Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00646—Type of implements
  • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
  • A61B2017/00672—Locating means therefor, e.g. bleed back lumen

Definitions

• the present invention relates to facilitating hemostasis at a puncture site. More particularly, the present invention relates to facilitating hemostasis at a puncture site by delivering a hemostasis promoting material to the blood vessel puncture site using a pin and pull technique. BACKGROUND OF THE INVENTION
• a large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery.
• coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involve accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.
• the present invention provides for a method and apparatus to facilitate hemostasis at a blood vessel puncture site having a cannula with a distal end, a proximal end, an inner diameter, and a lumen extending between said distal end and said proximal end; a bleed back port located near the distal end; a pusher having a top, a bottom, and a lumen extending between the top and bottom, the bottom is slidably received into the cannula lumen; a bleed back exit port located near the top; and a pledget having a first end and a second end, the first end positioned at the distal end within the cannula lumen, and the second end positioned below the bleed back port.
• FIG. 1 illustrates an apparatus within a blood vessel lumen to facilitate hemostasis at a blood vessel puncture site in accordance with one embodiment of the present invention.
• FIG. 2 illustrates an apparatus to facilitate hemostasis at a blood vessel puncture site in accordance with another embodiment of the present invention.
• FIGS. 3 A and 3B illustrates an apparatus to facilitate hemostasis at a blood vessel puncture site in accordance with yet another embodiment of the present invention.
• FIGS. 4A-4H illustrates the various pledgets positioned within the blood vessel lumen.
• FIGS. 5A-5B illustrates the pledget positioned within the blood vessel wall.
• FIGS. 6A-6B illustrates the pledget positioned adjacent the blood vessel puncture site.
• FIGS. 7A-7H illustrates a method for facilitating hemostasis at a blood vessel puncture site.
• FIGS. 8A-8D illustrate embodiments of the pledget in accordance with the present invention. DETAILED DESCRIPTION
• FIG. 1 an embodiment of the present invention illustrating an apparatus within a blood vessel lumen to facilitate hemostasis at a blood vessel puncture site.
• the apparatus 100 comprises a delivery cannula 102 having a distal end 106, a proximal end 104, an inner diameter 108, and a lumen 110 extending between the distal end 106 and the proximal end 104.
• the cannula 102 may also have a bleed back port 112 located near the distal end 106 of the cannula 102 to detect blood flow out of the blood vessel lumen.
• the present invention allows for the synergistic coexistence of both a hemostatic agent and a bleed back system. Both do not compete or detract from each of their functions which allows a user to locate the blood vessel puncture site using visual bleed back indication and to deploy a hemostatic agent to the blood vessel puncture site in one single pass.
• the apparatus 100 may have a pusher 116 with a top 118, a bottom 120, and a lumen 122 extending between the top 118 and bottom 120.
• the pusher bottom 120 may be placed inside the cannula lumen 110 such that the pusher 116 may be able to slidably move within the cannula lumen 110.
• the pusher bottom 120 may have a diameter equal to or less than the inner diameter of the cannula 108.
• the diameter may be as small as 1 French, but preferably greater than 3 French.
• the pusher top 118 may have a pair of finger levers 124a and 124b to assist a user in holding the pusher 116 in a fixed position or to assist in moving the pusher 116 within the cannula lumen 110.
• the pusher 116 may also have a bleed back exit port 126 located near the pusher top 118. Blood flow entering the apparatus 100 from the bleed back port 112 will flow through the pusher lumen 122 and out the bleed back exit port 126 as indicated by arrow 128.
• a bleed back exit port 126 located near the pusher top 118. Blood flow entering the apparatus 100 from the bleed back port 112 will flow through the pusher lumen 122 and out the bleed back exit port 126 as indicated by arrow 128.
• the bleed back exit port 202 may be located near the cannula proximal end 104. In this case, blood will flow from the bleed back port 112, through the cannula lumen 110, and out the bleed back exit port 202 as indicated by arrow 204.
