Extracorporeal protection device for implantable medical devices

Abstract

This disclosure discloses an external protective device for an implantable medical device having an implant for insertion into the skin of the chest. The external protective device includes a restraint sleeve and a shoulder strap. The restraint sleeve is at least partially positioned below the implant and restrained externally to form a front and a rear portion located on the front and back sides of the body, respectively. The two ends of the shoulder strap are connected to the front and rear portions, respectively, and wrap around the shoulder, with the wrapping path including the implantation location of the implant. The shoulder strap is adjustable in position along the shoulder width direction within the restraint sleeve. This disclosed device restricts the movement of the implant inserted into the skin of the chest to reduce the risk of the implant becoming exposed to the skin, and has a wide range of applications and saves materials.

Description

Technical Field

[0001] This disclosure relates to the field of medical assistive device technology, and more particularly to external protective devices for implantable medical devices. Background Technology

[0002] Implantable medical devices, such as implantable cardiac electronic devices, consist of one or more electrodes and a pulse generator, performing key functions such as pacing, defibrillation, and / or cardiac resynchronization therapy. They include pacemakers, implantable defibrillators, and cardiac resynchronization therapy devices. The indications for implantable cardiac electronic devices cover a wide range of conditions, including sick sinus syndrome, bradycardia-tachycardia syndrome, third-degree atrioventricular block, ventricular tachycardia / fibrillation, and heart failure treatment, with a broad range of applications and a steadily increasing number of devices in use.

[0003] The pacemaker's pulse generator is typically implanted in the skin beneath the pectoralis major muscle, below the clavicle. However, because many pacemaker patients are elderly, their skin is thin, has little subcutaneous fat, and poor elasticity. Therefore, the pacemaker's pulse generator often protrudes slightly. Furthermore, the pulse generator is susceptible to external forces, such as involuntary touching, long-term friction from clothing, or accidental impacts, which can cause it to move and become exposed. Pacemaker exposure often leads to problems such as local infection, thin skin and soft tissue, and progressive worsening of skin ulceration, requiring aggressive surgical intervention for treatment. While the pacemaker's pulse generator is generally implanted in the left chest, some patients with specific conditions, such as previous injury, lesions, or deformities in the left chest, may have it implanted in the right chest. Therefore, protective devices are needed to protect the implant and its site within the skin of either the left or right chest.

[0004] However, some pacemaker pocket protection devices in related patented technologies use two shoulder straps, which can restrict the movement of the right chest or the pulse generator in the right chest, but wastes shoulder strap material. If a single shoulder strap is used, it cannot be applied to the two different situations mentioned above, thus limiting its applicability. Summary of the Invention

[0005] In view of the above-described disadvantages of the prior art, the purpose of this disclosure is to provide an external protective device for implantable medical devices, for restricting the movement of the implant implanted inside the skin of the chest to reduce the risk of the implant being exposed to the skin, and with a wide range of applications and material savings.

[0006] This disclosure provides an external protective device for an implantable medical device, the implantable medical device having an implant for implantation into the skin of the chest; including: a restraint sleeve for restraining the body externally, at least partially located below the implant, to form a front portion and a rear portion located on the front and back sides of the body respectively; and a shoulder strap, with both ends connected to the front portion and the rear portion respectively and passing around the shoulder, the path of which includes the implantation position of the implant, and the strap is adjustable in position along the shoulder width direction.

[0007] According to some embodiments provided in this disclosure, it further includes: a cushioning member disposed on the shoulder strap and covering the implant.

[0008] According to some embodiments provided in this disclosure, the shoulder strap has a closed interlayer cavity, and the cushioning member is disposed within the interlayer cavity.

[0009] According to some embodiments provided in this disclosure, the cushioning element is made of an elastic material, which is a sponge.

[0010] According to some embodiments provided in this disclosure, the implantable medical device is a cardiac implantable electronic device;

[0011] The restraint sleeve is configured to be restrained outside the chest and at least partially covers the implant.

[0012] According to some embodiments provided in this disclosure, both ends of the shoulder strap are provided with Velcro that is attached to different positions along the shoulder width direction of the restraint sleeve.

