U.S. patent number 3,811,449 [Application Number 05/232,748] was granted by the patent office on 1974-05-21 for dilating apparatus and method.
This patent grant is currently assigned to Becton Dickinson and Company. Invention is credited to Hulbert V. Barringer, Leland C. Gravlee.
United States Patent |
3,811,449 |
Gravlee , et al. |
May 21, 1974 |
DILATING APPARATUS AND METHOD
Abstract
To accurately dilate tissue preparatory to introducing medical
instruments therein, an elongated, flexible probe of uniform
diameter having a rounded insertion tip is employed to sound the
tissue. An elongated, hollow, flexible dilator is then slidably
passed over the probe to coaxially abut the probe insertion tip.
The probe is withdrawn through the dilator. A second, hollow,
flexible dilator is coaxially inserted over the first dilator and
the first dilator is withdrawn from the second dilator. Thereafter
the procedure is repeated with dilators of successively larger
internal diameter such that a final dilator is implanted which
stretches the tissue to a desired degree. A medical instrument may
thereafter be passed through the final dilator in proper alignment
for treating purposes. The final dilator is thereafter withdrawn
leaving the medical instrument to be utilized as needed. The
apparatus provides for accurate insertion of subsequent dilators
and the desired medical instrument with reduced patient trauma.
Inventors: |
Gravlee; Leland C. (Mountain
Brook, AL), Barringer; Hulbert V. (Hohokus, NJ) |
Assignee: |
Becton Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
22874391 |
Appl.
No.: |
05/232,748 |
Filed: |
March 8, 1972 |
Current U.S.
Class: |
606/191; 604/104;
604/523 |
Current CPC
Class: |
A61M
29/02 (20130101) |
Current International
Class: |
A61M
29/00 (20060101); A61m 029/00 () |
Field of
Search: |
;128/341,343,348,349R,350 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Vlietstra - Surgery, Vol. 37, No. 5, May, 1955, pp.
811-819..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Claims
1. A method of facilitating entrance through a body orifice and
dilation of the orifice thereafter to a desired degree
comprising:
inserting an elongated flexible plastic probe of uniform diameter
throughout its length and having distal and proximal ends into the
body orifice to the desired extent;
shifting at least one elongated hollow flexible plastic dilator
member of uniform inner and outer diameter and open at both ends
and having a slightly larger inner diameter than the outer diameter
of the probe axially with respect to the probe from the proximal
end to the distal end thereof into a concentric position therewith
after the probe has been inserted into the orifice so as to dilate
the orifice;
facilitating dilation by providing a probe and each dilator member
which are conformable in configuration to the orifice; and
removing the probe from within the dilator member by shifting the
probe from the concentric relationship with the dilator member in
the orifice so as to remove the probe while retaining the dilator
member in the dilated orifice with the dilator member independently
retaining the orifice in the dilated condition, providing an access
passageway through the hollow dilator member to facilitate
insertion and removal of instruments to and from the interior of
the body, and providing a support for insertion of a further
dilator member when one is to be employed.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a dilating apparatus permitting
extremely accurate insertion and dilation with significantly
reduced patient trauma. More particularly, it relates to a dilating
apparatus permitting accurate insertion of medical instruments with
reduced patient trauma.
In order to treat various internal portions of the body it is often
necessary to dilate stretchable tissue and insert the required
medical instrument into the cavity to be treated. For example,
dilation of the cervical canal is required in the performance of
several female medical procedures. In order to insert an
intrauterine coil, curettes or the Gravlee JET WASHER described in
U.S. Pat. No. 3,527,203, there must be an extremely accurate
dilation and insertion procedure. Conventionally, this has been
accomplished by employing a series of Hegar dilators. These
instruments are round, rigid and metal probes of graduated sizes
which are sequentially inserted and removed from the cervical os,
each probe larger in diameter than the other. Because of the
difficulty of passing an instrument into the uterine cavity, the
cervix is usually dilated to a point larger than the instrument
itself. Often this procedure can be painful, usually requiring
anesthetic.
In many cases there is considerable pain associated with the
inaccurate insertion of the metal probes and/or medical
instruments. Often the passage to be dilated closes after removal
of the conventional dilators. Finding the originally dilated
opening in the partially closed passage can be difficult, painful
and time consuming.
Other body cavities also require dilation prior to treatment. The
urinary tract in both males and females is often probed and dilated
as part of routine medical procedure. Dilation of the Sphincter of
Oddi to facilitate passage of residual stones or debris left in the
common duct is a common procedure.