• bleed back port 112 When the bleed back port 112 is located within the blood vessel lumen 114, a steady stream of blood will flow out of the bleed back exit port 126. However, when the bleed back port is positioned outside the blood vessel lumen (not shown) or within the wall of the blood vessel, blood will not steadily flow out of the bleed back exit port 126. This visual indication of blood flow out of the bleed back exit port 126, 202 assists a user in positioning the apparatus 100 at the blood vessel puncture site 128.
• the lumen 110 and the plunger lumen 122, through which the blood flows to the bleed back exit port 126, 202 be maximized.
• the present invention allows for an accurate visual bleed back indication by maximizing the lumen 110 through the use of a cannula 102.
• the pusher lumen 122 be substantially equal or between about 0.5 French to 0.2 French smaller than the inner diameter of the cannula 108 as shown in Fig. 1.
• a shown in Fig. 2 it is preferable that obstructions within the cannula lumen 110 be eliminated and the pusher bottom 120 be positioned above the bleed back exit port 202.
• the pusher 302 may be a stylet and disk or any other similar type of pusher 312.
• the bleed back exit port 304 is located near the cannula proximal end 104.
• the pusher 302 may have a disk or piston 306, a top 308, and an extension 310 between the disk 306 and the top 308.
• the stylet may be attached to the disk as a single unit, may be attached to the disk by other means such as a string 314, or the stylet and disk may not be attached together.
• the disk 306 may be located below the bleed back port 112 adjacent the pledget second end 133.
• the disk 306 may have a diameter substantially equal to the inner diameter of the cannula 108, but it may be smaller than the inner diameter of the cannula 108. It is preferable that the diameter of the extension or stylet 310 be as small as possible, for example less than 3 French, yet be strong enough to eject the pledget 130 from the cannula 102. This allows for maximum space within the cannula lumen 110 for blood to flow from the bleed back port 112 to the bleed back exit port 304. Moreover, the stylet may be configured in any shape such as a shaft as shown in Figs. 3A and 3B or as a plenum (not shown) to divide the cannula lumen into two or more lumens.
• the apparatus 100 may also have a pledget 130 compressed within the cannula lumen 110 at the cannula distal end 106.
• the pledget 130 is positioned below the bleed back port 112 such that the pledget serves as the distal "seal" or the boundary of the bleed back circuit.
• the pledget 130 may be any biocompatible material, preferably a sponge.
• the sponge is non-immunogenic and may be absorbable, dissolved or resorbed by the body, or non-absorbable.
• Non-absorbable pledgets may include various polymeric foams, such as polyurethanes, as are well-known in the art.
• Absorbable sponges may include those made from Gelatin, Colagen, Oxydized Cellulose, PGA, and other like materials.
• the pledget 130 may also have a coagulant or clot formation accelerating agent such as Thrombin, Fibrinogen (Biomolecules), Protamine, and additives that can create a negative or positive charged pledget such as calcium chloride, magnesium, ferric chloride, or an acid such as hydrochloric acid, and other similar additives.
• a coagulant or clot formation accelerating agent such as Thrombin, Fibrinogen (Biomolecules), Protamine, and additives that can create a negative or positive charged pledget such as calcium chloride, magnesium, ferric chloride, or an acid such as hydrochloric acid, and other similar additives.
• the coagulants are used to effect local hemostasis and chemically activate a clotting cascade.
• the coagulants may be incorporated into the pledget as part of the gelatin formation or may be applied as a coating to the surface of a pledget.
• the pledget 130 may be pre-hydrated to facilitate rapid expansion or the pledget 130 may contain a wetting agent for rapid expansion of the pledget with or without pre- hydrating the pledget.
• the pledget 130 may be pre-hydrated in various ways as disclosed in detail in U.S. Patent No. 6,071,301, filed May 1, 1998, entitled “Device And Method For Facilitating Hemostasis Of A Biopsy Tract” by inventors Andrew H. Cragg, Rodney Brenneman, and Mark Ashby and U.S. Patent No. 6,162,192, filed May 1, 1998, entitled “System And Method For Facilitating Hemostasis Of Blood Vessel Punctures With Absorbable Sponge” by inventors Andrew H.
