US20170303959A1 - Pericardiocentesis needle component - Google Patents

Abstract

Disclosed is a pericardiocentesis needle component (10), comprising a guide wire (13) and a puncture needle (12). The guide wire (13) extends into and through the puncture needle (12), and the guide wire (13) comprises a bent section (32) at the distal end and a straight section at the proximal end. The bent section (32) at the distal end is formed by bending the guide wire (13), and the end of the bent section is a pointed-shape structure. The guide wire (13) is made of a highly elastic material. The pointed end rotates at least 90 degrees within a range of no more than 3 mm starting from the pointed end at the bent section (32) of the guide wire. The pericardiocentesis needle component (10) of the present disclosure is less likely to damage a heart during a pericardiocentesis procedure.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 14/123,014 filed Nov. 27, 2013, which is the U.S. National Stage of PCT/CN2012/000728, filed May 25, 2012, which in turn claims the priority of Chinese application CN201110139534.9, filed on May 27, 2011, the entire contents of all applications are incorporated herein by reference in their entireties.
FIELD
• The present disclosure relates to a puncture needle assembly, and more particularly, it relates to a pericardium puncture needle assembly.
BACKGROUND
• 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 catheter to access the space between the pericardium and the outwall of heart to conduct ablation.
• There are a great diversity of pericardium puncture equipments on market. For example, Chinese patent CN00257117.X 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 Once the pericardium is pierced by the needle, the needle is then withdrawn.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.
• However, most of existing puncture needles are straight needle structure. In clinical operations, such a structure often pierces insufficiently and leads to puncture failure, or sometimes it tends to over-pierce and hurts the heart.
SUMMARY
• The present disclosure provides a pericardium puncture needle assembly, characterized in comprising a guide wire and a puncture needle, wherein the guide wire extends within the puncture needle, the guide wire has a curved distal section and a straight proximal section, the curved distal section is formed by bending the guide wire, the tip end of the curved distal section is a sharp tip structure, the guide wire is made from highly elastic material, the sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire.
• Preferably, the sharp tip bends at least 90 degrees within a length range of 1-2 mm starting from the sharp tip of the curved distal section of the guide wire.
• Preferably, within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section, which has a curvature radius of less than 2 mm.
• After the sharp tip bends 90 degrees, a curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve, helix curve, or irregular curve.
• In one exemplary embodiment, after the sharp tip bends 90 degrees, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve or helix curve with a curvature radius increasing gradually or stepwise.
• In one exemplary embodiment, after the sharp tip bends 90 degrees, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is irregular curved shape including at least one curved section.
• Preferably, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section includes a first curved section and a second curved section.
• The curvature radius of the first curved section is not greater than 1.5 mm, and the curvature radius of the second curved section is not greater than 2 mm.
• In one preferable embodiment, a part of the curved distal end extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in cylindrical shape, which has a diameter of 0.2-1 mm.
• In another preferable embodiment, a part of the curved distal section extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in flat sheet shape, which has a width of 0.2-1 mm.
• In one preferable embodiment, the puncture needle is formed by connecting two tubes, one is the distal end tube and the other is the proximal end tube, the distal end tube has a length of 40-100 mm, and the proximal end tube has a length of 60-120 mm.
• The diameter of distal end of the puncture needle is smaller than the diameter of its proximal end.
• The inner diameter of the proximal end of the puncture needle is 0.5-2.5 mm, and the inner diameter of its distal end is 0.2-1.5 mm.
• Preferably, an outer sheath is nested around the puncture needle, and the distal end of the outer sheath is in a spherical structure.