[0013] According to some embodiments provided in this disclosure, the circumference of the restraint sleeve is adjustable; and / or the length of the shoulder strap is adjustable.

[0014] According to some embodiments provided in this disclosure, the restraint sleeve includes: a restraint strap, the two ends of which are overlapped and detachably connected along the length of the strap, so that the restraint sleeve has different circumferences when the overlap length is different; and / or

[0015] The shoulder strap includes a front strap segment and a rear strap segment, with one end of each segment being far apart from each other and respectively connected to the front side and the rear side, and the other end of each segment being close to each other and can be overlapped and detachably connected along the length of the strap, so that the shoulder strap has different lengths when the overlap length is different.

[0016] According to some embodiments provided in this disclosure, the restraint sleeve includes: a restraint strap, one end of which has multiple rows of first fastening portions, and the other end has a first fastening portion for fastening to the first fastening portions, so that the restraint sleeve has different circumferences when fastened to different rows of the first fastening portions; and / or

[0017] The shoulder strap includes a front strap section and a rear strap section, one end of which is connected to the front side and the rear side respectively, and the other end is provided with multiple rows of second fastening parts and second fastening parts for fastening to the second fastening parts, so that the shoulder strap has different lengths when fastened to different rows of second fastening parts.

[0018] According to some embodiments provided in this disclosure, the two ends of the restraint strap are fastened to the rear side; and / or

[0019] The front strap segment is longer than the rear strap segment, so that it wraps around the shoulder and fastens to the rear strap segment. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the external protective device of an implantable medical device according to an embodiment of the present disclosure at an angle.

[0021] Figure 2 This is a schematic diagram of the external protective device of the implantable medical device according to an embodiment of the present disclosure from another angle.

[0022] Figure 3 A schematic diagram of a patient wearing the external protective device at an angle.

[0023] Figure 4 A schematic diagram from another angle showing the patient wearing the external protective device.

[0024] Figure 5 This is a schematic diagram of the restraint sleeve portion of an embodiment of the present disclosure when it is folded.

[0025] Figure 6 This is a schematic diagram of the restraint sleeve when fully extended according to an embodiment of this disclosure.

[0026] Figure 7 This is a schematic diagram of the shoulder strap exploding according to an embodiment of this disclosure.

[0027] Figure label:

[0028] 11. Restraint sleeve; 11a. Front side; 11b. Rear side; 111. First Velcro closure; 112. First fastened part; 113. First fastening part; 114. First end; 115. Second end;

[0029] 12. Shoulder strap; 121. Interlayer cavity; 122. Second Velcro; 123. Front strap section; 1231. Second fastening part; 124. Back strap section; 1241. Second fastening part;

[0030] 13. Buffer components. Detailed Implementation

[0031] The following specific examples illustrate the implementation of this disclosure. Those skilled in the art can easily understand other advantages and effects of this disclosure from the information disclosed herein. This disclosure can also be implemented or applied through other different specific embodiments, and various details in this disclosure can be modified or changed according to different viewpoints and application modules without departing from the spirit of this disclosure. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of this disclosure can be combined with each other.

[0032] The embodiments of this disclosure will now be described in detail with reference to the accompanying drawings, so that those skilled in the art to which this disclosure pertains can readily implement it. This disclosure may be embodied in many different forms and is not limited to the embodiments described herein.

[0033] In this disclosure, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic represented in connection with that embodiment or example is included in at least one embodiment or example of this disclosure. Furthermore, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in any one or a group of embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples represented in this disclosure, as well as the features of those different embodiments or examples.

[0034] Furthermore, the terms "first" and "second" are used for illustrative purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the representation of this disclosure, "a set" means two or more, unless otherwise explicitly specified.

[0035] For the purpose of clarity, devices unrelated to the description are omitted, and the same or similar components throughout the specification are given the same reference numerals.

[0036] Throughout this specification, when it is said that a device is "connected" to another device, this includes not only "direct connection" but also "indirect connection" by placing other components in between. Furthermore, when it is said that a device "comprises" a certain constituent element, unless otherwise stated otherwise, this does not exclude other constituent elements, but rather implies that other constituent elements may be included.

