Cannula lined with tissue in-growth material
42 claims: 27 independent, 15 dependent
- 1生体組織を通して挿入するためのカニューレであって、 近位端部分、および遠位端部分、ならびにその間で延びる管腔を備えるシャフトと、 近位端部分、遠位先端端部、およびその間で延びる管腔を有する先端部であり、前記先端部の前記近位端部分が、前記シャフトの前記遠位先端端部に固定される先端部とを備え、 前記先端部が、前記管腔と連通し、かつ前記遠位先端端部に対して近位方向に延びる開口部を有しており、近位方向に延びる前記開口部が、前記遠位先端端部が塞がれた場合であっても、液が前記先端部の前記管腔中に連続的に引き込まれることを可能にするように構成され 、 前記先端部が、遠位方向に先細りする切頭円錐形を有する外側表面をさらに含み、前記先端部の外側表面は、前記先端部が前記生体組織を通して配置されたとき、前記生体組織の第1の側に当接するように構成された肩部を含み、前記肩部が切頭円錐形部分の近位端と一体的に形成される カニューレ。
- 2近位端部分、および遠位端部分、ならびにその間で延びる管腔を有するハブであり、前記ハブの前記遠位端部分が、前記シャフトの前記近位端部分に配置され、したがって、前記ハブの前記管腔が、前記シャフトの前記管腔と流体連通し、かつ前記ハブの前記近位端部分が、補助装置に結合されるように構成される、ハブをさらに備える、請求項1に記載のカニューレ。
- 3前記ハブが、内側の円筒形部分と、前記内側の円筒形部分と一体に形成された複数の外側の長手方向に間隔を空けた環状部材とをさらに備え、前記長手方向に間隔を空けた環状部材が、前記ハブのねじれ半径を制御するように動作可能である、請求項2に記載のカニューレ。
- 4前記シャフトが、内側ライナ、前記内側ライナに固定された補強構造、ならびに前記補強構造および前記内側ライナに固定された外側被覆を備える複合構成をさらに備える、請求項1に記載のカニューレ。
- 5前記内側ライナが、前記シャフトの前記管腔を画定する同時押出しされた内側層と、前記同時押出しされた内側層に結合された外側層とを備える、請求項4に記載のカニューレ。
- 6前記内側ライナの前記同時押出しされた内側層は、第1の熱可塑性材料から製作され、また 前記 内側ライナの前記外側層は、前記第1の熱可塑性材料とは異なる第2の熱可塑性材料から製作される、請求項5に記載のカニューレ。
- 7前記外側被覆が、前記補強構造、および前記内側ライナに結合される、請求項4に記載のカニューレ。
- 8前記補強構造が編組みされた構成を含む、請求項4に記載のカニューレ。
- 9前記補強構造が、金属材料、またはポリマー材料から製作される、請求項4に記載のカニューレ。
- 10前記補強構造が、コイル状に巻いた構成を備える、請求項4に記載のカニューレ。
- 11近位方向に延びる前記開口部が、前記先端部の前記管腔と外側表面の間で延びる少なくとも1つの窓孔を含む、請求項1に記載のカニューレ。
- 12近位方向に延びる前記開口部が、前記遠位先端端部から近位方向に、かつ前記先端部の前記管腔と外側表面の間で延びる少なくとも1つの切込みを含む、請求項1に記載のカニューレ。
- 13近位方向に延びる前記開口部が、前記遠位先端端部から近位方向に、かつ前記先端部の前記管腔と外側表面の間で延びる複数の切込みを含み、前記複数の切込みが、前記先端部の周囲で円周方向に離間されている、請求項1に記載のカニューレ。
- 14前記肩部が、挿入位置に対して前記先端部の心出しを行い、かつ組織による閉塞を阻止するようにさらに構成される、請求項 1 に記載のカニューレ。
- 15前記先端部が、熱可塑性材料または熱硬化性材料から構成される、請求項1に記載のカニューレ。
- 16前記先端部の外側表面が、ポリマーの被覆をさらに含む、請求項 15 に記載のカニューレ。
- 17前記先端部の内側表面が、抗血栓性の被覆を含む、請求項 15 に記載のカニューレ。
- 18前記先端部の前記近位端部分の外側表面が、血栓形成を促進する被覆を含む、請求項 16 に記載のカニューレ。
- 19前記先端部が、前記管腔に分割線がないように成形される材料から構成される、請求項1に記載のカニューレ。
- 20前記先端部が金属材料から構成される、請求項1に記載のカニューレ。
- 21前記先端部の外側表面の少なくとも一部が、組織の内部成長を促進する、請求項 20 に記載のカニューレ。
- 22前記先端部が、収縮した状態から拡大した状態に展開されるように構成される第1のアンカーをさらに含み、前記第1のアンカーが、前記拡大した状態で、前記生体組織の少なくとも一方の側に係合するように構成され、かつ前記先端部の長手方向中心軸に沿った少なくとも一方向に前記先端部が移動するのに抗するように動作可能である、請求項1に記載のカニューレ。
- 23前記第1のアンカーが、前記先端部の前記長手方向中心軸を概して横断する方向に延びる複数のストラットをさらに備える、請求項 22 に記載のカニューレ。
- 24前記複数のストラットが、超弾性材料から形成され、収縮した状態にあるとき、前記長手方向中心軸に概して平行な位置に折り畳まれ、拡大した状態にあるとき、前記長手方向中心軸を概して横断する位置へと拡大する、請求項 23 に記載のカニューレ。
- 25前記第1のアンカーが、前記第1のアンカーを前記生体組織に固定するための組織の内部成長を容易にするように、前記複数のストラットと結合された多孔質のポリマー構造をさらに含む、請求項 23 に記載のカニューレ。
- 26遠位方向に前記先端部が移動するのを阻止するように動作可能な、前記第1のアンカーに対して近位方向に位置する第2のアンカーをさらに備える、請求項 22 に記載のカニューレ。
- 27前記第2のアンカーが、前記先端部の前記長手方向中心軸を概して横断する方向に延びる複数のストラットをさらに備える、請求項 26 に記載のカニューレ。
- 28前記複数のストラットが、超弾性材料から形成され、収縮した状態にあるとき、前記長手方向中心軸に概して平行な位置に折り畳まれ、拡大した状態にあるとき、前記長手方向中心軸を概して横断する位置へと拡大する、請求項 27 に記載のカニューレ。
- 29前記第2のアンカーが、前記複数のストラットと結合された、前記生体組織に前記第2のアンカーを固定するための組織の内部成長を容易にする多孔質のポリマー構造をさらに含む、請求項 27 に記載のカニューレ。
- 30請求項 22 の前記カニューレと、 前記カニューレを受け入れるように構成され、かつ前記第1のアンカーを前記拡大した状態に展開するために前記カニューレに対して移動するように構成された送達シースと を備える送達システム。
- 31前記送達シースが、はく離できる材料から構成される、請求項 30 に記載の送達システム。
- 32患者の心腔と前記患者の動脈との間で血流を増加させるための血液循環支援システムであって、 (i)入口および出口を有する血液ポンプと、 (ii)(a)近位端部分および遠位端部分、ならびにその間で延びる管腔を備えるシャフトと、 (b)前記心臓の組織を通して延びるように構成され、近位端部分、遠位先端端部、およびその間で延びる管腔を有する先端部であり、前記先端部の前記管腔が前記シャフトの前記管腔と流体連通するように、前記先端部の前記近位端部分が前記シャフトの前記遠位端部分に固定され、前記先端部が、前記遠位先端端部に対して近位方向に延びる開口部を有し、かつ前記開口部が前記先端部の前記管腔と流体連通する、先端部とを備える流入カニューレと、 (iii)近位端部分および遠位端部分、ならびにその間で延びる管腔を有する流出カニューレであり、前記近位端部分が、前記動脈に結合されるように構成される、流出カニューレと を備え 、 前記先端部が、遠位方向に先細りする切頭円錐形を有する外側表面をさらに含み、前記先端部の外側表面は、前記先端部が前記生体組織を通して配置されたとき、前記生体組織の第1の側に当接するように構成された肩部を含み、前記肩部が切頭円錐形部分の近位端と一体的に形成される 血液循環支援システム。
- 33前記先端部が、収縮した状態から拡大した状態に展開するように構成される第1のアンカーをさらに含み、前記第1のアンカーが、前記拡大した状態で、前記心臓の前記組織の少なくとも一方の側に係合するように構成され、かつ前記先端部の長手方向中心軸に沿った少なくとも一方向に前記先端部が移動するのに抗するように動作可能である、請求項 32 に記載の血液循環支援システム。
- 34前記第1のアンカーが、前記先端部の前記長手方向中心軸を概して横断する方向に延びる複数のストラットをさらに備える、請求項 33 に記載の血液循環支援システム。
- 35前記第1のアンカーが、前記複数のストラットと結合された、前記心臓の前記組織に前記第1のアンカーを固定するための組織の内部成長を容易にする多孔質のポリマー構造をさらに含む、請求項 34 に記載の血液循環支援システム。
- 36遠位方向に前記先端部が移動するのを阻止するように動作可能な、前記先端部上の前記第1のアンカーに対して近位方向に位置する第2のアンカーをさらに備える、請求項 33 に記載の血液循環支援システム。
- 37前記第2のアンカーが、前記先端部の前記長手方向中心軸を概して横断する方向に延びる複数のストラットをさらに備える、請求項 36 に記載の血液循環支援システム。
- 38前記第2のアンカーが、前記複数のストラットと結合された、前記心臓の前記組織に前記第2のアンカーを固定するための組織の内部成長を容易にする多孔質のポリマー構造をさらに含む、請求項 37 に記載の血液循環支援システム。
- 39前記外側表面が、抗血栓性の被覆を含む、請求項 32 に記載の血液循環支援システム。
- 40前記先端部の前記近位端部分が、血栓形成を最小化する被覆を有する外側表面を含む、請求項 32 に記載の血液循環支援システム。
- 41近位方向に延びる前記開口部が、前記遠位先端端部から近位方向に、かつ前記先端部の前記管腔と外側表面の間で延びる少なくとも1つの切込みを含む、請求項 32 に記載の血液循環支援システム。
- 42近位方向に延びる前記開口部が、前記遠位先端端部から近位方向に、かつ前記先端部の前記管腔と外側表面の間で延びる複数の切込みを含み、前記複数の切込みが、前記先端部の周囲で円周方向に離間されている、請求項 32 に記載の血液循環支援システム。
Independent claims42
62 paragraphs, as filed
0001(Cross-reference of related applications) This application claims the benefit of (pending) US Patent Provisional Application No. 61 / 303,351 filed on February 11, 2010, the disclosure of which is incorporated herein by reference.
0002The application generally relates to medical devices and methods, and more particularly to devices and methods for assisting the transmission of body fluids.
0003Various devices and methods have been used to assist in the transmission of body fluids. For example, a blood pump with inflow and outflow cannulas helps the heart circulate blood in patients who have experienced congestive heart failure and has never had a transplant organ or is a suitable candidate for transplantation. is not it. Therefore, the blood pump can be attached to the left side of the heart to allow fluid communication, and then placed remotely, such as subcutaneously or submuscularly, in what is called a "pump pocket" in a pacemaker-like manner. can do. The pump pocket can generally be placed in a location accessible by a surgical incision from below the clavicle over the pectoral muscles to the chest. The cannula can then be used to connect the heart to the pump for fluid communication. In yet another example, the cannula is inserted into the bladder or kidney by dialysis, or by urinary tract obstruction or infection.
