Medical device and medical device control system

By designing a medical device that includes the main box body, electrical components, connecting components and patch components, the problems of bulkiness and infection risk of existing temporary pacemakers are solved, and the effect of lightness, compactness and easy-to-wear is achieved, and the wearer's rehabilitation effect is improved.

WO2025066496A1PCT designated stage expired Publication Date: 2025-04-03MICROPORT SORIN CRM (SHANGHAI) CO LTD

Patent Information

Application Number
PCT/CN2024/107437
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-26
Filing Date
2024-07-25
Publication Date
2025-04-03

AI Technical Summary

Technical Problem

Existing temporary pacemakers are bulky and difficult to wear, and there is a risk of infection, making it difficult to meet the wearer's lightness and safety needs.

Method used

A medical device including a main box body, an electrical component, a connecting component and a patch assembly is designed. By setting the electrical component and the connecting component in the main box body, combined with the use of the patch assembly, the medical device is lightweight, compact and easy to wear.

Benefits of technology

The lightness and compactness of the medical device is achieved, reducing the wearer's restricted movement and infection risks, and improving the wearer's rehabilitation effect.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a medical device and a medical device control system. The medical device comprises a main casing body, an electrical assembly, a connecting assembly and a patch assembly, the electrical assembly and the connecting assembly being arranged in the main casing body, the main casing body being provided with a first through hole through which an electrode wire penetrates, the connecting assembly being configured to electrically connect the electrical assembly and the electrode wire, and the patch assembly being configured to fix at least one of the main casing body and the electrode wire to a target position. The medical device provided by the present invention is portable and compact, is more convenient to wear by wearers, and is not liable to cause infection, thus helping to rehabilitation of wearers.
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Description

Medical devices and medical device control systems Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical device and a medical device control system. Background Art

[0002] Currently, temporary (transitional) implantable medical devices are widely used. Taking pacemakers as an example, the use of temporary pacemakers can not only prevent the wearer from experiencing adverse events due to bradycardia after surgery, but also prevent the wearer from prematurely implanting unnecessary permanent pacemakers. They mainly respond to the following three types of needs:

[0003] 1) Preventive needs: Suitable for any wearer with potential temporary pacing protection needs, such as perioperative use during common surgeries including surgical valve replacement, transcatheter valve intervention, radiofrequency ablation of arrhythmias, removal of permanent pacemaker infection, surgical resection of hypertrophic cardiomyopathy or chemical ablation, etc.

[0004] 2) Therapeutic needs: any wearer who requires temporary pacing treatment, any pacing indication caused by surgery, unpredictable recovery, acute myocardial infarction, or use after percutaneous coronary intervention (PCI).

[0005] 3) Transitional needs: The original implanted pacemaker is removed for any reason, and protective overtreatment is required during the implantation period while waiting for a replacement pacemaker, such as removal of the original pacemaker system for infection, and transitional use between the treatment of the infection and replacement.

[0006] However, conventional temporary pacemakers are relatively bulky and heavy. Whether they are hung on a medical IV holder or placed at the wearer's bedside, they restrict the wearer's activities, which is detrimental to the wearer's recovery.

[0007] To address these issues, one type of transitional pacemaker in the related art includes an electrode lead adapted for implantation within the wearer's body and a pulse generator connected to the electrode lead. The pulse generator has connector tabs that allow it to be sewn to the wearer's skin or implanted subcutaneously. While this solution facilitates movement, it requires sewing the pulse generator to the wearer's skin, increasing the risk of trauma and infection. Furthermore, the limited range of electrode leads suitable for this device hinders doctors from tailoring preventive / treatment measures or transitional measures to the wearer's condition.

[0008] Another related temporary pacing lead fixation device primarily uses a combination of Velcro and straps to secure the lead to the wearer's surface, facilitating movement. However, this solution only secures the lead, while conventional temporary pacemakers are bulky, heavy, and difficult to wear. This solution does not effectively address the pacemaker's fixation issues.

[0009] It should be noted that the information disclosed in the background technology section of the invention is only intended to deepen the understanding of the general background technology of the invention, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0010] Summary of the Invention

[0011] The technical problem to be solved by the present invention is one or more of the problems existing in the prior art, such as temporary pacemakers being bulky, difficult to wear, and having a high risk of infection. A medical device and a medical device control system are provided. The medical device provided by the present invention is light and compact, more convenient for the wearer to wear, and less likely to cause infection.

[0012] To achieve the above object, the present invention is implemented through the following technical solution: a medical device comprising: a main box body, an electrical component, a connection component, and a patch component; the electrical component and the connection component are disposed in the main box body, and the main box body is provided with a first through hole for passing an electrode wire;

[0013] The connecting assembly is configured to electrically connect the electrical assembly and the electrode wire;

[0014] The patch assembly is configured to fix at least one of the main box body and the electrode wire at a target position.

[0015] Optionally, the electrical assembly includes an electrical protection box body and an electrically connected power supply and control system circuit module; the power supply and the control system circuit module are located in a closed accommodation space formed by the electrical protection box body and the main box body;

[0016] The power supply is used to provide electrical energy to the control system circuit module.

[0017] Optionally, the electrical component further includes a connecting cable, and the control system circuit module is electrically connected to the connecting component via the connecting cable; and a second through hole for the connecting cable to pass through is provided on the electrical protection box body.

[0018] Optionally, the electrical protection box body further includes a sealing member for sealing a gap between the second through hole and the connecting cable.

[0019] Optionally, the connection component includes at least one mounting slot and at least one electrical connector; the mounting slot is configured to place the connector of the electrode wire; the connector of the electrode wire is electrically connected to the electrical component through the electrical connector.

[0020] Optionally, the main box body includes an upper shell, a lower shell and a locking member, the upper shell and the lower shell are hingedly connected so that the main box body is a flip-type main box body, or the upper shell and the lower shell are slidably connected so that the main box body is a slide-type main box body;

[0021] When the upper shell and the lower shell are closed, the upper shell and the lower shell are fixedly connected by the locking member.

[0022] Optionally, a recessed accommodating portion corresponding one-to-one to the electrical connector is provided on the upper shell of the main box body, the electrical connector is partially located in the corresponding recessed accommodating portion, and the mounting groove is correspondingly provided on the lower shell of the main box body.

[0023] Optionally, the recessed accommodating portion is a blind hole structure perpendicular to the plane where the upper shell is located;

[0024] The electrical connector comprises:

[0025] A contact probe, wherein the outer periphery of the contact probe is provided with a first spring clamping portion;

[0026] a connecting piece fixed to the upper shell of the main box body, wherein the connecting piece and the extension direction of the contact probe form a non-zero angle, and the contact probe passes through the connecting piece;

[0027] a first spring, wherein the first spring is sleeved on the contact probe and two ends of the first spring are respectively connected to the first spring clamping portion and the blind hole structure;

[0028] When the electrical connector is electrically connected to the connector of the electrode wire, the contact probe is located at a first position, the first spring is in a first compressed state, the first spring is at a first length, a gap exists between the first spring clamping portion and the connecting piece, and the end of the contact probe away from the blind hole structure abuts against the connector;

[0029] When the electrical connector is separated from the connector of the electrode wire, the contact probe is located at the second position, the first spring is in a second compressed state, at which time the first spring has a second length, and the first spring clamping portion abuts against the connecting piece;

[0030] The second length is greater than the first length.

[0031] Optionally, the recessed accommodating portion is a through-hole structure perpendicular to the plane where the upper shell is located;

[0032] The electrical connector comprises:

[0033] A set screw, wherein the outer periphery of the set screw is provided with a second spring clamping portion;

[0034] a conductive connection block fixed to the upper shell of the main box body, wherein the conductive connection block is provided with a third through hole at a position corresponding to the through hole structure, the set screw is threadedly connected to the third through hole, and the second spring clamping portion is located on a side of the conductive connection block away from the lower shell of the main box body;

[0035] a second spring, the second spring being sleeved on the set screw and having two ends connected to the second spring clamping portion and the conductive connecting block respectively;

[0036] The position of the set screw relative to the conductive connection block is adjusted by rotating the set screw, so that the electrical connector is switched between two states of being electrically connected to and separated from the connector of the electrode wire.

[0037] Optionally, it further includes a cable auxiliary fixing member arranged in the main box body.

[0038] Optionally, a sealing ring is further included, and the sealing ring is arranged at the abutment position between the upper shell and the lower shell of the main box body;

[0039] and / or;

[0040] A sealing gasket is used to seal the connection between the electrode wire and the first through hole, and the sealing gasket includes a silicone pad with a cross groove; the connector of the electrode wire passes through the cross groove and is connected to the connecting assembly.

[0041] Optionally, the patch assembly includes at least one first patch for fixing the main box body at the target position; the first patch is detachably connected to the main box body.

