Patent Publication Number: US-2022233268-A1

Title: Disposable radial access catheterization sleeve

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 13/273,796, filed on Oct. 14, 2011, which claims priority from U.S. Provisional Appl. No. 61/394,815 filed on Oct. 20, 2010. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to a disposable sleeve that can be used to provide sterility during a surgical procedure in which a blood vessel in a patient&#39;s arm or wrist is accessed. 
     2. Description of the Related Art 
     Cardiac catheterization is a medical procedure that inserts a catheter into a blood vessel at a location spaced from the heart. The catheter then is advanced through the blood vessel to a location near the heart and is used to guide surgical tools or prosthetic components into the region of the heart. For example, cardiac catheterization may be used to repair a damaged section of the blood vessel or a damaged valve or to implant a graft or stent. 
     For many years, cardiac catheterization was carried out by accessing the femoral artery in a portion of the thigh near the groin. More recently, cardiac catheterization has been carried out by accessing a blood vessel in the wrist or forearm. Cardiac catheterization that accesses a blood vessel in the wrist area generally is referred to as radial access catheterization. Catheterization that accesses a blood vessel closer to the elbow area of the forearm generally is referred to as brachial catheterization. 
     A patient typically is lying prone on an operating table during a radial or brachial access catheterization procedure. The arm that will be accessed is supported on a lateral extension of the operating table. Thus, doctors and other medical personnel who will be involved in the procedure will be on the side of the patient with the arm that will be accessed and in proximity to the arm during the procedure. 
     Sterility is extremely important during all invasive medical procedures. Medical personnel performing the procedure take steps to scrub and/or cover parts of their body. Areas of the patient near the access or entity site must be sterilized and must be isolated from parts of the patient that are not sterilized. Areas near the entry site are likely to be shaved, scrubbed and wiped with an antiseptic solution. Sterile sheets or drapes then are placed over other areas of the patient and are taped or otherwise secured to the patient to ensure that non-sterile areas of the patient do not adversely affect areas near the entry side that have been cleaned. 
     Cardiac catheterization that accesses the femoral artery will sterilize areas near the access site in the upper thigh or groin area. Sterile surgical drapes then will be positioned on the operating table and over the patient to cover the torso, the leg that is not being accessed and the lower part of the leg that is being accessed. These drapes are secured to the patient and areas of these sterile surgical drapes that extend beyond the patient can be positioned conveniently on the operating table in a manner that will not interfere with the doctor and other medical personnel. 
     Cardiac catheterization that enters the blood vessel in the patient&#39;s forearm typically has utilized the same sterile surgical drapes that are used for cardiac catheterization that accesses the thigh. However, the size and orientation of the extension of the operating table on which the arm is supported and the size and shape of the arm complicates efforts to use traditional sterile surgical drapes. More particularly, the drapes are likely to hang over the sides of the operating table extension on which the arm is supported and are prone to being displaced. Doctors are likely to improvise arrangements of clamps, tapes and the like in efforts to hold the sterile surgical drapes in a position that permit access to the location on the patient where the blood vessel will be entered while also keeping other non-sterile areas of the patient covered and isolated from the site of the surgical entry. A patient who is undergoing cardiac catheterization also typically has a blood oxygen monitor clipped to a finger. The presence of a blood oxygen monitor on a finger of the arm that is being accessed further complicates efforts to maintain sterility at the surgical access site. 
     The subject invention has been developed in view of the above-described problems. 
     SUMMARY OF THE INVENTION 
     The subject invention relates to a disposable sleeve that can be placed over a patient&#39;s arm during radial or brachial access catheterization. The sleeve may be formed from plastic or non-woven fabric that is coated with plastic or other fluid impermeable material. The sleeve preferably has a closed or closable end that will cover the hand of the patient and an open end that will extend to or slightly beyond the shoulder area. Sides of the sleeve may be closed permanently between the opposite ends of the sleeve. Alternatively, one side of the sleeve may define a closable opening, such as an opening that may be closed by an adhesive material. One or more tabs may be provided at or near the open end of the sleeve to facilitate gripping of the sleeve as the sleeve is being positioned over the patient&#39;s arm. The tab also will define areas of the sleeve that will be gripped initially by a health care professional when the sleeve is being removed from its sterile package and will be held by the health care professional during mounting over the patient&#39;s arm. The tab or tabs also can be used for anchoring a sleeve more securely near the shoulder. For example, the tabs can define a convenient location for applying adhesive tape to secure the open end of the sleeve to the shoulder area of the patient or can be engaged by a clamp to secure the open end of the sleeve to structure on or near the operating table. 
