JPH038220B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a device for performing percutaneous or non-incisional procedures involving forming an opening or portal into a body cavity or hollow internal organ.

A number of devices have been proposed for the non-incisional creation of openings into body cavities or hollow internal organs, particularly for tracheotomy. Such devices are typically preferred for open procedures, which often involve large numbers of blood vessels that tend to bleed profusely during the procedure, and require considerable surgical skill.

My U.S. Pat. No. 3,511,243 discloses a method and apparatus that utilizes a dilator with a releasably attached flexible leader. A device is provided for introducing a guide member into the lumen of the trachea during a tracheostomy.

The inventor's U.S. patent application Ser. No. 206,709 discloses a similar method and device, but with a permanently attached dilator lead member and device elements properly positioned within the lumen of the trachea. It utilizes improved equipment for placement. The device and method also utilizes a pair of coaxially arranged needles to facilitate introduction of the dilator lead member into the lumen of the trachea, and further includes removal of the dilator. A breathing tube in coaxial relationship with a dilator is utilized to hold the breathing tube within the lumen of the trachea during this process. This dual needle configuration is relatively expensive and complex to use;
The coaxial configuration of the dilator and breathing tube also limits the length of the breathing tube that can be easily used. This is a disadvantage if the patient's trachea is located deeper than normal.

In accordance with the present invention, devices and methods are provided that utilize a single needle for insertion into a body cavity or hollow internal organ. The needle is structurally weakened along a longitudinal line and has a spreader device that acts to longitudinally split the needle along the line of structural weakness to form an elongated slot. A syringe attached to the needle facilitates needle insertion and directs penetration into the body cavity by aspiration. This is because once such penetration is made, the plunger of the syringe can easily move outward.

The device includes a dilator insertable into a side opening in a flexible tube, the dilator having a tapered introduction portion coaxial with the distal end of the tube.

Attached to the distal end of the introducer portion of the dilator is a flexible guide member that can be fitted into the bore of the needle after removal of the needle syringe. Once the guide member is in place, the segmented needles are separated from the guide member and removed. The dilator is forced into the body cavity along the path formed by the guide member, bringing the breathing tube along with it. The dilator is then removed from the side opening of the breathing tube, and the remaining length of the breathing tube is then pushed into the body cavity.

When the device is used to perform a tracheostomy, the flexible tube preferably has a deflated cuff with an attached inflation tube. Inflation of the cuff by means of an associated syringe prevents foreign objects from entering the area of the respiratory tract from the head and upper throat.

Other objects and features of the invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

As will be seen from the following description, the device of the present invention will be described in connection with a tracheostomy procedure. however,
Openings to other body cavities or hollow internal organs, such as thoracotomy, which creates an opening into the chest, laparoscopy, which creates an opening into the abdominal cavity, or gallbladder placement, which creates an opening into the gallbladder. The device can equally be used with relatively minor obvious modifications in making a section or an inlet. Accordingly, the following specific description of a tracheostomy is merely illustrative of the invention.

The device of the present invention, like the device of the inventor's original U.S. patent application and co-pending U.S. patent application Ser. It is increasingly being used to perform percutaneous tracheostomies. The device of the invention does not require the same level of skill and is therefore suitable for use in emergency cases by persons without extensive surgical training.

When performing a tracheostomy, in the initial stages of the method,
Utilizes a single needle associated with a syringe. When the needle is positioned within the lumen of the trachea, the plunger of the syringe can be withdrawn. Knowing the location of this needle is important for a successful tracheostomy. A feature of this device is the use of a unique needle configuration with a structural weakness that allows the needle to be split lengthwise to form an opening slot. As will be seen, the needle bore provides a pathway for insertion of the flexible guide member into the lumen of the trachea. The vertical division of the needle forms a slot through which the needle can be passed and laterally separated for withdrawal from the trachea. the guide member is attached to the dilator, and the dilator is then pushed inwardly to gradually widen or widen the needle opening occupied by the guide member;
A breathing tube associated with the dilator is then placed. The breathing tube provides a passageway for breathing.

As will be apparent to those skilled in the medical field, the various components of the device are shaped and dimensioned to suit the size and condition of the patient, which dimensions may be reduced, for example, in the case of a child. . Furthermore, the ability to insert the breathing tube used deep enough to reach the deep trachea, which is unique to a person,
This is an important feature of the invention.

The accompanying drawings generally follow the sequence of steps characterizing the implementation of the method.