[0042] Optionally, the patch assembly includes a tearable first patch, and the first patch has a fourth through hole for passing the electrode wire;

[0043] Alternatively, the patch assembly includes at least two of the first patches, and the at least two of the first patches are detachably connected to the main box body to fix the main box body at the target position, and there is a gap between the at least two of the first patches to allow the electrode wire to pass through.

[0044] Optionally, the patch assembly includes a main patch and an auxiliary bonding sheet that can be connected to the target position, and the main box body and part of the electrode wire are located between the main patch and the auxiliary bonding sheet.

[0045] Optionally, the main box body and the patch assembly are of split design, the main box body is a wearable main box body and the patch assembly includes a second patch for fixing the electrode wire at the target position.

[0046] Optionally, the main box body includes at least two independent sub-main box bodies, the electrical components, the connecting components and part of the electrode wires are accommodated in at least two independent sub-main box bodies, and the connecting components and part of the electrode wires are located in the same sub-main box body.

[0047] Optionally, the device further includes an adjustment component disposed on the outer wall of the main box body, wherein the adjustment component includes at least one adjustment knob electrically connected to the electrical component.

[0048] In order to achieve the above object, the present invention further provides a medical device control system, which includes a medical program-controlled device in communication connection and any one of the medical devices described above.

[0049] Compared with the prior art, the medical device and medical device control system provided by the present invention have the following beneficial effects:

[0050] The present invention provides a medical device, comprising: a main box body, an electrical component, a connecting component and a patch component; the electrical component and the connecting component are arranged in the main box body, and the main box body is provided with a first through hole for the electrode wire to pass through; the connecting component is configured to electrically connect the electrical component and the electrode wire; the patch component is configured to fix at least one of the main box body and the electrode wire to a target position (for example, when the patch component is used to fix the main box body, the target position is the body surface position of the wearer where the medical device is located). Therefore, the design method of the medical device provided by the present invention, which combines the main box body, the electrical component, the connecting component and the patch component, integrates the relevant technologies of implantable medical devices (such as implantable pacemakers) and temporary medical devices (such as traditional temporary pacemakers), so that the medical device provided by the present invention is light and compact, more convenient for the wearer to wear, and not easy to get infected, and thus more conducive to the wearer's recovery. Furthermore, the design of placing the electrical components and the connection components inside the main box body can not only protect the electrical components and the connection components, but also facilitates the wearing of the main body of the medical device (main box body, electrical components and connection components) on the wearer through the patch component. In addition, the main body of the lightweight and compact medical device can also be worn by means of straps, braces, etc., or even placed in the wearer's pocket, so that the electrode wire can be fixed by the patch component and the wound (that is, the target position is the wound in this case) can be cared for and protected, thereby reducing the risk of infection at the puncture site. Furthermore, the connection component of the medical device provided by the present invention can be applicable to different electrode wires (for example, the connector of the electrode wire can be a standard IS-1 electrode wire connector, a temporary pacing floating electrode connector and a temporary pacing electrode connection needle, etc.). By enhancing the scope of application of the electrode wire, it is more helpful for medical staff to adopt different rehabilitation plans according to the actual situation of the wearer (such as prevention, treatment or temporary transition using the medical device provided by the present invention).

[0051] Since the medical device control system provided by the present invention and the medical device provided by the present invention belong to the same inventive concept, the medical device control system provided by the present invention has at least all the advantages of the medical device provided by the present invention. For the beneficial effects of the medical device control system, please refer to the relevant description of the beneficial effects of the medical device, and no further details will be given here. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] FIG1 is a schematic diagram of the overall structure of the medical device provided by the present invention;

[0053] FIG2 is a schematic structural diagram of a medical device provided in Example 1 of the present invention;

[0054] FIG3 is a schematic diagram showing the connection between the medical device and the implantable IS-1 ventricular electrode lead provided in one embodiment of the present invention;

[0055] FIG4 is a schematic diagram showing the connection between the medical device and the implantable IS-1 ventricular electrode lead and the atrial electrode lead provided by another embodiment of the first embodiment of the present invention;

[0056] FIG5 is a schematic diagram showing the connection between a medical device and a conventional temporary pacing electrode lead according to yet another embodiment of the present invention;

[0057] FIG6 is an example diagram of one of the placement methods of the medical device and the electrode wire connected thereto provided in the main box according to the first embodiment of the present invention;

[0058] FIG7 is an exemplary diagram of another placement method of the medical device and the electrode wire connected thereto provided in the main box according to the first embodiment of the present invention;

[0059] FIG8 is a cross-sectional view along a first direction of a specific example of a connecting assembly in a medical device provided in the second embodiment of the present invention;

[0060] FIG9 is a three-dimensional cross-sectional view along a first direction of a specific example of a connecting assembly in a medical device provided in Embodiment 2 of the present invention;

[0061] FIG10 is a partial three-dimensional cross-sectional view of a specific example of a connecting assembly in a medical device provided in Embodiment 2 of the present invention, taken along a second direction (perpendicular to the first direction);

[0062] FIG11 is a cross-sectional view of the medical device provided in the third embodiment of the present invention along the third direction;

[0063] FIG12 is a three-dimensional cross-sectional view of the medical device provided in the third embodiment of the present invention along the third direction;

[0064] FIG13 is a partial cross-sectional view of the medical device provided in Example 3 of the present invention along a fourth direction (perpendicular to the third direction);

[0065] FIG14 is a front view of a medical device provided in accordance with a fourth embodiment of the present invention;

[0066] FIG15 is a schematic diagram showing the connection between the medical device provided in Example 4 of the present invention and the implantable IS-1 ventricular electrode lead;

[0067] FIG16 is a schematic diagram showing the connection between the medical device provided in Example 4 of the present invention and the implantable IS-1 ventricular electrode lead and atrial electrode lead;

[0068] FIG17 is a schematic diagram showing the connection between the medical device provided by the fourth embodiment of the present invention and a conventional temporary pacing electrode lead;

[0069] FIG18 is a schematic structural diagram of the upper and lower shells of the medical device provided in the fifth embodiment of the present invention in an open state;

[0070] FIG19 is a schematic structural diagram of the medical device shown in FIG18 with the main box body in a closed state and the anti-accidental touch protection member in an open state;

[0071] FIG20 is a schematic structural diagram of the main box body and the anti-accidental touch protection member of the medical device shown in FIG18 in a closed state;

[0072] FIG21 is a schematic diagram of the overall structure of the medical device provided in Example 6 of the present invention when the main box body is in an open state;

[0073] FIG22 is a schematic structural diagram of the main box body of the medical device provided in Example 6 of the present invention in a closed state;

[0074] FIG23 is a schematic structural diagram of the main box body of the medical device shown in FIG22 in an open state;

[0075] 1. The reference numerals are as follows: Main box body 100, upper housing 110, lower housing 120, locking member 130; Electrical assembly 200, electrical protection box body 210, baffle 211, power supply 220, control system circuit module 230, adjustment assembly 240, adjustment knob 241, accidental touch protection member 242; Connecting assembly 300, mounting slot 310, electrical connector 320, blind hole structure 321a, contact probe 321b, first spring clamping portion 321b1, first spring 321c, connecting piece 321d, through-hole structure 322a, set screw 322b, second spring clamping portion 322b1, external thread 322b2, second spring 322c, conductive connecting block 322d; First patch 410, main patch 421, auxiliary adhesive patch 422; sealing ring 510, sealing pad 520; electrode lead 600, IS-1 ventricular electrode lead 610, IS-1 atrial electrode lead 620, temporary pacemaker electrode lead 630; patch-type temporary pacemaker - P-TPG; heart 700. DETAILED DESCRIPTION

[0076] To further clarify the objectives, advantages, and features of the present invention, the medical device and medical device control system proposed by the present invention are further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and are not to exact scale, and are only used to facilitate and clearly illustrate the purpose of the embodiments of the present invention. It should be understood that the drawings in the specification do not necessarily show the specific structure of the present invention to scale, and the illustrative features used in the drawings to illustrate certain principles of the present invention may also be slightly simplified. The specific design features of the present invention disclosed herein, including, for example, specific dimensions, directions, positions, and shapes, will be determined in part by the specific application and use environment. In addition, in the embodiments described below, the same reference numerals are sometimes used across different drawings to represent the same parts or parts with the same function, and their repeated descriptions are omitted. In this specification, similar numbers and letters are used to represent similar items. Therefore, once a term is defined in one figure, it does not need to be further discussed in subsequent figures. Where appropriate, these terms are used interchangeably.

[0077] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element. The singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance or implicitly indicating the number of the indicated technical features.

[0078] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0079] In the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific circumstances.

[0080] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0081] It should be noted that the medical device and medical device control system proposed in the present invention can be used as a transitional (temporary) replacement device for various implantable medical devices, and there is no limitation on the specific type and implantation location of the implantable medical device. For example, the aforementioned implantable medical device can be any one of a cardiac defibrillator, a cardiac pacemaker, a leadless pacemaker, and a brain nerve stimulator. For ease of understanding, this article uses an implantable cardiac pacemaker as an example of an implantable medical device to illustrate the medical device provided by the present invention.

