JPS60212153A - Apparatus and method for providing opening part to body cavity or internal organ - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to devices and methods for performing percutaneous or non-incisional procedures involving the creation of openings or portals.

A number of devices for tracheostomy have been proposed for the non-incisional creation of an opening into a body cavity or hollow internal organ. Such devices are generally preferred for open procedures, which require considerable surgical skill as they often involve a large number of blood vessels that tend to bleed profusely during the procedure.

Inventor's US Patent No. 3, ! ;//, No. 2'lJ is a flexible leading member.
) discloses a method and apparatus using a dilator with a removably attached dilator. A device is provided for introducing a guide member into the lumen of the trachea during a tracheostomy.

The inventor's US patent application cylinder θA. '109 discloses a similar method and device, but with a permanently attached dilator guide member and an improved device for properly positioning the device components within the lumen of the trachea. and is used. The device and method utilizes a pair of coaxially arranged needles to facilitate introduction of the dilator guide member into the lumen of the trachea and further utilizes a coaxial breathing tube with respect to the dilator. and keep the breathing tube within the tracheal lumen during dilator removal.

Dual needle arrangements are relatively expensive and complex to use, and the coaxial arrangement of the dilator and breathing tube limits the length of breathing tube that can easily be used. This is a disadvantage if the patient's trachea is located deeper than normal.

The devices and methods provided by the present invention utilize a single needle that is inserted into a body cavity or hollow internal organ. The needle is structurally weakened along a longitudinal line and has a device for manipulating the needle to longitudinally split the needle along the structurally weakened line to form an elongated slot. . Injection attached to a needle.

The device facilitates insertion of the needle and immediately directs penetration of the body cavity through suction, and the plunger of the syringe can easily move outward during this penetration.

The device includes a dilator insertable through a side opening of the 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 is fitted through the bore of the needle after removal of the needle syringe. Once the guide member is in place, the split needle is 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 respiratory tube along with the dilator. The dilator is then removed through the side opening of the breathing tube, and a portion of the remaining length of the breathing tube is then forced into the body cavity.

When the device is used to perform a tracheostomy, it is preferred to attach a deflated cuff to the flexible tube and an inflation tube to the cuff. By inflating the force 7 through the associated syringe, foreign objects are prevented 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 the following description considered in conjunction with the accompanying drawings.

As will be appreciated from the following description, the methods and apparatus of the present invention are described in connection with a tracheostomy procedure. However, other procedures in the human body other than the trachea, such as thoracotomy, which creates an opening into the chest, laparoscopy, which creates an opening into the abdominal cavity, or cholecystotomy, which creates an opening into the gallbladder, The present apparatus and method may also be used with relatively minor and obvious modifications in creating openings or entrances to hollow or hollow internal organs. Therefore,
The following specific description of a tracheostomy is merely illustrative of the invention.

The devices and methods of the present invention are similar to the devices of the inventor's original U.S. patent application and co-pending U.S. patent application Ser. It is now used to perform percutaneous tracheostomies as opposed to percutaneous tracheostomies.

The apparatus and method of the present invention do not require the same level of skill;
It is therefore suitable for use in emergency cases by persons without extensive surgical training.

When performing a tracheostomy, a single needle associated with a syringe is utilized in the initial stages of the method. When the needle is positioned within the lumen of the trachea, the plunger of the syringe can be withdrawn. Knowing this needle position is superimposed to a successful tracheostomy.

An important feature of this method and apparatus is the use of a uniquely shaped needle with a structural weakness in such a way that the needle splits lengthwise to form an open slot. As is known, the bore of the needle provides a pathway for insertion of the flexible guide member into the lumen of the trachea.

The longitudinal crack in the needle forms a slot which allows the needle to be laterally cut away in order to withdraw it from the trachea. A guide member is attached to the dilator, the dilator is then pushed inward to gradually widen the needle opening occupied by the guide member, and a breathing tube associated with the dilator is then placed. This tube provides a passageway for breathing.

As will be apparent to those skilled in the medical arts, the various components of the device are shaped and dimensioned to suit the size and condition of the patient. This size is made small, for example, in the case of small children.

Furthermore, it is an important feature of the invention that the breathing tube used may be inserted deep enough to reach the deep trachea characteristic of some individuals.

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 into the trachea and associated tissue and cartilage. The needle 10 has a central hole 12, which is structurally weakened in the longitudinal direction by providing a very narrow groove 14, as shown in FIG.
;t, extending almost completely through the wall thickness of the needle 10. The needle 10 is also preferably structurally weakened to a lesser extent (by locating the longitudinal groove 16 on the opposite side of the groove 14).

