JP4653083B2 - A system that closes the puncture site using a fixed and withdrawing technique - Google Patents

Description

  The present invention relates to a method for promoting hemostasis at a puncture site. More specifically, the present invention relates to a method for promoting hemostasis of a puncture site by supplying a hemostasis promoting material to the puncture site of a blood vessel using a pin and pulling technique.

  In many diagnostic and interventional procedures, instruments are introduced percutaneously into veins and arteries. For example, coronary angioplasty, angiography, atherectomy, arterial stenting, and many other operations often involve proximity to the vasculature via a catheter in the femoral artery or other blood vessel . Once the procedure is complete and the catheter or other instrument is removed, bleeding from the punctured artery must be suppressed.

  In the prior art, external pressure is applied to the skin insertion site to prevent bleeding from a puncture wound on a blood vessel. Pressure is continuously applied until the puncture site is hemostatic. In some examples, pressure is applied for an hour or more during which the patient is restrained in an uncomfortable state. In addition, there is a risk of hematoma because bleeding from the blood vessels continues under the skin until sufficient hemostasis results in hemostasis. In addition, external pressure to close the vascular puncture site works best when the blood vessel is close to the skin surface, but patients with thick subcutaneous adipose tissue have a considerable distance from the vascular puncture site to the skin surface. It might be better to avoid it.

  Some prior art attempts to solve the disadvantages of the prior art described above that apply external pressure. For example, there is a device that applies a hemostatic agent to a blood vessel blood flow, a blood vessel wall, or a position adjacent to a puncture site of the blood vessel wall in order to close a perforation. However, for the surgeon, the only indication that the instrument for closing the perforation is properly positioned is hand sensation. Other prior art requires a separate device to find the vascular puncture site, which must then be removed for insertion of a second device that releases the hemostatic agent. Furthermore, in order to find the puncture site of the blood vessel wall, it is connected to other devices such as a foot plate arranged close to the blood vessel wall or an occlusion device having an anchor, and the blood flow arranged at the puncture site of the blood vessel. There are other conventional techniques that use a mouth. However, these prior arts require the surgeon to use a thread and / or needle to close the blood vessel perforation. In addition, some prior art requires applying external pressure to the skin surface.

  Thus, there is still a need for more effective and simpler devices and methods for closing blood vessel perforations. There is a need for an apparatus and method that uses only one instrument to promote hemostasis and accurately find perforations in blood vessel walls. Furthermore, there is a need for a method and apparatus that introduces a hemostatic agent in vitro using a single channel, finds a puncture site in a blood vessel wall more accurately, and guides the hemostatic agent to the puncture site in a blood vessel. Furthermore, there is a need for an apparatus and method that can accurately guide the hemostatic agent to various locations as desired by the surgeon or deemed appropriate by the surgeon for the patient.

  The present invention comprises a cannula having a distal end, a proximal end, an inner diameter, and a lumen extending from the distal end to the proximal end, a bleed back port located near the distal end, A pusher having a top, a bottom slidably received in the lumen of the cannula, and a lumen extending from the top to the bottom, a bleed back exit port located near the top, and in the lumen of the cannula A method and apparatus for promoting hemostasis of a vascular puncture site, comprising a glued having a first end located at the distal end of the blood vessel and a second end located below the blood flow port.

Cross-reference to related applications The filing date is July 11, 2000, and the name is "System and method for promoting hemostasis of blood vessel puncture site by absorbent sponge", the inventors are Andrew H. Cragg, Rodney Brennemann, and Mark Ashby. 1. Pending US application Ser. No. 09 / 613,439, which is a divisional application of US Pat. No. 6,162,192, filed on Mar. 1, 1998; The filing date is March 25, 2002, the name is “Device and method for percutaneous sealing of vascular puncture site”, the inventors are Andrew H. Cragg, Rodney Brennemann, and Richard Greff, the inventor Is a partial continuation of U.S. Pat. This is a continuation-in-part application of pending US application No. 10 / 107,539, which is a divisional application of U.S. Pat.No. 6,371,979 filed on August 2, 1999, which is a divisional application. Claims the benefit of priority under 35 USC 120, the entire contents of which are hereby incorporated by reference.

  The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments of the invention, and together with the detailed description, serve to explain the principles and embodiments of the invention.

  Embodiments of the present invention are described in the description of a puncture site occlusion system using a fixation and withdrawal technique. Those skilled in the art will appreciate that the following detailed description of the present invention is illustrative only and not intended to be limiting. One of ordinary skill in the art could readily devise other embodiments using the present disclosure. The association is made in detail so that the invention can be implemented as shown in the accompanying drawings. In the drawings and the following detailed description, the same reference numbers are used to refer to the same or like parts.

