Abstract:
An instrument for achieving rapid hemostasis at the conclusion of a catheterization procedure comprising a hemostatic agent injection device for use with a conventional introducer sheath used to gain access to the blood vessel. The injection device includes an elongated tubular member having ejection ports proximate its distal end. A hub member includes an elongated groove or track located in its surface with a transparent cover. The enclosed track is sealed from the lumen extending through the tubular member with a compliant membrane and filled with a predetermined amount of fluid. After the catheterization procedure, the device is inserted into the introducer sheath. Blood flows into the lumen of the device and pulsates against the compliant membrane. The fluid in the track pulsates within the enclosed track, clearly indicating that the ports are located in the blood vessel and subjected to variations in blood pressure. The instrument and introducer sheath are then slowly retracted as a unit in the puncture wound. The blood flow will stop pulsating against the compliant membrane when the ports have exited the blood vessel wall. A hemostatic agent is then injected by the instrument adjacent the vessel wall.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application is a continuation-in-part of application Ser. No. 08/800,047, filed Feb. 14, 1997, now U.S. Pat. No. 5,855,559 and assigned to the same assignee. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to a surgical device which is used in catheterization procedures, and more particularly, to a device with a pressure sensing feature used to inject a hemostatic agent at the end of the catheterization procedure. 
     DISCUSSION OF THE PRIOR ART 
     In a percutaneous intravascular procedure, such as performing an angioplasty or angiography, access to the vascular space is generally obtained by using the so called Seldinger technique. In this technique, a hollow needle is used to create a puncture wound through the skin, the underlaying muscle tissue and through the wall of selected blood vessel, such as the femoral artery. Next, a guide wire is inserted through the tubular needle until its distal end is located in the blood vessel. The needle is then removed from the guide wire and replaced with an introducer sheath and dilator. The introducer sheath typically will include a self-sealing hemostatic valve on its proximal end. The guide wire is then advanced into the vascular space through the introducer and directed to a preselected area of the vascular system. Once the guide wire is positioned, a catheter, such as a balloon catheter in the case of a balloon angioplasty procedure, is advanced over the guide wire until the balloon is at a selected location, such as a stenosis in a coronary artery. 
     At the conclusion of the procedure, when the catheter, guide wire and introducer sheath are removed from the puncture site there may be profuse bleeding, hematoma or dissections, especially where the patient has been on an anticoagulant therapy, such as heparin, coumadin, aspirin or alpha, beta II  blockade thrombolytic agent. Manual pressure may have to be applied for a prolonged time period to obtain hemostasis. So as to not unduly tie-up trained medical personnel, an external vascular clamp, sand bags or a pressure dressing may be used to apply pressure to the puncture site to help ensure satisfactory, permanent hemostasis. 
     Prior art methods have addressed the problem of achieving hemostasis following removal of a percutaneously applied intravascular introducer in such uses as angiography or angioplasty. The Makower et al. U.S. Pat. No. 5,290,310 describes a device for delivering a hemostatic substance subcutaneously against a penetration site in the wall of a blood vessel. An instrument containing a toroidal-shaped collagen plug within a barrel thereof is made to surround the exterior of the tubular introducer. The instrument includes a pusher mechanism for injecting the collagen plug into the puncture wound and against the exterior wall of the blood vessel at the site of the puncture. 
     The Weldon et al. U.S. Pat. No. 5,129,882 also discloses a surgical implement for injecting a hemostatic agent in a puncture wound by routing the injection device through the lumen of the introducer sheath after it has been retracted sufficiently so that the distal end thereof is no longer in the blood vessel. Then, by deploying a plunger, the hemostatic agent is forced out of the instrument and against the exterior wall of the artery proximate the puncture wound. 
     U.S. Pat. Nos. 4,744,364, 4,852,974, 4,890,612, 5,021,059 and 5,222,974, issued to Kenneth Kensey, each describe a method and apparatus for effecting hemostasis by first inserting an anchoring device through the puncture wound and into the blood vessel while using a filament attached to the anchoring device to hold it in place as an appropriate sealant is injected into the wound. The anchoring device prevents entrance of the sealing material into the blood vessel and serves as anchor and guide for addressing selected vessels. 
