Hemostasis valve and catheter sheath comprising same

Abstract

The invention provides a hemostasis valve and a catheter sheath comprising the same. The hemostasis valve comprises a valve body and a magnetic control assembly. The valve body is provided with a valve cavity for an instrument to pass through, and the valve cavity can be filled with magnetofluid; the magnetic control assembly is arranged on the valve body and used for providing a working magnetic field for the magnetic fluid in the valve cavity so that the magnetic fluid can seal the valve cavity when an instrument is inserted into the valve cavity or no instrument is inserted into the valve cavity. The catheter sheath comprises a sheath tube body and a hemostasis valve, and the far end of the hemostasis valve is hermetically connected with the near end of the sheath tube body. An instrument channel in the valve body is sealed through the magnetic fluid, the magnetic fluid can provide good sealing performance, friction force on instruments passing through the magnetic fluid is small, the operation hand feeling is better, misjudgment is avoided, and the operation success rate is increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a magnetic fluid hemostatic valve. Background Art

[0002] With the continuous development of percutaneous minimally invasive surgery, more and more instruments can enter the blood vessels or other body cavities through incisions such as the femoral artery for treatment. During the operation, in order to reduce damage to human tissues and reduce blood loss, a catheter sheath or such an instrument is usually inserted into the blood vessel or body cavity first, and other diagnostic or treatment instruments enter and exit through the catheter sheath. Usually, a hemostatic valve is required to seal the diagnostic or treatment instrument.

[0003] A conventional hemostatic valve is a ring-shaped silicone rubber sealing ring. When it is squeezed, the middle ring-shaped hole shrinks. When an instrument is inserted, the instrument expands this ring-shaped hole, thereby ensuring the sealing effect.

[0004] However, since the sealing is ensured by relying on the deformation of the silicone rubber sealing ring, the resistance to the entry and exit of the instrument is large. Multiple patents describe various forms of silicone rubber ring structures. By relying on the extrusion deformation of the sealing ring, the resistance to the instrument is minimized as much as possible, but still a large frictional force will be generated on the instrument, affecting the surgical feel. In particular, it is impossible to determine whether the resistance is generated by the blood vessel or the silicone rubber hemostatic valve, which is likely to cause misjudgment.

[0005] It should be noted that the information disclosed in the above background art section is only used to enhance the understanding of the background of the present disclosure, and therefore may include information that does not constitute the prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of the embodiments of the present invention is to provide a hemostatic valve and a catheter sheath including the same. The instrument channel in the valve body is sealed by magnetic fluid. The magnetic fluid can not only provide good sealing performance, but also has very little frictional force on the instrument passing through it, making the operation feel better, avoiding misjudgment, and improving the surgical success rate.

[0007] To solve the above technical problems, in a first aspect, the embodiments of the present invention provide a hemostatic valve, including: a valve body and a magnetic control component; the valve body has a valve cavity for passing an instrument, and the valve cavity can also be filled with magnetic fluid; the magnetic control component is arranged on the valve body and is used to provide a working magnetic field for the magnetic fluid in the valve cavity so that the magnetic fluid seals when an instrument is inserted or not inserted into the valve cavity.

[0008] As an embodiment, an annular installation cavity coaxial with the valve body is arranged inside the peripheral wall of the valve body, and the annular installation cavity extends along the axial direction of the valve body;

[0009] The magnetic control assembly includes: a coil controller and at least one set of electromagnetic coils; the at least one set of electromagnetic coils is electrically connected to the coil controller;

[0010] The at least one set of electromagnetic coils is coaxially arranged in the annular installation cavity and is used to generate a working magnetic field;

[0011] The hemostatic valve further includes a valve cover covering the end of the annular installation cavity.

[0012] As an embodiment, there are multiple sets of the electromagnetic coils, and each set of electromagnetic coils includes a plurality of annular coils; the multiple sets of electromagnetic coils are spaced apart along the axial direction of the valve body.

[0013] As an embodiment, the hemostatic valve further includes a flushing tube, the inner end of the flushing tube is connected to the circumferential wall of the distal end of the valve body, and a two-way valve is provided at the outer end of the flushing tube.

[0014] As an embodiment, an opening is provided on the circumferential wall of the proximal end of the valve body, and the wires of the at least one set of electromagnetic coils pass through the opening, and the other ends of the wires are connected to the coil controller.

[0015] As an embodiment, an electromagnetic shielding member is sleeved on the outer periphery of the valve body.