[0082] [Example 1]

[0083] This embodiment provides a medical device, namely a patch-type temporary pacemaker. Specifically, please refer to Figures 1 and 2, wherein Figure 1 is a schematic diagram of the overall structure of the medical device provided by this embodiment; Figure 2 is a schematic diagram of the structure of the medical device provided by this embodiment. As can be seen from Figures 1 and 2, the medical device provided by this embodiment includes: a main box body 100, an electrical component 200, a connecting component 300, and a patch component (the patch component in Figure 1 includes a first patch 410); the electrical component 200 and the connecting component 300 are disposed in the main box body 100, and the main box body 100 is provided with a first through hole (not shown in the figure) for an electrode wire 600 (not shown in the figure, see Figure 6 or Figure 7 below for details) to pass through; the connecting component 300 is configured to electrically connect the electrical component 200 and the electrode wire 600; and the patch component is configured to fix the main box body 100 at a target position.

[0084] In other specific embodiments, the patch assembly can fix the electrode wire 600 at the target position, or fix both the main box body 100 and the electrode wire 600 at the target position, which will not be described in detail here.

[0085] It should be noted that, as those skilled in the art can understand, the target position mentioned in this article includes but is not limited to the following positions: when the patch assembly is used to fix the main box body 100, the target position is the position where the medical device is placed on the wearer's body surface; when the patch assembly is used to fix the electrode wire 600 and care for or protect the wearer's wound, the target position is the position where the wearer's wound is located. At this time, the patch assembly includes a second patch, the electrode wire 600 is fixed by the second patch, and the main box body 100 is a wearable main box body 100 and is placed on the wearer's body strap, shoulder strap or pocket.

[0086] Thus, the medical device provided in this embodiment, the design of the main box body 100, the electrical component 200, the connecting component 300 and the patch component combined integrates the relevant technologies of implantable medical devices (such as implantable pacemakers) and temporary medical devices (such as traditional temporary pacemakers), making the medical device provided by the present invention light and compact, easier for the wearer to wear and less prone to infection, thereby more conducive to the wearer's recovery. Furthermore, the design of placing the electrical component 200 and the connecting component 300 inside the main box body 100 not only protects the electrical component 200 and the connecting component 300, but also makes it easier to wear the main body of the medical device (main box body 100, electrical component 200 and connecting component 300) on the wearer through the patch component. In addition, the main body of the lightweight and compact medical device can also be worn by means of a strap, a brace, or even placed in the wearer's pocket, thereby allowing the patch component to fix the electrode wire and care for and protect the wound (in this case, the target location is the wound), thereby reducing the risk of infection at the puncture site. Furthermore, the connection component 300 of the medical device provided in this embodiment can be applicable to different electrode wires 600 (for example, the connector of the electrode wire can be a standard IS-1 electrode wire connector, a temporary pacing floating electrode connector and a temporary pacing electrode connector needle, etc.). By enhancing the scope of application of the electrode wire 600, it is more helpful for medical staff to adopt different rehabilitation plans according to the actual situation of the wearer (such as prevention, treatment or temporary transition using the medical device provided by the present invention).

[0087] More specifically, referring to FIG. 2 , it can be seen that the medical device provided in this embodiment comprises a main housing 100 comprising an upper housing 110, a lower housing 120, and a locking member 130. The upper housing 110 and the lower housing 120 are hingedly connected, forming a clamshell main housing 100. When the upper housing 110 and the lower housing 120 are closed, the upper housing 110 and the lower housing 120 are fixedly connected via the locking member 130. In this embodiment, the locking member 130 is a snap. Thus, the hinged connection between the upper housing 110 and the lower housing 120 of the main housing 100 not only provides the main housing 100 with advantages of good stability and durability, but also facilitates assembly of the medical device and maintenance and commissioning of functional components within the main housing 100 (such as the electrical component 200 and the connection component 300). Furthermore, the locking member 130 ensures the securement of the main housing 100 in the closed state.

[0088] Continuing with Figures 1 and 2 , in some exemplary embodiments, the electrical assembly 200 is disposed on the lower housing 120 of the main box body 100. Thus, by disposing the electrical assembly 200 on the lower housing 120, the medical device provided in this embodiment can ensure the stability of the electrical assembly 200 while also facilitating the closing and opening of the main box body 100 by flipping the upper housing 110. Optionally, a first through-hole for the electrode lead 600 to pass through is disposed on the lower housing 120, thereby further facilitating the securing of the electrode lead 600.

[0089] 2 , in some exemplary embodiments, the electrical assembly 200 includes an electrical protection housing 210, an electrically connected power supply 220, and a control system circuit module 230. The power supply 220 and the control system circuit module 230 are located within a sealed housing space formed by the electrical protection housing 210 and the main housing 100. The power supply 220 is configured to provide electrical energy to the control system circuit module 230. Thus, the sealed housing space formed by the electrical protection housing 210 and the main housing 100 provides enhanced protection for the power supply 220 and the control system circuit module 230, thereby preventing direct contact between the electrode lead 600 and the power supply 220 and the control system circuit module 230 within the electrical protection housing 210. This could potentially lead to relative movement or friction between the electrode lead 600, the power supply 220, and the control system circuit module 230 due to the wearer's movements, and thus damage to the electrode lead 600, the power supply 220, and the control system circuit module 230. This ultimately increases the service life of the medical device provided by this embodiment.

[0090] Furthermore, as those skilled in the art will appreciate, the power supply 220 primarily provides electrical energy for the control system circuit module 230. The present invention does not limit the specific type of the power supply 220. For example, in some embodiments, the power supply 220 may be a button battery, such as a CR2032 chip or other lithium battery commonly used in consumer electronic devices. The power supply 220 may also be installed in the electrical protection box 210 using a conventional battery holder. In addition, as those skilled in the art will appreciate, the present invention does not limit the specific composition of the control system circuit module 230. The control system circuit module 230 (schematically represented by a dotted box in the figure) may include one or more submodules.

[0091] Specifically, the control system circuit module 230 includes a medical circuit module (not shown in the figure), which is configured to monitor the physiological state of the wearer's existing internal organs and tissues and / or enhance or replace the physiological function of the wearer's damaged internal organs and tissues. In other words, the functions of the control system circuit module 230 are substantially similar to those of the control system circuit module 230 of a corresponding implantable medical device (such as an implantable cardiac pacemaker). For example, the medical circuit module may include a heart rate response function. The heart rate response function enables the medical device to increase the pacing heart rate accordingly when the patient's metabolism increases due to physical exercise, thereby requiring an increase in heart rate.

[0092] For example, in one exemplary embodiment, the medical device serves as a temporary replacement for an implantable cardiac pacemaker (i.e., a patch-type temporary pacemaker, referred to as "P-TPG"). The medical circuit module further includes a pacing control submodule (not shown in the figure). The pacing control submodule is configured to provide pacing functions at a basal heart rate of 60 beats / minute and 180 beats / minute. The 180 beats / minute pacing function is a special pacing function for postoperative rehabilitation after TAVR (Transcatheter Aortic Valve Replacement) / TAVI (Transcatheter Aortic Valve Implantation).

[0093] Optionally, in some exemplary embodiments, the control system circuit module 230 further includes a wireless communication module (not shown), which is configured to communicate with the medical circuit module and the medical programmable device. Thus, the medical device (e.g., P-TPG) provided by the present invention can communicate with other devices (e.g., remote controls, programmable devices, electrocardiogram monitors, etc.), thereby enabling medical personnel (including nurses, attending physicians, etc.) to monitor the operating status of the medical device (e.g., P-TPG) in real time and adjust the parameters of the medical device (e.g., P-TPG) as needed.

[0094] Specifically, the present invention does not limit the specific type of the wireless communication module of the control system circuit module 230 in the provided medical device. The wireless communication module may include but is not limited to a Bluetooth communication module, a radio frequency communication module, a WIFI module, etc., which will not be repeated here.

[0095] When a temporary pacemaker (P-TPG) is implemented using the medical device provided in this embodiment, the electrode lead 600 includes, but is not limited to, an IS-1 ventricular electrode lead 610, an IS-1 atrial electrode lead 620, and a temporary pacemaker electrode lead 630. Specifically, please refer to Figures 3 to 5 , wherein Figure 3 is a schematic diagram of the connection between the medical device provided in one embodiment of this embodiment and the implantable IS-1 ventricular electrode lead. As can be seen from Figure 3 , in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the IS-1 ventricular electrode lead 610 can be connected to the wearer's heart 700 for single-chamber (ventricular) temporary pacing. FIG4 is a schematic diagram illustrating the connection between a medical device provided in another embodiment of this embodiment and an implantable IS-1 ventricular electrode lead and an implantable atrial electrode lead. FIG4 illustrates that, in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the IS-1 ventricular electrode lead 610 and the IS-1 atrial electrode lead 620 can be connected to the wearer's heart 700 for dual-chamber (atrium and ventricle) temporary pacing. FIG5 is a schematic diagram illustrating the connection between a medical device provided in another embodiment of this embodiment and a conventional temporary pacing electrode lead. FIG5 illustrates that, in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the temporary pacemaker electrode lead 630 can be connected to the wearer's heart 700 for temporary pacing.