• It is not likely to hurt the heart during pericardium puncture with the pericardium puncture needle assembly in preferable embodiments of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a structural perspective view of the pericardium puncture needle assembly according to one exemplary embodiment of the present disclosure;
• FIG. 2 is a plan view of the pericardium puncture needle assembly according to one exemplary embodiment of the present disclosure;
• FIG. 3 is a sectional view taken along line B-B as shown inFIG. 2, which illustrates the inner structure of the pericardium puncture needle assembly according to one exemplary embodiment of the present disclosure;
• FIG. 4 is a sectional view taken along line A-A shown inFIG. 2, which illustrates the sectional structure of the pericardium puncture needle assembly according to one exemplary embodiment of the present disclosure;
• FIG. 5 is the enlarged view of part C ofFIG. 1, which illustrates the structure of the curved distal section according to one exemplary embodiment of the present disclosure;
• FIG. 6 illustrates the structure of the curved distal section of theguide wire13 according to another exemplary embodiment of the present disclosure;
• FIG. 7 is a structural perspective view of the pericardiumpuncture needle assembly10 according to another exemplary embodiment of the present disclosure;
• FIG. 8 is the enlarged view of the part D ofFIG. 7;
• FIG. 9 is a structural perspective view of the curveddistal section32 according to another exemplary embodiment of the present disclosure;
• FIG. 10 is a structural perspective view of the curveddistal section32 according to another exemplary embodiment of the present disclosure;
• FIG. 11 is a structural perspective view of the pericardiumpuncture needle assembly10 according to another exemplary embodiment of the present disclosure;
• FIG. 12 is a sectional view taken along line E-E ofFIG. 11.
DETAILED DESCRIPTION
• This disclosure will now be described and explained in detail through embodiments and in combination with the drawings. However, this disclosure is not limited to the following embodiments.
• FIG. 1 is a perspective view of the pericardiumpuncture needle assembly10 according to one exemplary embodiment of the present disclosure, which comprises aneedle12 and aguide wire13 extending within theneedle12. Theguide wire13 has an elongated, bendable flexible construction, which comprises a curved distal section and a straight proximal section. The curved distal section ofguide wire13 is formed by bending the guide wire, and its tip end is a sharp tip structure. Theguide wire13 is made from highly elastic material. The curved distal section is adapted to regain its preset curved shape from straightened state. The sharp tip, within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire, bends at least 90 degrees. Once the pericardium is pierced by the sharp tip of the guide wire, the angle between the pointing direction of the sharp tip and the advancing direction of guide wire is bigger than 90 degrees. Therefore, it is less likely to hurt the pericardium. The sharp tip structure of this disclosure means such a part of the guide wire that is within a length range of no more than 3 mm starting from the sharp tip and in which the sharp tip bends through 90 degrees. The curvature radius of the surface of the sharp tip is not greater than 0.1 mm. The sharp tip structure comprises a distal end and a proximal end. The sharp tip mentioned above means the distal end of the sharp tip structure, and the sharp tip is extremely sharp and may be a spherical structure at the micro level. Aconnector11 is fixed at the proximal end of thepuncture needle12.
• FIG. 2 is a schematic plan view of the pericardiumpuncture needle assembly10 according to one exemplary embodiment of the present disclosure;FIG. 3 is the sectional view of the pericardiumpuncture needle assembly10 according to one exemplary embodiment of the present disclosure, which illustrates the connecting relationships of theconnector11, thepuncture needle12, and theguide wire13; andFIG. 4 is the cross sectional view taken along line B-B indicated inFIG. 2. Thepuncture needle12 has a tubular construction with a distal end and a proximal end, and may be made from any suitable biocompatible materials, such as stainless steel or nickel titanium alloy. The distal end ofneedle12 may has a structure without or with a needlepoint.
• Thepuncture needle12 may be formed by a single tube, or can be joined by two sections of tubes. While thepuncture needle12 is joined by two sections of tubes, it may include adistal end tube21 and aproximal end tube22, as shown inFIG. 3. One means for connecting thedistal end tube21 andproximal end tube22 is to insert one end of thedistal end tube21 into theproximal end tube22, and fix them by bonding or welding. Thedistal end tube21 andproximal end tube22 may be made from the same materials, or different materials. For example, thedistal end tube21 is made from nickel titanium alloy, while theproximal end tube22 is made from stainless steel, a matter which insures that thepuncture needle12 has a certain degree of curvature while in human body.
