U.S. patent number 3,552,384 [Application Number 04/650,863] was granted by the patent office on 1971-01-05 for controllable tip guide body and catheter.
This patent grant is currently assigned to American Hospital Supply Corporation. Invention is credited to Will R. Pierie, Donald A. Raible, David L. Swendson.
United States Patent |
3,552,384 |
Pierie , et al. |
January 5, 1971 |
CONTROLLABLE TIP GUIDE BODY AND CATHETER
Abstract
A device for general and selective angiography and other
purposes having a handle, controllable tip guide body, injection
tube unit and catheter outer body wherein the tip of the guide body
may be bent, rotated, exposed and sheathed in the catheter by
control means on the handle and injection tube unit, and locked in
selected position, the several parts being usable as a complete
assemblage and in different combinations. The guide body is made
torsionally rigid so that the rotation of the tip corresponds to
the manipulation of a rotator on the handle, the guide body
rotating within the catheter outer body which is nonrotatable. The
guide body extends through the injection tube unit which is
interposed between the handle and the catheter outer body. The
injection tube unit has a sliding telescoping part for extending
the catheter outer body to sheath the guide body and for retracting
the catheter outer body to unsheath the tip of the guide body. For
certain purposes the injection tube unit and catheter outer body
may be removed and the guide body and handle used together as an
operative unit. Also, the guide body is conveniently removable from
the handle.
Inventors: |
Pierie; Will R. (Tustin,
CA), Raible; Donald A. (Corona, CA), Swendson; David
L. (Garden Grove, CA) |
Assignee: |
American Hospital Supply
Corporation (Evanston, IL)
|
Family
ID: |
24610623 |
Appl.
No.: |
04/650,863 |
Filed: |
July 3, 1967 |
Current U.S.
Class: |
600/434;
604/95.04 |
Current CPC
Class: |
A61M
25/0136 (20130101); A61M 25/0147 (20130101); A61M
25/09041 (20130101); A61M 5/00 (20130101); A61M
25/09033 (20130101); A61M 25/0144 (20130101); A61B
6/504 (20130101); A61M 25/0108 (20130101); A61B
6/481 (20130101) |
Current International
Class: |
A61B
6/00 (20060101); A61M 25/01 (20060101); A61M
5/00 (20060101); A61b 005/02 (); A61m 025/00 () |
Field of
Search: |
;128/2,2.05,348--351,356,303 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. An instrument comprising an elongated flexible guide body having
bending means in its tip portion, a pull wire in said guide body
for actuating said bending means, a handle on the proximal end of
said guide body, means in said handle connected with said guide
body for rotating said guide body relative to said handle, means in
said handle for pulling said pull wire relative to said guide body,
an injection tube unit fixedly mounted on said handle, a catheter
outer body fixedly mounted on a portion of said injection tube
unit, said guide body extending through said catheter outer body
and said injection tube unit, detachable connections between the
proximal end of said injection tube unit and said handle and
between the distal end of said injection tube unit and said
catheter outer body, a shutoff valve in said injection tube unit
arranged to close a passageway for said guide body in said unit, a
branch fitting on said injection tube unit between said valve and
the distal end of the unit, and a resilient circular seal in said
unit on the opposite side of said valve engaging said guide
body.
2. A handle for a flexible, elongated controllable tip guide body
having a pull wire extending out of said body for bending said tip;
said handle comprising an elongated body member, a rotator on said
body member, a slide mounted in said body member for rotation and
reciprocation on the axis of said rotator, means on said rotator or
rotating said slide, means on said handle for reciprocating said
slide, axial passageways through said rotator and slide, an axial
thrust seat in said rotator passageway for the proximal end of said
guide body, an axial thrust seat on said side at the proximal end
of said slide passageway for a button on the proximal end of said
pull wire, a hole in the proximal end of said slide at one side of
said button thrust seat arranged to convey said button to a
position emergent from said slide when said guide body and pull
wire are inserted in said passageways, and a slot of less width
than said button interconnecting said hole and button seat for
lateral transfer of said pull wire from said hole to said button
seat for seating said button.
3. A handle as defined in claim 2, said rotator being situated at
the distal end of said slide, said rotator having a sliding
connection with said slide for rotating the slide.
