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    • 专利摘要:
    BIDIRECTIONAL PERFUSION CANNULA The present invention relates to a bidirectional perfusion cannula comprising an elongated tube for insertion into an artery, the elongated tube comprising: a first opening at a distal end of the elongated tube that is advanced during insertion, the first opening being configured so that blood can flow into the artery towards insertion; a knee formed in the elongated tube; and a second opening, the second opening being formed at or slightly behind the knee and configured to supply blood to the artery in a second direction that is generally opposite to the insertion direction.
    公开号:BR112013025854B1
    申请号:R112013025854-3
    申请日:2012-04-04
    公开日:2020-12-22
    发明作者:Randall Moshinsky；James McMillan；Elli Tutungi
    申请人:Sorin Group Italia S.R.L；
    IPC主号:
    专利说明:

    Field of the Invention
    [001] The present invention relates to a bidirectional perfusion cannula. Fundamentals of the Invention
    [002] Some cardiac surgery procedures require cannulation of the peripheral artery for extracorporeal circulation. In addition, some disease states require extracorporeal mechanical support through cannulation of the peripheral artery. This peripheral artery in general, although not always, is the femoral artery. The insertion in the femoral artery of an arterial cannula large enough to support the patient with extracorporeal circulation frequently causes impaired blood flow to the lower limb, which can lead to ischemia and tissue necrosis during prolonged procedures.
    [003] The methods of providing perfusion to the body already suggested, while maintaining perfusion for the lower limb, are typically inconvenient and generally do not produce a satisfactory solution.
    [004] Previously, it was suggested the use of an undersized cannula, on the assumption that a smaller cannula will allow blood to reflux over the cannula between the cannula and the arterial wall. In practice, it is difficult to achieve adequate perfusion to the lower limb, and the use of a smaller cannula than the one actually required compromises perfusion to the body and increases linear pressures, thereby increasing the risk of cell hemolysis red blood, increased resistance in the membrane oxygenator and infusion pump and increased risk of damage to these vital pieces of equipment.
    [005] The insertion of another perfusion cannula downstream of a first main perfusion cannula has also been suggested previously. Inserting a cannula downstream can be technically difficult and, in general, the percutaneous approach requires ultrasound guidance to allow for precise installation. This technique requires an extra cannula and an extra perfusion line that must be connected to the arterial face of the perfusion circuit, which can be an exhaustive procedure. This also results in the provision of additional equipment in the groin incision area, an area that is already compromised in terms of space with the femoral venous and arterial femoral lines already installed. The downstream cannula would typically be a small cannula that is more susceptible to changes in position, resulting in a less reliable downstream flow.
    [006] In addition, it was previously suggested to sew a lateral graft in the artery when using cannulation of the femoral artery. In this technique, surgeons sewed a Dacron graft to the side of the femoral artery as an end-to-side anastomosis and a cannula is inserted into the graft. This technique is time consuming, taking approximately 30 minutes to sew the graft and arrange the cannula, if we buy it at about the 2 minutes necessary for the insertion of a bidirectional femoral cannula. In addition, this technique requires an open surgical procedure, which can be complex in ICU configuration. Bleeding is another possible problem in patients requiring prolonged periods of support and when the support is removed, the base of the Dacron graft can be left in situ with this technique, generating a potential source of infection and formation of the thrombus.
    [007] It is desirable to provide a single cannula that provides adequate perfusion to the lower limb. However, as will be discussed below, the previously suggested cannulas show a number of disadvantages.
    [008] Previously it was suggested to provide a conventional cannula with lateral perfusion holes through which blood could flow towards the lower limb. These provisions were disclosed in WO03 / 068303 granted to Laksen et al. and in "A Novel Femoral Arterial Cannula to Prevent Limb Ischemia During Cardiopulmonary Support: Preliminary Report of Experimental and Clinical Experiences" by Matsui et al. in Artif Organs, Vol. 30, N ° 7 2006. In the arrangements with lateral perfusion holes, the cannula needs to be positioned correctly in the artery so that the holes are not blocked, and remain in this position. In these provisions, the tactile response to help position the holes is non-existent, without any assistance so that the holes are kept in the correct position. If the cannula migrates distally, the orifices will be blocked by the arterial wall. If the cannula migrates proximally, then the orifices can move out of the artery and cause bleeding. If the lateral orifices are level with the arteriotomy, perfusion to the artery wall can cause dissection.
