A floating temporary pacing lead with a pig-tail shaped tip

Abstract

This invention discloses a floating temporary pacing lead with a pig-tail shaped tip, comprising a lead body, an air bladder and a conductive area at the tip of the lead body, an inflation tube and an electrode wire along the length of the lead body, the inflation tube communicating with the air bladder, and the electrode wire connected to the conductive area; the tip of the lead body is bent inward to form an unclosed loop pig tail loop, the air bladder is located inside the pig tail loop, and the conductive area is located outside the pig tail loop; by providing an inwardly bent, unclosed loop pig tail loop at the tip of the lead body, this application changes the contact between the lead body tip and the ventricular wall from point contact to surface contact, increasing the contact area between the pacing lead and the right ventricle, and the contact surface between the pacing lead and the ventricular wall is a smooth curve, avoiding complications such as ventricular wall perforation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a floating temporary pacing lead with a pig-tail shaped tip. Background Technology

[0002] Currently used temporary pacing leads in clinical practice all have straight tips. The straight tip area is conductive, and an air bladder is located near the tip. When inflated, the air bladder allows the pacing lead to cross the tricuspid valve and enter the right ventricle. However, using this type of straight-tipped pacemaker electrode can easily lead to ventricular perforation, causing cardiac tamponade, and in severe cases, endangering the patient's life, if the tension is too high or the patient's right ventricular wall is thin. Summary of the Invention

[0003] To address the shortcomings of existing technologies, the purpose of this invention is to provide a floating temporary pacing lead with a pig-tail shaped tip, which can reduce complications such as ventricular perforation.

[0004] The technical solution adopted in this invention is:

[0005] A floating temporary pacing lead with a pig tail-shaped tip includes a lead body, the tip of which is provided with an air bladder and a conductive area. An inflation tube and an electrode wire are provided along the length of the lead body. The inflation tube is connected to the air bladder, and the electrode wire is connected to the conductive area. The tip of the lead body is bent inward to form an unclosed loop-shaped pig tail ring. The air bladder is located inside the pig tail ring, and the conductive area is located outside the pig tail ring.

[0006] Furthermore, it also includes a pre-plasticized region, which is formed by bending the head end of the conductor body inward, and the pigtail ring is formed by bending the head end of the pre-plasticized region inward.

[0007] Furthermore, the conductor body, the pre-plasticized area, and the pigtail ring are located in the same plane.

[0008] Furthermore, the conductor body is a straight conductor with a diameter of 5F and a length of 110cm.

[0009] Furthermore, the pre-plasticized region has an arc of 110° and a length of 15cm.

[0010] Furthermore, the diameter of the pig tail ring is 10mm.

[0011] Furthermore, the conductive area is arranged along the outer length of the pig tail ring, and its length is 15mm.

[0012] Furthermore, the length of the airbag is 10mm.

[0013] Furthermore, the airbag is tightly attached to the inside of the pig tail ring when it is not inflated.

[0014] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of this application. Attached Figure Description

[0015] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the accompanying drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn to scale.

[0016] Figure 1 A schematic diagram of the structure of a floating temporary pacing lead with a pig-tail-shaped tip provided in an embodiment of this application in the uninflated state;

[0017] Figure 2 A schematic diagram of the structure of the floating temporary pacing lead with a pig tail-shaped tip provided in this application embodiment in the inflated state;

[0018] Figure 3 This is an enlarged schematic diagram of the tip of a floating temporary pacing lead with a pig-tail-shaped tip, as provided in an embodiment of this application.

[0019] The components include: 1. Conductor body; 2. Pre-plasticized area; 3. Pig tail pen; 4. Electrode wire; 5. Inflatable tube; 6. Airbag; and 7. Conductive area. Detailed Implementation

[0020] The embodiments of the technical solution of the present invention will be described in detail below with reference to specific examples. These embodiments are only used to more clearly illustrate the technical solution of the present invention, and are therefore merely examples and should not be used to limit the scope of protection of the present invention.

[0021] It should be noted that, unless otherwise stated, the technical or scientific terms used in this application should have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0022] See Figures 1-3 This application discloses a floating temporary pacing lead with a pig tail-shaped tip, comprising a lead body 1. The tip of the lead body 1 is provided with an air bladder 6 and a conductive area 7. An inflation tube 5 and an electrode wire 4 are provided along the length of the lead body 1. The inflation tube 5 is connected to the air bladder 6, and the electrode wire 4 is connected to the conductive area 7. The tip of the lead body 1 is bent inward to form an unclosed loop pig tail ring 3. The air bladder 6 is disposed on the inner side of the pig tail ring 3, and the conductive area 7 is disposed on the outer side of the pig tail ring 3.

[0023] This application provides an inwardly curved, unclosed loop pigtail loop 3 at the tip of the lead body 1, which changes the contact between the tip of the lead body 1 and the ventricular wall from point contact to surface contact, increasing the contact area between the pacing lead and the right ventricle. Furthermore, the contact surface between the pacing lead and the ventricular wall is a smooth curve, avoiding complications such as ventricular wall perforation.

[0024] In order to achieve safe and rapid insertion of the pacing lead, the pacing lead of this application also includes a pre-plasticized region 2, which is formed by bending the head end of the lead body 1 inward, and the pigtail loop 3 is formed by bending the head end of the pre-plasticized region 2 inward.

[0025] By setting an inwardly curved pre-molded area 2 at the tip of the lead body 1, the lead can be directly inserted during use without the operator needing to manually bend the tip of the lead body 1 beforehand. The bending arc is also standard and has a small error, which facilitates the rapid and safe insertion of the pacing lead. The pacing lead of this application sets a pre-molded area 2 and a pig tail loop 3 in sequence at the tip of the lead body 1, so that the tip of the pacing lead is a smooth arc shape, which facilitates the intravenous delivery of the pacing lead and reduces the hard contact between the pre-molded area 2 and the vein wall.