4. A handle as defined in claim 2, including means for adjusting
said button seat lengthwise on said slide.
5. A handle as defined in claim 2, including adjustable stop means
on said handle to hold said slide in longitudinally adjusted
positions.
6. A handle as defined in claim 2, including a connector on the
distal end of the handle for mounting a tubular member over said
guide body.
7. A handle as defined in claim 2 including a rotator support
having an outer end extending outside of said handle and means on
said outer end of said rotator support for mounting a tubular
member concentric with said passageways.
8. A handle as defined in claim 2, including a spring urging said
slide in a distal direction, said means for reciprocating said
slide comprising a lever on said handle arranged to move said slide
in a proximal direction.
9. A handle as defined in claim 8, including a lever bracket in
said body member having a pivotal support for said lever, a slide
bracket mounted on said lever bracket and having a bearing for said
slide, said lever having a cam-shaped inner end, a cam washer on
said slide engaging said cam-shaped inner end, and a thumb screw
securing said lever bracket in said body member, said brackets,
slide and lever being removable from said proximal end of said body
member as a unit when said thumb screw is removed.
10. An injection tube unit comprising a guide tube, an injection
tube slidably mounted in said guide tub, a longitudinal passageway
through said injection tube, a shutoff valve for said passageway, a
branch fitting communication with said passageway between said
valve and one end of said injection tube, and a resilient circular
seal in said passageway at the opposite end of said injection tube
arranged to engage a body extending through said passageway.
11. An injection tube unit as defined in claim 10, said one end of
said injection tube projecting out of one end of said guide tube,
connector means in communication with said passageway on said one
end of said injection tube, and connector means in communication
with said passageway on the opposite end of said guide tube.
12. An injection tube unit as defined in claim 10, including a
longitudinal guide slot in said guide tube, a stop screw in said
injection tube slidable in said slot, and stop means for said screw
at the opposite ends of said slot.
13. A torsionally rigid controllable tip guide body comprising a
plural layer wire coil having adjacent turns in each layer in
contact with each other and adjacent layers wound in opposite
directions, a pull wire slidable in said coil, a distal end fitting
on said guide body abutting the distal ends of said coil and layers
of wire, a spring leaf having a proximal end connected with said
fitting, said pull wire extending slidably through said fitting and
connected with the distal end of said spring leaf, and a continuous
plastic covering over said coil, said fitting and said spring leaf
and pull wire, said plastic being adherent to said coil, fitting
and spring leaf and nonadherent to said pull wire.
14. A guide body as defined in claim 13, including guide means for
said pull wire along the length of said spring leaf.
15. A guide body as defined in claim 14, said guide means
comprising a coil of wire surrounding said spring leaf and pull
wire.
16. A guide body as defined in claim 13, including a fitting on the
proximal end of said guide body having an end seating surface and a
flat tongue extending therefrom for rotating the guide body.
17. An instrument comprising an elongated flexible and torsionally
rigid guide body having bending means in its tip portion, a handle
on said guide body having means to operate said bending means and
means to rotate said guide body relative to said handle, a catheter
outer body surrounding said guide body, and means connected with
said handle and said catheter outer body arranged to slide said
catheter outer body on said guide body so as to sheath and unsheath
the bendable tip portion of said guide body, said last means
holding said catheter outer body nonrotatable relative to said
handle.
Description
BACKGROUND OF THE INVENTION
It is often desired to place a catheter or other instrument at a
particular point in a body lumen, such as a blood vessel, which is
difficult of access. In selective angiography, for example, the
blood vessel often must be entered at some remote point and the
catheter or instrument guided into a selected branch as it is
pushed along through the vessel. The necessary guidance to effect
entry into the selected branch involves the two variables of
bending and orientation of bending.
The change of direction has generally been accomplished heretofore
by the use of prebent catheter tips. This has advantages for
certain purposes but the configuration of the bend cannot be
changed after the catheter has been inserted in the vessel and it
is difficult to orient the bend in the desired direction because of
the torsional flexibility of the catheter tube.
