WO1991007202A1

WO1991007202A1 - A percutaneous transtracheal airway device and procedure

Info

Publication number: WO1991007202A1
Application number: PCT/US1990/006740
Authority: WO
Inventors: Kenneth Kensey; John Nash; Harold Clupper
Original assignee: Kensey Nash Corporation
Priority date: 1989-11-16
Filing date: 1990-11-16
Publication date: 1991-05-30
Also published as: AU6752090A

Abstract

An integrated device (20) for performing a percutaneous transtracheal airway procedure on a living being comprising a small diameter tubular penetrator (24) having a tapered free end (42), an enlarged diameter air passageway (26), a tissue spreader (40A, 40B) and a device positioner (22). The tapered free end (42) penetrates the being's tissue to produce a small puncture which the tissue spreader (40A, 40B) enlarges so that the air passageway (26) may fit therethrough. The air passageway (26) has one end (52) open to the ambient atmosphere and a second end (54) adapted for fluid communication with the interior of the trachea. The positioner (22) comprises a helical screw thread (40A, 40B) for engaging the tissue, whereupon when the device is twisted the thread precisely draws the tissue spreader and the second end of the air passageway into the tissue puncture, whereupon the second end of the air passageway is brought in fluid communication with the interior of the trachea.

Description

A PERCUTANEOUS TRANSTRACHEAL AIRWAY DEVTCE AND PROCEDURE

SPECIFICATION This invention relates generally to medical devices and methods of use, and more specifically to devices and methods of use for performing emergency percutaneous transtracheal airway procedures.

BACKGROUND OF THE INVENTION

The tracheotomy device art is a highly developed one; providing a variety of devices for effecting a tracheotomy on a patient. For example, the following patents relate to such devices and/or procedures: 2,865,374 (Brown et al) , 2,873,742 (Shelden) , 2,991,787 (Shelden et al) , 3,137,299 (Tabor), 3,263,684 (Bolton) , 3,659,611 (Miller), 3,688,773 (Weiss), 3,889,688 (Eam aow) , 3,916,903 (Pozzi) , 4,003,381 (Gilbert), 4,009,720 (Crandall) , 4,182,337 (Nickson) , 4,235,229 (Ranford et al) , 4,269,184 (Montgomery), 4,291,690 (Jessen) , 4,331,138 (Jessen), 4,332,245 (Boone, Sr.), 4,520,810 (Weiss), 4,649,913 (Watson), 4,677,978 (Melker) , and 4,794,924 (Eliachar) .

While many of the devices disclosed in the foregoing patents are stated to be for emergency use, such devices nevertheless suffer from one or more drawbacks, e.g., difficulty of use, inefficiency, ineffectiveness, tendency to perforate adjacent tissue, induce coughing, or produce excessive bleeding.

OBJECTS OF THE INVENTION

Accordingly, it is a general object of this invention to provide a device and methods of use which overcome(s) the disadvantages of the prior art tracheotomy devices.

It is a further object of this invention to provide a device and method of use for quickly, easily, and effectively performing an emergency tracheotomy on a living being.

It is yet a further object of this invention to provide a tracheotomy device and method of use for quickly, easily, and precisely positioning a tube within the trachea of a living being to provide a passageway for ventilation.

It is still a further object of this invention to provide an integrated tracheotomy device and method of use which produces a passageway for ventilation, isolates the air flow channel to the mouth, precludes the aspiration of material from the stomach into the lungs, controls bleeding, and reduces tracheal irritation SUMMARY OF THE INVENTION

These and other objects of this invention are achieved by providing apparatus and methods for performing a tracheotomy on a living being. The apparatus comprises penetrating means, air passage means, and positioning means. The penetrating means comprises a tubular member having a tapered free end for penetrating tissue of the being to produce a puncture therein. The air passage means comprises a hollow passageway having one portion adapted for fluid communication with the ambient atmosphere or a ventilation system, and a second portion adapted for fluid communication with the interior of the trachea of the being. The first and second portions are in fluid communication with each other. The positioning means comprises a helical screw thread for engaging the tissue. The method entails bringing the device into a position wherein the free end of the penetrating means engages the skin of the being located over the trachea. A portion of the apparatus is pushed so that the free end penetrates the tissue to form a small opening therein and moves to a position within the trachea. Another portion of the apparatus is then twisted so that the thread engages the tissue of the being to precisely draw the second portion of the air passage means into the opening to an operative position, whereupon the free end is located within the trachea and the air passageway means is in fluid communication with the interior of the trachea.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and many of the attendant advantages of this invention will readily be appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