    [009] To avoid occlusion of the side holes provided in a conventional cannula, it was suggested to provide rails adjacent to the holes that would prevent the occlusion of the holes. This arrangement was revealed in the document "A femoral artery cannula that allows distal blood flow" by Magovern, J. et al. (The Journal of Thoracic and Cardiovascular Surgery, September 2005). The configuration of the tracks can be complicated and difficulties will arise from their insertion and removal through the artery wall. The rails also give rise to a striated cross section with the potential for bleeding during the insertion and removal procedures. In addition, the blood that passes through the lateral orifices is not communicated efficiently because it is directed against the artery arterial walls.
    [010] Alternative rail configurations have also been suggested to facilitate the insertion of the cannula into the artery with the simultaneous attempt to prevent occlusion of the lateral orifices. US 5,171,218 and US 5,330,433 by Fonger, J. et., Reveal an arrangement in which the rails are in the form of forward-facing burrs between which an oblique and elongated orifice established in a depression is arranged. outside the cannula wall. Depression invades the main lumen to act as a collector and to divert blood towards the lower limb.
    [011] As in the previous proposals, difficulties will emerge from insertion and removal due to the cross-sectional shape of the burrs, which, as can be seen in Figure 5 of each of the documents, is striated in the burrs / rails region and will require the artery to distend during insertion and removal. As this region passes through the artery wall, this striated cross section can also create channels between the streaks that can result in bleeding during insertion and removal.
    [012] In addition, the main lumen is narrowed by the depression of the lateral orifice, reducing the flow capacity. The most important determinant of flow through a cannula, as the Poiseuille-Hagen equation establishes, is the radius of the cannula. Halving the radius in half causes a flow reduction of sixteen times. Reducing the radius in a femoral cannula that is already being tensioned to achieve maximum flow rates represents a serious impairment of primary function, that is, providing a flow similar to systemic heart failure.
    [013] Due to the configuration of the burrs and the lateral opening, this arrangement can mean the complexity of its manufacture. Furthermore, there is no open area in the artery where the flow from the lateral opening can enter, which reduces the flow efficiency and makes this area turbulent.
    [014] As discussed above, each of the previously suggested bidirectional cannulas has a number of drawbacks. In addition, low overall performance has been observed due to the occlusion issues of the orifices / openings directed laterally. The inventors have found that the poor previous performance can be attributed, at least partially, to two factors, arterial spasm and downstream compression.
    [015] Arterial spasm refers to the normal physiological response of contraction of the arterial smooth muscle to distension or local trauma. Arterial spasm around the cannula's body will result in reduced blood reflux around the cannula and to the leg. This can occur even around undersized cannulas.
    [016] Downstream compression, as shown in Figure 1, is a mechanism not previously recognized. The body of a conventional femoral cannula causes distortion of the arterial wall around the insertion point. As the cannula tends to rest on the orientation of the artery, the cannula's body causes the descending displacement of the distal margin of the arteriotomy, and the compression of the artery exactly distal to the arteriotomy. It is necessary to remedy the obstruction of the flow downstream to the arteriotomy if the reliable flow downstream is to be provided.
    [017] The issues of arterial spasm and downstream compression have not yet been recognized or addressed in previous proposals.
    [018] The examples of the invention seek to address, or at least mitigate, one or more disadvantages of the anterior cannula. Summary of the Invention
    [019] According to the present invention, a bidirectional perfusion cannula is provided comprising an elongated tube for insertion into an artery, the elongated tube comprising: a first opening at a distal end of the tube which is advanced during insertion, the first opening being configured so that blood can flow into the artery towards insertion; a knee formed in the elongated tube; and a second opening, the second opening being formed at or slightly behind the knee and configured to supply blood to the artery in a second direction that is usually opposite to the insertion direction.
