U.S. patent number 3,867,937 [Application Number 05/474,303] was granted by the patent office on 1975-02-25 for flexible protective sheath for catheter.
Invention is credited to Boris Schwartz.
United States Patent |
3,867,937 |
Schwartz |
February 25, 1975 |
FLEXIBLE PROTECTIVE SHEATH FOR CATHETER
Abstract
This invention pertains to the use of catheters and the
sterilized protection of their exterior surface as they are
inserted into a patient and particularly for catheters used with
intravascular feedings and transfusions and pressure determining
systems, suprapubic catheterization and spinal taps. A needle or
stylet within the catheter is used for the initial penetration and
usually assembled and packaged with the catheter and sheath of this
invention. The protective sheath is a very thin plastic tubular
member which is a loose sliding fit on the outer diameter of the
catheter. This sleeve remains mounted on the catheter as the
catheter is inserted into the patient. The loose sheath is disposed
to collapse upon itself up to and around the hub of the inserting
catheter. As and during its collapse the sheath acts as a guard to
prevent contamination of the inserting member as it is advanced
into the patient. The sheath member may be approximately one-third
larger than the diameter of the catheter on which it is mounted and
is approximately one-thousandths of an inch in thickness which is
just sufficient to permit heat sealing to form the tube and to
provide a reasonable protection against manipulative handling. In
its initial mounted condition the end of the sheath is brought to
or very near the sharp end of the inserting member.
Inventors: |
Schwartz; Boris (Paterson,
NJ) |
Family
ID: |
26978620 |
Appl.
No.: |
05/474,303 |
Filed: |
May 30, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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312952 |
Dec 7, 1972 |
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Current U.S.
Class: |
604/164.09 |
Current CPC
Class: |
A61M
25/0111 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61m 005/32 () |
Field of
Search: |
;128/218N,218R,221,214R,214.2,214.4,276,348-350,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Roberts; Ralph R.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a Continuation-in-Part of my U.S. Pat.
Application Ser. No. 312,952, filed Dec. 7th, 1972 and upon the
acceptance of this application expressly abandoned.
Claims
What is claimed is:
1. In combination with a flexible catheter for percutaneous use
with a patient there is provided a flexible protective sheath
slidably mounted on the midshaft portion, said combination
including: (a) a flexible catheter of determined length and having
an entering end and a hub end and with that midshaft portion of
said catheter forwardly of the hub having a selected outside
relatively constant bore; (b) a stiff bore puncturing member
slidably carried in the bore of the catheter and removable through
the hub end after the desired penetration of the skin of a patient
has been achieved, and (c) a very thin flexible plastic sheath of
tube-like form whose wall thickness is less than two-thousandths of
an inch in thickness and formed and sized so as to provide a
sliding fit on the outer diameter of the midshaft of the catheter
which it is to protect, the tube size being about one-third larger
than the midshaft portion of the catheter for which it provides the
protection, said sheath in an unmounted condition being open at
both ends and when mounted having a length sufficient to extend
from the skin-entering end of said catheter to a determined larger
stop portion such as the hub of the catheter, said mounted sheath
particularly adapted to engage the skin at the point of penetration
and to be engaged by the skin at this opening to prevent further
forward progress of the sheath whereat said sheath slides on the
midshaft of the catheter and to the extent of shortening the sheath
length progressively collapses into accordion-like folds as the
catheter is caused to enter the entrance into and through the skin,
the sheath providing a sliding guard continuously protecting
against accidental contact of the outer surface diameter of the
uninserted portion of the midshaft of the catheter by the user of
the instrument during both the initial and progressive insertion
through the skin, said sheath in its folded and unfolded portion
remaining on the uninserted portion of the midshaft of the catheter
during inserted use in a patient.
2. A combination of sheath and catheter as in claim 1 in which the
skin puncturing member is a metal stylet.
3. A combination of sheath and catheter as in claim 1 in which the
skin puncturing member is a hollow metal needle.