  For the sake of brevity, we will not describe and show all the features that are of course to be realized. Of course, it is appreciated that many implementation-specific decisions need to be made in implementation development to achieve developer-specific goals such as compliance with application and business constraints. Let's go. Such goals will vary from implementation to implementation and from developer to developer. In addition, such development efforts will be appreciated due to the time consuming and time consuming process, but would be a normal technical task for those skilled in the art who can utilize the present disclosure.

  In FIG. 1, an embodiment of the present invention shows a device in the lumen of a blood vessel to promote hemostasis at the puncture site of the blood vessel. Device 100 includes a delivery cannula 102 having a distal end 106, a proximal end 104, an inner diameter 108, and a lumen 110 extending from the distal end 106 to the proximal end 104. The cannula 102 has a blood flow port 112 located near the distal end 106 to detect blood flow out of the lumen of the blood vessel. In the present invention, the actions of both the hemostatic agent and the bleed back system can coexist. Both actions are not competing or impaired, and the user uses one flow channel to identify the vascular puncture site using the bleedback visual indicator and to stop hemostasis at the vascular puncture site. Agents can be placed.

  The device 100 includes a pusher 116 having a top 118, a bottom 120, and a lumen extending from the top 118 to the bottom 120. The pusher bottom 120 is positioned within the cannula lumen 110 such that the pusher 116 can slide within the cannula lumen 110. The pusher bottom 120 has a diameter that is less than or equal to the inner diameter 108 of the cannula. The diameter of the bottom 120 of the pusher may be as small as 1 French, but preferably larger than 3 French. Further, the pusher bottom 120 is preferably substantially the same as the cannula inner diameter 108 to maximize the visual indication of bleedback, as will be described below. The pusher top 119 provides a set of pushers to help the user hold the pusher 116 in place and to help the pusher 116 move within the cannula lumen 110. Finger levers 124a and 124b are provided. However, those skilled in the art will appreciate that other means can be used to grasp and hold the pusher 116.

  The pusher 116 has a blood flow outlet 126 near the top 118. Blood flows into device 100 from blood flow port 112, through pusher lumen 122, and out of blood flow outlet 126 as indicated by arrow 128. FIG. 2 illustrates another embodiment of a device according to the present invention that promotes hemostasis at a vascular puncture site. In this embodiment, the blood flow outlet 202 is near the proximal end 104 of the cannula. In this embodiment, blood flows from the blood flow port 112 through the cannula lumen 110 and out of the blood flow outlet 202 as indicated by arrow 204.

  When the blood flow port is located within the blood vessel lumen 114, blood will flow out of the blood flow outlet 126 regularly. However, blood will not flow out of the blood flow outlet 126 regularly when the blood flow port is outside the lumen of the blood vessel (not shown) or within the blood vessel wall. The visual indication of blood outflow from the blood flow outlets 126, 202 assists the user in placing the device 100 at the puncture site 128 of the blood vessel.

  In order to maximize the visual effect of bleed back, it is preferable to maximize the diameter of lumen 110 and plunger lumen 122 through which blood flows from outlet ports 126, 202 pass. The present invention uses the cannula 102 to maximize the diameter of the lumen 110 so that the bleedback visual indicator is accurate. To be more accurate, the pusher lumen 122 is substantially the same as the cannula inner diameter 108 or 0.5 to 0.2 French smaller than the cannula inner diameter 108, as shown in FIG. Is preferred. Alternatively, as shown in FIG. 2, a configuration in which the obstruction of the cannula lumen 110 is removed and the pusher bottom 120 is located above the blood flow outlet 202 is preferred.

  In other embodiments, the pusher 302 may be of the same type as the stylet and disk, or pusher 312 as shown in FIGS. 3A and 3B. In these embodiments, the blood flow outlet 304 is near the proximal end 104 of the cannula. The pusher 302 has a disk or piston 306, a top 308, and an extension 310 that extends from the disk 306 to the top 308. As shown in FIGS. 3A and 3B, the stylet may be connected to the disk and configured as a single member, or the stylet and the disk may be connected as another member such as a string 314. Or the stylet and the disk may not be connected. The disk 306 is disposed below the blood flow port 112 so as to be close to the second end 133 of the gauze. The diameter of the disk 306 is substantially the same as the cannula inner diameter 108, but smaller than the cannula inner diameter 108. The diameter of the stretched part or stylet 310 is preferably as small as possible. This maximizes the space in the cannula lumen 110 through which the blood flowing from the blood flow port 112 to the blood flow outlet 304 passes. In addition, the stylet may have a shaft shape as shown in FIGS. 3A and 3B, or a plenum shape that divides the lumen of the cannula into two or more lumens (not shown). It may be configured in any shape.

