Percutaneous gastrostomy feeding tube applicator and method.

Various embodiments of a gastrostomy method and applicator device are shown and described. The gastrostomy device has an elongated body for insertion into the patient's stomach, a removable for piercing a channel through the stomach and abdomen walls, a shield means for removably covering the needle as it is inserted into the stomach, and an actuating means for moving the needle forward to pierce the channel. The gastrostomy method includes piercing the channel from the inside of the stomach to the outside of the patient's body. The method includes insertion of the invented device into the stomach, placement of the needle, unshielding the needle, and actuating the needle to pierce the channel. Optionally, the method may include steps of drawing a strand through the channel and out the mouth, attachment to a feeding tube, and drawing the feeding tube into the stomach and into the channel.

BACKGROUND OF THE INVENTION 
1. Technical Field 
This invention relates generally to medical methods and apparatus and more 
specifically to procedures for forming a channel through a stomach wall in 
percutaneous gastrostomy. 
2. Background Art 
In recent years, the field of percutaneous gastrostomy has emerged in 
veterinary medicine as an effective technique for providing nutritional 
support for critically ill small animals. Animals that are malnourished or 
unwilling or unable to eat may benefit from this treatment, especially if 
nutritional support is needed for longer than about one week. 
Percutaneous gastrostomy is a procedure involving the placement of a 
feeding tube through the skin, abdomen wall, and stomach wall of a patient 
as a means of supplying nutrients to the stomach without involving the 
head or esophagus. Percutaneous placement of the gastrostomy tube can be 
faster and involve less tissue trauma than the alternative of surgical 
placement, which involves making a grid incision through the skin and 
abdominal wall to locate and reach the stomach wall. 
Percutaneous gastrostomy has been done in the past with the aid of an 
endoscope, which is a fiber-optic instrument that can be directed through 
the esophagus and into the stomach for viewing the inside of the stomach. 
The endoscope typically has a forceps extending through it and reaching to 
the distal end and a channel for delivery of gas or liquid to the vicinity 
of the distal end. 
Percutaneous Endoscopic Gastrostomy (PEG) for veterinary patients is 
discussed in the article "Enteral Feeding of Critically Ill Pets: The 
Choices and Techniques," by P. Jane Armstrong, Veterinary Medicine, 
September 1992. Typically, the endoscope is introduced into the stomach 
and air is pumped through the endoscope to insufflate and distend the 
stomach. As the endoscopist views the inside of the stomach wall, an 
assistant chooses a point on the abdominal wall where the endoscope light 
can be clearly seen through the abdominal wall. The location of that point 
is confirmed by the assistant applying pressure to the abdominal wall and 
the endoscopist observing the resulting depression in the stomach wall. 
After good visualization of this point is confirmed, the assistant inserts 
a needle holding a suture strand through the skin, the abdominal wall, and 
stomach wall, creating a channel through these tissues. The endoscopist 
uses the endoscope forceps to grasp the strand and pulls the endoscope out 
of the stomach and esophagus and thus pulls the suture strand out through 
the patient's mouth. 
The end of the suture strand exiting the mouth is attached to a pipette tip 
and then to a feeding tube such as a mushroom-shaped catheter. The pipette 
tip is usually threaded tip end first on to the suture strand to act as a 
smooth guide for the end of the feeding tube as it travels through the 
esophagus. 
The end of the suture strand exiting the abdominal wall is pulled so that 
the pipette and feeding tube move through the esophagus, into the stomach, 
and into the channel through the stomach wall and abdominal wall. The 
suture strand and pipette may then be removed from the end of the feeding 
tube which exits from the abdominal skin. The feeding tube may be held in 
place by flanges, tape, or other anchoring devices. The feeding tube then 
serves as a conduit for nutritional supplements to flow into the stomach. 
Thus, PEG involves locating the site for the channel by viewing the inside 
of the stomach and involves piercing into the abdominal wall and stomach 
wall from the outside of the body. PEG requires two people to perform the 
technique and requires an expensive endoscopic instrument. 