    [020] Preferably, the knee is preformed in the elongated tube so that, in a relaxed state before insertion of the cannula, it has a knee curve, preferably in the range of 90 to 180 degrees.
    [021] Preferably, the elongated tube has a projection formed at least partially on the knee, the projection being configured to facilitate the positioning of the cannula in the artery. Preferably, the protrusion and the knee form a transition zone that opens the artery by immobilization. In one embodiment, the transition zone is inflatable. Preferably, the protrusion can taper in the direction of insertion to allow insertion of the cannula into the artery.
    [022] Preferably, a rear portion of the protrusion is tapered in greater proportion than in the insertion direction in order to provide greater resistance during removal than during insertion. A side profile of the projection may be in the form of a shoulder, preferably a rounded shoulder.
    [023] The cross section of the protrusion in general can be oval. The protrusion may extend over an external surface of the knee. Preferably, the second opening extends through the projection. Preferably, the second opening extends in a direction generally opposite to the front end of the tube.
    [024] The elongated tube can end at the first opening. The elongated tube can be configured to receive an elongated introducer through it to assist in the insertion of the cannula and prevent blood from flowing through the first opening while the elongated tube and introducer are inserted into an artery.
    [025] The elongated tube can be configured so that its internal diameter, in a region around the second opening, is greater than the diameter of a corresponding portion of the elongated introducer when received through it, so that the blood - which can pass into the elongated tube through the second opening to indicate that the second opening has reached the inside of the artery. Preferably, the internal diameter of the elongated tube is generally constant along the length of the tube.
    [026] Preferably, the knee forms an angled curve of approximately 130 degrees. The elongated tube can be formed of flexible material in order to undergo at least partial narrowing when an introducer is inserted into the cannula. The elongated tube may be formed of a flexible wire-reinforced polyurethane material.
    [027] Preferably, the cannula is configured for insertion into a femoral artery. The cannula can also be configured for insertion into a subclavian or axillary artery.
    [028] The cannula can also include a manometer tube in communication with a pressure transducer, the manometer tube configured to measure blood pressure flowing in the second direction.
    [029] According to the present invention, a bidirectional perfusion cannula of the type described above and an oblique introducer received through the elongated tube are additionally provided in combination.
    [030] According to the present invention, a method of insertion into an artery of a bidirectional perfusion cannula is also provided, comprising a long tube with a first opening at a distal end to supply blood to the artery in a insertion direction, a knee formed in the elongated tube, a projection formed at least partially on the knee and a second opening formed in the projection to supply blood to the artery in opposition to the insertion direction, the method comprising the steps of: inserting the distal end of the elongated tube in the artery until an increase in resistance to insertion is perceived to indicate that the protrusion is entering the artery; gently move the elongated tube in the artery until the knee and the protrusion have passed into the artery and the degree of resistance has been decreased; and retract the elongated tube until the increase in resistance to retraction is perceived to indicate that the protrusion is touching the artery wall and the cannula is in position.
    [031] Preferably, blood flows into the elongated tube through the second opening after the second opening has been moved smoothly inside the artery.
    [032] Preferably, after treatment, the cannula is retracted by gently moving the protrusion through an artery wall, and thus an opening formed in the artery wall is gradually enlarged by increasing the cross section size. protrusion, so that the elongated tube can usually be removed without causing further trauma to the artery.
    [033] In accordance with the present invention, a method of providing perfusion to a limb during peripheral artery cannulation is also provided, the method including the steps of: inserting a cannula of the type described above into an artery; pump blood through the cannula to the artery; and monitor the pressure measured by the pressure transducer to ensure that the member has the right level of blood flow.
