Patent Description:
The present invention relates to a puncture needle assembly, and more particularly, it relates to a pericardium puncture needle assembly.

Pericardium is a layer of connective tissue membrane that tightly wraps around the heart. In epicardial ablation, it is necessary to manually open a path through the pericardium tightly around the heart, in order to let the ablation device to access the space between the pericardium and the outwall of heart to conduct ablation.

There is a great diversity of pericardium puncture equipment on market. For example, Chinese patent <CIT> disclosed a type of noninvasive pericardium puncture needle, which comprises an outer sheath, an inner needle, and an end cap. The outer sheath is a flexible hollow tube that accommodates the inner needle. The inner needle is a solid puncture needle, which is fixed to the distal end of the outer sheath by the end cap. Once the pericardium is pierced by the needle, the needle is then withdrawn. The outer sheath continues advancing into the pericardium, so that the pericardial effusion can be extracted or drugs can be injected.

In <CIT>), it has disclosed a pericardial puncture needle assembly, which comprises a guidewire and a puncture needle, wherein the guidewire extends within the puncture needle. The guidewire has a curved distal end and a straight proximal end. The curved distal end is formed by bending the guidewire, and the curved distal end has a sharp structure at its distal end. The guidewire is made from highly elastic material. The sharp tip rotates at least <NUM> degrees within a range of no more than <NUM> starting from the sharp tip of the curved distal end of the guidewire. It is less likely to damage the heart during pericardial puncture procedure when using the pericardial puncture needle assembly.

In the <CIT>), it has disclosed a system and method for reducing noise on a touchpad that uses mutual capacitance on an X axis and Y axis grid of transverse electrodes that function as stimulus or drive electrodes on one axis and function as inputs or sense electrodes on a different axis, wherein there is significant noise that can affect operation of the touchpad, and wherein it is desirable to minimize the effects of this noise by simultaneously sampling a group of sense electrodes, wherein by sampling the sense electrodes at the same time, the level of noise on each sense electrode should be similar and can therefore be subtracted out of measured sense signals to therefore more accurately determine a position of a sensed object or objects on the touchpad.

In the US patent application "TRANSSEPTAL PUNCTURE APPARATUS" (<CIT>), it has disclosed devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

In the US patent application " TRANSSEPTAL GUIDEWIRE" (<CIT>), it has disclosed a transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

In the US patent application "METHOD AND APPARATUS FOR ACCESSING THE PERICARDIAL SPACE" (<CIT>), it has disclosed apparatus for accessing the pericardial space including an elongate tubular member terminating in an opening that permits the induction of pericardial tissue. A piercing member operating within the tubular member can pierce the pericardial tissue providing guidewire access to the pericardial space of a patient's heart.

However, in clinical operations, the existing puncture needles often pierce insufficiently and lead to puncture failure.

The invention is defined only by the independent claims and the preferred embodiments are listed in the dependent claims. Also disclosed is pericardium puncture needle assembly, characterized in comprising a puncture needle and a guide wire, wherein the guide wire can slide in the puncture needle, and the guide wire is made of a high elastic material; the guide wire comprises a distal end bent section, the distal end bent section is formed by bending the guide wire and has a preset bent shape, and the distal end bent section is adapted to regain the preset bent shape from a straightened state, and its tip end part is of a sharp tip structure; the sharp tip structure is provided with a distal end and a proximal end, the distal end of the sharp tip structure is provided with a sharp tip end for puncturing, and within a length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree; the puncturing direction of the guide wire is located in a plane defined by the normal direction of the needle point plane of the puncture needle and the axial line of the puncture needle.

Also disclosed is pericardium puncture needle assembly, characterized in comprising an outer sheath and a guide wire, wherein the guide wire can slide in the outer sheath, and the guide wire is made of a high elastic material; the guide wire comprises a distal end bent section, the distal end bent section is formed by bending the guide wire and has a preset bent shape, and the distal end bent section is adapted to regain the preset bent shape from a straightened state, and its tip end part is of a sharp tip structure; the sharp tip structure is provided with a distal end and a proximal end, the distal end of the sharp tip structure is provided with a sharp tip end for puncturing, and within a length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree; the puncturing direction of the guide wire is located in a plane defined by the normal direction of the needle point plane of the outer sheath and the axial line of the outer sheath.

Also disclosed is pericardium puncture needle assembly, characterized in comprising an outer sheath, a puncture needle and a guide wire, wherein the puncture needle can slide in the outer sheath, and when the puncture needle is pulled out of the outer sheath, the guide wire can slide in the outer sheath, and the guide wire is made of a high elastic material; the guide wire comprises a distal end bent section, the distal end bent section is formed by bending the guide wire and has a preset bent shape, and the distal end bent section is adapted to regain the preset bent shape from a straightened state, and its tip end part is of a sharp tip structure; the sharp tip structure is provided with a distal end and a proximal end, the distal end of the sharp tip structure is provided with a sharp tip end for puncturing, and within a length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree; the puncturing direction of the guide wire is located in a plane defined by the normal direction of the needle point plane of the outer sheath and the axial line of the outer sheath.

In a specific implementation of the present invention, the puncturing direction of the guide wire is in the normal direction of the needle point plane of the puncture needle or the outer sheath.

In a specific implementation of the present invention, the distal end of the puncture needle or the outer sheath comprises a distal end bent section, the axial line or the center line of the distal end bent section of the guide wire is located in a plane, and the axial line or the center line of the distal end bent section of the puncture needle or the outer sheath is located in a plane.