Similar PEG techniques are used in human gastrostomy operations. Grobe 
(U.S. Pat. No. 5,112,310) discusses the "pull" PEG technique, which is 
similar to the veterinary technique described above. Grobe also discusses 
the similar "push" and "introducer" techniques and discloses apparatus for 
use in PEG. All these techniques involve the viewing of the inside of the 
stomach with an endoscope and an incision made from the outside toward the 
inside of the body and stomach. 
Several U.S. patents disclose apparatus for use in PEG. Krol (U.S. Pat. No. 
4,573,576) discloses a PEG kit. Picha et al. (U.S. Pat. No. 5,007,900) 
discloses a T-bar device for anchoring a catheter in the abdomen wall. 
Poirier et al. (U.S. Pat. No. 4,897,081) discloses a button-like device 
for anchoring a catheter. 
Improved methods and devices, which are simple, reliable, and safe, are 
needed for placement of a percutaneous gastrostomy tube. Methods that can 
be done by one person are needed. Apparatus that is simpler and less 
expensive than an endoscope is needed. 
DISCLOSURE OF INVENTION 
The invented methods and apparatus allow percutaneous gastrostomy to be 
performed by a single person and without an endoscope. These methods and 
apparatus are especially useful in the field of veterinary medicine, 
because inexpensive and simple apparatus is preferred in veterinary 
clinics, and few of these clinics choose to invest in an endoscope. These 
invented methods and apparatus may also be useful in the field of human 
medicine, especially in areas or situations where the lack of personnel or 
lack of money for expensive equipment makes endoscope procedures difficult 
to perform. 
The invented method includes the insertion of a device through the 
esophagus into the stomach so that the distal region is inside the stomach 
and the proximal region extends outside the mouth for access by the 
surgeon. The device has a removable needle near the distal region and this 
needle is shielded during the insertion into the stomach. The needle is 
placed in a desired location in the stomach near the stomach wall by 
manipulating the proximal region. The shield means is remotely actuated to 
uncover the needle and the needle is remotely actuated to move the needle 
forward to pierce through the stomach wall and abdomen wall to reach the 
outside of the body. The needle may be remotely actuated to move backward 
to retract back into the stomach. Thus, the invented method cuts or 
pierces a channel from the inside of the stomach to the outside of the 
body. The channel may be used for receiving a suture strand, a feeding 
tube, or other apparatus and may be used for other access of the stomach. 
The step of placing the needle in the desired location may include the 
procedure of tapping a blunt end of the device against the stomach wall so 
that the tapping may be palpated or felt on the outside of the body. 
Because the blunt end is a predetermined distance and location relative to 
the needle, this tapping is used to indicate where the blunt end is 
located inside the stomach and therefore where the needle is located 
inside the stomach. 
Optionally, the method may include attaching a suture strand to the needle 
after the needle pierces through to the outside of the body and remotely 
actuating the needle to move backward into the stomach to pull the suture 
strand through the channel and into the stomach. Optionally, the method 
may include pulling the device out of the stomach and esophagus to pull 
the suture strand out through the esophagus and mouth for attachment to a 
feeding tube or other apparatus. The end of the suture strand exiting the 
channel may then be pulled to move the feeding tube or other apparatus 
through the esophagus and the stomach and into the channel. 
The applicator device invented for this procedure has an elongated body 
with a distal region and a proximal region. The device includes a 
removable needle, a shield means, and an actuating means. The shield means 
is for covering the needle to prevent damage to the mouth, esophagus, and 
stomach when the needle in being inserted into the stomach. The actuating 
means is for remotely moving the needle forward to pierce through the body 
tissue and backward to retract into the stomach. 
The elongated body of the device may comprise a probe, with a distal region 
having a blunt end, and a rod that is generally parallel to and slidably 
attached to the probe. The removable needle may be attached to the distal 
region of the rod so that it slides forward and backward, relative to the 
blunt end, to pierce the stomach wall and abdomen wall and to retract away 
from the stomach wall, respectively. Optionally, the probe may be a hollow 
tube with open ends, and the rod may be slidably received inside the tube.