    [034] According to preferred modalities, the blood pressure flowing in the second direction is constantly monitored and maintained in a range close to a pressure level in the second direction determined at the beginning of the flow. Brief Description of Drawings
    [035] The invention will be described further, solely as a non-limiting example, with reference to the accompanying drawings where: Figure 1 is a side sectional view of a conventional cannula inserted into an artery; Figure 2 is a side view of a bidirectional perfusion cannula of a modality of the invention, receiving an introducer; Figure 3 is a cross-sectional view of the cannula along line A-A of Figure 4; Figure 4 is a front view of the cannula where the wire reinforcement has been removed for clarity; Figure 5 is a side view of the bidirectional perfusion cannula of Figure 4; Figures 6A, 6B and 6C are cross-sectional views of the cannula of Figure 5, the sections being obtained along the lines C-C, D-D and E-E of Figure 5 respectively; Figure 7 is a cross-sectional view of the cannula inserted in an artery; Figure 8A is a rear perspective view of the cannula with a manometer tube attached to it; and Figure 8B is an approximate rear view of the pressure gauge tube. Detailed Description
    [036] With reference to Figure 2, a bidirectional perfusion cannula 10 comprising an elongated tube 12 configured for insertion into an artery is presented. The elongated tube 12 comprises a first opening 14 at a distal end of the elongated tube 12 which is advanced during insertion of the cannula into an artery. The first opening 14 is configured so that blood can flow into the artery towards the insertion and towards the patient's arterial circulation.
    [037] The elongated tube 12 further comprises a knee 16 which is formed in the elongated tube. Knee 16 is pre-formed so that, in a relaxed state before insertion of the cannula, it has a knee curve. In the example shown, the knee forms a 130-degree angle, perceived as the angle that most relieves compression downstream of the artery distal to the arteriotomy and allows the cannula to reach an adequate seat outside the artery. It would be interesting if other angles, for example, 120 degrees, and particularly those in the 90 to 180 degree range, would also be convenient. Angles beyond this range may not be effective in relieving downstream compression or in allowing the intravascular and extravascular sections of the cannula to reach a suitable seat. The knee 16 allows the elongated tube 12 to travel to a convenient extent, so that a second opening 18, in the form of a rear-facing opening, can be provided for bidirectional perfusion.
    [038] The provisions suggested above, like those revealed by Fonger et al, do not include a knee, so an opening facing backwards, directing blood to the artery and not to the artery wall, can be provided. The inventors found that, in use, a naturally flexible artery, and less rigid than a conventional cannula, tends to involve a straight cannula when inserted into the artery, with an action that closes the artery as shown in Figure 1. Arrangements with orifices facing to the side are particularly susceptible to this problem. By providing a knee and an opening facing backwards, it is possible to avoid obstruction or masking of the opening by the artery wall, as shown in Figure 7, thereby increasing the effectiveness of the cannula. In particular, the problems discussed above regarding arterial spasm and downstream compression can be mitigated with the opening facing backwards opposite the artery wall.
    [039] Knee 16 also contributes to the positioning of the cannula 10 as it passes from the femoral artery to the surface of the leg. The angle used for knee 16 is selected in order to reduce the intensity of compression of the distal or downstream artery.
    [040] As illustrated, the second opening 18 is formed in the posterior or partially posterior part, that is, contrary to the insertion or anterior direction, of the knee 16. The second opening 18 faces back and is configured to supply blood to the artery in a second direction usually opposite to the insertion or anterior direction in order to allow bidirectional perfusion in the artery. In the examples shown, the second opening 18 is formed in the knee, although it can be partially formed in the posterior part of the knee and still allow adequate bidirectional perfusion in the artery. Forming the second opening 18 in the posterior or partially posterior part of the knee 16, it provides a second blood flow path without invading or narrowing the lumen of the elongated tube 12, thus avoiding the reduction of blood flow through the cannula 10. The configuration of the knee 16 and of the second opening 18 is such that when the cannula 10 is inserted into the artery, the second opening 18 is oriented correctly inside the artery.
    [041] The elongated tube 12 has a projection 20 formed over the knee 16 and configured to facilitate the insertion and positioning of the cannula 10 in the artery. The protrusion 20 is formed on an external surface of the knee 16 and extends along it. As can be seen in Figures 6A to 6C, the extent of the projection 20 is generally limited to the lower half of the cross section, not seen when viewed from the front (Figure 4) or from above the cannula 10.