     U.S. Pat. No. 5,676,689 to Kensey et al discloses another system for sealing percutaneous puncture in a blood vessel. The system includes a hemostatic closure device, a blood vessel locator device for determining the position of the blood vessel and a deployment instrument for deploying the closure device within the puncture to seal it. The blood vessel locator device is tubular with a port at a distal end and valve at a proximal end. When the distal end is positioned within a blood vessel, blood will enter the port and flow out of the valve, thus enabling the physician to determine whether or not the locator distal end is positioned within the blood vessel. 
     Other devices for injecting a hemostatic agent into a puncture wound following a vascular procedure include the Arias et al. U.S. Pat. No. 5,281,197, the Haaga U.S. Pat. No. 4,838,280, the Fowler U.S. Pat. No. 5,192,300, the Magro et al. U.S. Pat. No. 4,738,658 and published European Patent Application 0 476 178 A1 of Bioplex Medical, B. V. Furthermore, pending application Ser. No. 08/629,022, of which some of the present inventors are named as co-inventors, addresses the problem by providing a self-contained assembly of a combined introducer sheath, introducer dilator and a device for effecting hemostasis following a vascular procedure. 
     For the most part, these references describe devices that are intended to be used in combination with the tubular introducer sheath for deploying a hemostatic agent following withdrawal of any guide wire, guide catheter or working catheter at the conclusion of the procedure. These devices require significant skill in their use to preclude potential complications occasioned by unwanted placement of the hemostatic agent within the blood vessel itself. 
     A need exists for a device for effecting hemostasis following a vascular procedure which can be inserted into the introducer sheath and which will indicate whether its ejection port is within the blood vessel. In our earlier design described in the aforereferenced application, we depended on a flash of blood flowing into a transparent tube to indicate that the ejection ports on the combined introducer and hemostatic injection device were exterior to the blood vessel. When the device of the present invention indicates that the ejection ports are outside the blood vessel, the hemostatic agent can then be injected into a lumen of the device leading to the ejection ports on the device at a location proximate the outer wall of the blood vessel to be sealed. Such a device effectively insures that the hemostatic agent will not be injected into the blood vessel. 
     While the prior art has included catheters with pressure sensing devices, such as the Brooks U.S. Pat. No. 4,809,709, Griffin et al. U.S. Pat. No. 4,878,898, Miller U.S. Pat. No. 4,901,731 , Frank U.S. Pat. No. 4,924,872 and the Goodin et al. U.S. Pat. No. 4,928,693, no provision has been made in these devices for injecting a hemostatic fluid nor do they describe a pressure indicator that comprises a pulsation type micro-manometer. 
     SUMMARY OF THE INVENTION 
     The present invention is a device for sealing percutaneous punctures in a blood vessel that is used in conjunction with a tubular introducer sheath having a distal end insertable into a wound resulting from a percutaneous puncture in a blood vessel wall. The device consists of an elongated tubular member having a hub member on its proximal end and a soft tip and ports proximate its distal end. The elongated tubular member has a lumen extending therethrough. The lumen is closed at its distal end and its proximal end terminates at a hemostatic seal in the hub. 
     The hub member also includes an elongated grooved track formed on its outer surface. A transparent member overlays the grooved track and cooperates with the groove to form a sealed fluid tight track. The transverse bore extends from a first end of the grooved track to the lumen of the tubular member. A second transverse bore extends from the second end of the grooved track to a fluid tight air compression chamber. This chamber may be formed on the exterior surface of the hub member or it may be formed in the hub member between the outer surface and the lumen of the tubular member. If the chamber is formed on the outer surface, the transparent member overlays this also to form a sealed fluid tight chamber. In an alternative embodiment of the hub member, a compliant membrane seals the first transverse bore from the lumen of the tubular member and a predetermined volume of fluid partially fills the sealed track. 
     The tubular member is sized so that it fits within the lumen of the introducer sheath with the soft distal tip and ports extending out of the distal end of the sheath into the blood vessel. The plurality of ports are in fluid communication with the first lumen. 