     In a particularly preferred embodiment, adhesive may be applied entirely around the open end of the sleeve and/or an open side of the sleeve. The adhesive may be covered by a release lining or layer that can be removed after the sleeve is positioned properly over the arm of the patient. The adhesive enables the health care professional to securely but removably attach the open end of the sleeve directly to the patient&#39;s skin to ensure that sterility will be maintained entirely along the arm of the patient and to maintain proper positioning of the sleeve during the procedure. The adhesive also may be used to secure one region of the sleeve to another region of the sleeve. For example, a strip of adhesive may extend along a free side edge of the sleeve and may be secured to an opposed side area of the sleeve to close the sleeve between the end of the sleeve that will cover the hand and the end of the sleeve that will be near the shoulder. Still further, adhesive may be provided to form a closure around the hand and/or to secure an area of the sleeve near the wrist or forearm to the closure for the hand. 
     The sleeve may further include an oxygen saturation monitor incorporated into the closed end of the sleeve and at a position where the fingers will be located. The oxygen saturation monitor can be clipped or otherwise mounted onto the patient&#39;s finger after the sleeve has been positioned properly over the patient&#39;s arm. Appropriate connections to signal carrying means, such as cables, can be connected to the oxygen saturation monitor at a connection that is accessible from the outside of the sleeve. Thus, the oxygen saturation monitor can be positioned as part of the mounting of the sleeve to obtain sterility during the surgery. 
     Importantly, the sleeve includes at least one area that can be opened selectively to expose the area on the arm that will be catheterized. The opening may be defined by a generally U-shaped cut that extends at least partly through the plastic or plastic coated non-woven fabric to form a flap that can be opened a desired amount to expose the skin of the arm. An adhesive can be applied to the interior surface of the sleeve at locations surrounding the U-shaped cut so that a sleeve can be secured to the skin of the patient generally around the perimeter of the area where the catheter will access the blood vessel. As an alternative, the sleeve can have a single linear cut that permits areas on opposite sides of the cut to be separated from one another for accessing the skin of the patient. The linear cut preferably extends from the area of the wrist to the area of the elbow. Adhesive can be applied to the inner surface of the sleeve on opposite sides of the cut so that the plastic or fabric of the sleeve can be secured to the patient, thereby enhancing sterility at the location where the catheter is inserted into the blood vessel. Still further, the opening may be a generally circular opening covered by a repositionable adhesive-backed flap that can be partly removed from the sleeve for accessing the skin of the patient for catheterization. 
     The sleeve can be packaged and used with a small sterile sheet that can be positioned at least partly over the slit or other access opening in the sleeve. The additional small sterile sheet optionally can be used to limit the size of the access opening in the sleeve. Alternatively, the sleeve can have an extension that functions as a drape for covering areas adjacent to the arm that will be catheterized. 
     The subject invention provides several significant advances over the prior art. More particularly, the invention provides a small neat sterile enclosure that avoids the above-described problems associated with large sterile drapes that must be secured over and attached to the operating table extension for the arm. The absence of drapes hanging from the operating table extension improves safety and efficiency. Additionally, the sleeve of the subject invention will not be dislodged accidentally from the patient, thereby ensuring a highly sterile environment. Furthermore, the sleeve is easy to position by one person and does not require a complex assembly of clamps or the like. 
     The sleeve of the subject invention also is well suited for placement in a small sterile package that can be opened immediately prior to mounting the sleeve. The open end of the sleeve can be collapsed toward the closed end in much the manner of an accordion. The health care professional merely needs to grab the tabs near the open end of the sleeve to remove the sleeve from the package. The closed end of the sleeve then merely is positioned over the patient&#39;s hand and the tabs are pulled toward the shoulder to position the sleeve over the arm of the patient. In other embodiments, the sleeve can have top and bottom panels hingedly connected to one another along eightfold area that extends from the closed end of the sleeve to the open end. The bottom panel can be positioned under the arm of the patient and the top panel can be folded over the arm. Areas of the top and bottom panels opposite the failed area can be secured to one another by adhesive tape. With these and other embodiments described herein, the sleeve can be removed from its package, positioned and mounted on the patient efficiently and quickly. 
     The sleeve is well suited to the size of the area that needs to be protected sterily. There is no need for large sterile drapes, and hence costs remain low. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top plan view of a sleeve in accordance with a first embodiment of the subject invention in a collapsed state. 
         FIG. 2  is a side elevational view of the sleeve in a partly expanded state. 
         FIG. 3  is a top plan view of the sleeve in a fully expanded state. 
         FIG. 4  is a top plan view of a variation of the sleeve of  FIG. 3  in a fully expanded state. 