• The diameter ofpuncture needle12 may be set according to actual need of applications by those skilled in the art. Thepuncture needle12 may has a tubular structure with a constant diameter, or with different diameters at the distal end and the proximal end. While thepuncture needle12 has a constant diameter, the diameter may be 0.5-1.0 mm. While thepuncture needle12 has different diameters at the distal end and proximal end, preferably, the diameter of the distal end is smaller than the diameter of proximal end, because thepuncture needle12 needs to provide some supporting force at the proximal end, while the distal end of thepuncture needle12 needs to be flexible in order to bend. In one exemplary embodiment of the present disclosure, the inner diameter of the proximal end of thepuncture needle12 is 0.5-2.5 mm, and the inner diameter of the distal end is 0.2-1.5 mm.
• The length of thepuncture needle12 may be set according to actual need of applications by those skilled in the art. In one exemplary embodiment of the present disclosure, when thepuncture needle12 is made by connecting thedistal end tube21 andproximal end tube22, the length of thedistal end tube21 may be 40-100 mm, and the length of theproximal end tube22 may be 60-120 mm. The length of the connecting part may be set according to actual need of applications by those skilled in the art.
• FIG. 5 shows an enlarged view of part C ofFIG. 1, illustrating the structure of the curved distal section of theguide wire13 of the pericardium puncture needle assembly according to one exemplary embodiment of the present disclosure, andFIG. 6 shows the structure of the curved distal section of theguide wire13 of the pericardium puncture needle assembly according to another exemplary embodiment of the present disclosure. As shown inFIG. 3,FIG. 5, andFIG. 6, theguide wire13 has an elongated and bendable flexible construction, which may be made from any suitable highly elastic materials, such as nickel titanium alloys. Theguide wire13 comprises a curveddistal section32 and a straight proximal section, and the curveddistal section32 is formed by bending the guide wire. The curveddistal section32 has such a structure that is adapted to regain its preset curved shape from straightened state. Because the guide wire is made from highly elastic material, the curveddistal section32 is in a straightened state when it is placed within thepuncture needle12, and regains its preset curved shape when it passes through thepuncture needle12. The curveddistal section32 and theguide wire13 may be formed integrately, or formed separately. Theguide wire13 may be a solid structure without cavity inside, or may be any other suitable structures.
• As shown inFIG. 3,FIG. 5, andFIG. 6, the tip end of the curveddistal section32 has a sharp tip structure, which is used for piercing pericardium without inducing any hurt. The sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire. Preferably, the sharp tip bends at least 90 degrees within a length range of no more than 1-2 mm starting from the sharp tip of the curved distal section of the guide wire. Within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire, the sharp tip structure comprises acurved section323 which has a curvature radius of no more than 2 mm.
• As shown inFIG. 3,FIG. 5, andFIG. 6, after the sharp tip bends 90 degrees, the curved shape of the curveddistal section32 starting from the proximal end of the sharp tip structure may be helix curve, involute curve, or other suitable irregular curves, such as combination of arcs and straight line, combination of involute curve and straight line, or any other appropriate curved shapes. When the curved shape, starting from the proximal end of the sharp tip structure, of the curveddistal section32 is helix curve or involute curve, its curvature radius may increase gradually or stepwise. When the curved shape, starting from the proximal end of the sharp tip structure, of the curveddistal section32 is irregular curve, such as combination of arcs and straight line, combination of involute curve and straight line, or any other appropriate curved shapes, its curvature radius may change irregularly, e.g. increasing gradually or stepwise, but decreasing along with the further bending of the guide wire, and then increasing again gradually or stepwise. After the pericardium is pierced by the sharp tip of the