Short and rigid controllable tip devices have also heretofore been
proposed for special purposes in which the degree of bending of the
tip could be controlled from a handle but such devices have not
been satisfactory for vascular purposes were the catheter must be
long, slender and flexible throughout its entire length. It is
desireable to provide precise control of the orientation of the
bendable tip as well as the degree of bending and it is further
desirable to afford greater flexibility in the manner in which such
instruments may be used in blood vessels and other body lumens.
Torsional rigidity is necessary for control of orientation.
SUMMARY OF THE INVENTION
This invention relates to an improved controllable tip guide body
which may be used to guide a catheter tube or other instrument into
a relatively inaccessible location in a blood vessel or other body
lumen and to an improved intralumenal device including such a guide
body.
The present instrument comprises a handle detachably connected with
an injection tube unit. A catheter outer body may be detachably
mounted on the latter. The handle carries a controllable tip guide
body which extends through the injection tube unit and catheter
outer body and is removable therefrom. The guide body is freely
flexible in bending but torsionally rigid. It has a tip which is
bendable in one direction. Devices are provided on the handle for
bending and rotating the tip. Means are provided on the injection
tube unit for sliding the catheter outer body on the guide body to
expose or sheath the bendable tip. Means are also provided for
locking the bending and sliding adjustments in selected
positions.
The detachable connections are arranged in such a way that the
guide body may be inserted into the vessel first and then the
catheter outer body applied over the guide body, or the catheter
outer body may be first inserted in the vessel and then the guide
body inserted through the catheter. After the catheter has been
inserted to its desired position in the vessel or other lumen, the
handle and guide body may be removed from the injection fitting and
catheter. The injection tube unit may be used to introduce an X-ray
opaque dye through the catheter either while the guide body remains
in the catheter or after the guide body has been removed. These
capabilities provide a flexibility of operation which is of great
advantage to the surgeon and which has not been available in prior
instruments.
Objects of the invention are, therefore, to provide an improved
controllable tip guide body for a catheter and other purposes, to
provide a controllable tip guide body in which the degree of
bending may be controlled and locked in selected adjustment on a
handle part, to provide a controllable tip guide body and catheter
combination in which the guide body tip may be sheathed and
unsheathed by the catheter, to provide a catheter probe assembly
having an inner guide body which is rotatable within a nonrotatable
catheter outer body, to provide an improved injection tube unit for
a catheter of the type described to provide a handle having a
controllable tip guide body and detachable injection tube unit and
catheter wherein the guide body is removable along with the handle
from the injection tube unit and catheter and to provide an
instrument of the type described in which the several parts may be
used in different combinations and as a complete assemblage.
The foregoing and other objects and advantages will become apparent
and the invention will be better understood with reference to the
following description of the preferred embodiment illustrated in
the accompanying drawings. Various changes may be made, however, in
the details of construction and arrangement of the parts and
certain features may be used without others. All such modifications
within the scope of the appended claims are included in the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevation view of a complete instrument embodying the
features of the invention, showing the bendable tip of the guide
body unsheathed by the catheter;
FIG. 2 is view similar to FIG. 1, showing the bendable tip
sheathed;
FIG. 3 is a longitudinal sectional view of the handle of the
instrument, showing the palm lever in relaxed position
FIG. 4 is an elevation view of the handle, with parts broken away,
showing the palm lever in actuated position;
FIG. 5 is a view on the line 5-5 in FIG. 3;
FIG. 6 is a view on the line 6-6 in FIG. 3;
FIG. 7 is a view on the line 7-7 in FIG. 3;
FIG. 8 is an exploded perspective view of the slide in FIGS. 3 and
4;
FIG. 9 is a longitudinal sectional view of the injection tube
unit;
FIG. 10 is a view on the line 10-10 in FIG. 9;
FIG. 11 is an enlarged fragmentary sectional view showing a portion
of the handle and a portion of the injection tube unit;
FIG. 12 is an elevation view of the catheter outer body;
FIG. 13 is an elevation view of the controllable tip guide body,
with parts broken away, showing the tip in straight position
FIG. 14 is a view similar to FIG. 13, showing the tip in bent
position;
FIG. 15 is an enlarged longitudinal sectional view, showing the
bendable tip portion of the guide body;
FIG. 16 is a view on the line 16-16 in FIG. 15;
FIG. 17 is an enlarged view on the line 17-17 in FIG. 14; and
FIG. 18 is a view on the line 18-18 in FIG. 17.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The Handle A
The complete instrument comprises a handle A, guide body B,
injection tube unit C and catheter outer body D as shown in FIGS. 1
and 2.
