Apparatus and method to stop bleeding
27 claims: 2 independent, 25 dependent
- 1止血デバイスであって、 出血が停止されるべき手首上の穿刺部位において患者の手首の周囲に巻着されるように適合されるバンドと、 前記バンドを巻着された状態で前記患者の手首に固着するための締結具と、 内側 を有する圧迫部材であって、前記圧迫部材は、前記圧迫部材が前記バンドより剛性であるような材料から作製され、前記圧迫部材は、前記圧迫部材の中心と第1の端部との間に位置する、前記圧迫部材の第1の半分内の第1の部分と、前記圧迫部材の前記中心と第2の端部との間に位置する、前記圧迫部材の第2の半分内の第2の部分と、前記圧迫部材の前記第1の端部から、前記中心を通って、前記圧迫部材の前記第2の端部まで横断する軸とを保有する、圧迫部材と、 前記圧迫部材の前記第1の端部から前記圧迫部材の前記中心に対してオフセットされた位置において前記圧迫部材の前記第1の半分内の前記 内側 上に提供される第1のバルーンであって、前記第1のバルーンは、複数の線形側を備え、前記第1のバルーンは、前記バンドと接触する少なくとも第1の線形側を有し、前記第1のバルーンは、流体がその中に導入されると膨張するように構成されている、第1のバルーンと、 前記圧迫部材の前記第2の半分内の前記 内側 上に提供される第2のバルーンであって、前記第2のバルーンは、複数の線形側を備え、前記第2のバルーンは、前記バンドと接触する少なくとも第1の線形側を有し、前記第2のバルーンは、前記流体がその中に導入されると膨張するように構成されている、第2のバルーンと を備える、止血デバイス。
- 2膨張に応じて、前記第1のバルーンの少なくとも第1の線形側は、前記バンドとの接触から外れて移動可能であり、膨張に応じて、前記第2のバルーンの少なくとも第1の線形側は、前記バンドとの接触から外れて移動可能である、請求項1に記載の止血デバイス。
- 3前記第1のバルーンは、前記第1のバルーンの第2の線形側上の第1のコネクタによって前記バンドに接続され、前記第1のバルーンの第2の線形側は、前記圧迫部材の前記中心に隣接し、前記圧迫部材の前記軸と垂直であり、前記第2のバルーンは、前記第2のバルーンの第2の線形側上の第2のコネクタによって前記バンドに接続され、前記第2のバルーンは、前記圧迫部材の前記中心から前記圧迫部材の縁に対してオフセットされた位置にあり、前記第2のバルーンの第2の線形側は、前記圧迫部材の前記縁に隣接し、前記圧迫部材の前記軸と平行である、請求項1または2に記載の止血デバイス。
- 4前記第1のバルーンは、前記第1のバルーンの第2の線形側上の第1のコネクタによって前記バンドに接続される、請求項1または2に記載の止血デバイス。
- 5前記第1のバルーンの第2の線形側は、前記圧迫部材の前記中心に隣接し、前記圧迫部材の前記軸と垂直である、請求項4に記載の止血デバイス。
- 6前記第2のバルーンは、前記第2のバルーンの第2の線形側上の第2のコネクタによって前記バンドに接続される、請求項1または2に記載の止血デバイス。
- 7前記第2のバルーンは、前記圧迫部材の前記中心から前記圧迫部材の縁に対してオフセットされた位置にあり、前記第2のバルーンの第2の線形側は、前記圧迫部材の前記縁に隣接し、前記圧迫部材の前記軸と平行である、請求項6に記載の止血デバイス。
- 8前記第2のバルーンは、前記圧迫部材の前記第2の端部から前記圧迫部材の前記中心に対してオフセットされた位置にあり、前記第2のバルーンの第2の線形側は、前記圧迫部材の前記中心に隣接し、前記圧迫部材の前記軸と垂直である、請求項6に記載の止血デバイス。
- 9前記圧迫部材は、複数の横木と、前記圧迫部材の前記第1の半分内の第1の湾曲部分と、前記圧迫部材の前記第2の半分内の第2の湾曲部分とを備える湾曲フレームである、請求項1または2に記載の止血デバイス。
- 10前記圧迫部材は、湾曲プレートである、請求項1または2に記載の止血デバイス。
- 11前記第1のバルーンの幅は、前記バンドの幅とほぼ同一であり、前記第2のバルーンの幅は、前記バンドの幅未満である、請求項1または2に記載の止血デバイス。
- 12前記第2のバルーンの幅は、前記バンドの幅の70%未満である、請求項11に記載の止血デバイス。
- 13前記バンド、前記圧迫部材、および前記第1のバルーンは、出血が停止されるべき部位が、前記 バ ンドを通して、前記圧迫部材を通して、および前記第1のバルーンを通して視認され得るように、実質的に透明材料から作製される、請求項1または2に記載の止血デバイス。
- 14前記圧迫部材の前記第1の湾曲部分の曲率半径は、前記圧迫部材の前記第2の湾曲部分の曲率半径とほぼ同一である、請求項9に記載の止血デバイス。
- 15圧迫部材ホルダを画定する二重層構造を含む第1のスリーブをさらに備え、前記圧迫部材は、前記圧迫部材が前記バンドの圧迫部材ホルダ内に保持されるように、前記二重層構造内の間隙の中に位置付けられる、請求項1または2に記載の止血デバイス。
- 16前記第1のバルーンを出血が停止されるべき部位に位置付けるためのマーカをさらに備える、請求項1または2に記載の止血デバイス。
- 17前記第1のバルーンの内部と連通する第1の管と、前記第1の管に接続された第1のアダプタであって、その中に第1の注射器が挿入可能であり、前記第1の注射器内の第1の流体を前記第1の管を経由して前記第1のバルーンの中に導入する、第1のアダプタと、前記第2のバルーンの内部と連通する第2の管と、前記第2の管に接続された第2のアダプタであって、その中に第2の注射器が挿入可能であり、前記第2の注射器内の第2の流体を前記第2の管を経由して前記第2のバルーンの中に導入する、第2のアダプタとをさらに備える、請求項15に記載の止血デバイス。
- 18前記第1のアダプタおよび前記第2のアダプタのためのアダプタホルダを画定する二重層構造を含む第2のスリーブをさらに備え、前記第1のアダプタおよび前記第2のアダプタは、前記第1および第2のアダプタが前記バンドの前記アダプタホルダ内に保持されるように、前記二重層構造内の間隙の中に位置付けられる、請求項17に記載の止血デバイス。
- 19前記第1のアダプタは、前記第2のアダプタと識別可能に異なり、識別可能差異は、色、形状、質感、またはそれらの組み合わせを含む、請求項17に記載の止血デバイス。
- 20前記穿刺部位における皮膚に接触する前記第1のバルーンの表面は、少なくとも血管拡張薬で処置される、請求項1または2に記載の止血デバイス。
- 21前記締結具は、フック材料およびループ材料を備え、前記フック材料は、前記バンドの第1の端部に設置され、前記ループ材料は、前記バンドの第2の端部に設置される、請求項1または2に記載の止血デバイス。
- 22前記バンドの幅は、40mmを上回る、請求項1または2に記載の止血デバイス。
- 23前記第1のバルーンの幅は、前記バンドの幅とほぼ同一であり、前記第2のバルーンの幅は、前記バンドの幅とほぼ同一である、請求項1または2に記載の止血デバイス。
- 24前記第1のバルーンを前記バンドに接続する第3のコネクタをさらに備え、前記第3のコネクタは、前記第1のバルーンの第3の線形側上にある、請求項4に記載の止血デバイス。
- 25前記第1のバルーンの第3の線形側は、 前 記圧迫部材の前記軸と平行である、請求項24に記載の止血デバイス。
- 26前記第2のバルーンを前記バンドに接続する第4のコネクタをさらに備え、前記第4のコネクタは、前記第2のバルーンの第3の線形側上にある、請求項6に記載の止血デバイス。
- 27前記第2のバルーンを前記バンドに接続する第4のコネクタをさらに備え、前記第4のコネクタは、前記第2のバルーンの第3の線形側上にあり、前記第2のバルーンの第3の線形側は、 前 記圧迫部材の前記軸と平行である、請求項8に記載の止血デバイス。
Independent claims27
57 paragraphs, as filed
(Cross-reference to related applications) This application is ahead of U.S. Provisional Patent Application No. 62 / 288,982 filed on January 29, 2016 and U.S. Patent Application No. 14 / 8,19,383 filed on August 5, 2015. Claims the benefit of the filing date of.
The embodiments described herein relate to devices and methods for obtaining hemostasis after puncturing a blood pathway, including, but not limited to, puncturing a radial or ulnar artery.
Vascular puncture is generally required for performing intravascular procedures. The smaller the inner diameter of the artery, including the radius, ulna, and ankle, the easier it is to manage after the procedure because bleeding can be more easily controlled using external pressure. However, occlusion of these arteries occurs more frequently and results in a permanent loss of patency compared to larger arteries.
Radial artery occlusion is the result of a radial artery cannulation, which refers to the obstruction of the radial artery and causes the radial artery lumen to disappear. Hemostatic devices that are attached by wrapping around the part of the arm where the puncture site (also called the access site) is located and compress the puncture site where bleeding should be stopped are prior art (eg, first. It is already known in US7,498,477B2, US8,481,803, US8,481,805, JP3,031,486U). In prior art hemostatic devices, the pressure applied to the puncture site can lead to radial artery occlusion and make it unavailable for future access.