In a specific implementation, the guide wire comprises a proximal end bent section, the outer sheath is further provided with an inner sheath, and the proximal end of the inner sheath comprises a bent section; the length between the proximal end bent section of the guide wire and the sharp tip end of the guide wire is L, and the length L is larger than <NUM>.

In a specific implementation of the present invention, the curvature radius of the proximal end bent section of the guide wire is selected such that within a length range of not larger than <NUM>, the rotation angle of the proximal end bent section of the guide wire is larger than <NUM> degree and is preferably <NUM>-<NUM> degree; the curvature radius of the proximal end bent section of the inner sheath is selected such that within a length range of not larger than <NUM>, the rotation angle of the proximal end bent section of the inner sheath is larger than <NUM> degree and is preferably <NUM>-<NUM> degree.

In a specific implementation, the normal direction of the needle point plane of the outer sheath and the axial line of the pipe body of the outer sheath define a plane A, the axial line or the center line of the proximal end bent section of the inner sheath is located in the same plane B, and an included angle α is formed between the plane A and the plane B; the axial line or the center line of the proximal end bent section of the guide wire is located in the same plane C, and an included angle β is formed between the plane C and a plane D where the axial line or the center line of the distal end bent section of the guide wire is located; the included angle β is equal to the included angle α; preferably, both of the included angle α and the included angle β are <NUM> degree.

In a specific implementation, the internal structure of the puncture needle is of a non-revolution body structure, and the guide wire is of a non-revolution body structure.

In a specific implementation, a guide wire positioner is provided at the proximal end of the guide wire, and the cross section of the guide wire positioner is of a non-revolution body structure.

In a specific implementation, the outer sheath is further provided with an inner sheath, the inner sheath can freely slide in the outer sheath, and the guide wire extends in the inner sheath; preferably, the end face of the distal end port of the inner sheath and the end face of the distal end port of the outer sheath are located in the same plane; more preferably, the distal end of the outer sheath is of a blunt end structure.

In a specific implementation, the guide wire positioner is removably fixed on the guide wire; when the guide wire is propelled forwardly, the guide wire positioner is clamped and fixed at the proximal end of the outer sheath; preferably, a joint is fixed at the proximal end of the outer sheath, the proximal end of the joint is provided with a groove matched with the shape of the distal end of the guide wire positioner, and the guide wire positioner can be clamped and fixed at the proximal end of the joint; preferably, after the guide wire positioner is clamped and fixed at the proximal end of the outer sheath, the sharp tip structure of the distal end of the guide wire extends to the outside of the outer sheath.

In a specific implementation, an included angle α is formed between the plane where the axial line or the center line of the distal end bend section of the guide wire is located and the normal direction of the end face of the distal end port of the outer sheath, wherein the included angle α is <NUM> or <NUM> degree.

In a specific implementation, a negative pressure device is fixed at the proximal end of the puncture needle or the outer sheath.

In a specific implementation, a flexible element, which is made of a high molecular material, is provided at the distal end of the puncture needle or the outer sheath.

In a preferable implementation of the present invention, when the pericardium puncture needle assembly is penetrating the pericardium, the torsional freedom of the guide wire may be limited to some extent.

A further detailed description of the technical solutions of the present invention will be given below by means of embodiments and examples in combination with the accompanying drawings. However, the present invention is not merely limited to the following embodiments and examples. When describing the distal end and the proximal end of a component, in general, the distal end refers to the end of the component close to the puncturing part of a puncture needle assembly, and the proximal end refers to the end of the component close to the handle part or the operating part of the puncture needle assembly.

<FIG> is a schematic diagram of the structure of a pericardium puncture needle assembly according to a specific implementation of the present invention. The pericardium puncture needle assembly includes a puncture needle <NUM>, and a guide wire <NUM> extends in the puncture needle <NUM>. The guide wire <NUM> is of a slender and bendable flexible structure and includes a distal end bent section <NUM>. The distal end bent section <NUM> of the guide wire <NUM> is formed by bending the guide wire <NUM> and has a distal end and a proximal end. The tip end part (i.e., the distal end part) of the distal end bent section <NUM> is of a sharp tip structure, and the proximal end is connected with the rest part of the guide wire <NUM>. The guide wire <NUM> is made of a high elastic material. The distal end bent section has a preset bent shape, and due to the flexibility, the distal end bent section can enter into a straightened state under the action of an external force (for example, when being located in the puncture needle or an outer sheath) and is adapted to regain the preset bent shape from the straightened state after the external force is removed (for example, after penetrating through the puncture needle or the outer sheath). The distal end bent section <NUM> and the guide wire <NUM> can be integrally formed, or can be separately formed and connected together. The guide wire <NUM> can be of a solid structure and no hollow cavity is provided therein, or the guide wire <NUM> can be of other proper structures.

Within a length range not larger than <NUM> beginning from the sharp tip end of the distal end bent section of the guide wire, the rotation angle of the sharp tip end is at least <NUM> degree (namely, on a length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree). Preferably, within a length range of <NUM>-<NUM> beginning from the sharp tip end of the distal end bent section of the guide wire, the rotation angle of the sharp tip end is at least <NUM> degree.