  The device 100 has a gauze 130 that is compressed to the distal end 106 within the lumen 110 of the cannula. The gauze 130 is located below the blood flow port 112 and serves as a boundary for a distal seal or bleedback circulation. The gauze 130 is made of a biocompatible material, preferably a sponge. This sponge is preferably non-immunogenic and exhibits absorbability and degradability in vivo, or is absorbed in vivo, or non-absorbable. Non-absorbable gauze may include a variety of polymeric foams such as polyurethane, as well known in the art, and absorbent sponges include gelatin, collagen, cellulose oxide, PGA, and It may contain other similar substances.

  The gauze 130 is a coagulant, a thrombin, a fibrinogen (biomolecule), a preparation that promotes coagulation such as protamine, and calcium chloride, magnesium, ferric chloride, or hydrochloric acid that makes the gauze negatively or positively charged. And other similar additives. Coagulants are used to stop hemostasis locally and chemically activate the coagulation cascade. The coagulant may be included in the gauze as part of the gelatinous component or applied to cover the surface of the gauze.

  The gauze 130 may be pre-watered to promote rapid expansion, or a moistening agent, whether or not pre-watered. Filed on May 1, 1998, the entire contents of which are hereby incorporated by reference, the name of the invention is “apparatus and method for promoting hemostasis in biopsy tract”, the inventor is Andrew H. Cragg US Pat. No. 6,071,301, Rodney Brennemann, and Mark Ashby, filed May 1, 1998, entitled “System and method for promoting hemostasis of vascular puncture with absorbent sponge”, Water may be pre-filled in a variety of ways as disclosed in US Pat. No. 6,162,192 by Andrew H. Cragg, Rodney Brennemann, and Mark Ashby. The wetting agent, hereby incorporated by reference in its entirety, is filed on Feb. 4, 2002, entitled “Interlinked Gelatin Composition Containing Wetting Agent”, the inventor is Richard J. Greff And is described in detail in co-pending US application Ser. No. 10 / 068,812. The wetting agent may be included in the gauze as part of the gelatinous component or used to cover the surface of the gauze.

  The surface of the gauze 130 is covered with a bioadhesive agent to increase the extensibility and / or adhesion of the surface that increases the retention and frictional forces between the surrounding tissue or artery wall and the gauze. This will ensure that the gauze remains in the lumen of the vessel, the vessel wall at the site of the arteriotomy, or the tissue region adjacent to the puncture site of the vessel. A bioadhesive agent is a tissue with long lasting adhesion and / or binding properties, such as cyanoacrylate or fibrin derived compositions. Alternatively, the bioadhesive agent may be mucoadhesive that becomes functional with a liquid such as blood. Synthetic mucoadhesive agents include those composed of polyacrylic acid and polyvinyl carboxylic acids such as methacrylic acid. Examples of such acids include Carbopol-974 NF (high performance polymer), Noveon in Cleveland, Ohio, and Noveon-AAI sold by Inc. In addition, cellulose derivatives, polysaccharides such as poly (methyl vinyl ether-alt-meric anhydride), carboxymethylcellulose (sodium salt), and chitosan (high molecular weight) sold by Aldrich Chemical Company in Milwaukee, Wis. May be used. The bioadhesive agent may be included in the gauze as part of the gelatin element or may be applied to cover the surface of the gauze.

  As shown in FIGS. 4B-4E, the gauze 130 is secured to the vessel lumen 114, to the vessel wall at the arteriotomy site, or to have a frictional force and / or retention force against the vessel wall. A fixing means is provided at the first end 132. Alternatively, the securing means is arranged near the first end 132 of the gauze and includes a second end 133 along the length of the gauze so that the deployed gauze can resist any movement. May be. As shown in FIG. 4B, the fixing means may be a pair of side protrusions 400a, 400b, a more central star structure 402, or as shown in FIGS. 4G, 4H. Alternatively, the holding end 410 on the outer surface of the dissolvable distal tip 412 or the adjacent step 413 may be used. Other gauze securing means placed in the vicinity of the gauze include an expandable clip 800 shown in FIG. 8A and a close shuttlecock-like shape shown in FIG. 8B to prevent proximal movement of the gauze after the gauze is placed. Member 802, expandable pineapple-like member (pineapple) 804 shown in FIG. 8C, trampoline or umbrella frame-like member 806 shown in FIG. Other fixing means such as a ridge or a protrusion may be used. These anchoring means are held in the cannula lumen in an undeployed state (not shown) and deployed from the cannula, and the anchoring means are ready to function as shown in FIGS. FIG. 4C shows the gauze in an undeployed state, where the side protrusions 400a, 400b are retained at the distal end 106 within the cannula lumen 110 prior to deployment. When the gauze 130 is deployed, the side protrusions 400a, 400b expand as shown in FIG. 4D. The side protrusions are composed of any biocompatible material such as various polymers well known in the art. The side protrusions may be constructed of a non-absorbable material such as SST, nitinol, titanium, or other biocompatible metal. The protrusions may also be composed of absorbent polymers such as PGA, gelatin, methylcellulose, carboxymethylcellulose, carbowax, and gelatin (especially pig skin gelatin). Polylactic acid glycolic acid, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide are suitable polymers.

