GB2160776A

GB2160776A - Adjustable drainage tube holder

Info

Publication number: GB2160776A
Application number: GB08515917A
Authority: GB
Inventors: James J Pedicano; James G Kane; Ernest Pedicano
Original assignee: Individual
Current assignee: Individual
Priority date: 1984-06-29
Filing date: 1985-06-24
Publication date: 1986-01-02
Also published as: FR2566669A1; DE3523071A1; GB8515917D0

Abstract

An adjustable drainage tube holder (10) has a clear, flexible mounting plate (12) which conforms to the contour of the patient's body and is held in place by a medically acceptable adhesive (26), forming an airtight seal between the skin and mounting plate except through the aperture (22). A collar (14) integral with the mounting plate (12) has an axial bore aligned with the aperture (22) to define a tube passageway for slidingly receiving a tube (24), and sealing means (16) are provided for forming a substantially airtight seal between the collar and the tube. Locking means (30) are provided to selectively prevent displacement of the tube (24) relative to the tube holder (10). Means are also provided for positively engaging the locking means so that the secure positional locking of the tube will not be unintentionally compromised. <IMAGE>

Description

SPECIFICATION Adjustable Drainage Tube Holder Technical Field This invention relates to an adjustable device for securing a drainage tube to the human body.

Background and Objects of the Invention Medical treatment of patients commonly requires insertion of a drainage tube into the thoracic or abdominal cavities. Most often this insertion is accomplished by making an incision at the desired entry point, inserting the drainage tube, closing the incision around the tube and taping or stitching the tube to the skin of the patient to prevent inward or outward movement of the tube relative to the patient's body. An X-ray is then taken to determine whether the tube is correctly positioned within the body cavity, but the tube must be secured to the body prior to the X-ray in order to prevent movement of the tube prior to and during the X-ray.

If the X-ray photograph shows that positional adjustment of the tube is necessary the tape or stitches securing the tube to the body must be removed, the required adjustment made, and the tube retaped or restitched to the body. It is common for these steps to be repeated several times until correct positioning of the tube is achieved. Finally, the entire area around the incision and tube is bandaged to effectively seal the incision and prevent infection.

Drainage from the thoracic cavity is particularly important when air leaks into the pleural space of the chest cavity, upsetting the delicate balance of air pressures which keeps the human lung expanded, thereby causing the lung to collapse. Drainage suction to remove the air within the chest cavity pleural space is applied by inserting a drainage tube into the pleural space through an incision. However, if air is allowed to leak into the pleural space via the incision around the drainage tube, efforts to remove air from the pleural space by suction through the tube become hindered, if not futile. Therefore, an essentially airtight seal around the incision is necessary. Typically, such a seal is obtained by tightly bandaging the incision around the tube.

Inspection of the incision for infection or leakage around the tube requires that the bandages be removed. Since conscientious treatment of the patient requires fairly frequent, i.e., daily, inspection of the incision, frequent undressing and dressing of the area is necessary. Moreover, as the patient recuperates, further positional adjustment of the tube is generally necessary. This requires removal of the dressing over the area around the tube and adjustment by the tedious procedure of taping or stitching the tube to the body in conjunction with X-ray photography. During inspection and adjustment of the tube the airtight seal around the incision is jeopardized, if not destroyed. Personnel making such inspections and adjustments must constantly be aware of and protect against the danger this presents to the patient.

Various attempts have heretofore been made to overcome the inconvenience of the traditional positional adjustment procedures discussed above, but such attempts have disregarded the need for an airtight seal around the incision. The most relevant of these references are U.S. Patent No. 3,783,876 issued to John F. Dye for a Tabbed Eccentric Locking Device and U.S. Patent No. 4,287,891 issued to Joseph L. Peters for a Securing Device for Surgical Tubes.

The Dye '876 patent discloses a device for locking a tube in position by rotating two members relative to one another such that the eccentric relationship of the tube passageways in the two members exerts a pinching action on the tube to secure it relative to the locking device. There are several disadvantages to such a structure. First, that structure allows "overpinching" of the tube when excess rotational force is applied. This can result in constricted flow within the tube which is hazardous to the patient.

Secondly, while Dye discloses an adhesive backing to make securing the tube to the body easier, attachment of the holder to the body in this manner exaggerates the problem of inspecting the incision for infection or leakage. With the Dye structure the locking device must be completely removed from the surface of the patient's body to properly inspect the incision. During such inspections of the incision the pulling action necessary to remove the adhesive locking device from the skin can painfully aggravate the wound. Finally, the Dye structure does not effectively seal the tube incision. Rather, the adhesive disclosed in Dye merely attaches the locking device to the patient's body.

The Peters '891 patent discloses a device wherein a gripping force upon a tube contained therein is created by rotation of two members relative to one another, causing a flexible bore element anchored at each end to the two rotational elements to twist around and hold the tube. Peters primarily discloses his device anchored to the patient in the traditional stitching manner, but does disclose a collar plate which can be provided to allow the device to be anchored to the patient's body with adhesive tape over the plate. With the stitching method the device must be anchored in very close relationship to the body to prevent the displacement of the tube relative to the body which would result from a loose association of the device with the body. When so positioned the structure obscures inspection of the incision.Both the stitching and taping methods require removal of the device from the position closely against the patient's body for inspection of the incision. Furthermore, the Peters '891 patent does not disclose a structure which forms an airtight seal around the tube entry.