After the sharp tip end of the guide wire penetrates through the pericardium, the angle between the orientation of the sharp tip end and the advancing direction of the guide wire is larger than <NUM> degree, thus the pericardium is unlikely to be hurt. In the present invention, the sharp tip structure refers to a structure formed by a part of the guide wire within the length range not larger than <NUM> beginning from the sharp tip end by rotating the sharp tip end of the guide wire at least <NUM> degree, and the minimal curvature radius of the sharp tip structure is not larger than <NUM>. That is to say, the sharp tip structure of the tip end part of the distal end bent section of the guide wire is provided with a distal end and a proximal end, wherein the distal end of the sharp tip structure is provided with a sharp tip end, and the proximal end of the sharp tip structure is connected with the rest part of the distal end bent section. The rotation angle of the axial line of the sharp tip end of the sharp tip structure relative to the normal direction of the cross-section of the proximal end of the sharp tip structure is at least <NUM> degree. In an implementation, the length of the sharp tip structure is not larger than <NUM>. In a preferable implementation, the length range of the sharp tip structure is <NUM>-<NUM>. In the present invention, the sharp tip end refers to the tip end of the distal end of the sharp tip structure, which is very sharp and can be of a micro spherical structure.

As shown in <FIG>, after the sharp tip end rotates <NUM> degree, the bend of the distal end bent section <NUM> extending from the proximal end of the sharp tip structure to the proximal end of the distal end bent section <NUM> can be in the shape of a spiral line or an involute and can also be other proper irregular bends, such as a combination of a circular arc and a straight line, a combination of an involute and a straight line or other proper bends. When the bend of the distal end bent section <NUM> extending from the proximal end of the sharp tip structure to the proximal end of the distal end bent section <NUM> is in the shape of the spiral line or the involute, the curvature radius thereof can increase gradually or increase step by step. When the bend of the distal end bent section <NUM> extending from the proximal end of the sharp tip structure to the proximal end of the distal end bent section <NUM> is an irregular bend, such as the combination of the circular arc and the straight line, the combination of the involute and the straight line or other proper bends, the curvature radius thereof can also change irregularly. For example, the curvature radius thereof increase gradually or increase step by step, but with the further bending of the guide wire, the curvature radius thereof starts to become small and then gradually increases or increases step by step. After the distal end of the distal end bent section <NUM> penetrates the pericardium, since the distal end is adapted to regain the preset bent shape from the straightened state, the angle between the orientation of the sharp tip end and the advancing direction of the guide wire is larger than <NUM> degree, and thus the heart will not be punctured. Even if the distal end bent section <NUM> gradually enters the pericardium, and the angle between the orientation of the sharp tip end and the advancing direction of the guide wire may become smaller than <NUM> degree due to the action of the external force, the heart is unlikely to be hurt, because at this time, the guide wire is long and flexible, and thus the force acted on the guide wire cannot be transmitted to the sharp tip end. In addition, the sharp tip end is within the three-dimensional enclosure of the bent shape of the distal end bent section, and thus the pericardium is unlikely to be hurt during puncture. Even if the sharp tip end is beyond the three-dimensional enclosure of the bent shape of the distal end bent section, since the guide wire is long and flexible, the force acted on the guide wire cannot be transmitted to the sharp tip end, and therefore the heart is unlikely to be hurt. Within a length range not larger than <NUM> beginning from the sharp tip end, the sharp tip structure includes a bent section <NUM>, and the curvature radius thereof is not larger than <NUM>.

The puncture needle <NUM> is of a tubular structure, includes a distal end and a proximal end and can be made of any proper biocompatible material, such as stainless steel material or nickel-titanium alloy material. The pipe body of the puncture needle <NUM> can be consisted of a section of pipe and can also be consisted of two sections of pipes. The distal end of the puncture needle <NUM> can further include a distal end bent section (not shown in the figure). The distal end of the puncture needle <NUM> can be of a structure without a needle point, for example, a blunt end structure, thus avoiding hurt to the internal organs during puncture, and ensuring that the blunt end structure abuts the pericardium during puncture of the guide wire <NUM> in the puncture needle <NUM>, so as not to hurt the heart or the pericardium. The distal end of the puncture needle <NUM> can also be of a structure with a needle point.

According to a preferred embodiment, when the pericardium puncture needle assembly is in use, the distal end bent section of the guide wire <NUM> is located in a plane, and the distal end bent section of the puncture needle <NUM> is located in a plane (namely, the axial line or the center line of the distal end bent section of the guide wire <NUM> is located in a plane, and the axial line or the center line of the distal end bent section of the puncture needle <NUM> is located in a plane). Due to such a structure of the guide wire and the puncture needle, the flexible guide wire <NUM> can be automatically rotated and located in the puncture needle <NUM> easily, such that the puncturing direction of the guide wire can be automatically adjusted. When the distal end bent section <NUM> is entirely located in the puncture needle <NUM>, the distal end bent section <NUM> is at the straightened state. When the guide wire <NUM> is propelled forwardly, the sharp tip end of the distal end bent section <NUM> extends out from the pipe body of the puncture needle <NUM>. The sharp tip end punctures the pericardium, the guide wire <NUM> gradually enters into the pericardium, during the process the part of the distal end bent section <NUM> entered into the pericardium begins to gradually bend until regaining the preset shape, and the puncture is finished.