     The device is used following the conclusion of the catheterization procedure. The catheter and guide wire are removed leaving the tubular introducer sheath with its proximal end extending outside the puncture and the distal end extending through the puncture in the vessel wall with its distal end open into the vessel. The distal end of the tubular member is inserted into the sheath with the hub of the sealing device remaining proximate the proximal end of the tubular introducer sheath. 
     As the distal end of the sealing device exits the introducer and enters the vessel, blood enters the lumen and sealed track, pulsating against the air trapped ahead of it. Likewise, with the alternative embodiment, the blood enters the lumen and pulsates against the compliant membrane. This causes the fluid located within the track to oscillate but stop once the air trapped ahead of the fluid in the sealed grooved track and compression chamber reaches equilibrium with the blood pressure. As blood pressure changes from systolic pressure to diastolic pressure, the fluid or blood pulsates back and forth in the track. Because of the transparent overlay, the pulsating fluid or blood is highly visible, thus operating as a micro-manometer. 
     The sheath and the sealing device are then slowly retracted as a unit. The visible oscillating movement of fluid or blood in the grooved track stops as soon as the distal end of the second lumen leaves the blood vessel. At that time, a hemostatic agent is injected via a syringe into the first lumen of the tubular member through a valve on the hub. The hemostatic agent then exits the ports to deposit a predetermined quantity thereof into the puncture wound, but not into the blood vessel. The sealing agent remains in place following removal of the introducer sheath and the sealing device from the puncture wound. 
     In one alternative embodiment, the tubular member includes a thin compliant membrane comprising the wall between the ports and the soft distal tip. A positioning wire extends through the lumen of the tubular member and is anchored at its distal end to the soft distal tip. The wire&#39;s proximal tip extends out of the tubular member for manipulation by the physician. The wire is used to move the thin membrane into two positions. In the first position the thin membrane wall is substantially in line with the exterior wall of the tubular member. In the second position, the wire is pulled in the proximal direction to move the distal tip towards the ports. This movement causes the thin membrane wall to flex and fold so that is forms an annular disc surrounding the tubular member between the ports and the distal tip. During the procedure, the thin membrane is initially in its first position. As the ports are positioned outside of the patient&#39;s blood vessel, the wire is pulled to position the annular disc formed by the thin membrane adjacent the puncture site forming a temporary plug. The hemostatic agent is then injected into the puncture site and prevented from entering the blood vessel due to the temporary plug. After the hemostatic agent is injected, the wire is pushed in the distal direction returning the thin membrane to its first position and the tubular member is removed before the hemostatic agent solidifies at the puncture site. 
     In a second alternative embodiment, a dual syringe assembly is used to inject a hemostatic agent consisting of platelet rich product and thrombin product mixture into the indicator. The syringe assembly includes two hypodermic syringes coupled to a manifold. The syringes are coupled by a molded plastic cap at the upper end of the syringe assembly so that when the cap is depressed both syringes are simultaneously deployed. The larger syringe contains a platelet rich product or fibrin-rich product obtained from the patient and the smaller diameter syringe contains thrombin or other activator. When the two mix, they create a semi-solid plug like material in about two minutes after they are mixed. This is sufficient time for the mixture to travel through the indicator device and out the ejection port before solidifying in the puncture area. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     The foregoing features, objects and advantages of the invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, especially when considered in conjunction with the accompanying drawings in which: 
     FIG. 1 is a perspective view of the present invention; 
     FIG. 2 is a side elevational view of the present invention; 
     FIG. 3 is a cross-sectional view taken along line  3 — 3  in FIG. 1; 
     FIG. 4 is a side elevational view of introducer sheath used with the present invention as it remains in the patient near the completion of a catheterization procedure; 
     FIG. 5 is a side elevational view of the present invention fully inserted into the introducer sheath of FIG. 4; 
