures for
aspirating bone marrow. The aspiration needle is configured to be
received in, and extend from, the cannulated introducer needle to
reach a bone marrow aspiration site in the iliac crest.
Inventors: |
Landrigan; Matthew D.; (Fort
Wayne, IN) ; McKale; James M.; (Leesburg,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biomet Biologics, LLC |
Warsaw |
IN |
US |
|
|
Assignee: |
Biomet Biologics, LLC
Warsaw
IN
|
Family ID: |
45556643 |
Appl. No.: |
14/281168 |
Filed: |
May 19, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12849412 |
Aug 3, 2010 |
8728008 |
|
|
14281168 |
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Current U.S.
Class: |
600/566 |
Current CPC
Class: |
A61B 10/025 20130101;
A61B 2010/0258 20130101 |
Class at
Publication: |
600/566 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A bone marrow aspiration assembly comprising: a cannulated
introducer needle curved to approximate a natural curvature of an
iliac crest; and an aspiration needle including apertures for
aspirating bone marrow, the aspiration needle is configured to be
received in, and extend from, the cannulated introducer needle to
reach a bone marrow aspiration site in the iliac crest.
2. The bone marrow aspiration assembly of claim 1, wherein the
cannulated introducer needle includes an open tip and is without
aspiration openings about a radius thereof.
3. The bone marrow aspiration assembly of claim 1, wherein the
cannulated introducer needle includes a connector configured to
mate with an aspiration syringe for aspirating bone marrow directly
through the cannulated introducer needle.
4. The bone marrow aspiration assembly of claim 1, wherein the
aspiration needle includes a single group of apertures.
5. The bone marrow aspiration assembly of claim 1, wherein the
aspiration needle includes a distal group, an intermediate group,
and a proximal group of apertures each having a first array of
apertures and a second array of apertures, each of the groups are
arranged 120.degree. apart and each of the first arrays are
arranged 180.degree. apart from each of the second arrays.
6. The bone marrow aspiration assembly of claim 1, wherein the
cannulated introducer needle is rigid and the aspiration needle is
flexible.
7. A bone marrow aspiration assembly comprising: a cannulated bone
piercing needle; a rigid, cannulated introducer needle that is
curved to approximate a natural curvature of an iliac crest, the
rigid, cannulated introducer needle has a length longer than the
cannulated bone piercing needle and is configured to be received
within and pass through the cannulated bone piercing needle; and a
flexible aspiration needle having apertures for aspirating bone
marrow, the flexible aspiration needle is configured to be received
in, and extend from, the rigid, cannulated introducer needle to
reach a bone marrow aspiration site in the iliac crest.
8. The bone marrow aspiration assembly of claim 7, wherein the
rigid, cannulated introducer needle has an open tip and is without
aspiration openings about a radius thereof.
9. The bone marrow aspiration assembly of claim 7, wherein the
rigid, cannulated introducer needle includes a connector configured
to mate with an aspiration syringe for aspirating bone marrow
directly through the rigid, cannulated introducer needle.
10. The bone marrow aspiration assembly of claim 7, wherein the
flexible aspiration needle includes a single group of
apertures.
11. The bone marrow aspiration assembly of claim 7, wherein the
flexible aspiration needle includes a distal group, an intermediate
group, and a proximal group of apertures each having a first array
of apertures and a second array of apertures, each of the groups
are arranged 120.degree. apart and each of the first arrays are
arranged 180.degree. apart from each of the second arrays.
12. A method for aspirating bone marrow comprising: piercing bone
with a cannulated bone piercing needle; inserting into the
cannulated bone piercing needle a rigid, cannulated introducer
needle that is curved to approximate a natural curvature of an
iliac crest and has a length longer than the cannulated bone
piercing needle such that at least a tip of the rigid, cannulated
introducer needle extends out from within the cannulated bone
piercing needle; and inserting into the rigid, cannulated
introducer needle a flexible aspiration needle having apertures for
aspirating bone marrow such that the flexible aspiration needle
extends from the rigid, cannulated introducer needle to reach a
bone marrow aspiration site in the iliac crest.
13. The method of claim 12, further comprising mating an aspiration
syringe with a connector of the cannulated introducer needle for
aspirating bone marrow directly through the cannulated introducer
needle.
14. The method of claim 12, further comprising aspirating bone
marrow through a single group of apertures of the flexible
aspiration needle.
15. The method of claim 12, further comprising aspirating bone
marrow through a distal group, an intermediate group, and a
proximal group of apertures of the flexible aspiration needle each
having a first array of apertures and a second array of apertures,
each of the groups are arranged 120.degree. apart and each of the
first arrays are arranged 180.degree. apart from each of the second
arrays.
16. The method of claim 12, wherein the cannulated introducer
needle includes an open tip and is without aspiration openings
about its radius.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 12/849,412 filed on Aug. 3, 2010, the entire
disclosure of which is incorporated by reference herein.
FIELD
[0002] The present disclosure relates to bone marrow aspiration
needles.
BACKGROUND
[0003] This section provides background information related to the
present disclosure which is not necessarily prior art.
[0004] Autologous stem cell therapies often utilize a patient's
bone marrow or concentrated bone marrow aspirate to deliver
autologous adult mononuclear stem cells to the patient for the
treatment of a wide variety of disorders. Concentrated autologous
cell therapies utilize in vitro cell culture to expand a desired
cell line, or a point-of-care device to concentrate the mononuclear
cell-rich fraction (CRF), for delivery to a desired treatment site.
An exemplary point-of-care device is the MarrowStim.TM. device by
Biomet Biologics, LLC of Warsaw, Ind.