[0037] While the terms first, second, etc., are used in some examples herein to refer to various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, first interface and second interface, etc., are used. Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to also include the plural forms unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” indicate the presence of the stated feature, step, operation, element, module, item, kind, and / or group, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, modules, items, kinds, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition will only occur if the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0038] The technical terms used herein are for reference only to specific embodiments and are not intended to limit the scope of this disclosure. The singular form used herein includes the plural form unless the statement explicitly indicates otherwise. The word "comprising" as used in this specification means to specify a particular characteristic, region, integer, step, operation, element, and / or component, and does not exclude the presence or addition of other characteristics, regions, integers, steps, operations, elements, and / or components.

[0039] Although not explicitly defined, all terms, including technical and scientific terms used herein, shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Terms defined in commonly used dictionaries shall be further interpreted as having a meaning consistent with the relevant technical literature and the message of the present disclosure, and shall not be over-interpreted as having an ideal or overly formulaic meaning unless otherwise defined.

[0040] As described above, implantable medical devices, such as the cardiac implantable electronic device, the pacemaker, defibrillator, or other cardiac resynchronization therapy device, include electrodes and a pulse generator. The electrodes are implanted in the heart to output pulsed currents to stimulate the heart. The pulse generator is connected to the electrodes and implanted within the skin of the left or right chest to generate electrical pulse signals and transmit them to the electrodes for output. However, due to thin skin, thin subcutaneous fat, and involuntary manipulation after implantation, the pulse generator may move and become exposed, necessitating a protective device. Some pacemaker protection devices in related technologies use two shoulder straps to restrict movement of the pulse generator in or on the right side of the chest, but this wastes strap material. A single shoulder strap is unsuitable for these situations, limiting its applicability.

[0041] In view of this, the present disclosure provides an external protective device for implantable medical devices, used to restrict the movement of the implant implanted inside the skin of the chest to reduce the risk of the implant being exposed to the skin, and has a wide range of applications and saves materials. Optionally, the implant can be a pulse generator of the aforementioned cardiac implantable electronic device. However, it is understood that the implant in the embodiments of the present disclosure is not limited to this, and can also be other electronic components implanted inside the skin of the chest that have the risk of exposure.

[0042] Figure 1 This is a schematic diagram of the external protective device of an implantable medical device according to an embodiment of the present disclosure at an angle. Figure 2 This is a schematic diagram of the external protective device of an implantable medical device according to an embodiment of this disclosure from another angle. See also... Figure 1 and Figure 2 An external protective device for an implantable medical device according to an embodiment of this disclosure includes a restraint sleeve 11 and a shoulder strap 12.

[0043] The restraint sleeve 11 is provided to be at least partially located below the implant and restrained to the outside of the human body.

[0044] Figure 3 A schematic diagram of a patient wearing the external protective device at an angle. Figure 4 A schematic diagram from another angle showing the patient wearing the external protective device. From Figure 3 and Figure 4 As can be seen, when the restraint sleeve 11 is restrained outside the human body, the restraint sleeve 11 forms a front side portion 11a and a rear side portion 11b located on the front and back sides of the human body, respectively.

[0045] See Figure 3 and Figure 4The restraint sleeve 11 is configured to be worn outside the chest and at least partially covers the implant. For example, the restraint sleeve 11 may partially or completely cover the implant, thereby allowing the restraint sleeve 11 to compress the implant for better protection. Of course, it is understood that the restraint sleeve 11 of this disclosure may also be positioned completely below the implant, in which case the shoulder strap 12 can simply compress the implant.

[0046] Optionally, the circumference of the restraint sleeve 11 is adjustable. Thus, the restraint sleeve 11 can be adjusted to different circumferences to suit people of different body types. Specifically, when the restraint sleeve 11 is configured to be worn outside the chest, different circumferences of the restraint sleeve 11 can accommodate people with different chest sizes.