<p num="0004"><patcit num="1"><text>U.S. Pat. No. 6,176,848</text></patcit><patcit num="2"><text>U.S. Pat. No. 6,116,862</text></patcit><patcit num="3"><text>U.S. Pat. No. 6,942,611</text></patcit><patcit num="4"><text>U.S. Pat. No. 6,623,475</text></patcit><patcit num="5"><text>German public release No. DE102004019721</text></patcit><patcit num="6"><text>U.S. Patent Application No. 12 / 256,911</text></patcit><patcit num="7"><text>U.S. Patent Application Publication No. 2009/0112050</text></patcit><patcit num="8"><text>U.S. Patent Application No. 12 / 720,012</text></patcit><patcit num="9"><text>U.S. Patent Application Publication No. 2010/0249490</text></patcit></p>
<p num="0005"> However, known conventional cannula designs are susceptible to obstruction by adjacent living tissue. Therefore, there remains a need to develop a cannula to address these and other challenges associated with traditional cannulas and ancillary fluid flow systems.</p>
<p num="0006"> In one exemplary embodiment, the invention is directed to a cannula for insertion through living tissue. The cannula includes a shaft with a proximal end portion and a distal end portion with a lumen in between. The cannula further includes a proximal end portion, a distal tip end, and a tip having a lumen in between. The proximal end portion of the tip is fixed to the distal end portion of the shaft so that the lumen at the tip communicates fluidly with the lumen of the shaft. The tip includes an opening that communicates with the lumen and extends proximally to the distal tip end, allowing fluid to reach the tip even if the distal tip end is blocked. Allows it to flow into the lumen.</p><p num="0007"> Proximal openings are at least one notch in the tip extending between the tip lumen and the outer surface, at least one window hole extending between the tip lumen and the outer surface, of the tip. It can be an inclined edge angled with respect to the longitudinal central axis, or a combination thereof.</p><p num="0008"> In another exemplary embodiment, the invention is directed to a blood circulation support system that includes a cannula that extends from a pump to the patient's heart. The assistive system further includes an outflow cannula extending from the pump to the patient's arteries.</p><p num="0009"> According to other exemplary embodiments, the present invention is directed to a method of delivering fluid into the lumen of a cannula, including the distal tip. The method comprises inserting the distal tip through a living tissue into a cavity. The fluid is drained from the cavity and enters the tip through the opening at the distal tip of the cannula. The distal tip opening extends proximally with respect to the distal tip end of the distal tip.</p><p num="0010"> Yet another exemplary embodiment of the invention is directed to a method of blocking fluid flow obstruction in a cannula having a lumen and a distal tip. The method comprises the step of inserting the distal tip through the living tissue and into the cavity. The fluid is drained from the cavity and enters the tip through an opening at the distal tip of the cannula. The distal tip opening extends proximally with respect to the distal tip end of the distal tip. If the distal tip of the cannula is obstructed by adjacent living tissue, fluid will continue to drain through the opening from lumen to lumen.</p>
0011<figref num="1A">Schematic of the anatomy of the chest, an example of an outer pathway of the vasculature used to access the patient's heart according to embodiments of the present invention and to implant a circulatory support system coupled to the aortic arch. It is a figure which shows.</figref><figref num="1B">Similar to FIG. 1A, but schematic of another exemplary embodiment in which the circulatory support system is coupled to the subclavian artery.</figref><figref num="1C">Similar to FIG. 1A, but is a schematic representation of yet another exemplary embodiment in which the circulatory support system is coupled to the descending aorta below the heart and close to the iliac artery.</figref><figref num="2">FIG. 5 is a side view of an exemplary embodiment of an inflow cannula having a cannula tip.</figref><figref num="3">It is an enlarged perspective view of the tip of the cannula shown in FIG.</figref><figref num="4">It is a cross-sectional view through the diameter of the inflow cannula along line 4-4 of FIG.</figref><figref num="4A">It is a cross-sectional view of the inner liner of the inflow cannula along line 4A-4A of FIG.</figref><figref num="5">It is a side view of the hub of the inflow cannula shown in FIG.</figref><figref num="6A">FIG. 3 is an enlarged cross-sectional view showing a series of steps of an exemplary method of surgically implanting the tip of a cannula into the left ventricle of the heart.</figref><figref num="6B">FIG. 3 is an enlarged cross-sectional view showing a series of steps of an exemplary method of surgically implanting the tip of a cannula into the left ventricle of the heart.</figref><figref num="6C">FIG. 3 is an enlarged cross-sectional view showing a series of steps of an exemplary method of surgically implanting the tip of a cannula into the left ventricle of the heart.</figref><figref num="6D">FIG. 3 is an enlarged cross-sectional view showing a series of steps of an exemplary method of surgically implanting the tip of a cannula into the left ventricle of the heart.</figref><figref num="7">FIG. 3 is a perspective view of an inflow cannula including other embodiments of the cannula tip.</figref><figref num="8">FIG. 3 is a perspective view of an inflow cannula including yet another embodiment of the cannula tip.</figref><figref num="8A">It is a side view of the tip of the cannula shown in FIG. 8 which shows the inclination angle of the surface of the distal end of the tip of a cannula.