  In other embodiments, the first end 132 of the gauze may partially extend from the distal end 106 of the cannula, as shown in FIG. 4F. In this case, the first end 132 of the gauze has a diameter equal to the outer diameter 404 of the cannula.

  Further, the first end 132 of the gauze may have different characteristics than the second end 133. For example, the first end 132 may have different characteristics than the second end 133 in terms of traction, tackiness, hardness, dissolution rate, thrombocinicity, shape, or other similar characteristics. Good.

  As shown in FIG. 1, the gauze 130 has a first end 132 and a second end 133 that are proximate to the distal end 106 of the cannula. To prevent blood from escaping from the cannula distal end 106, the diameter of the gauze first end 132 is preferably substantially the same as the inner diameter of the cannula 102. The second end 133 is located below the blood flow port 112. The gauze 130 expands when exposed to a liquid such as blood or released from the cannula lumen 110.

  The embodiments described above can be used with or without guidewire 136, or other placement devices. When used with the guide wire 136, the gauze 130 has an axial passage (not shown) for passing the guide wire or the like over the entire longitudinal direction S. Without the use of a guide wire, the device of the present invention will be placed in an existing process sheath that is placed in an artery or blood vessel (not shown). However, if a process covering is utilized, in order to properly position the device 100, the blood flow port 112 needs to be positioned before the distal end of the process covering.

  In order to place the device 100 in the proper position, the user uses the tissue 100 until the blood flow port 112 enters the blood vessel lumen 114 as indicated by the initial bleeding observed at the blood flow outlet 126. Insert below the area. Thereafter, the user draws the blood flow port 112 from the blood vessel lumen 114 until the blood flow port 112 is located in the blood vessel wall 134, using the indication that bleeding is not observed at the blood flow outlet 126.

  As shown in FIG. 1, after the device 100 is positioned at the appropriate location of the vascular puncture site 128, the gauze 130 is positioned at various locations to facilitate hemostasis of the vascular puncture site 128. One location is within the lumen of a blood vessel as shown in FIGS. 4a and 4b. Other locations include the vessel wall and arteriotomy site 500 as shown in FIGS. 5a and 5b. As another position, there is a position adjacent to the blood vessel wall as shown in FIG.

  As shown in FIGS. 4a and 4b, in order to place the gauze 30 within the lumen 114 of the blood vessel, a distance D (FIG. 1), which is the distance from the cannula distal end 106 to the blood flow port 112, is a gauze. The distance S is equal to or longer than the distance S. Furthermore, the distance S is made larger than the distance P, which is the distance from the blood flow port 112 to the bottom 120 of the pusher. With the pusher 116 in the home or fixed position, the cannula 102 is pulled a distance R so that the proximal end 104 of the cannula is near the top 118 of the pusher. The distance R is equal to or greater than the distance obtained by adding the distance D and the distance P. The first end 132 of the gauze is disposed within the lumen 114 of the blood vessel approximately the length of SP.

  If the gauze 130 is used with a securing means at its first end 132, the cannula 102 may be pulled a distance R, or the pusher 116 may be pushed a distance R with the cannula 102 secured as shown in FIG. 7D. The distance R is expressed as follows.

カニューレ１０２を距離Ｒ引いたとき、又は図７Ｄに示すように押し込み器１１６を距離Ｒ押し込んだとき、固定手段のみがカニューレの遠位端１０６を越えて露出するように距離Ｒは距離Ｄと距離Ｐの合計より小さい方がよい。この位置では、固定手段は血管の管腔７０４内にあり広がる。そして、カニューレ１０２と押し込み器１１６を、固定手段が血管壁１３４の内側に達するように同時に引き出し、血管の穿刺部位１２８に達するガーゼ１３０が止血を促進することを確実とする。

When the cannula 102 is pulled a distance R, or when the pusher 116 is pushed a distance R as shown in FIG. 7D, the distance R is a distance D and a distance so that only the securing means is exposed beyond the distal end 106 of the cannula. It is better to be smaller than the sum of P. In this position, the anchoring means lies within the vessel lumen 704 and expands. The cannula 102 and pusher 116 are then withdrawn simultaneously so that the anchoring means reaches the inside of the vessel wall 134, ensuring that the gauze 130 reaching the vascular puncture site 128 promotes hemostasis.