[0026] Specifically, the lead body 1, the pre-molding region 2, and the pigtail loop 3 are located in the same plane. The lead body 1 is a straight lead with a diameter of 5F and a length of 110cm. The tip of the lead body 1 is bent inward to form the pre-molding region 2, which has an arc of 110° and a length of 15cm. This angle and size setting better matches the physiological and anatomical angles of the inferior vena cava with the right atrium and right ventricle, further ensuring the safety of the pacing lead placement process. The tip of the pre-molding region 2 is bent inward to form an unclosed loop pigtail loop 3 with a diameter of 10mm. The tip of the pigtail loop 3 is located inside the pre-molding region 2.

[0027] The electrode wire 4 includes a cathode electrode wire 4 and an anode electrode wire 4. Both the cathode electrode wire 4 and the anode electrode wire 4 are arranged along the length direction of the lead wire body 1, with their tail ends extending out of the tail end of the lead wire body 1 and their head ends connected to the conductive area 7 at the head end of the lead wire body 1. The conductive area 7 is arranged along the outer length direction of the pig tail loop 3 and has a length of 15mm. By setting the conductive area 7, the conductive area 7 between the pacing lead and the right ventricle is greatly improved, the conductivity is good, and electrode detachment is avoided.

[0028] An inflation tube 5 is installed along the length of the conductor body 1, with its tail end extending beyond the tail end of the conductor body 1. An air valve is located near the tail end of the inflation tube 5 to open or close it. The head end of the inflation tube 5 is connected to an airbag 6 for inflating the airbag 6. The airbag 6 is located inside the pig tail ring 3, with a length of 10mm. In its uninflated state, it adheres tightly to the inside of the pig tail ring 3; in its inflated state, it expands inwards, providing a buoyancy effect.

[0029] When in use, air can be injected into the inflation tube 5 through a syringe to inflate the airbag 6. The maximum inflation volume of the airbag 6 is 2ml.

[0030] The pig tail collar 3 can be an inwardly curved, unclosed ring, or it can be straightened by the airbag 6. For example... Figure 1 As shown, when the airbag 6 is not inflated, the pig tail ring 3 is an inwardly curved, unclosed loop. Figure 2 As shown, when the airbag 6 is inflated, the pig tail loop 3 is straightened. This state is only used for the process of the pacing lead entering the right atrium, crossing the tricuspid valve and entering the right ventricle, so that the lead body 1 can quickly cross the tricuspid valve under the floating action of the airbag 6.

[0031] The floating temporary pacing lead with a pigtail-shaped tip, as described in this application, can be implanted using the following steps:

[0032] a) Insert the head end of the pig tail ring 3 into the lower limb venous sheath and push it inward. Under fluoroscopy, observe that after the pig tail ring 3 exits the sheath, it enters the right atrium along the iliac vein and inferior vena cava.

[0033] b) At this point, inflate the balloon 6 with 2ml of air using an inflation syringe, and then gently push the balloon 6 to make it float into the right ventricle.

[0034] c) Extract the gas from the air bag 6, and then continue pushing until the head of the pig tail ring 3 is pressed tightly against the apex of the right ventricle, thus completing the entire operation.

[0035] d) Connect the positive and negative electrodes to the temporary pacemaker and test whether the rapid pacing rate has dislodged.

[0036] This application features a floating temporary pacing lead with a pigtail-shaped tip, enabling safe and rapid insertion of the temporary pacing electrode lead. It adheres well to the right ventricular wall and has good conductivity, reducing complications such as temporary pacing electrode dislodgement and ventricular perforation. It can be widely used in the rescue of patients requiring temporary pacing and can also be applied to the intraoperative temporary rapid pacing needs in the field of transcatheter aortic valve replacement (TAVR).

[0037] In this application, unless otherwise expressly specified and limited, the terms "connected," "linked," "fixed," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0038] Numerous specific details are set forth in this specification. However, it will be understood that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, systems, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0039] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, system, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, systems, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0040] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

Claims

1. A floating temporary pacing lead with a pig-tail-shaped tip, comprising a lead body, the tip of which is provided with an air bladder and a conductive region, an inflation tube and an electrode wire provided along the length of the lead body, the inflation tube communicating with the air bladder, and the electrode wire connected to the conductive region; characterized in that, The head end of the conductor body is bent inward to form an unclosed loop pig tail ring. The air bladder is located inside the pig tail ring, and the conductive area is located outside the pig tail ring. The conductor body and the pig tail ring are located in the same plane. When the air bladder is not inflated, it is tightly attached to the inside of the pig tail ring. The pig tail ring is configured as an inwardly bent unclosed loop. When the air bladder is inflated, the pig tail ring is straightened, allowing the conductor body to cross the tricuspid valve under the buoyancy of the air bladder.

2. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 1, characterized in that, It also includes a pre-plasticized region formed by bending the head end of the conductor body inward, and the pigtail ring is formed by bending the head end of the pre-plasticized region inward.

3. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The conductor body, the pre-plasticized area, and the pigtail ring are located in the same plane.

4. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The conductor body is a straight conductor with a diameter of 5F and a length of 110cm.

5. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The pre-plasticized region has an arc of 110° and a length of 15cm.

6. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The diameter of the pig tail ring is 10mm.

7. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The conductive area is arranged along the outer length of the pig tail ring, and its length is 15mm.

8. The floating temporary pacing lead with a pig-tail-shaped tip according to claim 2, characterized in that, The length of the airbag is 10mm.

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