[0005] Concentration of the mononuclear CRF is limited by the
number of recovered mononuclear cells in the aspirate. Often,
aspiration of four 1 ml aspirates recovers almost twice the number
of osteoblast progenitor cells as compared to a single 4 ml
aspirate. This discrepancy is often attributed to aspirate dilution
from peripheral blood. Harvesting smaller volumes of aspirate from
a variety of different locations, such as along the curved iliac
crest of the pelvis, can improve the baseline and concentrated
mononuclear CRF, which will lead to more effective stem cell
therapies.
SUMMARY
[0006] This section provides a general summary of the disclosure,
and is not a comprehensive disclosure of its full scope or all of
its features.
[0007] The present teachings provide for a bone marrow aspiration
assembly including a cannulated introducer needle and an aspiration
needle. The cannulated introducer needle is curved to approximate a
natural curvature of an iliac crest. The aspiration needle includes
apertures for aspirating bone marrow. The aspiration needle is
configured to be received in, and extend from, the cannulated
introducer needle to reach a bone marrow aspiration site in the
iliac crest.
[0008] The present teachings further provide for a bone marrow
aspiration assembly including a cannulated bone piercing needle, a
rigid, cannulated introducer needle, and a flexible aspiration
needle. The rigid, cannulated introducer needle is curved to
approximate a natural curvature of an iliac crest. The rigid,
cannulated introducer needle has a length longer than the
cannulated bone piercing needle and is configured to be received
within and pass through the cannulated bone piercing needle. The
flexible aspiration needle has apertures for aspirating bone
marrow, and is configured to be received in, and extend from, the
rigid, cannulated introducer needle to reach a bone marrow
aspiration site in the iliac crest.
[0009] The present teachings also provide for a method for
aspirating bone marrow. The method includes piercing bone with a
cannulated bone piercing needle; inserting into the cannulated bone
piercing needle a rigid, cannulated introducer needle that is
curved to approximate a natural curvature of an iliac crest and has
a length longer than the cannulated bone piercing needle such that
at least a tip of the rigid, cannulated introducer needle extends
out from within the cannulated bone piercing needle; and inserting
into the rigid, cannulated introducer needle a flexible aspiration
needle having apertures for aspirating bone marrow such that the
flexible aspiration needle extends from the rigid, cannulated
introducer needle to reach a bone marrow aspiration site in the
iliac crest.
[0010] Further areas of applicability will become apparent from the
description provided herein. The description and specific examples
in this summary are intended for purposes of illustration only and
are not intended to limit the scope of the present disclosure.
DRAWINGS
[0011] The drawings described herein are for illustrative purposes
only of selected embodiments and not all possible implementations,
and are not intended to limit the scope of the present
disclosure.
[0012] FIG. 1 is a perspective view of a bone marrow aspiration
assembly according to the present teachings;
[0013] FIG. 2 illustrates an inner needle assembly separated from
an outer needle assembly of the bone marrow aspiration assembly of
FIG. 1;
[0014] FIG. 3 is a cross-sectional view of the bone marrow
aspiration assembly;
[0015] FIG. 3A is an enlarged cross-sectional view of the bone
marrow aspiration assembly showing cooperation between the inner
needle assembly and the outer needle assembly;
[0016] FIG. 4 is a perspective view of an insert of the outer
needle assembly;
[0017] FIG. 4A is a cross-sectional view of the insert of FIG.
4;
[0018] FIG. 5 is a top view of the insert;
[0019] FIG. 6 is a perspective view of a handle of the outer needle
assembly;
[0020] FIG. 7A illustrates a distal end of each of an outer cannula
(right side of Figure) and an inner cannula (left side of Figure)
of the bone marrow aspiration assembly;
[0021] FIG. 7B illustrates the inner cannula seated within the
outer cannula;
[0022] FIG. 8 illustrates a distal end of each of another outer
cannula (right side of Figure) and another inner cannula (left side
of Figure) according to the present teachings;
[0023] FIG. 9 is a perspective view of a distal side of a handle of
the inner needle assembly;
[0024] FIG. 9A is a perspective view of a connection region of the
handle of the inner needle assembly;
[0025] FIG. 9B is a planar view of a distal end of the connection
region;
[0026] FIG. 10 is a perspective view of a trocar (left side of
Figure) configured to be received by the outer needle assembly
(right side of Figure);
[0027] FIG. 11 is an assembled view of the trocar in cooperation
with the outer needle assembly;
[0028] FIG. 12 is a posterior view of a pelvis with the inner
cannula and the outer cannula engaging the iliac crest;
[0029] FIG. 13 is a cross-sectional view of the pelvis and
illustrates the bone marrow aspiration assembly engaging the
pelvis, the assembly including a trocar mounted to the outer needle
assembly;
[0030] FIG. 14 is a cross-sectional view of the pelvis and
illustrates the bone marrow aspiration assembly engaging the
pelvis, the assembly including the outer needle assembly and the
inner needle assembly;
[0031] FIG. 15A is a top, cross-sectional view of interaction
between the inner needle assembly and the outer needle assembly in
a first position;
[0032] FIG. 15B is a top, cross-sectional view of interaction
between the inner needle assembly and the outer needle assembly in
a second position;
[0033] FIG. 15C is a top, cross-sectional view of interaction
between the inner needle assembly and the outer needle assembly in
a third position;
[0034] FIG. 16 is a cross-sectional view of the pelvis and the bone
marrow aspiration assembly of FIG. 1 in the first position engaging
the pelvis, and a syringe for aspirating bone marrow from the
pelvis;
[0035] FIG. 17 is a cross-sectional view of the bone marrow
aspiration assembly engaging the pelvis with the inner needle
assembly and the outer needle assembly each in a first position
such that openings of outer and inner distal opening groups are
aligned;
[0036] FIG. 18 is a cross-sectional view of the bone marrow
aspiration assembly engaging the pelvis with the inner needle
assembly and the outer needle assembly each in a second position
such that openings of outer and inner intermediate opening groups
are aligned;
[0037] FIG. 19 is a cross-sectional view of the bone marrow
aspiration assembly engaging the pelvis with the inner needle
assembly and the outer needle assembly each in a third position
such that openings of outer and inner proximal opening groups are
aligned;
[0038] FIG. 20 illustrates an outer needle assembly (right side of
Figure) and an inner needle assembly (left side of Figure) of
another bone marrow aspiration assembly of the present
teachings;
[0039] FIG. 20A is another distal tip that may be provided with the
outer needle assembly of FIG. 20;
[0040] FIG. 21 is a perspective view of a bone piercing needle of
the present teachings;
[0041] FIG. 22 is a posterior view of a pelvis with the bone
piercing needle of FIG. 21 and the bone marrow aspiration assembly
of FIG. 20 seated therein;
[0042] FIG. 23A illustrates a curved introducer needle according to
the present teachings;
[0043] FIG. 23B illustrates a flexible needle assembly according to
the present teachings;
[0044] FIG. 24 is a cross-sectional view of the pelvis with the
bone piercing needle of FIG. 21, the introducer needle of FIG. 23A,
and the flexible needle of FIG. 23B seated therein; and
[0045] FIG. 24A is similar to FIG. 24, but with the flexible needle
including a plurality of circular openings.