Description
BACKGROUND OF THE INVENTION
1. FIELD of the INVENTION
With reference to the classification of art as established in the
U.S. Patent Office the present invention pertains to the general
Class entitled, "Surgery" (Class 128) and more particularly to the
subclass entitled, "catheter" (subclass 214).
DESCRIPTION OF THE PRIOR ART
In the present use of catheters at least the penetrating portion is
generally in a sterile condition when packaged and shipped and is
maintained so until time of use. Conventionally at the time of use
the protective cover is removed and by manipulation and grasping
the exterior surface the catheter is inserted into the arm, leg or
other portion of the patient. Although in an initially sterile
condition the handling necessary for satisfactory insertion of this
catheter into the patient often causes this exterior surface to be
pressed against the skin of the patient during manipulation and
prior to insertion below the skin. Although the patient may have
been locally cleaned prior to insertion into the area, this skin is
not in a sterile condition particularly where the insertion is a
difficult one. In addition, the manipulator's fingers may touch the
shaft portion adjacent to the grasped hub portion of the catheter.
In addition, the skin entrance site may act as an entrance for
bacteria.
The present invention provides an additional sheath for the
exterior surface of the catheter. This added sheath is loosely
retained in a protecting position until inserting penetration of
the catheter into the patient is begun. As the insertion into and
through the skin continues the sheath engages the skin at the
penetration point and slids up the catheter or needle. The sterile
catheter is not exposed to any outside condition but is slid
through the skin opening. This sheath as it collapses usually folds
in an accordion-like manner as it slides up to the hub of the
catheter. In addition to providing a protection of the now inserted
catheter the collapsed sheath also shields that uninserted catheter
portion between the skin and hub and also provides a barrier to
entrance of bacteria into the skin puncture.
SUMMARY OF THE INVENTION
In this invention a catheter which is slidably mounted on a needle
or stylet has its exterior diameter forward of the hub enclosed in
a protective sheath. It is contemplated that this sheath be tubular
in configuration and plastic in construction and have a wall
thickness of approximately one-thousandths of an inch. The sheath
is a loose sliding fit upon the exterior diameter of the catheter.
This sheath as it collapses moves generally into an accordion-like
accumulation and readily is so formed since it is a very thin
sheath which is approximately one and one-half times the diameter
of the catheter. In its shortened accumulated condition the several
folds of this thin plastic occupy very little space when the
catheter has been inserted to the desired depth into the skin of
the patient. The sheath is not removed from the catheter during its
use by provides a protective cushion around the skin puncture.
In addition to the above summary the following disclosure is
detailed to insure adequacy and aid in understanding of the
invention. This disclosure, however, it not intended to prejudice
that purpose of a patent which is to cover the inventive concept no
matter how it may later be disguised by variations in form or
additions. For this reason there has been chosen a specific
embodiment of the flexible sheath as adopted for use on a catheter.
This specific embodiment has been chosen for the purposes of
illustration and description as shown in the accompanying drawing
wherein:
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 represents a sectional side view showing a sheath mounted on
a catheter, this view in an enlarged scale to show the relationship
of the sheath member in mounted condition on a catheter before the
insertion thereof, and
FIG. 2 represents the view of the catheter and sheath of FIG. 1
after insertion of the catheter into the body of the patient, the
sheath during the insertion has been collapsed to form accordion
folds in the portion between the hub of the catheter and the
entrance into the skin of the patient.
In the following description and in the claims details are
identified by specific names for convenience; these names, however,
are intended to be generic in their application. Corresponding
reference characters refer to like members throughout the two
figures of the drawing but it should be understood that structural
details may be modified in various respects without departure from
the concept and principles of the invention.
DESCRIPTION OF THE SHEATH
Referring now to the drawing and FIGS. 1 and 2, there is depicted a
catheter 10 which is attached to a hub 12 in a conventional manner.