[0016] As an embodiment, the electromagnetic shielding member includes: a metal shell and / or a metal mesh.

[0017] In a second aspect, an embodiment of the present invention further provides a catheter sheath, which includes a sheath tube body and the hemostatic valve as described above, and the distal end of the hemostatic valve is hermetically connected to the proximal end of the sheath tube body.

[0018] As an embodiment, the catheter sheath further includes a connecting member, and the sheath tube body is connected to the hemostatic valve through the connecting member.

[0019] As an embodiment, the connecting member has a distal tube portion, the distal tube portion is hermetically sleeved on the proximal end of the sheath tube body, the connecting member further has a proximal convex ring, and the distal end of the hemostatic valve is hermetically sleeved on the proximal convex ring.

[0020] It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

[0021] A magnetic control assembly is provided on the valve body, and the magnetic control assembly provides a working magnetic field for the magnetic fluid in the valve cavity, so that the magnetic fluid can achieve sealing when an instrument is inserted or not inserted into the valve cavity, thereby enabling the hemostatic valve to have good sealing performance. At the same time, since the frictional force of the magnetic fluid on the instrument is very small, the operation feel is better, misjudgment is avoided, and it is beneficial to improve the surgical efficiency and success rate. Description of the Drawings

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. It can be understood that the drawings described below are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on the provided drawings.

[0023] Figure 1 It is a schematic structural diagram of the sealing state of the hemostatic valve of the catheter sheath in the embodiment of the present invention when no instrument is inserted.

[0024] Figure 2 For Figure 1 It is a schematic structural diagram when the magnetic fluid is not filled in the shown hemostatic valve.

[0025] Figure 3 For Figure 1 It is a schematic structural diagram of the sealing state of the shown hemostatic valve when an instrument is inserted.

[0026] In the figure: 10, sheath body; 20, connecting piece; 21, distal tube part; 22, proximal convex ring; 30, valve body; 31, valve cavity; 32, annular installation cavity; 40, electromagnetic coil; 50, magnetic fluid; 60, valve cover; 70, wire; 80, flushing tube; 90, two-way valve; 100, coil controller; 120, instrument. Specific embodiments

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will elaborate on each embodiment of the present invention in conjunction with the drawings. However, those of ordinary skill in the art can understand that in each embodiment of the present invention, many technical details are presented to help readers better understand the present invention. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed by the present invention can still be implemented.

[0028] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation to the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0029] It should be noted that, unless otherwise clearly specified, terms such as "connected" and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two components.

[0030] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator. The above definitions are only for convenience of description and should not be construed as a limitation of the present invention.

[0031] Please refer to Figures 1 to 3 As shown, Embodiment 1 of the present invention provides a catheter sheath, which can be used to establish an instrument channel for percutaneous minimally invasive surgery. It should be noted that the hemostatic valve in the catheter sheath of the embodiment of the present invention can also be used in cooperation with other suitable instruments, and no excessive limitation is made here. The catheter sheath includes: a sheath tube body 10 and a hemostatic valve. The distal end of the hemostatic valve is hermetically connected to the proximal end of the sheath tube body 10.

[0032] The hemostatic valve includes: a valve body 30 and a magnetic control assembly. The valve body 30 has a valve cavity 31 for passing instruments, and the valve cavity 31 can also be filled with magnetic fluid 50. The magnetic control assembly is disposed on the valve body 30 and is used to provide a working magnetic field for the magnetic fluid 50 in the valve cavity 31, so that the magnetic fluid 50 seals when an instrument is inserted or not inserted into the valve cavity 31. The working magnetic field is, for example, a circular magnetic field concentric with the valve body 30. Under the action of the working magnetic field, the magnetic fluid 50 forms a stable liquid barrier, such as Figure 1 shown in the form of a colloidal sealing interface, which can prevent blood or air from passing through, and at the same time can smoothly pass the instrument. The magnetic fluid seal has an adaptive ability. When the size of the passed instrument 120 changes, resulting in a change in the sealing gap between the instrument 120 and the valve body 30, the magnetic fluid 50 can also quickly adjust its shape and position to fill any tiny gaps and maintain the sealing effect. The magnetic fluid mainly includes magnetic particles, surfactants, and a carrier liquid (solvent). The magnetic fluid preferably used for the seal of the hemostatic valve has the following characteristics: good stability, no aggregation, no precipitation, no decomposition, high saturation magnetization intensity, large initial magnetic permeability, and low viscosity. The magnetic fluid 50 may or may not have biocompatibility. It can be understood that the selection of the magnetic fluid 50 can meet the performance requirements of the hemostatic valve, and no excessive limitation is made here.

