U.S. patent application number 13/342456 was filed with the patent office on 2012-04-26 for bending resistant male connector for a guide wire.
This patent application is currently assigned to RADI MEDICAL SYSTEMS AB. Invention is credited to Paer Gustafsson, Ola Hammarstroem, Paer von MALMBORG.
Application Number | 20120101409 13/342456 |
Document ID | / |
Family ID | 25532096 |
Filed Date | 2012-04-26 |
United States Patent
Application |
20120101409 |
Kind Code |
A1 |
von MALMBORG; Paer ; et
al. |
April 26, 2012 |
BENDING RESISTANT MALE CONNECTOR FOR A GUIDE WIRE
Abstract
During use there is a risk that a male connector for a guide
wire is bent. With the present male connector (1) more material
with high modulus of elasticity can be provided inside the male
connector (1), which makes the male connector (1) more bending
resistant. The male connector (1) comprises a core wire (3), a
plurality of conductive members (4) spaced apart longitudinally
along said core wire (3), a plurality of conductors (5) disposed
along the core wire (3), each of the conductors (5) being connected
to a respective conductive member (4). The connector (1) has such a
configuration that the conductors (5) are protected from damage at
the location where the conductors (5) connect to the conductive
members (4).
Inventors: |
von MALMBORG; Paer;
(Uppsala, SE) ; Hammarstroem; Ola; (Lerdala,
SE) ; Gustafsson; Paer; (Uppsala, SE) |
Assignee: |
RADI MEDICAL SYSTEMS AB
|
Family ID: |
25532096 |
Appl. No.: |
13/342456 |
Filed: |
January 3, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12831650 |
Jul 7, 2010 |
8109889 |
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13342456 |
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10812914 |
Mar 31, 2004 |
7775992 |
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12831650 |
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09986117 |
Nov 7, 2001 |
6908442 |
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10812914 |
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Current U.S.
Class: |
600/585 |
Current CPC
Class: |
H01R 2201/12 20130101;
A61B 5/303 20210101; A61B 2017/22038 20130101; A61B 2018/00178
20130101; A61B 2562/227 20130101; A61M 25/09 20130101; A61B 18/14
20130101; A61B 2562/0219 20130101 |
Class at
Publication: |
600/585 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61M 25/09 20060101 A61M025/09 |
Claims
1.-20. (canceled)
21. A guide wire assembly, comprising: a male connector including a
metal core wire, a plurality of circular-shaped conductive members
spaced apart longitudinally along the core wire and defining a
central longitudinal axis of the male connector, a plurality of
conductors disposed along the core wire, the conductors being
connected to respective conductive members, and insulating
material, wherein, at least one point along the length of the male
connector, a thickness of the core wire in the male connector,
measured along lines that pass through the central longitudinal
axis of the male connector, is 47% or more of the diameter of the
circular-shaped conductive members.
22. A guide wire assembly as set forth in claim 21, further
comprising a circular-shaped sleeve of insulating material between
the core wire and the plurality of circular-shaped conductive
members.
23. A guide wire assembly as set forth in claim 21, wherein the
core wire is made from titanium.
24. A guide wire assembly as set forth in claim 21, wherein the
core wire is coated with titanium dioxide.
25. A guide wire assembly as set forth in claim 21, wherein the
core wire is coated with oxidized aluminum.
26. A guide wire assembly as set forth in claim 21, wherein the
core wire is generally cylindrically shaped.
27. A guide wire assembly as set forth in claim 21, wherein the
core wire is D-shaped.
28. A guide wire assembly as set forth in claim 21 wherein, at
least one point along the length of the male connector, a thickness
of the core wire in the male connector, measured along lines that
pass through the central longitudinal axis of the male connector,
is 53% or more of the diameter of the circular-shaped conductive
members.
29. A guide wire assembly as set forth in claim 21, wherein the
core wire in the male connector contains at least one groove to
accommodate at least one conductor.
30. A guide wire assembly as set forth in claim 21, wherein the
core wire inside the male connector has a flat surface.