A pair of metal spreader tabs 18 are spot welded or otherwise secured at their ends to the needle 10 on opposite sides of the groove 14, as best seen in FIGS. 5 and 3. has been done. If desired, tab 18 may be a length of seven metal members extending around needle 10 in overlying relation to groove 16.

To prevent air from entering the central bore 12 of the needle through the groove 14.16, the portion of the needle adjacent the groove 14.16 is provided with a suitable polymer or other coating.

Needles of the type described above are currently available on the market as intravenous fluid delivery needles and the like. Groove 1
4 and 16 are believed to be precisely formed using laser beam technology. In use, the tab 1B is grasped between the thumb and forefinger of both hands and spread apart to vertically split the groove 14 into the hole 12 to form a slot. Groove 16
The hole 12 is passed through the hole 12 without being vertically divided, and serves as a kind of hinge in its place. The slot formed in this way is
The associated catheter is allowed to pass through the slot and remains within the vein when the needle is removed.

In the present invention, this shape of the needle has been modified so that the needle 10 can be split open with one hand operation.

More specifically, the fitting or spreader 22 is made from a plastic material such as polyethylene in an X shape;
The upper part of the spreader 22 is formed into a leg part 20 that branches upward, and the inner tip of the leg part 2o is joined to the tab 1.
8, and the joint portion of the leg portion 20 forms a hinge #r24. The lower portion of the X-shaped profile of the spreader 22 is formed by a pair of downwardly branching legs 26 that are integral with the legs 20 .

The tab 18 abuts the inner surface of the upper leg 20 and the tab 1
The outer ends of 8 fit under and are held in place by a pair of end flanges 28 integral with upper leg 20. The distal ends of the tabs 18 lie below and are held in place by a pair of side flanges 30 integral with the upper legs 20.

A cylindrical syringe receptacle 32 with an upwardly branching ^ or tab 34 is positioned adjacent the proximal end of the needle 1o. Tab 34 is held between leg 2o and tab 18. The central portion of the syringe receptacle 32 constitutes an extension of the central bore of the needle 10 and is longitudinally split along a line aligned with the groove 14 of the needle.

In the arrangement described above, by grasping the opposing legs 26 between the thumb and forefinger of one hand and pushing the legs 26 forward, the needle 10 is spread open along the groove 14 and split vertically. You can do it. It will be appreciated that such one-handed operation may leave the other hand free to manipulate the dilator's guide member.

In practicing the method and apparatus, the needle 10 is inserted into the syringe receptacle 32.
It removably fits into a normal conventional syringe in the 0 position. 1st
As can be seen, the needle 10 is inserted into the region adjacent to the tracheal lumen, and the position of the needle 10 within the tracheal lumen causes the plunger 42 of the syringe to be withdrawn by pneumatic withdrawal from the trachea. It is signified by the doctor's skill. At this time, it is impossible for air to enter through the grooves 14 or 16. The reason for this is that the needle 10 is coated with a coating to prevent fluid leakage.

Once the needle 10 is in the trachea, angle the needle 10 down the throat at about 4ts degrees, as shown in Figure 182.
Then advance about 6-gm. Next, the syringe 38 is removed from the syringe receiver 32 (FIG. 3).

The opening of the breathing tube is then widened using an elongated dilation 544;
Introduce the guide member into the breathing tube. Dilator 44 includes an elongated handle portion 46 with an integral curved or arcuate intermediate portion 4B, which terminates in a downwardly tapered conical introduction portion. 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 introducer section 48 is an elongated flexible introducer member 72 made of a suitable flexible material, such as a thin polyethylene tube. The guide member 72 and the distal end of the introduction section 50 are inserted into an incision forming a side opening within the vent g52.

Breathing tube 52 is conveniently constructed from a length of plastic surgical tubing, rounded at the distal end to facilitate movement along the lumen of the trachea.

The plastic material is sufficiently flexible so that the side openings expand to accommodate the dilator 44 (6J) and sufficiently resilient so that the side openings are substantially closed upon removal of the dilator.

The breathing tube 52 is coaxial at its distal end with the distal portion of the curved intermediate portion 5o of the dilator 44, as seen in FIG.

Although not necessary for procedures other than tracheotomy, tube 52
A plastic cuff 54 is attached to the lower end. Cuff 54 has an inflatable central portion and is adhered to the outer surface of breathing tube 52 at opposite ends thereof. Cuff 54, as best seen in Figure 1s.
an opening 5 for communicating between the inside of the air pipe 58 and the air pipe 58;
6 is formed on the wall of the breathing tube 52. The air pipe 58 is
It extends towards the proximal end of the breathing tube 52 through a suitable opening 6o provided in the side of the breathing tube 52 and communicates with the interior of the bladder 61. Air bladder 61 is force fit onto the end of air inflation syringe 62 for purposes described below.