[0033] The magnetic control assembly includes: a coil controller 100 and at least one set of electromagnetic coils 40. At least one set of electromagnetic coils 40 is electrically connected to the coil controller 100. The coil controller 100 can control the magnetic flux of the electromagnetic coils 40 to enable the magnetorheological fluid 50 to obtain sealing effects with different differential pressure intensities, so as to obtain a better operating feel. The electromagnetic coils 40 are used to generate a working magnetic field. There can be multiple sets of electromagnetic coils 40. Each set of electromagnetic coils 40 can provide a working magnetic field for a magnetorheological fluid sealing structure. The multiple sets of electromagnetic coils 40 are spaced along the axial direction of the valve body 30. The multiple sets of electromagnetic coils 40 can be evenly spaced or unevenly spaced along the axial direction of the valve body 30. The multiple sets of electromagnetic coils 40 cooperate with the magnetorheological fluid 50 respectively to form multiple magnetorheological fluid sealing structures, so as to provide multi-stage sealing along the axial direction of the valve body 30 and achieve more reliable sealing. By way of example and not limitation, there can be 3 sets of electromagnetic coils 40. The 3 sets of electromagnetic coils 40 cooperate with the magnetorheological fluid to form 3 magnetorheological fluid sealing structures. Each set of electromagnetic coils 40 can include multiple toroidal coils. The coil controller 100 can pass a proper amount of direct current through each toroidal coil to generate a stable working magnetic field. The multiple toroidal coils can obtain a stronger working magnetic field, so that the magnetorheological fluid placed in this working magnetic field forms a sealing structure. Each magnetorheological fluid sealing structure can prevent blood from flowing out at a pressure of 1 to 50 kPa (kilopascals). In some examples, there can also be 1 set of electromagnetic coils. In this embodiment, there are no specific limitations on the number of sets of electromagnetic coils 40 and the number of toroidal coils included in each set of electromagnetic coils.

[0034] An annular installation cavity 32 coaxial with the valve body 30 is provided in the peripheral wall of the valve body 30. The annular installation cavity 32 extends along the axial direction of the valve body 30. The annular installation cavity 32 is used to install at least one set of electromagnetic coils 40. The axial length of the annular installation cavity 32 can be determined according to the installation position of the electromagnetic coils. At least one set of electromagnetic coils 40 is coaxially arranged in the annular installation cavity 32. The hemostatic valve further includes a valve cover covering the end of the annular installation cavity 32. By embedding the electromagnetic coils 40 in the annular installation cavity 32 of the valve body 30, the electromagnetic coils can be isolated from the blood and the magnetorheological fluid 50, and the electromagnetic coils 40 can be prevented from contacting the blood and the magnetorheological fluid. In this embodiment, there are no specific limitations on the number, installation position, excitation method, etc. of the electromagnetic coils 40, as long as the required hemostatic sealing effect can be generated.

[0035] An opening is provided in the proximal peripheral wall of the valve body 30. The wires 70 of at least one set of electromagnetic coils 40 pass through the opening. The other ends of the wires 70 are connected to the coil controller 100. It can be understood that the multiple sets of electromagnetic coils 40 can be connected in series or in parallel.

[0036] An electromagnetic shielding member (not shown in the figure) can also be sleeved on the outer periphery of the valve body 30. The electromagnetic shielding member can include: a metal shell and / or a metal mesh. The magnetic field generated by the electromagnetic coils is shielded by the electromagnetic shielding member to avoid electromagnetic interference to surrounding instruments.

[0037] The hemostatic valve further includes a flushing tube 80. The inner end of the flushing tube 80 is connected to the circumferential wall of the distal end of the valve body 30, and a two-way valve 90 is provided at the outer end of the flushing tube 80. Through the flushing tube 80, flushing liquid can be injected to clean the catheter sheath or other functional liquids can be injected, and no specific limitation is made here.

[0038] The catheter sheath further includes a connecting member 20. The sheath body 10 is connected to the hemostatic valve through the connecting member 20. The connecting member 20 has a distal tube portion 21, and the distal tube portion 21 is hermetically sleeved on the proximal end of the sheath body 10. The connecting member 20 also has a proximal convex ring 22, and the distal end of the hemostatic valve is hermetically sleeved on the proximal convex ring 22, thereby realizing the connection between the sheath body 10 and the hemostatic valve.