     FIG. 6 is a side elevational view of the present invention and introducer sheath partially removed from the patient; 
     FIG. 7 is a cross sectional view of a first alternative embodiment of the tubular member in its first relaxed position; 
     FIG. 8 is a cross sectional view of the first alternative embodiment of the tubular member in its second contracted position; 
     FIG. 9 is a cross-sectional view of a second alternative embodiment of the tubular member of the present invention; 
     FIG. 10 is a side elevational view of first alternative embodiment of the tubular member partially removed from the blood vessel and in the second contracted position; 
     FIG. 11 is an exploded front elevational view of an syringe assembly, indicator injection tube and introducer sheath of an alternative embodiment of the present invention; 
     FIG. 12 is a cross-sectional view taken along line A—A in FIG.  11 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     A device for sealing percutaneous punctures in the blood vessel and having a built-in pressure indicator is shown in FIG.  1  and is indicated generally by numeral  10 . It is comprised of an elongated tubular member  12  with a hub member  14  on its proximal end. The tubular member  12  has a distal end  16  and a proximal end  18  which extends into a distal end  24  of the hub member  14 . Attached to the distal end  16  of tubular member  12  is an elongated, highly flexible soft plastic extension  17  that seals the distal end  18  of the tubular member  12 . A lumen  22  (FIG. 3) extends the length of the tubular member  12 . Affixed to the proximal end  16  of the lumen  22  and extending partially into a proximal end  26  of the hub member  14  is an integrally molded or an otherwise affixed hemostatic seal housing  28 . The seal  30  typically comprises one or more elastomeric discs having self closing slits formed through the thickness to cooperate with any instrument that may be inserted into the slits, such as the end of a hypodermic syringe to block the flow of blood out through the proximal end of the lumen  22 . 
     The hub  14  includes an elongated grooved track  32  formed into its exterior surface of its upper surface  34   a  as seen in FIGS. 1-3. The grooved track  32  has a first end  36  and a second end  38  and may be convoluted as shown or any other suitable configuration. The first end  36  of the grooved track  32  opens into a first transverse bore  40  (FIG. 3) that provides the fluid communication between the lumen  22  and the grooved track  32 . The second end  38  of the grooved track leads to an enlarged chamber  44 . As shown in FIGS. 1 and 2, the chamber is shown as being formed into the exterior surface of side wall  34   b  of the hub  14 . However, the chamber  44  can be formed into the top surface  34   a  or even internally formed and positioned between the exterior surface of the hub  14  and the lumen  22 . A transparent cover member  46  overlays the grooved track  32  and the chamber  44  to form a fluid tight seal. The enclosed sealed grooved track  32  may be coated with heparin to reduce any tendency for blood entering the track  32  to coagulate. 
     The soft deformable tip  17 , positioned on the distal end  16  of the tubular member  12 , may comprise an elastomeric material having a durometer less than about 70 shore A. Immediately proximal of the soft tip  17  are a plurality of ejection ports, designated generally as  50 . These ejection ports  50  provide a fluid passageway from lumen  22  to the exterior of tubular member as shown by ports  52  and  54  in FIG.  3 . The tubular member  12  has a sufficient length such that the soft tip  17  and the ports  50  will extend out of the distal end of the vascular introducer with which it is used when the tubular member  12  is inserted into the vascular introducer, as will be further explained when the operation of the device is discussed with the aid of FIGS. 4 through 6. 
     In use, toward the termination of the catheterization procedure, any working catheters, guide catheters and guide wires will be stripped out of the proximal end of the introducer sheath, designated  60  in FIGS. 4,  5  and  6 , with the introducer sheath  60  remaining in place as seen in FIG.  4 . The introducer sheath  60  has proximal hub  62  and a distal end  64  and a lumen  66  extending therebetween. The physician will slide the tubular member  12  of the hemostatic agent injection device  10  down the lumen  66  of the introducer  60  until the soft tip  17  and ports  50  extend out of the distal end of the introducer sheath  60  into the blood vessel  68 . The hub  14  is larger than the hub  62  of the sheath  66  and hence, the hub  62  serves as a stop, limiting the extent that the soft end  17  of the device  10  can enter the blood vessel  68 . 