BEST MODE FOR CARRYING OUT INVENTION 
Referring to FIGS. 1-4, there are shown the preferred but not the only 
embodiments of the invented device and method. The gastrostomy device 10 
has an elongated body, which has a distal region 14 for extending into the 
patient's stomach 16, and a proximal region 18 for extending out from the 
patient's mouth 20. 
In the preferred embodiment, the elongated body comprises an elongated rod 
30 and an elongated probe, which is a tube 32. The rod 30 has a distal 
region 34 and a proximal region 36, and the tube 32 has a distal region 38 
and a proximal region 40. The tube 32 has a hollow interior 42 and open 
ends that are referred to as the opening 44 at the distal region 38 and 
the aperture 46 at the proximal region 40. The rod 32 may be slidably 
received inside the tube 32, so that the rod distal region 34 may slide 
forward and backward through the opening 44 and the rod proximal region 36 
may slide forward and backward through the aperture 46. The terms 
"forward" and "front" mean toward or past the distal region 38 of the tube 
32 and the terms "backward" and "in back of" mean toward or past the 
proximal region 40 of the tube 32. 
A removable needle 50 is attached to the distal region 34 of the rod 32 and 
50 is removable and re-attachable for easy cleaning, autoclaving, 
sharpening, or replacement. Removable needle 50 can be attached to rod 32 
by any conventional means, such as a bayonet mount or friction fit. Here 
needle 50 has threaded extension 51 for threadable engagement in distal 
region 34 of rod 32. The preferred needle 50 is a narrow arrow-head shape, 
with a V-shaped cutting edge 52 oriented with the cutting edge 52 facing 
generally distally and generally parallel to the longitudinal axis of the 
device 10. Other shapes and orientations may be used to optimize the 
cutting edge 52 for a particular application. A thin, sewing-needle shape 
or a scalpel-shaped blade could be used. The cutting edge 52 could face 
distally but at a 45.degree. angle, for example, to the longitudinal axis 
of the device 10. The limitation is that the needle 50 should be a shape 
and orientation that allows it to be shielded to fit through the mouth 20, 
esophagus 54, and into the stomach 16. 
The proximal region 36 of the rod 30 extends back past the proximal region 
40 of the tube 32 so that the surgeon may access and push the rod 30 
forward to slide the removable needle 50 to an extended position and pull 
the rod backward to slide the needle 50 to a retracted position. When 
pushed forward, the distal region 34 of the rod 30 and the needle 50 
extend out from the opening 44 and in front of the blunt end 56 of the 
tube 32, thus becoming unshielded and exposed. When the blunt end 56 of 
the tube 32 has been placed in a desired location against the stomach wall 
58, this pushing of the rod 30 and needle 50 forward acts to force the 
needle 50 through the stomach wall 58 and abdomen wall 60, piercing a 
channel 62 through these tissues. Therefore, grasping the rod proximal 
region 36 or optional handle 64 and the tube proximal region 40 or 
optional grip 65 and pushing the rod 30 forward relative to the tube 32 is 
both the preferred way of actuating the shield means to unshield the 
needle 50 and the preferred way of actuating the needle 50 to move forward 
to pierce the channel. In the preferred embodiment and preferred method, 
the tube distal region 38 acts as the retractable shield means, because it 
covers the removable needle 50 during the insertion through the esophagus 
54 and, in effect, retracts from the needle 50 when the needle 50 is 
pushed forward. Thus, the rod proximal region 36, tube proximal region 40, 
and slidably connection between the rod 30 and tube 32 cooperate to act as 
the actuating means for moving the needle 50 forward and backward. 
Alternatively, other designs for the gastrostomy device 10 may be used. For 
example, the rod could be slidably connected parallel and beside, but not 
inside, the probe. In such an embodiment, a shield plate could be attached 
to the probe in such a way that it extends to cover the removable needle 
during insertion through the esophagus but allows the needle to slide 
forward and out from under the plate when the rod is pushed. Another 
shield means for this embodiment could be a hinged shield plate that is 
biased to cover the removable needle until the needle pushes the plate out 
of the way when the rod is pushed forward. In another embodiment, the 
probe could have the needle and a hinged shield attached to its distal end 
and have linkage extending through or beside the probe for actuating the 
hinged shield to unshield the needle. In such an embodiment, after the 
unshielding of the needle, the proximal region of the probe would be 
pushed forward to actuate the needle to pierce a channel in the stomach 
and abdomen walls. Thus, the actuating means may be as simple as the 
surgeon pushing the device forward into the tissue. 