31. A guide wire assembly as set forth in claim 21, wherein the
guide wire assembly comprises a second core wire distal of said
core wire, the second core wire and said core wire being separated
by a longitudinal gap.
32. A guide wire assembly as set forth in claim 21, wherein at
least one point along the length of the male connector, at least
one thickness of the core wire, measured along a line that passes
through the central longitudinal axis of the male connector, is
less than 100% of another thickness measured along a line that
passes through the central longitudinal axis of the male
connector.
33. A guide wire assembly as set forth in claim 21 wherein, at
least one point along the length of the male connector, a thickness
of the core wire in the male connector, measured along lines that
pass through the central longitudinal axis of the male connector,
is 58% or more of the diameter of the circular-shaped conductive
members.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 12/831,650, filed Jul. 7, 2010, which is a
continuation application of U.S. application Ser. No. 10/812,914,
filed Mar. 31, 2004, now U.S. Pat. No. 7,775,992, which is a
divisional application of U.S. application Ser. No. 09/986,117,
filed Nov. 7, 2001, now U.S. Pat. No. 6,908,442, the contents of
which are incorporated herein in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a bending resistant male
connector for a guide wire, and in particular to a bending
resistant male connector having a core wire with such a shape that
the total configuration consisting of the core wire, conductors and
insulating material makes an optimal use of the available space
inside the male connector.
BACKGROUND OF THE INVENTION
[0003] Guide wires are generally known in the art. They are, for
example, used in connection with the treatment of coronary
diseases, where an x-ray of a blood vessel may be done to detect
the presence of an occlusion, which, however, does not show the
cross section of a stenosis. It is accepted that the best way to
diagnose the significance of the stenosis is to perform a
measurement of the blood pressure upstream and downstream of the
stenosis. In this case, a guide wire is used to position a
pressure-measuring sensor in the area of interest. Once the guide
wire is positioned, a catheter is slid over the guide wire and a
balloon dilation may then be done. The electrical signals from the
pressure-measuring sensor at the distal end of the guide wire are
lead through conductors embedded in the guide wire to a male
connector at the proximal end of the guide wire. In use, the male
connector is connected to a female connector and the signals from
the pressure-measuring sensor are transferred to an interface,
which converts the signals and presents them in the desired form
for an operator.
[0004] The male connector disposed at the proximal end of the guide
wire comprises basically a core wire, a plurality of conductors, a
plurality of conductive members, and insulating material
therebetween. When the male connector is connected to the female
connector, the conductive members transfer the electrical signals
from the conductors of the male connector to similar conductive
members inside the female connector. The core wire, which
conventionally extends through the guide wire, is used to prevent
kinks, to provide strength to the guide wire and to hold the guide
wire together. Especially when the male connector is inserted into
the female connector, there exists a substantial risk of
over-bending the male connector or damaging the thin conductors
inside the male connector. The core wire inside the male connector
is therefore normally made of a material with high modulus of
elasticity, such as stainless steel. Examples of such male
connectors are disclosed in U.S. Pat. No. 5,178,159 and U.S. Pat.
No. 5,938,624.
[0005] From the above, it should be obvious that the core wire
should be as large as possible, so that a large amount of high
strength material is provided inside the male connector, while
leaving enough room for the conductors and insulation to fit within
the guide wire. In U.S. Pat. No. 5,178,159 and U.S. Pat. No.
5,938,624 it is assumed that the core wire is cylindrical and that
the conductors are disposed at the outside of the core wire. With
this shape of the core wire, the total configuration consisting of
the core wire and the conductors will occupy a large part of the
space inside the male connector, without the core wire and the thin
conductors themselves actually utilizing an optimum of the
available space, or, with other words, there is an excess of
insulating material inside the male connector. Here it should be
mentioned that the available space inside the guide wire is limited
by the diameter of the catheter that is slid over the guide wire.
Since the catheter also is slid over the male connector, which
extends from the proximal end of the guide wire, the size of the
entire male connector is also limited by the diameter of this
catheter. The nominal diameter of a conventional small catheter may
be as small as 0.355 mm, which provides an upper limit for the
diameter of a male connector used together with such a
catheter.