Referring now to FIG. 3, the operating mechanism in the handle A is
carried by a tubular body member 10. Body member 10 has a distal
end wall 11 provided with a bore 12 to receive a cylindrical
rotator support 13. The rotator support is fixedly secured in this
bore by setscrews 14. Extending through the rotator support is n
axial passageway 15 which opens into a socket 16 in the outer end
of the rotator support. The inside of socket 16 is provided with a
plurality of longitudinal grooves 17. Rotatably mounted on the
outside of socket 16 is a threaded support collar 20 for connecting
the injection tube unit C with handle A.
A knurled cylindrical rotator 21 is rotatably mounted on Teflon
balls 22 on the inner end of support 13. These balls are introduced
through a radial bore 23 which is closed by a screw plug 24. An
index fitting 25 is fixedly mounted by press fit in rotator 21.
This fitting has an axial passageway 26 in alignment with
passageway 15. A pair of longitudinal grooves 27 intersect opposite
sides of passageway 26 to form a transversely elongated slot
extending through the length of index fitting 25. The adjacent ends
of passageways 15 and 26 are chamfered at 28. The distal end of
passageway 26 is counterbored to form an enlarged circular end
portion 29 having a seating shoulder at 30. The proximal end of
guide body B extends through passageway 15 and seats against
shoulder 30. The proximal end of passageway 26 is chamfered at 31.
An axial tube 35 is soldered onto the proximal end of index fitting
25, this tube being provided with a pair of longitudinal slots
36.
A lever bracket 40 is detachably mounted in body 10 by means of
thumb screw 41. A forwardly extending palm lever 42 is pivotally
mounted on a pin 43 in ears 44 on the bracket 40 as shown in FIG.
6. In order to reduce friction, the pin 43 is preferably equipped
with an oil-less nylon bushing 45.
A slide bracket 46 is mounted on lever bracket 40 by means of
screws 47. Slide bracket 46 is bored to receive a bushing 48 for a
cylindrical slide 50 which is adapted to reciprocate and rotate in
the bushing 48. Slide 50 is urged toward the left in FIG. 3 by a
compression spring 51 which is seated at its opposite ends on the
bushing 48 and a support washer 52 which is rotatable on the slide.
Washer 52 abuts a radial flange 53 on the slide. The distal end of
slide 50 is equipped with a pair of radial guide pins 54 which are
disposed in the slots 36 of tube 35. Slide 50 further contains an
axial passageway 55 in alignment with the in alignment with the
passageways 15 and 26, the distal end of passageway 55 being
chamfered at 56.
Palm lever 42 is in bell crank shape having a forked inner end 60
which straddles slide 50 on the proximal side of slide bracket 46.
The end 60 is rounded to function as a cam and is normally held in
a limit position against slide bracket 46 by a cam washer 61 on the
slide. Washer 61 is mounted so that it rotates when the slide 50
rotates, by means of a setscrew 62 which enters a longitudinal slot
63 in the slide. The position of washer 61 is fixed by a retainer
65 which bears against a thrust abutment in the form of a two-part
stop washer 66. Washer 66 is mounted in a circumferential groove 67
in slide 50 as best shown in FIG. 8. The position of washer 66 is
fixed by its abutment against the right side of groove 67 as shown
in FIG. 3.
When palm lever 42 is squeezed toward body 10 as shown in FIG. 4,
its cam-shaped inner end 60 bearing against washer 61 moves slide
50 to the right in FIG. 3, causing pins 54 to slide in slots 36.