[0046] Corresponding reference numerals indicate corresponding
parts throughout the several views of the drawings.
DETAILED DESCRIPTION
[0047] Example embodiments will now be described more fully with
reference to the accompanying drawings.
[0048] With initial reference to FIG. 1 and FIG. 2, a bone marrow
aspiration assembly according to the present teachings is generally
illustrated at reference numeral 10. The assembly 10 generally
includes an outer needle assembly 12 and an inner needle assembly
14.
[0049] The outer needle assembly 12 includes an outer handle 16 and
an outer cannula 18 extending therefrom. With additional reference
to FIG. 3 and FIG. 3A, the outer handle 16 includes a proximal
surface 20 and a distal surface 22 opposite to the proximal surface
20. The distal surface 22 has a raised neck 24 at a center thereof.
The raised neck 24 includes a distal portion 26.
[0050] With reference to FIGS. 3 and 3A, the outer handle 16
defines a through bore 28 extending between the proximal surface 20
and a center of the distal portion 26 of the raised neck 24. A
longitudinal axis A extending through an axial center of the
through bore 28 is perpendicular to each of a plane extending
across the proximal surface 20, a plane extending across the distal
surface 22, and a plane extending across the distal portion 26 of
the raised neck 24.
[0051] With reference to FIG. 3A, at approximately a mid-point of
the through bore 28, the outer handle 16 defines a stepped, annular
retention surface 30. Between the retention surface 30 and the
proximal surface 20 is an annular flange 31 protruding into the
through bore 28 toward the longitudinal axis A. The outer handle 16
defines a plurality of diameter areas of the through bore 28 having
diameters of various sizes.
[0052] A first area 29 is between the proximal surface 20 and the
flange 31. From the proximal surface 20, the first area 29 tapers
inward toward the longitudinal axis A, and retains a generally
uniform diameter about the longitudinal axis A as it extends in the
distal direction (toward the distal surface 22) until it reaches
the flange 31. A second area 33 is at the flange 31. The second
area 33 has a diameter that is smaller than the diameter of the
first area 29. A third area 35 is adjacent to the flange 31 on a
distal side thereof (closest to the distal surface 22). The third
area 35 has a diameter that is similar in size to the diameter of
the first area 29. A fourth area 37 is between the annular
retention surface 30 and the third area 35. A fifth area 39 is
between the annular retention surface 30 and the distal portion 26
of the neck 24. The fifth area 39 has the smallest diameter, which
is generally uniform throughout its length. The fourth area 37 has
a diameter that is greater than the diameter of the fifth area 39,
but smaller than the diameter of the second area 33.
[0053] With additional reference to FIGS. 4 and 4A, an insert 32 is
seated within the through bore 28. The insert 32 defines a center
channel 34 having a longitudinal axis that is common with the
longitudinal axis A. Near a proximal end 36 of the insert 32, but
spaced apart therefrom, is an annular recess 38 extending around an
outer surface 40 of the insert 32. Proximate to a distal end 42 of
the insert 32, but spaced apart therefrom, is an annular collar 44
extending from the insert 32 in a direction perpendicular to the
longitudinal axis A. Between the annular recess 38 and the annular
collar 44, but closer to the annular recess 38, is a pair of
flexible retention fins 46.
[0054] The diameter of the center channel 34 is greatest at a
portion 48 that is at the proximal end 36. The diameter of the
center channel 34 tapers inward from the proximal end 36 to a point
along the length of the center channel 34 that is approximately
even with the fins 46. The remainder of the center channel 34,
which extends along the longitudinal axis A to the distal end 42
has a generally uniform diameter.
[0055] With additional reference to FIG. 5, protruding from a
portion of the insert 32 defining the large diameter portion 48 of
the center channel 34 are a series of raised surfaces or bumps 50.
A first pair 52a, a second pair 52b, and a third pair 52c of the
bumps 50 are arranged at 120.degree. intervals around the large
diameter portion 48. The two bumps 50 of each pair 52a, 52b, and
52c are spaced apart to securely receive a portion of the inner
handle 90 therebetween, as described herein. FIGS. 4 and 5 also
illustrate six planar surfaces 54 of the outer surface 40, which
are in a hexagonal arrangement and are between the collar 4 and the
fins 46. The planar surfaces 54 restrict rotational movement of the
insert 32 about the longitudinal axis A when seated in the through
bore 28.