In U.S. Pat. No. 3,196,876, issued to Miller, it has been proposed
to employ a metal probe having a rigid handle and a bulbous tip on
the guide probe. Thereafter, a series of sleeves are inserted over
the imbedded guide probe to dilate the passage. The sleeves also
have an enlarged, oval-shaped tip. It is impossible to insert a
medical instrument into the dilated passage employing the Miller
device without first withdrawing all the dilators and, thereafter,
also withdrawing the implanted probe. This procedure must be
followed because the bulbous tip on the Miller probe does not
permit it to be removed from the passage without the prior removal
of the subsequently inserted sleeves. Should the Miller dilated
passage relax and close, after removal of the sleeves and probe,
then insertion of a medical instrument therein can be difficult,
traumatic and time consuming for both the doctor and patient.
Particularly, on the battlefield there is an urgent need for a
dilation apparatus that would allow rapid and accurate dilation of
a bullet wound passage and the subsequent introduction of a medical
instrument to remove the bullet. Conventional dilating apparatus,
particularly, rigid dilating apparatus, do not permit this
procedure to be carried out rapidly, accurately and with reduced
trauma to the patient.
SUMMARY OF THE INVENTION
It is, therefore, a primary object of the present invention to
provide a dilating apparatus adapted to dilate a passage with
increased accuracy and reduced trauma as compared to prior art
apparatus.
It is another object of the invention to provide a dilating
apparatus which permits the rapid and accurate insertion of a
medical instrument into an internal cavity while the opening to the
cavity remains in a dilated state, greater than the size of the
medical instrument.
It is also an object to provide a method for accurately dilating a
body passage to permit an immediate, accurate, insertion of a
medical instrument through a final dilator into the passage.
The above and other objects are obtained by the combination of an
elongated, flexible probe of uniform diameter and at least one
elongated, hollow, flexible dilator adapted to be slidably guided
over the probe wherein the probe and dilator are removably mounted
with respect to each other. The probe has a rounded insertion tip
which permits the probe to be freely retracted through the
surrounding hollow dilator, after sounding.
To expand the probed passage a plurality of elongated, hollow,
flexible, uniform dilators are provided wherein successive dilators
are adapted to be slidably mounted over each other. The dilator of
least diameter is adapted to be slidably guided along the probe to
at least concentric abutment with the probe insertion tip. The
probe and dilator of least diameter are removably mounted with
respect to each other. Likewise, the dilators of successively
increasing diameter are removably mounted with respect to each
other.
A method is also provided for accurately dilating stretchable
tissue as body orifices, ducts or wounds with reduced trauma and
for accurately introducing medical instruments into the dilated
orifices, ducts or wounds. The method includes inserting an
elongated, flexible probe of uniform diameter into the stretchable
tissue to a predetermined position therein. The probe has a rounded
insertion tip. A first elongated flexible hollow dilator is
inserted over the probe up to the insertion tip of the probe. Then,
the flexible probe is removed from the tissue through the
dilator.
Next, a second elongated, hollow, flexible dilator is inserted over
the first dilator co-extensive with the first dilator. The second
dilator is of slightly larger internal diameter than the external
diameter of the first dilator. Thereafter, the first dilator is
removed from the tissue through the second dilator. Dilators of
successively greater internal diameter are sequentially inserted
over dilators of lesser diameter and the smaller, inner dilators
removed therefrom, until the tissue is stretched to a predetermined
size by a final dilator.
Thereafter, a desired medical instrument, such as a curette or JET
WASHER or even an intrauterine coil is passed through the final
dilator. The final dilator is withdrawn from the tissue such that
the medical instrument remains in a predetermined position for
treatment.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and advantages of the present invention will be
readily apparent from the following detailed description taken in
conjunction with the accompanying drawings wherein:
FIG. 1 is a fragmentary view of the flexible probe and a pair of
dilators of successively greater diameter;
FIG. 2 is a schematic view illustrating the positioning of the
probe of FIG. 1 in a cervical canal;
FIG. 3 is a schematic view illustrating the withdrawal of the probe
from the cervical canal after insertion of a dilator over the
probe;
FIG. 4 is a schematic view illustrating the withdrawal of the
dilator subsequent to the enlargement of the cervical canal by the
insertion of a dilator with a larger diameter; and
FIG. 5 is a schematic view illustrating the enlargement of the
cervical canal by a final dilator to a predetermined size and the
placement of a Jet Washer therein.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now to the drawings and, more particularly, to FIG. 1,
there is illustrated elongated, smooth, flexible probe 10 of
uniform external and internal diameter having a rounded insertion
tip 12. In order to facilitate exploration and sounding a
pre-formed curve is formed into the body of the probe adjacent the
insertion tip 12. The probe is fabricated from smooth, flexible
materials, as flexible thermoplastic resins, such as polyethylene,
polypropylene, vinyl, polyvinyl chloride, and copyolymers and
homopolymers of the same and the like. The probe may be formed from
a solid or hollow tube. It is preferred that the probe be
manufactured from non-irritating materials.