Radial artery occlusion occurs in 2-10% of patients after transradial access and is often associated with the disappearance of the radial artery lumen, making the radial artery an intravascular procedure, invasive monitoring, or bypass conduit. Make it unsuitable for future access due to its usefulness. Prevention of radial artery occlusion is paramount to avoiding loss of primary blood source, future repetitive access, and other usefulness of the radial artery after transradial access. Maintaining radial artery flow during hemostatic compression has been shown to reduce the risk of radial artery occlusion (PROPHET Trial, Pancholy S et al, Catheterization and Cardiovascular Interventions 2008: 72 (3); 335-340). .. Shortening the duration of compression has also been shown to reduce the risk of radial artery occlusion (Pancholy S et al, Catheterization and Cardiovascular Interventions 2012: 79 (1): 78-81). Therefore, it is known that maintaining blood flow in the radial artery while compressing the access site after using the device reduces the risk of radial artery occlusion after using the device. Patriotic hemostasis is therefore understood to mean achieving bleeding arrest at the cannulated wound (access site) of the radial artery while allowing blood to flow through that artery.
In an article entitled Efficacy and Safety of Transient Ulnar Artery Compression to Recanalize Acute Radial Artery Occlusion After Transradial Catheterization (Am J Cardiol 2011; 107: 1698-1701), Ivo Bernat (MD) et al. It discusses methods aimed at opening the later occluded radial artery. In this study, in patients with radial artery occlusion, ulnar artery compression was applied 3 to 4 hours after the radial artery was stopped, and an attempt was made to reopen the radial artery. Bernat et. Al. Achieved a higher success rate in reopening the radial artery by administration of heparin and compression of the ipsilateral ulnar artery.
<p><patcit num="1"><text>U.S. Pat. No. 7,498,477B2</text></patcit><patcit num="2"><text>U.S. Pat. No. 8,481,803</text></patcit><patcit num="3"><text>U.S. Pat. No. 8,481,805</text></patcit><patcit num="4"><text>Utility Model Registration No. 3,031,486 Gazette</text></patcit></p>
<p><nplcit num="1"><text>PROPHET Trial, Pancholy S et al, Catheterization and Cardiovascular Interventions 2008: 72 (3); 335-340</text></nplcit><nplcit num="2"><text>Pancholy S et al, Catheterization and Cardiovascular Interventions 2012: 79 (1): 78-81</text></nplcit><nplcit num="3"><text>Efficacy and Safety of Transient Ulnar Artery Compression to Recanalize Acute Radial Artery Occlusion After Transradial Catheterization (Am J Cardiol 2011; 107: 1698-1701)</text></nplcit></p>
<p> Transradial and ulnar ulnar punctures are increasingly being used to gain vascular access for intravascular procedures. In one embodiment, the hemostatic device comprises two balloons, and after transradial artery access, bleeding from the radial artery is stopped by compressing the radial artery at the puncture site using the expansion of the first balloon. Radial artery flow is increased by occlusive compression of the ipsilateral ulnar artery using dilation of the second balloon. The method maintains blood flow within the radial artery while compressing the access site after removal of the catheter, thereby reducing the risk of radial artery occlusion after instrument use. In one embodiment, the first balloon covers the puncture site, which is located over the radial artery and is generally about 2 cm from the base of the palm, and the second balloon is close to the base of the palm (Guillon's canal). Located over the ulnar artery in position, thereby compressing the ulnar artery at the most accessible location for compression.</p><p> In another embodiment, the two balloons are part of a band, which is wrapped around the limbs. The center of the first balloon and the center of the second balloon are offset from each other in relation to the centerline of the band axis. In yet another embodiment, the first balloon is larger than the second balloon. In another embodiment, the balloon has a rectangular shape. In one embodiment, the first balloon extends over the width of the band. In one embodiment, the width of the band exceeds 40 mm. In another embodiment, the width of the band exceeds 45 mm. In yet another embodiment, the band has a width of about 55 mm.</p><p> In another embodiment, the hemostatic device has a flexible band and a medial peripheral side that is adapted to be wrapped and anchored around the patient's hand at the site of the hand where bleeding should be stopped. A first compression member, made of a material that is more rigid than the band, and provided on the medial peripheral side at a position deviating from the central portion of the compression member in the length direction of the band. A first balloon and the width direction of the band, which is a balloon that is connected to the band by a connector on the side of the first balloon adjacent to the central portion of the compression member and inflates when fluid is introduced into it. A second balloon provided on the inner peripheral side of the compression member at a position deviating from the central portion of the compression member with respect to the edge of the compression member, and the side of the second balloon adjacent to the edge of the compression member. It comprises a second balloon, which is connected to the band by the upper connector and inflates when fluid is introduced into it. In one embodiment, the compression member is a curved frame with crossbars. In some embodiments, the crossbars may be equidistant from each other along the length of the frame. In other embodiments, the crossbars may alternate, whereby some crossbars are in close proximity to each other while others are diffused. In another embodiment, the frame has a crossbar at the center and curved solid pieces at the proximal and distal ends of the frame. In yet another embodiment, the compression member is a curved plate.</p><p> In some embodiments, at least a portion of the compression member is curved towards the medial periphery at the proximal and distal ends of the compression member. In one embodiment, the radius of curvature of the compression member at the proximal end is approximately the same as the radius of curvature of the compression member at the distal end. In another embodiment, the compression member may have a contour shape, whereby the band presses snugly against the wrist and the base of the palm, and the contour shape facilitates compression of the ulnar artery at the base of the palm. To do.</p><p> In one embodiment, the curved compression member is located between the center of the compression member and the first end, a first curved portion within the first half of the compression member, and a center and a first curved compression member. From the second curved portion in the second half of the compression member and the first end of the curved compression member, located between the two ends, through the center of the compression member, the second of the curved compression member. Has an axis that traverses to the end of. The first balloon is provided on the medial peripheral side within the first half of the curved compression member at a position offset from the first end of the curved compression member with respect to the center of the curved compression member. In another embodiment, the second balloon is provided on the medial peripheral side within the second half of the curved compression member at a position offset from the center of the curved compression member with respect to the edge of the curved compression member.</p><p> During operation, the method of catheterization of the radial artery involves inserting the sheath into the patient's radial artery at the access site. The desired catheter placement procedure is then performed using a sheath or catheter to access the radial artery. In one embodiment, once the catheter placement procedure is complete, ulnar pressure is applied to the ipsilateral ulnar artery at the ulnar pressure site while the sheath remains inserted within the radial artery. The sheath is then removed from the radial artery while maintaining ulnar pressure on the ulnar artery. Once the sheath is removed while continuing to apply ulnar pressure, pressure is applied to the radial artery at the access site, resulting in hemostasis at the access site. In another embodiment, once the catheter placement procedure is complete, radial pressure is applied to the radial artery at the access site. Ulnar pressure is then applied to the ulnar artery at the ulnar pressure site while maintaining pressure on the radial artery. In yet another embodiment, the application of pressure at the access site to the radial artery to obtain hemostasis at the access site is performed while maintaining the ulnar pressure on the ulnar artery.<u style="single">The present invention provides, for example,:</u><u style="single">(Item 1)</u><u style="single">Hemostatic device</u><u style="single">With a band, which is adapted to be wrapped around the patient's wrist at the puncture site on the wrist where bleeding should be stopped,</u><u style="single">A fastener for fixing the band to the patient's wrist in a wound state, and</u><u style="single">A compression member having an inner peripheral side, wherein the compression member is made of a material such that the compression member is more rigid than the band, and at least a part thereof is curved toward the inner peripheral side. The compression member includes a first curved portion within the first half of the compression member, a center and a second end of the compression member, located between the center of the compression member and the first end. A second curved portion within a second half of the compression member, located between the two, and a first end of the compression member, traverse through the center to a second end of the compression member. The compression member that holds the shaft,</u><u style="single">A first balloon provided on the inner peripheral side within the first half of the compression member at a position offset from the first end of the compression member with respect to the center of the compression member. The first balloon comprises a plurality of linear sides, the first balloon has at least a first linear side in contact with the band, and the first balloon has a fluid introduced therein. With the first balloon, which inflates and, in response to the expansion, at least the first linear side of the first balloon can move out of contact with the band.</u><u style="single">A second balloon provided on the medial peripheral side within the second half of the compression member, wherein the second balloon comprises a plurality of linear sides, the second balloon being said. Having at least the first linear side in contact with the band, the second balloon inflates when the fluid is introduced into it, and in response to expansion, at least the first of the second balloon. The linear side is a second balloon that can move out of contact with the band,</u><u style="single">A hemostatic device.</u><u style="single">(Item 2)</u><u style="single">The hemostatic device of item 1, wherein the first balloon is connected to the band by a first connector on the second linear side of the first balloon.