<FIG> is a schematic diagram of a three-dimensional structure of a preferred pericardium puncture needle assembly <NUM> of the present invention; <FIG> is a sectional view of a pericardium puncture needle assembly <NUM> according to a preferred example useful for understanding the present invention and indicates the connection relationship of a joint <NUM>, an outer sheath <NUM> and the guide wire <NUM>. The outer sheath <NUM> is of a tubular structure, includes a distal end and a proximal end and can be made of any proper biocompatible material, for example, stainless steel material or nickel-titanium alloy material. The pipe body of the outer sheath <NUM> can be consisted of a section of pipe and can also be consisted of two sections of pipes. According to a preferred implementation of the present invention, an inner sheath <NUM> can also be provided in the outer sheath <NUM>, as shown in <FIG>; the inner sheath <NUM> can freely slide in the outer. sheath <NUM>. The proximal end of the inner sheath <NUM> can further include a bent section <NUM>, the curvature radius of the bent section <NUM> is selected such that within a length range not larger than <NUM>, the rotation angle of the bent section <NUM> is larger than <NUM> degree, and preferably, within the length range not larger than <NUM>, the rotation angle of the bent section <NUM> is <NUM>-<NUM> degree. The joint <NUM> is fixed at the proximal end of the inner sheath <NUM>, and a joint <NUM> is fixed at the proximal end of the outer sheath <NUM>. The joint <NUM> and the joint <NUM> can be Luer joints. Due to the cooperation of the joint <NUM> and the joint <NUM>, the inner sheath <NUM> can be prevented from penetrating through the outer sheath <NUM> to puncture the heart. Alternatively, no inner sheath is arranged in the outer sheath <NUM>, and under this condition, the proximal end of the outer sheath <NUM> includes a bent section. The distal end of the outer sheath <NUM> can further include a distal end bent section (not shown in the figure). The distal end of the outer sheath <NUM> can be of a structure without a needle point, for example, a blunt end structure, thus avoiding hurt to the internal organs during puncture, and ensuring that the blunt end structure abuts the pericardium during puncture of the guide wire <NUM> in the outer sheath <NUM>, so as not to hurt the heart or the pericardium. The distal end of the outer sheath <NUM> can also be of a structure with a needle point. Or, a flexible element <NUM> is arranged at the distal end of the outer sheath <NUM>, and the flexible element <NUM> is made of a high molecular material, for example, silica gel or other proper materials. In a puncture process, the flexible element <NUM> can prevent the puncture needle from puncturing the internal organs and can increase the contact surface area of the puncture needle and tissues to ensure better abutment. A flexible element fixing structure (not shown in the figure) can also be arranged at the distal end of the outer sheath <NUM> for installing the flexible element <NUM>, the installation manner can be welding or adhering, and in this way, when being inserted onto the outer sheath <NUM>, the flexible element <NUM> is unlikely to twist or drop.

<FIG> is a structure diagram of an inner sheath in a pericardium puncture needle assembly of a preferred embodiment of the present invention; and as shown in <FIG>, the normal direction of the needle point plane of the outer sheath <NUM> and the axial line or the center line of the pipe body of the outer sheath <NUM> define a plane A, and the axial line or the center line of the bent section <NUM> of the proximal end of the inner sheath <NUM> is located in a plane B. The included angle between the plane A and the plane B is α, and the included angle α is <NUM>-<NUM> degree; and preferably, the included angle α is <NUM> degree. The needle point plane refers to the section of the outer sheath <NUM> abutting the tissues, namely, the end face of the outer sheath <NUM>.

<FIG> is an enlarged view of C portion in <FIG> and indicates a structure of a distal end bent section of a guide wire <NUM> of a pericardium puncture needle assembly of an implementation of the present invention. As shown in <FIG> and <FIG>, the guide wire <NUM> is of a slender and bendable flexible structure and can be made of any proper high elastic material, for example, nickel-titanium alloy material. The guide wire <NUM> includes a distal end bent section <NUM> and a proximal end bent section <NUM>. The distal end bent section <NUM> and the proximal end bent section <NUM> are formed by bending the guide wire. The structure of the distal end bent section <NUM> is a structure adapted to regain the preset bent shape from a straightened state. Since the guide wire is made of the high elastic material, the distal end bent section <NUM> is at the straightened state when being located in the outer sheath <NUM> and can regain the preset bent shape after penetrating through the outer sheath <NUM>.

<FIG> is a structure diagram of a guide wire in a pericardium puncture needle assembly of a preferred embodiment of the present invention. As shown in <FIG>, the length between the proximal end bent section <NUM> of the guide wire <NUM> and the sharp tip end of the guide wire <NUM> is L, namely, when the guide wire <NUM> is in the straightened state, in the area spacing a length of L from the sharp tip end, the proximal end bent section <NUM> is provided. The length L is larger than <NUM>. The curvature radius of the proximal end bent section <NUM> is selected such that within a length range not larger than <NUM>, the rotation angle of the proximal end bent section <NUM> (i.e., the included angle between the axial lines of the two end parts of the proximal end bent section <NUM>) is larger than <NUM> degree, and preferably, within the length range not larger than <NUM>, the rotation angle of the proximal end bent section <NUM> (i.e., the included angle between the axial lines of the two end parts of the proximal end bent section <NUM>) is <NUM>-<NUM> degree. The curvature radius of all points of the proximal end bent section <NUM> are located in the same plane C (i.e., the plane where the axial line of the proximal end bent section <NUM> is located is the plane C), the included angle between the plane C and a plane D where the distal end bent section <NUM> of the guide wire <NUM> is located (i.e., the plane where the axial line of the distal end bent section <NUM> is located is the plane D) is β, and the included angle β is <NUM>-<NUM> degree; the included angle β is equal to the included angle α; and preferably, the included angle β is <NUM> degree. In this way, in a puncture process, the torsional freedom of the guide wire can be limited to some extent.