At the opposite or proximal end of the tube 52, a ventilator fitting 64 is press fit within the tube 52 such that the tube 52 passes into the trachea even if the ventilator fitting 64 is removed. To prevent this possibility, an upper collar 66 is fitted and glued around the outside circumference of the tube 52.

A blade or cutting blade 68 mounted in a recess 70 formed in the intermediate portion 48 cuts tissue forced across the cutting blade 68 as the dilator 44 is introduced into the lumen of the trachea. It is supposed to be done.

The flexibility of the guide member 12 allows it to be easily passed through the open upper end of the bore 12 of the needle 10 to project the guide member 72 into the lumen of the trachea, as seen in FIG. I can do it. The guide member 72 tends to align with the trachea to provide lateral guidance for the dilator 44.

Once the guide member 72 has been inserted to the extent shown in Figure 1, the needle 10 is longitudinally split open along the groove 14, and the guide member 72 is separated laterally while the needle is withdrawn. The leading member is separated laterally through the vertically split groove 14,
This groove 14 is kept open by uniform pressure acting on the legs 26 of the spreader.

The axis of the dilator introduction portion 48 is then oriented at an approximately 95 degree angle, as seen in FIG. 1O, and pushed into the opening through which the guide member T2 extends.

The tapered introduction section 50 and subsequent larger diameter breathing tube 52 and K force 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. Only cutting of the tissue that has been forced across the midsection is necessary to loosen the tension and bring it into contact with the blade 68.

Dilator 30 is then withdrawn from the trachea and inserted into breathing tube 52.
is withdrawn through the side opening of the breathing tube, which tends to close due to the elasticity or memory of the plastic material from which the breathing tube is made. The breathing tube 52 is the fifteenth
Left in place as shown, if the trachea is deep, as it is in some patients, the breathing tube 52 may be advanced further into the trachea.

As seen in FIGS. 1/-13, the thin cuff 54 is collapsed against the tube 52 during insertion of the tube 52 into the trachea. After this insertion, the sycuff 54 can be inflated by depressing the plunger of the syringe 62. Inflated cuff 54 closes the throat above the open distal end of breathing tube 52, as seen in Figure 1. A respirator (not shown) is then attached to fitting 64,
It is operated in a conventional manner obvious to those skilled in the art.

From the foregoing description, it can be seen that the insertion procedure is greatly simplified as only one needle 10 is used, and that the dilator 44 is connected to the breathing tube 52.
According to the arrangement that can be introduced into the side of the tube, there is also a tube arrangement that can be adopted in the inventor's US patent application Ser. No. 20A, 709. It is possible to use a breathing tube as long as ;m.

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 the drawing]

FIG. 1 is an elevational view showing the initial stages of insertion of the needle and syringe of the present invention into the lumen of the trachea during a tracheostomy procedure, the lumen of the trachea being shown schematically for simplicity. FIG. 2 is a view similar to FIG. 1, but showing an oblique orientation for continued passage of the needle into the trachea. FIG. 3 is a view similar to FIG. 2, but showing the syringe removed from the needle. Figure 3 is a view similar to Figure 3, but with the leading member of the dilator inserted into the needle hole and into the trachea. This is a diagram showing the inside. FIG. 5 is a view taken along line S-5 in FIG. 4 in the direction of the arrow. FIG. 6 is an enlarged sectional view of the needle before it is vertically split, as seen in the direction of the arrow along line 6-6 in the figure. FIG. 7 is a view similar to FIG. 6 showing a needle with a longitudinally split 9 opening. Figure 5 is a view similar to Figure S showing the position of the spreader component after the needle is split open; FIG. 9 shows the lateral separation of the guide member from the vertically opened slot of the needle during withdrawal of the needle;
FIG. FIG. 10 is a view similar to FIG. 9 showing the orientation of the dilator prior to passing the dilator into the trachea. Figure 11 shows the initial stages of passing the dilator and breathing tube into the trachea. Figure 72 shows the first fully inserted state of the breathing tube.
This figure is similar to Figure 1. Figure 1J shows the first dilator partially withdrawn.
．． This figure is similar to Figure 2. Figure 1Q is a front elevational view of the breathing tube. Figure 75 is a cross-sectional view of a breathing tube partially inserted into the trachea. Figure 16 is a side view similar to Figure 15 showing the installation of the inflation syringe; Figure 16 shows the inflated cuff of the breathing tube.
FIG. 10... Needle (hollow needle) 12... Needle hole 14... Structurally weakened first region (groove) 16...
・Structurally weakened λ-th region (groove 18... tag 20... upwardly branching leg 22... spreader 26... downwardly branching leg 34... tab 44... ... Dilator 52 ... Flexible tube (breathing tube) 66 ... Collar 72 ... Flexible leading member

Claims (1)