    [042] Tapering of the protrusion 20 in the insertion direction occurs to allow the cannula to be inserted into the artery with a minimum level of trauma. In this regard, the tapering is gradual to allow the artery wall to expand gradually while the cannula 10 is inserted. The angle of the taper remains approximately between 3 and 25 degrees. For cannulae of different dimensions, the tapering angle will be the same, although the maximum protrusion thickness will depend on the size of the cannula. For example, a 20F cannula will have a projection with a maximum thickness, excluding the length of the elongated tube in which it is formed, of about 1.5mm. It would be interesting if the size of the protrusion formed on the smaller cannula was produced on a smaller scale.
    [043] The size of the protrusion 20 is small enough to allow insertion of the cannula 10 into the artery with minimal trauma, although large enough to prevent accidental dislodgement of the cannula 10. The size of the protrusion 20 is also sufficient, so that the second opening 18 can be positioned inside the projection 20 orienting the second opening 18 inside the artery.
    [044] Together, the protrusion 20 and the knee 16 form a transition zone 28 where the size of the elongated tube section 12 gradually increases and then decreases so that it can be inserted into the artery inflicting a minimal degree of trauma to the artery wall - laugh. In the examples shown, the protrusion 20 is generally oval in its cross section, as can be seen in Figures 6A, 6B and 6C, although other shapes can also be used.
    [045] Transition zone 28 acts by immobilizing and opening the artery so that it is not compressed by the cannula body, allowing unimpeded flow in the second direction. The transition zone 28 supports the artery wall in contrast to the second opening 18, so the artery remains open and does not block the flow of blood from the cannula 10 to the artery. The transition zone 28 also provides stability to the cannula 10 when inserted into an artery, keeping the cannula 10 in position.
    [046] The tapering of the rear portion of the protrusion 20 is more pronounced than in the insertion direction, so it gives greater resistance during removal than during insertion. The tapering of the rear portion of the projection 20 is more pronounced, therefore, in general, the lateral profile of the projection 20 has the shape of a rounded shoulder.
    [047] The inventors found that by providing a projection in the form of a rounded shoulder, it is possible to achieve a good balance between minimizing arterial trauma during removal and resistance to removal. The projection also provides a self-locating mechanism. In this regard, the increased resistance against removal of the cannula allows the surgeon to insert the cannula 10 subjected to the slight resistance at a predetermined depth at which the resistance will be reduced. The cannula 10 can then be gently retracted until the increase in resistance is noticed, providing a direct tactile response indicating that the cannula is correctly positioned in the artery. The provided increased resistance to removal also prevents involuntary or accidental removal of the cannula 10 from the artery. This is important if the second opening 18 is displaced out of the artery, as blood can flow from the cannula out of the artery causing bleeding.
    [048] By providing a projection in the form of a rounded boss, it prevents streaks, rails or burrs, which can create channels for bleeding during insertion and removal.
    [049] The rear portion of the protrusion 20 is arranged at a predetermined distance from the second opening 18 so that when the cannula 10 is positioned in the desired position in the artery, the second opening 18 is positioned perfectly inside the artery.
    [050] The rear portion of the protrusion 20 is seated against the arteriotomy to act as a support structure, effectively maintaining the opening of the downstream artery, which would otherwise adjust, through its movements, to the shape of the cannula and compress the artery downstream, potentially obstructing the lateral perfusion orifice of the artery. Preserving the opening of the artery, the protrusion maintains a channel through which blood can flow freely to the leg.
    [051] In the examples shown, the second opening 18 extends through the ledge 20 and in a direction generally opposite to the front end of the tube, as can be seen in Figure 3, allowing the flow towards the lower limb that is usually unimpeded . Because of the size of the cannula and the artery where it will be received, the protrusion generally surrounds the second opening 18 so that the second opening 18 is perfectly positioned inside the artery when the cannula is positioned inside the artery.
    [052] As can be seen in Figure 2, an inner portion of the second opening 18 in the lumen of the elongated tube 12 is generally tapered in order to minimize the turbulence of blood flow in the elongated tube 12 and through the second opening 18. The size of the second opening 18 can vary according to elongated tubes of different sizes to obtain different proportions of flow to the lower limb. In the example shown, the diameter of the second opening 18 is 2.0 mm.