As shown in <FIG> and <FIG>, after the sharp tip end rotates <NUM> degree, the bend of the distal end bent section <NUM> extending from the proximal end of the sharp tip structure to the proximal end of the distal end bent section <NUM> can be in the shape of a spiral line or in the shape of an involute or can be other proper irregular bends. According to a preferred embodiment of the present invention, when the pericardium puncture needle assembly is in use, the puncturing direction of the guide wire is located in a plane A defined by the normal direction of the needle point plane of the outer sheath <NUM> and the axial line of the pipe body of the outer sheath <NUM>. Preferably, the puncturing direction of the guide wire is in the normal direction of the needle point plane of the outer sheath <NUM>. When the distal end bent section <NUM> is entirely located in the outer sheath <NUM>, the distal end bent section <NUM> is at the straightened state. When the guide wire <NUM> is propelled forwardly, the sharp tip end of the distal end bent section <NUM> extends out from the pipe body of the outer sheath <NUM>. The sharp tip end punctures the pericardium, the guide wire <NUM> gradually enters into the pericardium, the part of the distal end bent section <NUM> entered into the pericardium begins to gradually bend until regaining the preset shape, and the puncture is finished. In the implementations as shown in <FIG>, the rest of the structure of the guide wire <NUM> is the same as that in the implementation as shown in <FIG>.

<FIG> is a schematic diagram of a structure of a pericardium puncture needle assembly <NUM> according to the present invention. As shown in <FIG>, the pericardium puncture needle assembly <NUM> includes an outer sheath <NUM>, and a guide wire <NUM> extends in the outer sheath <NUM>. An inner sheath <NUM> can be provided in the outer sheath <NUM> or there is no inner sheath provided in the outer sheath. The guide wire <NUM> is of a slender and bendable flexible structure and includes a distal end and a proximal end. The guide wire <NUM> includes a distal end bent section <NUM> and a proximal end bent section <NUM>, and the tip end part of the distal end bent section <NUM> is of a sharp tip structure. A negative pressure device is further fixed at the proximal end of the outer sheath <NUM>, a flexible element <NUM> can be arranged at the distal end of the outer sheath <NUM>, and the flexible element <NUM> is made of a high molecular material, for example, silica gel or other proper materials. In a puncture process, the flexible element <NUM> can prevent the outer sheath from puncturing the internal organs and can increase the contact surface area of the outer sheath and tissues to ensure better abutment, and a certain absorbing area can be formed between the distal end of the outer sheath <NUM> and the tissues to generate a negative pressure.

The guide wire <NUM> is made of a high elastic material, the distal end bent section <NUM> is formed by bending the guide wire <NUM>, and the structure of the distal end bent section <NUM> is a structure adapted to regain a preset bent shape from a straightened state. The sharp tip structure of the distal end bent section <NUM> is provided with a sharp tip end at the distal end. Within a length range not larger than <NUM> extending from the sharp tip end of the sharp tip structure to the proximal end of the sharp tip structure at the distal end bent section of the guide wire, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree (i.e., the included angle between the orientation or the axial direction of the sharp tip end relative to the normal direction of the lateral section of the proximal end of the sharp tip structure is at least <NUM> degree). After the sharp tip end rotates <NUM> degree, beginning from the proximal end of the sharp tip structure, the distal end bent section <NUM> can be in the shape of an involute, for example, a square involute, a triangular involute or other involute, and the curvature radius thereof continuously increases or increases step by step, as shown in <FIG>.

In the implementation, the normal direction of the needle point plane of the outer sheath <NUM> and the axial line of the pipe body of the outer sheath <NUM> define a plane A, the curvature radius of the proximal end bent section <NUM> of the inner sheath <NUM> is located in the same plane B (i.e., the plane where the axial line or the center line of the bent section <NUM> is located is the plane B), the included angle between the plane A and the plane B is α, and the included angle α is <NUM>-<NUM> degree; and preferably, the included angle α is <NUM> degree, similarly as shown in <FIG>.

The length between the proximal end bent section <NUM> of the guide wire <NUM> and the sharp tip end of the guide wire <NUM> is L, namely, when the guide wire <NUM> is in the straightened state, in the area spacing a length of L from the sharp tip end, the proximal end bent section <NUM> is provided. The curvature radius of all points of the proximal end bent section <NUM> is located in the same plane C (i.e., the plane where the axial line or the center line of the proximal end bent section <NUM> is located is the plane C), the included angle between the plane C and a plane D where the distal end bent section <NUM> of the guide wire <NUM> is located is β, and the included angle β is <NUM>-<NUM> degree; the included angle β is equal to the included angle α; and preferably, the included angle β is <NUM> degree. In this way, in a puncture process, the torsional freedom of the guide wire can be limited to some extent, similarly as shown in <FIG>. The negative pressure device includes a connecting valve <NUM> and a negative pressure tee <NUM>, and the connecting valve <NUM> is connected with the negative pressure tee <NUM> through a negative pressure connecting pipe <NUM>. The connecting valve <NUM> can be integrally formed or can be separately formed, and as shown in <FIG>, the connecting valve <NUM> includes a valve body <NUM> which is provided with a distal end, a proximal end and a central chamber. A lower end cover <NUM> is arranged at the distal end of the valve body <NUM>, and an upper end cover <NUM> is arranged at the proximal end of the valve body <NUM>. The proximal end of the outer sheath <NUM> is fixed in the lower end cover <NUM>, and a section of protective pipe can also be sleeved on the end part of the outer sheath <NUM>. A sealing fin <NUM> is further arranged in the upper end cover <NUM> for sealing. One end of the negative pressure connecting pipe <NUM> is fixed on the connecting valve <NUM>, and the other end of the negative pressure connecting pipe <NUM> is fixed on the negative pressure tee <NUM>. A joint <NUM> is further connected to the proximal end of the inner sheath <NUM>, and the joint can be a Luer joint.