The rotational movement of one element relative to another found in both the Dye and Peters structures can cause a pulling action on the patient's skin, resulting in discomfort due to strain upon the stitched incision or other sensitivities in the area.

Similar discomfort can result during removal of these structures from the patient's skin to inspect the incision.

It is therefore one object of the present invention to provide a drainage tube holder which is secured to the patient's body and which selectively secures the positional adjustment of the tube relative to the body.

It is a further object of the present invention to provide an adjustable drainage tube holder which allows infinite positional adjustment of the tube with minimal discomfort to the patient.

A still further object of the present invention is to provide, in an adjustable drainage tube holder, infinite positional adjustment of the tube without interfering with the internal flow of the tube.

Another object of the present invention is to provide an adjustable drainage tube holder which allows inspection of the tube entry incision without removal of the tube holderfromthe patient's body.

Another object of the present invention is to provide, in an adjustable drainage tube holder, means for effectively sealing the tube entry incision against air and fluid leakage.

It is a further object of the present invention to provide an adjustable drainage tube holder which may be inexpensively formed from commonly available, inexpensive materials.

Objects and advantages of the present invention are setforth in part herein and in part will be obvious herefrom, or may be learned by practice with the invention, the same being realized and attained by means of the instrumentalities and combinations pointed out in the appended claims.

The invention consists in the novel parts, constructions, arrangements, combinations, steps, and improvements herein shown and described.

Summary of the Invention In accordance with the present invention a drainage tube holder in which low cost plastic manufacturing techniques are used and an airtight seal between the tube and the patient's body is provided allows selective positional adjustment of the tube relative to the patient's body. An additional advantage of the present invention is that visual inspection of the incision underlying the novel tube holder can be made without removing the tube holder from the patient's body. In a preferred embodiment of the present invention a desirable axial, rather than rotational, locking motion is used to secure the tube relative to the holder.

In accordance with the present invention, a drainage tube holder is adapted to provide a substantially airtight seal around the tube incision and secure positional adjustment of the tube without obstructing internal tube flow. In addition, means are provided adhering the novel tube holder to the patient's body while allowing visual inspection of the tube incision without displacement of the tube holder from the patient's body.

In a preferred embodiment of the invention a clear, flexible mounting plate with a clear adhesive disposed on one side thereof and an aperture therein is provided. A collar having an axial bore aligned with the mounting plate aperture protrudes from the side of the mounting plate opposite to the clear adhesive. The axial bore and aperture define a tube passageway adapted to slidingly receive a drainage tube inserted therein. A sealing member of non-porous elastic material forms an essentially airtight seal between a tube in the tube passageway and the collar without interfering with the sliding relationship of the tube within the tube passageway Locking means are provided to selectively create friction between the holder and the tube to prevent the tube from sliding within the tube passageway.

However, the friction created by the locking means does not interfere with either the fluid flow within the tube or the seal formed by the non-porous sealing member between the tube and collar.

In accordance with the preferred embodiment of the present invention the clear, flexible mounting plate is molded from polyvinyl plastic. The mounting plate must be sufficiently flexible to conform to the contour of the patient's body and form an essentially airtight seal around the tube incision except through the aperture. The mounting plate is sufficiently transparent to allow visual inspection of the incision by looking therethrough and is provided with a clear adhesive on the side contacting the patient's body to assure that the mounting plate remains against the patient's body to form the airtight seal. The collar is stiff relative to the mounting plate and may be molded together with the mounting plate.The junction between the collar and mounting plate must be airtight so that the only air passage from the incision to the atmosphere is through the tube passageway defined by the mounting plate aperture and the axial bore of the collar. The relatively stiff collar also guides a tube through the tube passageway for correct entry into the patient's body through the incision.

In the preferred embodiment the sealing member covers the open end of the collar and wraps around a a tube exiting therefrom to provide an essentially airtight seal between the collar and the tube. The sealing member is made of a non-porous, resilient material with a natural size adapted to form an airtight seal around the tube while maintaining a sliding relationship therewith. The resilient nonporous sealing member is attached to the collar to form the necessary airtight seal therewith, e.g., by being deformed to wrap around the open end of the collar or by being adapted to form a permanent friction fit within the axial bore of the collar.Since relatively low pressure differentials exist between the body cavity and the atmosphere, a close fitting size-on-size sliding relationship between the sealing member and the tube establishes a sufficiently airtight seal to complete the seal around the tube entry into the body cavity without interfering with the operation of a drain pump via the tube. A lubricant may be provided between the tube and the collar or sealing member to promote sliding of the tube through the tube passageway, particularly where a size-on-size tube to sealing member relationship exists.

