US20040068290A1 - Device and method for compressing wounds - Google Patents

Abstract

A dressing for applying compression to a wound in a patient includes a bladder having a non-deformable end wall and a deformable membrane. The dressing may include a flexible web having an adhesive layer on one side thereof for securing the dressing to the patient so as to hold the bladder against the patient's skin. Upon inflation, the deformable membrane projects towards the patient's skin and exerts pressure on the wound to reduce the flow of blood from the wound.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application claims the benefit of U.S. Provisional Patent Application No. 60/368,013 filed Mar. 27, 2002, the disclosure of which is incorporated by reference herein.[0001]
BACKGROUND OF THE INVENTION
• The present invention relates generally to a device and method for compressing a wound in a patient caused by any one of a number of medical procedures. In a particular embodiment, the present invention is directed to a device and method for compressing and sealing a puncture wound in a blood vessel of a patient caused by a medical procedure.[0002]
• In certain medical procedures, such as cardiac catheterization, dilation and counterpulsation, a catheter or other device is inserted into an artery, most commonly by percutaneous methods, and then fed through the arterial tree to the site where needed, frequently, the region of the heart. The site usually selected for insertion is the groin because the femoral artery in that region is relatively easy to locate.[0003]
• These procedures are normally initiated by insertion of an angiographic needle, followed by passing a guide wire through that needle into the artery. The needle is then removed, leaving the guide wire in place. Next, a sheath/dilator set is passed over the guide wire into the artery in order to enlarge the opening sufficiently to permit entry of the catheter or other device. The dilator is then removed, leaving the sheath or guide cannula in place. The catheter or other device can then be inserted through the cannula with full confidence that when it emerges from the distal end it will be within the lumen of the artery.[0004]
• After a procedure, for example, counterpulsation, has been completed, the sheath must be removed and the wound closed. Often, this can be accomplished simply by the application of digital pressure, generally augmented by the use of a conventional pressure dressing, until hemostasis is achieved. Customarily, pressure must be applied for at least one half hour, and frequently for much longer than that. In addition, during this period the patient must be immobilized, lest movement interfere with the closing process. Because of the pressure required, the time during which it must be applied and the need for immobilization, the procedure is painful and uncomfortable. It also requires the prolonged personal attention of a health care professional. Finally, wound closures accomplished in this manner are prone to open unexpectedly long after closure appears to have been completed. Patients are therefore often required to maintain bedrest, oftentimes in the hospital, for 24 hours or longer.[0005]
• In addition to the need for applied pressure to seal a puncture wound in an artery or blood vessel of a patient, there are other medical situations in which the application of pressure to a particular region of a patient's body is required. For example, there may be a requirement for pressure to stanch bleeding or reduce hematomas following biopsies, ambulatory dialysis, insertion of intravenous needles, emergency procedures and other such situations.[0006]
• Although devices have been developed to address these situations, and particularly the difficulties associated with achieving hemostasis of an artery or blood vessel, these devices have met with various degrees of success and oftentimes create new difficulties. There therefore exists a need for a device for applying compression to wounds in patients which is inexpensive, effective, easy to use and comfortable for the patient, and which overcomes many of the drawbacks of the prior art devices.[0007]
SUMMARY OF THE INVENTION
• The present invention addresses these needs.[0008]
• One aspect of the present invention provides a dressing for applying compression to a wound in a patient. The dressing includes an inflatable bladder having a non-deformable end wall and a deformable membrane connected to the end wall so as to define an enclosed space therebetween. The bladder has a deflated condition in which the membrane is adjacent the end wall and an inflated condition in which the membrane is spaced from the end wall. Holding means are provided for holding the bladder against the skin of the patient in a position substantially overlying the wound.[0009]
• The holding means may include a flexible web connected to the end wall of the bladder and projecting outwardly therefrom. The flexible web may extend radially outward in all directions from the bladder and may include a layer of adhesive on one surface for adhering the flexible web to the skin of the patient.[0010]
• The bladder in the inflated condition may decrease in size in a direction away from the end wall. In preferred embodiments, the bladder in the inflated condition may have a frusto-conical or frusto-pyramidal shape.[0011]
• The end wall may be formed from a rigid material, such as plastic, and may be transparent. The end wall may also be formed from the same material as the deformable membrane, and may be molded integrally with the deformable membrane.[0012]
• Another aspect of the present invention provides a method of applying compression to a wound in a patient. The method includes providing a dressing including an inflatable bladder having a non-deformable end wall and a deformable membrane connected to the end wall so as to define an enclosed space therebetween; holding the dressing against the skin of the patient in a position overlying the wound; and inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound to reduce the flow of blood from the wound.[0013]
• The holding step may include providing a flexible web connected to the end wall of the bladder, the flexible web having a layer of adhesive on one surface thereof, and adhering the flexible web to the patient's skin.[0014]
• The bladder in the inflated condition may decrease in size in a direction away from the end wall. In preferred methods, the bladder in the inflated condition may have a frusto-conical or frusto-pyramidal shape.[0015]
