Percutaneous fixation of hollow organs

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.

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 along-side 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 to 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.

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 pass 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 be 
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 through-one 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.