The locking means may be any appropriate mechanism for causing sufficient friction between the tube and tube holder to prevent sliding of the tube within the tube passageway while not interfering with either the internal tube flow or the seal formed around the tube. In general, these objectives are accomplished by positioning the locking means so that frictional engagement with the tube occurs at a point away from the seal formed around the tube by the sealing member. Thus, where the sealing member forms a seal around the tube at the open end of the collar the locking means is positioned so that the frictional engagement with the tube occurs along the collar toward the mounting plate from the sealing member.The locking means may comprise a threaded screw adjustment of limited travel and, hence, limited tightening capability or may be a clamp with a preset closed position having a diameter which creates the proper friction on the tube without permitting overtightening. Preferably, the locking means comprises an axial slide lock which creates the necessary friction on the tube by constricting the collar in a sliding motion. The axial sliding action is desirable to obtain frictional locking since discomfort to the patient is minimized by eliminating any twisting action. The axial slide lock assumes an unlocked position not constricting the collar and a locking position overriding a portion of the collar away from the sealing member to exert a radially constricting force thereon.In the unlocked position the axial slide lock may be completely separate from the collar or may overlie part of the collar without causing a radially constricting force thereon.

Thus, the present invention achieves the surprising and highly desirable results of (i) effectively covering the tube incision with an airtight seal, (ii) not requiring removal of bandages to inspect the incision, and (iii) allowing infinite positional adjustment of the tube within the tube holder without obstructing the internal flow of the tube.

It will be apparent from the foregoing general description that the objects of the invention specifically enumerated herein are accomplished by the invention here embodied.

Thus, as one advantage of the present invention the adjustable drainage tube holder allows selective positional adjustment of a drainage tube relative to the patient's body without interfering with the internal flow of the tube.

As a further advantage of the present invention the adjustable drainage tube holder provides an airtight seal between a drainage tube and the area of the patient's body surrounding the tube incision.

As yet further advantages of the adjustable drainage tube holder according to the present invention infinite positional adjustment of the tube is remarkably obtained without danger of overtightening while airtight sealing of the incision and visual inspection of the incision without the need for removal of the holder from the patient's body are provided. A medically acceptable adhesive conveniently allows the tube holder to be secured to the patient's body.

It will be understood that the foregoing general description and the following detailed description as well are exemplary and explanatory of the invention but are not restrictive thereof.

Brief Description of the Drawings The accompanying drawings, referred to herein and constituting a part hereof, illustrate preferred embodiments of the product of the present invention, and together with the description serve to explain the principles of the invention, in which: Figure 1 is a perspective view of the preferred embodiment of the invention having an axial slide lock disposed over the collar and a sealing member protruding from the open end of the collar; Figure 2 is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 1 shown in the unlocked position; Figure 3 is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 1 shown in the locked position;; Figure 3A is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 3 and illustrating an alternative method of joining the sealing member to the collar; Figure 4 is a front elevation view of the preferred embodiment of the invention in accordance with Figure 1 from the collar side of the mounting plate illustrating axial slide stops configured as pegs; Figure 4A is a front elevation view of the adjustable drainage tube holder in accordance with Figure 4 illustrating the axial slide lock in the locked position constricting the tube relative to the tube holder; Figure 5 is a perspective view of the first alternative embodiment of the invention having an axial slide lock disposed over the collar and a sealing member contained within the collar;; Figure 6 is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 5 and illustrating a sealing member positioned adjacent to the thick-walled region of the collar; Figure 7 is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 5 and illustrating the axial slide lock in the locked position; Figure 8 is an axial cross-section view of the adjustable drainage tube holder in accordance with Figure 5 and illustrating a sealing member positioned within the collar adjacent to the relatively thin-walled region of the collar.

Figure 9 is a perspective view of the second alternative embodiment of the adjustable drainage tube holder and illustrating the axial slide lock in the unlocked position; Figure 10 is a perspective view of the second alternative embodiment according to Figure 9 and illustrating the axial slide lock in the locked position; Figure 11 is a perspective view of the third alternative embodiment of the adjustable drainage tube holder having a threaded screw as the tube lock; Figures 12, 12A, 1 2B and 12C are axial crosssection views of the third alternative embodiment of the invention illustrating various positional relationships between the threaded screw tube lock and the sealing member; Figure 13 is a perspective view of the fourth alternative embodiment of the adjustable drainage tube holder according to the invention having a clamp as the tube lock;; Figure 14 is a front elevation view of the adjustable drainage tube holder according to Figure 13 illustrating the clamp in the locked position; and Figure 15 is a partial axial cross-section view of the preferred embodiment of the invention in accordance with Figure 1 and illustrating a means for securing the axial slide lock in the locked position.

Detailed Description of the Preferred Embodiments Referring now more particularly to Figures 1~4, an adjustable drainage tube holder 10 constructed in accordance with the present invention includes a clear, flexible mounting plate 12 having an adhesive 26 on one surface thereof and an aperture 22 therein. A collar 14 protrudes from the side of the mounting plate away from adhesive 26 and has an axial bore 18 aligned with aperture 22 to define a tube passageway. A sealing member 16 is attached to collar 14and provides an essentially airtight seal between the collar and a tube 24 which slides freely within the tube passageway. A tube lock generally designated as 30 is provided on collar 14 to selectively create frictional engagement between tube holder 10 and tube 24, preventing movement of the tube within the tube passageway.The tube lock exerts limited radially constricting force on the tube to secure the tube's position relative to the holder. Specific tube lock structures will be discussed in more detail below in relation to the various alternative embodiments. Advantageously, the tube lock is not capable of exerting undue radial force on the tube sufficient to collapse the tube or otherwise obstruct the internal tube flow. In the locked position tube lock 30 preferably creates radial constriction of the tube at a point away from the seal formed by the sealing member in order not to interfere with that seal.