[0096] Optionally, in some exemplary embodiments, the electrical assembly 200 further includes a connecting cable (not shown), through which the control system circuit module 230 is electrically connected to the connecting assembly 300. The electrical protection box 210 includes a second through-hole (not shown) for the connecting cable to pass through. Thus, the electrical protection box 210 not only protects the electrical assembly 200 but also allows the connecting cable of the control system circuit module 230 to be connected to the connecting assembly 300 via the second through-hole.

[0097] Optionally, in some exemplary embodiments, the electrical protection box 210 further includes a sealant (not shown) for sealing the gap between the second through hole and the connecting cable. Thus, the sealant seals the gap between the connecting cable and the second through hole, ensuring that the electrical protection box 210 seals the electrical assembly 200, thereby extending the service life of the medical device.

[0098] It should be noted that the present invention does not impose any restrictions on the shape and material of the sealing member. For example, the second through hole may be sealed by applying silicone or using a sealing ring.

[0099] For more detailed information about the connection component 300 of the medical device provided in this embodiment, please refer to the relevant description of the connection component 300 in the second or third embodiment below. In order to avoid redundancy, the description is not expanded for the time being.

[0100] Continuing with Figure 2 , some exemplary embodiments of the medical device further include a sealing ring 510 ; the sealing ring 510 is disposed at the junction of the upper shell 110 and the lower shell 120 of the main case 100 . Thus, the sealing ring 510 included in the medical device provided in this embodiment not only further enhances the sealing effect of the medical device provided by the present invention, thereby further expanding the wearer's range of motion, but also eliminates the need for additional protective measures, such as disposable waterproof protective patches, thereby facilitating the wearer's ability to bathe at appropriate times.

[0101] Please continue to refer to Figure 2. Optionally, the medical device further includes a sealing pad 520, which is used to seal the connection between the electrode wire 600 and the first through hole. For example, as an option, the sealing pad 520 includes a cross-grooved silicone pad (not shown in the figure), and the connector of the electrode wire 600 is electrically connected to the connecting assembly 300 after passing through the cross-grooved silicone pad. Therefore, by providing a cross-grooved silicone pad, the sealing protection effect of the medical device provided by the present invention can be further enhanced, thereby expanding the wearer's range of activities (such as a relatively humid environment such as a bathroom).

[0102] Continuing with FIG1 , in some exemplary embodiments, the patch assembly includes a first patch 410 for securing the main box 100 at the target location; the first patch 410 is detachably connected to the main box 100. Thus, the detachable connection between the first patch 410 and the main box 100 facilitates replacement of the first patch 410 when needed.

[0103] Specifically, the first patch 410 and the main box body 100 can be connected by at least one of buckles, snaps, bonding and Velcro.

[0104] As shown in FIG1 or FIG2 , the first patch 410 has a fourth through hole (not shown) for passing the electrode wire 600. Thus, the fourth through hole allows the connector of the electrode wire 600 to pass through the fourth through hole and the sealing gasket 520 (for sealing the first through hole) into the main box body 100 and be electrically connected to the connection assembly 300.

[0105] Optionally, in some exemplary embodiments, the material of the first patch 410 includes 3M liquid dressing, hydrogel dressing, silicone dressing, alginate, calcium alginate dressing or hydrophilic fiber dressing, as well as anti-inflammatory drugs or antibiotic drugs. Specifically, since the first patch 410 is mainly used to adhere the main body of the medical device (such as a patch-type temporary pacemaker, P-TPG) to the wearer's body surface, the first patch 410 is made of 3M liquid dressing, hydrogel dressing, silicone dressing, alginate, calcium alginate dressing or hydrophilic fiber dressing so that the first patch 410 has the functions of breathability, waterproofness and antibacterial, and can be worn for a long time, such as longer than 3 days, 7 days, 15 days, 30 days, etc. The material of the first patch 410 includes anti-inflammatory drugs or antibiotic drugs, which can better protect the puncture site and reduce the risk of infection at the puncture site. For example, if the adhesion between the first patch 410 and the wearer's skin decreases due to factors such as the wearer's activities and sweating, resulting in a decrease in connection reliability or inability to maintain adhesion, or if the wearer's allergies and other factors require replacement of the first patch 410, the first patch 410 can be torn off from the main box body 100, and then a new first patch 410 can be replaced and used to fix the main box body 100 to the target position.

[0106] In other embodiments, the patch assembly may also include two first patches 410, each of which is detachably connected to the main box body 100 to secure the main box body 100 to the target location (e.g., the wearer's body surface), and a gap is provided between the two first patches 410 to allow the electrode wire 600 to pass through. Thus, by using multiple first patches 410, part or all of the first patches 410 can be replaced, further enhancing the convenience of the medical device provided by the present invention.

[0107] Of course, the patch assembly may also include more first patches, such as three, four or even more, as long as there is a gap between at least two patches for the electrode wire 600 to pass through, which will not be repeated here.

[0108] Please refer to Figures 6 and 7, wherein Figure 6 is an example diagram of one of the placement methods of the medical device provided in this embodiment and the electrode wire 600 connected thereto within the main box body 100; and Figure 7 is an example diagram of another placement method of the medical device provided in this embodiment and the electrode wire 600 connected thereto within the main box body 100. As can be seen from Figures 6 and 7, the main box body 100 of the medical device provided by the present invention has a storage space for accommodating the electrode wire 600. In some embodiments, the storage space can be located between the electrical protection box body 210 and the upper shell 110. Thus, the provision of the storage space for the electrode wire 600 enables the medical device provided by the present invention to be suitable for electrode wires 600 of different lengths.

[0109] Optionally, the medical device provided in some exemplary embodiments further includes a cable auxiliary fixing member (such as the baffle 211 hereinafter) disposed within the main box body 100. Thus, the cable auxiliary fixing member can secure the coiled electrode wire 600 within the main box body 100, thereby preventing the electrode wire 600 from partially popping out of the main box body 100 due to deformation after coiling, thereby making it easier for medical personnel to operate.

[0110] Continuing to refer to FIG. 1 or FIG. 2 , the auxiliary cable fixing member illustratively includes four baffles 211 disposed in pairs on the electrical protection box 210 of the electrical assembly 200. Each baffle 211 may be an arc-shaped plate bent toward the center of the electrical protection box 210 to facilitate winding the electrode wire 600 within the four baffles 211. The present invention does not limit the material of the baffles 211, and they may be made of plastic or rubber.

[0111] In other specific embodiments, the number, shape and material of the baffles 211 can be changed. The number can be 1, 2 or more, and the shape can be a straight plate, etc. For example, there is only one baffle 211, but it is a plate-like structure with a U-shaped cross-section. This can also serve to coil the electrode wire 600 and store it in the baffle 211. It will not be repeated here.

[0112] In other specific embodiments, the cable auxiliary fixing member may also be a buckle, a spring clip, a cable tie, etc. For more details on how to set and use the buckle, spring clip, and cable tie to fix the electrode wire 600, please refer to the relevant technology known to those skilled in the art and will not be described in detail here.

[0113] In other specific embodiments, the main box body 100 may also include two independent sub-main box bodies, and the electrical component 200, the connection component 300 and part of the electrode wire 600 are housed in at least two independent sub-main box bodies, and the connection component 300 and part of the electrode wire 600 are located in the same sub-main box body. Therefore, in the medical device provided in this embodiment, the main box body 100 includes two independent sub-main box bodies. This split design method is conducive to reducing the overall height of each sub-box body, which can improve the overall appearance of the wearer after wearing it (after the patient wears it, it is easier to hide. Compared with the overall design of the main box body 100, the size of each sub-box body is smaller and there will be no obvious bulge after wearing it) and is more conducive to patient activities; further, the split setting is also conducive to the doctor to separate and fix the various modules of the medical device in more appropriate positions according to specific circumstances.

[0114] Of course, the main box body 100 may also include more independent sub-main boxes, such as three, four, etc., which can be flexibly designed according to actual conditions and will not be described in detail here.

[0115] [Example 2]

[0116] This example provides another medical device. The basic principle of the medical device provided in this embodiment is the same as that of the medical device provided in Example 1. Due to space limitations, only the differences between this embodiment and Example 1 and the connection component 300 not described in Example 1 are described in detail below. For the parts not mentioned in this embodiment, please refer to the relevant description of Example 1 for adaptive understanding.