According to a preferred embodiment of the present invention, when the pericardium puncture needle assembly is in use, firstly a negative pressure source is turned on, and after absorbing the pericardium onto the flexible element, the puncturing process is started. The puncturing direction of the guide wire <NUM> is in a plane defined by the normal direction of the needle point plane of the outer sheath <NUM> and the axial line of the pipe body of the outer sheath <NUM>. Preferably, the puncturing direction of the guide wire <NUM> is in the normal direction of the needle point plane of the outer sheath <NUM>. When the distal end bent section <NUM> is entirely located in the outer sheath <NUM>, the distal end bent section <NUM> is in the straightened state. When the guide wire <NUM> is propelled forwardly, the sharp tip end of the distal end bent section <NUM> extends out from the pipe body of the outer sheath <NUM> and is located in the plane A. The sharp tip end punctures the pericardium, the guide wire <NUM> gradually enters into the pericardium, the part of the distal end bent section <NUM> entered into the pericardium begins to gradually bend until regaining the preset shape, and the puncture is finished. In the implementation as shown in <FIG>, the rest of the structures of the guide wire <NUM> are the same as those in the implementation as shown in <FIG>, and the rest of the structures of the outer sheath <NUM> are the same as those in the implementations as shown in <FIG>.

<FIG> is a schematic diagram of a cross section of a pericardium puncture needle assembly <NUM> according to the present invention; and <FIG> is a schematic diagram of a cross section along the F-F line in <FIG>. As shown in <FIG>, the pericardium puncture needle assembly <NUM> includes an outer sheath <NUM>, and a guide wire <NUM> extends in the outer sheath <NUM>. An inner sheath <NUM> can also be arranged in the outer sheath <NUM> or there is no inner sheath arranged in the outer sheath. The guide wire <NUM> is of a slender and bendable flexible structure and includes a distal end and a proximal end. A joint <NUM> is further fixed at the proximal end of the outer sheath <NUM>, and a joint <NUM> is fixed at the proximal end of the inner sheath <NUM>. The guide wire <NUM> includes a distal end bent section <NUM>, and the tip end part of the distal end bent section <NUM> is of a sharp tip structure.

The guide wire <NUM> is made of a high elastic material, the distal end bent section <NUM> is formed by bending the guide wire <NUM>, and the structure thereof is a structure adapted to regain a preset bent shape from a straightened state. The cross section of the guide wire <NUM> is of a non-revolution body structure and can be non-revolution body structures such as a rectangle, a square, a triangle, an oval or the like. The internal structure of the inner sheath <NUM> is of a non-revolution body structure and can be non-revolution body structures such as a rectangle, a square, a triangle, an oval or the like. When the guide wire <NUM> is placed in the inner sheath <NUM>, the cross section of the inner sheath <NUM> and the cross section of the guide wire <NUM> cannot be displaced. Preferably, the cross sections of the guide wire <NUM> and the inner sheath <NUM> have the same shape. Therefore, in a puncture process, the torsional freedom of the guide wire can be limited to some extent. Due to these cross sections of the guide wire <NUM> and the inner sheath, the guide wire <NUM> is easy to be orientated. Or, there is no inner sheath arranged in the outer sheath <NUM>, and at this time, the internal structure of the outer sheath <NUM> is of a non-revolution body structure. The non-revolution body structure means that the shape of the cross section of the guide wire or the inner sheath is any geometrical shape except a revolution body structure. The revolution body herein means that two points are assumed at the two ends of an object, the two points are connected to form a line passing through the object, the line is used as the rotation center of the object, and each part of the object has the same shape when rotating to any position. Within a length range not larger than <NUM> beginning from the sharp tip end of the distal end of the guide wire, the rotation angle of the sharp tip end is at least <NUM> degree (i.e., on the length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree). After the sharp tip end rotates <NUM> degree, beginning from the proximal end of the sharp tip structure, the distal end bent section <NUM> can be in the shape of a spiral line, and the curvature radius thereof continuously increases, as shown in <FIG>. When the pericardium puncture needle assembly is in use, the puncturing direction of the guide wire is located in a plane defined by the normal direction of the needle point plane of the outer sheath <NUM> and the axial line of the pipe body of the outer sheath. Preferably, the puncturing direction of the guide wire is in the normal direction of the needle point plane of the outer sheath <NUM>.

In the implementations as shown in <FIG>, the structures of the distal end bent section of the guide wire <NUM> are the same as those in the implementation as shown in <FIG>. In the implementations as shown in <FIG>, the rest of the structures of the outer sheath <NUM> are the same as the structures as shown in <FIG>; and the structures of the joint <NUM> and the joint <NUM> can also be the same as those in the implementation as shown in <FIG>.

<FIG> is a schematic diagram of a structure of a pericardium puncture needle assembly <NUM> according to another implementation. As shown in <FIG>, the pericardium puncture needle assembly <NUM> includes an outer sheath <NUM>, and a guide wire <NUM> extends in the outer sheath <NUM>. An inner sheath <NUM> can also be arranged in the outer sheath <NUM> or there is no inner sheath arranged in the outer sheath. When the inner sheath <NUM> is arranged, the guide wire <NUM> extends in the inner sheath <NUM>. The guide wire <NUM> is of a slender and bendable flexible structure and includes a distal end and a proximal end. The guide wire <NUM> includes a distal end bent section <NUM>, and the tip end part of the distal end bent section <NUM> is of a sharp tip structure. A joint <NUM> is further fixed at the proximal end of the outer sheath <NUM>, and a joint <NUM> is fixed at the proximal end of the inner sheath <NUM>.