</figref><figref num="9">FIG. 3 is a perspective view of an inflow cannula including other embodiments of a cannula tip used in a transseptal procedure.</figref><figref num="9A">FIG. 9 is an enlarged cross-sectional view of the tip of the cannula in FIG. 9 implanted across the intraatrial septum.</figref><figref num="10">FIG. 3 is a perspective view of an inflow cannula including other transseptal embodiments at the tip of the cannula.</figref><figref num="10A">FIG. 10 is an enlarged cross-sectional view of the tip of the cannula in FIG. 10 implanted across the intracardiac septum.</figref><figref num="11">FIG. 3 is a perspective view of an inflow cannula including yet another transseptal embodiment of the cannula tip.</figref><figref num="11A">FIG. 11 is an enlarged cross-sectional view of the tip of the cannula in FIG. 11 implanted across the intracardiac septum.</figref>
0012FIG. 1A shows one of many possible schematic configurations of the blood circulation support system 10. Devices and systems configured according to the teachings herein can be implanted by any suitable surgical method, including but not limited to those outlined herein, and, for example, within the kidney. It can be used in connection with other living tissue such as a chamber (not shown), or in connection with yet other living tissue from which a cavity or chamber is accessed and drained.
0013System 10 can be used to pump blood from the heart chamber of patient 22's heart 20 containing oxygenated blood (ie, the left atrium 24, or the left side of left ventricle 26) into the patient's arterial system. It "unloads" the heart 20, which is weakened due to disease or genetic defects. System 10 includes a blood pump 28 having an inlet 30 and an outlet 32. The pump 28 can be implanted on the left or right side of the patient 22 (implantation on the left side is shown), or it can be located outside the patient's body. The pump 28 can include a power cord 34 that extends percutaneously from the pump 28 to the abdominal location, from which the power cord 34 exits the patient 22 and is connected to a power source (not shown). .. Patent Document 1 entitled "Intravascular Blood Pump" published by Rau et al. On January 23, 2001, Patent Document 2 entitled "Blood Pump" published by Rau et al. On September 12, 2000, September 2005 "Paracardiac Blood" published to Siess on March 13th Patent Document 3 entitled "Pump", Patent Document 4 entitled "Blood Pump Without Bearing" published to Sies on September 23, 2003, and Patent Document entitled "Pump" published on October 6, 2005. Various blood pump designs are known and can be used, including the conventional designs described in 5, the disclosure of which is incorporated herein by reference in its entirety.
0014System 10 further includes an outflow cannula 36 that connects the outlet 32 of the pump 28 to an artery such as the aorta 38 at the arterial access site 39a shown in FIG. 1A, above the heart 20. Alternatively, the outflow cannula 36 can also be connected to an arterial access site 39b located in the left subclavian artery 40, as shown in FIG. 1B. In the configuration shown in FIGS. 1A and 1B, the pump 28 can be superficially implanted in the pump pocket 42a. As another alternative, and as shown in FIG. 1C, the outflow cannula 36 can connect to the descending aorta 44 and to the arterial access site 39c in close proximity to the left and right iliac arteries 46, 48. In this case, the pump 28 can be superficially implanted in the pump pocket 42b located in the abdomen of patient 22. The outflow cannula 36 can be connected to the selected artery by an appropriate surgical procedure that can include the use of appropriate implants (not shown) and / or sutures (not shown).
0015Referring again to FIG. 1A, the inflow cannula 50 connects the inlet 30 of the pump 28 to the outer wall of the heart 20, such as the wall 52 of the left ventricle 26. The inflow cannula 50 can be delivered into the heart 20 by any desired surgical procedure, such as one of the techniques discussed below.
0016Before or after implanting the pump 28, the outflow cannula 36 and the inflow cannula 50 can be connected to the outlet 32 and the inlet 30 of the blood pump 28, respectively. In this regard, the cannulas 36, 50 can first be cut to the appropriate length by a properly disinfected cutting tool (not shown), thus the system 10 does not twist the cannulas 36, 50. It can be implanted more easily. The inflow cannula 50 can be configured to be easily cut to the desired length, as will be discussed later.
0017In motion, blood can be pumped from the left ventricle 26 to pump 28 via the inflow cannula 50, and the arteries selected from pump 28 (aorta 38 in FIG. 1A, left subclavian artery 40 in FIG. 1B, FIG. It can be sent to the descending aorta 44 of 1C, or otherwise if desired).
0018For illustration and reference purposes, specific additional anatomical structures are shown on the right side of the heart 20, including the right atrium 54 and the right ventricle 56. The right atrium 54 draws blood from the venous network, more specifically, the left and right subclavian veins 58, 60, the left and right jugular veins 62, 64, and the ascending and descending vena cava. Receive from 66, 68. Blood travels from the right atrium 54 to the right ventricle 56 and is then pumped into the lungs (not shown) for oxygenation. Blood returned from the lungs passes through the pulmonary vein 70 and enters the left atrium 24 of the heart 20. The blood in the left atrium 24 travels to the left ventricle 26 and is pumped to the aorta 38, the arm leading to the left subclavian artery 40, the left carotid artery 72, the right carotid artery 76 and the right subclavian artery 78. It is delivered to the tip of the arterial system, including the cranial artery 74.