[0056] As illustrated in FIGS. 3A and 6 for example, the insert 32
is positioned within the through bore 28 of the handle 16 such that
the proximal end 36 is at, or closely proximate to, the plane
extending across the proximal surface 20 of the outer handle 16 and
such that the distal end 42 extends beyond the distal portion 26 of
the raised neck 24. The collar 44 abuts the distal portion 26 of
the raised neck 24 and the fins 46 are seated on the retention
surface 30. The handle 16 can be manufactured such that the insert
32 is a separately formed component that is inserted into the
through bore 28 at the distal portion 26 until the annular,
flexible fins 46 pass across the annular retention surface 30, at
which point they expand from a contracted or first position to an
expanded or second position to contact the annular retention
surface 30. The collar 44 and the flexible fins 46 retain the
insert 32 within the through bore 28.
[0057] Alternatively, the handle 16 can be manufactured such that
the insert 32 is molded together with the remainder of the handle
16 or the insert 32 can be formed integral with the remainder of
the handle 16 during manufacturing. The handle 16 and the insert 32
may also be manufactured in any other suitable manner. Both the
handle 16 and the insert 32 can be made of any suitable material,
such as a suitable polymer.
[0058] With reference to FIGS. 2 and 3 for example, the outer
cannula 18 includes a proximal end 58 and a distal end 60 and
defines an outer cannula passageway 62 that extends an entire
length of the outer cannula 18, from the proximal end 58 to the
distal end 60. A longitudinal axis A extending through an axial
center of the outer cannula passageway 62 is aligned with the
longitudinal axis A of the through bore 28 (see FIG. 3); thus the
longitudinal axis of the outer cannula passageway 62 is also
designated with reference letter A.
[0059] With additional reference to FIG. 7A, the distal end 60 is
open and includes a plurality of sharpened edges or teeth 64. The
outer cannula 18 defines a plurality of openings 66 between the
distal end 60 and the proximal end 58. The openings 66 provide
communication between the passageway 62 and an exterior of the
outer cannula 18.
[0060] As illustrated in FIG. 2, an outer distal set 68 and an
outer proximal set 70 of the openings 66 are provided. Each of the
outer distal set 68 and the outer proximal set 70 include multiple
openings 66 spaced apart along the longitudinal axis A of the outer
cannula 18. The outer distal set 68 is substantially similar to the
outer proximal set 70. The description of the outer distal set 68
below is therefore also sufficient to describe the outer proximal
set 70. Only one of the outer distal set 68 and the outer proximal
set 70 may be provided in some applications. Additional sets of the
openings 66 may also be included.
[0061] With specific reference to FIG. 7A, the outer distal set 68
will now be described. The outer distal set 68 includes an outer
distal opening group 72a, an outer intermediate opening group 72b,
and an outer proximal opening group 72c. The different outer
opening groups 72a, 72b, and 72c are not radially aligned, but
rather radially offset 120.degree. from each other about axis
A.
[0062] The outer distal opening group 72a includes a first distal
array 74a of openings 66 and a second distal array 74b of openings
66. The first and the second distal arrays 74a and 74b are spaced
180.degree. apart about the radius of the outer cannula 18. Each of
the first and the second distal arrays 74a and 74b include a
plurality of the openings 66 aligned parallel to the longitudinal
axis A in the distal-to-proximal direction. The first distal array
74a includes four of the openings 66 and the second distal array
74b includes three of the openings 66. None of the openings 66 of
the first distal array 74a are aligned in the distal to proximal
direction with any of the openings 66 of the second distal array
74b, but rather the openings 66 are spaced apart.
[0063] The intermediate opening group 72b includes a first
intermediate array 76a of openings 66 and a second intermediate
array 76b of openings 66, which are each substantially similar to
the first and the second distal arrays 74a and 74b respectively.
The only substantial difference between the intermediate opening
group 72b and the distal opening group 72a is that the first and
the second intermediate arrays 76a and 76b are each radially
rotated or shifted approximately 120.degree. about the longitudinal
axis A as compared to the first and the second distal arrays 74a
and 74b.
[0064] The proximal opening group 72c includes a first proximal
array 78a of openings 66 and a second proximal array 78b of
openings 66. The first proximal array 78a is substantially similar
to both the first intermediate array 76a and the first distal array
74a. The second proximal array 78b is substantially similar to both
the second intermediate array 76b and the second distal array 74b.
The only substantial difference between the proximal opening group
72c and both the intermediate opening group 72b and the distal
opening group 72a is that the first and the second proximal arrays
78a and 78b are each radially rotated or shifted approximately
120.degree. about the longitudinal axis A such that the first and
the second proximal arrays 78a and 78b are not radially aligned
with either the first and the second intermediate arrays 76a and
76b or the first and the second distal arrays 74a and 74b.
[0065] With additional reference to FIG. 8, the outer cannula 18
can alternatively include elongated slots 80, instead of the
openings 66, which each extend parallel to the longitudinal axis A.
Each of the arrays 74a, 74b (obscured behind array 74a in FIGS. 8),
76a, 76b, 78a, and 78b include two slots 80 that are radially
aligned with each other. The slots 80 of each of the first arrays
74a, 76a, and 78a are aligned with the slots 80 of each of the
corresponding second arrays 74b, 76b, and 78b such that they
overlap along the longitudinal axis A. The distal opening group
72a, the intermediate opening group 72b, and the proximal opening
group 72c are each orientated such that the slots 80 of the
different opening groups 72a, 72b, and 72c are not radially
aligned, but rather offset by 120.degree. degrees each as
illustrated. This offset can also be 180.degree..
[0066] With reference to FIGS. 3 and 3A, the proximal end 58 of the
outer cannula 18 includes a pair of opposing flared surfaces 82
that extend outward and away from the longitudinal axis A. At least
a portion of the proximal end 58, including the flared surfaces 82,
is seated within the insert 32 to mount the outer cannula 18 to the
outer handle 16 by way of the insert 32. The flared surfaces 82
extend within the portion of the insert 32 defining the center
channel 34 to secure the outer cannula 18 to the insert. The outer
cannula 18 may also be secured to the insert 32 with a suitable
adhesive or the insert 32 can be molded to the outer cannula 18
during manufacturing. The outer cannula passageway 62 is aligned
with the center channel 34 of the insert 32 to provide a continuous
passage from the proximal surface 20 of the handle 16 to the distal
end 60 of the outer cannula 18.