         FIG. 5  is a cross-sectional view taken along line  5 - 5  in  FIG. 3 . 
         FIG. 6  is a perspective view showing the sleeve during mounting on a patient during a procedure. 
         FIG. 7  is a perspective view showing the sleeve fully mounted on the patient. 
         FIG. 8  is a top plan view of a sleeve in accordance with a second embodiment of the invention. 
         FIG. 9  is a perspective view showing the sleeve of the second embodiment during mounting on a patient. 
         FIG. 10  is a perspective view showing the sleeve of the second embodiment fully mounted on the patient. 
         FIG. 11  is a top plan view of a sleeve in accordance with a variation of the second embodiment. 
         FIG. 12  is a top plan view of a sleeve in accordance with a third embodiment of the invention. 
         FIG. 13  is a perspective view showing the sleeve of the third embodiment during mounting on a patient. 
         FIG. 14  is a perspective view showing the sleeve of the third embodiment fully mounted on the patient. 
         FIG. 15  is a top plan view of a sleeve in accordance with a fourth embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     A radial or brachial access catheterization sleeve in accordance with a first embodiment the subject invention is identified generally by the numeral  10  in  FIGS. 1-3 and 5-7 . The sleeve  10  is formed from a flexible plastic, such as polypropylene, or alternatively from a flexible nonwoven fabric or paper material that is coated with plastic or other fluid impermeable material and may be formed from materials currently used for disposable medical or surgical drapes. The sleeve  10  of the first embodiment has a closed end  12 , an open end  14  and a generally collapsed or collapsible tubular side wall  16  extending between the ends. 
     The sleeve  10  preferably is packaged in a sterile enclosure, such as a poly-paper laminated enclosure (not shown), and will be opened and accessed immediately prior to a procedure in the operating room or other medical facility. For convenient storage, the sleeve is collapsed in a generally accordion shape so that the open end  14  nests on the closed end  12 . The sleeve  10  has an outer surface  18 , as shown most clearly in  FIGS. 3 and 5 , and an opposite inner surface  20 , as shown most clearly in  FIGS. 1 and 5 . With reference to  FIG. 3 , the sleeve  10  has an overall length from the closed end  12  to the open end  14  that will permit the sleeve to extend over the arm of a patient so that the closed end  12  covers the hand of the patient and so that the open end  14  is in proximity to the shoulder  14  of the patient. In a preferred embodiment, the sleeve  10  will have a length of approximately 90 cm. As shown in  FIGS. 1 and 2 , tabs  22  project outwardly from the sleeve  10  in proximity to the open end  14 . The tabs  22  facilitate removal of the sleeve  10  from its container without significant risk of affecting the sterility of the interior surface  20  of the sleeve  10 . 
     An adhesive  24  is provided on the inner surface  20  of the sleeve  10  in proximity to the open end  14  thereof. The adhesive  24  preferably is covered by a release layer or liner  26  that can be removed to expose the adhesive. The adhesive  24  is used to secure areas of the sleeve  10  adjacent the open end  14  to areas of the patient near the shoulder. The adhesive preferably is selected to provide a secure attachment but easy separation from the patient. Such adhesives are well known in the art and are used for securing sterile drapes to patients in other surgical applications. 
     An oxygen sensor  28  (e.g., OSM) preferably is provided in the inner surface  20  of the sleeve  10  adjacent the closed end  12 . A connection means can be provided for connecting the sensor  28  to an appropriate cable so that oxygen levels can be monitored during the medical procedure. 
     The sleeve  10  includes an opening  30  at a position between the closed end  12  and the open end  14 . The opening  30  illustrated in the embodiment of  FIG. 3  extends substantially linearly and substantially parallel to the longitudinal direction of the sleeve  10  from an area  30 R near the wrist to an area  30 B near the elbow for either radial or brachial access. The opening  30  can be defined by a perforation line or other weakened area through the plastic of the sleeve  10 . Alternatively, the opening  30  can be in the form of a releasable and resealable lock, such as the types that are provided on plastic food storage bags. An adhesive  32  is provided in proximity to the opening  30  so that the inner surface  20  of the sleeve  10  can be secured to the skin of the patient near the site where catheterization will take place. The adhesive may initially be covered by a removable release liner that can be removed after the sleeve  10  is placed on the patient  1 . 
       FIG. 4  shows an alternate sleeve  10 A that is identical to the sleeve  10  in most respects. However, the sleeve  10 A has a U-shaped cut  30 A to define a flap that enables access to the patient. 