  As shown in FIGS. 5a and 5b, in order to place the gauze 130 within the vessel wall, the distance D (FIG. 1), which is the distance between the distal end 106 of the cannula and the blood flow port 112, is It is set to the distance S which is the length or more. Furthermore, the distance S is made the same as the distance P, which is the distance between the blood flow port 112 and the bottom 120 of the pusher. With the pusher 116 in the home or fixed position, the cannula 102 is pulled a distance R so that the proximal end 104 of the cannula is near the pusher 118. The distance R is not less than the distance obtained by adding the distance D and the distance P.

  As shown in FIG. 7D, when the gauze 130 is used with the fixing means of the first end 132, the cannula 102 may be pulled by the distance R, or the pusher 116 may be pushed by the distance R while the cannula 102 is fixed. Here, R is described as follows.

カニューレ１０２を距離Ｒ引いたとき、又は押し込み器１１６を距離Ｒ押し込んだとき、固定手段のみがカニューレの遠位端１０６を越えて露出するように、距離Ｒは距離Ｄと距離Ｐを足しあわせた距離より小さい距離とする。この位置で、固定手段は血管の管腔７０４内に露出し、広がる。そして、カニューレ１０２と押し込み器１１６を、固定手段が血管壁１３４の内側に達するように同時に引き出し、血管の穿刺部位１２８に達するガーゼ１３０が止血を促進することを確実とする。

When the cannula 102 is pulled a distance R or when the pusher 116 is pushed a distance R, the distance R is the sum of the distance D and the distance P so that only the securing means is exposed beyond the distal end 106 of the cannula. The distance is smaller than the distance. In this position, the anchoring means is exposed and spreads within the vessel lumen 704. The cannula 102 and pusher 116 are then withdrawn simultaneously so that the anchoring means reaches the inside of the vessel wall 134, ensuring that the gauze 130 reaching the vascular puncture site 128 promotes hemostasis.

  As shown in FIG. 6A, in order to place the gauze 130 adjacent to the vascular puncture site 128, the distance D, which is the distance between the distal end 106 of the cannula and the blood flow port 112, is determined by the length of the gauze. The distance S is greater than or equal to Furthermore, the distance S is smaller than the distance P, which is the distance between the blood flow port 112 and the bottom 120 of the pusher. With the pusher in place or fixed position, pulling the cannula 102 a distance R brings the proximal end 104 of the cannula to a position adjacent to the top 118 of the pusher. The distance R is not less than the distance obtained by adding the distance D and the distance P. A length corresponding to approximately PS of the first end 132 of the gauze is located outside the puncture site 128 of the blood vessel. As shown in FIG. 6B, a gauze having protrusions 600a, 600b with distal ends extending laterally may also be used to effectively place the gauze 130 adjacent to the puncture site 128 of the blood vessel.

  When using the embodiment shown in FIG. 2 or FIG. 3, once the device 100 is correctly positioned at the vascular puncture site 128, the pusher bottom 306 is positioned at a distance P before deploying the gauze 130. . The distance P differs depending on whether the gauze 130 is placed in the lumen of the blood vessel, in the blood vessel wall, or in a position adjacent to the puncture site of the blood vessel.

  7A-7H illustrate a method of promoting hemostasis at a vascular puncture site. As shown in FIG. 7A, the cannula 700 has a blood flow port 706 at the distal end 708 of the cannula and a gauze 710 disposed below the blood flow port 706. The cannula 700 and pusher 702 are pushed into the blood vessel lumen 704 until the blood flow port 706 is located in the blood vessel lumen 704. In this position, blood flows from within the blood flow port 706 through the pusher lumen 712 and out of the blood flow outlet 714 as indicated by arrow 724. When the blood flow port 706 is located in the lumen 704 of the blood vessel, the blood flows stably from the blood flow outlet 714. However, in the case where the blood vessel is located outside the blood vessel lumen or inside the blood vessel wall, the blood does not flow stably from the blood flow outlet 714 as will be described later with reference to FIG. 7B. Such visual indicators of blood flow out of the blood flow outlet 714 assist the user in placing the device 716 at the puncture site 718 of the blood vessel.

  The device can be used with or without guidewire 722, or other placement devices. When used with the guide wire 722, the gauze 710 has an axial passage for passing the guide wire or the like (not shown). When used without a guide wire, the present invention is placed in an existing process envelope that is already placed in an artery or vessel (not shown). However, if a process cover is used, the blood flow port 112 needs to be positioned beyond the distal end of the process cover in order to properly position the device 716.