[0117] Specifically, please refer to Figures 8, 9 and 10, wherein Figure 8 is a cross-sectional view of one specific example of the connecting component in the medical device provided in this embodiment along the first direction; Figure 9 is a stereoscopic cross-sectional view of one specific example of the connecting component in the medical device provided in this embodiment along the first direction; Figure 10 is a partial stereoscopic cross-sectional view of one specific example of the connecting component in the medical device provided in this embodiment along the second direction (perpendicular to the first direction) of the medical device provided in this embodiment.

[0118] First, by comparing Figures 8 to 10 corresponding to the medical device provided in this embodiment with Figures 1 to 7 corresponding to the medical device provided in Example 1, it is not difficult to see that the main box body 100 of the medical device provided in this embodiment is different in shape from the main box body 100 of the medical device provided in Example 1. The main box body 100 of the medical device provided in this embodiment is a rectangular box body, while the main box body 100 of the medical device provided in Example 1 is a hexagonal box body. Therefore, it can be seen that the shape of the main box body 100 of the medical device provided in the present invention is not limited. In other embodiments, the shape of the main box body 100 of the medical device can also be an oblate oval box body, an oblate round box body, an irregular box body, etc., which are not listed one by one.

[0119] Next, the connection assembly 300 will be described in detail. Referring to Figures 8, 9, and 10, the connection assembly 300 includes at least one mounting slot 310 and at least one electrical connector 320. The mounting slot 310 is configured to accommodate the connector of the electrode lead 600. The connector of the electrode lead 600 is electrically connected to the electrical assembly 200 via the electrical connector 320. Thus, the medical device provided by the present invention, through the coordinated operation of the mounting slot 310 and the electrical connector 320, facilitates clamping of electrode connectors of different sizes, such as standard IS-1 electrode lead connectors, temporary pacing floating electrode connectors, and temporary pacing electrode connection needles. Furthermore, the electrical connector 320 maintains close contact with the electrodes of the connection cable and the connector of the electrode lead 600, ensuring the reliability of the electrical connection. Furthermore, the connection of the connection cable to the control system circuit module 230 allows monitoring of the physiological status of the wearer's existing internal organs and tissues, and / or enhancing or replacing the physiological functions (such as pacing sensing) of damaged internal organs and tissues.

[0120] It should be noted that the present invention does not limit the correspondence between the mounting slot 310 and the electrical connector 320. It can be specifically set according to the type of electrode wire 600 that the connection component 300 needs to match. In some embodiments, one mounting slot 310 can correspond to one electrical connector 320. In other embodiments, one mounting slot 310 can also correspond to two or more electrical connectors 320. The following is an example of one mounting slot 310 corresponding to two electrical connectors 320. For the case where one mounting slot 310 corresponds to other numbers of electrical connectors 320, the length of the mounting slot 310 can be reduced or increased to achieve that one mounting slot 310 can accommodate one or more electrical connectors 320. Due to space limitations, the explanation will not be given in detail.

[0121] In this embodiment, as shown in FIG. 8 , the mounting slot 310 and the electrical connector 320 of the medical device connection assembly 300 are split-type designs, that is, the mounting slot 310 is provided in the lower housing 120 , and the electrical connector 320 is provided in the upper housing 110 .

[0122] Specifically, the upper housing 110 of the main box body 100 is provided with a recessed receiving portion corresponding to each of the electrical connectors 320. The electrical connectors 320 are partially located within the corresponding recessed receiving portion, and the mounting grooves 310 are correspondingly provided on the lower housing 120 of the main box body 100. Thus, this split design, in which the electrical connector 320 of the connection assembly 300 is provided on the upper housing 110 and the mounting grooves 310 are provided on the lower housing 120, not only makes it easier to place the connector of the electrode wire 600 within the mounting grooves 310, allowing the mounting grooves 310 to initially secure the connector of the electrode wire 600, but also, through the mutual cooperation between the electrical connector 320 provided on the upper housing 110 and the mounting grooves 310 provided on the lower housing 120, further enhances the stability and firmness of the main box body 100 when in the closed state. In addition, the design of partially positioning the electrical connector 320 within the corresponding recessed receiving portion can reduce the height of the main box body 100 and lay a solid foundation for the medical device to have a compact and lightweight appearance.

[0123] Please continue to refer to Figures 8, 9 and 10. It is not difficult to see from Figures 8, 9 and 10 that in this embodiment, the recessed accommodating portion is a blind hole structure 321a perpendicular to the plane where the upper shell 110 is located, and the electrical connector 320 includes: a contact probe 321b, a connecting piece 321d and a first spring 321c. Among them, the outer periphery of the contact probe 321b is provided with a first spring clamping portion 321b1 in an annular shape; the connecting piece 321d is fixed on the upper shell 110 of the main box body 100, and the connecting piece 321d has a non-zero angle with the extension direction of the contact probe 321b. In this embodiment, the connecting piece 321d and the extension direction of the contact probe 321b form a 90° angle, and the contact probe 321b passes through the connecting piece 321d; the first spring 321c is sleeved on the contact probe 321b and its two ends are respectively abutted against the first spring clamping portion 321b1 and the blind hole structure 321a. In other specific embodiments, the first spring 321c can also be welded at the corresponding positions mentioned above, which will not be repeated here.

[0124] When the electrical connector 320 is electrically connected to the connector of the electrode wire 600, the contact probe 321b is located in the first position, the first spring 321c is in the first compression state, at this time the first spring 321c is the first length, the first spring clamping portion 321b1 and the connecting piece 321d have a gap and the end of the contact probe 321b away from the blind hole structure 321a abuts against the connector.

[0125] When the electrical connector 320 is separated from the connector of the electrode wire 600, the contact probe 321b is located at the second position, the first spring 321c is in the second compressed state, the first spring 321c is at the second length, and the first spring clamping portion 321b1 abuts against the connecting piece 321d.

[0126] The second length is greater than the first length.

[0127] Thus, in the medical device provided in this embodiment, a portion of the contact probe 321b and the first spring 321c are located within the blind hole structure 321a, making the overall structure more compact. The arrangement of the contact probe 321b and the connecting piece 321d can electrically connect the connector of the electrode wire 600 to the electrical component 200 in the medical device (e.g., P-TPG), and the connecting piece 321d having a non-zero angle with the contact probe 321b is fixed to the upper shell 110, thereby preventing the contact probe 321b from falling downward from the blind hole structure 321a. Furthermore, the arrangement of the first spring 321c allows the contact probe 321b to be pressed against the electrode of the connector by the first spring 321c when the connector of the electrode wire 600 is inserted into the electrical connector 320, thereby ensuring the reliability of the electrical connection and adapting to different models of electrode wires 600.

[0128] In other specific embodiments, the first spring clamping portion 321b1 is not necessarily annular, but may also be an arc-shaped block structure, as long as it can support one end of the first spring 321c; the angle between the connecting piece 321d and the extension direction of the contact probe 321b is not limited to this example, and may be a non-zero angle such as 15°, 20°, 30°, etc., but a relatively better way is that the extension direction of the contact probe 321b is parallel to the height direction of the main box body 100, and the extension direction of the connecting piece 321d is parallel to the plane where the main box body 100 is located, which will not be repeated here.

[0129] It should be noted that, depending on whether the contact probe 321b, the connecting piece 321d and the first spring 321c of the connecting assembly 300 are conductive or not, there are two specific implementations as follows:

[0130] The first method involves contact probe 321b being conductive, and first spring 321c and connecting piece 321d being either conductive or non-conductive. In this case, contact probe 321b is connected to the connecting cable. Under the force of first spring 321c, contact probe 321b presses against the corresponding position of the connector of electrode wire 600 to achieve electrical connection.

[0131] The second method involves contact probe 321b and connecting piece 321d being conductive, while first spring 321c can be either conductive or non-conductive. In this case, the connecting cable is connected to connecting piece 321d, and the outer periphery of contact probe 321b contacts the inner wall of the corresponding hole in connecting piece 321d, achieving electrical continuity. Under the force of first spring 321c, contact probe 321b presses against the corresponding position of the connector of electrode lead 600, achieving electrical connection.

[0132] Taking the second case mentioned above as an example, when the connector of the contact probe 321b and the electrode wire 600 is in a separated state (for example, when the lower shell 120 and the upper shell 110 of the main box body 100 are opened or the electrode wire is not extended into the main box body), the first spring 321c is in a second compressed state (that is, the first spring 321c is the second length at this time, and the lower end face of the first spring clamping portion 321b1 is in contact with the upper end face of the connecting piece 321d) under the upward force provided to it by the connecting piece 321d.