The flexible mounting plate conforms to the contour of the patient's body so as to seal the general area of the tube incision exceptthrough mounting plate aperture 22. Although variously shown in the Figures as oval and rectangular, the shape of the mounting plate is not critical. The mounting plate is held in sealing contact with the patient's body by adhesive 26 or, alternatively, by common taping procedures. The clear mounting plate permits visual inspection of the incision directly therethrough without any need to remove the tube holder from the patient's body. Therefore, the adhesive or tape used to fasten the holder in place should be clear in order not to frustrate the inspection advantage obtained with the clear mounting plate. The clear flexible mounting plate may be a molded sheet of plastic made from a polymer plastic such as a polyvinyl.

Collar 14 protrudes from the side of mounting plate 12 away from the adhesive and, hence, away from the patient's body. Axial bore 18 and aperture 22 align to form the tube passageway which guides tube 24 for proper entry into the tube incision. The collar preserves the seal establ:shed by the mounting plate around the incision so that the only air passage from the incision is through the tube passageway. The collar is stiffer than the mounting plate, which relative stiffness may be obtained by forming the collar from a stiffer plastic than the mounting plate. A suitable collar material is polystyrene.For ease of manufacture the collar may be formed together with the mounting plate such that the desired stiffness of the collar is achieved by forming the collar with thick walls relative to the thickness of the mounting plate, in which case the collar would also be made of a polymer plastic such as polyvinyl. Molding the mounting plate and collar together is particularly desirable since a seal between the mounting plate and collar is readily formed, ensuring that the only air passage from the incision is through the tube passageway.

The tube lock acts either directly on tube 24 through collar 14 or by constricting both the collar and the tube, but in either case creates sufficient friction between the tube and tube holder to selectively prevent sliding of the tube through the tube passageway. When the lock acts directly on the tube care must be taken to preserve the airtight seal formed by the collar around the tube passageway.

One example of a tube lock which acts directly on the tube through the collar is a threaded screw positioned in a correspondingly threaded radial aperture in the collar. The screw is provided with limited travel in both the tightening and loosening directions to prevent loss by becoming detached from the holder and, more importantly, to prevent overtightening of the lock which could interfere with internal tube flow. The seal of the collar around the tube passageway is preserved by placing a sealant, such as teflon tape, between the threads of the screw and receiving aperture. Tube locks which act upon both the collar and tube generally deform the collar by a predetermined amount to create friction between the inner surface of the collar and the outer surface of the tube.This type of tube lock is rigid relative to the collar and tube and can, for example, be made from a rigid polystyrene plastic. The constriction of the collar is limited to prevent overtightening which could interfere with internal tube flow. Structures which act on both the collar and tube will be discussed below in relation to the various alternative embodiments of the present invention.

The sealing member 16 is made of a non-porous material and forms an essentially airtight seal between collar 14 and tube 24. The sealing member is attached to the collar by elastically stretching to overlap the open end thereof, by being made integral with the collar, or by being fitted within the tube passageway, i.e., by a secure friction fit. In any event, the attachment of the sealing member to the collar forms an airtight seal between those two elements and completes the airtight seal around the drainage tube exiting from the patient's body. The non-porous sealing member must form the essentially airtight seal around the tube without retarding the sliding action of the tube within the tube passageway.Since the pressure differentials between the body cavity and atmosphere are not very large, the preferred method of obtaining this combination of sealing and sliding is to mold the non-porous sealing member in a size-on-size fitting relationship with tube 24. Polystyrene plastic is particularly appropriate for establishing a size-onsize relationship which will provide sufficient sealing performance while allowing the tube to slide within the tube passageway when the tube lock is disengaged. To facilitate tube sliding a small amount of a medically acceptable lubricant, such as petroleum jelly, may be provided between the sealing member and the tube. However, such a lubricant cannot interfere with or substantially weaken the seal between the sealing member and tube.The constricting action of the tube lock should occur away from the point where the sealing member to tube seal is formed in order to ensure that the tube lock constriction and consequent slight distortion of the tube and collar does not interfere with the airtight seal between the sealing member and tube. In this manner the limited deformation of the tube and, perhaps, the sealing member created by the tube lock will not prevent the tube and sealing member from resuming their size-on-size sealing relationship. As a practical matter, the consequence of this requirement is that the tube lock should be positioned on the collar at a point away from the seal. Various arrangements for satisfying this condition will be discussed below in relation to the alternative embodiments of the invention.