• The providing step may include providing the dressing such that the end wall and the deformable membrane are formed from the same material. The providing step may further include providing the dressing such that the end wall and the deformable membrane are molded integrally with one another.[0016]
• Preferred dressings in accordance with the present invention and compression methods employing same reduce the time in which health care professionals must exert manual compression to a wound, while at the same time increasing patient mobility and comfort.[0017]
BRIEF DESCRIPTION OF THE DRAWINGS
• A more complete appreciation of the subject matter of the present invention and the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:[0018]
• FIG. 1 is an enlarged, schematic, cross-sectional view of one type of insertion site, showing a balloon catheter having passed over a guide wire through a guide cannula into the femoral artery of the patient;[0019]
• FIG. 2 is a bottom plan view of one embodiment of the compression dressing of the present invention showing the side that faces the puncture wound;[0020]
• FIG. 3 is a top plan view of the compression dressing of FIG. 2;[0021]
• FIG. 4 is a cross-sectional view of the compression dressing taken along line[0022]4-4 of FIG. 3 and showing the bladder in a deflated condition;
• FIG. 5 is the same view as FIG. 4, but showing the bladder in an inflated condition;[0023]
• FIG. 6 is a perspective view showing the application of the compression dressing to a patient, the bladder of the compression dressing being in a deflated condition;[0024]
• FIG. 7 is a perspective view showing the application of the compression dressing to a patient, the bladder of the compression dressing being in an inflated condition;[0025]
• FIG. 8 is an enlarged, schematic, cross-sectional view showing the insertion site of FIG. 1 after the catheter, cannula and guide wire have been removed, and showing the use of the compression dressing to seal the puncture wound; and[0026]
• FIG. 9 is a cross-sectional view of a compression dressing in accordance with an alternate embodiment of the present invention, showing the bladder in an inflated condition.[0027]
DETAILED DESCRIPTION
• In certain procedures, for example, intra-aortic balloon pumping (“IABP”), percutaneous transluminal coronary angioplasty (“PTCA”) and angiography, as best seen in FIG. 1, a catheter or[0028]other device10 is inserted through apuncture wound14 and into a blood vessel orartery16, most frequently, the common femoral artery in the groin area of the patient'sleg20.Puncture wound14 includes a tissue channel extending through a layer oftissue separating artery16 from the patient's skin. Often, the insertion ofdevice10 is facilitated by passing the device over aguide wire22 and through aguide cannula24. When the procedure (e.g., counterpulsation) has been completed, the device (e.g., the catheter), the guide wire and the guide cannula must be removed and the puncture wound closed. Although puncture wounds of the sort made by percutaneous procedures will generally, after removal of all cannulas and catheters, be in the nature of slits, for ease of understanding, they are depicted in the drawings herein more as holes. The shape of the puncture wound, however, is not critical.
• It should be understood that the subject invention is independent of the nature of the medical device being used to treat the patient. Accordingly, the term “catheter” is used herein in a very generic and broad way to include not only “catheters” in the strict sense, but any device that is inserted into the body.[0029]
• Similarly, the subject invention is independent of whether a particular blood vessel is involved, and if so, which blood vessel. While it is anticipated that the femoral artery will be the most commonly used blood vessel for many percutaneous procedures, other arteries as well as veins might just as easily be involved.[0030]
• A compression dressing[0031]100 for use in sealing puncture wound14 is shown in FIGS. 2 and 3. Dressing100 includes anexpandable bladder102 having anupper wall104 and alower membrane106 enclosing aninternal region108.Upper wall104 is formed from a material that will resist substantial deformation at the pressures to whichbladder102 is inflated during normal use. Thus, for example,upper wall104 may be formed from a rigid plastic material, a rigid metal or some other relatively rigid material. Preferably,upper wall104 is formed from a transparent plastic disc so that the inflation ofbladder102 and any leakage of blood from puncture wound14 can be readily observed therethrough.
• In contrast,[0032]membrane106 is formed from a pliant, air-impermeable material such thatmembrane106 will deform upon inflation ofbladder102. In one arrangement,membrane106 may be formed from the same material asupper wall104. For example, in a one-piece molding operation,upper wall104 may be formed with a relatively thick cross-section such that it will not substantially deform at the pressures to whichbladder102 is inflated during use, andmembrane106 may be formed with a relatively thin cross-section such that it will readily deform upon inflation ofbladder102. Alternatively,upper wall104 andmembrane106 may be formed from different materials altogether.
• [0033]Bladder102 in the inflated condition may have any shape capable of exerting sufficient pressure on the patient's leg to occlude bleeding. In a preferred arrangement, however,membrane106 has a shape such that theinflated bladder102 will taper from a larger size to a smaller size in the direction toward the patient. For example, in the inflated state,bladder102 may have the shape of an inverted pyramid or cone. Such shapes will concentrate the pressure exerted by compression dressing100 on a localized region of the patient, desirably a region overlying the wounded artery.Bladder102 in the inflated condition may alternatively have a frusto-pyramidal or frusto-conical shape, thereby avoiding any pain to the patient which may result from having the inflated point ofbladder102 forced against the patient's skin. Other shapes are also contemplated herein. Moreover, it will be appreciated that by varying the wall thickness and shape ofmembrane106, various levels of force and conformity with the contour of the patient's skin may be achieved.
• [0034]Membrane106 may be treated with an anti-bacterial coating in order to minimize the occurrence of infections in puncture wound14 resulting from the use ofcompression dressing100. In addition,membrane106 may be treated with any number of materials known to those skilled in the art to aid in the healing of puncture wound14 or to reduce pain or complications.