[0067] The outer cannula 18 can be made of any suitable polymer or
metal and can be rigid or flexible, as further discussed herein.
For example, rigid stainless steel can be used, as well as flexible
material, such as Nitinol.
[0068] With reference to FIG. 2, the inner needle assembly 14
generally includes an inner handle 90 and an inner cannula 92 that
extends from the inner handle 90 along longitudinal axis B. The
inner handle 90 includes a distal surface 94 and a proximal surface
96 that is opposite to the distal surface 94. With continued
reference to FIG. 2 and additional reference to FIGS. 9, 9A, and
9B, the distal surface 94 includes a connection region 98 at a
center thereof. The connection region 98 includes a connection cone
100 between two connection tabs 102.
[0069] The connection cone 100 has a tapered outer surface 104 that
is tapered in the proximal to distal direction such that a diameter
of the outer surface 104 is greatest at the distal surface 94.
Extending from the tapered outer surface 104 is a first ridge 106a,
a second ridge 106b, and a third ridge 106c that are each
positioned at 120.degree. intervals about the outer surface 104 of
the cone 100. The ridges 106 are elongated and extend along a
portion of a length of the outer surface 104. An inner surface 108
of the connection cone 100 defines an inner connection channel 110
that extends through the connection cone 100. The inner surface 108
is cylindrical and has a generally uniform diameter throughout,
which provides the inner connection channel 110 with a uniform
diameter.
[0070] The connection tabs 102 each terminate at a tooth 112. The
teeth 112 extend from their respective connection tabs 102 towards
each other and oppose each other. The teeth 112 are sized to be
received within the annular recess 38 of the insert 32.
[0071] The inner connection channel 110 is aligned along the
longitudinal axis B with, and in communication with, a syringe
receptacle 114 defined by the inner handle 90, as illustrated in
FIG. 3A for example. The receptacle 114 extends from the proximal
surface 96 and into a portion of the inner handle 90. The
receptacle 114 has an inner diameter that is greatest at the
proximal surface 96 of the inner cannula handle 90. From the
proximal surface 96, the inner diameter of the syringe receptacle
114 tapers inward toward the longitudinal axis B, which is at an
axial center of the syringe receptacle 114 and is co-linear with
the longitudinal axis A when the inner needle assembly 14 is in
cooperation with the outer needle assembly 12, as illustrated in
FIGS. 3 and 3A.
[0072] The inner cannula 92 includes a proximal end 120 extending
to the receptacle 114 and a distal end 122 that terminates at a
closed tip 124. The inner cannula 92 defines an inner cannula
passageway 126, as illustrated in FIGS. 3 and 3A, for example. The
longitudinal axis B extends through an axial center of the inner
cannula passageway 126. Between the proximal end 120 and the distal
end 122 of the inner cannula 92 are a plurality of openings or
ports 128, which provide communication between the inner cannula
passageway 126 and an exterior of the inner cannula 92. As
illustrated in FIG. 2, the openings 128 are arranged in an inner
distal set 130 and an inner proximal set 132. The inner distal set
130 is substantially similar to the inner proximal set 132 and thus
the below description of the inner distal set 130 also describes
the inner proximal set 132. As with the outer distal and proximal
sets 68 and 70, only one of the inner sets 130 and 132 need be
provided, or additional inner sets of the openings 128 can be
provided depending on the application. The number of sets of
openings 128 provided will generally correspond to the number and
sets of openings 66 provided.
[0073] With reference to FIG. 7A, the inner distal set 130 includes
an inner distal opening group 134a, an inner intermediate opening
group 134b, and an inner proximal opening group 134c. Unlike the
outer opening groups 72a, 72b, and 72c of the outer distal set 68,
the inner opening groups 134a, 134b, and 134c are all radially
aligned along the longitudinal axis B.
[0074] The inner distal opening group 134a includes a first inner
distal array 136a of openings 128 and a second inner distal array
136b of openings 128. The first inner distal array 136a is radially
spaced apart 180.degree. from the second inner distal array 136b.
The first inner distal array 136a is substantially similar to the
first outer distal array 74a of openings 66. The second inner
distal array 136b is substantially similar to the second outer
distal array 74b. Thus, the first inner distal array 136a includes
four openings 128 radially aligned and spaced apart along a line
parallel to the longitudinal axis B and the second inner distal
array 136b includes three openings 128 that are radially aligned
and spaced apart along a line parallel to the longitudinal axis B.
The openings 128 of the first inner distal array 136a and the
openings 128 of the second inner distal array 136b are not aligned
in the distal to proximal direction, but rather staggered such that
the openings 128 of the second inner distal array 136b are between
the openings 128 of the first inner distal array 136a in the distal
to proximal direction of the inner cannula 92.
[0075] The inner intermediate opening group 134b and the inner
proximal opening group 134c are radially aligned with, and are
substantially similar to, the inner distal opening group 134a, but
spaced apart from the inner distal opening group 134a along the
longitudinal axis B. Therefore, the description of the inner distal
opening group 134a is also sufficient to describe both the inner
intermediate opening group 134b and the inner proximal opening
group 134c.
[0076] As illustrated in FIG. 3A, the proximal end 120 of the inner
cannula 92 includes a syringe connector 140 having external threads
142. The syringe connector 140 may have any configuration suitable
to couple a syringe to the inner cannula 92 in order to aspirate
material there through, such as bone marrow, as further described
herein.
[0077] The inner cannula 92 can be made of a suitable polymer or
metal and can be rigid or flexible. For example, rigid stainless
steel can be used, as well as flexible material, such as
Nitinol.