     The sleeve  10  is employed by telescoping sleeve over the arm of the patient on the operating table and gradually expanding the collapsed sleeve so that the open end  14  can extend toward the shoulder of the patient. Health care personnel then will remove the release liner  26  from the adhesive  24  adjacent the open end  14  and will secure areas of the sleeve adjacent the open end  14  to the areas of the patient near the shoulder. The oxygen sensor  28  then is connected appropriately to a finger of the patient and an external cable is joined to the oxygen sensor  28 . The doctor then separates the plastic of the sleeve  10  at the opening  30  to access the desired area for either radial or brachial catheterization. The  10  sleeve need not be spread open along the entire length of the opening  30 . Rather, the doctor chooses the size needed for the appropriate location to carry out the catheterization. The release liner on the adhesive  32  near the opening  30  can be removed and the adhesive  32  then can be secured to the patient to ensure that the desired location on the patient remains accessible and to maintain sterility of that location. 
     The radial access catheterization sleeve described  10  above has several advantages over the prior art use of conventional sterile surgical drapes. In particular, the sleeve  10  can be mounted quickly and easily onto a patient by one health care professional. The arm of the patient is substantially completely enclosed to ensure sterility during the procedure. The adhesive around the open end  14  of the sleeve  10  facilitates secure releasable attachment to the shoulder area of the patient. Additionally, the size and shape of the sleeve  10  prevents parts of the sleeve  10  from hanging off the operating table extension in a way that could interfere with the doctor or other health care personnel working near the patient. 
     A radial access catheterization sleeve in accordance with a second embodiment of the invention is identified generally by the numeral  110  in  FIGS. 8-10 . The sleeve  110  differs from the sleeve  10  described and illustrated above primarily with respect to the initial configuration prior to mounting on the patient and the method of mounting onto the patient. However, the sleeve  110  has a shape similar to the sleeve  10  after mounting on the patient and has all of the above-described advantages. More particularly, the sleeve  110  initially is a substantially rectangular sheet  112  with opposite first and second side edges  114  and  116 , a proximal edge  118  and a distal edge  120 . The sheet  112  has a length of approximately 90 cm. A strip of adhesive  122  extends adjacent the first side edge  14  and is covered by a removable release liner  124 . An extension  126  extends from the proximal edge  118  beginning at a position approximately 25 cm. from the adhesive strip  122  and continuing for a distance of approximately 60 cm. toward the second side edge  116 . The extension  126  is provided with a layer of adhesive  128  covered by a release liner  130 . A closed mitten  132  extends from the distal edge  120  and has an opening facing toward the proximal edge  118 . The mitten  132  is dimensioned to accommodate a hand. More particularly, the mitten  132  defines a substantially semicircular shape with a radius of approximately 25 cm. A strip of adhesive  134  extends from the mitten  132  along the distal edge  120  toward the second side edge  116 . The adhesive  134  is covered by a release liner  136 . An access opening  138  is formed through the sheet  112  at a location substantially aligned with the extension  126  and the mitten  132 . The access opening  138  in this embodiment is illustrated as being a circle having a diameter of approximately 5 cm. The access opening  138  is covered by a sterile closure  140  that is at least partly removable to provide access through the access opening  138 . First and second fold lines  144  and  146  extend parallel to the first and second side edges  114  and  116  on opposite respective sides of the access opening  138 . 
     The sleeve  110  of the second embodiment is employed by positioning areas of the sleeve between the first side edge  114  and the access opening  138  under the arm of the patient that will be catheterized and with the hand of the patient in the mitten  132 , as shown in  FIG. 9 . The portion of the sheet  112  between the arm of the patient and the second side edge then is folded over the arm of the patient, as shown in  FIG. 9 . The release liners  124 ,  130  and  136  can be removed at this stage. As a result, the adhesive  128  on the extension  126  from the proximal end  118  can be removably engaged with the skin of the patient at locations near the shoulder. The adhesive  134  adjacent the proximal edge  120  can be secured to the outer surface of the mitten  132 . Additionally, portions of the sheet  112  near the second side edge  116  can be secured to the adhesive  122  adjacent the first side edge  114 . The properly mounted sleeve  110  then is used substantially in the same manner as the sleeve  10  of the previous embodiment. 
     A variation of the sleeve  110  is illustrated in  FIG. 11  and is identified by the numeral  110 A. The sleeve  110 A is identical to the sleeve  110  in most respects. However, the sleeve  110 A has two access openings  138 A for providing access to optional catheterization sites in the arm of the patient. 