The probe is employed in conjunction with at least one hollow,
flexible tubular dilator 14. It is preferred that both probe 10 and
dilator 14 are of such uniform diameter such that dilator 14 may be
inserted over the proximal end 16 of probe 10 and advanced down the
external surface 18 of the probe until the distal end 20 of the
dilator is coaxial with the probe insertion tip 12. For this and
other purposes, it is preferred that dilator 14 be formed from
flexible, non-irritating plastic resins such as vinyl,
polyethylene, polypropylene, polyvinyl chloride and homopolymers
and copolymers thereof. In general, dilator 14 should be of
sufficient thickness in order that it be able to withstand the
pressures involved in introducing the dilator into the desired body
cavity over the probe.
In order to permit dilation to a desired degree, additional
dilators are provided, as required. The succeeding dilators are
formed from flexible materials as described hereinbefore and are
uniform diameter, each dilator of increasingly larger internal
diameter. As illustrated in FIG. 4, dilator 22 is of sufficient
internal diameter, as to slidably pass over dilator 14.
A workable dilating apparatus includes a probe formed from a
flexible vinyl polymer. The probe is 12.5 inches long having a
curved portion with a radius of 4 inches at the distal end. The
internal diameter of the probe is 0.040 inch and the outer wall of
the probe is 0.024 inch thick. A first dilator adapted to be
slidably mounted over the probe is 6.6 inches long. The dilator is
formed from a vinyl polymer and has an internal bore of 0.095 inch
and a thickness of 0.030 inch. Additional dilators of the same
material having successively larger internal diameters are
provided, as needed.
The above described dilating apparatus is useful for various
medical procedures. The apparatus may be employed for dilating or
enlarging the cervical canal, the urinary tract in both males and
females and body ducts, as well as wound cavities. After dilation,
various medical instruments such as an intrauterine coil, curettes,
Jet Washers, forceps and the like may be introduced into the
cavity, held retracted by the final dilator. Thereafter, the final
dilator is withdrawn thereby allowing accurate insertion of the
instrument.
Turning now to FIGS. 2-5 there is illustrated a medical procedure
wherein the cervical canal is probed and dilated. Thereafter, a Jet
Washer, the subject of U.S. Pat. No. 3,527,203, is inserted
therein. As shown in FIG. 2 the distal tip 12 of probe 10 is
inserted into the cervical os. The opening is probed and the
directions determined. As illustrated in FIG. 3, dilator 14 (solid
arrow) is inserted over the proximal end 16 of probe 10 and passed
over the outer surface of the probe until in approximate coaxial
alignment with distal end 12 of the probe. In this manner the
dilator is accurately inserted into the cervical canal with a
minimum of movement and a corresponding reduction in patient
trauma. Next, probe 10 is withdrawn (dotted arrow) from the bore of
dilator 14.
At this point, if desired, a syringe adapter (not shown) may be
connected to the proximal end 15 of the dilator 14. If desired, the
syringe adapter may be permanently connected to the proximal end 15
of the dilator. Thereafter, a syringe containing a desired
medicament may be connected to and injected into the bore of
dilator 14, thus introducing a desired medication into the uterine
cavity.
As illustrated in FIG. 4 the cervical canal 30 is enlarged by the
sequential passage and removal of successive dilators of increasing
internal diameter. As depicted in FIG. 4 dilator 14 is withdrawn
(dotted arrow) from the cervical canal after having served as a
guide for the introduction of dilator 22 (solid arrow). After the
cervical canal has been enlarged to a desired degree by the use of
successive dilators, as depicted in FIG. 5, a medical instrument,
the Gravlee Jet Washer 34, is inserted through the bore of the
final dilator 32 (solid arrow). For this purpose, final dilator 32
should be of sufficient internal diameter to permit the free
passage of the Jet Washer 34. The dilator is then withdrawn (dotted
arrow) leaving the instrument 34 in accurate alignment. In use, a
solution is discharged through holes in the Washer and thereafter
collected through other orifices. The collected solution contains
cell specimens.
The above described procedure is applicable with obvious
modifications for the medical procedures outlined hereinabove. For
example, a small fine probe may be employed to sound a bullet wound
to locate a bullet. Next, a hollow dilator is introduced over the
original probe to retract the tissue and vessels and the probe is
withdrawn. A dilator of larger internal diameter is slidably
engaged over the dilator to further retract the tissue and the
first dilator is removed. Thereafter, a series of dilators are
slidably engaged over successive dilators to further retract the
tissue and vessels to a point where the bullet may be removed
through the inside bore of the final dilator.
Likewise, in a tubal ligation only a small incision need be made in
the abdomen. A series of dilators as described hereinabove can be
employed to stretch the tissue to a point where the final dilator
would have increased the diameter of the incision sufficiently to a
point where the fallopian tube is exposed. The tube is tied off,
the dilator removed, with only one or two sutures necessary to
close the incision.
While we have described a somewhat preferred form dilating
apparatus and method, it is to be understood that various
modifications may be made herein without departing from the spirit
of the invention as defined in the appended claims.
* * * * *