</u><u style="single">(Item 3)</u><u style="single">The hemostatic device according to item 2, wherein the second linear side of the first balloon is adjacent to the center of the compression member and perpendicular to the axis of the compression member.</u><u style="single">(Item 4)</u><u style="single">The hemostatic device of item 1, wherein the second balloon is connected to the band by a second connector on the second linear side of the second balloon.</u><u style="single">(Item 5)</u><u style="single">The second balloon is located at a position offset from the center of the compression member with respect to the edge of the compression member, and the second linear side of the second balloon is adjacent to the edge of the compression member. The hemostatic device according to item 4, which is parallel to the axis of the compression member.</u><u style="single">(Item 6)</u><u style="single">The second balloon is located at a position offset from the second end of the compression member with respect to the center of the compression member, and the second linear side of the second balloon is the center of the compression member. 4. The hemostatic device according to item 4, which is adjacent to and perpendicular to the axis of the compression member.</u><u style="single">(Item 7)</u><u style="single">The hemostatic device according to item 1, wherein the compression member is a curved frame including a plurality of crossbars.</u><u style="single">(Item 8)</u><u style="single">The hemostatic device according to item 1, wherein the compression member is a curved plate.</u><u style="single">(Item 9)</u><u style="single">The hemostatic device according to item 1, wherein the width of the first balloon is substantially the same as the width of the band, and the width of the second balloon is less than the width of the band.</u><u style="single">(Item 10)</u><u style="single">9. The hemostatic device of item 9, wherein the width of the second balloon is less than 70% of the width of the band.</u><u style="single">(Item 11)</u><u style="single">The band, the compression member, and the first balloon are substantially such that the site where bleeding should be stopped can be seen through the flexible band, through the compression member, and through the first balloon. The hemostatic device according to item 1, which is made of a transparent material.</u><u style="single">(Item 12)</u><u style="single">The hemostatic device according to item 1, wherein the radius of curvature of the first curved portion of the compression member is substantially the same as the radius of curvature of the second curved portion of the compression member.</u><u style="single">(Item 13)</u><u style="single">The compression member further comprises a first sleeve comprising a double layer structure defining a compression member holder, the compression member having a gap in the double layer structure such that the compression member is held within the compression member holder of the band. The hemostatic device according to item 1, which is positioned in.</u><u style="single">(Item 14)</u><u style="single">The hemostatic device of item 1, further comprising a marker for locating the first balloon at a site where bleeding should be stopped.</u><u style="single">(Item 15)</u><u style="single">A first tube communicating with the inside of the first balloon and a first adapter connected to the first tube, wherein a first syringe can be inserted into the first tube. A first adapter that introduces a first fluid in a syringe into the first balloon via the first tube, a second tube that communicates with the inside of the second balloon, and the above. A second adapter connected to a second tube through which a second syringe can be inserted and a second fluid in the second syringe via the second tube. 13. The hemostatic device of item 13, further comprising a second adapter to be introduced into the second balloon.</u><u style="single">(Item 16)</u><u style="single">The first adapter and the second adapter further include a second sleeve, including a dual layer structure defining an adapter holder for the first adapter and the second adapter, the first adapter and the second adapter. The hemostatic device of item 15, wherein the second adapter is positioned in a gap within the bilayer structure such that it is held within the adapter holder of the band.</u><u style="single">(Item 17)</u><u style="single">The hemostatic device of item 15, wherein the first adapter is identifiable different from the second adapter, the identifiable difference comprising color, shape, texture, or a combination thereof.</u><u style="single">(Item 18)</u><u style="single">The hemostatic device of item 1, wherein the surface of the first balloon that will come into contact with the skin at the puncture site is treated with at least a vasodilator.</u><u style="single">(Item 19)</u><u style="single">The fastener comprises a hook material and a loop material, the hook material is installed at the first end of the band, and the loop material is installed at the second end of the band, item 1. Hemostatic device described in.</u><u style="single">(Item 20)</u><u style="single">The hemostatic device according to item 1, wherein the band width exceeds 40 mm.</u><u style="single">(Item 21)</u><u style="single">The hemostatic device according to item 1, wherein the width of the first balloon is substantially the same as the width of the band, and the width of the second balloon is substantially the same as the width of the band.</u><u style="single">(Item 22)</u><u style="single">The hemostatic device of item 2, further comprising a third connector for connecting the first balloon to the band, wherein the third connector is on the third linear side of the first balloon.</u><u style="single">(Item 23)</u><u style="single">22. The hemostatic device of item 22, wherein the third linear side of the first balloon is adjacent to the edge of the compression member and parallel to the axis of the compression member.</u><u style="single">(Item 24)</u><u style="single">The hemostatic device of item 4, further comprising a fourth connector for connecting the second balloon to the band, wherein the fourth connector is on the third linear side of the second balloon.</u><u style="single">(Item 25)</u><u style="single">Further comprising a fourth connector for connecting the second balloon to the band, the fourth connector is on the third linear side of the second balloon and is a third of the second balloon. The hemostatic device according to item 6, wherein the linear side is adjacent to the edge of the compression member and parallel to the axis of the compression member.</u></p>
<figref num="1">FIG. 1 is a schematic front view (FIG. 1A) and a schematic side view (FIG. 1B) of an embodiment of a hemostatic device 100 comprising at least two balloons 101 and 103 and a compression member, wherein the compression member is a crossbar. It is a curved frame with 104 and is installed in the sleeve 118 formed by the covers 110 attached to the strap 108.</figref>
<figref num="2">FIG. 2 is a schematic three-dimensional view (FIG. 2A), a schematic top view (FIG. 2B), and a schematic front view (FIG. 2C) of an embodiment of the compression member 200, wherein the compression member is a curved frame with a crossbar. Yes, with a crossbar 221 located between the two curved beams 223 and 225.</figref>
<figref num="3">FIG. 3 is a schematic front view (FIG. 3A) and a schematic side view (FIG. 3B) of an embodiment of the hemostatic device 300 comprising at least two balloons 301 and 303 and a compression member, wherein the compression member is curved. It is a plate 304 and is installed in a sleeve 318 formed by covers 310 attached to a strap 308.</figref>
<figref num="4">FIG. 4 is a schematic three-dimensional view (FIG. 4A), a schematic top view (FIG. 4B), and a schematic front view (FIG. 4C) of an embodiment of the compression member 400 which is a curved plate.</figref>
<figref num="5">FIG. 5 is a schematic representation of a hemostatic device 500 with two balloons 501 and 503. FIG. 5A is a schematic top view showing the side of the device that acts as an inner surface when the device is attached to the patient's wrist. FIG. 5B is a schematic front view of the device.</figref>
<figref num="6">FIG. 6 is a schematic cross-sectional view showing the hemostatic device of FIG. 1 during use. FIG. 6A shows a schematic cross-sectional front view of an embodiment of a hemostatic device applied on the patient's forearm. The two balloons 601, 603 are located between the patient's forearm and the strap 608 around the patient's forearm. FIG. 6B is a schematic cross-sectional side view of a portion of an embodiment of a hemostatic device showing that the balloon 603 is pressed onto the ulnar artery 607.</figref>
<figref num="7">FIG. 7 is a schematic representation of an embodiment of a hemostatic device showing the placement of a balloon 701 across the radial artery 705 and a balloon 703 across the ulnar artery 707.</figref>
<figref num="8">FIG. 8 is a schematic view of an embodiment of a hemostatic device wrapped around a patient's wrist, FIG. 8A is a front view and FIG. 8B is a rear view.</figref>
<figref num="9">FIG. 9 is a schematic representation of a balloon 900 in which the surface of the balloon to be in contact with the skin is placed with composition 905 and liner 907.</figref>
<figref num="10">FIG. 10 is a schematic front view (FIG. 10A) and a schematic side view (FIG. 10B) of an embodiment of a hemostatic device comprising at least two balloons 151 and 153 and a compression member, wherein the compression member is a frame. A curved frame 154 with a crossbar in the central portion and a curved solid piece 155 at the proximal and distal ends of the frame, mounted within a sleeve 168 formed by covers 160 to which the frame is attached to strap 158. To.</figref>
<figref num="11">FIG. 11 is a schematic three-dimensional view (FIG. 11A), a schematic top view (FIG. 11B), and a schematic front view (FIG. 11C) of an embodiment of the compression member, wherein the compression member is a curved frame with a crossbar. Includes a crossbar 261 located between the two curved beams 263 and 265 and a curved solid piece 264 at the proximal and distal ends of the frame.</figref>
<figref num="12">FIG. 12 is a schematic front view (FIG. 12A) and a schematic side view (FIG. 12B) of an embodiment of a hemostatic device comprising at least two balloons 351 and 353 and a compression member, wherein the compression member is a frame. A curved frame with a crossbar 354 in the central portion and a curved solid piece 355 at the proximal and distal ends of the frame, mounted within a sleeve 368 formed by covers 360 to which the frame is attached to strap 358. To.</figref>
<figref num="13">FIG. 13 is a schematic front view (FIG. 13A) and a schematic side view (FIG. 13B) of an embodiment of a hemostatic device comprising at least one balloon 451 and a compression member, wherein the compression member is a central portion of the frame. A curved frame with a crossbar 454 in the frame and a curved solid piece 455 at the proximal and distal ends of the frame, the frame being installed in a sleeve 468 formed by covers 460 attached to strap 458.</figref>
In the embodiments described herein, pressure is applied to an artery, eg, the access site of the radial artery, to obtain hemostasis, and the same device is used to apply pressure to another artery, eg, the ulnar artery. Provide users with safe, simple, and reliable devices and methods for applying to.