In FIG. 1, the device includes an elongated needle 10 with a wedge-shaped distal end to facilitate penetration of the trachea and associated tissue and cartilage. needle 10
has a central bore 12 which, as can be seen in FIG. 6, is structurally weakened in the longitudinal direction by providing a very small groove 14, which
0 almost completely through the wall thickness. The needle 10 is also preferably structurally weakened to a lesser extent than the groove 14 by a longitudinal groove 16 located opposite the groove 14.

A pair of metal spreader tabs 18 have ends thereof, as best seen in FIGS.
It is spot welded or otherwise secured to the needle 10 on both sides of the groove 14. If desired, tab 18 may be a common length metal member extending around needle 10 in overlying relation to groove 16.

As should be shown in the drawings, the portions of the needle adjacent to the grooves 14, 16 are coated with a suitable polymer or other coating to prevent air leakage through the grooves 14, 16 into the central bore 12 of the needle. It is provided.

Needles of the type described above are currently available for use in parenteral nutrition. It is believed that grooves 14 and 16 are precisely formed by laser beam technology. In this application, the tabs 18 are grasped between the thumbs and forefingers of both hands and spread apart to vertically split open the release grooves 14 to the holes 12 to form the slots. The groove 16 is usually
Up to the hole 12 it is not vertically divided, but instead serves as a kind of hinge. The slot thus formed allows the associated catheter to be passed through the slot so as to be retained within the vein.

In the present invention, this form of needle has been modified so that the needle 10 can be split open with one-handed operation. More specifically, the fitting or spreader 22
is made of a plastic material, such as polyethylene, in an Extending around the ends, the joints of the legs 20 constitute hinges 24 . The lower part of the X-shape of the spreader 22 is connected to the leg 2
0 and a pair of downwardly branching legs 26.

The tab 18 abuts the inner surface of the upper leg 20, and the outer end of the tab 18 fits under and is held in place by a pair of end flanges 28 integral with the upper leg 20. There is. The distal edges of the tabs 18 underlie and are held in place by a pair of side flanges 30 integral with the upper legs 20.

A cylindrical syringe receptacle 32 having upwardly branching wings or tabs 34 is positioned adjacent the proximal end of the needle 10. Tab 34 is held between leg 20 and tab 18. The central portion of the syringe receptacle 32 constitutes an extension of the bore of the needle 10 and is longitudinally split along a line aligned with the groove 14 of the needle.

In the above-described configuration, the legs 26 can be removed by grasping the opposing legs 26 between the thumb and index finger of one hand.
By pushing away, the needle 10 can be expanded or split along the groove 14. This one-handed operation leaves the other hand free for manipulating the dilator lead member described below.

In practicing the device, the needle 10 is removably fitted into a conventional conventional syringe 38 at the syringe receptacle 32. As can be seen from Figure 1, needle 1
0 is inserted into the area adjacent to the lumen of the trachea, and the placement of the needle 10 within the lumen of the trachea is confirmed by the physician's skill in pulling the plunger 42 of the syringe, thereby removing air from the trachea. You will be given instructions. At this time, it is impossible for air to enter through the grooves 14 or 16 because the needle 10 is coated to prevent fluid leakage.

Once the needle 10 is in the trachea, the needle 10 is angled down the throat at about a 45 degree angle and then advanced about 6-8 mm, as shown in FIG. The syringe 38 is then inserted into the syringe receiver 32 as shown in FIG.
Remove from.

The elongate dilator 44 is then used to dilate the breathing tube opening and introduce the breathing tube lead member.
Dilator 44 has a curved or arcuate intermediate portion 48
an elongated handle portion 46 integral with the intermediate portion 48 having a downwardly tapered conical lead-in portion 5;
It terminates at 0. The larger diameter of the introduction section 50 is the same as the diameter of the intermediate section 48.

Attached to the distal end of the introduction section 50 is an elongated, flexible jar lead member 72 made of a suitable flexible material, such as a thin polyethylene tube. The distal end of the guide member 72 and the introduction section 50 are inserted into a cut defining a side opening of the breathing tube 52.

Breathing tube 52 is conveniently constructed from a length of plastic surgical tubing with a radiused distal end to facilitate movement along the lumen of the trachea. The plastic material is flexible enough to allow the side openings to expand to accommodate the dilator 44, and resilient enough to substantially close the side openings when the dilator is removed.

The breathing tube 52 has its distal end connected to the curved intermediate portion 48 of the dilator 44, as seen in FIG.
is coaxial with the distal end of the

Although not necessary for procedures other than tracheotomy, a plastic cuff 54 is attached to the lower or distal end of breathing tube 52. Cuff 54 has an inflatable central portion and its ends are adhered to the outer surface of breathing tube 52 .
As best seen in FIG. 15, an opening 56 is formed in the wall of breathing tube 52 to provide communication between the interior of cuff 54 and the distal end of air tube 58. Air tube 58 extends toward the proximal end of breathing tube 52 through a suitable opening 60 in the side of breathing tube 52 and communicates with the interior of bladder 61 . The air bladder 61 is press fit into the end of the air inflation syringe 62 for purposes described below.