The guide wire <NUM> is made of a high elastic material, the distal end bent section <NUM> is formed by bending the guide wire <NUM>, and the structure thereof is a structure adapted to regain a preset bent shape from a straightened state. Within a length range not larger than <NUM> beginning from the sharp tip end of the distal end bent section of the guide wire, the rotation angle of the sharp tip end is at least <NUM> degree (i.e., on the length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree). After the sharp tip end rotates <NUM> degree, beginning from the proximal end of the sharp tip structure, the distal end bent section <NUM> can be in the shape of an involute, for example, a square involute, a triangular involute or others, and the curvature radius thereof continuously increases or increases step by step, as shown in <FIG>.

A guide wire positioner <NUM> is arranged at the proximal end of the guide wire13, and the guide wire positioner <NUM> is of a removable structure and is clamped and fixed at the proximal end of the guide wire <NUM>. A groove (not shown in the figure) is arranged on the proximal end of the joint <NUM>, the shape of the distal end of the guide wire positioner <NUM> is matched with that of the groove, and thus the distal end can be inserted in the groove. The cross section of the guide wire positioner <NUM> is of a non-revolution body structure and can be non-revolution body structures such as a rectangle, a square, a triangle, an oval or the like. Therefore, in a puncture process, the torsional freedom of the guide wire can be limited to some extent.

In the implementation as shown in <FIG>, the structures of the distal end bent section of the guide wire <NUM> are the same as those in the implementation as shown in <FIG>. In the implementation as shown in <FIG>, the rest of the structures of the outer sheath <NUM> are the same as the structures as shown in <FIG>; and the structures of the joint <NUM> and the joint <NUM> can also be the same as those in the implementation as shown in <FIG>.

<FIG> is a schematic diagram of a structure of a preferred pericardium puncture needle assembly <NUM>. and <FIG> is an enlarged view of D portion in <FIG>. As shown in <FIG>, the pericardium puncture needle assembly <NUM> includes a puncture needle <NUM> and an outer sheath <NUM>, and the puncture needle <NUM> extends in the outer sheath <NUM>. The distal end of the puncture needle <NUM> is of a structure with needle point for puncturing the thoracic wall. The distal end of the outer sheath <NUM> can further include a distal end bent section (not shown in the figure). The distal end of the outer sheath <NUM> is of a blunt end structure; namely, the surface of the distal end of the outer sheath <NUM> in contact with tissues is a smooth transition surface, in order to prevent all the tissues or organs in contact with the outer sheath <NUM> from being scratched. A joint <NUM> is fixed at the proximal end of the outer sheath <NUM>, and the joint <NUM> can be a Luer joint.

<FIG> is a sectional view of the pericardium puncture needle assembly shown in <FIG> and shows the internal structure of the pericardium puncture needle assembly of a preferred example useful for understanding the present invention. When the distal end of the puncture needle <NUM> punctures the thoracic wall to enter the thoracic cavity, t the puncture needle is withdrawn from the outer sheath <NUM>, and the guide wire <NUM> is propelled forwardly along the outer sheath <NUM>.

The guide wire <NUM> extends in the outer sheath <NUM> and can freely slide in the outer sheath <NUM>. The guide wire <NUM> is of a slender and bendable flexible structure and includes a distal end bent section <NUM>; the distal end bent section <NUM> is formed by bending the guide wire <NUM>, and the tip end part thereof is of a sharp tip structure. The guide wire <NUM> can be made of any proper high elastic material, for example, a nickel-titanium alloy material, and the distal end bent section <NUM> is adapted to regain a preset bent shape from a straightened state. A guide wire positioner <NUM> is fixed at the proximal end of the guide wire <NUM>.

As shown in <FIG>, after the sharp tip end rotates <NUM> degree, the bend of the distal end bent section <NUM> beginning from the proximal end of the sharp tip structure can be in the shape of a spiral line or an involute and can also be other proper irregular bends, for example, a combination of a circular arc and a straight line, a combination of an involute and a straight line or other proper bends.

The guide wire positioner <NUM> is removably fixed on the guide wire <NUM>. When the guide wire is propelled forwardly, the guide wire positioner <NUM> is clamped and fixed at the proximal end of the joint <NUM>, such that the rotation angle and the relative position of the guide wire <NUM> and the outer sheath <NUM> are fixed. Before the guide wire positioner <NUM> is fixed on the guide wire <NUM>, the guide wire can be rotated and then fixed according to the demand on the puncturing direction. When the guide wire positioner <NUM> is clamped and fixed at the proximal end of the joint <NUM>, an included angle α is formed between the plane where the axial line or the center line of the distal end bent section <NUM> of the guide wire is located and the normal direction of the end face of the distal end port of the outer sheath <NUM>; preferably, the included angle α is <NUM> or <NUM> degree. When the guide wire positioner <NUM> is clamped and fixed at the proximal end of the joint <NUM>, the sharp tip structure of the distal end of the guide wire extends to the outside of the sheath, in order to ensure the operation of puncture. After the guide wire positioner <NUM> is clamped and fixed at the proximal end of the joint <NUM> to adjust the rotation angle and the relative position of the guide wire <NUM> and the outer sheath <NUM>, the guide wire positioner <NUM> can be removed to further insert the guide wire <NUM>. As long as the rotation angle and the relative position of the guide wire <NUM> and the outer sheath <NUM> can be fixed to ensure the operation of puncture, the guide wire positioner <NUM> in the present invention can be of any proper structure or shape, which shall fall within the scope of the present invention.