In one embodiment of the invention (see FIG. 1), the hemostatic device 100 is wrapped and secured around the patient's wrist by ties 112 and 114 at the puncture site on the hand where bleeding should be stopped. A flexible band comprising a fitted flexible strap 108, a curved frame 104, a first balloon 101, and a second balloon 103. The curved frame 104 is made of a material that has an inner peripheral side and the frame is more rigid than the flexible strap 108. In one embodiment, the frame is made of hard plastic and has a substantially fixed shape. In another embodiment, the frame is a material that is flexible (eg, plastic) so that the frame does not maintain a substantially fixed shape and flexes with the balloon as the balloon expands and contracts with pressure. ). In another embodiment, the spacing between crossbars within the frame is increased to make the frame more flexible. In yet another embodiment, the spacing between crossbars within the frame is reduced because the frame is not very flexible. At least a part of the frame is curved toward the inner peripheral side. The first balloon 101 is provided on the inner peripheral side at a position deviating from the first end of the curved frame in the length direction of the band with respect to the central portion of the curved frame, that is, the first balloon 101. Is provided on the medial peripheral side within the first half of the curved frame at a position offset from the first end of the curved frame with respect to the center of the curved frame, and the first balloon is the center of the curved frame. It is connected to the strap 108 by a connector 102 on the side of the first balloon adjacent to the portion. The first balloon inflates when a fluid is introduced into it. The second balloon 103 is provided on the inner peripheral side of the curved frame at a position deviating from the central portion of the curved frame in the width direction of the band with respect to the edge of the curved frame, that is, the second balloon 103 is provided. Curved flare at a position offset from the center of the curved frame to the edge of the curved frame Provided on the medial peripheral side within the second half of the mud, the second balloon is connected to strap 108 by a connector (not shown) on the side of the second balloon adjacent to the edge of the curved frame. To. The second balloon 103 inflates when a fluid is introduced into it. In one embodiment, the band 100 is adapted to be wrapped around the wrist using surface fasteners for fastening to the band around the wrist, such as hooks and loops 112 and 114. In some embodiments, cotton balls (not shown) are provided for patient comfort. In one embodiment, the cotton ball is made from foam.
In one embodiment, the band may have a first sleeve for holding the frame 104. In the embodiment shown in FIG. 1, the first sleeve is a bilayer structure formed by connecting a piece of film 110 to the strap 108 of the band at the central portion of the band. The connection is made by a suitable method such as welding (eg, thermal welding, high frequency welding, ultrasonic welding) or bonding / gluing (using an adhesive or solvent, etc.) to form a double layer structure. May be good. The frame 104 is inserted into the gap 118 in the double layer and thereby held. In one embodiment, in addition to the central portion of the band, at least one side edge of the band also has a sleeve. As shown in FIG. 1, the band may have a second sleeve 116 at the side end portion of the band. The second sleeve is a double layer structure formed by connecting a piece of film 106 to the strap 108 of the band. The connection may be made by a suitable method similar to that used to build the first sleeve.
The material of the film or sheet construction used to process the straps, balloons, and sleeves of the band 100 is preferably substantially transparent so that the patient's arm is visible through the band. Examples of structural materials include polyvinyl chloride, polyolefins such as polyethylene, polypropylene, polybutadiene and ethylene vinyl acetate copolymers (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polychloride. Examples include vinylidene, silicones, polyurethanes, various thermoplastic elastomers such as polyamide elastomers, polyurethane elastomers, and polyester elastomers, and any of the aforementioned combinations in the form of, for example, resin mixtures, polymeric alloys, or laminates. The sheet constituting the band may have any suitable thickness. In one embodiment, the thickness of the sheet material is in the range of about 0.1 to about 0.5 mm, and in some embodiments, from about 0.2 to about 0.3 mm. The band can be secured using hook and loop type fasteners or other suitable fasteners such as buttons, clips, and buckles.
The frame 200 (see Figure 2) is curved at both the proximal and distal ends, with the curvature towards the medial peripheral side. In one embodiment, the radius of curvature R at the proximal end<sub>1</sub>Is the radius of curvature R at the distal end<sub>2</sub>Is substantially the same as. In another embodiment, R<sub>1</sub>= R<sub>2</sub>Is. In another embodiment, the frame is symmetrical about its center. In one embodiment, the frame is constructed from a material that is more rigid than the band, but retains some flexibility so that the frame conforms to the wrist contour and accompanies the expansion and contraction of the balloon. And bend. In another embodiment, the frame maintains a substantially fixed shape.
In one embodiment, the frame 200 in FIG. 2 may be constructed from a substantially transparent material. In another embodiment, the material of the frame structure does not have to be transparent. Examples of materials for frame construction include acrylic resin, polyvinyl chloride (rigid polyvinyl chloride and flexible polyvinyl chloride), polyolefins such as polyethylene, polypropylene, and polybutadiene, polystyrene, poly (4-methyl-1). -Penten), Polycarbonate, ABS Resin, Polymethyl Methacrylate (PMMA), Polyacetal, Polyallylate, Polyacrylonitrile, Polyvinyl Fluoride Denylidene, Ionomer, Acrylonitrile-butadiene-Sinter Copolymer, Polyesters, eg Polyethylene terephthalate (PET) and Poly Examples include butylene terephthalate (PBT), butadiene-styrene copolymers, aromatic and aliphatic polyamides, and fluorocarbon resins such as polytetrafluoroethylene. The frame may also be made of metal or metal alloy.
The curved frame compression member 200 has a gap between the crossbars 221 that provides visibility of the puncture site. The crossbar is held between the two beams 223 and 225. Crossbars and beams can have a variety of shapes, such as circles, squares, rectangles, and ellipses. In one embodiment, the frame is completely curved. In another embodiment, the frame is straight in the center and curved at its ends. In one embodiment, the crossbars 221 are circular, with each crossbar having a diameter of about 2 mm. In another embodiment, the beams 223, 225 are also circular with a diameter of about 3 mm. In yet another embodiment, the gap 204 between the crossbars is about 2 mm. In one embodiment, the width of the frame is about 4 mm smaller than the width of the strap 108 of the band 100 in FIG. In yet another embodiment, the interstitial gap 204 in the central portion of the frame exceeds the interstitial gap 204 in the vicinity of the proximal and distal ends of the frame. In another embodiment, the curved frame compression member has a crossbar at the central portion of the frame and solid curved pieces at the proximal and distal ends of the compression member. In one embodiment, the solid piece has a thickness of about 2 mm. The width of the solid piece is about 4 mm smaller than the width of the band strap, thereby leaving a gap of about 2 mm on either side of the curved frame between the edge of the curved frame and the edge of the band strap. ..
In another embodiment of the invention (see FIG. 3), the hemostatic device comprises a flexible band 300. The band has a medial peripheral side and is flexible, adapted to be wrapped and secured around the patient's limbs using ties 312 and 314 at the site on the limb where bleeding should be stopped. It has a sex strap 308 and a plate 304 made of a material that is more rigid than the band, and at least a portion of the plate is curved towards its medial periphery at the proximal and distal ends of the plate. In one embodiment, the plate 304 has a substantially fixed shape. In another embodiment, the plate 304 is flexible and does not substantially maintain a fixed shape. The structural material of the plate 304 is the same as the structural material of the frame 200 discussed above. In one embodiment, the plate 304 is installed in a sleeve 318 formed by covers 310 attached to the strap 308 on the outer peripheral side of the strap in the central portion of the band. In another embodiment, the covers 310 and the strap 308 are both made of flexible plastic and are transparent. The covers 310 can be attached to the strap 308 using known techniques such as ultrasonic welding. In one embodiment, in addition to the central portion of the band, at least one side edge portion of the band has a sleeve 316. The sleeve at the side edge portion of the band may also have a double layer structure formed by connecting a piece of film 306 to the strap 308 on the outer peripheral side of the strap 308. The connection may be made by a suitable method similar to that used to build the sleeve in the central portion of the band. Plastic sheet materials used to make band straps can also be used to make sleeves.
The first balloon 301 is provided on the medial peripheral side at a position deviating from the first end of the curved plate in the length direction of the band with respect to the central portion of the curved plate, and the first balloon is the curved plate. It is connected to the strap 308 by a connector 302 on the side of the first balloon adjacent to the central portion of the. The first balloon inflates when a fluid is introduced into it. The second balloon 303 is provided on the inner peripheral side of the curved plate at a position deviating from the central portion of the curved plate in the width direction of the band with respect to the edge of the curved plate, and the second balloon is provided on the inner peripheral side of the curved plate. It is connected to strap 308 by a connector (not shown) on the side of the second balloon adjacent to. The second balloon 303 expands as the fluid is introduced into it. In one embodiment, the band 300 is adapted to be wrapped around the wrist using surface fasteners for fastening to the band around the wrist, such as hooks and loops 312 and 314.