This catheter is slidably mounted on a needle or stylet 14 which,
typical of the percutaneous instruments used with this invention,
has a sharpened end 16 adapted for penetration into and below the
skin of the patient. Slidable on and providing a covering for the
body penetrating extent of the catheter is a sheath member 18
which, as depicted in enlarged cross-section, is disportionate in
thickness in order to illustrate a thickness. This sheath member
18, in practice, is only about a thousandth of an inch in thickness
and when mounted on the catheter extends from the hub end 12 to the
sharpened tip portion 16 of the penetrating means. Preferably the
loose sheath terminates at or very near the rear of the sharpened
point.
Referring now in particular to FIG. 2, it is to be seen that the
catheter 10 has penetrated the skin and has been inserted into the
body 20 of the patient. Sheath 18 has been pushed up the catheter
as the catheter has penetrated the skin and passed through the
opening and into the patient. The forced collapse of the sheath
causes a folding upon itself in a generally accordion-like manner
and during the collapse acts as a guard to prevent accidental
contact with the outer surface of the catheter and contamination
thereof as the catheter is moved through the skin and into the body
of the patient.
USE OF THE SHEATH OF THIS INVENTION
Catheters or other like members which are inserted into the arms,
legs or other portions of the patient are generally of a diameter
of an eighth of an inch or less. The sheath 18 of this invention is
deliberately made several thousandths of an inch larger in diameter
than the catheter 10 on which it is mounted. In particular, assume
that a catheter 10 is three-thirty-seconds of an inch in diameter,
the inside diameter of the sheath would be approximately five
thirty-seconds to three-sixteenths of an inch in diameter. As the
catheter with the sheath in mounted condition is inserted into and
through the skin and into the tissue of the patient 20, the sheath
18 whose wall is approximately one-thousandths of an inch in
thickness has its distal end brought into engagement with the skin
adjacent the penetration opening. During penetration of the end and
entering length of the catheter the sheath end continues to engage
the skin of the patient.
As the insertion of the catheter into the patient continues the
very thin plastic sheath which is quite supple, crumples in an
accordion-like manner and slides up the catheter in accordance with
the progress of the penetration. This accordion-like sheath portion
is disposed between the skin entrance and the hub 12 of the
catheter. As the insertion is made to almost the full depth of the
catheter, the sheath 18 is bunched together to assume more-or-less
the condition as seen in FIG. 2. During the penetration the force
necessary to crumple and slide the sheath along the catheter is
minimal as the wall thickness of the sheath is only sufficiently
rigid to keep the sheath in a more-or-less extended condition which
is overcome to collapse or fold the sheath as the penetration of
the skin is accomplished. Sheath 18 which protects the catheter 10
is a very thin, substantially transparent tubular member. It may be
an extruded plastic tube or may be made by longitudinal heat
sealing of sheet plastic material. When the sheath is made of one-
to two-thousandths of an inch thick supple plastic, a hundred
accordion folds may be easily made and will occupy a length which
may be less than a quarter of an inch. As the catheter is not
intended for full insertion into the patient, the bunched,
accordion-like, collapsed sheath does not impede the use of the
catheter. The plastic which is used to make the sheath is
preferably quite inexpensive and may be one of many acceptable for
use on or near the skin of a patient for periods of time up to a
few days.
The conditions to which the sheath is subject influences the
selection of the material from which it is made. Some of the
conditions include sterilization, storage, medicants, etc. A use
and service characteristics chart enables the manufacture of the
percutaneous appliance to select the material for the sheaths and
manufacture may be by heat sealing and/or extrusion.
Terms such as "in," "out" and the like are applicable to the thin
plastic sheath shown and described in conjunction with the drawing.
These terms are merely for the purposes of description and do not
necessarily apply to the position in which the sheath and
percutaneous appliance may be constructed or used.
While a particular assembly has been shown and described it is to
be understood the invention is not limited thereto and protection
is sought to the broadest extent the prior art allows.
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