U.S. patent number RE34,021 [Application Number 07/435,343] was granted by the patent office on 1992-08-04 for percutaneous fixation of hollow organs.
This patent grant is currently assigned to Abbott Laboratories. Invention is credited to Alan S. Brown, Frank B. Crawford, Peter R. Mueller, Marc J. Tolkoff.
United States Patent |
RE34,021 |
Mueller , et al. |
August 4, 1992 |
Percutaneous fixation of hollow organs
Abstract
For percutaneous fixation of a hollow organ of a body, a hollow
needle carrying a retaining device attached to a tension filament
through the skin into the hollow organ, the retaining device is
released from the needle, and the organ is fixed by adjusting the
tension on the filament and clamping the filament outside the body
by means bearing upon the exterior of the body.
Inventors: |
Mueller; Peter R. (Lexington,
MA), Brown; Alan S. (Longmeadow, MA), Tolkoff; Marc
J. (Brookline, MA), Crawford; Frank B. (New Boston,
NH) |
Assignee: |
Abbott Laboratories (Abbott
Park, IL)
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Family
ID: |
27030524 |
Appl.
No.: |
07/435,343 |
Filed: |
November 13, 1989 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
798781 |
Nov 18, 1985 |
04705040 |
Nov 10, 1987 |
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Current U.S.
Class: |
604/533;
606/108 |
Current CPC
Class: |
A61B
17/0401 (20130101); A61B 17/0469 (20130101); A61B
17/8695 (20130101); A61B 2017/0406 (20130101); A61B
2017/0409 (20130101); A61B 2017/0417 (20130101); A61B
2017/0496 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61B 17/86 (20060101); A61B
17/68 (20060101); A61M 031/00 () |
Field of
Search: |
;604/51,52,53,280,281,282,283,264,272 ;606/108,215,220 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2157529 |
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May 1973 |
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DE |
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2438464 |
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Jun 1980 |
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FR |
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401677 |
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Nov 1933 |
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GB |
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Other References
Cope, "Suture Anchor for Visceral Drainage", AJR, vol. 146, Jan.
1986, pp. 160-161. .
Gauderer and Ponsky, "A Simplified Technique for Constructing a
Tube Feeding Gastrostomy", Surgery, Gynecology & Obsterics,
Jan. 1981, vol. 152, pp. 83-85. .
Russell, Brotman and Norris, "Percutaneous Gastrostomy", The
American Journal of Surgery, Jul. 1984, vol. 148, pp.
132-137..
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Primary Examiner: Yasko; John D.
Attorney, Agent or Firm: Fish & Richardson
Parent Case Text
.Iadd.This application is a reissue of Ser. No. 06/798,781 filed
Nov. 18, 1985, U.S. Pat. No. 4,705,040. .Iaddend.
Claims
What is claimed is:
1. A method for the fixation of a hollow organ of a living body to
a body wall comprising:
percutaneously inserting a rigid hollow needle carrying a retaining
device attached to a trailing tension filament, through the skin,
from outside the body, into said hollow organ in the manner that a
portion of said trailing tension filament remains outside of the
body,
said retaining device having a portion adapted to engage and apply
pressure to an interior wall of said hollow organ,
releasing said retaining device within said hollow organ from said
needle,
pulling a portion of said trailing tension filament from outside
the body to draw said retaining device against the interior wall of
said hollow organ to pull said organ against the body wall, and
fixing said organ by adjusting the tension on said filament and
clamping said filament outside the body by means bearing upon the
exterior of the body.
2. The method of claim 1 wherein said retaining device comprises a
head that extends cross-wise to said filament in a "T" arrangement
upon release from said needle.
3. A percutaneous fixation device suitable to fix the position of a
hollow organ within a body which comprises:
a hollow needle; and
a "T" head, wherein said head comprises a stiff hollow tube having
a hole in its side, a root mass of resinous material larger than
said hole disposed within said tube, a tension filament attached to
the mid-portion of said head, said head dislodgedly held within
said needle, said filament extending through said hole and bonded
to said mass, with said filament extending back with said needle,
and means threaded on said filament for bearing with compression
against the body to apply tension to said filament to draw said
head against the inner surface of said hollow organ.