[0078] As illustrated in FIG. 8, in place of the circular openings
128 the inner cannula 92 can include openings 129 shaped as
elongated slots extending parallel to the longitudinal axis B. Each
inner opening group 134a, 134b, and 134c can include a pair of the
slotted openings 129 orientated at 180.degree. relative to each
other. The pairs of openings 129 of the inner distal opening groups
134a, 134b, and 134c are each radially aligned.
[0079] With additional reference to FIGS. 10 and 11, a trocar is
illustrated at reference numeral 200. The trocar 200 generally
includes a trocar handle 202 and a trocar needle 204 extending
therefrom. The trocar handle 202 includes a distal surface 206 and
a proximal surface 208 that is opposite to the distal surface 206.
The trocar needle 204 includes a proximal end 210 and a distal end
212. The proximal end 210 is attached to a connector 214 at a
center of the distal surface 206 of the trocar handle 202 with a
press-fit, for example. The distal end 212 includes a pointed tip
216. The trocar needle 204 is rigid and made from any suitable
rigid material, such as a suitable metal. At opposite sides of the
connector 214 are locking tabs 218 configured to cooperate with the
annular recess 38 of the insert 32 of the outer handle 16 to secure
the trocar 200 to the outer handle 16, as further described
herein.
[0080] With continued reference to FIGS. 1-11 and additional
reference to FIGS. 12-19, use of the outer needle assembly 12, the
inner needle assembly 14, and the trocar 200 to aspirate bone
marrow will now be described. While aspiration of bone marrow from
a posterior iliac crest 302 of a pelvis 300 is described, the outer
needle assembly 12, the inner needle assembly 14, and the trocar
200 can be used to retrieve/isolate a variety of biological
materials from a variety of different sources.
[0081] With initial reference to FIGS. 12 and 13, cortical bone 304
and cancellous bone 306 of the iliac crest 302 is initially pierced
with a suitable piercing device, such as the trocar 200. As
illustrated in FIG. 13, the trocar 200 can be coupled with the
outer needle assembly 12 such that the trocar needle 204 extends
through the outer cannula passageway 62 and the distal end 212 of
the trocar needle 204, including the pointed tip 216, extends
beyond the teeth 64 of the distal end 60 of the outer cannula 18.
The teeth 64 facilitate piercing and cutting of the cortical bone
304 and the cancellous bone 306 of the iliac crest 302.
[0082] The trocar 200 can be secured to the outer needle assembly
12 through cooperation between the locking tabs 218 of the handle
202 and the annular recess 38 of the insert 32 of the outer handle
16. Once the outer cannula 18 is in a desired position and at a
desired bone depth within the cancellous bone 306, the trocar 200
can be removed from cooperation with the outer needle assembly 12,
which is left in position in the iliac crest 302.
[0083] With reference to FIG. 14, the inner needle assembly 14 is
coupled to the outer needle assembly 12 seated in the iliac crest
302 by inserting the inner cannula 92 within the outer cannula 18
such that the distal end 122 of the inner cannula 92, including the
closed tip 124, extends beyond the distal end 60 of the outer
cannula 18. The connection tabs 102 are coupled to the annular
recess 38 of the insert 32 of the outer handle 16 to lock the inner
needle assembly 14 to the outer needle assembly 12. The connection
cone 100 of the inner cannula handle 90 is seated within the insert
32 such that each of the ridges 106 of the cone 100 are between
bumps 50 of each pair of bumps 52, as illustrated in FIG. 15A.
[0084] The longitudinal axis A of the outer needle assembly 12 is
aligned with the longitudinal axis B when the inner needle assembly
14 is coupled to the outer needle assembly 12, as illustrated in
FIGS. 3 and 3A for example. The outer cannula 18 and the inner
cannula 92 are arranged such that the outer distal set 68 and the
outer proximal set 70 of openings 66 are each aligned along the
longitudinal axes A and B with the inner distal set 130 and the
inner proximal set 132 of openings 128 respectively.
[0085] Because the recess 38 is annular, the inner needle assembly
14 can be rotated with respect to the outer needle assembly 12
about the longitudinal axis A of the outer needle assembly 12,
while maintaining alignment of the longitudinal axis A and the
longitudinal axis B. The inner needle assembly 14 is generally
rotated between a first position (FIG. 15A), a second position
(FIG. 15B), and a third position (FIG. 15C).
[0086] As illustrated in FIG. 15A, in the first position the first
ridge 106a of the connection core 100 is between the bumps 50 of
the first pair of bumps 52a, the second ridge 106b is seated
between the bumps 50 of the second pair of bumps 52b, and the third
ridge 106c is seated between the bumps 50 of the third pair of
bumps 52c. Each opening 66 of the outer distal opening group 72a is
aligned with an opening 128 of the inner distal opening group 134a.
In particular and with reference to FIGS. 16 and 17, the openings
66 of the first and the second outer distal arrays 74a/74b are
aligned with the openings 128 of the first and the second inner
distal arrays 136a and 136b respectively, thus permitting
aspiration of material, such as bone marrow, there through. In
contrast, the openings 66 of the outer intermediate and outer
proximal arrays 76a, 76b, 78a, and 78b are not aligned with the
openings 128 of the inner intermediate and inner proximal arrays
138a, 138b, 140a, and 140b, thus restricting aspiration of bone
marrow there through.
[0087] With reference to FIG. 16, aspiration is performed using any
suitable device, such as a syringe 400. The syringe 400 generally
includes a luer lock 402 with threads 404 and a chamber 406
including a plunger 408 (chamber 406 and plunger 408 are
conventional features that are partially illustrated). The syringe
400 is connected to the inner handle 90 through cooperation between
the threads 404 of the luer lock 402 and the threads 142 at the
proximal end 120 of the inner cannula 92. As the plunger 408 is
pulled away from the luer lock 402, a negative pressure is
established in the chamber 406 and in the passageway 126 of the
inner cannula 92, thereby drawing bone marrow through the aligned
openings 66 and 128 through the passageway 126 of the inner cannula
92 and into the chamber 406 of the syringe 400. Thus, when the
inner needle assembly 14 is in the first position relative to the
outer needle assembly 12, bone marrow can be aspirated from an area
of the iliac crest 302 that is in close proximity to the outer
distal opening group 72a and the inner distal opening group
134a.