The purpose of this movement is to retract a pull wire, presently
to be described, which bends the tip of guide body B. The proximal
end of the guide body seats in counterbore 29 and the pull wire
extends through passageways 26 and 55 and has its end anchored at
the extreme proximal end of slide 50 by means presently to be
described. Such squeezing movement of lever 42 compresses the
spring 51 and when the squeezing force on the lever is relaxed, the
spring acts through washer 61 to return the parts to their FIG. 3
position. Slide bracket 46 acts as a stop for this return movement,
as washer 61 presses lever end 60 against the end of bracket
46.
Slide 50 may be rotated at all times by finger and thumb
manipulation of rotator 21. Rotator 21 directly rotates the guide
body seating bore 29 and indirectly rotates slide 50 through its
pins 54. During such rotation, washer 61 slides freely against the
inner lever end 60 regardless of the position of the lever.
An adjustable anchor for the guide body pull wire will now be
described with reference to FIG. 3. A slide cap 70 is mounted for
longitudinal sliding movement on the end of slide 50. For this
purpose the slide 50 is provided with a longitudinal tongue 71
which is received in a slot 72 in one side of the slide cap. The
slide cap is externally threaded at 73 for engagement with an
internally threaded adjustment nut 75. The inner end of nut 75 is
externally threaded at 74 for connection with the retainer 65, this
connection being screwed tightly together so that the retainer will
rotate as a part of the nut. Thus, the longitudinal position of nut
75 is fixed by retainer 65 which is confined between stop washer 66
and cam washer 61 so that rotation of the nut causes slide cap 70
to move longitudinally on slide 50.
Slide cap 70 has a slot for the guide body pull wire with a narrow
central portion 76 interconnecting a wider end portion 77 and a
hole 78. Wide portion 77 has a seat 80 for a button on the end of
the pull wire while hole 78 forms a smooth bore angular passage for
insertion of the pull wire from the distal end of the handle. The
inner end of this slot communicates with passageway 55 and the
proximal end of passageway 55 is chamfered as indicated at 81.
The proximal end of body 10 is covered by a cap 85 having an
opening 86 therein for the adjusting nut 75. This cap is secured to
handle bracket 40 by screws 87. Mounted on the cap is a locking
thumb screw 90 for holding the palm lever 42 in adjusted position.
The inner end of this thumb screw has threaded engagement with a
bore 91 in lever bracket 40. Thumb screw 90 extends between the
forks of lever end portion 60 and is equipped with an abutment
flange 92 which is adapted to bear against the forks. When lever 42
is squeezed toward body 10 in a position to obtain the desired
degree of bending in the bendable tip of guide body B, such
adjustment may be locked by screwing out the thumb screw 90 until
abutment flange 92 engages the forked lever end 60 as shown in FIG.
4.
By removing thumb screw 41, the entire assemblage of palm lever 42,
brackets 40 and 46, slide 50, and adjustment devices 75 and 90 are
removable through the proximal end of handle body 10.
Injection Tube Unit C and Catheter Outer Body D
Referring now to FIG. 9, the injection tube unit C comprises an
injection tube 100 slidably mounted in a guide tube 101. The guide
tube has a threaded proximal end 102 for detachable connection with
support collar 20 on the handle A and a projection 103 to fit in
the socket 16 as shown in FIG. 11. Lands 104 fit in grooves 17 so
that the unit will fit in the handle in different rotative
positions but will be fixedly held against relative rotation.
A stop screw 105 in tube 100 extends through a longitudinal slot
106 in guide tube 101. Tightening screw 105 clamps the two parts in
adjusted position and loosening the screw permits longitudinal
movement of the injection tube 100 in the guide tube 101 within the
range of travel allowed by end stops 107 and 108. The injection
tube is shown fully retracted in FIGS. 1 and 9 and fully extended
in FIG. 2.
Injection tube 100 has an axial passageway 110 for the guide body
B. The distal end of the injection tube is provided with a branch
fitting 111 communicating with passageway 110 and immediately on
the proximal side of branch 111 is a shutoff valve 112 to open and
close passageway 110. The distal extremity of tube 100 is threaded
at 113 for connection with the catheter outer body D. Fitting 111
may be used for injecting dye or medication through catheter outer
body D, for withdrawing a blood sample or for taking blood pressure
measurements.
The proximal end of injection tube 100 is threaded at 119 to
receive a squeeze nut 120 containing a resilient rubber O-ring 121.