4. A retaining element adapted for insertion by a needle and
eventual removal through the passage formed by said needle,
comprising an elongated stiff head, a primary flexible tension
filament secured to said head, and a secondary tension filament
secured to an end of said head, adapted to be pulled upon to
withdraw said head end-wise upon release of tension on said first
tension element. .Iadd.
5. A percutaneous fixation device suitable to fix the position of a
hollow organ within a body, comprising:
a "T" head comprising a stiff member,
an elongated, relatively more flexible primary tension filament
secured at the mid-region of said head, said elongated primary
tension filament having a free end trailing back from said head,
and
compressible means threaded on said elongated primary tension
filament for bearing in a cushioning manner with compression
against the skin of the body, and means for pressing upon said
compressible means while clamping said primary tension member to
apply tension to said primary tension filament to draw said head
against the inner surface of the hollow organ. .Iaddend. .Iadd.6.
The primary fixation device of claim 5 wherein said device is
adapted for insertion through a passage, and further comprises a
secondary tension filament secured at an end of said head, adapted
to be pulled upon to withdraw said head endwise upon release of
tension on said primary tension filament. .Iaddend. .Iadd.7. The
percutaneous fixation device of claim 5 or 6 wherein said head
comprises a hollow tube having a hole defined in its side wall, and
said primary tension filament extends through said hole. .Iaddend.
.Iadd.8. The percutaneous fixation device of claim 5 or 6 wherein
said head comprises a stainless steel tube having a hole defined in
its side wall, and said primary tension filament extends
through said hole. .Iaddend. .Iadd.9. The percutaneous fixation
device of claim 5 or 6 wherein said compressible means comprises a
compressible cushioning element and a retention member. .Iaddend.
.Iadd.10. The percutaneous fixation device of claim 9 wherein said
compressible cushioning element comprises an absorbent for fluids.
.Iaddend. .Iadd.11. The percutaneous fixation device of claim 5 or
6 wherein said means for pressing upon said compressible means
comprises:
a crimpable element in a first state adapted for sliding movement
along said primary tension filament, toward said head, in a manner
for application of compressive force upon said compressible
cushioning element, and in a second state adapted for engagement
upon said primary tension filament for maintaining said
compressible cushioning element in a compressive state, and
a clamping element in a first state adapted for sliding movement
along said primary tension filament, toward said head, in a manner
for application of compressive force upon said compressible
cushioning element, and in a second state adapted upon application
of radially directed force upon said clamping element for
engagement upon said primary tension filament for maintaining said
compressible cushioning element in a compressive state. .Iaddend.
.Iadd.12. A method for the fixation of a hollow organ of a living
body to a body wall comprising:
inserting a retaining device attached to a trailing tension
filament, through the skin, from outside the body, into the hollow
organ in the manner that a portion of said trailing tension
filament remains outside of the body,
said retaining device having a portion adapted to engage and apply
pressure to an interior wall of the hollow organ,
releasing said retaining device within said hollow organ,
pulling a portion of said trailing filament from outside the body
to draw said retaining device against the interior wall of the
hollow organ to pull the hollow organ against the body wall,
and
fixing the hollow organ by adjusting the tension on said filament
outside
the body. .Iaddend. .Iadd.13. The method of claim 12 wherein said
retaining device comprises a head that extends cross-wise to said
filament in a "T" arrangement upon release within the hollow organ.
.Iaddend.