0019The inflow cannula 50 is shown in more detail, with reference to Figure 2 below and continuing with Figure 1A. The inflow cannula 50 includes a tip 110 configured to be inserted through living tissue, such as the wall 52 of the left ventricle 26. The tip 110 includes a lumen 112 extending between the proximal end 114 and the distal end 116. The inflow cannula 50 also includes a shaft 120 having a lumen 122 extending between the proximal end portion 124 and the distal end portion 126. The inflow cannula 50 further includes a hub 130 having a lumen 132 extending between the proximal end portion 134 and the distal end portion 136. The distal end portion 126 of the shaft 120 is coupled to the proximal end portion 114 of the tip 110, and the proximal end portion 124 of the shaft 120 is coupled to the distal end portion 136 of the hub 130. The hub 130 can be molded directly onto the proximal end portion 124 of the shaft 120, but instead, the hub 130 is configured separately and using a biocompatible adhesive to form the proximal end portion. It can also be attached to 124. The lumens 112, 122, 132 are aligned so that they are in collinear and fluid communication. The lumens 112, 122, 132 can have the same diameter so as to eliminate steps or other discontinuities in order to minimize the formation of thrombi and restricting flow there.
0020The proximal end portion 134 of the hub 130 can be configured to be coupled to the inlet 30 of the blood pump 28, as shown in FIG. 1A, so that blood flows from the left ventricle 26 of the heart 20 to the lumen. It can flow through 112, 122, 132 to inlet 30 of blood pump 28. Blood is then pumped through the outflow cannula 36 to the desired artery, such as the aorta 38, the descending aorta 44, or the left subclavian artery 40, as previously described for FIGS. 1A, 1B, and 1C. Can be done.
0021The tip 110 can be made of a metallic material such as titanium, titanium alloy, stainless steel, or platinum. The tip 110, when composed of a metallic material, can include a sintered section, or at least a portion covered with fibers that promote internal growth of the tissue. Alternatively, the tip 110 can be molded from a thermosetting material such as silicone or from a thermoplastic material such as polyurethane. An example of polyurethane that can be used is CARBOTHANE (Lubrizol Advanced Materials, Inc., Cleveland, Ohio, USA). If a relatively comfortable design is desired, the tip 110 can be composed of a thermosetting or thermoplastic material having a durometer hardness ranging from a shore hardness of about 25 A to a shore hardness of about 90 A. If a relatively rigid design is desired, the tip 110 can be composed of a thermosetting or thermoplastic material having a durometer hardness ranging from shore hardness of about 55D to shore hardness of about 90D.
0022To further reduce the likelihood of thrombus formation, the molding step can include an insert molding step that eliminates the dividing line, i.e., where material misalignment can occur. By using the insert molding process, a smooth, seamless, luminal surface that comes into direct contact with blood flowing through the tip 110 is obtained. Therefore, it is not necessary to cover the inner surface of the lumen 112 with an antithrombotic material, but if it is desirable, a coating may be included.
0023To enhance blood compatibility, the distal end portion 116 of the tip 110 can be polished to minimize irregularities resulting from the machining process. A well-polished surface minimizes the spread of tissue growth and thus minimizes the possibility that tissue will grow on the tip 110 and impede blood flow into the inflow cannula 50.
0024Further details of the tip 110 can be seen by referring to FIG. 2 and further with reference to FIG. The distal end portion 116 of the tip 110 is configured to be inserted into the heart chamber of the patient's heart 20 (FIG. 1A). In that regard, the diameter of the lumen 112 can be constant throughout the length of the proximal end 114 and the distal end 116 of the tip 110, but the outer surface 138 of the tip 110 is discontinuous. Can be. One such discontinuity, the shoulder 140, can be placed between the proximal end 114 and the distal end 116, and the distal end 116, for example, is the left ventricle 26 ( When inserted into FIG. 1A), it is configured to be placed relative to the inner surface of wall 52 (FIG. 1A) of heart 20 (FIG. 1A). By doing so, the length of the distal end portion 116 inserted into the heart chamber is controlled, and the distal end portion 116 sutures the tip 110 to the wall 52 (FIG. 1A) of the heart 20 (FIG. 1A). Do not let it come out of the heart chamber before doing so.
0025The outer surface 138 can be tapered or tapered, such as a truncated cone, between the shoulder 140 and the distal end 116 towards the distal tip 142. The distal tip end 142 may be configured or molded to be substantially orthogonal to the longitudinal central axis 144 of the tip 110, as shown. This configuration allows blood to be continuously drawn from the left ventricle 26 (Fig. 1A), but allows for a variety of alternative structures, including alternative tips, which will be discussed later.
0026The tip 110 allows blood to enter the lumen 112 of the tip 110 even if the distal tip end 142 of the tip 110 is blocked or obstructed by adjacent internal heart tissue or the like. It further includes an opening 146 extending proximally with respect to the distal distal end 142, which is configured to allow continuous withdrawal. The opening 146 can include the various shapes shown by the two notches 146, which communicate fluidly with the lumen 112. Two circumferentially spaced cuts 146 (shown 180 ° opposite) extend longitudinally and proximally from the distal tip end 142 and also laterally to the lumen 112 of the tip 110. Extends radially between surfaces 138. It will be appreciated that the particular exemplary embodiments of FIGS. 2 and 3 include two notches 146, but any number of openings 146, or window holes, of various shapes or dimensions can be used. The dimensions and number of cuts 146 can be chosen so that the total cross-sectional area of all cuts 146 is approximately equal to or greater than the minimum cross-sectional area of lumen 112. This configuration avoids diminished blood flow even if the distal tip end 142 is blocked or obstructed during pump operation. Whether or not such a blockage occurs depends on the proximity of the distal tip end 142 to the medial surface of the tissue extending through it and the heart chamber as blood is pumped into the inflow cannula 50. Depends on the minimum hydrostatic pressure within. More specifically, the decrease in hydrostatic pressure in the heart chamber during the operation of the pump causes the heart chamber to contract sufficiently to bring the tissue into contact with the tip 110 and at least partially the distal tip end 142. There is a possibility of blocking. When such a blockage occurs at the tip configured according to an embodiment of the present invention, blood can flow into the lumen 112 through the incision 146 to allow continuous operation of the pump 28. Therefore, an undesired interruption of blood flow into the inflow cannula 50 can be avoided.
0027The outer surface 150 of the proximal end 114 is polished, sintered, or promotes or accelerates wound healing of the tissue in contact with the outer surface 150 when the tip 110 is inserted into the tissue. Can be coated with the material to be used. Suitable materials can include, but are not limited to, calcium phosphate, and collagen. The portion of the outer surface 138 of the tip 110 exposed to blood can include an antithrombotic coating to minimize the formation of thrombi. Examples of antithrombotic coating materials that can be used include, but are not limited to, heparin and silver.