     As the ports  50  enter the sheath  60  and blood vessel  68 , blood travels into the lumen  22  of the device  10 , through the first transverse bore  40  and into the sealed grooved track  32 . As the blood enters, air ahead of the blood flow is trapped in the sealed grooved track  32  and chamber  44 . Chamber  44  operates as an air compression chamber by having a predetermined volume that enables the blood pressure to compress the air trapped ahead of the blood flow in the sealed grooved track  32  and chamber  44  resulting in blood flow into the sealed grooved track  32 . When the pressure of the trapped air reaches equilibrium with the blood pressure, blood stops filling the sealed track  32 . As the blood pressure varies between systolic and diastolic pressure levels, the blood will appear to oscillate back and forth in the track. The blood movement is highly visible because of the transparent cover member  46 . As shown in FIG. 1, number  72  designates a location of the leading edge of the blood flow when at diastolic pressure and number  74  designates the leading edge of blood at systolic pressure. 
     The device  10  and introducer sheath  60  are then slowly retracted as a unit while the physician views the oscillating movement of the blood in the track. When the movement of the blood stops, this indicates that the ejection ports  50  are now in the tissue  76  and out of the blood vessel  68  as shown in FIG.  6 . The hemostatic agent may now be injected through hemostatic seal member  30  on the hub  14  of the device  10 . The hemostatic agent is made to flow through the lumen  22  where it ultimately exudes out of the ejection ports  50  of the tubular member  14 . Normal blood pressure can be relied upon to prevent the hemostatic agent from entering the blood vessel  68  upon removal of the sheath  60  and device  10 . 
     The fluid hemostatic agent employed in carrying out the present invention may be a clotting agent, such as thrombin, fibrin, fibrin glue, platelet glue or a collagen slurry or gel. It may also comprise a tissue adhesive, such as methacrylates or cyanocrylates. Vasoconstrictive drugs, such as phenylephrine, norepinephrine, epinephrine, prostaglandin F2 alpha endothelin, methergine, oxytocin and isoprel may also be used in stemming blood flow. Other astringent substances, such as ferric chloride, zinc oxide, permaganates or tannic acid can be approximately formulated with colors, binders or matrix materials so as to have a sufficiently low viscosity to permit introduction, through the lumen  22 . 
     A first alternative embodiment of the tubular member  80  is shown in FIGS. 7-9. In this embodiment, a thin, compliant membrane forms a wall  82  between the ports  84  and the distal tip  86 . A positioning wire  88  extends through the lumen and is anchored at its distal end  90  to the distal tip  86 . Its proximal end  92  forms a loop or other conventional configuration for manipulation by the physician as will be explained. 
     The wire  88  is used to position the thin membrane wall  82  into two positions. In the first position, or relaxed position, shown in FIG. 8, the thin membrane wall  82  is substantially in line with the exterior wall surface  94  of the tubular member  80  and the distal tip exterior surface  96  resulting in a substantially smooth exterior surface In the second position, the wire  88  is pulled in the proximal direction moving the distal tip  86  also in the proximal direction. This causes the thin membrane  82  to flex and fold forming an annular member  98  around the tubular member  80  as seen in FIG.  8 . 
     The procedure with the first alternative embodiment is similar to that described with respect to FIGS. 4-6. The tubular member  80  is in its first position when it is introduced into the puncture site  97  and as the tubular member  80  is slowly withdrawn until the ports  84  are positioned outside the blood vessel  99  as seen in FIG.  9 . When the ports  84  are positioned outside the blood vessel  99 , the wire  88  is pulled in the proximal direction causing the thin membrane  82  to contract and form the annular member  98 . The annular member  98  is positioned inside the blood vessel  99  adjacent to and blocking the puncture site  97  as seen in FIG.  9 . The hemostatic agent is then introduced through the ports  84  and the annular member  98  prevents its entry into the blood vessel  99 . After the hemostatic agent is introduced, the wire  88  is moved in the proximal direction returning the thin membrane  82  to its first position and the tubular member  80  is withdrawn before the hemostatic agent plugs the puncture site  97 . 
     FIG. 9 discloses an alternative embodiment  200  in which the visible track  202  in the hub body  204  is sealed from any blood of the patient filling lumen  206  of the hub embodiment  200 . A fluid tight compliant membrane  208  is placed over the opening of transverse bore  210  extending from the track  202 , sealing it from lumen  206 . A predetermined volume of fluid, designated  212 , is located within the transverse bore  210  and sealed track  202 , extending from the compliant membrane  208  to a predetermined distance along the track  202 . The remaining configuration of the tubular member can be that shown in FIGS. 1-6 or FIGS. 7-8. When embodiment  200  is inserted into a blood vessel, the blood will flow into lumen  206  though ports  216  and pulsate against the compliant membrane  208 . This in turn causes the fluid  212  to pulsate in the track  202  against the air trapped in the track  202  and thus act as a micro manometer. 