[0133] When the contact probe 321b is in an electrically connected state with the connector of the electrode wire 600 (for example, when the lower shell 120 and the upper shell 110 of the main box body 100 are closed (such as by snap connection, screw connection, etc.), and the electrode wire is inserted into the connecting component), the contact probe 321b is in close contact with the corresponding position of the connector of the electrode wire 600 and provides a certain holding force. The contact probe 321b is in close contact with the connecting piece 321d in the circumferential direction to achieve electrical connection. The other end of the connecting piece 321d is connected to the connecting cable of the electrical component 200, thereby ensuring that the connector of the electrode wire 600 can be electrically connected to the electrical component 200.

[0134] Furthermore, in some exemplary embodiments, the blind hole structure 321a can be optionally a stepped blind hole structure, specifically referring to Figure 8, Figure 9 or Figure 10. It can be seen from Figure 8, Figure 9 or Figure 10 that the blind hole structure 321a includes a coaxial hole with a first radius (not marked in the figure) and a blind hole with a second radius (not marked in the figure), wherein the first radius is greater than the second radius, that is, the connection between the hole with the first radius and the blind hole with the second radius constitutes a step of the blind hole structure 321a, and the two ends of the first spring 321c are respectively in contact with the step and the first spring clamping portion 321b1. Thus, by providing the blind hole structure 321a with a step, on the one hand, by having one end of the first spring engaging portion 321b1 abut against the aforementioned step, the first spring 321c can be shortened, thereby reducing costs. Furthermore, the first spring 321c is at least partially located within the hole of the first radius, thereby ensuring that the expansion and contraction direction of the first spring 321c remains straight and does not tilt when deformed. Furthermore, the radially smaller portion above the step (in the direction shown in FIG8 ) can also serve as a guide for the contact probe 321b, preventing the contact probe 321b from tilting during reciprocating movement within the blind hole structure 321a, thereby increasing the service life of the contact probe 321b. Of course, the radially larger portion below the step (in the direction shown in FIG8 ) matches the circumferential size of the first spring engaging portion 321b1 and can also serve as a guide for the contact probe 321b, which will not be further described here.

[0135] [Example 3]

[0136] This example provides another medical device. The basic principle of the medical device provided in this embodiment is similar to that of the medical device provided in Example 1. Due to space limitations, only the differences between this embodiment and Example 1 are described in detail below. For parts not mentioned in this embodiment, please refer to the relevant description of Example 1 for adaptive understanding.

[0137] Specifically, please refer to Figures 11, 12 and 13, wherein Figure 11 is a cross-sectional view of the medical device provided in this embodiment along the third direction; Figure 12 is a stereoscopic cross-sectional view of the medical device provided in this embodiment along the third direction; and Figure 13 is a partial stereoscopic cross-sectional view of the medical device provided in this embodiment along the fourth direction (perpendicular to the third direction).

[0138] First, by comparing Figures 11 to 13 corresponding to the medical device provided in this embodiment with Figures 1 to 7 corresponding to the medical device provided in Example 1, it is not difficult to see that the main box body 100 of the medical device provided in this embodiment is different in shape from the main box body 100 of the medical device provided in Example 1. The shell shape of the main box body 100 of the medical device provided in this embodiment is a rectangular box body, while the shell shape of the main box body 100 of the medical device provided in Example 1 is a hexagonal box body. Therefore, it can be seen that the shape of the main box body 100 of the medical device provided in the present invention is not limited. In other embodiments, the shape of the main box body 100 of the medical device can also be an oblate oval box body, an oblate round box body, an irregular box body, etc., which are not listed one by one.

[0139] Secondly, by comparing Figures 11 to 13 corresponding to the medical device provided in this embodiment with Figures 1 to 7 corresponding to the medical device provided in Example 1, it can be seen that the locking member 130 of the medical device provided in this embodiment is different from the snap-on locking member 130 of the medical device provided in Example 1. The locking member 130 of the medical device provided in this embodiment is a bolt structure, which is connected to the upper shell and the lower shell by engaging with the threaded holes on the upper shell and the lower shell. Therefore, the medical device provided by the present invention does not limit the specific implementation of the locking member 130. In other embodiments, the locking member 130 of the medical device can also adopt other structures, which are not listed one by one.

[0140] Next, the connection assembly 300 will be described in detail. Referring to Figures 11, 12, and 13, it is readily apparent that in these exemplary embodiments, the recessed receiving portion is a through-hole structure 322a perpendicular to the plane of the upper housing 110; the electrical connector 320 includes a set screw 322b, a conductive connection block 322d, and a second spring 322c. In which, the outer periphery of the locking screw 322b is provided with a ring-shaped second spring clamping portion 322b1; the conductive connecting block 322d is fixed on the upper shell 110 of the main box body 100, and the conductive connecting block 322d is provided with a third through hole at the position corresponding to the through hole structure, the locking screw 322b has an external thread 322b2 threadedly connected to the third through hole, and the second spring clamping portion 322b1 is located on the side of the conductive connecting block 322d away from the lower shell 120 of the main box body 100; the second spring 322c is sleeved on the locking screw 322b and its two ends respectively abut against the second spring clamping portion 322b1 and the conductive connecting block 322d; by rotating the locking screw 322b to adjust the position of the locking screw 322b relative to the conductive connecting block 322d, the electrical connector 320 is switched between the two states of being electrically connected and disconnected with the connector of the electrode wire 600.

[0141] Thus, the medical device provided in this embodiment has a recessed receiving portion formed as a through-hole structure 322a perpendicular to the plane of the upper housing 110. This facilitates adjustment of the relative position between the conductive connection block 322d and the set screw 322b using auxiliary tools, thereby accommodating different connectors of the electrode lead 600. Furthermore, the set screw 322b is threadedly connected to the conductive connection block 322d, and the conductive connection block 322d is fixed to the upper housing 110 of the main box body 100. This prevents the set screw 322b from ejecting from the upper housing 110 due to the action of the second spring 322c, and also prevents the set screw 322b from dislodging from the through-hole structure 322a. Furthermore, the provision of the set screw 322b and the conductive connection piece 321d enables connection of the corresponding electrical connection portion of the connector of the electrode lead 600 to the electrical component 200 of the medical device (e.g., P-TPG).

[0142] In other specific embodiments, the second spring clamping portion 322b1 may also be in other shapes, such as an arc-shaped block structure, as long as it can support one end of the second spring 322c, which will not be repeated here.

[0143] Specifically, when the electrical connector 320 and the connection head of the electrode wire 600 need to be in a separated state (for example, the lower shell 120 and the upper shell 110 of the main box body 100 are opened), the setting screw 322b can be adjusted by rotating the setting screw 322b so that the setting screw 322b moves away from the mounting groove 310 relative to the conductive connection block 322d, so that the lower end of the setting screw 322b (i.e., the lower end of the setting screw 322b in Figure 11) is separated from the connection head of the electrode wire 600; at this time, the second spring 322c can be in the first state, and at this time, the lower end of the second spring 322c (i.e., the lower end of the second spring 322c in Figure 11) is in contact with the upper end of the conductive connection block 322d.

[0144] When the contact probe 321b is electrically connected to the connector of the electrode wire 600 (for example, when the lower housing 120 and the upper housing 110 of the main box body 100 are closed, such as by a snap connection, screw connection, etc.), the second spring 322c is in a second state, which is a compressed state. The set screw 322b is tightened to move toward the mounting slot 310 until the set screw 322b is in close contact with the corresponding position of the connector of the electrode wire 600 and provides a certain holding force. At this time, the set screw 322b is threadedly connected to one end of the conductive connecting block 322d, and the two are electrically conductive. The other end of the conductive connecting block 322d is connected to the connecting cable of the electrical component 200, ultimately achieving electrical connection between the connector of the electrode wire 600 and the electrical component 200.

[0145] Furthermore, in some optional embodiments, the through-hole structure 322a can be provided with sealing and insulating measures at a position above the set screw 322b (as shown in the direction of FIG. 11 ), such as a sealing silicone pad with a slit. A tightening tool, such as a torque wrench, can then be used to squeeze through the slit of the silicone pad and then cooperate with the set screw 322b to rotate the set screw 322b. When the tightening tool is used to rotate the set screw 322b, the end of the tightening tool withdraws from the through-hole structure 322a, and the slit of the silicone pad is restored, thereby achieving sealing and insulating protection at the upper end of the through-hole structure 322a. The sealing silicone pad can be made of a waterproof and insulating medical dressing, which is not exemplified one by one.

[0146] Furthermore, in some exemplary embodiments, the through-hole structure 322a may be a stepped through-hole structure. Specifically, as shown in FIG11 , FIG12 , or FIG13 , the through-hole structure 322a includes a coaxial through-hole with a third radius (not shown) and a through-hole with a fourth radius (not shown). The through-hole with the third radius is adjacent to the conductive connection block 322d, and the third radius is greater than the fourth radius. Thus, a step is formed at the junction of the through-hole structure 322a and the through-hole with the fourth radius. When the set screw 322b is rotated away from the mounting slot 310, the step of the through-hole structure 322a abuts against the second spring engaging portion 322b1, thereby limiting the set screw 322b from further exiting the conductive connection block 322d along the axis of the through-hole structure 322a. This limits the set screw 322b's ability to exit the conductive connection block 322d during rotation.

