AU2007201004B2 - Device and method for compressing wounds - Google Patents

Description

AUSTRALIA

Patents Act COMPLETE SPECIFICATION

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority Related Art: Name of Applicant: Datascope Investment Corporation Actual Inventor(s): James S. Bates, John P. Budris Address for Service and Correspondence: PHILLIPS ORMONDE FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Melbourne 3000 AUSTRALIA Invention Title: DEVICE AND METHOD FOR COMPRESSING WOUNDS Our Ref: 795885 POF Code: 1421/324284 The following statement is a full description of this invention, including the best method of performing it known to applicant(s): -1- SO6q 2 DEVICE AND METHOD FOR COMPRESSING WOUNDS The present application is a divisional application from Australian patent application number 2003226013, the entire disclosure of which is incorporated herein by reference.

Technical Field 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.

A reference herein to a patent document or other matter which is given as prior art is not to be taken as an admission that that document or matter was, in Australia, known or that the information it contains was part of the common general knowledge as at the priority date of any of the claims.

Backqround Art 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.

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 P.\Use BelnREH\72e613\72613 DIV.doc confidence that when it emerges from the distal end it will be within the lumen 0 of the artery.

SAfter 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 N must be immobilized, lest movement interfere with the closing process.

Because of the pressure required, the time during which it must be applied and c 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.

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 staunch bleeding or reduce hematomas following biopsies, ambulatory dialysis, insertion of intravenous needles, emergency procedures and other such situations.

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 one of more of the drawbacks of devices known to the Applicant.

Summary of the Invention According to the present invention, there is provided a method of applying compression to a wound in a patient, the method including: Y:BE79g5885XSped Amondts_27JanO.doc providing a dressing including an inflatable bladder having a deformable membrane defining a cavity having an open end, and a substantially nondeformable member connected to the open end so as to define an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying manual pressure to the dressing against the skin of the patient in a position substantially overlying the wound for a time sufficient to achieve hemostasis of the wound; and then inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound to maintain the hemostasis of the wound.

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.

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.

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.

According to the present invention, there is also provided a method of applying compression to a wound in a patient, the method including: providing a dressing including an inflatable bladder having a deformable membrane defining a cavity having an open end, and a substantially nondeformable member connected to the open and so as to define an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying the dressing against the skin of the patient in a position substantially overlying the wound; inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound; and then applying manual pressure to the dressing against the skin of the patient for a time sufficient to achieve hemostasis of the wound.

According to the present invention, there is further provided a method of applying compression to a wound in a patient, the method including: applying manual pressure to the wound for a time sufficient to achieve hemostasis of the wound; providing a dressing including an inflatable bladder Y :BE' 79585kSpoc Amendts.27Jan00 doc including a deformable membrane defining a cavity having an open end, and a N substantially non-deformable member connected to the open and so as to Sdefine an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying 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 maintain the hemostasis of the wound.

Compression methods according to embodiments of the present N invention can reduce the time in which health care professionals must exert manual compression to a wound, while at the same time increasing patient Smobility and comfort.

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: Figure 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; Figure 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; Figure 3 is a top plan view of the compression dressing of Fig. 2; Figure 4 is a cross-sectional view of the compression dressing and showing the bladder in a deflated condition; Figure 5 is the same view as Fig. 4, but showing the bladder in an inflated condition; Figure 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; YABEK705885ASpei Amendts 2lJanO9.doc

I

Figure 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; Figure 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 Figure 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.

Detailed Description of the Drawings In certain procedures, for example, intra-aortic balloon pumping percutaneous transluminal coronary angioplasty ("PTCA") and angiography, as best seen in Fig. 1, a catheter or other device 10 is inserted through a puncture wound 14 and into a blood vessel or artery 16, most frequently, the common femoral artery in the groin area of the patient's leg Puncture wound 14 includes a tissue channel extending through a layer of tissue separating artery 16 from the patient's skin. Often, the insertion of device 10 is facilitated by passing the device over a guide wire 22 and through a guide cannula 24. When the procedure counterpulsation) has been completed, the device 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.

Similarly, the subject invention is independent of whether a particular blood vessel is involved, and if so, which blood vessel. While it is anticipated P:\Use ridBEla3BH72613\7261 3 DIV.doC 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.

A compression dressing 100 for use in sealing puncture wound 14 is shown in Figs. 2 and 3. Dressing 100 includes an expandable bladder 102 having an upper wall 104 and a lower membrane 106 enclosing an internal region 108. Upper wall 104 is formed from a material that will resist substantial deformation at the pressure to which bladder 102 is inflated during normal use.