.Iadd.4. A percutaneous fixation device suitable to fix the
position of a hollow organ within a body which comprises
a tension filament having a distal end destined for the interior of
the organ and a trailing portion extending in usage through an
adjacent wall of the body and terminating outside the exterior of
the body,
a cross bar attached to the distal end of said filament so as to
form a "T" head for forcible engagement of the inner surface of the
organ, and
a fastener connected to said filament for securing the trailing
portion of said filament on the exterior of the body under tension
so as to draw the
organ toward the adjacent wall. .Iaddend. .Iadd.15. The device of
claim 14, wherein said fastener comprises means for bearing against
the exterior of the body. .Iaddend. .Iadd.16. The device of claim
15, wherein said fastener further comprises means for fixing the
position of said bearing means along the trailing end of said
filament. .Iaddend. .Iadd.17. A method of securing a hollow organ
within a body to a wall of the body in preparation for insertion of
a catheter through the wall into the interior of the organ,
comprising the steps of
selecting a site for catheter insertion on the exterior of the
body,
inserting a first retaining device from outside the body through
the body wall into the hollow organ at a position on the exterior
of the body nearby but displaced from said catheter insertion site,
said retaining device having a head portion adapted to forcibly
engage an interior wall of the hollow organ and a trailing tension
filament attached to said head portion extending through the organ
and body walls outside of the body,
pulling the trailing filament from outside the body to draw said
retaining device against the interior wall of the hollow organ to
pull the hollow organ against the body wall,
fixing the hollow organ by adjusting the tension on said filament
outside the body, and
repeating the steps of inserting, pulling and fixing with a
plurality of similar retaining devices at other positions, said
other positions together with the position of said first retaining
device surrounding said
catheter insertion site. .Iaddend. .Iadd.18. The method of claim
17, wherein four of said retaining devices are used in a square
configuration centered on said catheter insertion site. .Iaddend.
.Iadd.19. A method for the fixation of a hollow organ of a living
body to a body wall comprising:
percutaneously providing a tract from outside the body through the
skin and into the hollow organ,
inserting a retaining device attached to a trailing tension
filament, through the tract from outside the body, into said hollow
organ in the manner that a portion of said trailing tension
filament remains outside of the body,
said retaining device having a portion adapted to engage and apply
pressure to an interior wall of said hollow organ,
releasing said retaining device within said hollow organ from said
tract,
pulling a portion of said trailing tension filament from outside
the body to draw said retaining device against the interior wall of
said hollow organ to pull said organ against the body wall, and
fixing said organ by adjusting the tension on said filament.
.Iaddend.
Description
In preparation for inserting a tube such as drainage or feeding
tube into a hollow organ of the body, it is desired to fix the
hollow organ to a body wall. This aids in accurate placement of the
tube and in preventing leakage that can contaminate the peritoneal
cavity and lead to peritonitus.
In the past, fixation of hollow organs has mainly been accomplished
by suturing during open surgery as part of the procedure of placing
the tube. However, to avoid the drawbacks of incision, general
anesthesia and need for an operating room, it is desirable to
accomplish the entire procedure without surgery.
For this purpose, a technique has been used which obtains some
degree of fixation, particularly of the gastric wall to the body
wall. A tube with a blunt end which is installed, in a retrograde
manner from the inside of the stomach towards the outside, the
blunt end of the tube engaging the stomach wall and holding it in
place. For this purpose, a gastroscope is placed in the patient's
stomach, a site is chosen on the skin using the light from the
gastroscope, a puncture is made through the skin and a guidewire is
introduced into the stomach. This guidewire is grasped by the
gastroscope and pulled out of the stomach through the esophagus and
out of the mouth. The end of the wire protruding from the mouth is
then attached to a tube, having a leading pointed end and a
trailing blunt end. The guidewire is pulled back into the stomach
and the pointed end of the tube is pulled through the gastric wall
and the skin until the blunt end of the tube is secured against the
stomach and holds the stomach wall against the body wall.
The disadvantages of this technique are that it requires a big
gastroscope which has inherent risks, it is not possible to employ
a gastroscope with all patients, and the tube is critically
dependent upon its own fixation. If such tube were removed
inadvertently, the fixation would be lost, leaving an open hole in
the stomach and no method of fixation, with resultant leak into the
peritoneal cavity.
Also in the prior art, but not to be confused with techniques which
achieve secure fixation of the wall of the hollow organ to the body
wall, are the uses of tubes which have ends of various designs to
prevent inadvertent withdrawal of the tube itself. There are
several of these, some of which are introduced percutaneously while
others are utilized during surgical procedures. One is known by the
name Mallincott, another is a balloon employed on the end of a
Foley catheter, and there are various looped catheters such as the
Cope loop. Basically, the ends of these catheters prevent the
catheter from being withdrawn and to some degree may serve to
retain the hollow organ in position against the body wall. However,
in order to fix a hollow organ wall in place one has to apply
traction, but traction on the catheter tends, after a period of
time, to pull the catheter out, and therefore the needed degree of
traction, for secure fixation, is incompatible with the primary
objective of such devices.
Objects of the present invention are to provide a device and method
to obtain better fixation of hollow organs by techniques that do
not require surgery.