Plate 400 (see Figure 4) is curved at both the proximal and distal ends, with the curvature towards the medial peripheral side. In one embodiment, the radius of curvature R at the proximal end<sub>1</sub>Is the radius of curvature R at the distal end<sub>2</sub>Is almost the same as. In another embodiment, the plate 404 is symmetrical about its center. In one embodiment, the plate is constructed from a material that is stiffer than the band, but retains some flexibility so that the plate conforms to the wrist contour and as the balloon expands and contracts. Flexure. In another embodiment, the plate maintains a substantially fixed shape. The plate 400 may be constructed using the same materials used to construct the frame 200 in FIG. In one embodiment, the thickness of the plate is about 2 mm. The width of the plate is about 4 mm smaller than the width of the straps of the band, thereby leaving a gap of about 2 mm on either side of the plate between the edges of the plate and the edges of the straps of the band.
In another embodiment of the invention (see FIG. 5), the hemostatic device 500 comprises a flexible band. The band has a medial peripheral side and is flexible, adapted to be wrapped and secured around the patient's limbs using ties 512 and 514 at the site on the limb where bleeding should be stopped. Has a sex strap 508. The band has a central portion and two side portions on either side of the central portion. In one embodiment, the central portion has a first sleeve 518 formed by covers 510 attached to strap 508. The compression member (not shown) is installed in the first sleeve 518. In one embodiment, the compression member is a curved frame (see Figure 2). In another embodiment, the compression member is a curved plate (see Figure 4). In one embodiment, the covers 510 and the strap 508 are both made of flexible plastic and are transparent. The covers 510 can be attached to the strap 508 using known techniques such as ultrasonic welding. The first balloon 501 is provided on the medial peripheral side at a position deviating from the proximal end of the first sleeve in the length direction of the band with respect to the central portion of the first sleeve 518, and the first balloon is , Connected to the strap 508 of the band by a connector 502 on the side of the first balloon adjacent to the central portion of the first sleeve 518. In one embodiment, the width of the first balloon is about the same as the width of the strap 508 of the band, and the length of the first balloon is about half the length of the first sleeve 518. The first balloon 501 expands when a fluid is introduced into it. The second balloon 503 is provided on the inner peripheral side of the first sleeve 518 at a position deviating from the central portion of the first sleeve in the width direction of the band with respect to the edge of the first sleeve, and the second balloon 503 is provided. The balloon is connected to the strap 508 of the band by a connector 504 on the side of the second balloon adjacent to the edge of the first sleeve 518. The width of the second balloon 503 is about half the width of the band strap 508 Therefore, the length of the second balloon is about half the length of the first sleeve 518. In another embodiment, the width of the second balloon is about 70% of the width of the band. In yet another embodiment, the width of the second balloon is about 60% of the width of the band. In a further embodiment, the width of the second balloon is about 50% of the width of the band. In another embodiment, the width of the second balloon is approximately the same as the width of the strap 508 of the band. In yet another embodiment, the width of the second balloon is approximately the same as the width of the first balloon. The second balloon 503 inflates when a fluid is introduced into it.
The compression member is located between the center of the compression member and the first end, between the first curved portion in the first half of the compression member and between the center of the compression member and the second end. A second curved portion within the second half of the compression member and an axis that traverses from the first end of the compression member through the center of the compression member to the second end of the compression member. Possess. The first balloon 501 is provided on the medial peripheral side within the first half of the compression member at a position offset from the first end of the compression member with respect to the center of the compression member. , Has multiple linear sides and is connected to the band by a connector 502 only on the first linear side of the first balloon, the first linear side adjacent to the center of the compression member and the axis of the compression member. Is vertical. In one embodiment, the first balloon has a first surface and at least a second linear side in contact with the band, the first balloon inflating when a fluid is introduced into it, In response to expansion, the first surface and at least the second linear side of the first balloon can move out of contact with the band. The second balloon 503 is provided on the medial peripheral side within the second half of the compression member at a position offset from the center of the compression member with respect to the edge of the compression member, and the second balloon is a plurality of linear lines. It has a side and is connected to the band by the connector 504 only on the first linear side of the second balloon, the first linear side of the second balloon adjacent to the edge of the compression member and of the compression member. It is parallel to the axis. In another embodiment, the second balloon has a second surface and at least a second linear side in contact with the band, which inflates as fluid is introduced into it. In response to expansion, the second surface and at least the second linear side of the second balloon can move out of contact with the band.
In yet another embodiment, the second balloon is on the medial peripheral side within the second half of the curved compression member at a position offset from the second end of the curved compression member with respect to the center of the curved compression member. The second balloon has multiple linear sides and is connected to the band by a connector only on the first linear side of the second balloon, the first linear side of the second balloon. , Adjacent to the center of the curved compression member and perpendicular to the axis of the curved compression member. In another embodiment, the second balloon is banded by at least two connectors, namely the first connector on the first linear side of the second balloon and the second connector on the second linear side. Connected, the first linear side of the second balloon is adjacent to the edge of the compression member, parallel to the axis of the compression member, and the second linear side of the second balloon is at the center of the compression member. Adjacent and perpendicular to the axis of the compression member.
In another embodiment, the first balloon is provided on the medial peripheral side within the first half of the compression member, the first balloon has a plurality of linear sides, and the first of the first balloons. Connected to the band by a connector only on the linear side of the balloon, the first linear side of the first balloon is adjacent to the edge of the compression member and parallel to the axis of the compression member. In yet another embodiment, the first balloon is banded by at least two connectors, i.e., a first connector on the first linear side of the first balloon and a second connector on the second linear side. The first linear side of the first balloon is adjacent to the edge of the compression member, parallel to the axis of the compression member, and the second linear side of the first balloon is the center of the compression member. Adjacent to and perpendicular to the axis of the compression member.
The material of the structure of the balloon is preferably transparent and may be the same as that used to make the band. In one embodiment, the material of the balloon structure can be a sheet of similar thickness to that used to make straps for the band. In another embodiment, the sheet used to make the balloon can be thinner than the sheet used to make the strap of the band. In one embodiment, the strap is made from a 20 mil (0.508 mm) thick polyvinyl chloride film and the balloon is made from a 10 mil (0.254 mm) thick polyvinyl chloride film. The balloon can have any shape, such as square, rectangular, circular, and oval. Balloons are made by cutting a sealing sheet into a suitable shape and can be sealed to the edges using sealing techniques such as gluing or welding. The balloon is connected to the band by flexible connectors 502 and 504, which can be made from the same material as the balloon and band. In one embodiment, the band and compression member are substantially transparent. In another embodiment, the balloon 503 is made of a translucent or opaque material and the balloon 501 is made of a substantially transparent material.
As shown in FIG. 5, the first balloon 501 has a tube 521 connected there to introduce the fluid into the first balloon, and the second balloon 503 has the fluid second. Has a tube 525 connected there for introduction into the balloon. In one embodiment, the tube is transparent and flexible. At its proximal end, tube 521 is connected to a first balloon 501 at 522. At its proximal end, tube 525 is connected to a second balloon 503 at 526. Tube 521 may include an adapter 523, which is connected to the distal side of the tube, and tube 525 may include an adapter 527, which is connected to the distal side of the tube. In one embodiment, the adapter 523 is identifiablely different from the adapter 527 so that the user knows that he or she has selected the appropriate adapter to connect to the balloon that the user wants to inflate. The identifiable differences of the adapters may be made through visual distinctions, including color, shape, texture, or a combination thereof. Inflating the balloon is performed by inserting the protruding tip of the syringe (not shown) into the adapter and pushing the plunger on the syringe so that the fluid in the syringe is introduced into the balloon through the inflator. Will be done. Once the fluid has been injected into the balloon and the protruding tip of the syringe has been removed from the adapter, the check valve in the adapter closes to prevent the fluid from leaking, thus inflating the balloon. Keep in. In another embodiment, a two- or three-way valve directs the flow of fluid into and from the balloon to prevent the fluid from leaking and thus to keep the balloon inflated. used.
In one embodiment, in addition to the central portion of the band, at least one side edge portion of the band has a sleeve. As shown in FIG. 5, the band may have a second sleeve 516 at one end of the band. The second sleeve is a double layer structure formed by connecting a piece of film 506 to the strap 508 of the band. The connection may be made by a suitable method similar to that used to build the first sleeve. The second sleeve 516 may be used to hold the tubes 521, 525 and the adapters 523, 527 when the band is wrapped around the patient's wrist (see Figure 8). In one embodiment, the width of the second sleeve 516 is less than the width of the band. In another embodiment, the width of the second sleeve 516 is approximately the same as the width of the band.
The technique of providing the compression member on the band is not limited to the arrangement shown and may involve joining the compression member to the inner or outer surface of the band by a suitable method such as welding or gluing. .. It is not necessary for the band to completely surround the limbs, eg the wrists. For example, in another arrangement, the band may be held in place by a tie that holds the band firmly on the wrist. In another embodiment, the band does not have any compression member to improve rigidity.