[0006] As mentioned above, the core wire conventionally extends
through the guide wire, all the way from the sensor at the distal
end of the guide wire to the male connector at the proximal end of
the guide wire, where the core wire provides stiffness to the male
connector. For such a long core wire, the most economical and
practical shape of the core wire is cylindrical, and the
conventional thinking has been to keep the cylindrical shape of the
core wire also inside the male connector, despite the disadvantage
that the total configuration consisting of the core wire and the
conductors occupies less than the optimum of the available space,
which involves the risk that the male connector will be bent or
damaged when inserted into the female connector.
[0007] Consequently, there exists a need for a male connector
having a core wire with such a shape that the total configuration
consisting of the core wire, conductors and insulating material
makes an optimal use of the available space inside the male
connector. In order to keep the cylindrical shape of the part of
the core wire that extends from the male connector to the sensor,
the male connector should preferably constitute a separate unit,
which can be mounted at the proximal end of an existing guide wire.
Obviously, the last requirement implies that the core wire inside
the male connector is different from the core wire inside the rest
of the guide wire.
SUMMARY OF THE INVENTION
[0008] The main object of the present invention is to provide a
male connector having a core wire with such a shape that more
material with high modulus of elasticity can be provided inside the
male connector, while still leaving enough space for the
conductors.
[0009] A second object of the present invention is to provide a
male connector which is durable and resistant against bending, and
which is easy to insert into a female connector without
bending.
[0010] A third object of the present invention is to provide a male
connector having a core wire with such a shape that the conductors
are protected from damage even if the male connector is bent.
[0011] A fourth object of the present invention is to provide a
male connector that allows a long insulation distance between the
conductive members with preserved stiffness.
[0012] A fifth object of the present invention is to provide a male
connector that is separately mountable on an existing guide
wire.
[0013] A sixth object of the present invention is to provide a male
connector that allows filling of insulation material with a minimum
of voids, which yields a waterproof and constant quality
design.
[0014] These objects are achieved with a male connector as defined
in claim 1. Preferred embodiments of the male connector according
to the invention are defined in the dependent claims.
[0015] A preferred embodiment of the male connector according to
the present invention comprises a core wire, a plurality of
conductive members, a plurality of conductors, and insulating
material. Each of the conductors is connected to a respective
conductive member. The conductive members, which are annular with
the same outer diameter as the guide wire, are spaced apart
longitudinally from each other. The core wire is not cylindrical,
but a part of its mantel surface is flat, thereby giving the core
wire a D-shaped cross section.
[0016] When the male connector is assembled, the conductors are
positioned outside the straight leg of the D-shaped cross section.
When the male connector has been attached to the proximal end of a
guide wire and the D-shaped core wire has been inserted a small
distance into the guide wire, the conductors at the distal end of
the male connector are therefore positioned in the elongated cavity
created between the inner surface of the cylindrical guide wire and
the D-shaped core wire. The more proximal sections of the
conductors that are inside the annular conductive members are in
the corresponding way positioned in the cavities created between
the conductive members and the D-shaped core wire.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates a male connector according to the present
invention mounted on a guide wire.
[0018] FIG. 2 illustrates the male connector of FIG. 1 provided
with extra insulating material.
[0019] FIG. 3 illustrates a guide wire with a male connector used
within a catheter, and a female connector connected to a
monitor.
[0020] FIG. 4 shows the cross section of a male connector according
to prior art.
[0021] FIG. 5 shows the cross section of a first embodiment of a
male connector according to the present invention.
[0022] FIG. 5a shows an enlarged part of the core wire of FIG.
5.
[0023] FIG. 5b shows an enlarged part of the conductors of FIG.
5.
[0024] FIG. 6 shows the cross section of a second embodiment of a
male connector according to the present invention.
[0025] FIG. 7 shows the cross section of a third embodiment of a
male connector according to the present invention.
[0026] FIG. 8 shows the cross section of a fourth embodiment of a
male connector according to the present invention.