• wetting agents are discussed in detail in co-pending application serial number 10/068,812, filed February 4, 2002, entitled "Cross-Linked Gelatin Composition Comprising A Wetting Agent” by inventor Richard J. Greff which is hereby incorporated by reference in its entirety.
• the wetting agents may be incorporated into the pledget as part of the gelatin formation or may be applied as a coating to the surface of a pledget.
• the pledget 130 may also comprise a surface coating made of bioadhesive agents to increase surface traction and/or adhesion which will increase grip and friction between the surrounding tissue or artery wall and pledget. This will ensure that the pledget remains within the lumen of the blood vessel, intraarteriotomy the blood vessel wall, or within the tissue tract adjacent the blood vessel puncture site.
• the bioadhesive agent may be a permanent tissue adhesive and/or bonding agent such as cyanoacrylates or fibrin derived compositions.
• the bioadhesive agent may be mucoadhesives that are triggered by moisture such as blood.
• Some synthetic mucoadhesives are polyvinyl carboxylic acids such as polyacrylic and methacrylic acids.
• Such acids are Carbopol-974 NF (high performance polymer) and Noveon-AAl sold by Noveon, Inc. located in Cleveland, Ohio. Additionally, cellulosics and polysaccarides may be used such as Poly(methyl vinyl ether - alt - Melaic Anhydride), Carboxymethyl Cellulose (sodium salt), and Chitosan (high molecular weight) sold by Aldrich Chemical Company, Inc. located in Milwauikee, WI.
• the bioadhesive agents may be incorporated into the pledget as part of the gelatin formation or may be applied as a coating to the surface of a pledget.
• the pledget 130 may comprise a securing mechanism at the pledget first end 132 to secure the pledget to the blood vessel lumen 114, the intraarteriotomy the blood vessel wall, or provide friction and/or traction to the blood vessel wall.
• the securing mechanism may be located proximally of the pledget first end 132 along the pledget length, including at the pledget second end 133, to secure the deployed pledget against any movement. As shown in Fig.
• the securing mechanism may be a pair of lateral projections 400a, 400b or more centrally originating star configuration 402, or a retention flange 410 or proximal shoulders 413 on the outer surface of a distal dissolvable tip 412 as shown in Figs. 4G and 4H.
• Other proximally located pledget securing mechanisms may be used such as the expandable clip 800 shown in Fig. 8 A, the proximal shuttlecock 802 shown in Fig. 8B, the expandable pineapple 804 shown in Fig. 8C, a trampoleen or umbrella frame 806 as shown in Fig.
• securing mechanisms can be retained within the cannula lumen in a non-deployed position (not shown) and upon deployment from the cannula, the securing features activate as shown in Figs. 8A-D.
• Fig. 4C illustrating a pledget in a non-deployed state
• the lateral projections 400a, 400b may be retained within the cannula lumen 110 at the cannula distal end 106 prior to deployment. After the pledget 130 is deployed, the lateral projections 400a, 400b expand as shown in Fig.
• the lateral projections may be made of any biocompatible material such as various polymers that are well known in the art.
• the lateral projections may also be made of non-absorbable materials such as SST, nitinol, titanium, or other biocompatible metals.
• the projections may also be made of absorbable polymers such as PGA, Gelatin, methyl cellulose, carboxymethyl cellulose, carbowaxes, and gelatin (particularly pigskin gelatin).
• suitable polymers are polylactic glycolic acids, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide.
• the pledget first end 132 may extend partially out of the cannula distal end 106 as shown in Fig. 4F.
• the pledget first end 132 will have a diameter equal to the outside diameter of the cannula 404.
• the pledget first end 132 may have different characteristics than the pledget second end 133.
• the first end 132 may vary in traction, stickiness, hardness, dissolution rate, thrombocinicity, shape, or other similar characteristics from the second end 133.
• the pledget 130 may have a first end 132 and a second end 133 where the first end 132 may be positioned immediate the cannula distal end 106. It is preferable that the diameter of the pledget first end 132 be substantially equal to the inner diameter of the cannula 102 to prevent blood from flowing though the cannula distal end 106.