FIG. 6 is a cross-sectional view showing a band wrapped around the wrist 611. The band is attached to the wrist by connecting together surface fasteners (eg, hook and loop fasteners) 612 and 614. Other means of anchoring the band around the wrist while wrapped include buttons, clips, snaps, zippers, and buckles through which the ends of the band pass. The frame 604 is installed in a sleeve formed by covers 610 attached to the strap 608 on the outer peripheral side of the strap in the central portion of the band. One side of the balloon 601 is connected to the strap 608 of the band by the connector 602 at a position deviating from the end of the curved frame in the length direction of the band with respect to the central portion of the curved frame 604. As a result, the balloon is oriented in a certain orientation, which causes the compressive force F1 applied to the puncture site on the radial artery 605 to act outward, generally away from the central part of the wrist (see Figure 6A). ). As a result, force F1 does not affect the location of ulnar artery 607. On the other hand, if the balloon 601 is connected to the band at a position deviating from the end of the curved frame, the balloon will have an orientation, which will cause the compression force to be oblique towards the center of the wrist. Thereby, the component of force F1 will affect the ulnar artery 607.
The ulnar artery 607 is compressed by a balloon 603 provided on the medial peripheral side of the curved frame 604 at a position deviating from the central portion of the curved frame in the width direction of the band with respect to the edge of the curved frame. It is connected to the band by a connector 606 on the side of the balloon 603 adjacent to the edge of the curved frame 604 (see Figure 6B). In this embodiment, the balloon 603 has an orientation in which one side of the balloon 603 is connected by a connector at the edge of the band and the width of the balloon 603 is shorter than the width of the strap 608, thereby causing a force F2 in the cross-sectional plane of the wrist. The components of are approximately vertical (see Figure 6A). The force F2 has a component in the direction towards the elbow, but may have a negligible component in the direction towards the radial artery. Therefore, the action of the balloon 603 to pressurize or depressurize the ulnar artery generally does not affect the action of the balloon 601 to pressurize or depressurize the radial artery, and vice versa. FIG. 7 outlines a band 708 wrapped around the wrist, whereby the balloon 701 compresses the radial artery 705 and the balloon 703 compresses the ulnar artery 707. In the embodiment in FIG. 7, the balloon 703 is located at or near the base of the palm (Guillon's canal) 704, thereby compressing the ulnar artery 707 where it is most accessible for compression, and the balloon 701 It is located over the puncture site, generally about 2 cm from the base of the palm. The pressure applied to the radial and ulnar arteries, at the same time, is the pressure at which sufficiently high pressure is applied to the ulnar artery to prevent or minimize occlusion of the radial artery while stopping bleeding from the radial artery. It can be manipulated simultaneously and independently to optimize. In one embodiment, a mark or multiple marks (not shown) are placed on the radial balloon 701 so that the user can visually position the central portion of the radial balloon 701 on the radial artery 705 at or near the puncture site of the artery. May help install in. The mark or plurality of marks may also be placed on the compression member and the sleeve holding the compression member to assist in the placement of the radial balloon 701 on the user's puncture site. The mark may be a point, line, square, triangle, or any other shape that assists the installation.
FIG. 8 is a schematic diagram showing a front view (FIG. 8A) and a rear view (FIG. 8B) of an embodiment of the band 808 wrapped around the patient's wrist. One side of the radial balloon 801 is connected to the band by the connector 832 so that the connector 832 is positioned towards the center of the wrist. The radial balloon 801 is inflated or contracted by passing a fluid (gas such as air or liquid such as saline) through tube 821 using a syringe (not shown) connected to adapter 823. .. The ulnar balloon 803 is inflated or contracted by passing a fluid (gas such as air or liquid such as saline) through tube 825 using a syringe (not shown) connected to adapter 827. .. The balloon will inflate as fluid is introduced into it, thereby applying pressure to the patient's skin where the balloon is located. In one embodiment, the fluid is introduced using a syringe. The syringe may have a marker for determining the amount of fluid that will be inserted into the balloon. The syringe may also have an outlet that can be connected to a pressure measuring device such as a pressure gauge. In another embodiment, the balloon may have an outlet that can be connected to a pressure measuring device. Pressure measurement helps the user inflate the balloon to a pressure not significantly higher than the patient's systolic pressure, thereby allowing for reliable hemostasis but preventing overall overcompression due to excessive pressure. , Thereby reducing the probability of lumen compression and flow arrest to the occlusion point.
The edge of the band is located close to the base of the palm, 834. The band 808 may have a sleeve 806 at the side end portion of the band. The sleeve has a double layer structure and the tubes 821, 825 and adapters 823 and 827 may be inserted into the sleeve 806 so that the tubes do not get entangled when the patient moves their hands.
FIG. 9 shows an embodiment of balloon 900 in which the surface of balloon 901 in contact with the skin is coated with composition 905. In one embodiment, the composition 905 may optionally comprise a hydrophilic colloidal adhesive or a zinc oxide-based adhesive that can be used on the surface of the balloon when the balloon is pressed onto the patient's skin. Hydrocolloid or zinc oxide based adhesives can be used either alone or in combination with other medical grade adhesives. Hydrocolloid and zinc oxide-based adhesives are less likely to hurt the patient's skin when removed. This can be especially important for patients whose skin is more sensitive or fragile. In one embodiment, the coated composition 905 has an exfoliation laminate (liner) 907 that is removed before placing the balloon on the puncture site. In another embodiment, the composition also contains an antibacterial agent. In one embodiment, the composition contains an oil. Such compositions are known and commercially available in the art. For example, Vancive Medical Technologies, Avery Dennison See compositions and laminates sold by business. In some embodiments, connector 902 may be provided to connect the balloon to the band. In another embodiment, a vasodilator is present on the surface of the balloon that presses onto the puncture site to reduce spasm. Convulsions play a role in the process of disruption of flow and are thought to lead to luminal disappearance resulting from thrombosis and fibrosis. Prevention and alleviation of seizures can help reduce the probability of obstruction. An example of such a vasodilator is nitroglycerin. In one embodiment, the surface of the balloon in contact with the puncture site is treated with nitroglycerin. In another embodiment, other vasodilators, including, but not limited to, calcium channel inhibitors, adenosine analogs, and alpha sympathetic blockers, may be used to coat the balloon surface. Hemostasis can be facilitated by materials that promote the coagulation cascade. In another embodiment, a balloon surface in which an agent known to promote hemostasis, such as thrombi, marine polymers, gel foams, surgery, and other polymers and inorganic materials, such as potassium ironate, comes into contact with the skin. May be applied to.
The embodiment of the hemostatic device depicted in FIG. 10 is similar to that depicted in FIG. 1, but the hemostatic device in FIG. 10 uses the frame embodiment depicted in FIG. The frame embodiment depicted in FIG. 11 comprises a plurality of crossbars 261 at the central portion of the frame and curved solid pieces 264 at the proximal and distal ends of the frame. The balloon 151 is connected to the strap 158 by a connector 152 on the side of the balloon 151 adjacent to the central portion of the curved frame. As shown in FIG. 10, in one embodiment, the band may have a second sleeve 166 at the side edge portion of the band. The second sleeve is a double layer structure formed by connecting a piece of film 156 to the strap 158 of the band. In another embodiment, the band does not have to have a second sleeve. Two fasteners 162 and 164 hold the band around the patient's wrist.
In another embodiment of the hemostatic device (see FIG. 12), the fastener 362 is located on the covers 360 attached to the strap 358. The covers 360 form a sleeve 368 and hold the frame. Fastener 364 is located on strap 358 and holds the band around the patient's wrist by connecting the two fasteners 362 and 364. In yet another embodiment, the covers 360 may be a continuous portion of strap 358 that is flipped around the frame in a loop, thereby forming a sleeve and holding the frame. The balloon 351 is connected to the strap 358 by a connector 352 on the side of the balloon 351 adjacent to the central portion of the curved frame. As shown in FIG. 12, in one embodiment, the band may have a second sleeve 366 at the side edge portion of the band. The second sleeve is a double layer structure formed by connecting a piece of film 356 to the strap 358 of the band. In another embodiment, the band does not have to have a second sleeve. The embodiment of the hemostatic device depicted in FIG. 13 is similar to that depicted in FIG. 12, but the embodiment in FIG. 13 is a single balloon that presses onto the artery at the access site to stop bleeding. Has 451.
The band embodiments of the present invention are used in methods aimed at minimizing the occurrence of radial artery occlusion during a radial artery catheterization procedure. In one embodiment, once the catheter placement procedure is complete, ulnar pressure is applied to the ipsilateral ulnar artery at the ulnar pressure site with the sheath, eg, the catheter, still inserted into the radial artery. The sheath is then removed from the radial artery while maintaining pressure on the ulnar artery. Once the sheath is removed while continuing to apply ulnar pressure, pressure is applied to the radial artery at the access site, resulting in hemostasis at the access site. In another embodiment, once the catheter placement procedure is complete, radial pressure is applied to the radial artery at the access site. Radial pressure may be applied while the sheath, eg, catheter, remains inserted into the radial artery or after the sheath has been removed from the radial artery. Ulnar pressure is then applied to the ipsilateral ulnar artery at the ulnar pressure site. In one embodiment, the ulnar pressure is applied continuously and simultaneously with the radial pressure to obtain hemostasis of the radial artery. In another embodiment, the ulnar pressure is gradually reduced to zero before hemostasis is obtained. In yet another embodiment, the pressure applied to the radial and ulnar arteries is simultaneously high enough from the radial artery while being applied to the ulnar artery to prevent or minimize occlusion of the radial artery. It is operated simultaneously and independently to optimize the pressure at which the bleeding stops.