  In other embodiments, the blood flow outlet 202 is located at the proximal end of the cannula, as shown in FIG. In this embodiment, blood flows from the blood flow port 112 through the cannula lumen 110 and from the blood flow outlet 202. The cannula lumen 110 is preferably undisturbed to maximize blood flow in the lumen toward the blood flow outlet in order to visually capture the bleedback. Thus, the bottom 120 of the pusher is preferably located above the blood flow outlet 202. In other embodiments, as shown in FIGS. 3A and 3B, the pusher 302 may be a stylet and disk, or other similar type of pusher 312. As shown in FIGS. 3A and 3B, the stylet may be connected integrally to the disk, connected to the disk by another member such as a string 314, or connected to the disk. It does not have to be. The disk 306 is disposed below the blood flow port 112 and close to the second end 133 of the gauze. The diameter of the disk 306 is less than or equal to the inner diameter of the cannula. The diameter of the disc is as small as 1 French, preferably larger than 3 French. The stylet or extension 310 is preferably as small as possible, such as 3 French or less, and is strong enough to remove the gauze from the cannula. With such a configuration, the space in the lumen 110 of the cannula, which is a blood flow path from the blood flow port 112 to the blood flow outlet 304, is maximized. The stylet may have a shaft shape as shown in FIGS. 3A and 3B or a plenum shape that divides the lumen of the cannula into two or more lumens (not shown). Any shape is acceptable.

  FIG. 7B shows the device in a state after FIG. 7A. The cannula 700, the gauze 710, the blood flow port 706, and the pusher 702 are simultaneously withdrawn from the vessel lumen 704 until no bleed back is observed from the blood flow outlet. This indicates to the user that the device 716 is located at or near the puncture site 718 of the blood vessel.

  Once the device is in place, the gauze 710 is released to promote hemostasis. When using the apparatus of the embodiment of FIGS. 2 and 3, the pusher 116 is repositioned at a distance P before deploying the gauze 130. As described above, the distance P varies depending on whether the gauze 710 is disposed in the lumen of the blood vessel, in the blood vessel wall, or in the vicinity of the puncture site of the blood vessel.

  The gauze 710 is placed at various locations to promote hemostasis at the vascular puncture site 718. One location is within the lumen 704 of the blood vessel as shown in FIGS. Other locations include within the vessel wall or arteriotomy site 742 as shown in FIGS. 7F and 7G. As another position, there is a position adjacent to the blood vessel wall 718 as shown in FIG. 7H.

  As shown in FIGS. 7C-7E, a distance D (FIG. 7B), which is the distance between the distal end 708 of the cannula and the blood flow port 706, is used to place the gauze 710 within the lumen 704 of the blood vessel. The distance S is the length of the gauze 710 or more. Further, the distance S is made larger than the distance P, which is the distance between the blood flow port 706 and the bottom portion 726 of the pusher. As shown in FIG. 7C, with the pusher 702 in the home or fixed position, the cannula 700 is pulled a distance R in the direction of arrow 732 so that the proximal end 728 of the cannula is near the top 730 of the pusher. . The distance R is equal to or greater than the distance obtained by adding the distances D and P. The approximate distance SP of the first end 734 of the gauze will be within the lumen 704 of the blood vessel.

  In another embodiment as shown in FIGS. 7D and 7E, a gauze having a fixing means is used. The securing means is arranged at the first end, the second end or the longitudinal direction of the gauze so that it does not move when the gauze is deployed. The fixing means includes a pair of side protrusions as shown in FIGS. 7D and 7E, an expandable clip 800 as shown in FIG. 8A, a close shuttlecock-like member 802 as shown in FIG. 8B, and shown in FIG. 8C. 8 can be an expandable pineapple-shaped member, a trampoline or umbrella frame-shaped member 806 as shown in FIG. 8D, a vertically or horizontally intersecting surface, an expandable mesh, ridge, or protrusion. May be.

  When using a gauze 710 with a securing means 736 at the first end 734, the gauze is stuffed into the cannula lumen without being deployed. Pull the cannula 700 a distance R with the pusher 702 fixed, or push the pusher 702 a distance R into the cannula with the cannula 700 fixed. The distance R is smaller than the distance obtained by adding the distance D and the distance P, and is equal to or longer than the length of the fixing means 736. The distance R is such that the securing means 736 is exposed beyond the distal end 708 of the cannula when the cannula is pulled by the distance R or when the pusher 702 is pushed into the cannula. In this position, as shown in FIG. 7D, the securing means 736 is exposed and expands into the vessel lumen 704. Part or all of the second end of the gauze remains in the cannula 700. As shown in FIG. 7E, cannula 700 and pusher 702 are simultaneously withdrawn from the tissue region in the direction of arrow 732. As a result, the fixing means catches the inside of the blood vessel wall 740, the gauze 710 is separated from the cannula 700, is located at the puncture site 718 of the blood vessel, and promotes hemostasis.