     Another alternative embodiment of the indicator injection tube and introducer sheath is shown in FIGS. 10,  11  and  12 . A syringe assembly  100  is used with the indicator injection tube  102  for ejecting a platelet rich product and thrombin mixture to create hemostasis. The assembly  100  includes a plunger assembly  104  with a single plunge cap  106  at one end and finger ring assembly  108  at the other end. Syringe clips  110  and  112  help secure syringes  114  and  116  in place with the syringe plungers  118  and  120  secured in plunger cap  106 . The finger ring assembly  108  operates as a manifold and includes port  122  for receiving the distal end of syringe  114  and port  124  for receiving the distal end of syringe  116 . Port  122  is an inlet for passageway  126  leading to a mixing chamber  128  located within the finger ring assembly  108 . Port  124  is an inlet for passageway  130  leading to the mixing chamber  128 . The mixing chamber  128  then leads to an outlet port  132 . 
     Syringe  14  is larger than syringe  116  and is intended to contain the platelet rich product. The platelet rich product is prepared by drawing blood from the patient via a hypodermic needle, and then centerfuging the blood in the syringe to cause the platelets to separate out and become concentrated at the outlet end  114 A of the syringe  114 . Use of the patient&#39;s own blood is desirable so there is no concern about transmitting AIDS or other blood-borne viruses to the patient. Syringe  116  contains a thrombin/activator. The size of syringes  114  and  116  are adjusted so that the desired proportions of the platelet rich product and thrombin constitute the mixed product, such as one part thrombin/activator to ten parts platelet rich product. As can be appreciated by those of skill in the art, the passageways  126  and  130  and the mixing chamber  128  are designed to create a vortex or turbulence to uniformly mix the platelet rich product and thrombin/activator before the mixture exits port  132 . 
     The indicator  102  of the alternative embodiment is similar to the indicator  10  of FIGS. 1-3 and  5 - 6 . A circular hub  134  is affixed to or integrally molded with an hemostatic seal housing  136  and an elongated tubular member  138 . The elongated tubular member  138  has a soft deformable tip  140  on its distal end  142 . A plurality of ports designated  144  are positioned approximate the distal end  142 . A lumen (not shown) extends from the inlet housing  136  to the ports  144 . 
     The hub  134  includes a circular enclosed track  146  which is preferably heparin coated. End  148  of the track  146  is in fluid communication with the lumen (not shown) of tube  138 . End  150  of the track  146  is in fluid communication with an enlarged chamber  152  as seen in FIG.  12 . The track  146  is sealed with a transparent cover  154  to form a fluid tight seal while allowing observation of a liquid moving in the track. Alternatively, the track  106  can be sealed from the lumen (not shown) with a compliant membrane and partially filled with a liquid as in the hub embodiment disclosed in FIG.  9 . 
     The indicator  102  is used with the introducer sheath  156  in the same manner described earlier with respect to the first embodiment of FIGS. 4-6. When the blood is observed to have stopped pulsating in track  146 , the physician inserts outlet  132  of the syringe assembly  100  into the hemostatic seal housing  136 . The physician then depresses plunger cap  106 , simultaneously discharging the contents of both syringes  114  and  116 . The platelet rich product from syringe  114  enters mixing chamber  128  through passageway  126  and the thrombin from syringe  116  enters mixing chamber  128  through passageway  130 . The mixture then exits outlet port  132  into a lumen in the indicator  102  and then through the ports  144  into the tissue proximate the puncture in the blood vessel. The mixture creates a semi-solid plug-like material approximately two minutes after being mixed, providing sufficient time for the mixture to travel through the indicator  102  and out the ejection ports  144  before solidifying. 
     This invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principals and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment details and operating procedures, can be accomplished without departing from the scope of the invention itself.