SUMMARY OF THE INVENTION
According to the present invention, the task of fixation or
anchoring of the hollow organ is separated from that of
catheterization for drainage or infusion, and fixation is achieved
by percutaneous placement of tack devices.
According to the invention, a series of spaced apart tacks or
retention devices are introduced percutaneously to the inside of
the hollow organ, each associated with a filament-like tension
piece which is used to apply fixation force, outside of the body by
a device that bears against the exterior of the body. Preferably,
the introduction is achieved by placing a stiff T-shaped end of a
tension filament within the lumen of a needle and allowing the
flexible filament to protrude from a small slot at the tip of the
needle, with the filament trailing alongside during introduction.
After the needle is passed through the skin and enters the hollow
organ, a stylette or obturator is used to dislodge the head of the
T piece from the lumen and the needle can be withdrawn. At this
point tension is applied along the filament and the "T" head is
urged snugly against the inside surface of the hollow organ and
holds it there. In practice, four needles may be employed to place
four separate T-shaped devices. Preferably, the head of the T
element is of the order of a centimeter long and the filament is
approximately 10 to 15 centimeters long. In the case of the
stomach, four of these tack devices are placed at the corners of a
one or two-inch square and then the feeding tube is placed in the
center of this square.
The head of the T is preferably an elongated cylinder, at the mid
portion of which is attached a filament of synthetic resin, the
head being small enough to be introduced percutaneously and
sufficiently stiff to prevent bending of the head so that it does
not bend and pull out, and the filament being strong in tension and
flexible enough to bend approximately 90.degree. at its junction
with the head of the T piece. In the presently preferred form, the
head of the T element is aligned with the axis of the needle and
housed within it during insertion.
Preferably, the needle comprises conventional hypodermic tubing, 16
gauge, regular or thin wall, the needle has a single bevel and the
slot is cut from the more proximal surface of the bevel, and
extends back, approximately 3/4 of a centimeter in length,
sufficient to expose the point of attachment of the filament when
the head of the T element is entirely housed within the needle.
Before use of the needle, usually a small puncture with a hemostat
is made in the skin to free the subcutaneous tissues, without
penetrating the organ. The needle is then used to make the initial
puncture into the organ. At the time of the initial puncture, the
organ is not fixed at all, so it is important that the needle be
quite pointed, e.g. beveled about 30.degree..
By having the needle hollow throughout its length, a stylette or
obturator can pass down the lumen to dislodge the T after it is in
place, and during introduction, the hollow lumen is utilized to
aspirate air from the stomach to prove the location of the needle
tip.
In preferred embodiments, a sterile kit is provided to the
physician comprising the percutaneous insertion needle, the "T"
element, with head preloaded in the needle, and with the filament
lying alongside. An appropriate assembly of devices is pre-arranged
along the filament for applying traction and securing the "T"
element in place, preferably comprising a compressible pledgette to
bear against the body, a compression-applying retention disc to
bear against the pledgette and a crimpable clamping element for
permanently clamping the filament and applying compression to the
compression disc.
The method of the invention for the percutaneous fixation of organs
is characterized by the steps of inserting a hollow needle carrying
a retaining device attached to a filament, through the skin into
the organ, releasing the retaining device from the needle, and
fixing the organ by adjusting the tension on the filament and
clamping the filament by means bearing on the exterior of the
body.
In preferred embodiments of this method, the retaining device
comprises a head that extends cross-wise to the filament in a "T"
arrangement and a second filament is secured to one end of the head
such that the head can be removed from the organ by pulling on the
second filament while releasing the first filament.
In preferred embodiments of manufacture of the percutaneous
fixation device, the device comprises a hollow tubular head and a
tension filament, the method comprising: drilling a hole in the
side of the tubular head, introducing thermoplastic resin, e.g. a
second filament, into the tubular head, melting the resin within
the head, fusing the melted second filament to the first filament
by passing the first filament through the side hole so that it
contacts the melted resin, and allowing the device to cool.
A preferred embodiment of the percutaneous fixation device
comprises: a slotted hollow needle, a "T" head element attached to
a filament, the filament being attached to the mid-portion of the
head. The head is preloaded within the slotted needle such that the
filament passes through the slot of the slotted needle, and a set
of exterior tension applying devices are prearranged along the
length of the filament. In another embodiment, a second filament is
attached to one end of the head, adapted to withdraw it by
releasing the first filament.