0028With reference to FIGS. 2-4 below, the shaft 120 shall be secured to the tip 110 and the hub 130 by thermal bonding, molding steps, or by other means such as applying sufficient temperature and pressure to the parts to be joined. Can be done. The shaft 120 can be configured as an integrated structure in which the tip portion 110 and the hub 130 are thermally joined. Alternatively, the shaft 120 can have a composite structure, an example of which is shown in the cross section of FIG. In an exemplary embodiment, the shaft 120 can include an inner liner 152, a reinforcing structure 154 fixed to the inner liner 152, and an outer coating 156 fixed to both the reinforcing structure 154 and the inner liner 152. Thus, as shown in FIG. 4A, the inner liner 152 is tubular and can define the lumen 122 of the shaft 120. The inner liner 152 can be a co-extruded liner with an inner part 158 and an outer part 160, which in combination can be combined with the wall thickness of the inner liner 152 (t)<sub>sum</sub>(Indicated by) is defined. The inner diameter of the inner portion 158, which corresponds to the diameter of the lumen 122, may vary depending on the desired blood flow for the individual application. Generally, the lumen 122 will have the same diameter as the lumen 132 of the hub 130 and the lumen 112 of the tip 110. For example, the diameter of lumen 122 can vary from about 0.040 inches (1.016 mm) to about 0.400 inches (10.016 mm). The overall wall thickness of the shaft 120 may vary depending on the desired mechanical performance characteristics of the shaft 120 (bending, column strength, torsional strength, etc.). For example, the wall thickness of shaft 120 can vary from about 0.004 inches (0.1016 mm) to about 0.080 inches (2.032 mm).
0029The inner portion 158 of the inner liner 152 has a relatively high durometer hardness ranging from, for example, a shore hardness of about 55D to a shore hardness of about 80D, and has a shore hardness of about 0.0005 inches (0.0127 mm) to about 0.0050 inches (1.27 mm). Thickness that can span t<sub>1</sub>It can be composed of a thermosetting material having the above, or a thermoplastic material. Suitable thermosetting materials can include, but are not limited to, etched fluoropolymers and polyimides. Examples of suitable thermoplastic materials include, but are not limited to, polyamides, polyurethanes, and polyethylenes. An example of polyurethane that can be used is CARBO THANE.
0030The outer portion 160 of the inner liner 152 has a low durometer hardness ranging from, for example, a shore hardness of about 25 A to a shore hardness of about 60 A, and has a thickness ranging from about 0.0005 inches (0.0127 mm) to about 0.0100 inches (0.254 mm). T<sub>2</sub>It can be composed of a thermoplastic material having. An example of a suitable material that can be used is polyurethane such as CARBOTHANE®.
0031The reinforced structure 154 can be overlaid on the outer portion 160 of the inner liner 152 and may have a braided configuration as shown in FIG. 3 or a coiled configuration as shown in FIG. it can. The reinforced structure 154 can be constructed from metal wires such as stainless steel or titanium wire, but can also be made from polymeric materials such as KEVLAR (EI du Pont de Nemours and Co., Wilmington, Delaware, USA). Further, the constituent material can have various cross-sectional shapes including, but not limited to, circular or rectangular. When circular wire is used, the diameter of the wire can typically vary from about 0.001 inch (0.0254 mm) to about 0.005 inch (0.127 mm). When a material with a rectangular cross section is used, the rectangle typically has a height in the range of about 0.001 inch (0.0254 mm) to about 0.005 inch (0.127 mm) and is about 0.003 inch (0.0762 mm). It can have a width in the range of about 0.010 inches (0.254 mm) from.
0032The coiled configuration in Figure 2 has a coil pitch ranging from about 0.001 inch (0.0254 mm) to about 0.060 inch (1.524 mm), depending on the individual wires used and the diameter of the lumen 122. Can include. In some embodiments, the coil pitch can be varied along the length of the shaft 120, increasing distal flexibility when higher coil pitches are placed distally. In the braided configuration shown in FIG. 3, the braided pick (pic) rate (ie, the number of intersections per inch of braid) can range from about 10 ppi to about 100 ppi. In some embodiments, the pick ratio can be varied along the length of the shaft 120, and higher pick ratios placed distally also increase flexibility.
0033The outer coating 156 is placed on the inner liner 152 and the reinforcing structure 154 to complete the composite configuration. The outer coating 156 can be composed of a thermoplastic material such as polyurethane having a durometer hardness in the range of shore hardness of about 25 A to shore hardness of about 60 A. The material of the outer coating 156 is selected to be compatible with the material of the outer portion 160 of the inner liner 152 and the material of the reinforcing structure 154. This compatibility consideration guarantees a complete polymer bond between the outer coating 156 and the inner liner 152, ensuring complete encapsulation of the reinforcing structure 154 and preventing delamination.
0034In some embodiments, the inner portion 158 and the outer portion 160 can be made of similar or the same material, but not necessarily.
0035Although not specifically shown, the shaft 120 may include a reverse spine and / or a cannula stop that assists in assembling the tip 110 onto the shaft 120. The reverse thorn provides a tight fit between the shaft 120 and the tip 110, and the stop ensures that the shaft 120 is fully inserted into the tip 110.
0036Further referring to FIG. 2, an exemplary embodiment of the hub 130 is shown and includes an inner cylindrical portion 162 extending from the proximal end portion 134 to the distal end portion 136. The hub 130 may further include a plurality of longitudinally spaced annular members 164 that are integrated with the cylindrical portion 162 and extend around it. The annular member 164 controls the twist radius of the hub 130, allowing the physician to trim the length of the hub 130 and adapt it to the individual anatomy of the patient 22. The twist radius can be thought of as the local deformation of the shaft 120 or the bend radius of the shaft 120 that can lead to twisting. In FIG. 2, the annular member 164 has a predetermined distance d.<sub>1</sub>Only equally spaced. The physician can cut the hub 130 to the required length by cutting the circular portion 162 between adjacent annular members 164 so that the desired length of the hub 130 is provided. The distal end portion 136 of the hub 130 may also lack the annular member 164 to easily join the distal end portion 136 of the hub 130 to the proximal end portion 124 of the shaft 120.
0037Figure 5 shows the d specified above.<sub>1</sub>Distance over d<sub>2</sub>Only shows an alternative embodiment of the hub 130'including the most distal annular member 164a longitudinally separated from the adjacent annular member 164b. d<sub>2</sub>The dimensions of can be selected to accommodate the flow sensor 166 indicated by the imaginary line, which can be used to measure the flow rate of blood through the inflow cannula 50. The flow sensor 166 can be any commercially available product, such as a flow meter commercially available from Transonic Systems, Inc. (Ithaca, NY, USA) that surrounds the hub 130 and is operated by ultrasonic technology. The flow sensor 166 can be clipped to the hub 130 or otherwise secured. The wire or cable associated with the flow sensor 166 can be routed along with the power cord 34 (FIG. 1A) associated with the pump 28 (FIG. 1).
0038The constituent material of the hub 130 can be selected from known materials such as, for example, a thermosetting material such as silicone or a thermoplastic material such as polyurethane. The selected material can have a durometer hardness varying from a shore hardness of about 25 A to a shore hardness of about 75 A, and can have a stiffness generally equal to or greater than the overall stiffness of the composite structure of the shaft 120. it can. The hub 130 can then be formed or joined to the proximal end portion 124 of the shaft 120.
0039An exemplary procedure for connecting the inflow cannula 50 to the heart 20 is shown in FIGS. 6A-6D, but further reference is made to FIG. 1A. It will be appreciated that the method comprises tip 110 from FIG. 2, but any design can be incorporated, including those shown herein.