[0047] Figure 5 This is a schematic diagram of the restraint sleeve 11 portion being folded according to an embodiment of the present disclosure, wherein the straight line L is the crease. Figure 6 This is a schematic diagram of the restraint sleeve 11 in an embodiment of this disclosure when fully extended. (See also...) Figure 5 and Figure 6 The restraint sleeve 11 includes a restraint strap. The two ends of the restraint strap are overlapped and detachably connected along its length, so that the restraint sleeve 11 has different circumferences when the overlap length is different. Therefore, when the overlap length when the two ends of the restraint sleeve 11 are connected is relatively large, the circumference of the resulting restraint sleeve 11 is relatively small. When the overlap length when the two ends of the restraint sleeve 11 are connected is relatively small, the circumference of the resulting restraint sleeve 11 is relatively large. Thus, this embodiment of the present disclosure can adjust the circumference of the restraint sleeve 11 by adjusting the overlap length when the two ends of the restraint strap are overlapped.

[0048] Optionally, one of the first end 114 and the second end 115 of the restraint strap has multiple rows of first fastened portions 112, and the other has a first engaging portion 113 for fastening to the first fastened portions 112, so that the restraint strap 11 has different circumferences when fastened to different rows of the first fastened portions 112. Specifically, the restraint strap is elastic, and the first end 114 has first fastened portions 112 configured as first buckles. The first buckles are in multiple rows, for example, three rows, with the three rows of first buckles arranged along the length of the strap, and each row having four first buckles. The second end 115 has a first engaging portion 113 configured as a first hook for fastening to the first buckles, and a row of first hooks includes four first hooks corresponding to the four first buckles in a row. However, it is understood that the number of first buckles and first hooks is not limited to this and can be adjusted adaptively.

[0049] Optionally, see Figure 4 The two ends of the restraint strap are fastened to the rear side 11b. Therefore, the movement of the human arm in front of the body is less likely to affect the fastening of the two ends of the restraint strap, resulting in good comfort and safety.

[0050] See Figure 3 and Figure 4 The shoulder strap 12 is connected at both ends to the front portion 11a and the rear portion 11b, respectively, and wraps around the shoulder, with the wrapping path including the implantation site of the implant. In other words, when the shoulder strap 12 wraps from the front portion 11a to the rear portion 11b and passes through the patient's shoulder, or when the shoulder strap 12 wraps from the rear portion 11b to the front portion 11a and passes through the patient's shoulder, the shoulder strap 12 passes through the implantation site of the implant and presses against the implant located at the implantation site. Therefore, the shoulder strap 12 can restrict the movement of the implant and isolate the implant from the outside environment, reducing the probability that the implant will move and be exposed to the skin at the implantation site due to the patient's thin skin, thin subcutaneous fat, or involuntary manipulation, thus reducing the risk of implant exposure and protecting the implantation site. The shoulder strap 12 is adjustablely positioned on the restraint sleeve 11 along the shoulder width direction.

[0051] See Figure 3 and Figure 4 Both the front side portion 11a and the rear side portion 11b are provided with a first Velcro strap 111 arranged along the shoulder width direction.

[0052] Figure 7 This is a schematic diagram of the shoulder strap 12 when it explodes open according to an embodiment of this disclosure. Both ends of the shoulder strap 12 are provided with second hook and loop fasteners 122 for attaching to different positions of the first hook and loop fastener 111. Specifically, the first hook and loop fastener 111 layer is one of a textured hook and loop fastener and a barbed hook and loop fastener, and the second hook and loop fastener 122 is the other of a textured hook and loop fastener and a barbed hook and loop fastener. See also... Figure 4 and Figure 6 The first hook and loop fastener 111 can be a single piece, extending circumferentially along the restraint sleeve 11 and located on the outer side of the restraint sleeve 11. Alternatively, a single first hook and loop fastener 111 can be located on the inner side of the restraint sleeve 11. Or, there can be two first hook and loop fasteners 111, with one first hook and loop fastener 111 located on the outer or inner side of the front portion 11a, and the other first hook and loop fastener 111 located on the outer or inner side of the rear portion 11b.

[0053] Therefore, when the two second Velcro straps 122 at both ends of the shoulder strap 12 are attached to the first Velcro straps 111 located on the front side 11a and the rear side 11b, the shoulder strap 12 is installed on the restraint sleeve 11. Furthermore, when the two second Velcro straps 122 are attached to different positions of the first Velcro straps 111 along the shoulder width direction, the shoulder strap 12 is located at different positions along the shoulder width direction, thus making the installation position of the shoulder strap 12 along the shoulder width direction adjustable.