DESCRIPTION OF PREFERRED EMBODIMENTS
The drawings will first briefly be described.
FIG. 1 is a side view of a "T" element for use in the percutaneous
fixation device according to the invention.
FIG. 1(a) is a sectional view of highly enlarged scale through the
"T" element of FIG. 1;
FIG. 2 is a side view of a preloaded needle assembly for
percutaneous insertion of the "T" element into the body to fix the
position of an organ;
FIG. 2(a) is a plan view of enlarged scale of the needle tip region
of the assembly of FIG. 2;
FIG. 2(b) is a longitudinal sectional view of enlarged scale
through the hub region of the needle of FIG. 2;
FIG. 3--3(c) are diagrammatic representations to illustrate steps
taken during the insertion of a "T" element and subsequent
manipulations for securing the "T" element in place to fix the
stomach to the abdominal wall;
FIG. 3(d) is a view similar to FIG. 3(c) of an alternative
embodiment;
FIG. 4 is a diagrammatic representation of the positioning of four
tacks according to the invention, securing the stomach to the
abdominal wall in preparation for insertion of a feeding catheter
through the abdominal wall.
STRUCTURE
Percutaneous fixation device
(a) "T" element
Referring to FIGS. 1 and 1(a) the "T" element 8 consists of head 10
and filamentary tension leg 12. In this embodiment, head 10
preferably has length A, 1/4 inch, outer diameter B, 0.035 inch and
rounded ends, and filament 12 has length C, 5 inch, and outer
diameter D, 0.008 inch and is highly flexible. The head is
constructed to resist bending when pulled by attached filament 12
and is radiopaque so that it can be seen with a fluoroscope during
and after insertion into the body.
In this embodiment the head is of stiff stainless steel tubing with
internal diameter E, 0.025 inch and with a central hole 14 formed
in its side of diameter F, 0.020 inch. Filament 12 is attached to
head 10 by inserting a separate segment of filament 16 within and
axially aligned with head 10, heating the head to melt segment 16
with the result that the resinous filament melts and draws into the
form of a large central ball 18, and pushing filament 12 through
hole 14 into the molten ball 18. When cooled and set, ball 18 is
substantially larger than central hole 14 and forms a firm root for
filament 12, attaching it to head 10. Attachment of filament 12 to
ball 18 also prevents the edges of the filament from touching the
portions of the tube that bound hole 14, to avoid abrasion and
subsequent breakage of filament 12. Also, the gradually enlarging
transition region from filament to ball serves as a strain relief.
Filament 12 is preferably of nylon material such as suture material
or fishing line, or of similar polymers, such as polyester. Inner
ball 18 may be of any compatible, strong material but preferably is
of the same thermoplastic material as that of filament 12 to ensure
good bonding, to form a strong, integrated structure.
(b) Percutaneous introductory device
Referring to FIG. 2(a), head 10 of the "T" element is inserted into
the tip of hollow insertion needle 30 which has a longitudinal slot
of approximate length I, 0.3 inch in its tubular wall. Filament 12
passes through slot 32 and bends back in the proximal direction. In
one embodiment a second filament 34 is attached to one end of head
10. This second filament is provided as a means for removing the
head of an inserted "T" element from the body after use (see
below). Preferably filament 34 is of material similar to filament
12 and is attached to head 10, through a hollow end of the head, at
the same time as filament 12 is attached, when ball 18 is
molten.
Needle 30 has a sharp tip, a length suitable to permit percutaneous
insertion (e.g. 5 inches for stomach tack purposes) and an internal
diameter G great enough to accept head 10 so that head 10 is
entirely within the needle when the needle is thrust through the
flesh and the organ wall. Preferably needle 30 is 16 gauge, small
enough in external diameter H that it can be percutaneously
introduced and penetrate the skin and flesh of the patient and the
wall of the desired hollow organ (e.g. the stomach) without
bending.