Nut 120 is adjusted to squeeze the O-ring sufficiently to effect a
seal with the guide body B at the end of passageway 110 while still
permitting the guide body to be inserted and removed through the
O-ring, as shown in FIG. 11. Thus, when valve 112 is open and guide
body B is in place in passageway 110, the passageway is sealed by
O-ring 121 so that fluid injected through branch 111 cannot escape
from tube 100 and enter the handle A. When the guide body is
removed in a proximal direction, valve 112 is closed as soon as the
distal end of the guide body has cleared the valve in FIG. 9 but
before the end of the guide body has cleared the seal 121. After
the guide body has been completely withdrawn, the valve 112
prevents any fluid in branch 111 and outer body D from escaping
from tube 100.
The catheter outer body D is shown in FIG. 12. This is simply a
flexible plastic tube 125 having a screw threaded fitting 126 on
its proximal end for connection wit the threaded member 113 in FIG
9. The distal end 127 of tube 125 is open so that guide body B may
be projected as shown in FIG. 2 and for the other purposes
mentioned.
Guide Body B
Guide body B is illustrated in FIGS. 13 to 18. This guide body
comprises a flexible plastic tube 140 having a tip end portion 141
equipped with a bending element. The proximal end is equipped with
a proximal end fitting 142 and extending through this fitting is a
flexible pull wire 150 equipped with a button 151 on its end.
Pull wire 150 extends through a thrust coil 155 which is a coil of
spring wire wound on a mandrel with adjacent turns in contact with
each other so that the coil is rigid as a column and cannot be
compressed lengthwise, although it is freely flexible in bending.
The mandrel on which coil 155 is wound is of a suitable size so
that the pull wire 150 will be freely slidable therein. Surrounding
coil 155 is a tightly wound triple wrap coil 156 of finer wire in
three layers as best shown in FIG. 17. The center layer is wound in
the opposite direction from the inner and outer layers. That is to
say, that if the center layer is wound clockwise, the inner and
outer layers are wound counterclockwise. Coil 156 is wound on a
mandrel of a size to form an inside coil diameter suitable for
insertion of coil 155.
Coil 155 may be omitted if desired. Triple wrap coil 156 in itself
provides adequate thrust resistance for the pull wire.
The purpose of the three layer, triple wrap coil 156 is to provide
torsional rigidity for guide body B while still retaining free
flexibility in bending. Since the middle layer of coil 156 is
locked between the inner and outer layers, the middle layer can
neither contract nor expand radially when the tube is stressed in
torsion in opposite directions of rotation. Also, the inner layer
cannot expand in one direction of rotation and the outer layer
cannot contract in the opposite direction of rotation. This
internal and external restraint eliminates all torsional
flexibility so that when one end of the tube is rotated about its
axis, the opposite end will rotate precisely the same amount.
Such rotation is imparted by the flat tongue 160 on the end of
fitting 142 which fits in the grooves 27 of index fitting 25 on the
rotator 21 in FIG. 3. Fitting 142 has a flat end surface 161 which
seats against the shoulder 30. FIG. 11 shows these parts in
assembled relation.
Guide body tube 140 further includes an outer layer of plastic 162
which encloses the wire coil assemblage just described and provides
a smooth outer surface to minimize sliding and rotating friction
against other objects. Plastic 162 also prevents leakage of any
fluid into the coils 155 and 156. Fitting 142 is secured tightly to
the tube 140 so as to transmit rotative movements of rotator 21 to
the tube. Pull wire 150 slides freely in a bore 163 in the fitting
142.
The distal end of tube 140 is equipped with a tip junction fitting
165 which is likewise securely attached to the tube. The opposite
ends of both coils 155 and 156 seat against end walls in the two
fittings 142 and 165 as shown. Fitting 165 has a bore 166 slidably
receiving the pull wire 150. Fitting 165 has an extension 167 with
a flat side 168 offset from bore 166 on which is soldered a
proximal end of a metal leaf spring member 170. The distal end of
spring leaf 170 is similarly soldered to a tip wire fitting 171.
Pull wire 150 extends along one flat side of spring leaf 170 and
the end of the pull wire is soldered at 172 to the fitting 171.