[0054] For example, before the shoulder strap 12 is applied to a patient, it can be attached to different sides of the restraint sleeve 11 via Velcro for different patients. For instance, in the case where the implant is placed in the left chest of a patient, the shoulder strap 12 can be attached to the left side of the restraint sleeve 11 via Velcro. Figure 3 and Figure 4 The state shown allows the shoulder strap 12 to wrap around the patient's left shoulder during actual application, compressing and isolating the implant located at the left implantation site from the outside, thereby protecting the implant and the implantation site located on the left chest.

[0055] In the case where the implant is placed in the right chest of the patient, the shoulder strap 12 can be attached to the right side of the restraint sleeve 11 with Velcro. In actual use, the shoulder strap 12 can wrap around the patient's right shoulder and compress and isolate the implant located at the right implantation site from the outside, thereby protecting the implant and the implantation site located in the right chest.

[0056] Therefore, the shoulder strap 12 of this embodiment can achieve a similar effect of "being able to be modified laterally", which can adapt to different situations where the implant is implanted in the left and right breasts, has a wide range of adaptability, and saves shoulder strap material.

[0057] Optionally, see Figure 4 and Figure 7 The length of the shoulder strap 12 is adjustable. For people of different heights and builds, the distance from the shoulder to the chest varies, thus requiring different shoulder strap lengths. Therefore, to accommodate people of different body types, the shoulder strap 12 of this disclosure can be adjusted to different lengths.

[0058] Optionally, the shoulder strap 12 includes a front strap segment 123 and a rear strap segment 124. One end of the front strap segment 123 and the rear strap segment 124 are far apart from each other, and each of the far apart ends is provided with the second Velcro 122 to connect to the front side portion 11a and the rear side portion 11b respectively through the second Velcro 122. The other ends of the front strap segment 123 and the rear strap segment 124 are close to each other and can overlap and be detachably connected along the strap length direction, so that the shoulder strap 12 has different lengths when the overlap length is different.

[0059] For example, the front strap segment 123 and the rear strap segment 124 are respectively provided with multiple rows of second fastening portions 1231 and second fastening portions 1241 for fastening to the second fastening portions 1231 at their respective close ends, so that when fastened to different rows of the second fastening portions 1231, the front strap segment 123 and the rear strap segment 124 overlap by different lengths, thereby making the shoulder strap 12 have different lengths.

[0060] Specifically, the second fastened portion 1231 is a second buckle. The front belt segment 123 has three rows of second buckles near the end of the rear belt segment 124, with three second buckles in each row. The rear belt segment 124 has a row of second hooks near the end of the front belt segment 123, with each row of second hooks including three hooks corresponding to the three second buckles in that row. However, it is understood that the number of second buckles and second hooks is not limited to this and can be adjusted adaptively.

[0061] Optionally, see Figure 4 and Figure 7 The front strap segment 123 is longer than the rear strap segment 124, so that it wraps around the shoulder and fastens to the rear strap segment 124. Thus, the front strap segment 123 and the rear strap segment 124 are fastened at the back of the body. Therefore, the movement of the body's arm at the front of the body is less likely to affect the fastening of the shoulder strap 12, resulting in good comfort and safety.

[0062] Optionally, see Figure 3The external protective device of the implantable medical device also includes a buffer 13. The buffer 13 is disposed on the shoulder strap 12 and covers the implant. Specifically, the size and shape of the buffer 13 can be adaptively adjusted according to the shape and size of the implant to ensure that the buffer 13 can completely cover the implant. The buffer 13 can cushion the impact of external force on the implantation site, such as when a person with intellectual disabilities involuntarily touches the implantation site or when someone else's arm accidentally bumps into it, reducing the impact of external contact force on the implantation site. At the same time, for patients, especially elderly patients whose implants are slightly protruding into thin skin, the buffer 13 can also resist friction from clothing, preventing clothing from repeatedly rubbing against the implantation site, thereby reducing the risk of the implant being exposed to the skin.