curveddistal section32, the angle between the advancing direction of the guide wire and the pointing direction of the sharp tip is bigger than 90 degrees, thus avoiding piercing the heart. Even if the angle between the advancing direction of the guide wire and the pointing direction of the sharp tip is less than 90 degrees when the curveddistal section32 enters the pericardium gradually, it is not likely to hurt the heart, because the guide wire is very long and flexible, and thus the force of the guide wire is not able to be delivered to the sharp tip. Besides, the sharp tip may be encircled by the curved shape of the curved distal section, and is less likely to hurt the pericardium during piercing. Even if the sharp tip is not encircled by the curved shape of the curved distal section, the force of the guide wire is not able to be delivered to the sharp tip because the guide wire is very long and flexible. Therefore, it is not likely to hurt the heart.
• As shown inFIG. 5, in this embodiment, after the sharp tip bends 90 degrees, the curved shape of the curveddistal section32 starting from the proximal end of the sharp tip structure is a combination of involute curve and straight line. As shown inFIG. 6, in this embodiment, after the sharp tip bends 90 degrees, the curved shape of the curveddistal section32 starting from the proximal end of the sharp tip structure is a combination of helix curve and straight line. The curveddistal section32 comprises at least one curved section, which may be one curved section, two curved sections, three curved sections or more curved sections. As shown inFIG. 5 andFIG. 6, the curved shape, starting from the proximal end of the sharp tip structure, of the curveddistal section32 includes a firstcurved section321 and a secondcurved section322. Preferably, the part of guide wire between the firstcurved section321 and the secondcurved section322, and the part of guide wire between the secondcurved section322 and thecurved section323 of the sharp tip structure extend along a direction parallel to thepuncture needle12. The part of guide wire between the firstcurved section321 and the secondcurved section322, and the part of guide wire between the secondcurved section322 and thecurved section323 of the sharp tip structure may be in the form of straight line.
• The curvature radius of the firstcurved section321 and the secondcurved section322 may be set according to actual need of applications by those skilled in the art. For example, in one exemplary embodiment of the present disclosure, the curvature radius of the firstcurved section321 is not greater than 1.5 mm, and the curvature radius of the secondcurved section323 is not greater than 2 mm.
• The part of the curveddistal section32 extending from the proximal end of the sharp tip structure to the proximal end of the guide wire may be cylindrical, the diameter of which may be set according to actual need of applications by those skilled in the art. For example, the diameter is 0.2-1 mm in one preferred embodiment of the present disclosure. The part of the curveddistal section32 extending from the proximal end of the sharp tip structure to the proximal end of the guide wire may also be a flat sheet shape, which has a width of 0.2-1 mm as shown inFIG. 5. The width of the flat sheet shape structure means the width indicated bysymbol324 inFIG. 5.
• A sheath, not shown in figures, may be disposed within thepuncture needle12 as shown inFIG. 1,FIG. 2, andFIG. 3. The sheath extends within thepuncture needle12. The proximal end of the sheath is fixed to theconnector11. The distal end of the sheath may be a free end, or may also be fixed to the distal end of thepuncture needle12. The distal end of theguide wire13 enters thepuncture needle12 through the sheath, and extends within thepuncture needle12 along its axial direction. The proximal end ofguide wire13 may be fixed to theconnector11 depending on actual needs, or may be a free end without being fixed. It is possible that there is no sheath within thepuncture needle12. Theguide wire13 is pushed through thepuncture needle12 by a guide wire pusher when the puncture needle is used. The guide wire pusher also works as a sheath.
• Theconnector11, which is fixed to the proximal end of thepuncture needle12, may be a luer connector. Once completing piercing and drawing out theguide wire13, the connector may be used for injecting drugs or other liquids, or extracting effusion from the body.