Fig. 1 is a perspective view of an instrument constructed in accordance with this invention;

Fig. 2 is an enlarged, exploded, perspective view of the instrument of Fig. 1;

Fig. 3 is a sectional view taken along line 3-3 of Fig.2 and showing the instrument at an intermediate point during its insertion into the trachea of a living being; and Fig. 4 is a sectional view similar to that of Fig. 3 but showing the instrument in its operative position in the trachea of a living being.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now in greater detail to the various figures of the drawings wherein like reference characters refer to like parts, an instrument embodying the present invention is generally shown at 20 in Fig. 1. The instrument is particularly suited for performing an emergency, transtracheal airway procedure, e.g., tracheotomy or cricothyrotomy, on a living being. The device 20 basically comprises positioning means in the form of a body 22 (Figs. 1-4) arranged to be grasped by the user to position the device, tissue penetrating means in the form of a pointed tubular member 24 (Figs. 1-4) located at the end of the body 22, air passage means in the form of a large diameter air passageway 26 (Figs. 2 and 4) extending through the body, force applying means in the form of a removable plunger 28 (Figs. 2 and 3) located within the air passageway 26, and trachea blocking means in the form of an inflatable balloon 30 (Fig. 3 and 4) and associated pump and valve (to be described later) .

The details of the structure and operation of the device 20 will also be described later. Suffice it for now to state that the device 20 is arranged to be held by its body 22 in one hand of the user (i.e., the person performing the emergency procedure) so that it can be positioned on the patient's neck directly over the trachea, with the penetrating means 24 engaging the skin 32 at that site. The force applying plunger 28 is then pressed by the user's other hand to cause the penetrating means 24 to puncture through the skin 32 and underlying tissue 34 to pass into the trachea 36. Once the penetrating means is in that position the body 22 of the positioning means is twisted (rotated) about the longitudinal axis 38 (Fig. 3) of the device while applying some slight force to the device via the plunger 28. This action is shown in Fig. 3 and has the effect of screwing threads 40A and 40B extending about respective portions of the body 22 of the positioning means into the underlying tissue, to enlarge the puncture created by the penetrating means 24 and to carry the air passageway 26 into an operative position, like that shown in Fig. 4, wherein it extends between the interior of the trachea 36 and the ambient surroundings, e.g., atmosphere. The force applying plunger 28 is then removed from the air passageway 26 to effect the air communication between the interior of the trachea and the ambient atmosphere. The trachea blocking means is then actuated to place the balloon 30 within the trachea 36 upstream of the device 20 and to inflate it, whereupon the trachea is blocked to prevent aspiration of material into the lungs.

As can be seen clearly in Figs. 3 and 4 the penetrating means 24 basically comprises a tubular member of short, e.g., 6 mm, length, small outside diameter, e.g., 2 mm, and small inside diameter, e.g., 1.5 mm. The free end of the member 24 is tapered, e.g., cut at an acute angle, to form a piercing point or tip 42. The tubular member 24 is located within a bore 44 in a tapered, distal end portion 46 of the device's body 22.

The device's body 22 basically comprises a tubular member having a central portion 48 of relatively large outside diameter, e.g., 2 cm, The lower end of the tubular body 48 is the heretofore identified tapered portion 46, while the upper end of the tubular body is in the form of a thick walled projecting flange 50. The flange 50 serves as a handle portion for the body. To facilitate the grasping of the handle 50 by the user, the outer surface may be knurled.

The air passageway 26 basically comprises a centrally located, large diameter, e.g., 16 mm, passageway extending through the tubular body 22 between an opening 52 in the flange 50 and an airway opening or port 54 (Figs. 1, 3 and 4) in the tapered distal end of the tubular body 22. The port 54 extends about a substantial portion, e.g., 180 degrees, of the periphery of the tapered distal end of the tubular body 22. The lower end of the passageway 26 is tapered in the region where the central tubular portion 48 of the body 22 merges with the tapered distal end 46. The upper end 56 of the tubular penetrating means is open as shown in Fig. 4 and is thus in fluid communication with the tapered lower end portion of the air passageway 26.