Thus, the adjustable drainage tube holder 10 according to the present invention provides mounting plate 12 to secure the tube holder to the patient's body and collar 14 which, in conjunction with mounting plate aperture 22, forms a tube passageway which allows a tube to slide therethrough and which provides support for tube lock 30 and sealing member 16. Tube lock 30 is provided to selectively prevent tube 24 from sliding through the tube passageway by creating friction between tube 24 and tube holder 10. Sealing member 16 provides a seal between collar 14 and tube 24. Advantageously, an airtight seal is provided between the tube and the patient's body by the combined sealing action of the mounting plate with adhesive, collar and sealing member.Thus, air is conveniently prevented from entering the body cavity through the incision to defeat the purpose of the drainage tube; to remove airfrom the body cavity. The airtight seal of the present invention is provided without the currently used, tedious stitching and bandaging procedures. Furthermore, sliding of the tube through the tube passageway can be selectively prevented without danger of overtightening or the resulting obstruction of tube flow. The clear adhesive and mounting plate allow visual inspection of the incision without inconvenient removal of bandages or displacement of the tube holder from the patient's body.

In the preferred embodiment of the invention shown in Figures 1-3 collar 14 has a constant inner diameter throughout its length and an outer diameter which varies as a function of position along the collar length. The greatest outer diameter occurs in a first region 14a near mounting plate 12 to provide relatively thick, stiff collar walls which establish structural integrity at the airtight junction of the mounting plate and collar and provide guidance for tube 24 through the tube passageway into the incision. At the end of the collar distal from mounting plate 12 there is a second collar region 14b of lesser outer diameter than first region 14a.

Between first and second regions 14a and 14b is an intermediate region 14c of graduated outer diameter. Sealing member 16 is attached to collar 14 as, for example, by tightly engaging the collar in a permanent friction fit so that the collar and the sealing member cannot easily be separated. The tight fit of the collar and sealing member establishes an essentially airtight seal at that juncture. As shown in Figure 3A, sealing member 16 may, alternatively, be wrapped around the outer diameter of the collar, resiliently resuming its natural diameter in size-on-size relationship surrounding and sealing the tube as it exits from the collar. Tube lock 30 comprises axial slide lock 32 assuming an unlocked position, as shown in Figure 2, overlying second region 14b of the collar without causing constriction of either collar 14 or tube 24.The inner diameter of axial slide lock 32 is dimension to loosely slide over the collar in second region 14b. A slide stop 15 may be provided at the extreme distal end of collar 14 to prevent axial slide lock 32 from becoming disengaged from collar 14. Slide stop 15 may consist of an annular ridge about the circumference of the collar or may consist of one or more peg members (see Fig. 4).

Axial slide lock 32 assumes a locked position as shown in Figure 3. The axial slide lock frictionally engages the graduated outer diameter of intermediate region 14c and distorts collar 14 radially inward to frictionally engage tube 24, securing the tube relative to the tube holder. Axial slide lock 32 cannot be forced over relatively thick section 14a without extreme and undue force which would impair the structural integrity of the axial slide lock itself. The frictional engagement of the axial slide lock and collar is such that the axial slide lock will only return to the unlocked position when a conscious effort is made to unlock the tube holder.

The constriction of collar 14 may occur around the entire circumference thereof or only at discreet points, depending upon whether intermediate region 1 4c is continuous about the circumference of the collar. In the locked position the distortion caused by the frictional locking does not affect the seal formed between the sealing member and the tube. Even if some distortion of the collar is communicated to the sealing member, the sealing member resumes its natural position in size-on-size relationship to the tube at a point away from the distorted portion of the collar.

Figure 4 is a plan view of the preferred embodiment of the invention in accordance with Figure 1 wherein axial slide lock stops 15 are configured as pegs rather than as a continuous annular ridge. Although shown as two, the number of pegs is not critical. Figure 4A illustrates the adjustable drainage tube holder in accordance with Figure 4 with axial slide lock 32 in the locked position constricting discrete collar sections 14c of graduated outer diameter to secure tube 24 relative to tube holder 10.

The first alternative embodiment of the present invention is illustrated in Figures 57 with reference numerals corresponding to Figures 1-4.

In this embodiment collar 14 is integral with clear, flexible mounting plate 12 and has first, second and graduated regions 14a, 14b and 14c, respectively, of various outer diameters as previously discussed.

Axial slide lock 32 assumes the unlocked and locked positions shown in Figures 57, respectively, corresponding to the positions previously discussed in relation to Figures 2-3. In the locked position the axial slide lock constricts the collar in the intermediate graduated region 14coo create frictional engagement between tube holder 10 and tube 24. Sealing member 16 is wholly contained within the tube passageway to form an airtight seal between the tube and collar at a point away from the frictional engagement of the tube and holder.

Sealing member 16 is here shown secured to the inner surface of the relatively thick side wall region 14a of collar 14. Positioning the sealing member against region 14a is particularly advantageous since the relatively thick side walls of region 14a do not readily distort when axial slide lock 32 is in the locked position, so the size-on-size relationship of sealing member 16 and tube 24 is protected from distortion. Alternatively, sealing member 16 may be positioned within the collar adjacent to region 14b if similarly held away from the point of constriction in region 14c (see Figure 8). In this cqnfiguration, the seal formed by sealing member 16 between collar region 14b and tube 24 is obtained near the open end of the collar while the frictional locking occurs in intermediate region 14c.

A second alternative embodiment of the adjustable drainage tube holder in accordance with the present invention is shown in Figures S10 with reference numerals corresponding to Figures 1-8.