Radial pressure is applied by inflating a radial balloon, eg, the balloon 601 in FIG. The radial balloon is positioned across the access site of the radial artery 605. In response to the expansion of the radial balloon, the radial balloon takes an orientation so that the compressive force applied to the puncture site on the radial artery 605 acts outward, generally away from the central portion of the wrist. The compression force applied to the puncture site on the radial artery 605 is directed away from the ulnar artery. Depending on the expansion of the ulnar balloon, the compression force on the ulnar artery may have a component in the direction towards the elbow, but a negligible component in the direction towards the radial artery. The compressive force applied on the ulnar artery directs it away from the radial artery. Therefore, the action of the ulnar balloon 603 to pressurize or depressurize the ulnar artery 607 generally does not affect the action of the balloon 601 to pressurize or depressurize the radial artery 605, and vice versa. There will be.
The radial and ulnar arteries are the two conduits for the flow of oxygenated blood to the hand. The arteries are interconnected and thus form an interdependent flow network. When flow is reduced in one of the arteries, for example by compression, flow increases in the other artery. When the ulnar artery is compressed, the flow in the ulnar artery is reduced, which causes an increase in pressure and flow in the radial artery.
In one embodiment, the method of catheter placement of the patient's radial artery, which aims to minimize the occurrence of radial artery occlusion, includes (a) the step of inserting the sheath into the radial artery at the access site. (b) The step of performing a catheter placement procedure using the sheath to access the radial artery, and (c) the first pressure is ipsilateral at the ulnar pressure site with the sheath still inserted in the radial artery. The step of applying to the ulnar artery, thereby increasing the flow in the radial artery, and (d) removing the sheath from the radial artery while maintaining the first pressure on the ulnar artery, and (e) the second. Step (c) precedes step (e), including the step of applying the pressure of the above to the radial artery at the access site to obtain hemostasis at the access site.
In another embodiment, a catheter placement procedure is performed using a sheath to access the radial artery, followed by obtaining patency hemostatic of the radial artery of the patient, wherein the sheath is inside the radial artery at the access site. The method is to (i) apply a first pressure to the ipsilateral ulnar artery at the ulnar pressure site while the sheath is still inserted in the radial artery, thereby increasing the flow in the radial artery. A step of reading the first metric, including (ii) sensing skin blood flow and / or beating elsewhere downstream of the fingertip or access site, and (iii) a first for the ulnar artery. The steps of removing the sheath from the radial artery while maintaining pressure, (iv) applying a second pressure to the radial artery at the access site to obtain bleeding at the access site, and (v) the second related to sensing. It involves performing a sequence of steps to confirm the patency of the radial artery by obtaining two metrics and comparing the second and first metrics.
In yet another embodiment, a catheter placement procedure is performed using a sheath to access the radial artery, followed by obtaining patency hemostatic of the radial artery of the patient, wherein the sheath is of the radial artery at the access site. Inserted into, the method is (i) applying a first pressure to the radial artery and (ii) applying ulnar pressure to the ulnar artery at the ulnar pressure site, thereby increasing the radial artery flow. By continuously applying ulnar pressure to the ulnar artery while achieving bleeding arrest at the access site of the radial artery by continuing to apply the first pressure to the radial artery at the same time as the step (iii). It involves a sequence of steps to maintain increased flow and increased pressure of blood inside the radial artery and (iv) to achieve hemostasis of the radial artery.
In another embodiment, the method of obtaining hemostasis of the radial artery of a patient after performing a catheter placement procedure at the access site of the radial artery is to (A) simultaneously apply ulnar pressure to the ulnar artery at the site of ulnar pressure. Continue ulnar pressure on the ulnar artery while increasing the radial artery flow, applying hemostatic pressure to the radial artery to initiate radial hemostasis, and (B) achieving bleeding arrest at the access site of the radial artery. Steps include (C) achieving hemostasis of the radial artery while slowly reducing the pressure on the ulnar artery, and (D) relieving pressure on the ulnar artery. (A) and (B) precede step (C). Ulnar pressure may be applied over the entire duration of radial compression, or at any rate thereof, at any time during the process of radial hemostasis after radial hemostasis has begun.
In certain embodiments, a further step includes confirming that the application of ulnar pressure has reduced blood flow through the ulnar artery. This is done by monitoring the flow of the ulnar arteries prior to and after the application of ulnar pressure. In a further embodiment, the step of monitoring ulnar artery flow comprises sensing cutaneous blood flow and / or pulsation elsewhere downstream of the fingertip or ulnar pressure site. Digital plethysmography is employed in one embodiment.
In another embodiment, the method further comprises confirming the patency of the radial artery during the step of applying pressure to the radial artery. Confirmation of patency is accomplished by sensing cutaneous blood flow and / or pulsation elsewhere downstream of the fingertip or access site. Other sensing sites, both upstream and downstream, may be used to confirm the patency of the radial artery. In one embodiment, the sensing step is that the ulnar artery is fully compressed (does not allow flow through the ulnar artery) and / or partially compressed (less flow than when not compressed at all). Made in between). In certain embodiments, patency is confirmed by obtaining a metric for sensing and comparing that metric with the patient's standard or previously sensed metric. A metric is understood to mean a perceptible and quantifiable value or reading for characterization. Digital plethysmography may be employed to obtain the metric. Other sensing modes may also be adopted as long as the selected mode can confirm patency in one form or another.
<p> (Example 1) The band was machined from a substantially transparent polyvinyl chloride sheet material with a thickness of 0.5 mm. The band had a length of 240 mm and a width of 55 mm. The radial and ulnar artery balloons were each machined from a substantially clear polyvinyl chloride sheet material with a thickness of 0.25 mm. The radial artery balloon had a size of 38 mm × 55 mm, and the ulnar artery balloon had a size of 38 mm × 38 mm. The radial artery balloon, ulnar artery balloon, and band were welded together where needed to form a hemostatic device with the structure according to FIG. Two adapters with check valves were connected to the two balloons via a conduit, as shown in Figure 5. The curved frame was made from 2 mm diameter crossbars with a 2 mm crossbar spacing (the center-to-center distance between the crossbars was 4 mm). The crossbar was held between two parallel beams 3 mm in diameter. The frame was curved at both ends and had the same radius of curvature at both ends. The radius of curvature at each end was 20 mm. The frame had a straight central part and had a length of 28 mm. The width of the frame was 52 mm. The frame was constructed according to Figure 2. Hook and loop (Velcro®) fasteners were used to fasten. The hemostatic device was wrapped around the wrists of normal volunteers and two balloons were inflated by injecting air into the balloons using a 20 mL syringe with Luerlock. It was observed that the swelling of the radial balloon did not affect finger perfusion through the ulnar artery. A 20 mL swelling of the radial artery balloon led to complete extinction of the antegrade radial flow, but did not affect perfusion through the ulnar artery. On the ulnar side, using a shorter width (38 mm) balloon, a complete 15 mL swelling of the ulnar balloon did not affect the status of flow within the radial artery.</p><p> Any stenotic band device would be expected to first constrict the veins and cause venous congestion in the fingers, even at lower pressures. Surprisingly, a complete lack of venous congestion was observed, and no symptoms of venous congestion were reported by any of the applicants. Several 2-hour applications of the band were performed as would be clinically performed for hemostasis. No venous congestion occurred. Neither pressure-related symptoms on the ulnar rough surface were reported by the volunteers. This is due to (i) the application of concentrated pressure due to the orientation of the balloons (within the central compartment of the forearm where the largest vein is located), while leaving perhaps sufficient soft tissue space for venous return, and (ii) two balloons. It is likely due to the reduced magnitude of pressure required due to design features such as orientation and size of the balloon, its location within the band, and the shape and structure of the frame. (Comparative Example 2)</p><p> Bands similar to those used in Example 1 were processed, with the only difference being that in Comparative Example 2, the width of the ulnar balloon was approximately the same as the width of the band. In Example 1, the ulnar balloon has a width of 38 mm, which is about 70% of the width of the band. Using the larger ulnar balloon of Comparative Example 2, the ulnar balloon swelling was found to affect the perfusion of the radial artery. This is especially noticeable in the small forearm, where larger ulnar balloons can be oriented such that the force applied to the wrist when the ulnar balloon is inflated affects the radial artery.</p><p> Studies have shown that the location of the ulnar balloon on the forearm side of the band increases the effectiveness of the balloon that compresses and occludes the ulnar artery. Moving the balloon towards the hand, especially gluing it to the volar side of the band, increases the effectiveness of the ulnar balloon and concentrates the ulnar artery without any other effect or symptom. Compress and block.