A respirator fitting 64 is press fit into the breathing tube 52 at the opposite or proximal end of the tube 52, and a stop collar 66 is fitted and glued around the outer surface of the breathing tube 52. This prevents passage of the breathing tube 52 into the trachea even if the fitting 64 of the respiratory mask becomes dislodged.

A blade or cutting blade 68 mounted in a recess 70 formed in the intermediate portion 48 cuts tissue that is forced across the cutting blade 68 upon introduction of the dilator 44 into the lumen of the trachea. I'm starting to do that.

The flexibility of the guide member 72 facilitates the insertion of the guide member 72 into the open upper end of the bore 12 of the needle 10 so that the guide member 72 projects into the lumen of the trachea, as seen in FIG. Can pass. Leading member 72 tends to align with the trachea to provide posterior guidance for dilator 44 .

Once the guide member 72 is inserted to the extent shown in FIG. 4, the needle 10 is split open longitudinally along the groove 14, and the guide member 72 is separated laterally while the needle is withdrawn. The lead member is laterally separated from the longitudinally open groove 14, which groove 14 is maintained open by uniform pressure acting on the legs 26 of the spreader.

Next, the axis of the introduction portion 50 of the dilator is adjusted to the 10th
As can be seen, it is oriented at approximately a 45 degree angle and pushed into the opening through which the guide member 72 extends. A tapered introduction section 50 followed by a larger diameter breathing tube 52 forces the tissue apart. The flexible cuff 54 conforms to and easily slides through the opening. This dilation, rather than cutting, action minimizes bleeding and provides the desired thrombostatic effect. The tissue cuts are only those necessary to relieve the tension in the tissue that is forced across the midsection and in contact with the blade 68.

The dilator 44 is then withdrawn from the trachea and through the side opening of the breathing tube 52. The side opening is
It has a tendency to close due to the elasticity or "restoring force" of the plastic material from which breathing tube 52 is made. breathing tube 5
2 remains in place as can be seen in Figure 15, and if the trachea is in a deep position, as is the case with some patients, the breathing tube 52 can be pushed further into the trachea.

As can be seen in FIGS. 11-13, during insertion of the breathing tube 52 into the trachea, the thin cuff 54 is inserted into the breathing tube 52.
2. It is crushed tightly on top. After this insertion, cuff 54 can be inflated by depressing the plunger of syringe 62. The inflated cuff 54 is inserted into the breathing tube 52, as seen in FIG.
Close the throat above the open distal end of. next,
A respirator (not shown) can be attached to fitting 64 and operated in a conventional manner that will be apparent to those skilled in the art.

From the foregoing description, it can be seen that the use of only one needle 10 greatly simplifies the insertion procedure;
The configuration that allows the dilator 44 to be introduced into the side of the breathing tube 52 allows the dilator 44 to be introduced into the side of the breathing tube 52.
It is possible to use a breathing tube that is about 25 mm longer than the tube that can be used with the device of No. 206709.

Various modifications and changes may be made to the foregoing detailed description, particularly with respect to procedures other than tracheotomy, without departing from the spirit of the invention.

[Brief explanation of drawings]

FIG. 1 is an elevational view showing the initial insertion of the needle and syringe of the present invention into the lumen of the trachea in a tracheostomy procedure, the lumen of the trachea being shown schematically for simplicity. FIG. 2 is a view similar to FIG. 1 showing the oblique direction of continued passage of the needle into the trachea. FIG. 3 is a view similar to FIG. 2 showing removal of the syringe from the needle; FIG. 4 is a view similar to FIG. 3 with the dilator lead member passed through the needle bore and into the trachea. FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 4. FIG. 6 is an enlarged cross-sectional view taken along line 6--6 in FIG. 4 before the needle is vertically divided. FIG. 7 is a view similar to FIG. 6, showing a vertically split needle.
FIG. 8 is a view similar to FIG. 5 showing the position of the components of the spreader after longitudinal splitting of the needle; FIG. 9 is a view similar to FIG. 4 showing the lateral separation of the guide member from the longitudinal slot of the needle during withdrawal of the needle; FIG. 10 is a view similar to FIG. 9 showing the orientation of the dilator prior to passing the dilator into the trachea. FIG. 11 shows the initial penetration of the dilator and breathing tube into the trachea. FIG. 12 is a view similar to FIG. 11 showing more complete insertion of the breathing tube. FIG. 13 is a view similar to FIG. 12 showing the dilator partially withdrawn; FIG. 14 is a front view of the breathing tube. FIG. 15 is a cross-sectional view of a breathing tube partially inserted into the trachea. 1st
FIG. 6 is a side view similar to FIG. 15 showing the installation of the inflation syringe. FIG. 17 is a view similar to FIG. 16 showing the inflated cuff of the breathing tube. 10... Needle (hollow needle), 12... Needle hole, 14
...Structurally weak first region (groove), 16...Structurally weak second region (groove), 18...Tab, 2
0...Upwardly branched leg, 22...Spreader, 26...Downwardly branched leg, 34...Tab, 44...Dilator, 48...Introduction part, 52...
...Flexible tube (breathing tube), 66...Color, 72
...Flexible leading member.