     A third embodiment of the invention is identified generally by the reference numeral  210  in  FIGS. 12-14 . The sleeve  210  is similar to the sleeve  110  described and illustrated above. However, the sleeve  210  does not have a preformed mitten. More particularly, the sleeve  210  is formed from a generally rectangular sheet  212  having opposite first and second side edges  214  and  216 , a proximal edge  218  and a distal edge  220 . First and second longitudinally extending fold lines  222  and  224  extend substantially parallel to the first and second side edges  214  and  216 . The first fold line  222  is spaced from the first side edge  214  by approximately 60 cm. and a bottom panel  226  is defined between the first side edge  214  and the first fold line  222 . The first and second fold lines  222  and  224  are spaced from one another by approximately 60 cm and define a top panel  228  therebetween. A small surgical drape panel  230  extends from the second fold line  224  to the second side edge  216 . An access opening  230  is formed in the top panel  228  substantially as described with respect to the previous embodiments. More particularly, the access opening  230  may be covered by a releasable panel and may be surrounded at least partly by an adhesive that can be secured to the skin of the patient at areas surrounding the location of catheterization. Bottom and top semicircular extensions  236  and  238  extend from the distal edge  220  at locations aligned respectively with the bottom and top panels  226  and  228 . The semicircular extensions  236  and  238  each have a radius of approximately 25 cm. A strip of adhesive  240  extends adjacent the first side edge  214  and is covered by a release liner  242 . An extension  244  extends proximally from the top panel  228  and has a layer of adhesive  246  covered by a release liner  248  thereon. Additionally, a layer of adhesive  250  covered by a release liner  252  extends around the curved edge of the semicircular top extension  238 . 
     The sleeve  210  is used in a manner similar to the sleeve  110  described above. More particularly, the bottom panel  226  is positioned below the arm of the patient as shown in  FIG. 13 . The top panel  228  then is rotated about the fold line  222  to cover the arm of the patient. The release liners  242 ,  248  and  252  then are removed to expose the adhesive  240 ,  246  and  250 . The adhesive  246  on the extension from the top panel  228  is secured directly to the skin of the patient near the shoulder. The adhesive  250  on the top semicircular extension is secured to the bottom semicircular extension  236  to form the mitten that encloses the hand of the patient. Areas of the top panel  228  near the fold area  224  then are secured to the adhesive  240  that extends adjacent to the first side edge  214 . 
     A sleeve in accordance with a fourth embodiment of the invention is identified generally by the reference numeral  310  in  FIG. 15 . The sleeve  310  includes a rectangular sheet  312  having first and second side edges  314  and  316 , a proximal edge  318  and a distal edge  320 . A fold line  322  extends the length of the sheet  312  from the proximal edge  318  to the distal edge  320  and is aligned substantially parallel to the side edges  314  and  316 . Thus, a bottom panel  324  is defined between the first side edge  314  and the fold line  322 , and a top panel  326  is defined between the fold line  322  and the second side edge  316 . An adhesive strip  328  covered by a release liner  330  extends substantially along the second side edge  316 . Additionally, a distal adhesive strip  332  covered by a release liner  334  extends along portions of the distal edge  320  aligned with the top panel  326 . An access opening  336  is formed in the top panel  326  approximately centrally between the fold area  322  and the second side edge  316 . The access opening  336  is closer to the distal edge  325  than the proximal edge  318 , and preferably is about 10 inches from the proximal edge  320 . 
     The sleeve  310  is used in a manner similar to the sleeves  110  and  210  described above. More particularly, the bottom panel  324  is positioned under the arm of the patient as shown in  FIG. 16 . The top panel  326  then is folded about the fold area  322 . The release liners  330  and  334  can be removed so that the adhesive  332  adjacent the distal edge  320  can be secured to areas of the bottom panel  324  adjacent the distal edge  320 . Similarly, the adhesive  328  can be secured to areas of the bottom panel  324  substantially adjacent the first side edge  314 . With this arrangement, the access opening  336  is positioned adjacent the desired catheterization location on the arm of the patient, as shown most clearly in  FIG. 17 . 
     The above-described embodiments are one examples of the disposable radial or brachial access catheterization sleeve in accordance with the invention. Openings of different sizes or shapes can be provided in addition to the alternates illustrated herein. Other means for closing the openings also can be provided. Additionally, the oxygen saturation monitor can be omitted in certain less preferred embodiments. The proximal edge of the sleeve is configured as being aligned perpendicular to a longitudinal direction of the sleeve. However, the proximal end can be aligned at an acute angle to the longitudinal direction to nest more securely at the shoulder of the patient. Although only one sleeve is illustrated, sleeves may come in a plurality of different sizes. Furthermore, the sleeve can be packaged with and used with a small sterile sheet that can be used to reduce the size of the opening in the sleeve.