0040In FIG. 6A, the doctor drills a hole in the wall 52 with a guide wire 168 at the surgical site 169. An expansion device 170, including a tip 172 secured to a shaft 174 having a lumen 175 configured to receive the guide wire 168, is mounted posteriorly over the guide wire 168 and delivered to the wall 52 of the heart 20. Be done. The inflow cannula 50 is mounted posteriorly over the dilator 170 and advances to the wall 52 of the heart 20.
0041As shown in FIG. 6A, the distal portion of the guide wire 168 can be at least partially looped, coiled or j-shaped, traumatic to the tissue of heart 20 during and after insertion. Try not to.
0042The tip 172 of the expansion device 170 generally includes a conical shape that can be used to gradually expand the hole in the wall 52 created by the guide wire 168. This gradual expansion facilitates the insertion of the tip 110 through the wall 52. Insertion is further facilitated by the truncated cone shape of the distal end portion 116 of the tip 110.
0043FIG. 6B shows the next step in which the entire distal end portion 116 of the tip 110 is inserted into the left ventricle 26. After insertion, the inflow cannula 50 can be slightly retracted so that the shoulder 140 of the tip 110 is positioned relative to the inner surface of the wall 52, acting as a stable stop and perceptible to the physician. Provide feedback.
0044Once the tip 110 is so positioned, drawstring sutures 176, 178 can be used to ligate as shown in FIG. 6C to completely secure the inflow cannula 50 to the wall 52. If desired, additional drawstring sutures (not shown) can be used to collect additional tissue, but this is not specified. As discussed earlier, the outer surface 150 of the proximal end 114 of the tip 110 extending across the hole in the wall 52 promotes or accelerates wound healing of vascular tissue in contact with the outer surface 150. It can be coated with the material to be used. This can further assist in making a leak prevention seal.
0045FIG. 6D shows the surgical site 169 after the extension device 170 with sutures 176, 178 tightened and the guide wire 168 retracted from the left ventricle 26. As a result, the distal end 116 of the tip 110 remains inserted into the left ventricle 26 and is anchored to the wall 52 of the heart 20.
0046It will be easily understood that the procedure shown in FIGS. 6A-6D is only one exemplary surgery-based procedure for inserting the tip 110. Alternatively, the procedure is left so that the tip 110 is anchored at a position on the posterior medial wall near the intraatrial septum 180, i.e., the so-called "Waterson's Groove". Lateral thoracotomy to access the atrium 24, thoracic surgery using a tubular trocar to access an intrathoracic location (eg, Waterson's groove), or a needle through the intraatrial septum 180 A crossing over-the-wire (Seldinger) technique can be included, a guide wire can be placed through it, and a special obturator (or dilator) can be used to place the inflow cannula 50 into the atrial septum 180. It can be advanced in, which is described in more detail below.
0047It is readily appreciated by those skilled in the art that the openings extending proximally with respect to the distal tip end can be configured to include any number of alternative configurations beyond the embodiments shown in FIGS. Will be understood. For example, FIG. 7 is similar to Tip 110 in FIGS. 2-3 so as to allow continuous flow of blood, even if partially or completely clogged or obstructed. It shows a tip 182 including at least one configured opening 183. In that regard, the tip 182 includes a proximal end 184 and a distal end 186 with a lumen 188 extending between them, and may be constructed and made similar to the tip 110 of FIG. it can. The proximal end portion 184 and the distal end portion 186 can be separated by an annular member, the seating ring 190, which is similar to the shoulder 140 of the tip 110 shown in FIG. The method, i.e., is configured to act as a clear stop during insertion. The proximal end portion 184 is secured to the distal end portion 126 of the shaft 120 as previously described, thus the lumen 188 of the tip 182 is in fluid communication with the lumen 122 of the shaft 120.
0048At least one opening 183 is defined by a plurality of incisions, i.e., the opening 183 extends proximally from the distal tip end 193 and is, in fact, identical to the distal tip end 193. Has a spread. Therefore, the distal tip end 193 can be configured to be substantially perpendicular to the longitudinal central axis 194. In an exemplary embodiment, the notches 183 are equally spaced in the circumferential direction, but this spacing configuration is not always necessary. In addition, although four notches 183 are shown, the number of notches 183 can vary from 2 (shown in Figure 3) to 8 and also the cross-sectional area of lumen 188, the length of notches 183, and It will be understood that / or should depend on the width of the notch 183. In other words, the number and composition of cuts 183 will make the sum of the flow cross-sectional areas of all cuts 183 approximately the same as the cross-sectional area of lumen 188 to avoid restricted blood flow. Can be selected as.
00498 and 8A show yet another embodiment of the tip 196, including the proximal end 198 and the distal end 200, with the lumen 202 extending between them. As mentioned earlier, the proximal end portion 198 is secured to the distal end portion 126 of the shaft 120, thus the lumen 202 of the tip 196 fluidly communicates with the lumen 122 of the shaft 120. Furthermore, also like the tip 182 of FIG. 7, the tip 196 can include a seat ring 204 separating the proximal end 198 and the distal end 200, and the tissue wall 52 (FIG. 1A). ) Is configured to be placed relative to the inner surface.
0050In an exemplary embodiment, the opening 206 at the tip 196 is defined by a sloping edge extending proximally from the distal tip end 207 of the tip 196. The degree of inclination can be an angle α that changes from about 15 ° to about 75 ° with respect to the longitudinal centerline axis 208 of the tip portion 196.
0051The distal end portion 200 is enclosed by a material including the tip 196 and is shown herein as a window hole 210 extending between the lumen 202 of the tip 196 and the outer surface. Includes a second opening 210 extending proximally to 207. Although only one window hole 210 is shown, it will be appreciated that the distal end portion 200 may optionally contain multiple window holes.
0052The possibility of the sloping edge 206 becoming clogged during normal pump operation is greatly reduced. In this method, the proximally extending opening 206 will help ensure that blood flow enters lumen 202. However, if the blood flow through the sloping opening 206 is reduced, the blood flow can continue through the second opening 209, the window hole 210. Thus, the tip 196 provides two ways to prevent a decrease in blood flow.
0053In yet another embodiment, the tip can be configured in a way that reduces the need for drawstring sutures. Furthermore, and / or optionally, the tip is less invasive, such as that described in Patent Document 6 entitled "Transseptal Cannula, Tip, Delivery System, and Method" published as Patent Document 7. It can be configured to facilitate use in catheter-based surgical procedures, the disclosure of which is incorporated herein by reference in its entirety.
0054An exemplary embodiment of a suitable tip design is shown in FIG. 9, which includes a tip 250 having a truncated cone similar to the shape previously described with reference to FIG. The tip 250 has a proximal end 252 and a distal end 254, between which a lumen 256, which is in line with the lumen 122 of the shaft 120 (FIG. 2), extends. The distal end 254 includes at least one opening 258 defined as two notches in FIG. 9, which extends proximally from the distal tip end 260.