• According to one preferable embodiment of the present disclosure, during the use of pericardium puncture needle assembly, the curveddistal section32 is in straightened state while it is wholly within thepuncture needle12. When pushing forward theguide wire13, the sharp tip of the curveddistal section32 pierces the pericardium, and theguide wire13 gradually enters the pericardium. The curveddistal section32 gradually becomes curved until regaining its preset shape. Thepuncture needle12 enters into the pericardium, and the piercing procedure is finished. Then theguide wire13 is drawn out of human body. During the drawing out of theguide wire13, it gradually regains straightened state from curved state, and is withdrawn into thepuncture needle12. After theguide wire13 is drawn out of the body, it is possible to inject drugs or contrast agents, or extract pericardial effusion through theconnector11.
• FIG. 7 is a perspective structural view of the pericardiumpuncture needle assembly10 according to another exemplary embodiment of the present disclosure.FIG. 8 is the enlarged view of the part indicated by symbol D ofFIG. 7. As shown inFIG. 7 andFIG. 8, the pericardiumpuncture needle assembly10 comprisespuncture needle12, and theguide wire13 extends within theneedle12. Theguide wire13 is a bendable, elongated flexible construction including a distal end and a proximal end. Theguide wire13 includes a curveddistal section32 and a straight proximal section. The curved distal section comprises a sharp tip structure at its distal end. A negative pressure device is fixed to the proximal end of thepuncture needle12. The distal end of the puncture needle comprises a lateral abutment area in order to form certain suction area between the distal end of the puncture needle and the pericardial tissue, thus producing negative pressure.
• Theguide wire13 is made from highly elastic material. The curveddistal section32 is formed by bending the guide wire, and has such a structure that is adapted to regain its preset curved shape from straightened state. The sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire. The curveddistal section32 may be in any other suitable curved shape. Within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section with a curvature radius of not greater than 2 mm. When the sharp tip bends 90 degrees, the curveddistal section32, starting from the proximal end of the sharp tip structure, may be involute curve, e.g. square involute, triangle involute, or any other involutes, the curvature radius of which increases continuously or stepwise, as shown inFIG. 7 andFIG. 8.
• The negative pressure device comprises ajunction valve14 and a negativepressure tee valve15. Thejunction valve14 and negativepressure tee valve15 are connected by anegative pressure tube16. Thejunction valve14 may be formed integrately, or formed in separate parts. As shown inFIG. 7, thejunction valve14 comprises avalve body141. Thevalve body141 includes a distal end, a proximal end and a central cavity. Alower end cap142 is disposed at the distal end of thevalve body141, and anupper end cover143 is disposed at the proximal end of thevalve body141. The proximal end of thepuncture needle12 is fixed inside thelower end cap142, and a protective sheath may be disposed at the proximal end. Agasket144 is disposed within theupper end cap143 for sealing purpose. One end of the negativepressure connecting tube16 is fixed to thejunction valve14, and the other end is fixed to the negativepressure tee valve15.
• Preferably, asheath17 is disposed within thepuncture needle12. Thesheath17 extends within thepuncture needle12, and the proximal end ofsheath17 extends out of thejunction valve14. Theguide wire13 extends through thesheath17 into thepuncture needle12, and extends within thepuncture needle12.
• Aconnector11 is disposed at the proximal end of thejunction valve14, which may be a luer connector. After finishing piercing and drawing out theguide wire13, the connector may be used for injecting drugs or other liquids into the body, or extracting pericardial effusion from the body.
• In the embodiment shown inFIG. 7 andFIG. 8, the other structures of theguide wire13 and punctureneedle12 are identical to those in the embodiments illustrated inFIG. 1 toFIG. 5.
• FIG. 9 is a structural perspective view of the curveddistal section32 according to another embodiment of the present disclosure. As shown inFIG. 9, theguide wire13 is an elongated and bendable flexible structure, which includes a curveddistal section32 and a straight proximal section. The guide wire is made from highly elastic material. The curveddistal section32 is formed by bending theguide wire13, and comprises a sharp tip structure at its distal end. The curveddistal section32 has such a structure that is adapted to regain its preset curved shape from straightened state.