[0027] FIG. 9 illustrates a male connector having an alternative
conductor configuration.
[0028] FIG. 10 shows the cross section of the male connector
according to FIG. 9.
DETAILED DESCRIPTION OF THE INVENTION
[0029] FIG. 1 illustrates a male connector 1 according to the
present invention. The male connector 1 is disposed on the proximal
end of a guide wire 2. The male connector 1 comprises basically a
core wire 3, a plurality of conductive members 4, and plurality of
conductors 5.
[0030] The conductive members 4, which are annular with the same
outer diameter as the guide wire 2, are spaced apart longitudinally
from each other. When the male connector 1 is assembled, each of
the conductors 5 is electrically connected to a respective
conductive member 4 and insulating material 6 is provided between
the core wire 3 and the conductive members 4. The insulating
material 6 fixates the conductors 5 inside the conductive members 4
and insulates the conductive members 4 from the core wire 3.
[0031] In FIG. 2, the male connector 1 of FIG. 1 has been provided
with an extra continuous outer insulating material 7, the outer
surface of which being coextensive with the outer surfaces of the
conductive members 4. The insulating material 7 insulates the
conductors 5 and the conductive members 4 from each other, and
provides the male connector with additional stiffness.
[0032] Note that in FIGS. 1 and 2 there is a small gap provided
between the core wire 3 of the male connector 1 and the core wire
that extends through the rest of the guide wire 2, i.e. the core
wire 3 of the male connector 1 is not an integral part of the core
wire in the more distal and much longer part of the guide wire 2
that is not shown in FIG. 1 or FIG. 2. Consequently, this small gap
indicates that the male connector 1 can be regarded as a separate
part of the overall guide wire assembly, which is in contrast to
the prior art designs. The special advantages with this feature
will be described below.
[0033] From FIG. 1 and FIG. 2 it should be noted that the proximal
end of a conductor 5 is connected the proximal end of the
corresponding conductive member 4, i.e. the adjacent proximal part
of the conductor 5 is supported by the conductive member 4 and the
insulating material 6 inside this conductive member 4. The
conductive members 4 are relatively stiff, and, when the male
connector 1 is bent, the connections between the conductive members
4 and the conductors 5 are therefore experiencing less bending
stress than they would do if the conductors 5 were attached to the
distal ends of the conductive members 4.
[0034] The overall guide wire assembly is illustrated in FIG. 3,
where a male connector 1 is attached to the proximal end of a guide
wire 2. The guide wire 2 is inserted within a balloon catheter 8.
At the distal end of the guide wire 2 is a sensor 9. The male
connector 1 is inserted into a female connector 10. The female
connector 10 is electrically connectable into a monitor device 11.
In practise, the distal end of the guide wire 2 is inserted into
the body, for example into an opening into the femoral artery. Once
positioned by a physician at the appropriate location, a catheter 8
of the desired type is guided onto the guide wire 2. In use, the
signals from the sensor 9 are lead by the conductors enclosed in
the guide wire 2 to the conductive members of the male connector 1.
The signals are then transferred from the conductive members of the
male connector 1 to similar conductive members inside the female
connector 10. The signals are then presented for the physician by
the monitor device 11.
[0035] FIG. 4 shows the cross section of a male connector according
to a prior art design. In this case, three conductors are
symmetrically disposed around a cylindrical core wire positioned
eccentrically in the male connector. A conductive member surrounds
the core wire and the three conductors, and insulating material
fills the rest of the space inside the male connector. A major
disadvantage with such a prior art design is that if the male
connector illustrated in FIG. 4 is bent, for instance during
insertion into a female connector, all parts of the male connector
will experience a bending stress. In this case, the thin and
sensitive conductors embedded in the relatively soft insulating
material may be squeezed between the harder core wire and
conductive member, which involves the risk that one or several of
these conductors will be damaged or break.
[0036] In FIG. 5 the cross section of a preferred embodiment of a
male connector according to the present invention is illustrated.