Claims (1)

[Scope of Claims] 1. A device for performing a percutaneous procedure for forming an opening into a body cavity or a hollow internal organ, the device: being inserted into a body cavity or hollow internal organ to form an opening; means for forming a pointed distal end, a proximal end having an open end, and a longitudinal slot extending lengthwise between the distal and proximal ends; a flexible tube having a side opening and having a distal end and a proximal end; a flexible tube having a side opening in the tube; an elongate dilator having a tapered introducer portion at its distal end adapted to protrude, the introducer portion being stiffer than the tube to facilitate entry of the introducer portion into the side opening. , further comprising an elongated flexible guide member disposed at the distal end of the introducer portion and adapted to be inserted into the bore of the needle, thereby causing expansion upon insertion of the needle into the body cavity or hollow internal organ. In order to expand the opening with the vessel, the guide member
forming a path for insertion of the dilator and flexible tube into the body cavity or hollow viscera, and upon removal of the needle from the body cavity or hollow viscera, the guide member passes laterally outwardly from the needle slot; and the dilator is characterized in that it is slidably removable from a side opening of the tube to keep the tube in place and in communication with the body cavity or hollow internal organ. Device. 2. A device for performing a percutaneous procedure to create an opening into a body cavity or hollow internal organ, the device having a pointed tip that can be inserted into the body cavity or hollow internal organ to create the opening. an elongated hollow needle having a distal end, a proximal end having an open end, and means for forming a longitudinal slot extending longitudinally between the distal and proximal ends; and the means takes the form of a region of structural weakness provided between the distal and proximal ends, and adjacent to the proximal end opposite the region of structural weakness. a spreader device secured to the needle and operative to spread apart the walls of the needle in a region adjacent the proximal end to form a slot and widen the slot to the distal end; a flexible tube having an open end and a side opening; a tapered lead-in portion adapted to enter the side opening of the tube and project from the distal end of the tube; an elongate dilator having an elongate dilator at the end thereof, the introducer section being stiffer than the tube to facilitate entry of the introducer section into the side opening, the introducer section having an elongated dilator at the distal end of the introducer section and a needle. further comprising an elongate flexible guide member adapted to be inserted into the aperture, such that upon insertion of the needle into the body cavity or hollow internal organ, the guide member is adapted to dilate the opening with the dilator. ,
forming a path for insertion of the dilator and flexible tube into the body cavity or hollow viscera, and upon removal of the needle from the body cavity or hollow viscera, the guide member passes laterally outwardly from the needle slot; and the dilator is characterized in that it is slidably removable from a side opening of the tube to keep the tube in place and in communication with the body cavity or hollow internal organ. Device. 3. The hollow needle extends longitudinally between the distal and proximal ends and has a diameter of the structurally weak first region to serve as a hinge portion when forming the slot. 3. Device according to claim 2, characterized in that it comprises a second region of structural weakness arranged directionally opposite. 4. The spreader device comprises a tab device with upwardly branched legs that protrudes from both sides of the structurally weak area and can be moved away to form the slot. Apparatus according to scope 2. 5. said spreader device comprises a tab device having upwardly bifurcated legs projecting from opposite sides of said structurally weak area; said upwardly bifurcated legs for receiving and retaining said legs and forming said slot; 3. A device as claimed in claim 2, characterized in that it comprises a spreader with downwardly branched legs which are movable towards each other so as to spread the spreaders. 6. Device according to claim 2, characterized in that the tube has a side opening arranged to allow the dilator to be inserted into a body cavity or hollow internal organ. 7. Device according to claim 6, characterized in that the tube is made of flexible tubing material. 8. characterized by a collar provided on the tube adjacent to its proximal end to prevent the entire tube from inadvertently entering a body cavity or hollow internal organ. , the apparatus according to claim 2.