• The sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire. Within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section, which has a curvature radius of not greater than 2 mm. After the sharp tip bends 90 degrees, the curved shape of the curved distal section of the guide wire starting from the proximal end of the sharp tip structure may be helix curve, which has a curvature radius increasing continuously, as shown inFIG. 9. The curveddistal section32 may be in form of other suitable curved shape.
• FIG. 10 is a structural perspective view of the curveddistal section32 according to another embodiment of the present disclosure. As shown inFIG. 10, theguide wire13 is an elongated and bendable flexible structure, which includes a curveddistal section32 and a straight proximal section. The guide wire is made from highly elastic material. The curveddistal section32 is formed by bending theguide wire13, and includes a sharp tip structure at its distal end. The curveddistal section32 is such a structure that it is adapted to regain its preset shape from straightened state.
• The sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the distal end of the guide wire. Within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section, which has a curvature radius of not greater than 2 mm. After the sharp tip bends 90 degrees, the curveddistal section32, starting from the proximal end of the sharp tip structure, may be irregular curve, which has a curvature radius changing irregularly, as shown inFIG. 10. For example, the curvature radius may increase gradually or stepwise, but decrease along with the further bending of the guide wire, and then increase again gradually or stepwise, or it may repeatedly change as above. The curveddistal section32 may be in form of other suitable curved shape.
• FIG. 11 is a structural perspective view of the pericardiumpuncture needle assembly10 according to another preferable embodiment of the present disclosure.FIG. 12 is the cross sectional view taken as indicated by arrows E-E ofFIG. 11. As shown inFIG. 11 andFIG. 12, the pericardiumpuncture needle assembly10 comprises apuncture needle12, and aguide wire13 extends within thepuncture needle12. Theguide wire13 is an elongated and bendable flexible structure, which includes a curveddistal section32 and a straight proximal section. The guide wire is made from highly elastic material. The curveddistal section32 is formed by bending theguide wire13, which includes a sharp tip structure at its distal end. The curveddistal section32 is adapted to regain its preset curved shape from straightened state. The sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the distal end of the guide wire. Within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section, which has a curvature radius of not greater than 2 mm. Aconnector11 is fixed to the proximal end of thepuncture needle12.
• After the sharp tip bends 90 degrees, the curveddistal section32, starting from the proximal end of the sharp tip structure, may be helix curve, which has a curvature radius increasing continuously, as shown inFIG. 11 andFIG. 12. The curveddistal section32 may be in form of other suitable curved shape.
• Anouter sheath18, which comprises a distal end and a proximal end, is nested outside thepuncture needle12. The distal end of theouter sheath18 is aspherical structure81, or may be other suitable shape. Thespherical structure81 and theouter sheath18 may be formed separately or integrately. Theouter sheath18 may be made from any suitable biocompatible materials, e.g. stainless steel. When thespherical structure81 is formed separately to theouter sheath18, they may be made from the same material, or from different materials. The proximal end of theouter sheath18 is fixed to aconnector19 by bonding or other suitable methods. Theconnector19 may be any suitable configuration, e.g. luer connector. Theconnector11 may slide freely at the proximal end of theconnector19, or be fixed through self-locking. After entering into thoracic cavity, the distal end of thepuncture needle12 may be withdrawn into theouter sheath18 by controlling theconnector11. Therefore, while theouter sheath18 is pushed forward, it is less likely to hurt the tissue. During the pericardium puncture procedure, the distal end of thepuncture needle12 may be used to abut on the pericardium, or alternatively, thepuncture needle12 may be withdrawn and thespherical structure81 of the distal end of the outer sheath may be directly used to abut on the pericardium, so as to complete the punctured procedure.
• The embodiments of present disclosure are not limited to those embodiments described above. Without departing from the spirit and scopes of the present disclosure, various variations and improvements may be made to the disclosure in forms and details by those skilled in the art, all of which are regarded as falling into the protection scopes of the present disclosure.