In order for the device 20 to readily accommodate the balloon 30 and its associated components the air passageway 26 is not circular in cross section. Rather, as can be seen clearly in Figs. 3 and 4, it includes two flatted sidewall portions, namely, a lower sidewall portion 58 and upper side¬ wall portion 60. The presence of these sidewall portions provide sufficient space between them and the outer peripheral surface of the tubular body 22 to accommodate a cavity or chamber 62 for the balloon 30. A longitudinally extending passageway 64 for inflating and deflating the balloon is located within the sidewall of the tubular body 22. Thus, as can be seen the sidewall 58 is offset toward the central longitudinal axis of the air passageway 26 than the sidewall 60. This creates the heretofore identified chamber 62 between the sidewall 58 and the outer peripheral wall of the tubular body at the portion wherein the portions 46 and 48 merge together. The balloon 30, whose details will be described later, is disposed within the chamber 62 in a compact (i.e., uninflated) condition. The inflation passageway 64 extends down the body 22 between the flatted sidewall portion 60 and the other periphery of the body 22 and communicates with the chamber 62, via a port 66. The upper end of the passageway 64 is in the form of a port 68. This port communicates with a tube (to be described later) connected to a pump (to be described later) and associated valve (to be described later) for inflating/deflating the balloon.

The plunger 28, as discussed above, is arranged to be located within the air passageway 26 during the positioning of the device, and then removed. Thus, as can be seen in Figs. 2 and 3 the plunger basically comprises a hollow member whose outer profile corresponds or mates with the interior profile of the air passageway 26. The tapered lower end of the plunger, when in position within the air passageway, closes the port 54 in the tapered lower end of the body to form the root for the thread 40B. The upper end of the plunger is open at 70 and in fluid communication with the hollow interior thereof. The upper end of the plunger also includes a peripheral flange 72. The flange forms a head which is arranged to be pressed by the user when the device is used to penetrate the patient's neck tissue. The lower end of the plunger includes an opening or port 74 (Figs. 2 and 3) which communicates with the open upper end 56 of the tubular penetrating means 24 when the plunger 28 is in place within the air passageway 26.

The tubular penetration means 24, by virtue of its pointed end 42 and small outside diameter, is arranged to readily penetrate through the skin 32 of a being's neck, through the cricothyroid membrane 34, and into the interior 36 of the trachea, as shown in Fig. 3, when moderate pressure is applied to the head 72 of the plunger 28 with the plunger in the passageway 26 in the body 22. This action establishes a small, initial airway to the ambient atmosphere, via the tubular penetrating means 24, port 74 and the hollow interior of the plunger and opening 70 at the top thereof. The creation of this airway produces the sound of air rushing therethrough. That sound signals the user of the device 20 that the open tip 42 is within the trachea (like shown in Fig. 3) .

As will be appreciated by those skilled in the art the body 22 of the positioning means is constructed so that it can be drawn into the small puncture produced by the penetrating means 24 to open or enlarge that puncture and to carry the larger diameter body portion 48 with the air passageway 26 therein through the enlarged puncture to the operative position wherein the air passageway port 54 is in fluid communication with the interior of the trachea. To facilitate the such action the body 22 includes the heretofore identified screw threads 40A and 40B thereon. As can be seen the screw threads 40A and 40B extend helically about the periphery of the tapered distal end 46 of the body from the interface with the penetrating tube 24 to a intermediate point on the enlarged diameter tubular portion 48. While designated by the reference numerals 40A and 40B, the screw threads actually comprise a continuous helical thread of increasing pitch and thread height, from a fine pitch and low height portion, designated by the reference numeral 40A, on the tapered distal end portion 46, to a gross pitch and high height portion designated by the reference numeral 40B, on the tubular portion 48. The thread 40A at the penetrating tip 24, may if desired, be of the multistart, e.g., double, triple, etc., type.

The fine pitch, low height, thread portion 40A is arranged to engage the skin and underlying tissue once the free end 42 of the penetrating means 24 has penetrated that tissue. The device's body 22 can then be twisted about the axis 38 while slight manual pressure is applied to the flanged top 72 of the plunger. This action enables the device 20 to be screwed into the puncture in a precisely controlled manner, whereupon the puncture (opening) produced by the penetrating means 24 is enlarged to accommodate and the enlarged diameter body portion 48 as that portion is drawn into the interior of the trachea to the operative position shown in Fig. 4. The engagement of the screw threads 4OB with the contiguous tissue serves to hold the device 20 in the operative position.