• the second end 133 may be positioned below the bleed back port 112. The pledget 130 may expand when exposed to fluids such as blood or when expelled out of the cannula lumen 110.
• the embodiments above may be used with or without a guidewire 136 or other locating device. If used with a guidewire 136, the entire pledget 130 may have an axial passage (not shown) through its length, S, to receive a guidewire or the like. If used without a guidewire, the present invention may be placed within an existing procedural sheath already positioned within the artery or blood vessel (not shown). However, if a procedural sheath is used, the bleed back port 112 must extend beyond the procedural sheath distal end such that bleed back may be detected to properly position the apparatus 100.
• the user may insert the apparatus 100 down the tissue tract until the bleed back port 112 enters the blood vessel lumen 114 as indicated by when bleeding is first observed exiting the bleed back exit port 126. The user may then withdraw the apparatus 100 out of the blood vessel lumen 114 until the bleed back port 126 is located within the wall of the blood vessel 134 as indicated by when bleeding is no longer observed exiting the bleed back exit port 126.
• the pledget 130 may be positioned in several positions to facilitate hemostasis at the blood vessel puncture site 128.
• One position may be within the blood vessel lumen, as shown in Figs. 4a and 4b.
• Another position may be within the blood vessel wall or intraarteriotomy 500 as shown in Figs. 5a and 5b.
• Still another position may be adjacent the wall of the blood vessel 134 as shown in Fig. 6.
• distance D (Fig. 1), the distance between the cannula distal end 106 and the bleed back port 112
• distance S may be greater than or equal to distance S, the length of the pledget 130.
• distance P may be greater than distance between the bleed back port 112 and the pusher bottom 120.
• the pusher 116 With the pusher 116 in a fixed or pinned positioned, the cannula 102 may be pulled back a distance R such that the cannula proximal end 104 is adjacent the pusher top 118.
• Distance R may be greater than or equal to the sum of distances D and P.
• the pledget first end 132 is positioned approximately a distance S-P within the blood vessel lumen 114.
• the cannula 102 When using a pledget 130 with a securing mechanism at the pledget first end 132, the cannula 102 may be pulled back a distance R or in the alternative, the cannula 102 may be fixed and pusher 116 pushed down a distance R where R is described by:
• Distance R may be less than the sum of distances D and P such that only the securing mechanism is exposed beyond the cannula distal end 106 when the cannula 102 is pulled back a distance R or the pusher 116 is pushed down distance R as shown in FIG. 7D. In this position, the securing mechanism is exposed within the blood vessel lumen 704 and expands. The cannula 102 and pusher 116 may then be simultaneously pulled out of the tissue tract such that the securing mechanism catches the inside wall of the blood vessel 134 which secures the pledget 130 at the blood vessel puncture site 128 to facilitate hemostasis.
• the distance D (Fig. 1), the distance between the cannula distal end 106 and the bleed back port 112
• distance S the distance between the bleed back port 112 and the pusher bottom 120.
• the pusher 116 With the pusher 116 in a fixed or pinned positioned, the cannula 102 may be pulled back a distance R such that the cannula proximal end 104 is adjacent the pusher top 118.
• Distance R may be greater than or equal to the sum of distances D and P.
• the cannula 102 when using a pledget 130 with a securing mechanism at the pledget first end 132, the cannula 102 may be pulled back a distance R or in the alternative, the cannula 102 may be fixed and pusher 116 pushed down a distance R, where R is described as follows:
• Minimum distance to expose the securing mechanism ⁇ R ⁇ D+P (2) Distance R may be less than the sum of distances D and P such that only the securing mechanism is exposed beyond the cannula distal end 106 when the cannula 102 is pulled back a distance R or the pusher 116 is pushed down distance R. In this position, the securing mechanism is exposed within the blood vessel lumen 704 and expands. The cannula 102 and pusher 116 may then be simultaneously pulled out of the tissue tract such that the securing mechanism catches the inside wall of the blood vessel 134 which secures the pledget 130 at the blood vessel puncture site 128 to facilitate hemostasis.
• distance D (Fig. 1), the distance between the cannula distal end 106 and the bleed back port 112
• distance S the length of the pledget 130.