Collar 14 has a constant inner diameter and two regions of differing outer diameter. The sealing member (not shown) is positioned within collar 14 adjacent to first collar region 14a of relatively thick outer diameter in a manner similar to that shown in Figure 7. A second collar region 14d protrudes from the thick region 14a. Axial slide lock 32 assumes an unlocked position disassociated from the collar as shown in Figure 9 and a locked position surrounding and constricting second region 14d of collar 14 as shown in Figure 10. In the locked position region 14d is either continuously or discretely constricted in a manner similar to the locked position shown in Figure 4A without interfering with the seal formed around the tube by the sealing member positioned within the collar.

A third alternative embodiment of the present invention is illustrated in perspective and axial cross-section views in Figures 11-12, respectively, with common reference numerals to Figures 1-10.

Collar 14 has substantially constant inner and outer diameters throughout its length and is provided with a threaded screw hole 34 to receive the tube lock configured as screw 36. Tip 38 of screw 36 is blunt and screw 36 has limited freedom of travel in threaded screw hole 34. A finger handle 40 is provided to facilitate tightening and loosening of screw 36. A sealant 42, such as teflon tape, is provided between the threads of screw 36 and threaded hole 34 to maintain the airtight seal around the tube passageway. The limited travel of screw 36 in screw hole 34 allows the screw in the locked position to exert a maximum pressure upon tube 24 sufficient to prevent the tube from sliding within the tube passageway but not great enough to collapse the tube or otherwise obstruct the internal tube flow.Blunt tip 38 exerts inward radial pressure on tube 24 when screw 36 is tightened but will not puncture tube 24. In Figures 11-12 sealing member 16 is shown wrapped around the open end of collar 14 and resiliently conforming to the shape of tube 24 to create the airtight seal between the tube and collar which is necessary to complete the seal of the tube incision.

Figures 12A, 12B, and 12C illustrate alternative configurations of the adjustable tube holder in accordance with the third alternative embodiment of the invention showing various positions for sealing member 16 and threaded screw 36. In all cases the frictional engagement of screw lock 36 and tube 24 occurs at a point away from the seal formed by the sealing member with the tube. In Figure 12A screw 36 is positioned on collar 14 similarly to Figure 12 and sealing member 16 is fixed to collar 14 in a manner similar to that discussed in relation to Figures 2-3, that is, fixedly secured to the inner diameter of the collar, such as by a tight friction fit, and protruding from the collar to form the seal around tube 24.Figure 12B shows sealing member 16 mounted within collar 14 near mounting plate 12 with tightening screw 36 mounted on collar 14 outward from.mounting plate 12. Figure 12C shows tightening screw 36 mounted on collar 14 relatively close to mounting plate 12 with sealing member 16 positioned within collar 14 near the open end thereof.

A fourth alternative embodiment of the adjustable drainage tube holder according to the present invention is shown in Figures 13-14, with common reference numerals to Figures 1-12. In this embodiment tube lock 30 comprises a clamp to create predetermined radial constriction of collar 14 resulting in frictional engagement of collar 14 and tube 24. Figure 13 is a perspective view showing the fourth alternative embodiment of the present invention in the unlocked position. Figure 14 is a front elevation view of the fourth embodiment of the adjustable drainage tube holder in the locked position. Clamp 50 is provided with a hinge 52, an outwardly projecting tab 54 (see Fig. 14) and an inwardly projecting tab 56. Preferably, the portion of the clamp between hinge 52 and outwardly projecting tab 54 is permanently attached to collar 14 and that portion of the clamp between hinge 52 and inwardly projecting tab 56 is allowed to swing freely away from collar 14. Clamp 50 is preferably made of a resilient plastic such as polystyrene and hinge 52 may be a deformable crease therein. In the unlocked position shown in Figure 13 no radially constricting force is exerted on collar 14 and tube 24 slides freely within the tube passageway. The clamp is locked by forcing inwardly projecting tab 54 over outwardly projecting tab 56 (see Figure 14).The diameter of clamp 50 in the locked position is smaller than the outer diameter of collar 14 by an amount sufficient to constrict collar 14, thereby locally reducing the diameter of the tube passageway to create sufficient friction between tube 24 and tube holder 10 to prevent the tube from sliding within the tube passageway. However, since clamp 50 only assumes a single locked position creating controlled constriction of the collar overtightening of the clamp which might obstruct the internal flow of the tube is prevented. A finger tab 58 is provided to facilitate leveraging inwardly projecting tab 56 away from outwardly projecting tab 54to conveniently unlock the clamp and allow readjustment of the tube.

The clamp may be positioned in relation to sealing member 16 as shown in Figure 13 or may, alternatively, be positioned similarly to the threaded screw positions illustrated in Figures 12, 12A, 12B, and 12C depending upon the position of sealing member 16. Sealing member 16 may join collar 14 in tight friction fit as shown in Figure 13, may overlap the open end of the collar as shown in Figure 12, or may be positioned wholly contained within collar 14 in a manner similar to that shown in Figures 12B and 12C.

Preferably, the surfaces of the adjustable drainage tube in closed proximity to the incision, e.g., the side of the mounting plate which contacts the patient's body and the interior surfaces of the tube passageway and sealing member, are provided with medicinal substances which promote healing and prevent infection.