    [053] As can be seen in Figure 2, the elongated tube 12 ends at the first opening 14. Furthermore, it is noticed that the elongated tube 12 undergoes tapering at the front end in the region proximal to the first opening 14. An elongated introducer flexible 22 can be received through the elongated tube 12 with its tip passing outside the first opening 14. The introducer 22 assists in arterial insertion by providing a tapered end that protrudes from the first opening 14. The introducer also prevents the blood flows back from the first opening 14. The first opening 14 is configured to engage the introducer 22 which is received through the elongated tube 12 in order to prevent blood flow from entering the elongated tube 12 through the first opening 14 while the introducer 22 is received in the elongated tube 12.
    [054] As can be seen in Figure 7, the elongated tube 12 can be configured so that the internal diameter of the elongated tube 12, in a region around the second opening 18, is greater than the diameter of a corresponding portion of the elongated introducer 22 when received through it, which allows blood to penetrate the elongated tube 12 through the second opening 18 to indicate that the second opening 18 has penetrated artery 21. In this regard, the elongated introducer 22, when inserted into the elongated tube, tapers in the region of the second opening 18 to allow blood to enter the elongated tube 12. In general, the internal diameter of the elongated tube 12 is constant over the length of the elongated tube 12.
    [055] The flash resulting from blood access in the elongated tube 12 while the second opening 18 penetrates the artery provides the clinician with a visual indication that the cannula 10 has practically reached its position. This flash of blood is particularly useful during percutaneous insertion. Inserting the cannula 10 just beyond this position in artery 21 allows a rear portion of the protrusion 20 to penetrate the artery. Once this rear portion has penetrated artery 21, the sharp tapering of the rear portion of the protrusion 20 operates to prevent accidental or accidental withdrawal.
    [056] As can be seen in Figure 6A, after the projection 20 and before the proximal tapering of the first opening 14, the external diameter of the elongated tube 12 is generally constant before making the transition to the projection 20 (Figure 6B) . The diameter of the elongated tube 12 is recovered or returns to this constant value at the rear of the projection 20, as can be seen in Figure 6C. The size of the elongated tube 12 is selected to provide an appropriate blood flow to the patient, and, on average, the external diameter of the elongated tube can be between 3 mm and 8 mm. Depending on the size of the patient and the elongated tube used, obstruction of flow around the cannula body may occur.
    [057] The elongated tube 12 is formed of flexible material so that it can be corrected at least partially when the introducer 22 is inserted into the cannula 10 and facilitates the insertion of the cannula 10 into the artery. Once the introducer 22 has been removed, the elongated tube 12 will return to its natural shape, preserving the opening of the artery, as discussed above. The elongated tube 12 can be completely straight when the introducer 22 is inserted into the cannula 10. As can be seen in Figure 2, the elongated tube 12 is formed of reinforced wire. In the example described, the elongated tube is formed of flexible polyurethane material, which is generally transparent, although it is interesting that other materials, for example silicon, could also be used.
    [058] In some examples, different sections of the cannula 10 can be produced from different materials. For example, knee 16 can be formed from a material other than the elongated tube 12. In addition, knee 16 can be formed from flexible material, such as PVC, polyurethane, silicone or rubber and configured in such a way as to allow it to expand. The inflatable knee can be configured to inflate manually or automatically. In this example, knee 16 can remain in an uninflated or partially inflated state during insertion and then inflate to assume a shape generally compatible with that previously described in the ready-to-use condition. In this regard, when correctly positioned and inflated, the inflatable knee provides a projection 20 and houses the second opening 18 so that bidirectional perfusion can be achieved. The inflatable knee can be configured to expand against the internal wall of the artery in order to fix the cannula in place and keep the wall away from the second opening 18.
    [059] The proximal end 24 of the cannula 10 is shown with a standard 3/8 "connector. This generic connection can be used, or other commercially available connections can replace it allowing the cannula 10 to be used with different tubes infusion.