• distance P the distance between the bleed back port 112 and the pusher bottom 120.
• the pledget first end 132 is positioned approximately a distance P-S outside the blood vessel puncture site 128.
• a pledget with distally extending lateral prongs 600a and 600b may also be used to effectively place the pledget 130 adjacent the blood vessel puncture site 128.
• the pusher bottom 306 is then positioned at distance P prior to deployment of the pledget 130.
• the distance P may vary depending on whether the pledget 130 is deployed within the blood vessel lumen, within the blood vessel wall, or adjacent the blood vessel puncture site.
• Figs. 7A-7H illustrates a method for facilitating hemostasis at a blood vessel puncture site.
• a cannula 700 has a bleed back port 706 at the cannula distal end 708 and a pledget 710 positioned below the bleed back port 706.
• the cannula 700 and pusher 702 are advanced into the blood vessel lumen 704 until the bleed back port 706 is located within the blood vessel lumen 704. In this position, blood flows into the bleed back port 706, through the pusher lumen 712, and out a bleed back exit port 714 as indicated by arrow 724.
• a steady stream of blood will flow out of the bleed back exit port 714.
• the bleed back port is positioned outside the blood vessel lumen or within the wall of the blood vessel as further discussed below in Fig. 7B, blood will not steadily flow out of the bleed back exit port 714.
• This visual indication of blood flow out of the bleed back exit port 714 assists a user in positioning the apparatus 716 at the blood vessel puncture site 718.
• the apparatus may be used with or without a guidewire 722 or other locating device. If used with a guidewire 722, the pledget 710 may have an axial passage (not shown) through its length to receive a guidewire or the like. If used without a guidewire, the present invention may be placed within an existing procedural sheath already positioned within the artery or blood vessel (not shown). However, if a procedural sheath is used, the bleed back port 706 must extend beyond the procedural sheath distal end such that bleed back may be detected to properly position the apparatus 716.
• the bleed back exit port 202 may be located near the cannula proximal end as shown in Fig. 2.
• blood will flow from the bleed back port 112, through the cannula lumen 110, and out the bleed back exit port 202.
• the cannula lumen 110 have little to no obstructions to maximize blood flow through the lumen to the bleed back exit port 202 to provide an accurate visualization of bleed back.
• the pusher bottom 120 be positioned above the bleed back exit port 202.
• the pusher 302 may be a stylet and disk or any other similar type of pusher 312. As illustrated in Figs.
• the stylet may be attached to the disk as a single unit, may be attached to the disk by other means such as a string 314, or the stylet and disk may not be attached.
• the disk 306 may be located below the bleed back port 112 adjacent the pledget second end 133.
• the disk 306 may have a diameter equal to or less than the inner diameter of the cannula.
• the disk diameter may be as small as 1 French, but preferably greater than 3 French. It is also preferable that the diameter of the stylet or extension 310 be as small as possible, such as less than 3 French, yet be strong enough to eject the pledget from the cannula.
• the stylet may be configured in any shape such as a shaft as shown in Figs. 3A and 3B or as a plenum (not shown) to divide the cannula lumen into two or more lumens.
• Fig. 7B shows the apparatus later in time than Fig. 7A.
• the cannula 700, pledget 710, bleed back port 706, and pusher 702 are simultaneously withdrawn from the blood vessel lumen 704 until bleed back is no longer visible out of the bleed back exit port 714. This informs a user that the apparatus 716 is located at or near the blood vessel puncture site 718.
• the pledget 710 may be discharged to facilitate hemostasis once the apparatus is positioned at the proper position.
• the pusher 116 may be repositioned at distance P prior to deployment of the pledget 130. The distance P may vary depending on whether the pledget 710 is deployed within the blood vessel lumen, within the blood vessel wall, or adjacent the blood vessel puncture site as further discussed below.
• the pledget 710 may be positioned in several positions to facilitate hemostasis at the blood vessel puncture site 718.
• One position is within the blood vessel lumen 704 as shown in Figs. 7C - 7E.
• Another position is within the blood vessel wall or intraarteriotomy 742 as shown in Figs. 7F and 7G.