The alternative embodiments of the present invention wherein the threaded screw lock or locking clamp are provided do not involve any significant risk that the tube lock will accidentally become unlocked since those embodiments involve tube locks which positively engage in the locked position and are unlikely to become accidentally disengaged. While the same is generally true of the preferred embodiments involving the axial slide lock, the sliding frictional engagement of that lock may under some circumstances be subject to accidental unlocking. This accidental unlocking can be prevented by providing means for positively engaging the axial slide lock in the locked position constricting collar 14.

In Figure 15, a partial cross-section view of axial slide lock 32 in the locked position, protrusions 60 are provided on collar 14to engage recesses 62 in axial slide lock 32. As axial slide lock 32 is forced into the locked position the axial slide lock rides over protrusions 60 until recesses 62 become aligned with protrusions 60 and axial slide lock 32 resiliently snaps over the protrusions to be securely held in the locked position by engagement of protrusions 60 in recesses 62. The protrusions may, alternatively, be configured as a ridge to engage a continuous recess in axial slide lock 32.

In use, the adjustable drainage tube holder is mounted, preferably with the tube already slidingly engaged in the tube passageway, on the patient's body with tube lock 30 in the unlocked position. As thus positioned tube 24 can freely slide within the tube passageway as clear, flexible mounting plate 12 is pressed against the patient's body. The mounting plate conforms to the contour of the patient's body to form an airtight seal between the patient's skin and mounting plate 12. Adhesive 26 secures the mounting plate against the patient's skin to ensure that the airtight seal is properly maintained. The tube passageway is properly aligned with the tube incision so that the tube may be slidingly adjusted within the tube passageway when the tube lock is in the unlocked position.The sliding of the tube within the tube passageway may be enhanced by providing a small amount of lubricant between these surfaces. The airtight seal between the mounting plate and collar ensures that the only air passage to the incision is through the tube passageway. Sealing member 16 completes the substantially airtight seal over the tube incision by sealing the exit of the tube from the open end of the collar, making the only available air passage to the incision through the tube itself. Sliding of the tube through the sealing member may also be enhanced with a small amount of lubricant.

The tube is slidingly adjusted to the desired position and the tube lock, whether it be the threaded screw, clamp, or axial slide lock, is urged into the locked position to secure the position of the tube relative to the tube holder without affecting the airtight seal around the tube or obstructing the internal tube flow. The tube lock cannot be overtightened without undue force and is retained in the locked position to prevent accidental unlocking. Where the preferred axial slide lock is used discomfort to the patient during locking is minimized since little or no pulling of the skin occurs.

The tube may be readily adjusted within tube holder 10 by unlocking the tube lock, sliding the tube within the tube passageway, and re-fastening the tube lock, ail without displacing the tube holder from the patient's body. Visual inspection of the incision may be made by looking through the clear mounting plate and clear adhesive without removing the tube holder from the patient's body.

The medicinal substances provided on the surfaces of the tube holder prevent infection and promote healing of the incision.

To the extent not already indicated, it also will be understood by those of ordinary skill in the art that any one of the various specific embodiments herein described and illustrated may be further modified to incorporate features sbown in other of the specific embodiments, as desired.

The invention in its broader aspects therefore is not limited to the specific embodiments herein shown and described but departures may be made therefrom within the scope of the accompanying claims, without departing from the principles of the invention and without sacrificing its chief advantages.

Claims

1. An adjustable drainage tube holder for securing a tube relative to a patient's skin comprising: a flexible mounting plate having a tube aperture, said mounting plate being adapted to conform to said patient's skin and form a substantially airtight seal with said skin other than through said aperture; collar means protruding from one side of said mounting plate, the bore of said collar means being aligned with said tube aperture to define a tube passageway adapted to slidingly receive a tube, said collar means being attached to said mounting plate to form a substantially airtight seal around said aperture so that the only air passage through said aperture is through said tube passageway;; sealing means for forming a substantially airtight seal between said collar means and said tube when said tube is inserted into said tube passageway without inhibiting the sliding engagement of said tube within said tube passageway; and securing means for selectively preventing said tube inserted into said tube passageway from sliding within said tube passageway without impairing the substantially airtight seal formed by said sealing means.

2. The adjustable drainage tube holder according to claim 1 wherein said sealing means is substantially tubular and provides said seal between said tube inserted into said tube passageway and said collar means by being sealingly attached to said collar means and by being configured to assume a size-on-size sealing relationship surrounding said tube when said tube is inserted into said tube passageway.

3. The adjustable drainage tube holder according to claim 2 wherein said sealing means further comprises a non-porous elastic material.

4. The adjustable drainage tube holder according to claim 3 wherein said sealing means is attached to said collar means by being stretch fitted over the open end of said collar means distal to said mounting plate and protrudes from said collar means to assume said size-on-size relationship surrounding said tube when said tube is inserted into said tube passageway.

5. The adjustable drainage tube holder according to claim 3 further comprising a lubricant provided between said sealing means and said tube when said tube is inserted into said tube passageway.