Referring to FIG. 2 the two filaments 12 and 34 and needle 30 are
inserted through compressible pledgette 36 such that the filaments
run alongside the exterior of the needle. Pledgette 36 is
preferably of a soft, absorbent, spongy material such as cotton or
methylcellulose, and acts as a cushion against the skin and as an
absorbent for fluids. The filaments also ass through retention
washer 38, and crimpable clamp devices 44 and 46. Filament 12 also
passes through plastic tube 48 which acts as a temporary clamping
site (see below). (In another embodiment, FIG. 3d, filament 12
passes through a second crimpable clamp device 70, between device
44 and retention washer 38, which can be used to reset the device
should it loosen over time after device 44 has been initially
clamped). Washer 38 is of material such as acrylic or a similar
plastic or of metal, of approximate thickness 0.060", sufficiently
stiff to transmit retention stresses between filament and
pledgette. Plastic tube 48 must be of a material which satisfies
two different requirements, (i) sufficiently supple in the
direction of its diameter so that it can be squeezed by a clamp to
grip the filament within it, and (ii) strong in compression to
temporarily axially bear upon device 44 and via device 44, upon the
pledgette, to apply tension and fix "T" element 8 in place. For
example, tube 48 may be of polyethylene, vinyl, or other flexible
polymer tubing of suitable wall thickness. Tube 48 is of length K,
approximately 1 inch. Crimp rings 44, 46, and 70, are preferably of
aluminum so that they are readily fixed in place using common
medical instruments that apply clamping pressure (e.g., a
hemostatic clamp).
Referring to FIG. 2, needle 30 ends at a leur lock fitting at hub
50, into which syringe 52 with plunger 56 may be inserted.
Referring to FIG. 2b, obturator or stylette 54 is placed within
needle 30 with one end near to or touching head 10 of the "T"
element 8, and the other end extending through hub 50. The proximal
end 55 of obturator 54 is of sufficient width, N, greater than the
internal diameter, M, of needle 30, that it is unable to pass
through needle 30, so that it serves as a stop. Obturator 54 is of
sufficient length to extend from the distal end of needle 30
approximately 1 inch into syringe 52. When plunger 56 of syringe 52
is pushed fully down it can engage the proximal end of obturator 54
and eject head 10 from the distal end of needle 30, by moving
obturator 54 distance J, approximately the length of head 10 plus
any distance provided between the tip of the needle and head 10.
(If desired obturator 54 may instead by moved distance J by pushing
it with a finger).
METHOD OF INSERTION
Prior to insertion of the "T" element 8 of the percutaneous
fixation device into the stomach according to this embodiment, a
nasogastric tube is passed and the patient given intravenous
glucogon to temporarily stop the motion of the gastro-intestinal
tract and thus make it easier to distend the stomach. An air
pumping bulb is then attached to the nasogastric tube and air is
carefully pumped into the stomach. When the stomach is moderately
distended, site 72 (FIG. 4) is chosen, at which a catheter is to be
inserted through the skin and an area of approximately 2 inch
square around the site is infiltrated with local anaethesia. The
points 74 (FIG. 4) for introduction of the heads of the
percutaneous fixation devices (usually four in number) are chosen
and marked.
Referring to FIG. 3, needle 30 containing the head 10 of the "T"
element 8 is filled with liquid by the syringe and the percutaneous
fixation device is inserted through skin and flesh 62, across
intraperitoneal space 66 and through stomach wall 60 into the
stomach cavity 64. Insertion is followed using a fluoroscope to
ensure that needle 30 is correctly positioned. If desired, needle
30 may be filled with an appropriate liquid, such as radiopaque
material. If this is done, then the movement of needle 30 into the
body is more easily followed with the fluoroscope. When the tip of
needle 30 is within the air-containing stomach, by moving the
plunger of the syringe proximally, air bubbles will enter needle 30
and the attached syringe. Observance of these air bubbles will aid
the inserter in confirming insertion into the stomach cavity (FIG.
3).
Referring to FIG. 3(a), head 10 of the percutaneous fixation device
is removed from needle 30 by insertion of obturator 54 into needle
hub 50 and gently pushing obturator 54 down distance J (FIG. 2b)
until its distal end is next to the distal end of needle 30 (FIG.
3(a). The head 10 may be displaced using the syringe as shown in
FIG. 2(b). Once head 10 has been displaced into the stomach space,
needle 30 may be removed.