As mentioned earlier the tapered wall portion at the lower end of the plunger closes port 54 when the plunger is within the air passageway and forms the root of thread 4OB. This feature is of considerable importance to preclude any of the being's tissue from entering the port 54 as the device is screwed in place, thereby obviating a snagging hazard. It should be pointed out at this juncture that the port 54 may be of greater height than shown in Figs. 3 and 4 to form the root of plural immediately adjacent convolutions of the thread 4OB.

When the device is in the operative position the air passageway 26 would be in free and unobstructed fluid communication with the interior of said trachea, but for the presence of the plunger within the passageway blocking the airway port 54. Thus, all that is now required to permit the free flow of air into and out of the trachea from/to the ambient atmosphere (or some ventilating system, not shown) via the device 20 is for the user to remove the plunger 28 from the passageway 26 by simply pulling it out, thereby unblocking port 54.

Referring now to Figs. 3 and 4 the details of the balloon 30 and its associated inflation/deflation means will now be considered. Thus, as can be seen the balloon is a hollow resilient material member of any suitable construction and which includes an access mouth 75. The mouth 75 is sealed to the inner periphery of a port 76 in the sidewall of the body portion 46 forming the chamber 62. In its normal position the balloon is uninflated and is disposed within the chamber 62 as shown in Fig. 3. When the device 20 is in the operative position shown in Fig. 4 the balloon is inflated by a gas, e.g., air, or a liquid, e.g., saline, which is introduced into the chamber via passageway 64. In particular the introduction of the gas or liquid into the chamber 62 causes the balloon to invert, i.e., pass out of port 76 into the interior of the trachea 36, and then inflate until a portion 78 of its periphery engages a peripheral portion of the interior of the trachea, to thereby block the trachea upstream of the device. Accordingly, when the device is in this position the patient cannot aspirate vomit or anything else from his/her stomach.

The means for moving the balloon out of the device and inflating it basically comprises a pump 80 and an associated valve 82. The pump itself is in the form of a compressible, hollow bulb in which the inflation gas or liquid is located. The bulb is connected via the valve 82 to a flexible tube or conduit 84, which is in turn connected to port 68 of the inflation passageway 64. The valve 82 is a selectable, bidirectional valve disposed in fluid communication between the conduit 84 and the pump 80. The valve is arranged when in its normal state to enable the fluid from the bulb to flow through it into the passageway 64 (and thus into the balloon) when the bulb is squeezed and to prevent any fluid to flow back into the bulb until it is manually released. Such action is accomplished by squeezing or pressing on a release mechanism 86 forming a portion of the valve.

Normally the balloon is deflated when it is desired to removed the device 20 from the patient. To that end the valve's release mechanism 86 is actuated, e.g., squeezed, whereupon the valve enables the gas or liquid to be pumped from the balloon back to the bulb or reservoir by squeezing the bulb. Accordingly, the balloon can be readily deflated. Once the balloon is deflated the device can then be readily removed from the patient by merely unscrewing it from engagement with the contiguous tissue of the neck.

In order to minimize bleeding at the site of the puncture the device 20 also includes means 88 in the form of an annular collar 90 and a hemostatic ring 92. The collar extends about the tubular portion 48 of the body 22 immediately above the thread portion 40B. The ring 92 is formed of any conventional material, e.g., foam, which acts as blood absorption and coalescent agent, and can optionally include one or more medicaments. Thus, when the device 20 is in the operative position shown in Fig. 4 the ring 92 is squeezed between the surface of the skin 32 of the patient and the underside of the collar 90. This action provides pressure on the site of the puncture to reduce the flow of blood out of the puncture while the foam agent facilitates the clotting of any blood which should gain egress from the puncture. In addition to it's bleeding prevention function the means 88 also aids in holding the device in place in the operative position. In this connection the tissue through which the body portion of the device extends is tightly interposed between the thread portions 40B and the underside of the ring 92.

It should be pointed out at this juncture that the penetrating member (tube) 24 may be formed as a portion of the plunger 28 and not as a portion of the body 22 as shown herein. In such an alternative arrangement the member 24 is made part of or fixedly secured to the lower end of the plunger 28 and in fluid communication with the plunger's hollow interior. Moreover, when the plunger is in place in the body 22 the penetrating member 24 extends through, but is not fixedly secured in, the bore 44 in the lower end of the body 22. An advantage of this arrangement is that when the plunger 28 is removed from the body 22 such action will also remove the penetrating member 24 from the inside of the trachea, thereby eliminating any potential for injury that the sharp point 42 at the free end of member 24 may present to adjacent tracheal tissue.

Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.

Claims

CLAIMS What is claimed is:

1. A device for performing a transtracheal airway procedure on a living being comprising, penetrating means, air passage means, and positioning means, said penetrating means comprising a tubular member having a tapered free end for penetrating tissue of said being to produce a puncture therein, said air passage means comprising a hollow passageway having one portion adapted for fluid communication with the ambient atmosphere and a second portion adapted for fluid communication with the interior of the trachea of said being, said first and second portions being in fluid communication with each other, said positioning means comprising a helical screw thread for engaging said tissue once said free end has penetrated said tissue so that when said device is twisted said thread precisely draws said second portion of said air passageway into said puncture to an operative position, whereupon said free end is located within the trachea and said air passageway is in fluid communication with the interior of said trachea.

2. The device of Claim 1 wherein said tubular penetrating member is of small diameter to produce a small puncture in said tissue.

3. The device of Claim 2 wherein said air passageway has a cross sectional area larger than said tubular penetrating member.

4. The device of Claim 3 additionally comprising tissue spreading means, said tissue spreading means comprising a tubular body portion having a larger cross-sectional area than said tubular penetrating member for enlarging the size of said puncture when said tissue spreading means is brought into engagement with said tissue, said air passageway extending through said body portion, said body portion being arranged to be twisted by the user of said device after said penetrating means has penetrated said tissue, whereupon when said device is twisted said thread precisely draws a portion of said body portion of said tissue spreading means and said second portion of said air passageway into said puncture.

5. The device of Claim 1 additionally comprising balloon means for introduction into the trachea adjacent the oral end thereof once said device is in said operative position within said trachea.

6. The device of Claim 5 wherein said device additionally comprises pump means for inflating said balloon means once said device is in said operative position.

7. The device of Claim 1 additionally comprising tissue engagement means for engaging the skin of said being contiguous with said puncture to deter bleeding therefrom.

8. The device of Claim 7 wherein said tissue engagement means comprises a collar surrounding said device.

9. The device of Claim 8 wherein said collar is formed of material comprising a blood absorption coalescent agent and/or at least one medicament.

10. The device of Claim 8 additionally comprising holding means to hold said collar tightly between it and the skin of said being when said device is in said operative position.

11. The device of Claim 9 additionally comprising holding means to hold said collar tightly between it and the skin of said being when said device is in said operative position.

12. The device of Claim 1 additionally comprising a plunger, said plunger being disposed within said air passageway, said plunger being arranged to be pressed by a user of said device to cause said tubular penetrating means to penetrate said tissue.

13. The device of Claim 4 wherein said tubular body has a tapered distal end portion, said helical thread extending about said tapered distal end portion and a portion of said tubular body contiguous therewith.

14. The device of Claim 13 wherein said thread is of a fine pitch and small pitch height adjacent the penetrating means and is of a large pitch and large height proximally thereof.

15. The device of Claim 4 additionally comprising a plunger, said plunger being disposed within said air passageway, said plunger being arranged to be pressed by a user of said device to cause said tubular penetrating means to penetrate said tissue.

16. The device of Claim 15 wherein said tubular body has a tapered distal end portion, said helical thread extending about said tapered distal end portion and a portion of said tubular body contiguous therewith.

17. The device of Claim 16 wherein said thread is of a fine pitch and small pitch height adjacent the penetrating means and is of a large pitch and large height proximally thereof.

18. The device of Claim 16 wherein said distal portion of said tubular body includes an airway opening therein and wherein said plunger includes a first distal end portion arranged to selectively block said airway opening, a second distal end portion having a port therein, and a passageway extending through said plunger between said port and the ambient atmosphere, said port being in fluid communication with the interior of said tubular penetrating means.

19. The device of Claim 18 wherein said plunger is selectively removable from said tubular body, whereupon when said plunger is removed said airway opening is unblocked.

20. The device of Claim 17 wherein said distal portion of said tubular body includes an airway opening therein and wherein said plunger includes a first distal end portion arranged to selectively block said airway opening, a second distal end portion having a port therein, and a passageway extending through said plunger between said port and the ambient atmosphere, said port being in fluid communication with the interior of said tubular penetrating means.