[0039] Combined Figures 1 to 3 As shown, the usage method of the catheter sheath according to the embodiment of the present invention is as follows:

[0040] The electromagnetic coil 40 is charged through the coil controller 100. At this time, the electromagnetic coil 40 is filled with a magnetic field. The magnetic fluid 50 is injected into the valve cavity of the hemostatic valve using a syringe. The magnetic fluid 50 is constrained by the magnetic force in the magnetic field to form a sealing interface with an arc-shaped surface and a certain thickness, which can prevent blood, air, etc. from passing through. When inserting an instrument, such as a dilator, the dilator can pass through the magnetic fluid 50, and the magnetic fluid 50 adheres to the inner surface of the valve body of the hemostatic valve under the pushing action of the instrument, sealing the channel between the instrument and the inner wall of the valve body. After the dilator is withdrawn, the magnetic fluid 50 returns to the initial sealing state under the action of the magnetic force. When inserting other treatment instruments, the magnetic fluid 50 can form an adaptive seal according to the shape and size of the other treatment instruments. After the operation, the magnetic fluid can be recovered, and the recovered magnetic fluid can be recycled after strict disinfection, which is beneficial to reducing costs.

[0041] Compared with the prior art in the embodiment of the present invention, a magnetic control component is provided on the valve body. The magnetic control component provides a working magnetic field for the magnetic fluid in the valve cavity, so that the magnetic fluid can seal when an instrument is inserted or not inserted into the valve cavity, thereby enabling the hemostatic valve to have good sealing performance. At the same time, since the frictional force of the magnetic fluid on the instrument is very small, the operation feel is more sensitive, avoiding misjudgment, which is beneficial to improving the surgical efficiency and success rate.

[0042] Those of ordinary skill in the art can understand that the above embodiments are specific embodiments for implementing the present invention, and in actual applications, various changes can be made in form and details without departing from the spirit and scope of the present invention.

Claims

1. A hemostatic valve, characterized in that: include: A valve body and a magnetic control component; the valve body has a valve cavity for passing an instrument, and the valve cavity can also be filled with a magnetic fluid; the magnetic control component is arranged on the valve body, and is used to provide a working magnetic field for the magnetic fluid in the valve cavity, so that the magnetic fluid can seal the valve cavity when an instrument is inserted or not.

2. The hemostatic valve according to claim 1, characterized in that: An annular installation cavity coaxial with the valve body is provided in the peripheral wall of the valve body, and the annular installation cavity extends axially along the valve body; The magnetic control assembly includes: a coil controller and at least one set of electromagnetic coils; the at least one set of electromagnetic coils is electrically connected to the coil controller; The at least one group of electromagnetic coils is coaxially arranged in the annular mounting cavity and is used to generate a working magnetic field; The hemostatic valve also includes a valve cover which is arranged on the end of the annular mounting cavity.

3. The hemostatic valve according to claim 2, characterized in that: The electromagnetic coils are in multiple groups, and each group of electromagnetic coils includes multiple annular coils; the multiple groups of electromagnetic coils are distributed at intervals along the axial direction of the valve body.

4. The hemostatic valve according to claim 2, characterized in that: The hemostatic valve also includes a flushing tube, the inner end of which is connected to the peripheral wall of the valve body at the distal end, and a two-way valve is arranged at the outer end of the flushing tube.

5. The hemostatic valve according to claim 2, characterized in that: An opening is provided on the peripheral wall of the proximal end of the valve body, and the wires of the at least one group of electromagnetic coils pass through the opening, and the other end of the wires is connected to the coil controller.

6. The hemostatic valve according to claim 1, characterized in that: An electromagnetic shielding member is sleeved on the outer periphery of the valve body.

7. The hemostatic valve according to claim 6, characterized in that: The electromagnetic shielding component includes: a metal shell and / or a metal mesh.

8. A catheter sheath, characterized in that: It comprises a sheath body and a hemostatic valve as claimed in any one of claims 1 to 7, wherein the distal end of the hemostatic valve is sealingly connected to the proximal end of the sheath body.

9. The catheter sheath according to claim 8, characterized in that: The catheter sheath also includes a connecting piece, and the sheath body is connected to the hemostatic valve via the connecting piece.

10. The catheter sheath according to claim 9, characterized in that: The connector has a distal tube portion, the distal tube portion sealing sleeve is arranged at the proximal end of the sheath body, and the connector also has a proximal convex ring, and the hemostatic valve distal sealing sleeve is arranged at the proximal convex ring.

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