0055With reference to FIG. 9 and further referring to FIG. 9A, the tip 250 is a patent document entitled "Transseptal Cannula Device, Coaxial Balloon Delivery Device, and Methods of Using the Same" published as Patent Document 9. A first anchor 262 with the plurality of strut 264 described in 8 is further included, the disclosure of which is incorporated herein by reference in its entirety. Four struts 264 are shown, but this number is not so limited and the anchor has fewer or more struts, depending on the needs or preferences of the individual physician. It should also be understood that it may be necessary or desirable. However, by providing at least three struts 264, even greater stability of the implanted tip 250 can be obtained.
0056The strut 264 of the first anchor 262 chemically etches the part from a flat sheet material, electropolishs the etched part to remove the rough edges generated during the forming process, and then the part. Can be at least partially constructed from a superelastic NiTi material by heating to a superelastic state. However, other suitable biocompatible, non-compliant, flexible materials are also sufficient. As shown, the struts 264 extend from a common ring structure 266 secured in a groove 268 within the tip 250 using adhesive, epoxy resin, friction fit, or other known means. .. As a result, the strut 264 of the first anchor 262 can extend radially from the common ring structure 266 and with respect to the longitudinal central axis 269 at the unfolded position. In this unfolded position, the first anchor 262 is placed between the right atrium 54 and the left atrium 24, along the first side of the living tissue, here shown as the intraatrial septum 180. It is configured as follows. The hyperelastic state of the strut 264 allows the strut 264 to bend to a folded position (shown by the imaginary line) that points angularly away from the unfolded position (shown by the solid line). The foldable nature of the first anchor 262 allows the tip 250 to be preloaded into the delivery sheath (not shown), reducing the invasiveness of the procedure. More specifically, the strut 264 of the first anchor 262 is bent distally and the inflow cannula 50 is loaded posteriorly into the delivery sheath. The distally oriented struts 264 are therefore positioned for the deployment shown by the imaginary line in FIG. 9A. If desired, the balloon catheter can also be delivered through the lumen of the shaft 120 and tip 250. When the balloon is inflated, it comes into contact with the inner diameter of the tip 250. This contact between the tip 250 and the balloon allows the physician to manipulate the position of the tip 250 within the delivery sheath. To do. After the tip 250 is positioned within the intraatrial septum 180 and the first anchor 262 is deployed, the delivery sheath can be retracted from the surgical site. Alternatively, the delivery sheath can also be constructed from a removable material such that the delivery sheath is split and removed from the surgical site.
0057Further referring to FIGS. 9 and 9A, the proximal end portion 252 of the tip 250 can be formed to accept and secure a second anchor 270 containing multiple struts 272 attached to band 274. .. The struts 272 can be configured to extend from a common ring structure 276 secured within the groove 278 of the band 274. The strut 272 of the second anchor 270 is capable of transitioning from a contracted state (for insertion as described below) to an expanded state, using wires as described above. Can be machined from a tubular structure formed from a flat sheet material. The wire or flat sheet material can be any shape memory material (such as nickel titanium, NiTi, or MP35N). Many shapes are possible for the strut 272, but the shapes shown include the angled portion 272a and the contact portion 272b when the strut 272 is in the unfolded state. The contact portion 272b will come into contact with the living tissue, while the angled portion 272a allows the anchor 270 to adapt to a wide range of anatomical structures and tissue thickness. The angled portion 272a also generates a force against the distal movement of the anchor 270 after being properly attached to the tip 250.
0058The band 274 can be constructed from the same material as the tip 250 and using the same method. As shown in FIG. 9A, the band 274 is shaped and dimensioned to be accepted by the proximal end portion 252 of the tip 250, and is a friction fit, a tight fit, a magnet, a thread, or other commonly known. It is fixed by an in vivo assembly method.
0059To perform delivery, the second anchor 270 is placed on the first delivery sheath 242 with the incisions 244 present in the struts 272 in a contracted state in the proximal direction. The notch 244 contributes to an overall low profile assembly for percutaneous delivery of the second anchor 270. The first delivery sheath 242 and the second anchor 270 are preloaded into the second delivery sheath 248 and delivered percutaneously as a unit towards the previously inserted tip 250. Band 274 is attached to the proximal end portion 252 of the inserted tip 250 by mechanical connection with sufficient distal force. Multiple struts 272 are then deployed by retracting the second delivery sheath 248 from the intraatrial septum 180, which goes from the second delivery sheath 248 into the hub catheter insertion site (not shown). It can include pulling one or more connecting members 246 extending in the proximal direction. After sufficient retraction, the struts 272 are unfolded from a contracted state to an unfolded state with respect to the intraatrial septum 180. Both the first and second delivery sheaths 242 and 248 can then be retracted away from the tip 250.
0060As further shown in FIG. 9, one or both struts 264, 272 of the anchors 262, 270 contain a porous polymeric structure 280 and are multiple to engage with the intraatrial septum 180 (FIG. 9A). It can provide a wider surface than the struts 264, 272 alone. The porous polymer structure 280 also allows internal growth of the tissue, in which case the biological tissue from the intraatrial septum 180 grows and is embedded within the porous polymer structure 280 to a larger structure. Stability and sealing ability can be provided. Suitable materials for the porous polymer structure 280 can include, but are not limited to, polyester monofibers or polyfiber yarns, ePTFE monofibers or polyfiber yarns, or fluorinated polyolefin fibers or yarns. , They can be woven, braided, knitted, or felted for proper composition. The porous polymer structure 280 can further include various unique configurations including woven, braided, or knitted fabrics having a two-dimensional or three-dimensional honeycomb structure, a circular, flat, or triaxial tubular structure. In other embodiments, the porous polymer structure 280 can consist of ePTFE components in tubular, cylindrical, or sheet form. Generally, the porous polymer structure 280 will be constructed by etching or laser cutting the shape from the raw materials of the two sheets (such as those mentioned above). The polymer structure 280 formed is then ultrasonically welded together such that the polymer structure 280 formed captures struts 264, 272 in between.
0061FIG. 9 further shows that anchors 262, 270 can be placed such that the struts 264 of the first anchor 262 are offset in position with respect to the struts 272 of the second anchor 270. This configuration has the advantage of withstanding certain loads, but should not be considered necessary.
0062With reference to FIGS. 10 and 10A below, yet another exemplary embodiment of the tip 286 is shown. Tip 286 is constructed in a manner similar to Tip 182 (FIG. 4), but is similar to that shown in FIG. 9 but does not contain the porous polymer structure 280 (FIG. 9). Includes 288 and an engageable second anchor 290. Anchors 288 and 290 each include a plurality of struts 292 so as to be on opposite sides of the intraatrial septum 180. Tip 286 is proximal from distal end 298 to provide fluid access to lumen 296 of tip 286 if distal tip end 298 is obstructed or blocked. It further includes at least one opening 294, shown as a plurality of notches extending.
006311 and 11A show yet another embodiment of an integral septal tip 300 to which the first and second anchors 302, 304 are joined, with the anchors 302, 304 being single, respectively. Includes multiple struts 305 that can be delivered percutaneously to living tissue using the delivery sheath 318. The tip 300 includes one or more rings 306 provided for several reasons. These rings 306 act to engage the anchors 302, 304 and / or work in conjunction with one or more clamps 308 to secure the anchors 302, 304 onto the tip 300. be able to. Suitable clamps 308 can include pressure deformed or crimped clamps, or can be attached to the tip 300 by gluing, welding, or ligating.