[0088] With reference to FIGS. 15B and 18, to aspirate bone marrow
from an area of the iliac crest 302 that is proximate to the outer
intermediate opening group 72b and the inner intermediate opening
group 134b, the inner needle assembly 14 is rotated 120.degree.
about the longitudinal axes A and B from the first position to the
second position. In the second position, the first ridge 106a is
locked between the bumps 50 of the second pair of bumps 52b, the
second ridge 106b is locked between the bumps 50 of the third pair
of bumps 52c and the third ridge 106c is locked between the bumps
50 of the first pair of bumps 52a. In this second position, as
illustrated in FIG. 18, the openings 66 of the first and the second
outer intermediate arrays 76a/76b are aligned with the openings 128
of the first and the second inner intermediate arrays 138a/138b
respectively, thus permitting aspiration of material, such as bone
marrow, there through. In contrast, the openings 66 of the outer
distal and proximal arrays 74a, 74b, 78a, and 78b are not aligned
with the openings 128 of the inner distal and proximal arrays 136a,
136b, 140a, 140b, thus restricting aspiration of bone marrow there
through.
[0089] With reference to FIGS. 15c and 19, to aspirate bone marrow
from an area of the iliac crest 302 that is proximate to the outer
proximal opening group 72c and the inner proximal opening group
134c, the inner needle assembly 14 is rotated 120 degrees about the
longitudinal axes A and B from the second position to the third
position. In the third position, the first ridge 106a is locked
between the bumps 50 of the third pair of bumps 52c, the second
ridge 106b is locked between the bumps 50 of the first pair of
bumps 52a, and the third ridge 106c is locked between the bumps 50
of the second pair of bumps 52b. In this third position, as
illustrated in FIG. 19, the openings 66 of the first and the second
outer proximal arrays 78a/78b are aligned with the openings 128 of
the first and the second inner proximal arrays 140a/140b
respectively, thus permitting aspiration of material, such as bone
marrow, there through. In contrast, the openings 66 of the outer
distal and intermediate arrays 74a, 74b, 76a, and 76b are not
aligned with the openings 128 of the inner distal and intermediate
arrays 136a, 136b, 138a, 138b, thus restricting aspiration of bone
marrow there through.
[0090] The outer proximal set 70 of openings 66 is substantially
similar to the outer distal set 68 of openings 66. The inner
proximal set 132 of openings 128 is substantially similar to the
inner distal set 130 of openings 128. Thus, alignment of the
openings 66 and the openings 128 of the outer proximal and inner
proximal sets 70 and 132 respectively in each of the first
position, the second position, and the third position is the same
as the alignment of the openings 66 and 128 of the outer and the
inner distal sets 68 and 130 in each of the first, the second, and
the third positions.
[0091] Thus, cooperation between the outer needle assembly 12 and
the inner needle assembly 14 permits aspiration of bone marrow from
three different areas of the iliac crest 250. The three different
areas are relatively offset both radially and longitudinally
without having to move the outer needle assembly 12. Such movement
may cause patient discomfort and increase the complexity of the
procedure.
[0092] With additional reference to FIG. 20, another bone marrow
aspiration assembly according to the present teachings is
illustrated at reference numeral 10'. The aspiration assembly 10'
is similar to the assembly 10 described above and thus like
features are designated with the same reference numerals, but
include the prime symbol ('). The assembly 10 generally includes an
outer needle assembly 12' including an outer cannula 18' and an
inner needle assembly 14' including an inner cannula 92'.
[0093] The outer cannula 18' and the inner cannula 92' are both
flexible and can be made of any suitable flexible material, such as
a suitable polymer or Nitinol. The outer cannula 18' is illustrated
as including slots 80' and the inner cannula 92' is illustrated as
including slots 129' arranged in the same manner as illustrated in
FIG. 8 on the assembly 10 (i.e. proximal, intermediate, and distal
groups of slots 80/129 each positioned 120.degree. apart radially).
However, the slots 80' and 129' can be provided in any suitable
arrangement and/or shape to permit aspiration through selective
slots 80' and 129' (or openings 66/128) by rotating the inner
cannula 92' with respect to the outer cannula 18'. For example, the
slots 80' and 129' can be arranged in two groups of slots 80'/129'
positioned 120.degree. apart radially or can have the arrangement
of circular openings 66/128 illustrated in, for example, FIGS. 7A
and 7B.
[0094] With reference to FIG. 21, a bone piercing needle is
illustrated at reference numeral 450. The bone piercing needle 450
includes a head 452, a cannula 454 terminating at an open tip 456,
and a collar 458 between the head 452 and the cannula 454. The bone
piercing needle 450 is substantially shorter in length than the
bone marrow aspiration assembly 10' and is rigid throughout. The
cannula 454 is about 3-4 inches in length. The bone piercing needle
450 can be made of any suitable rigid material, such as a
metal.
[0095] With additional reference to FIG. 22, use of the bone
piercing needle 450 and the aspiration assembly 10' to aspirate
bone marrow from the pelvis 300 will now be described. The bone
piercing needle 450 is driven into the pelvis 300 such that the
collar 458 is at an outer surface of the iliac crest 302 and the
cannula 454 extends through the cortical bone 304 to the cancellous
bone 306. With the inner needle assembly 14' mated with the outer
needle assembly 12', the inner and outer cannulas 18' and 92' are
inserted into the iliac crest 302 either through the cannula 454
when the bone piercing needle 450 is left in the pelvis 300 or
through the opening created in the pelvis 300 when the bone
piercing needle 450 is removed. Because the inner and outer
cannulas 18' and 92' are flexible, they are able to track along a
curved perimeter 308 of the iliac crest 302, which is typically a
rich source of bone marrow. To aspirate bone marrow from the iliac
crest 302, a syringe is attached to the assembly 10', which is
operated in the same manner as the assembly 10 described above.