Referring to FIG. 3(b), by pulling on filament 12, head 10, engaged
cross-wise upon the stomach wall, can be used to pull stomach wall
60 towards abdominal wall 62 until they touch. Head 10 is then
secured by pushing pledgette 36 along filament 12 with washer 38
until the indentation of the skin by the pledgette indicates a
safisfactory tension on filament 12. Washer 38 and pledgette 36 are
then secured in place temporarily by clamp 68 applied to tube
48.
Referring to FIG. 4, the remaining percutaneous fixation devices
74, are inserted and fixed in a similar manner to the first one and
the tension on each of filaments 12 adjusted. Then each is more
permanently clamped by crimping the crimpable clamp devices 44
(FIG. 3(c)). (The devices are usually placed distance L, e.g. 1",
apart around site 72, the proposed site for insertion of the
catheter (FIG. 4).) The parts of the percutaneous fixation device
apparatus proximal of the crimped device 46 may then be removed and
filament 12 cut to an appropriate length (FIG. 3(c)). Device 44 may
be clamped at this point to ensure the availability of filament 34
for utilization at a later time. (see below).
Referring to FIG. 3(d), in an alternative embodiment a second
crimpable device 70 may be provided for later adjustment of the
tension on filament 12. For example, if the tension slackens,
filament 12 may be pulled through crimpable device 70 and then
device 70 is fixed to reposition pledgette 36 more inwardly along
filament 12, see FIG. 3(d) dotted lines.
REMOVAL OF TACK AND REMAINDER OF PERCUTANEOUS FIXATION DEVICE
Referring to FIGS. 3(c) and (d), the percutaneous fixation devices
normally remain in place until the stomach wall and skin have
adhered to each other (2-3 weeks). At this point the percutaneous
fixation devices may be removed either by cutting filament 12 and
allowing head 10 to pass through the intestinal tract of the body
or, if filament 34 is present, filament 12 may be cut to release it
from clamp 44 or 70 and head 10 may be pulled through the skin
using filament 34. Because filament 34 is attached to the end of
the head, tension on filament 34 causes the head to turn to align
itself with the filament and the exiting opening, thus to
facilitate end-wise movement of the head.
MANUFACTURE OF THE PERCUTANEOUS FIXATION DEVICE
Referring to FIG. 1(a) hole 14 of diameter F is drilled into one
side of tubular head 10 near to its mid point. Filament 16 of
strong thermoplastic is introduced into head 10 and the head is
held horizontally with hole 14 pointing upward. The head is then
heated in an inert atmosphere (for example nitrogen gas) to a
temperature above the melting temperature of filament 16 but below
the annealing temperature of the stainless steel of head 10. Using
a nylon filament a temperature between 500.degree.-600.degree. F.
is suitable. Preferably head 10 is heated using a soldering iron
applied to its mid region, on the side opposite of hole 14. When
filament 16 has melted, filament 12 of the same material is
introduced through hole 16 and pushed into molten ball 18. If to be
employed, filament 34 is also inserted at this time throughone end
of head 10 and pushed into molten ball 18. The assembly is then
permitted to cool.
Once molten ball 18 and the filament are bonded together, pledgette
36, washer 38, tube 48, and clamping devices 44, 46, and 70 are
threaded in appropriate order along filaments 12 and 34. Each of
these pieces has a hole just greater in diameter than the
respective filament, i.e. approximately 0.010". Head 10 is inserted
into hollow slotted needle 30 such that filament 12 passes through
the slot and the attached end of filament 34 is at the distal end
of needle 30. The whole apparatus may be gas sterilized.
USES
The percutaneous fixation device is useful for the fixation or
anchoring of hollow organs without the need for a complex
operation, or the need to engage a surgeon. Organs such as the
stomach, kidney, gall bladder, large and small bowel, urinary
bladder, and duodenum may be readily moved within the body to any
desired position simply by inserting "T" element 8 of the
percutaneous fixation device into the organ and adjusting the
tension on attached filament 12. Once fixed in place, catheters are
readily inserted into the desired organ. Since the percutaneous
fixation device may be readily removed, using filament 34, there is
no problem with leaving the head of the percutaneous fixation
device within the body, though in certain cases the elimination
system of the body may be employed to remove the head, and in still
other cases the head may be left permanently in the body.
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