</p><p> The band embodiments of the present invention may also be used in methods aimed at minimizing the occurrence of ulnar artery occlusion during ulnar artery catheterization procedures. In one embodiment, once the catheter placement procedure is complete, radial pressure is applied to the radial artery at the radial pressure site with the sheath, eg, the catheter, still inserted into the ulnar artery. The sheath is then removed from the ulnar artery while maintaining pressure on the radial artery. Once the sheath is removed while continuing to apply radial pressure, pressure is applied to the ulnar artery at the access site, resulting in hemostasis at the access site. In another embodiment, once the catheter placement procedure is complete, ulnar pressure is applied to the ulnar artery at the access site. Ulnar pressure may be applied while the sheath, eg, catheter, remains inserted into the ulnar artery or after the sheath has been removed from the ulnar artery. Radial pressure is then applied to the radius at the radial pressure site. In one embodiment, the radial pressure is applied continuously and simultaneously with the ulnar pressure to obtain hemostasis of the ulnar artery. In another embodiment, the radial pressure is gradually reduced to zero before obtaining hemostasis of the ulnar artery. In yet another embodiment, the pressure applied to the radial and ulnar arteries is simultaneously high enough from the ulnar artery while being applied to the radial artery to prevent or minimize occlusion of the ulnar artery. It is operated simultaneously and independently to optimize the pressure at which the bleeding stops.</p><p> The band embodiments of the present invention may also be used in methods intended to obtain hemostasis in both the radius and ulnar arteries when the catheter placement procedure is performed simultaneously in both the radius and ulnar arteries.</p><p> It should be understood that some of the aforementioned disclosures and other features and functions or alternatives or variations thereof may preferably be combined with many other different systems or applications. Also, various alternatives, modifications, variations, or improvements herein may be subsequently made by one of ordinary skill in the art, which are also intended to be incorporated by the following claims.</p><p> In the above description, for purposes of explanation, a number of specific requirements and some specific details have been provided to provide a complete understanding of the embodiments. However, it will be apparent to those skilled in the art that one or more other embodiments may be practiced without some of these specific details. The particular embodiments described are provided not to limit the invention, but to illustrate it. The scope of the present invention is not determined by the specific examples provided above. In other cases, well-known structures, devices, and behaviors are shown in block diagram form or without details to avoid obscuring the understanding of the description. Where deemed appropriate, the reference number or the terminal number of the reference number is repeated between the figures and optionally indicates a corresponding or similar element that may have similar properties.</p><p> Also, throughout the specification, references to "one embodiment," "one embodiment," "one or more embodiments," or "different embodiments" are referred to, for example, in particular features of the invention. Please understand that it means that it may be included in the practice of. Similarly, in the description, various features are sometimes grouped together in a single embodiment, in a diagram, or in the description thereof, for the purpose of rationalizing the disclosure and assisting in understanding various aspects of the invention. Please understand that it will be transformed. However, the methods of the present disclosure should not be construed as a reflection of the intent of the present invention to require more features explicitly listed in each claim. Rather, aspects of the invention may be less than all features of a single disclosed embodiment, as the following claims reflect. In another situation, aspects of the invention may include combinations of embodiments described herein or combinations of less than all aspects described in Combinations of Embodiments.</p>
17 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17
Every citation, both ways
| Document | Relation | Office |
|---|---|---|
| US20150018869A1 | Cites | United States of America |
| JP200441599A | Cites | Japan |
| JP5137730A | Cites | Japan |
| US4863429A | Cites | United States of America |
| US20050153090A1 | Cites | United States of America |
92 members in 8 offices
Priority claims14
| Document | Office | Kind | Date |
|---|---|---|---|
| 14819383 | United States of America | – | |
| 201514819383 | United States of America | A | |
| 201514819383 | United States of America | A | |
| 201662288982 | United States of America | P | |
| 201662288982 | United States of America | P | |
| 62288982 | United States of America | – | |
| 2016041801 | United States of America | W | |
| 2016041801 | United States of America | W | |
| 14819383 | – | – | – |
| 62288982 | – | – | – |
| US201514819383 | – | – | – |
| US2016041801 | – | – | – |
| US201662288982P | – | – | – |
| WO2016US41801 | – | – | – |
Members92
| Document | Office | Kind | |
|---|---|---|---|
| US2015018868A1 | United States of America | A1 | |
| US2015335334A1 | United States of America | A1 | |
| US9308000B2 | United States of America | B2 | |
| US9332994B2 | United States of America | B2 | |
| US2016183951A1 | United States of America | A1 | |
| US9408611B1 | United States of America | B1 | |
| AU2016203461B1 | Australia | B1 | |
| US9510838B2 | United States of America | B2 | |
| EP3127493A2 | European Patent Office (EPO) | A2 | |
| CA2993297A1 | Canada | A1 | |
| US2017035438A1 | United States of America | A1 | |
| US2017035439A1 | United States of America | A1 | |
| WO2017023499A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2017023951A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP3127493A3 | European Patent Office (EPO) | A3 | |
| US2017042552A1 | United States of America | A1 | |
| CN106419995A | China | A | |
| US9592060B2 | United States of America | B2 | |
| US9642628B2 | United States of America | B2 | |
| US2017135702A1 | United States of America | A1 | |
| US2017143346A1 | United States of America | A1 | |
| US9668744B2 | United States of America | B2 | |
| US2017215892A1 | United States of America | A1 | |
| US2017238939A1 | United States of America | A1 | |
| US2017281195A1 | United States of America | A1 | |
| US2018000495A1 | United States of America | A1 | |
| KR20180037190A | Republic of Korea | A | |
| US9949738B2 | United States of America | B2 | |
| EP3127493B1 | European Patent Office (EPO) | B1 | |
| EP3331456A1 | European Patent Office (EPO) | A1 | |
| US2018168662A1 | United States of America | A1 | |
| EP3127493B8 | European Patent Office (EPO) | B8 | |
| US2018206847A1 | United States of America | A1 | |
| JP2018522706A | Japan | A | |
| EP3372175A1 | European Patent Office (EPO) | A1 | |
| US10117672B2 | United States of America | B2 | |
| US2018344325A1 | United States of America | A1 | |
| US2019008523A1 | United States of America | A1 | |
| US2019015106A1 | United States of America | A1 | |
| US2019015110A1 | United States of America | A1 | |
| US2019015111A1 | United States of America | A1 | |
| US2019021743A1 | United States of America | A1 | |
| US10213212B2 | United States of America | B2 | |
| US10213213B2 | United States of America | B2 | |
| US10213214B2 | United States of America | B2 | |
| US2019069905A1 | United States of America | A1 | |
| EP3331456A4 | European Patent Office (EPO) | A4 | |
| US10245041B2 | United States of America | B2 | |
| US2019150939A1 | United States of America | A1 | |
| US2019150940A1 | United States of America | A1 | |
| US2019150941A1 | United States of America | A1 | |
| US2019175192A1 | United States of America | A1 | |
| US10335161B2 | United States of America | B2 | |
| US10342545B2 | United States of America | B2 | |
| US10342551B2 | United States of America | B2 | |
| US10349951B2 | United States of America | B2 | |
| US10357254B2 | United States of America | B2 | |
| US10507026B2 | United States of America | B2 | |
| US10639042B2 | United States of America | B2 | |
| US2020222052A1 | United States of America | A1 | |
| US10716576B2 | United States of America | B2 | |
| US10722245B2 | United States of America | B2 | |
| US10722246B2 | United States of America | B2 | |
| US2020289130A1 | United States of America | A1 | |
| US2020315631A1 | United States of America | A1 | |
| CN106419995B | China | B | |
| US2020390448A1 | United States of America | A1 | |
| US2020390448A1 | United States of America | A1 | |
| US10888334B2 | United States of America | B2 | |
| EP3331456B1 | European Patent Office (EPO) | B1 | |
| US2021085337A1 | United States of America | A1 | |
| US2021100560A1 | United States of America | A1 | |
| JP6862003B2This record | Japan | B2 | |
| US10987109B2 | United States of America | B2 | |
| JP2021100610A | Japan | A | |
| US2021219987A1 | United States of America | A1 | |
| EP3868312A2 | European Patent Office (EPO) | A2 | |
| EP3868312A3 | European Patent Office (EPO) | A3 | |
| US11350943B2 | United States of America | B2 | |
| EP3372175B1 | European Patent Office (EPO) | B1 | |
| US2022257253A1 | United States of America | A1 | |
| JP2022123034A | Japan | A | |
| US2023018664A1 | United States of America | A1 | |
| US11564697B2 | United States of America | B2 | |
| JP7232541B2 | Japan | B2 | |
| US11653931B2 | United States of America | B2 | |
| US11653932B2 | United States of America | B2 | |
| CA2993297C | Canada | C | |
| US2024065705A1 | United States of America | A1 | |
| US2024065706A1 | United States of America | A1 | |
| US12178436B2 | United States of America | B2 | |
| US2025072898A1 | United States of America | A1 |
12 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Cancellation because of no payment of annual feesLAPS | LAPS | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| First payment of annual fees (during grant procedure)JAPANESE INTERMEDIATE CODE: A61A61 | A61 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Decision of grant or rejection writtenTRDD | TRDD | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written request for extension of timeJAPANESE INTERMEDIATE CODE: A601A601 | A601 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Report on retrievalJAPANESE INTERMEDIATE CODE: A971007A977 | A977 | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621 | A621 |
Numbers
- Publication
- 6862003
- Publication, DOCDB
- 6862003
- Publication, EPODOC
- JP6862003B
- Application
- 2018526484
- Application, DOCDB
- 2018526484
- Application, EPODOC
- JP20180526484
Titles2
- Japanese
- 出血を止めるための装置および方法
- English
- Devices and methods to stop bleeding
Classification
- CPC, 7
- A61B17/135
- A61B17/1325
- A61B2017/00951
- A61B2017/00889
- A61B90/92
- A61B2017/00893
- A61B2017/00907
- IPC, 1
- A61B17 135