In this case, a core wire 3 having a homogenous D-shaped cross
section constitutes the central part of a male connector. In this
case, three conductors 5 are positioned outside the flat part of
the D-shaped core wire 3, and a cylindrical conductive member 4
surrounds the conductors 5 and the D-shaped core wire 3. The rest
of the space inside the cylindrical conductive member 4 is filled
with insulating material 6, with a minimum of insulating material 6
being provided between the conductive member 4 and the curved part
of the D-shaped core wire 3.
[0037] It should be noted that the D-shape of the core wire 3
provides a cavity between the inner surface of the cylindrical
conductive member 4 and the flat part of the D-shaped core wire 3.
This cavity, in which the conductors 5 are disposed, will remain
practically intact even when the male connector is bent. This means
that even if a bending stress is imposed on the male connector,
there is no risk that the conductors 5 will be squeezed between the
core wire 3 and the conductive member 4, which obviously prevents
the conductors 5 from being damaged during, for example, insertion
into a female connector. From FIG. 5 it should be obvious that a
requirement for such a protecting cavity is that the ends of the
straight leg of the D-shaped cross section are positioned near the
conductive member 4, i.e. there is a minimum of insulating material
6 between the inner surface of the conductive member 4 and these
parts of the D-shaped core wire 3. Note that herein, the term
"cavity" should not be taken literally. As is apparent from FIG. 5,
also the cavity is filled with the continuous insulating material
6.
[0038] An enlarged part of the core wire 3 of FIG. 5 is illustrated
in FIG. 5a. FIG. 5a shows that the core wire 3 is provided with a
separate layer of insulating material 12. The core wire 3 may
therefore be regarded as an insulated core wire 3, and the amount
of insulating material 6 being provided between the curved part of
the D-shaped core wire 3 and the conductive member 4 can
practically be reduced to zero. An example of such an insulating
material 12 is ceramic particles contained in a polymer matrix. As
an alternative, the insulating material 12 can consist of a metal
oxidized to ceramic state. For instance, the core wire 3 could be
made of titanium, the surface of which is oxidized to titanium
dioxide, or the core wire 3 could be made of a metal having a
coating of aluminium oxidized to Al.sub.2O.sub.3. It is also
possible to manufacture the core wire 3 from an insulating
material, in which case no insulating material has to be provided
between the curved part of the D-shaped core wire 3 and the
conductive members 4. With the proper choice of material for the
core wire 3 and/or the insulating material 12, the conductors 5 may
be connected to the conductive members 4 by a crimping
technique.
[0039] In FIG. 5b an enlarged part of the conductors 5 of FIG. 5 is
illustrated. FIG. 5b shows that the conductors 5 each are provided
with a separate layer of insulating material 13. The conductors 5
may therefore be regarded as insulated conductors 5, which means
that conductors 5 may be positioned very close to each other, i.e.
without insulating material 6 being provided between them.
[0040] As mentioned above, the conventional design of a male
connector for a guide wire is to let the core wire extend into the
male connector, i.e. the core wire of the male connector is an
integral part of the core wire in the guide wire. As an example,
since the guide wire may be rather long and thin, up to 300 cm long
and 0.355 mm in diameter, it seems practical and economical to have
a cylindrical core wire inside the guide wire. The core wire in
such a conventional 0.355 mm guide wire has typically a diameter of
only 0.15 mm. To let such a thin cylindrical core wire extend into
a male connector and simply flatten a part of the mantle surface of
the core wire in order to create a D-shaped cross section would not
provide the special advantages described above. This fact is easy
to recognize from FIG. 4, where a core wire according to a
conventional design is illustrated. To just strip off a part of the
mantle surface of a core wire having such a small diameter would
obviously not create a cavity in which the conductors could reside
without the risk of being damaged when the male connector is bent.
Although it is conceivable, and within the scope of the present
invention, to enlarge the part of the core wire that extends into
the male connector and form this part into the desired cross
section, such as a D-shaped cross section, a better solution is to
provide male connector which is separately mountable on an existing
guide wire.