In another embodiment, the gastrostomy device may include or be a part of 
an endoscope. The elongated body may slide through a channel in the 
endoscope. Such embodiment allows viewing of the inside of the stomach, 
which is beneficial in human gastrostomy. 
Preferably, a biasing means is included in the device 10 for biasing the 
rod 30 backwards relative to the tube 32, so that the needle 50 is 
shielded except when the surgeon purposely pushes the rod 30 forward. In 
the preferred embodiment, the biasing means is a coiled spring 66, which 
extends to force apart the rod handle 64 and the tube proximal region 40. 
The elongated body of the device 10 may be of various degrees of 
flexibility, ranging from rigid to somewhat flexible for allowing some 
bending when significant force is placed on the device 10. Embodiments 
that are somewhat flexible may aid in making easier the insertion of the 
device 10 through the esophagus 54, however, flexibility should be limited 
to a degree that assures efficient and confident placement of the needle 
50 without buckling, bending, or crimping of the device 10. 
In the preferred embodiment, the tube 32 is rigid and curved, resulting in 
the tube distal region 38 and tube proximal region 40 lying at an obtuse 
angle, of preferably, but not limited to, about 130.degree.-150.degree. to 
each other. This curve is slight enough and gradual enough to allow easy 
insertion of the device 10 through the esophagus 54 but also is great 
enough to allow easy pointing of the blunt end 56 toward the front or side 
of the stomach 16, which are the preferred locations for the channel 62 
for a gastrostomy feeding tube 68. In embodiments having a curve, the rod 
30 should be flexible enough to follow the curve of the tube 32 when 
pushed and pulled but rigid enough to prevent buckling or bending that 
would bind the rod 30 inside the tube 32 or interfere with the needle 50 
piercing through the stomach wall 58 and abdomen wall 60. 
The invented gastrostomy method involves making the channel through the 
stomach and abdomen walls 58,60 from the inside out, as discussed in the 
above description of the invented device. The method may be used to make 
the channel 62 for various medical uses, including the insertion of a 
feeding tube 68 or other catheter. 
The preferred method involves tapping the blunt end 56 against the stomach 
wall 58 to determine when the blunt end 56 and therefore the needle 50 are 
in a desirable location for piercing the channel 62. The surgeon or 
veterinarian may palpate the tapping from the outside of the patient's 
body to accurately confirm the location of blunt end 56 and needle 50 
before actuating the needle 50 to pierce the channel 62. Thus, the 
invented method provides a simple, accurate, and quick way of piercing the 
channel 62 without expensive equipment and without the assistance of a 
second person. 
The method may optionally include other steps. A suture strand 70 or other 
elongated string may be attached to the needle 50, for example, by 
threading the strand 70 through the eye 72 of the needle 50. The use of 
the term "suture strand" is not intended to limit the strand 70 to a 
particular design or material. The needle 50 may be actuated backwards to 
draw the first end 74 of the suture strand 70 back into the stomach 16 and 
the device 10 may be pulled out of the esophagus 54 to draw the first end 
74 out of the mouth 20. The first end 74 may be attached to a pipette 76 
and feeding tube 68, as is done in the other gastrostomy techniques 
discussed in the above section "Background Art." The pipette 76 and 
feeding tube 68 may then be drawn into the channel 62 by pulling the 
second end 78 of the strand 70. The feeding tube 68 may then be anchored 
in place and used for nutritional support as described in the "Background 
Art" section and the P. Jane Armstrong article. 
The preferred materials for the invented device are stainless or surgical 
steel. Other materials that fulfill the sterility, strength and piercing 
requirements may also be used. 
While there is shown and described the present preferred embodiment of the 
invention, it is to be distinctly understood that this invention is not 
limited thereto but may be variously embodied to practice within the scope 
of the following claims.