Spring leaf 170 and pull wire 150 are enclosed in a cage formed by
wrapping a wire 173 around the two elements in spiral
configuration. One end of wire 173 is soldered at 174 to spring
leaf 170 and fitting 165 and the other end is soldered at 175 to
spring leaf 170 and fitting 171. The spiral wrap 173 is
sufficiently loose that it does not impede free axial movement of
pull wire 150.
The metal parts 165, 170, 171 and 173 are then coated with a primer
and pull wire 150 is coated with a lubricant and a plastic covering
176 is molded around the parts as shown. The plastic bonds itself
to the primer coated surfaces but does not adhere to pull wire 150
whereby the latter may slide freely through the plastic and through
wire cage 173 for bending the tip 141. During the molding operation
the plastic 176 on the tip is merged with the plastic 162 on the
tube portion 140 making a smooth surfaced juncture completely
covering the fitting 165. The tip 141, however, may be molded
separately and attached to the body 140.
When pull wire 150 is drawn through fitting 165, leaf spring 170 is
caused to bend, producing the curved tip configuration shown in
FIG. 14. Coil 155 in the main tube portion 140 acts as a thrust
member to prevent snaking of the whole length of the guide body
when the pull wire is tensioned. Thus, the tip 141 may be bent at
any angle desired up to 180.degree..
An advantage of the present form of construction of guide body tube
140 is that this tube may be manufactured conveniently in
continuous length and then cut to the desired lengths for different
surgical purposes. The bendable tip portions 141 may be
standardized and used with any length tube portion 140. This
effects distinct economy in manufacture while still permitting the
different lengths required by surgeons.
Adjustment nut 75 in conjunction with slide cap 70 in FIG. 3 allows
for reasonable manufacturing tolerance in the length of pull wire
150. In installing guide body B in handle A, the button 151 is
inserted in a proximal direction through passageways 15, 26 and 55
until the button appears in wide slot portion 78 of slide cap 70.
The depth of insertion is limited by the seating of tube fitting
142 against shoulder 30. If necessary, adjusting nut 75 is turned
to retract slide cap 70 into the nut until button 151 is emergent
from the slide cap so that guide wire 150 may be passed through the
narrow portion 76 of the slot to the upper wide portion 77 in FIGS.
3 and 7. Then nut 75 is rotated in the reverse direction to seat
button 151 against the seat 80. This longitudinal adjustment of
slide cap 70 thereby compensates for any variation in the distance
between button 151 and the proximal end fitting 142 on the tube
140.
When lever 42 is squeezed toward handle body 10, the entire slide
50 is moved rearwardly carrying with it slide cap 70 and nut 75 and
causing tip 141 to bend. A desired degree of bending may be
retained by means of locking thumb screw 90 is previously
described.
Guide body B is removed from handle A by merely returning palm
lever 42 to its FIG. 3 position and moving slide cap 70 inwardly by
rotating nut 75 until button 151 emerges from the wide slot portion
77. Then pull wire 150 is shifted through narrow slot portion 76 to
the opposite wide slot portion 78. Guide body B may then be
withdrawn from the distal end of the handle. Passageway 55 and hole
78 are of sufficient width to permit the button 151 to pass freely
through the angular juncture.
Operation
The parts A, B, C and D may be assembled in different order and
used in different combinations for different purposes.
In one type of use guide body B may be assembled with handle A
without injection tube unit C and catheter outer body D. After
guide body B has been advanced to its destination in a blood vessel
or other body lumen, the handle A maybe removed and catheter outer
body D, with or without injection tube unit C, may be introduced
over guide body B and inserted into the vessel or lumen to follow
the path of the guide body. Then guide body B may be withdrawn if
desired, leaving outer body D in the vessel.
Alternatively, the catheter outer body D, with injection tube unit
C attached, may be inserted first for a distance into the vessel or
lumen and then the guide body B, assembled with handle A, may be
pushed through the injection tube unit and catheter outer body and
the handle connected with the injection tube unit. Then the
complete assemblage may be advanced farther into the vessel or into
a branch of the vessel.