Claims: 1. A device for performing a percutaneous procedure that creates an entrance or opening into a body cavity or hollow internal organ, the device comprising: a flexible tube; a dilator that is fitted through the tube and an elongate flexible guide member on the dilator that is adapted to be inserted through the bore of a needle, thereby entering a body cavity or hollow internal organ. the guide member providing a path for insertion of the dilator and the tube into a body cavity or hollow viscera when inserting a needle; and a needle for receiving the guide member into a lumen. a sharpened distal end; a proximal end having an open end for introduction of the guide member; and a proximal end having a sharpened distal end; an elongate hollow needle having a longitudinally extending structurally weakened region; and a spreader device secured to the hollow needle with an opposing portion of the region adjacent the proximal end, the spreader device comprising: separating the walls of the needle in the region adjacent the proximal end to form a groove and acting to propagate the groove to the distal end, thereby inserting the dilator and the breathing tube; A device for performing a percutaneous procedure comprising: laterally separating the guide member from the hollow needle prior to withdrawal of the needle device. λ in the needle device, the hollow needle is disposed diametrically opposite the first structurally weakened region and extends longitudinally between the distal and proximal ends; 2. A device as claimed in claim 1, characterized in that it has a second region with a cylindrical shape, said first region serving as a hinge portion when forming said groove. a: the spreader device of the needle device includes a tag device having an upwardly branching leg protruding from an opposite side of the structurally weakened region, and away from the leg to form the groove; Device according to claim 1, characterized in that it is movable. h) the spreader device includes a tab device having upwardly branching legs projecting from opposite sides of the structurally weakened region; and downwardly branching legs that receive and retain the upwardly branching legs; a spreader having a portion;
2. The apparatus of claim 1, further comprising scales for moving said downwardly branching legs toward each other to spread said upwardly branching legs apart to form said groove. 5. Claim 1, wherein the tube has a side opening, through which the dilator is placed, and the dilator inserted into a cavity or hollow internal organ of the body. The device described in. 6. The device of claim 5, wherein the tube is made of flexible tubing material. 2. characterized in that it has a collar attached to said tube adjacent to its proximal end to prevent the entire tube from inadvertently passing into a body cavity or hollow internal organ. Apparatus according to claim 5. & A percutaneous, non-incisional method for creating an entrance or opening into a body cavity or hollow internal organ, the method comprising: a needle that is split longitudinally and separated along the length of the needle; forming an entrance into a body cavity or hollow internal organ by inserting said needle into the body; until a flexible guide member secured to the dilator enters the body cavity or hollow internal organ; , passing the guide member through the central hole of the needle; splitting the needle apart to form a longitudinal slot; and transversely passing the guide member from the needle through the longitudinal slot while removing the needle. separating: attaching a flexible tube to the dilator and inserting the dilator and tube into a body cavity or hollow internal organ along an opening formed by the guide member; and withdrawing the dilator and the guide member from the body opening or hollow viscus d- and the tube. A percutaneous, non-incisional method for creating a. (d) the tube is relatively long and the dilator is inserted through the side of the tube and through the distal end of the tube before inserting the dilator and tube into a body orifice or hollow internal organ; 6. A method according to claim 5, characterized in that it is extruded. 10. The method of claim 9, further comprising the step of further protruding the tube into a body cavity or internal organ after the step of withdrawing the dilator. /l A device for performing a percutaneous non-incisional procedure for creating an entrance or opening into a body cavity or hollow internal organ, the device comprising: a distal end and a proximal end. a flexible tube having an open end and a side opening; an elongated dilator adapted to fit through the side opening and project through the distal end of the tube; Attaching to the distal end of the dilator is an elongated flexible guide member adapted for insertion through the bore of the needle; and inserting the guide member into a body cavity or hollow internal organ. a needle adapted to receive the needle, the needle having a device forming an elongated slot, thereby removing the needle from a body cavity or hollow internal organ, leaving the guide member in place; wherein the guide member provides a pathway for insertion of the dilator and tube into a body cavity or hollow internal organ, and the dilator is slidably removed from the side opening. Apparatus for performing percutaneous non-incisional procedures comprising: being able to be separated from the tube and leaving the tube in place within the body cavity or hollow internal organ. The side opening is capable of widening the incision to receive the dilator, and the tube is made of a plastic material that tends to close the incision while simultaneously removing the dilator from the incision. Device according to claim 1'/claim, characterized in that it is manufactured. /, 2 the device forming the longitudinal slot having a structurally weakened region extending longitudinally between the distal and proximal ends of the needle; Apparatus according to claim 1I, characterized in that it includes a spreader device operative to break up the weakened region to form the longitudinal slot. l11. 14. The device of claim 13, wherein a fluid-tight coating is provided over the structurally weakened region.