  Similar to FIG. 7D, but in other embodiments, as shown in FIG. 7G, when using a gauze 710 having a locking means 736 at the first end 734 of the gauze, the locking means 736 is within the lumen of the cannula. Compressed in an unexpanded state. Pull the cannula 700 a distance R with the pusher fixed, or push the pusher 702 the distance R into the cannula with the cannula 700 fixed. The distance R is smaller than the distance obtained by adding the distance D and the distance P, and is not less than the length of the fixing means 736. The distance R is such that when the cannula 700 is pulled a distance R, or when the pusher 702 is pushed a distance R into the cannula 700, only the securing means 736 is exposed beyond the distal end 708 of the cannula. In this position, as shown in FIG. 7D, the securing means 736 is exposed and spreads within the lumen 704 of the blood vessel. Part or all of the second end of the gauze remains inside the cannula 700. Thereafter, as shown in FIG. 7E, the cannula 700 and pusher 702 are simultaneously pulled from the tissue region in the direction of arrow 732 so that the securing means captures the inside of the vessel wall 740 and the gauze 710 is released at the puncture site 718 of the vessel. Be sure to promote hemostasis.

  To place the gauze 710 adjacent to the vascular puncture site 718, as shown in FIG. 7H, the distance D (FIG. 7B), which is the distance between the distal end 708 of the cannula and the blood flow port 706, is The distance S is equal to or longer than the distance S. Further, the distance S is made smaller than the distance P, which is the distance between the blood flow port 706 and the bottom 726 of the pusher. As shown in FIG. 7H, with the pusher 702 in the home or fixed position, the cannula 700 is pulled a distance R in the direction of arrow 732 such that the proximal end 728 of the cannula is located near the top 730 of the pusher. . The distance R is equal to or greater than the distance obtained by adding the distance D and the distance P. The first end 734 of the gauze will be located outside the puncture site 718 of the blood vessel by a distance PS approximately.

  While multiple embodiments and devices of the present invention are disclosed herein, it will be apparent to those skilled in the art that the benefits of this disclosure can be variously modified without departing from the spirit of the invention herein. is there. Accordingly, the invention is not limited except as by the spirit of the appended claims.

1 shows an apparatus according to an embodiment of the present invention placed in a lumen of a blood vessel to promote hemostasis at a vascular puncture site. Fig. 4 shows another embodiment of the device according to the present invention for promoting hemostasis of a vascular puncture site. Fig. 6 shows a device according to yet another embodiment of the present invention for promoting hemostasis of a vascular puncture site. Fig. 6 shows a device according to yet another embodiment of the present invention for promoting hemostasis of a vascular puncture site. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Figure 3 shows gauze placed in the lumen of a blood vessel. Fig. 2 shows a gauze placed in a vessel wall. Fig. 2 shows a gauze placed in a vessel wall. Fig. 3 shows a gauze placed adjacent to a puncture site of a blood vessel. Fig. 3 shows a gauze placed adjacent to a puncture site of a blood vessel. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. A method of promoting hemostasis at a puncture site of a blood vessel is shown. One form of gauze concerning the present invention is shown. One form of gauze concerning the present invention is shown. One form of gauze concerning the present invention is shown. One form of gauze concerning the present invention is shown.

Explanation of symbols

100 device 102 cannula 104 proximal end 106 distal end 108 inner diameter 110 lumen 112 blood flow port 114 blood vessel lumen 116 pusher 118 top 120 bottom 126 blood flow outlet 134 blood vessel wall

Claims (38)