[0041] In FIG. 6 the cross section of a first alternative
embodiment of the male connector according to the present invention
is illustrated. In this embodiment, the core wire 3 has been
provided with a trough-shaped recess, in which the conductors 5 are
accommodated. The cavity created by this trough-shaped recess would
obviously protect the conductors 5 from being squeezed between the
conductive member 4 and the core wire 3 if the male connector is
bent.
[0042] In FIG. 6, the conductors 5 are all positioned in a common
cavity created by a single recess in the mantle surface of the core
wire 3. However, each of the connectors 5 could be positioned in a
separate cavity. This type of configuration is illustrated in FIG.
7, where three recesses are provided in the mantle surface of the
core wire 3. Each of these three recesses accommodates a single
conductor 5.
[0043] As mentioned above, the main object of the present invention
is to provide a male connector having a core wire with such a shape
that a large amount of material with high modulus of elasticity can
be provided inside the male connector, so that core wire, and
therefore the male connector, is as stiff as possible. In
accordance with this object, it is also conceivable to replace the
recesses described above with one or several longitudinal holes, in
which the conductors are disposed. An example of such a
configuration is shown in FIG. 8, where the core wire 3 has been
provided with a cavity in the form of a central hole, in which the
conductors 5 are accommodated.
[0044] From the illustrated embodiments of the present invention it
should be obvious that from a manufacturing point of view the
conductive members 4 may be regarded as resting against the core
wire 3, since at least two points on the mantle surface of the core
wire 3 have such positions that there is only one way to radially
position the core wire 3 inside the conductive member 4. The core
wire 3 may therefore be described as a self-centering or
self-positioning core wire 3, and, consequently, no extra
positioning step is necessary in the manufacturing of the present
male connector 1. From FIG. 4 it should be obvious that this
advantage is in contrast to prior art designs, in which the core
wire has to be carefully positioned in the centre of the conductive
member, or at some other location inside the conductive member.
[0045] In FIG. 9 a male connector 1 with another configuration of
the conductors 5 is illustrated. In the depicted configuration,
each of the conductors 5 is drawn in a 180.degree. loop before
being connected to the respective conductive member 4. Tests have
shown that this loop, which extends in the proximal direction of
the male connector 1 before going back to the distal end of the
conductive member 4, where the conductor 5 is connected, further
improves the durability of the conductors 5. Especially when the
conductor arrangement according to FIG. 9 is combined with one of
the core wire cross sections described above a surprisingly bending
insensitive male connector is provided.
[0046] A cross section of the conductor arrangement of FIG. 9 will
obviously exhibit an extra conductor cross section, since each
conductor loop contains two conductors, one going in the forward
direction and one going in the backward direction. An example of
such a cross section is shown in FIG. 10, where the D-shaped core
wire according to FIG. 5 has been combined with the conductor
arrangement according to FIG. 9. In this case, the three conductors
5 give rise to four conductor cross-sections inside the conductive
member 4.
[0047] To summarize, with the present male connector, which has
such a design that the total configuration consisting of the core
wire and the conductors presents a substantially circular cross
section, more material with high modulus of elasticity can be
provided in the interior of the male connector, in comparison with
prior art designs. This feature makes the male connector according
to the invention durable and resistant against bending, which, in
turn, makes it easy to insert the male connector into a female
connector, with a minimum risk of bending the male connector and
thereby damaging the conductors or other parts of the male
connector.
[0048] Further, with a larger amount of material with high modulus
of elasticity, the male connector becomes stiffer, which allows a
long insulation distance between the longitudinally spaced apart
annular conductive members with preserved stiffness. This is an
advantage since a long insulation distance means that the risk of
leakage currents between the conductive members is minimized.
[0049] Still further, with a larger amount of material with high
modulus of elasticity, the amount of insulating material inside the
male connector becomes less, which allows filling of insulation
material with a minimum of voids, which, in turn, yields a
waterproof and constant quality design.
[0050] Although the present invention has been described with
reference to specific embodiments, also shown in the appended
drawings, it will be apparent for those skilled in the art that
many variations and modifications can be done within the scope of
the invention as described in the specification and defined in the
following claims.
* * * * *