In a third alternative, the parts B and D of the complete
assemblage may be inserted in the vessel or other lumen. This may
be done with the catheter outer body D retracted as shown in FIG. 1
or with the catheter outer body projected to cove the bendable tip
of the guide body as shown in FIG. 2. In some cases, it is most
effective to proceed with a step-by-step movement advancing first
the guide body B and then the catheter outer body D by sliding stop
screw 105 back and forth in its slot 106 in FIG. 9 and continuing
in this manner until the objective has been reached. In this
connection, it will be mentioned that the bendable tip portion 141
of the guide body will bend the catheter outer body D when
completely enclosed by the latter, when desired.
The instrument may be used in three different catheterization
techniques known as cutdown, percutaneous with separate guide wire
and percutaneous using guide body B in place of separate guide
wire. The cutdown procedure involves simply cutting through the
overlying tissue to obtain access to the desired vessel, then
cannulating this vessel and, finally, inserting guide body B and
catheter outer body D into this vessel for further advance in the
vessel or into a branch vessel.
In the general percutaneous procedure, a conventional flexible
guide wire is first inserted into the vessel and then the catheter
outer body D is inserted over the guide wire. Injection tube unit C
may be assembled to the catheter outer body D optionally before or
after the catheter outer body is inserted over the guide wire.
Then, the flexible guide wire is removed and guide body B,
assembled with handle A, is inserted through injection tube unit C
and catheter outer body D for further advance.
In the second percutaneous procedure, guide body B is inserted
through the needle cannula into the vessel. Then the cannula is
removed over the proximal end of guide body B and catheter outer
body D is inserted into the vessel over guide body B. Handle A may
be assembled to guide body B before or after the guide body is
inserted through the needle cannula into the vessel. Likewise, the
injection tube unit C may optionally be assembled with the catheter
outer body D before or after the latter is inserted into the vessel
over guide body B. A surgeon will usually elect to minimize the
bulk assembled to intralumenal devices during the installation
phases, hence will defer attachment of assemblies and
instrumentalities.
Specialized types of catheters may be used instead of the plan tube
catheter outer body D. For example, the guide body B is of
particular advantage in guiding a double lumen balloon catheter to
a desired location in the body. Such catheter is attached to the
injection tube unit C for injection of an X-ray contrast medium or
localized medication through branch connector 111. With the vessel
occluded by inflation of the balloon, washing of the blood is
minimized and less contrast dye or medication is required.
The present instrument is also useful in connection with other
specialized instrumentalities. For example, in fiber optics
visualization guide body B is used as previously described to get
an outer body tube D to the desired location within the body. Then
the guide body B is removed and a fiber optic device inserted
through the outer body D for the visualization study. Similarly,
the present instrument may be used to guide the placement of other
devices such as flow probes, pressure probes, etc.
For still other purposes, a PH probe, pressure transducer or
thermistor is attached to the tip of guide body B which my then be
used advantageously in combination with a double lumen balloon
catheter. Very selective localized measurements of a variety of
kinds are thereby possible concurrently with angiography or
administration of medication in a single procedure. Such
modifications are applicable to systems other than vascular, such a
the urinary system.
The foregoing examples are merely illustrative of the wide variety
of uses of the present instrument. Still other applications are
possible and the field of use is not intended to be limited to the
specific examples cited.
The handle A is easily taken apart for cleaning and autoclaving and
is reusable indefinitely as is also the injection tube unit C.
Guide body B is intended to be reusable for a limited time.
Catheter outer body D is essentially a single-use, disposable
device, although it may be cleaned, sterilized and reused a number
of times, if desired.
Two other advantages of major importance are the rotatability of
guide body B continuously in one direction without twisting the
pull wire 150 and the rotatability of the guide body within the
nonrotatable catheter outer body D. In regard to the former, it
will be observed in FIG. 3 that rotator 21 rotates the pull wire
anchorage in slide cap 70 together with index fitting 25 which
rotates guide body tube 140. There is no restraint upon the degree
of rotation. The advantage of the latter is that the smooth inner
surface of catheter outer body D imposes less frictional resistance
against rotation of the guide body than does the inner surface of a
body lumen. This makes it easier to orient the bendable tip.
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