Claims (20)

1. A pericardium puncture needle assembly, characterized in comprising a guide wire and a puncture needle, wherein the guide wire extends within the puncture needle, the guide wire has a curved distal section and a straight proximal section, the curved distal section is formed by bending the guide wire, the tip end of the curved distal section is a sharp tip structure, the guide wire is made from highly elastic material, the sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire.

2. The pericardium puncture needle assembly ofclaim 1, characterized in that the sharp tip bends at least 90 degrees within a length range of 1-2 mm starting from the sharp tip of the curved distal section of the guide wire.

3. The pericardium puncture needle assembly ofclaim 1, characterized in that within a length range of no more than 3 mm starting from the sharp tip, the sharp tip structure comprises a curved section, which has a curvature radius of less than 2 mm.

4. The pericardium puncture needle assembly ofclaim 1, characterized in that after the sharp tip bends 90 degrees, a curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve, helix curve, or irregular curve.

5. The pericardium puncture needle assembly ofclaim 2, characterized in that after the sharp tip bends 90 degrees, a curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve, helix curve, or irregular curve.

6. The pericardium puncture needle assembly ofclaim 4, characterized in that after the sharp tip bends 90 degrees, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve or helix curve with a curvature radius increasing gradually or stepwise.

7. The pericardium puncture needle assembly ofclaim 5, characterized in that after the sharp tip bends 90 degrees, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is involute curve or helix curve with a curvature radius increasing gradually or stepwise.

8. The pericardium puncture needle assembly ofclaim 4, characterized in that after the sharp tip bends 90 degrees, the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section is irregular curved shape including at least one curved section.

9. The pericardium puncture needle assembly ofclaim 8, characterized in that the curved shape, starting from the proximal end of the sharp tip structure, of the curved distal section includes a first curved section and a second curved section.

10. The pericardium puncture needle assembly ofclaim 9, characterized in that the curvature radius of the first curved section is not greater than 1.5 mm, and the curvature radius of the second curved section is not greater than 2 mm.

11. The pericardium puncture needle assembly ofclaim 1, characterized in that a part of the curved distal section extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in cylindrical shape, which has a diameter of 0.2-1 mm.

12. The pericardium puncture needle assembly ofclaim 1, characterized in that a part of the curved distal section extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in flat sheet shape, which has a width of 0.2-1 mm.

13. The pericardium puncture needle assembly ofclaim 2, characterized in that a part of the curved distal section extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in flat sheet shape, which has a width of 0.2-1 mm.

14. The pericardium puncture needle assembly ofclaim 5, characterized in that a part of the curved distal section extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in flat sheet shape, which has a width of 0.2-1 mm.

15. The pericardium puncture needle assembly ofclaim 1, characterized in that the distal end of the puncture needle has a structure without a needlepoint.

16. The pericardium puncture needle assembly ofclaim 2, characterized in that the distal end of the puncture needle has a structure without a needlepoint.

17. The pericardium puncture needle assembly ofclaim 1, characterized in that the puncture needle is formed by connecting two tubes, one is the distal end tube and the other is the proximal end tube, the diameter of the distal end of the puncture needle is smaller than the diameter of its proximal end, the inner diameter of the proximal end of the puncture needle is 0.5-2.5 mm, and the inner diameter of its distal end is 0.2-1.5 mm.

18. The pericardium puncture needle assembly ofclaim 1, characterized in that a sheath is disposed inside the puncture needle, and the guide wire extends within the sheath.

19. The pericardium puncture needle assembly ofclaim 1, characterized in that a negative pressure device is fixed at the proximal end of the puncture needle.

20. The pericardium puncture needle assembly ofclaim 1, characterized in that an outer sheath is nested outside the puncture needle, and the distal end of the outer sheath is in a spherical structure.

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