[0147] It is particularly important to note that the present invention does not limit the layout positions of the electrical assembly 200 and the connection assembly 300 within the main box body 100. Taking the main box body 100 as a clamshell box body as an example, in some embodiments, the electrical assembly 200 can be positioned near the hinged side of the upper and lower housings 110 and 120, while the connection assembly 300 can be positioned relatively near the non-hinged side of the upper and lower housings 110 and 120. In other embodiments, the electrical assembly 200 can also be positioned near the non-hinged side of the upper and lower housings 110 and 120, while the connection assembly 300 can be positioned relatively near the hinged side of the upper and lower housings 110 and 120. Alternatively, other layout arrangements besides the above can be employed, which are not listed here.

[0148] [Example 4]

[0149] This embodiment provides another medical device. The basic principle of the medical device provided in this example is the same as that of the medical device provided in Examples 2 to 3. Due to space limitations, only the differences are described below. For the parts not mentioned in this embodiment, please refer to the relevant descriptions of Examples 2 to 3 for adaptive understanding. Specifically, please refer to Figure 14, which is a front view of the medical device provided in one embodiment of this embodiment. It is not difficult to see from Figure 14 that the difference between the medical device provided in this embodiment and Examples 2 to 3 is that the patch assembly provided in this embodiment includes a main patch 421 connected to the wearer's body surface and an auxiliary adhesive sheet 422.

[0150] Specifically, the main body 100 of the medical device and a portion of the electrode lead 600 are located between the main patch 421 and the auxiliary adhesive sheet 422. With this arrangement, the main patch 421 not only bonds the main body of the medical device (excluding the patch assembly) to a target location (e.g., the wearer's body surface), thereby securing the main body of the medical device; the area formed between the main patch 421 and the auxiliary adhesive sheet 422 also accommodates the electrode lead 600, thereby securing it. Optionally, the projection of the main patch 421 onto the main body 100 is located within the projection of the auxiliary adhesive sheet 422 onto the main body 100. With this configuration, the perimeter of the auxiliary adhesive sheet 422 (i.e., the portion larger than the main patch 421) contacts the wearer's body surface, thereby further assisting in securing the main body of the medical device.

[0151] Optionally, the main patch 421 is made of a breathable material, and the auxiliary adhesive sheet 422 is made of a waterproof material. Thus, the main patch 421 made of a breathable material can improve the wearing comfort of the medical device provided by the present invention; the auxiliary adhesive sheet 422 can be used to block water, thereby providing waterproof protection for the main body of the medical device.

[0152] Exemplarily, when a temporary pacemaker (P-TPG) is implemented using the medical device provided in this embodiment, the connector of the electrode lead 600 may be, but is not limited to, a standard IS-1 electrode lead connector, a temporary pacing floating electrode, and a temporary pacing electrode connection needle. Specifically, please refer to Figures 15 to 17 , wherein Figure 15 is a schematic diagram of the connection between the medical device provided in one embodiment of this embodiment and an implantable IS-1 ventricular electrode lead. As can be seen from Figure 15 , in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the IS-1 ventricular electrode lead 610 can be connected to the wearer's heart 700 for single-chamber (ventricular) temporary pacing. FIG16 is a schematic diagram illustrating the connection between a medical device provided in another embodiment of this embodiment and an implantable IS-1 ventricular electrode lead and an implantable atrial electrode lead. FIG16 illustrates that, in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the IS-1 ventricular electrode lead 610 and the IS-1 atrial electrode lead 620 can be connected to the wearer's heart 700 for temporary dual-chamber (atrium and ventricle) pacing. FIG17 is a schematic diagram illustrating the connection between a medical device provided in another embodiment of this embodiment and a conventional temporary pacing electrode lead. FIG17 illustrates that, in this embodiment, when the medical device provided by the present invention is a patch-type temporary pacemaker P-TPG, the temporary pacemaker electrode lead 630 can be connected to the wearer's heart 700 for temporary pacing.

[0153] [Example 5]

[0154] This embodiment provides another medical device. The basic principle of the medical device provided in this example is the same as that of the medical devices provided in Examples 1 to 3. Due to space limitations, only the differences are described below. For the parts not mentioned in this embodiment, please refer to the relevant descriptions of Examples 1 to 3 for adaptive understanding. Specifically, the differences from Examples 1 to 3 are as follows: as shown in Figures 18 to 20, Figure 18 is a structural schematic diagram of the upper shell and lower shell of the medical device provided in another embodiment of Example 3 of the present invention in the open state; Figure 19 is a structural schematic diagram of the main box body of the medical device shown in Figure 18 in the closed state and the anti-accidental touch protection member in the open state; Figure 20 is a structural schematic diagram of the main box body of the medical device shown in Figure 18 in the closed state and the anti-accidental touch protection member in the closed state.

[0155] The medical device also includes an adjustment assembly 240 disposed on the outer wall of the main case 100. The adjustment assembly 240 includes at least one adjustment knob 241 electrically connected to the electrical assembly 200. This configuration facilitates an operator to manually adjust medical device parameters (such as the pacing rate of a patch pacemaker) using the adjustment knob 241, etc., as appropriate. For example, the adjustment knob 241 can be a manual adjustment knob 241.

[0156] To prevent the adjustment knob 241 from being accidentally touched, the adjustment assembly 240 further includes an anti-accidental touch protection member 242. This improves the safety of the medical device. In this embodiment, the anti-accidental touch protection member 242 is specifically an independent inverted U-shaped protective plate that is mounted around the outer periphery of the adjustment knob 241 and is slidably connected to the main box body 100 to keep the adjustment knob 241 in a shielded or exposed state.

[0157] It should be noted that the anti-incorrect touch protection member 242 of the present invention may also be implemented in other ways, which is not limited here.

[0158] [Example 6]

[0159] This embodiment provides another medical device. The basic principles of the medical device provided in this example are the same as those of the medical device provided in Example 3. Due to space limitations, only the differences are described below. For parts not mentioned in this embodiment, please refer to the relevant descriptions of Example 3 for an adaptive understanding. Specifically, please refer to Figures 21, 22, and 23. Figure 21 is a schematic diagram of the overall structure of the medical device provided in this embodiment, Figure 22 is a schematic diagram of the structure of the main box body 100 of the medical device provided in this embodiment in a closed state, and Figure 23 is a schematic diagram of the structure of the main box body 100 of the medical device shown in Figure 22 in an open state. As can be readily seen from Figures 21, 22, and 23, the upper housing 110 and lower housing 120 of the main housing 100 of the medical device provided in this embodiment are slidably connected, resulting in a sliding-cover type main housing 100. The main housing 100 further comprises two locking members 130. In this embodiment, the locking members 130 are bolts; in other embodiments, the number of locking members 130 is not limited. When the upper housing 110 and the lower housing 120 are closed, the locking members 130 are used to secure the upper housing 110 and the lower housing 120. Thus, the medical device provided in this embodiment employs a sliding-cover design for the main housing 100, effectively reducing the inconvenience of opening the upper housing 110 and increasing the security of the upper and lower housings when closed. The locking members 130 further enhance the security of the main housing 100 when closed. For more detailed implementations of the sliding-cover type housing, please refer to the relevant art known to those skilled in the art, which will not be described in detail here.

[0160] [Example 7]

[0161] This embodiment provides a medical device control system, which includes a medical program-controlled device in communication connection and the medical device described in any one of the above embodiments 1 to 6.

[0162] Since the medical device control system provided in this embodiment and the medical devices provided in the above embodiments belong to the same inventive concept, the medical device control system provided in this embodiment has at least all the advantages of the medical devices provided in the above embodiments. For the beneficial effects of the medical device control system, please refer to the relevant description of the beneficial effects of the medical device, and no further details will be given here.

[0163] For example, the medical device control system provided in this embodiment can set the parameters of the medical device (for ease of description, the P-TPG is used as an example below) in the following manner:

[0164] 1) The parameters of P-TPG are fixed. The medical staff (doctor) selects the corresponding model of P-TPG according to the wearer's condition. Once the P-TPG is connected and running, it will work with fixed parameters;

[0165] 2) P-TPG parameters can be set via wireless communication (such as Bluetooth communication). After the connection is established, the doctor will set the parameters according to the wearer's condition. Once the P-TPG is connected and running, it will work with the set parameters. If the parameters need to be changed later, the doctor will also reset the parameters in the same way.