• Still another position is adjacent the wall of the blood vessel 718 as shown in Fig. 7H.
• distance D (Fig. 7B)
• distance S the distance between the cannula distal end 708 and the bleed back port 706, may be greater than or equal to distance S, the length of the pledget 710.
• distance S may be greater than distance P, the distance between the bleed back port 706 and the pusher bottom 726.
• the cannula 700 may be pulled back a distance R in the direction of arrow 732 such that the cannula proximal end 728 is adjacent the pusher top 730.
• the pledget first end 734 is positioned approximately a distance S-P within the blood vessel lumen 704.
• a pledget with a securing mechanism may be used.
• the securing mechanism may be located at the pledget first end, the pledget second end, or along the pledget length to secure the deployed pledget against any movement.
• the securing mechanism may be a pair of lateral projections as shown in Figs. 7D and 7E, an expandable clip 800 shown in Fig. 8A, the proximal shuttlecock 802 shown in Fig. 8B, the expandable pineapple 804 shown in Fig. 8C, a trampoleen or umbrella frame 806 as shown in Fig. 8D, or other gripping features such as a crisscross surface, expandable braid, ridges, or bumps.
• Distance R is the a length such that the securing mechanism 736 is exposed beyond the cannula distal end 708 when the cannula 700 is pulled back or, in the alternative, the pusher 702 is advanced down the cannula a distance R. In this position, as shown in Fig. 7D, the securing mechanism 736 is exposed within the blood vessel lumen 704 and expands. A portion or all of the pledget second end remains inside the cannula 700. As shown in Fig.
• the cannula 700 and pusher 702 may then be simultaneously pulled out of the tissue tract in the direction of arrow 732 such that the securing mechanism catches the inside wall of the blood vessel 740 which secures the pledget 710 at the blood vessel puncture site 718 to remove the pledget 710 from the cannula 700 and facilitate hemostasis.
• the distance D (Fig. 7B), the distance between the cannula distal end 708 and the bleed back port 706, may be greater than or equal to distance S, the length of the pledget 710. Moreover, distance S is equal to distance P, the distance between the bleed back port 716 and the pusher bottom 726.
• the cannula 700 may be pulled back a distance R in the direction of arrow 732 such that the cannula proximal end 728 is adjacent the pusher top 730.
• Distance R may be greater than or equal to the sum of distances D and P.
• Figs. 7G which is similar to Fig. 7D
• the securing mechanism 736 when using a pledget 710 with a securing mechanism 736 at the pledget first end 734, the securing mechanism 736 it is compressed in its non-deployed state within the cannula lumen.
• the cannula 700 With the pusher fixed, the cannula 700 may be pulled back a distance R or in the alternative, cannula 700 may be fixed and pusher 702 pushed down the cannula a distance R.
• Distance R may be less than the sum of distances D and P and equal to or greater than the length of the securing mechanism 736.
• Distance R is the a length such that only the securing mechanism 736 is exposed beyond the cannula distal end 708 when the cannula 700 is pulled back or, in the alternative, the pusher 702 is advanced down the cannula a distance R. In this position, as shown in Fig. 7D, the securing mechanism 736 is exposed within the blood vessel lumen 704 and expands. A portion or all of the pledget second end remains inside the cannula 700. As shown in Fig.
• the cannula 700 and pusher 702 may then be simultaneously pulled out of the tissue tract in the direction of arrow 732 such that the securing mechanism catches the inside wall of the blood vessel 740 which secures the pledget 710 at the blood vessel puncture site 718 to remove the pledget from the cannula and to facilitate hemostasis.
• the distance between the cannula distal end 708 and the bleed back port 706, may be greater than or equal to distance S, the length of the pledget 710. Moreover, distance S may be less than distance P, the distance between the bleed back port 706 and the pusher bottom 726.
• the cannula 700 may be pulled back a distance R in the direction of arrow 732 such that the cannula proximal end 728 is adjacent the pusher top 730.
• Distance R may be greater than or equal to the sum of distances D and P.
• the pledget first end 734 is positioned approximately a distance P-S outside the blood vessel puncture site 718.

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