    [060] The previously described modalities were discussed in relation to the general way of inserting the cannula 10 in an artery. It would be interesting if cannula 10 was suitable for direct insertion into the artery with open surgical exposure and also for percutaneous use.
    [061] During percutaneous use, which can persist for several days, it is desirable to ensure that the cannula remains correctly positioned in the artery in order to preserve the correct perfusion. To ensure the preservation of adequate perfusion, the pressure of the blood flowing to the artery behind the cannula towards the limb, that is, the blood of the perfusion flowing contrary to the patient's arterial circulation, can be monitored.
    [062] Figures 8A and 8B illustrate an example of an arrangement to monitor the pressure of the perfusion blood flow towards a limb, in order to indicate the suitability of the downstream flow and the position of the cannula 10. In the illustrated example , a manometer tube 30 extends adjacent the elongated tube 12. The manometer tube 30 passes through a wall of the elongated tube behind the protrusion 20 in the insertion direction. This location is such that its position will be external to the patient when in use. It would be interesting if the manometer tube 30 could pass through the elongated tube wall at other locations behind the projection 20 and still provide the required communication between the manometer tube 30 and the pressure transducer. The manometer tube 30 passes through the elongated tube 12 and ends at the opening 32 adjacent to the second opening 18. The position of the opening 32 is such that the flow of blood pressure towards the limb can be monitored.
    [063] The manometer tube 30 is configured to accept a connector 34 and allow the connection between the manometer tube 30 and the pressure transducer (not shown). In use, when cannula 10 is inserted into the artery, blood will flow through opening 18 and penetrate the patient's artery to a limb. The pressure transducer will measure the pressure of this blood flow to the limb to be able to determine if the flow to the limb is sufficient. The pressure transducer reading can then be used to indicate whether the cannula is installed correctly in the artery. In this regard, when the cannula is correctly installed in the artery, the pressure reading will initially show the pulsatile flow transmitted through the elongated tube since opening 14. Once the non-pulsatile flow is initiated through the elongated tube, monitoring the trend of the pressure, as well as the absolute pressure, will indicate all changes in the perfusion towards the member. Incorrect installation may involve inserting the cannula into the artery in a very advanced position, in which case the second opening may be covered, or not inserted enough. In this condition, the second opening would not be located inside the artery and there would be, or would be insufficient, the flow to the artery.
    [064] The pressure transducer can also be used to confirm that the initial cannula 10 installation is correct.
    [065] The use of a pressure transducer can be beneficial in environments where prolonged use of infusion is common, such as the Extracorporeal Oxygenation Units (ECMO) and Intensive Care Units.
    [066] To allow insertion of the cannula 10 and the oblique introducer 22 into the artery, guide wire techniques are used.
    [067] A method of inserting the bidirectional perfusion cannula 10 into the artery comprises the steps of inserting the introducer 22 received at the distal end of the elongated tube 12 through the artery (through a guide wire after previously dilating the dilators) until you notice that there was an increase in resistance to insertion to indicate that the protrusion 20 is entering the artery. The elongated tube 12 is then moved smoothly into the artery until the knee 16 and the projection 20 have penetrated the artery and the degree of resistance has decreased. The elongated tube 12 is then retracted until the increase in resistance to retraction is perceived to indicate that the protrusion 20 is touching the artery wall and the cannula 10 is in position.
    [068] Once the cannula is in place, the introducer 22 can be removed and the cannula 10 connected to the appropriate perfusion equipment.
    [069] After treatment, the cannula 10 is retracted by gently moving the protrusion 20 through an artery wall, and with this an opening formed in the artery wall is gradually enlarged with the increase in size of the cross section of the artery. 20, so that the elongated tube 12 can be removed, almost always without causing additional trauma to the artery. Pressure can be applied to the femoral artery at a distal location to help the protrusion pass through the artery wall so that the elongated tube can be removed.
    [070] The modalities were discussed only as an example, admitting modifications within the scope of the disclosed invention.