6. The adjustable drainage tube holder according to claim 2 wherein said sealing means is attached to said collar means by secure frictional engagement of the outer circumferential surface of said tubular sealing means with the inner circumferential surface of said collar means.

7. The adjustable drainage tube holder according to claim 6 wherein said sealing means protrudes from said collar means to surround said tube when said tube is inserted into said tube passageway.

8. The adjustable drainage tube holder according to claim 6 wherein said sealing means is wholly contained within said tube passageway.

9. The adjustable drainage tube holder according to claim 1 wherein said securing means selectively creates inward radial force upon said tube when said tube is inserted into said tube passageway to create friction between said inserted tube and said adjustable drainage tube holder to prevent said sliding engagement of said inserted tube in said tube passageway.

10. The adjustable drainage tube holder according to claim 9 wherein said inward radial force is created at a point away from the seal formed between said sealing means and said tube when said tube is inserted into said tube passageway.

11. The adjustable drainage tube holder according to claim 10 wherein said securing means is configured to create a maximum inward radial force sufficient to prevent said sliding engagement but insufficient to interfere with the internal flow of said tube inserted into said tube passageway.

12. The adjustable drainage tube holder according to claim 11 wherein said securing means comprises a screw engaging a correspondingly threaded hole in said collar means.

13. The adjustable drainage tube holder according to claim 12 further comprising a screw hole sealant provided between said screw and said threaded hole in said collar means.

14. The adjustable drainage tube holder according to claim 11 wherein said securing means comprises a clamp adapted to assume a first, unlocked position and a second, locked position surrounding and constricting a portion of said collar means to create said inward radial force.

15. The adjustable drainage tube holder according to claim 1 wherein said flexible mounting plate is clear.

16. The adjustable drainage tube holder according to claim 15 further comprising a clear-drying adhesive provided on the side of said mounting plate away from said collar means for securing said mounting plate to said patient's skin.

17. The adjustable drainage tube holder according to claim 1 further comprising a medicinal substance provided on the surfaces of said adjustable drainage tube holder to prevent infection and/or promote healing.

18. The adjustable drainage tube holder according to claim 11 wherein said securing means comprises an axial slide lock adapted to assume a first, unlocked position disassociated from said collar means and a second, locked position surrounding and constricting said collar means to create said inward radial force.

19. An adjustable drainage tube holder for securing a tube relative to a patient's skin comprising: a flexible mounting plate having a tube aperture, said mounting plate being adapted to conform to said patient's skin and form a substantially airtight seal with said skin other than through said aperture;; collar means protruding from one side of said flexible mounting plate, said collar means having an essentially uniform minor diameter aligned with said tube aperture to form a tube passageway adapted to slidingly engage a tube inserted therein, said collar means being attached to said mounting plate so that the only air passage through said tube aperture is through said tube passageway, said collar means having a first region of substantially uniform major diameter, a second region of lesser uniform major diameter than said first region, and an intermediate region of graduated major diameter joining said first and second regions; sealing means for forming an essentially airtight seal between said collar means and said tube when said tube is inserted into said tube passageway without inhibiting said sliding engagement of said inserted tube in said tube passageway; and an axial slide lock assuming a first, unlocked position surrounding said second region of said collar means without interfering with said sliding engagement of said tube when inserted into said tube passageway and a second, locked position engaging said intermediate region of said collar means to create inward radial pressure on said collar means, thereby inwardly distorting said collar means to selectively prevent said s!iding engagement of said inserted tube within said tube passageway by creating friction between said inserted tube and said collar means.

20. The adjustable drainage tube holder according to claim 19 wherein said flexible mounting plate is clear.

21. The adjustable drainage tube holder according to claim 20 further comprising a clear-drying adhesive provided on the surface of said mounting plate away from said collar means.

22. The adjustable drainage tube holder according to claim 21 further comprising a lubricant provided between said sealing means and said tube when said tube is inserted into said tube passageway.

23. The adjustable drainage tube holder according to claim 19 wherein said sealing means is substantially tubular and provides said airtight seal between said collar means and said tube when inserted into said tube passageway by being sealingly affixed to said collar means and by being configured to assume a size-on-size sealing relationship surrounding said inserted tube, said seal between said inserted tube and said sealing means being formed at a point away from said inward distortion of said collar means by said axial slide lock.

24. The adjustable drainage tube holder according to claim 23 wherein said sealing means comprises a non-porous elastic material stretch fitted over the open end of said collar means distal to said mounting plate and protruding from said collar means to assume said size-on-size sealing relationship surrounding said tube when said tube is inserted into said tube passageway.

25. The adjustable drainage tube holder according to claim 23 wherein said sealing means is attached to said collar means by secure frictional engagement of the outer circumferential surface of said tubular sealing means with the inner circumferential surface of said collar means.

26. The adjustable drainage tube holder according to claim 25 wherein said sealing means is wholly contained within said tube passageway.

27. The adjustable drainage tube holder according to claim 1 further comprising a drainage tube slidingly disposed within said tube passageway.

28. An adjustable drainage tube holder substantially as hereinbefore described with reference to and as illustrated in Figures 1 to 4, 5 to 9, to 12 or 13,14 and 15 of the accompanying drawings.