[0166] 3) When a corresponding mechanical adjustment method is added, such as adding an adjustment knob (such as a manual adjustment knob), the parameters (such as the adjustment knob) and the corresponding anti-accidental touch protection parts (such as an inverted U-shaped protection plate) can be adjusted. After the connection is run, the doctor sets the parameters according to the wearer's situation. After the P-TPG is connected and run, it works with the set parameters, and the anti-accidental touch protection parts (such as an inverted U-shaped protection plate) are used to prevent the wearer or others from accidentally touching or operating. If the parameters need to be changed later, the doctor will also open the anti-accidental touch protection parts (such as the inverted U-shaped protection plate) and reset the parameters through the adjustment knob.

[0167] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0168] In summary, compared with the prior art, the medical device and medical device control system provided by the present invention have the following beneficial effects:

[0169] The present invention provides a medical device, comprising: a main box body, an electrical component, a connecting component and a patch component; the electrical component and the connecting component are arranged in the main box body, and the main box body is provided with a first through hole for the electrode wire to pass through; the connecting component is configured to electrically connect the electrical component and the electrode wire; the patch component is configured to fix at least one of the main box body and the electrode wire to a target position (for example, when the patch component is used to fix the main box body, the target position is the body surface position of the wearer where the medical device is located). Therefore, the design method of the medical device provided by the present invention, which combines the main box body, the electrical component, the connecting component and the patch component, integrates the relevant technologies of implantable medical devices (such as implantable pacemakers) and temporary medical devices (such as traditional temporary pacemakers), so that the medical device provided by the present invention is light and compact, more convenient for the wearer to wear and not prone to infection, and thus more conducive to the wearer's recovery. Furthermore, the design of placing the electrical components and the connection components in the main box body can not only protect the electrical components and the connection components, but also facilitate the wearing of the main body of the medical device (main box body, electrical components and connection components) on the wearer through the patch component. In addition, the main body of the lightweight and compact medical device can also be worn by means of straps, braces, etc., or even placed in the wearer's pocket, so that the electrode wire can be fixed by the patch component and the wound (the target position is the wound in this case) can be cared for and protected, thereby reducing the risk of infection at the puncture site. Furthermore, the connection component of the medical device provided by the present invention can be applicable to different electrode wires (for example, the connector of the electrode wire can be a standard IS-1 electrode wire connector, a temporary pacing floating electrode connector and a temporary pacing electrode connection needle, etc.). By enhancing the scope of application of the electrode wire, it is more helpful for medical staff to adopt different rehabilitation plans according to the actual situation of the wearer (such as prevention, treatment or temporary transition using the medical device provided by the present invention).

[0170] Since the medical device control system provided by the present invention and the medical device provided by the present invention belong to the same inventive concept, the medical device control system provided by the present invention has at least all the advantages of the medical device provided by the present invention. For the beneficial effects of the medical device control system, please refer to the relevant description of the beneficial effects of the medical device, and no further details will be given here.

[0171] In summary, the above embodiments provide detailed descriptions of different configurations of medical devices and medical device control systems. Of course, the above descriptions are only descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. The present invention includes but is not limited to the configurations listed in the above embodiments. Those skilled in the art can draw inferences based on the contents of the above embodiments. Any changes or modifications made by those skilled in the art in the field of the present invention based on the above disclosures shall fall within the scope of protection of the claims.

Claims

1. A medical device, characterized in that: include: A main box body, an electrical component, a connection component and a patch component; the electrical component and the connection component are arranged in the main box body, and a first through hole for the electrode wire to pass through is opened on the main box body; The connection component is configured to electrically connect the electrical component and the electrode wire; The patch assembly is configured to fix at least one of the main box body and the electrode wire at a target position.

2. The medical device according to claim 1, characterized in that The electrical assembly comprises an electrical protection box body and an electrically connected power supply and control system circuit module; the power supply and the control system circuit module are located in a closed accommodation space formed by the electrical protection box body and the main box body; The power supply is used to provide electrical energy to the control system circuit module.

3. The medical device according to claim 2, characterized in that The electrical component also includes a connecting cable, and the control system circuit module is electrically connected to the connecting component via the connecting cable; a second through hole for the connecting cable to pass through is provided on the electrical protection box body.

4. The medical device according to claim 3, characterized in that The electrical protection box body further includes a sealing member for sealing a gap between the second through hole and the connecting cable.

5. The medical device according to claim 1, characterized in that The connection component includes at least one mounting groove and at least one electrical connector; the mounting groove is configured to place the connector of the electrode wire; the connector of the electrode wire is electrically connected to the electrical component through the electrical connector.

6. The medical device according to any one of claims 1 to 5, characterized in that: The main box body comprises an upper shell, a lower shell and a locking member, the upper shell and the lower shell are hinged so that the main box body is a flip-type main box body, or the upper shell and the lower shell are slidably connected so that the main box body is a sliding-type main box body; When the upper shell and the lower shell are closed, the upper shell and the lower shell are fixedly connected by the locking member.

7. The medical device according to claim 5, characterized in that The upper shell of the main box body is provided with a recessed accommodating portion corresponding to the electrical connector one by one, the electrical connector is partially located in the corresponding recessed accommodating portion, and the mounting groove is correspondingly provided on the lower shell of the main box body.

8. The medical device according to claim 7, characterized in that The recessed accommodation portion is a blind hole structure perpendicular to the plane where the upper shell is located; The electrical connector comprises: A contact probe, wherein a first spring clamping portion is provided on the outer periphery of the contact probe; A connecting piece fixed to the upper shell of the main box body, wherein the connecting piece and the extending direction of the contact probe have a non-zero angle, and the contact probe passes through the connecting piece; A first spring, wherein the first spring is sleeved on the contact probe and two ends of the first spring are respectively connected to the first spring clamping portion and the blind hole structure; When the electrical connector is electrically connected to the connector of the electrode wire, the contact probe is located at the first position. The first spring is in a first compression state, at which time the first spring is of a first length, a gap exists between the first spring clamping portion and the connecting sheet, and an end of the contact probe away from the blind hole structure abuts against the connecting head; When the electrical connector is separated from the connector of the electrode wire, the contact probe is located at the second position, the first spring is in the second compression state, at which time the first spring is at the second length, and the first spring clamping portion abuts against the connecting piece; The second length is greater than the first length.

9. The medical device according to claim 7, characterized in that: The recessed accommodation portion is a through-hole structure perpendicular to the plane where the upper shell is located; The electrical connector comprises: A set screw, wherein the outer periphery of the set screw is provided with a second spring clamping portion; A conductive connection block fixed to the upper shell of the main box body, wherein the conductive connection block is provided with a third through hole at a position corresponding to the through hole structure, the set screw is threadedly connected to the third through hole, and the second spring clamping portion is located on a side of the conductive connection block away from the lower shell of the main box body; A second spring, wherein the second spring is sleeved on the set screw and two ends of the second spring are respectively connected to the second spring clamping portion and the conductive connecting block; The position of the set screw relative to the conductive connection block is adjusted by rotating the set screw, so that the electrical connector is switched between two states of being electrically connected to and separated from the connector of the electrode wire.

10. The medical device according to claim 1, characterized in that It also includes a cable auxiliary fixing member arranged in the main box body.

11. The medical device according to claim 1, characterized in that Also includes: A sealing ring, which is arranged at the abutment position between the upper shell and the lower shell of the main box body; and / or; A sealing pad is used to seal the connection between the electrode wire and the first through hole, and the sealing pad includes a cross-grooved silicone pad; the connector of the electrode wire passes through the cross-grooved groove and is connected to the connecting component.

12. The medical device according to claim 1, characterized in that The patch assembly includes at least one first patch for fixing the main box body at the target position; the first patch is detachably connected to the main box body.

13. The medical device according to claim 12, characterized in that The patch assembly includes a tearable first patch, and the first patch has a fourth through hole for passing the electrode wire; Alternatively, the patch assembly includes at least two of the first patches, and the at least two of the first patches are detachably connected to the main box body to fix the main box body at the target position, and there is a gap between the at least two of the first patches for the electrode wire to pass through.

14. The medical device according to claim 1, characterized in that The patch assembly comprises a main patch and an auxiliary bonding sheet that can be connected to the target position, and the main box body and part of the electrode wire are located between the main patch and the auxiliary bonding sheet.

15. The medical device according to claim 1, characterized in that The main box body and the patch assembly are of split design, the main box body is a wearable main box body and the patch assembly includes a second patch for fixing the electrode wire at the target position.

16. The medical device according to claim 1, characterized in that The main box body includes at least two independent sub-main box bodies, the electrical components, the connecting components and part of the electrode wires are accommodated in at least two independent sub-main box bodies, and the connecting components and part of the electrode wires are located in the same sub-main box body.

17. The medical device according to claim 1, characterized in that It also includes an adjustment component arranged on the outer wall of the main box body, and the adjustment component includes at least one adjustment knob electrically connected to the electrical component.

18. A medical device control system, characterized in that: A medical programming device comprising a communication connection and a medical device as described in any one of claims 1 to 17.

Citation Information

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    CN117224842A

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Cited By

  • Medical device and medical device control system

    CN117224842A