0064The tip 300 is provided, for example, by an opening 310 defined by an inclined distal end surface extending proximally from the distal tip end 313 of the tip 196, and an opening in the form of a window hole, as shown. It further includes a structure similar to the tip 196 of FIG. 5 having two openings 310, 312, such as the defined opening 312. The openings 310, 312 reduce the possibility of clogging of lumen 314 or restriction of flow when inserted through the intraatrial septum 180. The tip 300 further includes a reverse thorn 316 to provide a frictional fit with the shaft 120.
0065The present invention has been shown by describing various exemplary embodiments, and these embodiments have been described in some detail, but such details limit the scope of the appended claims or. It is not the applicant's intention to limit it in any way. Further advantages and variations will be readily apparent to those skilled in the art. The various features of the invention can be used alone or in any combination, depending on the needs and preferences of the user. However, the invention itself should be defined only by the appended claims.
006610 Blood circulation support system 20 heart 22 patients 24 Left atrium 26 Left ventricle 28 blood pump 30 entrance 32 exit 34 Power cord 36 Spill Cannula 38 aorta 39a Arterial access site 39b Arterial access site 39c Arterial access site 40 Left subclavian artery 42a pump pocket 42b pump pocket 44 Descending aorta 46 Left iliac artery 48 Right iliac artery 50 Inflow Cannula 52 Left ventricular wall 54 Right atrium 56 Right ventricle 58 Left subclavian vein 60 Right subclavian vein 62 Left jugular vein 64 Right jugular vein 66 Ascending vena cava 68 Descending Vena Cava 70 Pulmonary vein 72 Left carotid artery 74 Brachiocephalic artery 76 Right carotid artery 78 Right subclavian artery 110 Tip 112 lumen 114 Proximal end 116 Distal end 120 shaft 122 lumen 124 Proximal end 126 Distal end 130 hub 130'hub 132 lumen 134 Proximal end 136 Distal end 138 outer surface 140 shoulders 142 Distal tip end 144 Longitudinal central axis 146 Opening, notch 150 outer surface 152 Inner liner 154 Reinforcement structure 156 Outer coating 158 Inner part 160 outer part 162 Cylindrical part 164 Ring member 164a annular member 164b annular member 166 Flow sensor 168 Guide wire 169 Surgical site 170 Expansion device 172 tip 174 shaft 175 lumen 176 Drawstring suture 178 Drawstring suture 180 Intracardiac septum 182 tip 183 Opening, notch 184 Proximal end 186 Distal end 188 lumen 190 Seat ring 193 Distal tip end 194 Longitudinal central axis 196 Tip 198 Proximal end 200 Distal end 202 lumen 204 Seat ring 206 Opening, edge 207 Distal tip end 208 Longitudinal centerline axis 209 Second opening 210 Window hole, second opening 242 First delivery sheath 244 Notch 246 Connection member 248 Second delivery sheath 250 tip 252 Proximal end, proximal end part 254 Distal end 256 lumens 258 opening 260 Distal tip end 262 1st anchor 264 struts 266 Common ring structure 268 groove 269 Longitudinal central axis 270 Second anchor 272 struts 272a Angled part 272b contact part 274 band 276 Common ring structure 278 groove 280 Porous polymer structure 286 tip 288 1st anchor 290 Second anchor 292 struts 294 opening 296 lumen 298 Distal tip end, distal end 300 tip 302 1st anchor 304 Second anchor 305 struts 306 ring 308 clamp 310 opening 312 opening 313 Distal tip end 314 lumen 316 Reverse thorn 318 Delivery sheath d<sub>1</sub> distance d<sub>2</sub> distance t<sub>1</sub> thickness t<sub>2</sub> thickness t<sub>sum</sub> thickness α angle
21 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 Sheet 18 Sheet 19 Sheet 20 Sheet 21
Every citation, both ways
| Document | Relation | Office |
|---|---|---|
| JP02095377A | Cites | Japan |
| JP02156961A | Cites | Japan |
| JP11239617A | Cites | Japan |
| JP2005058304A | Cites | Japan |
| JP2005144054A | Cites | Japan |
| JP2005508717A | Cites | Japan |
| US20020099392A1 | Cites | United States of America |
| US20040122283A1 | Cites | United States of America |
| WO2009055651A1 | Cites | World Intellectual Property Organization (WIPO) |
27 members in 5 offices
Priority claims9
| Document | Office | Kind | Date |
|---|---|---|---|
| 30335110 | United States of America | P | |
| 30335110 | United States of America | P | |
| 61303351 | United States of America | – | |
| 2011024533 | United States of America | W | |
| 2011024533 | United States of America | W | |
| 61303351 | – | – | – |
| US20100303351P | – | – | – |
| US2011024533 | – | – | – |
| WO2011US24533 | – | – | – |
Members27
| Document | Office | Kind | |
|---|---|---|---|
| US2011196190A1 | United States of America | A1 | |
| US2011196191A1 | United States of America | A1 | |
| CA2787632A1 | Canada | A1 | |
| CA2788129A1 | Canada | A1 | |
| WO2011100552A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2011100568A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2012004496A1 | United States of America | A1 | |
| EP2533824A1 | European Patent Office (EPO) | A1 | |
| EP2533825A1 | European Patent Office (EPO) | A1 | |
| JP2013519450A | Japan | A | |
| JP2013526899A | Japan | A | |
| US8768487B2 | United States of America | B2 | |
| US2014249357A1 | United States of America | A1 | |
| US9132216B2 | United States of America | B2 | |
| CA2788129C | Canada | C | |
| JP5916632B2This record | Japan | B2 | |
| JP5992339B2 | Japan | B2 | |
| US9504776B2 | United States of America | B2 | |
| CA2787632C | Canada | C | |
| US9750866B2 | United States of America | B2 | |
| EP2533825A4 | European Patent Office (EPO) | A4 | |
| EP2533824A4 | European Patent Office (EPO) | A4 | |
| US2018008765A1 | United States of America | A1 | |
| WO2011100552A8 | World Intellectual Property Organization (WIPO) | A8 | |
| EP2533825B1 | European Patent Office (EPO) | B1 | |
| EP2533824B1 | European Patent Office (EPO) | B1 | |
| US10342913B2 | United States of America | B2 |
12 legal events, as the office reported them to INPADOC
Over the term
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| Event | Code | |
|---|---|---|
| Cancellation because of no payment of annual feesLAPS | LAPS | |
| 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 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Written amendmentJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written permission of extension of timeJAPANESE INTERMEDIATE CODE: A602A602 | A602 | |
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| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Report on retrievalJAPANESE INTERMEDIATE CODE: A971007A977 | A977 | |
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Numbers
- Publication
- 5916632
- Publication, DOCDB
- 5916632
- Publication, EPODOC
- JP5916632B
- Application
- 2012553035
- Application, DOCDB
- 2012553035
- Application, EPODOC
- JP20120553035
Titles2
- Japanese
- 循環系中に補助的な血流を確立するための装置、方法、およびシステム
- English
- Devices, methods, and systems for establishing ancillary blood flow in the circulatory system
Classification
- CPC, 8
- A61M1/3659
- A61B2017/00252
- A61F2210/0076
- A61M1/3653
- A61M60/178
- A61M60/205
- A61M60/861
- A61M60/148
- IPC, 2
- A61M25 00
- A61M1 10