[0063] Optionally, the shoulder strap 12 has a closed interlayer cavity 121, and the cushioning member 13 is disposed within the interlayer cavity 121. Thus, the shoulder strap 12 can protect the cushioning member 13 located inside it, and is not easily dislodged from the shoulder strap 12 due to external contact forces or clothing friction, providing good fixation.

[0064] Optionally, the buffer 13 is made of an elastic material, so that when subjected to external contact or friction, the buffer 13 is elastically compressed and absorbs the external force, thereby reducing the impact of the external force on the implant and the implantation site. Specifically, the elastic material is sponge, which has good elasticity and low cost. Of course, it is understood that the elastic material is not limited to this, and may also be other elastic materials, such as latex.

[0065] In summary, the external protection device of this disclosure provides patients with implantable medical devices, especially traditional cardiac implantable electronic devices, with a non-invasive option to reduce skin abrasion and exposure at the implantation site. It has many advantages such as convenience, simple operation, high cost-effectiveness, and high compliance with medical practice by avoiding reoperation. It has excellent practical value and application promotion value.

[0066] The above embodiments are merely illustrative of the principles and effects of this disclosure and are not intended to limit this disclosure. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this disclosure. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this disclosure should still be covered by the protection scope of this disclosure.

Claims

1. An external protective device for an implantable medical device, characterized in that, The implantable medical device has an implant for insertion into the skin of the chest; including: A restraint sleeve, at least partially located below the implant, is used to restrain the body externally to form a front and rear portion located on the front and back sides of the body, respectively. The shoulder strap is connected at both ends to the front and rear sides respectively and passes around the shoulder. The path of the strap includes the implantation position of the implant and is adjustable in position along the shoulder width direction on the restraint sleeve.

2. The external protective device for the implantable medical device according to claim 1, characterized in that, Also includes: A cushioning element is provided on the shoulder strap and covers the implant.

3. The external protection device for the implantable medical device according to claim 2, characterized in that, The shoulder strap has a closed interlayer cavity, and the cushioning element is located inside the interlayer cavity.

4. The external protection device for the implantable medical device according to claim 2, characterized in that, The cushioning element is made of an elastic material, which is a sponge.

5. The external protective device for the implantable medical device according to claim 1, characterized in that, The implantable medical device is a cardiac implantable electronic device; The restraint sleeve is configured to be restrained outside the chest and at least partially covers the implant.

6. The external protection device for the implantable medical device according to claim 1, characterized in that, Both ends of the shoulder strap are provided with Velcro that attaches to different positions along the shoulder width direction of the restraint sleeve.

7. The external protective device for the implantable medical device according to claim 1, characterized in that, The circumference of the restraint sleeve is adjustable; and / or the length of the shoulder strap is adjustable.

8. The external protective device for the implantable medical device according to claim 1, characterized in that, The restraint sleeve includes: a restraint strap, the two ends of which are overlapped and detachably connected along the length of the strap, so that the restraint sleeve has different circumferences when the overlap length is different; and / or The shoulder strap includes a front strap segment and a rear strap segment, with one end of each segment being far apart from each other and respectively connected to the front side and the rear side, and the other end of each segment being close to each other and can be overlapped and detachably connected along the length of the strap, so that the shoulder strap has different lengths when the overlap length is different.

9. The external protective device for the implantable medical device according to claim 1, characterized in that, The restraint sleeve includes: a restraint strap, one end of which has multiple rows of first fastening portions, and the other end has a first fastening portion for fastening to the first fastening portions, so that the restraint sleeve has different circumferences when fastened to different rows of the first fastening portions; and / or The shoulder strap includes a front strap section and a rear strap section, one end of which is connected to the front side and the rear side respectively, and the other end is provided with multiple rows of second fastening parts and second fastening parts for fastening to the second fastening parts, so that the shoulder strap has different lengths when fastened to different rows of second fastening parts.

10. The external protective device for the implantable medical device according to claim 9, characterized in that, The two ends of the restraint strap are fastened to the rear side; and / or The front strap segment is longer than the rear strap segment, so that it wraps around the shoulder and fastens to the rear strap segment.

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