    权利要求:
    Claims (10)
    [0001]
    1. Bidirectional perfusion cannula (10) comprising an elongated tube (12) for insertion into an artery, the elongated tube (12) comprising: a first opening (14) at a distal end of the elongated tube (12) which is advanced during the insertion, the first opening (14) being configured so that blood can flow into the artery (21) in the direction of insertion; a knee (16) preformed in the elongated tube (12); and a second opening (18), the second opening (18) being formed at or slightly behind the knee (16) and configured to supply blood to the artery in a second direction that is generally opposite to the insertion direction, in which the elongated tube (12) has a single protrusion (20) formed at least partially in the knee (16), the protrusion (20) being configured to facilitate the positioning of the cannula (10) in the artery (21), and in which the second opening (18) extends through the projection, the bidirectional perfusion cannula (10) being CHARACTERIZED by the fact that the projection (20) tapers in the insertion direction to allow the insertion of the cannula (10) in the artery (21), where a rear portion of the projection (20) tapers at a higher rate than in the direction of insertion, in order to provide greater resistance during removal than during insertion, and where a lateral profile of the projection (20) has the shape of a ledge.
    [0002]
    2. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the protrusion (20) and the knee (16) form a transition zone that opens the artery.
    [0003]
    3. Bidirectional perfusion cannula (10), according to claim 2, CHARACTERIZED by the fact that the transition zone is inflatable.
    [0004]
    4. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the elongated tube (12) is configured to receive an elongated introducer (22) through it to aid in the insertion of the cannula (10) and preventing blood from flowing through the first opening (14) while the elongated tube (12) and the introducer (22) are inserted into an artery (21).
    [0005]
    5. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the elongated tube (12) is configured so that an internal diameter of the elongated tube (12), in a region around the second opening (18), is larger than the diameter of a corresponding portion of the elongated introducer (22) when received through it, so that blood can pass into the elongated tube through the second opening (18) to indicate that the second opening reached the inside of the artery.
    [0006]
    6. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the knee (16) forms a curve at an angle of approximately 130 degrees.
    [0007]
    7. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the elongated tube (12) is formed of flexible material in order to undergo at least partial narrowing when an introducer (22) is inserted into the inside the cannula (10).
    [0008]
    8. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that the cannula (10) is configured to be inserted into a femoral artery.
    [0009]
    9. Bidirectional perfusion cannula (10), according to claim 1, CHARACTERIZED by the fact that it additionally comprises a manometer tube in communication with a pressure transducer, the manometer tube configured to measure the blood pressure flowing in the second direction .
    [0010]
    10. Combination, of a bidirectional perfusion cannula (10), as defined in any of claims 1 to 9, and the oblique introducer (22) CHARACTERIZED by the fact that it is received through the elongated tube.
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    同族专利:
    公开号 | 公开日
    US10183148B2|2019-01-22|
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    CA2832214A1|2012-10-11|
    US20190143074A1|2019-05-16|
    EP2694148A4|2014-12-24|
    AU2012239851B2|2016-09-15|
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    EP2694148B1|2019-01-16|
    WO2012135904A1|2012-10-11|
    CA2832214C|2017-07-11|
    US8795253B2|2014-08-05|
    EP2694148A1|2014-02-12|
    JP2014517721A|2014-07-24|
    AU2012239851A1|2013-10-24|
    US20140330250A1|2014-11-06|
    JP5932969B2|2016-06-08|
    EP3492133B1|2020-06-10|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-08-04| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-12-22| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/04/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    2022-01-25| B21F| Lapse acc. art. 78, item iv - on non-payment of the annual fees in time|Free format text: REFERENTE A 10A ANUIDADE. |
    优先权:
    申请号 | 申请日 | 专利标题
    AU2011901258A|AU2011901258A0|2011-04-05|Bi-directional perfusion cannula|
    AU2011901258|2011-04-05|
    AU2011902210|2011-06-03|
    AU2011902210A|AU2011902210A0|2011-06-03|Bi-directional perfusion cannula|
    PCT/AU2012/000347|WO2012135904A1|2011-04-05|2012-04-04|Bi-directional perfusion cannula|
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