21. The device of Claim 20 wherein said plunger is selectively removable from said tubular body, whereupon when said plunger is removed said airway opening is unblocked.

22. The device of Claim 5 wherein said balloon means is disposed in a compact condition within a cavity in said device.

23. The device of Claim 22 wherein said device additionally comprises pump means for inflating said balloon means once said device is in said operative position, whereupon said balloon expands and projects out of said device for engagement with the interior of the trachea upstream of said device.

24. The device of Claim 23 additionally comprising valve means associated with said pump means to enable said balloon to be maintained inflated as desired and then to be selectively deflated.

25. The device of Claim 21 additionally comprising balloon means is disposed in a compact condition within a cavity in said tubular body.

26. The device of Claim 25 wherein said device additionally comprises pump means for inflating said balloon means once said device is in said operative position, whereupon said balloon expands and projects out of said device for engagement with the interior of the trachea upstream of said device.

27. The device of Claim 26 additionally comprising valve means associated with said pump means to enable said balloon to be maintained inflated as desired and then to be selectively deflated.

28. The device of Claim 21 additionally comprising tissue engagement means for engaging the skin of said being contiguous with said puncture to deter bleeding therefrom.

29. The device of Claim 28 wherein said tissue engagement means comprises a collar surrounding said device.

30. The device of Claim 29 wherein said collar is formed of a material comprising a blood absorption coalescent agent.

31. The device of Claim 29 additionally comprising holding means to hold said collar tightly between it and the skin of said being when said device is in said operative position.

32. The device of Claim 30 additionally comprising holding means to hold said collar tightly between it and the skin of said being when said device is in said operative position.

33. A method of performing a percutaneous transtracheal airway procedure on a living being by use of a integrated device comprising penetrating means, air passage means, and positioning means, said penetrating means comprising a tubular member having a tapered free end for penetrating tissue of said being to produce a puncture therein, said air passage means comprising a hollow passageway having one portion adapted for fluid communication with the ambient atmosphere and a second portion adapted for fluid communication with the interior of the trachea of said being, said first and second portions being in fluid communication with each other, said positioning means comprising a helical screw thread for engaging said tissue contiguous with said puncture, said method comprising the steps of bringing said free end of said tubular penetrating means into engagement with the skin of the being located over the being's trachea, pressing on a portion of said device so that said tapered free end of said penetrating means punctures said tissue, continuing to press on said portion until said free end is located within said trachea, twisting a portion of said device while applying some pressure thereto so that said thread engages the tissue contiguous with said puncture to draw said second portion of said air passageway into said puncture to an operative position wherein said free end is located within the trachea and said air passageway is in fluid communication with the interior of said trachea.

34. The method of Claim 33 wherein said device is pressed until a sound is produced by the passage of said taper free end of said penetrating means into the interior of said trachea.

35. The method of Claim 33 wherein said device additionally comprises inflatable balloon means, and wherein said method additionally comprises the step of inflating said balloon when said device is in said operative position, whereupon said balloon engages the interior of said trachea upstream of said device.

36. The method of Claim 34 wherein said device additionally comprises inflatable balloon means, and wherein said method additionally comprises the step of inflating said balloon when said device is in said operative position, whereupon said balloon engages the interior of said trachea upstream of said device.

37. The method of Claim 33 wherein said device additionally comprises tissue engagement means, and wherein said method additionally comprises the step of bringing said tissue engagement means into engagement with the skin of said being contiguous with said puncture to deter bleeding therefrom when said device is in said operative position.

38. The method of Claim 34 wherein said device additionally comprises tissue engagement means, and wherein said method additionally comprises the step of bringing said tissue engagement means into engagement with the skin of said being contiguous with said puncture to deter bleeding therefrom when said device is in said operative position.

39. The method of Claim 36 wherein said device additionally comprises valve means, and wherein said method additionally comprises maintaining said balloon inflated for as long as desired and then actuating said valve means to enable said balloon to be deflated, whereupon said device is then removed from said being.

40. The method of Claim 38 wherein said device additionally comprises valve means, and wherein said method additionally comprises maintaining said balloon inflated for as long as desired and then actuating said valve means to enable said balloon to be deflated, whereupon said device is then removed from said being.