• [0035]Bladder102 is secured to the lower surface of anattachment web110.Web110 is preferably formed from a flexible material which will readily conform to the contour of the patient's leg. Particularly preferred are materials that are permeable to air, such as woven fabrics and perforated plastic sheets. The attachment ofbladder102 toweb110 may be made by an adhesive; mechanical means, such as sewing or stapling; ultrasonic or solvent welding; and any other known techniques. In a preferred arrangement, the edges ofbladder102 are encased within one or more layers of adhesive as discussed below in connection with FIG. 9. Anaperture112 may be formed inweb110 in a region overlyingupper wall104.Aperture112 may enable substantially the entirety ofbladder102 to be seen throughweb110 to assure proper placement and operation ofcompression dressing100.
• [0036]Web110 may extend outwardly frombladder102 in all directions so as to define a continuous region aroundbladder102 by which dressing100 may be attached to the patient's leg. However,web110 need not extend outwardly frombladder102 by equal amounts in all directions. Thus, as shown in FIG. 2,web110 may include substantiallyperpendicular arms114 and116 which extend radially outwardly frombladder102 by a greater extent than the remainder ofweb110. Although FIG. 2 showsarms114 as shorter thanarms116, that is not necessarily the case;arms114 may be longer thanarms116 orarms114 and116 may have substantially the same length.
• The bottom surface of web[0037]110 (i.e., the surface confronting the patient's skin) includes anadhesive layer120 for adhering dressing100 to the patient's skin in the region surrounding puncture wound14.Adhesive layer120 may entirely coat the bottom surface ofweb110. Alternatively,adhesive layer120 may be applied only in discrete regions of the bottom surface ofweb110 such that the portion ofweb110adjacent bladder102 is held tightly against the patient's skin. Moreover, as noted above,adhesive layer120 may be used to adhereupper wall104 ofbladder102 toattachment web110, such as shown in FIGS. 4 and 5. A removableprotective sheet130 may coveradhesive layer120 during shipping and handling. As explained below,protective sheet130 is removed from dressing100 prior to its use.
• A[0038]mechanism140 for inflatingbladder102 is provided on theupper wall104 of the bladder.Mechanism140 includes atube142 having one end connected toupper wall104 by aconnector144 and communicating with the interior ofbladder102 through anaperture146 inupper wall104. A one-way valve assembly148 is connected to the other end oftube142. Any known inflation mechanism may be used to inflatebladder102. One such inflation device is a squeeze bulb, such assqueeze bulb150 shown in FIG. 6, which may be connected tomechanism140 throughvalve assembly148. Other inflation mechanisms include, but are not limited to, compressed air canisters, a centralized source of air distributed through the wall or ceiling, or a gas generated through a chemical reaction withinbladder102, such as by crushing chemical-containing vials, etc. Alternatively,bladder102 may be inflated by a fluid, such as saline, in order to provide weight to the dressing and reduce the compressibility of the inflated bladder.
• The application of compression dressing[0039]100 to a patient and the operation thereof will now be described with particular reference to FIGS.6-8. Afterprotective sheet130 has been removed and beforebladder102 is inflated, the dressing100 is applied so thatadhesive layer120 contacts the skin of the patient, and so thatbladder102 is positioned over or just upstream of puncture wound14.Squeeze bulb150 or another inflation device may then be used to inflatebladder102 to a desired pressure. Sinceupper wall104 resists deformation asbladder102 is inflated, as the inflation material fillsinternal region108 ofbladder102,membrane106 will be pushed away fromupper wall104 and toward the patient's skin. As this occurs, theadhesive layer120 onweb110 holdsbladder102 in tight relationship against the skin of the patient. As a result, the inflation ofbladder102 causes the patient's skin and underlying tissue and artery to be compressed, thereby stanching the flow of blood through the tissue below.
• [0040]Dressing100 may be used with or without an initial period of manual compression. In that regard, manual compression may initially be applied to the wound site to achieve hemostasis before application ofdressing100. After hemostasis has been achieved, dressing100 may be applied andbladder102 inflated. Alternatively, manual compression may be performed directly over dressing100 after its application to the patient but before it has been inflated. In a further variant, manual compression may be performed directly over dressing100 subsequent to inflation ofbladder102. In this regard,membrane106 may be formed with a shape which will facilitate the ease of applying this compression. In all of these methods, once manual compression has been completed, theinflated bladder102 would continue to maintain pressure on the puncture wound to maintain hemostasis.
• An alternate embodiment of a dressing in accordance with the present invention is illustrated as dressing[0041]200 in FIG. 9. Dressing200 is substantially the same as dressing100 described above, but differs in the shape of the deformable membrane and in the method of securing the bladder to the attachment web. Thus, dressing200 includes adeformable membrane206 which is more rounded thanmembrane106, eliminating any sharp corners or edges which could cause discomfort for the patient. Also, dressing200 includes a first layer of adhesive220 which substantially coats one surface ofattachment web210 and adheresbladder202 to the web, and a second layer of adhesive280 which covers the peripheral edge ofmembrane206 in the region in which the membrane is connected toupper wall204. With this arrangement, the outer edges ofupper wall204 andmembrane206 are encased within adhesive so that no free edges are exposed to the patient's skin. It will be appreciated that the same effect can be achieved withoutadhesive layer280 having the same outward extent asadhesive layer220, or withoutadhesive layer220 having the same outward extent asadhesive layer280.
• Variants of[0042]dressings100 and200 will be readily apparent to those skilled in the art. For example, rather than having the attachment web adhesively secured to the patient's skin,arms116 of the web may be formed with sufficient length that they can extend around the patient's leg and connect to one another, such as by tying, clasps, hook and loop fasteners, etc. Alternatively, the bladder may be secured to a patient's leg by a belt, strap or other device positioned over or operatively connected to the upper wall thereof.
• Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as set forth in the appended claims.[0043]