Thus, for example, upper wall 104 may be formed from a rigid plastic material, a rigid metal or some other relatively rigid material. Preferably, upper wall 104 is formed from a transparent plastic disc so that the inflation of bladder 102 and any leakage of blood from puncture wound 14 can be readily observed therethrough.

In contrast, membrane 106 is formed from a pliant, air-impermeable material such that membrane 106 will deform upon inflation of bladder 102. In one arrangement, membrane 106 may be formed from the same material as upper wall 104. For example, in a one-piece molding operation, upper wall 104 may be formed with a relatively thick cross-section such that it will not substantially deform at the pressures to which bladder 102 is inflated during use, and membrane 106 may be formed with a relatively this cross-section such that it will readily deform upon inflation of bladder 102. Alternatively, upper wall 104 and membrane 106 may be formed from different materials altogether.

Bladder 102 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, membrane 106 has a shape such that the inflated bladder 102 will taper from a larger size to a smaller size in the direction toward the patient. For example, in the inflated state, bladder 102 may have the shape of an inverted pyramid or cone. Such shapes will concentrate the pressure exerted by compression dressing 100 on a localized region of the patient, desirably a region overlying the wounded artery. Bladder 102 in the inflated condition may alternatively have a frusto-pyramidal or frustoconical shape, thereby avoiding any pain to the patient which may result from having the inflated point of bladder 102 forced against the patient's skin. Other P uebeindabEH\728813726813-DIVdoc shapes are also contemplated herein. Moreover, it will be appreciated that by varying the wall thickness and shape of membrane 106, various levels of force and conformity with the contour of the patient's skin may be achieved.

Membrane 106 may be treated with an anti-bacterial coating in order to minimize the occurrence of infections in puncture wound 14 resulting from the use of compression dressing 100. In addition, membrane 106 may be treated with any number of materials known to those skilled in the art to aid in the healing of puncture wound 14 or to reduce pain or complications.

Bladder 102 is secured to the lower surface of an attachment web 110.

Web 110 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 of bladder 102 to web 110 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 of bladder 102 are encased within one or more layers of adhesive as discussed below in connection with Fig. 9. An aperture 112 may be formed in web 110 in a region overlying upper wall 104. Aperture 112 may enable substantially the entirety of bladder 102 to be seen through web 110 to assure proper placement and operation of compression dressing 100.

Web 110 may extend outwardly from bladder 102 in all directions so as to define a continuous region around bladder 102 by which dressing 100 may be attached to the patient's leg. However, web 110 need not extend outwardly from bladder 102 by equal amounts in all directions. Thus, as shown in Fig. 2, web 110 may include substantially perpendicular arms 114 and 116 which extend radially outwardly from bladder 102 by a greater extent than the remainder of web 110. Although Fig. 2 shows arms 114 as shorter than arms 116, that is not necessarily the case; arms 114 may be longer than arms 116 or arms 114 and 116 may have substantially the same length.

The bottom surface of web 110 the surface confronting the patient's skin) includes an adhesive layer 120 for adhering dressing 100 to the patient's skin in the region surrounding the puncture wound 14. Adhesive layer 120 may entirely coat the bottom surface of web 110. Alternatively, adhesive layer 120 may be applied only in discrete regions of the bottom surface of web P UseIBe\bnaEH726813726813 DIV doC 9 110 such that the portion of web 110 adjacent bladder 102 is held tightly against the patient's skin. Moreover, as noted above, adhesive layer 120 may be used to adhere upper wall 104 of bladder 102 to attachment web 110, such as shown in Figures 4 and 5. A removable protective sheet 130 may cover adhesive layer 120 during shipping and handling. As explained below, protective sheet 130 is removed from dressing 100 prior to its use.

A mechanism 140 for inflating bladder 102 is provided on the upper wall 104 of the bladder. Mechanism 140 includes a tube 142 having one end Cconnected to upper wall 104 by a connector 144 and communicating with the interior of bladder 102 through an aperture 146 in upper wall 104. A one-way valve assembly 148 is connected to the other end of tube 142. Any known inflation mechanism may be used to inflate bladder 102. One such inflation device is a squeeze bulb, such as squeeze bulb 150 shown in Fig. 6, which may be connected to mechanism 140 through valve assembly 148. 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 within bladder 102, such as by crushing chemical-containing vials, etc. Alternatively, bladder 102 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 100 to a patient and the operation thereof will now be described with particular reference to Figures 6- 8. After protective sheet 130 has been removed and before bladder 102 is inflated, the dressing 100 is applied so that adhesive layer 120 contacts the skin of the patient, and so that bladder 102 is positioned over or just upstream of puncture wound 14. Squeeze bulb 150 or another inflation device may then be used to inflate bladder 102 to a desire pressure. Since upper wall 104 resists deformation as bladder 102 is inflated, as the inflation material fills internal region 108 of bladder 102, membrane 106 will be pushed away from upper wall 104 and toward the patient's skin. As this occurs, the adhesive layer 120 on web 110 holds bladder 102 in tight relationship against the skin of the patient. As a result, the inflation of bladder 102 causes the patient's skin and underlying tissue and artery to be compressed, thereby stanching the flow of blood through the tissue below.