[0096] The assembly 10' may also include the trocar 200 of FIG. 10,
or any other suitable trocar or rigid device, which can be inserted
within the outer cannula 18' to facilitate insertion of the outer
cannula 18' into the iliac crest 302. The outer cannula 18' may
have an open tip 60' as illustrated in FIG. 20, or it may have a
closed tip (FIG. 20A). When the tip 60' is open, the trocar 200 may
extend beyond the tip 60'.
[0097] With additional reference to FIG. 23A, an introducer needle
is illustrated at reference numeral 500. The introducer needle 500
generally includes a handle 502 and a cannula 504. The handle 502
includes a center connector 506 with an annular recess 508
extending about an exterior surface thereof. The connector 506
includes an opening 510 extending through a center thereof. The
opening 510 extends through the handle 502 and is in communication
with the cannula 504.
[0098] The cannula 504 includes a proximal end 512 secured to the
handle 502 and a distal end 514 that is opposite to the proximal
end 512. The distal end 514 includes an open tip 516 that may
include sharpened edges 518 to facilitate positioning of the of the
introducer needle 500 at an implantation site. The cannula 504
defines a channel 520 that extends between the proximal end 512 and
the distal end 514. The channel 520 is in cooperation with the
opening 510 to provide a continuous passageway through the
introducer needle 500.
[0099] The cannula 504 is rigid and curved between the proximal end
512 and the distal end 514. The cannula 504 can have any suitable
shape and any suitable degree of curvature to match or closely
approximate either the overall natural curve of the iliac crest or
specific portions thereof to facilitate positioning the cannula 504
proximate to areas with the greatest amount of bone marrow. The
cannula 504 can be curved along its entire length or only portions
thereof. The cannula 504 can be made of any suitable material, such
as a suitable metal. The cannula 504 can optionally include holes
along its length in communication with the channel 520, such as the
openings 66 or the slots 80 of the outer cannula 18, which can be
provided in any suitable size, shape, and arrangement, such as the
arrangement herein with respect to the outer cannula 18.
[0100] A flexible needle assembly 550 is illustrated in FIG. 23B.
The flexible needle assembly 550 is substantially similar to the
inner needle assembly 14' and therefore similar features are
designated with the same reference numerals, but with the prime (')
symbol added. Unlike the inner needle assembly 14', the assembly
550 as illustrated includes only a single pair of slots 129' at the
distal end 122', but can include any suitable number of slots 129'
or openings (such as openings 128 as arranged in FIGS. 2 and 7A) in
any suitable shape, number, or arrangement, such as is provided
with the inner needle assembly 14 or 14'.
[0101] With additional reference to FIG. 24, use of the curved
introducer needle 500 to aspirate bone marrow from the iliac crest
302 of the pelvis 300 will now be described. The cortical bone 304
of the iliac crest 302 is initially pierced with the bone piercing
needle 450, which is driven within the iliac crest 302 such that
the open tip 456 extends to within the cancellous bone 306. The
cannula 504 of the introducer needle 500 is then inserted through
the cannula 454 of the bone piercing needle 450 and into the iliac
crest 302. The bone piercing needle 450 can be curved, as
illustrated, to accommodate the introducer needle. The curvature of
the cannula 504 is similar to the curvature of the perimeter 308 of
the iliac crest 302 and thus the cannula 504 can be positioned
proximate to the perimeter 308, an area rich in bone marrow, along
at least a majority of its length. Alternatively, the bone piercing
needle 450 can be removed prior to insertion of the cannula 504,
which can be inserted through the opening in the iliac crest 302
formed by insertion of the cannula 454.
[0102] Once the cannula 504 of the introducer needle 500 is at an
area of the iliac crest 302 from which bone marrow is to be
aspirated, the flexible needle assembly 550 can be mated with the
introducer needle 500 such that the tabs 102' are coupled to the
annular recess 508 and the inner cannula 92' extends through the
channel 520 such that the distal end 122', including a portion with
the slots 129' (illustrated as a plurality of circular openings in
FIG. 24A), extends beyond the distal end 514. To aspirate bone
marrow, a syringe 400 can be coupled to threads of the cannula
handle 90' (in a manner substantially similar to that illustrated
in FIG. 16) to aspirate bone marrow through the slots 129' of the
inner cannula. Alternatively, a syringe can be attached directly to
the connector 506 of the introducer needle 500 to aspirate bone
marrow directly through the open tip 516. The flexible needle
assembly 550 can be rotated to aspirate bone marrow from different
areas of the iliac crest 302.
[0103] When the cannula 504 includes the slots 80 or the openings
66 of the outer cannula 18 and the cannula 92' includes the slots
129 or the openings 128 of the inner cannula 92, as arranged in
FIGS. 7A and 8 for example, bone marrow may be aspirated through
select slots 80/129 or openings 66/128 by rotating the flexible
needle assembly 550 relative to the cannula 504 to provide
selective alignment, and selective aspiration, through the
different slots 80/129 or openings 66/128 in the same manner as
described in FIGS. 15 and 17-19 with respect to use of the outer
needle assembly 12 and the inner needle assembly 14.
[0104] The foregoing description of the embodiments has been
provided for purposes of illustration and description. It is not
intended to be exhaustive or to limit the invention. Individual
elements or features of a particular embodiment are generally not
limited to that particular embodiment, but, where applicable, are
interchangeable and can be used in a selected embodiment, even if
not specifically shown or described. The same may also be varied in
many ways. Such variations are not to be regarded as a departure
from the invention, and all such modifications are intended to be
included within the scope of the invention.
* * * * *