Claims (17)

1. A dressing for applying compression to a wound in a patient, comprising:

an inflatable bladder having a non-deformable end wall and a deformable membrane connected to said end wall so as to define an enclosed space therebetween, said bladder having a deflated condition in which said membrane is adjacent said end wall and an inflated condition in which said membrane is spaced from said end wall; and

holding means for holding said bladder against the skin of the patient in a position substantially overlying the wound.

2. The dressing as claimed inclaim 1, wherein said holding means includes a flexible web connected to said end wall of said bladder and projecting outwardly therefrom.

3. The dressing as claimed inclaim 2, wherein said flexible web extends radially outward in all directions from said bladder.

4. The dressing as claimed inclaim 2, further comprising a layer of adhesive on one surface of said flexible web for adhering said flexible web to the skin of the patient.

5. The dressing as claimed inclaim 1, wherein said bladder in said inflated condition decreases in size in a direction away from said end wall.

6. The dressing as claimed inclaim 5, wherein said bladder in said inflated condition has a frusto-conical or frusto-pyramidal shape.

7. The dressing as claimed inclaim 1, wherein said end wall is formed from a rigid material.

8. The dressing as claimed inclaim 1, wherein said end wall is formed from plastic.

9. The dressing as claimed inclaim 1, wherein said end wall is transparent.

10. The dressing as claimed inclaim 1, wherein said end wall and said deformable membrane are formed from the same material.

11. The dressing as claimed inclaim 10, wherein said end wall and said deformable membrane are molded integrally with one another.

12. A method of applying compression to a wound in a patient, the method comprising:

providing a dressing including an inflatable bladder having a non-deformable end wall and a deformable membrane connected to the end wall so as to define an enclosed space therebetween;

holding the dressing against the skin of the patient in a position substantially overlying the wound; and

inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound to reduce the flow of blood from the wound.

13. The method as claimed inclaim 12, wherein the holding step includes providing a flexible web connected to the end wall of the bladder, the flexible web having a layer of adhesive on one surface thereof, and adhering the flexible web to the skin of the patient.

14. The method as claimed inclaim 12, wherein the bladder in the inflated condition decreases in size in a direction away from the end wall.

15. The method as claimed inclaim 14, wherein the bladder in the inflated condition has a frusto-conical or frusto-pyramidal shape.

16. The method as claimed inclaim 12, wherein the providing step includes providing the dressing so that the end wall and the deformable membrane are formed from the same material.

17. The method as claimed inclaim 16, wherein the providing step includes providing the dressing so that the end wall and the deformable membrane are molded integrally with one another.

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