A cannula having a distal end, a proximal end, an inner diameter, and a lumen extending from the distal end to the proximal end, the distal end being positionable in the blood vessel from a puncture site of the blood vessel;
A blood flow port located near the distal end;
Top, bottom, and a pusher having a lumen extending from the top to the bottom, the bottom is slidably received through the proximal end to the lumen of the cannula, lumen of the cannula and pusher The pusher constituting the blood flow channel by communicating with the lumen of
A blood flow outlet located near the top;
A first end located at the distal end in the lumen of the cannula and a second end located distal to the blood flow port and forming a boundary on the distal side of the blood flow passage; Having gauze,
A device for promoting hemostasis of a puncture site of a blood vessel having a blood vessel.   The apparatus of claim 1, further comprising a guide wire slidably received in the pusher lumen, the lumen of the cannula, the gauze, and the puncture site of the blood vessel.   The apparatus of claim 1, wherein the bottom of the pusher is approximately equal to or less than the inner diameter of the cannula. A first distance from the proximal end to the top;
A second distance from the blood flow port to the bottom;
A third distance from the distal end to the blood flow port;
A fourth distance from the first end to the second end;
The apparatus of claim 1 further comprising:   The apparatus according to claim 4, wherein the third distance is equal to or greater than the fourth distance, and the first distance is equal to or greater than a distance obtained by adding the second distance and the third distance. The fourth distance is greater than the second distance and when the proximal end of the cannula is pulled adjacent the top of the pusher with the pusher in place, the gauze The apparatus of claim 5, wherein a first end is located within the vessel wall.   The fourth distance is less than the second distance and when the proximal end of the cannula is pulled adjacent to the top of the pusher with the pusher in place, the gauze The apparatus of claim 5, wherein the first end is located within the lumen of the blood vessel.   The fourth distance is equal to the second distance and when the proximal end of the cannula is pulled adjacent to the top of the pusher with the pusher in place, the gauze The apparatus of claim 5, wherein a first end is adjacent to the puncture site of the blood vessel.   The apparatus of claim 1, wherein a diameter of the first end of the gauze is substantially the same as an inner diameter of the cannula.   The device of claim 1, wherein the gauze further comprises a hemostatic agent that chemically activates the coagulation cascade.   The apparatus of claim 1, wherein the gauze further comprises a wetting agent.   The apparatus of claim 1, wherein the gauze further comprises a securing means.   The apparatus according to claim 12, wherein the fixing means is a bioadhesive agent.   The apparatus of claim 12, wherein the securing means is connected to the first end of the gauze.   The apparatus of claim 12, wherein the securing means is connected to the second end of the gauze.   The apparatus of claim 12, wherein the securing means comprises at least one expandable protrusion.   13. Apparatus according to claim 12, wherein the securing means has at least one side protrusion.   The apparatus of claim 12, wherein the securing means is expandable.   13. A device according to claim 12, wherein the securing means is absorbent. A cannula having a distal end, a proximal end, an inner diameter, and a lumen extending from the distal end to the proximal end, the distal end being positionable in the blood vessel from a puncture site of the blood vessel;
A blood flow port located near the distal end;
A blood flow outlet located near the proximal end;
A pusher having a top, a bottom, and a lumen extending from the top to the bottom, the bottom being slidably received through the proximal end of the cannula to form a flow path for blood flow The pusher;
A first end located at the distal end in the lumen of the cannula and a second end located distal to the blood flow port and forming a boundary on the distal side of the blood flow passage; Having gauze,
A device for promoting hemostasis of a puncture site of a blood vessel having a blood vessel.   21. The device of claim 20, wherein the bottom diameter of the pusher is less than or equal to the inner diameter of the cannula. A first distance from the proximal end to the top;
A second distance from the blood flow port to the bottom;
A third distance from the distal end to the blood flow port;
A fourth distance from the first end to the second end;
21. The apparatus of claim 20, further comprising:   23. The apparatus according to claim 22, wherein the third distance is equal to or greater than the fourth distance, and the first distance is equal to or greater than a distance obtained by adding the second distance and the third distance.   The fourth distance is greater than the second distance and when the proximal end of the cannula is pulled adjacent the top of the pusher with the pusher in place, the gauze 24. The device of claim 23, wherein a first end is located within the vessel wall.   The fourth distance is less than the second distance and when the proximal end of the cannula is pulled adjacent to the top of the pusher with the pusher in place, the gauze 24. The device of claim 23, wherein the first end is located within the lumen of the blood vessel.   The fourth distance is equal to the second distance and when the proximal end of the cannula is pulled adjacent to the top of the pusher with the pusher in place, the gauze 24. The device of claim 23, wherein a first end is adjacent to the puncture site of the blood vessel.   21. The apparatus of claim 20, wherein the diameter of the first end of the gauze is substantially the same as the inner diameter of the cannula.   21. The device of claim 20, wherein the gauze further comprises a wetting agent.   21. The apparatus of claim 20, wherein the gauze further comprises a securing means.   30. The apparatus of claim 29, wherein the fixing means is a bioadhesive agent.   30. The apparatus of claim 29, wherein the securing means is connected to the first end of the gauze.   30. The apparatus of claim 29, wherein the securing means is connected to the second end of the gauze.   30. The apparatus of claim 29, wherein the securing means has at least one expandable protrusion. 30. The apparatus of claim 29, wherein the securing means has at least one side protrusion.   21. The device of claim 20, wherein the gauze further comprises a hemostatic agent that chemically activates the coagulation cascade.   21. The device of claim 20, wherein the bottom of the pusher is positioned adjacent to the second end of the gauze, initially below the blood flow port.   21. The apparatus of claim 20, wherein the bottom of the pusher has a diameter that is less than or equal to the inner diameter of the cannula. The bottom of the pusher is initially positioned to be located above the blood flow outlet so as to maximize the area within the lumen of the cannula and maximize the blood flow from the blood flow outlet. as the apparatus of claim 20.

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