P\srBl J\EA2837el DIV cloc Dressing 100 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 of dressing 100. After hemostasis has been achieved, dressing 100 may be applied and bladder 102 inflated. Alternatively, manual compression may be performed directly over dressing 100 after its application to the patient but before it has been inflated.

In a further variant, manual compression may be performed directly over dressing 100 subsequent to inflation of bladder 102. In this regard, membrane 106 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, the inflated bladder 102 would continue to maintain pressure on the puncture wound to maintain hemostasis.

An alternative embodiment of a dressing is illustrated as dressing 200 in Fig. 9. Dressing 200 is substantially the same as dressing 100 described above, but differs in the shape of the deformable membrane and in the method of securing the bladder to the attachment web. Thus, dressing 200 includes a deformable membrane 206 which is more rounded than membrane 106, eliminating any sharp corners or edges which could cause discomfort for the patient. Also, dressing 200 includes a first layer of adhesive 220 which substantially coats one surface of attachment web 210 and adheres bladder 202 to the web, and a second layer of adhesive 280 which covers the peripheral edge of membrane 206 in the region in which the membrane is connected to upper wall 204. With this arrangement, the outer edges of upper wall 204 and membrane 206 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 without adhesive layer 280 having the same outward extent as adhesive layer 220, or without adhesive layer 220 having the same outward extent as adhesive layer 280.

Variants of dressings 100 and 200 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, arms 116 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 P:\UserBei aBE-72O813\726813 DIV.doC 11 other device positioned over or operatively connected to the upper wall thereof.

SAlthough 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 Sdeparting from the spirit and scope of the present invention as set forth in the Sappended claims.

Industrial Applicabilit SThe dressing of the present invention enables compression to be applied to wounds in patients without the constant attention of medical personnel.

Throughout the description and claims of this specification the word "comprise" and variations of that word, such as "comprises" and "comprising", are not intended to exclude other additives or components or integers.

PUserBseinaBEK726813\7213l DIV.dom

Claims (9)

1. A method of applying compression to a wound in a patient, the method including: providing a dressing including an inflatable bladder having a deformable membrane defining a cavity having an open end, and a substantially non- deformable member connected to the open end so as to define an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying manual pressure to the dressing against the skin of the patient in a position substantially overlying the wound for a time sufficient to achieve hemostasis of the wound; and then inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound to maintain the hemostasis of the wound.

2. The method as claimed in claim 1, further including providing a flexible web connected to the substantially non-deformable member 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.

3. The method as claimed in claim 1 or 2, wherein the bladder in the inflated condition decreases in size in a direction away from the substantially non-deformable member.

4. The method as claimed in claim 3, wherein the bladder in the inflated condition has a frusto-conical or frusto-pyramidal shape.

5. The method as claimed in any one of claims 1 to 4, wherein the step of providing a dressing includes providing the dressing so that the substantially non-deformable member and the deformable membrane are formed from the same material. YIBEM7g588$Spd A-sdts27J-09doc

6. The method as claimed in claim 5, wherein the step of providing the Sdressing includes providing the dressing so that the substantially non- Sdeformable member and the deformable membrane are molded integrally with one another.

7. A method of applying compression to a wound in a patient, the method including: providing a dressing including an inflatable bladder having a deformable membrane defining a cavity having an open end, and a substantially non- cN deformable member connected to the open and so as to define an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying the dressing against the skin of the patient in a position substantially overlying the wound; inflating the bladder to an inflated condition, whereby the inflated bladder exerts pressure on the wound; and then applying manual pressure to the dressing against the skin of the patient for a time sufficient to achieve hemostasis of the wound.

8. A method of applying compression to a wound in a patient, the method including: applying manual pressure to the wound for a time sufficient to achieve hemostasis of the wound; providing a dressing including a deformable membrane defining a cavity having an open end, and a substantially non-deformable member connected to the open and so as to define an enclosed space in the bladder between the deformable membrane and the substantially non-deformable member; applying 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 maintain the hemostasis of the wound. Y:\BEMH705885Sp.cd Amondts_27JanOg doc 14

9. A method according to any one of the embodiments substantially as herein described. Y .BEHM7g5SP- A w1186 27Jan09 dOC