According to a preferred embodiment of the present invention, when the pericardium puncture needle assembly is in use, the puncture needle <NUM> punctures the thoracic wall and enters into the thoracic cavity, the puncture needle is then withdrawn from the outer sheath <NUM>, and the guide wire <NUM> is propelled forwardly along the outer sheath <NUM>. When the distal end bent section <NUM> is entirely located in the puncture needle <NUM>, the distal end bent section <NUM> is in the straightened state. When the guide wire <NUM> is propelled forwardly, the sharp tip end of the distal end bent section <NUM> extends out from the pipe body of the outer sheath <NUM>. The sharp tip end punctures the pericardium, the guide wire <NUM> gradually enters the pericardium, the part of the distal end bent section <NUM> entered into the pericardium begins to gradually bend until regaining the preset shape, and the puncture is finished.

In the implementations as shown in <FIG>, the rest of the structures of the guide wire <NUM> are the same as those in the implementation as shown in <FIG>; and the rest of the structures of the puncture needle <NUM> are the same as those in the implementation as shown in <FIG>. A negative pressure device can also be arranged at the proximal end of the pericardium puncture needle assembly <NUM>, as described in the implementations as shown in <FIG>.

<FIG> is a schematic diagram of a structure of a pericardium puncture needle assembly according to another preferred example useful for understanding the present invention. As shown in <FIG>, an inner sheath <NUM> is further arranged in the outer sheath <NUM>, and the inner sheath <NUM> can freely slide in the outer sheath <NUM>. When the inner sheath <NUM> is propelled forwardly to the distal end of the outer sheath <NUM>, the distal end port of the outer sheath <NUM> and the distal end port of the inner sheath <NUM> are located in the same plane, so as to ensure that the distal ends of the outer sheath <NUM> and the inner sheath <NUM> do not hurt the pericardium when abutting the pericardium and ensure the operation of puncture. The outer sheath <NUM> is of a blunt end structure, and the inner sheath <NUM> can be of a blunt end structure or a non-blunt end structure. Due to the arrangement of the inner sheath <NUM>, the inner diameter of the sheath is decreased, thus ensuring that the puncturing direction of the sharp tip end is vertical to the plane of the distal end port of the inner sheath <NUM> as much as possible in a puncture process of the guide wire <NUM>. A joint <NUM> is fixed at the proximal end of the outer sheath <NUM>, a joint <NUM> is fixed at the proximal end of the inner sheath <NUM>, and the joint <NUM> and the joint <NUM> can be Luer joints.

After the distal end of the puncture needle <NUM> punctures the thoracic wall and enters into the thoracic cavity, the puncture needle is withdrawn from the outer sheath <NUM>; the inner sheath <NUM> is conveyed into the outer sheath <NUM>, and the guide wire <NUM> extends in the inner sheath <NUM>; or the inner sheath <NUM> is conveyed into the outer sheath <NUM> at first, and then the guide wire <NUM> is propelled forwardly along the inner sheath <NUM>.

The guide wire <NUM> can freely slide in the inner sheath <NUM>. The puncturing direction of the guide wire is in the plane where the distal end bent section <NUM> of the guide wire <NUM> is located. When the distal end bent section <NUM> is entirely located in the puncture needle <NUM>, the distal end bent section <NUM> is in the straightened state. When the guide wire <NUM> is propelled forwardly, the sharp tip end of the distal end bent section <NUM> extends out from the pipe body of the inner sheath <NUM>. The sharp tip end punctures the pericardium, the guide wire <NUM> gradually enters into the pericardium, the part of the distal end bent section <NUM> entered into the pericardium begins to gradually bend until regaining the preset shape, and the puncture is finished.

In the implementation as shown in <FIG>, the rest of the structures are the same as those in the implementations as shown in <FIG>.

Various components and structures described in the above implementations of the present invention can be mutually combined, as long as not conflicting with the original structures.

Claim 1:
A pericardium puncture needle assembly (<NUM>), comprising an outer sheath (<NUM>) and a guide wire (<NUM>), wherein the guide wire (<NUM>) can slide in the outer sheath (<NUM>), and the guide wire (<NUM>) is made of a high elastic material; the guide wire (<NUM>) comprises a distal end bent section (<NUM>), the distal end bent section (<NUM>) is formed by bending the guide wire (<NUM>) and has a preset bent shape, and the distal end bent section (<NUM>) is adapted to regain the preset bent shape from a straightened state, and its tip end part is of a sharp tip structure; the sharp tip structure is provided with a distal end and a proximal end, the distal end of the sharp tip structure is provided with a sharp tip end for puncturing, and within a length not larger than <NUM> of the sharp tip structure, the rotation angle of the sharp tip end relative to the proximal end of the sharp tip structure is at least <NUM> degree;
wherein the puncturing direction of the guide wire (<NUM>) is located in a plane defined by the normal direction of the needle point plane of the outer sheath (<NUM>) and the axial line of the outer sheath (<NUM>);
characterized in that:
the guide wire (<NUM>) comprises a proximal end bent section (<NUM>), and the proximal end of the outer sheath (<NUM>) comprises a proximal bent section; or
the guide wire (<NUM>) comprises a proximal end bent section (<NUM>), the outer sheath (<NUM>) is further provided with an inner sheath (<NUM>), and the proximal end of the inner sheath (<NUM>) comprises a proximal end bent section (<NUM>), wherein
the curvature radius of the proximal end bent section (<NUM>) of the guide wire (<NUM>) is selected such that within a length range of not larger than <NUM>, the rotation angle of the proximal end bent section (<NUM>) of the guide wire (<NUM>) is larger than <NUM> degree; the curvature radius of the proximal end bent section (<NUM>) of the inner sheath (<NUM>) is selected such that within a length range of not larger than <NUM>, the rotation angle of the proximal end bent section (<NUM>) of the inner sheath (<NUM>) is larger than <NUM> degree.